Developing a Standard Set of Patient-Centred Outcomes for Inflammatory Bowel Disease-an International, Cross-disciplinary Consensus.

PubMed

Kim, Andrew H; Roberts, Charlotte; Feagan, Brian G; Banerjee, Rupa; Bemelman, Willem; Bodger, Keith; Derieppe, Marc; Dignass, Axel; Driscoll, Richard; Fitzpatrick, Ray; Gaarentstroom-Lunt, Janette; Higgins, Peter D; Kotze, Paulo Gustavo; Meissner, Jillian; O'Connor, Marian; Ran, Zhi-Hua; Siegel, Corey A; Terry, Helen; van Deen, Welmoed K; van der Woude, C Janneke; Weaver, Alandra; Yang, Suk-Kyun; Sands, Bruce E; Vermeire, Séverine; Travis, Simon Pl

2018-03-28

Success in delivering value-based healthcare involves measuring outcomes that matter most to patients. Our aim was to develop a minimum Standard Set of patient-centred outcome measures for inflammatory bowel disease [IBD], for use in different healthcare settings. An international working group [n = 25] representing patients, patient associations, gastroenterologists, surgeons, specialist nurses, IBD registries and patient-reported outcome measure [PROM] methodologists participated in a series of teleconferences incorporating a modified Delphi process. Systematic review of existing literature, registry data, patient focus groups and open review periods were used to reach consensus on a minimum set of standard outcome measures and risk adjustment variables. Similar methodology has been used in 21 other disease areas [www.ichom.org]. A minimum Standard Set of outcomes was developed for patients [aged ≥16] with IBD. Outcome domains included survival and disease control [survival, disease activity/remission, colorectal cancer, anaemia], disutility of care [treatment-related complications], healthcare utilization [IBD-related admissions, emergency room visits] and patient-reported outcomes [including quality of life, nutritional status and impact of fistulae] measured at baseline and at 6 or 12 month intervals. A single PROM [IBD-Control questionnaire] was recommended in the Standard Set and minimum risk adjustment data collected at baseline and annually were included: demographics, basic clinical information and treatment factors. A Standard Set of outcome measures for IBD has been developed based on evidence, patient input and specialist consensus. It provides an international template for meaningful, comparable and easy-to-interpret measures as a step towards achieving value-based healthcare in IBD.

Progress on core outcome sets for critical care research.

PubMed

Blackwood, Bronagh; Marshall, John; Rose, Louise

2015-10-01

Appropriate selection and definition of outcome measures are essential for clinical trials to be maximally informative. Core outcome sets (an agreed, standardized collection of outcomes measured and reported in all trials for a specific clinical area) were developed due to established inconsistencies in trial outcome selection. This review discusses the rationale for, and methods of, core outcome set development, as well as current initiatives in critical care. Recent systematic reviews of reported outcomes and measurement instruments relevant to the critically ill highlight inconsistencies in outcome selection, definition, and measurement, thus establishing the need for core outcome sets. Current critical care initiatives include development of core outcome sets for trials aimed at reducing mechanical ventilation duration; rehabilitation following critical illness; long-term outcomes in acute respiratory failure; and epidemic and pandemic studies of severe acute respiratory infection. Development and utilization of core outcome sets for studies relevant to the critically ill is in its infancy compared to other specialties. Notwithstanding, core outcome set development frameworks and guidelines are available, several sets are in various stages of development, and there is strong support from international investigator-led collaborations including the International Forum for Acute Care Trialists.

Defining Outcome Measures for Psoriasis: The IDEOM Report from the GRAPPA 2016 Annual Meeting.

PubMed

Callis Duffin, Kristina; Gottlieb, Alice B; Merola, Joseph F; Latella, John; Garg, Amit; Armstrong, April W

2017-05-01

The International Dermatology Outcome Measures (IDEOM) psoriasis working group was established to develop core domains and measurements sets for psoriasis clinical trials and ultimately clinical practice. At the 2016 annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis, the IDEOM psoriasis group presented an overview of its progress toward developing this psoriasis core domain set. First, it summarized the February 2016 meeting of all involved with the IDEOM, highlighting patient and payer perspectives on outcome measures. Second, the group presented an overview of the consensus process for developing the core domain set for psoriasis, including previous literature reviews, nominal group exercises, and meeting discussions. Future plans include the development of working groups to review candidate measures for at least 2 of the domains, including primary pathophysiologic manifestations and patient-reported outcomes, and Delphi surveys to gain consensus on the final psoriasis core domain set.

Measurement properties of outcome measures for vitiligo. A systematic review.

PubMed

Vrijman, Charlotte; Linthorst Homan, May W; Limpens, Jacqueline; van der Veen, Wietze; Wolkerstorfer, Albert; Terwee, Caroline B; Spuls, Phyllis I

2012-11-01

OBJECTIVE To summarize and critically appraise the evidence on the measurement properties of clinician-, patient-, and observer-reported outcomes, measuring any construct of interest in patients with all types of vitiligo. DATA SOURCES Electronic databases including PubMed (1948 to July 2011), OVID EMBASE (1980 to July 2011), and CINAHL (EBSCOhost) (1982 to July 2011) were searched. STUDY SELECTION Two authors independently screened all records for eligibility. For inclusion, the study population had to include patients with vitiligo, for which outcome measures were developed or evaluated on their measurement properties. The initial search retrieved 1249 records, of which 14 articles met the inclusion criteria. DATA EXTRACTION Characteristics of the included instruments, study population, and results of the measurement properties were extracted. The Consensus-Based Standards for the Selection of Health Status Measurement Instruments (COSMIN) 4-point checklist, combined with quality criteria for measurement properties, was used to calculate the overall level of evidence per measurement property of each instrument. Independent extraction and assessment was performed by 2 authors. DATA SYNTHESIS Eleven different measurement instruments were identified. Strong evidence was found for a positive internal consistency of the Dermatology Life Quality Index. For other instruments, the evidence of measurement properties was limited or unknown. CONCLUSIONS Recommendations on the use of specific outcome measures for vitiligo should be formulated with caution because current evidence is insufficient owing to a low number of studies with poor methodological quality and unclear clinical relevance. To recommend outcome measures for vitiligo, further research on measurement properties of clinical relevant outcome measures for vitiligo according to COSMIN quality criteria is needed.

Towards global consensus on outcome measures for atopic eczema research: results of the HOME II meeting.

PubMed

Schmitt, Jochen; Spuls, Phyllis; Boers, Maarten; Thomas, Kim; Chalmers, Joanne; Roekevisch, Evelien; Schram, Mandy; Allsopp, Richard; Aoki, Valeria; Apfelbacher, Christian; Bruijnzeel-Koomen, Carla; Bruin-Weller, Marjolein; Charman, Carolyn; Cohen, Arnon; Dohil, Magdalene; Flohr, Carsten; Furue, Masutaka; Gieler, Uwe; Hooft, Lotty; Humphreys, Rosemary; Ishii, Henrique Akira; Katayama, Ichiro; Kouwenhoven, Willem; Langan, Sinéad; Lewis-Jones, Sue; Merhand, Stephanie; Murota, Hiroyuki; Murrell, Dedee F; Nankervis, Helen; Ohya, Yukihiro; Oranje, Arnold; Otsuka, Hiromi; Paul, Carle; Rosenbluth, Yael; Saeki, Hidehisa; Schuttelaar, Marie-Louise; Stalder, Jean-Francois; Svensson, Ake; Takaoka, Roberto; Wahlgren, Carl-Fredrik; Weidinger, Stephan; Wollenberg, Andreas; Williams, Hywel

2012-09-01

The use of nonstandardized and inadequately validated outcome measures in atopic eczema trials is a major obstacle to practising evidence-based dermatology. The Harmonising Outcome Measures for Eczema (HOME) initiative is an international multiprofessional group dedicated to atopic eczema outcomes research. In June 2011, the HOME initiative conducted a consensus study involving 43 individuals from 10 countries, representing different stakeholders (patients, clinicians, methodologists, pharmaceutical industry) to determine core outcome domains for atopic eczema trials, to define quality criteria for atopic eczema outcome measures and to prioritize topics for atopic eczema outcomes research. Delegates were given evidence-based information, followed by structured group discussion and anonymous consensus voting. Consensus was achieved to include clinical signs, symptoms, long-term control of flares and quality of life into the core set of outcome domains for atopic eczema trials. The HOME initiative strongly recommends including and reporting these core outcome domains as primary or secondary endpoints in all future atopic eczema trials. Measures of these core outcome domains need to be valid, sensitive to change and feasible. Prioritized topics of the HOME initiative are the identification/development of the most appropriate instruments for the four core outcome domains. HOME is open to anyone with an interest in atopic eczema outcomes research. © 2012 John Wiley & Sons A/S.

Health-related quality of life, satisfaction, and economic outcome measures in studies of prostate cancer screening and treatment, 1990-2000.

PubMed

McNaughton-Collins, Mary; Walker-Corkery, Elizabeth; Barry, Michael J

2004-01-01

Prostate cancer outcomes research incorporates a broad spectrum of endpoints, from clinical or intermediate endpoints, such as tumor shrinkage or patient compliance, to final endpoints, such as survival or disease-free survival. Three types of nontraditional endpoints that are of growing interest-health-related quality of life (QOL), satisfaction with care, and economic cost impact-hold the promise of improving our ability to understand the full burden of prostate cancer screening and treatment. In this article we review the last decade's published literature regarding the health-related QOL, satisfaction, and economic outcomes of prostate cancer screening and treatment to determine the "state of the science" of outcomes measurement. The focus is the enumeration of the types of outcome measurement used in the studies not the determination of the results of the studies. Studies were identified by searching Medline (1990-2000). Articles were included if they presented original data on any patient-centered outcome (including costs or survival alone) for men screened and treated for prostate cancer. Review papers were excluded unless they were quantitative syntheses of the results of other primary studies. Economic and decision analytic papers were included if they presented information on outcomes of real or hypothetical patient cohorts. Each retrieved article was reviewed by one of the authors. Included papers were assigned one primary, mutually exclusive study design. For the "primary data" studies, information was abstracted on care setting, dates of the study, sample size, racial distribution, age, tumor differentiation, tumor stage, survival, statistical power, and types of outcomes measures (QOL-generic, QOL-cancer specific, QOL-prostate cancer specific, satisfaction, costs, utilities, and other). For the "economic and decision analytic" papers, information was abstracted on stage of disease, age range, outcomes, costs, and whether utilities were measured. Of the 198 included papers, there were 161 primary data papers categorized as follows: randomized trial (n = 28), nonrandomized trial (n = 13), prospective or retrospective cohort study (n = 55), case-control study (n = 0), cross-sectional study (n = 63), and meta-analysis (n = 2). The remaining 37 papers were economic and decision analytic papers. Among the 149 primary data papers that contained patient outcome data, there were 42 standard instruments used, accounting for 44% (179 of 410) of the measures overall. Almost three-quarters (71%) of papers included one, two, or three outcomes measures of all types (standard and nonstandard); three papers included seven outcomes measures, and one paper included nine. Over the 11-year time period, there was a nonstatistically significant trend toward more frequent use of standardized QOL instruments and a statistically significant trend toward increased reporting of race (P = .003). Standardization of measurement of health-related QOL, satisfaction with care, and economic cost effect among men screened and treated for prostate cancer is needed. A core set of similar questions, both generic and disease-specific, should ideally be asked in every study, although investigators should be encouraged to include additional question sets as appropriate to individual studies to get a more complete picture of how patients screened and treated for this condition are doing over time.

Health-related quality-of-life outcome measures in paediatric palliative care: A systematic review of psychometric properties and feasibility of use

PubMed Central

Coombes, Lucy H; Wiseman, Theresa; Lucas, Grace; Sangha, Amrit; Murtagh, Fliss EM

2016-01-01

Background: The number of children worldwide requiring palliative care services is increasing due to advances in medical care and technology. The use of outcome measures is important to improve the quality and effectiveness of care. Aim: To systematically identify health-related quality-of-life outcome measures that could be used in paediatric palliative care and examine their feasibility of use and psychometric properties. Design: A systematic literature review and analysis of psychometric properties. Data sources: PsychInfo, Medline and EMBASE were searched from 1 January 1990 to 10 December 2014. Hand searches of the reference list of included studies and relevant reviews were also performed. Results: From 3460 articles, 125 papers were selected for full-text assessment. A total of 41 articles met the eligibility criteria and examined the psychometric properties of 22 health-related quality-of-life measures. Evidence was limited as at least half of the information on psychometric properties per instrument was missing. Measurement error was not analysed in any of the included articles and responsiveness was only analysed in one study. The methodological quality of included studies varied greatly. Conclusion: There is currently no ‘ideal’ outcome assessment measure for use in paediatric palliative care. The domains of generic health-related quality-of-life measures are not relevant to all children receiving palliative care and some domains within disease-specific measures are only relevant for that specific population. Potential solutions include adapting an existing measure or developing more individualized patient-centred outcome and experience measures. Either way, it is important to continue work on outcome measurement in this field. PMID:27247087

Application of WHO recommendations in outcome assessment of clinical series published in hand surgery journals with five years interval.

PubMed

Alarab, H; Dubert, T

2015-02-01

Outcome measurement is becoming increasingly important in hand surgery. The International classification of functioning, disability and health (ICF), is a WHO multi-dimensional approach to health condition including three domains: body "functions and structures", activities and participation. The aim of this study was to measure how often these three ICF domains were included in outcome measurements of the clinical series published in the American, European and French hand surgery journals. Our study included clinical series published in 2007 and 2012 in the American Journal Of Hand Surgery, European Journal Of Hand Surgery and Chirurgie de la Main. Analysis of each of these publications was done in two steps. First, we checked the presence or absence of the three domains of ICF in outcome measurement without considering the way it was measured. Then, we reported the use of evaluation instruments and/or quantitative measurement for each domain. We included 54 series in 2007 and 119 in 2012. The number of series reporting on the three domains and using at least one quantitative measurement for each domain represents 6% of articles in 2007 and 10% in 2012. This study shows that the quality of outcome measurement has improved over these 5 years, but remains poor according to the ICF recommendation. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

Measuring Outcomes for Young Children and Their Families. Outcome Indicators for Everyday Kids, Everyday Lives: A Vision for Pennsylvania's Children

ERIC Educational Resources Information Center

Trivette, Carol M.; Dunst, Carl J.

2011-01-01

This monograph includes the final report for a project funded by the Pennsylvania Developmental Disabilities Council for "Measuring Outcomes for Children" (2008 RFP). The goal of the project was to "develop and demonstrate the effectiveness of an instrument designed to measure life outcomes of children with disabilities being…

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.

How is the sustainability of chronic disease health programmes empirically measured in hospital and related healthcare services?—a scoping review

PubMed Central

Francis, Linda; Dunt, David; Cadilhac, Dominique A

2016-01-01

Objectives Programmes to address chronic disease are a focus of governments worldwide. Despite growth in ‘implementation science’, there is a paucity of knowledge regarding the best means to measure sustainability. The aim of this review was to summarise current practice for measuring sustainability outcomes of chronic disease health programmes, providing guidance for programme planners and future directions for the academic field. Settings A scoping review of the literature spanning 1985–2015 was conducted using MEDLINE, CINAHL, PsychINFO and The Cochrane Library limited to English language and adults. Main search terms included chronic disease, acute care, sustainability, institutionalisation and health planning. A descriptive synthesis was required. Settings included primary care, hospitals, mental health centres and community health. Participants Programmes included preventing or managing chronic conditions including diabetes, heart disease, depression, respiratory disease, cancer, obesity, dental hygiene and multiple chronic diseases. Primary and secondary outcome measures Outcome measures included clarifying a sustainability definition, types of methodologies used, timelines for assessment, criteria levels to determine outcomes and how methodology varies between intervention types. Results Among 153 abstracts retrieved, 87 were retained for full article review and 42 included in the qualitative synthesis. Five definitions for sustainability outcome were identified with ‘maintenance of programme activities’ most frequent. Achieving sustainability was dependent on inter-relationships between various organisational and social contexts supporting a broad scale approach to evaluation. An increasing trend in use of mixed methods designs over multiple time points to determine sustainability outcomes was found. Conclusions Despite the importance and investment in chronic disease programmes, few studies are undertaken to measure sustainability. Methods to evaluate sustainability are diverse with some emerging patterns in measurement found. Use of mixed methods approaches over multiple time points may serve to better guide measurement of sustainability. Consensus on aspects of standardised measurement would promote the future possibility of meta-analytic syntheses. PMID:27246000

How to Measure Outcomes of Peripheral Nerve Surgery

PubMed Central

Wang, Yirong; Sunitha, Malay; Chung, Kevin C.

2013-01-01

Synopsis Evaluation of outcomes after peripheral nerve surgeries include a number of assessment methods that reflect different aspects of recovery, including reinnervation, tactile gnosis, integrated sensory and motor function, pain and discomfort, neurophysiological and patient- reported outcomes. This review makes a list of measurements addressing these aspects as well as advantage and disadvantage of each tool. Because of complexities of neurophysiology, assessment remains a difficult process, which requires researchers focus on measurements best relevant to specific conditions and research questions. PMID:23895715

How to measure outcomes of peripheral nerve surgery.

PubMed

Wang, Yirong; Sunitha, Malay; Chung, Kevin C

2013-08-01

Evaluation of outcomes after peripheral nerve surgeries include several assessment methods that reflect different aspects of recovery, including reinnervation, tactile gnosis, integrated sensory and motor function, pain and discomfort, and neurophysiologic and patient-reported outcomes. This review lists measurements addressing these aspects as well as the advantages and disadvantages of each tool. Because of complexities of neurophysiology, assessment remains a difficult process, which requires researchers to focus on measurements best relevant to specific conditions and research questions. Copyright © 2013 Elsevier Inc. All rights reserved.

Systematic Review of Treatment Outcome Measures for Vulvodynia.

PubMed

Sadownik, Leslie A; Yong, Paul J; Smith, Kelly B

2018-07-01

To systematically evaluate the literature regarding vulvodynia treatment outcome measures. A systematic literature search on OVID, PubMed, and PsycINFO databases was conducted from inception until May 2016. Studies were included/excluded based on prespecified criteria. Reported outcome measures were organized into 6 core outcome domains recommended by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT): pain; physical functioning, emotional functioning, participant ratings of global improvement and satisfaction with treatment, symptoms and adverse events, and participant disposition. Of the 206 articles identified for full-text screening, 33 met our criteria. One study adhered to all IMMPACT recommendations. The number of outcomes measured per study ranged from 1 to greater than 20. Patient-reported pain outcomes were found in the majority (27/33; 82%) of studies. Pain severity with intercourse was reported by 24 (73%) of 33 studies-9 different scales were used to measure this outcome. Clinician-reported outcomes were present in 14 (42%) of 33 studies. Methods of measuring vestibular sensitivity by "cotton swab" test were different in 8 of 10 studies. Other domains reported included; physical function (8/33 studies; 24%), sexual function (23/33 studies; 70%), and emotional function (13/33 studies; 39%). Symptoms and adverse events were reported by 15 (45%) of 33 studies. One study formally reported participant disposition using all the information recommended by CONSORT. Comparison of clinical trial results in vulvodynia is not possible because of a lack of standard treatment outcome measures. Vulvodynia researchers should apply the IMMPACT criteria to guide the development of a minimum core set of standard outcome measures that measure holistic health.

Outcome Evaluation: Student Development Program, Special Studies Division, Cleveland State University.

ERIC Educational Resources Information Center

Pasch, Marvin

Techniques and procedures used to evaluate the outcomes of the student development program, and to use the evaluation results, are presented. Specific evaluation questions are posed that address overall outcomes, not individual student outcomes, and quantitative measures are suggested to accompany the questions. The measures include statistical…

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…

Literature review of outcome parameters used in studies of Geriatric Fracture Centers.

PubMed

Liem, I S L; Kammerlander, C; Suhm, N; Kates, S L; Blauth, M

2014-02-01

A variety of multidisciplinary treatment models have been described to improve outcome after osteoporotic hip fractures. There is a tendency toward better outcomes after implementation of the most sophisticated model with a shared leadership for orthopedic surgeons and geriatricians; the Geriatric Fracture Center. The purpose of this review is to evaluate the use of outcome parameters in published literature on the Geriatric Fracture Center evaluation studies. A literature search was performed using Medline and the Cochrane Library to identify Geriatric Fracture Center evaluation studies. The outcome parameters used in the included studies were evaluated. A total of 16 outcome parameters were used in 11 studies to evaluate patient outcome in 8 different Geriatric Fracture Centers. Two of these outcome parameters are patient-reported outcome measures and 14 outcome parameters were objective measures. In-hospital mortality, length of stay, time to surgery, place of residence and complication rate are the most frequently used outcome parameters. The patient-reported outcomes included activities of daily living and mobility scores. There is a need for generally agreed upon outcome measures to facilitate comparison of different care models.

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 database: CRD42017056610.

Systematic review of mental health and well-being outcomes following community-based obesity prevention interventions among adolescents.

PubMed

Hoare, Erin; Fuller-Tyszkiewicz, Matthew; Skouteris, Helen; Millar, Lynne; Nichols, Melanie; Allender, Steven

2015-01-05

This paper aimed to systematically evaluate the mental health and well-being outcomes observed in previous community-based obesity prevention interventions in adolescent populations. Systematic review of literature from database inception to October 2014. Articles were sourced from CINAHL, Global Health, Health Source: Nursing and Academic Edition, MEDLINE, PsycARTICLES and PsycINFO, all of which were accessed through EBSCOhost. The Cochrane Database was also searched to identify all eligible articles. PRISMA guidelines were followed and search terms and search strategy ensured all possible studies were identified for review. Intervention studies were eligible for inclusion if they were: focused on overweight or obesity prevention, community-based, targeted adolescents (aged 10-19 years), reported a mental health or well-being measure, and included a comparison or control group. Studies that focused on specific adolescent groups or were treatment interventions were excluded from review. Quality of evidence was assessed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) guidelines. Primary outcomes were measures of mental health and well-being, including diagnostic and symptomatic measures. Secondary outcomes included adiposity or weight-related measures. Seven studies met the inclusion criteria; one reported anxiety/depressive outcomes, two reported on self-perception well-being measures such as self-esteem and self-efficacy, and four studies reported outcomes of quality of life. Positive mental health outcomes demonstrated that following obesity prevention, interventions included a decrease in anxiety and improved health-related quality of life. Quality of evidence was graded as very low. Although positive outcomes for mental health and well-being do exist, controlled evaluations of community-based obesity prevention interventions have not often included mental health measures (n=7). It is recommended that future interventions incorporate mental health and well-being measures to identify any potential mechanisms influencing adolescent weight-related outcomes, and equally to ensure interventions are not causing harm to adolescent mental health. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Radiographic Measurement of Displacement in Acetabular Fractures: A Systematic Review of the Literature.

PubMed

Dodd, Andrew; Osterhoff, Georg; Guy, Pierre; Lefaivre, Kelly A

2016-06-01

To report methods of measurement of radiographic displacement and radiographic outcomes in acetabular fractures described in the literature. A systematic review of the English literature was performed using EMBASE and Medline in August 2014. Inclusion criteria were studies of operatively treated acetabular fractures in adults with acute (<6 weeks) open reduction and internal fixation that reported radiographic outcomes. Exclusion criteria included case series with <10 patients, fractures managed >6 weeks from injury, acute total hip arthroplasty, periprosthetic fractures, time frame of radiographic outcomes not stated, missing radiographic outcome data, and non-English language articles. Basic information collected included journal, author, year published, number of fractures, and fracture types. Specific data collected included radiographic outcome data, method of measuring radiographic displacement, and methods of interpreting or categorizing radiographic outcomes. The number of reproducible radiographic measurement techniques (2/64) and previously described radiographic interpretation methods (4) were recorded. One radiographic reduction grading criterion (Matta) was used nearly universally in articles that used previously described criteria. Overall, 70% of articles using this criteria documented anatomic reductions. The current standard of measuring radiographic displacement in publications dealing with acetabulum fractures almost universally lacks basic description, making further scientific rigor, such as testing reproducibility, impossible. Further work is necessary to standardize radiographic measurement techniques, test their reproducibility, and qualify their validity or determine which measurements are important to clinical outcomes. Diagnostic Level IV. See Instructions for Authors for a complete description of levels of evidence.

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

Geographic access to mammography and its relationship to breast cancer screening and stage at diagnosis: a systematic review

PubMed Central

Khan-Gates, Jenna A.; Ersek, Jennifer L.; Eberth, Jan M.; Adams, Swann A.; Pruitt, Sandi

2016-01-01

Introduction A review was conducted to summarize the current evidence and gaps in the literature on geographic access to mammography and its relationship to breast cancer-related outcomes. Methods Ovid Medline and PubMed were searched for articles published between January 1, 2000 and April 1, 2013 using Medical Subject Headings and key terms representing geographic accessibility and breast cancer-related outcomes. Due to a paucity of breast cancer treatment and mortality outcomes meeting the criteria (N=6), outcomes were restricted to breast cancer screening and stage at diagnosis. Studies included one or more of the following types of geographic accessibility measures: capacity, density, distance and travel time. Study findings were grouped by outcome and type of geographic measure. Results Twenty-one articles met inclusion criteria. Fourteen articles included stage at diagnosis as an outcome, five included mammography utilization, and two included both. Geographic measures of mammography accessibility varied widely across studies. Findings also varied, but most articles found either increased geographic access to mammography associated with increased utilization and decreased late-stage at diagnosis or no statistically significant association. Conclusion The gaps and methodologic heterogeneity in the literature to date limit definitive conclusions about an underlying association between geographic mammography access and breast cancer-related outcomes. Future studies should focus on the development and application of more precise and consistent measures of geographic access to mammography. PMID:26219677

A taxonomy has been developed for outcomes in medical research to help improve knowledge discovery.

PubMed

Dodd, Susanna; Clarke, Mike; Becker, Lorne; Mavergames, Chris; Fish, Rebecca; Williamson, Paula R

2018-04-01

There is increasing recognition that insufficient attention has been paid to the choice of outcomes measured in clinical trials. The lack of a standardized outcome classification system results in inconsistencies due to ambiguity and variation in how outcomes are described across different studies. Being able to classify by outcome would increase efficiency in searching sources such as clinical trial registries, patient registries, the Cochrane Database of Systematic Reviews, and the Core Outcome Measures in Effectiveness Trials (COMET) database of core outcome sets (COS), thus aiding knowledge discovery. A literature review was carried out to determine existing outcome classification systems, none of which were sufficiently comprehensive or granular for classification of all potential outcomes from clinical trials. A new taxonomy for outcome classification was developed, and as proof of principle, outcomes extracted from all published COS in the COMET database, selected Cochrane reviews, and clinical trial registry entries were classified using this new system. Application of this new taxonomy to COS in the COMET database revealed that 274/299 (92%) COS include at least one physiological outcome, whereas only 177 (59%) include at least one measure of impact (global quality of life or some measure of functioning) and only 105 (35%) made reference to adverse events. This outcome taxonomy will be used to annotate outcomes included in COS within the COMET database and is currently being piloted for use in Cochrane Reviews within the Cochrane Linked Data Project. Wider implementation of this standard taxonomy in trial and systematic review databases and registries will further promote efficient searching, reporting, and classification of trial outcomes. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

The effectiveness of virtual reality interventions in improving balance in adults with impaired balance compared to standard or no treatment: A systematic review.

PubMed

Booth, Vicky; Masud, Tahir; Bath-Hextall, Fiona

Balance impairment can result in falls and reduced activities of daily living and function. Virtual reality and interactive gaming systems provide a novel and potentially environmentally flexible treatment option to improve postural stability and reduce falls in balance impaired populations. There are no existing systematic reviews in this topic area. To search, critically appraise and synthesise the best available evidence on whether virtual reality interventions, including interactive gaming systems, are effective at improving balance in adults with impaired balance. Adults with impaired, altered or reduced balance identified either through reduced balance outcome measure score or increased risk or incidence of falls.Types of interventions:Any virtual reality or interactive gaming systems used within a rehabilitative setting.The primary outcome was an objective measure of balance (i.e. balance outcome measure such as Berg Balance Score) or number and/or incidence of falls. Secondary outcome measures of interest included any adverse effects experienced, an outcome measure indicating functional balance (i.e. walking speed), quality of life (through use of an objective measure i.e. EuroQOL), and number of days in hospital due to falls.Types of studies:Randomised controlled trials (RCT). A three-stage strategy searched the following electronic databases: The Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, AMED, CINAHL, PsycINFO, PsycBITE, OTseeker, Ei Compendex, Inspec, Current Controlled Trials, and the National Institute of Health Clinical Trials Database. The methodological quality of each included study was independently assessed using the Joanna Briggs Institute Meta Analysis of Statistics Assessment and Review Instrument (JBI-MAStARI) to systematically comment on influence of bias. Data was individually extracted from the included studies using the standardised JBI data extraction tool from JBI-MAStARI. Data was analysed using Review Manager 5 software. Results were expressed as mean difference (MD) with 95% confidence intervals for continuous outcomes. Meta-analysis was not possible due to the variation of the interventions given and small number of included trials; hence, a description of the results was given. Four studies were included in the systematic review. All the included studies used different types of virtual reality or interactive gaming interventions. Two of the included studies used the same balance outcome measure. There was a notable inconsistency of balance outcome measurement between all the included studies. No data was given regarding falls in any of the studies. A secondary outcome, the 10m walk test, was recorded in two of the studies. The four included studies had small sample sizes and poor methodological quality. Despite the presentation of statistically significant results, the clinical significance is questionable. The review can not recommend the inclusion of virtual reality or interactive gaming systems into the rehabilitation of balance impairment based on the results of the four included studies. Further investigation in this topic area is required.

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

PubMed

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

2015-12-01

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

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

PubMed Central

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

2016-01-01

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

Effectiveness of IT-based diabetes management interventions: a review of the literature.

PubMed

Costa, Beth M; Fitzgerald, Kristine J; Jones, Kay M; Dunning Am, Trisha

2009-11-17

Information technology (IT) is increasingly being used in general practice to manage health care including type 2 diabetes. However, there is conflicting evidence about whether IT improves diabetes outcomes. This review of the literature about IT-based diabetes management interventions explores whether methodological issues such as sample characteristics, outcome measures, and mechanisms causing change in the outcome measures could explain some of the inconsistent findings evident in IT-based diabetes management studies. Databases were searched using terms related to IT and diabetes management. Articles eligible for review evaluated an IT-based diabetes management intervention in general practice and were published between 1999 and 2009 inclusive in English. Studies that did not include outcome measures were excluded. Four hundred and twenty-five articles were identified, sixteen met the inclusion criteria: eleven GP focussed and five patient focused interventions were evaluated. Nine were RCTs, five non-randomised control trials, and two single-sample before and after designs. Important sample characteristics such as diabetes type, familiarity with IT, and baseline diabetes knowledge were not addressed in any of the studies reviewed. All studies used HbA1c as a primary outcome measure, and nine reported a significant improvement in mean HbA1c over the study period; only two studies reported the HbA1c assay method. Five studies measured diabetes medications and two measured psychological outcomes. Patient lifestyle variables were not included in any of the studies reviewed. IT was the intervention method considered to effect changes in the outcome measures. Only two studies mentioned alternative possible causal mechanisms. Several limitations could affect the outcomes of IT-based diabetes management interventions to an unknown degree. These limitations make it difficult to attribute changes solely to such interventions.

Modifying the Clinical Outcomes in Routine Evaluation Measure for Use with People Who Have a Learning Disability

ERIC Educational Resources Information Center

Marshall, Keith; Willoughby-Booth, Simon

2007-01-01

There are few reliable self-report measures suitable for people with a learning disability in reporting psychological distress. This study examines the modification of the Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM), exploring its reliability, using two different presentation styles. One style included a sequencing task then…

Core outcome measures for opioid abuse liability laboratory assessment studies in humans: IMMPACT recommendations

PubMed Central

Comer, Sandra D.; Zacny, James P.; Dworkin, Robert H.; Turk, Dennis C.; Bigelow, George E.; Foltin, Richard W.; Jasinski, Donald R.; Sellers, Edward M.; Adams, Edgar H.; Balster, Robert; Burke, Laurie B.; Cerny, Igor; Colucci, Robert D.; Cone, Edward; Cowan, Penney; Farrar, John T.; Haddox, J. David; Haythornthwaite, Jennifer A.; Hertz, Sharon; Jay, Gary W.; Johanson, Chris-Ellyn; Junor, Roderick; Katz, Nathaniel P.; Klein, Michael; Kopecky, Ernest A.; Leiderman, Deborah B.; McDermott, Michael P.; O’Brien, Charles; O’Connor, Alec B.; Palmer, Pamela P.; Raja, Srinivasa N.; Rappaport, Bob A.; Rauschkolb, Christine; Rowbotham, Michael C.; Sampaio, Cristina; Setnik, Beatrice; Sokolowska, Marta; Stauffer, Joseph W.; Walsh, Sharon L.

2012-01-01

A critical component in development of opioid analgesics is assessment of their abuse liability (AL). Standardization of approaches and measures used in assessing AL has the potential to facilitate comparisons across studies, research laboratories, and drugs. The goal of this report is to provide consensus recommendations regarding core outcome measures for assessing abuse potential of opioid medications in humans in a controlled laboratory setting. Although many of the recommended measures are appropriate for assessing the AL of medications from other drug classes, the focus here is on opioid medications because they present unique risks from both physiological (e.g., respiratory depression, physical dependence) and public health (e.g., individuals in pain) perspectives. A brief historical perspective on AL testing is provided and then those measures that can be considered primary and secondary outcomes and possible additional outcomes in AL assessment are discussed. These outcome measures include: (1) subjective effects (some of which comprise the primary outcome measures, including drug liking); (2) physiological responses; (3) drug self-administration behavior; and (4) cognitive and psychomotor performance. Prior to presenting recommendations for standardized approaches and measures to be used in AL assessments, the appropriateness of using these measures in clinical trials with patients in pain is discussed. PMID:22998781

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 expressly granted.

A protocol for developing, disseminating, and implementing a core outcome set for pre-eclampsia.

PubMed

Duffy, James M N; van 't Hooft, Janneke; Gale, Chris; Brown, Mark; Grobman, William; Fitzpatrick, Ray; Karumanchi, S Ananth; Lucas, Nuala; Magee, Laura; Mol, Ben; Stark, Michael; Thangaratinam, Shakila; Wilson, Mathew; von Dadelszen, Peter; Williamson, Paula; Khan, Khalid S; Ziebland, Sue; McManus, Richard J

2016-10-01

Pre-eclampsia is a serious complication of pregnancy and contributes to maternal and offspring mortality and morbidity. Randomised controlled trials evaluating therapeutic interventions for pre-eclampsia have reported many different outcomes and outcome measures. Such variation contributes to an inability to compare, contrast, and combine individual studies, limiting the usefulness of research to inform clinical practice. The development and use of a core outcome set would help to address these issues ensuring outcomes important to all stakeholders, including patients, will be collected and reported in a standardised fashion. An international steering group including healthcare professionals, researchers, and patients, has been formed to guide the development of this core outcome set. Potential outcomes will be identified through a comprehensive literature review and semi-structured interviews with patients. Potential core outcomes will be entered into an international, multi-perspective online Delphi survey. All key stakeholders, including healthcare professionals, researchers, and patients will be invited to participate. The modified Delphi method encourages whole and stakeholder group convergence towards consensus 'core' outcomes. Once core outcomes have been agreed upon it is important to determine how they should be measured. The truth, discrimination, and feasibility assessment framework will assess the quality of potential outcome measures. High quality outcome measures will be associated with core outcomes. Mechanisms exist to disseminate and implement the resulting core outcome set within an international context. Embedding the core outcome set within future clinical trials, systematic reviews, and clinical practice guidelines could make a profound contribution to advancing the usefulness of research to inform clinical practice, enhance patient care, and improve maternal and offspring outcomes. The infrastructure created by developing a core outcome set for pre-eclampsia could be leveraged in other settings, for example selecting research priorities and clinical practice guideline development. PROSPECTIVE REGISTRATION: [1] Core Outcome Measures in Effectiveness Trials (COMET) registration number: 588. [2] International Prospective Register of Systematic Reviews (PROSPERO) registration number: CRD42015015529. Copyright © 2016 International Society for the Study of Hypertension in Pregnancy. Published by Elsevier B.V. All rights reserved.

Barriers to the routine collection of health outcome data in an Australian community care organization.

PubMed

Nancarrow, Susan A

2013-01-01

For over a decade, organizations have attempted to include the measurement and reporting of health outcome data in contractual agreements between funders and health service providers, but few have succeeded. This research explores the utility of collecting health outcomes data that could be included in funding contracts for an Australian Community Care Organisation (CCO). An action-research methodology was used to trial the implementation of outcome measurement in six diverse projects within the CCO using a taxonomy of interventions based on the International Classification of Function. The findings from the six projects are presented as vignettes to illustrate the issues around the routine collection of health outcomes in each case. Data collection and analyses were structured around Donabedian's structure-process-outcome triad. Health outcomes are commonly defined as a change in health status that is attributable to an intervention. This definition assumes that a change in health status can be defined and measured objectively; the intervention can be defined; the change in health status is attributable to the intervention; and that the health outcomes data are accessible. This study found flaws with all of these assumptions that seriously undermine the ability of community-based organizations to introduce routine health outcome measurement. Challenges were identified across all stages of the Donabedian triad, including poor adherence to minimum dataset requirements; difficulties standardizing processes or defining interventions; low rates of use of outcome tools; lack of value of the tools to the service provider; difficulties defining or identifying the end point of an intervention; technical and ethical barriers to accessing data; a lack of standardized processes; and time lags for the collection of data. In no case was the use of outcome measures sustained by any of the teams, although some quality-assurance measures were introduced as a result of the project.

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

Outcome measures in coeliac disease trials: the Tampere recommendations.

PubMed

Ludvigsson, Jonas F; Ciacci, Carolina; Green, Peter Hr; Kaukinen, Katri; Korponay-Szabo, Ilma R; Kurppa, Kalle; Murray, Joseph A; Lundin, Knut Erik Aslaksen; Maki, Markku J; Popp, Alina; Reilly, Norelle R; Rodriguez-Herrera, Alfonso; Sanders, David S; Schuppan, Detlef; Sleet, Sarah; Taavela, Juha; Voorhees, Kristin; Walker, Marjorie M; Leffler, Daniel A

2018-02-13

A gluten-free diet is the only treatment option of coeliac disease, but recently an increasing number of trials have begun to explore alternative treatment strategies. We aimed to review the literature on coeliac disease therapeutic trials and issue recommendations for outcome measures. Based on a literature review of 10 062 references, we (17 researchers and 2 patient representatives from 10 countries) reviewed the use and suitability of both clinical and non-clinical outcome measures. We then made expert-based recommendations for use of these outcomes in coeliac disease trials and identified areas where research is needed. We comment on the use of histology, serology, clinical outcome assessment (including patient-reported outcomes), quality of life and immunological tools including gluten immunogenic peptides for trials in coeliac disease. Careful evaluation and reporting of outcome measures will increase transparency and comparability of coeliac disease therapeutic trials, and will benefit patients, healthcare and the pharmaceutical industry. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Osteoarthritis year in review: rehabilitation and outcomes.

PubMed

Davis, A M

2012-03-01

This review highlights seminal publications of rehabilitation interventions and outcomes in osteoarthritis (OA) of the hip or knee. Medline, CINAHL, and Embase databases from September 2010 through August 2011 were searched using the key words 'osteoarthritis', rehabilitation, physical therapy, exercise, and outcome(s), limited to human and English. Rehabilitation intervention studies were included if they were randomized trials (RCT), systematic reviews or meta-analyses. Studies of surgical interventions were excluded unless they included evaluation of a rehabilitation intervention. Outcome studies were included if they contributed methodologically to advancing outcome measurement. Reviews of measurement properties of outcomes were excluded. Eight publications were selected and reviewed that relate to interventions evaluating manual therapy in hip or knee OA, tele-rehabilitation and performance and participation measures as outcomes. One systematic review of hip and knee OA, one meta-analysis of knee OA provide limited support for the benefit of manual therapy with exercise for improving pain and function to a lesser extent in the short-term (3 months). Study quality overall was low. One high quality RCT in knee replacement of usual outpatient physiotherapy vs internet-based tele-rehabilitation based on a non-inferiority analysis demonstrated comparable outcomes on Western Ontario McMaster Universities' Osteoarthritis questionnaire (WOMAC) pain and function and performance measures. Three studies demonstrated that observed performance measures such as timed walk tests and stair-climbing and timed-up-and-go measure concepts differ from self-report of difficulty with physical function. Additionally, two studies showed differential times of recovery following total knee replacement (TKR). Two studies evaluated participation. One demonstrated the conceptual distinction of activity limitations and participation and a second re-analyzed trial data from knee OA studies. In one study, there were larger effects in combined activity/participation than for activity alone for arthroscopic lavage compared to intraarticular steroid and, in a second study, the effect was larger for activity with an advanced pharmacy intervention whereas the physiotherapy intervention demonstrated a larger effect for activity/participation. Interventions of manual therapy for hip and knee OA provided limited evidence of effectiveness. These studies are of limited quality due to lack of blinding and disclosure of co-intervention. Tele-rehabilitation may be a viable option to improve access to rehabilitation post joint replacement for those in rural and remote areas. Data continue to support the need to include performance measures as well as patient-reported outcomes in evaluating outcomes in OA. Additionally, measures of participation should be considered as core outcomes. Copyright © 2012 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

The ICF Core Sets for hearing loss--researcher perspective. Part I: Systematic review of outcome measures identified in audiological research.

PubMed

Granberg, Sarah; Dahlström, Jennie; Möller, Claes; Kähäri, Kim; Danermark, Berth

2014-02-01

To review the literature in order to identify outcome measures used in research on adults with hearing loss (HL) as part of the ICF Core Sets development project, and to describe study and population characteristics of the reviewed studies. A systematic review methodology was applied using multiple databases. A comprehensive search was conducted and two search pools were created, pool I and pool II. The study population included adults (≥ 18 years of age) with HL and oral language as the primary mode of communication. 122 studies were included. Outcome measures were distinguished by 'instrument type', and 10 types were identified. In total, 246 (pool I) and 122 (pool II) different measures were identified, and only approximately 20% were extracted twice or more. Most measures were related to speech recognition. Fifty-one different questionnaires were identified. Many studies used small sample sizes, and the sex of participants was not revealed in several studies. The low prevalence of identified measures reflects a lack of consensus regarding the optimal outcome measures to use in audiology. Reflections and discussions are made in relation to small sample sizes and the lack of sex differentiation/descriptions within the included articles.

Elevated Patient Body Mass Index Does Not Negatively Affect Self-Reported Outcomes of Thoracolumbar Surgery: Results of a Comparative Observational Study with Minimum 1-Year Follow-Up

PubMed Central

Manson, Neil A.; Green, Alana J.; Abraham, Edward P.

2015-01-01

Study Design Retrospective study. Objective Quantify the effect of obesity on elective thoracolumbar spine surgery patients. Methods Five hundred consecutive adult patients undergoing thoracolumbar spine surgery to treat degenerative pathologies with minimum follow-up of at least 1 year were included. Primary outcome measures included Numerical Rating Scales for back and leg pain, the Short Form 36 Physical Component Summary and Mental Component Summary, the modified Oswestry Disability Index, and patient satisfaction scores collected preoperatively and at 3, 6, 12, and 24 months postoperatively. Secondary outcome measures included perioperative and postoperative adverse events, postoperative emergency department presentation, hospital readmission, and revision surgeries. Patients were grouped according to World Health Organization body mass index (BMI) guidelines to isolate the effect of obesity on primary and secondary outcome measures. Results Mean BMI was 30 kg/m2, reflecting a significantly overweight population. Each BMI group reported statistically significant improvement on all self-reported outcome measures. Contrary to our hypothesis, however, there was no association between BMI group and primary outcome measures. Patients with BMI of 35 to 39.99 visited the emergency department with complaints of pain significantly more often than the other groups. Otherwise, we did not detect any differences in the secondary outcome measures between BMI groups. Conclusions Patients of all levels of obesity experienced significant improvement following elective thoracolumbar spine surgery. These outcomes were achieved without increased risk of postoperative complications such as infection and reoperation. A risk–benefit algorithm to assist with surgical decision making for obese patients would be valuable to surgeons and patients alike. PMID:26933611

Using the International Classification of Functioning, Disability, and Health to identify outcome domains for a core outcome set for aphasia: a comparison of stakeholder perspectives.

PubMed

Wallace, Sarah J; Worrall, Linda; Rose, Tanya; Le Dorze, Guylaine

2017-11-12

This study synthesised the findings of three separate consensus processes exploring the perspectives of key stakeholder groups about important aphasia treatment outcomes. This process was conducted to generate recommendations for outcome domains to be included in a core outcome set for aphasia treatment trials. International Classification of Functioning, Disability, and Health codes were examined to identify where the groups of: (1) people with aphasia, (2) family members, (3) aphasia researchers, and (4) aphasia clinicians/managers, demonstrated congruence in their perspectives regarding important treatment outcomes. Codes were contextualized using qualitative data. Congruence across three or more stakeholder groups was evident for ICF chapters: Mental functions; Communication; and Services, systems, and policies. Quality of life was explicitly identified by clinicians/managers and researchers, while people with aphasia and their families identified outcomes known to be determinants of quality of life. Core aphasia outcomes include: language, emotional wellbeing, communication, patient-reported satisfaction with treatment and impact of treatment, and quality of life. International Classification of Functioning, Disability, and Health coding can be used to compare stakeholder perspectives and identify domains for core outcome sets. Pairing coding with qualitative data may ensure important nuances of meaning are retained. Implications for rehabilitation The outcomes measured in treatment research should be relevant to stakeholders and support health care decision making. Core outcome sets (agreed, minimum set of outcomes, and outcome measures) are increasingly being used to ensure the relevancy and consistency of the outcomes measured in treatment studies. Important aphasia treatment outcomes span all components of the International Classification of Functioning, Disability, and Health. Stakeholders demonstrated congruence in the identification of important outcomes which related Mental functions; Communication; Services, systems, and policies; and Quality of life. A core outcome set for aphasia treatment research should include measures relating to: language, emotional wellbeing, communication, patient-reported satisfaction with treatment and impact of treatment, and quality of life. Coding using the International Classification of Functioning, Disability, and Health, presents a novel methodology for the comparison of stakeholder perspectives to inform recommendations for outcome constructs to be included in a core outcome set. Coding can be paired with qualitative data to ensure nuances of meaning are retained.

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

PubMed

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

2015-06-01

Outcome expectancy, or the degree to which a client believes that therapy will result in improvement, is related to improved treatment outcomes for multiple disorders. There is a paucity of research investigating this relation in regards to posttraumatic stress disorder (PTSD). Additionally, the bulk of the research on outcome expectancy and treatment outcomes has relied mostly on self-report outcome measures. The relation between outcome expectancy on self-report measures, clinician-rated measures, and two biological indices (fear-potentiated startle and cortisol reactivity) of PTSD symptoms was explored. The sample included combat veterans (N = 116) treated with virtual reality exposure therapy for PTSD. Results supported a negative association between outcome expectancy and both self-report and clinician-rated symptoms at the conclusion of treatment, but outcome expectancy was related to the magnitude of change during treatment for self-report measures only. Outcome expectancy was unrelated to biological measures of treatment response. These findings suggest that outcome expectancy may be related to patient and clinician perceptions of outcomes, but not biological indices of outcome for PTSD. © 2015 Wiley Periodicals, Inc.

Identifying and assessing strategies for evaluating the impact of mobile eye health units on health outcomes.

PubMed

Fu, Shiwan; Turner, Angus; Tan, Irene; Muir, Josephine

2017-12-01

To identify and assess strategies for evaluating the impact of mobile eye health units on health outcomes. Systematic literature review. Worldwide. Peer-reviewed journal articles that included the use of a mobile eye health unit. Journal articles were included if outcome measures reflected an assessment of the impact of a mobile eye health unit on health outcomes. Six studies were identified with mobile services offering diabetic retinopathy screening (three studies), optometric services (two studies) and orthoptic services (one study). This review identified and assessed strategies in existing literature used to evaluate the impact of mobile eye health units on health outcomes. Studies included in this review used patient outcomes (i.e. disease detection, vision impairment, treatment compliance) and/or service delivery outcomes (i.e. cost per attendance, hospital transport use, inappropriate referrals, time from diabetic retinopathy photography to treatment) to evaluate the impact of mobile eye health units. Limitations include difficulty proving causation of specific outcome measures and the overall shortage of impact evaluation studies. Variation in geographical location, service population and nature of eye care providers limits broad application. © 2017 National Rural Health Alliance Inc.

Protocol for developing, disseminating and implementing a core outcome set for endometriosis.

PubMed

Hirsch, Martin; Duffy, James M N; Barker, Claire; Hummelshoj, Lone; Johnson, Neil P; Mol, Ben; Khan, Khalid S; Farquhar, Cindy

2016-12-21

Endometriosis is a common gynaecological disease characterised by pain and subfertility. Randomised controlled trials evaluating treatments for endometriosis have reported many different outcomes and outcome measures. This variation restricts effective data synthesis limiting the usefulness of research to inform clinical practice. To address these methodological concerns, we aim to develop, disseminate and implement a core outcome set for endometriosis engaging with key stakeholders, including healthcare professionals, researchers and women with endometriosis. An international steering group has been established, including healthcare professionals, researchers and patient representatives. Potential outcomes identified from a systematic review of the literature will be entered into a modified Delphi method. Key stakeholders will be invited to participate including healthcare professionals, researchers and women with endometriosis. Participants will be invited to score individual outcomes on a nine-point Likert scale anchored between 1 (not important) and 9 (critical). Repeated reflection and rescoring should promote whole and individual stakeholder group converge towards consensus, 'core', outcomes. High-quality outcome measures will be associated with core outcomes. The implementation of a core outcome set for endometriosis within future clinical trials, systematic reviews and clinical guidelines will enhance the availability of comparable data to facilitate evidence-based patient care. This study was prospectively registered with Core Outcome Measures in Effectiveness Trials Initiative; number: 691. 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/.

Recommendations for a first Core Outcome Measurement set for complex regional PAin syndrome Clinical sTudies (COMPACT)

PubMed Central

Grieve, Sharon; Perez, Roberto SGM; Birklein, Frank; Brunner, Florian; Bruehl, Stephen; Harden R, Norman; Packham, Tara; Gobeil, Francois; Haigh, Richard; Holly, Janet; Terkelsen, Astrid; Davies, Lindsay; Lewis, Jennifer; Thomassen, Ilona; Connett, Robyn; Worth, Tina; Vatine, Jean-Jacques; McCabe, Candida S

2017-01-01

Complex Regional Pain Syndrome (CRPS) is a persistent pain condition that remains incompletely understood and challenging to treat. Historically, a wide range of different outcome measures have been used to capture the multidimensional nature of CRPS. This has been a significant limiting factor in the advancement of our understanding of the mechanisms and management of CRPS. In 2013, an international consortium of patients, clinicians, researchers and industry representatives was established, to develop and agree on a minimum core set of standardised outcome measures for use in future CRPS clinical research, including but not limited to clinical trials within adult populations The development of a core measurement set was informed through workshops and supplementary work, using an iterative consensus process. ‘What is the clinical presentation and course of CRPS, and what factors influence it?’ was agreed as the most pertinent research question that our standardised set of patient-reported outcome measures should be selected to answer. The domains encompassing the key concepts necessary to answer the research question were agreed as: pain, disease severity, participation and physical function, emotional and psychological function, self efficacy, catastrophizing and patient's global impression of change. The final core measurement set included the optimum generic or condition-specific patient-reported questionnaire outcome measures, which captured the essence of each domain, and one clinician reported outcome measure to capture the degree of severity of CRPS. The next step is to test the feasibility and acceptability of collecting outcome measure data using the core measurement set in the CRPS population internationally. PMID:28178071

A Scoping Review of Physical Performance Outcome Measures Used in Exercise Interventions for Older Adults With Alzheimer Disease and Related Dementias.

PubMed

McGough, Ellen L; Lin, Shih-Yin; Belza, Basia; Becofsky, Katie M; Jones, Dina L; Liu, Minhui; Wilcox, Sara; Logsdon, Rebecca G

2017-11-28

There is growing evidence that exercise interventions can mitigate functional decline and reduce fall risk in older adults with Alzheimer disease and related dementias (ADRD). Although physical performance outcome measures have been successfully used in older adults without cognitive impairment, additional research is needed regarding their use with individuals who have ADRD, and who may have difficulty following instructions regarding performance of these measures. The purpose of this scoping review was to identify commonly used physical performance outcome measures, for exercise interventions, that are responsive and reliable in older adults with ADRD. Ultimately, we aimed to provide recommendations regarding the use of outcome measures for individuals with ADRD across several domains of physical performance. A scoping review was conducted to broadly assess physical performance outcome measures used in exercise interventions for older adults with ADRD. Exercise intervention studies that included at least 1 measure of physical performance were included. All physical performance outcome measures were abstracted, coded, and categorized into 5 domains of physical performance: fitness, functional mobility, gait, balance, and strength. Criteria for recommendations were based on (1) the frequency of use, (2) responsiveness, and (3) reliability. Frequency was determined by the number of studies that used the outcome measure per physical performance domain. Responsiveness was assessed via calculated effect size of the outcome measures across studies within physical performance domains. Reliability was evaluated via published studies of psychometric properties. A total of 20 physical performance outcome measures were extracted from 48 articles that met study inclusion criteria. The most frequently used outcome measures were the 6-minute walk test, Timed Up and Go, repeated chair stand tests, short-distance gait speed, the Berg Balance Scale, and isometric strength measures. These outcome measures demonstrated a small, medium, or large effect in at least 50% of the exercise intervention studies. Good to excellent reliability was reported in samples of older adults with mild to moderate dementia. Fitness, functional mobility, gait, balance, and strength represent important domains of physical performance for older adults. The 6-minute walk test, Timed Up and Go, repeated chair stand tests, short-distance gait speed, Berg Balance Scale, and isometric strength are recommended as commonly used and reliable physical performance outcome measures for exercise interventions in older adults with mild to moderate ADRD. Further research is needed on optimal measures for individuals with severe ADRD. The results of this review will aid clinicians and researchers in selecting reliable measures to evaluate physical performance outcomes in response to exercise interventions in older adults with ADRD.

Using an evidence-based approach to measure outcomes in clinical practice.

PubMed

MacDermid, Joy C; Grewal, Ruby; MacIntyre, Norma J

2009-02-01

Evaluation of the outcome of evidence-based practice decisions in individual patients or patient groups is step five in the evidence-based practice approach. Outcome measures are any measures that reflect patient status. Status or outcome measures can be used to detect change over time (eg, treatment effects), to discriminate among clinical groups, or to predict future outcomes (eg, return to work). A variety of reliable and valid physical impairment and disability measures are available to assess treatment outcomes in hand surgery and therapy. Evidence from research studies that includes normative data, standard error of measurement, or comparative scores for important clinical subgroups can be used to set treatment goals, monitor recovery, and compare individual patient outcomes to those reported in the literature. Clinicians tend to rely on impairment measures, such as radiographic measures, grip strength, and range of motion, although self-report measures are known to be equally reliable and more related to global effects, such as return-to-work. The process of selecting and implementing outcome measures is crucial. This process works best when team members are involved and willing to trial new measures. In this way, the team can develop customized outcome assessment procedures that meet their needs for assessing individual patients and providing data for program evaluation.

Populations and outcome measures used in ongoing research in sarcopenia.

PubMed

Peña Ordóñez, Gloria Gabriela; Bustamante Montes, Lilia Patricia; Ramírez Duran, Ninfa; Sánchez Castellano, Carmen; Cruz-Jentoft, Alfonso J

2017-08-01

Sarcopenia research may be hampered by the heterogeneity of populations and outcome measures used in clinical studies. The aim of this study was to describe the inclusion/exclusion criteria and outcome measures used in ongoing research in sarcopenia. All active intervention studies registered in the World Health Organization with the keyword sarcopenia were included. Study design, type of intervention, inclusion/exclusion criteria and outcome measures were registered and classified. In April 2014, 151 studies on sarcopenia were registered in the WHO database. One hundred twenty-three were intervention studies. Most trials (94.3 %) were single centre and randomized (93.5 %), 51.2 % were double blind. Nutritional interventions (36.6 %), physical exercise (12.2 %) or both (19.5 %) were the most common interventions tested. Only 54.4 % included subjects of both genders, and 46.3 % had an upper age limit. Definition of the target populations was heterogeneous, with 57.7 % including healthy subjects and none using recent definitions of sarcopenia. Lifestyle and the degree of physical activity of subjects were not described or considered in most cases (79.7 %). Subjects with cardiovascular, neuropsychiatric or metabolic disorders and those with physical disability were usually excluded. Muscle mass and muscle strength were the primary outcome variables in 28.5 and 29.5 % of studies and physical performance in 19.5 %, but only 4.1 % used the three variables used the three of them. An additional 26.8 % used biological outcome variables. Little information and agreement existed in the way muscle and physical performance parameters were measured. We found a large heterogeneity in trial design, definition of populations and outcome measures in present research.

Engaging the hearts and minds of clinicians in outcome measurement - the UK Rehabilitation Outcomes Collaborative approach.

PubMed

Turner-Stokes, Lynne; Williams, Heather; Sephton, Keith; Rose, Hilary; Harris, Sarah; Thu, Aung

2012-01-01

This article explores the rationale for choosing the instruments included within the UK Rehabilitation Outcomes Collaborative (UKROC) data set. Using one specialist neuro-rehabilitation unit as an exemplar service, it describes an approach to engaging the hearts and minds of clinicians in recording the data. Measures included within a national data set for rehabilitation should be psychometrically robust and feasible to use in routine clinical practice; they should also support clinical decision-making so that clinicians actually want to use them. Learning from other international casemix models and benchmarking data sets, the UKROC team has developed a cluster of measures to inform the development of effective and cost-efficient rehabilitation services. These include measures of (1) "needs" for rehabilitation (complexity), (2) inputs provided to meet those needs (nursing and therapy intervention), and (3) outcome, including the attainment of personal goals as well as gains in functional independence. By integrating the use of the data set measures in everyday clinical practice, we have achieved a very high rate of compliance with data collection. However, staff training and ongoing commitment from senior staff and managers are critical to the maintenance of effort required to provide assurance of data quality in the longer term.

Engaging the hearts and minds of clinicians in outcome measurement – the UK rehabilitation outcomes collaborative approach

PubMed Central

2012-01-01

Purpose This article explores the rationale for choosing the instruments included within the UK Rehabilitation Outcomes Collaborative (UKROC) data set. Using one specialist neuro-rehabilitation unit as an exemplar service, it describes an approach to engaging the hearts and minds of clinicians in recording the data. Key messages and implications Measures included within a national data set for rehabilitation should be psychometrically robust and feasible to use in routine clinical practice; they should also support clinical decision-making so that clinicians actually want to use them. Learning from other international casemix models and benchmarking data sets, the UKROC team has developed a cluster of measures to inform the development of effective and cost-efficient rehabilitation services. These include measures of (1) “needs” for rehabilitation (complexity), (2) inputs provided to meet those needs (nursing and therapy intervention), and (3) outcome, including the attainment of personal goals as well as gains in functional independence. Conclusions By integrating the use of the data set measures in everyday clinical practice, we have achieved a very high rate of compliance with data collection. However, staff training and ongoing commitment from senior staff and managers are critical to the maintenance of effort required to provide assurance of data quality in the longer term. PMID:22506959

Achieving Goal-Concordant Care: A Conceptual Model and Approach to Measuring Serious Illness Communication and Its Impact

PubMed Central

Curtis, J. Randall; Tulsky, James A.

2018-01-01

Abstract Background: High-quality care for seriously ill patients aligns treatment with their goals and values. Failure to achieve “goal-concordant” care is a medical error that can harm patients and families. Because communication between clinicians and patients enables goal concordance and also affects the illness experience in its own right, healthcare systems should endeavor to measure communication and its outcomes as a quality assessment. Yet, little consensus exists on what should be measured and by which methods. Objectives: To propose measurement priorities for serious illness communication and its anticipated outcomes, including goal-concordant care. Methods: We completed a narrative review of the literature to identify links between serious illness communication, goal-concordant care, and other outcomes. We used this review to identify gaps and opportunities for quality measurement in serious illness communication. Results: Our conceptual model describes the relationship between communication, goal-concordant care, and other relevant outcomes. Implementation-ready measures to assess the quality of serious illness communication and care include (1) the timing and setting of serious illness communication, (2) patient experience of communication and care, and (3) caregiver bereavement surveys that include assessment of perceived goal concordance of care. Future measurement priorities include direct assessment of communication quality, prospective patient or family assessment of care concordance with goals, and assessment of the bereaved caregiver experience. Conclusion: Improving serious illness care necessitates ensuring that high-quality communication has occurred and measuring its impact. Measuring patient experience and receipt of goal-concordant care should be our highest priority. We have the tools to measure both. PMID:29091522

Achieving Goal-Concordant Care: A Conceptual Model and Approach to Measuring Serious Illness Communication and Its Impact.

PubMed

Sanders, Justin J; Curtis, J Randall; Tulsky, James A

2018-03-01

High-quality care for seriously ill patients aligns treatment with their goals and values. Failure to achieve "goal-concordant" care is a medical error that can harm patients and families. Because communication between clinicians and patients enables goal concordance and also affects the illness experience in its own right, healthcare systems should endeavor to measure communication and its outcomes as a quality assessment. Yet, little consensus exists on what should be measured and by which methods. To propose measurement priorities for serious illness communication and its anticipated outcomes, including goal-concordant care. We completed a narrative review of the literature to identify links between serious illness communication, goal-concordant care, and other outcomes. We used this review to identify gaps and opportunities for quality measurement in serious illness communication. Our conceptual model describes the relationship between communication, goal-concordant care, and other relevant outcomes. Implementation-ready measures to assess the quality of serious illness communication and care include (1) the timing and setting of serious illness communication, (2) patient experience of communication and care, and (3) caregiver bereavement surveys that include assessment of perceived goal concordance of care. Future measurement priorities include direct assessment of communication quality, prospective patient or family assessment of care concordance with goals, and assessment of the bereaved caregiver experience. Improving serious illness care necessitates ensuring that high-quality communication has occurred and measuring its impact. Measuring patient experience and receipt of goal-concordant care should be our highest priority. We have the tools to measure both.

The quality of systematic reviews of health-related outcome measurement instruments.

PubMed

Terwee, C B; Prinsen, C A C; Ricci Garotti, M G; Suman, A; de Vet, H C W; Mokkink, L B

2016-04-01

Systematic reviews of outcome measurement instruments are important tools for the selection of instruments for research and clinical practice. Our aim was to assess the quality of systematic reviews of health-related outcome measurement instruments and to determine whether the quality has improved since our previous study in 2007. A systematic literature search was performed in MEDLINE and EMBASE between July 1, 2013, and June 19, 2014. The quality of the reviews was rated using a study-specific checklist. A total of 102 reviews were included. In many reviews the search strategy was considered not comprehensive; in only 59 % of the reviews a search was performed in EMBASE and in about half of the reviews there was doubt about the comprehensiveness of the search terms used for type of measurement instruments and measurement properties. In 41 % of the reviews, compared to 30 % in our previous study, the methodological quality of the included studies was assessed. In 58 %, compared to 55 %, the quality of the included instruments was assessed. In 42 %, compared to 7 %, a data synthesis was performed in which the results from multiple studies on the same instrument were somehow combined. Despite a clear improvement in the quality of systematic reviews of outcome measurement instruments in comparison with our previous study in 2007, there is still room for improvement with regard to the search strategy, and especially the quality assessment of the included studies and the included instruments, and the data synthesis.

Evaluation of the Validity and Response Burden of Patient Self-Report Measures of the Pain Assessment Screening Tool and Outcomes Registry (PASTOR).

PubMed

Cook, Karon F; Kallen, Michael A; Buckenmaier, Chester; Flynn, Diane M; Hanling, Steven R; Collins, Teresa S; Joltes, Kristin; Kwon, Kyung; Medina-Torne, Sheila; Nahavandi, Parisa; Suen, Joshua; Gershon, Richard

2017-07-01

In 2009, the Army Pain Management Task Force was chartered. On the basis of their findings, the Department of Defense recommended a comprehensive pain management strategy that included development of a standardized pain assessment system that would collect patient-reported outcomes data to inform the patient-provider clinical encounter. The result was the Pain Assessment Screening Tool and Outcomes Registry (PASTOR). The purpose of this study was to assess the validity and response burden of the patient-reported outcome measures in PASTOR. Data for analyses were collected from 681 individuals who completed PASTOR at baseline and follow-up as part of their routine clinical care. The survey tool included self-report measures of pain severity and pain interference (measured using the National Institutes of Health Patient-Reported Outcome Measurement Information System [PROMIS] and the Defense and Veterans Pain Rating scale). PROMIS measures of pain correlates also were administered. Validation analyses included estimation of score associations among measures, comparison of scores of known groups, responsiveness, ceiling and floor effects, and response burden. Results of psychometric testing provided substantial evidence for the validity of PASTOR self-report measures in this population. Expected associations among scores largely supported the concurrent validity of the measures. Scores effectively distinguished among respondents on the basis of their self-reported impressions of general health. PROMIS measures were administered using computer adaptive testing and each, on average, required less than 1 minute to administer. Statistical and graphical analyses demonstrated the responsiveness of PASTOR measures over time. Reprint & Copyright © 2017 Association of Military Surgeons of the U.S.

Parameters and Measures in Assessment of Motor Learning in Neurorehabilitation; A Systematic Review of the Literature

PubMed Central

Shishov, Nataliya; Melzer, Itshak; Bar-Haim, Simona

2017-01-01

Upper limb function, essential for daily life, is often impaired in individuals after stroke and cerebral palsy (CP). For an improved upper limb function, learning should occur, and therefore training with motor learning principles is included in many rehabilitation interventions. Despite accurate measurement being an important aspect for examination and optimization of treatment outcomes, there are no standard algorithms for outcome measures selection. Moreover, the ability of the chosen measures to identify learning is not well established. We aimed to review and categorize the parameters and measures utilized for identification of motor learning in stroke and CP populations. PubMed, Pedro, and Web of Science databases were systematically searched between January 2000 and March 2016 for studies assessing a form of motor learning following upper extremity training using motor control measures. Thirty-two studies in persons after stroke and 10 studies in CP of any methodological quality were included. Identified outcome measures were sorted into two categories, “parameters,” defined as identifying a form of learning, and “measures,” as tools measuring the parameter. Review's results were organized as a narrative synthesis focusing on the outcome measures. The included studies were heterogeneous in their study designs, parameters and measures. Parameters included adaptation (n = 6), anticipatory control (n = 2), after-effects (n = 3), de-adaptation (n = 4), performance (n = 24), acquisition (n = 8), retention (n = 8), and transfer (n = 14). Despite motor learning theory's emphasis on long-lasting changes and generalization, the majority of studies did not assess the retention and transfer parameters. Underlying measures included kinematic analyses in terms of speed, geometry or both (n = 39), dynamic metrics, measures of accuracy, consistency, and coordination. There is no exclusivity of measures to a specific parameter. Many factors affect task performance and the ability to measure it—necessitating the use of several metrics to examine different features of movement and learning. Motor learning measures' applicability to clinical setting can benefit from a treatment-focused approach, currently lacking. The complexity of motor learning results in various metrics, utilized to assess its occurrence, making it difficult to synthesize findings across studies. Further research is desirable for development of an outcome measures selection algorithm, while considering the quality of such measurements. PMID:28286474

Measuring the Quality of VET Using the Student Outcomes Survey. Occasional Paper

ERIC Educational Resources Information Center

Lee, Wang-Sheng; Polidano, Cain

2010-01-01

The aim of this report is to examine the potential use of information from the Student Outcomes Survey, including the use of student course satisfaction information and post-study outcomes, as a means of determining markers of training quality. In an analysis of the student course satisfaction measures, the authors found there are very small…

Multiple Measures of Outcome in Assessing a Prison-Based Drug Treatment Program

ERIC Educational Resources Information Center

Prendergast, Michael L.; Hall, Elizabeth A.; Wexler, Harry K.

2003-01-01

Evaluations of prison-based drug treatment programs typically focus on one or two dichotomous outcome variables related to recidivism. In contrast, this paper uses multiple measures of outcomes related to crime and drug use to examine the impact of prison treatment. Crime variables included self-report data of time to first illegal activity,…

Outcome Rating Scale and Session Rating Scale in Psychological Practice: Clinical Utility of Ultra-Brief Measures

ERIC Educational Resources Information Center

Campbell, Alistair; Hemsley, Samantha

2009-01-01

The validity and reliability of the Outcome Rating Scale (ORS) and the Session Rating Scale (SRS) were evaluated against existing longer measures, including the Outcome Questionnaire-45, Working Alliance Inventory, Depression Anxiety Stress Scale-21, Quality of Life Scale, Rosenberg Self-Esteem Scale and General Self-efficacy Scale. The measures…

A Consensus Set of Outcomes for Parkinson’s Disease from the International Consortium for Health Outcomes Measurement

PubMed Central

de Roos, Paul; Bloem, Bastiaan R.; Kelley, Thomas A.; Antonini, Angelo; Dodel, Richard; Hagell, Peter; Marras, Connie; Martinez-Martin, Pablo; Mehta, Shyamal H.; Odin, Per; Chaudhuri, Kallol Ray; Weintraub, Daniel; Wilson, Bil; Uitti, Ryan J.

2017-01-01

Background Parkinson’s disease (PD) is a progressive neurodegenerative condition that is expected to double in prevalence due to demographic shifts. Value-based healthcare is a proposed strategy to improve outcomes and decrease costs. To move towards an actual value-based health care system, condition-specific outcomes that are meaningful to patients are essential. Objective Propose a global consensus standard set of outcome measures for PD. Methods Established methods for outcome measure development were applied, as outlined and used previously by the International Consortium for Health Outcomes Measurement (ICHOM). An international group, representing both patients and experts from the fields of neurology, psychiatry, nursing, and existing outcome measurement efforts, was convened. The group participated in six teleconferences over a six-month period, reviewed existing data and practices, and ultimately proposed a standard set of measures by which patients should be tracked, and how often data should be collected. Results The standard set applies to all cases of idiopathic PD, and includes assessments of motor and non-motor symptoms, ability to work, PD-related health status, and hospital admissions. Baseline demographic and clinical variables are included to enable case mix adjustment. Conclusions The Standard Set is now ready for use and pilot testing in the clinical setting. Ultimately, we believe that using the set of outcomes proposed here will allow clinicians and scientists across the world to document, report, and compare PD-related outcomes in a standardized fashion. Such international benchmarks will improve our understanding of the disease course and allow for identification of ‘best practices’, ultimately leading to better informed treatment decisions. PMID:28671140

Outcomes assessment in rotator cuff pathology: what are we measuring?

PubMed

Makhni, Eric C; Steinhaus, Michael E; Morrow, Zachary S; Jobin, Charles M; Verma, Nikhil N; Cole, Brian J; Bach, Bernard R

2015-12-01

Assessments used to measure outcomes associated with rotator cuff pathology and after repair are varied. This lack of standardization leads to difficulty drawing comparisons across studies. We hypothesize that this variability in patient-reported outcome measures and objective metrics used in rotator cuff studies persists even in high-impact, peer reviewed journals. All studies assessing rotator cuff tear and repair outcomes in 6 orthopedic journals with a high impact factor from January 2010 to December 2014 were reviewed. Cadaveric and animal studies and those without outcomes were excluded. Outcome measures included range of motion (forward elevation, abduction, external rotation, and internal rotation), strength (in the same 4 planes), tendon integrity imaging, patient satisfaction, and functional assessment scores. Of the 156 included studies, 63% documented range of motion measurements, with 18% reporting range of motion in all 4 planes. Only 38% of studies reported quantitative strength measurements. In 65% of studies, tendon integrity was documented with imaging (38% magnetic resonance imaging/magnetic resonance anrhrogram, 31% ultrasound, and 8% computed tomography arthrogram). Finally, functional score reporting varied significantly, with the 5 most frequently reported scores ranging from 16% to 61% in studies, and 15 of the least reported outcomes were each reported in ≤6% of studies. Significant variability exists in outcomes reporting after rotator cuff tear and repair, making comparisons between clinical studies difficult. Creating a uniformly accepted, validated outcomes tool that assesses pain, function, patient satisfaction, and anatomic integrity would enable consistent outcomes assessment after operative and nonoperative management and allow comparisons across the literature. Copyright © 2015 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.

Multidimensional change in psychotherapy.

PubMed

Jones, E E

1980-04-01

Assessed psychotherapy outcome for 177 patients who were seen for an average of 31 therapy hours with the Rating Scales for Outcome of Therapy and a Therapist Questionnaire. Results of a components analysis did not support Storrow's rational groupings of the Rating Scales into five dimensions and suggested that two general areas of psychological adjustment underlie the 11 scales. A second components analysis that included both outcome measures supports only in part the contention that when results from diverse outcome measures are factor analyzed, the factors necessarily are associated with method of measurement rather than substantive dimensions of change.

Service profiling and outcomes benchmarking using the CORE-OM: toward practice-based evidence in the psychological therapies. Clinical Outcomes in Routine Evaluation-Outcome Measures.

PubMed

Barkham, M; Margison, F; Leach, C; Lucock, M; Mellor-Clark, J; Evans, C; Benson, L; Connell, J; Audin, K; McGrath, G

2001-04-01

To complement the evidence-based practice paradigm, the authors argued for a core outcome measure to provide practice-based evidence for the psychological therapies. Utility requires instruments that are acceptable scientifically, as well as to service users, and a coordinated implementation of the measure at a national level. The development of the Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is summarized. Data are presented across 39 secondary-care services (n = 2,710) and within an intensively evaluated single service (n = 1,455). Results suggest that the CORE-OM is a valid and reliable measure for multiple settings and is acceptable to users and clinicians as well as policy makers. Baseline data levels of patient presenting problem severity, including risk, are reported in addition to outcome benchmarks that use the concept of reliable and clinically significant change. Basic quality improvement in outcomes for a single service is considered.

DEFINING THE RELEVANT OUTCOME MEASURES IN MEDICAL DEVICE ASSESSMENTS: AN ANALYSIS OF THE DEFINITION PROCESS IN HEALTH TECHNOLOGY ASSESSMENT.

PubMed

Jacobs, Esther; Antoine, Sunya-Lee; Prediger, Barbara; Neugebauer, Edmund; Eikermann, Michaela

2017-01-01

Defining relevant outcome measures for clinical trials on medical devices (MD) is complex, as there is a large variety of potentially relevant outcomes. The chosen outcomes vary widely across clinical trials making the assessment in evidence syntheses very challenging. The objective is to provide an overview on the current common procedures of health technology assessment (HTA) institutions in defining outcome measures in MD trials. In 2012-14, the Web pages of 126 institutions involved in HTA were searched for methodological manuals written in English or German that describe methods for the predefinition process of outcome measures. Additionally, the institutions were contacted by email. Relevant information was extracted. All process steps were performed independently by two reviewers. Twenty-four manuals and ten responses from the email request were included in the analysis. Overall, 88.5 percent of the institutions describe the type of outcomes that should be considered in detail and 84.6 percent agree that the main focus should be on patient relevant outcomes. Specifically related to MD, information could be obtained in 26 percent of the included manuals and email responses. Eleven percent of the institutions report a particular consideration of MD related outcomes. This detailed analysis on common procedures of HTA institutions in the context of defining relevant outcome measures for the assessment of MD shows that standardized procedures for MD from the perspective of HTA institutions are not widespread. This leads to the question if a homogenous approach should be implemented in the field of HTA on MD.

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.

Measuring spine fracture outcomes: common scales and checklists.

PubMed

Schoenfeld, Andrew J; Bono, Christopher M

2011-03-01

Although outcome instruments have been used extensively in spine surgical research, few studies at present specifically address their use in investigations regarding spine trauma. In this review we provide a summary of the outcome instruments used most frequently in spine trauma research, identify the unique challenges of studying outcomes of spine trauma patients, and propose an integrated approach that may be beneficial for future studies. We reviewed the use of outcome instruments applicable to spine trauma research, including generic health measures, inventories of back-specific function, pain scales, health related quality of life (HRQOL) instruments, and radiographic determinants of outcome. Several inventories have been utilised to measure clinical outcomes following spinal trauma. Excluding measures of neurological function (e.g. ASIA motor score), none have been specifically validated for use with spine fractures. The SF-36, RMDQ, and ODI are amongst the most commonly used instruments. Importantly, the use of validated functional outcome measures in spine trauma research is hampered by the fact that the pre-morbid state of patients who sustain spine trauma may not be accurately represented by normative values established for the general population. The VAS is used most frequently to assess degree of neck and back pain. Most studies have relied on non-validated measures to determine radiographic results of treatment, although more elegant radiographic metrics exist. Functional outcome measurement of traumatically injured spine patients is challenging because available generic and spine-specific instruments were not designed for or validated in this population. Furthermore, no single inventory is capable of capturing global data necessary to evaluate results following these injuries. Investigations seeking to quantify outcomes following spine trauma should consider the use of a combination of existing surveys in a complementary fashion that should include a generic health survey, a measure of back-specific function, and determinants of bodily pain and work-related disability. Copyright © 2010 Elsevier Ltd. All rights reserved.

Physician outcome measurement: review and proposed model.

PubMed

Siha, S

1998-01-01

As health care moves from a free-for-service environment to a capitated arena, outcome measurements must change. ABC Children's Medical Center is challenged with developing comprehensive outcome measures for an employed physician group. An extensive literature review validates that physician outcomes must move beyond revenue production and measure all aspects of care delivery. The proposed measurement model for this physician group is a trilogy model. It includes measures of cost, quality, and service. While these measures can be examined separately, it is imperative to understand their integration in determining an organization's competitive advantage. The recommended measurements for the physician group must be consistent with the overall organizational goals. The long-term impact will be better utilization of resources. This will result in the most cost effective, quality care for the health care consumer.

Exploration, Development, and Validation of Patient-reported Outcomes in Antineutrophil Cytoplasmic Antibody–associated Vasculitis Using the OMERACT Process

PubMed Central

Robson, Joanna C.; Milman, Nataliya; Tomasson, Gunnar; Dawson, Jill; Cronholm, Peter F.; Kellom, Katherine; Shea, Judy; Ashdown, Susan; Boers, Maarten; Boonen, Annelies; Casey, George C.; Farrar, John T.; Gebhart, Don; Krischer, Jeffrey; Lanier, Georgia; McAlear, Carol A.; Peck, Jacqueline; Sreih, Antoine G.; Tugwell, Peter; Luqmani, Raashid A.; Merkel, Peter A.

2016-01-01

Objective Antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) is a group of linked multisystem life- and organ-threatening diseases. The Outcome Measures in Rheumatology (OMERACT) vasculitis working group has been at the forefront of outcome development in the field and has achieved OMERACT endorsement of a core set of outcomes for AAV. Patients with AAV report as important some manifestations of disease not routinely collected through physician-completed outcome tools; and they rate common manifestations differently from investigators. The core set includes the domain of patient-reported outcomes (PRO). However, PRO currently used in clinical trials of AAV do not fully characterize patients’ perspectives on their burden of disease. The OMERACT vasculitis working group is addressing the unmet needs for PRO in AAV. Methods Current activities of the working group include (1) evaluating the feasibility and construct validity of instruments within the PROMIS (Patient-Reported Outcome Measurement Information System) to record components of the disease experience among patients with AAV; (2) creating a disease-specific PRO measure for AAV; and (3) applying The International Classification of Functioning, Disability and Health to examine the scope of outcome measures used in AAV. Results The working group has developed a comprehensive research strategy, organized an investigative team, included patient research partners, obtained peer-reviewed funding, and is using a considerable research infrastructure to complete these interrelated projects to develop evidence-based validated outcome instruments that meet the OMERACT filter of truth, discrimination, and feasibility. Conclusion The OMERACT vasculitis working group is on schedule to achieve its goals of developing validated PRO for use in clinical trials of AAV. (First Release September 1 2015; J Rheumatol 2015;42:2204–9; doi:10.3899/jrheum.141143) PMID:26329344

Relationships Among Student, Staff, and Administrative Measures of School Climate and Student Health and Academic Outcomes.

PubMed

Gase, Lauren N; Gomez, Louis M; Kuo, Tony; Glenn, Beth A; Inkelas, Moira; Ponce, Ninez A

2017-05-01

School climate is an integral part of a comprehensive approach to improving the well-being of students; however, little is known about the relationships between its different domains and measures. We examined the relationships between student, staff, and administrative measures of school climate to understand the extent to which they were related to each other and student outcomes. The sample included 33,572 secondary school students from 121 schools in Los Angeles County during the 2014-2015 academic year. A multilevel regression model was constructed to examine the association between the domains and measures of school climate and 5 outcomes of student well-being: depressive symptoms or suicidal ideation, tobacco use, alcohol use, marijuana use, and grades. Student, staff, and administrative measures of school climate were weakly correlated. Strong associations were found between student outcomes and student reports of engagement and safety, while school staff reports and administrative measures of school climate showed limited associations with student outcomes. As schools seek to measure and implement interventions aimed at improving school climate, consideration should be given to grounding these efforts in a multidimensional conceptualization of climate that values student perspectives and includes elements of both engagement and safety. © 2017, American School Health Association.

Outcomes in Economic Evaluations of Public Health Interventions in Low‐ and Middle‐Income Countries: Health, Capabilities and Subjective Wellbeing

PubMed Central

Lorgelly, Paula; Yamabhai, Inthira

2016-01-01

Abstract Public health programmes tend to be complex and may combine social strategies with aspects of empowerment, capacity building and knowledge across sectors. The nature of the programmes means that some effects are likely to occur outside the healthcare sector; this breadth impacts on the choice of health and non‐health outcomes to measure and value in an economic evaluation. Employing conventional outcome measures in evaluations of public health has been questioned. There are concerns that such measures are too narrow, overlook important dimensions of programme effect and, thus, lead to such interventions being undervalued. This issue is of particular importance for low‐income and middle‐income countries, which face considerable budget constraints, yet deliver a large proportion of health activities within public health programmes. The need to develop outcome measures, which include broader measures of quality of life, has given impetus to the development of a variety of new, holistic approaches, including Sen's capability framework and measures of subjective wellbeing. Despite their promise, these approaches have not yet been widely applied, perhaps because they present significant methodological challenges. This paper outlines the methodological challenges for the identification and measurement of broader outcomes of public health interventions in economic evaluation in low‐income and middle‐income countries. PMID:26804360

Relationships between Student, Staff, and Administrative Measures of School Climate and Student Health and Academic Outcomes

PubMed Central

Gase, Lauren Nichol; Gomez, Louis M.; Kuo, Tony; Glenn, Beth A.; Inkelas, Moira; Ponce, Ninez A.

