42 CFR 410.146 - Diabetes outcome measurements.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 2 2014-10-01 2014-10-01 false Diabetes outcome measurements. 410.146 Section 410... MEDICARE PROGRAM SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS Outpatient Diabetes Self-Management Training and Diabetes Outcome Measurements § 410.146 Diabetes outcome measurements. (a) Information...

42 CFR 410.146 - Diabetes outcome measurements.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 2 2012-10-01 2012-10-01 false Diabetes outcome measurements. 410.146 Section 410... MEDICARE PROGRAM SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS Outpatient Diabetes Self-Management Training and Diabetes Outcome Measurements § 410.146 Diabetes outcome measurements. (a) Information...

42 CFR 410.146 - Diabetes outcome measurements.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 2 2013-10-01 2013-10-01 false Diabetes outcome measurements. 410.146 Section 410... MEDICARE PROGRAM SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS Outpatient Diabetes Self-Management Training and Diabetes Outcome Measurements § 410.146 Diabetes outcome measurements. (a) Information...

42 CFR 410.146 - Diabetes outcome measurements.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 2 2010-10-01 2010-10-01 false Diabetes outcome measurements. 410.146 Section 410... MEDICARE PROGRAM SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS Outpatient Diabetes Self-Management Training and Diabetes Outcome Measurements § 410.146 Diabetes outcome measurements. (a) Information...

The use of shoulder scoring systems and outcome measures in the UK

PubMed Central

Lamb, J; Rambani, R; Venkateswaran, B

2014-01-01

Introduction In future, outcomes following shoulder surgery may be subject to public survey. Many outcome measures exist but we do not know whether there is a consensus between shoulder surgeons in the UK. The aim of this study was to survey the preferred outcome measures used by National Health Service (NHS) shoulder surgeons operating in the UK. Methods A total of 350 shoulder surgeons working in NHS hospitals were asked to complete a short written questionnaire regarding their use of scoring systems and outcome measures. Questionnaires were sent and responses were received by post. Results Overall, 217 responses were received (62%). Of the respondents, 171 (79%) use an outcome measure in their shoulder practice while 46 (21%) do not. There were 118 surgeons (69%) who use more than one outcome measure. The Oxford shoulder score was most commonly used by 150 surgeons (69%), followed by the Constant score with 106 (49%), the Oxford shoulder instability score with 82 (38%), and the Disabilities of the Arm, Shoulder and Hand score with 54 (25%). The less commonly used outcome measures were the SF-36® and SF-12® health questionnaires with 19 (9%), the University of California at Los Angeles activity score with 8 (4%), the American Shoulder and Elbow Surgeons shoulder assessment form with 8 (4%) and the EQ-5D™ with 10 (3%). Conclusions Validated outcome measures should be adopted by all practising surgeons in all specialties. This will allow better assessment of treatments in addition to assessment of surgical performance in a transparent way. PMID:25350180

The use of shoulder scoring systems and outcome measures in the UK.

PubMed

Varghese, M; Lamb, J; Rambani, R; Venkateswaran, B

2014-11-01

In future, outcomes following shoulder surgery may be subject to public survey. Many outcome measures exist but we do not know whether there is a consensus between shoulder surgeons in the UK. The aim of this study was to survey the preferred outcome measures used by National Health Service (NHS) shoulder surgeons operating in the UK. A total of 350 shoulder surgeons working in NHS hospitals were asked to complete a short written questionnaire regarding their use of scoring systems and outcome measures. Questionnaires were sent and responses were received by post. Overall, 217 responses were received (62%). Of the respondents, 171 (79%) use an outcome measure in their shoulder practice while 46 (21%) do not. There were 118 surgeons (69%) who use more than one outcome measure. The Oxford shoulder score was most commonly used by 150 surgeons (69%), followed by the Constant score with 106 (49%), the Oxford shoulder instability score with 82 (38%), and the Disabilities of the Arm, Shoulder and Hand score with 54 (25%). The less commonly used outcome measures were the SF-36® and SF-12® health questionnaires with 19 (9%), the University of California at Los Angeles activity score with 8 (4%), the American Shoulder and Elbow Surgeons shoulder assessment form with 8 (4%) and the EQ-5D™ with 10 (3%). Conclusions Validated outcome measures should be adopted by all practising surgeons in all specialties. This will allow better assessment of treatments in addition to assessment of surgical performance in a transparent way.

Goal specificity: a proxy measure for improvements in environmental outcomes in collaborative governance.

PubMed

Biddle, Jennifer C; Koontz, Tomas M

2014-12-01

Collaborative governance critics continually call for evidence to support its prevalent use. As is often the case in environmental policy, environmental outcomes occur at a rate incompatible with political agendas. In addition, a multitude of possibly confounding variables makes it difficult to correlate collaborative governance processes with environmental outcomes. The findings of this study offer empirical evidence that collaborative processes have a measurable, beneficial effect on environmental outcomes. Through the use of a unique paired-waterbody design, our dataset reduced the potential for confounding variables to impact our environmental outcome measurements. The results of a path analysis indicate that the output of setting specific pollutant reduction goals is significantly related to watershed partnerships' level of attainment of their environmental improvement goals. The action of setting specific goals (e.g. percentage of load reductions in pollutant levels) is fostered by sustained participation from partnership members throughout the lifecycle of the collaborative. In addition, this study demonstrates the utility of logic modeling for environmental planning and management, and suggests that the process of setting specific pollutant reduction goals is a useful proxy measure for reporting progress towards improvements in environmental outcomes when long-term environmental data are not available. Copyright © 2014 Elsevier Ltd. All rights reserved.

Standardized Outcome Measurement for Patients With Coronary Artery Disease: Consensus From the International Consortium for Health Outcomes Measurement (ICHOM).

PubMed

McNamara, Robert L; Spatz, Erica S; Kelley, Thomas A; Stowell, Caleb J; Beltrame, John; Heidenreich, Paul; Tresserras, Ricard; Jernberg, Tomas; Chua, Terrance; Morgan, Louise; Panigrahi, Bishnu; Rosas Ruiz, Alba; Rumsfeld, John S; Sadwin, Lawrence; Schoeberl, Mark; Shahian, David; Weston, Clive; Yeh, Robert; Lewin, Jack

2015-05-19

Coronary artery disease (CAD) outcomes consistently improve when they are routinely measured and provided back to physicians and hospitals. However, few centers around the world systematically track outcomes, and no global standards exist. Furthermore, patient-centered outcomes and longitudinal outcomes are under-represented in current assessments. The nonprofit International Consortium for Health Outcomes Measurement (ICHOM) convened an international Working Group to define a consensus standard set of outcome measures and risk factors for tracking, comparing, and improving the outcomes of CAD care. Members were drawn from 4 continents and 6 countries. Using a modified Delphi method, the ICHOM Working Group defined who should be tracked, what should be measured, and when such measurements should be performed. The ICHOM CAD consensus measures were designed to be relevant for all patients diagnosed with CAD, including those with acute myocardial infarction, angina, and asymptomatic CAD. Thirteen specific outcomes were chosen, including acute complications occurring within 30 days of acute myocardial infarction, coronary artery bypass grafting surgery, or percutaneous coronary intervention; and longitudinal outcomes for up to 5 years for patient-reported health status (Seattle Angina Questionnaire [SAQ-7], elements of Rose Dyspnea Score, and Patient Health Questionnaire [PHQ-2]), cardiovascular hospital admissions, cardiovascular procedures, renal failure, and mortality. Baseline demographic, cardiovascular disease, and comorbidity information is included to improve the interpretability of comparisons. ICHOM recommends that this set of outcomes and other patient information be measured for all patients with CAD. © 2015 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

Outcome measurement in Australian rehabilitation environments.

PubMed

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

2005-09-01

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

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 development of an outcome measure for liaison mental health services.

PubMed

Guthrie, Else; Harrison, Mathew; Brown, Richard; Sandhu, Rajdeep; Trigwell, Peter; Abraham, Seri; Nawaz, Shazada; Kelsall, Peter; Thomasson, Rachel

2018-06-01

Aims and methodTo develop and pilot a clinician-rated outcome scale to evaluate symptomatic outcomes in liaison psychiatry services. Three hundred and sixty patient contacts with 207 separate individuals were rated using six subscales (mood, psychosis, cognition, substance misuse, mind-body problems and behavioural disturbance) plus two additional items (side-effects of medication and capacity to consent for medical treatment). Each item was rated on a five-point scale from 0 to 5 (nil, mild, moderate, severe and very severe). The liaison outcome measure was acceptable and easy to use. All subscales showed acceptable interrater reliability, with the exception of the mind-body subscale. Overall, the measure appears to show stability and sensitivity to change.Clinical implicationsThe measure provides a useful and robust way to determine symptomatic change in a liaison mental health setting, although the mind-body subscale requires modification.Declaration of interestNone.

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.

Photoreceptor change and visual outcome after idiopathic epiretinal membrane removal with or without additional internal limiting membrane peeling.

PubMed

Ahn, Seong Joon; Ahn, Jeeyun; Woo, Se Joon; Park, Kyu Hyung

2014-01-01

To compare the postoperative photoreceptor status and visual outcome after epiretinal membrane removal with or without additional internal limiting membrane (ILM) peeling. Medical records of 40 eyes from 37 patients undergoing epiretinal membrane removal with residual ILM peeling (additional ILM peeling group) and 69 eyes from 65 patients undergoing epiretinal membrane removal without additional ILM peeling (no additional peeling group) were reviewed. The length of defects in cone outer segment tips, inner segment/outer segment junction, and external limiting membrane line were measured using spectral domain optical coherence tomography images of the fovea before and at 1, 3, 6, and 12 months after the surgery. Cone outer segment tips and inner segment/outer segment junction line defects were most severe at postoperative 1 month and gradually restored at 12 months postoperatively. The cone outer segment tips line defect in the additional ILM peeling group was significantly greater than that in the no additional peeling group at postoperative 1 month (P = 0.006), and best-corrected visual acuity was significantly worse in the former group at the same month (P = 0.001). There was no significant difference in the defect size and best-corrected visual acuity at subsequent visits and recurrence rates between the two groups. Patients who received epiretinal membrane surgery without additional ILM peeling showed better visual and anatomical outcome than those with additional ILM peeling at postoperative 1 month. However, surgical outcomes were comparable between the two groups, thereafter. In terms of visual outcome and photoreceptor integrity, additional ILM peeling may not be an essential procedure.

Use of Outcome Measurement by Paediatric AHPs in Northern Ireland

ERIC Educational Resources Information Center

Harron, Anita; Titterington, Jill

2016-01-01

Background: Professional standards advocate routine use of outcome measurement (OM) in the practice of allied health professionals (AHPs). Historically, OM has focused on impairment and its immediate constraints on activity, while current policy encourages the development and addition of impact-based OM. There appears to be an assumption at this…

Outcome measurement of hand function following mirror therapy for stroke rehabilitation: A systematic review.

PubMed

Cantero-Téllez, Raquel; Naughton, Nancy; Algar, Lori; Valdes, Kristin

2018-02-28

Systematic review. Mirror therapy is a treatment used to address hand function following a stroke. Measurement of outcomes using appropriate assessment tools is crucial; however, many assessment options exist. The purpose of this study is to systematically review outcome measures that are used to assess hand function following mirror therapy after stroke and, in addition, to identify the psychometric and descriptive properties of the included measures and through the linking process determine if the outcome measures are representative of the International Classification of Functioning, Disability and Health (ICF). Following a comprehensive literature search, outcome measures used in the included studies were linked to the ICF and analyzed based on descriptive information and psychometric properties. Eleven studies met inclusion criteria and included 24 different assessment tools to measure hand or upper limb function. Most outcome measures used in the selected studies (63%) were rated by the evaluating therapist. Thirteen outcome measures (54%) linked to the ICF body function category and 10 measures (42%) linked to activities and participation. One outcome measure was linked to not defined, and all other ICF categories were not represented. A majority of outcome measures have been assessed for validity, reliability, and responsiveness, but responsiveness was the least investigated psychometric property. Current studies on mirror therapy after stroke are not consistent in the assessment tools used to determine hand function. Understanding of study outcomes requires analysis of the assessment tools. The outcome measures used in the included studies are not representative of personal and environmental factors, but tools linking to body functions and activities and participations provide important information on functional outcome. Integrating a combination of measures that are psychometrically sound and reflective of the ICF should be considered for assessment of

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.

The impact of outcomes measurement on the hospital-physician relationship.

PubMed

Longo, D R

1994-01-01

Hospitals and physicians have a mutually dependent relationship. Although both are responsible for patient care, conflicts arise as physicians attempt to maintain professional autonomy and hospitals attempt to maintain organizational stability. In recent years the outcomes measurement movement has influenced this relationship in a variety of ways. This review chapter traces the major sociological, historical, theoretical, and political influences that have contributed to these conflicts. Additionally, based on an analysis of these trends, speculation is offered on the future of the hospital-physician relationship as society increasingly holds both groups responsible for outcomes of care.

Outcome Measurement in the Treatment of Spasmodic Dysphonia: A Systematic Review of the Literature.

PubMed

Rumbach, Anna; Aiken, Patrick; Novakovic, Daniel

2018-04-11

The aim of this review was to systematically identify all available studies reporting outcomes measures to assess treatment outcomes for people with spasmodic dysphonia (SD). Full-text journal articles were identified through searches of PubMed, Embase, CINAHL, and Cochrane databases and hand searching of journals. A total of 4,714 articles were retrieved from searching databases; 1,165 were duplicates. Titles and abstracts of 3,549 were screened, with 171 being selected for full-text review. During full-text review, 101 articles were deemed suitable for inclusion. An additional 24 articles were identified as suitable for inclusion through a hand search of reference lists. Data were extracted from 125 studies. A total of 220 outcome measures were identified. Considered in reference to the World Health Organization International Classification of Functioning, Disability and Health (ICF), the majority of outcomes were measured at a Body Function level (n = 212, 96%). Outcomes that explored communication and participation in everyday life and attitudes toward communication (ie, activity and participation domains) were infrequent (n = 8; 4%). Quality of life, a construct not measured within the ICF, was also captured by four outcome measures. No instruments evaluating communication partners' perspectives or burden/disability were identified. The outcome measures used in SD treatment studies are many and varied. The outcome measures identified predominately measure constructs within the Body Functions component of the ICF. In order to facilitate data synthesis across trials, the development of a core outcome set is recommended. Crown Copyright © 2018. Published by Elsevier Inc. All rights reserved.

The International Dermatology Outcome Measures Group: formation of patient-centered outcome measures in dermatology.

PubMed

Gottlieb, Alice B; Levin, Adriane A; Armstrong, April W; Abernethy, April; Duffin, Kristina Callis; Bhushan, Reva; Garg, Amit; Merola, Joseph F; Maccarone, Mara; Christensen, Robin

2015-02-01

As quality standards are increasingly in demand throughout medicine, dermatology needs to establish outcome measures to quantify the effectiveness of treatments and providers. The International Dermatology Outcome Measures Group was established to address this need. Beginning with psoriasis, the group aims to create a tool considerate of patients and providers using the input of all relevant stakeholders in assessment of disease severity and response to treatment. Herein, we delineate the procedures through which consensus is being reached and the future directions of the project. Copyright © 2014 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

Causal inference with measurement error in outcomes: Bias analysis and estimation methods.

PubMed

Shu, Di; Yi, Grace Y

2017-01-01

Inverse probability weighting estimation has been popularly used to consistently estimate the average treatment effect. Its validity, however, is challenged by the presence of error-prone variables. In this paper, we explore the inverse probability weighting estimation with mismeasured outcome variables. We study the impact of measurement error for both continuous and discrete outcome variables and reveal interesting consequences of the naive analysis which ignores measurement error. When a continuous outcome variable is mismeasured under an additive measurement error model, the naive analysis may still yield a consistent estimator; when the outcome is binary, we derive the asymptotic bias in a closed-form. Furthermore, we develop consistent estimation procedures for practical scenarios where either validation data or replicates are available. With validation data, we propose an efficient method for estimation of average treatment effect; the efficiency gain is substantial relative to usual methods of using validation data. To provide protection against model misspecification, we further propose a doubly robust estimator which is consistent even when either the treatment model or the outcome model is misspecified. Simulation studies are reported to assess the performance of the proposed methods. An application to a smoking cessation dataset is presented.

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.

Patient-Oriented Eczema Measure (POEM), a core instrument to measure symptoms in clinical trials: a Harmonising Outcome Measures for Eczema (HOME) statement.

PubMed

Spuls, P I; Gerbens, L A A; Simpson, E; Apfelbacher, C J; Chalmers, J R; Thomas, K S; Prinsen, C A C; von Kobyletzki, L B; Singh, J A; Williams, H C; Schmitt, J

2017-04-01

The Harmonising Outcome Measures for Eczema (HOME) initiative has defined four core outcome domains for a core outcome set (COS) to be measured in all atopic eczema (AE) trials to ensure cross-trial comparison: clinical signs, symptoms, quality of life and long-term control. The aim of this paper is to report on the consensus process that was used to select the core instrument to consistently assess symptoms in all future AE trials. Following the HOME roadmap, two systematic reviews were performed which identified three instruments that had sufficient evidence of validity, reliability and feasibility to be considered for the final COS. At the fourth international HOME meeting, there was broad consensus among all stakeholders that the Patient-Oriented Eczema Measure (POEM) should be used as the core instrument (87·5% agreed, 9·4% unsure, 3·1% disagreed). All relevant stakeholders are encouraged to use POEM as the chosen instrument to measure the core domain of symptoms in all future AE clinical trials. Other instruments of interest can be used in addition to POEM. © 2016 British Association of Dermatologists.

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

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.

The Harmonizing Outcome Measures for Eczema (HOME) roadmap: a methodological framework to develop core sets of outcome measurements in dermatology.

PubMed

Schmitt, Jochen; Apfelbacher, Christian; Spuls, Phyllis I; Thomas, Kim S; Simpson, Eric L; Furue, Masutaka; Chalmers, Joanne; Williams, Hywel C

2015-01-01

Core outcome sets (COSs) are consensus-derived minimum sets of outcomes to be assessed in a specific situation. COSs are being increasingly developed to limit outcome-reporting bias, allow comparisons across trials, and strengthen clinical decision making. Despite the increasing interest in outcomes research, methods to develop COSs have not yet been standardized. The aim of this paper is to present the Harmonizing Outcomes Measures for Eczema (HOME) roadmap for the development and implementation of COSs, which was developed on the basis of our experience in the standardization of outcome measurements for atopic eczema. Following the establishment of a panel representing all relevant stakeholders and a research team experienced in outcomes research, the scope and setting of the core set should be defined. The next steps are the definition of a core set of outcome domains such as symptoms or quality of life, followed by the identification or development and validation of appropriate outcome measurement instruments to measure these core domains. Finally, the consented COS needs to be disseminated, implemented, and reviewed. We believe that the HOME roadmap is a useful methodological framework to develop COSs in dermatology, with the ultimate goal of better decision making and promoting patient-centered health care.

Facility-level outcome performance measures for nursing homes.

PubMed

Porell, F; Caro, F G

1998-12-01

Risk-adjusted nursing home performance scores were developed for four health outcomes and five quality indicators from resident-level longitudinal case-mix reimbursement data for Medicaid residents of more than 500 nursing homes in Massachusetts. Facility performance was measured by comparing actual resident outcomes with expected outcomes derived from quarterly predictions of resident-level econometric models over a 3-year period (1991-1994). Performance measures were tightly distributed among facilities in the state. The intercorrelations among the nine outcome performance measures were relatively low and not uniformly positive. Performance measures were not highly associated with various structural facility attributes. For most outcomes, longitudinal analyses revealed only modest correlations between a facility's performance score from one time period to the next. Relatively few facilities exhibited consistent superior or inferior performance over time. The findings have implications toward the practical use of facility outcome performance measures for quality assurance and reimbursement purposes in the near future.

Ancillary outcome measures for assessment of individuals with cervical spondylotic myelopathy.

PubMed

Kalsi-Ryan, Sukhvinder; Singh, Anoushka; Massicotte, Eric M; Arnold, Paul M; Brodke, Darrel S; Norvell, Daniel C; Hermsmeyer, Jeffrey T; Fehlings, Michael G

2013-10-15

, Neck Disability Index, and 30-Meter Walk Test are most appropriate for the assessment of CSM. However, 6 additional outcome measures (QuickDASH, Berg Balance Scale, Graded Redefined Assessment of Strength Sensibility and Prehension, Grip Dynamometer, and GAITRite Analysis) were identified, which provide complementary assessments for CSM. SUMMARY STATEMENTS: There does not exist a single or composite of outcome instruments that measures myelopathy impairment, function/disability, and participation that have also demonstrated reliability, validity, and responsiveness in a CSM population. More work in the development and psychometric evaluation of new or existing measures is necessary to identify the ideal composite of measures to be used in the clinical and research settings. The mJOA, Nurick grade, NDI, MDI, and 30MWT should be adopted in any clinical practice that treats CSM both for screening and clinical follow-up. We propose that clinicians and researchers consider using the ancillary measures identified, such as the QuickDASH, Berg Balance Scale, GRASSP version 1.0, Grip Strength, and GAITRite Analysis. It is highly recommended that baseline and follow-up measurements should be performed in patients with CSM.

Generating Outcome Measurements: Economic and Societal. A Guide to Educational Outcomes Measurements and Their Uses. Seminar No. 4.

ERIC Educational Resources Information Center

Mushkin, Selma J.; Billings, Bradley B.

This guide is essentially designed as a teaching aid for those who would inform planners, officials of educational ministires, school administrators, principals, and teachers about educational outcome measurements. In outline and graphic form, the guide presents topics for discussion in a seminar dealing with generating outcome measurements:…

Outcomes measurement: compliance tool or strategic initiative?

PubMed

Linder, J C

1991-01-01

This article explores how hospitals are using outcomes measurement to deal with their changing environment. Based on interviews at thirty-one hospitals, the study reveals three very different management approaches and three different uses of the same outcomes measurement tool.

Core Outcome Measures in Effectiveness Trials (COMET) initiative: protocol for an international Delphi study to achieve consensus on how to select outcome measurement instruments for outcomes included in a 'core outcome set'.

PubMed

Prinsen, Cecilia A C; Vohra, Sunita; Rose, Michael R; King-Jones, Susanne; Ishaque, Sana; Bhaloo, Zafira; Adams, Denise; Terwee, Caroline B

2014-06-25

The Core Outcome Measures in Effectiveness Trials (COMET) initiative aims to facilitate the development and application of 'core outcome sets' (COS). A COS is an agreed minimum set of outcomes that should be measured and reported in all clinical trials of a specific disease or trial population. The overall aim of the Core Outcome Measurement Instrument Selection (COMIS) project is to develop a guideline on how to select outcome measurement instruments for outcomes included in a COS. As part of this project, we describe our current efforts to achieve a consensus on the methods for selecting outcome measurement instruments for outcomes to be included in a COS. A Delphi study is being performed by a panel of international experts representing diverse stakeholders with the intention that this will result in a guideline for outcome measurement instrument selection. Informed by a literature review, a Delphi questionnaire was developed to identify potentially relevant tasks on instrument selection. The Delphi study takes place in a series of rounds. In the first round, panelists were asked to rate the importance of different tasks in the selection of outcome measurement instruments. They were encouraged to justify their choices and to add other relevant tasks. Consensus was reached if at least 70% of the panelists considered a task 'highly recommended' or 'desirable' and if no opposing arguments were provided. These tasks will be included in the guideline. Tasks that at least 50% of the panelists considered 'not relevant' will be excluded from the guideline. Tasks that were indeterminate will be taken to the second round. All responses of the first round are currently being aggregated and will be fed back to panelists in the second round. A third round will only be performed if the results of the second round require it. Since the Delphi method allows a large group of international experts to participate, we consider it to be the preferred consensus-based method for our

Patient reported outcome measures in septorhinoplasty surgery.

PubMed

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

2015-01-01

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

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

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

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.

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.

Measurement of Outcomes in Vision-Related Rehabilitation.

ERIC Educational Resources Information Center

Head, Daniel

1998-01-01

Comments on an earlier article by Lorraine Lidoff on health insurance coverage of vision-related rehabilitation services. Urges a standard model of services involving selection of measurable outcomes that reflect treatment processes, selection of the most appropriate time to measure outcomes, and selection of the best method for collecting outcome…

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

Measurement tools and outcome measures used in transitional patient safety; a systematic review.

PubMed

van Melle, Marije A; van Stel, Henk F; Poldervaart, Judith M; de Wit, Niek J; Zwart, Dorien L M

2018-01-01

Patients are at risk for harm when treated simultaneously by healthcare providers from different healthcare organisations. To assess current practice and improvements of transitional patient safety, valid measurement tools are needed. To identify and appraise all measurement tools and outcomes that measure aspects of transitional patient safety, PubMed, Cinahl, Embase and Psychinfo were systematically searched. Two researchers performed the title and abstract and full-text selection. First, publications about validation of measurement tools were appraised for quality following COSMIN criteria. Second, we inventoried all measurement tools and outcome measures found in our search that assessed current transitional patient safety or the effect of interventions targeting transitional patient safety. The initial search yielded 8288 studies, of which 18 assessed validity of measurement tools of different aspects of transitional safety, and 191 assessed current transitional patient safety or effect of interventions. In the validated measurement tools, the overall quality of content and structural validity was acceptable; other COSMIN criteria, such as reliability, measurement error and responsiveness, were mostly poor or not reported. In our outcome inventory, the most frequently used validated outcome measure was the Care Transition Measure (n = 9). The most frequently used non-validated outcome measures were: medication discrepancies (n = 98), hospital readmissions (n = 55), adverse events (n = 34), emergency department visits (n = 33), (mental or physical) health status (n = 28), quality and timeliness of discharge summary, and patient satisfaction (n = 23). Although no validated measures exist that assess all aspects of transitional patient safety, we found validated measurement tools on specific aspects. Reporting of validity of transitional measurement tools was incomplete. Numerous outcome measures with unknown measurement properties are used in current studies on

Measurement properties of the Health of the Nation Outcome Scales (HoNOS) family of measures: protocol for a systematic review.