2018-01-01

BACKGROUND School climate is an integral part of a comprehensive approach to improving the wellbeing of students; however, little is known about the relationships between its different domains and measures. This study examined the relationships between student, staff, and administrative measures of school climate in order to understand the extent to which they were related to each other and student outcomes. METHODS The sample included 33,572 secondary school students from 121 schools in Los Angeles County during the 2014–2015 academic year. A multilevel regression model was constructed to examine the association between the domains and measures of school climate and five outcomes of student wellbeing: depressive symptoms or suicidal ideation, tobacco use, alcohol use, marijuana use, and grades. RESULTS Student, staff, and administrative measures of school climate were weakly correlated. Strong associations were found between student outcomes and student reports of engagement and safety, while school staff reports and administrative measures of school climate showed limited associations with student outcomes. CONCLUSIONS As schools seek to measure and implement interventions aimed at improving school climate, consideration should be given to grounding these efforts in a multi-dimensional conceptualization of climate that values student perspectives and includes elements of both engagement and safety. PMID:28382671

The importance of functional impairment to mental health outcomes: A case for reassessing our goals in depression treatment research

PubMed Central

McKnight, Patrick E.; Kashdan, Todd B.

2009-01-01

Outcomes in depression treatment research include both changes in symptom severity and functional impairment. Symptom measures tend to be the standard outcome but we argue that there are benefits to considering functional outcomes. An exhaustive literature review shows that the relationship between symptoms and functioning remains unexpectedly weak and often bidirectional. Changes in functioning often lag symptom changes. As a result, functional outcomes might offer depression researchers more critical feedback and better guidance when studying depression treatment outcomes. The paper presents a case for the necessity of both functional and symptom outcomes in depression treatment research by addressing three aims–1) review the research relating symptoms and functioning, 2) provide a rationale for measuring both outcomes, and 3) discuss potential artifacts in measuring functional outcomes. The three aims are supported by an empirical review of the treatment outcome and epidemiological literatures. PMID:19269076

Influence of interpersonal traits on patient outcomes in the treatment of chronic rhinosinusitis.

PubMed

Levy, Joshua M; Mace, Jess C; Smith, Timothy L; Soler, Zachary M

2017-04-01

Patient-reported outcome measures (PROMs) measure health states in chronic rhinosinusitis (CRS) and have become the dominant metrics of treatment outcomes. Interpersonal traits (IPTs) are patient-specific factors that include personality type, perceived social support, and trust in physicians. The association of IPTs on treatment outcomes among patients with CRS has not been described previously, and IPTs may represent major clinical factors influencing treatment outcomes. Adult patients electing medical or surgical treatment for recalcitrant CRS were prospectively enrolled into a multi-institutional, observational outcomes study. Validated measures of IPTs, including the Big Five Inventory-10 Short Version (BFI-10), Multidimensional Scale of Perceived Social Support (MSPSS), and the Trust in Physician Scale (TPS), were completed and compared with PROMs, which included the 22-item SinoNasal Outcome Test (SNOT-22), the Medical Outcomes Study Short Form-6D (SF-6D), and the Patient Health Questionnaire-2 (PHQ-2). Three hundred fifty-four participants were included and followed for an average (± standard deviation) of 16.3 (±4.8) months. Significant within-subject improvement in mean PROM scores was reported (all p <0.001). No association was detected between PROM score improvement and baseline BFI-10 or MSPSS scores (p > 0.050). Significant, but weak, absolute correlations were reported between baseline TPS scores and improvement in SNOT-22, SF-6D, and PHQ-2 total scores (p < 0.050; r ≤ 0.138). Personality type and perceived social support do not associate with improvement after treatment for CRS. However, increased trust in physicians is weakly associated with greater posttreatment improvement. Further study is needed to examine the relationship between physician trust, patient satisfaction, and treatment outcomes among patients with CRS. © 2016 ARS-AAOA, LLC.

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 a large extent, to selective outcome reporting. Readers should be aware of this to avoid implementation of false or misleading results in clinical practice. No funding received and there are no conflicts of interest. N/A. © The Author 2017. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com

School Gardens Enhance Academic Performance and Dietary Outcomes in Children.

PubMed

Berezowitz, Claire K; Bontrager Yoder, Andrea B; Schoeller, Dale A

2015-08-01

Schools face increasing demands to provide education on healthy living and improve core academic performance. Although these appear to be competing concerns, they may interact beneficially. This article focuses on school garden programs and their effects on students' academic and dietary outcomes. Database searches in CABI, Web of Science, Web of Knowledge, PubMed, Education Full Text, Education Resources Information Center (ERIC), and PsychINFO were conducted through May 2013 for peer-reviewed literature related to school-day garden interventions with measures of dietary and/or academic outcomes. Among 12 identified garden studies with dietary measures, all showed increases/improvements in predictors of fruit and vegetable (FV) consumption. Seven of these also included self-reported FV intake with 5 showing an increase and 2 showing no change. Four additional interventions that included a garden component measured academic outcomes; of these, 2 showed improvements in science achievement and 1 measured and showed improvements in math scores. This small set of studies offers evidence that garden-based learning does not negatively impact academic performance or FV consumption and may favorably impact both. Additional studies with more robust experimental designs and outcome measures are necessary to understand the effects of experiential garden-based learning on children's academic and dietary outcomes. © 2015, American School Health Association.

Examination of Attitude and Interest Measures for 4-H Science Evaluation

ERIC Educational Resources Information Center

Lewis, Kendra M.; Worker, Steven M.

2015-01-01

Science education research has demonstrated the influence of affect on learning. The National 4-H Science Logic Model outlines outcomes from youth participation in 4-H science programs, which includes attitude and interest outcomes. The associated measure, the National 4-H Science Common Measure, assesses these attitude constructs and not other…

How is the sustainability of chronic disease health programmes empirically measured in hospital and related healthcare services?-a scoping review.

PubMed

Francis, Linda; Dunt, David; Cadilhac, Dominique A

2016-05-31

Programmes to address chronic disease are a focus of governments worldwide. Despite growth in 'implementation science', there is a paucity of knowledge regarding the best means to measure sustainability. The aim of this review was to summarise current practice for measuring sustainability outcomes of chronic disease health programmes, providing guidance for programme planners and future directions for the academic field. A scoping review of the literature spanning 1985-2015 was conducted using MEDLINE, CINAHL, PsychINFO and The Cochrane Library limited to English language and adults. Main search terms included chronic disease, acute care, sustainability, institutionalisation and health planning. A descriptive synthesis was required. Settings included primary care, hospitals, mental health centres and community health. Programmes included preventing or managing chronic conditions including diabetes, heart disease, depression, respiratory disease, cancer, obesity, dental hygiene and multiple chronic diseases. Outcome measures included clarifying a sustainability definition, types of methodologies used, timelines for assessment, criteria levels to determine outcomes and how methodology varies between intervention types. Among 153 abstracts retrieved, 87 were retained for full article review and 42 included in the qualitative synthesis. Five definitions for sustainability outcome were identified with 'maintenance of programme activities' most frequent. Achieving sustainability was dependent on inter-relationships between various organisational and social contexts supporting a broad scale approach to evaluation. An increasing trend in use of mixed methods designs over multiple time points to determine sustainability outcomes was found. Despite the importance and investment in chronic disease programmes, few studies are undertaken to measure sustainability. Methods to evaluate sustainability are diverse with some emerging patterns in measurement found. Use of mixed methods approaches over multiple time points may serve to better guide measurement of sustainability. Consensus on aspects of standardised measurement would promote the future possibility of meta-analytic syntheses. 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/

Development, reliability, and validity of the Alberta Perinatal Stroke Project Parental Outcome Measure.

PubMed

Bemister, Taryn B; Brooks, Brian L; Kirton, Adam

2014-07-01

Perinatal stroke is a leading cause of cerebral palsy and lifelong disability, although parent and family outcomes have not yet been studied in this specific population. The Alberta Perinatal Stroke Project Parental Outcome Measure was developed as a 26-item questionnaire on the impact of perinatal stroke on parents and families. The items were derived from expert opinion and scientific literature on issues salient to parents of children with perinatal stroke, including guilt and blame, which are not well captured in existing measures of family impact. Data were collected from 82 mothers and 28 fathers who completed the Parental Outcome Measure and related questionnaires (mean age, 39.5 years; mean child age, 7.4 years). Analyses examined the Parental Outcome Measure's internal consistency, test-retest reliability, validity, and factor structure. The Parental Outcome Measure demonstrated three unique theoretical constructs: Psychosocial Impact, Guilt, and Blame. The Parental Outcome Measure has excellent internal consistency (Cronbach α = 0.91) and very good test-retest reliability more than 2-5 weeks (r = 0.87). Regarding validity, the Parental Outcome Measure is sensitive to condition severity, accounts for additional variance in parent outcomes, and strongly correlates with measures of anxiety, depression, stress, quality of life, family functioning, and parent adjustment. The Parental Outcome Measure contributes to the literature as the first brief measure of family impact designed for parents of children with perinatal stroke. Copyright © 2014 Elsevier Inc. All rights reserved.

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 instruments developed for a similar condition or that contain symptoms of importance to the RD patient population, or using a generic instrument validated for the context of use. This report provides state-of-the-art solutions to patient-reported outcome (PRO) and observer-reported outcome (ObsRO) assessments challenges in clinical trials of patients with RDs. These recommended solutions are both pragmatic and creative and posed with clear recognition of the global regulatory context used in RD clinical development programs. Copyright © 2017. Published by Elsevier Inc.

Evidence for outcomes of motivational rehabilitation interventions for children and adolescents with cerebral palsy: an American Academy for Cerebral Palsy and Developmental Medicine systematic review.

PubMed

Tatla, Sandy K; Sauve, Karen; Virji-Babul, Naznin; Holsti, Liisa; Butler, Charlene; Van Der Loos, Hendrik F Machiel

2013-07-01

This study reviewed evidence regarding the effect of motivational rehabilitation interventions on outcomes in children with cerebral palsy. Six databases were searched for literature published up to May 2012. Included studies measured the purported motivating effects of motor-based rehabilitation interventions and the measured impact on outcomes. The American Academy for Cerebral Palsy and Developmental Medicine (AACPDM) systematic review methodology was used as a framework. Eight studies evaluated outcomes of studies using virtual reality interventions and one in a functional therapy context. Conflicting evidence from three (level II and level III) studies exists about the impact of these motivating interventions on motor outcomes measured in body functions. No statistical evidence regarding activity and participation outcomes exists. A single level II study found no significant difference in participants' motivation between motivational and conventional interventions. This review revealed a paucity of research on the effects of motivational interventions. Weaknesses include a lack of consistency in the examination of motivational interventions, limited use of definitions or theories to ground the concept of motivation, and reliance on non-validated methodological tools. This body of evidence would be strengthened by the use and development of robust outcome measures of motivation. © 2013 Mac Keith Press.

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.

Focusing on Student Academic Outcomes. A Working Paper.

ERIC Educational Resources Information Center

Alexander, Joanne M.; Stark, Joan S.

Current methods and instruments for assessing college student academic outcomes are identified and described, and possible outcome measures of NCRIPTAL's (National Center for Research to Improve Postsecondary Teaching and Learning) are suggested. Section I defines college outcomes from several perspectives, including pressures for outcome…

Creation of a core outcome set for clinical trials of people with shoulder pain: a study protocol.

PubMed

Gagnier, Joel J; Page, Matthew J; Huang, Hsiaomin; Verhagen, Arianne P; Buchbinder, Rachelle

2017-07-20

The selection of appropriate outcomes or domains is crucial when designing clinical trials, to appreciate the effects of different interventions, pool results, and make valid comparisons between trials. If the findings are to influence policy and practice, then the chosen outcomes need to be relevant and important to key stakeholders, including patients and the public, healthcare professionals and others making decisions about health care. There is a growing recognition that insufficient attention has been paid to the outcomes measured in clinical trials. Recent reviews of the measurement properties of patient-reported outcome measures for shoulder disorders revealed a large selection of diverse measures, many with questionable validity, reliability, and responsiveness. These issues could be addressed through the development and use of an agreed standardized collection of outcomes, known as a core outcome set (COS), which should be measured and reported in all trials of shoulder disorders. The purpose of the present project is to develop and disseminate a COS for clinical trials in shoulder disorders. The methods for the COS development will include 3 phases: (1) a comprehensive review of the core domains used in shoulder disorder trials; (2) an international Delphi study involving relevant stakeholders (patients, clinicians, scientists) to define which domains should be core; and (3) an international focus group informed by the evidence identified in phases 1 and 2, to determine which measurement instruments best measure the core domains and identification of any evidence gaps that require further empiric evidence. The aim of the current proposal is to convene several meetings of international experts and patients to develop a COS for clinical trials of shoulder disorders and to develop an implementation strategy to ensure rapid uptake of the core set of outcomes in clinical trials. There would be an expectation that the core set of outcomes would always be collected and reported, but it would not preclude use of additional outcomes in a particular trial.

Osteoarthritis 2012 year in review: rehabilitation and outcomes.

PubMed

Roos, E M; Juhl, C B

2012-12-01

Recent scientific advances in the treatment of hip and knee osteoarthritis (OA) relating to education, exercise, weight control and passive non-pharmacological and non-surgical treatments such as manual therapy, orthoses/orthotics and other aids are described. A systematic literature search was performed in Medline from July 2011 to 10 April 2012 using the terms 'osteoarthritis, knee', 'osteoarthritis, hip' rehabilitation, physical therapy, exercise therapy and preoperative intervention; both as text words and as MeSH terms where possible. Trials evaluating rehabilitation interventions were included if they were randomized controlled trials (RCTs) or systematic reviews. Outcome papers were identified by combining the initial search with the terms 'outcome', 'measure*', 'valid*', 'reliabil*' or 'responsiveness'. Outcome studies were included if they contributed methodologically to advancing outcome measurement. The literature search identified 550 potentially relevant papers. Seventeen RCTs on rehabilitation were selected and the results from these were supported by six systematic reviews. Sixteen outcomes papers were considered relevant, but did not add significantly to current knowledge about outcome measures in OA and so, were not included. The current research focus on non-pharmacological and non-surgical treatments for hip and/or knee OA, when combined in systematic reviews, is improving the available evidence to identify best practice treatment. Education, exercise and weight loss are effective in the long term and supported as cost-effective first-line treatments. Copyright © 2012 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

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 describe the treatment's intended benefit as an effect on a clearly identified aspect of how a patient feels or functions. This aspect must have importance to the patient and be part of the patient's typical life. This meaningful health aspect can be measured directly or measured indirectly when it is impractical to evaluate it directly or when it is difficult to measure. For indirect measurement, a concept of interest (COI) can be identified. The COI must be related to how a patient feels or functions. Procedures are then developed to measure the COI. The relationship of these measurements with how a patient feels or functions in the intended setting and manner of use of the COA (the context of use) could then be defined. A COA has identifiable attributes or characteristics that affect the measurement properties of the COA when used in endpoints. One of these features is whether judgment can influence the measurement, and if so, whose judgment. This attribute defines four categories of COAs: patient reported outcomes, clinician reported outcomes, observer reported outcomes, and performance outcomes. A full description as well as explanation of other important COA features is included in this report. The information in this report should aid in the development, refinement, and standardization of COAs, and, ultimately, improve their measurement properties. Copyright © 2015 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

A 5-Year Review of Clinical Outcome Measures Published in the Journal of the American Podiatric Medical Association and the Journal of Foot and Ankle Surgery.

PubMed

Hasenstein, Todd; Greene, Timothy; Meyr, Andrew J

2017-05-01

This investigation presents a review of all of the clinical outcome measures used by authors and published in the Journal of the American Podiatric Medical Association and the Journal of Foot and Ankle Surgery from January 1, 2011, to December 31, 2015. Of 1,336 articles published during this time frame, 655 (49.0%) were classified as original research and included in this analysis. Of these 655 articles, 151 (23.1%) included at least one clinical outcome measure. Thirty-seven unique clinical outcome scales were used by authors and published during this period. The most frequently reported scales in the 151 included articles were the American Orthopaedic Foot and Ankle Society scales (54.3%; n = 82), visual analog scale (35.8%; n = 54), Medical Outcomes Study Short Form Health Survey (any version) (10.6%; n = 16), Foot Function Index (5.3%; n = 8), Maryland Foot Score (4.0%; n = 6), and Olerud and Molander scoring system (4.0%; n = 6). Twenty-four articles (15.9%) used some form of original/subjective measure of patient satisfaction/expectation. The results of this investigation detail the considerable variety of clinical outcome measurement tools used by authors in the Journal of the American Podiatric Medical Association and the Journal of Foot and Ankle Surgery and might support the need for a shift toward the consistent use of a smaller number of valid, reliable, and clinically useful scales in the podiatric medical literature.

Associations of Ischemic Lesion Volume With Functional Outcome in Patients With Acute Ischemic Stroke: 24-Hour Versus 1-Week Imaging.

PubMed

Bucker, Amber; Boers, Anna M; Bot, Joseph C J; Berkhemer, Olvert A; Lingsma, Hester F; Yoo, Albert J; van Zwam, Wim H; van Oostenbrugge, Robert J; van der Lugt, Aad; Dippel, Diederik W J; Roos, Yvo B W E M; Majoie, Charles B L M; Marquering, Henk A

2017-05-01

Ischemic lesion volume (ILV) on noncontrast computed tomography at 1 week can be used as a secondary outcome measure in patients with acute ischemic stroke. Twenty-four-hour ILV on noncontrast computed tomography has greater availability and potentially allows earlier estimation of functional outcome. We aimed to assess lesion growth 24 hours after stroke onset and compare the associations of 24-hour and 1-week ILV with functional outcome. We included 228 patients from MR CLEAN trial (Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands), who received noncontrast computed tomography at 24-hour and 1-week follow-up on which ILV was measured. Relative and absolute lesion growth was determined. Logistic regression models were constructed either including the 24-hour or including the 1-week ILV. Ordinal and dichotomous (0-2 and 3-6) modified Rankin scale scores were, respectively, used as primary and secondary outcome measures. Median ILV was 42 mL (interquartile range, 21-95 mL) and 64 mL (interquartile range: 30-120 mL) at 24 hours and 1 week, respectively. Relative lesion growth exceeding 30% occurred in 121 patients (53%) and absolute lesion growth exceeding 20 mL occurred in 83 patients (36%). Both the 24-hour and 1-week ILVs were similarly significantly associated with functional outcome (both P <0.001). In the logistic analyses, the areas under the curve of the receiver-operator characteristic curves were similar: 0.85 (95% confidence interval, 0.80-0.90) and 0.87 (95% confidence interval, 0.82-0.91) for including the 24-hour and 1-week ILV, respectively. Growth of ILV is common 24-hour poststroke onset. Nevertheless, the 24-hour ILV proved to be a valuable secondary outcome measure as it is equally strongly associated with functional outcome as the 1-week ILV. URL: http://www.isrctn.com. Unique identifier: ISRCTN10888758. © 2017 American Heart Association, Inc.

Defining a standard set of patient-centered outcomes for men with localized prostate cancer.

PubMed

Martin, Neil E; Massey, Laura; Stowell, Caleb; Bangma, Chris; Briganti, Alberto; Bill-Axelson, Anna; Blute, Michael; Catto, James; Chen, Ronald C; D'Amico, Anthony V; Feick, Günter; Fitzpatrick, John M; Frank, Steven J; Froehner, Michael; Frydenberg, Mark; Glaser, Adam; Graefen, Markus; Hamstra, Daniel; Kibel, Adam; Mendenhall, Nancy; Moretti, Kim; Ramon, Jacob; Roos, Ian; Sandler, Howard; Sullivan, Francis J; Swanson, David; Tewari, Ashutosh; Vickers, Andrew; Wiegel, Thomas; Huland, Hartwig

2015-03-01

Value-based health care has been proposed as a unifying force to drive improved outcomes and cost containment. To develop a standard set of multidimensional patient-centered health outcomes for tracking, comparing, and improving localized prostate cancer (PCa) treatment value. We convened an international working group of patients, registry experts, urologists, and radiation oncologists to review existing data and practices. The group defined a recommended standard set representing who should be tracked, what should be measured and at what time points, and what data are necessary to make meaningful comparisons. Using a modified Delphi method over a series of teleconferences, the group reached consensus for the Standard Set. We recommend that the Standard Set apply to men with newly diagnosed localized PCa treated with active surveillance, surgery, radiation, or other methods. The Standard Set includes acute toxicities occurring within 6 mo of treatment as well as patient-reported outcomes tracked regularly out to 10 yr. Patient-reported domains of urinary incontinence and irritation, bowel symptoms, sexual symptoms, and hormonal symptoms are included, and the recommended measurement tool is the Expanded Prostate Cancer Index Composite Short Form. Disease control outcomes include overall, cause-specific, metastasis-free, and biochemical relapse-free survival. Baseline clinical, pathologic, and comorbidity information is included to improve the interpretability of comparisons. We have defined a simple, easily implemented set of outcomes that we believe should be measured in all men with localized PCa as a crucial first step in improving the value of care. Measuring, reporting, and comparing identical outcomes across treatments and treatment centers will provide patients and providers with information to make informed treatment decisions. We defined a set of outcomes that we recommend being tracked for every man being treated for localized prostate cancer. Copyright © 2014 European Association of Urology. Published by Elsevier B.V. All rights reserved.

The uses of outcome measures within multidisciplinary early childhood intervention services: a systematic review.

PubMed

Calder, Samuel; Ward, Roslyn; Jones, Megan; Johnston, Jenelle; Claessen, Mary

2017-07-18

Purpose of the article: To review the use of outcome measures, across the domains of activity, participation, and environment, within multidisciplinary early childhood intervention services. A systematic literature search was undertaken that included four electronic databases: Medline, CINAHL, EMBASE, and the Cochrane Library and Cochrane Database of Systematic Review. Inclusion criteria were age 0-24 months, having or at risk of a developmental disability, in receipt of multidisciplinary early childhood intervention services, and included outcome measures across all domains of the International Classification of Functioning-Child & Youth (ICF-CY). Only peer-reviewed journal articles were considered. Eligible studies were coded using the Oxford Levels of Evidence. Methodological quality was assessed using the Physiotherapy Evidence Database (PEDro) Scale for randomised controlled trials and the QualSyst for non-randomised control trials. Of the total of 5764 records identified, 10 were considered to meet inclusion criteria. Fourteen outcome measures were identified, addressing the domains of activity, participation, and environment. Of these, eight have been recommended in the early intervention literature. While the methodological quality of the 10 studies varied, these papers make a contribution to the body of research that acknowledges the role of routine and enriched environments. Implications for Rehabilitation Core practice elements of multidisciplinary early childhood intervention services indicate it is necessary to select outcome measures framed within the International Classification of Functioning-Child & Youth to inform clinical decision-making for measuring intervention effectiveness across the domains of activity, participation and environment. Of the identified measures, three (Canadian Occupational Performance Measure, Pediatric Evaluation of Disability Inventory, and Goal Attainment Scaling) are well-established and identified in the literature as multidisciplinary outcome measures for children with developmental disability. The selection of an appropriate outcome measure depends on the age of the child, individual goals of the family, and the type of intervention. This requires the combination of measures as no one measure alone will capture all components of the International Classification of Functioning-Child & Youth.

Including patients in core outcome set development: issues to consider based on three workshops with around 100 international delegates.

PubMed

Young, Bridget; Bagley, Heather

2016-01-01

This commentary article describes three interactive workshops that explored how patients can contribute to decisions about what outcomes are measured in clinical trials across the world. Outcomes like quality of life, side-effects and pain are used in trials to measure whether a treatment is effective. Here, we outline how research groups are increasingly coming together to develop 'core outcomes sets' for particular conditions. Core outcome sets are lists of agreed outcomes. Their use will help in identifying which treatments are effective by enabling people to compare the findings of different clinical trials in the same condition. Currently, it is often very difficult to make these comparisons because different studies often measure different outcomes. Delegates attending the workshops included patients, clinicians and researchers. They discussed ways of making core outcome set development more meaningful and accessible for patients, and ensuring that they have a genuine say in the development process. This article summarises these discussions and concludes by identifying three distinctive challenges in securing patient input to core outcome set development: the process and objectives can seem far removed from the immediate concerns of patients, difficulties can arise in securing patient input on an international scale, and difficulties can also arise in bringing multiple stakeholder groups together to achieve consensus. While patient participation, involvement and engagement in core outcome set development can draw on lessons from other research areas, these distinctive challenges point to the need for distinctive solutions to enable meaningful patient input to core outcome set development. Background This article describes three workshops that explored how patients can contribute to decisions about what outcomes are measured in clinical trials. People need evidence about what treatments are best for particular health conditions. The strongest evidence comes from systematic reviews comparing outcomes across different studies of treatments for a particular condition. However, it is often difficult to do these comparisons because the different studies-even though they have all investigated the same condition-often measure different outcomes. To tackle this problem, research teams are increasingly coming together to develop core outcome sets (COS) for particular conditions or treatments. The goal is that across the world, all the research teams working on the same condition or treatment will then use the COS in their research. Main body We report on three interactive workshops that explored how patients and the public can contribute to decision making about what outcomes should be included in a COS. About 100 international delegates, including researchers, clinicians and patients, attended the workshops. The workshops were held in the United Kingdom, Italy and Canada as part of the COMET (Core Outcome Measures in Effectiveness Trials) Initiative annual meetings. Patients who had some experience as research advisors, collaborators, partners or co-ordinators facilitated the workshops together with a researcher. Notes made during each workshop informed the preparation of this article. Workshop discussion focussed on ways of making core outcome set development more meaningful and accessible for patients. Delegates wanted patients to have a genuine say, alongside other stakeholders, in what outcomes are included in COS. Delegates felt that key to ensuring this is recognising that patient participation in COS development alone is not enough, and that patients will also need to be involved in the design of COS development studies. Conclusion We conclude by pointing to some distinctive challenges in including patients in COS development. While the COS development community can draw on the lessons learnt from other research areas about patient participation, involvement and engagement, the distinctive challenges that arise in COS development point to the need for some distinctive solutions too.

From Implementation to Outcomes to Impacts: Designing a Comprehensive Program Evaluation

NASA Astrophysics Data System (ADS)

Shebby, S.

2015-12-01

Funders are often interested in learning about the impact of program activities, yet before the impacts are determined, educational evaluations should first examine program implementation and outcomes. Implementation evaluation examines how and the extent to which program activities are delivered as intended, including the extent to which activities reached the targeted participants. Outcome evaluation is comprised of a systematic examination of the effects that a program has on program participants, such as changes in knowledge, attitudes, beliefs, values, and behaviors. In this presentation, presenters will share insights on evaluating the implementation, outcomes, and impacts associated with an online science curriculum for K-2 students. The science curriculum was designed to provide students with access to science concepts and skills in an interactive and innovative environment, and teachers with embedded, aligned, and on-demand professional development. One of the most important—and challenging—steps in this evaluation was to select outcomes that were well-defined, measurable, and aligned to program activities, as well as relevant to program stakeholders. An additional challenge was to measure implementation given limited access to the classroom environment. This presentation will include a discussion of the process evaluators used to select appropriate implementation indicators and outcomes (teacher and student), design an evaluation approach, and craft data collection instruments. Although examples provided are specific to the K-2 science intervention, the best practices discussed are pertinent to all program and event evaluations. Impact evaluation goes beyond implementation and outcome evaluation to inform whether a program is working or not. It requires a comparison group to inform what outcomes would have been in the absence of the intervention. As such, this presentation will also include a discussion of impacts, including how impacts are defined and measured, and some common challenges in evaluating program impact.

Report from the third international consensus meeting to harmonise core outcome measures for atopic eczema/dermatitis clinical trials (HOME)

PubMed Central

Chalmers, JR; Schmitt, J; Apfelbacher, C; Dohil, M; Eichenfield, LF; Simpson, EL; Singh, J; Spuls, P; Thomas, KS; Admani, S; Aoki, V; Ardeleanu, M; Barbarot, S; Berger, T; Bergman, JN; Block, J; Borok, N; Burton, T; Chamlin, SL; Deckert, S; DeKlotz, CC; Graff, LB; Hanifin, JM; Hebert, AA; Humphreys, R; Katoh, N; Kisa, RM; Margolis, DJ; Merhand, S; Minnillo, R; Mizutani, H; Nankervis, H; Ohya, Y; Rodgers, P; Schram, ME; Stalder, JF; Svensson, A; Takaoka, R; Teper, A; Tom, WL; von Kobyletzki, L; Weisshaar, E; Zelt, S; Williams, HC

2014-01-01

Summary This report provides a summary of the third meeting of the Harmonising Outcome Measures for Eczema (HOME) initiative held in San Diego, CA, U.S.A., 6–7 April 2013 (HOME III). The meeting addressed the four domains that had previously been agreed should be measured in every eczema clinical trial: clinical signs, patient-reported symptoms, long-term control and quality of life. Formal presentations and nominal group techniques were used at this working meeting, attended by 56 voting participants (31 of whom were dermatologists). Significant progress was made on the domain of clinical signs. Without reference to any named scales, it was agreed that the intensity and extent of erythema, excoriation, oedema/papulation and lichenification should be included in the core outcome measure for the scale to have content validity. The group then discussed a systematic review of all scales measuring the clinical signs of eczema and their measurement properties, followed by a consensus vote on which scale to recommend for inclusion in the core outcome set. Research into the remaining three domains was presented, followed by discussions. The symptoms group and quality of life groups need to systematically identify all available tools and rate the quality of the tools. A definition of long-term control is needed before progress can be made towards recommending a core outcome measure. What's already known about this topic? Many different scales have been used to measure eczema, making it difficult to compare trials in meta-analyses and hampering improvements in clinical practice. HOME core outcome measures must pass the OMERACT (Outcome Measures in Rheumatology) filter of truth (validity), discrimination (sensitivity to change and responsiveness) and feasibility (ease of use, costs, time to perform and interpret). It has been previously agreed as part of the consensus process that four domains should be measured by the core outcomes: clinical signs, patient-reported symptoms, long-term control and health-related quality of life. What does this study add? Progress was made towards developing a core outcome set for measuring eczema in clinical trials. The group established the essential items to be included in the outcome measure for the clinical signs of eczema and was able to recommend a scale for the core set. The remaining three domains of patient-reported symptoms, long-term control and health-related quality of life require further work and meetings to determine the core outcome measures. PMID:24980543

Developing an OMERACT Core Outcome Set for Assessing Safety Components in Rheumatology Trials: The OMERACT Safety Working Group.

PubMed

Klokker, Louise; Tugwell, Peter; Furst, Daniel E; Devoe, Dan; Williamson, Paula; Terwee, Caroline B; Suarez-Almazor, Maria E; Strand, Vibeke; Woodworth, Thasia; Leong, Amye L; Goel, Niti; Boers, Maarten; Brooks, Peter M; Simon, Lee S; Christensen, Robin

2017-12-01

Failure to report harmful outcomes in clinical research can introduce bias favoring a potentially harmful intervention. While core outcome sets (COS) are available for benefits in randomized controlled trials in many rheumatic conditions, less attention has been paid to safety in such COS. The Outcome Measures in Rheumatology (OMERACT) Filter 2.0 emphasizes the importance of measuring harms. The Safety Working Group was reestablished at the OMERACT 2016 with the objective to develop a COS for assessing safety components in trials across rheumatologic conditions. The safety issue has previously been discussed at OMERACT, but without a consistent approach to ensure harms were included in COS. Our methods include (1) identifying harmful outcomes in trials of interventions studied in patients with rheumatic diseases by a systematic literature review, (2) identifying components of safety that should be measured in such trials by use of a patient-driven approach including qualitative data collection and statistical organization of data, and (3) developing a COS through consensus processes including everyone involved. Members of OMERACT including patients, clinicians, researchers, methodologists, and industry representatives reached consensus on the need to continue the efforts on developing a COS for safety in rheumatology trials. There was a general agreement about the need to identify safety-related outcomes that are meaningful to patients, framed in terms that patients consider relevant so that they will be able to make informed decisions. The OMERACT Safety Working Group will advance the work previously done within OMERACT using a new patient-driven approach.

Standardized Reporting of the Eczema Area and Severity Index (EASI) and the Patient-Oriented Eczema Measure (POEM): A Recommendation by the Harmonising Outcome Measures for Eczema (HOME) Initiative.

PubMed

Grinich, E; Schmitt, J; Küster, D; Spuls, P I; Williams, H C; Chalmers, J R; Thomas, K S; Apfelbacher, C; Prinsen, C A C; Furue, M; Stuart, B; Carter, B; Simpson, E

2018-05-10

Several organizations from multiple fields of medicine are setting standards for clinical research including protocol development, 1 harmonization of outcome reporting, 2 statistical analysis, 3 quality assessment 4 and reporting of findings. 1 Clinical research standardization facilitates the interpretation and synthesis of data, increases the usability of trial results for guideline groups and shared decision-making, and reduces selective outcome reporting bias. The mission of the Harmonising Outcome Measures for Eczema (HOME) initiative is to establish an agreed-upon core set of outcomes to be measured and reported in all clinical trials of atopic dermatitis (AD). This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Measurement properties of performance-based outcome measures to assess physical function in young and middle-aged people known to be at high risk of hip and/or knee osteoarthritis: a systematic review.

PubMed

Kroman, S L; Roos, E M; Bennell, K L; Hinman, R S; Dobson, F

2014-01-01

To systematically appraise the evidence on measurement properties of performance-based outcome measures to assess physical function in young and middle-aged people known to be at high risk of hip and/or knee osteoarthritis (OA). Electronic searches were performed in MEDLINE, CINAHL, Scopus and SPORTDiscus in May 2013. Two reviewers independently rated the measurement properties using the 4-point COSMIN checklist. Best evidence synthesis was made using COSMIN quality, consistency and direction of findings and sample size. Twenty of 2736 papers were eligible for inclusion and 24 different performance-based outcome measures knee or obese populations were evaluated. No tests related to hip populations were included. Twenty-five measurement properties including reliability (nine studies), construct validity (hypothesis testing) (nine studies), measurement error (three studies), structural validity (two studies), interpretability (one study) and responsiveness (one study) were evaluated. A positive rating was given to 12.5% (30/240) of all possible measurement ratings. Tests were grouped into two categories based on the population characteristics. The one-legged hop for distance, followed by the 6-m timed hop and cross over hop for distance were the best-rated tests for the knee-injured population. Whereas the 6-min walk test was the only included test for the obese population. This review highlights the many gaps in knowledge about the measurement properties of performance-based outcome measures for young and middle-aged people known to be at high risk of hip and/or knee OA. There is a need for consensus on which outcome measures should be used and/or combined when assessing physical function in this population. Further good quality research is required. Copyright © 2013 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

Use of standardized outcome measures in physical therapist practice: perceptions and applications.

PubMed

Jette, Diane U; Halbert, James; Iverson, Courtney; Miceli, Erin; Shah, Palak

2009-02-01

Standardized instruments for measuring patients' activity limitations and participation restrictions have been advocated for use by rehabilitation professionals for many years. The available literature provides few recent reports of the use of these measures by physical therapists in the United States. The primary purpose of this study was to determine: (1) the extent of the use of standardized outcome measures and (2) perceptions regarding their benefits and barriers to their use. A secondary purpose was to examine factors associated with their use among physical therapists in clinical practice. The study used an observational design. A survey questionnaire comprising items regarding the use and perceived benefits and barriers of standardized outcome measures was sent to 1,000 randomly selected members of the American Physical Therapy Association (APTA). Forty-eight percent of participants used standardized outcome measures. The majority of participants (>90%) who used such measures believed that they enhanced communication with patients and helped direct the plan of care. The most frequently reported reasons for not using such measures included length of time for patients to complete them, length of time for clinicians to analyze the data, and difficulty for patients in completing them independently. Use of standardized outcome measures was related to specialty certification status, practice setting, and the age of the majority of patients treated. The limitations included an unvalidated survey for data collection and a sample limited to APTA members. Despite more than a decade of development and testing of standardized outcome measures appropriate for various conditions and practice settings, physical therapists have some distance to go in implementing their use routinely in most clinical settings. Based on the perceived barriers, alterations in practice management strategies and the instruments themselves may be necessary to increase their use.

Outcomes sensitive to nursing service quality in ambulatory cancer chemotherapy: Systematic scoping review.

PubMed

Griffiths, Peter; Richardson, Alison; Blackwell, Rebecca

2012-07-01

There is long standing interest in identifying patient outcomes that are sensitive to nursing care and an increasing number of systems that include outcomes in order to demonstrate or monitor the quality of nursing care. We undertook scoping reviews of the literature in order to identify patient outcomes sensitive to the quality of nursing services in ambulatory cancer chemotherapy settings to guide the development of an outcomes-based quality measurement system. A 2-stage scoping review to identify potential outcome areas which were subsequently assessed for their sensitivity to nursing was carried out. Data sources included the Cochrane Library, Medline, Embase, the British Nursing Index, Google and Google scholar. We identified a broad range of outcomes potentially sensitive to nursing. Individual trials support many nursing interventions but we found relatively little clear evidence of effect on outcomes derived from systematic reviews and no evidence associating characteristics of nursing services with outcomes. The purpose of identifying a set of outcomes as specifically nurse-sensitive for quality measurement is to give clear responsibility and create an expectation of strong clinical leadership by nurses in terms of monitoring and acting on results. It is important to select those outcomes that nurses have most impact upon. Patient experience, nausea, vomiting, mucositis and safe medication administration were outcome areas most likely to yield sensitive measures of nursing service quality in ambulatory cancer chemotherapy. Copyright © 2011 Elsevier Ltd. All rights reserved.

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 standards of feasibility and psychometric credibility in relation to use for practice and policy.

Race, Income, and Disease Outcomes in Juvenile Dermatomyositis.

PubMed

Phillippi, Kathryn; Hoeltzel, Mark; Byun Robinson, Angela; Kim, Susan

2017-05-01

To determine the relationships among race, income, and disease outcomes in children with juvenile dermatomyositis (JDM). Data from 438 subjects with JDM enrolled in the Childhood Arthritis and Rheumatology Research Alliance (CARRA) Legacy Registry were analyzed. Demographic data included age, sex, race, annual family income, and insurance status. Clinical outcomes included muscle strength, presence of rash, calcinosis, weakness, physical function, and quality of life measures. Disease outcomes were compared based on race and income. Minority subjects were significantly more likely to have low annual family income and significantly worse scores on measures of physical function, disease activity, and quality of life measures. Subjects with lower annual family income had worse scores on measures of physical function, disease activity, and quality of life scores, as well as weakness. Black subjects were more likely to have calcinosis. Despite these differences in outcome measures, there were no significant differences among the racial groups in time to diagnosis or duration of disease. Using calcinosis as a marker of disease morbidity, black race, annual family income <$50 000 per year, negative antinuclear antibody, and delay in diagnosis >12 months were associated with calcinosis. Minority race and lower family income are associated with worse morbidity and outcomes in subjects with JDM. Calcinosis was more common in black subjects. Further studies are needed to examine these associations in more detail, to support efforts to address health disparities in subjects with JDM and improve disease outcomes. Copyright © 2017 Elsevier Inc. All rights reserved.

Development of a Core Set of Outcome Measures for Large-vessel Vasculitis: Report from OMERACT 2016.

PubMed

Sreih, Antoine G; Alibaz-Oner, Fatma; Kermani, Tanaz A; Aydin, Sibel Z; Cronholm, Peter F; Davis, Trocon; Easley, Ebony; Gul, Ahmet; Mahr, Alfred; McAlear, Carol A; Milman, Nataliya; Robson, Joanna C; Tomasson, Gunnar; Direskeneli, Haner; Merkel, Peter A

2017-12-01

Among the challenges in conducting clinical trials in large-vessel vasculitis (LVV), including both giant cell arteritis (GCA) and Takayasu arteritis (TA), is the lack of standardized and meaningful outcome measures. The Outcome Measures in Rheumatology (OMERACT) Vasculitis Working Group initiated an international effort to develop and validate data-driven outcome tools for clinical investigation in LVV. An international Delphi exercise was completed to gather opinions from clinical experts on LVV-related domains considered important to measure in trials. Patient interviews and focus groups were completed to identify outcomes of importance to patients. The results of these activities were presented and discussed in a "Virtual Special Interest Group" using telephone- and Internet-based conferences, discussions through electronic mail, and an in-person session at the 2016 OMERACT meeting. A preliminary core set of domains common for all forms of LVV with disease-specific elements was proposed. The majority of experts agree with using common outcome measures for GCA and TA, with the option of supplementation with disease-specific items. Following interviews and focus groups, pain, fatigue, and emotional effect emerged as health-related quality of life domains important to patients. Current disease assessment tools, including the Birmingham Vasculitis Activity Score, were found to be inadequate to assess disease activity in GCA and standardized assessment of imaging tests were felt crucial to study LVV, especially TA. Initial data from a clinician Delphi exercise and structured patient interviews have provided themes toward an OMERACT-endorsed core set of domains and outcome measures.

Measuring outcomes in children's rehabilitation: a decision protocol.

PubMed

Law, M; King, G; Russell, D; MacKinnon, E; Hurley, P; Murphy, C

1999-06-01

To develop and test the feasibility and clinical utility of a computerized self-directed software program designed to enable service providers in children's rehabilitation to make decisions about the most appropriate outcome measures to use in client and program evaluation. A before-and-after design was used to test the feasibility and initial impact of the decision-making outcome software in improving knowledge and use of clinical outcome measures. A children's rehabilitation center in a city of 50,000. All service providers in the children's rehabilitation center. Disciplines represented included early childhood education, occupational therapy, physical therapy, speech and language pathology, audiology, social work, and psychology. Using a conceptual framework based on the International Classification of Impairment, Disability, and Handicap (ICIDH), an outcome measurement decision-making protocol was developed. The decision-making protocol was computerized in an educational software program with an attached database of critically appraised measures. Participants learned about outcome measures through the program and selected outcome measures that met their specifications. The computer software was tested for feasibility in the children's rehabilitation center for 6 months. Knowledge and use of clinical outcome measures were determined before and after the feasibility testing using a survey of all service providers currently at the centre and audits of 30 randomly selected rehabilitation records (at pretest, posttest, and follow-up). Service providers indicated that the outcomes software was easy to follow and believed that the use of the ICIDH framework helped them in making decisions about selecting outcome measures. Results of the survey indicated that there were significant changes in the service providers' level of comfort with selecting measures and knowing what measures were available. Use of outcome measures as identified through the audit did not change. The "All About Outcomes" software is clinically useful. Further research should evaluate whether using the software affects the use of outcome measures in clinical practice.

Workplace Outcomes in Work-Disability Prevention Research: A Review with Recommendations for Future Research.

PubMed

Young, Amanda E; Viikari-Juntura, Eira; Boot, Cécile R L; Chan, Chetwyn; de Porras, David Gimeno Ruiz; Linton, Steven J

2016-12-01

Introduction Outcome assessment is a central issue in work disability prevention research. The goal of this paper was to (1) ascertain the most salient workplace outcomes; (2) evaluate the congruence between business and science perspectives; (3) illustrate new perspectives on assessing longitudinal outcomes; and (4) provide recommendations for advancing outcome evaluation in this area of research. Methods The authors participated in a year-long collaboration that culminated in a sponsored 3-day conference, "Improving Research of Employer Practices to Prevent Disability", held October 14-16, 2015, in Hopkinton, MA, USA. The collaboration included a topical review of the literature, group conference calls to identify key areas and challenges, drafting of initial documents, review of industry publications, and a conference presentation that included feedback from peer researchers and a question/answer session with a special panel of knowledge experts with direct employer experience. Results Numerous workplace work-disability prevention outcome measures were identified. Analysis indicated that their applicability varied depending on the type of work disability the worker was experiencing. For those who were working, but with health-related work limitations (Type 1), predominant outcomes were measures of productivity, presenteeism, and work-related limitations. For those who were off work due to a health condition (Type 2), predominant outcomes were measures of time off work, supervisor/employee interactions, and return-to-work (RTW) preparation. For those who had returned to work (Type 3), predominant outcomes were measures of presenteeism, time until RTW, percentage of work resumption, employment characteristics, stigma, work engagement, co-worker interactions, and sustained or durable RTW. For those who had withdrawn from the labor force (Type 4), predominant outcomes were cost and vocational status. Discussion Currently available measures provide a good basis to use more consistent outcomes in disability prevention in the future. The research area would also benefit from more involvement of employers as stakeholders, and multilevel conceptualizations of disability outcomes.

Post-thrombotic syndrome in children: a systematic review of frequency of occurrence, validity of outcome measures, and prognostic factors

PubMed Central

Goldenberg, Neil A.; Donadini, Marco P.; Kahn, Susan R.; Crowther, Mark; Kenet, Gili; Nowak-Göttl, Ulrike; Manco-Johnson, Marilyn J.

2010-01-01

Background Post-thrombotic syndrome is a manifestation of chronic venous insufficiency following deep venous thrombosis. This systematic review was conducted to critically evaluate pediatric evidence on frequency of occurrence, validity of outcome measures, and prognostic indicators of post-thrombotic syndrome. Design and Methods A comprehensive literature search of original reports revealed 19 eligible studies, totaling 977 patients with upper/lower extremity deep venous thrombosis. Calculated weighted mean frequency of post-thrombotic syndrome was 26% (95% confidence interval: 23–28%) overall, and differed significantly by prospective/non-prospective analysis and use/non-use of a standardized outcome measure. Results Standardized post-thrombotic syndrome outcome measures included an adaptation of the Villalta scale, the Clinical-Etiologic-Anatomic-Pathologic classification, and the Manco-Johnson instrument. Data on validity were reported only for the Manco-Johnson instrument. No publications on post-thrombotic syndrome-related quality of life outcomes were identified. Candidate prognostic factors for post-thrombotic syndrome in prospective studies included use/non-use of thrombolysis and plasma levels of factor VIII activity and D-dimer. Conclusions Given that affected children must endure chronic sequelae for many decades, it is imperative that future collaborative pediatric prospective cohort studies and trials assess as key objectives and outcomes the incidence, severity, prognostic indicators, and health impact of post-thrombotic syndrome, using validated measures. PMID:20595095

Measure of functional independence dominates discharge outcome prediction after inpatient rehabilitation for stroke.

PubMed

Brown, Allen W; Therneau, Terry M; Schultz, Billie A; Niewczyk, Paulette M; Granger, Carl V

2015-04-01

Identifying clinical data acquired at inpatient rehabilitation admission for stroke that accurately predict key outcomes at discharge could inform the development of customized plans of care to achieve favorable outcomes. The purpose of this analysis was to use a large comprehensive national data set to consider a wide range of clinical elements known at admission to identify those that predict key outcomes at rehabilitation discharge. Sample data were obtained from the Uniform Data System for Medical Rehabilitation data set with the diagnosis of stroke for the years 2005 through 2007. This data set includes demographic, administrative, and medical variables collected at admission and discharge and uses the FIM (functional independence measure) instrument to assess functional independence. Primary outcomes of interest were functional independence measure gain, length of stay, and discharge to home. The sample included 148,367 people (75% white; mean age, 70.6±13.1 years; 97% with ischemic stroke) admitted to inpatient rehabilitation a mean of 8.2±12 days after symptom onset. The total functional independence measure score, the functional independence measure motor subscore, and the case-mix group were equally the strongest predictors for any of the primary outcomes. The most clinically relevant 3-variable model used the functional independence measure motor subscore, age, and walking distance at admission (r(2)=0.107). No important additional effect for any other variable was detected when added to this model. This analysis shows that a measure of functional independence in motor performance and age at rehabilitation hospital admission for stroke are predominant predictors of outcome at discharge in a uniquely large US national data set. © 2015 American Heart Association, Inc.

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.

A meta-analysis of multicultural competencies and psychotherapy process and outcome.

PubMed

Tao, Karen W; Owen, Jesse; Pace, Brian T; Imel, Zac E

2015-07-01

For decades, psychologists have emphasized the provision of multiculturally competent psychotherapy to reduce racial and ethnic disparities in mental health treatment. However, the relationship between multicultural competencies (MC) and other measures of clinical process and treatment outcome has shown heterogeneity in effect sizes. This meta-analysis tested the association of client ratings of therapist MC with measures of therapeutic processes and outcome, including: (a) working alliance, (b) client satisfaction, (c) general counseling competence, (d) session impact, and (e) symptom improvement. Among 18 studies (20 independent samples) included in the analysis, the correlation between therapist MC and outcome (r = .29) was much smaller than the association with process measures (r = .75), but there were no significant differences in correlations across different types of MC or clinical process measures. Providing some evidence of publication bias, effect sizes from published studies (r = .67) were larger than those from unpublished dissertations (r = .28). Moderator analyses indicated that client age, gender, the representation of racial-ethnic minority (R-EM) clients, and clinical setting were not associated with effect size variability. Based on these findings, we discuss implications and recommendations for future research that might lead to a better understanding of the effects of therapist MC on treatment process and outcome. Primary needs in future research include the development and evaluation of observer ratings of therapist MC and the implementation of longitudinal research designs. (c) 2015 APA, all rights reserved).

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.

Clinical outcome assessment in malignant glioma trials: measuring signs, symptoms, and functional limitations.

PubMed

Blakeley, Jaishri O; Coons, Stephen Joel; Corboy, John R; Kline Leidy, Nancy; Mendoza, Tito R; Wefel, Jeffrey S

2016-03-01

The shared goal of all parties developing therapeutics against malignant gliomas is to positively impact the lives of people affected by these cancers. Clinical outcome assessment (COA) tools, including measures of patient-reported outcome, performance outcome, clinician-reported outcome, and observer-reported outcome, allow patient-focused assessments to complement traditional efficacy measures such as overall survival and radiographic endpoints. This review examines the properties of various COA measures used in malignant glioma clinical trials to date and cross references their content to the priority signs, symptoms, and functional limitations defined through a community survey conducted by the National Brain Tumor Society. The overarching goal of this initiative is to identify COA measures that are feasible and have appropriate psychometric properties for use in this patient population as well as highlight where further development is needed. Published by Oxford University Press on behalf of the Society for Neuro-Oncology 2016. This work is written by (a) US Government employee(s) and is in the public domain in the US.

The effect of measuring serum doxycycline concentrations on clinical outcomes during treatment of chronic Q fever.

PubMed

van Roeden, S E; Bleeker-Rovers, C P; Kampschreur, L M; de Regt, M J A; Vermeulen Windsant, A; Hoepelman, A I M; Wever, P C; Oosterheert, J J

2018-04-01

First choice treatment for chronic Q fever is doxycycline plus hydroxychloroquine. Serum doxycycline concentration (SDC) >5 μg/mL has been associated with a favourable serological response, but the effect on clinical outcomes is unknown. To assess the effect of measuring SDC during treatment of chronic Q fever on clinical outcomes. We performed a retrospective cohort study, to assess the effect of measuring SDC on clinical outcomes in patients treated with doxycycline and hydroxychloroquine for chronic Q fever. Primary outcome was the first disease-related event (new complication or chronic Q fever-related mortality); secondary outcomes were all-cause mortality and PCR-positivity. Multivariable analysis was performed with a Cox proportional hazards model, with shared-frailty terms for different hospitals included. We included 201 patients (mean age 68 years, 83% male): in 167 patients (83%) SDC was measured, 34 patients (17%) were treated without SDC measurement. First SDC was >5 μg/mL in 106 patients (63%), all with 200 mg doxycycline daily. In patients with SDC measured, dosage was adjusted in 41% (n = 68), concerning an increase in 64 patients. Mean SDC was 4.1 μg/mL before dosage increase, and 5.9 μg/mL afterwards. SDC measurement was associated with a lower risk for disease-related events (HR 0.51, 95% CI 0.26-0.97, P = 0.04), but not with all-cause mortality or PCR-positivity. SDC measurement decreases the risk for disease-related events, potentially through more optimal dosing or improved compliance. We recommend measurement of SDC and striving for SDC >5 μg/mL and <10 μg/mL during treatment of chronic Q fever.

Item Banks for Measuring Emotional Distress from the Patient-Reported Outcomes Measurement Information System (PROMIS[R]): Depression, Anxiety, and Anger

ERIC Educational Resources Information Center

Pilkonis, Paul A.; Choi, Seung W.; Reise, Steven P.; Stover, Angela M.; Riley, William T.; Cella, David

2011-01-01

The authors report on the development and calibration of item banks for depression, anxiety, and anger as part of the Patient-Reported Outcomes Measurement Information System (PROMIS[R]). Comprehensive literature searches yielded an initial bank of 1,404 items from 305 instruments. After qualitative item analysis (including focus groups and…

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 standards of feasibility and psychometric credibility in relation to use for practice and policy. PMID:24834111

Purchasing population health: aligning financial incentives to improve health outcomes.

PubMed

Kindig, D A

1999-01-01

To review the concept of population health, including its definition, measurement, and determinants, and to suggest an approach for aligning financial incentives toward this goal. DATA SOURCE, STUDY DESIGN, DATA EXTRACTION: Literature review, policy analysis The article presents the argument that a major reason for our slow progress toward health outcome improvement is that there is no operational definition of population health and that financial incentives are not aligned to this goal. Current attempts at process measures as indicators of quality or outcome are not adequate for the task. It is suggested that some measure of health-adjusted life expectancy be adopted for this purpose, and that integrated delivery systems and other agents responsible for nonmedical determinants be rewarded for improvement in this measure. This will require the development of an investment portfolio across the determinants of health based on relative marginal return to health, with horizontal integration strategies across sectoral boundaries. A 20-year three-phase development strategy is proposed, including components of research and acceptance, integrated health system implementation, and cross-sectoral integration. The U.S. health care system is a $1 trillion industry without a definition of its product. Until population outcome measures are developed and rewarded for, we will not solve the twenty-first century challenge of maximizing health outcome improvement for the resources available.

Purchasing population health: aligning financial incentives to improve health outcomes.

PubMed

Kindig, D A

1998-06-01

To review the concept of population health, including its definition, measurement, and determinants, and to suggest an approach for aligning financial incentives toward this goal. DATA SOURCE, STUDY DESIGN, DATA EXTRACTION. Literature review, policy analysis The article presents the argument that a major reason for our slow progress toward health outcome improvement is that there is no operational definition of population health and that financial incentives are not aligned to this goal. Current attempts at process measures as indicators of quality or outcome are not adequate for the task. It is suggested that some measure of health-adjusted life expectancy be adopted for this purpose, and that integrated delivery systems and other agents responsible for nonmedical determinants be rewarded for improvement in this measure. This will require the development of an investment portfolio across the determinants of health based on relative marginal return to health, with horizontal integration strategies across sectoral boundaries. A 20-year three-phase development strategy is proposed, including components of research and acceptance, integrated health system implementation, and cross-sectoral integration. The U.S. healthcare system is a $1 trillion industry without a definition of its product. Until population outcome measures are developed and rewarded for, we will not solve the twenty-first century challenge of maximizing health outcome improvement for the resources available.

A 5-Year Review of Clinical Outcome Measures Published in the Journal of the American Podiatric Medical Association and the Journal of Foot and Ankle Surgery®.

PubMed

Hasenstein, Todd; Greene, Timothy; Meyr, Andrew J

This investigation presents a review of all of the clinical outcome measures used by authors and published in the Journal of the American Podiatric Medical Association and the Journal of Foot and Ankle Surgery ® from January 1, 2011, to December 31, 2015. Of 1,336 articles published during this time frame, 655 (49.0%) were classified as original research and included in this analysis. Of these 655 articles, 151 (23.1%) included at least one clinical outcome measure. Thirty-seven unique clinical outcome scales were used by authors and published during this period. The most frequently reported scales in the 151 included articles were the American Orthopaedic Foot and Ankle Society scales (54.3%; n = 82), visual analog scale (35.8%; n = 54), Medical Outcomes Study Short Form Health Survey (any version) (10.6%; n = 16), Foot Function Index (5.3%; n = 8), Maryland Foot Score (4.0%; n = 6), and Olerud and Molander scoring system (4.0%; n = 6). Twenty-four (15.9%) articles used some form of original/subjective measure of patient satisfaction/expectation. The results of this investigation detail the considerable variety of clinical outcome measurement tools used by authors in the Journal of the American Podiatric Medical Association and the Journal of Foot and Ankle Surgery ® and might support the need for a shift toward the consistent use of a smaller number of valid, reliable, and clinically useful scales in the podiatric medical literature. Copyright © 2017 American Podiatric Medical Association and the American College of Foot and Ankle Surgeons. Published by Elsevier Inc. All rights reserved.

The patient-specific functional scale: psychometrics, clinimetrics, and application as a clinical outcome measure.

PubMed

Horn, Katyana Kowalchuk; Jennings, Sophie; Richardson, Gillian; Vliet, Ditte Van; Hefford, Cheryl; Abbott, J Haxby

2012-01-01

Systematic review of the literature. To summarize peer-reviewed literature on the reliability, validity, and responsiveness of the Patient-Specific Functional Scale (PSFS), and to identify its use as an outcome measure. Searches were performed of several electronic databases from 1995 to May 2010. Studies included were published articles containing (1) primary research investigating the psychometric and clinimetrics of the PSFS or (2) the implementation of the PSFS as an outcome measure. We assessed the methodological quality of studies included in the first category. Two hundred forty-two articles published from 1994 to May 2010 were identified. Of these, 66 met the inclusion criteria for this review, with 13 reporting the measurement properties of the PSFS, 55 implementing the PSFS as an outcome measure, and 2 doing both of the above. The PSFS was reported to be valid, reliable, and responsive in populations with knee dysfunction, cervical radiculopathy, acute low back pain, mechanical low back pain, and neck dysfunction. The PSFS was found to be reliable and responsive in populations with chronic low back pain. The PSFS was also reported to be valid, reliable, or responsive in individuals with a limited number of acute, subacute, and chronic conditions. This review found that the PSFS is also being used as an outcome measure in many other conditions, despite a lack of published evidence supporting its validity in these conditions. Although the use of the PSFS as an outcome measure is increasing in physiotherapy practice, there are gaps in the research literature regarding its validity, reliability, and responsiveness in many health conditions.

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 ClinRO assessments used as end points in clinical trials. Applying good measurement practices to ClinRO assessment development and evaluation will lead to more efficient and accurate measurement of treatment effects. This is important beyond regulatory approval in that it provides evidence for the uptake of new interventions into clinical practice and provides justification to payers for reimbursement on the basis of the clearly demonstrated added value of the new intervention. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Measurement of Religiosity/Spirituality in Adolescent Health Outcomes Research: Trends and Recommendations

PubMed Central

McGrady, Meghan E.; Rosenthal, Susan L.

2010-01-01

The relationship between religious/spiritual (R/S) factors and adolescent health outcomes has been studied for decades; however, the R/S measurement tools used may not be developmentally relevant for adolescents. A systematic literature review was conducted to review and evaluate trends in measuring R/S in adolescent health outcomes research. In this review a total of 100 articles met criteria for inclusion. Relatively few (n = 15) included adolescent-specific R/S measures or items accounting for developmentally relevant issues such as parental religiosity or age-appropriate language. Future R/S and health research with adolescents would be strengthened by incorporating developmentally relevant R/S measurement tools, psychometrics, and multidimensional measures. PMID:20127172

Developing core outcome sets for clinical trials: issues to consider

PubMed Central

2012-01-01

The selection of appropriate outcomes or domains is crucial when designing clinical trials in order to compare directly the effects of different interventions in ways that minimize bias. If the findings are to influence policy and practice then the chosen outcomes need to be relevant and important to key stakeholders including patients and the public, health care professionals and others making decisions about health care. There is a growing recognition that insufficient attention has been paid to the outcomes measured in clinical trials. These issues could be addressed through the development and use of an agreed standardized collection of outcomes, known as a core outcome set, which should be measured and reported, as a minimum, in all trials for a specific clinical area. Accumulating work in this area has identified the need for general guidance on the development of core outcome sets. Key issues to consider in the development of a core outcome set include its scope, the stakeholder groups to involve, choice of consensus method and the achievement of a consensus. PMID:22867278

Development of a core set of outcome measures for OAB treatment.

PubMed

Foust-Wright, Caroline; Wissig, Stephanie; Stowell, Caleb; Olson, Elizabeth; Anderson, Anita; Anger, Jennifer; Cardozo, Linda; Cotterill, Nikki; Gormley, Elizabeth Ann; Toozs-Hobson, Philip; Heesakkers, John; Herbison, Peter; Moore, Kate; McKinney, Jessica; Morse, Abraham; Pulliam, Samantha; Szonyi, George; Wagg, Adrian; Milsom, Ian

2017-12-01

Standardized measures enable the comparison of outcomes across providers and treatments giving valuable information for improving care quality and efficacy. The aim of this project was to define a minimum standard set of outcome measures and case-mix factors for evaluating the care of patients with overactive bladder (OAB). The International Consortium for Health Outcomes Measurement (ICHOM) convened an international working group (WG) of leading clinicians and patients to engage in a structured method for developing a core outcome set. Consensus was determined by a modified Delphi process, and discussions were supported by both literature review and patient input. The standard set measures outcomes of care for adults seeking treatment for OAB, excluding residents of long-term care facilities. The WG focused on treatment outcomes identified as most important key outcome domains to patients: symptom burden and bother, physical functioning, emotional health, impact of symptoms and treatment on quality of life, and success of treatment. Demographic information and case-mix factors that may affect these outcomes were also included. The standardized outcome set for evaluating clinical care is appropriate for use by all health providers caring for patients with OAB, regardless of specialty or geographic location, and provides key data for quality improvement activities and research.

Objective Assessment of Vergence after Treatment of Concussion-Related CI: A Pilot Study

PubMed Central

Scheiman, Mitchell; Talasan, Henry; Mitchell, Gladys L; Alvarez, Tara L.

2016-01-01

Purpose To evaluate changes in objective measures of disparity vergence after office-based vision therapy (OBVT) for concussion-related convergence insufficiency (CI), and determine the feasibility of using this objective assessment as an outcome measure in a clinical trial. Methods This was a prospective, observational trial. All participants were treated with weekly OBVT with home reinforcement. Participants included two adolescents and three young adults with concussion-related, symptomatic CI. The primary outcome measure was average peak velocity for 4-degree symmetrical convergence steps. Other objective outcome measures of disparity vergence included time to peak velocity, latency, accuracy, settling time, and main sequence. We also evaluated saccadic eye movements using the same outcome measures. Changes in clinical measures (near point of convergence, positive fusional vergence at near, Convergence Insufficiency Symptom Survey (CISS) score) were evaluated. Results There were statistically significant and clinically meaningful changes in all clinical measures for convergence. Four of the five subjects met clinical success criteria. For the objective measures, we found a statistically significant increase in peak velocity, response accuracy to 4° symmetrical convergence and divergence step stimuli and the main sequence ratio for convergence step stimuli. Objective saccadic eye movements (5° and 10°) appeared normal pre-OBVT, and did not show any significant change after treatment. Conclusions This is the first report of the use of objective measures of disparity vergence as outcome measures for concussion-related convergence insufficiency. These measures provide additional information that is not accessible with clinical tests about underlying physiological mechanisms leading to changes in clinical findings and symptoms. The study results also demonstrate that patients with concussion can tolerate the visual demands (over 200 vergence and versional eye movements) during the 25-minute testing time and suggest that these measures could be used in a large-scale randomized clinical trial of concussion-related CI as outcome measures. PMID:27464574

Objective Assessment of Vergence after Treatment of Concussion-Related CI: A Pilot Study.

PubMed

Scheiman, Mitchell M; Talasan, Henry; Mitchell, G Lynn; Alvarez, Tara L

2017-01-01

To evaluate changes in objective measures of disparity vergence after office-based vision therapy (OBVT) for concussion-related convergence insufficiency (CI) and determine the feasibility of using this objective assessment as an outcome measure in a clinical trial. This was a prospective, observational trial. All participants were treated with weekly OBVT with home reinforcement. Participants included two adolescents and three young adults with concussion-related, symptomatic CI. The primary outcome measure was average peak velocity for 4° symmetrical convergence steps. Other objective outcome measures of disparity vergence included time to peak velocity, latency, accuracy, settling time, and main sequence. We also evaluated saccadic eye movements using the same outcome measures. Changes in clinical measures (near point of convergence, positive fusional vergence at near, Convergence Insufficiency Symptom Survey [CISS] score) were evaluated. There were statistically significant and clinically meaningful changes in all clinical measures for convergence. Four of the five subjects met clinical success criteria. For the objective measures, we found a statistically significant increase in peak velocity, response accuracy to 4° symmetrical convergence and divergence step stimuli, and the main sequence ratio for convergence step stimuli. Objective saccadic eye movements (5 and 10°) appeared normal pre-OBVT and did not show any significant change after treatment. This is the first report of the use of objective measures of disparity vergence as outcome measures for concussion-related convergence insufficiency. These measures provide additional information that is not accessible with clinical tests about underlying physiological mechanisms leading to changes in clinical findings and symptoms. The study results also demonstrate that patients with concussion can tolerate the visual demands (over 200 vergence and versional eye movements) during the 25-minute testing time and suggest that these measures could be used in a large-scale randomized clinical trial of concussion-related CI as outcome measures.

Outcome Measures Used in Clinical Trials for Behçet Syndrome: A Systematic Review

PubMed Central

Hatemi, Gulen; Merkel, Peter A.; Hamuryudan, Vedat; Boers, Maarten; Direskeneli, Haner; Aydin, Sibel Z.; Yazici, Hasan

2015-01-01

Behçet syndrome (BS) is a multisystem vasculitis that is most active during young adulthood, causing serious disability and significant impairment in quality of life. Differences in the disease course, severity, and organ involvement between patients, depending on the age at presentation and sex, makes it impossible to determine a single management strategy. The diversity and variability in the outcome measures used in clinical trials in BS makes it difficult to compare the results or inform physicians about the best management strategy for individual patients. There is a large unmet need to determine or develop validated outcome measures for use in clinical trials in BS that are acceptable to researchers and regulatory agencies. We conducted a systematic review to describe the outcomes and outcome measures that have been used in clinical trials in BS. This review revealed the diversity and variability in the outcomes and outcome measures and the lack of standard definitions for most outcomes and rarity of validated outcome tools for disease assessment in BS. This systematic literature review will identify domains and candidate instruments for use in a Delphi exercise, the next step in the development of a core set of outcome measures that are properly validated and widely accepted by the collaboration of researchers from many different regions of the world and from different specialties, including rheumatology, ophthalmology, dermatology, gastroenterology, and neurology. PMID:24488418

Outcome measures used in clinical trials for Behçet syndrome: a systematic review.

PubMed

Hatemi, Gulen; Merkel, Peter A; Hamuryudan, Vedat; Boers, Maarten; Direskeneli, Haner; Aydin, Sibel Z; Yazici, Hasan

2014-03-01

Behçet syndrome (BS) is a multisystem vasculitis that is most active during young adulthood, causing serious disability and significant impairment in quality of life. Differences in the disease course, severity, and organ involvement between patients, depending on the age at presentation and sex, makes it impossible to determine a single management strategy. The diversity and variability in the outcome measures used in clinical trials in BS makes it difficult to compare the results or inform physicians about the best management strategy for individual patients. There is a large unmet need to determine or develop validated outcome measures for use in clinical trials in BS that are acceptable to researchers and regulatory agencies. We conducted a systematic review to describe the outcomes and outcome measures that have been used in clinical trials in BS. This review revealed the diversity and variability in the outcomes and outcome measures and the lack of standard definitions for most outcomes and rarity of validated outcome tools for disease assessment in BS. This systematic literature review will identify domains and candidate instruments for use in a Delphi exercise, the next step in the development of a core set of outcome measures that are properly validated and widely accepted by the collaboration of researchers from many different regions of the world and from different specialties, including rheumatology, ophthalmology, dermatology, gastroenterology, and neurology.

The Importance of Comprehensive Cam Correction: Radiographic Parameters Are Predictive of Patient-Reported Outcome Measures at 2 Years After Hip Arthroscopy.

PubMed

Lansdown, Drew A; Kunze, Kyle; Ukwuani, Gift; Waterman, Brian R; Nho, Shane J

2018-06-01

The specific influence of preoperative and postoperative radiographic measurements on patient-reported outcome measures after hip arthroscopy for femoroacetabular impingement (FAI) remains unclear. To investigate the relationship between radiographic measurements and 2-year outcomes after hip arthroscopy for the treatment of FAI. Case series; Level of evidence, 4. A clinical registry of patients undergoing primary hip arthroscopy for FAI between January 1, 2012, and December 31, 2014, was queried. Outcome measures included the Hip Outcome Score (HOS) Activities of Daily Living (ADL), HOS Sport-Specific Subscale (SSS), modified Harris Hip Score (mHHS), and visual analog scale (VAS) for pain and satisfaction. Preoperative and postoperative radiographic measurements were recorded. Univariate analysis was conducted to identify relationships between all radiographic and demographic variables and outcome scores. A multivariate regression analysis, controlling for demographic factors, was used to identify independent associations between radiographic measurements on plain radiographs and patient-reported outcomes. The authors identified 707 patients who underwent primary hip arthroscopic management for FAI who were included for analysis. Two-year outcome surveys were completed for 78% to 84% of patients. The mean age of the patients was 33.2 ± 12.3 years, and 64.4% of the patients (n = 456) were female. The mean anteroposterior (AP) alpha angle decreased by 34.3° ( P < .0001), false profile alpha angle by 25.2° ( P < .0001), Dunn lateral alpha angle by 28.9° ( P < .0001), lateral center edge angle by 2.6° ( P < .0001), and anterior center edge angle by 3.4° ( P < .0001). The HOS-ADL score increased from 65.7 ± 18.7 preoperatively to 85.9 ± 16.7 postoperatively ( P < .0001), HOS-SSS increased from 43.4 ± 23.1 to 72.6 ± 27.2 ( P < .0001), and mHHS increased from 57.7 ± 14.0 to 79.1 ± 17.2 ( P < .0001). With multivariate analysis, independent predictors of the postoperative HOS-ADL score included the preoperative false profile alpha angle (beta = -0.16, P = .028). Independent predictors of HOS-SSS score were preoperative AP alpha angle (beta = -0.33, P = .032) and preoperative false profile alpha angle (beta = -0.28, P = .041). For the postoperative mHHS score, independent predictors included preoperative AP alpha angle (beta = -0.18, P = .046), preoperative false profile alpha angle (beta = -0.20, P = .014), and postoperative false profile alpha angle (beta = -0.48, P = .035). The preoperative AP alpha angle (beta = 0.28, P = .024) was a significant predictor for the postoperative VAS pain score. The preoperative false profile alpha angle (beta = -0.34, P = .040) was a significant predictor for the postoperative VAS satisfaction score. The authors observed that radiographic measurements, specifically the preoperative false profile alpha angle, AP alpha angle, and postoperative false profile alpha angle, are independent predictors of 2-year clinical outcomes. The femoral-side measurements were the strongest independent predictors of outcomes, especially measurements of the anterior and lateral-based CAM lesion.

Quality Measures for the Care of Patients with Narcolepsy

PubMed Central

Krahn, Lois E.; Hershner, Shelley; Loeding, Lauren D.; Maski, Kiran P.; Rifkin, Daniel I.; Selim, Bernardo; Watson, Nathaniel F.

2015-01-01

The American Academy of Sleep Medicine (AASM) commissioned a Workgroup to develop quality measures for the care of patients with narcolepsy. Following a comprehensive literature search, 306 publications were found addressing quality care or measures. Strength of association was graded between proposed process measures and desired outcomes. Following the AASM process for quality measure development, we identified three outcomes (including one outcome measure) and seven process measures. The first desired outcome was to reduce excessive daytime sleepiness by employing two process measures: quantifying sleepiness and initiating treatment. The second outcome was to improve the accuracy of diagnosis by employing the two process measures: completing both a comprehensive sleep history and an objective sleep assessment. The third outcome was to reduce adverse events through three steps: ensuring treatment follow-up, documenting medical comorbidities, and documenting safety measures counseling. All narcolepsy measures described in this report were developed by the Narcolepsy Quality Measures Work-group and approved by the AASM Quality Measures Task Force and the AASM Board of Directors. The AASM recommends the use of these measures as part of quality improvement programs that will enhance the ability to improve care for patients with narcolepsy. Citation: Krahn LE, Hershner S, Loeding LD, Maski KP, Rifkin DI, Selim B, Watson NF. Quality measures for the care of patients with narcolepsy. J Clin Sleep Med 2015;11(3):335–355. PMID:25700880

Six-Month Changes in Spirituality and Religiousness in Alcoholics Predict Drinking Outcomes at Nine Months*

PubMed Central

Robinson, Elizabeth A. R.; Krentzman, Amy R.; Webb, Jon R.; Brower, Kirk J.

2011-01-01

Objective: Although spiritual change is hypothesized to contribute to recovery from alcohol dependence, few studies have used prospective data to investigate this hypothesis. Prior studies have also been limited to treatment-seeking and Alcoholics Anonymous (AA) samples. This study included alcohol-dependent individuals, both in treatment and not, to investigate the effect of spiritual and religious (SR) change on subsequent drinking outcomes, independent of AA involvement. Method: Alcoholics (N = 364) were recruited for a panel study from two abstinence-based treatment centers, a moderation drinking program, and untreated individuals from the local community. Quantitative measures of SR change between baseline and 6 months were used to predict 9-month drinking outcomes, controlling for baseline drinking and AA involvement. Results: Significant 6-month changes in 8 of 12 SR measures were found, which included private SR practices, beliefs, daily spiritual experiences, three measures of forgiveness, negative religious coping, and purpose in life. Increases in private SR practices and forgiveness of self were the strongest predictors of improvements in drinking outcomes. Changes in daily spiritual experiences, purpose in life, a general measure of forgiveness, and negative religious coping also predicted favorable drinking outcomes. Conclusions: SR change predicted good drinking outcomes in alcoholics, even when controlling for AA involvement. SR variables, broadly defined, deserve attention in fostering change even among those who do not affiliate with AA or religious institutions. Last, future research should include SR variables, particularly various types of forgiveness, given the strong effects found for forgiveness of self. PMID:21683048

Twin-Twin Transfusion Syndrome: study protocol for developing, disseminating, and implementing a core outcome set.

PubMed

Khalil, Asma; Perry, Helen; Duffy, James; Reed, Keith; Baschat, Ahmet; Deprest, Jan; Hecher, Kurt; Lewi, Liesbeth; Lopriore, Enrico; Oepkes, Dick

2017-07-14

Twin-Twin Transfusion Syndrome (TTTS) is associated with an increased risk of perinatal mortality and morbidity. Several treatment interventions have been described for TTTS, including fetoscopic laser surgery, amnioreduction, septostomy, expectant management, and pregnancy termination. Over the last decade, fetoscopic laser surgery has become the primary treatment. The literature to date reports on many different outcomes, making it difficult to compare results or combine data from individual studies, limiting the value of research to guide clinical practice. With the advent and ongoing development of new therapeutic techniques, this is more important than ever. The development and use of a core outcome set has been proposed to address these issues, prioritising outcomes important to the key stakeholders, including patients. We aim to produce, disseminate, and implement a core outcome set for TTTS. An international steering group has been established to oversee the development of this core outcome set. This group includes healthcare professionals, researchers and patients. A systematic review is planned to identify previously reported outcomes following treatment for TTTS. Following completion, the identified outcomes will be evaluated by stakeholders using an international, multi-perspective online modified Delphi method to build consensus on core outcomes. This method encourages the participants towards consensus 'core' outcomes. All key stakeholders will be invited to participate. The steering group will then hold a consensus meeting to discuss results and form a core outcome set to be introduced and measured. Once core outcomes have been agreed, the next step will be to determine how they should be measured, disseminated, and implemented within an international context. The development, dissemination, and implementation of a core outcome set in TTTS will enable its use in future clinical trials, systematic reviews and clinical practice guidelines. This is likely to advance the quality of research studies and their effective use in order to guide clinical practice and improve patient care, maternal, short-term perinatal outcomes and long-term neurodevelopmental outcomes. Core Outcome Measures in Effectiveness Trials (COMET), 921 Registered on July 2016. International Prospective Register of Systematic Reviews (PROSPERO), CRD42016043999 . Registered on 2 August 2016.

Beyond total treatment effects in randomised controlled trials: Baseline measurement of intermediate outcomes needed to reduce confounding in mediation investigations.

PubMed

Landau, Sabine; Emsley, Richard; Dunn, Graham

2018-06-01

Random allocation avoids confounding bias when estimating the average treatment effect. For continuous outcomes measured at post-treatment as well as prior to randomisation (baseline), analyses based on (A) post-treatment outcome alone, (B) change scores over the treatment phase or (C) conditioning on baseline values (analysis of covariance) provide unbiased estimators of the average treatment effect. The decision to include baseline values of the clinical outcome in the analysis is based on precision arguments, with analysis of covariance known to be most precise. Investigators increasingly carry out explanatory analyses to decompose total treatment effects into components that are mediated by an intermediate continuous outcome and a non-mediated part. Traditional mediation analysis might be performed based on (A) post-treatment values of the intermediate and clinical outcomes alone, (B) respective change scores or (C) conditioning on baseline measures of both intermediate and clinical outcomes. Using causal diagrams and Monte Carlo simulation, we investigated the performance of the three competing mediation approaches. We considered a data generating model that included three possible confounding processes involving baseline variables: The first two processes modelled baseline measures of the clinical variable or the intermediate variable as common causes of post-treatment measures of these two variables. The third process allowed the two baseline variables themselves to be correlated due to past common causes. We compared the analysis models implied by the competing mediation approaches with this data generating model to hypothesise likely biases in estimators, and tested these in a simulation study. We applied the methods to a randomised trial of pragmatic rehabilitation in patients with chronic fatigue syndrome, which examined the role of limiting activities as a mediator. Estimates of causal mediation effects derived by approach (A) will be biased if one of the three processes involving baseline measures of intermediate or clinical outcomes is operating. Necessary assumptions for the change score approach (B) to provide unbiased estimates under either process include the independence of baseline measures and change scores of the intermediate variable. Finally, estimates provided by the analysis of covariance approach (C) were found to be unbiased under all the three processes considered here. When applied to the example, there was evidence of mediation under all methods but the estimate of the indirect effect depended on the approach used with the proportion mediated varying from 57% to 86%. Trialists planning mediation analyses should measure baseline values of putative mediators as well as of continuous clinical outcomes. An analysis of covariance approach is recommended to avoid potential biases due to confounding processes involving baseline measures of intermediate or clinical outcomes, and not simply for increased precision.

Network meta-analysis of multiple outcome measures accounting for borrowing of information across outcomes.

PubMed

Achana, Felix A; Cooper, Nicola J; Bujkiewicz, Sylwia; Hubbard, Stephanie J; Kendrick, Denise; Jones, David R; Sutton, Alex J

2014-07-21

Network meta-analysis (NMA) enables simultaneous comparison of multiple treatments while preserving randomisation. When summarising evidence to inform an economic evaluation, it is important that the analysis accurately reflects the dependency structure within the data, as correlations between outcomes may have implication for estimating the net benefit associated with treatment. A multivariate NMA offers a framework for evaluating multiple treatments across multiple outcome measures while accounting for the correlation structure between outcomes. The standard NMA model is extended to multiple outcome settings in two stages. In the first stage, information is borrowed across outcomes as well across studies through modelling the within-study and between-study correlation structure. In the second stage, we make use of the additional assumption that intervention effects are exchangeable between outcomes to predict effect estimates for all outcomes, including effect estimates on outcomes where evidence is either sparse or the treatment had not been considered by any one of the studies included in the analysis. We apply the methods to binary outcome data from a systematic review evaluating the effectiveness of nine home safety interventions on uptake of three poisoning prevention practices (safe storage of medicines, safe storage of other household products, and possession of poison centre control telephone number) in households with children. Analyses are conducted in WinBUGS using Markov Chain Monte Carlo (MCMC) simulations. Univariate and the first stage multivariate models produced broadly similar point estimates of intervention effects but the uncertainty around the multivariate estimates varied depending on the prior distribution specified for the between-study covariance structure. The second stage multivariate analyses produced more precise effect estimates while enabling intervention effects to be predicted for all outcomes, including intervention effects on outcomes not directly considered by the studies included in the analysis. Accounting for the dependency between outcomes in a multivariate meta-analysis may or may not improve the precision of effect estimates from a network meta-analysis compared to analysing each outcome separately.

Transcranial Direct Current Stimulation Does Not Improve Language Outcome in Subacute Poststroke Aphasia.

PubMed

Spielmann, Kerstin; van de Sandt-Koenderman, W Mieke E; Heijenbrok-Kal, Majanka H; Ribbers, Gerard M

2018-04-01

The aim of the present study is to investigate the effect of transcranial direct current stimulation on word-finding treatment outcome in subacute poststroke aphasia. In this multi-center, double-blind, randomized controlled trial with 6-month follow-up, we included 58 patients with subacute aphasia (<3 months poststroke), who were enrolled in a stroke rehabilitation program. Patients participated in 2 separate intervention weeks. Each intervention week included 5 daily sessions of 45-minute word-finding therapy combined with either anodal transcranial direct current stimulation (1 mA, 20 minutes; experimental group) or sham transcranial direct current stimulation (control group) over the left inferior frontal gyrus. The primary outcome measure was the Boston Naming Test. Secondary outcome measures included naming performance for trained/untrained picture items and verbal communication. Both the experimental (n=26) and the control group (n=32) improved on the Boston Naming Test over the intervention period and 6-month follow-up; however, there were no significant differences between groups. Also for the secondary outcome measures, no significant differences were found. The results of the present study do not support an effect of transcranial direct current stimulation as an adjuvant treatment in subacute poststroke aphasia. URL: http://www.trialregister.nl/trialreg/admin/rctview.asp. Unique identifier: NTR4364. © 2018 American Heart Association, Inc.

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.

Staff perceptions of using outcome measures in stroke rehabilitation.

PubMed

Burton, Louisa-Jane; Tyson, Sarah; McGovern, Alison

2013-05-01

The use of standardised outcome measures is an integral part of stroke rehabilitation and is widely recommended as good practice. However, little is known about how measures are actually used or their impact. This study aimed to identify current clinical practice; how healthcare professionals working in stroke rehabilitation use outcome measures and their perceptions of the benefits and barriers to use. Eighty-four Health Care Professionals and 12 service managers and commissioners working in stroke services across a large UK county were surveyed by postal questionnaire. Ninety-six percent of clinical respondents used at least one measure, however, less than half used measures regularly during a patient's stay. The mean number of tools used was 3.2 (SD = 1.9). Eighty-one different tools were identified; 16 of which were unpublished and unvalidated. Perceived barriers in using outcome measures in day-to-day clinical practice included lack of resources (time and training) and lack of knowledge of appropriate measures. Benefits identified were to demonstrate the effectiveness of rehabilitation interventions and monitor patients' progress. Although the use of outcome measures is prevalent in clinical practice, there is little consistency in the tools utilised. The term "outcome measures" is used, but staff rarely used the measures at appropriate time points to formally assess and evaluate outcome. The term "measurement tool" more accurately reflects the purposes to which they were put and potential benefits. Further research to overcome the barriers in using standardised measurement tools and evaluate the impact of implementation on clinical practice is needed. • Health professionals working in stroke rehabilitation should work together to agree when and how outcome measures can be most effectively used in their service. • Efforts should be made to ensure that standardised tools are used to measure outcome at set time-points during rehabilitation, in order to achieve the anticipated benefits. • Communication between service providers and commissioners could be improved to highlight the barriers in using standardised measures of outcome.

Developing a core outcome set for chronic rhinosinusitis: a systematic review of outcomes utilised in the current literature.

PubMed

Soni-Jaiswal, Archana; Lakhani, Raj; Hopkins, Claire

2017-07-11

A core outcome set (COS) is an agreed standardised collection of outcomes that should be measured and reported by all trials for a specific clinical area, in this case chronic rhinosinusitis. These are not restrictive and researchers may continue to explore other outcomes alongside these that they feel are relevant to their intervention. The aim of this systematic review was to identify the need for a COS for chronic rhinosinusitis. A sensitive search strategy was used to identify all published Cochrane systematic reviews and randomised control trials of intervention for adult patients with chronic rhinosinusitis. Two independent authors reviewed these to obtain a list of outcomes and outcome measures reported by each clinical trial. Sixty-nine randomised control trials and eight Cochrane systematic reviews were included in this study. They reported 68 individual outcomes and outcome measures, with an average of four to ten outcomes per clinical trial. These outcomes were mapped to 23 subcategories belonging to eight core categories. The key finding of this review was the heterogeneity of outcomes reported and measured by clinical trials of patients with chronic rhinosinusitis, precluding meaningful meta-analysis of data. This review supports the need for development of a COS, to be used in future trials on adult patients with chronic rhinosinusitis.

The Impact of Children's Social Adjustment on Academic Outcomes

ERIC Educational Resources Information Center

DeRosier, Melissa E.; Lloyd, Stacey W.

2011-01-01

This study tested whether social adjustment added to the prediction of academic outcomes above and beyond prior academic functioning. Researchers collected school records and peer-, teacher-, and self-report measures for 1,255 third-grade children in the fall and spring of the school year. Measures of social adjustment included social acceptance…

A Measurement Feedback System (MFS) Is Necessary to Improve Mental Health Outcomes

ERIC Educational Resources Information Center

Bickman, Leonard

2008-01-01

The importance of measurement feedback system (MFS) for the improvement of mental health services for youths is discussed. As feedback obtained from clients and families is subject to distortions, a standardized MFS including clinical processes, contexts, outcomes, and feedback to clinicians and supervisors is necessary for improvement in quality…

Negative relationship behavior is more important than positive: Correlates of outcomes during stressful life events.

PubMed

Rivers, Alannah Shelby; Sanford, Keith

2018-04-01

When people who are married or cohabiting face stressful life situations, their ability to cope may be associated with two separate dimensions of interpersonal behavior: positive and negative. These behaviors can be assessed with the Couple Resilience Inventory (CRI). It was expected that scales on this instrument would correlate with outcome variables regarding life well-being, stress, and relationship satisfaction. It was also expected that effects for negative behavior would be larger than effects for positive and that the effects might be curvilinear. Study 1 included 325 married or cohabiting people currently experiencing nonmedical major life stressors and Study 2 included 154 married or cohabiting people with current, serious medical conditions. All participants completed an online questionnaire including the CRI along with an alternate measure of couple behavior (to confirm scale validity), a measure of general coping style (to serve as a covariate), and measures of outcome variables regarding well-being, quality of life, perceived stress, and relationship satisfaction. The effects for negative behavior were larger than effects for positive in predicting most outcomes, and many effects were curvilinear. Notably, results remained significant after controlling for general coping style, and scales measuring positive and negative behavior demonstrated comparable levels of validity. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

How Can We Improve Outcomes for Patients and Families Under Palliative Care? Implementing Clinical Audit for Quality Improvement in Resource Limited Settings

PubMed Central

Selman, Lucy; Harding, Richard

2010-01-01

Palliative care in India has made enormous advances in providing better care for patients and families living with progressive disease, and many clinical services are well placed to begin quality improvement initiatives, including clinical audit. Clinical audit is recognized globally to be essential in all healthcare, as a way of monitoring and improving quality of care. However, it is not common in developing country settings, including India. Clinical audit is a cyclical activity involving: identification of areas of care in need of improvement, through data collection and analysis utilizing an appropriate questionnaire; setting measurable quality of care targets in specific areas; designing and implementing service improvement strategies; and then re-evaluating quality of care to assess progress towards meeting the targets. Outcome measurement is an important component of clinical audit that has additional advantages; for example, establishing an evidence base for the effectiveness of services. In resource limited contexts, outcome measurement in clinical audit is particularly important as it enables service development to be evidence-based and ensures resources are allocated effectively. Key success factors in conducting clinical audit are identified (shared ownership, training, managerial support, inclusion of all members of staff and a positive approach). The choice of outcome measurement tool is discussed, including the need for a culturally appropriate and validated measure which is brief and simple enough to incorporate into clinical practice and reflects the holistic nature of palliative care. Support for clinical audit is needed at a national level, and development and validation of an outcome measurement tool in the Indian context is a crucial next step. PMID:20859465

Magnetic resonance imaging-based measures predictive of short-term surgical outcome in patients with Chiari malformation Type I: a pilot study.

PubMed

Alperin, Noam; Loftus, James Ryan; Bagci, Ahmet M; Lee, Sang H; Oliu, Carlos J; Shah, Ashish H; Green, Barth A

2017-01-01

OBJECTIVE This study identifies quantitative imaging-based measures in patients with Chiari malformation Type I (CM-I) that are associated with positive outcomes after suboccipital decompression with duraplasty. METHODS Fifteen patients in whom CM-I was newly diagnosed underwent MRI preoperatively and 3 months postoperatively. More than 20 previously described morphological and physiological parameters were derived to assess quantitatively the impact of surgery. Postsurgical clinical outcomes were assessed in 2 ways, based on resolution of the patient's chief complaint and using a modified Chicago Chiari Outcome Scale (CCOS). Statistical analyses were performed to identify measures that were different between the unfavorable- and favorable-outcome cohorts. Multivariate analysis was used to identify the strongest predictors of outcome. RESULTS The strongest physiological parameter predictive of outcome was the preoperative maximal cord displacement in the upper cervical region during the cardiac cycle, which was significantly larger in the favorable-outcome subcohorts for both outcome types (p < 0.05). Several hydrodynamic measures revealed significantly larger preoperative-to-postoperative changes in the favorable-outcome subcohort. Predictor sets for the chief-complaint classification included the cord displacement, percent venous drainage through the jugular veins, and normalized cerebral blood flow with 93.3% accuracy. Maximal cord displacement combined with intracranial volume change predicted outcome based on the modified CCOS classification with similar accuracy. CONCLUSIONS Tested physiological measures were stronger predictors of outcome than the morphological measures in patients with CM-I. Maximal cord displacement and intracranial volume change during the cardiac cycle together with a measure that reflects the cerebral venous drainage pathway emerged as likely predictors of decompression outcome in patients with CM-I.

Definitions and Outcome Measures in Pediatric Functional Upper Gastrointestinal Tract Disorders: A Systematic Review.

PubMed

Nassar-Sheikh Rashid, Amara; Taminiau, Jan A; Benninga, Marc A; Saps, Miguel; Tabbers, Merit M

2016-04-01

Functional disorders of the upper gastrointestinal tract are frequently diagnosed in children. Four different clinical entities are addressed by the Rome III committee: functional dyspepsia (FD), cyclic vomiting syndrome (CVS), adolescent rumination syndrome (ARS), and aerophagia. Management of these disorders is often difficult leading to a wide variety in therapeutic interventions. We hypothesize that definitions and outcome measures in these studies are heterogeneous as well. Our aim is to systematically assess how these disorders and outcomes are defined in therapeutic randomized controlled trials (RCTs). CENTRAL, Embase, and MEDLINE/PubMed were searched from inception to February 25, 2015. Search terms were FD, CVS, ARS, and aerophagia. Therapeutic RCTs, or systematic reviews of RCTs, in English language including subjects ages 4 to 18 years (0-18 years for CVS) were evaluated. Quality was assessed using the Delphi list. A total of 1398 articles were found of which 8 articles were included. Seven concerned FD and 1 concerned CVS. In all of the studies, Rome criteria or similar definitions were used; all the studies however used different outcome measures. Seventy-five percent of the trials were of good methodological quality. Only 57% used validated pain scales. Different outcome measures are used in therapeutic trials on functional disorders of the upper gastrointestinal tract. There is a clear paucity of trials evaluating different treatment regimens regarding CVS, ARS, and aerophagia. Uniform definitions, outcome measures, and validated instruments are needed to make a comparison between intervention studies possible.

Impact of study outcome on submission and acceptance metrics for peer reviewed medical journals: six year retrospective review of all completed GlaxoSmithKline human drug research studies.

PubMed

Evoniuk, Gary; Mansi, Bernadette; DeCastro, Barbara; Sykes, Jennie

2017-04-21

Objectives  To determine whether the outcome of drug studies influenced submission and/or acceptance rates for publication in peer reviewed medical journals. Design  A six year retrospective review of publication status by study outcome for all human drug research studies conducted by a single industry sponsor (GlaxoSmithKline) that completed from 1 January 2009 to 30 June 2014 and were therefore due for manuscript submission (per the sponsor's policy) to peer reviewed journals within 18 months of study completion-that is, 31 December 2015. In addition, manuscripts from studies completing after 30 June 2014 were included irrespective of outcome if they were submitted before 31 December 2015. Setting  Studies conducted by a single industry sponsor (GlaxoSmithKline) Studies reviewed  1064 human drug research studies. Main outcome measures  All studies were assigned a publication status at 26 February 2016 including (as applicable): study completion date, date of first primary manuscript submission, number of submissions, journal decision(s), and publication date. All studies were also classified with assessors blinded to publication status as "positive" (perceived favorable outcome for the drug under study), "negative" (perceived unfavorable outcome for the drug under study), mixed, or non-comparative based on the presence and outcome of the primary outcome measure(s) for each study. "Negative" studies included safety studies in which the primary outcome was achieved but was adverse for the drug under study. For the total cohort and each of the four study outcomes, measures included descriptive statistics for study phase, time from study completion to submission and publication, and number and outcome (accepted/rejected) of publication submissions. Results  Of the 1064 studies (phase I-IV, interventional and non-interventional) included, 321 had study outcomes classified as positive, 155 as negative, 52 as mixed, and 536 as non-comparative. At the time of publication cut-off date (26 February 2016), 904 (85%) studies had been submitted for publication as full manuscripts and 751 (71%) had been successfully published or accepted, with 100 (9%) still under journal review. An additional 77 (7%) studies were conference abstracts and were not included in submission or publication rates. Submission rates by study outcome were 79% for the 321 studies with positive outcomes, 92% for the 155 with negative outcomes, 94% for the 52 with mixed outcomes, and 85% for the 536 non-comparative studies; while rates of publication at the cut-off date were 66%, 77%, 77%, and 71%, respectively. Median time from study completion to submission was 537 days (interquartile range 396-638 days) and 823 days (650-1063 days) from completion to publication, with similar times observed across study outcomes. First time acceptance rates were 56% for studies with positive outcomes and 48% for studies with negative outcomes. Over 10% of studies across all categories required three or more submissions to achieve successful publication. At the time of analysis, 83 studies had not been submitted for publication, including 49 bioequivalence studies with positive outcomes and 33 non-comparative studies. Most studies (98%, 1041/1064) had results posted to one or more public registers, including all studies subject to FDAAA (Food and Drug Administration Amendments Act) requirements for posting to www.clinicaltrials.gov Conclusions  Over the period studied, there was no evidence of submission or publication bias: 92% of studies with negative outcomes were submitted for publication by the cut-off date versus 79% of those with positive outcomes. Publication rates were slightly higher for studies with a negative (that is, unfavorable) outcome compared with a positive outcome, despite a slightly lower rate of acceptance at first submission. Many studies required multiple submission attempts before they were accepted for publication. Analyses focusing solely on publication rates do not take into account unsuccessful efforts to publish. Sponsors and journal editors should share similar information to contribute to better understanding of issues and barriers to full transparency. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Outcome Measures for Clinical Trials in Down Syndrome

PubMed Central

Esbensen, Anna J.; Hooper, Stephen R.; Fidler, Deborah; Hartley, Sigan; Edgin, Jamie; d’Ardhuy, Xavier Liogier; Capone, George; Conners, Frances; Mervis, Carolyn B.; Abbeduto, Leonard; Rafii, Michael; Krinsky-McHale, Sharon J.; Urv, Tiina

2017-01-01

Increasingly individuals with intellectual and developmental disabilities, including Down syndrome, are being targeted for clinical trials. However, a challenge exists in effectively evaluating the outcomes of these new pharmacological interventions. Few empirically evaluated, psychometrically sound outcome measures appropriate for use in clinical trials with individuals with Down syndrome have been identified. To address this challenge, the NIH assembled leading clinicians and scientists to review existing measures and identify those that currently are appropriate for trials; those that may be appropriate after expansion of age range addition of easier items, and/or downward extension of psychometric norms; and areas where new measures need to be developed. This paper focuses on measures in the areas of cognition and behavior. PMID:28452584

Outpatient management of oral vitamin K antagonist therapy: defining and measuring high-quality management.

PubMed

Phillips, Katherine W; Ansell, Jack

2008-01-01

Oral anticoagulation therapy with warfarin is the mainstay of prevention and treatment of thromboembolic disease. However, it remains one of the leading causes of harmful medication errors and medication-related adverse events. The beneficial outcomes of oral anticoagulation therapy are directly dependent upon the quality of dose and anticoagulation management, but the literature is not robust with regards to what constitutes such management. This review focuses on, and attempts to define, the parameters of high-quality anticoagulation management and identifies the appropriate outcome measures constituting high-quality management. Elements discussed include the most fundamental measure, time in therapeutic range, along with other parameters including therapy initiation, time to therapeutic range, dosing management when patients are not in therapeutic range, perioperative dosing management, patient education, and other important outcome measures. Healthcare providers who manage oral anticoagulation therapy should utilize these parameters as a measure of their performance in an effort to achieve high-quality anticoagulation management.

Defining the value framework for prostate brachytherapy using patient-centered outcome metrics and time-driven activity-based costing.

PubMed

Thaker, Nikhil G; Pugh, Thomas J; Mahmood, Usama; Choi, Seungtaek; Spinks, Tracy E; Martin, Neil E; Sio, Terence T; Kudchadker, Rajat J; Kaplan, Robert S; Kuban, Deborah A; Swanson, David A; Orio, Peter F; Zelefsky, Michael J; Cox, Brett W; Potters, Louis; Buchholz, Thomas A; Feeley, Thomas W; Frank, Steven J

2016-01-01

Value, defined as outcomes over costs, has been proposed as a measure to evaluate prostate cancer (PCa) treatments. We analyzed standardized outcomes and time-driven activity-based costing (TDABC) for prostate brachytherapy (PBT) to define a value framework. Patients with low-risk PCa treated with low-dose-rate PBT between 1998 and 2009 were included. Outcomes were recorded according to the International Consortium for Health Outcomes Measurement standard set, which includes acute toxicity, patient-reported outcomes, and recurrence and survival outcomes. Patient-level costs to 1 year after PBT were collected using TDABC. Process mapping and radar chart analyses were conducted to visualize this value framework. A total of 238 men were eligible for analysis. Median age was 64 (range, 46-81). Median followup was 5 years (0.5-12.1). There were no acute Grade 3-5 complications. Expanded Prostate Cancer Index Composite 50 scores were favorable, with no clinically significant changes from baseline to last followup at 48 months for urinary incontinence/bother, bowel bother, sexual function, and vitality. Ten-year outcomes were favorable, including biochemical failure-free survival of 84.1%, metastasis-free survival 99.6%, PCa-specific survival 100%, and overall survival 88.6%. TDABC analysis demonstrated low resource utilization for PBT, with 41% and 10% of costs occurring in the operating room and with the MRI scan, respectively. The radar chart allowed direct visualization of outcomes and costs. We successfully created a visual framework to define the value of PBT using the International Consortium for Health Outcomes Measurement standard set and TDABC costs. PBT is associated with excellent outcomes and low costs. Widespread adoption of this methodology will enable value comparisons across providers, institutions, and treatment modalities. Copyright © 2016 American Brachytherapy Society. Published by Elsevier Inc. All rights reserved.

INTRODUCTION TO PATIENT-REPORTED OUTCOME ITEM BANKS: ISSUES IN MINORITY AGING RESEARCH

PubMed Central

Templin, Thomas N; Hays, Ron D; Gershon, Richard C; Rothrock, Nan; Jones, Richard N; Teresi, Jeanne A; Stewart, Anita; Weech-Maldonado, Robert; Wallace, Steve

2014-01-01

In 2004 NIH awarded contracts to initiate the development of high quality psychological and neuropsychological outcome measures for improved assessment of health-related outcomes. The workshop introduced these measurement development initiatives, the measures created, and the NIH supported resource (Assessment Center) for internet or tablet-based test administration and scoring. Presentation covered: (a) item response theory (IRT) and assessment of test bias, (b) construction of item banks and computerized adaptive testing, and (c) the different ways in which qualitative analyses contribute to the definition of construct domains and the refinement of outcome constructs. The panel discussion included questions about representativeness of samples, and assessment of cultural bias. PMID:23570428

Choice of outcomes and measurement instruments in randomised trials on eLearning in medical education: a systematic mapping review protocol.

PubMed

Law, Gloria C; Apfelbacher, Christian; Posadzki, Pawel P; Kemp, Sandra; Tudor Car, Lorainne

2018-05-17

There will be a lack of 18 million healthcare workers by 2030. Multiplying the number of well-trained healthcare workers through innovative ways such as eLearning is highly recommended in solving this shortage. However, high heterogeneity of learning outcomes in eLearning systematic reviews reveals a lack of consistency and agreement on core learning outcomes in eLearning for medical education. In addition, there seems to be a lack of validity evidence for measurement instruments used in these trials. This undermines the credibility of these outcome measures and affects the ability to draw accurate and meaningful conclusions. The aim of this research is to address this issue by determining the choice of outcomes, measurement instruments and the prevalence of measurement instruments with validity evidence in randomised trials on eLearning for pre-registration medical education. We will conduct a systematic mapping and review to identify the types of outcomes, the kinds of measurement instruments and the prevalence of validity evidence among measurement instruments in eLearning randomised controlled trials (RCTs) in pre-registration medical education. The search period will be from January 1990 until August 2017. We will consider studies on eLearning for health professionals' education. Two reviewers will extract and manage data independently from the included studies. Data will be analysed and synthesised according to the aim of the review. Appropriate choice of outcomes and measurement tools is essential for ensuring high-quality research in the field of eLearning and eHealth. The results of this study could have positive implications for other eHealth interventions, including (1) improving quality and credibility of eLearning research, (2) enhancing the quality of digital medical education and (3) informing researchers, academics and curriculum developers about the types of outcomes and validity evidence for measurement instruments used in eLearning studies. The protocol aspires to assist in the advancement of the eLearning research field as well as in the development of high-quality healthcare professionals' digital education. PROSPERO CRD42017068427.

A Diabetes Self-Management Program: 12-Month Outcome Sustainability From a Nonreinforced Pragmatic Trial.

PubMed

Lorig, Kate; Ritter, Philip L; Turner, Ralph M; English, Kathleen; Laurent, Diana D; Greenberg, Jay

2016-12-15

Diabetes self-management education has been shown to be effective in controlled trials. The 6-week Better Choices, Better Health-Diabetes (BCBH-D) self-management program was also associated with an improvement in health outcomes in a 6-month translation study. The objective of this study was to determine whether a national translation of the BCBH-D self-management program, offered both Web-based and face-to-face, was associated with improvements in health outcomes (including HbA1c) and health behaviors (including recommended medical tests) 1 year after intervention. Web-based programs were administered nationally, whereas face-to-face workshops took place in Atlanta, Indianapolis, and St Louis. Self-report questionnaires were either Web-based or administered by mail, at baseline and 1 year, and collected health and health-behavior measures. HbA1c blood samples were collected via mailed kits. A previous 6-month study found statistically significant improvements in 13 of 14 outcome measures, including HbA1c. For this study, paired t test compared baseline with 1-year outcomes. Subgroup analyses determined whether participants with specific conditions improved (high HbA1c, depression, hypoglycemia, nonadherence to medication, no aerobic exercise). The percentage of participants with improvements in effect size of at least 0.4 in at least 1 of the 5 measures was calculated. A total of 857 participants with 1-year data (69.7% of baseline participants) demonstrated statistically significant 1-year improvements in 13 of 15 outcome measures; 79.9% (685/857) of participants showed improvements in effect size of 0.4 or greater in at least 1 of the 5 criterial measures. Participants had small but significant benefits in multiple measures. Improvements previously noted at 6 months were maintained or amplified at 1 year. ©Kate Lorig, Philip L Ritter, Ralph M Turner, Kathleen English, Diana D Laurent, Jay Greenberg. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 15.12.2016.

Primary outcome indices in illicit drug dependence treatment research: systematic approach to selection and measurement of drug use end-points in clinical trials

PubMed Central

Donovan, Dennis M.; Bigelow, George E.; Brigham, Gregory S.; Carroll, Kathleen M.; Cohen, Allan J.; Gardin, John G.; Hamilton, John A.; Huestis, Marilyn A.; Hughes, John R.; Lindblad, Robert; Marlatt, G. Alan; Preston, Kenzie L.; Selzer, Jeffrey A.; Somoza, Eugene C.; Wakim, Paul G.; Wells, Elizabeth A.

2012-01-01

Aims Clinical trials test the safety and efficacy of behavioral and pharmacological interventions in drug-dependent individuals. However, there is no consensus about the most appropriate outcome(s) to consider in determining treatment efficacy or on the most appropriate methods for assessing selected outcome(s). We summarize the discussion and recommendations of treatment and research experts, convened by the US National Institute on Drug Abuse, to select appropriate primary outcomes for drug dependence treatment clinical trials, and in particular the feasibility of selecting a common outcome to be included in all or most trials. Methods A brief history of outcomes employed in prior drug dependence treatment research, incorporating perspectives from tobacco and alcohol research, is included. The relative merits and limitations of focusing on drug-taking behavior, as measured by self-report and qualitative or quantitative biological markers, are evaluated. Results Drug-taking behavior, measured ideally by a combination of self-report and biological indicators, is seen as the most appropriate proximal primary outcome in drug dependence treatment clinical trials. Conclusions We conclude that the most appropriate outcome will vary as a function of salient variables inherent in the clinical trial, such as the type of intervention, its target, treatment goals (e.g. abstinence or reduction of use) and the perspective being taken (e.g. researcher, clinical program, patient, society). It is recommended that a decision process, based on such trial variables, be developed to guide the selection of primary and secondary outcomes as well as the methods to assess them. PMID:21781202

Predicting functional remission in patients with schizophrenia: a cross-sectional study of symptomatic remission, psychosocial remission, functioning, and clinical outcome

PubMed Central

Valencia, Marcelo; Fresán, Ana; Barak, Yoram; Juárez, Francisco; Escamilla, Raul; Saracco, Ricardo

2015-01-01

Background New approaches to assess outcome in schizophrenia include multidimensional measures such as remission, cognition, psychosocial functioning, and quality of life. Clinical and psychosocial measures have been recently introduced to assess functional outcome. Objective The study presented here was designed to examine the rates of symptomatic remission, psychosocial remission, global functioning, and clinical global impressions in a sample of schizophrenia outpatients in order to assess functional remission and to identify predictive factors for functional remission. Methods A total of 168 consecutive Mexican outpatients receiving pharmacological treatment at the National Institute of Psychiatry in Mexico City were enrolled in a cross-sectional study. Symptomatic remission was assessed according to the definition and criteria proposed by the Remission in Schizophrenia Working Group using the Positive and Negative Symptom Scale. Psychosocial remission was assessed according to Barak criteria using the Psychosocial Remission in Schizophrenia scale. Functioning was measured with the Global Assessment of Functioning, and clinical outcome with the Clinical Global Impressions (CGI) Scale. Results Findings showed that 45.2% of patients fulfilled the symptomatic remission criteria, 32.1% achieved psychosocial remission, and 53% reported adequate functioning. However, the combination of these three outcome criteria – symptomatic, psychosocial remission, and functioning – indicated that 14.9% of the patients achieved our predefined functional remission outcome. The logistic regression model included five predictive variables for functional remission: (1) being employed, (2) use of atypical antipsychotics, (3) lower number of medications, (4) lower negative symptom severity, and (5) lower excitement symptom severity. Conclusion The study demonstrated that symptomatic remission, psychosocial remission, and functioning could be achievable goals for a considerable number of patients. The outcome of functional remission was achieved by a minority of patients, less than 15%. New approaches should include multidimensional measures to assess functional outcome in schizophrenia research. PMID:26396518

Determining and Communicating the Value of the Special Library.

ERIC Educational Resources Information Center

Matthews, Joseph R.

2003-01-01

Discusses performance measures for libraries that will indicate the goodness of the library and its services. Highlights include a general evaluation model that includes input, process, output, and outcome measures; balanced scorecard approach that includes financial perspectives; focusing on strategy; strategies for change; user criteria for…

Health economics research into supporting carers of people with dementia: A systematic review of outcome measures

PubMed Central

2012-01-01

Advisory bodies, such as the National Institute for Health and Clinical Excellence (NICE) in the UK, advocate using preference based instruments to measure the quality of life (QoL) component of the quality-adjusted life year (QALY). Cost per QALY is used to determine cost-effectiveness, and hence funding, of interventions. QALYs allow policy makers to compare the effects of different interventions across different patient groups. Generic measures may not be sensitive enough to fully capture the QoL effects for certain populations, such as carers, so there is a need to consider additional outcome measures, which are preference based where possible to enable cost-effectiveness analysis to be undertaken. This paper reviews outcome measures commonly used in health services research and health economics research involving carers of people with dementia. An electronic database search was conducted in PubMed, Medline, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycINFO, the National Health Service Economic Evaluation Database (NHS EED), Database of Abstracts of Reviews of Effects (DARE) and Health Technology Assessment database. Studies were eligible for inclusion if they included an outcome measure for carers of people with dementia. 2262 articles were identified. 455 articles describing 361 studies remained after exclusion criteria were applied. 228 outcome measures were extracted from the studies. Measures were categorised into 44 burden measures, 43 mastery measures, 61 mood measures, 32 QoL measures, 27 social support and relationships measures and 21 staff competency and morale measures. The choice of instrument has implications on funding decisions; therefore, researchers need to choose appropriate instruments for the population being measured and the type of intervention undertaken. If an instrument is not sensitive enough to detect changes in certain populations, the effect of an intervention may be underestimated, and hence interventions which may appear to be beneficial to participants are not deemed cost-effective and are not funded. If this is the case, it is essential that additional outcome measures which detect changes in broader QoL are included, whilst still retaining preference based utility measures such as EQ-5D to allow QALY calculation for comparability with other interventions. PMID:23181515

Health economics research into supporting carers of people with dementia: a systematic review of outcome measures.

PubMed

Jones, Carys; Edwards, Rhiannon Tudor; Hounsome, Barry

2012-11-26

Advisory bodies, such as the National Institute for Health and Clinical Excellence (NICE) in the UK, advocate using preference based instruments to measure the quality of life (QoL) component of the quality-adjusted life year (QALY). Cost per QALY is used to determine cost-effectiveness, and hence funding, of interventions. QALYs allow policy makers to compare the effects of different interventions across different patient groups. Generic measures may not be sensitive enough to fully capture the QoL effects for certain populations, such as carers, so there is a need to consider additional outcome measures, which are preference based where possible to enable cost-effectiveness analysis to be undertaken. This paper reviews outcome measures commonly used in health services research and health economics research involving carers of people with dementia. An electronic database search was conducted in PubMed, Medline, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycINFO, the National Health Service Economic Evaluation Database (NHS EED), Database of Abstracts of Reviews of Effects (DARE) and Health Technology Assessment database. Studies were eligible for inclusion if they included an outcome measure for carers of people with dementia. 2262 articles were identified. 455 articles describing 361 studies remained after exclusion criteria were applied. 228 outcome measures were extracted from the studies. Measures were categorised into 44 burden measures, 43 mastery measures, 61 mood measures, 32 QoL measures, 27 social support and relationships measures and 21 staff competency and morale measures. The choice of instrument has implications on funding decisions; therefore, researchers need to choose appropriate instruments for the population being measured and the type of intervention undertaken. If an instrument is not sensitive enough to detect changes in certain populations, the effect of an intervention may be underestimated, and hence interventions which may appear to be beneficial to participants are not deemed cost-effective and are not funded. If this is the case, it is essential that additional outcome measures which detect changes in broader QoL are included, whilst still retaining preference based utility measures such as EQ-5D to allow QALY calculation for comparability with other interventions.

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.

Solutions for filling gaps in accountable care measure sets.

PubMed

Valuck, Tom; Dugan, Donna; Dubois, Robert W; Westrich, Kimberly; Penso, Jerry; McClellan, Mark

2015-10-01

A primary objective of accountable care is to support providers in reforming care to improve outcomes and lower costs. Gaps in accountable care measure sets may cause missed opportunities for improvement and missed signals of problems in care. Measures to balance financial incentives may be particularly important for high-cost conditions or specialty treatments. This study explored gaps in measure sets for specific conditions and offers strategies for more comprehensive measurement that do not necessarily require more measures. A descriptive analysis of measure gaps in accountable care programs and proposed solutions for filling the gaps. We analyzed gaps in 2 accountable care organization measure sets for 20 high-priority clinical conditions by comparing the measures in those sets with clinical guidelines and assessing the use of outcome measures. Where we identified gaps, we looked for existing measures to address the gaps. Gaps not addressed by existing measures were considered areas for measure development or measurement strategy refinement. We found measure gaps across all 20 conditions, including those conditions that are commonly addressed in current measure sets. In addition, we found many gaps that could not be filled by existing measures. Results across all 20 conditions informed recommendations for measure set improvement. Addressing all gaps in accountable care measure sets with more of the same types of measures and approaches to measurement would require an impractical number of measures and would miss the opportunity to use better measures and innovative approaches. Strategies for effectively filling measure gaps include using preferred measure types such as cross-cutting, outcome, and patient-reported measures. Program implementers should also apply new approaches to measurement, including layered and modular models.

Endovascular repair or open repair for ruptured abdominal aortic aneurysm: a Cochrane systematic review

PubMed Central

Badger, S A; Harkin, D W; Blair, P H; Ellis, P K; Kee, F; Forster, R

2016-01-01

Objectives Emergency endovascular aneurysm repair (eEVAR) may improve outcomes for patients with ruptured abdominal aortic aneurysm (RAAA). The study aim was to compare the outcomes for eEVAR with conventional open surgical repair for the treatment of RAAA. Setting A systematic review of relevant publications was performed. Randomised controlled trials (RCTs) comparing eEVAR with open surgical repair for RAAA were included. Participants 3 RCTs were included, with a total of 761 patients with RAAA. Interventions Meta-analysis was performed with fixed-effects models with ORs and 95% CIs for dichotomous data and mean differences with 95% CIs for continuous data. Primary and secondary outcome measures Primary outcome was short-term mortality. Secondary outcome measures included aneurysm-specific and general complication rates, quality of life and economic analysis. Results Overall risk of bias was low. There was no difference between the 2 interventions on 30-day (or in-hospital) mortality, OR 0.91 (95% CI 0.67 to 1.22; p=0.52). 30-day complications included myocardial infarction, stroke, composite cardiac complications, renal complications, severe bowel ischaemia, spinal cord ischaemia, reoperation, amputation and respiratory failure. Reporting was incomplete, and no robust conclusion was drawn. For complication outcomes that did include at least 2 studies in the meta-analysis, there was no clear evidence to support a difference between eEVAR and open repair. Longer term outcomes and cost per patient were evaluated in only a single study, thus precluding definite conclusions. Conclusions Outcomes between eEVAR and open repair, specifically 30-day mortality, are similar. However, further high-quality trials are required, as the paucity of data currently limits the conclusions. PMID:26873043

American College of Rheumatology/European League against Rheumatism provisional definition of remission in rheumatoid arthritis for clinical trials.

PubMed

Felson, David T; Smolen, Josef S; Wells, George; Zhang, Bin; van Tuyl, Lilian H D; Funovits, Julia; Aletaha, Daniel; Allaart, Cornelia F; Bathon, Joan; Bombardieri, Stefano; Brooks, Peter; Brown, Andrew; Matucci-Cerinic, Marco; Choi, Hyon; Combe, Bernard; de Wit, Maarten; Dougados, Maxime; Emery, Paul; Furst, Daniel; Gomez-Reino, Juan; Hawker, Gillian; Keystone, Edward; Khanna, Dinesh; Kirwan, John; Kvien, Tore K; Landewé, Robert; Listing, Joachim; Michaud, Kaleb; Martin-Mola, Emilio; Montie, Pamela; Pincus, Theodore; Richards, Pamela; Siegel, Jeffrey N; Simon, Lee S; Sokka, Tuulikki; Strand, Vibeke; Tugwell, Peter; Tyndall, Alan; van der Heijde, Desirée; Verstappen, Suzan; White, Barbara; Wolfe, Frederick; Zink, Angela; Boers, Maarten

2011-03-01

Remission in rheumatoid arthritis (RA) is an increasingly attainable goal, but there is no widely used definition of remission that is stringent but achievable and could be applied uniformly as an outcome measure in clinical trials. This work was undertaken to develop such a definition. A committee consisting of members of the American College of Rheumatology, the European League Against Rheumatism, and the Outcome Measures in Rheumatology Initiative met to guide the process and review prespecified analyses from RA clinical trials. The committee requested a stringent definition (little, if any, active disease) and decided to use core set measures including, as a minimum, joint counts and levels of an acute-phase reactant to define remission. Members were surveyed to select the level of each core set measure that would be consistent with remission. Candidate definitions of remission were tested, including those that constituted a number of individual measures of remission (Boolean approach) as well as definitions using disease activity indexes. To select a definition of remission, trial data were analysed to examine the added contribution of patient-reported outcomes and the ability of candidate measures to predict later good radiographic and functional outcomes. Survey results for the definition of remission suggested indexes at published thresholds and a count of core set measures, with each measure scored as 1 or less (eg, tender and swollen joint counts, C reactive protein (CRP) level, and global assessments on a 0-10 scale). Analyses suggested the need to include a patient-reported measure. Examination of 2-year follow-up data suggested that many candidate definitions performed comparably in terms of predicting later good radiographic and functional outcomes, although 28-joint Disease Activity Score-based measures of remission did not predict good radiographic outcomes as well as the other candidate definitions did. Given these and other considerations, we propose that a patient's RA can be defined as being in remission based on one of two definitions: (1) when scores on the tender joint count, swollen joint count, CRP (in mg/dl), and patient global assessment (0-10 scale) are all ≤1, or (2) when the score on the Simplified Disease Activity Index is ≤3.3. We propose two new definitions of remission, both of which can be uniformly applied and widely used in RA clinical trials. The authors recommend that one of these be selected as an outcome measure in each trial and that the results on both be reported for each trial.

American College of Rheumatology/European League Against Rheumatism provisional definition of remission in rheumatoid arthritis for clinical trials.

PubMed

Felson, David T; Smolen, Josef S; Wells, George; Zhang, Bin; van Tuyl, Lilian H D; Funovits, Julia; Aletaha, Daniel; Allaart, Cornelia F; Bathon, Joan; Bombardieri, Stefano; Brooks, Peter; Brown, Andrew; Matucci-Cerinic, Marco; Choi, Hyon; Combe, Bernard; de Wit, Maarten; Dougados, Maxime; Emery, Paul; Furst, Daniel; Gomez-Reino, Juan; Hawker, Gillian; Keystone, Edward; Khanna, Dinesh; Kirwan, John; Kvien, Tore K; Landewé, Robert; Listing, Joachim; Michaud, Kaleb; Martin-Mola, Emilio; Montie, Pamela; Pincus, Theodore; Richards, Pamela; Siegel, Jeffrey N; Simon, Lee S; Sokka, Tuulikki; Strand, Vibeke; Tugwell, Peter; Tyndall, Alan; van der Heijde, Desirée; Verstappen, Suzan; White, Barbara; Wolfe, Frederick; Zink, Angela; Boers, Maarten

2011-03-01

Remission in rheumatoid arthritis (RA) is an increasingly attainable goal, but there is no widely used definition of remission that is stringent but achievable and could be applied uniformly as an outcome measure in clinical trials. This work was undertaken to develop such a definition. A committee consisting of members of the American College of Rheumatology, the European League Against Rheumatism, and the Outcome Measures in Rheumatology Initiative met to guide the process and review prespecified analyses from RA clinical trials. The committee requested a stringent definition (little, if any, active disease) and decided to use core set measures including, as a minimum, joint counts and levels of an acute-phase reactant to define remission. Members were surveyed to select the level of each core set measure that would be consistent with remission. Candidate definitions of remission were tested, including those that constituted a number of individual measures of remission (Boolean approach) as well as definitions using disease activity indexes. To select a definition of remission, trial data were analyzed to examine the added contribution of patient-reported outcomes and the ability of candidate measures to predict later good radiographic and functional outcomes. Survey results for the definition of remission suggested indexes at published thresholds and a count of core set measures, with each measure scored as 1 or less (e.g., tender and swollen joint counts, C-reactive protein [CRP] level, and global assessments on a 0-10 scale). Analyses suggested the need to include a patient-reported measure. Examination of 2-year followup data suggested that many candidate definitions performed comparably in terms of predicting later good radiographic and functional outcomes, although 28-joint Disease Activity Score-based measures of remission did not predict good radiographic outcomes as well as the other candidate definitions did. Given these and other considerations, we propose that a patient's RA can be defined as being in remission based on one of two definitions: (a) when scores on the tender joint count, swollen joint count, CRP (in mg/dl), and patient global assessment (0-10 scale) are all ≤ 1, or (b) when the score on the Simplified Disease Activity Index is ≤ 3.3. We propose two new definitions of remission, both of which can be uniformly applied and widely used in RA clinical trials. We recommend that one of these be selected as an outcome measure in each trial and that the results on both be reported for each trial. Copyright © 2011 by the American College of Rheumatology.

Role of Subdural Electrocorticography in Prediction of Long-Term Seizure Outcome in Epilepsy Surgery

ERIC Educational Resources Information Center

Asano, Eishi; Juhasz, Csaba; Shah, Aashit; Sood, Sandeep; Chugani, Harry T.

2009-01-01

Since prediction of long-term seizure outcome using preoperative diagnostic modalities remains suboptimal in epilepsy surgery, we evaluated whether interictal spike frequency measures obtained from extraoperative subdural electrocorticography (ECoG) recording could predict long-term seizure outcome. This study included 61 young patients (age…

Racial Variation in Vocational Rehabilitation Outcomes: A Structural Equation Modeling Approach

ERIC Educational Resources Information Center

Martin, Frank H.

2010-01-01

Numerous studies have indicated racial and ethnic disparities in the vocational rehabilitation (VR) system, including differences in acceptance, services provided, closure types, and employment outcomes. Few of these studies, however, have used advanced multivariate techniques or latent constructs to measure quality of employment outcomes (QEO) or…

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 of ClinRO assessments used as end points in clinical trials. Applying good measurement practices to ClinRO assessment development and evaluation will lead to more efficient and accurate measurement of treatment effects. This is important beyond regulatory approval in that it provides evidence for the uptake of new interventions into clinical practice and provides justification to payers for reimbursement on the basis of the clearly demonstrated added value of the new intervention. PMID:28212963

Salutogenically focused outcomes in systematic reviews of intrapartum interventions: a systematic review of systematic reviews.

PubMed

Smith, Valerie; Daly, Deirdre; Lundgren, Ingela; Eri, Tine; Benstoem, Carina; Devane, Declan

2014-04-01

research on intrapartum interventions in maternity care has focused traditionally on the identification of risk factors' and on the reduction of adverse outcomes with less attention given to the measurement of factors that contribute to well-being and positive health outcomes. We conducted a systematic review of reviews to determine the type and number of salutogenically-focused reported outcomes in current maternity care intrapartum intervention-based research. For the conduct of this review, we interpreted salutogenic outcomes as those relating to optimum and/or positive maternal and neonatal health and well-being. to identify salutogenically-focused outcomes reported in systematic reviews of randomised trials of intrapartum interventions. we searched Issue 9 (September) 2011 of the Cochrane Database of Systematic Reviews for all reviews of intrapartum interventions published by the Cochrane Pregnancy and Childbirth Group using the group filter "hm-preg". Systematic reviews of randomised trials of intrapartum interventions were eligible for inclusion. We excluded protocols for systematic reviews and systematic reviews that had been withdrawn. Outcome data were extracted independently from each included review by at least two review authors. Unique lists of salutogenically and non-salutogenically focused outcomes were established. 16 salutogenically-focused outcome categories were identified in 102 included reviews. Maternal satisfaction and breast feeding were reported most frequently. 49 non-salutogenically-focused outcome categories were identified in the 102 included reviews. Measures of neonatal morbidity were reported most frequently. there is an absence of salutogenically-focused outcomes reported in intrapartum intervention-based research. We recommend the development of a core outcome data set of salutogenically-focused outcomes for intrapartum research. © 2013 Published by Elsevier Ltd.

Core outcome sets and trial registries.

PubMed

Clarke, Mike; Williamson, Paula

2015-05-14

Some reasons for registering trials might be considered as self-serving, such as satisfying the requirements of a journal in which the researchers wish to publish their eventual findings or publicising the trial to boost recruitment. Registry entries also help others, including systematic reviewers, to know about ongoing or unpublished studies and contribute to reducing research waste by making it clear what studies are ongoing. Other sources of research waste include inconsistency in outcome measurement across trials in the same area, missing data on important outcomes from some trials, and selective reporting of outcomes. One way to reduce this waste is through the use of core outcome sets: standardised sets of outcomes for research in specific areas of health and social care. These do not restrict the outcomes that will be measured, but provide the minimum to include if a trial is to be of the most use to potential users. We propose that trial registries, such as ISRCTN, encourage researchers to note their use of a core outcome set in their entry. This will help people searching for trials and those worried about selective reporting in closed trials. Trial registries can facilitate these efforts to make new trials as useful as possible and reduce waste. The outcomes section in the entry could prompt the researcher to consider using a core outcome set and facilitate the specification of that core outcome set and its component outcomes through linking to the original core outcome set. In doing this, registries will contribute to the global effort to ensure that trials answer important uncertainties, can be brought together in systematic reviews, and better serve their ultimate aim of improving health and well-being through improving health and social care.

Neurocognition and community outcome in schizophrenia: long-term predictive validity.

PubMed

Fujii, Daryl E; Wylie, A Michael

2003-02-01

The present study examined the predictive validity of neuropsychological measures to functional outcome in 26 schizophrenic patients 15-plus year post-testing. Outcome measures included score on the Resource Associated Functional Level Scale (RAFLS), number of state hospital admissions, and total duration of state hospital inpatient stay. Results of several stepwise multiple regressions revealed that verbal memory significantly predicted RAFLS score, accounting for nearly half of the variance. Trails B significantly predicted duration of state hospital inpatient status. Discussion focused on the utility of these measures for clinicians and system planners. Copyright 2002 Elsevier Science B.V.

Faustmann and the forestry tradition of outcome-based performance measures

Treesearch

Peter J. Ince

1999-01-01

The concept of land expectation value developed by Martin Faustmann may serve as a paradigm for outcome-based performance measures in public forest management if the concept of forest equity value is broadened to include social and environmental benefits and costs, and sustainability. However, anticipation and accurate evaluation of all benefits and costs appears to...

Positive psychology outcome measures for family caregivers of people living with dementia: a systematic review.

PubMed

Stansfeld, Jacki; Stoner, Charlotte R; Wenborn, Jennifer; Vernooij-Dassen, Myrra; Moniz-Cook, Esme; Orrell, Martin

2017-08-01

Family caregivers of people living with dementia can have both positive and negative experiences of caregiving. Despite this, existing outcome measures predominately focus on negative aspects of caregiving such as burden and depression. This review aimed to evaluate the development and psychometric properties of existing positive psychology measures for family caregivers of people living with dementia to determine their potential utility in research and practice. A systematic review of positive psychology outcome measures for family caregivers of people with dementia was conducted. The databases searched were as follows: PsychINFO, CINAHL, MEDLINE, EMBASE, and PubMed. Scale development papers were subject to a quality assessment to appraise psychometric properties. Twelve positive outcome measures and six validation papers of these scales were identified. The emerging constructs of self-efficacy, spirituality, resilience, rewards, gain, and meaning are in line with positive psychology theory. There are some robust positive measures in existence for family caregivers of people living with dementia. However, lack of reporting of the psychometric properties hindered the quality assessment of some outcome measures identified in this review. Future research should aim to include positive outcome measures in interventional research to facilitate a greater understanding of the positive aspects of caregiving and how these contribute to well-being.

Casemix and process indicators of outcome in stroke. The Royal College of Physicians minimum data set for stroke.

PubMed

Irwin, P; Rudd, A

1998-01-01

The emphasis on outcomes measurement requires that casemix is considered in any comparative studies. In 1996 the Intercollegiate Working Party for Stroke agreed a minimum data set to measure the severity of casemix in stroke. The reasons for its development, the evidence base supporting the items included and the possible uses of the data set are described. It is currently being evaluated in national outcome and process audits to be reported at a later date.

Comparative Effectiveness Research and Children With Cerebral Palsy: Identifying a Conceptual Framework and Specifying Measures.

PubMed

Gannotti, Mary E; Law, Mary; Bailes, Amy F; OʼNeil, Margaret E; Williams, Uzma; DiRezze, Briano

2016-01-01

A step toward advancing research about rehabilitation service associated with positive outcomes for children with cerebral palsy is consensus about a conceptual framework and measures. A Delphi process was used to establish consensus among clinicians and researchers in North America. Directors of large pediatric rehabilitation centers, clinicians from large hospitals, and researchers with expertise in outcomes participated (N = 18). Andersen's model of health care utilization framed outcomes: consumer satisfaction, activity, participation, quality of life, and pain. Measures agreed upon included Participation and Environment Measure for Children and Youth, Measure of Processes of Care, PEDI-CAT, KIDSCREEN-10, PROMIS Pediatric Pain Interference Scale, Visual Analog Scale for pain intensity, PROMIS Global Health Short Form, Family Environment Scale, Family Support Scale, and functional classification levels for gross motor, manual ability, and communication. Universal forms for documenting service use are needed. Findings inform clinicians and researchers concerned with outcome assessment.

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.

Auditory development in early amplified children: factors influencing auditory-based communication outcomes in children with hearing loss.

PubMed

Sininger, Yvonne S; Grimes, Alison; Christensen, Elizabeth

2010-04-01

The purpose of this study was to determine the influence of selected predictive factors, primarily age at fitting of amplification and degree of hearing loss, on auditory-based outcomes in young children with bilateral sensorineural hearing loss. Forty-four infants and toddlers, first identified with mild to profound bilateral hearing loss, who were being fitted with amplification were enrolled in the study and followed longitudinally. Subjects were otherwise typically developing with no evidence of cognitive, motor, or visual impairment. A variety of subject factors were measured or documented and used as predictor variables, including age at fitting of amplification, degree of hearing loss in the better hearing ear, cochlear implant status, intensity of oral education, parent-child interaction, and the number of languages spoken in the home. These factors were used in a linear multiple regression analysis to assess their contribution to auditory-based communication outcomes. Five outcome measures, evaluated at regular intervals in children starting at age 3, included measures of speech perception (Pediatric Speech Intelligibility and Online Imitative Test of Speech Pattern Contrast Perception), speech production (Arizona-3), and spoken language (Reynell Expressive and Receptive Language). The age at fitting of amplification ranged from 1 to 72 mo, and the degree of hearing loss ranged from mild to profound. Age at fitting of amplification showed the largest influence and was a significant factor in all outcome models. The degree of hearing loss was an important factor in the modeling of speech production and spoken language outcomes. Cochlear implant use was the other factor that contributed significantly to speech perception, speech production, and language outcomes. Other factors contributed sparsely to the models. Prospective longitudinal studies of children are important to establish relationships between subject factors and outcomes. This study clearly demonstrated the importance of early amplification on communication outcomes. This demonstration required a participant pool that included children who have been fit at very early ages and who represent all degrees of hearing loss. Limitations of longitudinal studies include selection biases. Families who enroll tend to have high levels of education and rate highly on cooperation and compliance measures. Although valuable information can be extracted from prospective studies, not all factors can be evaluated because of enrollment constraints.

Challenges in Measuring Outcomes Following Digital Replantation

PubMed Central

Sebastin, Sandeep J.; Chung, Kevin C.

2013-01-01

In the early period of replantation surgery, the emphasis was on digit survival. Subsequently, with better microsurgical techniques and instrumentation, the focus has shifted to function and in recent years to consideration of cost-effectiveness. Despite over 40 years of effort in refining digital replantation surgery, a rigorous evaluation of the outcomes of digital replantation has not been performed. This is because of the many confounding variables that influence outcome comparisons. These variables include the mechanism of injury (guillotine, crush, avulsion), the injury itself (total, near total, subtotal, partial amputation), and the surgical procedure (replantation, revascularization). In addition, the traditional outcome measures (two-point discrimination, range of motion, grip strength, or the ability to return to work) are reported inconsistently and vary widely among publications. All these factors make meaningful comparison of outcomes difficult. The recent emphasis on outcome research and cost-effectiveness necessitates a rethinking in the way we report outcomes of digital replantation. In this article, the authors summarize the challenges in assessing outcomes of digital replantation and explain the need to measure outcomes using rigorous clinical research designs that incorporate cost-effectiveness studies in the research protocol. PMID:24872766

Update on Outcome Measure Development for Large Vessel Vasculitis: Report from OMERACT 12

PubMed Central

Aydin, Sibel Zehra; Direskeneli, Haner; Sreih, Antoine; Alibaz-Oner, Fatma; Gul, Ahmet; Kamali, Sevil; Hatemi, Gulen; Kermani, Tanaz; Mackie, Sarah L.; Mahr, Alfred; Meara, Alexa; Milman, Nataliya; Nugent, Heidi; Robson, Joanna; Tomasson, Gunnar; Merkel, Peter A.

2015-01-01

Objective The rarity of large vessel vasculitis (LVV) is a major factor limiting randomized controlled trials in LVV, resulting in treatment choices in these diseases that are guided mainly by observational studies and expert opinion. Further complicating trials in LVV is the absence of validated and meaningful outcome measures. The Outcome Measures in Rheumatology (OMERACT) vasculitis working group initiated the Large Vessel Vasculitis task force in 2009 to develop data-driven, validated outcome tools for clinical investigation in LVV. This report summarizes the progress that has been made on a disease activity assessment tool and patient-reported outcomes in LVV as well as the group’s research agenda. Methods The OMERACT LVV task force brought an international group of investigators and patient research partners together to work collaboratively on developing outcome tools. The group initially focused on disease activity assessment tools in LVV. Following a systematic literature review, an international Delphi exercise was conducted to obtain expert opinion on principles and domains for disease assessment. The OMERACT vasculitis working group’s LVV task force is also conducting qualitative research with patients, including interviews, focus groups, and engaging patients as research partners, all to ensure that the approach to disease assessment includes measures of patients’ perspectives and that patients have input into the research agenda and process. Results The preliminary results of both the Delphi exercise and the qualitative interviews were discussed at the OMERACT 12 (2014) meeting and the completion of the analyses will produce an initial set of domains and instruments to form the basis of next steps in the research agenda. Conclusion The research agenda continues to evolve, with the ultimate goal of developing an OMERACT-endorsed core set of outcome measures for use in clinical trials of LVV. PMID:26077399

Impact of a labor and delivery safety bundle on a modified adverse outcomes index.

PubMed

Tolcher, Mary Catherine; Torbenson, Vanessa E; Weaver, Amy L; McGree, Michaela E; El-Nashar, Sherif A; Nesbitt, Katharine M; Gostout, Bobbie S; Famuyide, Abimbola O

2016-03-01

The Obstetrics Adverse Outcomes Index was designed to measure the quality of perinatal care and includes 10 adverse events that may occur at or around the time of delivery. We hypothesized that adverse outcomes in the labor and delivery suite, including hypoxic ischemic encephalopathy, could be decreased with a combination of interventions, even among high-risk pregnancies. The objective of the study was to evaluate the impact of a labor and delivery care bundle on adverse obstetrics outcomes as measured by a modified Obstetrics Adverse Outcomes Index, Weighted Adverse Outcomes Index, and Severity Index. This is a retrospective cohort study including all women who delivered at our academic, tertiary care institution over a 3 year period of time, before and after the implementation of an intervention to decrease adverse outcomes. Outcome measures consisted of previously reported indices that were modified including the addition of hypoxic ischemic encephalopathy. The adverse outcomes index is a percentage of deliveries with 1 or more adverse events, the weighted adverse outcomes index is the sum of the points assigned to cases with adverse outcomes divided by the number of deliveries, and the severity index is the sum of the adverse outcome scores divided by the number of deliveries with an identified adverse outcome. A segmented regression analysis was utilized to evaluate the differences in the level and trend of each index before and after our intervention using calendar month as the unit of analysis. During the study period, 5826 deliveries met inclusion criteria. Comparing the pre- and postintervention periods, high-risk pregnancy was more common in the postintervention period (73.5% vs 79.4%, P < .001). Overall, there was a decrease in both the Modified Weighted Adverse Outcomes Index (P = .0497) and the Modified Severity Index (P = 0.01) comparing the pre- and postintervention periods; there was no difference in the Modified Adverse Outcomes Index (P = .43). For low-risk pregnancies, there was no significant difference in the levels for any of the measured indices over the study period (P = .61, P = .41, and P = .34 for the Modified Adverse Outcomes Index, Modified Weighted Adverse Outcomes Index, and Modified Severity Index, respectively). Among the high-risk pregnancies, the monthly Modified Weighted Adverse Outcomes Index decreased by 4.2 ± 1.8 (P = .03). The monthly Modified Severity Index decreased by 53.9 ± 17.7 points from the pre- to the postintervention periods (P = .01) and was < 50% of the predicted Modified Severity Index had the intervention not been implemented. The cesarean delivery rate was increasing prior to the intervention, but the rate was stable after the intervention, and the absolute rate did not differ between the pre- and the postintervention periods (28.4% vs 30.0%, P = .20). Overall and for high-risk pregnancies, the implementation of the labor and delivery care bundle had a positive impact on the Modified Weighted Adverse Outcomes Index and Modified Severity Index but not the Modified Adverse Outcomes Index. Copyright © 2016 Elsevier Inc. All rights reserved.

Comprehensive Outcome Researches of Intralesional Steroid Injection on Benign Vocal Fold Lesions.

PubMed

Wang, Chi-Te; Lai, Mei-Shu; Hsiao, Tzu-Yu

2015-09-01

This study investigated multidimensional treatment outcomes, including prognostic factors and side effects of vocal fold steroid injection (VFSI). We recruited 126 consecutive patients, including patients with 49 nodules, 47 polyps, and 30 mucus retention cysts. All the patients received VFSI under local anesthesia in the office settings. Treatment outcomes were evaluated 1 and 2 months after the procedure, including endoscopic evaluation, perceptual voice quality (GRB scores), acoustic analysis, and 10-item Voice Handicap Index (VHI-10). More than 80% of the patients reported subjective improvements after VFSI. Objective measurements revealed significant improvements from baseline in most of the outcome parameters (P<0.05). Higher occupational vocal demands and fibrotic vocal nodules were significantly associated with poorer clinical responses as measured by the VHI-10 and GRB scores, respectively. For vocal polyps, dysphonia for more than 12 months were significantly associated with higher postoperative VHI-10 scores, whereas patients with laryngopharyngeal reflux (LPR) showed significantly poor postoperative voice quality as measured by GRB scores. Side effects after VFSI included hematoma (27%), triamcinolone deposits (4%), and vocal atrophy (1%), which resolved spontaneously within 1-2 months. Presentation with vocal fold ectasias/varicosities and higher vocal demands were significantly correlated with postoperative vocal hematoma. This study demonstrated significant improvements after VFSI in vocal nodules, polyps, and cysts. Occupational vocal demand and subtypes of vocal nodules are closely related to the treatment outcomes after VFSI, whereas symptom duration and LPR were significant prognostic factors for VFSI treatment outcomes in vocal polyps. Side effects after receiving VFSI were mostly self-limited without sequel, whereas the incidence rates might be varied by the injection approach and the timing for postoperative follow-up. Copyright © 2015 The Voice Foundation. Published by Elsevier Inc. All rights reserved.

Retail price as an outcome measure for the effectiveness of drug law enforcement.

PubMed

Bright, David A; Ritter, Alison

2010-09-01

One outcome measure of law enforcement effectiveness is the reduction in drug consumption which occurs as a result of law enforcement interventions. A theoretical relationship between drug consumption and retail price has promoted the use of retail price as a surrogate measure for consumption. In the current article, retail price is examined as a potential outcome measure for the effectiveness of law enforcement. The predictions regarding the relationship between law enforcement intensity and price are only partially supported by research. Explanations for the disconnect between the drug law enforcement activity and retail price include: rapid adaptation by market players, enforcement swamping, assumptions of rational actors, short-run versus long-run effects, structure of the illicit market, simultaneous changes that affect price in perverse ways, the role of violence in markets, and data limitations. Researchers who use retail price as an outcome measure need to take into account the complex relationship between drug law enforcement interventions and the retail price of illicit drugs. Viable outcome measures which can be used as complements to retail price are worth investigation. Copyright 2009 Elsevier B.V. All rights reserved.

Lack of knowledge and training are the major obstacles in application of the Spinal Cord Independence Measure (SCIM) in China.

PubMed

Liu, Nan; Xing, Huayi; Zhou, Mouwang; Biering-Sørensen, Fin

2018-03-29

Objective To investigate the use of functional outcome measurements after spinal cord injury (SCI) in current clinical practice and to explore the knowledge about the Spinal Cord Independence Measure (SCIM) among SCI physicians in China, and to find facilitators for a broader utilization of SCIM. Design A survey-based study. Setting SCI workshops at Peking University. Participants 125 Chinese SCI physicians attending annual workshops in two consecutive years. Interventions Not applicable. Outcome measures A questionnaire was administered. The following items were included: whether functional outcome measurement for SCI individuals was performed and with which assessment tool(s); what items should be included in the assessment; whether they knew about the SCIM, its latest version, the Chinese translation, and if so from what source; the possible reasons why SCIM was not implemented in clinical practice; and whether training before using the SCIM was needed, and the training method preferred. Results Among these physicians, 84.8% performed functional outcome measurement for individuals with SCI, but only 29.6% of attendees were aware of the SCIM and 20.8% had used it. Lack of training was the major reason why SCIM was not used in clinical practice. Furthermore, 74.4% of the physicians felt they needed formal training before using the SCIM. Conclusion The use of SCIM is limited in clinical practice in China, which is mainly attributed to lack of knowledge and training. Formal training on the use of the SCIM is essential for its dissemination and will improve functional SCI outcome measurement in China.

American College of Rheumatology/European League against Rheumatism Preliminary Definition of Remission in Rheumatoid Arthritis for Clinical Trials

PubMed Central

Felson, David T.; Smolen, Josef S.; Wells, George; Zhang, Bin; van Tuyl, Lilian H. D.; Funovits, Julia; Aletaha, Daniel; Allaart, Renée; Bathon, Joan; Bombardieri, Stefano; Brooks, Peter; Brown, Andrew; Matucci-Cerinic, Marco; Choi, Hyon; Combe, Bernard; de Wit, Maarten; Dougados, Maxime; Emery, Paul; Furst, Dan; Gomez-Reino, Juan; Hawker , Gillian; Keystone, Edward; Khanna, Dinesh; Kirwan, John; Kvien, Tore; Landewé, Robert; Listing, Joachim; Michaud, Kaleb; Mola, Emilio Martin; Montie, Pam; Pincus, Ted; Richards, Pam; Siegel, Jeff; Simon, Lee; Sokka, Tuulikki; Strand, Vibeke; Tugwell, Peter; Tyndall, Alan; van der Heijde, Desirée; Verstappen, Suzan; White, Barbara; Wolfe, Fred; Zink, Angela; Boers, Maarten

2010-01-01

Background With remission in rheumatoid arthritis (RA) an increasingly attainable goal, there is no widely used definition of remission that is stringent but achievable and could be applied uniformly as an outcome in clinical trials. Methods A committee consisting of members of the American College of Rheumatology, the European League Against Rheumatism and the Outcome Measures in Rheumatology Initiative (OMERACT) met to guide the process and review prespecified analyses from clinical trials of patients with RA. The committee requested a stringent definition (little, if any, active disease) and decided to use core set measures to define remission including at least joint counts and an acute phase reactant. Members were surveyed to select the level of each core set measure consistent with remission. Candidate definitions of remission were tested including those that constituted a number of individual measures in remission (Boolean approach) as well as definitions using disease activity indexes. To select a definition of remission, trial data were analyzed to examine the added contribution of patient reported outcomes and the ability of candidate measures to predict later good x-ray and functional outcomes. Results Survey results for the definition of remission pointed to indexes at published thresholds and to a count of core set measures with each measure scored as 1 or less (e.g. tender and swollen joint counts, CRP and global assessments on 0-10 scale). Analyses suggested the need to include a patient reported measure. Examination of 2 year follow-up data suggested that many candidate definitions performed comparably in terms of predicting later good x-ray and functional outcomes, although DAS28 based measures of remission did not predict good radiographic outcomes as well as did the other candidate definitions. Given these and other considerations, we propose that a patient be defined as in remission based on one of two definitions : 1: When their scores on the following measures are all <1: tender joint count, swollen joint count, CRP (in mg/dL) and patient global assessment (0-10 scale), OR 2: when their score on the SDAI is < 3.3. Conclusion We propose two new definitions of remission both of which can be uniformly applied and widely used in RA clinical trials. We recommend that one of these be selected in each trial as an outcome and that the results on both be reported in each trial. PMID:21294106

Outcome Measures for Clinical Trials in Down Syndrome.

PubMed

Esbensen, Anna J; Hooper, Stephen R; Fidler, Deborah; Hartley, Sigan L; Edgin, Jamie; d'Ardhuy, Xavier Liogier; Capone, George; Conners, Frances A; Mervis, Carolyn B; Abbeduto, Leonard; Rafii, Michael; Krinsky-McHale, Sharon J; Urv, Tiina

2017-05-01

Increasingly individuals with intellectual and developmental disabilities, including Down syndrome, are being targeted for clinical trials. However, a challenge exists in effectively evaluating the outcomes of these new pharmacological interventions. Few empirically evaluated, psychometrically sound outcome measures appropriate for use in clinical trials with individuals with Down syndrome have been identified. To address this challenge, the National Institutes of Health (NIH) assembled leading clinicians and scientists to review existing measures and identify those that currently are appropriate for trials; those that may be appropriate after expansion of age range addition of easier items, and/or downward extension of psychometric norms; and areas where new measures need to be developed. This article focuses on measures in the areas of cognition and behavior.

Choosing important health outcomes for comparative effectiveness research: An updated systematic review and involvement of low and middle income countries.

PubMed

Davis, Katherine; Gorst, Sarah L; Harman, Nicola; Smith, Valerie; Gargon, Elizabeth; Altman, Douglas G; Blazeby, Jane M; Clarke, Mike; Tunis, Sean; Williamson, Paula R

2018-01-01

Core outcome sets (COS) comprise a minimum set of outcomes that should be measured and reported in all trials for a specific health condition. The COMET (Core Outcome Measures in Effectiveness Trials) Initiative maintains an up to date, publicly accessible online database of published and ongoing COS. An annual systematic review update is an important part of this process. This review employed the same, multifaceted approach that was used in the original review and the previous two updates. This approach has identified studies that sought to determine which outcomes/domains to measure in clinical trials of a specific condition. This update includes an analysis of the inclusion of participants from low and middle income countries (LMICs) as identified by the OECD, in these COS. Eighteen publications, relating to 15 new studies describing the development of 15 COS, were eligible for inclusion in the review. Results show an increase in the use of mixed methods, including Delphi surveys. Clinical experts remain the most common stakeholder group involved. Overall, only 16% of the 259 COS studies published up to the end of 2016 have included participants from LMICs. This review highlights opportunities for greater public participation in COS development and the involvement of stakeholders from a wider range of geographical settings, in particular LMICs.

Outcomes that Define Successful Advance Care Planning: A Delphi Panel Consensus

PubMed Central

Sudore, Rebecca L.; Heyland, Daren K.; Lum, Hillary D.; Rietjens, Judith A.C.; Korfage, Ida J.; Ritchie, Christine S.; Hanson, Laura C.; Meier, Diane E.; Pantilat, Steven Z.; Lorenz, Karl; Howard, Michelle; Green, Michael J.; Simon, Jessica E.; Feuz, Mariko A.; You, John J.

2017-01-01

Context Standardized outcomes that define successful advance care planning (ACP) are lacking. Objective To create an Organizing Framework of ACP outcome constructs and rate the importance of these outcomes. Methods This study convened a Delphi panel consisting of 52 multidisciplinary, international ACP experts including clinicians, researchers, and policy leaders from four countries. We conducted literature reviews and solicited attendee input from 5 international ACP conferences to identify initial ACP outcome constructs. In 5 Delphi rounds, we asked panelists to rate patient-centered outcomes on a 7-point “not-at-all” to “extremely important” scale. We calculated means and analyzed panelists’ input to finalize an Organizing Framework and outcome rankings. Results Organizing Framework outcome domains included process (e.g., attitudes), actions (e.g., discussions), quality of care (e.g., satisfaction), and healthcare (e.g., utilization). The top 5 outcomes included (1) care consistent with goals, mean 6.71 (±SD 0.04); (2) surrogate designation, 6.55 (0.45); (3) surrogate documentation, 6.50 (0.11); (4) discussions with surrogates, 6.40 (0.19); and (5) documents and recorded wishes are accessible when needed 6.27 (0.11). Advance directive documentation was ranked 10th, 6.01 (0.21). Panelists raised caution about whether “care consistent with goals” 6.01 (0.21). Panelists raised can be reliably measured. Conclusion A large, multidisciplinary Delphi panel developed an Organizing Framework and rated the importance of ACP outcome constructs. Top rated outcomes should be used to evaluate the success of ACP initiatives. More research is needed to create reliable and valid measurement tools for the highest rated outcomes, particularly “care consistent with goals.” PMID:28865870

Establishing a Core Outcome Measure for Fatigue in Patients on Hemodialysis: A Standardized Outcomes in Nephrology-Hemodialysis (SONG-HD) Consensus Workshop Report.

PubMed

Ju, Angela; Unruh, Mark; Davison, Sara; Dapueto, Juan; Dew, Mary Amanda; Fluck, Richard; Germain, Michael; Jassal, Sarbjit V; Obrador, Gregorio; O'Donoghue, Donal; Josephson, Michelle A; Craig, Jonathan C; Viecelli, Andrea; O'Lone, Emma; Hanson, Camilla S; Manns, Braden; Sautenet, Benedicte; Howell, Martin; Reddy, Bharathi; Wilkie, Caroline; Rutherford, Claudia; Tong, Allison

2018-03-15

Fatigue is one of the most highly prioritized outcomes for patients and clinicians, but remains infrequently and inconsistently reported across trials in hemodialysis. We convened an international Standardized Outcomes in Nephrology-Hemodialysis (SONG-HD) consensus workshop with stakeholders to discuss the development and implementation of a core outcome measure for fatigue. 15 patients/caregivers and 42 health professionals (clinicians, researchers, policy makers, and industry representatives) from 9 countries participated in breakout discussions. Transcripts were analyzed thematically. 4 themes for a core outcome measure emerged. Drawing attention to a distinct and all-encompassing symptom was explicitly recognizing fatigue as a multifaceted symptom unique to hemodialysis. Emphasizing the pervasive impact of fatigue on life participation justified the focus on how fatigue severely impaired the patient's ability to do usual activities. Ensuring relevance and accuracy in measuring fatigue would facilitate shared decision making about treatment. Minimizing burden of administration meant avoiding the cognitive burden, additional time, and resources required to use the measure. A core outcome measure that is simple, is short, and includes a focus on the severity of the impact of fatigue on life participation may facilitate consistent and meaningful measurement of fatigue in all trials to inform decision making and care of patients receiving hemodialysis. Copyright © 2018 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

Association of Leukoaraiosis With Convalescent Rehabilitation Outcome in Patients With Ischemic Stroke.

PubMed

Senda, Joe; Ito, Keiichi; Kotake, Tomomitsu; Kanamori, Masahiko; Kishimoto, Hideo; Kadono, Izumi; Suzuki, Yoshiro; Katsuno, Masahisa; Nishida, Yoshihiro; Ishiguro, Naoki; Sobue, Gen

2016-01-01

We investigated the factors influencing inpatient convalescent rehabilitation outcomes in patients with ischemic stroke, particularly severity of leukoaraiosis on magnetic resonance imaging. Participants included 520 patients with ischemic stroke (317 men and 203 women; mean age, 72.8±8.4 years) who were transferred from acute care hospitals for inpatient convalescent rehabilitation. Ischemic stroke subtypes included lacunar infarction (n=41), atherothrombosis (n=223), artery-to-artery embolism (n=67), cardiogenic embolism (n=97), undetermined embolism (n=76), and uncategorized ischemic stroke (n=16). Leukoaraiosis was graded according to periventricular hyperintensity (PVH) and deep white matter hyperintensity on magnetic resonance imaging. Functional Independence Measure scores were assessed on admission and at discharge. Multiple regression analysis revealed that rehabilitation outcomes, measured as total Functional Independence Measure scores, were significantly associated with leukoaraiosis estimated by PVH grade. This association was observed after adjustment for factors such as severity, age, and poststroke history. In all patients, PVH grades were associated with Functional Independence Measure motor scores (P<0.001), whereas in patients with artery-to-artery embolism or cardiogenic embolism and deep white matter hyperintensity grades were associated with Functional Independence Measure cognitive scores (P<0.05). Our study revealed that the degree of leukoaraiosis was associated with inpatient convalescent rehabilitation outcome in patients with ischemic stroke. Furthermore, the PVH grade was associated with motor function outcome, whereas the deep white matter hyperintensity grade correlated with cognitive function outcome, likely because the progression patterns and anatomic backgrounds of PVH and deep white matter hyperintensity differ according to ischemic stroke subtype. © 2015 American Heart Association, Inc.

How Measurement and Modeling of Attendance Matter to Assessing Dimensions of Inequality

ERIC Educational Resources Information Center

Dougherty, Shaun M.

2018-01-01

Each iteration of high stakes accountability has included requirements to include measures of attendance in their accountability programs, thereby increasing the salience of this measure. Researchers too have turned to attendance and chronic absence as important outcomes in evaluations and policy studies. Often, too little attention is paid to the…

Rasch Measurement Analysis of the Mayo-Portland Adaptability Inventory (MPAI-4) in a Community-Based Rehabilitation Sample

PubMed Central

Malec, James F.; Altman, Irwin M.; Swick, Shannon

2011-01-01

Abstract The precise measurement of patient outcomes depends upon clearly articulated constructs and refined clinical assessment instruments that work equally well for all subgroups within a population. This is a challenging task in those with acquired brain injury (ABI) because of the marked heterogeneity of the disorder and subsequent outcomes. Alhough essential, the iterative process of instrument refinement is often neglected. This present study was undertaken to examine validity, reliability, dimensionality and item estimate invariance of the Mayo-Portland Adaptability Inventory – 4 (MPAI-4), an outcome measure for persons with ABI. The sampled population included 603 persons with traumatic ABI participating in a home- and community-based rehabilitation program. Results indicated that the MPAI-4 is a valid, reliable measure of outcome following traumatic ABI, which measures a broad but unitary core construct of outcome after ABI. Further, the MPAI-4 is composed of items that are unbiased toward selected subgroups except where differences could be expected [e.g., more chronic traumatic brain injury (TBI) patients are better able to negotiate demands of transportation than more acute TBI patients]. We address the trade-offs between strict unidimensionality and clinical applicability in measuring outcome, and illustrate the advantages and disadvantages of applying single-parameter measurement models to broad constructs. PMID:21332409

Rasch measurement analysis of the Mayo-Portland Adaptability Inventory (MPAI-4) in a community-based rehabilitation sample.

PubMed

Kean, Jacob; Malec, James F; Altman, Irwin M; Swick, Shannon

2011-05-01

The precise measurement of patient outcomes depends upon clearly articulated constructs and refined clinical assessment instruments that work equally well for all subgroups within a population. This is a challenging task in those with acquired brain injury (ABI) because of the marked heterogeneity of the disorder and subsequent outcomes. Although essential, the iterative process of instrument refinement is often neglected. This present study was undertaken to examine validity, reliability, dimensionality and item estimate invariance of the Mayo-Portland Adaptability Inventory - 4 (MPAI-4), an outcome measure for persons with ABI. The sampled population included 603 persons with traumatic ABI participating in a home- and community-based rehabilitation program. Results indicated that the MPAI-4 is a valid, reliable measure of outcome following traumatic ABI, which measures a broad but unitary core construct of outcome after ABI. Further, the MPAI-4 is composed of items that are unbiased toward selected subgroups except where differences could be expected [e.g., more chronic traumatic brain injury (TBI) patients are better able to negotiate demands of transportation than more acute TBI patients]. We address the trade-offs between strict unidimensionality and clinical applicability in measuring outcome, and illustrate the advantages and disadvantages of applying single-parameter measurement models to broad constructs.

An International Standard Set of Patient-Centered Outcome Measures After Stroke.

PubMed

Salinas, Joel; Sprinkhuizen, Sara M; Ackerson, Teri; Bernhardt, Julie; Davie, Charlie; George, Mary G; Gething, Stephanie; Kelly, Adam G; Lindsay, Patrice; Liu, Liping; Martins, Sheila C O; Morgan, Louise; Norrving, Bo; Ribbers, Gerard M; Silver, Frank L; Smith, Eric E; Williams, Linda S; Schwamm, Lee H

2016-01-01

Value-based health care aims to bring together patients and health systems to maximize the ratio of quality over cost. To enable assessment of healthcare value in stroke management, an international standard set of patient-centered stroke outcome measures was defined for use in a variety of healthcare settings. A modified Delphi process was implemented with an international expert panel representing patients, advocates, and clinical specialists in stroke outcomes, stroke registers, global health, epidemiology, and rehabilitation to reach consensus on the preferred outcome measures, included populations, and baseline risk adjustment variables. Patients presenting to a hospital with ischemic stroke or intracerebral hemorrhage were selected as the target population for these recommendations, with the inclusion of transient ischemic attacks optional. Outcome categories recommended for assessment were survival and disease control, acute complications, and patient-reported outcomes. Patient-reported outcomes proposed for assessment at 90 days were pain, mood, feeding, selfcare, mobility, communication, cognitive functioning, social participation, ability to return to usual activities, and health-related quality of life, with mobility, feeding, selfcare, and communication also collected at discharge. One instrument was able to collect most patient-reported subdomains (9/16, 56%). Minimum data collection for risk adjustment included patient demographics, premorbid functioning, stroke type and severity, vascular and systemic risk factors, and specific treatment/care-related factors. A consensus stroke measure Standard Set was developed as a simple, pragmatic method to increase the value of stroke care. The set should be validated in practice when used for monitoring and comparisons across different care settings. © 2015 The Authors.

Exploring the broader health and well-being outcomes of mining communities in low- and middle-income countries: A systematic review.

PubMed

Mactaggart, Fiona; McDermott, Liane; Tynan, Anna; Whittaker, Maxine

2018-07-01

Health and well-being outcomes in communities living in proximity to mining activity may be influenced by a broad spectrum of factors including population growth, economic instability or land degradation. This review aims to synthesise broader outcomes associated with mining activity and in doing so, further explore possible determinants in communities of low- and middle-income countries. Four databases were systematically searched and articles were included if the study targeted adults residing in proximity to mining activity, and measured individual or community-level health or well-being outcomes. Narrative synthesis was conducted. Twelve articles were included. Mining was perceived to influence health behaviours, employment conditions, livelihoods and socio-political factors, which were linked to poorer health outcomes. Family relationships, mental health and community cohesion were negatively associated with mining activity. High-risk health behaviours, population growth and changes in vector ecology from environmental modification were associated with increased infectious disease prevalence. This review presents the broader health and well-being outcomes and their determinants, and strengthens the evidence to improve measurement and management of the public health implications of mining. This will support the mining sector to make sustainable investments, and support governments to maximise community development and minimise negative impacts.

Measuring the Early Adulthood Outcomes of Young Adults with Disabilities: Developing Constructs Using NLTS2 Data

ERIC Educational Resources Information Center

Shogren, Karrie A.; Shaw, Leslie A.; Little, Todd D.

2016-01-01

Secondary data analysis was used to develop and examine disability-related differences in outcome constructs from the National Longitudinal Transition Study-2. Findings suggest that outcome constructs could be created that represented key elements of quality of life domains including social relationships, financial independence, financial…

Measuring the Early Adulthood Outcomes of Young Adults with Disabilities: Developing Constructs Using NLTS2 Data

ERIC Educational Resources Information Center

Shogren, Karrie A.; Shaw, Leslie A.; Little, Todd D.

2016-01-01

Secondary data analysis was used to develop and examine disability-related differences in outcome constructs from the National Longitudinal Transition Study-2 (NLTS2). Findings suggest that outcome constructs could be created that represented key elements of quality of life domains including social relationships, financial independence, financial…

A Review of Quality Measures for Assessing the Impact of Antimicrobial Stewardship Programs in Hospitals

PubMed Central

Akpan, Mary Richard; Ahmad, Raheelah; Shebl, Nada Atef; Ashiru-Oredope, Diane

2016-01-01

The growing problem of antimicrobial resistance (AMR) has led to calls for antimicrobial stewardship programs (ASP) to control antibiotic use in healthcare settings. Key strategies include prospective audit with feedback and intervention, and formulary restriction and preauthorization. Education, guidelines, clinical pathways, de-escalation, and intravenous to oral conversion are also part of some programs. Impact and quality of ASP can be assessed using process or outcome measures. Outcome measures are categorized as microbiological, patient or financial outcomes. The objective of this review was to provide an overview of quality measures for assessing ASP and the reported impact of ASP in peer-reviewed studies, focusing particularly on patient outcomes. A literature search of papers published in English between 1990 and June 2015 was conducted in five databases using a combination of search terms. Primary studies of any design were included. A total of 63 studies were included in this review. Four studies defined quality metrics for evaluating ASP. Twenty-one studies assessed the impact of ASP on antimicrobial utilization and cost, 25 studies evaluated impact on resistance patterns and/or rate of Clostridium difficile infection (CDI). Thirteen studies assessed impact on patient outcomes including mortality, length of stay (LOS) and readmission rates. Six of these 13 studies reported non-significant difference in mortality between pre- and post-ASP intervention, and five reported reductions in mortality rate. On LOS, six studies reported shorter LOS post intervention; a significant reduction was reported in one of these studies. Of note, this latter study reported significantly (p < 0.001) higher unplanned readmissions related to infections post-ASP. Patient outcomes need to be a key component of ASP evaluation. The choice of metrics is influenced by data and resource availability. Controlling for confounders must be considered in the design of evaluation studies to adequately capture the impact of ASP and it is important for unintended consequences to be considered. This review provides a starting point toward compiling standard outcome metrics for assessing ASP. PMID:27025520

CONTENT VALIDITY OF SYMPTOM-BASED MEASURES FOR DIABETIC, CHEMOTHERAPY, AND HIV PERIPHERAL NEUROPATHY

PubMed Central

GEWANDTER, JENNIFER S.; BURKE, LAURIE; CAVALETTI, GUIDO; DWORKIN, ROBERT H.; GIBBONS, CHRISTOPHER; GOVER, TONY D.; HERRMANN, DAVID N.; MCARTHUR, JUSTIN C.; MCDERMOTT, MICHAEL P.; RAPPAPORT, BOB A.; REEVE, BRYCE B.; RUSSELL, JAMES W.; SMITH, A. GORDON; SMITH, SHANNON M.; TURK, DENNIS C.; VINIK, AARON I.; FREEMAN, ROY

2017-01-01

Introduction No treatments for axonal peripheral neuropathy are approved by the United States Food and Drug Administration (FDA). Although patient- and clinician-reported outcomes are central to evaluating neuropathy symptoms, they can be difficult to assess accurately. The inability to identify efficacious treatments for peripheral neuropathies could be due to invalid or inadequate outcome measures. Methods This systematic review examined the content validity of symptom-based measures of diabetic peripheral neuropathy, HIV neuropathy, and chemotherapy-induced peripheral neuropathy. Results Use of all FDA-recommended methods to establish content validity was only reported for 2 of 18 measures. Multiple sensory and motor symptoms were included in measures for all 3 conditions; these included numbness, tingling, pain, allodynia, difficulty walking, and cramping. Autonomic symptoms were less frequently included. Conclusions Given significant overlap in symptoms between neuropathy etiologies, a measure with content validity for multiple neuropathies with supplemental disease-specific modules could be of great value in the development of disease-modifying treatments for peripheral neuropathies. PMID:27447116

Content validity of symptom-based measures for diabetic, chemotherapy, and HIV peripheral neuropathy.

PubMed

Gewandter, Jennifer S; Burke, Laurie; Cavaletti, Guido; Dworkin, Robert H; Gibbons, Christopher; Gover, Tony D; Herrmann, David N; Mcarthur, Justin C; McDermott, Michael P; Rappaport, Bob A; Reeve, Bryce B; Russell, James W; Smith, A Gordon; Smith, Shannon M; Turk, Dennis C; Vinik, Aaron I; Freeman, Roy

2017-03-01

No treatments for axonal peripheral neuropathy are approved by the United States Food and Drug Administration (FDA). Although patient- and clinician-reported outcomes are central to evaluating neuropathy symptoms, they can be difficult to assess accurately. The inability to identify efficacious treatments for peripheral neuropathies could be due to invalid or inadequate outcome measures. This systematic review examined the content validity of symptom-based measures of diabetic peripheral neuropathy, HIV neuropathy, and chemotherapy-induced peripheral neuropathy. Use of all FDA-recommended methods to establish content validity was only reported for 2 of 18 measures. Multiple sensory and motor symptoms were included in measures for all 3 conditions; these included numbness, tingling, pain, allodynia, difficulty walking, and cramping. Autonomic symptoms were less frequently included. Given significant overlap in symptoms between neuropathy etiologies, a measure with content validity for multiple neuropathies with supplemental disease-specific modules could be of great value in the development of disease-modifying treatments for peripheral neuropathies. Muscle Nerve 55: 366-372, 2017. © 2016 Wiley Periodicals, Inc.