PubMed

Harris, Meredith G; Sparti, Claudia; Scheurer, Roman; Coombs, Tim; Pirkis, Jane; Ruud, Torleif; Kisely, Steve; Hanssen-Bauer, Ketil; Siqveland, Johan; Burgess, Philip M

2018-04-20

The Health of the Nation Outcome Scales (HoNOS) for adults, and equivalent measures for children and adolescents and older people, are widely used in clinical practice and research contexts to measure mental health and functional outcomes. Additional HoNOS measures have been developed for special populations and applications. Stakeholders require synthesised information about the measurement properties of these measures to assess whether they are fit for use with intended service settings and populations and to establish performance benchmarks. This planned systematic review will critically appraise evidence on the measurement properties of the HoNOS family of measures. Journal articles meeting inclusion criteria will be identified via a search of seven electronic databases: MEDLINE via EBSCOhost, PsycINFO via APA PsycNET, Embase via Elsevier, Cumulative Index to Nursing and Allied Health Literature via EBSCOhost, Web of Science via Thomson Reuters, Google Scholar and the Cochrane Library. Variants of 'Health of the Nation Outcome Scales' or 'HoNOS' will be searched as text words. No restrictions will be placed on setting or language of publication. Reference lists of relevant studies and reviews will be scanned for additional eligible studies. Appraisal of reliability, validity, responsiveness and interpretability will be guided by the COnsensus-based Standards for the selection of health Measurement INstruments checklist. Feasibility/utility will be appraised using definitions and criteria derived from previous reviews. For reliability studies, we will also apply the Guidelines for Reporting Reliability and Agreement Studies to assess quality of reporting. Results will be synthesised narratively, separately for each measure, and by subgroup (eg, treatment setting, rater profession/experience or training) where possible. Meta-analyses will be undertaken where data are adequate. Ethics approval is not required as no primary data will be collected. Outcomes will be

Measurement properties of the Health of the Nation Outcome Scales (HoNOS) family of measures: protocol for a systematic review

PubMed Central

Harris, Meredith G; Sparti, Claudia; Scheurer, Roman; Coombs, Tim; Pirkis, Jane; Ruud, Torleif; Kisely, Steve; Hanssen-Bauer, Ketil; Siqveland, Johan; Burgess, Philip M

2018-01-01

Introduction The Health of the Nation Outcome Scales (HoNOS) for adults, and equivalent measures for children and adolescents and older people, are widely used in clinical practice and research contexts to measure mental health and functional outcomes. Additional HoNOS measures have been developed for special populations and applications. Stakeholders require synthesised information about the measurement properties of these measures to assess whether they are fit for use with intended service settings and populations and to establish performance benchmarks. This planned systematic review will critically appraise evidence on the measurement properties of the HoNOS family of measures. Methods and analysis Journal articles meeting inclusion criteria will be identified via a search of seven electronic databases: MEDLINE via EBSCOhost, PsycINFO via APA PsycNET, Embase via Elsevier, Cumulative Index to Nursing and Allied Health Literature via EBSCOhost, Web of Science via Thomson Reuters, Google Scholar and the Cochrane Library. Variants of ‘Health of the Nation Outcome Scales’ or ‘HoNOS’ will be searched as text words. No restrictions will be placed on setting or language of publication. Reference lists of relevant studies and reviews will be scanned for additional eligible studies. Appraisal of reliability, validity, responsiveness and interpretability will be guided by the COnsensus-based Standards for the selection of health Measurement INstruments checklist. Feasibility/utility will be appraised using definitions and criteria derived from previous reviews. For reliability studies, we will also apply the Guidelines for Reporting Reliability and Agreement Studies to assess quality of reporting. Results will be synthesised narratively, separately for each measure, and by subgroup (eg, treatment setting, rater profession/experience or training) where possible. Meta-analyses will be undertaken where data are adequate. Ethics and dissemination Ethics approval is

A Systematic Review of Palliative Care Intervention Outcomes and Outcome Measures in Low-Resource Countries.

PubMed

Potts, Maryellen; Cartmell, Kathleen B; Nemeth, Lynne; Bhattacharjee, Gautam; Qanungo, Suparna

2018-05-01

To meet the growing need for palliative care in low-resource countries, palliative care programs should be evidence based and contextually appropriate. This study was conducted to synthesize the current evidence to guide future programmatic and research efforts. This systematic review evaluated palliative care outcome measures, outcomes, and interventions in low-resource countries. After title searches, abstracts and full-text articles were screened for inclusion. Data were extracted to report on intervention models, outcome measures used, and intervention outcomes. Eighteen papers were reviewed, reporting on interventions conducted across nine low-resource countries. These interventions evaluated home-based palliative care models; a community-managed model; palliative care integrated with hospitals, hospices, or HIV clinics; and models focused on patients' self-management. Three studies were randomized controlled trials. Other studies used nonrandomized trials, cohort studies, mixed methods, pre-post test evaluation, cost-accounting evaluation, and cross-sectional surveys. Thirteen studies measured physical outcomes, 10 using multidimensional instruments. Nine studies measured psychological outcomes, eight using multidimensional instruments. Nine studies measured social outcomes, seven using multidimensional instruments. Nine studies measured outcomes across multiple domains. Across outcomes evaluated, results were reported in the direction of benefit associated with palliative care interventions. Many palliative care intervention models exist to serve patients in low-resource countries. Yet, limited high-quality evidence from low-resource countries is available to document intervention outcomes. Rigorous experimental studies and greater measurement of multidimensional aspects of palliative care are needed to advance the science of palliative care in low-resource settings. Copyright © 2017 American Academy of Hospice and Palliative Medicine. Published by Elsevier

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

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.

Measuring the General Education Outcomes: Practical Strategies.

ERIC Educational Resources Information Center

Peterson, Anne; And Others

Prepared in an effort to more clearly define and measure general education outcomes at Columbus State Community College, in Ohio, this handbook describes outcomes and associated student behaviors and provides suggestions for assessing the outcomes. Following introductory materials, a list is provided of the college's six general education…

The incremental value of self-reported mental health measures in predicting functional outcomes of veterans.

PubMed

Eisen, Susan V; Bottonari, Kathryn A; Glickman, Mark E; Spiro, Avron; Schultz, Mark R; Herz, Lawrence; Rosenheck, Robert; Rofman, Ethan S

2011-04-01

Research on patient-centered care supports use of patient/consumer self-report measures in monitoring health outcomes. This study examined the incremental value of self-report mental health measures relative to a clinician-rated measure in predicting functional outcomes among mental health service recipients. Participants (n = 446) completed the Behavior and Symptom Identification Scale, the Brief Symptom Inventory, and the Veterans/Rand Short Form-36 at enrollment in the study (T1) and 3 months later (T2). Global Assessment of Functioning (GAF) ratings, mental health service utilization, and psychiatric diagnoses were obtained from administrative data files. Controlling for demographic and clinical variables, results indicated that improvement based on the self-report measures significantly predicted one or more functional outcomes (i.e., decreased likelihood of post-enrollment psychiatric hospitalization and increased likelihood of paid employment), above and beyond the predictive value of the GAF. Inclusion of self-report measures may be a useful addition to performance measurement efforts.

A method for developing outcome measures in the clinical laboratory.

PubMed

Jones, J

1996-01-01

Measuring and reporting outcomes in health care is becoming more important for quality assessment, utilization assessment, accreditation standards, and negotiating contracts in managed care. How does one develop an outcome measure for the laboratory to assess the value of the services? A method is described which outlines seven steps in developing outcome measures for a laboratory service or process. These steps include the following: 1. Identify the process or service to be monitored for performance and outcome assessment. 2. If necessary, form an multidisciplinary team of laboratory staff, other department staff, physicians, and pathologists. 3. State the purpose of the test or service including a review of published data for the clinical pathological correlation. 4. Prepare a process cause and effect diagram including steps critical to the outcome. 5. Identify key process variables that contribute to positive or negative outcomes. 6. Identify outcome measures that are not process measures. 7. Develop an operational definition, identify data sources, and collect data. Examples, including a process cause and effect diagram, process variables, and outcome measures, are given using the Therapeutic Drug Monitoring service (TDM). A summary of conclusions and precautions for outcome measurement is then provided.

Benchmarking: measuring the outcomes of evidence-based practice.

PubMed

DeLise, D C; Leasure, A R

2001-01-01

Measurement of the outcomes associated with implementation of evidence-based practice changes is becoming increasingly emphasized by multiple health care disciplines. A final step to the process of implementing and sustaining evidence-supported practice changes is that of outcomes evaluation and monitoring. The comparison of outcomes to internal and external measures is known as benchmarking. This article discusses evidence-based practice, provides an overview of outcomes evaluation, and describes the process of benchmarking to improve practice. A case study is used to illustrate this concept.

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

Framework of outcome measures recommended for use in the evaluation of childhood obesity treatment interventions: the CoOR framework.

PubMed

Bryant, M; Ashton, L; Nixon, J; Jebb, S; Wright, J; Roberts, K; Brown, J

2014-12-01

Consensus is lacking in determining appropriate outcome measures for assessment of childhood obesity treatments. Inconsistency in the use and reporting of such measures impedes comparisons between treatments and limits consideration of effectiveness. This study aimed to produce a framework of recommended outcome measures: the Childhood obesity treatment evaluation Outcomes Review (CoOR) framework. A systematic review including two searches was conducted to identify (1) existing trial outcome measures and (2) manuscripts describing development/evaluation of outcome measures. Outcomes included anthropometry, diet, eating behaviours, physical activity, sedentary time/behaviour, fitness, physiology, environment, psychological well-being and health-related quality of life. Eligible measures were appraised by the internal team using a system developed from international guidelines, followed by appraisal from national external expert collaborators. A total of 25,486 papers were identified through both searches. Eligible search 1 trial papers cited 417 additional papers linked to outcome measures, of which 56 were eligible. A further 297 outcome development/evaluation papers met eligibility criteria from search 2. Combined, these described 191 outcome measures. After internal and external appraisal, 52 measures across 10 outcomes were recommended for inclusion in the CoOR framework. Application of the CoOR framework will ensure greater consistency in choosing robust outcome measures that are appropriate to population characteristics. © 2014 The Authors. Pediatric Obesity © 2014 International Association for the Study of Obesity.

Analysis of Traditional versus Three-Dimensional Augmented Curriculum on Anatomical Learning Outcome Measures

ERIC Educational Resources Information Center

Peterson, Diana Coomes; Mlynarczyk, Gregory S.A.

2016-01-01

This study examined whether student learning outcome measures are influenced by the addition of three-dimensional and digital teaching tools to a traditional dissection and lecture learning format curricula. The study was performed in a semester long graduate level course that incorporated both gross anatomy and neuroanatomy curricula. Methods…

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

PubMed

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

2017-03-01

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

Conservation covenants on private land: issues with measuring and achieving biodiversity outcomes in Australia.

PubMed

Fitzsimons, James A; Carr, C Ben

2014-09-01

Conservation covenants and easements have become essential tools to secure biodiversity outcomes on private land, and to assist in meeting international protection targets. In Australia, the number and spatial area of conservation covenants has grown significantly in the past decade. Yet there has been little research or detailed policy analysis of conservation covenanting in Australia. We sought to determine how conservation covenanting agencies were measuring the biodiversity conservation outcomes achieved on covenanted properties, and factors inhibiting or contributing to measuring these outcomes. In addition, we also investigated the drivers and constraints associated with actually delivering the biodiversity outcomes, drawing on detailed input from covenanting programs. Although all conservation covenanting programs had the broad aim of maintaining or improving biodiversity in their covenants in the long term, the specific stated objectives of conservation covenanting programs varied. Programs undertook monitoring and evaluation in different ways and at different spatial and temporal scales. Thus, it was difficult to determine the extent Australian conservation covenanting agencies were measuring the biodiversity conservation outcomes achieved on covenanted properties on a national scale. Lack of time available to covenantors to undertake management was one of the biggest impediments to achieving biodiversity conservation outcomes. A lack of financial resources and human capital to monitor, knowing what to monitor, inconsistent monitoring methodologies, a lack of benchmark data, and length of time to achieve outcomes were all considered potential barriers to monitoring the biodiversity conservation outcomes of conservation covenants.

Conservation Covenants on Private Land: Issues with Measuring and Achieving Biodiversity Outcomes in Australia

NASA Astrophysics Data System (ADS)

Fitzsimons, James A.; Carr, C. Ben

2014-09-01

Conservation covenants and easements have become essential tools to secure biodiversity outcomes on private land, and to assist in meeting international protection targets. In Australia, the number and spatial area of conservation covenants has grown significantly in the past decade. Yet there has been little research or detailed policy analysis of conservation covenanting in Australia. We sought to determine how conservation covenanting agencies were measuring the biodiversity conservation outcomes achieved on covenanted properties, and factors inhibiting or contributing to measuring these outcomes. In addition, we also investigated the drivers and constraints associated with actually delivering the biodiversity outcomes, drawing on detailed input from covenanting programs. Although all conservation covenanting programs had the broad aim of maintaining or improving biodiversity in their covenants in the long term, the specific stated objectives of conservation covenanting programs varied. Programs undertook monitoring and evaluation in different ways and at different spatial and temporal scales. Thus, it was difficult to determine the extent Australian conservation covenanting agencies were measuring the biodiversity conservation outcomes achieved on covenanted properties on a national scale. Lack of time available to covenantors to undertake management was one of the biggest impediments to achieving biodiversity conservation outcomes. A lack of financial resources and human capital to monitor, knowing what to monitor, inconsistent monitoring methodologies, a lack of benchmark data, and length of time to achieve outcomes were all considered potential barriers to monitoring the biodiversity conservation outcomes of conservation covenants.

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

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

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.

Patient-reported outcome measures versus inertial performance-based outcome measures: A prospective study in patients undergoing primary total knee arthroplasty.

PubMed

Bolink, S A A N; Grimm, B; Heyligers, I C

2015-12-01

Outcome assessment of total knee arthroplasty (TKA) by subjective patient reported outcome measures (PROMs) may not fully capture the functional (dis-)abilities of relevance. Objective performance-based outcome measures could provide distinct information. An ambulant inertial measurement unit (IMU) allows kinematic assessment of physical performance and could potentially be used for routine follow-up. To investigate the responsiveness of IMU measures in patients following TKA and compare outcomes with conventional PROMs. Patients with end stage knee OA (n=20, m/f=7/13; age=67.4 standard deviation 7.7 years) were measured preoperatively and one year postoperatively. IMU measures were derived during gait, sit-stand transfers and block step-up transfers. PROMs were assessed by using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Knee Society Score (KSS). Responsiveness was calculated by the effect size, correlations were calculated with Spearman's rho correlation coefficient. One year after TKA, patients performed significantly better at gait, sit-to-stand transfers and block step-up transfers. Measures of time and kinematic IMU measures demonstrated significant improvements postoperatively for each performance-based test. The largest improvement was found in block step-up transfers (effect size=0.56-1.20). WOMAC function score and KSS function score demonstrated moderate correlations (Spearman's rho=0.45-0.74) with some of the physical performance-based measures pre- and postoperatively. To characterize the changes in physical function after TKA, PROMs could be supplemented by performance-based measures, assessing function during different activities and allowing kinematic characterization with an ambulant IMU. Copyright © 2015 Elsevier B.V. All rights reserved.

Does the addition of hip strengthening exercises improve outcomes following total knee arthroplasty? A study protocol for a randomized trial.

PubMed

Schache, Margaret B; McClelland, Jodie A; Webster, Kate E

2016-06-13

Total knee arthroplasty (TKA) is effective in reducing pain and improving function for end-stage knee osteoarthritis. However, muscle weakness and functional limitations persist despite assistance from post-operative rehabilitation programs that traditionally focus on quadriceps strengthening and range of movement exercises. Hip abductor muscle weakness is evident in knee osteoarthritis and hip muscle strengthening reduces knee pain in this group. Following TKA, people with weak hip abductor strength perform more poorly on measures of physical function. However, very little is known of the effectiveness of including hip abductor strengthening exercises in post-operative rehabilitation. The aim of this trial is to compare the effects of targeted hip abductor strengthening to those of traditional care in a TKA rehabilitation program on muscle strength, patient reported outcomes and functional performance measures. This protocol describes a single-blinded randomized controlled trial, where 104 participants referred for inpatient rehabilitation following TKA will be recruited. Participants will be randomized using computer-generated numbers to one of two groups: usual care or usual care with additional hip strengthening exercises. Participants will attend physiotherapy daily during their inpatient length of stay, and will then attend between six and eight physiotherapy sessions as an outpatient. Primary outcomes are isometric hip abductor strength and the Knee Injury and Osteoarthritis Outcome Score (KOOS). Secondary outcomes are stair climb test, 6 min walk test, timed up and go, 40 m fast-paced walk test, 30 second chair stand test, isometric quadriceps strength, Lower Extremity Functional Scale (LEFS) and SF-12. Outcome measures will be recorded at baseline (admission to inpatient rehabilitation), and then 3 weeks, 6 weeks and 6 months post admission to rehabilitation. The findings of this study will determine whether the addition of targeted hip strengthening

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

PubMed

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

2010-05-01

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

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.

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

PubMed

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

2015-03-01

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

Factors influencing the use of outcome measures in physical therapy practice.

PubMed

Wedge, Frances M; Braswell-Christy, Jennifer; Brown, Cynthia J; Foley, Kathleen T; Graham, Cecilia; Shaw, Sharon

2012-02-01

Use of outcome measures in physical therapy practice is central to evaluating the effectiveness of treatment interventions, providing accountability and addressing quality of physical therapy programs. There is limited discussion on barriers and facilitators to using outcome measures in physical therapy practice. The purpose of this study was to identify factors that influence a physical therapist when deciding to use outcome measures in clinical practice. Participants were 21 physical therapists, seven each from skilled nursing facilities, outpatient clinics, and inpatient rehabilitation facilities. A grounded theory approach was used for interview and data collection. Common themes were determined from the data and a theory developed to explain the rationale behind physical therapists' decisions to use or not use outcome measures in clinical practice. Three overlapping themes related to (1) concepts of time, (2) knowledge, and (3) facility culture were indentified as factors influencing the use of outcome measures. A fourth encompassing theme, professionalism, identified the value placed on the use of outcome measures in practice. Data revealed that therapists require more information on the outcome measures available, and this information needs to be easily accessible within the workplace. Therapists value information generated by using outcome measures in the clinical setting, but need information on what measures are available and psychometric properties. Information must be easily accessible and measures easy to use. Newer graduates and recent learners have a foundation in the use of outcome measures, but more needs to be done in the clinic and through continuing education to promote increased use and understanding.

The Popularity of Outcome Measures for Hip and Knee Arthroplasties.

PubMed

Lovelock, Thomas M; Broughton, Nigel S; Williams, Cylie M

2018-01-01

The optimal methods of determining outcomes following hip and knee arthroplasty remain controversial. The objectives of this study were to determine the most frequently used outcome measures in randomized controlled trials (RCT) and study protocols registered with clinical trials registries (CTR) on hip and knee arthroplasty. A systematic search strategy was undertaken to identify the outcome measures used in RCT and CTR following joint arthroplasty. Databases searched included Embase, Ovid MEDLINE (including In-Process), Cochrane Central Register of Controlled Trials, CINAHL Plus, clinicaltrials.gov, ISRCTN registry, and ANZCTR. Differences in the use of outcome measures between RCT and CTR were assessed using logistic regression. There were 291 RCT and 113 CTR on hip arthroplasty and 452 RCT and 184 CTR on knee arthroplasty that met the inclusion criteria. The most popular outcome measures were the Harris Hip Score and the Knee Society Score. Multiple outcome measures were used in greater than 50% of the included studies. The Oxford Hip Score, Oxford Knee Score, EuroQol-5D, and Knee Injury and Osteoarthritis Outcome Score (all P < .001) were used in significantly more CTR than RCT. There is a clear preference for the use of the Harris Hip Score and Knee Society Score, contrary to existing international guidelines and reviews on the topic. Both measures require clinician input, which potentially influences their validity and increases their overall administration cost. Some patient-reported outcome measures, such as the Oxford Hip and Knee Scores, EuroQol-5D, and KOOS, appear to be increasing in popularity. Copyright © 2017 Elsevier Inc. All rights reserved.

Clinical outcome measurement: Models, theory, psychometrics and practice.

PubMed

McClimans, Leah; Browne, John; Cano, Stefan

In the last decade much has been made of the role that models play in the epistemology of measurement. Specifically, philosophers have been interested in the role of models in producing measurement outcomes. This discussion has proceeded largely within the context of the physical sciences, with notable exceptions considering measurement in economics. However, models also play a central role in the methods used to develop instruments that purport to quantify psychological phenomena. These methods fall under the umbrella term 'psychometrics'. In this paper, we focus on Clinical Outcome Assessments (COAs) and discuss two measurement theories and their associated models: Classical Test Theory (CTT) and Rasch Measurement Theory. We argue that models have an important role to play in coordinating theoretical terms with empirical content, but to do so they must serve: 1) as a representation of the measurement interaction; and 2) in conjunction with a theory of the attribute in which we are interested. We conclude that Rasch Measurement Theory is a more promising approach than CTT in these regards despite the latter's popularity with health outcomes researchers. Copyright © 2017. Published by Elsevier Ltd.

Measuring Inclusive Education Outcomes in Alberta, Canada

ERIC Educational Resources Information Center

Loreman, Tim

2014-01-01

This study details the results of a review of the academic and public sector literature on measuring inclusive education in large systems. It highlights some outcomes drawn from the international literature on inclusion that might be indicative of the presence and quality of inclusive education in an effort to develop a set of outcomes for…

Applying Outcome Measurements: A Guide to Educational Outcome Measurements and Their Uses. Seminar No. 5.

ERIC Educational Resources Information Center

Glaser, Ezra

This guide is essentially designed as a teaching aid for those who would inform planners, officials of educational ministries, school administrators, principals, and teachers about educational outcome measurements. In outline and graphic form, the guide presents topics for discussion in a seminar dealing with the application of outcome…

Clinical assessment and patient-reported outcome measures in low-back pain - a survey among primary health care physiotherapists.

PubMed

Östhols, Sara; Boström, Carina; Rasmussen-Barr, Eva

2018-05-09

rehabilitation in low-back pain, yellow flags, and other factors need to be taken into the consideration in the assessment which means the use of patient-reported outcome measures in addition to clinical testing. The use of patient-reported outcome measures is an advantage in the clinical reasoning process to enhance the quality of assessment and to educate and motivate the patient. Barriers to use patient-reported outcome measures are mainly lack of time and knowledge, and administrative aspects. Through education or organizational change-work, barriers to the use of patient-reported outcome measures might be changed.

Job coach factors associated with community-based employment service programme outcome measures for people with disabilities--a Taiwan case study.

PubMed

Yun-Tung, Wang

2010-01-01

The aim of this study is to explore whether/which job coach factors were significantly associated with the community-based employment service (CBES) programme outcome measures in Taiwan. This study used the 2003-2005 CBES programme for People with Disabilities Database in Taipei City in Taiwan (n = 3924) to do a secondary data analysis using hierarchical multiple linear regression. This study found that 'occurrences of the services provided by the job coaches' variable was definitely the dominant predictor and explained additional 19.6% and 27.8% of the variances of annual salary and annual working month outcome measures, respectively. In addition, among six composition variables of 'occurrences of the services provided by the job coaches', 'occurrences of follow-up guidance', 'occurrences of intensive guidance', and 'occurrences of consultation before interviews with employer/director of human resources' were more powerful than the other three in predicting outcomes. Job coach factors in this study were significantly correlated with CBES programme outcome measures for people with disabilities in Taiwan after controlling for the socio-demographic variables. It indicates that the more inputs in the people with disabilities made by job coaches equates to better outcomes in this Taiwan case study.

OMERACT Filter Evidence Supporting the Measurement of At-work Productivity Loss as an Outcome Measure in Rheumatology Research.

PubMed

Beaton, Dorcas E; Dyer, Sarah; Boonen, Annelies; Verstappen, Suzanne M M; Escorpizo, Reuben; Lacaille, Diane V; Bosworth, Ailsa; Gignac, Monique A M; Leong, Amye; Purcaru, Oana; Leggett, Sarah; Hofstetter, Cathy; Peterson, Ingemar F; Tang, Kenneth; Fautrel, Bruno; Bombardier, Claire; Tugwell, Peter S

2016-01-01

Indicators of work role functioning (being at work, and being productive while at work) are important outcomes for persons with arthritis. As the worker productivity working group at OMERACT (Outcome Measures in Rheumatology), we sought to provide an evidence base for consensus on standardized instruments to measure worker productivity [both absenteeism and at-work productivity (presenteeism) as well as critical contextual factors]. Literature reviews and primary studies were done and reported to the OMERACT 12 (2014) meeting to build the OMERACT Filter 2.0 evidence for worker productivity outcome measurement instruments. Contextual factor domains that could have an effect on scores on worker productivity instruments were identified by nominal group techniques, and strength of influence was further assessed by literature review. At OMERACT 9 (2008), we identified 6 candidate measures of absenteeism, which received 94% endorsement at the plenary vote. At OMERACT 11 (2012) we received over the required minimum vote of 70% for endorsement of 2 at-work productivity loss measures. During OMERACT 12 (2014), out of 4 measures of at-work productivity loss, 3 (1 global; 2 multiitem) received support as having passed the OMERACT Filter with over 70% of the plenary vote. In addition, 3 contextual factor domains received a 95% vote to explore their validity as core contextual factors: nature of work, work accommodation, and workplace support. Our current recommendations for at-work productivity loss measures are: WALS (Workplace Activity Limitations Scale), WLQ PDmod (Work Limitations Questionnaire with modified physical demands scale), WAI (Work Ability Index), WPS (Arthritis-specific Work Productivity Survey), and WPAI (Work Productivity and Activity Impairment Questionnaire). Our future research focus will shift to confirming core contextual factors to consider in the measurement of worker productivity.

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.

Measuring Patient-Reported Outcomes: Key Metrics in Reconstructive Surgery.

PubMed

Voineskos, Sophocles H; Nelson, Jonas A; Klassen, Anne F; Pusic, Andrea L

2018-01-29

Satisfaction and improved quality of life are among the most important outcomes for patients undergoing plastic and reconstructive surgery for a variety of diseases and conditions. Patient-reported outcome measures (PROMs) are essential tools for evaluating the benefits of newly developed surgical techniques. Modern PROMs are being developed with new psychometric approaches, such as Rasch Measurement Theory, and their measurement properties (validity, reliability, responsiveness) are rigorously tested. These advances have resulted in the availability of PROMs that provide clinically meaningful data and effectively measure functional as well as psychosocial outcomes. This article guides the reader through the steps of creating a PROM and highlights the potential research and clinical uses of such instruments. Limitations of PROMs and anticipated future directions in this field are discussed.

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.

Learning Outcomes across Disciplines and Professions: Measurement and Interpretation

ERIC Educational Resources Information Center

Caspersen, Joakim; Frølich, Nicoline; Karlsen, Hilde; Aamodt, Per Olaf

2014-01-01

Learning outcomes of higher education are a quality tool in a changing higher education landscape but cannot be seen as neutral measures across professions and disciplines. Survey results from graduates and recent graduates indicate that prevailing measures of learning outcomes yield the same result within and across disciplinary and professional…

Surface texture measurement for additive manufacturing

NASA Astrophysics Data System (ADS)

Triantaphyllou, Andrew; Giusca, Claudiu L.; Macaulay, Gavin D.; Roerig, Felix; Hoebel, Matthias; Leach, Richard K.; Tomita, Ben; Milne, Katherine A.

2015-06-01

The surface texture of additively manufactured metallic surfaces made by powder bed methods is affected by a number of factors, including the powder’s particle size distribution, the effect of the heat source, the thickness of the printed layers, the angle of the surface relative to the horizontal build bed and the effect of any post processing/finishing. The aim of the research reported here is to understand the way these surfaces should be measured in order to characterise them. In published research to date, the surface texture is generally reported as an Ra value, measured across the lay. The appropriateness of this method for such surfaces is investigated here. A preliminary investigation was carried out on two additive manufacturing processes—selective laser melting (SLM) and electron beam melting (EBM)—focusing on the effect of build angle and post processing. The surfaces were measured using both tactile and optical methods and a range of profile and areal parameters were reported. Test coupons were manufactured at four angles relative to the horizontal plane of the powder bed using both SLM and EBM. The effect of lay—caused by the layered nature of the manufacturing process—was investigated, as was the required sample area for optical measurements. The surfaces were also measured before and after grit blasting.

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.

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.

Clinical outcomes of double staining and additional ILM peeling during ERM surgery.

PubMed

Oh, Ha Na; Lee, Joo Eun; Kim, Hyun Woong; Yun, Il Han

2013-08-01

To assess the clinical outcomes in idiopathic epiretinal membrane (ERM) patients after vitrectomy and ERM removal with or without additional indocyanine green (ICG)-assisted internal limiting membrane (ILM) peeling. The medical records of 43 patients with an idiopathic ERM that underwent vitrectomy and ERM removal between July 2007 and April 2010 were reviewed. The patients were divided into two groups: triamcinolone-assisted simple ERM peeling only (group A, n = 23) and triamcinolone-assisted ERM peeling followed by ICG staining and peeling of the remaining internal ILM (group B, n = 20). No difference was found between the two groups in terms of visual acuity, macular thickness, P1 amplitude or implicit time on multifocal-electroretinogram (mfERG) at six and 12 months postoperatively. In group B, ICG staining after ERM peeling demonstrated that the ILM had been removed together with the ERM in 12 eyes (60%), and all 12 eyes showed punctate retinal hemorrhages during ERM peeling. There was no recurrence of an ERM in either group. Additional procedures involving ICG staining and ILM peeling during ERM surgery do not appear to have an additive effect on the clinical outcomes in terms of visual acuity, retinal function based on mfERG, or recurrence rate.

Measuring Quality and Outcomes in Sports Medicine.

PubMed

Ruzbarsky, Joseph J; Marom, Niv; Marx, Robert G

2018-07-01

Patient-reported outcome measures (PROMs) are objective metrics critical to evaluating outcomes throughout orthopedic surgery. New instruments continue to emerge, increasing the breadth of information required for those intending to use these measures for research or clinical care. Although earlier metrics were developed using the principles of classic test theory, newer instruments constructed using item response theory are amenable to computer-adaptive testing and may change the way these instruments are administered. This article aims to define the psychometric properties that are important to understand when using all PROMs and to review the most widely used instruments in sports medicine. Copyright © 2018 Elsevier Inc. All rights reserved.

Use of outcome measures in pulmonary hypertension clinical trials.

PubMed

Parikh, Kishan S; Rajagopal, Sudarshan; Arges, Kristine; Ahmad, Tariq; Sivak, Joseph; Kaul, Prashant; Shah, Svati H; Tapson, Victor; Velazquez, Eric J; Douglas, Pamela S; Samad, Zainab

2015-09-01

To evaluate the use of surrogate measures in pulmonary hypertension (PH) clinical trials and how it relates to clinical practice. Studies of pulmonary arterial hypertension (PAH) employ a variety of surrogate measures in addition to clinical events because of a small patient population, participant burden, and costs. The use of these measures in PH drug trials is poorly defined. We searched PubMed/MEDLINE/Embase for randomized or prospective cohort PAH clinical treatment trials from 1985 to 2013. Extracted data included intervention, trial duration, study design, patient characteristics, and primary and secondary outcome measures. To compare with clinical practice, we assessed the use of surrogate measures in a clinical sample of patients on PH medications at Duke University Medical Center between 2003 and 2014. Between 1985 and 2013, 126 PAH trials were identified and analyzed. Surrogate measures served as primary endpoints in 119 trials (94.0%). Inclusion of invasive hemodynamics decreased over time (78.6%, 75.0%, 52.2%; P for trend = .02), while functional testing (7.1%, 60.0%, 81.5%; P for trend < .0001) and functional status or quality of life (0%, 47.6%, 62.8%; P for trend < .0001) increased in PAH trials over the same time periods. Echocardiography data were reported as a primary or secondary outcome in 32 trials (25.4%) with increased use from 1985-1994 to 1995-2004 (7.1% vs 35.0%, P = .04), but the trend did not continue to 2005-2013 (25.0%). In comparison, among 450 patients on PAH therapies at our institution between 2003 and 2013, clinical assessments regularly incorporated serial echocardiography and 6-minute walk distance tests (92% and 95% of patients, respectively) and repeat measurement of invasive hemodynamics (46% of patients). The majority of PAH trials have utilized surrogate measures as primary endpoints. The use of these surrogate endpoints has evolved significantly over time with increasing use of patient-centered endpoints and decreasing or

The interdependence of behavioral and somatic health: implications for conceptualizing health and measuring treatment outcomes

PubMed Central

LaBrie, Richard A.; LaPlante, Debi A.; Peller, Allyson J.; Christensen, Donald E.; Greenwood, Kristina L.; Straus, John H.; Garmon, Michael S.; Browne, Cheryl; Shaffer, Howard J.

2007-01-01

Purpose The interdependence of behavioral and somatic aspects of various health conditions warrants greater emphasis on an integrated care approach. Theory We propose that integrated approaches to health and wellness require comprehensive and empirically-valid outcome measures to assess quality of care. Method We discuss the transition from independent to integrated treatment approaches and provide examples of new systems for integrated assessment of treatment outcome. Results Evidence suggests that support for an independent treatment approach is waning and momentum is building towards more integrated care. In addition, research evidence suggests integrated care improves health outcomes, and both physicians and patients have favorable impressions of integrated care. Conclusions As treatment goals in the integrated perspective expand to take into account the intimate relationships among mental illness, overall health, and quality of life, clinicians need to develop outcome measures that are similarly comprehensive. Discussion Increased recognition, by researchers, providers, and insurers, of the interdependence between behavioral and physical health holds great promise for innovative treatments that could significantly improve patients' lives. PMID:17627294

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

Measuring Stress Before and During Pregnancy: A Review of Population-Based Studies of Obstetric Outcomes

PubMed Central

Witt, Whitney; Litzelman, Kristin; Cheng, Erika R; Wakeel, Fathima; Barker, Emily S.

2013-01-01

Objectives Mounting evidence from clinic and convenience samples suggests that stress is an important predictor of adverse obstetric outcomes. Using a proposed theoretical framework, this review identified and synthesized the population-based literature on the measurement of stress prior to and during pregnancy in relation to obstetric outcomes. Methods Population-based, peer-reviewed empirical articles that examined stress prior to or during pregnancy in relation to obstetric outcomes were identified in the PubMed and PsycInfo databases. Articles were evaluated to determine the domain(s) of stress (environmental, psychological, and/or biological), period(s) of stress (preconception and/or pregnancy), and strength of the association between stress and obstetric outcomes. Results Thirteen studies were evaluated. The identified studies were all conducted in developed countries. The majority of studies examined stress only during pregnancy (n=10); three examined stress during both the preconception and pregnancy periods (n=3). Most studies examined the environmental domain (e.g., life events) only (n=9), two studies examined the psychological domain only, and two studies examined both. No study incorporated a biological measure of stress. Environmental stressors before and during pregnancy were associated with worse obstetric outcomes, although some conflicting findings exist. Conclusions Few population-based studies have examined stress before or during pregnancy in relation to obstetric outcomes. Although considerable variation exists in the measurement of stress across studies, environmental stress increased the risk for poor obstetric outcomes. Additional work using a lifecourse approach is needed to fill the existing gaps in the literature and to develop a more comprehensive understanding of the mechanisms by which stress impacts obstetric outcomes. PMID:23447085

40 CFR 412.47 - Additional measures.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 29 2014-07-01 2012-07-01 true Additional measures. 412.47 Section 412.47 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS CONCENTRATED ANIMAL FEEDING OPERATIONS (CAFO) POINT SOURCE CATEGORY Swine, Poultry, and Veal...

40 CFR 412.47 - Additional measures.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 30 2012-07-01 2012-07-01 false Additional measures. 412.47 Section 412.47 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS CONCENTRATED ANIMAL FEEDING OPERATIONS (CAFO) POINT SOURCE CATEGORY Swine, Poultry, and Veal...

40 CFR 412.47 - Additional measures.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 30 2013-07-01 2012-07-01 true Additional measures. 412.47 Section 412.47 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS CONCENTRATED ANIMAL FEEDING OPERATIONS (CAFO) POINT SOURCE CATEGORY Swine, Poultry, and Veal...

40 CFR 412.47 - Additional measures.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 28 2010-07-01 2010-07-01 true Additional measures. 412.47 Section 412.47 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS CONCENTRATED ANIMAL FEEDING OPERATIONS (CAFO) POINT SOURCE CATEGORY Swine, Poultry, and Veal...

Measuring Outcomes for Children Late Placed for Adoption.

ERIC Educational Resources Information Center

Rushton, Alan

1998-01-01

Describes the selection of outcome measures used by the Maudsley Family Research team to assess outcomes--across a broad range of developmental dimensions--of permanent placement for children and adolescents. Developed a package of instruments to examine child emotional, cognitive, social, and academic development; attachment; and self-esteem, for…

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.

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.

Safety outcomes in the United States: trends and challenges in measurement.

PubMed

Greenberg, Michael D; Haviland, Amelia M; Yu, Hao; Farley, Donna O

2009-04-01

To prepare Agency for Healthcare Research and Quality (AHRQ) for monitoring the impact of its own patient safety initiative, by exploring available outcomes data, assessing usability of measures, and estimating national trends in patient outcomes. Annual summary data on incidence of Joint Commission Sentinel Events, MEDMARX medication error events, and MDS measures of falls and pressure ulcers in nursing home residents. HCUP National Inpatient Sample (NIS) administrative claims data. Description and assessment of published summary data on selected safety measures. Analysis of selected Patient Safety Indicators (PSIs) and Utah–Missouri adverse event measures using HCUP NIS claims data (1994–2003). Interpretation of safety outcome trends requires close attention to the characteristics of underlying data sources and measures. Encounter-based measures have been affected by changes in definitions and ICD-9 coding, as well as by changes in the structure of administrative datasets like HCUP NIS. Historical trends are mixed for the safety outcome measures reviewed, with some measures showing improvement, others deterioration, and still others remaining fairly stable. Constructing national trends of safety outcomes is difficult because of limitations in available data sources and measures. Tracking growth in the adoption of safe practices could offer an important strategy for complementing existing safety measurement capabilities.

Identifying an outcome measure to assess the impact of Mobility Dogs.

PubMed

Mudge, Suzie; Rewi, Dallas; Channon, Alexis

2017-01-01

Mobility Dogs® trains dogs to work with people with physical disabilities to increase independence, confidence, self-esteem and participation. Mobility Dogs® seeks to critically evaluate and improve its services as it grows. This study aimed to identify and implement a standardised outcome measure into practice at Mobility Dogs®. Based on the Consolidated Framework for Implementation Research and guided by a steering group of key stakeholders, a three-phase approach was developed to identify and assess an outcome measure. The steering group highlighted the organisation's specific needs, selected participation as the assessment domain and identified core utility requirements of the measure. A comprehensive review of evidence was undertaken to identify and rank potential measures according to the specified needs. Of the seven participation outcome measures that met inclusion criteria, the three highest ranked measures were critically evaluated by the steering group to determine suitability against the organisation's needs. The Impact on Participation and Autonomy (IPA) was selected for implementation into practice at Mobility Dogs®. Use of the IPA is an important first step for Mobility Dogs® to test the benefits of trained service dogs. This process could be replicated by other service dog organisations to identify outcome measures to assess their own services. Implications for Rehabilitation Service dogs (such as Mobility Dogs® in New Zealand) assist people living with physical impairments by performing tasks, however there is limited evidence on outcomes. The process for selecting an appropriate outcome measure for Mobility Dogs® involving partnership between Mobility Dogs® personnel and academics was an effective way to steer the project by determining important properties of the measure, before a search of the literature was undertaken. While the IPA was selected as the most appropriate outcome measure for use at Mobility Dogs®, it was the process that

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

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.

Presurgery resting-state local graph-theory measures predict neurocognitive outcomes after brain surgery in temporal lobe epilepsy.

PubMed

Doucet, Gaelle E; Rider, Robert; Taylor, Nathan; Skidmore, Christopher; Sharan, Ashwini; Sperling, Michael; Tracy, Joseph I

2015-04-01

This study determined the ability of resting-state functional connectivity (rsFC) graph-theory measures to predict neurocognitive status postsurgery in patients with temporal lobe epilepsy (TLE) who underwent anterior temporal lobectomy (ATL). A presurgical resting-state functional magnetic resonance imaging (fMRI) condition was collected in 16 left and 16 right TLE patients who underwent ATL. In addition, patients received neuropsychological testing pre- and postsurgery in verbal and nonverbal episodic memory, language, working memory, and attention domains. Regarding the functional data, we investigated three graph-theory properties (local efficiency, distance, and participation), measuring segregation, integration and centrality, respectively. These measures were only computed in regions of functional relevance to the ictal pathology, or the cognitive domain. Linear regression analyses were computed to predict the change in each neurocognitive domain. Our analyses revealed that cognitive outcome was successfully predicted with at least 68% of the variance explained in each model, for both TLE groups. The only model not significantly predictive involved nonverbal episodic memory outcome in right TLE. Measures involving the healthy hippocampus were the most common among the predictors, suggesting that enhanced integration of this structure with the rest of the brain may improve cognitive outcomes. Regardless of TLE group, left inferior frontal regions were the best predictors of language outcome. Working memory outcome was predicted mostly by right-sided regions, in both groups. Overall, the results indicated our integration measure was the most predictive of neurocognitive outcome. In contrast, our segregation measure was the least predictive. This study provides evidence that presurgery rsFC measures may help determine neurocognitive outcomes following ATL. The results have implications for refining our understanding of compensatory reorganization and predicting

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.

Outcomes measurement in hospitals: can the system change the organization?

PubMed

Linder, J C

1992-01-01

The U.S. health care industry is in crisis--a crisis of accountability. Many believe that improved information, especially outcomes information, is at least part of the solution. If this assessment is accurate, outcomes measurement could offer a powerful opportunity to help mold our dysfunctional health care machinery into an effective infrastructure. This article explores whether implementing an outcomes measurement system in a hospital compels this kind of change. It examines the experiences of 31 hospitals that implemented a market-leading outcomes measurement system. Despite its potential, MedisGroups did not compel important improvements in hospitals' quality of care or their internal practices. Hospitals found it particularly difficult to maintain momentum throughout implementation and to structure the system as a supporting tool, rather than a driving influence, in their pursuit of operating improvements.

Outcome Measures for Early Childhood Intervention Services.

ERIC Educational Resources Information Center

Accreditation Council on Services for People with Disabilities, Landover, MD.

This collection of 21 suggested outcome measures for early childhood intervention services is intended to apply to all types of service and support program models for children (birth to age 5) with various developmental delays and/or disabilities. The measures are appropriate for either home-based or center-based service delivery models. Section 1…

Responsiveness of outcome measures for upper limb prosthetic rehabilitation.

PubMed

Resnik, Linda; Borgia, Matthew

2016-02-01

There is limited research on responsiveness of prosthetic rehabilitation outcome measures. To examine responsiveness of the Box and Block test, Jebsen-Taylor Hand Function tests, Upper Extremity Functional Scale, University of New Brunswick skill and spontaneity tests, Activity Measure for Upper Limb Amputation, and the Patient-Specific Functional Scale. This was a quasi-experimental study with repeated measurements in a convenience sample of upper limb amputees. Measures were collected before, during, and after training with the DEKA Arm. Largest effect sizes were observed for Patient-Specific Functional Scale (effect size: 1.59, confidence interval: 1.00, 2.14), Activity Measure for Upper Limb Amputation (effect size: 1.33, confidence interval: 0.73, 1.90), and University of New Brunswick skill test (effect size: 1.18, confidence interval: 0.61, 1.73). Other measures that were responsive to change were Box and Block test, Jebsen-Taylor Hand Function light and heavy can tests, and University of New Brunswick spontaneity test. Responsiveness and pattern of responsiveness varied by prosthetic level. The Box and Block test, Jebsen-Taylor Hand Function light and heavy can tests, University of New Brunswick skill and spontaneity tests, Activities Measure for Upper Limb Amputation, and the Patient-Specific Functional Scale were responsive to change during prosthetic training. These findings have implications for choice of measures for research and practice and inform clinicians about the amount of training necessary to maximize outcomes with the DEKA Arm. Findings on responsiveness of outcome measures have implications for the choice of measures for clinical trials and practice. Findings regarding the responsiveness to change over the course of training can inform clinicians about the amount of training that may be necessary to maximize specific outcomes with the DEKA Arm. © The International Society for Prosthetics and Orthotics 2014.

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

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.

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

PubMed Central

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

2013-01-01

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

Why the NHS should abandon the search for the universal outcome measure.

PubMed

Brown, R B; McCartney, S; Bell, L

1995-08-01

This paper considers the use of outcome measures in the British National Health Service (NHS). Measuring outcomes is a major conceptual and practical problem. Many different measures are currently available yet no consensus has been reached on which should be preferred over others, or about which should take priority when they conflict. Some currently used measures are described, the relationship between these measures and the measured activities are discussed, and fundamental problems with both the measures and their use are revealed. It is shown that however assiduous the search, the 'perfect' outcome measure will always remain elusive.

Routine measurement of outcomes in Australia's public sector mental health services

PubMed Central

Pirkis, Jane; Burgess, Philip; Coombs, Tim; Clarke, Adam; Jones-Ellis, David; Dickson, Rosemary

2005-01-01

Objective This paper describes the Australian experience to date with a national 'roll out' of routine outcome measurement in public sector mental health services. Methods Consultations were held with 123 stakeholders representing a range of roles. Results Australia has made an impressive start to nationally implementing routine outcome measurement in mental health services, although it still has a long way to go. All States/Territories have established data collection systems, although some are more streamlined than others. Significant numbers of clinicians and managers have been trained in the use of routine outcome measures, and thought is now being given to ongoing training strategies. Outcome measurement is now occurring 'on the ground'; all States/Territories will be reporting data for 2003–04, and a number have been doing so for several years. Having said this, there is considerable variability regarding data coverage, completeness and compliance. Some States/Territories have gone to considerable lengths to 'embed' outcome measurement in day-to-day practice. To date, reporting of outcome data has largely been limited to reports profiling individual consumers and/or aggregate reports that focus on compliance and data quality issues, although a few States/Territories have begun to turn their attention to producing aggregate reports of consumers by clinician, team or service. Conclusion Routine outcome measurement is possible if it is supported by a co-ordinated, strategic approach and strong leadership, and there is commitment from clinicians and managers. The Australian experience can provide lessons for other countries. PMID:15840170

Ranking Surgical Residency Programs: Reputation Survey or Outcomes Measures?

PubMed

Wilson, Adam B; Torbeck, Laura J; Dunnington, Gary L

2015-01-01

The release of general surgery residency program rankings by Doximity and U.S. News & World Report accentuates the need to define and establish measurable standards of program quality. This study evaluated the extent to which program rankings based solely on peer nominations correlated with familiar program outcomes measures. Publicly available data were collected for all 254 general surgery residency programs. To generate a rudimentary outcomes-based program ranking, surgery programs were rank-ordered according to an average percentile rank that was calculated using board pass rates and the prevalence of alumni publications. A Kendall τ-b rank correlation computed the linear association between program rankings based on reputation alone and those derived from outcomes measures to validate whether reputation was a reasonable surrogate for globally judging program quality. For the 218 programs with complete data eligible for analysis, the mean board pass rate was 72% with a standard deviation of 14%. A total of 60 programs were placed in the 75th percentile or above for the number of publications authored by program alumni. The correlational analysis reported a significant correlation of 0.428, indicating only a moderate association between programs ranked by outcomes measures and those ranked according to reputation. Seventeen programs that were ranked in the top 30 according to reputation were also ranked in the top 30 based on outcomes measures. This study suggests that reputation alone does not fully capture a representative snapshot of a program's quality. Rather, the use of multiple quantifiable indicators and attributes unique to programs ought to be given more consideration when assigning ranks to denote program quality. It is advised that the interpretation and subsequent use of program rankings be met with caution until further studies can rigorously demonstrate best practices for awarding program standings. Copyright © 2015 Association of Program

Measuring outcomes in psychiatry: an inpatient model.

PubMed

Davis, D E; Fong, M L

1996-02-01

This article describes a system for measuring outcomes recently implemented in the department of psychiatry of Baptist Memorial Hospital, a 78-bed inpatient and day treatment unit that represents one service line of a large, urban teaching hospital in Memphis. In June 1993 Baptist Hospital began a 15-month pilot test of PsychSentinel, a measurement tool developed by researchers in the Department of Community Medicine at the University of Connecticut. The hospital identified the following four primary goals for this pilot project: provide data for internal hospital program evaluation, provide data for external marketing in a managed care environment, satisfy requirements of the Joint Commission on Accreditation of Health Care Organizations, and generate studies that add to the literature in psychiatry and psychology. PsychSentinel is based on the standardized diagnostic criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV). The outcome measure assesses the change in the number of symptoms of psychopathology that occurs between admission and discharge from the hospital. Included in the nonproprietary system are risk adjustment factors, as well as access to a national reference database for comparative analysis purposes. Data collection can be done by trained ancillary staff members, with as much or as little direct physician involvement as desired. The system has proven to be both time effective and cost effective, and it provides important outcome information both at the program level and at the clinician level. After the pilot test, the staff at Baptist Memorial Hospital determined that the system met all initial objectives identified and recently adopted the system as an ongoing measure of quality patient care in the department of psychiatry.

Use of patient-reported outcome measures in foot and ankle research.

PubMed

Hunt, Kenneth J; Hurwit, Daniel

2013-08-21

In the orthopaedic literature, there is a wide range of clinical outcome measurement tools that have been used in evaluating foot and ankle procedures, disorders, and outcomes, with no broadly accepted consensus as to which tools are preferred. The purpose of this study was to determine the frequency and distribution of the various outcome instruments used in the foot and ankle literature, and to identify trends for use of these instruments over time. We conducted a systematic review of all original clinical articles reporting on foot and/or ankle topics in six orthopaedic journals over a ten-year period (2002 to 2011). All clinical patient-reported outcome rating instruments used in these articles were recorded, as were study date, study design, clinical topic, and level of evidence. A total of 878 clinical foot and ankle articles that used at least one patient-reported outcome measure were identified among 16,513 total articles published during the ten-year period. There were 139 unique clinical outcome scales used, and the five most popular scales (as a percentage of foot/ankle outcome articles) were the American Orthopaedic Foot & Ankle Society (AOFAS) scales (55.9%), visual analog scale (VAS) for pain (22.9%), Short Form-36 (SF-36) Health Survey (13.7%), Foot Function Index (FFI) (5.5%), and American Academy of Orthopaedic Surgeons (AAOS) outcomes instruments (3.3%). The majority of articles described Level-IV studies (70.1%); only 9.4% reported Level-I studies. A considerable variety of outcome measurement tools are used in the foot and ankle clinical literature, with a small proportion used consistently. The AOFAS scales continue to be used at a high rate relative to other scales that have been validated. Data from the present study underscore the need for a paradigm shift toward the use of consistent, valid, and reliable outcome measures for studies of foot and ankle procedures and disorders. It is not clear which existing validated outcome instruments will

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.

General Outcome Measures for Verbal Operants

ERIC Educational Resources Information Center

Kubina, Richard M., Jr.; Wolfe, Pamela; Kostewicz, Douglas E.

2009-01-01

A general outcome measure (GOM) can be used to show progress towards a long-term goal. GOMs should sample domains of behavior across ages, be sensitive to change over time, be inexpensive and easy to use, and facilitate decision making. Skinner's (1957) analysis of verbal behavior may benefit from the development of GOM. To develop GOM, we…

Outcomes and benefits of pediatric cochlear implantation in children with additional disabilities: a review and report of family influences on outcomes.