Auditory Outcomes with Hearing Rehabilitation in Children with Unilateral Hearing Loss: A Systematic Review.

PubMed

Appachi, Swathi; Specht, Jessica L; Raol, Nikhila; Lieu, Judith E C; Cohen, Michael S; Dedhia, Kavita; Anne, Samantha

2017-10-01

Objective Options for management of unilateral hearing loss (UHL) in children include conventional hearing aids, bone-conduction hearing devices, contralateral routing of signal (CROS) aids, and frequency-modulating (FM) systems. The objective of this study was to systematically review the current literature to characterize auditory outcomes of hearing rehabilitation options in UHL. Data Sources PubMed, EMBASE, Medline, CINAHL, and Cochrane Library were searched from inception to January 2016. Manual searches of bibliographies were also performed. Review Methods Studies analyzing auditory outcomes of hearing amplification in children with UHL were included. Outcome measures included functional and objective auditory results. Two independent reviewers evaluated each abstract and article. Results Of the 249 articles identified, 12 met inclusion criteria. Seven articles solely focused on outcomes with bone-conduction hearing devices. Outcomes favored improved pure-tone averages, speech recognition thresholds, and sound localization in implanted patients. Five studies focused on FM systems, conventional hearing aids, or CROS hearing aids. Limited data are available but suggest a trend toward improvement in speech perception with hearing aids. FM systems were shown to have the most benefit for speech recognition in noise. Studies evaluating CROS hearing aids demonstrated variable outcomes. Conclusions Data evaluating functional and objective auditory measures following hearing amplification in children with UHL are limited. Most studies do suggest improvement in speech perception, speech recognition in noise, and sound localization with a hearing rehabilitation device.

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 access are critical to optimizing the comparability, reliability, and value of trial evidence to improve outcomes for patients requiring hemodialysis. Copyright © 2017 National Kidney Foundation, Inc. All rights reserved.

Effects of lifestyle change interventions for people with intellectual disabilities: Systematic review and meta-analysis of randomized controlled trials.

PubMed

Willems, Mariël; Waninge, Aly; Hilgenkamp, Thessa I M; van Empelen, Pepijn; Krijnen, Wim P; van der Schans, Cees P; Melville, Craig A

2018-05-08

Promotion of a healthy lifestyle for people with intellectual disabilities is important; however, the effectiveness of lifestyle change interventions is unclear. This research will examine the effectiveness of lifestyle change interventions for people with intellectual disabilities. Randomized controlled trials (RCTs) of lifestyle change interventions for people with intellectual disabilities were included in a systematic review and meta-analysis. Data on study and intervention characteristics were extracted, as well as data on outcome measures and results. Internal validity of the selected papers was assessed using the Cochrane Collaboration's risk bias tool. Eight RCTs were included. Multiple outcome measures were used, whereby outcome measures targeting environmental factors and participation were lacking and personal outcome measures were mostly used by a single study. Risks of bias were found for all studies. Meta-analysis showed some effectiveness for lifestyle change interventions, and a statistically significant decrease was found for waist circumference. Some effectiveness was found for lifestyle change interventions for people with intellectual disabilities. However, the effects were only statistically significant for waist circumference, so current lifestyle change interventions may not be optimally tailored to meet the needs of people with intellectual disabilities. © 2018 John Wiley & Sons Ltd.

A Systematic Review of Financial Toxicity Among Cancer Survivors: We Can't Pay the Co-Pay.

PubMed

Gordon, Louisa G; Merollini, Katharina M D; Lowe, Anthony; Chan, Raymond J

2017-06-01

To determine the extent of financial toxicity (FT) among cancer survivors, identify the determinants and how FT is measured. A systematic review was performed in MEDLINE, CINAHL and PsycINFO, using relevant terminology and included articles published from 1 January, 2013 to 30 June, 2016. We included observational studies where the primary outcomes included FT and study samples were greater than 200. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines were followed. From 417 citations, a total of 25 studies were included in this review. Seventy outcomes of FT were reported with 47 covering monetary, objective and subjective indicators of FT. A total of 28-48% of patients reported FT using monetary measures and 16-73% using subjective measures. The most commonly reported factors associated with FT were: being female, younger age, low income at baseline, adjuvant therapies and more recent diagnosis. Relative to non-cancer comparison groups, cancer survivors experienced significantly higher FT. Most studies were cross-sectional and causal inferences between FT and determinants were not possible. Measures of FT were varied and most were not validated, while monetary values of out-of-pocket expenses included different cost components across studies. A substantial proportion of cancer survivors experience financial hardship irrespective of how it is measured. Using standardised outcomes and longitudinal designs to measure FT would improve determination of the extent of FT. Further research is recommended on reduced work participation and income losses occurring concurrently with FT and on the impacts on treatment non-adherence.

Network meta-analysis of multiple outcome measures accounting for borrowing of information across outcomes

PubMed Central

2014-01-01

Background Network meta-analysis (NMA) enables simultaneous comparison of multiple treatments while preserving randomisation. When summarising evidence to inform an economic evaluation, it is important that the analysis accurately reflects the dependency structure within the data, as correlations between outcomes may have implication for estimating the net benefit associated with treatment. A multivariate NMA offers a framework for evaluating multiple treatments across multiple outcome measures while accounting for the correlation structure between outcomes. Methods The standard NMA model is extended to multiple outcome settings in two stages. In the first stage, information is borrowed across outcomes as well across studies through modelling the within-study and between-study correlation structure. In the second stage, we make use of the additional assumption that intervention effects are exchangeable between outcomes to predict effect estimates for all outcomes, including effect estimates on outcomes where evidence is either sparse or the treatment had not been considered by any one of the studies included in the analysis. We apply the methods to binary outcome data from a systematic review evaluating the effectiveness of nine home safety interventions on uptake of three poisoning prevention practices (safe storage of medicines, safe storage of other household products, and possession of poison centre control telephone number) in households with children. Analyses are conducted in WinBUGS using Markov Chain Monte Carlo (MCMC) simulations. Results Univariate and the first stage multivariate models produced broadly similar point estimates of intervention effects but the uncertainty around the multivariate estimates varied depending on the prior distribution specified for the between-study covariance structure. The second stage multivariate analyses produced more precise effect estimates while enabling intervention effects to be predicted for all outcomes, including intervention effects on outcomes not directly considered by the studies included in the analysis. Conclusions Accounting for the dependency between outcomes in a multivariate meta-analysis may or may not improve the precision of effect estimates from a network meta-analysis compared to analysing each outcome separately. PMID:25047164

Including a range of outcome targets offers a broader view of fibromyalgia treatment outcome: results from a retrospective review of multidisciplinary treatment.

PubMed

Marcus, Dawn A; Bernstein, Cheryl D; Haq, Adeel; Breuer, Paula

2014-06-01

Fibromyalgia is associated with substantial functional disability. Current drug and non-drug treatments result in statistically significant but numerically small improvements in typical numeric measures of pain severity and fibromyalgia impact. The aim of the present study was to evaluate additional measures of pain severity and functional outcome that might be affected by fibromyalgia treatment. This retrospective review evaluated outcomes from 274 adults with fibromyalgia who participated in a six-week, multidisciplinary treatment programme. Pain and function were evaluated on the first and final treatment visit. Pain was evaluated using an 11-point numerical scale to determine clinically meaningful pain reduction (decrease ≥ 2 points) and from a pain drawing. Function was evaluated by measuring active range of motion (ROM), walking distance and speed, upper extremity exercise repetitions, and self-reports of daily activities. Numerical rating scores for pain decreased by 10-13% (p < 0.01) and Fibromyalgia Impact Questionnaire (FIQ) scores decreased by 20% (p < 0.001). More substantial improvements were noted when using alternative measures. Clinically meaningful pain relief was achieved by 37% of patients, and the body area affected by pain decreased by 31%. ROM showed significant improvements in straight leg raise and cervical motion, without improvements in lumbar ROM. Daily walking distance increased fourfold and arm exercise repetitions doubled. Despite modest albeit statistically significant improvements in standard measures of pain severity and the FIQ, more substantial pain improvement was noted when utilizing alternative measures of pain and functional improvement. Alternative symptom assessment measures might be important outcome measures to include in drug and non-drug studies to better understand fibromyalgia treatment effectiveness. © 2013 John Wiley & Sons, Ltd.

Validity and reliability of a novel measure of activity performance and participation.

PubMed

Murgatroyd, Phil; Karimi, Leila

2016-01-01

To develop and evaluate an innovative clinician-rated measure, which produces global numerical ratings of activity performance and participation. Repeated measures study with 48 community-dwelling participants investigating clinical sensibility, comprehensiveness, practicality, inter-rater reliability, responsiveness, sensitivity and concurrent validity with Barthel Index. Important clinimetric characteristics including comprehensiveness and ease of use were rated >8/10 by clinicians. Inter-rater reliability was excellent on the summary scores (intraclass correlation of 0.95-0.98). There was good evidence that the new outcome measure distinguished between known high and low functional scoring groups, including both responsiveness to change and sensitivity at the same time point in numerous tests. Concurrent validity with the Barthel Index was fair to high (Spearman Rank Order Correlation 0.32-0.85, p > 0.05). The new measure's summary scores were nearly twice as responsive to change compared with the Barthel Index. Other more detailed data could also be generated by the new measure. The Activity Performance Measure is an innovative outcome instrument that showed good clinimetric qualities in this initial study. Some of the results were strong, given the sample size, and further trial and evaluation is appropriate. Implications for Rehabilitation The Activity Performance Measure is an innovative outcome measure covering activity performance and participation. In an initial evaluation, it showed good clinimetric qualities including responsiveness to change, sensitivity, practicality, clinical sensibility, item coverage, inter-rater reliability and concurrent validity with the Barthel Index. Further trial and evaluation is appropriate.

Multidimensional assessment of self-regulated learning with middle school math students.

PubMed

Callan, Gregory L; Cleary, Timothy J

2018-03-01

This study examined the convergent and predictive validity of self-regulated learning (SRL) measures situated in mathematics. The sample included 100 eighth graders from a diverse, urban school district. Four measurement formats were examined including, 2 broad-based (i.e., self-report questionnaire and teacher ratings) and 2 task-specific measures (i.e., SRL microanalysis and behavioral traces). Convergent validity was examined across task-difficulty, and the predictive validity was examined across 3 mathematics outcomes: 2 measures of mathematical problem solving skill (i.e., practice session math problems, posttest math problems) and a global measure of mathematical skill (i.e., standardized math test). Correlation analyses were used to examine convergent validity and revealed medium correlations between measures within the same category (i.e., broad-based or task-specific). Relations between measurement classes were not statistically significant. Separate regressions examined the predictive validity of the SRL measures. While controlling all other predictors, a SRL microanalysis metacognitive-monitoring measure emerged as a significant predictor of all 3 outcomes and teacher ratings accounted for unique variance on 2 of the outcomes (i.e., posttest math problems and standardized math test). Results suggest that a multidimensional assessment approach should be considered by school psychologists interested in measuring SRL. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

Graphic Strategies for Analyzing and Interpreting Curricular Mapping Data

PubMed Central

Leonard, Sean T.

2010-01-01

Objective To describe curricular mapping strategies used in analyzing and interpreting curricular mapping data and present findings on how these strategies were used to facilitate curricular development. Design Nova Southeastern University's doctor of pharmacy curriculum was mapped to the college's educational outcomes. The mapping process included development of educational outcomes followed by analysis of course material and semi-structured interviews with course faculty members. Data collected per course outcome included learning opportunities and assessment measures used. Assessment Nearly 1,000 variables and 10,000 discrete rows of curricular data were collected. Graphic representations of curricular data were created using bar charts and stacked area graphs relating the learning opportunities to the educational outcomes. Graphs were used in the curricular evaluation and development processes to facilitate the identification of curricular holes, sequencing misalignments, learning opportunities, and assessment measures. Conclusion Mapping strategies that use graphic representations of curricular data serve as effective diagnostic and curricular development tools. PMID:20798804

Graphic strategies for analyzing and interpreting curricular mapping data.

PubMed

Armayor, Graciela M; Leonard, Sean T

2010-06-15

To describe curricular mapping strategies used in analyzing and interpreting curricular mapping data and present findings on how these strategies were used to facilitate curricular development. Nova Southeastern University's doctor of pharmacy curriculum was mapped to the college's educational outcomes. The mapping process included development of educational outcomes followed by analysis of course material and semi-structured interviews with course faculty members. Data collected per course outcome included learning opportunities and assessment measures used. Nearly 1,000 variables and 10,000 discrete rows of curricular data were collected. Graphic representations of curricular data were created using bar charts and stacked area graphs relating the learning opportunities to the educational outcomes. Graphs were used in the curricular evaluation and development processes to facilitate the identification of curricular holes, sequencing misalignments, learning opportunities, and assessment measures. Mapping strategies that use graphic representations of curricular data serve as effective diagnostic and curricular development tools.

Restoring function in major depressive disorder: A systematic review.

PubMed

Sheehan, David V; Nakagome, Kazuyuki; Asami, Yuko; Pappadopulos, Elizabeth A; Boucher, Matthieu

2017-06-01

Functional impairment contributes to significant disability and economic burden in major depressive disorder (MDD). Treatment response is measured by improvement in depressive symptoms, but functional improvement often lags behind symptomatic improvement. Residual deficits are associated with relapse of depressive symptoms. A literature search was conducted using the following terms: "major depressive disorder," "functional impairment," "functional outcomes," "recovery of function," "treatment outcome," "outcome assessment," "social functioning," "presenteeism," "absenteeism," "psychiatric status rating scales," and "quality of life." Search limits included publication date (January 1, 1995 to August 31, 2016), English language, and human clinical trials. Controlled, acute-phase, nonrecurrent MDD treatment studies in adults were included if a functional outcome was measured at baseline and endpoint. The qualitative analysis included 35 controlled studies. The Sheehan Disability Scale was the most commonly used functional assessment. Antidepressant treatments significantly improved functional outcomes. Early treatment response predicted functional improvement, while baseline disease severity did not. Clinical studies utilized various methodologies and assessments for functional impairment, and were not standardized or adequately powered. The lack of synchronicity between symptomatic and functional improvement highlights an unmet need for MDD. Treatment guided by routine monitoring of symptoms and functionality may minimize residual functional impairments. Copyright © 2017. Published by Elsevier B.V.

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 following treatment as well as extend to involve other areas of the hand, follow-up times should be standardised and designed to capture both short and long term outcomes. PMID:23575442

Evaluation of third trimester uterine artery flow velocity indices in relationship to perinatal complications.

PubMed

Ghosh, G; Breborowicz, A; Brazert, M; Maczkiewicz, M; Kobelski, M; Dubiel, M; Gudmundsson, S

2006-09-01

Uterine artery Doppler is becoming a routine part of pregnancy surveillance in high-risk pregnancies. Which blood flow velocity waveform index to measure is debated and the 'notch' in early diastole is not widely accepted, as it is a subjective measure. The aim of the present study was to evaluate the different indices in the prediction of adverse outcome of pregnancies suspected for intrauterine fetal growth restriction (IUGR). Uterine artery blood flow was recorded in 217 pregnancies admitted for Doppler ultrasound surveillance due to suspected IUGR. The median gestational age at examination was 38 weeks (range 25-42 weeks). Only cases having bilateral uterine artery notching were included in the evaluation. The uterine artery Doppler spectrum was analyzed for different indices, including evaluation of notch and end-diastolic velocities. Umbilical artery Doppler velocimetry was also performed. The outcome variables chosen were: a small-for-gestational-age (SGA) newborn, preterm birth, and abdominal delivery. ROC-curve calculations were used to compare the different indices. The uterine artery blood velocity pulsatility index (PI) and resistance indices (RI) were the best predictors of adverse outcome of pregnancy. Apart from premature birth, the systolic/end-diastolic ratio was less predictive of adverse outcome. The indices including only diastolic blood velocities were the least predictive of adverse outcome. The group with notch velocity above end-diastolic velocity was compared with those having notch velocity below the end-diastolic velocity. No difference in outcome was seen between the two groups. RI and PI as measures of third trimester utero-placental vascular impedance are the best predictors of adverse outcome of IUGR-suspected pregnancies.

Evidence for Updating the Core Domain Set of Outcome Measures for Juvenile Idiopathic Arthritis: Report from a Special Interest Group at OMERACT 2016.

PubMed

Morgan, Esi M; Riebschleger, Meredith P; Horonjeff, Jennifer; Consolaro, Alessandro; Munro, Jane E; Thornhill, Susan; Beukelman, Timothy; Brunner, Hermine I; Creek, Emily L; Harris, Julia G; Horton, Daniel B; Lovell, Daniel J; Mannion, Melissa L; Olson, Judyann C; Rahimi, Homaira; Gallo, Maria Chiara; Calandra, Serena; Ravelli, Angelo; Ringold, Sarah; Shenoi, Susan; Stinson, Jennifer; Toupin-April, Karine; Strand, Vibeke; Bingham, Clifton O

2017-12-01

The current Juvenile Idiopathic Arthritis (JIA) Core Set was developed in 1997 to identify the outcome measures to be used in JIA clinical trials using statistical and consensus-based techniques, but without patient involvement. The importance of patient/parent input into the research process has increasingly been recognized over the years. An Outcome Measures in Rheumatology (OMERACT) JIA Core Set Working Group was formed to determine whether the outcome domains of the current core set are relevant to those involved or whether the core set domains should be revised. Twenty-four people from the United States, Canada, Australia, and Europe, including patient partners, formed the working group. Guided by the OMERACT Filter 2.0 process, we performed (1) a systematic literature review of outcome domains, (2) a Web-based survey (142 patients, 343 parents), (3) an idea-generation study (120 parents), (4) 4 online discussion boards (24 patients, 20 parents), and (5) a Special Interest Group (SIG) activity at the OMERACT 13 (2016) meeting. A MEDLINE search of outcome domains used in studies of JIA yielded 5956 citations, of which 729 citations underwent full-text review, and identified additional domains to those included in the current JIA Core Set. Qualitative studies on the effect of JIA identified multiple additional domains, including pain and participation. Twenty-one participants in the SIG achieved consensus on the need to revise the entire JIA Core Set. The results of qualitative studies and literature review support the need to expand the JIA Core Set, considering, among other things, additional patient/parent-centered outcomes, clinical data, and imaging data.

Family-centred service coordination in childhood health and disability services: the search for meaningful service outcome measures.

PubMed

Trute, B; Hiebert-Murphy, D; Wright, A

2008-05-01

Potential service outcome measures were tested for their utility in the assessment of the quality of 'family centred' service coordination in the provincial network of children's disability services in Manitoba, Canada. This study is based on in-home survey data provided by 103 mothers at 6 and 18 months following assignment of a 'dedicated' service coordinator. Service outcome indicators included measures of parent self-esteem, parenting stress, family functioning and the need for family support resources. Hierarchical regression analyses showed no relationship between level of quality of family-centred service coordination and standardized psychosocial measures of parent and family functioning. However, family centredness of service coordination was found to predict significant reduction in level of family need for psychosocial support resources after 18 months of contact with a service coordinator. Outcome measures that are focused on specific and tangible results of service coordination appear to be of higher utility in service quality assessment than are more global, standardized measures of parent and family functioning.

Information Technology-Based Interventions to Improve Drug-Drug Interaction Outcomes: A Systematic Review on Features and Effects.

PubMed

Nabovati, Ehsan; Vakili-Arki, Hasan; Taherzadeh, Zhila; Saberi, Mohammad Reza; Medlock, Stephanie; Abu-Hanna, Ameen; Eslami, Saeid

2017-01-01

The purpose of this systematic review was to identify features and effects of information technology (IT)-based interventions on outcomes related to drug-drug interactions (DDI outcomes). A literature search was conducted in Medline, EMBASE, and the Cochrane Library for published English-language studies. Studies were included if a main outcome was related to DDIs, the intervention involved an IT-based system, and the study design was experimental or observational with controls. Study characteristics, including features and effects of IT-based interventions, were extracted. Nineteen studies comprising five randomized controlled trials (RCT), five non-randomized controlled trials (NRCT) and nine observational studies with controls (OWC) were included. Sixty-four percent of prescriber-directed interventions, and all non-prescriber interventions, were effective. Each of the following characteristics corresponded to groups of studies of which a majority were effective: automatic provision of recommendations within the providers' workflow, intervention at the time of decision-making, integration into other systems, and requiring the reason for not following the recommendations. Only two studies measured clinical outcomes: an RCT that showed no significant improvement and an OWC that showed improvement, but did not statistically assess the effect. Most studies that measured surrogate outcomes (e.g. potential DDIs) and other outcomes (e.g. adherence to alerts) showed improvements. IT-based interventions improve surrogate clinical outcomes and adherence to DDI alerts. However, there is lack of robust evidence about their effectiveness on clinical outcomes. It is recommended that researchers consider the identified features of effective interventions in the design of interventions and evaluate the effectiveness on DDI outcomes, particularly clinical outcomes.

Quality Measurements in Radiology: A Systematic Review of the Literature and Survey of Radiology Benefit Management Groups.

PubMed

Narayan, Anand; Cinelli, Christina; Carrino, John A; Nagy, Paul; Coresh, Josef; Riese, Victoria G; Durand, Daniel J

2015-11-01

As the US health care system transitions toward value-based reimbursement, there is an increasing need for metrics to quantify health care quality. Within radiology, many quality metrics are in use, and still more have been proposed, but there have been limited attempts to systematically inventory these measures and classify them using a standard framework. The purpose of this study was to develop an exhaustive inventory of public and private sector imaging quality metrics classified according to the classic Donabedian framework (structure, process, and outcome). A systematic review was performed in which eligibility criteria included published articles (from 2000 onward) from multiple databases. Studies were double-read, with discrepancies resolved by consensus. For the radiology benefit management group (RBM) survey, the six known companies nationally were surveyed. Outcome measures were organized on the basis of standard categories (structure, process, and outcome) and reported using Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The search strategy yielded 1,816 citations; review yielded 110 reports (29 included for final analysis). Three of six RBMs (50%) responded to the survey; the websites of the other RBMs were searched for additional metrics. Seventy-five unique metrics were reported: 35 structure (46%), 20 outcome (27%), and 20 process (27%) metrics. For RBMs, 35 metrics were reported: 27 structure (77%), 4 process (11%), and 4 outcome (11%) metrics. The most commonly cited structure, process, and outcome metrics included ACR accreditation (37%), ACR Appropriateness Criteria (85%), and peer review (95%), respectively. Imaging quality metrics are more likely to be structural (46%) than process (27%) or outcome (27%) based (P < .05). As national value-based reimbursement programs increasingly emphasize outcome-based metrics, radiologists must keep pace by developing the data infrastructure required to collect outcome-based quality metrics. Copyright © 2015 American College of Radiology. Published by Elsevier Inc. All rights reserved.

Understanding the outcomes measures used in Huntington disease pharmacologicaltrials: A systematic review

PubMed Central

Carlozzi, Noelle E; Miciura, Angela; Migliore, Nicholas; Dayalu, Praveen

2014-01-01

Background The identification of the gene mutation causing Huntington disease has raised hopes for new treatments to ease symptoms and slow functional decline. As such, there has been a push towards designing efficient pharmacological trials (i.e., drug trials), especially with regard to selecting outcomes measures that are both brief and sensitive to changes across the course of the disease, from subtle prodromal changes, to more severe end-stage changes. Objectives Recently, to aid in efficient development of new HD research studies, the National Institute of Neurological Disorders and Stroke (NINDS) published recommendations for measurement selection in HD. While these recommendations are helpful, many of the recommended measures have little published data in HD. As such, we conducted a systematic review of the literature to identify the most common outcomes measures used in HD clinical trials. Methods Major medical databases, including PubMed, Embase, CINAHL, and the Cochrane Central Register of Controlled Trials, were used to identify peer-reviewed journal articles in English from 2001 through April 2013; 151 pharmacological trials were identified. Results The majority of HD clinical trials employed clinician-reported outcomes measures (93%); patient reported outcome measures (11%) and observer reported outcome measures (3%) were used with much less frequency. Conclusions We provide a review of the most commonly used measures across these trials, compare these measures to the clinical recommendations made by the NINDS working groups, and provide recommendations for selecting measures for future clinical trials that meet the Food and Drug Administration standards. PMID:25300328

Use of Objective Metrics in Dynamic Facial Reanimation: A Systematic Review.

PubMed

Revenaugh, Peter C; Smith, Ryan M; Plitt, Max A; Ishii, Lisa; Boahene, Kofi; Byrne, Patrick J

2018-06-21

Facial nerve deficits cause significant functional and social consequences for those affected. Existing techniques for dynamic restoration of facial nerve function are imperfect and result in a wide variety of outcomes. Currently, there is no standard objective instrument for facial movement as it relates to restorative techniques. To determine what objective instruments of midface movement are used in outcome measurements for patients treated with dynamic methods for facial paralysis. Database searches from January 1970 to June 2017 were performed in PubMed, Embase, Cochrane Library, Web of Science, and Scopus. Only English-language articles on studies performed in humans were considered. The search terms used were ("Surgical Flaps"[Mesh] OR "Nerve Transfer"[Mesh] OR "nerve graft" OR "nerve grafts") AND (face [mh] OR facial paralysis [mh]) AND (innervation [sh]) OR ("Face"[Mesh] OR facial paralysis [mh]) AND (reanimation [tiab]). Two independent reviewers evaluated the titles and abstracts of all articles and included those that reported objective outcomes of a surgical technique in at least 2 patients. The presence or absence of an objective instrument for evaluating outcomes of midface reanimation. Additional outcome measures were reproducibility of the test, reporting of symmetry, measurement of multiple variables, and test validity. Of 241 articles describing dynamic facial reanimation techniques, 49 (20.3%) reported objective outcome measures for 1898 patients. Of those articles reporting objective measures, there were 29 different instruments, only 3 of which reported all outcome measures. Although instruments are available to objectively measure facial movement after reanimation techniques, most studies do not report objective outcomes. Of objective facial reanimation instruments, few are reproducible and able to measure symmetry and multiple data points. To accurately compare objective outcomes in facial reanimation, a reproducible, objective, and universally applied instrument is needed.

Development of a core outcome set for clinical trials in inflammatory bowel disease: study protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey.

PubMed

Ma, Christopher; Panaccione, Remo; Fedorak, Richard N; Parker, Claire E; Khanna, Reena; Levesque, Barrett G; Sandborn, William J; Feagan, Brian G; Jairath, Vipul

2017-06-09

Crohn's disease (CD) and ulcerative colitis (UC), the main forms of inflammatory bowel disease (IBD), are chronic, progressive and disabling disorders of the gastrointestinal tract. Although data from randomised controlled trials (RCTs) provide the foundation of evidence that validates medical therapy for IBD, considerable heterogeneity exists in the measured outcomes used in these studies. Furthermore, in recent years, there has been a paradigm shift in IBD treatment targets, moving from symptom-based scoring to improvement or normalisation of objective measures of inflammation such as endoscopic appearance, inflammatory biomarkers and histological and radiographic end points. The abundance of new treatment options and evolving end points poses opportunities and challenges for all stakeholders involved in drug development. Accordingly, there exists a need to harmonise measures used in clinical trials through the development of a core outcome set (COS). The development of an IBD-specific COS includes four steps. First, a systematic literature review is performed to identify outcomes previously used in IBD RCTs. Second, semistructured qualitative interviews are conducted with key stakeholders, including patients, clinicians, researchers, pharmaceutical industry representatives, healthcare payers and regulators to identify additional outcomes of importance. Using the outcomes generated from literature review and stakeholder interviews, an international two-round Delphi survey is conducted to prioritise outcomes for inclusion in the COS. Finally, a consensus meeting is held to ratify the COS and disseminate findings for application in future IBD trials. Given that over 30 novel therapeutic compounds are in development for IBD treatment, the design of robust clinical trials measuring relevant and standardised outcomes is crucial. Standardising outcomes through a COS will reduce heterogeneity in trial reporting, facilitate valid comparisons of new therapies and improve clinical trial quality. © 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 expressly granted.

Surveillance of working conditions and the work environment: development of a national hazard surveillance tool in New Zealand.

PubMed

Lilley, Rebbecca; Feyer, Anne-Marie; Firth, Hilda; Cunningham, Chris; Paul, Charlotte

2010-02-01

Changes to work and the impact of these changes on worker health and safety have been significant. A core surveillance data set is needed to understand the impact of working conditions and work environments. Yet, there is little harmony amongst international surveys and a critical lack of guidance identifying the best directions for surveillance efforts. This paper describes the establishment of an instrument suitable for use as a hazard surveillance tool for New Zealand workers. An iterative process of critical review was undertaken to create a dimensional framework and select specific measures from existing instruments. Pilot testing to ascertain participant acceptability of the questions was undertaken. The final questionnaire includes measures of socio-demographic characteristics, occupational history, work organisation, physicochemical, ergonomic and psychosocial hazards. Outcome measures were also included. A robust New Zealand hazard surveillance questionnaire comprehensively covering the key measures of work organisation and work environments that impact upon worker health and safety outcomes was developed. Recommended measures of work organisation, work environment and health outcomes that should be captured in work environment surveillance are made.

Multidimensional outcome considerations in assessing the efficacy of medical educational programs.

PubMed

Blumberg, Phyllis

2003-01-01

To be accredited, schools must evaluate the effectiveness of their programs. Educators are looking for specific indicators beyond the traditional measures. Data from multiple methods, including indicators of student performance and of the institutional environment, can be used to determine if educational program goals are met. This article outlines specific ways to consider three types of efficacy outcomes that are consistent with accreditation guidelines: educational, clinical career, and environmental outcomes. Specific measurable outcomes for each of these categories are derived from higher education literature: for example, learning approaches and information acquisition for education; professional behaviors and interpersonal dimensions for clinical career, and scholarship of teaching and teaching itself as a shared and valued activity for environmental outcomes. These outcomes address student assessment and program evaluation. Data from problem-based learning programs illustrate these outcomes. Educators can determine if educational program innovations have met their goals by collecting efficacy outcome data.

Heart Failure Update: Chronic Disease Management Programs.

PubMed

Fountain, Lorna B

2016-03-01

With high mortality and readmission rates among patients with heart failure (HF), multiple disease management models have been and continue to be tested, with mixed results. Early postdischarge care improves outcomes for patients. Telemonitoring also can assist in reducing mortality and HF-related hospitalizations. Office-based team care improves patient outcomes, with important components including rapid access to physicians, partnerships with clinical pharmacists, education, monitoring, and support. Pay-for-performance measures developed for HF, primarily use of angiotensin-converting enzyme inhibitors and beta blockers, also improve patient outcomes, but the influence of adherence to other measures has been minimal. Evaluating comorbid conditions, including diabetes and hypertension, and making drug adjustments for patients with HF to include blood pressure control and use of metformin, when possible, can reduce mortality and morbidity. Written permission from the American Academy of Family Physicians is required for reproduction of this material in whole or in part in any form or medium.

Yes, but Can They Earn a Living? Methods for Creating an Effective System of Measuring Labor Market Outcomes in Higher Education. Research & Occasional Paper Series: CSHE.5.13

ERIC Educational Resources Information Center

Moore, Richard W.; Chapman, Kenneth; Huber, Bettina; Shors, Mark

2013-01-01

A new federal initiative calls for a College Scorecard which will include a yet to be determined measure of graduate earnings. In this paper we examine the political context that drives this initiative and examine the nascent efforts of four states to develop statewide systems to measure the labor market outcomes of higher education. We propose…

The impact of self-efficacy, expectations, and readiness on hearing aid outcomes.

PubMed

Ferguson, Melanie A; Woolley, Annie; Munro, Kevin J

2016-07-01

To examine the impact of self-efficacy and expectations for hearing aids, and readiness to improve hearing, on hearing aid outcome measures in first-time adult hearing aid users Design: A prospective, single centre design. Predictor variables measured at the hearing assessment included measures of self-efficacy, expectations and readiness to improve hearing. Outcome measures obtained at six-week follow-up were the Glasgow Hearing Aid Benefit Profile and Satisfaction with Amplification in Daily Life. A sample of 30 first-time adult hearing aid users were recruited through a public-sector funded audiology clinic. When measured prior to hearing aid fitting, self-efficacy for hearing aids predicted satisfaction with hearing aids but was not related to other hearing aid outcomes. Expectations of hearing aids, in particular positive expectations, and readiness to improve hearing predicted outcomes for hearing aid satisfaction and benefit, although not hearing aid use. Hearing sensitivity was not correlated with hearing aid outcomes. These results suggest that assessment of expectations of hearing aids, and readiness to improve hearing, may be useful to help identify individuals attending audiology clinics who would most likely benefit from hearing aid provision.

Montreal Accord on Patient-Reported Outcomes (PROs) use series-Paper 7: modern perspectives of measurement validation emphasize justification of inferences based on patient reported outcome scores.

PubMed

Sawatzky, Richard; Chan, Eric K H; Zumbo, Bruno D; Ahmed, Sara; Bartlett, Susan J; Bingham, Clifton O; Gardner, William; Jutai, Jeffrey; Kuspinar, Ayse; Sajobi, Tolulope; Lix, Lisa M

2017-09-01

Obtaining the patient's view about the outcome of care is an essential component of patient-centered care. Many patient-reported outcome (PRO) instruments for different purposes have been developed since the 1960s. Measurement validation is fundamental in the development, evaluation, and use of PRO instruments. This paper provides a review of modern perspectives of measurement validation in relation to the followings three questions as applied to PROs: (1) What evidence is needed to warrant comparisons between groups and individuals? (2) What evidence is needed to warrant comparisons over time? and (3) What are the value implications, including personal and societal consequences, of using PRO scores? Measurement validation is an ongoing process that involves the accumulation of evidence regarding the justification of inferences, actions, and decisions based on measurement scores. These include inferences pertaining to comparisons between groups and comparisons over time as well as consideration of value implications of using PRO scores. Personal and societal consequences must be examined as part of a comprehensive approach to measurement validation. The answers to these three questions are fundamental to the the validity of different types of inferences, actions, and decisions made on PRO scores in health research, health care administration, and clinical practice. Copyright © 2016 Elsevier Inc. All rights reserved.

The evolving landscape of quality measurement for heart failure

PubMed Central

Fitzgerald, Ashley A.; Allen, Larry A.; Masoudi, Frederick A.

2013-01-01

Heart failure (HF) is a major cause of mortality and morbidity, representing a leading cause of death and hospitalization among U.S. Medicare beneficiaries. Advances in science have generated effective interventions to reduce adverse outcomes in HF, particularly in patients with reduced left ventricular ejection fraction. Unfortunately, effective therapies for heart failure are often not utilized in an effective, safe, timely, equitable, patient-centered, and efficient manner. Further, the risk of adverse outcomes for HF remains high. The last decades have witnessed the growth of efforts to measure and improve the care and outcomes of patients with HF. This paper will review the evolution of quality measurement for HF, including a brief history of quality measurement in medicine; the measures that have been employed to characterize quality in heart failure; how the measures are obtained; how measures are employed; and present and future challenges surrounding quality measurement in heart failure. PMID:22548579

The effectiveness of education in the recognition and management of deteriorating patients: A systematic review.

PubMed

Connell, Clifford J; Endacott, Ruth; Jackman, Jennifer A; Kiprillis, Noelleen R; Sparkes, Louise M; Cooper, Simon J

2016-09-01

Survival from in-hospital cardiac arrest is poor. Clinical features, including abnormal vital signs, often indicate patient deterioration prior to severe adverse events. Early warning systems and rapid response teams are commonly used to assist the health profession in the identification and management of the deteriorating patient. Education programs are widely used in the implementation of these systems. The effectiveness of the education is unknown. The aims of this study were to identify: (i) the evidence supporting educational effectiveness in the recognition and management of the deteriorating patient and (ii) outcome measures used to evaluate educational effectiveness. A mixed methods systematic review of the literature was conducted using studies published between 2002 and 2014. Included studies were assessed for quality and data were synthesized thematically, while original data are presented in tabular form. Twenty-three studies were included in the review. Most educational programs were found to be effective reporting significant positive impacts upon learners, patient outcomes and organisational systems. Outcome measures related to: i learners, for example knowledge and performance, ii systems, including activation and responses of rapid response teams, and iii patients, including patient length of stay and adverse events. All but one of the programs used blended teaching with >87% including medium to high fidelity simulation. In situ simulation was employed in two of the interventions. The median program time was eight hours. The longest program lasted 44h however one of the most educationally effective programs was based upon a 40min simulation program. Educational interventions designed to improve the recognition and management of patient deterioration can improve learner outcomes when they incorporate medium to high-fidelity simulation. High-fidelity simulation has demonstrated effectiveness when delivered in brief sessions lasting only forty minutes. In situ simulation has demonstrated sustained positive impact upon the real world implementation of rapid response systems. Outcome measures should include knowledge and skill developments but there are important benefits in understanding patient outcomes. Copyright © 2016 Elsevier Ltd. All rights reserved.

The influence of ankle dorsiflexion and self-reported patient outcomes on dynamic postural control in participants with chronic ankle instability.

PubMed

Terada, Masafumi; Harkey, Matthew S; Wells, Ashley M; Pietrosimone, Brian G; Gribble, Phillip A

2014-01-01

We investigated the influence of ankle dorsiflexion range of motion (DF-ROM) and self-reported patient outcomes on dynamic postural control assessed with the Star Excursion Balance Test (SEBT) in individuals with chronic ankle instability (CAI). Twenty-nine participants with self-reported CAI volunteered. The primary outcome measurements were categorized into clinician-and patient-generated. Clinician-generated outcome measurements included anterior (SEBT-A), posteriormedial (SEBT-PM) and posteriorlateral (SEBT-PL) reach distances (cm) normalized by leg length (cm) of the SEBT, maximum weight-bearing dorsiflexion (WB-DF) (cm), and open-chain DF-ROM (°). Self-reported patient-generated outcome measures included the foot and ankle ability measure and the level of perceived pain, stiffness, stability, and function of their involved ankle on a 10-cm visual analog scale (VAS). Pearson product moment correlations were used to examine the relationship of the SEBT performances with DF-ROM and self-reported patient outcome measures. A multiple linear regression was performed to determine the influence of patient- and clinician-generated measures on the SEBT. SEBT-A performance was significantly and fairly correlated with WB-DF (r=0.410, p=0.014), perceived ankle stiffness (r=0.477, p=0.014), and open-chain DF-ROM (r=0.404, p=0.015). The strongest predictor of the variance in SEBT-A was the combination of the variance in WB-DF and VAS-stiffness (R2=0.348, p=0.004). There were no significant correlations with the SEBT-PM and SEBT-PL. WB-DF and VAS-stiffness may represent targets for intervention that need to be addressed to produce the best outcome in participants with CAI when altered dynamic postural control is detected on the SEBT-A. Copyright © 2014 Elsevier B.V. All rights reserved.

The impact of generalized joint laxity (GJL) on the posterior neck pain, cervical disc herniation, and cervical disc degeneration in the cervical spine.

PubMed

Lee, Sun-Mi; Oh, Su Chan; Yeom, Jin S; Shin, Ji-Hoon; Park, Sam-Guk; Shin, Duk-Seop; Ahn, Myun-Whan; Lee, Gun Woo

2016-12-01

Generalized joint laxity (GJL) can have a negative impact on lumbar spine pathology, including low back pain, disc degeneration, and disc herniation, but the relationship between GJL and cervical spine conditions remains unknown. To investigate the relationship between GJL and cervical spine conditions, including the prevalence of posterior neck pain (PNP), cervical disc herniation (CDH), and cervical disc degeneration (CDD), in a young, active population. Retrospective 1:2 matched cohort (case-control) study from prospectively collected data PATIENT SAMPLE: Of a total of 1853 individuals reviewed, 73 individuals with GJL (study group, gruop A) and 146 without GJL (control group, Group B) were included in the study according to a 1:2 case-control matched design for age, sex, and body mass index. The primary outcome measure was the prevalence and intensity of PNP at enrollment based on a visual analogue scale score for pain. The secondary outcome measures were (1) clinical outcomes as measured with the neck disability index (NDI) and 12-item short form health survey (SF-12) at enrollment, and (2) radiological outcomes of CDH and CDD at enrollment. We compared baseline data between groups. Descriptive statistical analyses were performed to compare the 2 groups in terms of the outcome measures. The prevalence and intensity of PNP were significantly greater in group A (patients with GJL) than in group B (patients without GJL) (prevalence: p=.02; intensity: p=.001). Clinical outcomes as measured with NDI and SF-12 did not differ significantly between groups. For radiologic outcomes, the prevalence of CDD was significantly greater in group A than in group B (p=.04), whereas the prevalence of CDH did not differ significantly between groups (p=.91). The current study revealed that GJL was closely related to the prevalence and intensity of PNP, suggesting that GJL may be a causative factor for PNP. In addition, GJL may contribute to the occurrence of CDD, but not CDH. Spine surgeons should screen for GJL in patientswith PNP and inform patients of its potential negative impact on disc degeneration of the cervical spine. Copyright © 2016 Elsevier Inc. All rights reserved.

The impact of performance incentives on child health outcomes: results from a cluster randomized controlled trial in the Philippines

PubMed Central

Peabody, John W; Shimkhada, Riti; Quimbo, Stella; Solon, Orville; Javier, Xylee; McCulloch, Charles

2014-01-01

Improving clinical performance using measurement and payment incentives, including pay for performance (or P4P), has, so far, shown modest to no benefit on patient outcomes. Our objective was to assess the impact of a P4P programme on paediatric health outcomes in the Philippines. We used data from the Quality Improvement Demonstration Study. In this study, the P4P intervention, introduced in 2004, was randomly assigned to 10 community district hospitals, which were matched to 10 control sites. At all sites, physician quality was measured using Clinical Performance Vignettes (CPVs) among randomly selected physicians every 6 months over a 36-month period. In the hospitals randomized to the P4P intervention, physicians received bonus payments if they met qualifying scores on the CPV. We measured health outcomes 4–10 weeks after hospital discharge among children 5 years of age and under who had been hospitalized for diarrhoea and pneumonia (the two most common illnesses affecting this age cohort) and had been under the care of physicians participating in the study. Health outcomes data collection was done at baseline/pre-intervention and 2 years post-intervention on the following post-discharge outcomes: (1) age-adjusted wasting, (2) C-reactive protein in blood, (3) haemoglobin level and (4) parental assessment of child’s health using general self-reported health (GSRH) measure. To evaluate changes in health outcomes in the control vs intervention sites over time (baseline vs post-intervention), we used a difference-in-difference logistic regression analysis, controlling for potential confounders. We found an improvement of 7 and 9 percentage points in GSRH and wasting over time (post-intervention vs baseline) in the intervention sites relative to the control sites (P ≤ 0.001). The results from this randomized social experiment indicate that the introduction of a performance-based incentive programme, which included measurement and feedback, led to improvements in two important child health outcomes. PMID:24134922

Auckland Stroke Outcomes Study. Part 1: Gender, stroke types, ethnicity, and functional outcomes 5 years poststroke.

PubMed

Feigin, V L; Barker-Collo, S; Parag, V; Senior, H; Lawes, C M M; Ratnasabapathy, Y; Glen, E

2010-11-02

Studying long-term stroke outcomes including body functioning (neurologic and neuropsychological impairments) and activity limitations and participation is essential for long-term evidence-based rehabilitation and service planning, resource allocation, and improving health outcomes in stroke. However, reliable data to address these issues is lacking. This study (February 2007-December 2008) sourced its participants from the population-based incidence study conducted in Auckland in 2002-2003. Participants completed structured self-administered questionnaires, and a face-to-face interview including a battery of neuropsychological tests. Logistic regression analysis was used to analyze associations between and within functional outcomes and their potential predictors. Of 418 5-year stroke survivors, two-thirds had good functional outcome in terms of neurologic impairment and disability (defined as modified Rankin Score <3), 22.5% had cognitive impairment indicative of dementia, 20% had experienced a recurrent stroke, almost 15% were institutionalized, and 29.6% had symptoms suggesting depression. Highly significant correlations were found between and within various measurements of body functioning (especially neuropsychological impairments), activity, and participation. Age, dependency, and depression were independently associated with most outcomes analyzed. The strong associations between neuropsychological impairment and other functional outcomes and across various measurements of body functioning, activity, and participation justify utilizing a multidisciplinary approach to studying and managing long-term stroke outcomes. Observed gender and ethnic differences in some important stroke outcomes warrant further investigations.

Tobacco industry denormalisation as a tobacco control intervention: a review

PubMed Central

Malone, Ruth E; Grundy, Quinn; Bero, Lisa A

2012-01-01

Objective To conduct a review of research examining the effects of tobacco industry denormalisation (TID) on smoking-related and attitude-related outcomes. Methods The authors searched Pubmed and Scopus databases for articles published through December 2010 (see figure 1). We included all peer-reviewed TID studies we could locate that measured smoking-related outcomes and attitudes toward the tobacco industry. Exclusion criteria included: non-English language, focus on tobacco use rather than TID, perceived ad efficacy as sole outcome, complex program interventions without a separately analysable TID component and non peer-reviewed literature. We analysed the literature qualitatively and summarised findings by outcome measured. Results After excluding articles not meeting the search criteria, the authors reviewed 60 studies examining TID and 9 smoking-related outcomes, including smoking prevalence, smoking initiation, intention to smoke and intention to quit. The authors also reviewed studies of attitudes towards the tobacco industry and its regulation. The majority of studies suggest that TID is effective in reducing smoking prevalence and initiation and increasing intentions to quit. Evidence is mixed for some other outcomes, but some of the divergent findings may be explained by study designs. Conclusions A robust body of evidence suggests that TID is an effective tobacco control intervention at the population level that has a clear exposure–response effect. TID may also contribute to other tobacco control outcomes not explored in this review (including efforts to ‘directly erode industry power’), and thus may enhance public support and political will for structural reforms to end the tobacco epidemic. PMID:22345240

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.

Effectiveness of befriending interventions: a systematic review and meta-analysis

PubMed Central

Siette, Joyce; Cassidy, Megan; Priebe, Stefan

2017-01-01

Objective Befriending is an emotional supportive relationship in which one-to-one companionship is provided on a regular basis by a volunteer. It is commonly and increasingly offered by the voluntary sector for individuals with distressing physical and mental conditions. However, the effectiveness of this intervention on health outcomes is largely unknown. We aim to conduct a systematic review of the benefits of befriending. Design Systematic review. Methods A systematic search of electronic databases was conducted to identify randomised controlled trials and quasi-experimental trials of befriending for a range of physical and mental health indications including depression, anxiety, mental illness, cancer, physical illness and dementia. Main outcomes included patient-relevant and disease-specific outcomes, such as depression, loneliness, quality of life, self-esteem, social support and well-being. Results A total of 14 trials (2411 participants) were included; 7 were judged at low risk of bias. Most trials showed improvement in symptoms associated with befriending but these associations did not reach statistical significance in all trials. Befriending was significantly associated with better patient-reported outcomes across primary measures (standardised mean difference 0.18 (95% CI, −0.002 to 0.36, I2=26%, seven trials)). However, there was no significant benefit on single outcomes, including depression, quality of life, loneliness ratings, self-esteem measures, social support structures and well-being. Conclusions There was moderate quality evidence to support the use of befriending for the treatment of individuals with different physical and mental health conditions. This evidence refers to an overall improvement benefit in patient-reported primary outcomes, although with a rather small effect size. The current evidence base does not allow for firm conclusions on more specific outcomes. Future trials should hypothesise a model for the precise effects of befriending and use specified inclusion and outcome criteria. PMID:28446525

A multisite evaluation of summer camps for children with cancer and their siblings.

PubMed

Wu, Yelena P; McPhail, Jessica; Mooney, Ryan; Martiniuk, Alexandra; Amylon, Michael D

2016-01-01

Summer camps for pediatric cancer patients and their families are ubiquitous. However, there is relatively little research, particularly studies including more than one camp, documenting outcomes associated with children's participation in summer camp. The current cross-sectional study used a standardized measure to examine the role of demographic, illness, and camp factors in predicting children's oncology camp-related outcomes. In total, 2,114 children at 19 camps participated. Campers were asked to complete the pediatric camp outcome measure, which assesses camp-specific self-esteem, emotional, physical, and social functioning. Campers reported high levels of emotional, physical, social, and self-esteem functioning. There were differences in functioning based on demographic and illness characteristics, including gender, whether campers/siblings were on or off active cancer treatment, age, and number of prior years attending camp. Results indicated that summer camps can be beneficial for pediatric oncology patients and their siblings, regardless of demographic factors (e.g., gender, treatment status) and camp factors (e.g., whether camp sessions included patients only, siblings only, or both). Future work could advance the oncology summer camp literature by examining other outcomes linked to summer camp attendance, using longitudinal designs, and including comparison groups.

Evidence for the impact of quality improvement collaboratives: systematic review

PubMed Central

2008-01-01

Objective To evaluate the effectiveness of quality improvement collaboratives in improving the quality of care. Data sources Relevant studies through Medline, Embase, PsycINFO, CINAHL, and Cochrane databases. Study selection Two reviewers independently extracted data on topics, participants, setting, study design, and outcomes. Data synthesis Of 1104 articles identified, 72 were included in the study. Twelve reports representing nine studies (including two randomised controlled trials) used a controlled design to measure the effects of the quality improvement collaborative intervention on care processes or outcomes of care. Systematic review of these nine studies showed moderate positive results. Seven studies (including one randomised controlled trial) reported an effect on some of the selected outcome measures. Two studies (including one randomised controlled trial) did not show any significant effect. Conclusions The evidence underlying quality improvement collaboratives is positive but limited and the effects cannot be predicted with great certainty. Considering that quality improvement collaboratives seem to play a key part in current strategies focused on accelerating improvement, but may have only modest effects on outcomes at best, further knowledge of the basic components effectiveness, cost effectiveness, and success factors is crucial to determine the value of quality improvement collaboratives. PMID:18577559

Pulmonary function tests as outcomes for systemic sclerosis interstitial lung disease.

PubMed

Caron, Melissa; Hoa, Sabrina; Hudson, Marie; Schwartzman, Kevin; Steele, Russell

2018-06-30

Interstitial lung disease (ILD) is the leading cause of morbidity and mortality in systemic sclerosis (SSc). We performed a systematic review to characterise the use and validation of pulmonary function tests (PFTs) as surrogate markers for systemic sclerosis-associated interstitial lung disease (SSc-ILD) progression.Five electronic databases were searched to identify all relevant studies. Included studies either used at least one PFT measure as a longitudinal outcome for SSc-ILD progression ( i.e. outcome studies) and/or reported at least one classical measure of validity for the PFTs in SSc-ILD ( i.e. validation studies).This systematic review included 169 outcome studies and 50 validation studies. Diffusing capacity of the lung for carbon monoxide ( D LCO ) was cumulatively the most commonly used outcome until 2010 when it was surpassed by forced vital capacity (FVC). FVC (% predicted) was the primary endpoint in 70.4% of studies, compared to 11.3% for % predicted D LCO Only five studies specifically aimed to validate the PFTs: two concluded that D LCO was the best measure of SSc-ILD extent, while the others did not favour any PFT. These studies also showed respectable validity measures for total lung capacity (TLC).Despite the current preference for FVC, available evidence suggests that D LCO and TLC should not yet be discounted as potential surrogate markers for SSc-ILD progression. Copyright ©ERS 2018.

Community, Family, and Subjective Socioeconomic Status: Relative Status and Adolescent Health

PubMed Central

Quon, Elizabeth C.; McGrath, Jennifer J.

2017-01-01

Objective Relative socioeconomic status (SES) may be an important social determinant of health. The current study aimed to examine how relative SES, as measured by subjective SES, income inequality, and individual SES relative to others in the community, is associated with a wide range of adolescent health outcomes, after controlling for objective family SES. Method Adolescents (13–16 years; N = 2,199) from the Quebec Child and Adolescent Health and Social Survey were included. Socioeconomic measures included adolescents’ subjective SES; parental education and household income; community education/employment, income, and poverty rate; and community income inequality. Health outcomes included self-rated health, mental health problems, dietary and exercise health behaviors, substance-related health behaviors, reported physical health, and biomarkers of health. Best-fitting multilevel regression models (participants nested within schools) were used to test associations. Results Findings indicated that lower subjective SES was associated with poorer health outcomes. After accounting for family SES, lower community education/employment had an additional negative effect on health, while lower community income had a protective effect for certain health outcomes. There was less evidence for an independent effect of income inequality. Conclusions Findings highlight the importance of measures of relative SES that span across a number of levels and contexts, and provide further understanding into the socioeconomic gradient in adolescence. PMID:25222085

Community, family, and subjective socioeconomic status: Relative status and adolescent health.

PubMed

Quon, Elizabeth C; McGrath, Jennifer J

2015-06-01

Relative socioeconomic status (SES) may be an important social determinant of health. The current study aimed to examine how relative SES, as measured by subjective SES, income inequality, and individual SES relative to others in the community, is associated with a wide range of adolescent health outcomes, after controlling for objective family SES. Adolescents (13-16 years; N = 2,199) from the Quebec Child and Adolescent Health and Social Survey were included. Socioeconomic measures included adolescents' subjective SES; parental education and household income; community education/employment, income, and poverty rate; and community income inequality. Health outcomes included self-rated health, mental health problems, dietary and exercise health behaviors, substance-related health behaviors, reported physical health, and biomarkers of health. Best-fitting multilevel regression models (participants nested within schools) were used to test associations. Findings indicated that lower subjective SES was associated with poorer health outcomes. After accounting for family SES, lower community education/employment had an additional negative effect on health, while lower community income had a protective effect for certain health outcomes. There was less evidence for an independent effect of income inequality. Findings highlight the importance of measures of relative SES that span across a number of levels and contexts, and provide further understanding into the socioeconomic gradient in adolescence. (c) 2015 APA, all rights reserved).

The SIMS trial: adjustable anchored single-incision mini-slings versus standard tension-free midurethral slings in the surgical management of female stress urinary incontinence. A study protocol for a pragmatic, multicentre, non-inferiority randomised controlled trial

PubMed Central

Abdel-Fattah, Mohamed; MacLennan, Graeme; Kilonzo, Mary; Assassa, R Phil; McCormick, Kirsty; Davidson, Tracey; McDonald, Alison; N’Dow, James; Wardle, Judith; Norrie, John

2017-01-01

Introduction Single-incision mini-slings (SIMS) represent the third generation of midurethral slings. They have been developed with the aim of offering a true ambulatory procedure for treatment of female stress urinary incontinence (SUI) with reduced morbidity and earlier recovery while maintaining similar efficacy to standard midurethral slings (SMUS). The aim of this study is to determine the clinical and cost-effectiveness of adjustable anchored SIMS compared with tension-free SMUS in the surgical management of female SUI, with 3-year follow-up. Methods and analysis A pragmatic, multicentre, non-inferiority randomised controlled trial. Primary outcome measure The primary outcome measure is the patient-reported success rate measured by the Patient Global Impression of Improvement at 12 months. The primary economic outcome will be incremental cost per quality-adjusted life year gained at 12 months. Secondary outcome measures The secondary outcomes measures include adverse events, objective success rates, impact on other lower urinary tract symptoms, health-related quality of life profile and sexual function, and reoperation rates for SUI. Secondary economic outcomes include National Health Service and patient primary and secondary care resource use and costs, incremental cost-effectiveness and incremental net benefit. Statistical analysis The statistical analysis of the primary outcome will be by intention-to-treat and also a per-protocol analysis. Results will be displayed as estimates and 95% CIs. CIs around observed differences will then be compared with the prespecified non-inferiority margin. Secondary outcomes will be analysed similarly. Ethics and dissemination The North of Scotland Research Ethics Committee has approved this study (13/NS/0143). The dissemination plans include HTA monograph, presentation at international scientific meetings and publications in high-impact, open-access journals. The results will be included in the updates of the National Institute for Health and Care Excellence and the European Association of Urology guidelines; these two specific guidelines directly influence practice in the UK and worldwide specialists, respectively. In addition, plain English-language summary of the main findings/results will be presented for relevant patient organisations. Trial registration number ISRCTN93264234. The SIMS study is currently recruiting in 20 UK research centres. The first patient was randomised on 4 February 2014, with follow-up to be completed at the end of February 2020. PMID:28801396

Regional Brain Biometrics at Term-Equivalent Age and Developmental Outcome in Extremely Low-Birth-Weight Infants.

PubMed

Melbourne, Launice; Murnick, Jonathan; Chang, Taeun; Glass, Penny; Massaro, An N

2015-10-01

This study aims to evaluate individual regional brain biometrics and their association with developmental outcome in extremely low-birth-weight (ELBW) infants. This is a retrospective study evaluating term-equivalent magnetic resonance imaging (TE-MRI) from 27 ELBW infants with known developmental outcomes beyond 12 months corrected age. Regional biometric measurements were performed by a pediatric neuroradiologist blinded to outcome data. Measures included biparietal width, transcerebellar diameter (TCD), deep gray matter area (DGMA), ventricular dilatation, corpus callosum, and interhemispheric distance. The relationship between regional biometrics and Bayley-II developmental scores were evaluated with linear regression models. The study cohort had an average±standard deviation birth weight of 684±150 g, gestational age of 24.6±2 weeks and 48% males. DGMA was significantly associated with both cognitive and motor outcomes. Significant associations were also observed between TCD and corpus callosum splenium with cognitive and motor outcomes, respectively. Other biometric measures were not associated with outcome (p>0.05). DGMA<10.26 cm2 was highly specific for poor motor and cognitive outcome. TE-MRI biometrics reflecting impaired deep gray matter, callosal, and cerebellar size is associated with worse early childhood cognitive and motor outcomes. DGMA may be the most robust single biometric measure to predict adverse developmental outcome in preterm survivors. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Upper Limb Outcome Measures Used in Stroke Rehabilitation Studies: A Systematic Literature Review

PubMed Central

Santisteban, Leire; Térémetz, Maxime; Bleton, Jean-Pierre; Baron, Jean-Claude; Maier, Marc A.; Lindberg, Påvel G.

2016-01-01

Background Establishing which upper limb outcome measures are most commonly used in stroke studies may help in improving consensus among scientists and clinicians. Objective In this study we aimed to identify the most commonly used upper limb outcome measures in intervention studies after stroke and to describe domains covered according to ICF, how measures are combined, and how their use varies geographically and over time. Methods Pubmed, CinHAL, and PeDRO databases were searched for upper limb intervention studies in stroke according to PRISMA guidelines and477 studies were included. Results In studies 48different outcome measures were found. Only 15 of these outcome measures were used in more than 5% of the studies. The Fugl-Meyer Test (FMT)was the most commonly used measure (in 36% of studies). Commonly used measures covered ICF domains of body function and activity to varying extents. Most studies (72%) combined multiple outcome measures: the FMT was often combined with the Motor Activity Log (MAL), the Wolf Motor Function Test and the Action Research Arm Test, but infrequently combined with the Motor Assessment Scale or the Nine Hole Peg Test. Key components of manual dexterity such as selective finger movements were rarely measured. Frequency of use increased over a twelve-year period for the FMT and for assessments of kinematics, whereas other measures, such as the MAL and the Jebsen Taylor Hand Test showed decreased use over time. Use varied largely between countries showing low international consensus. Conclusions The results showed a large diversity of outcome measures used across studies. However, a growing number of studies used the FMT, a neurological test with good psychometric properties. For thorough assessment the FMT needs to be combined with functional measures. These findings illustrate the need for strategies to build international consensus on appropriate outcome measures for upper limb function after stroke. PMID:27152853

A Review of Multidisciplinary Interventions in Atopic Dermatitis

PubMed Central

Spielman, Sara C.; LeBovidge, Jennifer S.; Timmons, Karol G.; Schneider, Lynda C.

2015-01-01

Multidisciplinary interventions have been developed for patients with atopic dermatitis (AD) and their families, with the aim of improving outcomes such as disease control, adherence, and quality of life. We reviewed the content of different multidisciplinary approaches to intervention for AD and evidence for their impact on key outcome measures. We also provided data from our multidisciplinary outpatient program for pediatric AD. Studies included in the review suggest benefits of multidisciplinary interventions as models of treatment or adjuncts to standard medical care, with a positive impact on outcomes including disease severity and itching/scratching. There were limitations to existing studies, including heterogeneous methods used to assess quality of life outcomes across studies and lack of controlled studies assessing the outcome of clinical care programs. Further research will be useful in assessing the impact of multidisciplinary interventions on important outcomes such as treatment adherence and sleep, identifying the elements of multidisciplinary interventions that are most critical for improved outcomes, and identifying the best candidates for multidisciplinary intervention approaches. PMID:26239470

Associations between nine family dinner frequency measures and child weight, dietary and psychosocial outcomes

PubMed Central

Fulkerson, Jayne A.; Friend, Sarah E.; Neumark-Sztainer, Dianne

2015-01-01

Background Family meal frequency has been consistently and significantly associated with positive youth dietary and psychosocial outcomes but less consistently associated with weight outcomes. Family meal frequency measurement has varied widely and it is unclear how this variation may impact relationships with youth weight, dietary, and psychosocial outcomes. Objective This study assesses how five parent/caregiver-reported and four child-reported family dinner frequency measures correlate with each other and are associated with health-related outcomes. Design/Participants This secondary, cross-sectional analysis uses baseline, parent/caregiver (n=160) and 8–12 year old child (n=160) data from the Healthy Home Offerings via the Mealtime Environment (HOME) Plus trial (collected 2011–2012). Data were obtained from objective measurements, dietary recall interviews, and psychosocial surveys. Outcome measures Outcomes included child body mass index z-scores (BMIz), fruit, vegetable and sugar-sweetened beverage intake, dietary quality (Healthy Eating Index-2010 [HEI-2010]), family connectedness, and meal conversations. Statistical analyses performed Pearson correlations and general linear models were used to assess associations between family dinner frequency measures and outcomes. Results All family dinner frequency measures had comparable means and were correlated within and across parent/caregiver- and child-reporters (r=0.17–0.94, p<0.01). In unadjusted analyses, 78% of family dinner frequency measures were significantly associated with BMIz scores and 100% were significantly associated with fruit/vegetable intake and HEI-2010. In adjusted models, most significant associations with dietary and psychosocial outcomes remained but associations with child BMIz remained significant only for parent/caregiver- (β±SE= −0.07±0.03; p<0.05) and child-reported (β±SE= −0.06+0.02; p<0.01) family dinner frequency measures asking about ‘sitting and eating’ dinner. Conclusions In spite of phrasing variations in family dinner frequency measures (e.g., which family members were present and how meals were occurring), few differences were found in associations with dietary and psychosocial outcomes but differences were apparent for child BMIz, which suggests phrasing of family dinner frequency measures may influence associations found with weight outcomes. PMID:26875023

Updating the OMERACT filter: core areas as a basis for defining core outcome sets.

PubMed

Kirwan, John R; Boers, Maarten; Hewlett, Sarah; Beaton, Dorcas; Bingham, Clifton O; Choy, Ernest; Conaghan, Philip G; D'Agostino, Maria-Antonietta; Dougados, Maxime; Furst, Daniel E; Guillemin, Francis; Gossec, Laure; van der Heijde, Désirée M; Kloppenburg, Margreet; Kvien, Tore K; Landewé, Robert B M; Mackie, Sarah L; Matteson, Eric L; Mease, Philip J; Merkel, Peter A; Ostergaard, Mikkel; Saketkoo, Lesley Ann; Simon, Lee; Singh, Jasvinder A; Strand, Vibeke; Tugwell, Peter

2014-05-01

The Outcome Measures in Rheumatology (OMERACT) Filter provides guidelines for the development and validation of outcome measures for use in clinical research. The "Truth" section of the OMERACT Filter presupposes an explicit framework for identifying the relevant core outcomes that are universal to all studies of the effects of intervention effects. There is no published outline for instrument choice or development that is aimed at measuring outcome, was derived from broad consensus over its underlying philosophy, or includes a structured and documented critique. Therefore, a new proposal for defining core areas of measurement ("Filter 2.0 Core Areas of Measurement") was presented at OMERACT 11 to explore areas of consensus and to consider whether already endorsed core outcome sets fit into this newly proposed framework. Discussion groups critically reviewed the extent to which case studies of current OMERACT Working Groups complied with or negated the proposed framework, whether these observations had a more general application, and what issues remained to be resolved. Although there was broad acceptance of the framework in general, several important areas of construction, presentation, and clarity of the framework were questioned. The discussion groups and subsequent feedback highlighted 20 such issues. These issues will require resolution to reach consensus on accepting the proposed Filter 2.0 framework of Core Areas as the basis for the selection of Core Outcome Domains and hence appropriate Core Outcome Sets for clinical trials.

Diabetes Care and Treatment Project: A Joslin Telemedicine Initiative

DTIC Science & Technology

2007-10-31

measures include clinical data (e.g. HbA1c , blood pressure, quality of life questionnaires) and secondary outcome measures include economic data (e.g...elevated HbA1c (³ 8.5%). Over 12-months we will measure HbA1c , office BP, and scores on the Problem Areas in Diabetes (PAID) questionnaire and Center

Development of a core outcome set for disease modification trials in mild to moderate dementia: a systematic review, patient and public consultation and consensus recommendations.

PubMed Central

Webster, Lucy; Groskreutz, Derek; Grinbergs-Saull, Anna; Howard, Rob; O'Brien, John T; Mountain, Gail; Banerjee, Sube; Woods, Bob; Perneczky, Robert; Lafortune, Louise; Roberts, Charlotte; McCleery, Jenny; Pickett, James; Bunn, Frances; Challis, David; Charlesworth, Georgina; Featherstone, Katie; Fox, Chris; Goodman, Claire; Jones, Roy; Lamb, Sallie; Moniz-Cook, Esme; Schneider, Justine; Shepperd, Sasha; Surr, Claire; Thompson-Coon, Jo; Ballard, Clive; Brayne, Carol; Burke, Orlaith; Burns, Alistair; Clare, Linda; Garrard, Peter; Kehoe, Patrick; Passmore, Peter; Holmes, Clive; Maidment, Ian; Murtagh, Fliss; Robinson, Louise; Livingston, Gill

2017-01-01

BACKGROUND There is currently no disease-modifying treatment available to halt or delay the progression of the disease pathology in dementia. An agreed core set of the best-available and most appropriate outcomes for disease modification would facilitate the design of trials and ensure consistency across disease modification trials, as well as making results comparable and meta-analysable in future trials. OBJECTIVES To agree a set of core outcomes for disease modification trials for mild to moderate dementia with the UK dementia research community and patient and public involvement (PPI). DATA SOURCES We included disease modification trials with quantitative outcomes of efficacy from (1) references from related systematic reviews in workstream 1; (2) searches of the Cochrane Dementia and Cognitive Improvement Group study register, Cochrane Central Register of Controlled Trials, Cumulative Index to Nursing and Allied Health Literature, EMBASE, Latin American and Caribbean Health Sciences Literature and PsycINFO on 11 December 2015, and clinical trial registries [International Standard Randomised Controlled Trial Number (ISRCTN) and clinicaltrials.gov] on 22 and 29 January 2016; and (3) hand-searches of reference lists of relevant systematic reviews from database searches. REVIEW METHODS The project consisted of four workstreams. (1) We obtained related core outcome sets and work from co-applicants. (2) We systematically reviewed published and ongoing disease modification trials to identify the outcomes used in different domains. We extracted outcomes used in each trial, recording how many used each outcome and with how many participants. We divided outcomes into the domains measured and searched for validation data. (3) We consulted with PPI participants about recommended outcomes. (4) We presented all the synthesised information at a conference attended by the wider body of National Institute for Health Research (NIHR) dementia researchers to reach consensus on a core set of outcomes. RESULTS We included 149 papers from the 22,918 papers screened, referring to 125 individual trials. Eighty-one outcomes were used across trials, including 72 scales [31 cognitive, 12 activities of daily living (ADLs), 10 global, 16 neuropsychiatric and three quality of life] and nine biological techniques. We consulted with 18 people for PPI. The conference decided that only cognition and biological markers are core measures of disease modification. Cognition should be measured by the Mini Mental State Examination (MMSE) or the Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-Cog), and brain changes through structural magnetic resonance imaging (MRI) in a subset of participants. All other domains are important but not core. We recommend using the Neuropsychiatric Inventory for neuropsychiatric symptoms: the Disability Assessment for Dementia for ADLs, the Dementia Quality of Life Measure for quality of life and the Clinical Dementia Rating scale to measure dementia globally. LIMITATIONS Most of the trials included participants with Alzheimer's disease, so recommendations may not apply to other types of dementia. We did not conduct economic analyses. The PPI consultation was limited to members of the Alzheimer's Society Research Network. CONCLUSIONS Cognitive outcomes and biological markers form the core outcome set for future disease modification trials, measured by the MMSE or ADAS-Cog, and structural MRI in a subset of participants. FUTURE WORK We envisage that the core set may be superseded in the future, particularly for other types of dementia. There is a need to develop an algorithm to compare scores on the MMSE and ADAS-Cog. STUDY REGISTRATION The project was registered with Core Outcome Measures in Effectiveness Trials [ www.comet-initiative.org/studies/details/819?result=true (accessed 7 April 2016)]. The systematic review protocol is registered as PROSPERO CRD42015027346. FUNDING The National Institute for Health Research Health Technology Assessment programme. PMID:28625273

Psychotherapy and Outcome Research in PTSD: Understanding the Challenges and Complexities in the Literature

ERIC Educational Resources Information Center

Black, Timothy G.

2004-01-01

The author reviews the existing literature on posttraumatic stress disorder (PTSD, American Psychiatric Association, 2000) as it relates to outcome research and psychotherapy. An initial examination of the issues involved in outcome research includes the issue of assessment and diagnosis, followed by the issue of measurement. The article is meant…

Evidence Based-Practice and Affect: The Impact of Physician Attitudes on Outcomes Associated with Clinical Reasoning and Decision-Making

ERIC Educational Resources Information Center

Dunphy, Bruce; Dunphy, Stacey; Cantwell, Robert; Bourke, Sid; Fleming, Mark

2010-01-01

The relationship between obstetrician attitudes and patient outcomes from intrapartum care was examined. Obstetrician attitudes were assessed utilizing a newly-designed pilot 35-item obstetrician attitude questionnaire (OAQ). Twelve obstetricians completed the OAQ, who provided intra-partum care to 4,149 women. Outcome measures included delivery…

The Effect of Linked Learning Certified Pathways on Selected Student Outcomes

ERIC Educational Resources Information Center

Fitzgerald, Robert; Ottem, Randolph; Hufford, Justine

2016-01-01

This report examines outcomes for grade-12 students in academic years (AY) 2010-11, 2011-12, and 2012-13 who were enrolled in a Linked Learning certified pathway (LLCP) in California. Outcomes include student engagement in learning, measured by high school attendance and discipline events, as well as college readiness and postsecondary enrollment.…

The Correlation between Teacher Self-Efficacy among Seminaries and Institutes Seminary Teachers and Student Outcomes

ERIC Educational Resources Information Center

Mangum, James Irvin, III

2012-01-01

This study examined the correlation between teacher self-efficacy and student outcomes. Teacher self-efficacy was measured in 99 Church of Jesus Christ of Latter-day Saints Seminaries and Institutes seminary teachers using Tschannen-Moran and Hoy's Teachers Sense of Efficacy Scale (2001). Student outcomes included academic grades, conduct…

Utilising the Intel RealSense Camera for Measuring Health Outcomes in Clinical Research.

PubMed

Siena, Francesco Luke; Byrom, Bill; Watts, Paul; Breedon, Philip

2018-02-05

Applications utilising 3D Camera technologies for the measurement of health outcomes in the health and wellness sector continues to expand. The Intel® RealSense™ is one of the leading 3D depth sensing cameras currently available on the market and aligns itself for use in many applications, including robotics, automation, and medical systems. One of the most prominent areas is the production of interactive solutions for rehabilitation which includes gait analysis and facial tracking. Advancements in depth camera technology has resulted in a noticeable increase in the integration of these technologies into portable platforms, suggesting significant future potential for pervasive in-clinic and field based health assessment solutions. This paper reviews the Intel RealSense technology's technical capabilities and discusses its application to clinical research and includes examples where the Intel RealSense camera range has been used for the measurement of health outcomes. This review supports the use of the technology to develop robust, objective movement and mobility-based endpoints to enable accurate tracking of the effects of treatment interventions in clinical trials.

Measuring Outcomes of Nursing Practice, Education, and Administration. Proceedings of the Annual SCCEN Research Conference (1st, Austin, Texas, December 4-5, 1981).

ERIC Educational Resources Information Center

Field, William E., Jr., Ed.

Thirty-five papers on the measurement of outcomes of nursing practice, education, and administration are presented from the 1981 research conference of the Southern Council on Collegiate Education for Nursing. Papers and authors include the following: "Why Nursing Research?" (Hildegard E. Peplau); "Job Satisfaction in Nurse Faculty: Test of a…

Connective tissue disease related interstitial lung diseases and idiopathic pulmonary fibrosis: provisional core sets of domains and instruments for use in clinical trials.

PubMed

Saketkoo, Lesley Ann; Mittoo, Shikha; Huscher, Dörte; Khanna, Dinesh; Dellaripa, Paul F; Distler, Oliver; Flaherty, Kevin R; Frankel, Sid; Oddis, Chester V; Denton, Christopher P; Fischer, Aryeh; Kowal-Bielecka, Otylia M; LeSage, Daphne; Merkel, Peter A; Phillips, Kristine; Pittrow, David; Swigris, Jeffrey; Antoniou, Katerina; Baughman, Robert P; Castelino, Flavia V; Christmann, Romy B; Christopher-Stine, Lisa; Collard, Harold R; Cottin, Vincent; Danoff, Sonye; Highland, Kristin B; Hummers, Laura; Shah, Ami A; Kim, Dong Soon; Lynch, David A; Miller, Frederick W; Proudman, Susanna M; Richeldi, Luca; Ryu, Jay H; Sandorfi, Nora; Sarver, Catherine; Wells, Athol U; Strand, Vibeke; Matteson, Eric L; Brown, Kevin K; Seibold, James R

2014-05-01

Clinical trial design in interstitial lung diseases (ILDs) has been hampered by lack of consensus on appropriate outcome measures for reliably assessing treatment response. In the setting of connective tissue diseases (CTDs), some measures of ILD disease activity and severity may be confounded by non-pulmonary comorbidities. The Connective Tissue Disease associated Interstitial Lung Disease (CTD-ILD) working group of Outcome Measures in Rheumatology-a non-profit international organisation dedicated to consensus methodology in identification of outcome measures-conducted a series of investigations which included a Delphi process including >248 ILD medical experts as well as patient focus groups culminating in a nominal group panel of ILD experts and patients. The goal was to define and develop a consensus on the status of outcome measure candidates for use in randomised controlled trials in CTD-ILD and idiopathic pulmonary fibrosis (IPF). A core set comprising specific measures in the domains of lung physiology, lung imaging, survival, dyspnoea, cough and health-related quality of life is proposed as appropriate for consideration for use in a hypothetical 1-year multicentre clinical trial for either CTD-ILD or IPF. As many widely used instruments were found to lack full validation, an agenda for future research is proposed. Identification of consensus preliminary domains and instruments to measure them was attained and is a major advance anticipated to facilitate multicentre RCTs in the field.

Defining the Value Framework for Prostate Brachytherapy using Patient-Centered Outcome Metrics and Time-Driven Activity-Based Costing

PubMed Central

Thaker, Nikhil G.; Pugh, Thomas J.; Mahmood, Usama; Choi, Seungtaek; Spinks, Tracy E.; Martin, Neil E.; Sio, Terence T.; Kudchadker, Rajat J.; Kaplan, Robert S.; Kuban, Deborah A.; Swanson, David A.; Orio, Peter F.; Zelefsky, Michael J.; Cox, Brett W.; Potters, Louis; Buchholz, Thomas A.; Feeley, Thomas W.; Frank, Steven J.

2017-01-01

PURPOSE Value, defined as outcomes over costs, has been proposed as a measure to evaluate prostate cancer (PCa) treatments. We analyzed standardized outcomes and time-driven activity-based costing (TDABC) for prostate brachytherapy (PBT) to define a value framework. METHODS AND MATERIALS Patients with low-risk PCa treated with low-dose rate PBT between 1998 and 2009 were included. Outcomes were recorded according to the International Consortium for Health Outcomes Measurement (ICHOM) standard set, which includes acute toxicity, patient-reported outcomes, and recurrence and survival outcomes. Patient-level costs to one year after PBT were collected using TDABC. Process mapping and radar chart analyses were conducted to visualize this value framework. RESULTS A total of 238 men were eligible for analysis. Median age was 64 (range, 46–81). Median follow-up was 5 years (0.5–12.1). There were no acute grade 3–5 complications. EPIC-50 scores were favorable, with no clinically significant changes from baseline to last follow-up at 48 months for urinary incontinence/bother, bowel bother, sexual function, and vitality. Ten-year outcomes were favorable, including biochemical failure-free survival of 84.1%, metastasis-free survival 99.6%, PCa-specific survival 100%, and overall survival 88.6%. TDABC analysis demonstrated low resource utilization for PBT, with 41% and 10% of costs occurring in the operating room and with the MRI scan, respectively. The radar chart allowed direct visualization of outcomes and costs. CONCLUSIONS We successfully created a visual framework to define the value of PBT using the ICHOM standard set and TDABC costs. PBT is associated with excellent outcomes and low costs. Widespread adoption of this methodology will enable value comparisons across providers, institutions, and treatment modalities. PMID:26916105

Discrepancy between results and abstract conclusions in industry- vs nonindustry-funded studies comparing topical prostaglandins.

PubMed

Alasbali, Tariq; Smith, Michael; Geffen, Noa; Trope, Graham E; Flanagan, John G; Jin, Yaping; Buys, Yvonne M

2009-01-01

To investigate the relationship between industry- vs nonindustry-funded publications comparing the efficacy of topical prostaglandin analogs by evaluating the correspondence between the statistical significance of the publication's main outcome measure and its abstract conclusions. Retrospective, observational cohort study. English publications comparing the ocular hypotensive efficacy between any or all of latanoprost, travoprost, and bimatoprost were searched from the MEDLINE database. Each article was reviewed by three independent observers and was evaluated for source of funding, study quality, statistically significant main outcome measure, correspondence between results of main outcome measure and abstract conclusion, number of intraocular pressure outcomes compared, and journal impact factor. Funding was determined by published disclosure or, in cases of no documented disclosure, the corresponding author was contacted directly to confirm industry funding. Discrepancies were resolved by consensus. The main outcome measure was correspondence between abstract conclusion and reported statistical significance of the publications' main outcome measure. Thirty-nine publications were included, of which 29 were industry funded and 10 were nonindustry funded. The published abstract conclusion was not consistent with the results of the main outcome measure in 18 (62%) of 29 of the industry-funded studies compared with zero (0%) of 10 of the nonindustry-funded studies (P = .0006). Twenty-six (90%) of the industry-funded studies had proindustry abstract conclusions. Twenty-four percent of the industry-funded publications had a statistically significant main outcome measure; however, 90% of the industry-funded studies had proindustry abstract conclusions. Both readers and reviewers should scrutinize publications carefully to ensure that data support the authors' conclusions.

Developing, implementing and disseminating a core outcome set for neonatal medicine.

PubMed

Webbe, James; Brunton, Ginny; Ali, Shohaib; Duffy, James Mn; Modi, Neena; Gale, Chris

2017-01-01

In high resource settings, 1 in 10 newborn babies require admission to a neonatal unit. Research evaluating neonatal care involves recording and reporting many different outcomes and outcome measures. Such variation limits the usefulness of research as studies cannot be compared or combined. To address these limitations, we aim to develop, disseminate and implement a core outcome set for neonatal medicine. A steering group that includes parents and former patients, healthcare professionals and researchers has been formed to guide the development of the core outcome set. We will review neonatal trials systematically to identify previously reported outcomes. Additionally, we will specifically identify outcomes of importance to parents, former patients and healthcare professionals through a systematic review of qualitative studies. Outcomes identified will be entered into an international, multi-perspective eDelphi survey. All key stakeholders will be invited to participate. The Delphi method will encourage individual and group stakeholder consensus to identify a core outcome set. The core outcome set will be mapped to existing, routinely recorded data where these exist. Use of a core set will ensure outcomes of importance to key stakeholders, including former patients and parents, are recorded and reported in a standard fashion in future research. Embedding the core outcome set within future clinical studies will extend the usefulness of research to inform practice, enhance patient care and ultimately improve outcomes. Using routinely recorded electronic data will facilitate implementation with minimal addition burden. Core Outcome Measures in Effectiveness Trials (COMET) database: 842 (www.comet-initiative.org/studies/details/842).

Perioperative fever and outcome in surgical patients with aneurysmal subarachnoid hemorrhage.

PubMed

Todd, Michael M; Hindman, Bradley J; Clarke, William R; Torner, James C; Weeks, Julie B; Bayman, Emine O; Shi, Qian; Spofford, Christina M

2009-05-01

We examined the incidence of perioperative fever and its relationship to outcome among patients enrolled in the Intraoperative Hypothermia for Aneurysm Surgery Trial. One thousand patients with initial World Federation of Neurological Surgeons grades of I to III undergoing clipping of intracranial aneurysms after subarachnoid hemorrhage were randomized to intraoperative normothermia (36 degrees C-37 degrees C) or hypothermia (32.5 degrees C-33.5 degrees C). Fever (> or =38.5 degrees C) and other complications (including infections) occurring between admission and discharge (or death) were recorded. Functional and neuropsychologic outcomes were assessed 3 months postoperatively. The primary outcome variable for the trial was dichotomized Glasgow Outcome Scale (good outcome versus all others). Fever was reported in 41% of patients. In 97% of these, fever occurred in the postoperative period. The median time from surgery to first fever was 3 days. All measures of outcome were worse in patients who developed fever, even in those without infections or who were World Federation of Neurological Surgeons grade I. Logistic regression analyses were performed to adjust for differences in preoperative factors (e.g., age, Fisher grade, initial neurological status). This demonstrated that fever continued to be significantly associated with most outcome measures, even when infection was added to the model. An alternative stepwise model selection process including all fever-related measures from the preoperative and intraoperative period (e.g., hydrocephalus, duration of surgery, intraoperative blood loss) resulted in the loss of significance for dichotomized Glasgow Outcome Scale, but significant associations between fever and several other outcome measures remained. After adding postoperative delayed ischemic neurological deficits to the model, only worsened National Institutes of Health Stroke Scale score, Barthel Activities of Daily Living index, and discharge destination (home versus other) remained independently associated with fever. These findings suggest that fever is associated with worsened outcome in surgical subarachnoid hemorrhage patients, although, because the association between fever and the primary outcome measure for the trial is dependent on the covariates used in the analysis (particularly operative events and delayed ischemic neurological deficits), we cannot rule out the possibility that fever is a marker for other events. Only a formal trial of fever treatment or prevention can address this issue.