PubMed

Cejas, Ivette; Hoffman, Michael F; Quittner, Alexandra L

2015-01-01

The number of children with hearing loss with additional disabilities receiving cochlear implantation has increased dramatically over the past decade. However, little is known about their auditory and speech and language development following implantation. The purpose of this review is to evaluate the effects of cochlear implantation on the most common genetic and developmental disorders in children with hearing loss. Benefits of cochlear implantation for children with autism spectrum disorder, developmental delay, CHARGE syndrome, cerebral palsy, learning disorders, Usher syndrome, Waardenburg syndrome, and attention deficit/hyperactivity disorder are reviewed. Our review indicates that children with hearing loss and additional disabilities benefit from cochlear implantation, especially when implanted early. Thus, early interventions seem as important for these children as for deaf children without additional disabilities. Comparisons of outcomes across these disabilities indicate that children with little to no cognitive impairment (eg, Waardenburg sydrome, attention deficit hyperactivity disorder) have better outcomes than those with greater deficits in intellectual functioning (eg, autism, CHARGE syndrome). In addition, parents of children with hearing loss and additional disabilities report higher levels of parenting stress and greater child behavior problems than those without comorbid diagnoses. However, these parents are as sensitive when interacting with their children as parents with typically developing children using cochlear implantation. Given these results, it is critical to evaluate these children's developmental milestones to provide early implantation and intervention, appropriately counsel families regarding realistic expectations for the implant, and facilitate family adaptation.

Outcomes and benefits of pediatric cochlear implantation in children with additional disabilities: a review and report of family influences on outcomes

PubMed Central

Cejas, Ivette; Hoffman, Michael F; Quittner, Alexandra L

2015-01-01

The number of children with hearing loss with additional disabilities receiving cochlear implantation has increased dramatically over the past decade. However, little is known about their auditory and speech and language development following implantation. The purpose of this review is to evaluate the effects of cochlear implantation on the most common genetic and developmental disorders in children with hearing loss. Benefits of cochlear implantation for children with autism spectrum disorder, developmental delay, CHARGE syndrome, cerebral palsy, learning disorders, Usher syndrome, Waardenburg syndrome, and attention deficit/hyperactivity disorder are reviewed. Our review indicates that children with hearing loss and additional disabilities benefit from cochlear implantation, especially when implanted early. Thus, early interventions seem as important for these children as for deaf children without additional disabilities. Comparisons of outcomes across these disabilities indicate that children with little to no cognitive impairment (eg, Waardenburg sydrome, attention deficit hyperactivity disorder) have better outcomes than those with greater deficits in intellectual functioning (eg, autism, CHARGE syndrome). In addition, parents of children with hearing loss and additional disabilities report higher levels of parenting stress and greater child behavior problems than those without comorbid diagnoses. However, these parents are as sensitive when interacting with their children as parents with typically developing children using cochlear implantation. Given these results, it is critical to evaluate these children’s developmental milestones to provide early implantation and intervention, appropriately counsel families regarding realistic expectations for the implant, and facilitate family adaptation. PMID:29388595

How to measure the outcomes of chronic disease management.

PubMed

Lewis, Al

2009-02-01

The fastest-growing methodology for disease management outcomes measurement is valid, transparent, easy to apply, and freely available in the public domain and this article. It measures the actual goal of disease management, which is to reduce the rate of adverse events associated with the disease(s) being managed. Changes in this rate can be translated into a return on investment using some explicit assumptions about comorbidities and episode costs. Outcomes measured in this way show that in the health plan community as a whole, disease management in the broadest sense is working, as measured by the relative stability in the rate of adverse medical events closely associated with common chronic disease during this decade of increasing prevalence of most of the common chronic conditions.

Systematic review: handwashing behaviour in low- to middle-income countries: outcome measures and behaviour maintenance.

PubMed

Vindigni, Stephen M; Riley, Patricia L; Jhung, Michael

2011-04-01

To describe global approaches to handwashing research in low- and middle-income communities, schools and health care settings using behavioural outcome measurement and temporal study design. Peer-reviewed and grey literature was screened for handwashing studies that evaluated behaviour change. Relevant articles were assessed by their research approach, including the investigator's selected outcome measure and time frame of various study components (e.g., formative research, intervention and evaluation). The initial search yielded 527 relevant articles. After application of exclusion criteria, we identified 27 unique studies (30 total articles). Of the 27 articles, most were focused in the community setting. Fifteen (56%) documented observed handwashing behaviour, while 18 (67%) used proxy measures (e.g., soap presence, diarrhoea) and 14 (52%) used self-reported behaviour. Several studies used multiple outcome measures. While all studies had an evaluation of behaviour change, there was a dearth of studies that evaluated long-term maintenance of behaviour change after the intervention's conclusion. While the literature is replete with a variety of handwashing studies in community, school and health care settings, none have been able to definitively document long-term behaviour change, thereby challenging the sustainability of various interventions. Additionally, there is a need to better understand which research approach is most effective in promoting long-term behaviour compliance in global low- and middle-income settings. © 2011 Blackwell Publishing Ltd.

Development of a spanish version of the Schwartz Outcome Scale-10: a brief mental health outcome measure.

PubMed

Rivas-Vazquez, R A; Rivas-Vazquez, A; Blais, M A; Rey, G J; Rivas-Vasquez, F; Jacobo, M; Carrazana, E J

2001-12-01

The lack of culturally appropriate psychometric instruments for the assessment of cognitive and emotional functioning in minority populations has been a concern often discussed in the assessment literature. With the increased focus on the measurement of outcome in mental health treatment, the lack of appropriate instruments for minorities has become readily apparent in this venue as well. We report on the Spanish translation of a brief and reliable measure of psychological health and well-being that has been shown to be sensitive to treatment outcomes. The original and Spanish translated versions of this measure are highly correlated, providing clinicians and organizations with a instrument that can be used for assessment of psychological well-being and treatment outcomes with Hispanic patients.

Generating Outcome Measurements: Achievement and Attitudes. A Guide to Educational Outcome Measurements and Their Uses. Seminar No. 3.

ERIC Educational Resources Information Center

Mushkin, Selma J.; Billings, Bradley B.

This guide is essentially designed as a teaching aid for those who would inform planners, officials of educational ministries, school administrators, principals, and teachers about educational outcome measurements. In outline and graphic form, the guide presents topics for discussion in a seminar dealing with how to obtain information on…

Patient-reported outcome measures in arthroplasty registries

PubMed Central

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

2016-01-01

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

Differential Impact of Serial Measurement of Nonplatelet Thromboxane Generation on Long-Term Outcome After Cardiac Surgery.

PubMed

Kakouros, Nikolaos; Gluckman, Tyler J; Conte, John V; Kickler, Thomas S; Laws, Katherine; Barton, Bruce A; Rade, Jeffrey J

2017-11-02

Systemic thromboxane generation, not suppressible by standard aspirin therapy and likely arising from nonplatelet sources, increases the risk of atherothrombosis and death in patients with cardiovascular disease. In the RIGOR (Reduction in Graft Occlusion Rates) study, greater nonplatelet thromboxane generation occurred early compared with late after coronary artery bypass graft surgery, although only the latter correlated with graft failure. We hypothesize that a similar differential association exists between nonplatelet thromboxane generation and long-term clinical outcome. Five-year outcome data were analyzed for 290 RIGOR subjects taking aspirin with suppressed platelet thromboxane generation. Multivariable modeling was performed to define the relative predictive value of the urine thromboxane metabolite, 11-dehydrothromboxane B 2 (11-dhTXB 2 ), measured 3 days versus 6 months after surgery on the composite end point of death, myocardial infarction, revascularization or stroke, and death alone. 11-dhTXB 2 measured 3 days after surgery did not independently predict outcome, whereas 11-dhTXB 2 >450 pg/mg creatinine measured 6 months after surgery predicted the composite end point (adjusted hazard ratio, 1.79; P =0.02) and death (adjusted hazard ratio, 2.90; P =0.01) at 5 years compared with lower values. Additional modeling revealed 11-dhTXB 2 measured early after surgery associated with several markers of inflammation, in contrast to 11-dhTXB 2 measured 6 months later, which highly associated with oxidative stress. Long-term nonplatelet thromboxane generation after coronary artery bypass graft surgery is a novel risk factor for 5-year adverse outcome, including death. In contrast, nonplatelet thromboxane generation in the early postoperative period appears to be driven predominantly by inflammation and did not independently predict long-term clinical outcome. © 2017 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.

Measuring treatment outcomes in gambling disorders: a systematic review.

PubMed

Pickering, Dylan; Keen, Brittany; Entwistle, Gavin; Blaszczynski, Alex

2018-03-01

Considerable variation of outcome variables used to measure recovery in the gambling treatment literature has precluded effective cross-study evaluations and hindered the development of best-practice treatment methodologies. The aim of this systematic review was to describe current diffuse concepts of recovery in the gambling field by mapping the range of outcomes and measurement strategies used to evaluate treatments, and to identify more commonly accepted indices of recovery. A systematic search of six academic databases for studies evaluating treatments (psychological and pharmacological) for gambling disorders with a minimum 6-month follow-up. Data from eligible studies were tabulated and analysis conducted using a narrative approach. Guidelines of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) were adhered to. Thirty-four studies were reviewed systematically (RCTs = 17, comparative designs = 17). Sixty-three different outcome measures were identified: 25 (39.7%) assessed gambling-specific constructs, 36 (57.1%) assessed non-gambling specific constructs, and two instruments were used across both categories (3.2%). Self-report instruments ranged from psychometrically validated to ad-hoc author-designed questionnaires. Units of measurement were inconsistent, particularly in the assessment of gambling behaviour. All studies assessed indices of gambling behaviour and/or symptoms of gambling disorder. Almost all studies (n = 30; 88.2%) included secondary measures relating to psychiatric comorbidities, psychological processes linked to treatment approach, or global functioning and wellbeing. In research on gambling disorders, the incorporation of broader outcome domains that extend beyond disorder-specific symptoms and behaviours suggests a multi-dimensional conceptualization of recovery. Development of a single comprehensive scale to measure all aspects of gambling recovery could help to facilitate uniform reporting practices

Overview: Measuring Early Learning Quality and Outcomes (MELQO)

ERIC Educational Resources Information Center

Brookings Institution, 2017

2017-01-01

The Measuring Early Learning Quality and Outcomes (MELQO) initiative began in 2014 in anticipation of a new global emphasis on early childhood development (ECD). Led by UNESCO, the World Bank, the Center for Universal Education at the Brookings Institution, and UNICEF, the initiative aims to promote feasible, accurate and useful measurement of…

Measuring and communicating meaningful outcomes in neonatology: A family perspective.

PubMed

Janvier, Annie; Farlow, Barbara; Baardsnes, Jason; Pearce, Rebecca; Barrington, Keith J

2016-12-01

Medium- and long-term outcomes have been collected and described among survivors of neonatal intensive care units for decades, for a number of purposes: (1) quality control within units, (2) comparisons of outcomes between NICUs, (3) clinical trials (whether an intervention improves outcomes), (4) end-of-life decision-making, (5) to better understand the effects of neonatal conditions and/or interventions on organs and/or long-term health, and finally (6) to better prepare parents for the future. However, the outcomes evaluated have been selected by investigators, based on feasibility, availability, cost, stability, and on what investigators consider to be important. Many of the routinely measured outcomes have major limitations: they may not correlate well with long-term difficulties, they may artificially divide continuous outcomes into dichotomous ones, and may have no clear relationship with quality of life and functioning of children and their families. Several investigations, such as routine term cerebral resonance imaging for preterm infants, have also not yet been shown to improve the outcome of children nor their families. In this article, the most common variables used in neonatology as well as some variables which are rarely measured but may be of equal importance for families are presented. The manner in which these outcomes are communicated to families will be examined, as well as recommendations to optimize communication with parents. Copyright © 2016 Elsevier Inc. All rights reserved.

Physician empathy: definition, outcome-relevance and its measurement in patient care and medical education.

PubMed

Neumann, Melanie; Scheffer, Christian; Tauschel, Diethard; Lutz, Gabriele; Wirtz, Markus; Edelhäuser, Friedrich

2012-01-01

The present study gives a brief introduction into 1. the definition of physician empathy (PE) and 2. its influence on patients' health outcomes. Furthermore 3. we present assessment instruments to measure PE from the perspective of the patient and medical student. The latter topic will be explored in detail as we conducted a pilot study on the German versions of two self-assessment instruments of empathy, which are mostly used in medical education research, namely the "Jefferson Scale of Physician Empathy, Student Version" (JSPE-S) and the "Interpersonal Reactivity Index" (IRI). We first present an overview of the current empirical and theoretical literature on the definition and outcome-relevance of PE. Additionally, we conducted basic psychometric analyses of the German versions of the JSPE-S and the IRI. Data for this analyses is based on a cross-sectional pilot-survey in N=44 medical students and N=63 students of other disciplines from the University of Cologne. PE includes the understanding of the patient as well as verbal and non-verbal communication, which should result in a helpful therapeutic action of the physician. Patients' health outcomes in different healthcare settings can be improved considerably from a high quality empathic encounter with their clinician. Basic psychometric results of the German JSPE-S and IRI measures show first promising results. PE as an essential and outcome-relevant element in the patient-physician relationship requires more consideration in the education of medical students and, thus, in medical education research. The German versions of the JSPE-S and IRI measures seem to be promising means to evaluate these education aims and to conduct medical education research on empathy.

Longitudinal evaluation of Patient Reported Outcomes Measurement Information Systems (PROMIS) measures in pediatric chronic pain

PubMed Central

Kashikar-Zuck, Susmita; Carle, Adam; Barnett, Kimberly; Goldschneider, Kenneth R.; Sherry, David D.; Mara, Constance A.; Cunningham, Natoshia; Farrell, Jennifer; Tress, Jenna; DeWitt, Esi Morgan

2015-01-01

The Patient Reported Outcomes Measurement Information System (PROMIS) initiative is a comprehensive strategy by the National Institutes of Health to support the development and validation of precise instruments to assess self-reported health domains across healthy and disease-specific populations. Much progress has been made in instrument development but there remains a gap in the validation of PROMIS measures for pediatric chronic pain. The purpose of this study was to investigate the construct validity and responsiveness to change of seven PROMIS domains for the assessment of children (ages 8-18) with chronic pain – Pain Interference, Fatigue, Anxiety, Depression, Mobility, Upper Extremity Function and Peer Relationships. PROMIS measures were administered at the initial visit and two follow-up visits at an outpatient chronic pain clinic (CPC; N=82) and at an intensive amplified pain day-treatment program (AMP; N= 63). Aim 1 examined construct validity of PROMIS measures by comparing them with corresponding “legacy” measures administered as part of usual care in the CPC sample. Aim 2 examined sensitivity to change in both CPC and AMP samples. Longitudinal growth models showed that PROMIS Pain Interference, Anxiety, Depression, Mobility, Upper Extremity and Peer Relationship measures and legacy instruments generally performed similarly with slightly steeper slopes of improvement in legacy measures. All seven PROMIS domains showed responsiveness to change. Results offered initial support for the validity of PROMIS measures in pediatric chronic pain. Further validation with larger and more diverse pediatric pain samples and additional legacy measures would broaden the scope of use of PROMIS in clinical research. PMID:26447704

Reaching clinically relevant outcome measures for new pharmacotherapy and immunotherapy of atopic eczema.

PubMed

Chalmers, Joanne; Deckert, Stefanie; Schmitt, Jochen

2015-06-01

This article describes the core outcome set (COS) for atopic eczema trials. COS describe a minimum set of outcomes to be assessed in a defined situation. COS are required to overcome the current situation of different trials using different endpoints with unclear/insufficient measurement properties resulting in incomparable trials. The global multi-stakeholder Harmonising Outcomes Measures for Eczema initiative developed the Harmonising Outcomes Measures for Eczema roadmap as a generic framework for COS development. Following the establishment of a panel representing all stakeholders, a core set of outcome domains need to be selected based on systematic reviews and consensus methods. Outcome measurement instruments to assess these core domains need to be valid, reliable, and feasible. There is broad global consensus that clinical signs, quality of life, symptoms, and long-term control of flares form the COS for atopic eczema trials. The Eczema Area and Severity Index is recommended to assess clinical signs in atopic eczema trials. Systematic reviews to identify adequate outcome measurement instruments for the other core outcome domains are underway. Clinical signs should be assessed in all atopic eczema trials by at least the Eczema Area and Severity Index. Quality of life, symptoms, and flares should also be assessed in all atopic eczema trials by a valid, reliable, and feasible instrument.

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

Variations in data collection can influence outcome measures of BMI measuring programmes.

PubMed

Townsend, Nick; Rutter, Harry; Foster, Charlie

2011-10-01

The World Health Organization (WHO) promotes the surveillance of obesity prevalence through standardized and harmonized surveillance systems. However, variations in data collection between countries, or between coordinating regions in countries can affect outcome measures. Multilevel analysis of 2007/08 National Child Measurement Programme (NCMP) data estimating the relationship between BMI z-score and data collection variations within coordinating regions whilst adjusting for individual-level and school-level variables. The 2007/08 NCMP collected height and weight measurements for 478,381 Reception year pupils (4-5-year-olds) and 496,297 year 6 pupils (10-11-year-olds) from 17,279 primary schools in 152 data collection coordinating regions in England. Data collection variables accounted for 29.7% of the regional variation in BMI z-score for Reception year pupils but only 5.3% for the older Year 6 pupils. Digit preference in the rounding of weight measurements had the greatest impact of all the data collection variables, explaining 26.4% of the regional variation in BMI z-score for Reception year pupils and 4.0% for Year 6 pupils. Although variations in data collection may have a small effect on individual measurements their impact can be magnified when scaled up to regional or national figures. All measurement programmes must regularly identify and minimize variations in data collection to improve accuracy of outcome measures. These factors include those identified within this study: participation and opt out rates, the time in the year the measurements are taken and the recording of measurements to the correct decimal place.

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

PubMed Central

Weldring, Theresa; Smith, Sheree M.S.

2013-01-01

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

Outcome measures for adult critical care: a systematic review.

PubMed

Hayes, J A; Black, N A; Jenkinson, C; Young, J D; Rowan, K M; Daly, K; Ridley, S

2000-01-01

1. To identify generic and disease specific measures of impairment, functional status and health-related quality of life that have been used in adult critical care (intensive and high-dependency care) survivors. 2. To review the validity, reliability and responsiveness of the measures in adult critical care survivors. 3. To consider the implications for future policy and to make recommendations for further methodological research. 4. To review what is currently known of the outcome of adult critical care. Searches of electronic databases (MEDLINE, EMBASE, CINAHL, PsycLIT, The Cochrane Library and SIGLE) from 1970 to August 1998. Manual searches of five journals (1985-98) not indexed in electronic databases and relevant conference proceedings (1993-98). Reference lists of six existing reviews, plus snowballing from reference lists of all relevant articles identified. Randomised trials, non-randomised trials (cohort studies) and case series that included data on outcomes after discharge from adult (16 years and over) critical care. If reported, the following data were extracted from each paper: patient characteristics (age, gender, severity of illness, diagnostic category) number of patients eligible for study, follow-up period, number of deaths before follow-up, number and proportion of survivors included in follow-up method of presentation of outcome data - proportion normal as defined by reference values, or aggregate value (e.g. mean or median), or aggregate values plus an indication of variance (e.g. standard deviation or inter-quartile range). Evidence for three measurement properties was sought for each outcome measure that had been used in at least two studies - their validity, reliability and responsiveness in adult critical care. If the authors did not report these aspects explicitly, an attempt was made to use the data provided to provide these measurement properties. For measures that were used in at least ten studies, information on actual reported

Testing Multiple Outcomes in Repeated Measures Designs

ERIC Educational Resources Information Center

Lix, Lisa M.; Sajobi, Tolulope

2010-01-01

This study investigates procedures for controlling the familywise error rate (FWR) when testing hypotheses about multiple, correlated outcome variables in repeated measures (RM) designs. A content analysis of RM research articles published in 4 psychology journals revealed that 3 quarters of studies tested hypotheses about 2 or more outcome…

Theoretical framework and methodological development of common subjective health outcome measures in osteoarthritis: a critical review

PubMed Central

Pollard, Beth; Johnston, Marie; Dixon, Diane

2007-01-01

Subjective measures involving clinician ratings or patient self-assessments have become recognised as an important tool for the assessment of health outcome. The value of a health outcome measure is usually assessed by a psychometric evaluation of its reliability, validity and responsiveness. However, psychometric testing involves an accumulation of evidence and has recognised limitations. It has been suggested that an evaluation of how well a measure has been developed would be a useful additional criteria in assessing the value of a measure. This paper explored the theoretical background and methodological development of subjective health status measures commonly used in osteoarthritis research. Fourteen subjective health outcome measures commonly used in osteoarthritis research were examined. Each measure was explored on the basis of their i) theoretical framework (was there a definition of what was being assessed and was it part of a theoretical model?) and ii) methodological development (what was the scaling strategy, how were the items generated and reduced, what was the response format and what was the scoring method?). Only the AIMS, SF-36 and WHOQOL defined what they were assessing (i.e. the construct of interest) and no measure assessed was part of a theoretical model. None of the clinician report measures appeared to have implemented a scaling procedure or described the rationale for the items selected or scoring system. Of the patient self-report measures, the AIMS, MPQ, OXFORD, SF-36, WHOQOL and WOMAC appeared to follow a standard psychometric scaling method. The DRP and EuroQol used alternative scaling methods. The review highlighted the general lack of theoretical framework for both clinician report and patient self-report measures. This review also drew attention to the wide variation in the methodological development of commonly used measures in OA. While, in general the patient self-report measures had good methodological development, the

Selection and visualisation of outcome measures for complex post-acute acquired brain injury rehabilitation interventions

PubMed Central

Ford, Catherine Elaine Longworth; Malley, Donna; Bateman, Andrew; Clare, Isabel C.H.; Wagner, Adam P.; Gracey, Fergus

2016-01-01

Background Outcome measurement challenges rehabilitation services to select tools that promote stakeholder engagement in measuring complex interventions. Objectives To examine the suitability of outcome measures for complex post-acute acquired brain injury (ABI) rehabilitation interventions, report outcomes of a holistic, neuropsychological ABI rehabilitation program and propose a simple way of visualizing complex outcomes. Methods Patient/carer reported outcome measures (PROMS), experience measures (PREMS) and staff-rated measures were collected for consecutive admissions over 1 year to an 18-week holistic, neuropsychological rehabilitation programme at baseline, 18 weeks and 3- and 6-month follow-up. Results Engagement with outcome measurement was poorest for carers and at follow-up for all stakeholders. Dependence, abilities, adjustment, unmet needs, symptomatology including executive dysfunction, and self-reassurance showed improvements at 18 weeks. Adjustment, social participation, perceived health, symptomatology including dysexecutive difficulties, and anxiety were worse at baseline for those who did not complete rehabilitation, than those who did. A radar plot facilitated outcome visualization. Conclusions Engagement with outcome measurement was best when time and support were provided. Supplementing patient- with staff-rated and attendance measures may explain missing data and help quantify healthcare needs. The MPAI4, EBIQ and DEX-R appeared suitable measures to evaluate outcomes and distinguish those completing and not completing neuropsychological rehabilitation. PMID:27341362

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.

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

Comparison of rheumatoid arthritis clinical trial outcome measures: a simulation study.

PubMed

Anderson, Jennifer J; Bolognese, James A; Felson, David T

2003-11-01

Isolated studies have suggested that continuous measures of response may be better than predefined, dichotomous definitions (e.g., the American College of Rheumatology 20% improvement criteria [ACR20]) for discriminating between rheumatoid arthritis (RA) treatments. Our goal was to determine the statistical power of predefined dichotomous outcome measures (termed "a priori"), compared with that of continuous measures derived from trial data in which there was no predefined response threshold (termed "data driven"), and to evaluate the sensitivity to change of these measures in the context of different treatments and early versus later-stage disease. In order to generalize beyond results from a single trial, we performed simulation studies. We obtained summary data from trials comparing disease-modifying antirheumatic drugs (DMARDs) and from comparative coxib-placebo trials to test the power of 2 a priori outcomes, the ACR20 and improvement of the Disease Activity Score (DDAS), as well as 2 data-driven outcomes. We studied patients with early RA and those with later-stage RA (duration of <4 years and 4-9 years, respectively). We performed simulation studies, using the interrelationship of ACR core set measures in the trials to generate multiple trial data sets consistent with the original data. The data-driven outcomes had greater power than did the a priori measures. The DMARD comparison was more powerful in early disease than in later-stage disease (the sample sizes needed to achieve 80% power for the most powerful test were 64 for early disease versus 100 for later disease), but the coxib-versus-placebo comparison was less powerful in early disease than in later disease (the sample sizes needed to achieve 80% power were 200 and 100, respectively). When the effects of treatment on core set items were small and/or inconsistent, power was reduced, particularly for a less broadly based outcome (e.g., DDAS) compared with the ACR20. The simulation studies demonstrate

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.

Need and greed in dermatology: disease and outcome measures in dermatological healthcare planning.

PubMed

Dalgard, Florence; Finlay, Andrew Y

2006-01-01

Assessing dermatological needs in the population and our ability to meet them is a challenge. The choice of outcome measures is central in dermatological healthcare planning. The concept of ill health and its relationship to dermatological outcome measures is described. Outcome measures used should provide information on these issues in order to gain insight into genuine needs and illness behavior in the population and to ensure quality of healthcare. Nevertheless, the dilemma of assigning priorities in healthcare planning remains; outcome measures in dermatology should be perceived as appropriate by patients as well as by caregivers and policy makers. It is important to stimulate research to develop and refine person-focused outcome measures. Their use is essential to assess dermatological health needs and to understand illness behavior. The information they can provide can enable provision and evaluation of healthcare quality and contribute to the challenge of making appropriate priority decisions in healthcare. Copyright (c) 2006 S. Karger AG, Basel.

Outcome Measurement in Nursing: Imperatives, Ideals, History, and Challenges

PubMed

Jones, Terry L

2016-05-31

Nurses have a social responsibility to evaluate the effect of nursing practice on patient outcomes in the areas of health promotion; injury and illness prevention; and alleviation of suffering. Quality assessment initiatives are hindered by the paucity of available data related to nursing processes and patient outcomes across these three domains of practice. Direct care nurses are integral to self-regulation for the discipline as they are the best source of information about nursing practice and patient outcomes. Evidence supports the assumption that nurses do contribute to prevention of adverse events but there is insufficient evidence to explain how nurses contribute to these and/or other patient outcomes. The purposes of this article are to examine the imperatives, ideal conditions, history, and challenges related to effective outcome measurement in nursing. The article concludes with recommendations for action to move quality assessment forward, such as substantial investment to support adequate documentation of nursing practice and patient outcomes.

A Binomial Test of Group Differences with Correlated Outcome Measures

ERIC Educational Resources Information Center

Onwuegbuzie, Anthony J.; Levin, Joel R.; Ferron, John M.

2011-01-01

Building on previous arguments for why educational researchers should not provide effect-size estimates in the face of statistically nonsignificant outcomes (Robinson & Levin, 1997), Onwuegbuzie and Levin (2005) proposed a 3-step statistical approach for assessing group differences when multiple outcome measures are individually analyzed…

Outcomes mapping study for childhood vaccination communication: too few concepts were measured in too many ways.

PubMed

Kaufman, Jessica; Ryan, Rebecca; Bosch-Capblanch, Xavier; Cartier, Yuri; Cliff, Julie; Glenton, Claire; Lewin, Simon; Rada, Gabriel; Ames, Heather; Muloliwa, Artur Manuel; Oku, Afiong; Oyo-Ita, Angela; Hill, Sophie

2016-04-01

The objectives of this article are to (1) comprehensively catalog outcomes measured in trials of childhood vaccination communication interventions and (2) analyze patterns and trends in outcome selection. To achieve these objectives, we developed a Trial Outcomes Map for vaccination communication. We searched the Cochrane Central Register of Controlled Trials for trials of childhood vaccination communication interventions, extracting verbatim all outcome information from included trials. Through thematic grouping, we categorized outcomes based on conceptual similarities, forming a Trial Outcomes Map. We identified 112 relevant trials containing 209 outcomes. Thematic analysis revealed three overarching Outcome Categories: consumer-, vaccination-, and health system-related outcomes. These categories contain 21 Outcome Types (eg, "knowledge," "cost"), measured using 66 different Outcome Variables. Vaccination outcomes were measured most frequently and health system-related outcomes least frequently. Consumer outcomes are increasingly measured in more recent trials. The number of measures used for the same outcomes complicates data synthesis and interpretation. Despite recent trends toward including consumer outcomes, intermediate outcome measurement is lacking, hampering understanding of how and why vaccination communication interventions do or do not work. This Map may improve outcome consistency in future trials and will contribute to a forthcoming core outcome set. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

An introduction to patient-reported outcome measures (PROMs) in physiotherapy.

PubMed

Kyte, D G; Calvert, M; van der Wees, P J; ten Hove, R; Tolan, S; Hill, J C

2015-06-01

The use of patient-reported outcome measures (PROMs) is set to rise in physiotherapy. PROMs provide additional 'patient-centred' data which is unique in capturing the patient's own opinion on the impact of their disease or disorder, and its treatment, on their life. Thus, PROMs are increasingly used by clinicians to guide routine patient care, or for the purposes of audit, and are already firmly embedded in clinical research. This article seeks to summarise the key aspects of PROM use for physiotherapists, both in routine clinical practice and in the research setting, and highlights recent developments in the field. Generic and condition-specific PROMs are defined and examples of commonly used measures are provided. The selection of appropriate PROMs, and their effective use in the clinical and research settings is discussed. Finally, existing barriers to PROM use in practice are identified and recent physiotherapy PROM initiatives, led by the Royal Dutch Society for Physical Therapy are explored. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

Patient-Reported Outcome Measures (PROM) as A Preoperative Assessment Tool.

PubMed

Kim, Sunghye; Duncan, Pamela W; Groban, Leanne; Segal, Hannah; Abbott, Rica Moonyeen; Williamson, Jeff D

2017-11-28

Patient-reported outcomes (PRO) on functional, social, and behavioral factors might be important preoperative predictors of postoperative outcomes. We conducted a literature review to explore associations of preoperative depression, socioeconomic status, social support, functional status/frailty, cognitive status, self-management skills, health literacy, and nutritional status with surgical outcomes. Two electronic data bases, including PubMed and Google Scholar, were searched linking either depression, socioeconomic status, social support, functional status/frailty, cognitive status, self-management skills, health literacy, or nutritional status with surgery, postoperative complications, or perioperative period within the past 2 decades. Preoperative depression has been linked to postoperative delirium, complications, persistent pain, longer lengths of stay, and mortality. Socioeconomic status associates with overall and cancer-free survival. Low socioeconomic status has also been connected to medication non- compliance. Social support can predict overall and cancer- free survival, as well as physical, social and emotional quality of life. Poor functional status and frailty have been related to postoperative complications, longer lengths of stay, post-discharge institutionalization, and higher costs. Preoperative cognitive impairment also associates with self-medication management errors, postoperative cognitive impairment, delirium, complications and mortality. In addition, a greater tendency for reduced adherence to preoperative medication instructions has been linked to health illiteracy. Preoperative malnutrition is prevalent and associates with postoperative morbidity. Efficient and effective assessments of social and behavioral determinants of health, functional status, health literacy, patient's perception of health, and preferences for self-management may improve postoperative management and surgical outcomes, particularly among vulnerable patients

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

Recommendations for the Use of Common Outcome Measures in Pediatric Traumatic Brain Injury Research

PubMed Central

Wilde, Elisabeth A.; Anderson, Vicki A.; Bedell, Gary; Beers, Sue R.; Campbell, Thomas F.; Chapman, Sandra B.; Ewing-Cobbs, Linda; Gerring, Joan P.; Gioia, Gerard A.; Levin, Harvey S.; Michaud, Linda J.; Prasad, Mary R.; Swaine, Bonnie R.; Turkstra, Lyn S.; Wade, Shari L.; Yeates, Keith O.

2012-01-01

Abstract This article addresses the need for age-relevant outcome measures for traumatic brain injury (TBI) research and summarizes the recommendations by the inter-agency Pediatric TBI Outcomes Workgroup. The Pediatric Workgroup's recommendations address primary clinical research objectives including characterizing course of recovery from TBI, prediction of later outcome, measurement of treatment effects, and comparison of outcomes across studies. Consistent with other Common Data Elements (CDE) Workgroups, the Pediatric TBI Outcomes Workgroup adopted the standard three-tier system in its selection of measures. In the first tier, core measures included valid, robust, and widely applicable outcome measures with proven utility in pediatric TBI from each identified domain including academics, adaptive and daily living skills, family and environment, global outcome, health-related quality of life, infant and toddler measures, language and communication, neuropsychological impairment, physical functioning, psychiatric and psychological functioning, recovery of consciousness, social role participation and social competence, social cognition, and TBI-related symptoms. In the second tier, supplemental measures were recommended for consideration in TBI research focusing on specific topics or populations. In the third tier, emerging measures included important instruments currently under development, in the process of validation, or nearing the point of published findings that have significant potential to be superior to measures in the core and supplemental lists and may eventually replace them as evidence for their utility emerges. PMID:21644810

Transforming Course Evaluations into a Meaningful Measure of Student Outcomes Achievement

ERIC Educational Resources Information Center

McCullough, Christopher A.

2008-01-01

Over the past few years, the author had the good fortune to engage many faculty and administrators in conversations about student outcomes assessment. The author has discovered that many faculty and administrators associate course valuations with student outcomes assessment measures. He also found that no items about student learning outcomes are…

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.

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.

Risk-adjusted outcome measurement in pediatric allogeneic stem cell transplantation.

PubMed

Matthes-Martin, Susanne; Pötschger, Ulrike; Bergmann, Kirsten; Frommlet, Florian; Brannath, Werner; Bauer, Peter; Klingebiel, Thomas

2008-03-01

The purpose of the study was to define a risk score for 1-year treatment-related mortality (TRM) in children undergoing allogeneic stem cell transplantation as a basis for risk-adjusted outcome assessment. We analyzed 1364 consecutive stem cell transplants performed in 24 German and Austrian centers between 1998 and 2003. Five well-established risk factors were tested by multivariate logistic regression for predictive power: patient age, disease status, donor other than matched sibling donor, T cell depletion (TCD), and preceding stem cell transplantation. The risk score was defined by rounding the parameter estimates of the significant risk factors to the nearest integer. Crossvalidation was performed on the basis of 5 randomly extracted equal-sized parts from the database. Additionally, the score was validated for different disease entities and for single centers. Multivariate analysis revealed a significant correlation of TRM with 3 risk factors: age >10 years, advanced disease, and alternative donor. The parameter estimates were 0.76 for age, 0.73 for disease status, and 0.97 for donor type. Rounding the estimates resulted in a score with 1 point for each risk factor. One-year TRM (overall survival [OS]) were 5% (89%) with a score of 0, 18% (74%) with 1, 28% (54%) with 2, and 53% (27%) with 3 points. Crossvalidation showed stable results with a good correlation between predicted and observed mortality but moderate discrimination. The score seems to be a simple instrument to estimate the expected mortality for each risk group and for each center. Measuring TRM risk-adjusted and the comparison between expected and observed mortality may be an additional tool for outcome assessment in pediatric stem cell transplantation.

Probabilistic metrology or how some measurement outcomes render ultra-precise estimates

NASA Astrophysics Data System (ADS)

Calsamiglia, J.; Gendra, B.; Muñoz-Tapia, R.; Bagan, E.

2016-10-01

We show on theoretical grounds that, even in the presence of noise, probabilistic measurement strategies (which have a certain probability of failure or abstention) can provide, upon a heralded successful outcome, estimates with a precision that exceeds the deterministic bounds for the average precision. This establishes a new ultimate bound on the phase estimation precision of particular measurement outcomes (or sequence of outcomes). For probe systems subject to local dephasing, we quantify such precision limit as a function of the probability of failure that can be tolerated. Our results show that the possibility of abstaining can set back the detrimental effects of noise.

Clinical research in implant dentistry: study design, reporting and outcome measurements: consensus report of Working Group 2 of the VIII European Workshop on Periodontology.

PubMed

Tonetti, Maurizio; Palmer, Richard

2012-02-01

The objective of this working group was to assess and make specific recommendations to improve the quality of reporting of clinical research in implant dentistry and discuss ways to reach a consensus on choice of outcomes. Discussions were informed by three systematic reviews on quality of reporting of observational studies (case series, case-control and cohort) and experimental research (randomized clinical trials). An additional systematic review provided information on choice of outcomes and analytical methods. In addition, an open survey among all workshop participants was utilized to capture a consensus view on the limits of currently used survival and success-based outcomes as well as to identify domains that need to be captured by future outcome systems. The Workshop attempted to clarify the characteristics and the value in dental implant research of different study designs. In most areas, measurable quality improvements over time were identified. The Workshop recognized important aspects that require continued attention by clinical researchers, funding agencies and peer reviewers to decrease potential bias. With regard to choice of outcomes, the limitations of currently used systems were recognized. Three broad outcome domains that need to be captured by future research were identified: (i) patient reported outcome measures, (ii) peri-implant tissue health and (iii) performance of implant supported restorations. Peri-implant tissue health can be measured by marginal bone level changes and soft tissue inflammation and can be incorporated in time to event analyses. The Workshop recommended that collaboration between clinicians and epidemiologists/clinical trials specialists should be encouraged. Aspects of design aimed at limitation of potential bias should receive attention by clinical researchers, funding agencies and journal editors. Adherence to appropriate reporting guidelines such as STROBE and CONSORT are necessary standards. Research on outcome

Pediatric cochlear implants: additional disabilities prevalence, risk factors, and effect on language outcomes.

PubMed

Birman, Catherine S; Elliott, Elizabeth J; Gibson, William P R

2012-10-01

To determine the prevalence of additional disabilities in a pediatric cochlear population, to identify medical and radiologic conditions associated with additional disabilities, and to identify the effect of additional disabilities on speech perception and language at 12 months postoperatively. Retrospective case review. Tertiary referral center and cochlear implant program. Records were reviewed for children 0 to 16 years old inclusive, who had cochlear implant-related operations over a 12-month period. Diagnostic and rehabilitative. Additional disabilities prevalence; medical history and radiologic abnormalities; and the effect on Categories of Auditory Performance (CAP) score at 12 months postoperatively. Eighty-eight children having 96 operations were identified. The overall prevalence of additional disabilities (including developmental delay, cerebral palsy, visual impairment, autism and attention deficit disorder) was 33%. The main conditions associated with additional disabilities were syndromes and chromosomal abnormalities (87%), jaundice (86%), prematurity (62%), cytomegalovirus (60%), and inner ear abnormalities including cochlea nerve hypoplasia or aplasia (75%) and semicircular canal anomalies (56%). At 12 months postoperatively, almost all (96%) of the children without additional disabilities had a CAP score of 5 or greater (speech), compared with 52% of children with additional disabilities. Children with developmental delay had a median CAP score of 4, at 12 months compared with 6 for those without developmental delay. Additional disabilities are prevalent in approximately a third of pediatric cochlear implant patients. Additional disabilities significantly affect the outcomes of cochlear implants.

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

Excursions out-of-lane versus standard deviation of lateral position as outcome measure of the on-the-road driving test.

PubMed

Verster, Joris C; Roth, Thomas

2014-07-01

The traditional outcome measure of the Dutch on-the-road driving test is the standard deviation of lateral position (SDLP), the weaving of the car. This paper explores whether excursions out-of-lane are a suitable additional outcome measure to index driving impairment. A literature search was conducted to search for driving tests that used both SDLP and excursions out-of-lane as outcome measures. The analyses were limited to studies examining hypnotic drugs because several of these drugs have been shown to produce next-morning sedation. Standard deviation of lateral position was more sensitive in demonstrating driving impairment. In fact, solely relying on excursions out-of-lane as outcome measure incorrectly classifies approximately half of impaired drives as unimpaired. The frequency of excursions out-of-lane is determined by the mean lateral position within the right traffic lane. Defining driving impairment as having a ΔSDLP > 2.4 cm, half of the impaired driving tests (51.2%, 43/84) failed to produce excursions out-of-lane. Alternatively, 20.9% of driving tests with ΔSDLP < 2.4 cm (27/129) had at least one excursion out-of-lane. Excursions out-of-lane are neither a suitable measure to demonstrate driving impairment nor is this measure sufficiently sensitive to differentiate adequately between differences in magnitude of driving impairment. Copyright © 2014 John Wiley & Sons, Ltd.

Surrogacy assessment using principal stratification when surrogate and outcome measures are multivariate normal.

PubMed

Conlon, Anna S C; Taylor, Jeremy M G; Elliott, Michael R

2014-04-01

In clinical trials, a surrogate outcome variable (S) can be measured before the outcome of interest (T) and may provide early information regarding the treatment (Z) effect on T. Using the principal surrogacy framework introduced by Frangakis and Rubin (2002. Principal stratification in causal inference. Biometrics 58, 21-29), we consider an approach that has a causal interpretation and develop a Bayesian estimation strategy for surrogate validation when the joint distribution of potential surrogate and outcome measures is multivariate normal. From the joint conditional distribution of the potential outcomes of T, given the potential outcomes of S, we propose surrogacy validation measures from this model. As the model is not fully identifiable from the data, we propose some reasonable prior distributions and assumptions that can be placed on weakly identified parameters to aid in estimation. We explore the relationship between our surrogacy measures and the surrogacy measures proposed by Prentice (1989. Surrogate endpoints in clinical trials: definition and operational criteria. Statistics in Medicine 8, 431-440). The method is applied to data from a macular degeneration study and an ovarian cancer study.

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.

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

Reference values for developing responsive functional outcome measures across the lifespan.

PubMed

McKay, Marnee J; Baldwin, Jennifer N; Ferreira, Paulo; Simic, Milena; Vanicek, Natalie; Burns, Joshua

2017-04-18

To generate a reference dataset of commonly performed functional outcome measures in 1,000 children and adults and investigate the influence of demographic, anthropometric, strength, and flexibility characteristics. Twelve functional outcome measures were collected from 1,000 healthy individuals aged 3-101 years: 6-minute walk test, 30-second chair stand test, timed stairs test, long jump, vertical jump, choice stepping reaction time, balance (Star Excursion Balance Test, tandem stance eyes open and closed, single-leg stance eyes closed), and dexterity (9-hole peg test, Functional Dexterity Test). Correlation and multiple regression analyses were performed to identify factors independently associated with each measure. Age- and sex-stratified reference values for functional outcome measures were generated. Functional performance increased through childhood and adolescence, plateaued during adulthood, and declined in older adulthood. While balance did not differ between the sexes, male participants generally performed better at gross motor tasks while female participants performed better at dexterous tasks. Height was the most consistent correlate of functional performance in children, while lower limb muscle strength was a major determinant in adolescents and adults. In older adults, age, lower limb strength, and joint flexibility explained up to 63% of the variance in functional measures. These normative reference values provide a framework to accurately track functional decline associated with neuromuscular disorders and assist development and validation of responsive outcome measures for therapeutic trials. © 2017 American Academy of Neurology.

Recommendation for measuring clinical outcome in distal radius fractures: a core set of domains for standardized reporting in clinical practice and research.

PubMed

Goldhahn, Jörg; Beaton, Dorcas; Ladd, Amy; Macdermid, Joy; Hoang-Kim, Amy

2014-02-01

Lack of standardization of outcome measurement has hampered an evidence-based approach to clinical practice and research. We adopted a process of reviewing evidence on current use of measures and appropriate theoretical frameworks for health and disability to inform a consensus process that was focused on deriving the minimal set of core domains in distal radius fracture. We agreed on the following seven core recommendations: (1) pain and function were regarded as the primary domains, (2) very brief measures were needed for routine administration in clinical practice, (3) these brief measures could be augmented by additional measures that provide more detail or address additional domains for clinical research, (4) measurement of pain should include measures of both intensity and frequency as core attributes, (5) a numeric pain scale, e.g. visual analogue scale or visual numeric scale or the pain subscale of the patient-reported wrist evaluation (PRWE) questionnaires were identified as reliable, valid and feasible measures to measure these concepts, (6) for function, either the Quick Disability of the arm, shoulder and hand questionnaire or PRWE-function subscale was identified as reliable, valid and feasible measures, and (7) a measure of participation and treatment complications should be considered core outcomes for both clinical practice and research. We used a sound methodological approach to form a comprehensive foundation of content for outcomes in the area of distal radius fractures. We recommend the use of symptom and function as separate domains in the ICF core set in clinical research or practice for patients with wrist fracture. Further research is needed to provide more definitive measurement properties of measures across all domains.

Physical outcome measures for conductive and mixed hearing loss treatment: A systematic review.

PubMed

Johansson, M L; Tysome, J R; Hill-Feltham, P; Hodgetts, W E; Ostevik, A; McKinnon, B J; Monksfield, P; Sockalingam, R; Wright, T

2018-05-07

The number of potential options for rehabilitation of patients with conductive or mixed hearing loss is continually expanding. To be able to inform patients and other stakeholders there is a need to identify and develop patient-centred outcomes for treatment of hearing loss. To identify outcome measures in the physical core area used when reporting the outcome after treatment of conductive and mixed hearing loss in adult patients. Systematic review. Systematic review of literature related to reported physical outcome measures after treatment of mixed or conductive hearing loss without restrictions regarding type of intervention, treatment or device. Any measure reporting the physical outcome after treatment or intervention of mixed or conductive hearing loss was sought and categorised. The physical outcomes measures that had been extracted were then grouped into domains. The literature search resulted in the identification of 1,434 studies, of which 153 were selected for inclusion in the review. The majority (57%) of papers reported results from middle ear surgery, with the remainder reporting results from either bone conduction hearing devices or middle ear implants. Outcomes related to complications were categorised into 17 domains, whereas outcomes related to treatment success was categorised in 22 domains. The importance of these domains to patients and other stakeholders needs to be further explored in order to establish which of these domains are most relevant to interventions for conductive or mixed hearing loss. This will allow us to then assess which outcomes measures are most suitable for inclusion in the core set This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Young drivers' responses to anti-speeding advertisements: Comparison of self-report and objective measures of persuasive processing and outcomes.

PubMed

Kaye, Sherrie-Anne; Lewis, Ioni; Algie, Jennifer; White, Melanie J

2016-05-18

Self-report measures are typically used to assess the effectiveness of road safety advertisements. However, psychophysiological measures of persuasive processing (i.e., skin conductance response [SCR]) and objective driving measures of persuasive outcomes (i.e., in-vehicle Global Positioning System [GPS] devices) may provide further insights into the effectiveness of these advertisements. This study aimed to explore the persuasive processing and outcomes of 2 anti-speeding advertisements by incorporating both self-report and objective measures of speeding behavior. In addition, this study aimed to compare the findings derived from these different measurement approaches. Young drivers (N = 20, M age = 21.01 years) viewed either a positive or negative emotion-based anti-speeding television advertisement. While viewing the advertisement, SCR activity was measured to assess ad-evoked arousal responses. The RoadScout GPS device was then installed in participants' vehicles for 1 week to measure on-road speed-related driving behavior. Self-report measures assessed persuasive processing (emotional and arousal responses) and actual driving behavior. There was general correspondence between the self-report measures of arousal and the SCR and between the self-report measure of actual driving behavior and the objective driving data (as assessed via the GPS devices). This study provides insights into how psychophysiological and GPS devices could be used as objective measures in conjunction with self-report measures to further understand the persuasive processes and outcomes of emotion-based anti-speeding advertisements.

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.

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

The Aphasia Communication Outcome Measure (ACOM): Dimensionality, Item Bank Calibration, and Initial Validation

ERIC Educational Resources Information Center

Hula, William D.; Doyle, Patrick J.; Stone, Clement A.; Hula, Shannon N. Austermann; Kellough, Stacey; Wambaugh, Julie L.; Ross, Katherine B.; Schumacher, James G.; St. Jacque, Ann

2015-01-01

Purpose: The purpose of this study is to investigate the structure and measurement properties of the Aphasia Communication Outcome Measure (ACOM), a patient-reported outcome measure of communicative functioning for persons with aphasia. Method: Three hundred twenty-nine participants with aphasia responded to 177 items asking about communicative…

The National Outcomes Measurement System for Pediatric Speech-Language Pathology

ERIC Educational Resources Information Center

Mullen, Robert; Schooling, Tracy

2010-01-01

Purpose: The American Speech-Language-Hearing Association's (ASHA's) National Outcomes Measurement System (NOMS) was developed in the late 1990s. The primary purpose was to serve as a source of data for speech-language pathologists (SLPs) who found themselves called on to provide empirical evidence of the functional outcomes associated with their…

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…

Measuring Outcome in the Treatment of Cocaine Dependence

PubMed Central

Crits-Christoph, Paul; Gallop, Robert; Gibbons, Mary Beth Connolly; Sadicario, Jaclyn S.; Woody, George

2015-01-01

Background Little in known about the extent to which outcome measures used in studies of the treatment of cocaine dependence are associated with longer-term use and with broader measures of clinical improvement. The current study examined reductions in use, and abstinence-oriented measures, in relation to functioning and longer-term clinical benefits in the treatment of cocaine dependence. Methods Overall drug use, cocaine use, and functioning in a number of addiction-related domains for 487 patients diagnosed with DSM-IV cocaine dependence and treated with one of four psychosocial interventions in the NIDA Cocaine Collaborative Treatment Study were assessed monthly during 6 months of treatment and at 9, 12, 15, and 18 month follow-up. Results Measures of during-treatment reduction in use were moderately correlated with drug and cocaine use measures 12 months, but showed non-significant or small correlations with measures of functioning at 12 months. Highest correlations were evident for abstinence measures (maximum consecutive days abstinence and completely abstinent) during treatment in relation to sustained (3 month) abstinence at 12 months. Latent class analysis of patterns of change over time revealed that most patients initially (months 1 to 4 of treatment) either became abstinent immediately or continued to use every month. Over the couse of follow-up, patients either maintained abstinence or used regularly – intermittent use was less common. Conclusions There were generally small associations between various measures of cocaine use and longer-term clinical benefits, other than abstinence was associated with continued abstinence. No one method of measuring outcome of treatment of cocaine dependence appears superior to others. PMID:26366427

Connecting Stuttering Management and Measurement: I. Core Speech Measures of Clinical Process and Outcome

ERIC Educational Resources Information Center

Shenker, Rosalee C.

2006-01-01

Background: There will always be a place for stuttering treatments designed to eliminate or reduce stuttered speech. When those treatments are required, direct speech measures of treatment process and outcome are needed in clinical practice. Aims: Based on the contents of published clinical trials of such treatments, three "core" measures of…

Evaluating test-retest reliability in patient-reported outcome measures for older people: A systematic review.

PubMed

Park, Myung Sook; Kang, Kyung Ja; Jang, Sun Joo; Lee, Joo Yun; Chang, Sun Ju

2018-03-01

This study aimed to evaluate the components of test-retest reliability including time interval, sample size, and statistical methods used in patient-reported outcome measures in older people and to provide suggestions on the methodology for calculating test-retest reliability for patient-reported outcomes in older people. This was a systematic literature review. MEDLINE, Embase, CINAHL, and PsycINFO were searched from January 1, 2000 to August 10, 2017 by an information specialist. This systematic review was guided by both the Preferred Reporting Items for Systematic Reviews and Meta-Analyses checklist and the guideline for systematic review published by the National Evidence-based Healthcare Collaborating Agency in Korea. The methodological quality was assessed by the Consensus-based Standards for the selection of health Measurement Instruments checklist box B. Ninety-five out of 12,641 studies were selected for the analysis. The median time interval for test-retest reliability was 14days, and the ratio of sample size for test-retest reliability to the number of items in each measure ranged from 1:1 to 1:4. The most frequently used statistical methods for continuous scores was intraclass correlation coefficients (ICCs). Among the 63 studies that used ICCs, 21 studies presented models for ICC calculations and 30 studies reported 95% confidence intervals of the ICCs. Additional analyses using 17 studies that reported a strong ICC (>0.09) showed that the mean time interval was 12.88days and the mean ratio of the number of items to sample size was 1:5.37. When researchers plan to assess the test-retest reliability of patient-reported outcome measures for older people, they need to consider an adequate time interval of approximately 13days and the sample size of about 5 times the number of items. Particularly, statistical methods should not only be selected based on the types of scores of the patient-reported outcome measures, but should also be described clearly in

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

PubMed

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

2007-07-01

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

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.

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

Evaluating the results of stress urinary incontinence surgery with objective and subjective outcome measures.