More quality measures versus measuring what matters: a call for balance and parsimony

PubMed Central

Nelson, Eugene C; Pryor, David B; James, Brent; Swensen, Stephen J; Kaplan, Gary S; Weissberg, Jed I; Bisognano, Maureen; Yates, Gary R; Hunt, Gordon C

2012-01-01

External groups requiring measures now include public and private payers, regulators, accreditors and others that certify performance levels for consumers, patients and payers. Although benefits have accrued from the growth in quality measurement, the recent explosion in the number of measures threatens to shift resources from improving quality to cover a plethora of quality-performance metrics that may have a limited impact on the things that patients and payers want and need (ie, better outcomes, better care, and lower per capita costs). Here we propose a policy that quality measurement should be: balanced to meet the need of end users to judge quality and cost performance and the need of providers to continuously improve the quality, outcomes and costs of their services; and parsimonious to measure quality, outcomes and costs with appropriate metrics that are selected based on end-user needs. PMID:22893696

More quality measures versus measuring what matters: a call for balance and parsimony.

PubMed

Meyer, Gregg S; Nelson, Eugene C; Pryor, David B; James, Brent; Swensen, Stephen J; Kaplan, Gary S; Weissberg, Jed I; Bisognano, Maureen; Yates, Gary R; Hunt, Gordon C

2012-11-01

External groups requiring measures now include public and private payers, regulators, accreditors and others that certify performance levels for consumers, patients and payers. Although benefits have accrued from the growth in quality measurement, the recent explosion in the number of measures threatens to shift resources from improving quality to cover a plethora of quality-performance metrics that may have a limited impact on the things that patients and payers want and need (ie, better outcomes, better care, and lower per capita costs). Here we propose a policy that quality measurement should be: balanced to meet the need of end users to judge quality and cost performance and the need of providers to continuously improve the quality, outcomes and costs of their services; and parsimonious to measure quality, outcomes and costs with appropriate metrics that are selected based on end-user needs.

Analysis of baseline, average, and longitudinally measured blood pressure data using linear mixed models.

PubMed

Hossain, Ahmed; Beyene, Joseph

2014-01-01

This article compares baseline, average, and longitudinal data analysis methods for identifying genetic variants in genome-wide association study using the Genetic Analysis Workshop 18 data. We apply methods that include (a) linear mixed models with baseline measures, (b) random intercept linear mixed models with mean measures outcome, and (c) random intercept linear mixed models with longitudinal measurements. In the linear mixed models, covariates are included as fixed effects, whereas relatedness among individuals is incorporated as the variance-covariance structure of the random effect for the individuals. The overall strategy of applying linear mixed models decorrelate the data is based on Aulchenko et al.'s GRAMMAR. By analyzing systolic and diastolic blood pressure, which are used separately as outcomes, we compare the 3 methods in identifying a known genetic variant that is associated with blood pressure from chromosome 3 and simulated phenotype data. We also analyze the real phenotype data to illustrate the methods. We conclude that the linear mixed model with longitudinal measurements of diastolic blood pressure is the most accurate at identifying the known single-nucleotide polymorphism among the methods, but linear mixed models with baseline measures perform best with systolic blood pressure as the outcome.

Behavioral and cognitive outcomes for clinical trials in children with neurofibromatosis type 1.

PubMed

van der Vaart, Thijs; Rietman, André B; Plasschaert, Ellen; Legius, Eric; Elgersma, Ype; Moll, Henriëtte A

2016-01-12

To evaluate the appropriateness of cognitive and behavioral outcome measures in clinical trials in neurofibromatosis type 1 (NF1) by analyzing the degree of deficits compared to reference groups, test-retest reliability, and how scores correlate between outcome measures. Data were analyzed from the Simvastatin for cognitive deficits and behavioral problems in patients with neurofibromatosis type 1 (NF1-SIMCODA) trial, a randomized placebo-controlled trial of simvastatin for cognitive deficits and behavioral problems in children with NF1. Outcome measures were compared with age-specific reference groups to identify domains of dysfunction. Pearson r was computed for before and after measurements within the placebo group to assess test-retest reliability. Principal component analysis was used to identify the internal structure in the outcome data. Strongest mean score deviations from the reference groups were observed for full-scale intelligence (-1.1 SD), Rey Complex Figure Test delayed recall (-2.0 SD), attention problems (-1.2 SD), and social problems (-1.1 SD). Long-term test-retest reliability were excellent for Wechsler scales (r > 0.88), but poor to moderate for other neuropsychological tests (r range 0.52-0.81) and Child Behavioral Checklist subscales (r range 0.40-0.79). The correlation structure revealed 2 strong components in the outcome measures behavior and cognition, with no correlation between these components. Scores on psychosocial quality of life correlate strongly with behavioral problems and less with cognitive deficits. Children with NF1 show distinct deficits in multiple domains. Many outcome measures showed weak test-retest correlations over the 1-year trial period. Cognitive and behavioral outcomes are complementary. This analysis demonstrates the need to include reliable outcome measures on a variety of cognitive and behavioral domains in clinical trials for NF1. © 2015 American Academy of Neurology.

Systematic review of middle ear implants: do they improve hearing as much as conventional hearing AIDS?

PubMed

Tysome, James R; Moorthy, Ram; Lee, Ambrose; Jiang, Dan; O'Connor, Alec Fitzgerald

2010-12-01

A systematic review to determine whether middle ear implants (MEIs) improve hearing as much as hearing aids. Databases included MEDLINE, EMBASE, DARE, and Cochrane searched with no language restrictions from 1950 or the start date of each database. Initial search found 644 articles, of which 17 met the inclusion criteria of MEI in adults with a sensorineural hearing loss, where hearing outcomes and patient-reported outcome measures (PROMs) compared MEI with conventional hearing aids (CHAs). Study quality assessment included whether ethical approval was gained, the study was prospective, eligibility criteria specified, a power calculation made and appropriate controls, outcome measures, and analysis performed. Middle ear implant outcome analysis included residual hearing, complications, and comparison to CHA in terms of functional gain, speech perception in quiet and in noise, and validated PROM questionnaires. Because of heterogeneity of outcome measures, comparisons were made by structured review. The quality of studies was moderate to poor with short follow-up. The evidence supports the use of MEI because, overall, they do not decrease residual hearing, result in a functional gain in hearing comparable to CHA, and may improve perception of speech in noise and sound quality. We recommend the publication of long-term results comparing MEI with CHA, reporting a minimum of functional gain, speech perception in quiet and in noise, complications, and a validated PROM to guide the engineering of the new generation of MEI in the future.

Effects of an Integrative Nursing Intervention on Pain in Critically Ill Patients: A Pilot Clinical Trial.

PubMed

Papathanassoglou, Elizabeth D E; Hadjibalassi, Maria; Miltiadous, Panagiota; Lambrinou, Ekaterini; Papastavrou, Evridiki; Paikousis, Lefkios; Kyprianou, Theodoros

2018-05-01

Pain, a persistent problem in critically ill patients, adversely affects outcomes. Despite recommendations, no evidence-based nonpharmacological approaches for pain treatment in critically ill patients have been developed. To investigate the effects of a multimodal integrative intervention on the incidence of pain and on secondary outcomes: intensity of pain, hemodynamic indices (systolic and mean arterial pressure, heart rate), anxiety, fear, relaxation, optimism, and sleep quality. A randomized, controlled, double-blinded repeated-measures trial with predetermined eligibility criteria was conducted. The intervention included relaxation, guided imagery, moderate pressure massage, and listening to music. The primary outcome was incidence of pain (score on Critical Care Pain Observation Tool > 2). Other outcomes included pain ratings, hemodynamic measurements, self-reported psychological outcomes, and quality of sleep. Repeated-measures models with adjustments (baseline levels, confounders) were used. Among the 60 randomized critically ill adults in the sample, the intervention group experienced significant decreases in the incidence ( P = .003) and ratings of pain ( P < .001). Adjusted models revealed a significant trend for lower incidence ( P = .002) and ratings ( P < .001) of pain, systolic arterial pressure ( P < .001), anxiety ( P = .01), and improved quality of sleep ( P = .02). A multimodal integrative intervention may be effective in decreasing pain and improving pain-related outcomes in critically ill patients. © 2018 American Association of Critical-Care Nurses.

Use of Salivary Diurnal Cortisol as an Outcome Measure in Randomised Controlled Trials: a Systematic Review.

PubMed

Ryan, Richella; Booth, Sara; Spathis, Anna; Mollart, Sarah; Clow, Angela

2016-04-01

Dysregulation of the hypothalamic-pituitary-adrenal (HPA) axis is associated with diverse adverse health outcomes, making it an important therapeutic target. Measurement of the diurnal rhythm of cortisol secretion provides a window into this system. At present, no guidelines exist for the optimal use of this biomarker within randomised controlled trials (RCTs). The aim of this study is to describe the ways in which salivary diurnal cortisol has been measured within RCTs of health or behavioural interventions in adults. Six electronic databases (up to May 21, 2015) were systematically searched for RCTs which used salivary diurnal cortisol as an outcome measure to evaluate health or behavioural interventions in adults. A narrative synthesis was undertaken of the findings in relation to salivary cortisol methodology and outcomes. From 78 studies that fulfilled the inclusion criteria, 30 included healthy participants (38.5 %), 27 included patients with physical disease (34.6 %) and 21 included patients with psychiatric disease (26.9 %). Psychological therapies were most commonly evaluated (n = 33, 42.3 %). There was substantial heterogeneity across studies in relation to saliva collection protocols and reported cortisol parameters. Only 39 studies (50 %) calculated a rhythm parameter such as the diurnal slope or the cortisol awakening response (CAR). Patterns of change in cortisol parameters were inconsistent both within and across studies and there was low agreement with clinical findings. Salivary diurnal cortisol is measured inconsistently across RCTs, which is limiting the interpretation of findings within and across studies. This indicates a need for more validation work, along with consensus guidelines.

Observational attachment theory-based parenting measures predict children's attachment narratives independently from social learning theory-based measures.

PubMed

Matias, Carla; O'Connor, Thomas G; Futh, Annabel; Scott, Stephen

2014-01-01

Conceptually and methodologically distinct models exist for assessing quality of parent-child relationships, but few studies contrast competing models or assess their overlap in predicting developmental outcomes. Using observational methodology, the current study examined the distinctiveness of attachment theory-based and social learning theory-based measures of parenting in predicting two key measures of child adjustment: security of attachment narratives and social acceptance in peer nominations. A total of 113 5-6-year-old children from ethnically diverse families participated. Parent-child relationships were rated using standard paradigms. Measures derived from attachment theory included sensitive responding and mutuality; measures derived from social learning theory included positive attending, directives, and criticism. Child outcomes were independently-rated attachment narrative representations and peer nominations. Results indicated that Attachment theory-based and Social Learning theory-based measures were modestly correlated; nonetheless, parent-child mutuality predicted secure child attachment narratives independently of social learning theory-based measures; in contrast, criticism predicted peer-nominated fighting independently of attachment theory-based measures. In young children, there is some evidence that attachment theory-based measures may be particularly predictive of attachment narratives; however, no single model of measuring parent-child relationships is likely to best predict multiple developmental outcomes. Assessment in research and applied settings may benefit from integration of different theoretical and methodological paradigms.

Neighborhood community characteristics associated with HIV disease outcomes in a cohort of urban women living with HIV.

PubMed

Burke-Miller, Jane K; Weber, Kathleen; Cohn, Susan E; Hershow, Ronald C; Sha, Beverly E; French, Audrey L; Cohen, Mardge H

2016-10-01

Recent studies have found geographic variations in immune and viral human immunodeficiency virus (HIV) disease outcomes associated with census measures of neighborhood poverty and segregation. Although readily available, such aggregate census measures are not based on health behavior models and provide limited information regarding neighborhood effect pathways. In contrast, survey-based measures can capture specific aspects of neighborhood disadvantage that may better inform community-based interventions. Therefore, the aim of this study is to assess the measurement validity of multi-dimensional survey measures of neighborhood disorder compared with census measures as predictors of HIV outcomes in a cohort of 197 low-income women in a major metropolitan area. The multi-dimensional survey measures were related to each other and to census measures of concentrated poverty and racial segregation, but not so highly correlated as to be uniform. We found notable variation between community areas in women's CD4 levels but there was no corresponding geographic variance in viral load, and relationships between community area measures and viral load disappeared after adjustment for individual characteristics, including HIV treatment adherence. In multilevel models adjusting for individual characteristics including substance use, depression, and HIV treatment adherence, one survey measure of neighborhood disadvantage (poor-quality built environment) and one census measure (racial segregation) were significantly associated with greater likelihood of CD4 < 500 (p < .05).

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 practice. Copyright © 2016 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

Development and initial cohort validation of the Arthritis Research UK Musculoskeletal Health Questionnaire (MSK-HQ) for use across musculoskeletal care pathways

PubMed Central

Hill, Jonathan C; Kang, Sujin; Benedetto, Elena; Myers, Helen; Blackburn, Steven; Smith, Stephanie; Hay, Elaine; Rees, Jonathan; Beard, David; Glyn-Jones, Sion; Barker, Karen; Ellis, Benjamin; Fitzpatrick, Ray; Price, Andrew

2016-01-01

Objectives Current musculoskeletal outcome tools are fragmented across different healthcare settings and conditions. Our objectives were to develop and validate a single musculoskeletal outcome measure for use throughout the pathway and patients with different musculoskeletal conditions: the Arthritis Research UK Musculoskeletal Health Questionnaire (MSK-HQ). Setting A consensus workshop with stakeholders from across the musculoskeletal community, workshops and individual interviews with a broad mix of musculoskeletal patients identified and prioritised outcomes for MSK-HQ inclusion. Initial psychometric validation was conducted in four cohorts from community physiotherapy, and secondary care orthopaedic hip, knee and shoulder clinics. Participants Stakeholders (n=29) included primary care, physiotherapy, orthopaedic and rheumatology patients (n=8); general practitioners, physiotherapists, orthopaedists, rheumatologists and pain specialists (n=7), patient and professional national body representatives (n=10), and researchers (n=4). The four validation cohorts included 570 participants (n=210 physiotherapy, n=150 hip, n=150 knee, n=60 shoulder patients). Outcome measures Outcomes included the MSK-HQ's acceptability, feasibility, comprehension, readability and responder burden. The validation cohort outcomes were the MSK-HQ's completion rate, test–retest reliability and convergent validity with reference standards (EQ-5D-5L, Oxford Hip, Knee, Shoulder Scores, and the Keele MSK-PROM). Results Musculoskeletal domains prioritised were pain severity, physical function, work interference, social interference, sleep, fatigue, emotional health, physical activity, independence, understanding, confidence to self-manage and overall impact. Patients reported MSK-HQ items to be ‘highly relevant’ and ‘easy to understand’. Completion rates were high (94.2%), with scores normally distributed, and no floor/ceiling effects. Test–retest reliability was excellent, and convergent validity was strong (correlations 0.81–0.88). Conclusions A new musculoskeletal outcome measure has been developed through a coproduction process with patients to capture prioritised outcomes for use throughout the pathway and with different musculoskeletal conditions. Four validation cohorts found that the MSK-HQ had high completion rates, excellent test–retest reliability and strong convergent validity with reference standards. Further validation studies are ongoing, including a cohort with rheumatoid/inflammatory arthritis. PMID:27496243

Reproducibility and Temporal Structure in Weekly Resting-State fMRI over a Period of 3.5 Years

PubMed Central

Choe, Ann S.; Jones, Craig K.; Joel, Suresh E.; Muschelli, John; Belegu, Visar; Caffo, Brian S.; Lindquist, Martin A.; van Zijl, Peter C. M.; Pekar, James J.

2015-01-01

Resting-state functional MRI (rs-fMRI) permits study of the brain’s functional networks without requiring participants to perform tasks. Robust changes in such resting state networks (RSNs) have been observed in neurologic disorders, and rs-fMRI outcome measures are candidate biomarkers for monitoring clinical trials, including trials of extended therapeutic interventions for rehabilitation of patients with chronic conditions. In this study, we aim to present a unique longitudinal dataset reporting on a healthy adult subject scanned weekly over 3.5 years and identify rs-fMRI outcome measures appropriate for clinical trials. Accordingly, we assessed the reproducibility, and characterized the temporal structure of, rs-fMRI outcome measures derived using independent component analysis (ICA). Data was compared to a 21-person dataset acquired on the same scanner in order to confirm that the values of the single-subject RSN measures were within the expected range as assessed from the multi-participant dataset. Fourteen RSNs were identified, and the inter-session reproducibility of outcome measures—network spatial map, temporal signal fluctuation magnitude, and between-network connectivity (BNC)–was high, with executive RSNs showing the highest reproducibility. Analysis of the weekly outcome measures also showed that many rs-fMRI outcome measures had a significant linear trend, annual periodicity, and persistence. Such temporal structure was most prominent in spatial map similarity, and least prominent in BNC. High reproducibility supports the candidacy of rs-fMRI outcome measures as biomarkers, but the presence of significant temporal structure needs to be taken into account when such outcome measures are considered as biomarkers for rehabilitation-style therapeutic interventions in chronic conditions. PMID:26517540

Delivery and Outcomes of a Yearlong Home Exercise Program After Hip Fracture

PubMed Central

Orwig, Denise L.; Hochberg, Marc; Yu-Yahiro, Janet; Resnick, Barbara; Hawkes, William G.; Shardell, Michelle; Hebel, J. Richard; Colvin, Perry; Miller, Ram R.; Golden, Justine; Zimmerman, Sheryl; Magaziner, Jay

2011-01-01

Background Hip fracture affects more than 1.6 million persons worldwide and causes substantial changes in body composition, function, and strength. Usual care (UC) has not successfully restored function to most patients, and prior research has not identified an effective restorative program. Our objective was to determine whether a yearlong home-based exercise program initiated following UC could be administered to older patients with hip fracture and improve outcomes. Methods A randomized controlled trial of 180 community dwelling female patients with hip fracture, 65 years and older, randomly assigned to intervention (n=91) or UC (n=89). Patients were recruited within 15 days of fracture from 3 Baltimore-area hospitals from November 1998 through September 2004. Follow-up assessments were conducted at 2, 6, and 12 months after fracture. The Exercise Plus Program was administered by exercise trainers that included supervised and independently performed aerobic and resistive exercises with increasing intensity. Main outcome measures included bone mineral density of the contralateral femoral neck. Other outcomes included time spent and kilocalories expended in physical activity using the Yale Physical Activity Scale, muscle mass and strength, fat mass, activities of daily living, and physical and psychosocial functioning. The effect of intervention for each outcome was estimated by the difference in outcome trajectories 2 to 12 months after fracture. Results More than 80% of participants received trainer visits, with the majority receiving more than 3 quarters (79%) of protocol visits. The intervention group reported more time spent in exercise activity during follow-up (P<.05). Overall, small effect sizes of 0 to 0.2 standard deviations were seen for bone mineral density measures, and no significant patterns of time-specific between-group differences were observed for the remaining outcome measures. Conclusion Patients with hip fracture who participate in a yearlong, in-home exercise program will increase activity level compared with those in UC; however, no significant changes in other targeted outcomes were detected. PMID:21357809

Comparison of Nurse Staffing Measurements in Staffing-Outcomes Research.

PubMed

Park, Shin Hye; Blegen, Mary A; Spetz, Joanne; Chapman, Susan A; De Groot, Holly A

2015-01-01

Investigators have used a variety of operational definitions of nursing hours of care in measuring nurse staffing for health services research. However, little is known about which approach is best for nurse staffing measurement. To examine whether various nursing hours measures yield different model estimations when predicting patient outcomes and to determine the best method to measure nurse staffing based on the model estimations. We analyzed data from the University HealthSystem Consortium for 2005. The sample comprised 208 hospital-quarter observations from 54 hospitals, representing information on 971 adult-care units and about 1 million inpatient discharges. We compared regression models using different combinations of staffing measures based on productive/nonproductive and direct-care/indirect-care hours. Akaike Information Criterion and Bayesian Information Criterion were used in the assessment of staffing measure performance. The models that included the staffing measure calculated from productive hours by direct-care providers were best, in general. However, the Akaike Information Criterion and Bayesian Information Criterion differences between models were small, indicating that distinguishing nonproductive and indirect-care hours from productive direct-care hours does not substantially affect the approximation of the relationship between nurse staffing and patient outcomes. This study is the first to explicitly evaluate various measures of nurse staffing. Productive hours by direct-care providers are the strongest measure related to patient outcomes and thus should be preferred in research on nurse staffing and patient outcomes.

“Nothing About Me Without Me”: An Interpretative Review of Patient Accessible Electronic Health Records

PubMed Central

Callahan, Ryan; Sevdalis, Nick; Mayer, Erik K; Darzi, Ara

2015-01-01

Background Patient accessible electronic health records (PAEHRs) enable patients to access and manage personal clinical information that is made available to them by their health care providers (HCPs). It is thought that the shared management nature of medical record access improves patient outcomes and improves patient satisfaction. However, recent reviews have found that this is not the case. Furthermore, little research has focused on PAEHRs from the HCP viewpoint. HCPs include physicians, nurses, and service providers. Objective We provide a systematic review of reviews of the impact of giving patients record access from both a patient and HCP point of view. The review covers a broad range of outcome measures, including patient safety, patient satisfaction, privacy and security, self-efficacy, and health outcome. Methods A systematic search was conducted using Web of Science to identify review articles on the impact of PAEHRs. Our search was limited to English-language reviews published between January 2002 and November 2014. A total of 73 citations were retrieved from a series of Boolean search terms including “review*” with “patient access to records”. These reviews went through a novel scoring system analysis whereby we calculated how many positive outcomes were reported per every outcome measure investigated. This provided a way to quantify the impact of PAEHRs. Results Ten reviews covering chronic patients (eg, diabetes and hypertension) and primary care patients, as well as HCPs were found but eight were included for the analysis of outcome measures. We found mixed outcomes across both patient and HCP groups, with approximately half of the reviews showing positive changes with record access. Patients believe that record access increases their perception of control; however, outcome measures thought to create psychological concerns (such as patient anxiety as a result of seeing their medical record) are still unanswered. Nurses are more likely than physicians to gain time efficiencies by using a PAEHR system with the main concern from physicians being the security of the PAEHRs. Conclusions This review implements a novel scoring system, which shows there is a lack of rigorous empirical testing that separates the effect of record access from other existing disease management programs. Current research is too targeted within certain clinical groups’ needs, and although there are positive signs for the adoption of PAEHRs, there is currently insufficient evidence about the effect of PAEHRs on health outcomes for patients or HCPs. PMID:26123476

Scar massage for hypertrophic burns scarring-A systematic review.

PubMed

Ault, P; Plaza, A; Paratz, J

2018-02-01

Scar massage is used in burn units globally to improve functional and cosmetic outcomes of hypertrophic scarring following a burn, however, the evidence to support this therapy is unknown. To review the literature and assess the efficacy of scar massage in hypertrophic burn scars. MEDLINE, PubMed, Embase, CINAHL and the Cochrane Library were searched using the key words "burn", "burn injury", "thermal injury" and "scar", "hypertrophic scar" and "massage", "manipulation", "soft tissue mobilisation", "soft tissue manipulation". The articles were scored by the assessors using the Physiotherapy Evidence Database (PEDro) scale and outcome measures on range of motion (ROM), cosmesis (vascularity, pliability, height), pain scores, pruritus, and psychological measures of depression and anxiety were extracted. Eight publications were included in the review with 258 human participants and 15 animal subjects who received scar massage following a thermal injury resulting in hypertrophic scarring. Outcome measures that demonstrated that scar massage was effective included scar thickness as measured with ultrasonography (p=0.001; g=-0.512); depression (Centre for Epidemiologic Studies - Depression [CES-D]) (p=0.031; g=-0.555); pain as measured with Visual Analogue Scale (VAS) (p=0.000; g=-1.133) and scar characteristics including vascularity (p=0.000; g=-1.837), pliability (p=0.000; g=-1.270) and scar height (p=0.000; g=-2.054). Outcome measures that trended towards significance included a decrease in pruritus (p=0.095; g=-1.157). It appears that there is preliminary evidence to suggest that scar massage may be effective to decrease scar height, vascularity, pliability, pain, pruritus and depression in hypertrophic burns scaring. This review reflects the poor quality of evidence and lack of consistent and valid scar assessment tools. Controlled, clinical trials are needed to develop evidence-based guidelines for scar massage in hypertrophic burns scarring. Copyright © 2017 Elsevier Ltd and ISBI. All rights reserved.

Are religion and spirituality barriers or facilitators to treatment for HIV: a systematic review of the literature.

PubMed

Medved Kendrick, Haley

2017-01-01

Much attention has been given to the relationship between religion/spirituality (R/S) and HIV in recent years, but comparatively little has been explored in regard to R/S and HIV testing, retention in care, and adherence to medication. Religious views concerning HIV risk behavior pose challenges to communication and education about sexual health in religious communities and may serve as barriers to HIV treatment and care. Conversely, religious coping and spiritual well-being, as well as social support could serve as facilitators to HIV treatment and care. This study aims to fill a gap in the literature by addressing the following questions: (1) what dimensions of R/S have been found to be factors associated with HIV outcomes?; (2) which R/S factors function as barriers or facilitators to care among people living with HIV (PLWH)?; and (3) which R/S factors, if any, vary across socio-demographic groups? Thirty-three empirical articles were identified for systematic review. Of the 33 empirical studies included, 24 studies found that at least one measure of R/S was associated with better adherence and clinical health outcomes. Twelve studies found at least one measure of R/S to be associated with poorer adherence and clinical health outcomes. Seven of the studies found at least one R/S measure to have no significant association with outcomes. Though all of the studies included in this review focused on R/S experiences of PLWH, there was very little consistency in regard to measurement of R/S. Studies in this review included a wide range of R/S measures, including beliefs, religious/spiritual practices, R/S coping, organizational religion, and many more. Of the 33 studies reviewed, only 9 focused on unique populations such as women, people with histories of substance abuse, immigrants, etc. Findings from this review highlight opportunities for more studies in various populations using standardized R/S measures.

Diabetes Self-Management Care via Cell Phone: A Systematic Review

PubMed Central

Krishna, Santosh; Boren, Suzanne Austin

2008-01-01

Background The objective of this study was to evaluate the evidence on the impact of cell phone interventions for persons with diabetes and/or obesity in improving health outcomes and/or processes of care for persons with diabetes and/or obesity. Methods We searched Medline (1966–2007) and reviewed reference lists from included studies and relevant reviews to identify additional studies. We extracted descriptions of the study design, sample size, patient age, duration of study, technology, educational content and delivery environment, intervention and control groups, process and outcome measures, and statistical significance. Results In this review, we included 20 articles, representing 18 studies, evaluating the use of a cell phone for health information for persons with diabetes or obesity. Thirteen of 18 studies measured health outcomes and the remaining 5 studies evaluated processes of care. Outcomes were grouped into learning, behavior change, clinical improvement, and improved health status. Nine out of 10 studies that measured hemoglobin A1c reported significant improvement among those receiving education and care support. Cell phone and text message interventions increased patient–provider and parent–child communication and satisfaction with care. Conclusions Providing care and support with cell phones and text message interventions can improve clinically relevant diabetes-related health outcomes by increasing knowledge and self-efficacy to carry out self-management behaviors. PMID:19885219

Diabetes self-management care via cell phone: a systematic review.

PubMed

Krishna, Santosh; Boren, Suzanne Austin

2008-05-01

The objective of this study was to evaluate the evidence on the impact of cell phone interventions for persons with diabetes and/or obesity in improving health outcomes and/or processes of care for persons with diabetes and/or obesity. We searched Medline (1966-2007) and reviewed reference lists from included studies and relevant reviews to identify additional studies. We extracted descriptions of the study design, sample size, patient age, duration of study, technology, educational content and delivery environment, intervention and control groups, process and outcome measures, and statistical significance. In this review, we included 20 articles, representing 18 studies, evaluating the use of a cell phone for health information for persons with diabetes or obesity. Thirteen of 18 studies measured health outcomes and the remaining 5 studies evaluated processes of care. Outcomes were grouped into learning, behavior change, clinical improvement, and improved health status. Nine out of 10 studies that measured hemoglobin A1c reported significant improvement among those receiving education and care support. Cell phone and text message interventions increased patient-provider and parent-child communication and satisfaction with care. Providing care and support with cell phones and text message interventions can improve clinically relevant diabetes-related health outcomes by increasing knowledge and self-efficacy to carry out self-management behaviors.

Commentary: getting real on addressing health care disparities and other systems problems.

PubMed

Madara, James L

2012-06-01

Physician membership organizations vary in the extent of their engagement in activities to address health disparities. Increasing engagement of those organizations not already highly active in this critical area is, thus, an opportunity. Studies that provide definitional contours of key issues, like disparities, are necessary and must be iteratively refined. However, parallel activities of intervention with measured outcomes to assess the effects of these interventions are necessary to truly address major problems in the health care system. To date, work in the problem definition category exceeds work toward intervention in and mitigation of these problems with measured outcomes. Many problems in health care, including disparities, are now sufficiently understood that it is time to shift focus toward bold intervention with measured outcomes. Optimal approaches that yield superior outcomes generally require collaboration across the provider-payer spectrum and the private sectors, including physicians, hospitals, insurers, etc. Stakeholders are now free to act in such coordinated fashion; it only requires social capital that permits cooperation and compromise. Interventions for problems such as health care disparities can be developed in the private sector and mirrored by government payers if physicians and organizations can get real about collaborating to implement outcomes-based initiatives to improve the health of all patients.

Do the same factors predict outcome in schizophrenia and non-schizophrenia syndromes after first-episode psychosis? A two-year follow-up study.

PubMed

Peña, Javier; Segarra, Rafael; Ojeda, Natalia; García, Jon; Eguiluz, José I; Gutiérrez, Miguel

2012-06-01

The aim of this two-year longitudinal study was to identify the best baseline predictors of functional outcome in first-episode psychosis (FEP). We tested whether the same factors predict functional outcomes in two different subsamples of FEP patients: schizophrenia and non-schizophrenia syndrome groups. Ninety-five patients with FEP underwent a full clinical evaluation (i.e., PANSS, Mania, Depression and Insight). Functional outcome measurements included the WHO Disability Assessment Schedule (DAS-WHO), Global Assessment of Functioning (GAF) and Clinical Global Impression (CGI). Estimation of cognition was obtained by a neuropsychological battery which included attention, processing speed, language, memory and executive functioning. Greater severity of visuospatial functioning at baseline predicted poorer functional outcome as measured by the three functional scales (GAF, CGI and DAS-WHO) in the pooled FEP sample (explaining ut to the 12%, 9% and 10% of the variance, respectively). Negative symptoms also effectively contributed to predict GAF scores (8%). However, we obtained different predictive values after differentiating sample diagnoses. Processing speed significantly predicted most functional outcome measures in patients with schizophrenia, whereas visuospatial functioning was the only significant predictor of functional outcomes in the non-schizophrenia subgroup. Our results suggest that processing speed, visuospatial functioning and negative symptoms significantly (but differentially) predict outcomes in patients with FEP, depending on their clinical progression. For patients without a schizophrenia diagnosis, visuospatial functioning was the best predictor of functional outcome. The performance on processing speed seemed to be a key factor in more severe syndromes. However, only a small proportion of the variance could be explained by the model, so there must be many other factors that have to be considered. Copyright © 2012 Elsevier Ltd. All rights reserved.

What is the value of the routine use of patient-reported outcome measures toward improvement of patient outcomes, processes of care, and health service outcomes in cancer care? A systematic review of controlled trials.

PubMed

Kotronoulas, Grigorios; Kearney, Nora; Maguire, Roma; Harrow, Alison; Di Domenico, David; Croy, Suzanne; MacGillivray, Stephen

2014-05-10

The systematic use of patient-reported outcome measures (PROMs) has been advocated as an effective way to standardize cancer practice. Yet, the question of whether PROMs can lead to actual improvements in the quality of patient care remains under debate. This review examined whether inclusion of PROM in routine clinical practice is associated with improvements in patient outcomes, processes of care, and health service outcomes during active anticancer treatment. A systematic review of five electronic databases (Medline, EMBASE, CINAHL [Cumulative Index to Nursing and Allied Health Literature], PsycINFO, and Psychology and Behavioral Sciences Collection [PBSC]) was conducted from database inception to May 2012 to locate randomized and nonrandomized controlled trials of patients receiving active anticancer treatment or supportive care irrespective of type of cancer. Based on prespecified eligibility criteria, we included 26 articles that reported on 24 unique controlled trials. Wide variability in the design and use of interventions delivered, outcomes evaluated, and cancer- and modality-specific context was apparent. Health service outcomes were only scarcely included as end points. Overall, the number of statistically significant findings were limited and PROMs' intervention effect sizes were predominantly small-to-moderate. The routine use of PROMs increases the frequency of discussion of patient outcomes during consultations. In some studies, PROMs are associated with improved symptom control, increased supportive care measures, and patient satisfaction. Additional effort is required to ensure patient adherence, as well as additional support to clinicians who will respond to patient concerns and issues, with clear system guidelines in place to guide their responses. More research is required to support PROM cost-benefit in terms of patient safety, clinician burden, and health services usage.

Developing core outcome measurement sets for clinical trials: OMERACT filter 2.0.

PubMed

Boers, Maarten; Kirwan, John R; Wells, George; Beaton, Dorcas; Gossec, Laure; d'Agostino, Maria-Antonietta; Conaghan, Philip G; Bingham, Clifton O; Brooks, Peter; Landewé, Robert; March, Lyn; Simon, Lee S; Singh, Jasvinder A; Strand, Vibeke; Tugwell, Peter

2014-07-01

Lack of standardization of outcome measures limits the usefulness of clinical trial evidence to inform health care decisions. This can be addressed by agreeing on a minimum core set of outcome measures per health condition, containing measures relevant to patients and decision makers. Since 1992, the Outcome Measures in Rheumatology (OMERACT) consensus initiative has successfully developed core sets for many rheumatologic conditions, actively involving patients since 2002. Its expanding scope required an explicit formulation of its underlying conceptual framework and process. Literature searches and iterative consensus process (surveys and group meetings) of stakeholders including patients, health professionals, and methodologists within and outside rheumatology. To comprehensively sample patient-centered and intervention-specific outcomes, a framework emerged that comprises three core "Areas," namely Death, Life Impact, and Pathophysiological Manifestations; and one strongly recommended Resource Use. Through literature review and consensus process, core set development for any specific health condition starts by identifying at least one core "Domain" within each of the Areas to formulate the "Core Domain Set." Next, at least one applicable measurement instrument for each core Domain is identified to formulate a "Core Outcome Measurement Set." Each instrument must prove to be truthful (valid), discriminative, and feasible. In 2012, 96% of the voting participants (n=125) at the OMERACT 11 consensus conference endorsed this model and process. The OMERACT Filter 2.0 explicitly describes a comprehensive conceptual framework and a recommended process to develop core outcome measurement sets for rheumatology likely to be useful as a template in other areas of health care. Copyright © 2014 The Authors. Published by Elsevier Inc. All rights reserved.

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.

Transfer of learning and patient outcome in simulated crisis resource management: a systematic review.

PubMed

Boet, Sylvain; Bould, M Dylan; Fung, Lillia; Qosa, Haytham; Perrier, Laure; Tavares, Walter; Reeves, Scott; Tricco, Andrea C

2014-06-01

Simulation-based learning is increasingly used by healthcare professionals as a safe method to learn and practice non-technical skills, such as communication and leadership, required for effective crisis resource management (CRM). This systematic review was conducted to gain a better understanding of the impact of simulation-based CRM teaching on transfer of learning to the workplace and subsequent changes in patient outcomes. Studies on CRM, crisis management, crew resource management, teamwork, and simulation published up to September 2012 were searched in MEDLINE(®), EMBASE™, CINAHL, Cochrane Central Register of Controlled Trials, and ERIC. All studies that used simulation-based CRM teaching with outcomes measured at Kirkpatrick Level 3 (transfer of learning to the workplace) or 4 (patient outcome) were included. Studies measuring only learners' reactions or simple learning (Kirkpatrick Level 1 or 2, respectively) were excluded. Two authors independently reviewed all identified titles and abstracts for eligibility. Nine articles were identified as meeting the inclusion criteria. Four studies measured transfer of simulation-based CRM learning into the clinical setting (Kirkpatrick Level 3). In three of these studies, simulation-enhanced CRM training was found significantly more effective than no intervention or didactic teaching. Five studies measured patient outcomes (Kirkpatrick Level 4). Only one of these studies found that simulation-based CRM training made a clearly significant impact on patient mortality. Based on a small number of studies, this systematic review found that CRM skills learned at the simulation centre are transferred to clinical settings, and the acquired CRM skills may translate to improved patient outcomes, including a decrease in mortality.

Development of a core outcome set for orthodontic trials using a mixed-methods approach: protocol for a multicentre study.

PubMed

Tsichlaki, Aliki; O'Brien, Kevin; Johal, Ama; Marshman, Zoe; Benson, Philip; Colonio Salazar, Fiorella B; Fleming, Padhraig S

2017-08-04

Orthodontic treatment is commonly undertaken in young people, with over 40% of children in the UK needing treatment and currently one third having treatment, at a cost to the National Health Service in England and Wales of £273 million each year. Most current research about orthodontic care does not consider what patients truly feel about, or want, from treatment, and a diverse range of outcomes is being used with little consistency between studies. This study aims to address these problems, using established methodology to develop a core outcome set for use in future clinical trials of orthodontic interventions in children and young people. This is a mixed-methods study incorporating four distinct stages. The first stage will include a scoping review of the scientific literature to identify primary and secondary outcome measures that have been used in previous orthodontic clinical trials. The second stage will involve qualitative interviews and focus groups with orthodontic patients aged 10 to 16 years to determine what outcomes are important to them. The outcomes elicited from these two stages will inform the third stage of the study in which a long-list of outcomes will be ranked in terms of importance using electronic Delphi surveys involving clinicians and patients. The final stage of the study will involve face-to-face consensus meetings with all stakeholders to discuss and agree on the outcome measures that should be included in the final core outcome set. This research will help to inform patients, parents, clinicians and commissioners about outcomes that are important to young people undergoing orthodontic treatment. Adoption of the core outcome set in future clinical trials of orthodontic treatment will make it easier for results to be compared, contrasted and combined. This should translate into improved decision-making by all stakeholders involved. The project has been registered on the Core Outcome Measures in Effectiveness Trials ( COMET ) website, January 2016.

Variation in the Diagnosis of Aspiration Pneumonia and Association with Hospital Pneumonia Outcomes.

PubMed

Lindenauer, Peter K; Strait, Kelly M; Grady, Jacqueline N; Ngo, Chi K; Parisi, Madeline L; Metersky, Mark; Ross, Joseph S; Bernheim, Susannah M; Dorsey, Karen

2018-05-01

National efforts to compare hospital outcomes for patients with pneumonia may be biased by hospital differences in diagnosis and coding of aspiration pneumonia, a condition that has traditionally been excluded from pneumonia outcome measures. To evaluate the rationale and impact of including patients with aspiration pneumonia in hospital mortality and readmission measures. Using Medicare fee-for-service claims for patients 65 years and older from July 2012 to June 2015, we characterized the proportion of hospitals' patients with pneumonia diagnosed with aspiration pneumonia, calculated hospital-specific risk-standardized rates of 30-day mortality and readmission for patients with pneumonia, analyzed the association between aspiration pneumonia coding frequency and these rates, and recalculated these rates including patients with aspiration pneumonia. A total of 1,101,892 patients from 4,263 hospitals were included in the mortality measure analysis, including 192,814 with aspiration pneumonia. The median proportion of hospitals' patients with pneumonia diagnosed with aspiration pneumonia was 13.6% (10th-90th percentile, 4.2-26%). Hospitals with a higher proportion of patients with aspiration pneumonia had lower risk-standardized mortality rates in the traditional pneumonia measure (12.0% in the lowest coding and 11.0% in the highest coding quintiles) and were far more likely to be categorized as performing better than the national mortality rate; expanding the measure to include patients with aspiration pneumonia attenuated the association between aspiration pneumonia coding rate and hospital mortality. These findings were less pronounced for hospital readmission rates. Expanding the pneumonia cohorts to include patients with a principal diagnosis of aspiration pneumonia can overcome bias related to variation in hospital coding.

Recommendations for incorporating patient-reported outcomes into clinical comparative effectiveness research in adult oncology.

PubMed

Basch, Ethan; Abernethy, Amy P; Mullins, C Daniel; Reeve, Bryce B; Smith, Mary Lou; Coons, Stephen Joel; Sloan, Jeff; Wenzel, Keith; Chauhan, Cynthia; Eppard, Wayland; Frank, Elizabeth S; Lipscomb, Joseph; Raymond, Stephen A; Spencer, Merianne; Tunis, Sean

2012-12-01

Examining the patient's subjective experience in prospective clinical comparative effectiveness research (CER) of oncology treatments or process interventions is essential for informing decision making. Patient-reported outcome (PRO) measures are the standard tools for directly eliciting the patient experience. There are currently no widely accepted standards for developing or implementing PRO measures in CER. Recommendations for the design and implementation of PRO measures in CER were developed via a standardized process including multistakeholder interviews, a technical working group, and public comments. Key recommendations are to include assessment of patient-reported symptoms as well as health-related quality of life in all prospective clinical CER studies in adult oncology; to identify symptoms relevant to a particular study population and context based on literature review and/or qualitative and quantitative methods; to assure that PRO measures used are valid, reliable, and sensitive in a comparable population (measures particularly recommended include EORTC QLQ-C30, FACT, MDASI, PRO-CTCAE, and PROMIS); to collect PRO data electronically whenever possible; to employ methods that minimize missing patient reports and include a plan for analyzing and reporting missing PRO data; to report the proportion of responders and cumulative distribution of responses in addition to mean changes in scores; and to publish results of PRO analyses simultaneously with other clinical outcomes. Twelve core symptoms are recommended for consideration in studies in advanced or metastatic cancers. Adherence to methodologic standards for the selection, implementation, and analysis/reporting of PRO measures will lead to an understanding of the patient experience that informs better decisions by patients, providers, regulators, and payers.

Can Grafts Provide Superior Tendon Healing and Clinical Outcomes After Rotator Cuff Repairs?

PubMed Central

Ono, Yohei; Dávalos Herrera, Diego Alejandro; Woodmass, Jarret M.; Boorman, Richard S.; Thornton, Gail M.; Lo, Ian K. Y.

2016-01-01

Background: Arthroscopic repair of large to massive rotator cuff tears commonly retear. To improve healing rates, a number of different approaches have been utilized, including the use of grafts, which may enhance the biomechanical and biologic aspects of the repair construct. However, the outcomes after the use of grafts are diverse. Purpose: To systematically review the literature for large to massive rotator cuff tears to determine whether the use of grafts generally provides superior tendon healing and clinical outcomes to the repairs without grafts. Study Design: Systematic review; Level of evidence, 3. Methods: A systematic review of the literature was performed. Clinical studies comparing the repairs with (graft group) and without grafts (control group) were included and analyzed. The primary outcome was tendon healing on either magnetic resonance imaging or ultrasound. The secondary outcome measures included visual analog scale for pain, University of California at Los Angles (UCLA) score, and forward elevation range. Differences between groups in all outcome measures were statistically analyzed. Results: Six comparative studies (level of evidence 2 or 3) with 13 study groups were included. A total of 242 repairs in the graft group (mean age, 62.5 ± 4.6 years) and 185 repairs in the control group (mean age, 62.5 ± 5.0 years) were analyzed. The graft types utilized included autograft (fascia lata) in 1 study, allograft (human dermis) in 2 studies, xenograft (bovine pericardium, porcine small intestine submucosa) in 2 studies, synthetic graft (polypropylene) in 1 study, and a combination of autograft (the long head of biceps) and synthetic graft (polypropylene) in 1 study. The overall mean follow-up time was 28.4 ± 9.0 months. When 1 or 2 studies/study groups were excluded due to practical or statistical reasons, the graft group demonstrated significantly improved healing (odds ratio, 2.48; 95% CI, 1.58-3.90; P < .0001) and all clinical outcome measures at final follow-up (P ≤ .02). Conclusion: The use of grafts generally provides superior tendon healing and clinical outcomes compared to repairs without grafts, except for some specific graft types (eg, porcine small intestine submucosa, bovine pericardium). Further investigations are required to determine the benefits of the use of grafts. PMID:28203585

The Council on Quality and Leadership in Supports for People with Disabilities: Personal Outcomes Chart Book.

ERIC Educational Resources Information Center

National Center on Outcomes Research, Council on Quality and Leadership, Towson, MD.

This report describes the genesis, definition and use of the Personal Outcomes database, a database designed to assess whether programs and services are being effective in helping individuals with disabilities. The database is based on 25 outcome measures in seven domains, including: (1) identity, which is designed to provide a sense of how people…

Validation of the Worry about Sexual Outcomes Scale for Use in STI/HIV Prevention Interventions for Adolescent Females

ERIC Educational Resources Information Center

Sales, Jessica M.; Spitalnick, Josh; Milhausen, Robin R.; Wingood, Gina M.; Diclemente, Ralph J.; Salazar, Laura F.; Crosby, Richard A.

2009-01-01

This study examined the psychometric properties of a new scale to measure adolescents' worry regarding outcomes of risky sexual behavior (i.e. sexually transmitted infections, including HIV [STI/HIV], and unintended pregnancy). The 10-item worry about sexual outcomes (WASO) scale, resulting in two subscales STI/HIV worry and pregnancy worry, was…

Cognitive and Noncognitive Changes From Participation in National Guard Youth ChalleNGe

DTIC Science & Technology

2013-10-01

confidence and locus of control (belief that one’s actions influence eventual outcomes). By the end of the program, the measured noncognitive skills of...quite detailed; it includes eight core compo- nents: leadership/ followership , responsible citizenship, service to community, life-coping skills, physical... actions (versus random factors or other powers) deter- mine outcomes. Essentially, the scale measures the extent to which respondents believe that they

Future Performance Trend Indicators: A Current Value Approach to Human Resources Accounting. Report II: Internal Consistencies and Relationships to Performance in Organization VI. Technical Report.

ERIC Educational Resources Information Center

Pecorella, Patricia A.; Bowers, David G.

Conventional accounting systems provide no indication as to what conditions and events lead to reported outcomes, since they traditionally do not include measurements of the human organization and its relationship to events at the outcome stage. Human resources accounting is used to measure these additional types of data. This research is…

A core outcome set for all types of cardiac surgery effectiveness trials: a study protocol for an international eDelphi survey to achieve consensus on what to measure and the subsequent selection of measurement instruments.

PubMed

Moza, A; Benstoem, C; Autschbach, R; Stoppe, C; Goetzenich, A

2015-12-02

Cardiovascular disease (CVD) is a major contributor to the burden of disease and the number one cause of death worldwide. From 1990 until today, more people died from coronary heart disease than from any other cause. CVD is regularly treated with minimally or non-minimally invasive off- or on-pump cardiothoracic surgery and several interventions related to the outcome of the surgical procedures have been evaluated in clinical trials, but heterogeneity in outcome reporting hinders comparison of interventions across trials and limits the ability of research synthesis. This problem is encountered with the introduction of core outcome sets (COSs), which should be measured and reported, as a minimum, in all clinical trials for a specific clinical field. This study protocol describes the methods used to develop a COS for all types of cardiac surgery effectiveness trials. We aim to reach consensus on what to measure in an international three-round eDelphi exercise involving adult patients in need or after cardiothoracic surgery, cardiothoracic surgeons, cardiologists, anaesthesiologists, nursing staff and researchers with expertise in this particular field of medical research. Subsequently, outcome measurement instruments (how to measure) will be determined. Recommendations on COS development given by the Core Outcome Measures in Effectiveness Trials (COMET) Initiative and the Outcome Measures in Rheumatology (OMERACT) Initiative were followed. The proposed COS aims to provide methodological guidance for future cardiothoracic surgical trials to ensure the comparability of effects of interventions across studies and enable research synthesis. This does not imply that primary outcomes should always and exclusively be those of the COS. However, to ensure the comparability of results across trials, the outcomes included in this COS should be considered for inclusion besides measuring trial-specific clinical endpoints.

Measurement of Behavioral and Emotional Outcomes of Youth in Foster Care: Investigation of the Roles of Age and Placement Type.

PubMed

Gabrielli, Joy; Jackson, Yo; Brown, Shaquanna

2015-09-01

The Behavioral Assessment System for Children-2 (BASC-2) is used to assess behavioral and emotional outcomes for youth. Research providing evidence for use of the BASC-2 parent-report form historically has included biological parents reporting on their children (Reynolds and Kamphaus 2004). For youth residing in out-of-home placements through enrollment in foster care, caregivers reporting on their functioning may include foster parents or residential staff. Given the significant adverse mental health outcomes for youth in foster care and the need to adequately assess adjustment in foster care, the purpose of the study was to evaluate the measurement properties of caregivers' report on the parent report form (PRS) of the BASC-2 in foster care youth. Using 479 respondents, a measurement model was fit to the data demonstrating adequate fit across Internalizing Problems, Externalizing Problems, and Adaptive Skills. Further, a comparison of measurement properties across child and adolescent groups and groups of youth residing in residential facilities versus foster homes was conducted. Factorial invariance and latent means also were assessed. The BASC-2 PRS was found to be an adequate assessment of psychological outcomes for youth in foster care when completed by foster parents or residential facility staff.

Measurement of Behavioral and Emotional Outcomes of Youth in Foster Care: Investigation of the Roles of Age and Placement Type

PubMed Central

Gabrielli, Joy; Jackson, Yo; Brown, Shaquanna

2014-01-01

The Behavioral Assessment System for Children–2 (BASC-2) is used to assess behavioral and emotional outcomes for youth. Research providing evidence for use of the BASC-2 parent-report form historically has included biological parents reporting on their children (Reynolds and Kamphaus 2004). For youth residing in out-of-home placements through enrollment in foster care, caregivers reporting on their functioning may include foster parents or residential staff. Given the significant adverse mental health outcomes for youth in foster care and the need to adequately assess adjustment in foster care, the purpose of the study was to evaluate the measurement properties of caregivers’ report on the parent report form (PRS) of the BASC-2 in foster care youth. Using 479 respondents, a measurement model was fit to the data demonstrating adequate fit across Internalizing Problems, Externalizing Problems, and Adaptive Skills. Further, a comparison of measurement properties across child and adolescent groups and groups of youth residing in residential facilities versus foster homes was conducted. Factorial invariance and latent means also were assessed. The BASC-2 PRS was found to be an adequate assessment of psychological outcomes for youth in foster care when completed by foster parents or residential facility staff. PMID:26478653

What is the impact of professional learning on physical activity interventions among preschool children? A systematic review.

PubMed

Peden, M E; Okely, A D; Eady, M J; Jones, R A

2018-05-31

The purpose of this systematic review was to investigate professional learning models (length, mode, content) offered as part of objectively measured physical childcare-based interventions. A systematic review of eight electronic databases was conducted to June 2017. Only English, peer-reviewed studies that evaluated childcare-based physical activity interventions, incorporated professional learning and reported objectively measured physical activity were included. Study designs included randomized controlled trails, cluster randomized trials, experimental or pilot studies. The search identified 11 studies. Ten studies objectively measured physical activity using accelerometers; five studies used both accelerometer and direct observation tools and one study measured physical activity using direct observation only. Seven of these studies reported statistically significant intervention effects. Only six studies described all components of professional learning, but only two studies reported specific professional learning outcomes and physical activity outcomes. No patterns were identified between the length, mode and content of professional learning and children's physical activity outcomes in childcare settings. Educators play a critical role in modifying children's levels of physical activity in childcare settings. The findings of this review suggest that professional learning offered as part of a physical activity intervention that potentially impacts on children's physical activity outcomes remains under-reported. © 2018 World Obesity Federation.

Association of surgical care improvement project infection-related process measure compliance with risk-adjusted outcomes: implications for quality measurement.

PubMed

Ingraham, Angela M; Cohen, Mark E; Bilimoria, Karl Y; Dimick, Justin B; Richards, Karen E; Raval, Mehul V; Fleisher, Lee A; Hall, Bruce L; Ko, Clifford Y

2010-12-01

Facility-level process measure adherence is being publicly reported. However, the association between measure adherence and surgical outcomes is not well-established. Our objective was to determine the degree to which Surgical Care Improvement Project (SCIP) process measures are associated with American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) risk-adjusted outcomes. This cross-sectional study included hospitals participating in the ACS NSQIP and SCIP (n = 200). ACS NSQIP outcomes (30-day overall morbidity, serious morbidity, surgical site infections [SSI], and mortality) and adherence to SCIP SSI-related process measures (from the Hospital Compare database) were collected from January 1, 2008, through December 31, 2008. Hospital-level correlation coefficients between compliance with 4 process measures (ie, antibiotic administration within 1 hour before incision [SCIP-1]; appropriate antibiotic prophylaxis [SCIP-2]; antibiotic discontinuation within 24 hours after surgery [SCIP-3]; and appropriate hair removal [SCIP 6]) and 4 risk-adjusted outcomes were calculated. Regression analyses estimated the contribution of process measure adherence to risk-adjusted outcomes. Of 211 ACS NSQIP hospitals, 95% had data reported by Hospital Compare. Depending on the measure, hospital-level compliance ranged from 60% to 100%. Of the 16 correlations, 15 demonstrated nonsignificant associations with risk-adjusted outcomes. The exception was the relationship between SCIP-2 and SSI (p = 0.004). SCIP-1 demonstrated an intriguing but nonsignificant relationship with SSI (p = 0.08) and overall morbidity (p = 0.08). Although adherence to SCIP-2 was a significant predictor of risk-adjusted SSI (p < 0.0001) and overall morbidity (p < 0.0001), inclusion of compliance for SCIP-1 and SCIP-2 caused only slight improvement in model quality. Better adherence to infection-related process measures over the observed range was not significantly associated with better outcomes with one exception. Different measures of quality might be needed for surgical infection. Copyright © 2010 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

Cost-effectiveness of a complex workplace dietary intervention: an economic evaluation of the Food Choice at Work study

PubMed Central

Fitzgerald, Sarah; Murphy, Aileen; Kirby, Ann; Geaney, Fiona; Perry, Ivan J

2018-01-01

Objective To evaluate the costs, benefits and cost-effectiveness of complex workplace dietary interventions, involving nutrition education and system-level dietary modification, from the perspective of healthcare providers and employers. Design Single-study economic evaluation of a cluster-controlled trial (Food Choice at Work (FCW) study) with 1-year follow-up. Setting Four multinational manufacturing workplaces in Cork, Ireland. Participants 517 randomly selected employees (18–65 years) from four workplaces. Interventions Cost data were obtained from the FCW study. Nutrition education included individual nutrition consultations, nutrition information (traffic light menu labelling, posters, leaflets and emails) and presentations. System-level dietary modification included menu modification (restriction of fat, sugar and salt), increase in fibre, fruit discounts, strategic positioning of healthier alternatives and portion size control. The combined intervention included nutrition education and system-level dietary modification. No intervention was implemented in the control. Outcomes The primary outcome was an improvement in health-related quality of life, measured using the EuroQoL 5 Dimensions 5 Levels questionnaire. The secondary outcome measure was reduction in absenteeism, which is measured in monetary amounts. Probabilistic sensitivity analysis (Monte Carlo simulation) assessed parameter uncertainty. Results The system-level intervention dominated the education and combined interventions. When compared with the control, the incremental cost-effectiveness ratio (€101.37/quality-adjusted life-year) is less than the nationally accepted ceiling ratio, so the system-level intervention can be considered cost-effective. The cost-effectiveness acceptability curve indicates there is some decision uncertainty surrounding this, arising from uncertainty surrounding the differences in effectiveness. These results are reiterated when the secondary outcome measure is considered in a cost–benefit analysis, whereby the system-level intervention yields the highest net benefit (€56.56 per employee). Conclusions System-level dietary modification alone offers the most value per improving employee health-related quality of life and generating net benefit for employers by reducing absenteeism. While system-level dietary modification strategies are potentially sustainable obesity prevention interventions, future research should include long-term outcomes to determine if improvements in outcomes persist. Trial registration number ISRCTN35108237; Post-results. PMID:29502090

Patient reported outcomes and patient empowerment in clinical genetics services.

PubMed

McAllister, M; Dearing, A

2015-08-01

Evaluation of clinical genetics services (CGS), including genetic counseling and genetic testing, has been problematic. Patient mortality and morbidity are unlikely to be directly improved by interventions offered in CGS. Patient-reported outcomes (PROs) are not routinely measured in CGS evaluation, but this may change as patient-reported outcome measures (PROMs) become a key part of how healthcare services are managed and funded across the world. However, there is no clear consensus about which PROMs are most useful for CGS evaluation. This review summarizes the published research on how PROs from CGS have been measured and how patients may benefit from using those services, with a focus on patient empowerment. Many patient benefits (PROs) identified repeatedly in the research literature can be re-interpreted within a patient empowerment framework. Other important PROs identified include family functioning, social functioning, altruism, sense of purpose, enabling development of future research and treatment/participating in research. Well-validated measures are available to capture (dimensions of) patient empowerment. Although generic measures of family functioning are available, suitable measures capturing social functioning, development of future treatments, and altruism were not identified in this review. Patient empowerment provides one useful approach to measuring PROs from CGS. © 2014 The Authors. Clinical Genetics published by John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Economic evaluations and usefulness of standardized nursing terminologies.

PubMed

Stone, Patricia W; Lee, Nam-Ju; Giannini, Melinna; Bakken, Suzanne

2004-01-01

To review different types of economic analyses commonly found in healthcare literature, discuss methodologic considerations in framing economic analyses, identify useful resources for economic evaluations, and describe the current and potential roles of standardized nursing terminologies in providing cost and outcome data for economic analysis. The Advanced Billing Concepts Code Resource-based Relative Value Scale and Nursing Outcomes Classification. Using case studies, the applicability of standardized nursing terminologies in cost-effectiveness analysis is demonstrated. While there is potential to inform specific questions, comparisons across analyses are limited because of the many outcome measures. Including a standardized quality-of-life measure in nursing terminologies would allow for the calculation of accepted outcome measures and dollars per quality adjusted life years gained. The nurse's ability to assess and contribute to all aspects of rigorous economic evidence is an essential competency for responsible practice.

Effectiveness of temporary deafferentation of the arm on somatosensory and motor functions following stroke: a systematic review.

PubMed

Opsommer, Emmanuelle; Zwissig, Camille; Korogod, Natalya; Weiss, Thomas

2016-12-01

After stroke, regaining functional use of the upper limb can be challenging. Temporary deafferentation (TD) is a novel approach used in neurorehabilitation to voluntarily reduce the somatosensory input in a body part by temporary anesthesia; which has been shown to improve sensorimotor functions in the affected limb. The primary objective of this systematic review was to present the best available evidence related to the effects of TD of the affected arm on the recovery of motor function and activity of the upper limb (arm and hand) following stroke. Further, this review aimed to assess the effects of TD on sensory function, activities of daily living (ADL) and quality of life following stroke, the acceptability and safety of the intervention as well as adverse events. Adult patients (18 years and older) with a clinical diagnosis of stroke, either hemorrhagic or ischemic. Reports of rehabilitation that included the use of a pneumatic tourniquet, regional anesthesia or nerve block to achieve TD of an arm, or the use of TD as a stand-alone intervention. Primary outcomes were motor function and activity of the upper limb using assessment scales, motor tests and global motor functions.Secondary outcomes included measures of sensory function, ADL, impact of stroke and quality of life and pain.Additional outcomes were neurophysiological changes as studied with functional magnetic resonance imaging, magnetoencephalography and/or transcranial magnetic stimulation.Acceptability and safety of the intervention as well as adverse events were also included. We included any experimental and epidemiological studies. There were no randomized controlled trials. We included non-randomized controlled trials, quasi-experimental, before and after studies and case-control studies. We searched for both published and unpublished studies in major databases and all reference lists of relevant articles in English, German or French languages. We included studies published from January 1980 to October 2015. Data were extracted from included studies using a standardized data extraction tool from the Joanna Briggs Institute. There was heterogeneity in the types of intervention and outcome measures, therefore statistical pooling of the findings was not appropriate. As such, the studies were grouped according to type of outcome where possible. Findings are presented in a narrative form. Eight studies met the eligibility criteria. All outcome parameters related to the primary outcome (motor function and activity of the more affected upper extremity) showed an improvement during or after TD. The sensory functions significantly improved during or after TD when measured either by the grating orienting task or the grating orientation accuracy, and slightly improved when measured using the von Frey hair testing during TD. There is evidence supporting the use of TD of the upper extremity in adults after stroke. Temporary deafferentation can be recommended (Grade B).

Development of a patient-centred, patient-reported outcome measure (PROM) for post-stroke cognitive rehabilitation: qualitative interviews with stroke survivors to inform design and content.

PubMed

Patchick, Emma L; Horne, Maria; Woodward-Nutt, Kate; Vail, Andy; Bowen, Audrey

2015-12-01

Improving cognition is service users' top research priority for life after stroke, and future research should include outcomes that they deem important. Patient perspectives on outcomes are collected using patient-reported outcome measures (PROMs). There is currently no patient-centred PROM specific for cognitive rehabilitation trials. Inform PROM development by exploring stroke survivor perspectives on the important, measurable impacts of persisting post-stroke cognitive problems. Qualitative semi-structured interviews in participants' homes. Purposive sample of 16 cognitively impaired stroke survivors at least six months post-stroke. Interviews used a schedule and communication aids developed through patient consultation. Interviews were transcribed verbatim with non-verbal communication recorded using field notes. Data were analysed using a framework approach to find commonalities to shape the focus and content of an outcome measure. Participants identified important impacts of their 'invisible' cognitive problems, outside of other stroke-related impairments. Cognitive problems exacerbated emotional issues and vice versa. Changes in self-identity and social participation were prominent. Impact was not spoken about in terms of frequency but rather in terms of the negative affect associated with problems; terms like 'bothered' and 'frustration' were often used. The results support the development of a PROM specifically designed to address the impact of cognitive problems. It should: include items addressing a comprehensive range of cognitive skills; ask questions about mood, self-identity and social participation; use accessible wording that respondents understand and endorse; measure impact rather than frequency; and explore perceived impact on carers. © 2014 John Wiley & Sons Ltd.

Preliminary investigation of an electromyography-controlled video game as a home program for persons in the chronic phase of stroke recovery.

PubMed

Donoso Brown, Elena V; McCoy, Sarah Westcott; Fechko, Amber S; Price, Robert; Gilbertson, Torey; Moritz, Chet T

2014-08-01

To investigate the preliminary effectiveness of surface electromyography (sEMG) biofeedback delivered via interaction with a commercial computer game to improve motor control in chronic stroke survivors. Single-blinded, 1-group, repeated-measures design: A1, A2, B, A3 (A, assessment; B, intervention). Laboratory and participants' homes. A convenience sample of persons (N=9) between 40 and 75 years of age with moderate to severe upper extremity motor impairment and at least 6 months poststroke completed the study. The electromyography-controlled video game system targeted the wrist muscle activation with the goal of increasing selective muscle activation. Participants received several laboratory training sessions with the system and then were instructed to use the system at home for 45 minutes, 5 times per week for the following 4 weeks. Primary outcome measures included duration of system use, sEMG during home play, and pre/post sEMG measures during active wrist motion. Secondary outcomes included kinematic analysis of movement and functional outcomes, including the Wolf Motor Function Test and the Chedoke Arm and Hand Activity Inventory-9. One third of participants completed or exceeded the recommended amount of system use. Statistically significant changes were observed on both game play and pre/post sEMG outcomes. Limited carryover, however, was observed on kinematic or functional outcomes. This preliminary investigation indicates that use of the electromyography-controlled video game impacts muscle activation. Limited changes in kinematic and activity level outcomes, however, suggest that the intervention may benefit from the inclusion of a functional activity component. Copyright © 2014 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

A systematic review of risk factors associated with accidental falls, outcome measures and interventions to manage fall risk in non-ambulatory adults.

PubMed

Rice, Laura A; Ousley, Cherita; Sosnoff, Jacob J

2015-01-01

To systematically review peer-reviewed literature pertaining to risk factors, outcome measures and interventions managing fall risk in non-ambulatory adults. Twenty-one papers were selected for inclusion from databases including PubMed/Medline, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Cochrane Library, Scopus, Consumer Health Complete and Web of Science. Selected studies involved a description of fall related risk factors, outcomes to assess fall risk and intervention studies describing protocols to manage fall risk in non-ambulatory adults. Studies were selected by two reviewers and consultation provided by a third reviewer. The most frequently cited risk factors/characteristics associated with falls included: wheelchair related characteristics, transfer activities, impaired seated balance and environmental factors. The majority of the outcomes were found to evaluate seated postural control. One intervention study was identified describing a protocol targeting specific problems of individual participants. A global fall prevention program was not identified. Several risk factors associated with falls were identified and must be understood by clinicians to better serve their clients. To improve objective assessment, a comprehensive outcome assessment specific to non-ambulatory adults is needed. Finally, additional research is needed to examine the impact of structured protocols to manage fall risk in non-ambulatory adults. Falls are a common health concern for non-ambulatory adults. Risk factors commonly associated with falls include wheelchair related characteristics, transfer activities, impaired seated balance and environmental factors. Limited outcome measures are available to assess fall risk in non-ambulatory adults. Clinicians must be aware of the known risk factors and provide comprehensive education to their clients on the potential for falls. Additional research is needed to develop and evaluate protocols to clinically manage fall risk.

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 are increasingly being used for ACL reconstruction throughout the last decade. PMID:27379330

Arthroscopic Surgical Procedures Versus Sham Surgery for Patients With Femoroacetabular Impingement and/or Labral Tears: Study Protocol for a Randomized Controlled Trial (HIPARTI) and a Prospective Cohort Study (HARP).

PubMed

Risberg, May Arna; Ageberg, Eva; Nilstad, Agnethe; Lund, Bent; Nordsletten, Lars; Løken, Sverre; Ludvigsen, Tom; Kierkegaard, Signe; Carsen, Sasha; Kostogiannis, Ioannis; Crossley, Kay M; Glyn-Jones, Sion; Kemp, Joanne L

2018-04-01

Study Design Study protocol for a randomized controlled trial and a prospective cohort. Background The number of arthroscopic surgical procedures for patients with femoroacetabular impingement syndrome (FAIS) has significantly increased worldwide, but high-quality evidence of the effect of such interventions is lacking. Objectives The primary objective will be to determine the efficacy of hip arthroscopic procedures compared to sham surgery on patient-reported outcomes for patients with FAIS (HIP ARThroscopy International [HIPARTI] Study). The secondary objective will be to evaluate prognostic factors for long-term outcome after arthroscopic surgical interventions in patients with FAIS (Hip ARthroscopy Prospective [HARP] Study). Methods The HIPARTI Study will include 140 patients and the HARP Study will include 100 patients. The international Hip Outcome Tool-33 will be the primary outcome measure at 1 year. Secondary outcome measures will be the Hip disability and Osteoarthritis Outcome Score, Arthritis Self-Efficacy Scale, fear of movement (Tampa Scale of Kinesiophobia), Patient-Specific Functional Scale, global rating of change score, and expectations. Other outcomes will include active hip range of motion, hip muscle strength tests, functional performance tests, as well as radiological assessments using radiographs and magnetic resonance imaging. Conclusion To determine the true effect of surgery, beyond that of placebo, double-blinded placebo-controlled trials including sham surgery are needed. The HIPARTI Study will direct future evidence-based treatment of FAIS. Predictors for long-term development and progression of degenerative changes in the hip are also needed for this young patient group with FAIS; hence, responders and nonresponders to treatment could be determined. J Orthop Sports Phys Ther 2018;48(4):325-335. doi:10.2519/jospt.2018.7931.

A Rapid Systematic Review of Outcomes Studies in Genetic Counseling.

PubMed

Madlensky, Lisa; Trepanier, Angela M; Cragun, Deborah; Lerner, Barbara; Shannon, Kristen M; Zierhut, Heather

2017-06-01

As healthcare reimbursement is increasingly tied to value-of-service, it is critical for the genetic counselor (GC) profession to demonstrate the value added by GCs through outcomes research. We conducted a rapid systematic literature review to identify outcomes of genetic counseling. Web of Science (including PubMed) and CINAHL databases were systematically searched to identify articles meeting the following criteria: 1) measures were assessed before and after genetic counseling (pre-post design) or comparisons were made between a GC group vs. a non-GC group (comparative cohort design); 2) genetic counseling outcomes could be assessed independently of genetic testing outcomes, and 3) genetic counseling was conducted by masters-level genetic counselors, or non-physician providers. Twenty-three papers met the inclusion criteria. The majority of studies were in the cancer genetic setting and the most commonly measured outcomes included knowledge, anxiety or distress, satisfaction, perceived risk, genetic testing (intentions or receipt), health behaviors, and decisional conflict. Results suggest that genetic counseling can lead to increased knowledge, perceived personal control, positive health behaviors, and improved risk perception accuracy as well as decreases in anxiety, cancer-related worry, and decisional conflict. However, further studies are needed to evaluate a wider array of outcomes in more diverse genetic counseling settings.

Defining and evaluating novel procedures for involving patients in Core Outcome Set research: creating a meaningful long list of candidate outcome domains.

PubMed

Smith, Harriet; Horobin, Adele; Fackrell, Kathryn; Colley, Veronica; Thacker, Brian; Hall, Deborah A

2018-01-01

Outcome domains are aspects of a condition that matter to patients and clinicians and can be measured to assess treatment effects. For tinnitus, examples include 'tinnitus loudness' and 'ability to concentrate'. This study focuses on the first stage of agreeing which outcome domains should be measured in all clinical trials of tinnitus. Crucially, it involves identifying outcome domains, prior to a voting process. This article describes how we effectively involved patients in that study design process, and reflects on the impact of their input.The study first compiled a long list of all possible outcome domains before asking interested parties, including patients, to vote which ones to include. Ensuring patients fully participate in this process holds unique challenges as it can be long, repetitive and its purpose far removed from their needs. These challenges may be addressed by involving patients in designing the research. There is evidence that other research teams are doing this, but its reporting is not detailed enough to guide others. Our paper seeks to address this.We describe how we involved patients (people living with tinnitus) in creating a long list of outcome domains that we included in our study. We also reflect on the benefits this brought. Two patients partnered with us in designing the survey. We also consulted an independent patient review panel. Involving patients reduced the list of domains included in the survey and made domain names and associated descriptions clearer. Our resulting survey performed well in recruiting and retaining patients as participants. Background Tinnitus is a complex audiological condition affecting many different domains of everyday life. Clinical trials of tinnitus interventions measure and report those outcome domains inconsistently and this hinders direct comparison between study findings. To address this problem, an ongoing project is developing a Core Outcome Set; an agreed list of outcome domains to be measured and reported in all future trials. Part of this project uses a consensus methodology ('Delphi' survey), whereby all relevant stakeholders identify important and critical outcome domains from a long list of candidates. This article addresses a gap in the patient involvement literature by describing and reflecting on our involvement of patients to create a meaningful long list of candidate outcome domains. Methods Two Public Research Partners with lived experience of tinnitus reviewed an initial list of 124 outcome domains over two face-to-face workshops. With the Study Management Team, they interpreted each candidate outcome domain and generated a plain language description. Following this, the domain names and descriptions underwent an additional lay review by 14 patients and 5 clinical experts, via an online survey platform. Results Insights gained from the workshops and survey feedback prompted substantial, unforeseen modifications to the long list. These included the reduction of the number of outcome domains (from 124 to 66) via the exclusion of broad concepts and consolidation of equivalent domains or domains outside the scope of the study. Reviewers also applied their lived experience of tinnitus to bring clarity and relevance to domain names and plain language descriptions. Four impacts on the Delphi survey were observed: recruitment exceeded the target by 171%, there were equivalent numbers of patient and professional participants ( n  = 358 and n  = 312, respectively), feedback was mostly positive, and retention was high (87%). Conclusions Patient involvement was an integral and transformative step of the study design process. Patient involvement was impactful because the online Delphi survey was successful in recruiting and retaining participants, and there were many comments about a positive participatory experience. Seven general methodological features are highlighted which fit with general principles of good patient involvement. These can benefit other Core Outcome Set developers.

Health literacy and child health outcomes: a systematic review of the literature.

PubMed

DeWalt, Darren A; Hink, Ashley

2009-11-01

To review the relationship between parent and child literacy and child health outcomes and interventions designed to improve child health outcomes for children or parents with low literacy skills. We searched Medline and the Cumulative Index to Nursing and Allied Health Literature (CINAHL) for articles published from 1980 through 2008 and included studies that reported original data, measured literacy and >or=1 health outcome, and assessed the relationship between literacy and health outcomes. Health outcomes included health knowledge, health behaviors, use of health care resources, intermediate markers of disease status, and measures of morbidity. Two abstractors reviewed each study for inclusion. Included studies were abstracted into evidence tables and were assessed by using an 11-item quality scale. We reviewed 4182 new titles and abstracts published since 2003. Fifty-eight articles were retained for full review, and 13 met the inclusion criteria. Eleven articles from the systematic review from 1980 to 2003 met the inclusion criteria, giving us a total of 24 articles. Children with low literacy generally had worse health behaviors. Parents with low literacy had less health knowledge and had behaviors that were less advantageous for their children's health compared with parents with higher literacy. Children whose parents had low literacy often had worse health outcomes, but we found mixed results for the relationship of literacy to the use of health care services. Interventions found that improving written materials can increase health knowledge, and combining good written materials with brief counseling can improve behaviors including adherence. The average quality of the studies was fair to good. Child and parent literacy seems associated with important health outcomes. Future research can help us understand under what circumstances this relationship is causal, how literacy and health outcomes are related in noncausal pathways, the relative importance of parent and child literacy, and what interventions effectively reduce health literacy-related disparities.

Association Between Arterial Hyperoxia and Outcome in Subsets of Critical Illness: A Systematic Review, Meta-Analysis, and Meta-Regression of Cohort Studies.

PubMed

Helmerhorst, Hendrik J F; Roos-Blom, Marie-José; van Westerloo, David J; de Jonge, Evert

2015-07-01

Oxygen is vital during critical illness, but hyperoxia may harm patients. Our aim was to systematically evaluate the methodology and findings of cohort studies investigating the effects of hyperoxia in critically ill adults. A meta-analysis and meta-regression analysis of cohort studies published between 2008 and 2015 was conducted. Electronic databases of MEDLINE, EMBASE, and Web of Science were systematically searched for the keywords hyperoxia and mortality or outcome. Publications assessing the effect of arterial hyperoxia on outcome in critically ill adults (≥ 18 yr) admitted to critical care units were eligible. We excluded studies in patients with chronic obstructive pulmonary disease, extracorporeal life support or hyperbaric oxygen therapy, and animal studies. Due to a lack of data, no studies dedicated to patients with acute lung injury, sepsis, shock, or multiple trauma could be included. Studies were included independent of admission diagnosis and definition of hyperoxia. The primary outcome measure was in-hospital mortality, and results were stratified for relevant subgroups (cardiac arrest, traumatic brain injury, stroke, post-cardiac surgery, and any mechanical ventilation). The effects of arterial oxygenation on functional outcome, long-term mortality, and discharge variables were studied as secondary outcomes. Twenty-four studies were included of which five studies were only for a subset of the analyses. Nineteen studies were pooled for meta-analyses and showed that arterial hyperoxia during admission increases hospital mortality: adjusted odds ratio, 1.21 (95% CI, 1.08-1.37) (p = 0.001). Functional outcome measures were diverse and generally showed a more favorable outcome for normoxia. In various subsets of critically ill patients, arterial hyperoxia was associated with poor hospital outcome. Considering the substantial heterogeneity of included studies and the lack of a clinical definition, more evidence is needed to provide optimal oxygen targets to critical care physicians.

Connective tissue disease related interstitial lung diseases and idiopathic pulmonary fibrosis: provisional core sets of domains and instruments for use in clinical trials

PubMed Central

Saketkoo, Lesley Ann; Mittoo, Shikha; Huscher, Dörte; Khanna, Dinesh; Dellaripa, Paul F; Distler, Oliver; Flaherty, Kevin R; Frankel, Sid; Oddis, Chester V; Denton, Christopher P; Fischer, Aryeh; Kowal-Bielecka, Otylia M; LeSage, Daphne; Merkel, Peter A; Phillips, Kristine; Pittrow, David; Swigris, Jeffrey; Antoniou, Katerina; Baughman, Robert P; Castelino, Flavia V; Christmann, Romy B; Christopher-Stine, Lisa; Collard, Harold R; Cottin, Vincent; Danoff, Sonye; Highland, Kristin B; Hummers, Laura; Shah, Ami A; Kim, Dong Soon; Lynch, David A; Miller, Frederick W; Proudman, Susanna M; Richeldi, Luca; Ryu, Jay H; Sandorfi, Nora; Sarver, Catherine; Wells, Athol U; Strand, Vibeke; Matteson, Eric L; Brown, Kevin K; Seibold, James R

2014-01-01

Rationale Clinical trial design in interstitial lung diseases (ILDs) has been hampered by lack of consensus on appropriate outcome measures for reliably assessing treatment response. In the setting of connective tissue diseases (CTDs), some measures of ILD disease activity and severity may be confounded by non-pulmonary comorbidities. Methods The Connective Tissue Disease associated Interstitial Lung Disease (CTD-ILD) working group of Outcome Measures in Rheumatology—a non-profit international organisation dedicated to consensus methodology in identification of outcome measures—conducted a series of investigations which included a Delphi process including >248 ILD medical experts as well as patient focus groups culminating in a nominal group panel of ILD experts and patients. The goal was to define and develop a consensus on the status of outcome measure candidates for use in randomised controlled trials in CTD-ILD and idiopathic pulmonary fibrosis (IPF). Results A core set comprising specific measures in the domains of lung physiology, lung imaging, survival, dyspnoea, cough and health-related quality of life is proposed as appropriate for consideration for use in a hypothetical 1-year multicentre clinical trial for either CTD-ILD or IPF. As many widely used instruments were found to lack full validation, an agenda for future research is proposed. Conclusion Identification of consensus preliminary domains and instruments to measure them was attained and is a major advance anticipated to facilitate multicentre RCTs in the field. PMID:24368713

Interventions for promoting reintegration and reducing harmful behaviour and lifestyles in street-connected children and young people.

PubMed

Coren, Esther; Hossain, Rosa; Pardo, Jordi Pardo; Veras, Mirella M S; Chakraborty, Kabita; Harris, Holly; Martin, Anne J

2013-07-01

Numbers of street-connected children and young people run into many millions worldwide and include children and young people who live or work in street environments. Whether or not they remain connected to their families of origin, and despite many strengths and resiliencies, they are vulnerable to a range of risks and are excluded from mainstream social structures and opportunities. To summarise the effectiveness of interventions for street-connected children and young people that promote inclusion and reintegration and reduce harms. To explore the processes of successful intervention and models of change in this area, and to understand how intervention effectiveness may vary in different contexts. We searched the following bibliographic databases, from inception to 2012, and various relevant non-governmental and organisational websites: Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE and PreMEDLINE; EMBASE and EMBASE Classic; CINAHL; PsycINFO; ERIC; Sociological Abstracts; Social Services Abstracts; Social Work Abstracts; Healthstar; LILACS; System for Grey literature in Europe (OpenGrey); ProQuest Dissertations and Theses; EconLit; IDEAS Economics and Finance Research; JOLIS Library Catalog of the holdings of the World Bank Group and IMF Libraries; BLDS (British Library for Development Studies); Google, Google Scholar. The review included data from harm reduction or reintegration promotion intervention studies that used a comparison group study design and were all randomised or quasi-randomised studies. Studies were included if they evaluated interventions aimed to benefit street-connected children and young people, aged 0 to 24 years, in all contexts. Two review authors independently extracted data and assessed the risk of bias of included studies. Data were extracted on intervention delivery, context, process factors, equity and outcomes. Outcome measures were grouped according to whether they measured psychosocial outcomes, risky sexual behaviours or substance use. A meta-analysis was conducted for some outcomes though it was not possible for all due to differences in measurements between studies. Other outcomes were evaluated narratively. We included 11 studies evaluating 12 interventions from high income countries. We did not find any sufficiently robust evaluations conducted in low and middle income countries (LMICs) despite the existence of many relevant programmes. Study quality overall was low to moderate and there was great variation in the measurement used by studies, making comparison difficult. Participants were drop-in and shelter based. We found no consistent results on a range of relevant outcomes within domains of psychosocial health, substance misuse and sexual risky behaviours despite the many measurements collected in the studies. The interventions being evaluated consisted of time limited therapeutically based programmes which did not prove more effective than standard shelter or drop-in services for most outcomes and in most studies. There were favourable changes from baseline in outcomes for most particpants in therapy interventions and also in standard services. There was considerable heterogeneity between studies and equity data were inconsistently reported. No study measured the primary outcome of reintegration or reported on adverse effects. The review discussion section included consideration of the relevance of the findings for LMIC settings. Analysis across the included studies found no consistently significant benefit for the 'new' interventions compared to standard services for street-connected children and young people. These latter interventions, however, have not been rigorously evaluated, especially in the context of LMICs. Robustly evaluating the interventions would enable better recommendations to be made for service delivery. There is a need for future research in LMICs that includes children who are on the streets due to urbanisation, war or migration and who may be vulnerable to risks such as trafficking. Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Interventions for promoting reintegration and reducing harmful behaviour and lifestyles in street-connected children and young people.