PubMed

Diez-Itza, I; Espuña-Pons, M

2014-09-01

To assess the outcomes of stress urinary incontinence (SUI) surgery using objective and subjective measures in women with pure SUI and mixed urinary incontinence (MUI). The degree of correlation between the different outcome measures was also evaluated for both groups. A multicentre prospective cohort study of women who underwent surgery for SUI. A standardized cough stress test was used as the objective outcome measure, and specific items of the Epidemiology of Prolapse and Incontinence Questionnaire were used as the subjective outcome measure. The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) and the Patient Global Impression of Improvement (PGI-I) questionnaires were used for global assessment. Kappa test was used to measure the degree of correlation between the outcome measures. The participants were categorized into two groups before surgery: pure SUI (n=116) and MUI (n=161). Six months after surgery, the cure rate of the SUI component was high in both groups according to the objective and subjective outcome measures. Global assessment showed lower cure rates. The degree of agreement between objective and subjective outcome measures was moderate (kappa 0.541, p<0.001) for women with pure SUI, and fair (kappa 0.377, p<0.001) for women with MUI. Correlation between the change in ICIQ-UI SF score (pre to post surgery) and the degree of satisfaction (PGI-I) was significant (p<0.01) for both the pure SUI group (0.43) and the MUI group (0.48). Both objective and subjective cure rates are high for women with pure SUI and MUI following SUI surgery in Spain. The degree of agreement between different outcome measures varies. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Surrogacy assessment using principal stratification when surrogate and outcome measures are multivariate normal

PubMed Central

Conlon, Anna S. C.; Taylor, Jeremy M. G.; Elliott, Michael R.

2014-01-01

In clinical trials, a surrogate outcome variable (S) can be measured before the outcome of interest (T) and may provide early information regarding the treatment (Z) effect on T. Using the principal surrogacy framework introduced by Frangakis and Rubin (2002. Principal stratification in causal inference. Biometrics 58, 21–29), we consider an approach that has a causal interpretation and develop a Bayesian estimation strategy for surrogate validation when the joint distribution of potential surrogate and outcome measures is multivariate normal. From the joint conditional distribution of the potential outcomes of T, given the potential outcomes of S, we propose surrogacy validation measures from this model. As the model is not fully identifiable from the data, we propose some reasonable prior distributions and assumptions that can be placed on weakly identified parameters to aid in estimation. We explore the relationship between our surrogacy measures and the surrogacy measures proposed by Prentice (1989. Surrogate endpoints in clinical trials: definition and operational criteria. Statistics in Medicine 8, 431–440). The method is applied to data from a macular degeneration study and an ovarian cancer study. PMID:24285772

Modeling and Predicting Hearing Aid Outcome

PubMed Central

Humes, Larry E.

2003-01-01

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

Measuring social inclusion--a key outcome in global mental health.

PubMed

Baumgartner, Joy Noel; Burns, Jonathan K

2014-04-01

Social inclusion is increasingly recognized as a key outcome for evaluating global mental health programmes and interventions. Whereas social inclusion as an outcome is not a new concept in the field of mental health, its measurement has been hampered by varying definitions, concepts and instruments. To move the field forward, this paper reviews the currently available instruments which measure social inclusion and are reported in the literature, realizing that no single measure will be appropriate for all studies or contexts. A systematic literature search of English language peer-reviewed articles published through February 2013 was undertaken to identify scales specifically developed to measure social inclusion or social/community integration among populations with mental disorders. Five instruments were identified through the search criteria. The scales are discussed in terms of their theoretical underpinnings, domains and/or key items and their potential for use in global settings. Whereas numerous reviewed abstracts discussed mental health and social inclusion or social integration, very few were concerned with direct measurement of the construct. All identified scales were developed in high-income countries with limited attention paid to how the scale could be adapted for cross-cultural use. Social inclusion is increasingly highlighted as a key outcome for global mental health policies and programmes, yet its measurement is underdeveloped. There is need for a global cross-cultural measure that has been developed and tested in diverse settings. However, until that need is met, some of the scales presented here may be amenable to adaptation.

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

45 CFR 287.145 - What measures will be used to determine NEW Program outcomes?

Code of Federal Regulations, 2010 CFR

2010-10-01

... Program outcomes? 287.145 Section 287.145 Public Welfare Regulations Relating to Public Welfare OFFICE OF... What measures will be used to determine NEW Program outcomes? Each grantee must develop its own... must identify planned program outcomes and the measures the Tribe will use to determine them. ACF will...

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.

Physical performance measures for predicting outcome in cancer patients: a systematic review.

PubMed

Verweij, Norbert M; Schiphorst, Anandi H W; Pronk, Apollo; van den Bos, Frederiek; Hamaker, Marije E

2016-12-01

Decision making regarding cancer treatment is challenging and there is a need for clinical parameters that can guide these decisions. As physical performance appears to be a reflection of health status, the aim of this systematic review is to assess whether physical performance tests (PPTs) are predictive of the clinical outcome and treatment tolerance in cancer patients. A literature search was conducted on 2 April 2015 in the electronic databases Medline and Embase to identify studies focusing on the association between objectively measured PPTs and outcome. No limitations in language or publication dates were applied. The search retrieved 9680 articles, 16 publications were included involving 4187 patients with various cancer types and different treatments. Reported median or mean age varied from 58 to 78 years. Nine studies used the Timed Up & Go (TUG) test, five the Short Physical Performance Battery (SPPB) and five studies focused on gait speed. Poorer TUG, SPPB and gait speed outcome were associated with decreased survival. TUG, SPPB and gait speed were also associated with treatment-related complications. Furthermore, two studies reported an association between poorer TUG and SPPB outcome with higher rates of functional decline. PPTs appear to show a significant correlation with survival and these tests could be used as a prognostic tool, particular for older adult patients. A less explicit correlation for treatment-related complications and functional decline was also found. To optimize decision making, future research should focus on developing and validating individualized treatment algorithms that incorporate PPTs in addition to cancer- and treatment-related variables.

CONSIDER - Core Outcome Set in IAD Research: study protocol for establishing a core set of outcomes and measurements in incontinence-associated dermatitis research.

PubMed

Van den Bussche, Karen; De Meyer, Dorien; Van Damme, Nele; Kottner, Jan; Beeckman, Dimitri

2017-10-01

This study protocol describes the methodology for the development of a core set of outcomes and a core set of measurements for incontinence-associated dermatitis. Incontinence is a widespread disorder with an important impact on quality of life. One of the most common complications is incontinence-associated dermatitis, resulting from chemical and physical irritation of the skin barrier, triggering inflammation and skin damage. Managing incontinence-associated dermatitis is an important challenge for nurses. Several interventions have been assessed in clinical trials, but heterogeneity in study outcomes complicates the comparability and standardization. To overcome this challenge, the development of a core outcome set, a minimum set of outcomes and measurements to be assessed in clinical research, is needed. A project team, International Steering Committee and panelists will be involved to guide the development of the core outcome set. The framework of the Harmonizing Outcomes Measures for Eczema roadmap endorsed by Cochrane Skin Group Core Outcomes Set Initiative, is used to inform the project design. A systematic literature review, interviews to integrate the patients' perspective and a consensus study with healthcare researchers and providers using the Delphi procedure will be performed. The project was approved by the Ethics review Committee (April 2016). This is the first project that will identify a core outcome set of outcomes and measurements for incontinence-associated dermatitis research. A core outcome set will reduce possible reporting bias, allow results comparisons and statistical pooling across trials and strengthen evidence-based practice and decision-making. This project has been registered in the Core Outcome Measures in Effectiveness Trials (COMET) database and is part of the Cochrane Skin Group Core Outcomes Set Initiative (CSG-COUSIN). © 2016 John Wiley & Sons Ltd.

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.

Measuring Student Learning Outcomes Using the SALG Instrument

ERIC Educational Resources Information Center

Scholl, Kathleen; Olsen, Heather M.

2014-01-01

U.S. higher education institutions are being called to question their central nature, priorities, and functions, with prominent and unprecedented attention being given to accountability and the measurement of student learning outcomes. As higher education evolves in how it assesses student learning and leisure studies and recreation departments…

[Improving care for cleft lip and palate patients: uniform and patient-orientated outcome measures].

PubMed

Haj, M; de Gier, H H W; van Veen-van der Hoek, M; Versnel, S L; van Adrichem, L N; Wolvius, E B; Hazelzet, J A; Koudstaal, M J

2018-02-01

The quality of care for patients with cleft lip and palate is extremely variable across the world. Treatment protocols differ and methods of data registration are not uniform. Improving this care by means of comparative research is challenging. The best treatment programmes can be identified by uniformly registering patient-orientated outcomes and comparing the outcomes with those of other treatment centres. That knowledge can be used to improve one's own care. An international team consisting of specialists and cleft lip and palate patients has developed a set of outcome measures that are considered by patients to be most important. This team is coordinated by the International Consortium of Health Outcomes Measurement (ICHOM). The cleft lip and palate outcome set can be used by all centres worldwide in following up on cleft lip and palate patients. In the Erasmus Medical Centre in Rotterdam, the 'Zorgmonitor Schisis' (Care Monitor Cleft Lip and Palate) has been built, an application in which these outcome measures are collected at fixed times. Implementing this set of outcome measures in other cleft lip and palate treatment centres and using the outcomes as (inter)national benchmarks will result in transparency and the improvement of the treatment of cleft lip and palate worldwide.

London Measure of Unplanned Pregnancy: guidance for its use as an outcome measure

PubMed Central

Hall, Jennifer A; Barrett, Geraldine; Copas, Andrew; Stephenson, Judith

2017-01-01

Background The London Measure of Unplanned Pregnancy (LMUP) is a psychometrically validated measure of the degree of intention of a current or recent pregnancy. The LMUP is increasingly being used worldwide, and can be used to evaluate family planning or preconception care programs. However, beyond recommending the use of the full LMUP scale, there is no published guidance on how to use the LMUP as an outcome measure. Ordinal logistic regression has been recommended informally, but studies published to date have all used binary logistic regression and dichotomized the scale at different cut points. There is thus a need for evidence-based guidance to provide a standardized methodology for multivariate analysis and to enable comparison of results. This paper makes recommendations for the regression method for analysis of the LMUP as an outcome measure. Materials and methods Data collected from 4,244 pregnant women in Malawi were used to compare five regression methods: linear, logistic with two cut points, and ordinal logistic with either the full or grouped LMUP score. The recommendations were then tested on the original UK LMUP data. Results There were small but no important differences in the findings across the regression models. Logistic regression resulted in the largest loss of information, and assumptions were violated for the linear and ordinal logistic regression. Consequently, robust standard errors were used for linear regression and a partial proportional odds ordinal logistic regression model attempted. The latter could only be fitted for grouped LMUP score. Conclusion We recommend the linear regression model with robust standard errors to make full use of the LMUP score when analyzed as an outcome measure. Ordinal logistic regression could be considered, but a partial proportional odds model with grouped LMUP score may be required. Logistic regression is the least-favored option, due to the loss of information. For logistic regression, the cut point

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.

Checklist to operationalize measurement characteristics of patient-reported outcome measures.

PubMed

Francis, David O; McPheeters, Melissa L; Noud, Meaghan; Penson, David F; Feurer, Irene D

2016-08-02

The purpose of this study was to advance a checklist of evaluative criteria designed to assess patient-reported outcome (PRO) measures' developmental measurement properties and applicability, which can be used by systematic reviewers, researchers, and clinicians with a varied range of expertise in psychometric measure development methodology. A directed literature search was performed to identify original studies, textbooks, consensus guidelines, and published reports that propose criteria for assessing the quality of PRO measures. Recommendations from these sources were iteratively distilled into a checklist of key attributes. Preliminary items underwent evaluation through 24 cognitive interviews with clinicians and quantitative researchers. Six measurement theory methodological novices independently applied the final checklist to assess six PRO measures encompassing a variety of methods, applications, and clinical constructs. Agreement between novice and expert scores was assessed. The distillation process yielded an 18-item checklist with six domains: (1) conceptual model, (2) content validity, (3) reliability, (4) construct validity, (5) scoring and interpretation, and (6) respondent burden and presentation. With minimal instruction, good agreement in checklist item ratings was achieved between quantitative researchers with expertise in measurement theory and less experienced clinicians (mean kappa 0.70; range 0.66-0.87). We present a simplified checklist that can help guide systematic reviewers, researchers, and clinicians with varied measurement theory expertise to evaluate the strengths and weakness of candidate PRO measures' developmental properties and the appropriateness for specific applications.

Minimal Clinically Important Difference: A Review of Outcome Measure Score Interpretation.

PubMed

Engel, Lisa; Beaton, Dorcas E; Touma, Zahi

2018-05-01

Clinicians, researchers, and outcome stakeholders have the crucial, albeit difficult, task of quantifying when a person or group experiences important change or difference on any given outcome measure, often in response to a specific intervention. The minimal clinically important difference (MCID) provides this quantified value of change/difference for a measure. There are many methods for MCID derivation, which can result in multiple values for the same measure. Thus, it is important for potential users of MCID values to be aware of the nuances of MCID development and cautions for interpreting values. This review outlines MCID-related definitions, methods, and guidelines. Copyright © 2018 Elsevier Inc. All rights reserved.

Patient characteristics and outcome measurement in a low secure forensic hospital.

PubMed

Longdon, Laura; Edworthy, Rachel; Resnick, Jeremy; Byrne, Adrian; Clarke, Martin; Cheung, Natalie; Khalifa, Najat

2018-06-01

Health services are increasingly required to measure outcomes after treatment, which can be reported to the funding body and may be scrutinised by the public. Extensive high-quality measurements are time consuming. Routinely collected clinical data might, if anonymised, provide good enough evidence of useful change consequent on service received. Do the Health of the Nation Scale and the 20-item Historical, Clinical, Risk structured professional judgement tool scores provide evidence of clinical and risk change among low security hospital patients at 6 and 12 months after admission? One hundred and eight men were either resident on the unit on 1 January 2011 or new admissions to the census date of 31 May 2013. Their routinely collected data were added to an outcome register following each patient's Care Programme Approach clinical review meeting and analysed using repeated measures t-tests with Bonferroni corrections. Most of the men, mean age 34.3 years, were single (93%), White British (71%) and with a primary diagnosis of schizophrenia (62%). There were significant reductions in the 11-item Health of the Nation Scale (excluding the community living condition scale) scores between baseline and 6 months and between 6 and 12 months, but no change on its additional 7-item secure subscale. Individual effect sizes indicated that 39% of the men had better social function, although 18% had deteriorated at 6 months. There was little overall change in the 20-item Historical, Clinical, Risk; individual effect sizes indicated that 11 men (15%) were rated as being at lower risk level and 10 (14%) at higher after 6 months in the study. Standard clinical measures are promising as indicators of change in low security hospital patients. Risk ratings may be conservative, but at this stage of a secure hospital admission, higher scores may be as likely to indicate progress in identifying and quantifying risks as apparent increase in risk. Copyright © 2017 John Wiley & Sons

The art and science of using routine outcome measurement in mental health benchmarking.

PubMed

McKay, Roderick; Coombs, Tim; Duerden, David

2014-02-01

To report and critique the application of routine outcome measurement data when benchmarking Australian mental health services. The experience of the authors as participants and facilitators of benchmarking activities is augmented by a review of the literature regarding mental health benchmarking in Australia. Although the published literature is limited, in practice, routine outcome measures, in particular the Health of the National Outcomes Scales (HoNOS) family of measures, are used in a variety of benchmarking activities. Use in exploring similarities and differences in consumers between services and the outcomes of care are illustrated. This requires the rigour of science in data management and interpretation, supplemented by the art that comes from clinical experience, a desire to reflect on clinical practice and the flexibility to use incomplete data to explore clinical practice. Routine outcome measurement data can be used in a variety of ways to support mental health benchmarking. With the increasing sophistication of information development in mental health, the opportunity to become involved in benchmarking will continue to increase. The techniques used during benchmarking and the insights gathered may prove useful to support reflection on practice by psychiatrists and other senior mental health clinicians.

Prosthetists' perceptions and use of outcome measures in clinical practice: Long-term effects of focused continuing education.

PubMed

Hafner, Brian J; Spaulding, Susan E; Salem, Rana; Morgan, Sara J; Gaunaurd, Ignacio; Gailey, Robert

2017-06-01

Continuing education is intended to facilitate clinicians' skills and knowledge in areas of practice, such as administration and interpretation of outcome measures. To evaluate the long-term effect of continuing education on prosthetists' confidence in administering outcome measures and their perceptions of outcomes measurement in clinical practice. Pretest-posttest survey methods. A total of 66 prosthetists were surveyed before, immediately after, and 2 years after outcomes measurement education and training. Prosthetists were grouped as routine or non-routine outcome measures users, based on experience reported prior to training. On average, prosthetists were just as confident administering measures 1-2 years after continuing education as they were immediately after continuing education. In all, 20% of prosthetists, initially classified as non-routine users, were subsequently classified as routine users at follow-up. Routine and non-routine users' opinions differed on whether outcome measures contributed to efficient patient evaluations (79.3% and 32.4%, respectively). Both routine and non-routine users reported challenges integrating outcome measures into normal clinical routines (20.7% and 45.9%, respectively). Continuing education had a long-term impact on prosthetists' confidence in administering outcome measures and may influence their clinical practices. However, remaining barriers to using standardized measures need to be addressed to keep practitioners current with evolving practice expectations. Clinical relevance Continuing education (CE) had a significant long-term impact on prosthetists' confidence in administering outcome measures and influenced their clinical practices. In all, approximately 20% of prosthetists, who previously were non-routine outcome measure users, became routine users after CE. There remains a need to develop strategies to integrate outcome measurement into routine clinical practice.

Integration of technology-based outcome measures in clinical trials of Parkinson and other neurodegenerative diseases.

PubMed

Artusi, Carlo Alberto; Mishra, Murli; Latimer, Patricia; Vizcarra, Joaquin A; Lopiano, Leonardo; Maetzler, Walter; Merola, Aristide; Espay, Alberto J

2018-01-01

We sought to review the landscape of past, present, and future use of technology-based outcome measures (TOMs) in clinical trials of neurodegenerative disorders. We systematically reviewed PubMed and ClinicalTrials.gov for published and ongoing clinical trials in neurodegenerative disorders employing TOMs. In addition, medical directors of selected pharmaceutical companies were surveyed on their companies' ongoing efforts and future plans to integrate TOMs in clinical trials as primary, secondary, or exploratory endpoints. We identified 164 published clinical trials indexed in PubMed that used TOMs as outcome measures in Parkinson disease (n = 132) or other neurodegenerative disorders (n = 32). The ClinicalTrials.gov search yielded 42 clinical trials using TOMs, representing 2.7% of ongoing trials. Sensor-based technology accounted for over 75% of TOMs applied. Gait and physical activity were the most common targeted domains. Within the next 5 years, 83% of surveyed pharmaceutical companies engaged in neurodegenerative disorders plan to deploy TOMs in clinical trials. Although promising, TOMs are underutilized in clinical trials of neurodegenerative disorders. Validating relevant endpoints, standardizing measures and procedures, establishing a single platform for integration of data and algorithms from different devices, and facilitating regulatory approvals should advance TOMs integration into clinical trials. Copyright © 2017 Elsevier Ltd. All rights reserved.

Development of Ethnoscience Approach in The Module Theme Substance Additives to Improve the Cognitive Learning Outcome and Student’s entrepreneurship

NASA Astrophysics Data System (ADS)

Sudarmin; Febu, R.; Nuswowati, M.; Sumarni, W.

2017-04-01

Ethnoscience approach is an interesting research today. The purpose of this research is to develop approaches ethnoscience and modules ethnoscience theme additives based ethnoscience; as well as assess the feasibility and effectiveness of module theme additives based ethnoscience to improve learning outcomes and the entrepreneurial character of students. This type of research is the Research and Development (R & D). In this research consist of four stages, namely define, design, development and implementation. The subjects of this study were students of the School of MTs Maarif NU Brebes. Data were analyzed by descriptive qualitative and quantitative. The results showed that ethnoscience approach and the module theme substance additives used declared worthy of National Education Standards Agency (BNSP) with an average percentage of validation on the feasibility aspect of the content, language feasibility, and feasibility of presenting respectively for 94.3%, 86 % and 92% and a very decent entry criteria. The effect of the application modules substance additive based ethnoscience can improve on the cognitive learning classical amounted to 90.63%, and increased learning outcomes category was based on the scores of N-gain. Influence ethnoscience approach application and module theme substances additives based ethnoscience able to improve the entrepreneurial character of students. Based on the results of this study concluded that the ethnoscience approach and module theme substance additives based ethnoscience effective to improve learning outcomes and students’ entrepreneurship.

Systematic review of tools to measure outcomes for young children with autism spectrum disorder.

PubMed

McConachie, Helen; Parr, Jeremy R; Glod, Magdalena; Hanratty, Jennifer; Livingstone, Nuala; Oono, Inalegwu P; Robalino, Shannon; Baird, Gillian; Beresford, Bryony; Charman, Tony; Garland, Deborah; Green, Jonathan; Gringras, Paul; Jones, Glenys; Law, James; Le Couteur, Ann S; Macdonald, Geraldine; McColl, Elaine M; Morris, Christopher; Rodgers, Jacqueline; Simonoff, Emily; Terwee, Caroline B; Williams, Katrina

2015-06-01

The needs of children with autism spectrum disorder (ASD) are complex and this is reflected in the number and diversity of outcomes assessed and measurement tools used to collect evidence about children's progress. Relevant outcomes include improvement in core ASD impairments, such as communication, social awareness, sensory sensitivities and repetitiveness; skills such as social functioning and play; participation outcomes such as social inclusion; and parent and family impact. To examine the measurement properties of tools used to measure progress and outcomes in children with ASD up to the age of 6 years. To identify outcome areas regarded as important by people with ASD and parents. The MeASURe (Measurement in Autism Spectrum disorder Under Review) research collaboration included ASD experts and review methodologists. We undertook systematic review of tools used in ASD early intervention and observational studies from 1992 to 2013; systematic review, using the COSMIN checklist (Consensus-based Standards for the selection of health Measurement Instruments) of papers addressing the measurement properties of identified tools in children with ASD; and synthesis of evidence and gaps. The review design and process was informed throughout by consultation with stakeholders including parents, young people with ASD, clinicians and researchers. The conceptual framework developed for the review was drawn from the International Classification of Functioning, Disability and Health, including the domains 'Impairments', 'Activity Level Indicators', 'Participation', and 'Family Measures'. In review 1, 10,154 papers were sifted - 3091 by full text - and data extracted from 184; in total, 131 tools were identified, excluding observational coding, study-specific measures and those not in English. In review 2, 2665 papers were sifted and data concerning measurement properties of 57 (43%) tools were extracted from 128 papers. Evidence for the measurement properties of the reviewed

A systematic review finds limited data on measurement properties of instruments measuring outcomes in adult intensive care unit survivors.

PubMed

Robinson, Karen A; Davis, Wesley E; Dinglas, Victor D; Mendez-Tellez, Pedro A; Rabiee, Anahita; Sukrithan, Vineeth; Yalamanchilli, Ramakrishna; Turnbull, Alison E; Needham, Dale M

2017-02-01

There is a growing number of studies evaluating the physical, cognitive, mental health, and health-related quality of life (HRQOL) outcomes of adults surviving critical illness. However, there is little consensus on the most appropriate instruments to measure these outcomes. To inform the development of such consensus, we conducted a systematic review of the performance characteristics of instruments measuring physical, cognitive, mental health, and HRQOL outcomes in adult intensive care unit (ICU) survivors. We searched PubMed, Embase, PsycInfo, Cumulative Index of Nursing and Allied Health Literature, and The Cochrane Library in March 2015. We also conducted manual searches of reference lists of eligible studies and relevant review articles. Two people independently selected studies, completed data abstraction, and assessed the quality of eligible studies using the COnsensus-based Standards for the selection of health Measurement Instruments (COSMIN) initiative checklist. We identified 20 studies which explicitly evaluated measurement properties for 21 different instruments assessing outcomes in ICU survivors. Eleven of the instruments assessed quality of life, with few instruments assessing other domains. Of the nine measurement properties evaluated on the COSMIN checklist, six were assessed in <10% of the evaluations. Overall quality of eligible studies was generally poor to fair based on the COSMIN checklist. Although an increasing number of studies measure physical, cognitive, mental health, and HRQOL outcomes in adult ICU survivors, data on the measurement properties of such instruments are sparse and generally of poor to fair quality. Empirical analyses evaluating the performance of instruments in adult ICU survivors are needed to advance research in this field. Copyright © 2016 Elsevier Inc. All rights reserved.

Measuring what matters to rare disease patients - reflections on the work by the IRDiRC taskforce on patient-centered outcome measures.

PubMed

Morel, Thomas; Cano, Stefan J

2017-11-02

Our ability to evaluate outcomes which genuinely reflect patients' unmet needs, hopes and concerns is of pivotal importance. However, much current clinical research and practice falls short of this objective by selecting outcome measures which do not capture patient value to the fullest. In this Opinion, we discuss Patient-Centered Outcomes Measures (PCOMs), which have the potential to systematically incorporate patient perspectives to measure those outcomes that matter most to patients. We argue for greater multi-stakeholder collaboration to develop PCOMs, with rare disease patients and families at the center. Beyond advancing the science of patient input, PCOMs are powerful tools to translate care or observed treatment benefit into an 'interpretable' measure of patient benefit, and thereby help demonstrate clinical effectiveness. We propose mixed methods psychometric research as the best route to deliver fit-for-purpose PCOMs in rare diseases, as this methodology brings together qualitative and quantitative research methods in tandem with the explicit aim to efficiently utilise data from small samples. And, whether one opts to develop a brand-new PCOM or to select or adapt an existing outcome measure for use in a rare disease, the anchors remain the same: patients, their daily experience of the rare disease, their preferences, core concepts and values. Ultimately, existing value frameworks, registries, and outcomes-based contracts largely fall short of consistently measuring the full range of outcomes that matter to patients. We argue that greater use of PCOMs in rare diseases would enable a fast track to Patient-Centered Care.