PubMed

Coren, Esther; Hossain, Rosa; Pardo Pardo, Jordi; Veras, Mirella M S; Chakraborty, Kabita; Harris, Holly; Martin, Anne J

2013-02-28

Numbers of street-connected children and young people run into many millions worldwide and include children and young people who live or work in street environments. Whether or not they remain connected to their families of origin, and despite many strengths and resiliencies, they are vulnerable to a range of risks and are excluded from mainstream social structures and opportunities. To summarise the effectiveness of interventions for street-connected children and young people that promote inclusion and reintegration and reduce harms. To explore the processes of successful intervention and models of change in this area, and to understand how intervention effectiveness may vary in different contexts.. We searched the following bibliographic databases, from inception to 2012, and various relevant non-governmental and organisational websites: Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE and PreMEDLINE; EMBASE and EMBASE Classic; CINAHL; PsycINFO; ERIC; Sociological Abstracts; Social Services Abstracts; Social Work Abstracts; Healthstar; LILACS; System for Grey literature in Europe (OpenGrey); ProQuest Dissertations and Theses; EconLit; IDEAS Economics and Finance Research; JOLIS Library Catalog of the holdings of the World Bank Group and IMF Libraries; BLDS (British Library for Development Studies); Google, Google Scholar. The review included data from harm reduction or reintegration promotion intervention studies that used a comparison group study design and were all randomised or quasi-randomised studies. Studies were included if they evaluated interventions aimed to benefit street-connected children and young people, aged 0 to 24 years, in all contexts. Two review authors independently extracted data and assessed the risk of bias of included studies. Data were extracted on intervention delivery, context, process factors, equity and outcomes. Outcome measures were grouped according to whether they measured psychosocial outcomes, risky sexual behaviours or substance use. A meta-analysis was conducted for some outcomes though it was not possible for all due to differences in measurements between studies. Other outcomes were evaluated narratively. We included 11 studies evaluating 12 interventions from high income countries. We did not find any sufficiently robust evaluations conducted in low and middle income countries (LMICs) despite the existence of many relevant programmes. Study quality overall was low to moderate and there was great variation in the measurement used by studies, making comparison difficult. Participants were drop-in and shelter based. We found no consistent results on a range of relevant outcomes within domains of psychosocial health, substance misuse and sexual risky behaviours despite the many measurements collected in the studies. The interventions being evaluated consisted of time limited therapeutically based programmes which did not prove more effective than standard shelter or drop-in services for most outcomes and in most studies. There were favourable changes from baseline in outcomes for most particpants in therapy interventions and also in standard services. There was considerable heterogeneity between studies and equity data were inconsistently reported. No study measured the primary outcome of reintegration or reported on adverse effects. The review discussion section included consideration of the relevance of the findings for LMIC settings. Analysis across the included studies found no consistently significant benefit for the 'new' interventions compared to standard services for street-connected children and young people. These latter interventions, however, have not been rigorously evaluated, especially in the context of LMICs. Robustly evaluating the interventions would enable better recommendations to be made for service delivery. There is a need for future research in LMICs that includes children who are on the streets due to urbanisation, war or migration and who may be vulnerable to risks such as trafficking.

Development of a core outcome set for effectiveness trials aimed at optimising prescribing in older adults in care homes.

PubMed

Millar, Anna N; Daffu-O'Reilly, Amrit; Hughes, Carmel M; Alldred, David P; Barton, Garry; Bond, Christine M; Desborough, James A; Myint, Phyo K; Holland, Richard; Poland, Fiona M; Wright, David

2017-04-12

Prescribing medicines for older adults in care homes is known to be sub-optimal. Whilst trials testing interventions to optimise prescribing in this setting have been published, heterogeneity in outcome reporting has hindered comparison of interventions, thus limiting evidence synthesis. The aim of this study was to develop a core outcome set (COS), a list of outcomes which should be measured and reported, as a minimum, for all effectiveness trials involving optimising prescribing in care homes. The COS was developed as part of the Care Homes Independent Pharmacist Prescribing Study (CHIPPS). A long-list of outcomes was identified through a review of published literature and stakeholder input. Outcomes were reviewed and refined prior to entering a two-round online Delphi exercise and then distributed via a web link to the CHIPPS Management Team, a multidisciplinary team including pharmacists, doctors and Patient Public Involvement representatives (amongst others), who comprised the Delphi panel. The Delphi panellists (n = 19) rated the importance of outcomes on a 9-point Likert scale from 1 (not important) to 9 (critically important). Consensus for an outcome being included in the COS was defined as ≥70% participants scoring 7-9 and <15% scoring 1-3. Exclusion was defined as ≥70% scoring 1-3 and <15% 7-9. Individual and group scores were fed back to participants alongside the second questionnaire round, which included outcomes for which no consensus had been achieved. A long-list of 63 potential outcomes was identified. Refinement of this long-list of outcomes resulted in 29 outcomes, which were included in the Delphi questionnaire (round 1). Following both rounds of the Delphi exercise, 13 outcomes (organised into seven overarching domains: medication appropriateness, adverse drug events, prescribing errors, falls, quality of life, all-cause mortality and admissions to hospital (and associated costs)) met the criteria for inclusion in the final COS. We have developed a COS for effectiveness trials aimed at optimising prescribing in older adults in care homes using robust methodology. Widespread adoption of this COS will facilitate evidence synthesis between trials. Future work should focus on evaluating appropriate tools for these key outcomes to further reduce heterogeneity in outcome measurement in this context.

Using the Patient Reported Outcomes Measurement Information System to Evaluate Psychosocial Functioning among Children with Craniofacial Anomalies.

PubMed

Shapiro, Danielle N; Waljee, Jennifer; Ranganathan, Kavitha; Buchman, Steven; Warschausky, Seth

2015-06-01

Children with craniofacial anomalies are at risk for social exclusion, bullying, and psychological symptoms, all of which are associated with poor developmental and health outcomes. The National Institutes of Health-developed Patient Reported Outcomes Measurement Information System instruments may be useful tools for monitoring psychosocial functioning in clinical settings and for integrating patient and parent perspectives. The current study included 74 children (50 percent male) with craniofacial anomalies recruited through a multidisciplinary clinic. The authors obtained child self-report and parent-proxy ratings of depression, anxiety, and peer relationship quality using National Institutes of Health Patient Reported Outcomes Measurement Information System instruments. The authors compared sample means to Patient Reported Outcomes Measurement Information System instruments norms and analyzed the reliability of parents' and children's reporting of psychosocial variables. All reliability statistics were satisfactory (α values ranging from 0.74 to 0.96) and sample standard deviations were similar to those obtained in a general population, suggesting that Patient Reported Outcomes Measurement Information System instruments are reliable among children with craniofacial anomalies. In general, children and parents did not report unusual levels of psychological distress; however, they did report poorer peer relationship quality relative to normed data, a trend that was particularly pronounced among boys. National Institutes of Health Patient Reported Outcomes Measurement Information System instruments are efficient and accurate tools for monitoring psychosocial adjustment among children with craniofacial anomalies. It may be especially important to monitor social functioning, particularly among boys.

Quality Markers in Cardiology. Main Markers to Measure Quality of Results (Outcomes) and Quality Measures Related to Better Results in Clinical Practice (Performance Metrics). INCARDIO (Indicadores de Calidad en Unidades Asistenciales del Área del Corazón): A SEC/SECTCV Consensus Position Paper.

PubMed

López-Sendón, José; González-Juanatey, José Ramón; Pinto, Fausto; Cuenca Castillo, José; Badimón, Lina; Dalmau, Regina; González Torrecilla, Esteban; López-Mínguez, José Ramón; Maceira, Alicia M; Pascual-Figal, Domingo; Pomar Moya-Prats, José Luis; Sionis, Alessandro; Zamorano, José Luis

2015-11-01

Cardiology practice requires complex organization that impacts overall outcomes and may differ substantially among hospitals and communities. The aim of this consensus document is to define quality markers in cardiology, including markers to measure the quality of results (outcomes metrics) and quality measures related to better results in clinical practice (performance metrics). The document is mainly intended for the Spanish health care system and may serve as a basis for similar documents in other countries. Copyright © 2015 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

Predictive performance of four frailty measures in an older Australian population

PubMed Central

Widagdo, Imaina S.; Pratt, Nicole; Russell, Mary; Roughead, Elizabeth E.

2015-01-01

Background: there are several different frailty measures available for identifying the frail elderly. However, their predictive performance in an Australian population has not been examined. Objective: to examine the predictive performance of four internationally validated frailty measures in an older Australian population. Methods: a retrospective study in the Australian Longitudinal Study of Ageing (ALSA) with 2,087 participants. Frailty was measured at baseline using frailty phenotype (FP), simplified frailty phenotype (SFP), frailty index (FI) and prognostic frailty score (PFS). Odds ratios (OR) were calculated to measure the association between frailty and outcomes at Wave 3 including mortality, hospitalisation, nursing home admission, fall and a combination of all outcomes. Predictive performance was measured by assessing sensitivity, specificity, positive and negative predictive values (PPV and NPV) and likelihood ratio (LR). Area under the curve (AUC) of dichotomised and the multilevel or continuous model of the measures was examined. Results: prevalence of frailty varied from 2% up to 49% between the measures. Frailty was significantly associated with an increased risk of any outcome, OR (95% confidence interval) for FP: 1.9 (1.4–2.8), SFP: 3.6 (1.5–8.8), FI: 3.4 (2.7–4.3) and PFS: 2.3 (1.8–2.8). PFS had high sensitivity across all outcomes (sensitivity: 55.2–77.1%). The PPV for any outcome was highest for SFP and FI (70.8 and 69.7%, respectively). Only FI had acceptable accuracy in predicting outcomes, AUC: 0.59–0.70. Conclusions: being identified as frail by any of the four measures was associated with an increased risk of outcomes; however, their predictive accuracy varied. PMID:26504118

Stroke outcomes measures must be appropriately risk adjusted to ensure quality care of patients: a presidential advisory from the American Heart Association/American Stroke Association.

PubMed

Fonarow, Gregg C; Alberts, Mark J; Broderick, Joseph P; Jauch, Edward C; Kleindorfer, Dawn O; Saver, Jeffrey L; Solis, Penelope; Suter, Robert; Schwamm, Lee H

2014-05-01

Because stroke is among the leading causes of death, disability, hospitalizations, and healthcare expenditures in the United States, there is interest in reporting outcomes for patients hospitalized with acute ischemic stroke. The American Heart Association/American Stroke Association, as part of its commitment to promote high-quality, evidence-based care for cardiovascular and stroke patients, fully supports the development of properly risk-adjusted outcome measures for stroke. To accurately assess and report hospital-level outcomes, adequate risk adjustment for case mix is essential. During the development of the Centers for Medicare & Medicaid Services 30-day stroke mortality and 30-day stroke readmission measures, concerns were expressed that these measures were not adequately designed because they do not include a valid initial stroke severity measure, such as the National Institutes of Health Stroke Scale. These outcome measures, as currently constructed, may be prone to mischaracterizing the quality of stroke care being delivered by hospitals and may ultimately harm acute ischemic stroke patients. This article details (1) why the Centers for Medicare & Medicaid Services acute ischemic stroke outcome measures in their present form may not provide adequate risk adjustment, (2) why the measures as currently designed may lead to inaccurate representation of hospital performance and have the potential for serious unintended consequences, (3) what activities the American Heart Association/American Stroke Association has engaged in to highlight these concerns to the Centers for Medicare & Medicaid Services and other interested parties, and (4) alternative approaches and opportunities that should be considered for more accurately risk-adjusting 30-day outcomes measures in patients with ischemic stroke.

Comparison of the clinical and functional outcomes following 3- and 4-corner fusions.

PubMed

Singh, Harvinder P; Dias, Joseph J; Phadnis, Joideep; Bain, Gregory

2015-06-01

To explore the clinical and functional outcomes of 3-corner fusion (3CF) for stage 2 and 3 scapholunate advanced collapse and scaphoid nonunion advanced collapse. We compared the results with 4-corner fusion (4CF) using a recent published report. Twelve patients (8 men and 4 women) who had a 3CF, mean age 60 years (range, 34-75 y) were reviewed in clinic more than 1 year after surgery. Subjective outcome measures included the Michigan Hand Questionnaire and Patient Evaluation Measure. Objective outcome measures included range of motion with a flexible electrogoniometer and grip strength measured with a digital dynamometer. The results were compared using a recent report of 24 patients (17 men and 7 women) with a 4CF, mean age 55 years (range, 34-68 y) assessed with similar techniques. The patients receiving 3CF had better subjective scores with the Michigan Hand Questionnaire, including the sub-scores for activities of daily living and satisfaction. The radioulnar arc was greater after the 3CF than after the 4CF. Circumduction of the 3CF was more like a normal wrist than the 4CF. This included having faster and smoother motion, with an axis of circumduction closer to the normal wrist. Peak grip strength was similar after either a 3CF or 4CF but grip strength in the 3CF was 82% of the contralateral wrist compared with 59% for the 4CF. The 3CF provided better patient-rated scores and the arc of wrist motion was more extended, with greater ulnar deviation. Motion was smoother and more closely replicated the normal axis and functional motion of the wrist. Therapeutic III. Copyright © 2015 American Society for Surgery of the Hand. Published by Elsevier Inc. All rights reserved.

Association between executive function and outcome measure of treatment in therapeutic community among cocaine dependent individuals.

PubMed

Vergara-Moragues, Esperanza; Verdejo-García, Antonio; Lozano, Oscar M; Santiago-Ramajo, Sandra; González-Saiz, Francisco; Betanzos Espinosa, Patricia; Pérez García, Miguel

2017-07-01

The aim of this study was to examine the association between baseline executive functioning and outcome measure of treatment in 226 cocaine dependent individuals who initiated treatment in therapeutic communities TCs. The study was conducted across six TCs located in the region of Andalusia (southern Spain). Neuropsychological testing included tests of working memory, reasoning, inhibition, switching, attention interference and decision making. The outcome measures were type of discharge (treatment dropout vs. therapeutic discharge) and clinical impression of the TC outcome (clinically significant vs. non-significant changes). In the present study a prospective comparative design was used. We found significant performance differences on selective executive components which account for the type of discharge: treatment quitters had poorer attention response inhibition and attention switching than non-quitters, and the individuals who failed to achieve therapeutic objectives had poorer attention interference and inhibitory control than compliers. No significant differences were found between the outcome measure and the neuropsychological performance score on the other tasks. The results provide important information about the impact of executive components on in-treatment follow-up outcomes among dependence disorders in TC. Copyright © 2017 Elsevier Inc. All rights reserved.

Implementation of learning outcome attainment measurement system in aviation engineering higher education

NASA Astrophysics Data System (ADS)

Salleh, I. Mohd; Mat Rani, M.

2017-12-01

This paper aims to discuss the effectiveness of the Learning Outcome Attainment Measurement System in assisting Outcome Based Education (OBE) for Aviation Engineering Higher Education in Malaysia. Direct assessments are discussed to show the implementation processes that become a key role in the successful outcome measurement system. A case study presented in this paper involves investigation on the implementation of the system in Aircraft Structure course for Bachelor in Aircraft Engineering Technology program in UniKL-MIAT. The data has been collected for five semesters, starting from July 2014 until July 2016. The study instruments used include the report generated in Learning Outcomes Measurements System (LOAMS) that contains information on the course learning outcomes (CLO) individual and course average performance reports. The report derived from LOAMS is analyzed and the data analysis has revealed that there is a positive significant correlation between the individual performance and the average performance reports. The results for analysis of variance has further revealed that there is a significant difference in OBE grade score among the report. Independent samples F-test results, on the other hand, indicate that the variances of the two populations are unequal.

Incorporating the patient experience into regulatory decision making in the USA, Europe, and Canada.

PubMed

Kluetz, Paul G; O'Connor, Daniel J; Soltys, Katherine

2018-05-01

The clinical development of cancer therapeutics is a global undertaking, and incorporation of the patient experience into the clinical decision-making process is of increasing interest to the international regulatory and health policy community. Disease and treatment-related symptoms and their effect on patient function and health-related quality of life are important outcomes to consider. The identification of methods to scientifically assess, analyse, interpret, and present these clinical outcomes requires sustained international collaboration by multiple stakeholders including patients, clinicians, scientists, and policy makers. Several data sources can be considered to capture the patient experience, including patient-reported outcome (PRO) measures, performance measures, wearable devices, and biosensors, as well as the careful collection and analysis of clinical events and supportive care medications. In this Policy Review, we focus on PRO measures and present the perspectives of three international regulatory scientists to identify areas of common ground regarding opportunities to incorporate rigorous PRO data into the regulatory decision-making process. Copyright © 2018 Elsevier Ltd. All rights reserved.

Early functional MRI activation predicts motor outcome after ischemic stroke: a longitudinal, multimodal study.

PubMed

Du, Juan; Yang, Fang; Zhang, Zhiqiang; Hu, Jingze; Xu, Qiang; Hu, Jianping; Zeng, Fanyong; Lu, Guangming; Liu, Xinfeng

2018-05-15

An accurate prediction of long term outcome after stroke is urgently required to provide early individualized neurorehabilitation. This study aimed to examine the added value of early neuroimaging measures and identify the best approaches for predicting motor outcome after stroke. This prospective study involved 34 first-ever ischemic stroke patients (time since stroke: 1-14 days) with upper limb impairment. All patients underwent baseline multimodal assessments that included clinical (age, motor impairment), neurophysiological (motor-evoked potentials, MEP) and neuroimaging (diffusion tensor imaging and motor task-based fMRI) measures, and also underwent reassessment 3 months after stroke. Bivariate analysis and multivariate linear regression models were used to predict the motor scores (Fugl-Meyer assessment, FMA) at 3 months post-stroke. With bivariate analysis, better motor outcome significantly correlated with (1) less initial motor impairment and disability, (2) less corticospinal tract injury, (3) the initial presence of MEPs, (4) stronger baseline motor fMRI activations. In multivariate analysis, incorporating neuroimaging data improved the predictive accuracy relative to only clinical and neurophysiological assessments. Baseline fMRI activation in SMA was an independent predictor of motor outcome after stroke. A multimodal model incorporating fMRI and clinical measures best predicted the motor outcome following stroke. fMRI measures obtained early after stroke provided independent prediction of long-term motor outcome.

Teacher, parent, and peer reports of early aggression as screening measures for long-term maladaptive outcomes: who provides the most useful information?

PubMed

Clemans, Katherine H; Musci, Rashelle J; Leoutsakos, Jeannie-Marie S; Ialongo, Nicholas S

2014-04-01

This study compared the ability of teacher, parent, and peer reports of aggressive behavior in early childhood to accurately classify cases of maladaptive outcomes in late adolescence and early adulthood. Weighted kappa analyses determined optimal cut points and relative classification accuracy among teacher, parent, and peer reports of aggression assessed for 691 students (54% male; 84% African American and 13% White) in the fall of first grade. Outcomes included antisocial personality, substance use, incarceration history, risky sexual behavior, and failure to graduate from high school on time. Peer reports were the most accurate classifier of all outcomes in the full sample. For most outcomes, the addition of teacher or parent reports did not improve overall classification accuracy once peer reports were accounted for. Additional gender-specific and adjusted kappa analyses supported the superior classification utility of the peer report measure. The results suggest that peer reports provided the most useful classification information of the 3 aggression measures. Implications for targeted intervention efforts in which screening measures are used to identify at-risk children are discussed.

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 studies reported 1 PROM in isolation. A pediatric-specific PROM was reported in 1 of the 17 studies. Conclusion: Studies on pediatric ACL reconstruction published in high-impact journals unreliably defined subjects’ skeletal maturity, inconsistently reported on objective outcome measures, and used disparate adult-validated PROMs to assess subjective outcomes. These findings highlight the need for standardized, pediatric-specific outcome measures to be applied in future studies evaluating ACL reconstruction in children and adolescents. PMID:28840156

75 FR 61144 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-04

... design includes both client-level outcomes and process evaluation components. The purpose of the outcome... assessment). Child Data Collection Tool (all children; descriptive biopsychosocial measure). Children's...--Detailed Annual Burden for All Interviews & Surveys Number of Interviews and surveys Respondent respondents...

A Systematic Review of Outcome Measurements and Quality of Studies Evaluating Fixed Tooth-Supported Restorations

PubMed Central

Patel, Devangkumar Rajnikant; O'Brien, Tim; Petrie, Aviva; Petridis, Haralampos

2014-01-01

Purpose The purpose of this systematic review was to review clinical studies of fixed tooth-supported prostheses, and to assess the quality of evidence with an emphasis on the assessment of the reporting of outcome measurements. Multiple hypotheses were generated to compare the effect of study type on different outcome modifiers and to compare the quality of publications before and after January 2005. Materials and Methods An electronic search was conducted using specific databases (MEDLINE via Ovid, EMBASE via Ovid, Cochrane Library) through July 2012. This was complemented by hand searching the past 10 years of issues of the Journal of Oral Rehabilitation, Journal of Prosthetic Dentistry, Journal of Prosthodontics, and the International Journal of Prosthodontics. All experimental and observational clinical studies evaluating survival, success, failure, and complications of tooth-supported extracoronal fixed partial dentures, crowns, and onlays were included. No restrictions on age or follow-up time were placed. Results The electronic search generated 14,869 papers, of which 206 papers were included for full-text review. Hand-searching added 23 papers. Inclusion criteria were met by 182 papers and were included for the review. The majority were retrospective studies. Only 8 (4.4%) were randomized controlled trials. The majority of the studies measured survival and failure, and few studies recorded data on success; however, more than 60% of the studies failed to define survival, success, and failure. Many studies did not use any standardized criteria for assessment of the quality of the restorations and, when standardized criteria were used, they were modified, thereby not allowing for comparisons with other studies. There was an increase of 21.8% in the number of studies evaluating outcome measurements of all-ceramic restorations in past 8 years. Conclusions Prosthodontic literature presents with a reduced percentage of RCTs compared to other disciplines in dentistry. The overall quality of recording prosthodontic outcome measurements has not improved greatly in the past 8 years. PMID:24947268

The CONSENSUS study: protocol for a mixed methods study to establish which outcomes should be included in a core outcome set for oropharyngeal cancer.

PubMed

Waters, Aoife Mi; Tudur Smith, Catrin; Young, Bridget; Jones, Terry M

2014-05-13

The incidence of oropharyngeal cancer is increasing in the developed world. This has led to a large rise in research activity and clinical trials in this area, yet there is no consensus on which outcomes should be measured. As a result, the outcomes measured often differ between trials of comparable interventions, making the combination or comparison of results between trials impossible. Outcomes may also be 'cherry-picked', such that favourable results are reported, and less favourable results withheld. The development of a minimum outcome reporting standard, known as a core outcome set, goes some way to addressing these problems. Core outcome sets are ideally developed using a patient-centred approach so that the outcomes measured are relevant to patients and clinical practice. Core outcome sets drive up the quality and relevance of research by ensuring that the right outcomes are consistently measured and reported in trials in specific areas of health or healthcare. This is a mixed methods study involving three phases to develop a core outcome set for oropharyngeal cancer clinical trials. Firstly, a systematic review will establish which outcomes are measured in published oropharyngeal cancer randomised controlled trials (RCTs). Secondly, qualitative interviews with patients and carers in the UK and the USA will aim to establish which outcomes are important to these stakeholders. Data from these first two stages will be used to develop a comprehensive list of outcomes to be considered for inclusion in the core outcome set. In the third stage, patients and clinicians will participate in an iterative consensus exercise known as a Delphi study to refine the contents of the core outcome set. This protocol lays out the methodology to be implemented in the CONSENSUS study. A core outcome set defines a minimum outcome reporting standard for clinical trials in a particular area of health or healthcare. Its consistent implementation in oropharyngeal cancer clinical trials will improve the quality and relevance of research. This study is registered at the National Institute for Health Research (NIHR) Clinical Research Network (CRN) portfolio, ID 13823 (17 January 2013).

The CONSENSUS study: protocol for a mixed methods study to establish which outcomes should be included in a core outcome set for oropharyngeal cancer

PubMed Central

2014-01-01

Background The incidence of oropharyngeal cancer is increasing in the developed world. This has led to a large rise in research activity and clinical trials in this area, yet there is no consensus on which outcomes should be measured. As a result, the outcomes measured often differ between trials of comparable interventions, making the combination or comparison of results between trials impossible. Outcomes may also be ‘cherry-picked’, such that favourable results are reported, and less favourable results withheld. The development of a minimum outcome reporting standard, known as a core outcome set, goes some way to addressing these problems. Core outcome sets are ideally developed using a patient-centred approach so that the outcomes measured are relevant to patients and clinical practice. Core outcome sets drive up the quality and relevance of research by ensuring that the right outcomes are consistently measured and reported in trials in specific areas of health or healthcare. Methods/Design This is a mixed methods study involving three phases to develop a core outcome set for oropharyngeal cancer clinical trials. Firstly, a systematic review will establish which outcomes are measured in published oropharyngeal cancer randomised controlled trials (RCTs). Secondly, qualitative interviews with patients and carers in the UK and the USA will aim to establish which outcomes are important to these stakeholders. Data from these first two stages will be used to develop a comprehensive list of outcomes to be considered for inclusion in the core outcome set. In the third stage, patients and clinicians will participate in an iterative consensus exercise known as a Delphi study to refine the contents of the core outcome set. This protocol lays out the methodology to be implemented in the CONSENSUS study. Discussion A core outcome set defines a minimum outcome reporting standard for clinical trials in a particular area of health or healthcare. Its consistent implementation in oropharyngeal cancer clinical trials will improve the quality and relevance of research. Trials and registration This study is registered at the National Institute for Health Research (NIHR) Clinical Research Network (CRN) portfolio, ID 13823 (17 January 2013). PMID:24885068

Outcome measures in older persons with acquired joint contractures: a systematic review and content analysis using the ICF (International Classification of Functioning, Disability and Health) as a reference.

PubMed

Bartoszek, Gabriele; Fischer, Uli; Müller, Martin; Strobl, Ralf; Grill, Eva; Nadolny, Stephan; Meyer, Gabriele

2016-02-09

Joint contractures are a common health problem in older persons with significant impact on activities of daily living. We aimed to retrieve outcome measures applied in studies on older persons with joint contractures and to identify and categorise the concepts contained in these outcome measures using the ICF (International Classification of Functioning, Disability and Health) as a reference. Electronic searches of Medline, EMBASE, CINAHL, Pedro and the Cochrane Library were conducted (1/2002-8/2012). We included studies in the geriatric rehabilitation and nursing home settings with participants aged ≥ 65 years and with acquired joint contractures. Two independent reviewers extracted the outcome measures and transferred them to concepts using predefined conceptual frameworks. Concepts were subsequently linked to the ICF categories. From the 1057 abstracts retrieved, 60 studies met the inclusion criteria. We identified 52 single outcome measures and 24 standardised assessment instruments. A total of 1353 concepts were revealed from the outcome measures; 96.2% could be linked to 50 ICF categories in the 2nd level; 3.8% were not categorised. Fourteen of the 50 categories (28%) belonged to the component Body Functions, 4 (8%) to the component Body Structures, 26 (52%) to the component Activities and Participation, and 6 (12%) to the component Environmental Factors. The ICF is a valuable reference for identifying and quantifying the concepts of outcome measures on joint contractures in older people. The revealed ICF categories remain to be validated in populations with joint contractures in terms of clinical relevance and personal impact.

Impact of cooking and home food preparation interventions among adults: outcomes and implications for future programs

PubMed Central

Reicks, Marla; Trofholz, Amanda C.; Stang, Jamie S; Laska, Melissa N.

2014-01-01

Objective Cooking programs are growing in popularity; however an extensive review has not examined overall impact. Therefore, this study reviewed previous research on cooking/home food preparation interventions and diet and health-related outcomes among adults and identified implications for practice and research. Design Literature review and descriptive summative method. Main outcome measures Dietary intake, knowledge/skills, cooking attitudes and self-efficacy/confidence, health outcomes. Analysis Articles evaluating effectiveness of interventions that included cooking/home food preparation as the primary aim (January 1980 through December 2011) were identified via OVID MEDLINE, Agricola and Web of Science databases. Studies grouped according to design and outcomes were reviewed for validity using an established coding system. Results were summarized for several outcome categories. Results Of 28 studies identified, 12 included a control group with six as non-randomized and six as randomized controlled trials. Evaluation was done post-intervention for five studies, pre- and post-intervention for 23 and beyond post-intervention for 15. Qualitative and quantitative measures suggested a positive influence on main outcomes. However, non-rigorous study designs, varying study populations, and use of non-validated assessment tools limited stronger conclusions. Conclusions and Implications Well-designed studies are needed that rigorously evaluate long-term impact on cooking behavior, dietary intake, obesity and other health outcomes. PMID:24703245

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.

Systematic review of the properties of tools used to measure outcomes in anxiety intervention studies for children with autism spectrum disorders.

PubMed

Wigham, Sarah; McConachie, Helen

2014-01-01

Evidence about relevant outcomes is required in the evaluation of clinical interventions for children with autism spectrum disorders (ASD). However, to date, the variety of outcome measurement tools being used, and lack of knowledge about the measurement properties of some, compromise conclusions regarding the most effective interventions. This two-stage systematic review aimed to identify the tools used in studies evaluating interventions for anxiety for high-functioning children with ASD in middle childhood, and then to evaluate the tools for their appropriateness and measurement properties. Electronic databases including Medline, PsychInfo, Embase, and the Cochrane database and registers were searched for anxiety intervention studies for children with ASD in middle childhood. Articles examining the measurement properties of the tools used were then searched for using a methodological filter in PubMed, and the quality of the papers evaluated using the COSMIN checklist. Ten intervention studies were identified in which six tools measuring anxiety and one of overall symptom change were used as primary outcomes. One further tool was included as it is recommended for standard use in UK children's mental health services. Sixty three articles on the properties of the tools were evaluated for the quality of evidence, and the quality of the measurement properties of each tool was summarised. Overall three questionnaires were found robust in their measurement properties, the Spence Children's Anxiety Scale, its revised version - the Revised Children's Anxiety and Depression Scale, and also the Screen for Child Anxiety Related Emotional Disorders. Crucially the articles on measurement properties provided almost no evidence on responsiveness to change, nor on the validity of use of the tools for evaluation of interventions for children with ASD. CRD42012002684.

Systematic Review of the Properties of Tools Used to Measure Outcomes in Anxiety Intervention Studies for Children with Autism Spectrum Disorders

PubMed Central

Wigham, Sarah; McConachie, Helen

2014-01-01

Background Evidence about relevant outcomes is required in the evaluation of clinical interventions for children with autism spectrum disorders (ASD). However, to date, the variety of outcome measurement tools being used, and lack of knowledge about the measurement properties of some, compromise conclusions regarding the most effective interventions. Objectives This two-stage systematic review aimed to identify the tools used in studies evaluating interventions for anxiety for high-functioning children with ASD in middle childhood, and then to evaluate the tools for their appropriateness and measurement properties. Methods Electronic databases including Medline, PsychInfo, Embase, and the Cochrane database and registers were searched for anxiety intervention studies for children with ASD in middle childhood. Articles examining the measurement properties of the tools used were then searched for using a methodological filter in PubMed, and the quality of the papers evaluated using the COSMIN checklist. Results Ten intervention studies were identified in which six tools measuring anxiety and one of overall symptom change were used as primary outcomes. One further tool was included as it is recommended for standard use in UK children's mental health services. Sixty three articles on the properties of the tools were evaluated for the quality of evidence, and the quality of the measurement properties of each tool was summarised. Conclusions Overall three questionnaires were found robust in their measurement properties, the Spence Children's Anxiety Scale, its revised version – the Revised Children's Anxiety and Depression Scale, and also the Screen for Child Anxiety Related Emotional Disorders. Crucially the articles on measurement properties provided almost no evidence on responsiveness to change, nor on the validity of use of the tools for evaluation of interventions for children with ASD. PROSPERO Registration number CRD42012002684. PMID:24465519

Entertainment-education radio serial drama and outcomes related to HIV testing in Botswana.

PubMed

Pappas-DeLuca, Katina A; Kraft, Joan Marie; Galavotti, Christine; Warner, Lee; Mooki, Maungo; Hastings, Phil; Koppenhaver, Todd; Roels, Thierry H; Kilmarx, Peter H

2008-12-01

Makgabaneng is an entertainment-education radio serial drama written and produced in Botswana to promote prevention of HIV. This effort is part of the national response to HIV/AIDS. Broadcast of the serial drama began in August 2001, and two new 15-minute episodes air each week. We examined associations between exposure to Makgabaneng and outcomes related to HIV testing, including stigmatizing attitudes, intention to be tested, talking with a partner about testing, and testing for HIV, among 555 sexually active respondents. The four measures of exposure to Makgabaneng were frequency of listening, duration of listening, talking about the program, and attentiveness to and identification with relevant characters. Data were collected approximately 18 months after the drama began airing. We found positive associations between exposure to the program and intermediate outcomes, including lower level of stigmatizing attitudes, stronger intention to have HIV testing, and talking to a partner about testing. Although associations were identified with all four measures of exposure, increased duration of listening was associated with more positive outcomes than the other measures. This finding suggests that longer term exposure to entertainment-education programming may be important for behavior change.

Value Based Care and Patient-Centered Care: Divergent or Complementary?

PubMed

Tseng, Eric K; Hicks, Lisa K

2016-08-01

Two distinct but overlapping care philosophies have emerged in cancer care: patient-centered care (PCC) and value-based care (VBC). Value in healthcare has been defined as the quality of care (measured typically by healthcare outcomes) modified by cost. In this conception of value, patient-centeredness is one important but not necessarily dominant quality measure. In contrast, PCC includes multiple domains of patient-centeredness and places the patient and family central to all decisions and evaluations of quality. The alignment of PCC and VBC is complicated by several tensions, including a relative lack of patient experience and preference measures, and conceptions of cost that are payer-focused instead of patient-focused. Several strategies may help to align these two philosophies, including the use of patient-reported outcomes in clinical trials and value determinations, and the purposeful integration of patient preference in clinical decisions and guidelines. Innovative models of care, including accountable care organizations and oncology patient-centered medical homes, may also facilitate alignment through improved care coordination and quality-based payment incentives. Ultimately, VBC and PCC will only be aligned if patient-centered outcomes, perspectives, and preferences are explicitly incorporated into the definitions and metrics of quality, cost, and value that will increasingly influence the delivery of cancer care.

Contemporary considerations in concurrent endoscopic sinus surgery and rhinoplasty.

PubMed

Steele, Toby O; Gill, Amarbir; Tollefson, Travis T

2018-06-11

Characterize indications, perioperative considerations, clinical outcomes and complications for concurrent endoscopic sinus surgery (ESS) and rhinoplasty. Chronic rhinosinusitis and septal deviation with or without inferior turbinate hypertrophy independently impair patient-reported quality of life. Guidelines implore surgeons to include endoscopy to accurately evaluate patient symptoms. Complication rates parallel those of either surgery (ESS and rhinoplasty) alone and are not increased when performed concurrently. Operative time is generally longer for joint surgeries. Patient satisfaction rates are high. Concurrent functional and/or cosmetic rhinoplasty and ESS is a safe endeavor to perform in a single operative setting and most outcomes data suggest excellent patient outcomes. Additional studies that include patient-reported outcome measures are needed.

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.

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.

Healthy urban environments for children and young people: A systematic review of intervention studies.

PubMed

Audrey, Suzanne; Batista-Ferrer, Harriet

2015-11-01

This systematic review collates, and presents as a narrative synthesis, evidence from interventions which included changes to the urban environment and reported at least one health behaviour or outcome for children and young people. Following a comprehensive search of six databases, 33 primary studies relating to 27 urban environment interventions were included. The majority of interventions related to active travel. Others included park and playground renovations, road traffic safety, and multi-component community-based initiatives. Public health evidence for effectiveness of such interventions is often weak because study designs tend to be opportunistic, non-randomised, use subjective outcome measures, and do not incorporate follow-up of study participants. However, there is some evidence of potential health benefits to children and young people from urban environment interventions relating to road safety and active travel, with evidence of promise for a multi-component obesity prevention initiative. Future research requires more robust study designs incorporating objective outcome measures. Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

Modeling and Predicting Hearing Aid Outcome

PubMed Central

Humes, Larry E.

2003-01-01

Following a brief tutorial on the application of factor analysis to hearing aid outcome measures, three studies of hearing aid outcome measures in elderly adults are presented and analyzed. Two of the studies were completed at Indiana University (IU-1 and IU-2), and one was a collaborative multisite study by the Veterans Administration and the National Institute of Deafness and other Communication Disorders (NIDCD/VA). IU-1 measured hearing aid outcome in 173 elderly wearers of single-channel, linear, in-the-ear hearing aids with output-limiting compression, whereas IU-2 obtained the same extensive set of outcome measures from 53 elderly wearers of two-channel, wide-dynamic-range compression, in-the-canal hearing aids. In the NIDCD/VA study, 333 to 338 participants wore three single-channel circuits in succession, with each circuit housed within an in-the-ear shell. The three circuits included in that study and in this analysis were: (1) linear with peak clipping, (2) linear with output-limiting compression, and (3) single-channel, wide-dynamic-range compression. Evaluation of the many outcome measures completed in each study using principal components factor analysis revealed that from three (both IU studies) to five (NIDCD/VA study) principal components captured the individual differences in hearing aid outcome. This was independent of hearing aid type (in-the-ear or in-the-canal) and circuitry. Subsequent multiple regression analyses of individual differences in performance along each dimension of hearing aid outcome revealed that these individual differences could be accounted for reasonably well by various prefit variables for some dimensions of outcome, but not others. In general, measures of speech recognition performance were well accounted for by prefit measures, with the best predictors being hearing loss, cognitive performance, and age. Measures of hearing aid usage were less well accounted for by prefit measures, with the most accurate predictor of current hearing aid use being prior hearing aid use. The outcome dimension accounted for most poorly was that associated with hearing aid satisfaction, with subjective measures of aided sound quality being the best predictor of performance along this dimension of hearing aid outcome. Additional multicenter, large-scale studies are needed to develop more complete models of hearing aid outcome and to identify the variables that influence various aspects of hearing aid outcome. It is only through this additional research that it will be possible to optimize outcome for hearing aid wearers. PMID:15004647

Bullying involvement, teacher-student relationships, and psychosocial outcomes.

PubMed

Huang, Francis L; Lewis, Crystal; Cohen, Daniel R; Prewett, Sara; Herman, Keith

2018-06-01

Students involved in bullying experience mental health issues and negative psychosocial outcomes. Few studies have investigated how teacher-student relationships (TSRs) may buffer the negative outcomes experienced by students involved in bullying. To investigate the moderating role of TSRs with bullying involvement status and psychosocial outcomes, we used data from 691 middle school students, 85 teachers, and 6 schools in one urban district. We used both student- and teacher-reported outcomes and regression models included baseline measures (i.e., depression, concentration problems, emotional regulation problems, behavioral engagement) taken 8 months earlier. Regardless of bullying involvement, student-reported TSR had a beneficial association for all outcomes controlling for baseline measures and student demographic variables. However, bully/victims with low TSRs experienced a heightened risk for depressive symptoms suggesting increased attention to this subgroup of students. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

Writing objectives and evaluating learning in the affective domain.

PubMed

Maier-Lorentz, M M

1999-01-01

Staff educators recognize the importance of affective competency for effective nursing practice. Inservice programs must include affective learning with objectives stated in measurable terms. Staff educators often express frustration in developing affective objectives and evaluating the learning outcome because attitudes and feelings are usually inferred from observations. This article presents affective learning objectives for a gerontological nursing inservice program and a rating scale that measures attitudes to evaluate the learning outcome.

Nephrologists’ Perspectives on Defining and Applying Patient-Centered Outcomes in Hemodialysis

PubMed Central

Winkelmayer, Wolfgang C.; Wheeler, David C.; van Biesen, Wim; Tugwell, Peter; Manns, Braden; Hemmelgarn, Brenda; Harris, Tess; Crowe, Sally; Ju, Angela; O’Lone, Emma; Evangelidis, Nicole; Craig, Jonathan C.

2017-01-01

Background and objectives Patient centeredness is widely advocated as a cornerstone of health care, but it is yet to be fully realized, including in nephrology. Our study aims to describe nephrologists’ perspectives on defining and implementing patient-centered outcomes in hemodialysis. Design, setting, participants, & measurements Face-to-face, semistructured interviews were conducted with 58 nephrologists from 27 dialysis units across nine countries, including the United States, the United Kingdom, Australia, Austria, Belgium, Canada, Germany, Singapore, and New Zealand. Transcripts were thematically analyzed. Results We identified five themes on defining and implementing patient-centered outcomes in hemodialysis: explicitly prioritized by patients (articulated preferences and goals, ascertaining treatment burden, defining hemodialysis success, distinguishing a physician-patient dichotomy, and supporting shared decision making), optimizing wellbeing (respecting patient choice, focusing on symptomology, perceptible and tangible, and judging relevance and consequence), comprehending extensive heterogeneity of clinical and quality of life outcomes (distilling diverse priorities, highly individualized, attempting to specify outcomes, and broadening context), clinically hamstrung (professional deficiency, uncertainty and complexity in measurement, beyond medical purview, specificity of care, mechanistic mindset [focused on biochemical targets and comorbidities], avoiding alarm, and paradoxical dilemma), and undermined by system pressures (adhering to overarching policies, misalignment with mandates, and resource constraints). Conclusions Improving patient-centered outcomes is regarded by nephrologists to encompass strategies that address patient goals and improve wellbeing and treatment burden in patients on hemodialysis. However, efforts are hampered by ambiguities about how to prioritize, measure, and manage the plethora of critical comorbidities and broader quality of life outcomes in a care setting that is technically demanding and driven by biochemical targets. Identifying critical patient–important outcomes and mechanisms for integrating them into practice may help to deliver patient-centered care in hemodialysis and other chronic disease settings. PMID:28223290

Characteristics and temporal trends in patient registries: focus on the life sciences industry, 1981–2012

PubMed Central

Travers, Karin; Sallum, Rachel H; Burns, Meghan D; Barr, Charles E; Beattie, Mary S; Pashos, Chris L; Luce, Bryan R

2015-01-01

Purpose Patient registries are used to monitor safety, examine real-world effectiveness, and may potentially contribute to comparative effectiveness research. To our knowledge, life sciences industry (LSI)-sponsored registries have not been systematically categorized. This study represents a first step toward understanding such registries over time. Methods Studies described as registries were identified in the ClinicalTrials.gov database. Characteristics from these registry records were abstracted and analyzed. Results Of 1202 registries identified, approximately 47% reported LSI sponsorship. These 562 LSI registries varied in focus: medical devices (n = 193, 34%), specific drugs (n = 173, 31%), procedures (n = 29, 5%), or particular diseases (n = 139, 25%). Thirty-three registries (<6%) evaluated pregnancy outcomes. The most common therapeutic area was cardiovascular (n = 234, 42%); others included endocrinology, immunology, oncology, musculoskeletal disorders, and neurology. The two most often measured outcomes were clinical effectiveness and safety, each of which appeared in 363/562 (65%) of LSI registries. Other outcomes included real-world clinical practice patterns (n = 122, 22%), patient-reported outcomes (n = 106, 19%), disease epidemiology/natural history (n = 69, 12%), and economic outcomes (n = 30, 5%). The number of LSI registries and their geographic diversity has increased over time. Conclusions The LSI registries represent a substantial proportion of all patient registries documented in ClinicalTrials.gov. These prospective studies are growing in number and encompass diverse therapeutic areas and geographic regions. Most registries measure multiple outcomes and capture real-world data that may be unavailable through other study designs. This classification of LSI registries documents their use for studying heterogeneity of diseases, examining treatment patterns, measuring patient-reported outcomes, examining economic outcomes, and performing comparative effectiveness research. © 2014 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons, Ltd. PMID:25079108

Identifying fundamental criteria for eating disorder recovery: a systematic review and qualitative meta-analysis.

PubMed

de Vos, Jan Alexander; LaMarre, Andrea; Radstaak, Mirjam; Bijkerk, Charlotte Ariane; Bohlmeijer, Ernst T; Westerhof, Gerben J

2017-01-01

Outcome studies for eating disorders regularly measure pathology change or remission as the only outcome. Researchers, patients and recovered individuals highlight the importance of using additional criteria for measuring eating disorder recovery. There is no clear consensus on which additional criteria are most fundamental. Studies focusing on the perspectives of recovered patients show criteria which are closely related to dimensions of positive functioning as conceptualized in the complete mental health model. The aim of this study was to identify fundamental criteria for eating disorder recovery according to recovered individuals. A systematic review and a qualitative meta-analytic approach were used. Eighteen studies with recovered individuals and meeting various quality criteria were included. The result sections of the included papers were searched for themes that were stated as criteria for recovery or 'being recovered'. All themes were analyzed using a meta-summary technique. Themes were labeled into criteria for recovery and the frequency of the found criteria was examined. In addition to the remission of eating disorder pathology, dimensions of psychological well-being and self-adaptability/resilience were found to be fundamental criteria for eating disorder recovery. The most frequently mentioned criteria were: self-acceptance, positive relationships, personal growth, decrease in eating disorder behavior/cognitions, self-adaptability/resilience and autonomy. People who have recovered rate psychological well-being as a central criterion for ED recovery in addition to the remission of eating disorder symptoms. Supplementary criteria, besides symptom remission, are needed to measure recovery. We recommend including measurements of psychological well-being and self-adaptability/resilience in future research, such as outcome studies and in routine outcome measurement.

Report from the fourth international consensus meeting to harmonize core outcome measures for atopic eczema/dermatitis clinical trials (HOME initiative).

PubMed

Chalmers, J R; Simpson, E; Apfelbacher, C J; Thomas, K S; von Kobyletzki, L; Schmitt, J; Singh, J A; Svensson, Å; Williams, H C; Abuabara, K; Aoki, V; Ardeleanu, M; Awici-Rasmussen, M; Barbarot, S; Berents, T L; Block, J; Bragg, A; Burton, T; Bjerring Clemmensen, K K; Creswell-Melville, A; Dinesen, M; Drucker, A; Eckert, L; Flohr, C; Garg, M; Gerbens, L A A; Graff, A L B; Hanifin, J; Heinl, D; Humphreys, R; Ishii, H A; Kataoka, Y; Leshem, Y A; Marquort, B; Massuel, M-A; Merhand, S; Mizutani, H; Murota, H; Murrell, D F; Nakahara, T; Nasr, I; Nograles, K; Ohya, Y; Osterloh, I; Pander, J; Prinsen, C; Purkins, L; Ridd, M; Sach, T; Schuttelaar, M-L A; Shindo, S; Smirnova, J; Sulzer, A; Synnøve Gjerde, E; Takaoka, R; Vestby Talmo, H; Tauber, M; Torchet, F; Volke, A; Wahlgren, C-F; Weidinger, S; Weisshaar, E; Wollenberg, A; Yamaga, K; Zhao, C Y; Spuls, P I

2016-07-01

This article is a report of the fourth meeting of the Harmonising Outcome Measures for Eczema (HOME) initiative held in Malmö, Sweden on 23-24 April 2015 (HOME IV). The aim of the meeting was to achieve consensus over the preferred outcome instruments for measuring patient-reported symptoms and quality of life for the HOME core outcome set for atopic eczema (AE). Following presentations, which included data from systematic reviews, consensus discussions were held in a mixture of whole group and small group discussions. Small groups were allocated a priori to ensure representation of different stakeholders and countries. Decisions were voted on using electronic keypads. For the patient-reported symptoms, the group agreed by vote that itch, sleep loss, dryness, redness/inflamed skin and irritated skin were all considered essential aspects of AE symptoms. Many instruments for capturing patient-reported symptoms were discussed [including the Patient-Oriented SCOring Atopic Dermatitis index, Patient-Oriented Eczema Measure (POEM), Self-Administered Eczema Area and Severity Index, Itch Severity Scale, Atopic Dermatitis Quickscore and the Nottingham Eczema Severity Score] and, by consensus, POEM was selected as the preferred instrument to measure patient-reported symptoms. Further work is needed to determine the reliability and measurement error of POEM. Further work is also required to establish the importance of pain/soreness and the importance of collecting information regarding the intensity of symptoms in addition to their frequency. Much of the discussion on quality of life concerned the Dermatology Life Quality Index and Quality of Life Index for Atopic Dermatitis; however, consensus on a preferred instrument for measuring this domain could not be reached. In summary, POEM is recommended as the HOME core outcome instrument for measuring AE symptoms. © 2016 The Authors. British Journal of Dermatology published by John Wiley & Sons Ltd on behalf of British Association of Dermatologists.

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 correlates and outcomes of physical activity participation, and is an advantageous primary outcome for measuring change in physical activity in response to an intervention.

A Preliminary Core Domain Set for Clinical Trials of Shoulder Disorders: A Report from the OMERACT 2016 Shoulder Core Outcome Set Special Interest Group.

PubMed

Buchbinder, Rachelle; Page, Matthew J; Huang, Hsiaomin; Verhagen, Arianne P; Beaton, Dorcas; Kopkow, Christian; Lenza, Mario; Jain, Nitin B; Richards, Bethan; Richards, Pamela; Voshaar, Marieke; van der Windt, Danielle; Gagnier, Joel J

2017-12-01

The Outcome Measures in Rheumatology (OMERACT) Shoulder Core Outcome Set Special Interest Group (SIG) was established to develop a core outcome set (COS) for clinical trials of shoulder disorders. In preparation for OMERACT 2016, we systematically examined all outcome domains and measurement instruments reported in 409 randomized trials of interventions for shoulder disorders published between 1954 and 2015. Informed by these data, we conducted an international Delphi consensus study including shoulder trial experts, clinicians, and patients to identify key domains that should be included in a shoulder disorder COS. Findings were discussed at a stakeholder premeeting of OMERACT. At OMERACT 2016, we sought consensus on a preliminary core domain set and input into next steps. There were 13 and 15 participants at the premeeting and the OMERACT 2016 SIG meeting, respectively (9 attended both meetings). Consensus was reached on a preliminary core domain set consisting of an inner core of 4 domains: pain, physical function/activity, global perceived effect, and adverse events including death. A middle core consisted of 3 domains: emotional well-being, sleep, and participation (recreation and work). An outer core of research required to inform the final COS was also formulated. Our next steps are to (1) analyze whether participation (recreation and work) should be in the inner core, (2) conduct a third Delphi round to finalize definitions and wording of domains and reach final endorsement for the domains, and (3) determine which instruments fulfill the OMERACT criteria for measuring each domain.

Outcome measures in European patients with haemophilia: Survey of implementation in routine clinical practice, perception of relevance and recommendations by European treaters in the EHTSB.

PubMed

Hermans, C; Klamroth, R; Richards, M; de Moerloose, P; Garrido, R P

2017-03-01

This study was conducted to evaluate the current implementation of outcome measures in routine clinical haemophilia practice and to explore and appreciate the perception of the relevance of such measures by treaters. A survey was completed by 19 of the 26 physicians involved in the European Haemophilia Therapy Strategy Board (EHTSB). Employing an extensive inventory of outcome measures used in patients with haemophilia, information was collected about the frequency of data collection and the subjective appreciation of their importance during clinic review. The survey revealed that most treaters currently collect data that are mainly related to the haemostatic treatment (consumption of concentrates) and the bleeding symptoms (number and location of bleeds) in a non-uniform and non-standardized way. By contrast, functional, physical and quality of life scorings are rarely used and show considerable heterogeneity between treaters. Also, many disparities emerged between practice and perception, in particular quality of life data that are perceived as being important but for most of the time are not collected. This survey represents, in our view, the first attempt to evaluate the actual utilization of outcome measures in haemophilia care. While the value of outcome measures is appreciated, they are not assessed regularly. Therefore, there is a need to include appropriate performance indicators (outcome measures) of haemophilia care in routine clinical practice. Consensus recommendations to provide a framework for achieving this aim are provided. © 2016 John Wiley & Sons Ltd.

Towards core outcome set (COS) development: a follow-up descriptive survey of outcomes in Cochrane reviews.

PubMed

Wuytack, Francesca; Smith, Valerie; Clarke, Mike; Williamson, Paula; Gargon, Elizabeth

2015-05-19

A core outcome set (COS) can address problems of outcome heterogeneity and outcome reporting bias in trials and systematic reviews, including Cochrane reviews, helping to reduce waste. One of the aims of the international Core Outcome Measures in Effectiveness Trials (COMET) Initiative is to link the development and use of COS with the outcomes specified and reported in Cochrane reviews, including the outcomes listed in the summary of findings (SoF) tables. As part of this work, an earlier exploratory survey of the outcomes of newly published 2007 and 2011 Cochrane reviews was performed. This survey examined the use of COS, the variety of specified outcomes, and outcome reporting in Cochrane reviews by Cochrane Review Group (CRG). To examine changes over time and to explore outcomes that were repeatedly specified over time in Cochrane reviews by CRG, we conducted a follow-up survey of outcomes in 2013 Cochrane reviews. A descriptive survey of outcomes in Cochrane reviews that were first published in 2013. Outcomes specified in the methods sections and reported in the results section of the Cochrane reviews were examined by CRG. We also explored the uptake of SoF tables, the number of outcomes included in these, and the quality of the evidence for the outcomes. Across the 50 CRGs, 375 Cochrane reviews that included at least one study specified a total of 3142 outcomes. Of these outcomes, 32 % (1008) were not reported in the results section of these reviews. For 23 % (233) of these non-reported outcomes, we did not find any reason in the text of the review for this non-report. Fifty-seven percent (216/375) of reviews included a SoF table. The proportion of specified outcomes that were reported in Cochrane reviews had increased in 2013 (68 %) compared to 2007 (61 %) and 2011 (65 %). Importantly, 2013 Cochrane reviews that did not report specified outcomes were twice as likely to provide an explanation for why the outcome was not reported. There has been an increased uptake of SoF tables in Cochrane reviews. Outcomes that were repeatedly specified in Cochrane reviews by CRG in 2007, 2011, and 2013 may assist COS development.

Use of continuous glucose monitoring as an outcome measure in clinical trials.

PubMed

Beck, Roy W; Calhoun, Peter; Kollman, Craig

2012-10-01

Although developed to be a management tool for individuals with diabetes, continuous glucose monitoring (CGM) also has potential value for the assessment of outcomes in clinical studies. We evaluated using CGM as such an outcome measure. Data were analyzed from six previously completed inpatient studies in which both CGM (Freestyle Navigator™ [Abbott Diabetes Care, Alameda, CA] or Guardian(®) [Medtronic, Northridge, CA]) and reference glucose measurements were available. The analyses included 97 days of data from 93 participants with type 1 diabetes (age range, 5-57 years; mean, 18 ± 12 years). Mean glucose levels per day were similar for the CGM and reference measurements (median, 148 mg/dL vs. 143 mg/dL, respectively; P = 0.92), and the correlation of the two was high (r = 0.89). Similarly, most glycemia metrics showed no significant differences comparing CGM and reference values, except that the nadir glucose tended to be slightly lower and peak glucose slightly higher with reference measurements than CGM measurements (respective median, 59 mg/dL vs. 66 mg/dL [P = 0.05] and 262 mg/dL vs. 257 mg/dL [P = 0.003]) and glucose variability as measured with the coefficient of variation was slightly lower with CGM than reference measurements (respective median, 31% vs. 35%; P<0.001). A reasonably high degree of concordance exists when comparing outcomes based on CGM measurements with outcomes based on reference blood glucose measurements. CGM inaccuracy and underestimation of the extremes of hyperglycemia and hypoglycemia can be accounted for in a clinical trial's study design. Thus, in appropriate settings, CGM can be a very meaningful and feasible outcome measure for clinical trials.

Use of Continuous Glucose Monitoring as an Outcome Measure in Clinical Trials

PubMed Central

Calhoun, Peter; Kollman, Craig

2012-01-01

Abstract Objective Although developed to be a management tool for individuals with diabetes, continuous glucose monitoring (CGM) also has potential value for the assessment of outcomes in clinical studies. We evaluated using CGM as such an outcome measure. Research Design and Methods Data were analyzed from six previously completed inpatient studies in which both CGM (Freestyle Navigator™ [Abbott Diabetes Care, Alameda, CA] or Guardian® [Medtronic, Northridge, CA]) and reference glucose measurements were available. The analyses included 97 days of data from 93 participants with type 1 diabetes (age range, 5–57 years; mean, 18±12 years). Results Mean glucose levels per day were similar for the CGM and reference measurements (median, 148 mg/dL vs. 143 mg/dL, respectively; P=0.92), and the correlation of the two was high (r=0.89). Similarly, most glycemia metrics showed no significant differences comparing CGM and reference values, except that the nadir glucose tended to be slightly lower and peak glucose slightly higher with reference measurements than CGM measurements (respective median, 59 mg/dL vs. 66 mg/dL [P=0.05] and 262 mg/dL vs. 257 mg/dL [P=0.003]) and glucose variability as measured with the coefficient of variation was slightly lower with CGM than reference measurements (respective median, 31% vs. 35%; P<0.001). Conclusions A reasonably high degree of concordance exists when comparing outcomes based on CGM measurements with outcomes based on reference blood glucose measurements. CGM inaccuracy and underestimation of the extremes of hyperglycemia and hypoglycemia can be accounted for in a clinical trial's study design. Thus, in appropriate settings, CGM can be a very meaningful and feasible outcome measure for clinical trials. PMID:23013201

Improving the outcome of infants born at <30 weeks' gestation - a randomized controlled trial of preventative care at home

PubMed Central

2009-01-01

Background Early developmental interventions to prevent the high rate of neurodevelopmental problems in very preterm children, including cognitive, motor and behavioral impairments, are urgently needed. These interventions should be multi-faceted and include modules for caregivers given their high rates of mental health problems. Methods/Design We have designed a randomized controlled trial to assess the effectiveness of a preventative care program delivered at home over the first 12 months of life for infants born very preterm (<30 weeks of gestational age) and their families, compared with standard medical follow-up. The aim of the program, delivered over nine sessions by a team comprising a physiotherapist and psychologist, is to improve infant development (cognitive, motor and language), behavioral regulation, caregiver-child interactions and caregiver mental health at 24 months' corrected age. The infants will be stratified by severity of brain white matter injury (assessed by magnetic resonance imaging) at term equivalent age, and then randomized. At 12 months' corrected age interim outcome measures will include motor development assessed using the Alberta Infant Motor Scale and the Neurological Sensory Motor Developmental Assessment. Caregivers will also complete a questionnaire at this time to obtain information on behavior, parenting, caregiver mental health, and social support. The primary outcomes are at 24 months' corrected age and include cognitive, motor and language development assessed with the Bayley Scales of Infant and Toddler Development (Bayley-III). Secondary outcomes at 24 months include caregiver-child interaction measured using an observational task, and infant behavior, parenting, caregiver mental health and social support measured via standardized parental questionnaires. Discussion This paper presents the background, study design and protocol for a randomized controlled trial in very preterm infants utilizing a preventative care program in the first year after discharge home designed to improve cognitive, motor and behavioral outcomes of very preterm children and caregiver mental health at two-years' corrected age. Clinical Trial Registration Number ACTRN12605000492651 PMID:19954550

Predicting Math Outcomes: Reading Predictors and Comorbidity

ERIC Educational Resources Information Center

Fletcher, Jack M.

2005-01-01

This commentary addresses issues concerning (a) the measurement of numbers, letters, and words versus cognitive processes in early screening batteries, and (b) comorbid associations of reading, math, and attention disorders. Based on reading prediction studies, assessments that include numbers should be most predictive of math outcomes. However,…

THE DETROIT ASTHMA MORBIDITY, AIR QUALITY AND TRAFFIC (DAMAT) STUDY

EPA Science Inventory

The project was completed successfully. In Project Year 1, the health outcome and exposure data sets were collected, cleaned and processed, including specifically:

• A set of daily exposure measures, based on measurements of the selected pollutants measure...

• An evidence-based framework to measure quality of allied health care.

  PubMed

  Grimmer, Karen; Lizarondo, Lucylynn; Kumar, Saravana; Bell, Erica; Buist, Michael; Weinstein, Philip

  2014-02-26

  There is no standard way of describing the complexities of allied health (AH) care, or its quality. AH is an umbrella term which excludes medicine and nursing, and variably includes disciplines which provide therapy, diagnostic, or scientific services. This paper outlines a framework for a standard approach to evaluate the quality of AH therapy services. A realist synthesis framework describing what AH does, how it does it, and what is achieved, was developed. This was populated by the findings of a systematic review of literature published since 1980 reporting concepts of quality relevant to AH. Articles were included on quality measurement concepts, theories, debates, and/or hypothetical frameworks. Of 139 included articles, 21 reported on descriptions of quality potentially relevant to AH. From these, 24 measures of quality were identified, with 15 potentially relating to what AH does, 17 to how AH delivers care, 8 relating to short term functional outcomes, and 9 relating to longer term functional and health system outcomes. A novel evidence-based quality framework was proposed to address the complexity of AH therapies. This should assist in better evaluation of AH processes and outcomes, costs, and evidence-based engagement of AH providers in healthcare teams.

• Mobility one week after a hip fracture - can it be predicted?

  PubMed

  Fitzgerald, Michelle; Blake, Catherine; Askin, David; Quinlan, John; Coughlan, Tara; Cunningham, Caitriona

  2018-05-01

  Better patient outcomes and more efficient healthcare could be achieved by predicting post hip fracture function at an early stage. This study aimed to identify independent predictors of mobility outcome one week post hip fracture surgery. All hip fracture inpatients (n=77) were included in this 6 month prospective observational cohort study. Predictor variables were obtained on the first postoperative day and included premorbid function using the New Mobility Score (NMS). Mobility outcome measures one week postoperatively included the Cumulated Ambulatory Score (CAS). Data were analysed with SPSS using binary multiple logistic regression analysis RESULTS: Patients who fell outdoors (OR 3.848; 95% CI, 1.053-14.061), had no delay to surgery (OR 5.472; 95% CI, 1.073-27.907) and had high pre-fracture function (OR3.366; 95% CI, 1.042-10.879) were predicted to achieve independent mobility (CAS = 6) one week postoperatively. Fall location, time to surgery and baseline function predict independent mobility one week after hip fracture, and can be used for early rehabilitation stratification. The NMS and CAS are recommended as standardised hip fracture clinical measures. Orthogeriatric and physiotherapy service initiatives may improve early functional outcome. Copyright © 2017. Published by Elsevier Ltd.

• The Outcome and Assessment Information Set (OASIS): A Review of Validity and Reliability

  PubMed Central

  O’CONNOR, MELISSA; DAVITT, JOAN K.

  2015-01-01

  The Outcome and Assessment Information Set (OASIS) is the patient-specific, standardized assessment used in Medicare home health care to plan care, determine reimbursement, and measure quality. Since its inception in 1999, there has been debate over the reliability and validity of the OASIS as a research tool and outcome measure. A systematic literature review of English-language articles identified 12 studies published in the last 10 years examining the validity and reliability of the OASIS. Empirical findings indicate the validity and reliability of the OASIS range from low to moderate but vary depending on the item studied. Limitations in the existing research include: nonrepresentative samples; inconsistencies in methods used, items tested, measurement, and statistical procedures; and the changes to the OASIS itself over time. The inconsistencies suggest that these results are tentative at best; additional research is needed to confirm the value of the OASIS for measuring patient outcomes, research, and quality improvement. PMID:23216513

• The impact of performance incentives on child health outcomes: results from a cluster randomized controlled trial in the Philippines.

  PubMed

  Peabody, John W; Shimkhada, Riti; Quimbo, Stella; Solon, Orville; Javier, Xylee; McCulloch, Charles

  2014-08-01

  Improving clinical performance using measurement and payment incentives, including pay for performance (or P4P), has, so far, shown modest to no benefit on patient outcomes. Our objective was to assess the impact of a P4P programme on paediatric health outcomes in the Philippines. We used data from the Quality Improvement Demonstration Study. In this study, the P4P intervention, introduced in 2004, was randomly assigned to 10 community district hospitals, which were matched to 10 control sites. At all sites, physician quality was measured using Clinical Performance Vignettes (CPVs) among randomly selected physicians every 6 months over a 36-month period. In the hospitals randomized to the P4P intervention, physicians received bonus payments if they met qualifying scores on the CPV. We measured health outcomes 4-10 weeks after hospital discharge among children 5 years of age and under who had been hospitalized for diarrhoea and pneumonia (the two most common illnesses affecting this age cohort) and had been under the care of physicians participating in the study. Health outcomes data collection was done at baseline/pre-intervention and 2 years post-intervention on the following post-discharge outcomes: (1) age-adjusted wasting, (2) C-reactive protein in blood, (3) haemoglobin level and (4) parental assessment of child's health using general self-reported health (GSRH) measure. To evaluate changes in health outcomes in the control vs intervention sites over time (baseline vs post-intervention), we used a difference-in-difference logistic regression analysis, controlling for potential confounders. We found an improvement of 7 and 9 percentage points in GSRH and wasting over time (post-intervention vs baseline) in the intervention sites relative to the control sites (P ≤ 0.001). The results from this randomized social experiment indicate that the introduction of a performance-based incentive programme, which included measurement and feedback, led to improvements in two important child health outcomes. Published by Oxford University Press in association with The London School of Hygiene and Tropical Medicine © The Author 2013; all rights reserved.

• Choice of Outcome Measure in an Economic Evaluation: A Potential Role for the Capability Approach.

  PubMed

  Lorgelly, Paula K

  2015-08-01

  The last decade has seen a renewed interest in Sen's capability approach; health economists have been instrumental in leading much of this work. One particular stream of research is the application of the approach to outcome measurement. To date, there have been a dozen attempts (some combined) to operationalise the approach, and produce an outcome measure that offers a broader evaluative space than health-related quality-of-life measures. Applications have so far been confined to public health, physical, mental health and social care interventions, but the capability approach could be of benefit to evaluations of pharmacotherapies and other technologies. This paper provides an introduction to the capability approach, reviews the measures that are available for use in an economic evaluation, including their current applications, and then concludes with a discussion of a number of issues that require further consideration before the approach is adopted more widely to inform resource allocation decisions.

• Review of Positive Psychology Outcome Measures for Chronic Illness, Traumatic Brain Injury and Older Adults: Adaptability in Dementia?

  PubMed

  Stoner, Charlotte R; Orrell, Martin; Spector, Aimee

  2015-01-01

  Despite positive psychology being increasingly recognised as an important agent in well-being, there is a lack of standardised outcome measures for psychosocial dementia research. This review assessed positive psychology outcome measures using standardised criterion in populations that were identified as having shared characteristics. It aimed to identify robust measures that were suitable for potential adaption or use within a dementia population. The review identified 16 positive psychology outcome measures (and 8 further psychometric assessments of these) within the constructs of resilience, self-efficacy, religiousness/spirituality, life valuation, sense of coherence, autonomy, resourcefulness and a combined measure (CASP-19). Scale development studies were subject to a quality assessment, and most were found to be lacking information on reproducibility and responsiveness. A wide range of measures within the constructs of positive psychology was identified as having potential utility for psychosocial research within a dementia population. Examples included the CD-RISC, GSWB, SWLS, MPAQ, RSOA and CASP-19. It is recommended that such scales are further adapted or validated for people with dementia. Underreporting of appropriate psychometric analyses hampered this review, and it is recommended that future authors endeavour to report such analyses. © 2015 S. Karger AG, Basel.

• Measuring masculinity in research on men of color: findings and future directions.

  PubMed

  Griffith, Derek M; Gunter, Katie; Watkins, Daphne C

  2012-05-01

  The purpose of this study was to examine the association between masculinity and the health of US men of color aged 18 years and older. We identified 22 population-based studies that included a measure of masculinity and a measure of health behavior, mental health, or physical health. The associations between masculinity and health were complex and varied by construct and health outcome, though they generally were significant in the hypothesized directions. Future research should explore the centrality of masculinity versus other identities and characteristics, how the relationship between masculinity and health varies by health outcome, and the identification of the conceptions and aspects of masculinity that are most relevant to and associated with specific health behaviors and health outcomes.

• Measuring Masculinity in Research on Men of Color: Findings and Future Directions

  PubMed Central

  Gunter, Katie; Watkins, Daphne C.

  2012-01-01

  The purpose of this study was to examine the association between masculinity and the health of US men of color aged 18 years and older. We identified 22 population-based studies that included a measure of masculinity and a measure of health behavior, mental health, or physical health. The associations between masculinity and health were complex and varied by construct and health outcome, though they generally were significant in the hypothesized directions. Future research should explore the centrality of masculinity versus other identities and characteristics, how the relationship between masculinity and health varies by health outcome, and the identification of the conceptions and aspects of masculinity that are most relevant to and associated with specific health behaviors and health outcomes. PMID:22401519

• Breastfeeding Outcomes After Oxytocin Use During Childbirth: An Integrative Review.

  PubMed

  Erickson, Elise N; Emeis, Cathy L

  2017-07-01

  Despite widespread use of exogenous synthetic oxytocin during the birth process, few studies have examined the effect of this drug on breastfeeding. Based on neuroscience research, endogenous oxytocin may be altered or manipulated by exogenous administration or by blocking normal function of the hormone or receptor. Women commonly cite insufficient milk production as their reason for early supplementation, jeopardizing breastfeeding goals. Researchers need to consider the role of birth-related medications and interventions on the production of milk. This article examines the literature on the role of exogenous oxytocin on breastfeeding in humans. Using the method described by Whittemore and Knafl, this integrative review of literature included broad search criteria within the PubMed, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Cochrane, and Scopus databases. Studies published in English associating a breastfeeding outcome in relation to oxytocin use during the birth process were included. Twenty-six studies from 1978 to 2015 met the criteria. Studies were analyzed according to the purpose of the research, measures and methods used, results, and confounding variables. The 26 studies reported 34 measures of breastfeeding. Outcomes included initiation and duration of breastfeeding, infant behavior, and physiologic markers of lactation. Timing of administration of oxytocin varied. Some studies reported on low-risk birth, while others included higher-risk experiences. Fifty percent of the results (17 of 34 measures) demonstrated an association between exogenous oxytocin and less optimal breastfeeding outcomes, while 8 of 34 measures (23%) reported no association. The remaining 9 measures (26%) had mixed findings. Breastfeeding intentions, parity, birth setting, obstetric risk, and indications for oxytocin use were inconsistently controlled among the studies. Research on breastfeeding and lactation following exogenous oxytocin exposure is limited by few studies and heterogeneous methods. Despite the limitations, researchers and clinicians may benefit from awareness of this body of literature. Continued investigation is recommended given the prevalence of oxytocin use in clinical practice. © 2017 by the American College of Nurse-Midwives.

• Efficacy of exercise therapy in workers with rotator cuff tendinopathy: a systematic review

  PubMed Central

  Desmeules, François; Boudreault, Jennifer; Dionne, Clermont E.; Frémont, Pierre; Lowry, Véronique; MacDermid, Joy C.; Roy, Jean-Sébastien

  2016-01-01

  Objective: To perform a systematic review of randomized controlled trials (RCTs) on the efficacy of therapeutic exercises for workers suffering from rotator cuff (RC) tendinopathy. Methods: A literature search in four bibliographical databases (Pubmed, CINAHL, EMBASE, and PEDro) was conducted from inception up to February 2015. RCTs were included if participants were workers suffering from RC tendinopathy, the outcome measures included work-related outcomes, and at least one of the interventions under study included exercises. The methodological quality of the studies was evaluated with the Cochrane Risk of Bias Assessment tool. Results: The mean methodological score of the ten included studies was 54.4%±17.2%. Types of workers included were often not defined, and work-related outcome measures were heterogeneous and often not validated. Three RCTs of moderate methodological quality concluded that exercises were superior to a placebo or no intervention in terms of function and return-to-work outcomes. No significant difference was found between surgery and exercises based on the results of two studies of low to moderate methodological quality. One study of low methodological quality, comparing a workplace-based exercise program focusing on the participants' work demands to an exercise program delivered in a clinical setting, concluded that the work-based intervention was superior in terms of function and return-to-work outcomes. Conclusion: There is low to moderate-grade evidence that therapeutic exercises provided in a clinical setting are an effective modality to treat workers suffering from RC tendinopathy and to promote return-to-work. Further high quality studies comparing different rehabilitation programs including exercises in different settings with defined workers populations are needed to draw firm conclusions on the optimal program to treat workers. PMID:27488037

• Efficacy of exercise therapy in workers with rotator cuff tendinopathy: a systematic review.

  PubMed

  Desmeules, François; Boudreault, Jennifer; Dionne, Clermont E; Frémont, Pierre; Lowry, Véronique; MacDermid, Joy C; Roy, Jean-Sébastien

  2016-09-30

  To perform a systematic review of randomized controlled trials (RCTs) on the efficacy of therapeutic exercises for workers suffering from rotator cuff (RC) tendinopathy. A literature search in four bibliographical databases (Pubmed, CINAHL, EMBASE, and PEDro) was conducted from inception up to February 2015. RCTs were included if participants were workers suffering from RC tendinopathy, the outcome measures included work-related outcomes, and at least one of the interventions under study included exercises. The methodological quality of the studies was evaluated with the Cochrane Risk of Bias Assessment tool. The mean methodological score of the ten included studies was 54.4%±17.2%. Types of workers included were often not defined, and work-related outcome measures were heterogeneous and often not validated. Three RCTs of moderate methodological quality concluded that exercises were superior to a placebo or no intervention in terms of function and return-to-work outcomes. No significant difference was found between surgery and exercises based on the results of two studies of low to moderate methodological quality. One study of low methodological quality, comparing a workplace-based exercise program focusing on the participants' work demands to an exercise program delivered in a clinical setting, concluded that the work-based intervention was superior in terms of function and return-to-work outcomes. There is low to moderate-grade evidence that therapeutic exercises provided in a clinical setting are an effective modality to treat workers suffering from RC tendinopathy and to promote return-to-work. Further high quality studies comparing different rehabilitation programs including exercises in different settings with defined workers populations are needed to draw firm conclusions on the optimal program to treat workers.

• On-going clinical trials for elderly patients with a hematological malignancy: are we addressing the right end points?

  PubMed

  Hamaker, M E; Stauder, R; van Munster, B C

  2014-03-01

  Cancer societies and research cooperative groups worldwide have urged for the development of cancer trials that will address those outcome measures that are most relevant to older patients. We set out to determine the characteristics and study objectives of current clinical trials in hematological patients. The United States National Institutes of Health clinical trial registry was searched on 1 July 2013, for currently recruiting phase I, II or III clinical trials in hematological malignancies. Trial characteristics and study objectives were extracted from the registry website. In the 1207 clinical trials included in this overview, patient-centered outcome measures such as quality of life, health care utilization and functional capacity were only incorporated in a small number of trials (8%, 4% and 0.7% of trials, respectively). Even in trials developed exclusively for older patients, the primary focus lies on standard end points such as toxicity, efficacy and survival, while patient-centered outcome measures are included in less than one-fifth of studies. Currently on-going clinical trials in hematological malignancies are unlikely to significantly improve our knowledge of the optimal treatment of older patients as those outcome measures that are of primary importance to this patient population are still included in only a minority of studies. As a scientific community, we cannot continue to simply acknowledge this issue, but must all participate in taking the necessary steps to enable the delivery of evidence-based, tailor-made and patient-focused cancer care to our rapidly growing elderly patient population.

• On-going clinical trials for elderly patients with a hematological malignancy: are we addressing the right end points?†

  PubMed Central

  Hamaker, M. E.; Stauder, R.; van Munster, B. C.

  2014-01-01

  Background Cancer societies and research cooperative groups worldwide have urged for the development of cancer trials that will address those outcome measures that are most relevant to older patients. We set out to determine the characteristics and study objectives of current clinical trials in hematological patients. Method The United States National Institutes of Health clinical trial registry was searched on 1 July 2013, for currently recruiting phase I, II or III clinical trials in hematological malignancies. Trial characteristics and study objectives were extracted from the registry website. Results In the 1207 clinical trials included in this overview, patient-centered outcome measures such as quality of life, health care utilization and functional capacity were only incorporated in a small number of trials (8%, 4% and 0.7% of trials, respectively). Even in trials developed exclusively for older patients, the primary focus lies on standard end points such as toxicity, efficacy and survival, while patient-centered outcome measures are included in less than one-fifth of studies. Conclusion Currently on-going clinical trials in hematological malignancies are unlikely to significantly improve our knowledge of the optimal treatment of older patients as those outcome measures that are of primary importance to this patient population are still included in only a minority of studies. As a scientific community, we cannot continue to simply acknowledge this issue, but must all participate in taking the necessary steps to enable the delivery of evidence-based, tailor-made and patient-focused cancer care to our rapidly growing elderly patient population. PMID:24458474

• Core Health Outcomes In Childhood Epilepsy (CHOICE): protocol for the selection of a core outcome set.

  PubMed

  Morris, Christopher; Dunkley, Colin; Gibbon, Frances M; Currier, Janet; Roberts, Deborah; Rogers, Morwenna; Crudgington, Holly; Bray, Lucy; Carter, Bernie; Hughes, Dyfrig; Tudur Smith, Catrin; Williamson, Paula R; Gringras, Paul; Pal, Deb K

  2017-11-28

  There is increasing recognition that establishing a core set of outcomes to be evaluated and reported in trials of interventions for particular conditions will improve the usefulness of health research. There is no established core outcome set for childhood epilepsy. The aim of this work is to select a core outcome set to be used in evaluative research of interventions for children with rolandic epilepsy, as an exemplar of common childhood epilepsy syndromes. First we will identify what outcomes should be measured; then we will decide how to measure those outcomes. We will engage relevant UK charities and health professional societies as partners, and convene advisory panels for young people with epilepsy and parents of children with epilepsy. We will identify candidate outcomes from a search for trials of interventions for childhood epilepsy, statutory guidance and consultation with our advisory panels. Families, charities and health, education and neuropsychology professionals will be invited to participate in a Delphi survey following recommended practices in the development of core outcome sets. Participants will be able to recommend additional outcome domains. Over three rounds of Delphi survey participants will rate the importance of candidate outcome domains and state the rationale for their decisions. Over the three rounds we will seek consensus across and between families and health professionals on the more important outcomes. A face-to-face meeting will be convened to ratify the core outcome set. We will then review and recommend ways to measure the shortlisted outcomes using clinical assessment and/or patient-reported outcome measures. Our methodology is a proportionate and pragmatic approach to expediently produce a core outcome set for evaluative research of interventions aiming to improve the health of children with epilepsy. A number of decisions have to be made when designing a study to develop a core outcome set including defining the scope, choosing which stakeholders to engage, most effective ways to elicit their views, especially children and a potential role for qualitative research.

• Web-based Comparative Patient-reported Outcome Feedback to Support Quality Improvement and Comparative Effectiveness Research in Total Joint Replacement.

  PubMed

  Zheng, Hua; Li, Wenjun; Harrold, Leslie; Ayers, David C; Franklin, Patricia D

  2014-01-01

  Patient-reported outcomes (PROs) are rarely included in quality monitoring systems, surgeon comparative feedback reports, or registries. We present the design and implementation of a secure website in a federally funded research program-Function and Outcomes Research for Comparative Effectiveness in Total Joint Replacement (FORCE-TJR)-to return comparative PRO reports to participating surgeons, in addition to including traditional quality measures, in order to monitor and improve quality and health outcomes. The surgeon-specific comparative PRO reports were designed and structured based on user input for content, data elements, integration, and display. Three questions are addressed regarding the knee and hip joint symptom profiles of patients before TJR, as well as outcomes of surgery. The website is organized with a hierarchical structure to display data at national, practice, and individual surgeon levels, and provides a comprehensive site-level executive summary and surgeon-level data reports that can be downloaded. As of September 2014, over 22,000 patients were enrolled from more than 130 surgeons in 22 states. The reporting website was launched in September 2012 and has been updated quarterly for all surgeons to review their site- and individual-specific outcomes data compared to national benchmarks. In this novel system, quarterly comparative surgeon feedback extends beyond traditional measures of complication rates to include PROs of pain relief and functional gain. We anticipate that this enhanced data will facilitate patient-centered quality improvement (QI) and outcomes research from the registry. As the Centers for Medicare & Medicaid Services (CMS) and other insurers consider future implementation of PROs, surgeons will increasingly need comparative data by which to self-monitor their practice outcomes.

• User involvement in service delivery predicts outcomes of assistive technology use: a cross-sectional study in Bangladesh.

  PubMed

  Borg, Johan; Larsson, Stig; Ostergren, Per-Olof; Rahman, A S M Atiqur; Bari, Nazmul; Khan, A H M Noman

  2012-09-20

  Knowledge about the relation between user involvement in the provision of assistive technology and outcomes of assistive technology use is a prerequisite for the development of efficient service delivery strategies. However, current knowledge is limited, particularly from low-income countries where affordability is an issue. The objective was therefore to explore the relation between outcomes of assistive technology use and user involvement in the service delivery process in Bangladesh. Using structured interviews, data from 136 users of hearing aids and 149 users of manual wheelchairs were collected. Outcomes were measured using the International Outcome Inventory for Hearing Aids (IOI-HA), which was adapted for wheelchair users. Predictors of user involvement included preference, measurement and training. Users reported outcomes comparable to those found in other high- and low-income countries. User involvement increased the likelihood for reporting better outcomes except for measurement among hearing aid users. The findings support the provision of assistive technology as a strategy to improve the participation of people with disabilities in society. They also support current policies and guidelines for user-involvement in the service delivery process. Simplified strategies for provision of hearing aids may be explored.

• Developing core economic outcome sets for asthma studies: a protocol for a systematic review.

  PubMed

  Hounsome, Natalia; Fitzsimmons, Deborah; Phillips, Ceri; Patel, Anita

  2017-08-11

  Core outcome sets are standardised lists of outcomes, which should be measured and reported in all clinical studies of a specific condition. This study aims to develop core outcome sets for economic evaluations in asthma studies. Economic outcomes include items such as costs, resource use or quality-adjusted life years. The starting point in developing core outcome sets will be conducting a systematic literature review to establish a preliminary list of reporting items to be considered for inclusion in the core outcome set. We will conduct literature searches of peer-reviewed studies published from January 1990 to January 2017. These will include any comparative or observational studies (including economic models) and systematic reviews reporting economic outcomes. All identified economic outcomes will be tabulated together with the major study characteristics, such as population, study design, the nature and intensity of the intervention, mode of data collection and instrument(s) used to derive an outcome. We will undertake a 'realist synthesis review' to analyse the identified economic outcomes. The outcomes will be summarised in the context of evaluation perspectives, types of economic evaluation and methodological approaches. Parallel to undertaking a systematic review, we will conduct semistructured interviews with stakeholders (including people with personal experience of asthma, health professionals, researchers and decision makers) in order to explore additional outcomes which have not been considered, or used, in published studies. The list of outcomes generated from the systematic review and interviews with stakeholders will form the basis of a Delphi survey to refine the identified outcomes into a core outcome set. The review will not involve access to individual-level data. Findings from our systematic review will be communicated to a broad range of stakeholders including clinical guideline developers, research funders, trial registries, ethics committees and other regulators. © 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 expressly granted.

• Cognitive behaviour therapy via interactive video.

  PubMed

  Manchanda, M; McLaren, P

  1998-01-01

  Interactive video has been identified as a potential delivery medium for psychotherapy. Interactive video may restrict the range of both verbal and non-verbal communication and consequently impede the development of a therapeutic relationship, thus influencing the process and outcome of therapy. A single case study explored the feasibility of the provision of congnitive behaviour therapy using interactive video with a client diagnosed as having mixed anxiety and depressive disorder. A range of outcome measures were included together with an independent psychiatric assessment prior to, and on completion of, therapy. Different levels of outcome were also examined: clinical, social, user views and administration. Outcome measures indicated a reduction in psychopathology and some modification of dysfunctional attitudes, with no apparent impairment of the working alliance.