Measuring Violence Risk and Outcomes among Mexican American Adolescent Females

ERIC Educational Resources Information Center

Cervantes, Richard C.; Duenas, Norma; Valdez, Avelardo; Kaplan, Charles

2006-01-01

Central to the development of culturally competent violence prevention programs for Hispanic youth is the development of psychometrically sound violence risk and outcome measures for this population. A study was conducted to determine the psychometric properties of two commonly used violence measures, in this case for Mexican American adolescent…

Manipulative therapy in addition to usual medical care accelerates recovery of shoulder complaints at higher costs: economic outcomes of a randomized trial.

PubMed

Bergman, Gert J D; Winter, Jan C; van Tulder, Maurits W; Meyboom-de Jong, Betty; Postema, Klaas; van der Heijden, Geert J M G

2010-09-06

Shoulder complaints are common in primary care and have unfavourable long term prognosis. Our objective was to evaluate the clinical effectiveness of manipulative therapy of the cervicothoracic spine and the adjacent ribs in addition to usual medical care (UMC) by the general practitioner in the treatment of shoulder complaints. This economic evaluation was conducted alongside a randomized trial in primary care. Included were 150 patients with shoulder complaints and a dysfunction of the cervicothoracic spine and adjacent ribs. Patients were treated with UMC (NSAID's, corticosteroid injection or referral to physical therapy) and were allocated at random (yes/no) to manipulative therapy (manipulation and mobilization). Patient perceived recovery, severity of main complaint, shoulder pain, disability and general health were outcome measures. Data about direct and indirect costs were collected by means of a cost diary. Manipulative therapy as add-on to UMC accelerated recovery on all outcome measures included. At 26 weeks after randomization, both groups reported similar recovery rates (41% vs. 38%), but the difference between groups in improvement of severity of the main complaint, shoulder pain and disability sustained. Compared to the UMC group the total costs were higher in the manipulative group (€1167 vs. €555). This is explained mainly by the costs of the manipulative therapy itself and the higher costs due sick leave from work. The cost effectiveness ratio showed that additional manipulative treatment is more costly but also more effective than UMC alone. The cost-effectiveness acceptability curve shows that a 50%-probability of recovery with AMT within 6 months after initiation of treatment is achieved at €2876. Manipulative therapy in addition to UMC accelerates recovery and is more effective than UMC alone on the long term, but is associated with higher costs. INTERNATIONAL STANDARD RANDOMIZED CONTROLLED TRIAL NUMBER REGISTER: ISRCTN11216.

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

A study protocol of a randomised controlled trial incorporating a health economic analysis to investigate if additional allied health services for rehabilitation reduce length of stay without compromising patient outcomes.

PubMed

Taylor, Nicholas F; Brusco, Natasha K; Watts, Jennifer J; Shields, Nora; Peiris, Casey; Sullivan, Natalie; Kennedy, Genevieve; Teo, Cheng Kwong; Farley, Allison; Lockwood, Kylee; Radia-George, Camilla

2010-11-12

Reducing patient length of stay is a high priority for health service providers. Preliminary information suggests additional Saturday rehabilitation services could reduce the time a patient stays in hospital by three days. This large trial will examine if providing additional physiotherapy and occupational therapy services on a Saturday reduces health care costs, and improves the health of hospital inpatients receiving rehabilitation compared to the usual Monday to Friday service. We will also investigate the cost effectiveness and patient outcomes of such a service. A randomised controlled trial will evaluate the effect of providing additional physiotherapy and occupational therapy for rehabilitation. Seven hundred and twelve patients receiving inpatient rehabilitation at two metropolitan sites will be randomly allocated to the intervention group or control group. The control group will receive usual care physiotherapy and occupational therapy from Monday to Friday while the intervention group will receive the same amount of rehabilitation as the control group Monday to Friday plus a full physiotherapy and occupational therapy service on Saturday. The primary outcomes will be patient length of stay, quality of life (EuroQol questionnaire), the Functional Independence Measure (FIM), and health utilization and cost data. Secondary outcomes will assess clinical outcomes relevant to the goals of therapy: the 10 metre walk test, the timed up and go test, the Personal Care Participation Assessment and Resource Tool (PC PART), and the modified motor assessment scale. Blinded assessors will assess outcomes at admission and discharge, and follow up data on quality of life, function and health care costs will be collected at 6 and 12 months after discharge. Between group differences will be analysed with analysis of covariance using baseline measures as the covariate. A health economic analysis will be carried out alongside the randomised controlled trial. This paper

A study protocol of a randomised controlled trial incorporating a health economic analysis to investigate if additional allied health services for rehabilitation reduce length of stay without compromising patient outcomes

PubMed Central

2010-01-01

Background Reducing patient length of stay is a high priority for health service providers. Preliminary information suggests additional Saturday rehabilitation services could reduce the time a patient stays in hospital by three days. This large trial will examine if providing additional physiotherapy and occupational therapy services on a Saturday reduces health care costs, and improves the health of hospital inpatients receiving rehabilitation compared to the usual Monday to Friday service. We will also investigate the cost effectiveness and patient outcomes of such a service. Methods/Design A randomised controlled trial will evaluate the effect of providing additional physiotherapy and occupational therapy for rehabilitation. Seven hundred and twelve patients receiving inpatient rehabilitation at two metropolitan sites will be randomly allocated to the intervention group or control group. The control group will receive usual care physiotherapy and occupational therapy from Monday to Friday while the intervention group will receive the same amount of rehabilitation as the control group Monday to Friday plus a full physiotherapy and occupational therapy service on Saturday. The primary outcomes will be patient length of stay, quality of life (EuroQol questionnaire), the Functional Independence Measure (FIM), and health utilization and cost data. Secondary outcomes will assess clinical outcomes relevant to the goals of therapy: the 10 metre walk test, the timed up and go test, the Personal Care Participation Assessment and Resource Tool (PC PART), and the modified motor assessment scale. Blinded assessors will assess outcomes at admission and discharge, and follow up data on quality of life, function and health care costs will be collected at 6 and 12 months after discharge. Between group differences will be analysed with analysis of covariance using baseline measures as the covariate. A health economic analysis will be carried out alongside the randomised

Measure once, cut twice--adding patient-reported outcome measures to the electronic health record for comparative effectiveness research.

PubMed

Wu, Albert W; Kharrazi, Hadi; Boulware, L Ebony; Snyder, Claire F

2013-08-01

This article presents the current state of patient-reported outcome measures and explains new opportunities for leveraging the recent adoption of electronic health records to expand the application of patient-reported outcomes in both clinical care and comparative effectiveness research. Historic developments of patient-reported outcome, electronic health record, and comparative effectiveness research are analyzed in two dimensions: patient centeredness and digitization. We pose the question, "What needs to be standardized around the collection of patient-reported outcomes in electronic health records for comparative effectiveness research?" We identified three converging trends: the progression of patient-reported outcomes toward greater patient centeredness and electronic adaptation; the evolution of electronic health records into personalized and fully digitized solutions; and the shift toward patient-oriented comparative effectiveness research. Related to this convergence, we propose an architecture for patient-reported outcome standardization that could serve as a first step toward a more comprehensive integration of patient-reported outcomes with electronic health record for both practice and research. The science of patient-reported outcome measurement has matured sufficiently to be integrated routinely into electronic health records and other electronic health solutions to collect data on an ongoing basis for clinical care and comparative effectiveness research. Further efforts and ideally coordinated efforts from various stakeholders are needed to refine the details of the proposed framework for standardization. Copyright © 2013 Elsevier Inc. All rights reserved.

Clinically Relevant Outcome Measures Following Limb Osseointegration; Systematic Review of the Literature.

PubMed

Al Muderis, Munjed M; Lu, William Y; Li, Jiao Jiao; Kaufman, Kenton; Orendurff, Michael; Highsmith, M Jason; Lunseth, Paul A; Kahle, Jason T

2018-02-01

The current standard of care for an amputee is a socket-based prostheses. An osseointegrated implant (OI) is an alternative for prosthetic attachment. Osseointegration addresses reported problems related to wearing a socket interface, such as skin issues, discomfort, diminished function, quality of life, prosthetic use, and abandonment. The purpose of this report is to systematically review current literature regarding OI to identify and categorize the reported clinically relevant outcome measures, rate the quality of available evidence, and synthesize the findings. A multidisciplinary team used PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) methods. Search methodology was based on identifying clinically relevant articles. Three databases were searched: PubMed, CINAHL, and Web of Science. Clinical studies with aggregated data reporting at least 1 clinically relevant outcome measure were included. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) criterion was used for critical appraisal and recommendations. This review identified 21 clinically relevant observational studies. Outcome measures were categorized into the following 9 categories: vibratory stimulation, complications, biomechanics, economics, patient-reported outcome measures, electromyography, x-ray, physical functional performance, and energy consumption. This systematic review consisted of Level III and IV observational studies. Homogeneous outcome measures with strong psychometric properties across prospective studies do not exist to date. Higher-level, prospective, randomized, long-term, clinically relevant trials are needed to prove efficacy of OI compared with socket prosthetic attachment. Osseointegration was at least equivalent to sockets in most studies. In some cases, it was superior. Osseointegration represents a promising alternative to socket prosthetic attachments for extremity amputees. Therapeutic Level III. See Instructions for

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.

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

PubMed

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

2011-11-01

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

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.

Developing a General Outcome Measure of Growth in Social Skills for Infants and Toddlers

ERIC Educational Resources Information Center

Carta, Judith; Greenwood, Charles; Luze, Gayle; Cline, Gabriel; Kuntz, Susan

2004-01-01

Proficiency in social interaction with adults and peers is an important outcome in early childhood. The development of an experimental measure for assessing growth in social skills in children birth to 3 years is described. Based on the general outcome measurement (GOM) approach (e.g., Deno, 1997), the measure is intended for use by early…

Developing a General Outcome Measure Off Growth in Social Skills for Infants and Toddlers

ERIC Educational Resources Information Center

Carta, Judith; Greenwood, Charles; Luze, Gayle; Cline, Gabriel; Kuntz, Susan

2004-01-01

Proficiency in social interaction with adults and peers is an important outcome in early childhood. The development of an experimental measure for assessing growth in social skills in children birth to 3 years is described. Based on the general outcome measurement (GOM) approach (e.g., Deno, 1997), the measure is intended for use by early…

Outcomes of an enhancement study with additional psychoeducational sessions for healthy siblings of a child with cancer during inpatient family-oriented rehabilitation.

PubMed

Niemitz, Mandy; Goldbeck, Lutz

2018-03-01

Chronic illness of a child puts healthy children of the family at risk of distress. Previous studies have demonstrated that healthy children's psychological symptoms can be reduced when the child knows more about the disease. So far, there is limited evidence of the effectiveness of psychoeducational interventions for healthy children. To compare the effectiveness of an inpatient family-oriented rehabilitation program with vs without additional psychoeducational sessions for healthy children of families with children with cancer. We performed a controlled study in 4 German family-oriented rehabilitation clinics. The outcomes of n = 73 healthy children (mean age: M = 9.55; SD = 3.14; range: 4-18), who participated in 5 additional psychoeducational sessions, were compared with the outcomes of n = 111 healthy children (mean age: M = 8.85; SD = 3.28; range: 4-17), who underwent the usual inpatient rehabilitation program. Primary outcomes were the healthy children's cancer-specific knowledge and their emotional symptoms. Secondary outcomes were family satisfaction and quality of life. Intention-to-treat analyses showed that both groups improved significantly from preintervention to postintervention. Improvements comprised knowledge about cancer (F(1,174) = 11.03, p < 0.001), self-reported emotional symptoms (F(1,135) = 31.68, p < 0.001), and parent-proxy-reported emotional symptoms (F(1,179) = 37.07, p < 0.001). The additional psycho-educational program did not significantly enhance the outcomes. The same pattern of significant improvement in both conditions emerged for all secondary outcomes. The immediate effects of the intervention persisted until 2 months after discharge from the rehabilitation program. Inpatient family-oriented rehabilitation is effective in improving multiple psychosocial outcomes of healthy children in families which have a child with cancer. Additional psycho-educational sessions did not show any substantial additional

Analysis of traditional versus three-dimensional augmented curriculum on anatomical learning outcome measures.

PubMed

Peterson, Diana Coomes; Mlynarczyk, Gregory S A

2016-11-01

This study examined whether student learning outcome measures are influenced by the addition of three-dimensional and digital teaching tools to a traditional dissection and lecture learning format curricula. The study was performed in a semester long graduate level course that incorporated both gross anatomy and neuroanatomy curricula. Methods compared student examination performance on material taught using lecture and cadaveric dissection teaching tools alone or lecture and cadaveric dissection augmented with computerized three-dimensional teaching tools. Additional analyses were performed to examine potential correlations between question difficulty and format, previous student performance (i.e., undergraduate grade point average), and a student perception survey. The results indicated that students performed better on material in which three-dimensional (3D) technologies are utilized in conjunction with lecture and dissection methodologies. The improvement in performance was observed across the student population primarily on laboratory examinations. Although, student performance was increased, students did not perceive that the use of the additional 3D technology significantly influenced their learning. The results indicate that the addition of 3D learning tools can influence long-term retention of gross anatomy material and should be considered as a beneficial supplement for anatomy courses. Anat Sci Educ 9: 529-536. © 2016 American Association of Anatomists. © 2016 American Association of Anatomists.

Development of the FOCUS (Focus on the Outcomes of Communication under Six), a Communication Outcome Measure for Preschool Children

ERIC Educational Resources Information Center

Thomas-Stonell, Nancy L.; Oddson, Bruce; Robertson, Bernadette; Rosenbaum, Peter L.

2010-01-01

Aim: Our aim was to develop an outcome measure, called Focus on the Outcomes of Communication Under Six (FOCUS), that captures real-world changes in preschool children's communication. Conceptually grounded in the World Health Organization International Classification of Functioning, Disability and Health framework, the FOCUS items were derived…

From clinically relevant outcome measures to quality of life in epilepsy: A time trade-off study.

PubMed

de Kinderen, Reina J A; Wijnen, Ben F M; van Breukelen, Gerard; Postulart, Debby; Majoie, Marian H J M; Aldenkamp, Albert P; Evers, Silvia M A A

2016-09-01

A proposed method for bridging the gap between clinically relevant epilepsy outcome measures and quality-adjusted life years is to derive utility scores for epilepsy health states. The aim of this study is to develop such a utility-function and to investigate the impact of the epilepsy outcome measures on utility. Health states, based on clinically important epilepsy attributes (e.g. seizure frequency, seizure severity, side-effects), were valued by a sample of the Dutch population (N=525) based on the time trade-off method. In addition to standard demographics, every participant was asked to rate 10 or 11 different health state scenarios. A multilevel regression analysis was performed to account for the nested structure of the data. Results show that the best health state (no seizures and no side-effects) is estimated at 0.89 and the worst state (seizures type 5 twice a day plus severe side-effects) at 0.22 (scale: 0-1). An increase in seizure frequency, occurrence of side-effects, and seizure severity were all significantly associated with lower utility values. Furthermore, seizure severity has the largest impact on quality of life compared with seizure frequency and side-effects. This study provides a utility-function for transforming clinically relevant epilepsy outcome measures into utility estimates. We advise using our utility-function in economic evaluations, when quality of life is not directly measured in a study and hence, no health state utilities are available, or when there is convincing empirical evidence of the insensitivity of a generic quality-of-life-instrument within epilepsy. Copyright © 2016 Elsevier B.V. All rights reserved.

Using Cross-Cultural Dimensions Exercises to Improve and Measure Learning Outcomes in International Business Courses

ERIC Educational Resources Information Center

Zainuba, Mohamed; Rahal, Ahmad

2012-01-01

This article proposes an approach for using cross-cultural dimensions exercises to improve and measure learning outcomes in international business courses. The following key issues are highlighted: (a) what are the targeted learning outcomes to be assessed, (b) how to measure the accomplishment of these learning outcomes, (c) the input measures…

Goal setting as an outcome measure: A systematic review.

PubMed

Hurn, Jane; Kneebone, Ian; Cropley, Mark

2006-09-01

Goal achievement has been considered to be an important measure of outcome by clinicians working with patients in physical and neurological rehabilitation settings. This systematic review was undertaken to examine the reliability, validity and sensitivity of goal setting and goal attainment scaling approaches when used with working age and older people. To review the reliability, validity and sensitivity of both goal setting and goal attainment scaling when employed as an outcome measure within a physical and neurological working age and older person rehabilitation environment, by examining the research literature covering the 36 years since goal-setting theory was proposed. Data sources included a computer-aided literature search of published studies examining the reliability, validity and sensitivity of goal setting/goal attainment scaling, with further references sourced from articles obtained through this process. There is strong evidence for the reliability, validity and sensitivity of goal attainment scaling. Empirical support was found for the validity of goal setting but research demonstrating its reliability and sensitivity is limited. Goal attainment scaling appears to be a sound measure for use in physical rehabilitation settings with working age and older people. Further work needs to be carried out with goal setting to establish its reliability and sensitivity as a measurement tool.

Validation of the Italian version of the Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM).

PubMed

Palmieri, Gaspare; Evans, Chris; Hansen, Vidje; Brancaleoni, Greta; Ferrari, Silvia; Porcelli, Piero; Reitano, Francesco; Rigatelli, Marco

2009-01-01

The Clinical Outcomes in Routine Evaluation--Outcome Measure (CORE-OM) was translated into Italian and tested in non-clinical (n = 263) and clinical (n = 647) samples. The translation showed good acceptability, internal consistency and convergent validity in both samples. There were large and statistically significant differences between clinical and non-clinical datasets on all scores. The reliable change criteria were similar to those for the UK referential data. Some of the clinically significant change criteria, particularly for the men, were moderately different from the UK cutting points. The Italian version of the CORE-OM showed respectable psychometric parameters. However, it seemed plausible that non-clinical and clinical distributions of self-report scores on psychopathology and functioning measures may differ by language and culture. *A good quality Italian translation of the CORE-OM, and hence the GP-CORE, CORE-10 and CORE-5 measures also, is now available for use by practitioners and anyone surveying or exploring general psychological state. The measures can be obtained from CORE-IMS or yourself and practitioners are encouraged to share anonymised data so that good clinical and non-clinical referential databases can be established for Italy.

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

Current palliative chemotherapy trials in the elderly neglect patient-centred outcome measures.

PubMed

van Bekkum, Marlies L; van Munster, Barbara C; Thunnissen, Peter L M; Smorenburg, Carolien H; Hamaker, Marije E

2015-01-01

The elderly comprise the majority of patients newly diagnosed with cancer. Despite this, little evidence-based data are available on the care of the growing number of older patients with cancer. The objective of the current study was to evaluate the characteristics and outcome measures of current clinical trials on palliative chemotherapy in elderly patients. Fourteen international clinical trials registries were searched using the terms "cancer" and "elderly" to identify clinical palliative chemotherapy trials designed specifically for patients aged 70+ years. From the trial protocol, data were extracted on trial characteristics and outcome measures. Of 127 trials, 81% formulated one or more stringent criteria with respect to organ function; 32% excluded patients with WHO performance status (PS) 2 and 83% with PS3. Functional outcomes, health care utilisation, cognitive function after treatment, and quality of life were reported in 6%, 3%, 6%, and 31% of trials, respectively. In only 16% of trials on palliative cancer treatment, a geriatric assessment was performed at baseline. Although recent years have seen a growing evidence base regarding fit older patients, our study suggests a lack of representative cohorts of older patients and patient-centred outcome measures in current palliative treatment trials for the elderly. Research addressing alternative outcome measures, including quality of life and impact of therapy on general functioning, cognition, and preservation of independence, and incorporation of a geriatric assessment are needed to provide elderly patients with cancer and their treating physicians with realistic information about palliative chemotherapy. Copyright © 2014 Elsevier Inc. All rights reserved.

Patient-Reported Outcome Measures for Hand and Wrist Trauma

PubMed Central

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

2016-01-01

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

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.

Developing measures of community-relevant outcomes for violence prevention programs: a community-based participatory research approach to measurement.

PubMed

Hausman, Alice J; Baker, Courtney N; Komaroff, Eugene; Thomas, Nicole; Guerra, Terry; Hohl, Bernadette C; Leff, Stephen S

2013-12-01

Community-Based Participatory Research is a research paradigm that encourages community participation in designing and implementing evaluation research, though the actual outcome measures usually reflect the "external" academic researchers' view of program effect and the policy-makers' needs for decision-making. This paper describes a replicable process by which existing standardized psychometric scales commonly used in youth-related intervention programs were modified to measure indicators of program success defined by community partners. This study utilizes a secondary analysis of data gathered in the context of a community-based youth violence prevention program. Data were retooled into new measures developed using items from the Alabama Parenting Questionnaire, the Hare Area Specific Self-Esteem Scale, and the Youth Asset Survey. These measures evaluated two community-defined outcome indicators, "More Parental Involvement" and "Showing Kids Love." Results showed that existing scale items can be re-organized to create measures of community-defined outcomes that are psychometrically reliable and valid. Results also show that the community definitions of parent or parenting caregivers exemplified by the two indicators are similar to how these constructs have been defined in previous research, but they are not synonymous. There are nuanced differences that are important and worthy of better understanding, in part through better measurement.

Does taping in addition to physiotherapy improve the outcomes in subacromial impingement syndrome? A systematic review.

PubMed

Saracoglu, Ismail; Emuk, Yusuf; Taspinar, Ferruh

2018-04-01

Taping is used with or without other interventions for many purposes, especially to manage pain and improve functional activity in patients with shoulder pain. The aim of this review was to determine whether any taping technique in addition to physiotherapy care is more effective than physiotherapy care alone in patients with shoulder impingement syndrome. A systematic search of Cochrane Database of Systematic Review, MEDLINE (EBSCO), Physiotherapy Evidence Database (PEDro), CINAHL (EBSCO), PUBMED, AMED, EMBASE (OVID), The Kinesio Kinesio® Taping Method, Kinesio® Tex Tape UK and International websites ( www.kinesiotaping.co.uk ; www.kinesiotaping.com ) was conducted to June 2015. The outcome measures were pain, disability, range of motion and muscle strength. As data were not suitable for meta-analysis, narrative synthesis were applied. Three randomized controlled trials and one controlled trial (135 patients) were included. The results were conflicting and weak on the effectiveness of taping as an adjunct therapy for improvement of pain, disability, range of motion and muscle strength. Clinical taping in addition to physiotherapy interventions (e.g. exercise, electrotherapy, and manual therapy) might be an optional modality for managing patients with shoulder impingement syndrome, especially for the initial stage of the treatment; however, we need further robust, placebo controlled and consistent studies to prove whether it is more effective than physiotherapy interventions without taping.

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.

Exploring Outcome Measures for Exercise Intervention in People with Parkinson's Disease

PubMed Central

King, L. A.; Salarian, A.; Mancini, M.; Priest, K. C.; Nutt, J.; Serdar, A.; Wilhelm, J.; Schlimgen, J.; Smith, M.; Horak, F. B.

2013-01-01

Background. It is widely believed that exercise improves mobility in people with Parkinson's disease (PD). However, it is difficult to determine whether a specific type of exercise is the most effective. The purpose of this study was to determine which outcome measures were sensitive to exercise intervention and to explore the effects of two different exercise programs for improving mobility in patients with PD. Methods. Participants were randomized into either the Agility Boot Camp (ABC) or treadmill training; 4x/week for 4 weeks. Outcome measures were grouped by the International Classification of Function/Disability (ICF). To determine the responsiveness to exercise, we calculated the standardized response means. t-tests were used to compare the relative benefits of each exercise program. Results. Four of five variables at the structure/function level changed after exercise: turn duration (P = 0.03), stride velocity (P = 0.001), peak arm speed (P = 0.001), and horizontal trunk ROM during gait (P = 0.02). Most measures improved similarly for both interventions. The only variable that detected a difference between groups was postural sway in ABC group (F = 4.95; P = 0.03). Conclusion. Outcome measures at ICF body structure/function level were most effective at detecting change after exercise and revealing differences in improvement between interventions. PMID:23738230

Preoperative cow-side lactatemia measurement predicts negative outcome in Holstein dairy cattle with right abomasal disorders.

PubMed

Boulay, G; Francoz, D; Doré, E; Dufour, S; Veillette, M; Badillo, M; Bélanger, A-M; Buczinski, S

2014-01-01

The objectives of the current study were (1) to determine the gain in prognostic accuracy of preoperative l-lactate concentration (LAC) measured on farm on cows with right displaced abomasum (RDA) or abomasal volvulus (AV) for predicting negative outcome; and (2) to suggest clinically relevant thresholds for such use. A cohort of 102 cows with on-farm surgical diagnostic of RDA or AV was obtained from June 2009 through December 2011. Blood was drawn from coccygeal vessels before surgery and plasma LAC was immediately measured by using a portable clinical analyzer. Dairy producers were interviewed by phone 30 d following surgery and the outcome was determined: a positive outcome if the owner was satisfied of the overall evolution 30 d postoperatively, and a negative outcome if the cow was culled, died, or if the owner reported being unsatisfied 30 d postoperatively. The area under the curve of the receiver operating characteristic curve for LAC was 0.92 and was significantly greater than the area under the curve of the receiver operating characteristic curve of heart rate (HR; 0.77), indicating that LAC, in general, performed better than HR to predict a negative outcome. Furthermore, the ability to predict a negative outcome was significantly improved when LAC measurement was considered in addition to the already available HR data (area under the curve: 0.93 and 95% confidence interval: 0.87, 0.99). Important inflection points of the misclassification cost term function were noted at thresholds of 2 and 6 mmol/L, suggesting the potential utility of these cut-points. The 2 and 6 mmol/L thresholds had a sensitivity, specificity, positive predictive value, and negative predictive value for predicting a negative outcome of 76.2, 82.7, 53.3, and 93.1%, and of 28.6, 97.5, 75, and 84%, respectively. In terms of clinical interpretation, LAC ≤2 mmol/L appeared to be a good indicator of positive outcome and could be used to support a surgical treatment decision. The

CHoice of Outcome In Cbt for psychosEs (CHOICE): The Development of a New Service User–Led Outcome Measure of CBT for Psychosis

PubMed Central

Greenwood, Kathryn E.; Sweeney, Angela; Williams, Sally; Garety, Philippa; Kuipers, Elizabeth; Scott, Jan; Peters, Emmanuelle

2010-01-01

Outcome measures for cognitive behavior therapy for psychosis (CBTp) have been derived from pharmacological studies, focusing on symptom change rather than outcomes such as distress or fulfilment. This study presents the development and psychometric properties of a new outcome measure (CHoice of Outcome In Cbt for psychosEs [CHOICE]), which reflects more strongly the aims of CBTp and the priorities of service users. Service users who had received CBTp participated in focus groups to discuss their outcome priorities, using a topic guide generated by a panel of experts in CBTp. A qualitative thematic analysis was undertaken to reach consensus on themes and generate items. Response scales were constructed for 3 dimensions: severity, satisfaction, and importance. The resulting questionnaire was piloted with service users who had not received CBTp, stratified by service type, ethnicity, and first language to ensure that it was user friendly and applicable prior to CBTp. The psychometric properties of the measure were then examined in a sample of 152 service users. Twenty-four items, and 2 of the dimensions (severity and satisfaction), were retained in the final measure. A factor analysis revealed a single psychological recovery factor interspersed throughout with both CBTp and recovery items. Test-retest reliability, construct validity, and sensitivity to change following CBTp were confirmed. The CHOICE measure is unique in being the first psychometrically adequate service user–led outcome measure of CBTp. It provides the opportunity to examine the evidence base for CBTp with an assessment approach that prioritizes service user definitions of recovery and CBT aims. PMID:19880823

Added Value of Patient-Reported Outcome Measures in Stroke Clinical Practice.