Measurement properties of gait-related outcomes in youth with neuromuscular diagnoses: a systematic review.

PubMed

Ammann-Reiffer, Corinne; Bastiaenen, Caroline H G; de Bie, Rob A; van Hedel, Hubertus J A

2014-08-01

Sound measurement properties of outcome tools are essential when evaluating outcomes of an intervention, in clinical practice and in research. The purpose of this study was to review the evidence on reliability, measurement error, and responsiveness of measures of gait function in children with neuromuscular diagnoses. The MEDLINE, CINAHL, EMBASE, and PsycINFO databases were searched up to June 15, 2012. Studies evaluating reliability, measurement error, or responsiveness of measures of gait function in 1- to 18-year-old children and youth with neuromuscular diagnoses were included. Quality of the studies was independently rated by 2 raters using a modified COnsensus-based Standards for the selection of health status Measurement INstruments (COSMIN) checklist. Studies with a fair quality rating or better were considered for best evidence synthesis. Regarding the methodological quality, 32 out of 35 reliability studies, all of the 13 measurement error studies, and 5 out of 10 responsiveness studies were of fair or good quality. Best evidence synthesis revealed moderate to strong evidence for reliability for several measures in children and youth with cerebral palsy (CP) but was limited or unknown in other diagnoses. The Functional Mobility Scale (FMS) and the Gross Motor Function Measure (GMFM) dimension E showed limited positive evidence for responsiveness in children with CP, but it was unknown or controversial in other diagnoses. No information was reported on the minimal important change; thus, evidence on measurement error remained undetermined. As studies on validity were not included in the review, a comprehensive appraisal of the best available gait-related outcome measure per diagnosis is not possible. There is moderate to strong evidence on reliability for several measures of gait function in children and youth with CP, whereas evidence on responsiveness exists only for the FMS and the GMFM dimension E. © 2014 American Physical Therapy Association.

Speaking Up: How Patient and Physician Voices Shaped a Trial to Improve Goals-of-Care Discussions.

PubMed

Solomon, Rachel; Smith, Cardinale; Kallio, Jay; Fenollosa, Amy; Benerofe, Barbara; Jones, Laurence; Adelson, Kerin; Gonsky, Jason P; Messner, Carolyn; Bickell, Nina A

2017-08-01

Patients with advanced cancer benefit from early goals-of-care (GoC) conversations, but few facilitators are known. We describe the process and outcomes of involving patient and physician stakeholders in the design and development of a trial, funded by the Patient-Centered Outcomes Research Institute (PCORI), to enhance oncologists' communication skills and their propensity to facilitate productive, meaningful GoC discussions with patients with advanced cancer. We recruited oncologists, palliative care physicians, and patient stakeholders to participate in proposal development, intervention design and modification, identification of outcome measures, and refinement of study tools. Formats for exchange included 1:1 structured interviews, workshops, and stakeholder meetings. Patient and physician voices helped craft and implement a study of an intervention to enhance oncologists' ability to facilitate GoC discussions with patients with advanced cancer. Physician inputs guided the creation of an oncologist and palliative care physician "joint visit" intervention at a turning point in disease management. Patient inputs impacted on the language used, outcome measures assessed, and approaches used to introduce patients to the intervention visit. Stakeholder input informed the development of a novel intervention that physicians seemed to find both valuable and in sync with their needs and their practice schedules. Where communication about difficult subjects and shared decision making are involved, including multiple stakeholder groups in study design, implementation, and outcomes measurement may have far-reaching effects.

Advancing Measurement of Locomotor Rehabilitation Outcomes to Optimize Interventions and Differentiate between Recovery versus Compensation

PubMed Central

Bowden, Mark G.; Behrman, Andrea L.; Woodbury, Michelle; Gregory, Chris M.; Velozo, Craig A.; Kautz, Steven A.

2017-01-01

Progress in locomotor rehabilitation has created an increasing need to understand the factors that contribute to motor behavior, to determine whether these factors are modifiable, and if so, to determine how best to modify them in a way that promotes improved function. Currently available measures do not have the capacity to distinguish between neuromotor recovery and compensation for impaired underlying body structure/functions. The purpose of this Special Interest article is to examine the state of outcomes measurement in physical therapy in regards outcomes to locomotor rehabilitation, and to suggest approaches that may improve assessment of recovery and clinical decision-making capabilities. We examine historical approaches to measurement of locomotor rehabilitation outcomes including rating scales, timed movement tasks, and laboratory-based outcome measures, and we discuss the emerging use of portable technology to assess walking in a free living environment. The ability to accurately measure outcomes of rehabilitation, both in and away from the laboratory setting, allows assessment of skill acquisition, retention, and long-term carryover in a variety of environments. Accurate measurement allows behavioral changes to be observed and assessments to be made, not only regarding an individual's ability to adapt during interventions, but also their ability to incorporate new skills into a real-world behavior. The result of such an approach to assessment may be that interventions truly translate from laboratory to real-world environments. Future locomotor measurement tools must be based on a theoretical framework that can guide their use to accurately quantify treatment effects and provide a basis upon which to develop and refine therapeutic interventions. PMID:22333921

First results of a national initiative to enable quality improvement of cardiovascular care by transparently reporting on patient-relevant outcomes.

PubMed

van Veghel, Dennis; Marteijn, Marloes; de Mol, Bas

2016-06-01

The aims of this study were to assess patient-relevant outcomes of delivered cardiovascular care by focusing on disease management as determined by a multidisciplinary Heart Team, to establish and share best practices by comparing outcomes and to embed value-based decision-making to improve quality and efficiency in Dutch heart centres. In 2014, 12 Dutch heart centres pooled patient-relevant outcome data, which resulted in transparent publication of the outcomes, including long-term follow-up up to 5 years, of approximately 86 000 heart patients. This study presents the results of both disease- and treatment patient-relevant outcome measures for coronary artery disease and aortic valve disease. The patients included were presented to a Heart Team and underwent invasive or operative treatment. In-hospital and out-of-hospital patient-relevant outcome measures were collected as well as initial conditions. Quality of life was assessed using the Short Form (SF)-36 or SF-12 health survey. In the Netherlands, patient-relevant and risk-adjusted outcomes of cardiovascular care in participating heart centres are published annually. Data were sufficiently reliable to enable comparisons and to subtract best practices. The statistically lower risk-adjusted mortality rate after coronary artery bypass grafting resulted in a voluntary roll-out of a perioperative safety check. The in-depth analysis of outcomes after percutaneous coronary intervention resulted in process improvements in several heart centres, such as pre-hydration for patients with renal insufficiency and the need of target vessel revascularizations within a year. Annual data collection on follow-up of patient-relevant outcomes of cardiovascular care, initiated and organized by physicians, appears feasible. Transparent publication of outcomes drives the improvement of quality within heart centres. The system of using a limited set of patient-relevant outcome measures enables reliable comparisons and exposes the quality of decision-making and the operational process. Transparent communication on outcomes is feasible, safe and cost-effective, and stimulates professional decision-making and disease management. © The Author 2016. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

Opiate and Cocaine Exposed Newborns: Growth Outcomes.

ERIC Educational Resources Information Center

Butz, Arlene M.; Kaufmann, Walter E.; Royall, Richard; Kolodner, Ken; Pulsifer, Margaret B.; Lears, Mary Kathleen; Henderson, Robin; Belcher, Harolyn; Sellers, Sherri; Wilson, Modena

1999-01-01

Examines growth parameters at birth in 204 infants born to mothers who used cocaine and/or opiates during pregnancy. Outcome measures included birth weight, length, and head circumference. Study provides support that in utero cocaine exposure may confer more risk for somatic growth retardation at birth than opiate exposure. (Author/GCP)

Tests examining skill outcomes in sport: a systematic review of measurement properties and feasibility.

PubMed

Robertson, Samuel J; Burnett, Angus F; Cochrane, Jodie

2014-04-01

A high level of participant skill is influential in determining the outcome of many sports. Thus, tests assessing skill outcomes in sport are commonly used by coaches and researchers to estimate an athlete's ability level, to evaluate the effectiveness of interventions or for the purpose of talent identification. The objective of this systematic review was to examine the methodological quality, measurement properties and feasibility characteristics of sporting skill outcome tests reported in the peer-reviewed literature. A search of both SPORTDiscus and MEDLINE databases was undertaken. Studies that examined tests of sporting skill outcomes were reviewed. Only studies that investigated measurement properties of the test (reliability or validity) were included. A total of 22 studies met the inclusion/exclusion criteria. A customised checklist of assessment criteria, based on previous research, was utilised for the purpose of this review. A range of sports were the subject of the 22 studies included in this review, with considerations relating to methodological quality being generally well addressed by authors. A range of methods and statistical procedures were used by researchers to determine the measurement properties of their skill outcome tests. The majority (95%) of the reviewed studies investigated test-retest reliability, and where relevant, inter and intra-rater reliability was also determined. Content validity was examined in 68% of the studies, with most tests investigating multiple skill domains relevant to the sport. Only 18% of studies assessed all three reviewed forms of validity (content, construct and criterion), with just 14% investigating the predictive validity of the test. Test responsiveness was reported in only 9% of studies, whilst feasibility received varying levels of attention. In organised sport, further tests may exist which have not been investigated in this review. This could be due to such tests firstly not being published in the peer-review literature and secondly, not having their measurement properties (i.e., reliability or validity) examined formally. Of the 22 studies included in this review, items relating to test methodological quality were, on the whole, well addressed. Test-retest reliability was determined in all but one of the reviewed studies, whilst most studies investigated at least two aspects of validity (i.e., content, construct or criterion-related validity). Few studies examined predictive validity or responsiveness. While feasibility was addressed in over half of the studies, practicality and test limitations were rarely addressed. Consideration of study quality, measurement properties and feasibility components assessed in this review can assist future researchers when developing or modifying tests of sporting skill outcomes.

A systematic review of evidence on the links between patient experience and clinical safety and effectiveness

PubMed Central

Doyle, Cathal; Lennox, Laura; Bell, Derek

2013-01-01

Objective To explore evidence on the links between patient experience and clinical safety and effectiveness outcomes. Design Systematic review. Setting A wide range of settings within primary and secondary care including hospitals and primary care centres. Participants A wide range of demographic groups and age groups. Primary and secondary outcome measures A broad range of patient safety and clinical effectiveness outcomes including mortality, physical symptoms, length of stay and adherence to treatment. Results This study, summarising evidence from 55 studies, indicates consistent positive associations between patient experience, patient safety and clinical effectiveness for a wide range of disease areas, settings, outcome measures and study designs. It demonstrates positive associations between patient experience and self-rated and objectively measured health outcomes; adherence to recommended clinical practice and medication; preventive care (such as health-promoting behaviour, use of screening services and immunisation); and resource use (such as hospitalisation, length of stay and primary-care visits). There is some evidence of positive associations between patient experience and measures of the technical quality of care and adverse events. Overall, it was more common to find positive associations between patient experience and patient safety and clinical effectiveness than no associations. Conclusions The data presented display that patient experience is positively associated with clinical effectiveness and patient safety, and support the case for the inclusion of patient experience as one of the central pillars of quality in healthcare. It supports the argument that the three dimensions of quality should be looked at as a group and not in isolation. Clinicians should resist sidelining patient experience as too subjective or mood-oriented, divorced from the ‘real’ clinical work of measuring safety and effectiveness. PMID:23293244

Predicting Well-being Longitudinally for Mothers Rearing Offspring with Intellectual and Developmental Disabilities

PubMed Central

Grein, Katherine A.; Glidden, Laraine Masters

2014-01-01

Background Well-being outcomes for parents of children with intellectual and developmental disabilities (IDD) may vary from positive to negative at different times and for different measures of well-being. Predicting and explaining this variability has been a major focus of family research for reasons that have both theoretical and applied implications. Methods The current study used data from a 23-year longitudinal investigation of adoptive and birth parents of children with IDD to determine which early child, mother, and family characteristics would predict the variance in maternal outcomes 20 years after their original measurement. Using hierarchical regression analyses, we tested the predictive power of variables measured when children were 7 years old on outcomes of maternal well-being when children were 26 years old. Outcome variables included maternal self-report measures of depression and well–being. Results Final models of well-being accounted for 20% to 34% of variance. For most outcomes, Family Accord and/or the personality variable of Neuroticism (emotional stability/instability) were significant predictors, but some variables demonstrated a different pattern. Conclusions These findings confirm that 1) Characteristics of the child, mother, and family during childhood can predict outcomes of maternal well-being 20 years later; and 2) Different predictor-outcome relationships can vary substantially, highlighting the importance of using multiple measures to gain a more comprehensive understanding of maternal well-being. These results have implications for refining prognoses for parents and for tailoring service delivery to individual child, parent, and family characteristics. PMID:25185956

Improving Value for Patients with Eczema.

PubMed

Block, Julie

2018-04-01

Chronic diseases now represent a cost majority in the United States health care system. Contributing factors to rising costs include expensive novel and emerging therapies, under-treatment of disease, under-management of comorbidities, and patient dissatisfaction with care results. Critical to identifying replicable improvement methods is a reliable model to measure value. If we understand value within healthcare consumerism to be equal to a patient's health outcome improvement over costs associated with care (Value=Outcomes/Costs), we can use this equation to measure the improvement of value. Research and literature show that patient activation-the skills and confidence that equip patients to become actively engaged in their health care-impact health outcomes, costs, and patient experience. Reaching patient activation through engagement methods including shared decision-making (SDM) lead to improved value of care received. The National Eczema Association (NEA) Shared Decision-Making Resource Center can be a transformative strategy to measure and evaluate value of health care interventions for eczema patients to advance a value-driven health care system in the United States. Through this Resource Center, NEA will measure patient value through their own perceptions using validated PRO instruments and other patient-generated health data. Assessment of this data will reveal findings that can assist researchers in evaluating the impact this care framework on patient-perceived value across other chronic diseases. Copyright © 2018 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Predicting sugar-sweetened behaviours with theory of planned behaviour constructs: Outcome and process results from the SIPsmartER behavioural intervention

PubMed Central

Zoellner, Jamie M.; Porter, Kathleen J.; Chen, Yvonnes; Hedrick, Valisa E.; You, Wen; Hickman, Maja; Estabrooks, Paul A.

2017-01-01

Objective Guided by the theory of planned behaviour (TPB) and health literacy concepts, SIPsmartER is a six-month multicomponent intervention effective at improving SSB behaviours. Using SIPsmartER data, this study explores prediction of SSB behavioural intention (BI) and behaviour from TPB constructs using: (1) cross-sectional and prospective models and (2) 11 single-item assessments from interactive voice response (IVR) technology. Design Quasi-experimental design, including pre- and post-outcome data and repeated-measures process data of 155 intervention participants. Main Outcome Measures Validated multi-item TPB measures, single-item TPB measures, and self-reported SSB behaviours. Hypothesised relationships were investigated using correlation and multiple regression models. Results TPB constructs explained 32% of the variance cross sectionally and 20% prospectively in BI; and explained 13–20% of variance cross sectionally and 6% prospectively. Single-item scale models were significant, yet explained less variance. All IVR models predicting BI (average 21%, range 6–38%) and behaviour (average 30%, range 6–55%) were significant. Conclusion Findings are interpreted in the context of other cross-sectional, prospective and experimental TPB health and dietary studies. Findings advance experimental application of the TPB, including understanding constructs at outcome and process time points and applying theory in all intervention development, implementation and evaluation phases. PMID:28165771

Evaluation of complex community-based childhood obesity prevention interventions.

PubMed

Karacabeyli, D; Allender, S; Pinkney, S; Amed, S

2018-05-16

Multi-setting, multi-component community-based interventions have shown promise in preventing childhood obesity; however, evaluation of these complex interventions remains a challenge. The objective of the study is to systematically review published methodological approaches to outcome evaluation for multi-setting community-based childhood obesity prevention interventions and synthesize a set of pragmatic recommendations. MEDLINE, CINAHL and PsycINFO were searched from inception to 6 July 2017. Papers were included if the intervention targeted children ≤18 years, engaged at least two community sectors and described their outcome evaluation methodology. A single reviewer conducted title and abstract scans, full article review and data abstraction. Directed content analysis was performed by three reviewers to identify prevailing themes. Thirty-three studies were included, and of these, 26 employed a quasi-experimental design; the remaining were randomized control trials. Body mass index was the most commonly measured outcome, followed by health behaviour change and psychosocial outcomes. Six themes emerged, highlighting advantages and disadvantages of active vs. passive consent, quasi-experimental vs. randomized control trials, longitudinal vs. repeat cross-sectional designs and the roles of process evaluation and methodological flexibility in evaluating complex interventions. Selection of study designs and outcome measures compatible with community infrastructure, accompanied by process evaluation, may facilitate successful outcome evaluation. © 2018 World Obesity Federation.

Influence of body habitus on feasibility and outcome of laparoscopic liver resections: a prospective study.

PubMed

Ratti, Francesca; D'Alessandro, Valentina; Cipriani, Federica; Giannone, Fabio; Catena, Marco; Aldrighetti, Luca

2016-06-01

The aim of the present study was to prospectively investigate whether the anthropometric measures of A Body Shape Index (ABSI, taking into account waist circumference adjusted for height and weight) affects feasibility and outcome of laparoscopic liver resections. One hundred patients undergoing laparoscopic liver resection were prospectively included in the study (2014-2015). Preoperative clinical parameters, including body mass index (BMI) and ABSI were evaluated for associations with intraoperative outcome and postoperative results (morbidity, mortality and functional recovery). Twenty-two and 78 patients underwent major and minor hepatectomies, respectively. Conversion rate was 9%, mean blood loss was 210 ± 115 ml. Postoperative morbidity was 15% and mortality was nil. Mean length of stay was 4 days. When considering the entire series, ABSI was not associated with intra and postoperative outcome. After stratification of patients according to difficulty score, Pearson's correlation demonstrated an association between ABSI and intraoperative blood loss (P = 0.03) and time for functional recovery (P = 0.05) in patients undergoing resections with high score of difficulty. Body habitus has an influence on outcome of laparoscopic liver resections with high degree of difficulty, while feasibility and outcome of low difficulty resections seem not to be affected by anthropometric measures. © 2016 Japanese Society of Hepato-Biliary-Pancreatic Surgery.

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

Core outcome measures for interventions to prevent or slow the progress of dementia for people living with mild to moderate dementia: Systematic review and consensus recommendations

PubMed Central

Groskreutz, Derek; Grinbergs-Saull, Anna; Howard, Rob; O’Brien, John T.; Mountain, Gail; Woods, Bob; Perneczky, Robert; McCleery, Jenny; Pickett, James; Challis, David; Charlesworth, Georgina; Featherstone, Katie; Jones, Roy; Schneider, Justine; Shepperd, Sasha; Thompson-Coon, Jo; Ballard, Clive; Burns, Alistair; Garrard, Peter; Kehoe, Patrick; Passmore, Peter; Robinson, Louise

2017-01-01

Background There are no disease-modifying treatments for dementia. There is also no consensus on disease modifying outcomes. We aimed to produce the first evidence-based consensus on core outcome measures for trials of disease modification in mild-to-moderate dementia. Methods and findings We defined disease-modification interventions as those aiming to change the underlying pathology. We systematically searched electronic databases and previous systematic reviews for published and ongoing trials of disease-modifying treatments in mild-to-moderate dementia. We included 149/22,918 of the references found; with 81 outcome measures from 125 trials. Trials involved participants with Alzheimer’s disease (AD) alone (n = 111), or AD and mild cognitive impairment (n = 8) and three vascular dementia. We divided outcomes by the domain measured (cognition, activities of daily living, biological markers, neuropsychiatric symptoms, quality of life, global). We calculated the number of trials and of participants using each outcome. We detailed psychometric properties of each outcome. We sought the views of people living with dementia and family carers in three cities through Alzheimer’s society focus groups. Attendees at a consensus conference (experts in dementia research, disease-modification and harmonisation measures) decided on the core set of outcomes using these results. Recommended core outcomes were cognition as the fundamental deficit in dementia and to indicate disease modification, serial structural MRIs. Cognition should be measured by Mini Mental State Examination or Alzheimer's Disease Assessment Scale-Cognitive Subscale. MRIs would be optional for patients. We also made recommendations for measuring important, but non-core domains which may not change despite disease modification. Limitations Most trials were about AD. Specific instruments may be superseded. We searched one database for psychometric properties. Interpretation This is the first review to identify the 81 outcome measures the research community uses for disease-modifying trials in mild-to-moderate dementia. Our recommendations will facilitate designing, comparing and meta-analysing disease modification trials in mild-to-moderate dementia, increasing their value. Trial registration PROSPERO no. CRD42015027346. PMID:28662127

Measures of outcome for stimulant trials: ACTTION recommendations and research agenda.

PubMed

Kiluk, Brian D; Carroll, Kathleen M; Duhig, Amy; Falk, Daniel E; Kampman, Kyle; Lai, Shengan; Litten, Raye Z; McCann, David J; Montoya, Ivan D; Preston, Kenzie L; Skolnick, Phil; Weisner, Constance; Woody, George; Chandler, Redonna; Detke, Michael J; Dunn, Kelly; Dworkin, Robert H; Fertig, Joanne; Gewandter, Jennifer; Moeller, F Gerard; Ramey, Tatiana; Ryan, Megan; Silverman, Kenneth; Strain, Eric C

2016-01-01

The development and approval of an efficacious pharmacotherapy for stimulant use disorders has been limited by the lack of a meaningful indicator of treatment success, other than sustained abstinence. In March, 2015, a meeting sponsored by Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) was convened to discuss the current state of the evidence regarding meaningful outcome measures in clinical trials for stimulant use disorders. Attendees included members of academia, funding and regulatory agencies, pharmaceutical companies, and healthcare organizations. The goal was to establish a research agenda for the development of a meaningful outcome measure that may be used as an endpoint in clinical trials for stimulant use disorders. Based on guidelines for the selection of clinical trial endpoints, the lessons learned from prior addiction clinical trials, and the process that led to identification of a meaningful indicator of treatment success for alcohol use disorders, several recommendations for future research were generated. These include a focus on the validation of patient reported outcome measures of functioning, the exploration of patterns of stimulant abstinence that may be associated with physical and/or psychosocial benefits, the role of urine testing for validating self-reported measures of stimulant abstinence, and the operational definitions for reduction-based measures in terms of frequency rather than quantity of stimulant use. These recommendations may be useful for secondary analyses of clinical trial data, and in the design of future clinical trials that may help establish a meaningful indicator of treatment success. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Computerised cognitive training in acquired brain injury: A systematic review of outcomes using the International Classification of Functioning (ICF).

PubMed

Sigmundsdottir, Linda; Longley, Wendy A; Tate, Robyn L

2016-10-01

Computerised cognitive training (CCT) is an increasingly popular intervention for people experiencing cognitive symptoms. This systematic review evaluated the evidence for CCT in adults with acquired brain injury (ABI), focusing on how outcome measures used reflect efficacy across components of the International Classification of Functioning, Disability and Health. Database searches were conducted of studies investigating CCT to treat cognitive symptoms in adult ABI. Scientific quality was rated using the PEDro-P and RoBiNT Scales. Ninety-six studies met the criteria. Most studies examined outcomes using measures of mental functions (93/96, 97%); fewer studies included measures of activities/participation (41/96, 43%) or body structures (8/96, 8%). Only 14 studies (15%) provided Level 1 evidence (randomised controlled trials with a PEDro-P score ≥ 6/10), with these studies suggesting strong evidence for CCT improving processing speed in multiple sclerosis (MS) and moderate evidence for improving memory in MS and brain tumour populations. There is a large body of research examining the efficacy of CCT, but relatively few Level 1 studies and evidence is largely limited to body function outcomes. The routine use of outcome measures of activities/participation would provide more meaningful evidence for the efficacy of CCT. The use of body structure outcome measures (e.g., neuroimaging) is a newly emerging area, with potential to increase understanding of mechanisms of action for CCT.

Measuring outcomes in adult spinal deformity surgery: a systematic review to identify current strengths, weaknesses and gaps in patient-reported outcome measures.

PubMed

Faraj, Sayf S A; van Hooff, Miranda L; Holewijn, Roderick M; Polly, David W; Haanstra, Tsjitske M; de Kleuver, Marinus

2017-08-01

Adult spinal deformity (ASD) causes severe disability, reduces overall quality of life, and results in a substantial societal burden of disease. As healthcare is becoming more value based, and to facilitate global benchmarking, it is critical to identify and standardize patient-reported outcome measures (PROMs). This study aims to identify the current strengths, weaknesses, and gaps in PROMs used for ASD. Studies were included following a systematic search in multiple bibliographic databases between 2000 and 2015. PROMs were extracted and linked to the outcome domains of WHO's International Classification of Functioning and Health (ICF) framework. Subsequently, the clinimetric quality of identified PROMs was evaluated. The literature search identified 144 papers that met the inclusion criteria, and nine frequently used PROMs were identified. These covered 29 ICF outcome domains, which could be grouped into three of the four main ICF chapters: body function (n = 7), activity and participation (n = 19), environmental factors (n = 3), and body structure (n = 0). A low quantity (n = 3) of papers was identified that studied the clinimetric quality of PROMs. The Scoliosis Research Society (SRS)-22 has the highest level of clinimetric quality for ASD. Outcome domains related to mobility and pain were well represented. We identified a gap in current outcome measures regarding neurological and pulmonary function. In addition, no outcome domains were measured in the ICF chapter body structure. These results will serve as a foundation for the process of seeking international consensus on a standard set of outcome domains, accompanied PROMs and contributing factors to be used in future clinical trials and spine registries.

Psychometric evaluation of dietary self-efficacy and outcome expectation scales in female college freshmen.

PubMed

Kedem, Leia E; Evans, Ellen M; Chapman-Novakofski, Karen

2014-11-01

Lifestyle interventions commonly measure psychosocial beliefs as precursors to positive behavior change, but often overlook questionnaire validation. This can affect measurement accuracy if the survey has been developed for a different population, as differing behavioral influences may affect instrument validity. The present study aimed to explore psychometric properties of self-efficacy and outcome expectation scales-originally developed for younger children-in a population of female college freshmen (N = 268). Exploratory principal component analysis was used to investigate underlying data patterns and assess validity of previously published subscales. Composite scores for reliable subscales (Cronbach's α ≥ .70) were calculated to help characterize self-efficacy and outcome expectation beliefs in this population. The outcome expectation factor structure clearly comprised of positive (α = .81-.90) and negative outcomes (α = .63-.67). The self-efficacy factor structure included themes of motivation and effort (α = .75-.94), but items pertaining to hunger and availability cross-loaded often. Based on cross-loading patterns and low Cronbach's alpha values, respectively, self-efficacy items regarding barriers to healthy eating and negative outcome expectation items should be refined to improve reliability. Composite scores suggested that eating healthfully was associated with positive outcomes, but self-efficacy to do so was lower. Thus, dietary interventions for college students may be more successful by including skill-building activities to enhance self-efficacy and increase the likelihood of behavior change. © The Author(s) 2014.

Evaluation of interventions for informed consent for randomised controlled trials (ELICIT): protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey.

PubMed

Gillies, Katie; Entwistle, Vikki; Treweek, Shaun P; Fraser, Cynthia; Williamson, Paula R; Campbell, Marion K

2015-10-27

The process of obtaining informed consent for participation in randomised controlled trials (RCTs) was established as a mechanism to protect participants against undue harm from research and allow people to recognise any potential risks or benefits associated with the research. A number of interventions have been put forward to improve this process. Outcomes reported in trials of interventions to improve the informed consent process for decisions about trial participation tend to focus on the 'understanding' of trial information. However, the operationalization of understanding as a concept, the tools used to measure it and the timing of the measurements are heterogeneous. A lack of clarity exists regarding which outcomes matter (to whom) and why. This inconsistency between studies results in difficulties when making comparisons across studies as evidenced in two recent systematic reviews of informed consent interventions. As such, no optimal method for measuring the impact of these interventions aimed at improving informed consent for RCTs has been identified. The project will adopt and adapt methodology previously developed and used in projects developing core outcome sets for assessment of clinical treatments. Specifically, the work will consist of three stages: 1) A systematic methodology review of existing outcome measures of trial informed consent interventions; 2) Interviews with key stakeholders to explore additional outcomes relevant for trial participation decisions; and 3) A Delphi study to refine the core outcome set for evaluation of trial informed consent interventions. All stages will include the stakeholders involved in the various aspects of RCT consent: users (that is, patients), developers (that is, trialists), deliverers (focusing on research nurses) and authorisers (that is, ethics committees). A final consensus meeting including all stakeholders will be held to review outcomes. The ELICIT study aims to develop a core outcome set for the evaluation of interventions intended to improve informed consent for RCTs for use in future RCTs and reviews, thereby improving the reliability and consistency of research in this area.

Child characteristics associated with outcome for children with autism in a school-based behavioral intervention.

PubMed

Pellecchia, Melanie; Connell, James E; Kerns, Connor M; Xie, Ming; Marcus, Steven C; Mandell, David S

2016-04-01

This study examined the extent to which clinical and demographic characteristics predicted outcome for children with autism spectrum disorder. Participants included 152 students with autism spectrum disorder in 53 kindergarten-through-second-grade autism support classrooms in a large urban public school district. Associations between child characteristics (including age, language ability, autism severity, social skills, adaptive behavior, co-occurring psychological symptoms, and restrictive and repetitive behavior) and outcome, as measured by changes in cognitive ability following one academic year of an intervention standardized across the sample were evaluated using linear regression with random effects for classroom. While several scales and subscales had statistically significant bivariate associations with outcome, in adjusted analysis, only age and the presence of symptoms associated with social anxiety, such as social avoidance and social fearfulness, as measured through the Child Symptom Inventory-4, were associated with differences in outcome. The findings regarding the role of social anxiety are new and have important implications for treatment. Disentangling the construct of social anxiety to differentiate between social fearfulness and social motivation has important implications for shifting the focus of early treatment for children with autism spectrum disorder. © The Author(s) 2015.

A systematic review of leadership training for medical students.

PubMed

Lyons, Oscar; Su'a, Bruce; Locke, Michelle; Hill, Andrew

2018-01-19

Leadership is increasingly being recognised as an essential requirement for doctors. Many medical schools are in the process of developing formal leadership training programmes, but it remains to be elucidated what characteristics make such programmes effective, and to what extent current programmes are effective, beyond merely positive learner reactions. This review's objective was to investigate the effectiveness of undergraduate medical leadership curricula and to explore common features of effective curricula. A systematic literature search was conducted. Articles describing and evaluating undergraduate medical leadership curricula were included. Outcomes were stratified and analysed according to a modified Kirkpatrick's model for evaluating educational outcomes. Eleven studies met inclusion criteria. Leadership curricula evaluated were markedly heterogeneous in their duration and composition. The majority of studies utilised pre- and post- intervention questionnaires for evaluation. Two studies described randomised controlled trials with objective measures. Outcomes were broadly positive. Only one study reported neutral outcomes. A wide range of leadership curricula have shown subjective effectiveness, including short interventions. There is limited objective evidence however, and few studies have measured effectiveness at the system and patient levels. Further research is needed investigating objective and downstream outcomes, and use of standard frameworks for evaluation will facilitate effective comparison of initiatives.

Strength, Multijoint Coordination, and Sensorimotor Processing Are Independent Contributors to Overall Balance Ability

PubMed Central

Lawrence, Emily L.; Cesar, Guilherme M.; Bromfield, Martha R.; Peterson, Richard; Valero-Cuevas, Francisco J.; Sigward, Susan M.

2015-01-01

For young adults, balance is essential for participation in physical activities but is often disrupted following lower extremity injury. Clinical outcome measures such as single limb balance (SLB), Y-balance (YBT), and the single limb hop and balance (SLHB) tests are commonly used to quantify balance ability following injury. Given the varying demands across tasks, it is likely that such outcome measures provide useful, although task-specific, information. But the extent to which they are independent and contribute to understanding the multiple contributors to balance is not clear. Therefore, the purpose of this study was to investigate the associations among these measures as they relate to the different contributors to balance. Thirty-seven recreationally active young adults completed measures including Vertical Jump, YBT, SLB, SLHB, and the new Lower Extremity Dexterity test. Principal components analysis revealed that these outcome measures could be thought of as quantifying the strength, multijoint coordination, and sensorimotor processing contributors to balance. Our results challenge the practice of using a single outcome measure to quantify the naturally multidimensional mechanisms for everyday functions such as balance. This multidimensional approach to, and interpretation of, multiple contributors to balance may lead to more effective, specialized training and rehabilitation regimens. PMID:26665007

Functional swallowing outcomes following treatment for oropharyngeal carcinoma: a systematic review of the evidence comparing trans-oral surgery versus non-surgical management.

PubMed

Dawe, N; Patterson, J; O'Hara, J

2016-08-01

Trans-oral surgical and non-surgical management options for oropharyngeal squamous cell carcinoma (OPSCC) appear to offer similar survival outcomes. Functional outcomes, in particular swallowing, have become of increasing interest in the debate regarding treatment options. Contemporary reviews on function following treatment frequently include surrogate markers and limit the value of comparative analysis. A systematic review was performed to establish whether direct comparisons of swallowing outcomes could be made between trans-oral surgical approaches (trans-oral laser microsurgery (TLM)/trans-oral robotic surgery (TORS)) and (chemo)radiotherapy ((C)RT). Systematic review. MEDLINE, Embase and Cochrane databases were interrogated using the following MeSH terms: antineoplastic protocols, chemotherapy, radiotherapy, deglutition disorders, swallowing, lasers, and trans-oral surgery. Two authors performed independent systematic reviews and consensus was sought if opinions differed. The WHO ICF classification was applied to generate analysis based around body functions and structure, activity limitations and participation restriction. Thirty-seven citations were included in the analysis. Twenty-six papers reported the outcomes for OPSCC treatment following primary (C)RT in 1377 patients, and 15 papers following contemporary trans-oral approaches in 768 patients. Meta-analysis was not feasible due to varying methodology and heterogeneity of outcome measures. Instrumental swallowing assessments were presented in 13/26 (C)RT versus 2/15 TLM/TORS papers. However, reporting methods of these studies were not standardised. This variety of outcome measures and the wide-ranging intentions of authors applying the measures in individual studies limit any practical direct comparisons of the effects of treatment on swallowing outcomes between interventions. From the current evidence, no direct comparisons could be made of swallowing outcomes between the surgical and non-surgical modalities. Swallowing is a multidimensional construct, and the range of assessments utilised by authors reflects the variety of available reporting methods. The MD Anderson Dysphagia Inventory is a subjective measure that allows limited comparison between the currently available heterogeneous data, and is explored in detail. The findings highlight that further research may identify the most appropriate tools for measuring swallowing in patients with OPSCC. Consensus should allow their standardised integration into future studies and randomised control trials. © 2015 John Wiley & Sons Ltd.

Core outcome sets for research and clinical practice.

PubMed

Chiarotto, Alessandro; Ostelo, Raymond W; Turk, Dennis C; Buchbinder, Rachelle; Boers, Maarten

This masterclass introduces the topic of core outcome sets, describing rationale and methods for developing them, and providing some examples that are relevant for clinical research and practice. A core outcome set is a minimum consensus-based set of outcomes that should be measured and reported in all clinical trials for a specific health condition and/or intervention. Issues surrounding outcome assessment, such as selective reporting and inconsistency across studies, can be addressed by the development of a core set. As suggested by key initiatives in this field (i.e. OMERACT and COMET), the development requires achieving consensus on: (1) core outcome domains and (2) core outcome measurement instruments. Different methods can be used to reach consensus, including: literature systematic reviews to inform the process, qualitative research with clinicians and patients, group discussions (e.g. nominal group technique), and structured surveys (e.g. Delphi technique). Various stakeholders should be involved in the process, with particular attention to patients. Several COSs have been developed for musculoskeletal conditions including a longstanding one for low back pain, IMMPACT recommendations on outcomes for chronic pain, and OMERACT COSs for hip, knee and hand osteoarthritis. There is a lack of COSs for neurological, geriatric, cardio-respiratory and pediatric conditions, therefore, future research could determine the value of developing COSs for these conditions. Copyright © 2017 Associação Brasileira de Pesquisa e Pós-Graduação em Fisioterapia. Publicado por Elsevier Editora Ltda. All rights reserved.

The Impact of Information Technology on Patient Engagement and Health Behavior Change: A Systematic Review of the Literature

PubMed Central

Rashrash, Mohamed; Phalakornkule, Kanitha; Carpenter, Janet S; Jones, Josette F

2016-01-01

Background Advancements in information technology (IT) and its increasingly ubiquitous nature expand the ability to engage patients in the health care process and motivate health behavior change. Objective Our aim was to systematically review the (1) impact of IT platforms used to promote patients’ engagement and to effect change in health behaviors and health outcomes, (2) behavior theories or models applied as bases for developing these interventions and their impact on health outcomes, (3) different ways of measuring health outcomes, (4) usability, feasibility, and acceptability of these technologies among patients, and (5) challenges and research directions for implementing IT platforms to meaningfully impact patient engagement and health outcomes. Methods PubMed, Web of Science, PsycINFO, and Google Scholar were searched for studies published from 2000 to December 2014. Two reviewers assessed the quality of the included papers, and potentially relevant studies were retrieved and assessed for eligibility based on predetermined inclusion criteria. Results A total of 170 articles met the inclusion criteria and were reviewed in detail. Overall, 88.8% (151/170) of studies showed positive impact on patient behavior and 82.9% (141/170) reported high levels of improvement in patient engagement. Only 47.1% (80/170) referenced specific behavior theories and only 33.5% (57/170) assessed the usability of IT platforms. The majority of studies used indirect ways to measure health outcomes (65.9%, 112/170). Conclusions In general, the review has shown that IT platforms can enhance patient engagement and improve health outcomes. Few studies addressed usability of these interventions, and the reason for not using specific behavior theories remains unclear. Further research is needed to clarify these important questions. In addition, an assessment of these types of interventions should be conducted based on a common framework using a large variety of measurements; these measurements should include those related to motivation for health behavior change, long-standing adherence, expenditure, satisfaction, and health outcomes. PMID:26795082

Neutrophil, lymphocyte and platelet counts, and risk of prostate cancer outcomes in white and black men: results from the SEARCH database.

PubMed

Vidal, Adriana C; Howard, Lauren E; de Hoedt, Amanda; Cooperberg, Matthew R; Kane, Christopher J; Aronson, William J; Terris, Martha K; Amling, Christopher L; Taioli, Emanuela; Fowke, Jay H; Freedland, Stephen J

2018-06-01

Systemic inflammation, as measured by C-reactive protein, has been linked with poor prostate cancer (PC) outcomes, predominantly in white men. Whether other immune measures like white blood cell counts are correlated with PC progression and whether results vary by race is unknown. We examined whether complete blood count (CBC) parameters were associated with PC outcomes and whether these associations varied by race. Analyses include 1,826 radical prostatectomy patients from six VA hospitals followed through medical record review for biochemical recurrence (BCR). Secondary outcomes included castration-resistant PC (CRPC), metastasis, all-cause mortality (ACM), and PC-specific mortality (PCSM). Cox-proportional hazards were used to assess the associations between pre-operative neutrophils, lymphocytes, platelets, neutrophil-lymphocyte ratio (NLR), and platelet-lymphocyte ratio (PLR) with each outcome. We used a Bonferroni-corrected p-value of 0.05/5 = 0.01 as the threshold for statistical significance. Of 1,826 men, 794 (43%) were black and 1,032 (57%) white. Neutrophil count (p < 0.001), NLR (p < 0.001), and PLR (p < 0.001) were significantly lower, while lymphocyte count (p < 0.001) was significantly higher in black versus white men. After adjusting for clinicopathological features, no CBC measures were significantly associated with BCR. There were no interactions between CBC and race in predicting BCR. Similarly, no CBC values were significantly associated with CRPC, metastases, or PCSM either among all men or when stratified by race. However, higher neutrophil count was associated with higher ACM risk in white men (p = 0.004). Pre-operative CBC measures were not associated with PC outcomes in black or white men undergoing radical prostatectomy, except for neutrophils-positive association with risk of ACM in white men. Whether circulating immune cell markers provide insight to the pathophysiology of PC progression or adverse treatment outcomes requires further study.

Orthodontic trial outcomes: Plentiful, inconsistent, and in need of uniformity? A scoping review.

PubMed

Tsichlaki, Aliki; O'Brien, Kevin; Johal, Ama; Fleming, Padhraig S

2018-06-01

The selection of appropriate outcomes that matter to both patients and operators is increasingly appreciated, with core outcome sets in clinical trials gaining in popularity. The first step in core outcome set development is the generation of a list of possible important outcomes based on a scoping literature review. Moreover, outcome heterogeneity is known to detract from the findings of systematic reviews and meta-analyses. The aim of this study was to identify the range of outcome domains and specific outcome measures in contemporary orthodontic research. Multiple electronic databases were searched from December 31, 2012, to December 31, 2016, to identify clinical trials of orthodontic interventions, with no language restrictions. Abstracts, eligible full texts, and reference lists were screened, and all reported primary and nonprimary outcomes and methods of measurement were recorded. The search identified 1267 abstracts, of which 189 full-text articles were retrieved, and 164 studies were included in the analysis. A total of 54 outcomes were identified and categorized into 14 outcome domains. The most frequently measured outcomes were patient-reported pain, periodontal health, tooth angulation/inclination changes, and treatment duration, followed by rate of tooth movement and skeletal changes. Outcomes that followed the overall course of treatment were assessed in only 14 studies. Patient perspectives are increasingly being accounted for in orthodontic trials; however, there is little consistency in outcome selection among them. The identified list of outcomes will be used to inform a ranking exercise with service users and providers to establish an agreed core outcome set for future orthodontic clinical trials. Copyright © 2018 American Association of Orthodontists. Published by Elsevier Inc. All rights reserved.

Does the addition of two exercise-focussed home visits to usual care improve outcomes for patients with balance impairments? A randomized controlled trial.

PubMed

Whitbourne, Craig; Shields, Nora; Tacey, Mark; Koh, Kenneth Wz; Lawler, Katherine; Hill, Keith D

2018-03-01

To investigate whether two additional home visits improve outcomes for rehabilitation outpatients with balance impairments compared to usual care. Randomized controlled trial. Outpatient rehabilitation. Fifty with balance impairments. Both groups received usual care including weekly group exercise over eight weeks. The intervention group received two home visits to individualize home exercises. Primary outcome measure was the Balance Outcome Measure for Elder Rehabilitation (BOOMER) score, and secondary outcomes included force platform measures using the NeuroCom Balance Master ® , assessed at baseline, after intervention and three-month follow-up. There was no between-group difference for BOOMER score. There were significant between-group differences in favour of the intervention group for limits of stability reaction time at week 9 (mean difference (MD) -0.27, 95% confidence interval (CI) -0.44 to -0.09) and week 22 (MD -0.28, 95% CI -0.45 to -0.10) and for limits of stability maximal excursion at week 9 (MD 8.66, 95% CI 1.67 to 15.65) and week 22 (MD 14.58, 95% CI 7.59 to 21.57). Significant between-group differences favoured the control group for Clinical Test of Sensory Interaction of Balance at week 9 (MD 0.40, 95% CI 0.13 to 0.66) and week 22 (MD 0.45, 95% CI 0.18 to 0.72) and step quick turn time at week 9 (MD 0.56, 95% CI 0.02 to 1.10). Two exercise-focussed home visits improved some dynamic balance outcomes in older patients with balance impairments. Some outcomes showed significant improvements with small effect sizes in favour of the control group which may be chance findings or because they completed a standard home exercise programme.

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.

Teacher, parent, and peer reports of early aggression as screening measures for long-term maladaptive outcomes: Who provides the most useful information?

PubMed Central

Clemans, Katherine H.; Musci, Rashelle J.; Leoutsakos, Jeannie-Marie S.; Ialongo, Nicholas S.

2014-01-01

Objective This study compared the ability of teacher, parent, and peer reports of aggressive behavior in early childhood to accurately classify cases of maladaptive outcomes in late adolescence and early adulthood. Method Weighted kappa analyses determined optimal cut points and relative classification accuracy among teacher, parent, and peer reports of aggression assessed for 691 students (54% male; 84% African American, 13% White) in the fall of first grade. Outcomes included antisocial personality, substance use, incarceration history, risky sexual behavior, and failure to graduate from high school on time. Results Peer reports were the most accurate classifier of all outcomes in the full sample. For most outcomes, the addition of teacher or parent reports did not improve overall classification accuracy once peer reports were accounted for. Additional gender-specific and adjusted kappa analyses supported the superior classification utility of the peer report measure. Conclusion The results suggest that peer reports provided the most useful classification information of the three aggression measures. Implications for targeted intervention efforts which use screening measures to identify at-risk children are discussed. PMID:24512126

What quantum measurements measure

NASA Astrophysics Data System (ADS)

Griffiths, Robert B.

2017-09-01

A solution to the second measurement problem, determining what prior microscopic properties can be inferred from measurement outcomes ("pointer positions"), is worked out for projective and generalized (POVM) measurements, using consistent histories. The result supports the idea that equipment properly designed and calibrated reveals the properties it was designed to measure. Applications include Einstein's hemisphere and Wheeler's delayed choice paradoxes, and a method for analyzing weak measurements without recourse to weak values. Quantum measurements are noncontextual in the original sense employed by Bell and Mermin: if [A ,B ]=[A ,C ]=0 ,[B ,C ]≠0 , the outcome of an A measurement does not depend on whether it is measured with B or with C . An application to Bohm's model of the Einstein-Podolsky-Rosen situation suggests that a faulty understanding of quantum measurements is at the root of this paradox.

Wound healing outcomes: Using big data and a modified intent-to-treat method as a metric for reporting healing rates.

PubMed

Ennis, William J; Hoffman, Rachel A; Gurtner, Geoffrey C; Kirsner, Robert S; Gordon, Hanna M

2017-08-01

Chronic wounds are increasing in prevalence and are a costly problem for the US healthcare system and throughout the world. Typically outcomes studies in the field of wound care have been limited to small clinical trials, comparative effectiveness cohorts and attempts to extrapolate results from claims databases. As a result, outcomes in real world clinical settings may differ from these published studies. This study presents a modified intent-to-treat framework for measuring wound outcomes and measures the consistency of population based outcomes across two distinct settings. In this retrospective observational analysis, we describe the largest to date, cohort of patient wound outcomes derived from 626 hospital based clinics and one academic tertiary care clinic. We present the results of a modified intent-to-treat analysis of wound outcomes as well as demographic and descriptive data. After applying the exclusion criteria, the final analytic sample includes the outcomes from 667,291 wounds in the national sample and 1,788 wounds in the academic sample. We found a consistent modified intent to treat healing rate of 74.6% from the 626 clinics and 77.6% in the academic center. We recommend that a standard modified intent to treat healing rate be used to report wound outcomes to allow for consistency and comparability in measurement across providers, payers and healthcare systems. © 2017 by the Wound Healing Society.

Physical Therapy and Exercise Interventions in Huntington's Disease: A Mixed Methods Systematic Review.

PubMed

Fritz, Nora E; Rao, Ashwini K; Kegelmeyer, Deb; Kloos, Anne; Busse, Monica; Hartel, Lynda; Carrier, Judith; Quinn, Lori

2017-01-01

A number of studies evaluating physical therapy and exercise interventions in Huntington's disease have been conducted over the past 15 years. However, an assessment of the quality and strength of the evidence in support of these interventions is lacking. The purpose of this systematic review was to investigate the effectiveness of physical therapy and exercise interventions in people with Huntington's disease, and to examine the perceptions of patients, families and caregivers of these interventions. This mixed-methods systematic review utilized the Joanna Briggs Institute (JBI) approach and extraction tools to evaluate the literature from January 2003 until May 2016. The review considered interventions that included exercise and physical therapy interventions, and included both quantitative and qualitative outcome measures. Twenty (20) studies met the inclusion criteria, including eighteen (18) that had quantitative outcome measures and two (2) that utilized qualitative methods. JBI Levels of evidence for the 18 quantitative studies were as follows: Eight studies were at evidence Level 1, seven were at Level 2, two were at Level 3, and one was at Level 4. Our review suggests that there is preliminary support for the benefits of exercise and physical activity in Huntington's disease in terms of motor function, gait speed, and balance, as well as a range of physical and social benefits identified through patient-reported outcomes. Variability in mode of intervention as well as outcome measures limits the interpretability of these studies, and high-quality studies that incorporate adaptive trial designs for this rare disease are needed.

Prognostic value of quantitative sensory testing in low back pain: a systematic review of the literature

PubMed Central

Marcuzzi, Anna; Dean, Catherine M; Wrigley, Paul J; Chakiath, Rosemary J; Hush, Julia M

2016-01-01

Quantitative sensory testing (QST) measures have recently been shown to predict outcomes in various musculoskeletal and pain conditions. The aim of this systematic review was to summarize the emerging body of evidence investigating the prognostic value of QST measures in people with low back pain (LBP). The protocol for this review was prospectively registered on the International Prospective Register of Systematic Reviews. An electronic search of six databases was conducted from inception to October 2015. Experts in the field were contacted to retrieve additional unpublished data. Studies were included if they were prospective longitudinal in design, assessed at least one QST measure in people with LBP, assessed LBP status at follow-up, and reported the association of QST data with LBP status at follow-up. Statistical pooling of results was not possible due to heterogeneity between studies. Of 6,408 references screened after duplicates removed, three studies were finally included. None of them reported a significant association between the QST measures assessed and the LBP outcome. Three areas at high risk of bias were identified which potentially compromise the validity of these results. Due to the paucity of available studies and the methodological shortcomings identified, it remains unknown whether QST measures are predictive of outcome in LBP. PMID:27660486

Prognostic value of quantitative sensory testing in low back pain: a systematic review of the literature.

PubMed

Marcuzzi, Anna; Dean, Catherine M; Wrigley, Paul J; Chakiath, Rosemary J; Hush, Julia M

2016-01-01

Quantitative sensory testing (QST) measures have recently been shown to predict outcomes in various musculoskeletal and pain conditions. The aim of this systematic review was to summarize the emerging body of evidence investigating the prognostic value of QST measures in people with low back pain (LBP). The protocol for this review was prospectively registered on the International Prospective Register of Systematic Reviews. An electronic search of six databases was conducted from inception to October 2015. Experts in the field were contacted to retrieve additional unpublished data. Studies were included if they were prospective longitudinal in design, assessed at least one QST measure in people with LBP, assessed LBP status at follow-up, and reported the association of QST data with LBP status at follow-up. Statistical pooling of results was not possible due to heterogeneity between studies. Of 6,408 references screened after duplicates removed, three studies were finally included. None of them reported a significant association between the QST measures assessed and the LBP outcome. Three areas at high risk of bias were identified which potentially compromise the validity of these results. Due to the paucity of available studies and the methodological shortcomings identified, it remains unknown whether QST measures are predictive of outcome in LBP.

Development of a Draft Core Set of Domains for Measuring Shared Decision Making in Osteoarthritis: An OMERACT Working Group on Shared Decision Making.

PubMed

Toupin-April, Karine; Barton, Jennifer; Fraenkel, Liana; Li, Linda; Grandpierre, Viviane; Guillemin, Francis; Rader, Tamara; Stacey, Dawn; Légaré, France; Jull, Janet; Petkovic, Jennifer; Scholte-Voshaar, Marieke; Welch, Vivian; Lyddiatt, Anne; Hofstetter, Cathie; De Wit, Maarten; March, Lyn; Meade, Tanya; Christensen, Robin; Gaujoux-Viala, Cécile; Suarez-Almazor, Maria E; Boonen, Annelies; Pohl, Christoph; Martin, Richard; Tugwell, Peter S

2015-12-01

Despite the importance of shared decision making for delivering patient-centered care in rheumatology, there is no consensus on how to measure its process and outcomes. The aim of this Outcome Measures in Rheumatology (OMERACT) working group is to determine the core set of domains for measuring shared decision making in intervention studies in adults with osteoarthritis (OA), from the perspectives of patients, health professionals, and researchers. We followed the OMERACT Filter 2.0 method to develop a draft core domain set by (1) forming an OMERACT working group; (2) conducting a review of domains of shared decision making; and (3) obtaining opinions of all those involved using a modified nominal group process held at a session activity at the OMERACT 12 meeting. In all, 26 people from Europe, North America, and Australia, including 5 patient research partners, participated in the session activity. Participants identified the following domains for measuring shared decision making to be included as part of the draft core set: (1) identifying the decision, (2) exchanging information, (3) clarifying views, (4) deliberating, (5) making the decision, (6) putting the decision into practice, and (7) assessing the effect of the decision. Contextual factors were also suggested. We proposed a draft core set of shared decision-making domains for OA intervention research studies. Next steps include a workshop at OMERACT 13 to reach consensus on these proposed domains in the wider OMERACT group, as well as to detail subdomains and assess instruments to develop a core outcome measurement set.

Assessing Adult Exposure to Community Violence: A Review of Definitions and Measures.

PubMed

DeCou, Christopher R; Lynch, Shannon M

2017-01-01

Although experiences of community violence are linked with negative outcomes for adults and children, few standardized measures assessing community violence exist, and available measures lack consistency concerning the definition of community violence. Further, most measures currently utilized to assess adult exposure to community violence were designed for use with children and adolescents. To address these identified concerns and make recommendations for future research, this article reviews contemporary definitions of community violence, identifies the outcomes of exposure to community violence for adults, and evaluates measures of exposure to community violence with published psychometric data employing adult samples. A systematic review of the literature was conducted to identify studies that (1) included a self-report of community violence exposure, (2) included primarily adult respondents, and (3) reported psychometric data. Seventeen studies met the inclusion criteria. Measures employed in these studies were reviewed and basic psychometric properties discussed. Notably, the Survey of Exposure to Community Violence was the most commonly used measure among these studies. Although multiple measures demonstrated limited but acceptable psychometric performance in select studies, few in-depth psychometric analyses exist for measures of adult exposure to community violence. Also, it is difficult to compare studies due to variations in definitions of community violence and multiple versions of each measure. Recommendations for future research include provision of explicit definitions of community violence and reporting psychometric data for measures. © The Author(s) 2015.

Do Natural Experiments of Changes in Neighborhood Built Environment Impact Physical Activity and Diet? A Systematic Review

PubMed Central

George, Emma S.; Feng, Xiaoqi; Merom, Dafna; Bennie, Andrew; Cook, Amelia; Dwyer, Genevieve; Pang, Bonnie; Astell-Burt, Thomas

2018-01-01

Physical activity and diet are major modifiable risk factors for chronic disease and have been shown to be associated with neighborhood built environment. Systematic review evidence from longitudinal studies on the impact of changing the built environment on physical activity and diet is currently lacking. A systematic review of natural experiments of neighborhood built environment was conducted. The aims of this systematic review were to summarize study characteristics, study quality, and impact of changes in neighborhood built environment on physical activity and diet outcomes among residents. Natural experiments of neighborhood built environment change, exploring longitudinal impacts on physical activity and/or diet in residents, were included. From five electronic databases, 2084 references were identified. A narrative synthesis was conducted, considering results in relation to study quality. Nineteen papers, reporting on 15 different exposures met inclusion criteria. Four studies included a comparison group and 11 were pre-post/longitudinal studies without a comparison group. Studies reported on the impact of redeveloping or introducing cycle and/or walking trails (n = 5), rail stops/lines (n = 4), supermarkets and farmers’ markets (n = 4) and park and green space (n = 2). Eight/15 studies reported at least one beneficial change in physical activity, diet or another associated health outcome. Due to limitations in study design and reporting, as well as the wide array of outcome measures reported, drawing conclusions to inform policy was challenging. Future research should consider a consistent approach to measure the same outcomes (e.g., using measurement methods that collect comparable physical activity and diet outcome data), to allow for pooled analyses. Additionally, including comparison groups wherever possible and ensuring high quality reporting is essential. PMID:29373567

Do Natural Experiments of Changes in Neighborhood Built Environment Impact Physical Activity and Diet? A Systematic Review.

PubMed

MacMillan, Freya; George, Emma S; Feng, Xiaoqi; Merom, Dafna; Bennie, Andrew; Cook, Amelia; Sanders, Taren; Dwyer, Genevieve; Pang, Bonnie; Guagliano, Justin M; Kolt, Gregory S; Astell-Burt, Thomas

2018-01-26

Physical activity and diet are major modifiable risk factors for chronic disease and have been shown to be associated with neighborhood built environment. Systematic review evidence from longitudinal studies on the impact of changing the built environment on physical activity and diet is currently lacking. A systematic review of natural experiments of neighborhood built environment was conducted. The aims of this systematic review were to summarize study characteristics, study quality, and impact of changes in neighborhood built environment on physical activity and diet outcomes among residents. Natural experiments of neighborhood built environment change, exploring longitudinal impacts on physical activity and/or diet in residents, were included. From five electronic databases, 2084 references were identified. A narrative synthesis was conducted, considering results in relation to study quality. Nineteen papers, reporting on 15 different exposures met inclusion criteria. Four studies included a comparison group and 11 were pre-post/longitudinal studies without a comparison group. Studies reported on the impact of redeveloping or introducing cycle and/or walking trails ( n = 5), rail stops/lines ( n = 4), supermarkets and farmers' markets ( n = 4) and park and green space ( n = 2). Eight/15 studies reported at least one beneficial change in physical activity, diet or another associated health outcome. Due to limitations in study design and reporting, as well as the wide array of outcome measures reported, drawing conclusions to inform policy was challenging. Future research should consider a consistent approach to measure the same outcomes (e.g., using measurement methods that collect comparable physical activity and diet outcome data), to allow for pooled analyses. Additionally, including comparison groups wherever possible and ensuring high quality reporting is essential.

Approach bias modification training and consumption: A review of the literature.

PubMed

Kakoschke, Naomi; Kemps, Eva; Tiggemann, Marika

2017-01-01

Recent theoretical perspectives and empirical evidence have suggested that biased cognitive processing is an important contributor to unhealthy behaviour. Approach bias modification is a novel intervention in which approach biases for appetitive cues are modified. The current review of the literature aimed to evaluate the effectiveness of modifying approach bias for harmful consumption behaviours, including alcohol use, cigarette smoking, and unhealthy eating. Relevant publications were identified through a search of four electronic databases (PsycINFO, Google Scholar, ScienceDirect and Scopus) that were conducted between October and December 2015. Eligibility criteria included the use of a human adult sample, at least one session of avoidance training, and an outcome measure related to the behaviour of interest. The fifteen identified publications (comprising 18 individual studies) were coded on a number of characteristics, including consumption behaviour, participants, task, training and control conditions, number of training sessions and trials, outcome measure, and results. The results generally showed positive effects of approach-avoidance training, including reduced consumption behaviour in the laboratory, lower relapse rates, and improvements in self-reported measures of behaviour. Importantly, all studies (with one exception) that reported favourable consumption outcomes also demonstrated successful reduction of the approach bias for appetitive cues. Thus, the current review concluded that approach bias modification is effective for reducing both approach bias and unhealthy consumption behaviour. Copyright © 2016 Elsevier Ltd. All rights reserved.

Comparison between Different Measures of Body Fat with Kidney Function Decline and Incident CKD.

PubMed

Madero, Magdalena; Katz, Ronit; Murphy, Rachel; Newman, Anne; Patel, Kushang; Ix, Joachim; Peralta, Carmen; Satterfield, Suzanne; Fried, Linda; Shlipak, Michael; Sarnak, Mark

2017-06-07

Although anthropometric measures of body fat are associated with development of CKD, they may not be able to distinguish between various forms of fat and therefore may be less accurate than computed tomography (CT) measures. We compared the association of CT and anthropometric measures of obesity with kidney outcomes in the Health Aging and Body Composition Study. Participants were recruited from March of 1997 through July of 1998. CT measures included visceral abdominal fat (VAT), subcutaneous adipose tissue (SAT), and intermuscular fat area (IMAT), whereas anthropometric measures included waist circumference (WC) and body mass index (BMI). Kidney outcomes included kidney function (KF) decline (30% decrease in eGFR cysC in follow-up at either year 3 or 10) or incident CKD (follow-up eGFR cysC ≤60 ml/min per 1.73 m 2 in individuals with baseline GFR>60 ml/min per 1.73 m 2 ). Multivariable logistic regression models and Poisson regression models were used to evaluate the association with decline in KF and incident kidney disease, respectively. We also assessed for the independent associations among the exposure measures by including them in the same model. Two-thousand four-hundred and eighty-nine individuals were included. Mean age was 74±3 years, 49% were men, 39% were black, 59% were hypertensive, and 15% were diabetic. KF decline occurred in 17% of the population, whereas incident CKD also occurred in 17% of those at risk. In continuous models, SAT, VAT, IMAT, BMI, and WC (per SD increase) were all significantly associated with KF decline. There was a significant interaction between VAT and CKD with regard to KF decline ( P =0.01). Only VAT, BMI, and WC were associated with incident CKD. Only VAT remained a significant risk factor for incident CKD when other exposure variables were included in the same model. There was no association between any measure of obesity and kidney outcomes when creatinine values at years 3 and 10 were used to estimate changes in eGFR. Anthropometric measures of body fat appear to provide as consistent estimates of KF decline risk as CT measures in elders. Copyright © 2017 by the American Society of Nephrology.

Mapping to Estimate Health-State Utility from Non-Preference-Based Outcome Measures: An ISPOR Good Practices for Outcomes Research Task Force Report.

PubMed

Wailoo, Allan J; Hernandez-Alava, Monica; Manca, Andrea; Mejia, Aurelio; Ray, Joshua; Crawford, Bruce; Botteman, Marc; Busschbach, Jan

2017-01-01

Economic evaluation conducted in terms of cost per quality-adjusted life-year (QALY) provides information that decision makers find useful in many parts of the world. Ideally, clinical studies designed to assess the effectiveness of health technologies would include outcome measures that are directly linked to health utility to calculate QALYs. Often this does not happen, and even when it does, clinical studies may be insufficient for a cost-utility assessment. Mapping can solve this problem. It uses an additional data set to estimate the relationship between outcomes measured in clinical studies and health utility. This bridges the evidence gap between available evidence on the effect of a health technology in one metric and the requirement for decision makers to express it in a different one (QALYs). In 2014, ISPOR established a Good Practices for Outcome Research Task Force for mapping studies. This task force report provides recommendations to analysts undertaking mapping studies, those that use the results in cost-utility analysis, and those that need to critically review such studies. The recommendations cover all areas of mapping practice: the selection of data sets for the mapping estimation, model selection and performance assessment, reporting standards, and the use of results including the appropriate reflection of variability and uncertainty. This report is unique because it takes an international perspective, is comprehensive in its coverage of the aspects of mapping practice, and reflects the current state of the art. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Defining food literacy: A scoping review.

PubMed

Truman, Emily; Lane, Daniel; Elliott, Charlene

2017-09-01

The term "food literacy" describes the idea of proficiency in food related skills and knowledge. This prevalent term is broadly applied, although its core elements vary from initiative to initiative. In light of its ubiquitous use-but varying definitions-this article establishes the scope of food literacy research by identifying all articles that define 'food literacy', analysing its key conceptualizations, and reporting outcomes/measures of this concept. A scoping review was conducted to identify all articles (academic and grey literature) using the term "food literacy". Databases included Medline, Pubmed, Embase, CAB Abstracts, CINAHL, Scopus, JSTOR, and Web of Science, and Google Scholar. Of 1049 abstracts, 67 studies were included. From these, data was extracted on country of origin, study type (methodological approach), primary target population, and the primary outcomes relating to food literacy. The majority of definitions of food literacy emphasize the acquisition of critical knowledge (information and understanding) (55%) over functional knowledge (skills, abilities and choices) (8%), although some incorporate both (37%). Thematic analysis of 38 novel definitions of food literacy reveals the prevalence of six themes: skills and behaviours, food/health choices, culture, knowledge, emotions, and food systems. Study outcomes largely focus on knowledge generating measures, with very few focusing on health related outcome measures. Current definitions of food literacy incorporate components of six key themes or domains and attributes of both critical and functional knowledge. Despite this broad definition of the term, most studies aiming to improve food literacy focus on knowledge related outcomes. Few articles address health outcomes, leaving an important gap (and opportunity) for future research in this field. Copyright © 2017 Elsevier Ltd. All rights reserved.

Cost-Effectiveness of Buprenorphine and Naltrexone Treatments for Heroin Dependence in Malaysia

PubMed Central

Ruger, Jennifer Prah; Chawarski, Marek; Mazlan, Mahmud; Ng, Nora; Schottenfeld, Richard

2012-01-01

Aims To aid public health policymaking, we studied the cost-effectiveness of buprenorphine, naltrexone, and placebo interventions for heroin dependence in Malaysia. Design We estimated the cost-effectiveness ratios of three treatments for heroin dependence. We used a microcosting methodology to determine fixed, variable, and societal costs of each intervention. Cost data were collected from investigators, staff, and project records on the number and type of resources used and unit costs; societal costs for participants’ time were estimated using Malaysia’s minimum wage. Costs were estimated from a provider and societal perspective and reported in 2004 US dollars. Setting Muar, Malaysia. Participants 126 patients enrolled in a randomized, double-blind, placebo-controlled clinical trial in Malaysia (2003–2005) receiving counseling and buprenorphine, naltrexone, or placebo for treatment of heroin dependence. Measurements Primary outcome measures included days in treatment, maximum consecutive days of heroin abstinence, days to first heroin use, and days to heroin relapse. Secondary outcome measures included treatment retention, injection drug use, illicit opiate use, AIDS Risk Inventory total score, and drug risk and sex risk subscores. Findings Buprenorphine was more effective and more costly than naltrexone for all primary and most secondary outcomes. Incremental cost-effectiveness ratios were below $50 for primary outcomes, mostly below $350 for secondary outcomes. Naltrexone was dominated by placebo for all secondary outcomes at almost all endpoints. Incremental treatment costs were driven mainly by medication costs, especially the price of buprenorphine. Conclusions Buprenorphine appears to be a cost-effective alternative to naltrexone that might enhance economic productivity and reduce drug use over a longer term. PMID:23226534

Profiling outcomes of ambulatory care: casemix affects perceived performance.

PubMed

Berlowitz, D R; Ash, A S; Hickey, E C; Kader, B; Friedman, R; Moskowitz, M A

1998-06-01

The authors explored the role of casemix adjustment when profiling outcomes of ambulatory care. The authors reviewed the medical records of 656 patients with hypertension, diabetes, or chronic obstructive pulmonary disease (COPD) receiving care at one of three Department of Veterans Affairs medical centers. Outcomes included measures of physiological control for hypertension and diabetes, and of exacerbations for COPD. Predictors of poor outcomes, including physical examination findings, symptoms, and comorbidities, were identified and entered into regression models. Observed minus expected performance was described for each site, both before and after casemix adjustment. Risk-adjustment models were developed that were clinically plausible and had good performance properties. Differences existed among the three sites in the severity of the patients being cared for. For example, the percentage of patients expected to have poor blood pressure control were 35% at site 1, 37% at site 2, and 44% at site 3 (P < 0.01). Casemix-adjusted measures of performance were different from unadjusted measures. Sites that were outliers (P < 0.05) with one approach had observed performance no different from expected with another approach. Casemix adjustment models can be developed for outpatient medical conditions. Sites differ in the severity of patients they treat, and adjusting for these differences can alter judgments of site performance. Casemix adjustment is necessary when profiling outpatient medical conditions.

Social Ecology of Child Soldiers: Child, Family, and Community Determinants of Mental Health, Psychosocial Wellbeing, and Reintegration in Nepal

PubMed Central

Kohrt, Brandon A.; Jordans, Mark J.D.; Tol, Wietse A.; Perera, Em; Karki, Rohit; Koirala, Suraj; Upadhaya, Nawaraj

2013-01-01

This study employs social ecology to evaluate psychosocial wellbeing in a cross-sectional sample of 142 former child soldiers in Nepal. Outcome measures included the Depression Self Rating Scale (DSRS), Child Posttraumatic Stress Scale (CPSS), and locally developed measures of function impairment and reintegration. At the child level, traumatic exposures, especially torture, predicted poor outcomes, while education improved outcomes. At the family level, conflict-related death of a relative, physical abuse in the household, and loss of wealth during the conflict predicted poor outcomes. At the community level, living in high caste Hindu communities predicted fewer reintegration supports. Ultimately, social ecology is well-suited to identify intervention foci across ecological levels, based on community differences in vulnerability and protective factors. PMID:21088102

Comparing college students' value-, outcome-, and impression-relevant involvement in health-related issues.

PubMed

Marshall, Heather M; Reinhart, Amber M; Feeley, Thomas H; Tutzauer, Frank; Anker, Ashley

2008-01-01

The purpose of this study was to examine the role of receiver involvement in the context of health communication. Students (N = 277) completed Cho and Boster's (2005) measures of value-, outcome-, and impression-relevant involvement across 6 health behaviors, including cigarette smoking, organ and tissue donation, sunscreen use, alcohol use, sexually transmitted disease testing, and nutrition. Confirmatory factor analyses across all 6 health topics provided evidence of the 3-factor structure conceptualized by Johnson and Eagly (1989) and measured by Cho and Boster (2005). When health behaviors were regressed onto value-, outcome-, and impression-relevant involvement, outcome- and value-involvement, generally speaking, emerged as significant predictors. Results and implications of considering health campaign audience members' levels of involvement are discussed in the domain of preventive medicine.

Measuring social communication behaviors as a treatment endpoint in individuals with autism spectrum disorder.

PubMed

Anagnostou, Evdokia; Jones, Nancy; Huerta, Marisela; Halladay, Alycia K; Wang, Paul; Scahill, Lawrence; Horrigan, Joseph P; Kasari, Connie; Lord, Cathy; Choi, Dennis; Sullivan, Katherine; Dawson, Geraldine

2015-07-01

Social communication impairments are a core deficit in autism spectrum disorder. Social communication deficit is also an early indicator of autism spectrum disorder and a factor in long-term outcomes. Thus, this symptom domain represents a critical treatment target. Identifying reliable and valid outcome measures for social communication across a range of treatment approaches is essential. Autism Speaks engaged a panel of experts to evaluate the readiness of available measures of social communication for use as outcome measures in clinical trials. The panel held monthly conference calls and two face-to-face meetings over 14 months. Key criteria used to evaluate measures included the relevance to the clinical target, coverage of the symptom domain, and psychometric properties (validity and reliability, as well as evidence of sensitivity to change). In all, 38 measures were evaluated and 6 measures were considered appropriate for use, with some limitations. This report discusses the relative strengths and weaknesses of existing social communication measures for use in clinical trials and identifies specific areas in need of further development. © The Author(s) 2014.

PROMIS Physical Function Computer Adaptive Test Compared With Other Upper Extremity Outcome Measures in the Evaluation of Proximal Humerus Fractures in Patients Older Than 60 Years.

PubMed

Morgan, Jordan H; Kallen, Michael A; Okike, Kanu; Lee, Olivia C; Vrahas, Mark S

2015-06-01

To compare the PROMIS Physical Function Computer Adaptive Test (PROMIS PF CAT) to commonly used traditional PF measures for the evaluation of patients with proximal humerus fractures. Prospective. Two Level I trauma centers. Forty-seven patients older than 60 years with displaced proximal humerus fractures treated between 2006 and 2009. Evaluation included completion of the PROMIS PF CAT, the Constant Shoulder Score, the Disabilities of the Arm, Shoulder, and Hand (DASH) and the Short Musculoskeletal Functional Assessment (SMFA). Observed correlations among the administered PF outcome measures. On average, patients responded to 86 outcome-related items for this study: 4 for the PROMIS PF CAT (range: 4-8 items), 6 for the Constant Shoulder Score, 30 for the DASH, and 46 for the SMFA. Time to complete the PROMIS PF CAT (median completion time = 98 seconds) was significantly less than that for the DASH (median completion time = 336 seconds, P < 0.001) and for the SMFA (median completion time = 482 seconds, P < 0.001). PROMIS PF CAT scores correlated statistically significantly and were of moderate-to-high magnitude with all other PF outcome measure scores administered. This study suggests using the PROMIS PF CAT as a sole PF outcome measure can yield an assessment of upper extremity function similar to those provided by traditional PF measures, while substantially reducing patient assessment time.

Investigating ESL Students' Performance on Outcomes Assessments in Higher Education

ERIC Educational Resources Information Center

Lakin, Joni M.; Elliott, Diane Cardenas; Liu, Ou Lydia

2012-01-01

Outcomes assessments are gaining great attention in higher education because of increased demand for accountability. These assessments are widely used by U.S. higher education institutions to measure students' college-level knowledge and skills, including students who speak English as a second language (ESL). For the past decade, the increasing…

Peer Educators and Close Friends as Predictors of Male College Students' Willingness to Prevent Rape

ERIC Educational Resources Information Center

Stein, Jerrold L.

2007-01-01

Astin's (1977, 1991, 1993) input-environment-outcome (I-E-O) model provided a conceptual framework for this study which measured 156 male college students' willingness to prevent rape (outcome variable). Predictor variables included personal attitudes (input variable), perceptions of close friends' attitudes toward rape and rape prevention…

Psychosocial Adjustment and Life Satisfaction until 5 Years after Severe Brain Damage

ERIC Educational Resources Information Center

Sorbo, Ann K.; Blomqvist, Maritha; Emanuelsson, Ingrid M.; Rydenhag, Bertil

2009-01-01

The objectives of this study were to describe psychosocial adjustment and outcome over time for severely brain-injured patients and to find suitable outcome measures for clinical practice during the rehabilitation process and for individual rehabilitation planning after discharge from hospital. The methods include a descriptive, prospective,…

Impact of Intended and Unintended Outcomes of Performance-Based Funding on Community Colleges

ERIC Educational Resources Information Center

Smith, Charanne P.

2015-01-01

Nationally, state and federal legislative bodies are increasingly requiring higher education institutions to demonstrate a solid return on investment. One of the key ways to do this is through performance based funding which links funding received to specific institutional performance measures and outcomes including graduation, and/or completion…

Testing the Relation between Fidelity of Implementation and Student Outcomes in Math

ERIC Educational Resources Information Center

Crawford, Lindy; Carpenter, Dick M., II; Wilson, Mary T.; Schmeister, Megan; McDonald, Marilee

2012-01-01

The relation between fidelity of implementation and student outcomes in a computer-based middle school mathematics curriculum was measured empirically. Participants included 485 students and 23 teachers from 11 public middle schools across seven states. Implementation fidelity was defined using two constructs: fidelity to structure and fidelity to…

77 FR 21986 - Agency Information Collection Activities; Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-12

... the Child Welfare Sector and Comparison Study with an administrative record review form to lessen... in the study is up to 24 months. The outcome measures include the following: child symptomatology and............ 1,081 3 1.00 3,243 649 Child and Family Outcome Study Caregiver Information Questionnaire, Caregiver...

77 FR 34961 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-12

... the Child Welfare Sector and Comparison Study with an administrative record review form to lessen... in the study is up to 24 months. The outcome measures include the following: Child symptomatology and... site informants......... 1081 3 1.00 3,243 649 Child and Family Outcome Study Caregiver Information...

Systematic review of HIV prevention interventions in China: a health communication perspective.

PubMed

Xiao, Zhiwen; Noar, Seth M; Zeng, Lily

2014-02-01

To examine whether communication strategies and principles have been utilized in the HIV prevention intervention programs conducted in China. Comprehensive literature searches were conducted using PsycINFO, Medline, and Academic Search Complete with combinations of a number of keywords. Studies were included if they (1) were conducted in China and published prior to October 2011; (2) tested interventions promoting HIV/sexual risk reduction; and (3) reported empirical outcome evaluations on HIV knowledge, condom use and other condom-related variables. Data on 11 dimensions were extracted and analyzed, including formative research, theory, message targeting, messenger and channels, process evaluation, evaluation design, outcome measures. The majority of the 45 intervention studies were not theory-based, did not report conducting formative research or process evaluation, used pretest-posttest control group designs, combined nonmedia channels, printed and visual materials, and employed HIV knowledge and condom use as outcome measures. Many HIV prevention interventions in China have been successful in reducing HIV risk-related outcomes. This literature has its weaknesses; however, the current review illuminates gaps in the literature and points to important future directions for research.

A combination HIV reporter virus system for measuring post-entry event efficiency and viral outcome in primary CD4+ T cell subsets.

PubMed

Tilton, Carisa A; Tabler, Caroline O; Lucera, Mark B; Marek, Samantha L; Haqqani, Aiman A; Tilton, John C

2014-01-01

Fusion between the viral membrane of human immunodeficiency virus (HIV) and the host cell marks the end of the HIV entry process and the beginning of a series of post-entry events including uncoating, reverse transcription, integration, and viral gene expression. The efficiency of post-entry events can be modulated by cellular factors including viral restriction factors and can lead to several distinct outcomes: productive, latent, or abortive infection. Understanding host and viral proteins impacting post-entry event efficiency and viral outcome is critical for strategies to reduce HIV infectivity and to optimize transduction of HIV-based gene therapy vectors. Here, we report a combination reporter virus system measuring both membrane fusion and viral promoter-driven gene expression. This system enables precise determination of unstimulated primary CD4+ T cell subsets targeted by HIV, the efficiency of post-entry viral events, and viral outcome and is compatible with high-throughput screening and cell-sorting methods. Copyright © 2013 Elsevier B.V. All rights reserved.

Patient-Reported Disease Activity and Adverse Pregnancy Outcomes in Systemic Lupus Erythematosus and Rheumatoid Arthritis.

PubMed

Harris, Nathaniel; Eudy, Amanda; Clowse, Megan

2018-06-15

While increased rheumatic disease activity during pregnancy has been associated with adverse pregnancy outcomes, this activity is typically assessed by the physician. Little is known, however, about the association between patient-reported measures of disease activity and pregnancy outcomes. Univariate and multivariable regression models were used to assess the relationship between patient and physician-reported measures of disease activity and adverse pregnancy outcomes in 225 patients with lupus or rheumatoid arthritis (RA) enrolled in a prospective registry at a single academic center from 2008-2016. In women with RA, patient-reported disease activity is associated with preterm birth (OR 5.9 (1.5-23.9)), and gestational age (beta -1.5 weeks (-2.6, -0.4 weeks)). The physician assessment of disease activity also predicted preterm (OR 2.1 (1.2-3.5)), small for gestational age births (OR 1.8 (1.03-3.1), and gestational age in weeks (beta -0.6 weeks (-0.9, -0.02 weeks)). On the other hand, SLE patient-reported disease activity measures, including the HAQ, pain or global health measures, are not associated with adverse pregnancy outcomes. However, physician measures of SLE disease activity are associated with preterm birth (OR 2.9 (1.-6.3)), cesarean delivery (OR 2.3 (1.0-5.3)), and preeclampsia (OR 2.8 (1.3-6.3)). The results do not appear to be driven by lupus nephritis or antiphospholipid syndrome. For women with RA, patient-reported measures of disease activity may be useful adjuncts to physician-reported measures in identifying pregnancies at greater risk. In contrast, in SLE, no patient-reported measures were associated with adverse outcomes while physician measures of disease activity helped predict several adverse pregnancy outcomes. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Childhood vaccination communication outcomes unpacked and organized in a taxonomy to facilitate core outcome establishment.

PubMed

Kaufman, Jessica; Ryan, Rebecca; Glenton, Claire; Lewin, Simon; Bosch-Capblanch, Xavier; Cartier, Yuri; Cliff, Julie; Oyo-Ita, Angela; Ames, Heather; Muloliwa, Artur Manuel; Oku, Afiong; Rada, Gabriel; Hill, Sophie

2017-04-01

We present a comprehensive taxonomy of outcomes for childhood vaccination communication interventions. Adding to our earlier map of trial outcomes, we aimed to (1) identify relevant outcomes not measured in trials, (2) identify outcomes from stakeholder focus groups, and (3) organize outcomes into a taxonomy. We identified additional outcomes from nonvaccination health communication literature and through parent and health care professional focus groups. We organized outcomes into the taxonomy through iterative discussion and informed by organizational principles established by leaders in core outcome research. The taxonomy includes three overarching core areas, divided into eight domains and then into outcomes. Core area one is psychosocial impact, including the domains "knowledge or understanding," "attitudes or beliefs," and "decision-making." Core area two is health impact, covering "vaccination status and behaviors" and "health status and well-being." Core area three is community, social, or health system impact, containing "intervention design and implementation," "community participation," and "resource use." To our knowledge, this taxonomy is the first attempt to conceptualize the range of potential outcomes for vaccination communication. It can be used by researchers selecting outcomes for complex communication interventions. We will also present the taxonomy to stakeholders to establish core outcome domains. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Detecting gait abnormalities after concussion or mild traumatic brain injury: A systematic review of single-task, dual-task, and complex gait.

PubMed

Fino, Peter C; Parrington, Lucy; Pitt, Will; Martini, Douglas N; Chesnutt, James C; Chou, Li-Shan; King, Laurie A

2018-05-01

While a growing number of studies have investigated the effects of concussion or mild traumatic brain injury (mTBI) on gait, many studies use different experimental paradigms and outcome measures. The path for translating experimental studies for objective clinical assessments of gait is unclear. This review asked 2 questions: 1) is gait abnormal after concussion/mTBI, and 2) what gait paradigms (single-task, dual-task, complex gait) detect abnormalities after concussion. Data sources included MEDLINE/PubMed, Scopus, Web of Science, and Cumulative Index to Nursing and Allied Health Literature (CINAHL) accessed on March 14, 2017. Original research articles reporting gait outcomes in people with concussion or mTBI were included. Studies of moderate, severe, or unspecified TBI, and studies without a comparator were excluded. After screening 233 articles, 38 studies were included and assigned to one or more sections based on the protocol and reported outcomes. Twenty-six articles reported single-task simple gait outcomes, 24 reported dual-task simple gait outcomes, 21 reported single-task complex gait outcomes, and 10 reported dual-task complex gait outcomes. Overall, this review provides evidence for two conclusions: 1) gait is abnormal acutely after concussion/mTBI but generally resolves over time; and 2) the inconsistency of findings, small sample sizes, and small number of studies examining homogenous measures at the same time-period post-concussion highlight the need for replication across independent populations and investigators. Future research should concentrate on dual-task and complex gait tasks, as they showed promise for detecting abnormal locomotor function outside of the acute timeframe. Additionally, studies should provide detailed demographic and clinical characteristics to enable more refined comparisons across studies. Copyright © 2018 Elsevier B.V. All rights reserved.

Functional and cognitive impairment, social environment, frailty and adverse health outcomes in older patients with head and neck cancer, a systematic review.

PubMed

van Deudekom, Floor J; Schimberg, Anouk S; Kallenberg, Marije H; Slingerland, Marije; van der Velden, Lily-Ann; Mooijaart, Simon P

2017-01-01

Older head and neck cancer patients are at increased risk for adverse health outcomes, but little is known about which geriatric assessment associates with poor outcome. The aim is to study the association of functional or cognitive impairment, social environment and frailty with adverse health outcomes in patients with head and neck cancer. Four libraries were searched for studies reporting on an association of functional or cognitive impairment, social environment and frailty with adverse outcomes in head and neck cancer patients. Of 4158 identified citations, 31 articles were included. The mean age was ⩾60years in twelve studies (39%). Geriatric conditions were prevalent: between 40 and 50% of the included participants were functional impaired, around 50% had depressive symptoms, and around 40% did not have a partner. Functional impairment was assessed in 18 studies, two studies reported on a cognitive test, eight studies examined mood and social status was depicted by 14 studies. None of the included studies addressed frailty or objectively measured physical capacity such as hand grip strength, gait speed or balance tests. In 64% of the reported associations, a decline in functional or cognitive impairment, mood or social environment was associated with adverse outcomes. Functional and cognitive impairment, depressive symptoms and social isolation are highly prevalent in head and neck cancer patients and associate with high risk of adverse health outcomes. In the future, these measurements may guide decision-making and customize treatments, but more research is needed to further improve and firmly establish clinical usability. Copyright © 2016 The Author(s). Published by Elsevier Ltd.. All rights reserved.

Item Banks for Measuring Emotional Distress From the Patient-Reported Outcomes Measurement Information System (PROMIS®): Depression, Anxiety, and Anger

PubMed Central

Pilkonis, Paul A.; Choi, Seung W.; Reise, Steven P.; Stover, Angela M.; Riley, William T.; Cella, David

2011-01-01

The authors report on the development and calibration of item banks for depression, anxiety, and anger as part of the Patient-Reported Outcomes Measurement Information System (PROMIS®). Comprehensive literature searches yielded an initial bank of 1,404 items from 305 instruments. After qualitative item analysis (including focus groups and cognitive interviewing), 168 items (56 for each construct) were written in a first person, past tense format with a 7-day time frame and five response options reflecting frequency. The calibration sample included nearly 15,000 respondents. Final banks of 28, 29, and 29 items were calibrated for depression, anxiety, and anger, respectively, using item response theory. Test information curves showed that the PROMIS item banks provided more information than conventional measures in a range of severity from approximately −1 to +3 standard deviations (with higher scores indicating greater distress). Short forms consisting of seven to eight items provided information comparable to legacy measures containing more items. PMID:21697139

Item banks for measuring emotional distress from the Patient-Reported Outcomes Measurement Information System (PROMIS®): depression, anxiety, and anger.

PubMed

Pilkonis, Paul A; Choi, Seung W; Reise, Steven P; Stover, Angela M; Riley, William T; Cella, David

2011-09-01

The authors report on the development and calibration of item banks for depression, anxiety, and anger as part of the Patient-Reported Outcomes Measurement Information System (PROMIS®). Comprehensive literature searches yielded an initial bank of 1,404 items from 305 instruments. After qualitative item analysis (including focus groups and cognitive interviewing), 168 items (56 for each construct) were written in a first person, past tense format with a 7-day time frame and five response options reflecting frequency. The calibration sample included nearly 15,000 respondents. Final banks of 28, 29, and 29 items were calibrated for depression, anxiety, and anger, respectively, using item response theory. Test information curves showed that the PROMIS item banks provided more information than conventional measures in a range of severity from approximately -1 to +3 standard deviations (with higher scores indicating greater distress). Short forms consisting of seven to eight items provided information comparable to legacy measures containing more items.

Outcomes for implementation science: an enhanced systematic review of instruments using evidence-based rating criteria.

PubMed

Lewis, Cara C; Fischer, Sarah; Weiner, Bryan J; Stanick, Cameo; Kim, Mimi; Martinez, Ruben G

2015-11-04

High-quality measurement is critical to advancing knowledge in any field. New fields, such as implementation science, are often beset with measurement gaps and poor quality instruments, a weakness that can be more easily addressed in light of systematic review findings. Although several reviews of quantitative instruments used in implementation science have been published, no studies have focused on instruments that measure implementation outcomes. Proctor and colleagues established a core set of implementation outcomes including: acceptability, adoption, appropriateness, cost, feasibility, fidelity, penetration, sustainability (Adm Policy Ment Health Ment Health Serv Res 36:24-34, 2009). The Society for Implementation Research Collaboration (SIRC) Instrument Review Project employed an enhanced systematic review methodology (Implement Sci 2: 2015) to identify quantitative instruments of implementation outcomes relevant to mental or behavioral health settings. Full details of the enhanced systematic review methodology are available (Implement Sci 2: 2015). To increase the feasibility of the review, and consistent with the scope of SIRC, only instruments that were applicable to mental or behavioral health were included. The review, synthesis, and evaluation included the following: (1) a search protocol for the literature review of constructs; (2) the literature review of instruments using Web of Science and PsycINFO; and (3) data extraction and instrument quality ratings to inform knowledge synthesis. Our evidence-based assessment rating criteria quantified fundamental psychometric properties as well as a crude measure of usability. Two independent raters applied the evidence-based assessment rating criteria to each instrument to generate a quality profile. We identified 104 instruments across eight constructs, with nearly half (n = 50) assessing acceptability and 19 identified for adoption, with all other implementation outcomes revealing fewer than 10 instruments. Only one instrument demonstrated at least minimal evidence for psychometric strength on all six of the evidence-based assessment criteria. The majority of instruments had no information regarding responsiveness or predictive validity. Implementation outcomes instrumentation is underdeveloped with respect to both the sheer number of available instruments and the psychometric quality of existing instruments. Until psychometric strength is established, the field will struggle to identify which implementation strategies work best, for which organizations, and under what conditions.

Outcome of first-episode schizophrenia in India: longitudinal study of effect of insight and psychopathology.

PubMed

Saravanan, Balasubramanian; Jacob, K S; Johnson, Shanthi; Prince, Martin; Bhugra, Dinesh; David, Anthony S

2010-06-01

Transcultural studies have found lack of insight to be an almost invariable feature of acute and chronic schizophrenia, but its influence on prognosis is unclear. To investigate the relationship between insight, psychopathology and outcome of first-episode schizophrenia in Vellore, India. Patients with a DSM-IV diagnosis of schizophrenia (n = 131) were assessed prospectively at baseline and at 6-month and 12-month follow-up. Demographic and clinical measures included insight, psychopathology, duration of untreated psychosis (DUP) and social functioning. Linear and logistic regression was used to measure predictors of outcome. Follow-up data were available for 115 patients at 1 year. All achieved remission, half of them with and half without residual symptoms. Changes in psychopathology and insight during the first 6 months and DUP strongly predicted outcome (relapse or functional impairment), controlling for baseline measures. Outcome of schizophrenia in this setting is driven by early symptomatic improvement and is relatively favourable, in line with other studies from low- and middle-income countries. Early improvement in insight might be a useful clinical guide to future outcome. Reduction of DUP should be a target for intervention.

The Home-Based Older People's Exercise (HOPE) trial: study protocol for a randomised controlled trial

PubMed Central

2011-01-01

Background Frailty is common in older age, and is associated with important adverse health outcomes including increased risk of disability and admission to hospital or long-term care. Exercise interventions for frail older people have the potential to reduce the risk of these adverse outcomes by increasing muscle strength and improving mobility. Methods/Design The Home-Based Older People's Exercise (HOPE) trial is a two arm, assessor blind pilot randomised controlled trial (RCT) to assess the effectiveness of a 12 week exercise intervention (the HOPE programme) designed to improve the mobility and functional abilities of frail older people living at home, compared with usual care. The primary outcome is the timed-up-and-go test (TUGT), measured at baseline and 14 weeks post-randomisation. Secondary outcomes include the Barthel Index of activities of daily living (ADL), EuroQol Group 5-Dimension Self-Report Questionnaire (EQ-5D) quality of life measure and the geriatric depression scale (GDS), measured at baseline and 14 weeks post-randomisation. We will record baseline frailty using the Edmonton Frail Scale (EFS), record falls and document muscle/joint pain. We will test the feasibility of collection of data to identify therapy resources required for delivery of the intervention. Discussion The HOPE trial will explore and evaluate a home-based exercise intervention for frail older people. Although previous RCTs have used operationalised, non-validated methods of measuring frailty, the HOPE trial is, to our knowledge, the first RCT of an exercise intervention for frail older people that includes a validated method of frailty assessment at baseline. Trial registration ISRCTN: ISRCTN57066881 PMID:21651805

Improving adolescent contraceptive use: evaluation of a theory-driven classroom-based intervention.

PubMed

Brown, Katherine E; Hurst, Keith M; Arden, Madelynne A

2011-03-01

The aim of the research was to evaluate the impact of intervention materials, designed to enhance self-efficacy and anticipated regret, on contraceptive behaviour and antecedents of contraceptive use in a sample of adolescents. It was hypothesised that materials designed to enhance self-efficacy and anticipated regret would lead to improvements in outcome measures compared with controls. A 4(intervention condition) × 3(time) mixed design was used to assess the impact of intervention materials. Participants (N = 414) were recruited from five secondary schools in the north of England. They were assigned to an active control group, an anticipated regret (AR) manipulation, a self-efficacy (SE) manipulation or both AR and SE manipulations. Outcome measures included psychological antecedents of contraceptive behaviour change, intentions and behaviour. Multivariate analysis of variance (MANOVA) revealed increases across several outcome measures over time (F[14,287] = 8.99, P < 0.001, η(p)(2) = 0.305) including intentions, but these did not differ by condition (F[42,852] = 1.35, P = 0.07, η(p)(2) = 0.062). There was evidence that the questionnaires may have caused reactivity in participants. Amongst sexually active participants with relatively low levels of intention to use contraception at the outset, increases in several outcome measures including intention and behaviour were observed (F[3,35] = 10.359, P < 0.001, η(p)(2) = 0.47). Findings support the potential for effective delivery of behaviour change theory-driven interventions in classroom settings. The possibility that the questionnaires may have acted as a form of intervention contributes to recent discussion of this issue in the literature, and the findings also strengthen the case for post-decisional and behavioural skills interventions to enhance behaviour amongst those already motivated to use contraception.

Improving child nutrition and development through community-based childcare centres in Malawi - The NEEP-IE study: study protocol for a randomised controlled trial.

PubMed

Gelli, Aulo; Margolies, Amy; Santacroce, Marco; Sproule, Katie; Theis, Sophie; Roschnik, Natalie; Twalibu, Aisha; Chidalengwa, George; Cooper, Amrik; Moorhead, Tyler; Gladstone, Melissa; Kariger, Patricia; Kutundu, Mangani

2017-06-19

The Nutrition Embedded Evaluation Programme Impact Evaluation (NEEP-IE) study is a cluster randomised controlled trial designed to evaluate the impact of a childcare centre-based integrated nutritional and agricultural intervention on the diets, nutrition and development of young children in Malawi. The intervention includes activities to improve nutritious food production and training/behaviour-change communication to improve food intake, care and hygiene practices. This paper presents the rationale and study design for this randomised control trial. Sixty community-based childcare centres (CBCCs) in rural communities around Zomba district, Malawi, were randomised to either (1) a control group where children were attending CBCCs supported by Save the Children's Early Childhood Health and Development (ECD) programme, or (2) an intervention group where nutritional and agricultural support activities were provided alongside the routine provision of the Save the Children's ECD programme. Primary outcomes at child level include dietary intake (measured through 24-h recall), whilst secondary outcomes include child development (Malawi Development Assessment Tool (MDAT)) and nutritional status (anthropometric measurements). At household level, primary outcomes include smallholder farmer production output and crop-mix (recall of last production season). Intermediate outcomes along theorised agricultural and nutritional pathways were measured. During this trial, we will follow a mixed-methods approach and undertake child-, household-, CBCC- and market-level surveys and assessments as well as in-depth interviews and focus group discussions with project stakeholders. Assessing the simultaneous impact of preschool meals on diets, nutrition, child development and agriculture is a complex undertaking. This study is the first to explicitly examine, from a food systems perspective, the impact of a preschool meals programme on dietary choices, alongside outcomes in the nutritional, child development and agricultural domains. The findings of this evaluation will provide evidence to support policymakers in the scale-up of national programmes. ISRCTN registry, ID: ISRCTN96497560 . Registered on 21 September 2016.

The role of early childhood education programmes in the promotion of child and adolescent mental health in low- and middle-income countries.

PubMed

Baker-Henningham, Helen

2014-04-01

There is growing evidence that early childhood education (ECE) interventions can reduce the loss of developmental potential of disadvantaged children in low- and middle-income countries (LAMIC). Less attention has been paid to the potential of these programmes to prevent child mental health problems and promote child well-being. Peer-reviewed journal articles describing controlled evaluations of ECE interventions in LAMIC were reviewed to identify studies with child mental health outcomes. Studies with proximal outcomes for child mental health including caregiver practices and caregiver mental health were also reviewed. Of 63 studies identified, 21 (33.33%) included child mental health outcomes; 12 of 16 studies with short-term measures showed benefits; 6 studies included a longer-term follow-up and all found benefits; 25 studies included caregiver outcomes: consistent benefits were found for caregiver practices (21 studies) and 6 of 9 studies that measured caregiver mental health reported benefits. Gains to child mental health may be most likely when ECE interventions include three main elements: (i) activities to increase child skills including cognition, language, self-regulation and social-emotional competence; (ii) training caregivers in the skills required to provide a cognitively stimulating and emotionally supportive environment; and (iii) attention to the caregivers' mental health, motivation and self-efficacy. Recommendations for the design and implementation of programmes are provided. ECE interventions are an important component of mental health prevention and promotion in LAMIC, and promoting child and caregiver well-being is a fundamental aspect of interventions to improve child development.

Evaluating nursing administration instruments.

PubMed

Huber, D L; Maas, M; McCloskey, J; Scherb, C A; Goode, C J; Watson, C

2000-05-01

To identify and evaluate available measures that can be used to examine the effects of management innovations in five important areas: autonomy, conflict, job satisfaction, leadership, and organizational climate. Management interventions target the context in which care is delivered and through which evidence for practice diffuses. These innovations need to be evaluated for their effects on desired outcomes. However, busy nurses may not have the time to locate, evaluate, and select instruments to measure expected nursing administration outcomes without research-based guidance. Multiple and complex important contextual variables need psychometrically sound and easy-to-use measurement instruments identified for use in both practice and research. An expert focus group consensus methodology was used in this evaluation research to review available instruments in the five areas and evaluate which of these instruments are psychometrically sound and easy to use in the practice setting. The result is a portfolio of measures, clustered by concept and displayed on a spreadsheet. Retrieval information is provided. The portfolio includes the expert consensus judgment as well as useful descriptive information. The research reported here identifies psychometrically sound and easy-to-use instruments for measuring five key variables to be included in a portfolio. The results of this study can be used as a beginning for saving time in instrument selection and as an aid for determining the best instrument for measuring outcomes from a clinical or management intervention.

Resilience Mediates the Longitudinal Relationships Between Social Support and Mental Health Outcomes in Multiple Sclerosis.

PubMed

Koelmel, Emily; Hughes, Abbey J; Alschuler, Kevin N; Ehde, Dawn M

2017-06-01

To investigate the longitudinal relationships between social support and subsequent mental health outcomes in individuals with multiple sclerosis (MS), and to examine resilience as a mediator between social support and subsequent mental health outcomes in this population. Observational, longitudinal cohort study. Participants were assessed at 4 time points over 12 months in the context of a previously reported randomized controlled trial. Telephone-based measures administered to community-based participants. Individuals (N=163) with MS and 1 or more of the following symptoms: depression, fatigue, and pain. Not applicable. Mental health outcomes included (1) depressive symptomatology, assessed using the Patient Health Questionnaire-9; (2) anxious symptomatology, assessed using the short form of the Emotional Distress-Anxiety Scale from the Patient-Reported Outcomes Measurement Information System; and (3) general mental health status, assessed using the Mental Component Summary score from the Short Form-8 Health Survey. Resilience was assessed using the Connor-Davidson Resilience Scale. At any given time, social support from significant others, family members, and friends was significantly associated with subsequent mental health outcomes for all 3 measures assessed (all P values <.05). Resilience measured concomitantly with social support significantly mediated the relationships between social support and subsequent mental health outcomes. After controlling for resilience, most of the direct relationships between social support and mental health outcomes were no longer significant. There are significant longitudinal relationships between social support, resilience, and mental health outcomes for people with MS. Given the mediating role of resilience in supporting better mental health outcomes, future clinical research and practice may benefit from an emphasis on resilience-focused psychological interventions. Copyright © 2016 American Congress of Rehabilitation Medicine. All rights reserved.

Patient-centered Medical Home Capability and Clinical Performance in HRSA-supported Health Centers

PubMed Central

Shi, Leiyu; Lock, Diana C.; Lee, De-Chih; Lebrun-Harris, Lydie A.; Chin, Marshall H.; Chidambaran, Preeta; Nocon, Robert S.; Zhu, Jinsheng; Sripipatana, Alek

2015-01-01

Objectives To evaluate the relationship between Patient-centered Medical Home (PCMH) model adoption in health centers (HCs) and clinical performance measures and to determine if adoption of PCMH characteristics is associated with better clinical performance. Research Design Data came from the Health Resources and Services Administration’s 2009 Uniform Data System and the 2009 Commonwealth Fund National Survey of Federally Qualified Health Centers. Clinical performance measures included 2 process measures (childhood immunization and cervical cancer screening) and 2 outcome measures (hypertension control and diabetes control). Total and subscale PCMH scores were regressed on the clinical performance measures, adjusting for patient, provider, financial, and institutional characteristics. Results The findings showed different directional relationships, with some PCMH domains (care management, test/referral tracking, quality improvement, and external coordination) showing little or no effect on outcome measures of interest, 1 domain (access/communication) associated with improved outcomes, and 1 domain (patient tracking/registry) associated with worse outcomes. Conclusions This study is among the first to examine the association between PCMH transformation and clinical performance in HCs, providing an understanding of the impact of PCMH adoption within safety-net settings. The mixed results highlight the importance of examining relationships between specific PCMH domains and specific clinical quality measures, in addition to analyzing overall PCMH scores which could yield distorted findings. PMID:25793267

Early Social-Emotional Functioning and Public Health: The Relationship Between Kindergarten Social Competence and Future Wellness.

PubMed

Jones, Damon E; Greenberg, Mark; Crowley, Max

2015-11-01

We examined whether kindergarten teachers' ratings of children's prosocial skills, an indicator of noncognitive ability at school entry, predict key adolescent and adult outcomes. Our goal was to determine unique associations over and above other important child, family, and contextual characteristics. Data came from the Fast Track study of low-socioeconomic status neighborhoods in 3 cities and 1 rural setting. We assessed associations between measured outcomes in kindergarten and outcomes 13 to 19 years later (1991-2000). Models included numerous control variables representing characteristics of the child, family, and context, enabling us to explore the unique contributions among predictors. We found statistically significant associations between measured social-emotional skills in kindergarten and key young adult outcomes across multiple domains of education, employment, criminal activity, substance use, and mental health. A kindergarten measure of social-emotional skills may be useful for assessing whether children are at risk for deficits in noncognitive skills later in life and, thus, help identify those in need of early intervention. These results demonstrate the relevance of noncognitive skills in development for personal and public health outcomes.

Role of subdural electrocorticography in prediction of long-term seizure outcome in epilepsy surgery

PubMed Central

Juhász, Csaba; Shah, Aashit; Sood, Sandeep; Chugani, Harry T.

2009-01-01

Since prediction of long-term seizure outcome using preoperative diagnostic modalities remains suboptimal in epilepsy surgery, we evaluated whether interictal spike frequency measures obtained from extraoperative subdural electrocorticography (ECoG) recording could predict long-term seizure outcome. This study included 61 young patients (age 0.4–23.0 years), who underwent extraoperative ECoG recording prior to cortical resection for alleviation of uncontrolled focal seizures. Patient age, frequency of preoperative seizures, neuroimaging findings, ictal and interictal ECoG measures were preoperatively obtained. The seizure outcome was prospectively measured [follow-up period: 2.5–6.4 years (mean 4.6 years)]. Univariate and multivariate logistic regression analyses determined how well preoperative demographic and diagnostic measures predicted long-term seizure outcome. Following the initial cortical resection, Engel Class I, II, III and IV outcomes were noted in 35, 6, 12 and 7 patients, respectively. One child died due to disseminated intravascular coagulation associated with pseudomonas sepsis 2 days after surgery. Univariate regression analyses revealed that incomplete removal of seizure onset zone, higher interictal spike-frequency in the preserved cortex and incomplete removal of cortical abnormalities on neuroimaging were associated with a greater risk of failing to obtain Class I outcome. Multivariate logistic regression analysis revealed that incomplete removal of seizure onset zone was the only independent predictor of failure to obtain Class I outcome. The goodness of regression model fit and the predictive ability of regression model were greatest in the full regression model incorporating both ictal and interictal measures [R2 0.44; Area under the receiver operating characteristic (ROC) curve: 0.81], slightly smaller in the reduced model incorporating ictal but not interictal measures (R2 0.40; Area under the ROC curve: 0.79) and slightly smaller again in the reduced model incorporating interictal but not ictal measures (R2 0.27; Area under the ROC curve: 0.77). Seizure onset zone and interictal spike frequency measures on subdural ECoG recording may both be useful in predicting the long-term seizure outcome of epilepsy surgery. Yet, the additive clinical impact of interictal spike frequency measures to predict long-term surgical outcome may be modest in the presence of ictal ECoG and neuroimaging data. PMID:19286694

Quality of care for patients with type 2 diabetes mellitus in the Netherlands and the United States: a comparison of two quality improvement programs.

PubMed

Valk, Gerlof D; Renders, Carry M; Kriegsman, Didi M W; Newton, Katherine M; Twisk, Jos W R; van Eijk, Jacques Th M; van der Wal, Gerrit; Wagner, Edward H

2004-08-01

To assess differences in diabetes care and patient outcomes by comparing two multifaceted quality improvement programs in two different countries, and to increase knowledge of effective elements of such programs. Primary care in the ExtraMural Clinic (EMC) of the Department of General Practice of the Vrije Universiteit in Amsterdam, the Netherlands, and the Group Health Cooperative (GHC), a group-model health maintenance organization (HMO) in western Washington State in the United States. Data were collected from 1992 to 1997. In this observational study two diabetes cohorts in which a quality improvement program was implemented were compared. Both programs included a medical record system, clinical practice guidelines, physician educational meetings, audit, and feedback. Only the Dutch program (EMC) included guidelines on the structure of diabetes care and a recall system. Only the GHC program included educational outreach visits, formation of multidisciplinary teams, and patient self-management support. Included were 379 EMC patients, and 2,119 GHC patients with type 2 diabetes mellitus. Main process outcomes were: annual number of diabetes visits, and number of HbA1c and blood lipid measurements. Main patient outcomes were HbA1c and blood lipid levels. Multilevel analysis was used to adjust for dependency between repeated observations within one patient and for clustering of patients within general practices. In the EMC process outcomes and glycemic control improved more than at GHC, however, GHC had better baseline measures. There were no differences between programs on blood lipid control. During follow-up, intensification of pharmacotherapy was noted at both sites. Differences noted between programs were in line with differences in diabetes guidelines. Following implementation of guidelines and organizational improvement efforts, change occurred primarily in the process outcomes, rather than in the patient outcomes. Although much effort was put into improving process and patient outcomes, both complex programs still showed only moderate effects.

Province-Level Income Inequality and Health Outcomes in Canadian Adolescents

PubMed Central

McGrath, Jennifer J.

2015-01-01

Objective To examine the effects of provincial income inequality (disparity between rich and poor), independent of provincial income and family socioeconomic status, on multiple adolescent health outcomes. Methods Participants (aged 12–17 years; N = 11,899) were from the Canadian National Longitudinal Survey of Children and Youth. Parental education, household income, province income inequality, and province mean income were measured. Health outcomes were measured across a number of domains, including self-rated health, mental health, health behaviors, substance use behaviors, and physical health. Results Income inequality was associated with injuries, general physical symptoms, and limiting conditions, but not associated with most adolescent health outcomes and behaviors. Income inequality had a moderating effect on family socioeconomic status for limiting conditions, hyperactivity/inattention, and conduct problems, but not for other outcomes. Conclusions Province-level income inequality was associated with some physical and mental health outcomes in adolescents, which has research and policy implications for this age-group. PMID:25324533

Risk prediction in the community: A systematic review of case-finding instruments that predict adverse healthcare outcomes in community-dwelling older adults.

PubMed

O'Caoimh, Rónán; Cornally, Nicola; Weathers, Elizabeth; O'Sullivan, Ronan; Fitzgerald, Carol; Orfila, Francesc; Clarnette, Roger; Paúl, Constança; Molloy, D William

2015-09-01

Few case-finding instruments are available to community healthcare professionals. This review aims to identify short, valid instruments that detect older community-dwellers risk of four adverse outcomes: hospitalisation, functional-decline, institutionalisation and death. Data sources included PubMed and the Cochrane library. Data on outcome measures, patient and instrument characteristics, and trial quality (using the Quality In Prognosis Studies [QUIPS] tool), were double-extracted for derivation-validation studies in community-dwelling older adults (>50 years). Forty-six publications, representing 23 unique instruments, were included. Only five were externally validated. Mean patient age range was 64.2-84.6 years. Most instruments n=18, (78%) were derived in North America from secondary analysis of survey data. The majority n=12, (52%), measured more than one outcome with hospitalisation and the Probability of Repeated Admission score the most studied outcome and instrument respectively. All instruments incorporated multiple predictors. Activities of daily living n=16, (70%), was included most often. Accuracy varied according to instruments and outcomes; area under the curve of 0.60-0.73 for hospitalisation, 0.63-0.78 for functional decline, 0.70-0.74 for institutionalisation and 0.56-0.82 for death. The QUIPS tool showed that 5/23 instruments had low potential for bias across all domains. This review highlights the present need to develop short, reliable, valid instruments to case-find older adults at risk in the community. Copyright © 2015 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

Use of active video gaming in children with neuromotor dysfunction: a systematic review.

PubMed

Hickman, Robbin; Popescu, Lisa; Manzanares, Robert; Morris, Brendan; Lee, Szu-Ping; Dufek, Janet S

2017-09-01

To examine current evidence on use of active video gaming (AVG) to improve motor function in children with movement disorders including cerebral palsy, developmental coordination disorder, and Down syndrome. Scopus, MEDLINE, Cochrane Library, EMBASE, and CINAHL were searched. Included papers studied the use of AVG for improving movement-related outcomes in these populations. Parameters studied included health condition, strength of evidence, AVG delivery methods, capacity for individualizing play, outcomes addressed, effectiveness for achieving outcomes, and challenges/limitations. The 20 extracted articles varied in quality. Studies involved children with six different conditions using AVG in clinical, home, or school settings for 49 different motor outcomes. Dosage varied in frequency and duration. Choice of games played and difficulty level were therapist determined (n=6) or child controlled (n=14). The most common study limitations were small sample sizes and difficulty individualizing treatment. All articles showed improvement in outcomes with AVG, although differences were not consistently significant compared with conventional therapy. Heterogeneity of measurement tools and target outcomes prevented meta-analysis or development of formal recommendations. However, AVG is feasible and shows potential for improving outcomes in this population. Additional investigations of dosing variables, utility as a home supplement to clinical care, and outcomes with larger sample sizes are merited. © 2017 Mac Keith Press.

Diabetes Health Literacy Among Somali Patients with Diabetes Mellitus in a US Primary Care Setting.

PubMed

Njeru, Jane W; Hagi-Salaad, Misbil F; Haji, Habibo; Cha, Stephen S; Wieland, Mark L

2016-06-01

The purpose of this study was to describe diabetes literacy among Somali immigrants with diabetes and its association with diabetes outcomes. Among Somali immigrants in North America, the prevalence of diabetes exceeds that of the general population, and their measures of diabetes control are suboptimal when compared with non-Somali patients. Diabetes literacy is an important mediator of diabetes outcomes in general populations that has not been previously described among Somali immigrants and refugees. Diabetes literacy was measured using a translated version of the spoken knowledge in low literacy in diabetes (SKILLD) scale among Somali immigrants and refugees with type 2 diabetes. Diabetes outcome measures, including hemoglobin A1C, low-density lipoprotein (LDL) cholesterol, and blood pressure, were obtained for each patient. Multivariate logistic regression was used to assess associations between diabetes literacy and diabetes outcomes. Among 50 Somali patients with diabetes who completed the survey, the mean SKILLD score was low (42.2 %). The diabetes outcome measures showed a mean hemoglobin A1C of 8 %, LDL cholesterol of 99.17 mg/dL (2.57 mmol/L), systolic blood pressure of 130.9 mmHg, and diastolic blood pressure of 70.2 mmHg. There was no association between diabetes literacy scores and diabetes outcome measures. Somali patients with diabetes mellitus had low diabetes literacy and suboptimal measures of diabetes disease control. However, we found no association between diabetes literacy and diabetes outcomes. Future work aimed at reduction of diabetes-related health disparities among Somali immigrants and refugees to high-income countries should go beyond traditional means of patient education for low-literacy populations.

Outcome assessment for spasticity management in the patient with traumatic brain injury: the state of the art.

PubMed

Elovic, Elie P; Simone, Lisa K; Zafonte, Ross

2004-01-01

The objective of this article was to (1) review the engineering and medical literature to structure the available information concerning the assessment of spasticity in the neurological population; (2) to discuss the strengths and weaknesses of the different methods currently in use in spasticity assessment; and (3) make recommendations for future efforts in spasticity outcome assessment. Spasticity textbooks, Web sites, and OVID, IEEE, and Medline searches from 1966 through 2003 of spasticity, quantitative measure, or outcome assessment in the rehabilitation population were used as data sources. Over 500 articles were reviewed. Articles that discussed outcome measures used to assess interventions and evaluation of spasticity were included. Authors reviewed the articles looking at inclusion criteria, data collection, methodology, assessment methods, and conclusions for validity and relevance to this article. Issues such as clinical relevance, real-world function and lack of objectivity, and time consumed during performance are important issues for spasticity assessment. Some measures such as the Ashworth Scale remain in common use secondary to ease of use despite their obvious functional limitations. More functional outcome goals are plagued by being more time consuming and a general inability to demonstrate changes after an intervention. This may be secondary to the other factors that combine with spasticity to cause dysfunction at that level. Quantitative metrics can provide more objective measurements but their clinical relevance is sometimes problematic. The assessment of spasticity outcome is still somewhat problematic. Further work is necessary to develop measures that have real-world functional significance to both the individuals being treated and the clinicians. A lack of objectivity is still a problem. In the future it is important for clinicians and the engineers to work together in the development of better outcome measures.

Readability Level of Spanish-Language Patient-Reported Outcome Measures in Audiology and Otolaryngology

PubMed Central

Coco, Laura; Colina, Sonia; Atcherson, Samuel R.

2017-01-01

Purpose The purpose of this study was to examine the readability level of the Spanish versions of several audiology- and otolaryngology-related patient-reported outcome measures (PROMs) and include a readability analysis of 2 translation approaches when available—the published version and a “functionalist” version—using a team-based collaborative approach including community members. Method Readability levels were calculated using the Fry Graph adapted for Spanish, as well as the Fernandez-Huerta and the Spaulding formulae for several commonly used audiology- and otolaryngology-related PROMs. Results Readability calculations agreed with previous studies analyzing audiology-related PROMs in English and demonstrated many Spanish-language PROMs were beyond the 5th grade reading level suggested for health-related materials written for the average population. In addition, the functionalist versions of the PROMs yielded lower grade-level (improved) readability levels than the published versions. Conclusion Our results suggest many of the Spanish-language PROMs evaluated here are beyond the recommended readability levels and may be influenced by the approach to translation. Moreover, improved readability may be possible using a functionalist approach to translation. Future analysis of the suitability of outcome measures and the quality of their translations should move beyond readability and include an evaluation of the individual's comprehension of the written text. PMID:28892821

The role of art education in adult prisons: The Western Australian experience

NASA Astrophysics Data System (ADS)

Giles, Margaret; Paris, Lisa; Whale, Jacqui

2016-12-01

Incarceration costs are high; in Australia, for example, each prisoner costs an average of AUD 115,000 per year. Other countries are also feeling the fiscal pinch of high incarceration costs, and a number of jurisdictions are now closing some of their prisons. Most prison costs are non-discretionary (accommodation, meals, etc.). But some of the costs relate to discretionary activities, services and facilities (including schooling). In terms of correctional education, many prison managers try to invest any meagre correctional education resources available to them in those classes and courses which have proven to have the best results, such as improved labour market outcomes and reduced recidivism, minimising subsequent re-imprisonment. Course offers for prisoner-students include vocational training, adult basic education (ABE) and art studies. The two-tiered question this paper asks is: do art classes and courses produce these measurable outcomes and, if not, are there other reasons why they should continue to be funded? Addressing these issues, the authors argue that (1) these measurable outcomes are too narrow and do not reflect the complex but less quantifiable benefits to the individual and the community of studying art in prison, and (2) better measures of all impacts of art studies in prisons are needed, including qualitative and humanitarian aspects.

Neonatal Outcomes in the Birth Center Setting: A Systematic Review.

PubMed

Phillippi, Julia C; Danhausen, Kathleen; Alliman, Jill; Phillippi, R David

2018-01-01

This systematic review investigates the effect of the birth center setting on neonatal mortality in economically developed countries to aid women and clinicians in decision making. We searched the Google Scholar, CINAHL, and PubMed databases using key terms birth/birthing center or out of hospital with perinatal/neonatal outcomes. Ancestry searches identified additional studies, and an alert was set for new publications. We included primary source studies in English, published after 1980, conducted in a developed country, and researching planned birth in centers with guidelines similar to American Association of Birth Centers standards. After initial review, we conducted a preliminary analysis, assessing which measures of neonatal health, morbidity, and mortality were included across studies. Neonatal mortality was selected as the sole summary measure as other measures were sporadically reported or inconsistently defined. Seventeen studies were included, representing at least 84,500 women admitted to a birth center in labor. There were substantial differences of study design, sampling techniques, and definitions of neonatal outcomes across studies, limiting conclusive statements of the effect of intrapartum care in a birth center. No reviewed study found a statistically increased rate of neonatal mortality in birth centers compared to low-risk women giving birth in hospitals, nor did data suggest a trend toward higher neonatal mortality in birth centers. As in all birth settings, nulliparous women, women aged greater than 35 years, and women with pregnancies of more than 42 weeks' gestation may have an increased risk of neonatal mortality. There are substantial flaws in the literature concerning the effect of birth center care on neonatal outcomes. More research is needed on subgroups at risk of poor outcomes in the birth center environment. To expedite research, consistent use of national and international definitions of perinatal and neonatal mortality within data registries and greater detail on adverse outcomes would be beneficial. © 2018 by the American College of Nurse-Midwives.

Family structure and risk behaviors: the role of the family meal in assessing likelihood of adolescent risk behaviors.

PubMed

Goldfarb, Samantha; Tarver, Will L; Sen, Bisakha

2014-01-01

Previous literature has asserted that family meals are a key protective factor for certain adolescent risk behaviors. It is suggested that the frequency of eating with the family is associated with better psychological well-being and a lower risk of substance use and delinquency. However, it is unclear whether there is evidence of causal links between family meals and adolescent health-risk behaviors. The purpose of this article is to review the empirical literature on family meals and adolescent health behaviors and outcomes in the US. A SEARCH WAS CONDUCTED IN FOUR ACADEMIC DATABASES: Social Sciences Full Text, Sociological Abstracts, PsycINFO®, and PubMed/MEDLINE. We included studies that quantitatively estimated the relationship between family meals and health-risk behaviors. Data were extracted on study sample, study design, family meal measurement, outcomes, empirical methods, findings, and major issues. Fourteen studies met the inclusion criteria for the review that measured the relationship between frequent family meals and various risk-behavior outcomes. The outcomes considered by most studies were alcohol use (n=10), tobacco use (n=9), and marijuana use (n=6). Other outcomes included sexual activity (n=2); depression, suicidal ideation, and suicide attempts (n=4); violence and delinquency (n=4); school-related issues (n=2); and well-being (n=5). The associations between family meals and the outcomes of interest were most likely to be statistically significant in unadjusted models or models controlling for basic family characteristics. Associations were less likely to be statistically significant when other measures of family connectedness were included. Relatively few analyses used sophisticated empirical techniques available to control for confounders in secondary data. More research is required to establish whether or not the relationship between family dinners and risky adolescent behaviors is an artifact of underlying confounders. We recommend that researchers make more frequent use of sophisticated methods to reduce the problem of confounders in secondary data, and that the scope of adolescent problem behaviors also be further widened.

Predicting well-being longitudinally for mothers rearing offspring with intellectual and developmental disabilities.

PubMed

Grein, K A; Glidden, L M

2015-07-01

Well-being outcomes for parents of children with intellectual and developmental disabilities (IDD) may vary from positive to negative at different times and for different measures of well-being. Predicting and explaining this variability has been a major focus of family research for reasons that have both theoretical and applied implications. The current study used data from a 23-year longitudinal investigation of adoptive and birth parents of children with IDD to determine which early child, mother and family characteristics would predict the variance in maternal outcomes 20 years after their original measurement. Using hierarchical regression analyses, we tested the predictive power of variables measured when children were 7 years old on outcomes of maternal well-being when children were 26 years old. Outcome variables included maternal self-report measures of depression and well-being. Final models of well-being accounted for 20% to 34% of variance. For most outcomes, Family Accord and/or the personality variable of Neuroticism (emotional stability/instability) were significant predictors, but some variables demonstrated a different pattern. These findings confirm that (1) characteristics of the child, mother and family during childhood can predict outcomes of maternal well-being 20 years later; and (2) different predictor-outcome relationships can vary substantially, highlighting the importance of using multiple measures to gain a more comprehensive understanding of maternal well-being. These results have implications for refining prognoses for parents and for tailoring service delivery to individual child, parent and family characteristics. © 2014 MENCAP and International Association of the Scientific Study of Intellectual and Developmental Disabilities and John Wiley & Sons Ltd.

Treatment of trauma-affected refugees with venlafaxine versus sertraline combined with psychotherapy - a randomised study.

PubMed

Sonne, Charlotte; Carlsson, Jessica; Bech, Per; Elklit, Ask; Mortensen, Erik Lykke

2016-11-08

The prevalence of trauma-related psychiatric disorders is high among refugees. Despite this, little is known about the effect of pharmacological treatment for this patient group. The objective of the present study was therefore to examine differences in the effects of venlafaxine and sertraline on Post-Traumatic Stress Disorder (PTSD), depression and functional impairment in trauma-affected refugees. The study was a randomised pragmatic trial comparing venlafaxine and sertraline in combination with psychotherapy and social counselling. PTSD symptoms were measured on the Harvard Trauma Questionnaire - part IV, which was the primary outcome measure. Other outcome measures included: Hopkins Symptom Check List-25 (depression and anxiety), Social Adjustment Scale - short version (social functioning), WHO-5 Well-being Index (quality of life), Crisis Support Scale (support from social network), Sheehan Disability Scale (disability in three areas of functioning), Hamilton Depression and Anxiety scale, the somatisation items of the Symptoms Checklist-90, Global Assessment of Functioning scales and the summarised score of pain in four body areas rated on visual analogue scales. Two hundred seven adult refugee patients were included in the trial (98 in the venlafaxine and 109 in the sertraline group). Of these, 195 patients were eligible for intention-to-treat analyses. Small but significant pre-treatment to post-treatment differences were found on the Harvard Trauma Questionnaire and a number of other ratings in both groups. On the primary outcome measure, no difference was found in treatment effect between the sertraline and venlafaxine group. A significant group difference was found in favour of sertraline on the Sheehan Disability Scale. Sertraline had a slightly better outcome than venlafaxine on some of the secondary outcome measures, but not on the primary outcome measure. Furthermore, a higher percentage of dropouts was found in the venlafaxine group compared to the sertraline group. Although this could indicate that sertraline was better tolerated, which is supported by other studies, a final conclusion on tolerability cannot be drawn from the current study due to lack of systematic reporting of side effects. ClinicalTrials.gov NCT01569685 . Registration date: 28/2/12.

Interventions to improve communication between people with dementia and nursing staff during daily nursing care: A systematic review.

PubMed

Machiels, Mariska; Metzelthin, Silke F; Hamers, Jan P H; Zwakhalen, Sandra M G

2017-01-01

To provide adequate nursing care it is important for nursing staff to communicate effectively with people with dementia. Due to their limited communication skills, people with dementia have difficulties in understanding communication and expressing themselves verbally. Nursing staff members often report communication difficulties with people with dementia, which emphasises the urgent need for interventions to improve their communication with people in this specific target group. To provide an up-to-date overview of communication interventions that are applicable during daily nursing care activities, irrespective of care setting, and to describe the effects on communication outcomes in people with dementia and nursing staff. Systematic literature review DATA SOURCES: The Cochrane Library, CINAHL, PsycINFO, and Pubmed databases were searched for all articles published until the 23rd of February 2016. Papers were included, if: (1) interventions focused on communication between nursing staff and people with dementia and were applicable during daily nursing care; (2) studies were (randomised) controlled trials; (3) papers were written in English, Dutch, or German. Data were extracted on content and communication outcomes of interventions, and on methodological quality of the studies. The data extraction form and methodological quality checklist were based on the Method Guidelines for Systematic Reviews for the Cochrane Back Review Group. Six studies on communication interventions were included. All of the studies incorporated a communication skills training for nursing staff with a broad range in frequency, duration and content. In addition, there was wide variation in the communication outcome measures used. Four studies measured non-verbal communication, all found positive effects on at least some of the communication outcomes. Four studies measured verbal communication, of which three found positive effects on at least one of the measured outcomes. Methodological quality assessment demonstrated a high risk of bias in five of the six studies. Few studies have been identified with wide variation in interventions and outcome measures. In addition, the methodological shortcomings make it difficult, to draw conclusions about the effectiveness. More research is needed to develop and evaluate communication interventions. Additionally, it is useful to reach consensus on defining and measuring communication. Copyright © 2017 Elsevier Ltd. All rights reserved.

Improving food environments and tackling obesity: A realist systematic review of the policy success of regulatory interventions targeting population nutrition

PubMed Central

Sisnowski, Jana; Merlin, Tracy

2017-01-01

Background This systematic review (PROSPERO: CRD42015025276) employs a realist approach to investigate the effect of “real-world” policies targeting different aspects of the food environment that shape individual and collective nutrition. Objectives We were interested in assessing intermediate outcomes along the assumed causal pathway to “policy success”, in addition to the final outcome of changed consumption patterns. Data sources We performed a search of 16 databases through October 2015, with no initial restriction by language. Study eligibility criteria We included all publications that reported the effect of statutory provisions aimed at reducing the consumption of energy-dense foods and beverages in the general population. We allowed all methodological approaches that contained some measure of comparison, including studies of implementation progress. Study appraisal and synthesis methods We reviewed included studies using the appraisal tools for pre-post and observational studies developed by the National Heart, Lung, and Blood Institute. Given the considerable heterogeneity in interventions assessed, study designs employed, and outcome measures reported, we opted for a narrative synthesis of results. Results and implications Results drawn from 36 peer-reviewed articles and grey literature reports demonstrated that isolated regulatory interventions can improve intermediate outcomes, but fail to affect consumption at clinically significant levels. The included literature covered six different types of interventions, with 19 studies reporting on calorie posting on chain restaurant menus. The large majority of the identified interventions were conducted in the US. Early results from recent taxation measures were published after the review cut-off date but these suggested more favorable effects on consumption levels. Nevertheless, the evidence assessed in this review suggests that current policies are generally falling short of anticipated health impacts. PMID:28783757

How do somatosensory deficits in the arm and hand relate to upper limb impairment, activity, and participation problems after stroke? A systematic review.

PubMed

Meyer, Sarah; Karttunen, Auli H; Thijs, Vincent; Feys, Hilde; Verheyden, Geert

2014-09-01

The association between somatosensory impairments and outcome after stroke remains unclear. The aim of this study was to systematically review the available literature on the relationship between somatosensory impairments in the upper limb and outcome after stroke. The electronic databases PubMed, CINAHL, EMBASE, Cochrane Library, PsycINFO, and Web of Science were systematically searched from inception until July 2013. Studies were included if adult patients with stroke (minimum n=10) were examined with reliable and valid measures of somatosensation in the upper limb to investigate the relationship with upper limb impairment, activity, and participation measures. Exclusion criteria included measures of somatosensation involving an overall score for upper and lower limb outcome and articles including only lower limb outcomes. Eligibility assessment, data extraction, and quality evaluation were completed by 2 independent reviewers. A cutoff score of ≥65% of the maximal quality score was used for further inclusion in this review. Six articles met all inclusion criteria. Two-point discrimination was shown to be predictive for upper limb dexterity, and somatosensory evoked potentials were shown to have predictive value in upper limb motor recovery. Proprioception was significantly correlated with perceived level of physical activity and social isolation and had some predictive value in functional movements of the upper limb. Finally, the combination of light touch and proprioception impairment was shown to be significantly related to upper limb motor recovery as well as handicap situations during activities of daily living. Heterogeneity of the included studies warrants caution when interpreting results. Large variation in results was found due to heterogeneity of the studies. However, somatosensory deficits were shown to have an important role in upper limb motor and functional performance after stroke. © 2014 American Physical Therapy Association.

Public reporting of cost and quality information in orthopaedics.

PubMed

Marjoua, Youssra; Butler, Craig A; Bozic, Kevin J

2012-04-01

Public reporting of patient health outcomes offers the potential to incentivize quality improvement by fostering increased accountability among providers. Voluntary reporting of risk-adjusted outcomes in cardiac surgery, for example, is viewed as a "watershed event" in healthcare accountability. However, public reporting of outcomes, cost, and quality information in orthopaedic surgery remains limited by comparison, attributable in part to the lack of standard assessment methods and metrics, provider fear of inadequate adjustment of health outcomes for patient characteristics (risk adjustment), and historically weak market demand for this type of information. We review the origins of public reporting of outcomes in surgical care, identify existing initiatives specific to orthopaedics, outline the challenges and opportunities, and propose recommendations for public reporting of orthopaedic outcomes. We performed a comprehensive review of the literature through a bibliographic search of MEDLINE and Google Scholar databases from January 1990 to December 2010 to identify articles related to public reporting of surgical outcomes. Orthopaedic-specific quality reporting efforts include the early FDA adverse event reporting MedWatch program and the involvement of surgeons in the Physician Quality Reporting Initiative. Issues that require more work include balancing different stakeholder perspectives on quality reporting measures and methods, defining accountability and attribution for outcomes, and appropriately risk-adjusting outcomes. Given the current limitations associated with public reporting of quality and cost in orthopaedic surgery, valuable contributions can be made in developing specialty-specific evidence-based performance measures. We believe through leadership and involvement in policy formulation and development, orthopaedic surgeons are best equipped to accurately and comprehensively inform the quality reporting process and its application to improve the delivery and outcomes of orthopaedic care.

The impact of patient support programs on adherence, clinical, humanistic, and economic patient outcomes: a targeted systematic review

PubMed Central

Ganguli, Arijit; Clewell, Jerry; Shillington, Alicia C

2016-01-01

Background Patient support programs (PSPs), including medication management and counseling, have the potential to improve care in chronic disease states with complex therapies. Little is known about the program’s effects on improving clinical, adherence, humanistic, and cost outcomes. Purpose To conduct a targeted review describing medical conditions in which PSPs have been implemented; support delivery components (eg, face-to-face, phone, mail, and internet); and outcomes associated with implementation. Data sources MEDLINE – 10 years through March 2015 with supplemental handsearching of reference lists. Study selection English-language trials and observational studies of PSPs providing at minimum, counseling for medication management, measurement of ≥1 clinical outcome, and a 3-month follow-up period during which outcomes were measured. Data extraction Program characteristics and related clinical, adherence, humanistic, and cost outcomes were abstracted. Study quality and the overall strength of evidence were reviewed using standard criteria. Data synthesis Of 2,239 citations, 64 studies met inclusion criteria. All targeted chronic disease processes and the majority (48 [75%]) of programs offered in-clinic, face-to-face support. All but 9 (14.1%) were overseen by allied health care professionals (eg, nurses, pharmacists, paraprofessionals). Forty-one (64.1%) reported at least one significantly positive clinical outcome. The most frequent clinical outcome impacted was adherence, where 27 of 41 (66%) reported a positive outcome. Of 42 studies measuring humanistic outcomes (eg, quality of life, functional status), 27 (64%) reported significantly positive outcomes. Only 15 (23.4%) programs reported cost or utilization-related outcomes, and, of these, 12 reported positive impacts. Conclusion The preponderance of evidence suggests a positive impact of PSPs on adherence, clinical and humanistic outcomes. Although less often measured, health care utilization and costs are also reduced following PSP implementation. Further research is needed to better quantify which support programs, delivery methods, and components offer the greatest value for any particular medical condition. PMID:27175071

Managing the space between visits: a randomized trial of disease management for diabetes in a community health center.

PubMed

Anderson, Daren R; Christison-Lagay, Joan; Villagra, Victor; Liu, Haibei; Dziura, James

2010-10-01

Diabetes outcomes are worse for underserved patients from certain ethnic/racial minority populations. Telephonic disease management is a cost-effective strategy to deliver self-management services and possibly improve diabetes outcomes for such patients. We conducted a trial to test the effectiveness of a supplemental telephonic disease management program compared to usual care alone for patients with diabetes cared for in a community health center. Randomized controlled trial. All patients had type 2 diabetes, and the majority was Hispanic or African American. Most were urban-dwelling with low socioeconomic status, and nearly all had Medicaid or were uninsured. Clinical measures included glycemic control, blood pressure, lipid levels, and body mass index. Validated surveys were used to measure dietary habits and physical activity. A total of 146 patients were randomized to the intervention and 149 to the control group. Depressive symptoms were highly prevalent in both groups. Using an intention to treat analysis, there were no significant differences in the primary outcome (HbA1c) between the intervention and control groups at 12 months. There were also no significant differences for secondary clinical or behavioral outcome measures including BMI, systolic or diastolic blood pressure, LDL cholesterol, smoking, or intake of fruits and vegetables, or physical activity. A clinic-based telephonic disease management support for underserved patients with diabetes did not improve clinical or behavioral outcomes at 1 year as compared to patients receiving usual care alone.

A Systematic Review of Associations between Amount of Meditation Practice and Outcomes in Interventions Using the Four Immeasurables Meditations

PubMed Central

Zeng, Xianglong; Chio, Floria H. N.; Oei, Tian P. S.; Leung, Freedom Y. K.; Liu, Xiangping

2017-01-01

Interventions using the “Four Immeasurables Meditations” (FIM) are effective for various outcomes; however, whether increased meditation practice in these interventions leads to better results has not been well investigated. This systematic review included 22 FIM interventions that reported associations between the amount of meditation practice and its outcomes. Despite the heterogeneity in intervention components and outcome variables, there were generally few significant associations between amount of meditation practice and its outcomes. Specifically, only five studies reported that more than half of the calculated results were significant. In comparison with correlations between total amount of practice and overall outcomes, the short-term influence of meditation practice was evaluated in fewer studies; however, it had a better association with outcomes. More studies are required that address the underlying mechanisms that elucidate how meditation practice leads to outcome changes in daily life. In this study, two promising mechanisms with initial evidence were discussed. This review also summarized common methodological issues including a lack of experimental manipulation and inaccurate measuring of meditation practice. PMID:28220101

A Systematic Review of Associations between Amount of Meditation Practice and Outcomes in Interventions Using the Four Immeasurables Meditations.

PubMed

Zeng, Xianglong; Chio, Floria H N; Oei, Tian P S; Leung, Freedom Y K; Liu, Xiangping

2017-01-01

Interventions using the "Four Immeasurables Meditations" (FIM) are effective for various outcomes; however, whether increased meditation practice in these interventions leads to better results has not been well investigated. This systematic review included 22 FIM interventions that reported associations between the amount of meditation practice and its outcomes. Despite the heterogeneity in intervention components and outcome variables, there were generally few significant associations between amount of meditation practice and its outcomes. Specifically, only five studies reported that more than half of the calculated results were significant. In comparison with correlations between total amount of practice and overall outcomes, the short-term influence of meditation practice was evaluated in fewer studies; however, it had a better association with outcomes. More studies are required that address the underlying mechanisms that elucidate how meditation practice leads to outcome changes in daily life. In this study, two promising mechanisms with initial evidence were discussed. This review also summarized common methodological issues including a lack of experimental manipulation and inaccurate measuring of meditation practice.

HEALTH EFFECTS INSTITUTE (2005-2010)

EPA Science Inventory

The center is conducting research in a number of priority areas, including: new approaches to understanding exposure to and health effect of multiple pollutants including particulate matter, gases, and air toxics; measuring health outcomes and benefits resulting from air qu...

HEALTH EFFECTS INSTITUTE (2010-2015)

EPA Science Inventory

The center is conducting research in a number of priority areas, including: new approaches to understanding exposure to and health effect of multiple pollutants )including particulate matter, gases, and air toxics; measuring health outcomes and benefits resulting from air qual...

Medication safety programs in primary care: a scoping review.

PubMed

Khalil, Hanan; Shahid, Monica; Roughead, Libby

2017-10-01

Medication safety plays an essential role in all healthcare organizations; improving this area is paramount to quality and safety of any wider healthcare program. While several medication safety programs in the hospital setting have been described and the associated impact on patient safety evaluated, no systematic reviews have described the impact of medication safety programs in the primary care setting. A preliminary search of the literature demonstrated that no systematic reviews, meta-analysis or scoping reviews have reported on medication safety programs in primary care; instead they have focused on specific interventions such as medication reconciliation or computerized physician order entry. This scoping review sought to map the current medication safety programs used in primary care. The current scoping review sought to examine the characteristics of medication safety programs in the primary care setting and to map evidence on the outcome measures used to assess the effectiveness of medication safety programs in improving patient safety. The current review considered participants of any age and any condition using care obtained from any primary care services. We considered studies that focussed on the characteristics of medication safety programs and the outcome measures used to measure the effectiveness of these programs on patient safety in the primary care setting. The context of this review was primary care settings, primary healthcare organizations, general practitioner clinics, outpatient clinics and any other clinics that do not classify patients as inpatients. We considered all quantitative studied published in English. A three-step search strategy was utilized in this review. Data were extracted from the included studies to address the review question. The data extracted included type of medication safety program, author, country of origin, aims and purpose of the study, study population, method, comparator, context, main findings and outcome measures. The objectives, inclusion criteria and methods for this scoping review were specified in advance and documented in a protocol that was previously published. This scoping review included nine studies published over an eight-year period that investigated or described the effects of medication safety programs in primary care settings. We classified each of the nine included studies into three main sections according to whether they included an organizational, professional or patient component. The organizational component is aimed at changing the structure of the organization to implement the intervention, the professional component is aimed at the healthcare professionals involved in implementing the interventions, and the patient component is aimed at counseling and education of the patient. All of the included studies had different types of medication safety programs. The programs ranged from complex interventions including pharmacists and teams of healthcare professionals to educational packages for patients and computerized system interventions. The outcome measures described in the included studies were medication error incidence, adverse events and number of drug-related problems. Multi-faceted medication safety programs are likely to vary in characteristics. They include educational training, quality improvement tools, informatics, patient education and feedback provision. The most likely outcome measure for these programs is the incidence of medication errors and reported adverse events or drug-related problems.

The Effect of Yoga on Menstrual Disorders: A Systematic Review.

PubMed

Oates, Jennifer

2017-06-01

To summarize and evaluate evidence for the effect of yoga on menstrual disorders. PubMed, CINAHL/MEDLINE, Web of Science, AMED, and Scopus were searched for English-language literature relevant to the review question. All primary research studies were included. Fifteen studies described in 18 papers were included in the review. A range of yoga interventions were used. Some studies used a combination of Asana, Pranayama, and other yogic relaxation or meditation techniques. All included studies reported some change in their outcome measures, suggesting reduced symptoms of menstrual distress following a yoga intervention; however, the heterogeneity and intensity of the interventions and outcome measures meant that findings have limited generalizability and applicability in practice settings. Further research on the relationship between yoga practice and menstrual disorders is warranted, but there must be both consistency in the methods, measures, and quality of studies and a shift toward research on yoga practices that are replicable outside of the clinical trial setting.

Recommended Patient-Reported Core Set of Symptoms to Measure in Adult Cancer Treatment Trials

PubMed Central

Mitchell, Sandra A.; Dueck, Amylou C.; Basch, Ethan; Cella, David; Reilly, Carolyn Miller; Minasian, Lori M.; Denicoff, Andrea M.; O’Mara, Ann M.; Fisch, Michael J.; Chauhan, Cynthia; Aaronson, Neil K.; Coens, Corneel; Bruner, Deborah Watkins

2014-01-01

Background The National Cancer Institute’s Symptom Management and Health-Related Quality of Life Steering Committee held a clinical trials planning meeting (September 2011) to identify a core symptom set to be assessed across oncology trials for the purposes of better understanding treatment efficacy and toxicity and to facilitate cross-study comparisons. We report the results of an evidence-synthesis and consensus-building effort that culminated in recommendations for core symptoms to be measured in adult cancer clinical trials that include a patient-reported outcome (PRO). Methods We used a data-driven, consensus-building process. A panel of experts, including patient representatives, conducted a systematic review of the literature (2001–2011) and analyzed six large datasets. Results were reviewed at a multistakeholder meeting, and a final set was derived emphasizing symptom prevalence across diverse cancer populations, impact on health outcomes and quality of life, and attribution to either disease or anticancer treatment. Results We recommend that a core set of 12 symptoms—specifically fatigue, insomnia, pain, anorexia (appetite loss), dyspnea, cognitive problems, anxiety (includes worry), nausea, depression (includes sadness), sensory neuropathy, constipation, and diarrhea—be considered for inclusion in clinical trials where a PRO is measured. Inclusion of symptoms and other patient-reported endpoints should be well justified, hypothesis driven, and meaningful to patients. Conclusions This core set will promote consistent assessment of common and clinically relevant disease- and treatment-related symptoms across cancer trials. As such, it provides a foundation to support data harmonization and continued efforts to enhance measurement of patient-centered outcomes in cancer clinical trials and observational studies. PMID:25006191

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.

Functional outcomes following the prosthetic training phase of rehabilitation after dysvascular lower extremity amputation

PubMed Central

Christiansen, Cory; Fields, Thomas; Lev, Guy; Stephenson, Ryan O.; Stevens-Lapsley, Jennifer E.

2015-01-01

Objective To describe physical function outcomes and modes of physical therapy intervention for a cohort of patients with dysvascular lower extremity amputation (LEA) during the prosthetic training phase of rehabilitation. Design A retrospective cohort study. Setting Physical rehabilitation clinics at a Veterans Affairs Medical Center and a University Hospital. Patients Forty-two patients (38 men, 4 women, age 60.2±8.4 years) who completed outpatient physical therapy rehabilitation with prosthetic training after dysvascular LEA. Methods All patients underwent a prosthetic training phase of rehabilitation, with standardized outcome measures performed at initiation and discharge. Main Outcome Measures Performance-based physical function measures included: Two-Minute Walk (2MW), Timed-Up and Go (TUG), and 5-meter gait speed. Self-report physical function measures included: the Prosthesis Evaluation Questionnaire – Mobility Section (PEQ-MS) and the Patient-Specific Functional Scale (PSFS). Rehabilitation dose was tracked as total number of clinic visits, rehabilitation duration, and specific intervention modes. Results There were significant improvements in 2MW (mean±SD) [67.5±29.9 m (initial) and 103.3±45.8 m (discharge) (p<0.001)], gait speed [0.58±0.27 m/s (initial) and 0.88±0.39 m/s (discharge) (p<0.001)], TUG [34.8±21.3 s (initial) and 18.6±13.9 s (discharge) (p<0.001)], PEQ-MS [2.2±0.9 (initial) and 2.8±0.8 (discharge) (p<0.001)], and PSFS [3.2±2.0 (initial) and 5.9±2.3 (discharge) (p<0.001)]. Performance-based (TUG) and self-report (PEQ-MS) changes in functional mobility from initial exam to discharge had low or no correlations with rehabilitation dose measures. Number of clinic visits was 12.7±13.1 and rehabilitation duration was 13.7±16.8 weeks. Conclusions Significant improvements in performance-based and self-report measures of physical function occurred during the prosthetic training phase of physical rehabilitation following dysvascular major LEA. Despite improvements in function, gait speed and TUG outcomes remained below clinically important thresholds, indicating patients were limited in community ambulation and at risk for falls. Lack of moderate or higher correlation between rehabilitation dose and outcome measures may indicate need for more specific rehabilitation dose measures. PMID:25978948

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 providers raised by adopting the patient empowerment paradigm. Summary Healthcare policy is driving the need to consider patient empowerment as a measurable patient outcome from healthcare services. Research is needed to (1) tighten up the construct (2) develop consensus about what is important to include (3) (re)develop a generic measure of patient empowerment for use in evaluating healthcare (4) understand if/how people make trade-offs between empowerment and gain in health status. PMID:22694747

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.

Internet-Based Programs Incorporating Behavior Change Techniques Are Associated With Increased Smoking Cessation in the General Population: A Systematic Review and Meta-analysis.

PubMed

McCrabb, Sam; Baker, Amanda L; Attia, John; Skelton, Eliza; Twyman, Laura; Palazzi, Kerrin; McCarter, Kristen; Ku, Dominic; Bonevski, Billie

2018-05-10

This study aims to (i) examine the effectiveness of internet-based smoking cessation programs; (ii) describe the number and type of behavior change techniques (BCTs) employed; and (iii) explore whether BCTs included in internet-based smoking cessation programs are related to program effectiveness. MEDLINE, CINAHL, EMBASE, PsycINFO, and CENTRAL databases were searched. Randomized controlled trials were included if they described the study of a smoking cessation program delivered via the internet; included current adult tobacco smokers from the general population; and were written in English. Random effects meta-analyses and meta-regressions were used to examine program effectiveness (pooled odds ratios, by outcome measure, i.e., 7 day point prevalence abstinence [PPA], 30 day PPA, other abstinence measure) in short- and long-term outcomes, and examine the associations between BCT number and type (individual BCTs and BCT domain) and program effectiveness. Results from 45 studies were included (n = 65,736). Intervention effectiveness was found in the short term for all outcome measures (OR = 1.29, 95% CI 1.12, 1.50, p = .001), for "prolonged abstinence" (OR = 1.43, 95% CI 1.09, 1.87, p = .009), and "30 day PPA" (OR = 1.75, 95% CI 1.13, 2.72, p = .013). Internet-based programs were effective in the long term for all outcome measures (OR = 1.19, 95% CI = 1.06, 1.35, p = .004) and for "prolonged abstinence" (OR = 1.40, 95% CI 1.19, 1.63, p < .001). On average, interventions used more BCTs than comparison groups (6.6 vs. 3.1, p = .0002). The impact of specific individual BCTs and BCT domains on effectiveness was examined and is reported. Internet-based smoking cessation interventions increased the odds of cessation by 29 per cent in the short term and by 19 per cent in the long term. Internet-based smoking cessation intervention development should incorporate BCTs to increase effectiveness. CRD42015014676.

The effectiveness of a manual therapy and exercise protocol in patients with thumb carpometacarpal osteoarthritis: a randomized controlled trial.

PubMed

Villafañe, Jorge H; Cleland, Joshua A; Fernández-de-Las-Peñas, César

2013-04-01

Double-blind, randomized controlled trial. To examine the effectiveness of a manual therapy and exercise approach relative to a placebo intervention in individuals with carpometacarpal (CMC) joint osteoarthritis (OA). Recent studies have reported the outcomes of exercise, joint mobilization, and neural mobilization interventions used in isolation in patients with CMC joint OA. However, it is not known if using a combination of these interventions as a multimodal approach to treatment would further improve outcomes in this patient population. Sixty patients, 90% female (mean ± SD age, 82 ± 6 years), with CMC joint OA were randomly assigned to receive a multimodal manual treatment approach that included joint mobilization, neural mobilization, and exercise, or a sham intervention, for 12 sessions over 4 weeks. The primary outcome measure was pain. Secondary outcome measures included pressure pain threshold over the first CMC joint, scaphoid, and hamate, as well as pinch and strength measurements. All outcome measures were collected at baseline, immediately following the intervention, and at 1 and 2 months following the end of the intervention. Mixed-model analyses of variance were used to examine the effects of the interventions on each outcome, with group as the between-subject variable and time as the within-subject variable. The mixed-model analysis of variance revealed a group-by-time interaction (F = 47.58, P<.001) for pain intensity, with the patients receiving the multimodal intervention experiencing a greater reduction in pain compared to those receiving the placebo intervention at the end of the intervention, as well as at 1 and 2 months after the intervention (P<.001; all group differences greater than 3.0 cm, which is greater than the minimal clinically important difference of 2.0 cm). A significant group-by-time interaction (F = 3.19, P = .025) was found for pressure pain threshold over the hamate bone immediately after the intervention; however, the interaction was no longer significant at 1 and 2 months postintervention. This clinical trial provides evidence that a combination of joint mobilization, neural mobilization, and exercise is more beneficial in treating pain than a sham intervention in patients with CMC joint OA. However, the treatment approach has limited value in improving pressure pain thresholds, as well as pinch and grip strength. Future studies should include several therapists, a measure of function, and long-term outcomes. Current Controlled Trials ISRCTN37143779. Therapy, level 1b.

Evaluating a measure of social health derived from two mental health recovery measures: the California Quality of Life (CA-QOL) and Mental Health Statistics Improvement Program Consumer Survey (MHSIP).

PubMed

Carlson, Jordan A; Sarkin, Andrew J; Levack, Ashley E; Sklar, Marisa; Tally, Steven R; Gilmer, Todd P; Groessl, Erik J

2011-08-01

Social health is important to measure when assessing outcomes in community mental health. Our objective was to validate social health scales using items from two broader commonly used measures that assess mental health outcomes. Participants were 609 adults receiving psychological treatment services. Items were identified from the California Quality of Life (CA-QOL) and Mental Health Statistics Improvement Program (MHSIP) outcome measures by their conceptual correspondence with social health and compared to the Social Functioning Questionnaire (SFQ) using correlational analyses. Pearson correlations for the identified CA-QOL and MSHIP items with the SFQ ranged from .42 to .62, and the identified scale scores produced Pearson correlation coefficients of .56, .70, and, .70 with the SFQ. Concurrent validity with social health was supported for the identified scales. The current inclusion of these assessment tools allows community mental health programs to include social health in their assessments.

Historical perspective: The pros and cons of conventional outcome measures in Parkinson's disease.

PubMed

Lim, Shen-Yang; Tan, Ai Huey

2018-01-01

Conventional outcome measures (COMs) in Parkinson's disease (PD) refer to rating scales, questionnaires, patient diaries and clinically-based tests that do not require specialized equipment. It is timely at this juncture - as clinicians and researchers begin to grapple with the "invasion" of digital technologies - to review the strengths and weaknesses of these outcome measures. This paper discusses advances (including an enhanced understanding of PD itself, and the development of clinimetrics as a field) that have led to improvements in the COMs used in PD; their strengths and limitations; and factors to consider when selecting and using a measuring instrument. It is envisaged that in the future, a combination of COMs and technology-based objective measures will be utilized, with different methods having their own strengths and weaknesses. Judgement is required on the part of the clinician and researcher in terms of which instrument(s) are appropriate to use, depending on the particular clinical or research setting or question. Copyright © 2017 Elsevier Ltd. All rights reserved.

Fibromyalgia syndrome module at OMERACT 9: domain construct.

PubMed

Mease, Philip; Arnold, Lesley M; Choy, Ernest H; Clauw, Daniel J; Crofford, Leslie J; Glass, Jennifer M; Martin, Susan A; Morea, Jessica; Simon, Lee; Strand, C Vibeke; Williams, David A

2009-10-01

The objective of the module was to (1) establish a core domain set for fibromyalgia (FM) assessment in clinical trials and practice, (2) review outcome measure performance characteristics, (3) discuss development of a responder index for assessment of FM in clinical trials, (4) review objective markers, (5) review the domain of cognitive dysfunction, and (6) establish a research agenda for outcomes research. Presentations at the module included: (1) Results of univariate and multivariate analysis of 10 FM clinical trials of 4 drugs, mapping key domains identified in previous patient focus group: Delphi exercises and a clinician/researcher Delphi exercise, and breakout discussions to vote on possible essential domains and reliable measures; (2) Updates regarding outcome measure status; (3) Update on objective markers to measure FM disease state; and (4) Review of the issue of cognitive dysfunction (dyscognition) in FM. Consensus was reached as follows: (1) Greater than 70% of OMERACT participants agreed that pain, tenderness, fatigue, patient global, multidimensional function and sleep disturbance domains should be measured in all FM clinical trials; dyscognition and depression should be measured in some trials; and stiffness, anxiety, functional imaging, and cerebrospinal fluid biomarkers were identified as domains of research interest. (2) FM domain outcome measures have generally proven to be reliable, discriminative, and feasible. More sophisticated and comprehensive measures are in development, as is a responder index for FM. (3) Increasing numbers of objective markers are being developed for FM assessment. (4) Cognitive dysfunction assessment by self-assessed and applied outcome measures is being developed. In conclusion, a multidimensional symptom core set is proposed for evaluation of FM in clinical trials. Research on improved measures of single domains and composite measures is ongoing.

A systematic review of outcome measures utilised to assess self-management in clinical trials in patients with chronic pain.

PubMed

Banerjee, Anirban; Hendrick, Paul; Bhattacharjee, Purba; Blake, Holly

2018-05-01

The aim of this review was to identify, appraise and synthesise the outcome measures used to assess self-management in patients with chronic pain. Medline, Embase, CINAHL, PsycINFO, the Cochrane Library and Google Scholar were searched to identify quantitative measures used within randomised or non-randomised clinical trials to assess self-management in adults (≥18 years) with chronic pain. 25 RCTs published between 1998 and 2016 were included in this review. Studies included patients with chronic pain, hip/knee osteoarthritis, rheumatoid arthritis, chronic low back pain, fibromyalgia and chronic fatigue syndrome. Included studies utilised 14 different measures assessing a variety of constructs including self-efficacy (n = 19), coping (n = 4), empowerment (n = 2), pain attitude and management (n = 3), self-care (n = 1), role behaviour (n = 1) and multiple constructs of self-management (n = 1). The Chronic Pain Coping Inventory (CPCI) and Health Education Impact Questionnaire (heiQ) cover different self-management related constructs across the physical, mental and social health domains. The review identified 14 measures used as proxy measure to assess self-management in patients with chronic pain. These measures have good content and construct validity, and internal consistency. However additional research is required to develop their reliability, responsiveness and interpretability. Multi-constructs measures (CPCI, heiQ) are suitable for assessing self-management. Copyright © 2017 Elsevier B.V. All rights reserved.

Are Changes in Leg Power Responsible for Clinically Meaningful Improvements in Mobility Among Older Adults?

PubMed Central

Bean, Jonathan F.; Kiely, Dan K.; LaRose, Sharon; Goldstein, Richard; Frontera, Walter R.; Leveille, Suzanne G.

2010-01-01

Objectives Mobility as measured by the Short Physical Performance Battery (SPPB) or habitual Gait Speed (GS) is predictive of mortality and disability among older adults. Clinically meaningful changes of these measures have been identified. Among physiologic attributes commonly targeted in rehabilitation, we sought to identify those attributes in which changes led to clinically meaningful differences (CMD) in the mobility outcomes. Participants Community-dwelling, mobility-limited older adults (n=116) participating in a 16-week randomized controlled trial (RCT) of two modes of exercise Setting Outpatient rehabilitation centers Design Secondary analysis of data collected for a RCT of exercise using binary outcomes defined by recording a large CMD (SPPB=1 unit; GS=.1m/s). Iterative models were performed to evaluate possible confounding between physiologic variables and relevant covariates. Measures Physiologic measures included leg power, leg strength, balance as measured by the Performance Oriented Mobility Assessment (POMA), rate pressure product (RPP) at the maximal stage of an exercise tolerance test. Outcomes included GS and SPPB. Leg power and leg strength were measured using computerized pneumatic strength training equipment and recorded in Watts and Newtons respectively. Results Participants were 68% female, had a mean age of 75.2 years, with a mean of 5.5 chronic conditions and a baseline mean SPPB score of 8.7. After controlling for age, site, group assignment, and baseline outcome values, leg power was the only attribute in which changes were significantly associated with a large CMD in SPPB (OR 1.48, 95% CI 1.09, 2.02) and GS (OR1.31, 95% CI 1.01, 1.70). Conclusion Improvements in leg power, independent of strength, appear to make an important contribution towards clinically meaningful improvements in both SPPB and GS. PMID:21143443

Effectiveness of a Multilevel Workplace Health Promotion Program on Vitality, Health, and Work-Related Outcomes

PubMed Central

Hendriksen, Ingrid J.M.; Snoijer, Mirjam; de Kok, Brenda P.H.; van Vilsteren, Jeroen; Hofstetter, Hedwig

2016-01-01

Objective: Evaluation of the effectiveness of a workplace health promotion program on employees’ vitality, health, and work-related outcomes, and exploring the influence of organizational support and the supervisors’ role on these outcomes. Methods: The 5-month intervention included activities at management, team, and individual level targeting self-management to perform healthy behaviors: a kick-off session, vitality training sessions, workshops, individual coaching, and intervision. Outcome measures were collected using questionnaires, health checks, and sickness absence data at baseline, after the intervention and at 10 months follow-up. For analysis linear and generalized mixed models were used. Results: Vitality, work performance, sickness absence, and self-management significantly improved. Good organizational support and involved supervisors were significantly associated with lower sickness absence. Conclusions: Including all organizational levels and focusing on increasing self-management provided promising results for improving vitality, health, and work-related outcomes. PMID:27136605

Effectiveness of a Multilevel Workplace Health Promotion Program on Vitality, Health, and Work-Related Outcomes.

PubMed

Hendriksen, Ingrid J M; Snoijer, Mirjam; de Kok, Brenda P H; van Vilsteren, Jeroen; Hofstetter, Hedwig

2016-06-01

Evaluation of the effectiveness of a workplace health promotion program on employees' vitality, health, and work-related outcomes, and exploring the influence of organizational support and the supervisors' role on these outcomes. The 5-month intervention included activities at management, team, and individual level targeting self-management to perform healthy behaviors: a kick-off session, vitality training sessions, workshops, individual coaching, and intervision. Outcome measures were collected using questionnaires, health checks, and sickness absence data at baseline, after the intervention and at 10 months follow-up. For analysis linear and generalized mixed models were used. Vitality, work performance, sickness absence, and self-management significantly improved. Good organizational support and involved supervisors were significantly associated with lower sickness absence. Including all organizational levels and focusing on increasing self-management provided promising results for improving vitality, health, and work-related outcomes.

Predictors of delay in heart failure patients and consequences for outcomes.

PubMed

Sethares, Kristen A; Chin, Elizabeth; Jurgens, Corrine Y

2015-02-01

Persons with heart failure (HF) symptoms delay up to 7 days before seeking treatment. Delay can result in worse symptoms and potentially impact outcomes. The purpose of this review was to describe predictors and outcomes of delay in HF patients. Demographic factors, increased symptom number, social factors, greater HF knowledge, lower anxiety, and depression predicted increased delay. HF patients had difficulty recognizing and interpreting symptoms of HF. Results are conflicting related to symptom pattern, time of care seeking, and history of HF as predictors of delay. The only outcome predicted by delay was length of stay with those delaying longer reporting longer lengths of stay. Future research related to delay should include theoretical frameworks and larger, more ethnically diverse samples from multiple sites and link delay to outcomes. Valid and reliable instruments are needed to measure delay and related factors. HF education should include supportive others.

Validity of the AusTOM scales: A comparison of the AusTOMs and EuroQol-5D

PubMed Central

Unsworth, Carolyn A; Duckett, Stephen J; Duncombe, Dianne; Perry, Alison; Skeat, Jemma; Taylor, Nicholas

2004-01-01

Background Clinicians require brief outcome measures in their busy daily practice to document global client outcomes. Based on the UK Therapy Outcome Measure, the Australian Therapy Outcome Measures were designed to capture global therapy outcomes of occupational therapy, physiotherapy and speech pathology in the Australian clinical context. The aim of this study was to investigate the construct (convergent) validity of the Australian Therapy Outcome Measures (AusTOMs) by comparing it with the EuroQuol-5D (EQ-5D). Methods The research was a prospective, longitudinal cohort study, with data collected over a seven month time period. The study was conducted at a total of 13 metropolitan and rural health-care sites including acute, sub-acute and community facilities. Two-hundred and five clients were asked to score themselves on the EQ-5D, and the same clients were scored by approximately 115 therapists (physiotherapists, speech pathologists and occupational therapists) using the AusTOMs at admission and discharge. Clients were consecutive admissions who agreed to participate in the study. Clients of all diagnoses, aged 18 years and over (a criteria of the EQ-5D), and able to give informed consent were scored on the measures. Spearman rank order correlation coefficients were used to analyze the relationships between scores from the two tools. The clients were scored on the AusTOMs and EQ-5D. Results There were many health care areas where correlations were expected and found between scores on the AusTOMs and the EQ-5D. Conclusion In the quest to measure the effectiveness of therapy services, managers, health care founders and clinicians are urgently seeking to undertake the first step by identifying tools that can measure therapy outcome. AusTOMs is one tool that can measure global client outcomes following therapy. In this study, it was found that on the whole, the AusTOMs and the EQ-5D measure similar constructs. Hence, although the validity of a tool is never 'proven', this study offers preliminary support for the construct validity of AusTOMs. PMID:15541181

Fetal Growth and Neurobehavioral Outcomes in Childhood

PubMed Central

Chatterji, Pinka; Lahiri, Kajal; Kim, Dohyung

2014-01-01

Using a sample of sibling pairs from a nationally representative U.S. survey, we examine the effects of the fetal growth rate on a set of neurobehavioral outcomes in childhood measured by parent-reported diagnosed developmental disabilities and behavior problems. Based on models that include mother fixed effects, we find that the fetal growth rate, a marker for the fetal environment, is negatively associated with lifetime diagnosis of developmental delay. We also find that the fetal growth rate is negatively associated with disruptive behaviors among male children. These results suggest that developmental disabilities and problem behaviors may play a role in explaining the well-documented association between birth weight and human capital outcomes measured in adulthood. PMID:25464342

Can the Assessment of Spontaneous Oscillations by Near Infrared Spectrophotometry Predict Neurological Outcome of Preterm Infants?

PubMed

Stammwitz, André; von Siebenthal, Kurt; Bucher, Hans U; Wolf, Martin

2016-01-01

The aim was to assess the correlation between cerebral autoregulation and outcome. Included were 31 preterm infants, gestational age 26 1/7 to 32 2/7 and <24 h life. Coherence between cerebral total haemoglobin (tHb) or oxygenation index (OI) measured by near-infrared spectrophotometry (NIRS) and systemic heart rate (HR) or arterial blood pressure (MAP) was calculated as a measure of autoregulation. In contrast to previous studies, low coherences in the first 24 h were significantly associated with intraventricular haemorrhage, death or abnormal neurodevelopmental outcome at 18 months or later. We suggest that our results can be explained by the concept of a multi-oscillatory-functions-order.

Key performance outcomes of patient safety curricula: root cause analysis, failure mode and effects analysis, and structured communications skills.

PubMed

Fassett, William E

2011-10-10

As colleges and schools of pharmacy develop core courses related to patient safety, course-level outcomes will need to include both knowledge and performance measures. Three key performance outcomes for patient safety coursework, measured at the course level, are the ability to perform root cause analyses and healthcare failure mode effects analyses, and the ability to generate effective safety communications using structured formats such as the Situation-Background-Assessment-Recommendation (SBAR) situational briefing model. Each of these skills is widely used in patient safety work and competence in their use is essential for a pharmacist's ability to contribute as a member of a patient safety team.

Trials with patient-reported outcomes registered on the Australian New Zealand Clinical Trials Registry (ANZCTR).

PubMed

Mercieca-Bebber, Rebecca; Williams, Douglas; Tait, Margaret-Ann; Roydhouse, Jessica; Busija, Lucy; Sundaram, Chindhu Shunmuga; Wilson, Michelle; Langford, Ailsa; Rutherford, Claudia; Roberts, Natasha; King, Madeleine; Vodicka, Elisabeth; Devine, Beth

2018-06-18

It is important to understand the number, types and regions of trials that include patient-reported outcomes (PROs) to appreciate how patient experiences have been considered in studies of health and interventions. Twenty-seven percent of trials registered with ClinicalTrials.gov (2007-2013) included PROs; however, a regional breakdown was not provided and no reviews have been conducted of the Australia New Zealand Clinical Trials Registry (ANZCTR). We aimed to identify trials registered with ANZCTR with PRO endpoints and describe their characteristics. ANZCTR was systematically searched from inception (2005) to 31 March 2017 for trials with PRO endpoints. Search terms included PRO measures listed in Patient-Reported Outcomes Quality of Life Instrument Database and Grid-Enabled Measures, as well as generic PRO terms (e.g. "quality of life" (QOL)). Trial endpoints were individually coded using an established framework to identify trials with PROs for the analysis. Of 13,666 registered trials, 6168 (45.1%) included a PRO. The proportion of studies including PROs increased between 2006 and 2016 (r = 0.74, p = 0.009). Among the 6168 trials, there were 17,961 individual PRO endpoints, including symptoms/functional outcomes/condition-specific QOL (65.6%), generic QOL (13.2%), patient-reported experiences (9.9%), patient-reported behaviours (7.9%). Mental health was the most common category (99.8% included PROs), followed by physical medicine/rehabilitation (65.6%), musculoskeletal (63.5%), public health (63.1%), and cancer (54.2%). Our findings suggest growing use of PROs in the assessment of health and interventions in ANZ. Our review identifies trial categories with limited patient-reported information and provides a basis for future work on the impact of PRO findings in clinical care.

The use of errorless learning strategies for patients with Alzheimer's disease: a literature review.

PubMed

Li, Ruijie; Liu, Karen P Y

2012-12-01

The aim of this article was to review the evidence of errorless learning on learning outcomes in patients with early-stage Alzheimer's disease. A computer-aided literature search from 1999 to 2011 was carried out using MEDLINE, Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycINFO and PsycArticles. Keywords included 'errorless learning or practice' and 'Alzheimer's disease'. Four studies that fulfilled the inclusion criteria were selected and reviewed. Two of the studies were clinical controlled trials: one was a single-group pretest-post-test trial and the other was a multiple single-participant study. Demographic variables, design, treatment and outcome measures were summarized. Recall trials were used as the primary outcome measure. Results indicate that the use of errorless learning promotes better retention of specific types of information. Errorless learning is effective in memory rehabilitation of older adults with Alzheimer's disease. However, it would require more studies with unified outcome measures to allow for the formulation of standardized clinical protocol and recommendations.