PubMed

Katzan, Irene L; Thompson, Nicolas R; Lapin, Brittany; Uchino, Ken

2017-07-21

There is uncertainty regarding the clinical utility of the data obtained from patient-reported outcome measures (PROMs) for patient care. We evaluated the incremental information obtained by PROMs compared to the clinician-reported modified Rankin Scale (mRS). This was an observational study of 3283 ischemic stroke patients seen in a cerebrovascular clinic from September 14, 2012 to June 16, 2015 who completed the routinely collected PROMs: Stroke Impact Scale-16 (SIS-16), EQ-5D, Patient Health Questionnaire-9, PROMIS Physical Function, and PROMIS fatigue. The amount of variation in the PROMs explained by mRS was determined using r 2 after adjustment for age and level of stroke impairment. The proportion with meaningful change was calculated for patients with ≥2 visits. Concordance with change in the other scales and the ability to discriminate changes in health state as measured by c-statistic was evaluated for mRS versus SIS-16. Correlation between PROMs and mRS was highest for SIS-16 ( r =-0.64, P <0.01). The r 2 ranged from 0.11 (PROMIS fatigue) to 0.56 (SIS-16). Change in scores occurred in 51% with mRS and 35% with SIS-16. There was lower agreement and less ability to discriminate change in mRS than in SIS-16 with change in the other measures. PROMs provide additional valuable information compared to the mRS alone in stroke patients seen in the ambulatory setting. SIS-16 may have a better ability to identify change than mRS in health status of relevance to the patient. PROMs may be a useful addition to mRS in the assessment of health status in clinical practice. © 2017 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.

Ultrasound cervical length measurement in prediction of labor induction outcome.

PubMed

Kehila, M; Abouda, H S; Sahbi, K; Cheour, H; Chanoufi, M Badis

2016-05-17

Induction of labor is one of the most common procedures in modern obstetrics, with an incidence of approximately 20% of all deliveries. Not all of these inductions result in vaginal delivery; some lead to cesarean sections, either for emergency reasons or for failed induction. That's why, It seems necessary to outline strategies for the improvement of the success rate of induced deliveries. Traditionally, the identification of women in whom labor induction is more likely to be successful is based on the Bishop score. However, several studies have shown it to be subjective, with high variation and a poor predictor of the outcome of labor induction. Transvaginal sonography for cervical measurement can be a more objective criterion in assessing the success of labor induction. Many studies have been done recently to compare cervical measurement and Bishop Score in labor induction.This paper reviewed the literature that evaluated sonographic cervical length measurement to predict induction of labor outcome.

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

PubMed

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

2016-03-01

We present a range of evidence for the reliability and validity of data generated by the Personal Questionnaire (PQ), a client-generated individualized outcome measure, using 5 data sets from 3 countries. Overall pretherapy mean internal consistency (alpha) across clients was .80, and within-client alphas averaged .77; clients typically had 1 or 2 items that did not vary with the other items. Analyses of temporal structure indicated high levels of between-clients variance (58%), moderate pretherapy test-retest correlation (r = .57), and high session-to-session Lag-1 autocorrelation (.82). Scores on the PQ provided clear evidence of convergence with a range of outcome measures (within-client r = .41). Mean pre-post effects were large (d = 1.25). The results support a revised caseness cutoff of 3.25 and a reliable change index interval of 1.67. We conclude that PQ data meet criteria for evidence-based, norm-referenced measurement of client psychological distress for supporting psychotherapy practice and research. (c) 2016 APA, all rights reserved).

Comparison of reliability and responsiveness of patient-reported clinical outcome measures in knee osteoarthritis rehabilitation.

PubMed

Williams, Valerie J; Piva, Sara R; Irrgang, James J; Crossley, Chad; Fitzgerald, G Kelley

2012-08-01

Secondary analysis, pretreatment-posttreatment observational study. To compare the reliability and responsiveness of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), the Knee Outcome Survey activities of daily living subscale (KOS-ADL), and the Lower Extremity Functional Scale (LEFS) in individuals with knee osteoarthritis (OA). The WOMAC is the current standard in patient-reported measures of function in patients with knee OA. The KOS-ADL and LEFS were designed for potential use in patients with knee OA. If the KOS-ADL and LEFS are to be considered viable alternatives to the WOMAC for measuring patient-reported function in individuals with knee OA, they should have measurement properties comparable to the WOMAC. It would also be important to determine whether either of these instruments may be superior to the WOMAC in terms of reliability or responsiveness in this population. Data from 168 subjects with knee OA, who participated in a rehabilitation program, were used in the analyses. Reliability and responsiveness of each outcome measure were estimated at follow-ups of 2, 6, and 12 months. Reliability was estimated by calculating the intraclass correlation coefficient (ICC2,1) for subjects who were unchanged in status from baseline at each follow-up time, based on a global rating of change score. To examine responsiveness, the standard error of the measurement, minimal detectable change, minimal clinically important difference, and the Guyatt responsiveness index were calculated for each outcome measure at each follow-up time. All 3 outcome measures demonstrated reasonable reliability and responsiveness to change. Reliability and responsiveness tended to decrease somewhat with increasing follow-up time. There were no substantial differences between outcome measures for reliability or any of the 3 measures of responsiveness at any follow-up time. The results do not indicate that one outcome measure is more reliable or responsive than

Comparative study of outcome measures and analysis methods for traumatic brain injury trials.

PubMed

Alali, Aziz S; Vavrek, Darcy; Barber, Jason; Dikmen, Sureyya; Nathens, Avery B; Temkin, Nancy R

2015-04-15

Batteries of functional and cognitive measures have been proposed as alternatives to the Extended Glasgow Outcome Scale (GOSE) as the primary outcome for traumatic brain injury (TBI) trials. We evaluated several approaches to analyzing GOSE and a battery of four functional and cognitive measures. Using data from a randomized trial, we created a "super" dataset of 16,550 subjects from patients with complete data (n=331) and then simulated multiple treatment effects across multiple outcome measures. Patients were sampled with replacement (bootstrapping) to generate 10,000 samples for each treatment effect (n=400 patients/group). The percentage of samples where the null hypothesis was rejected estimates the power. All analytic techniques had appropriate rates of type I error (≤5%). Accounting for baseline prognosis either by using sliding dichotomy for GOSE or using regression-based methods substantially increased the power over the corresponding analysis without accounting for prognosis. Analyzing GOSE using multivariate proportional odds regression or analyzing the four-outcome battery with regression-based adjustments had the highest power, assuming equal treatment effect across all components. Analyzing GOSE using a fixed dichotomy provided the lowest power for both unadjusted and regression-adjusted analyses. We assumed an equal treatment effect for all measures. This may not be true in an actual clinical trial. Accounting for baseline prognosis is critical to attaining high power in Phase III TBI trials. The choice of primary outcome for future trials should be guided by power, the domain of brain function that an intervention is likely to impact, and the feasibility of collecting outcome data.

Comparative Study of Outcome Measures and Analysis Methods for Traumatic Brain Injury Trials

PubMed Central

Alali, Aziz S.; Vavrek, Darcy; Barber, Jason; Dikmen, Sureyya; Nathens, Avery B.

2015-01-01

Abstract Batteries of functional and cognitive measures have been proposed as alternatives to the Extended Glasgow Outcome Scale (GOSE) as the primary outcome for traumatic brain injury (TBI) trials. We evaluated several approaches to analyzing GOSE and a battery of four functional and cognitive measures. Using data from a randomized trial, we created a “super” dataset of 16,550 subjects from patients with complete data (n=331) and then simulated multiple treatment effects across multiple outcome measures. Patients were sampled with replacement (bootstrapping) to generate 10,000 samples for each treatment effect (n=400 patients/group). The percentage of samples where the null hypothesis was rejected estimates the power. All analytic techniques had appropriate rates of type I error (≤5%). Accounting for baseline prognosis either by using sliding dichotomy for GOSE or using regression-based methods substantially increased the power over the corresponding analysis without accounting for prognosis. Analyzing GOSE using multivariate proportional odds regression or analyzing the four-outcome battery with regression-based adjustments had the highest power, assuming equal treatment effect across all components. Analyzing GOSE using a fixed dichotomy provided the lowest power for both unadjusted and regression-adjusted analyses. We assumed an equal treatment effect for all measures. This may not be true in an actual clinical trial. Accounting for baseline prognosis is critical to attaining high power in Phase III TBI trials. The choice of primary outcome for future trials should be guided by power, the domain of brain function that an intervention is likely to impact, and the feasibility of collecting outcome data. PMID:25317951

Effect of choice of outcome measure on studies of the etiology of obesity in children.

PubMed

Basterfield, Laura; Pearce, Mark S; Adamson, Ashley J; Reilly, Jessica K; Parkinson, Kathryn N; Reilly, John J

2012-12-01

Epidemiologic studies of the etiology of childhood obesity often use proxies for adiposity as outcomes. This study aimed to compare the ability of a range of proxy measures to detect associations with sedentary behavior. Longitudinal study of children in the Gateshead Millennium Study who were 7 years at baseline and 9 years at follow-up. Associations between 2-year changes in objectively measured sedentary behavior and changes in proxies for adiposity (waist circumference, waist Z score, body mass index, body mass index Z score) and measurement of body composition (fat mass index from bioelectric impedance) were examined. Associations were tested with linear regression. Associations between 2-year increases in sedentary behavior and increases in adiposity were detectable by using the fat mass index as the outcome, but not the simple proxy measures of adiposity, as outcomes. Proxy measures are inferior to measures of body composition as outcomes in epidemiologic studies. Copyright © 2012 Elsevier Inc. All rights reserved.

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.

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.

Effectiveness of Telebehavioral Health Program Nurse Case Managers (NCM): Data Collection Tools and the Process for NCM-Sensitive Outcome Measures.

PubMed

Carlson, Judy; Cohen, Roslyn; Bice-Stephens, Wynona

2014-01-01

As a part of our nation's pursuit of improvements in patient care outcomes, continuity of care, and cost containment, the case manager has become a vital member on interdisciplinary teams and in health care agencies. Telebehavioral health programs, as a relatively new method of delivering behavioral health care, have recently begun to incorporate case management into their multidisciplinary teams. To determine the efficacy and efficiency of healthcare programs, program managers are charged with the determination of the outcomes of the care rendered to patient populations. However, programs that use telehealth methods to deliver care have unique structures in place that impact ability to collect outcome data. A military medical center that serves the Pacific region developed surveys and processes to distribute, administer, and collect information about a telehealth environment to obtain outcome data for the nurse case manager. This report describes the survey development and the processes created to capture nurse case manager outcomes. Additionally, the surveys and processes developed in this project for measuring outcomes may be useful in other settings and disciplines.

Measuring economic outcomes of alcohol treatment using the Economic Form 90.

PubMed

Bray, Jeremy W; Zarkin, Gary A; Miller, William R; Mitra, Debanjali; Kivlahan, Daniel R; Martin, Daniel J; Couper, David J; Cisler, Ron A

2007-03-01

This article assesses the ability of the economic outcome measures in the Economic Form 90 to detect differences across levels of alcohol dependence as measured by the Alcohol Dependence Scale. We used baseline data from the Combining Medications and Behavioral Interventions (COMBINE) Study, a large, multisite clinical trial, to assess the extent to which the economic items on the Economic Form 90 instrument can detect differences across levels of alcohol dependence. After adjusting for differences in demographic characteristics, the Economic Form 90 can detect significant differences across a range of dependence severity levels for the economic outcomes of inpatient medical care, emergency-department medical care, behavioral health care, being on parole or probation, and missed workdays, conditional on being employed. We did not detect significant differences across dependence severity for employment status, outpatient medical care, other criminal justice involvement, or motor vehicle accidents. The Economic Form 90 can identify differences in many economic outcomes associated with differing levels of alcohol dependence. This suggests that the Economic Form 90 may be useful in assessing changes in economic outcomes that result from changes in alcohol dependence.

Measuring outcomes for neurosurgical procedures.

PubMed

Theodosopoulos, Philip V; Ringer, Andrew J

2015-04-01

Health care evolution has led to focused attention on clinical outcomes of care. Surgical disciplines are increasingly asked to provide evidence of treatment efficacy. As the technological advances push the surgical envelope further, it becomes imperative that postoperative outcomes are studied in a prospective fashion to assess the quality of care provided. The authors present their experience from a multiyear implementation of an outcomes initiative and share lessons learned, emphasizing the important structural elements of such an endeavor. Copyright © 2015 Elsevier Inc. All rights reserved.

Measure Once, Cut Twice – Adding Patient-Reported Outcome Measures to the Electronic Health Record for Comparative Effectiveness Research

PubMed Central

Wu, Albert W.; Kharrazi, Hadi; Boulware, L. Ebony; Snyder, Claire F.

2013-01-01

Objective This paper presents the current state of patient-reported outcome measures, and explains new opportunities for leveraging the recent adoption of electronic health records to expand the application of patient-reported outcomes in both clinical care and comparative effectiveness research. Study Design and Setting Historic developments of patient-reported outcome, electronic health record, and comparative effectiveness research are analyzed in two dimensions: patient-centeredness and digitization. We pose the question: “What needs to be standardized around the collection of patient-reported outcomes in electronic health records for comparative effectiveness research?” Results We identified three converging trends: the progression of patient-reported outcomes toward greater patient centeredness and electronic adaptation; the evolution of electronic health records into personalized and fully digitized solutions; the shift toward patient-oriented comparative effectiveness research. Related to this convergence, we propose an architecture for patient-reported outcome standardization that could serve as a first step toward a more comprehensive integration of patient-reported outcomes with electronic health record for both practice and research. Conclusion The science of patient-reported outcome measurement has matured sufficiently to be integrated routinely into electronic health records and other e-health solutions to collect data on an ongoing basis for clinical care and comparative effectiveness research. Further efforts and ideally coordinated efforts from various stakeholders are needed to refine the details of the proposed framework for standardization. PMID:23849145

Progressive addition lenses--measurements and ratings.

PubMed

Sheedy, Jim; Hardy, Raymond F; Hayes, John R

2006-01-01

This study is a followup to a previous study in which the optics of several progressive addition lens (PALs) designs were measured and analyzed. The objective was to provide information about various PAL designs to enable eye care practitioners to select designs based on the particular viewing requirements of the patient. The optical properties of 12 lenses of the same power for each of 23 different PAL designs were measured with a Rotlex Class Plus lens analyzer. Lenses were ordered through optical laboratories and specified to be plano with a +2.00 diopters add. Measurements were normalized to plano at the manufacturer-assigned location for the distance power to eliminate laboratory tolerance errors. The magnitude of unwanted astigmatism and the widths and areas of the distance, intermediate, and near viewing zones were calculated from the measured data according to the same criteria used in a previous study. The optical characteristics of the different PAL designs were significantly different from one another. The differences were significant in terms of the sizes and widths of the viewing zones, the amount of unwanted astigmatism, and the minimum fitting height. Ratings of the distance, intermediate, and near viewing areas were calculated for each PAL design based on the widths and sizes of those zones. Ratings for unwanted astigmatism and recommended minimum fitting heights were also determined. Ratings based on combinations of viewing zone ratings are also reported. The ratings are intended to be used to select a PAL design that matches the particular visual needs of the patient and to evaluate the success and performance of currently worn PALs. Reasoning and task analyses suggest that these differences can be used to select a PAL design to meet the individual visual needs of the patient; clinical trials studies are required to test this hypothesis.

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.

Psychometric properties of carer-reported outcome measures in palliative care: A systematic review

PubMed Central

Michels, Charlotte TJ; Boulton, Mary; Adams, Astrid; Wee, Bee; Peters, Michele

2016-01-01

Background: Informal carers face many challenges in caring for patients with palliative care needs. Selecting suitable valid and reliable outcome measures to determine the impact of caring and carers’ outcomes is a common problem. Aim: To identify outcome measures used for informal carers looking after patients with palliative care needs, and to evaluate the measures’ psychometric properties. Design: A systematic review was conducted. The studies identified were evaluated by independent reviewers (C.T.J.M., M.B., M.P.). Data regarding study characteristics and psychometric properties of the measures were extracted and evaluated. Good psychometric properties indicate a high-quality measure. Data sources: The search was conducted, unrestricted to publication year, in the following electronic databases: Applied Social Sciences Index and Abstracts, Cumulative Index to Nursing and Allied Health Literature, The Cochrane Library, EMBASE, PubMed, PsycINFO, Social Sciences Citation Index and Sociological Abstracts. Results: Our systematic search revealed 4505 potential relevant studies, of which 112 studies met the inclusion criteria using 38 carer measures for informal carers of patients with palliative care needs. Psychometric properties were reported in only 46% (n = 52) of the studies, in relation to 24 measures. Where psychometric data were reported, the focus was mainly on internal consistency (n = 45, 87%), construct validity (n = 27, 52%) and/or reliability (n = 14, 27%). Of these, 24 measures, only four (17%) had been formally validated in informal carers in palliative care. Conclusion: A broad range of outcome measures have been used for informal carers of patients with palliative care needs. Little formal psychometric testing has been undertaken. Furthermore, development and refinement of measures in this field is required. PMID:26407683

Modeling Errors in Daily Precipitation Measurements: Additive or Multiplicative?

NASA Technical Reports Server (NTRS)

Tian, Yudong; Huffman, George J.; Adler, Robert F.; Tang, Ling; Sapiano, Matthew; Maggioni, Viviana; Wu, Huan

2013-01-01

The definition and quantification of uncertainty depend on the error model used. For uncertainties in precipitation measurements, two types of error models have been widely adopted: the additive error model and the multiplicative error model. This leads to incompatible specifications of uncertainties and impedes intercomparison and application.In this letter, we assess the suitability of both models for satellite-based daily precipitation measurements in an effort to clarify the uncertainty representation. Three criteria were employed to evaluate the applicability of either model: (1) better separation of the systematic and random errors; (2) applicability to the large range of variability in daily precipitation; and (3) better predictive skills. It is found that the multiplicative error model is a much better choice under all three criteria. It extracted the systematic errors more cleanly, was more consistent with the large variability of precipitation measurements, and produced superior predictions of the error characteristics. The additive error model had several weaknesses, such as non constant variance resulting from systematic errors leaking into random errors, and the lack of prediction capability. Therefore, the multiplicative error model is a better choice.

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

The public health value of vaccines beyond efficacy: methods, measures and outcomes.

PubMed

Wilder-Smith, A; Longini, I; Zuber, P L; Bärnighausen, T; Edmunds, W J; Dean, N; Spicher, V Masserey; Benissa, M R; Gessner, B D

2017-07-26

Assessments of vaccine efficacy and safety capture only the minimum information needed for regulatory approval, rather than the full public health value of vaccines. Vaccine efficacy provides a measure of proportionate disease reduction, is usually limited to etiologically confirmed disease, and focuses on the direct protection of the vaccinated individual. Herein, we propose a broader scope of methods, measures and outcomes to evaluate the effectiveness and public health impact to be considered for evidence-informed policymaking in both pre- and post-licensure stages. Pre-licensure: Regulatory concerns dictate an individually randomised clinical trial. However, some circumstances (such as the West African Ebola epidemic) may require novel designs that could be considered valid for licensure by regulatory agencies. In addition, protocol-defined analytic plans for these studies should include clinical as well as etiologically confirmed endpoints (e.g. all cause hospitalisations, pneumonias, acute gastroenteritis and others as appropriate to the vaccine target), and should include vaccine-preventable disease incidence and 'number needed to vaccinate' as outcomes. Post-licensure: There is a central role for phase IV cluster randomised clinical trials that allows for estimation of population-level vaccine impact, including indirect, total and overall effects. Dynamic models should be prioritised over static models as the constant force of infection assumed in static models will usually underestimate the effectiveness and cost-effectiveness of the immunisation programme by underestimating indirect effects. The economic impact of vaccinations should incorporate health and non-health benefits of vaccination in both the vaccinated and unvaccinated populations, thus allowing for estimation of the net social value of vaccination. The full benefits of vaccination reach beyond direct prevention of etiologically confirmed disease and often extend across the life course of a

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

Quality and Safety in Health Care, Part XXXII: Additional Outcome Predictors for Transcatheter Aortic Valve Replacement.

PubMed

Harolds, Jay A

2018-02-01

Mortality 12 months after a transcatheter aortic valve replacement (TAVR) is partly due to a number of reasons in addition to the usual preprocedural medical patient risk factors. In patients who need a permanent pacemaker placed after the procedure, the mortality risk goes up. The death rate following a TAVR varies considerably at different institutions, and the past death rate of TAVR patients at an institution is predictive of the mortality rate of new patients having this procedure. In addition, the quality of life of the individual before the procedure is predictive of the 12-month mortality outcome after the TAVR is done.

Measuring Exposure Opportunities: Using Exogenous Measures in Assessing Effects of Media Exposure on Smoking Outcomes

PubMed Central

Liu, Jiaying; Hornik, Robert

2016-01-01

Measurement of exposure has long been one of the most central and fundamental issues in communication research. While self-reported measures remain dominant in the field, alternative approaches such as exogenous or hybrid measures have received increasing scholarly attention and been employed in various contexts for the estimation of media exposure; however, systematic scrutiny of such measures is thin. This study aims to address the gap by systematically reviewing the studies which utilized exogenous or hybrid exposure measures for examining the effects of media exposure on tobacco-related outcomes. We then proceed to discuss the strengths and weaknesses, current developments in this class of measurement, drawing some implications for the appropriate utilization of exogenous and hybrid measures. PMID:27746848

Medication Regimen Complexity Measured by MRCI: A Systematic Review to Identify Health Outcomes.

PubMed

Alves-Conceição, Vanessa; Rocha, Kérilin Stancine Santos; Silva, Fernanda Vilanova Nascimento; Silva, Rafaella Oliveira Santos; Silva, Daniel Tenório da; Lyra-Jr, Divaldo Pereira de

2018-05-01

To perform a systematic review to identify health outcomes related to medication regimen complexity as measured by the Medication Regimen Complexity Index (MRCI) instrument. Cochrane Library, LILACS, PubMed, Scopus, EMBASE, Open Thesis, and Web of Science were searched from January 1, 2004, until April 02, 2018, using the following search terms: outcome assessment, drug therapy, and Medication Regimen Complexity Index and their synonyms in different combinations. Studies that used the MRCI instrument to measure medication regimen complexity and related it to clinical, humanistic, and/or economic outcomes were evaluated. Two reviewers independently carried out the analysis of the titles, abstracts, and complete texts according to the eligibility criteria, performed data extraction, and evaluated study quality. A total of 23 studies met the inclusion criteria; 18 health outcomes related to medication regimen complexity were found. The health outcomes most influenced by medication regimen complexity were hospital readmission, medication adherence, hospitalization, adverse drug events, and emergency sector visit. Only one study related medication regimen complexity with humanistic outcomes, and no study related medication regimen complexity to economic outcomes. Most of the studies were of good methodological quality. Relevance to Patient Care and Clinical Practice: Health care professionals should pay attention to medication regimen complexity of the patients because this may influence health outcomes. This study identified some health outcomes that may be influenced by medication regimen complexity: hospitalization, hospital readmission, and medication adherence were more prevalent, showing a significant association between MRCI increase and these health outcomes.

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.

Does the Addition of Hip Strengthening to a Knee-Focused Exercise Program Improve Outcomes in Patients With Patellofemoral Pain Syndrome?

PubMed

Bloomer, Ben A; Durall, Chris J

2015-11-01

Patellofemoral pain syndrome (PFPS) is one of the most common disorders affecting the lower extremities. To improve function and decrease pain, affected individuals often undergo a guided rehabilitation program. Traditional programs have concentrated on quadriceps strengthening and other knee-focused exercises, but recent literature suggests that adding hip-muscle strengthening may improve outcomes. This review was conducted to determine the extent to which current evidence supports the addition of hip-muscle strengthening to a knee-focused strengthening and stretching program in the treatment of PFPS. Focused Clinical Question: Does the addition of hip-muscle strengthening to a knee-focused strengthening and stretching program improve outcomes in patients with PFPS?

The evaluation of three treatments for plantar callus: a three-armed randomised, comparative trial using biophysical outcome measures.

PubMed

Hashmi, Farina; Nester, Christopher J; Wright, Ciaran R F; Lam, Sharon

2016-05-17

Callus is one of the most common foot skin complaints experienced by people of all ages. These painful and unsightly lesions often result in disability. The 'gold standard' of treatment is scalpel debridement by a trained specialist; however, people also seek over-the-counter remedies. There is a lack of clinical evidence for the efficacy of such products, which makes selection by patients and practitioners difficult. This randomised, three-armed, parallel, comparative trial aimed to test the efficacy of two home treatments for plantar callus using novel, objective outcome measures (skin hydration using the capacitance method; elasticity using negative pressure application; and surface texture using imaging). Additional outcome measures were: size of callus, quality of life (Foot Health Status Questionnaire) and self-reported participant satisfaction and compliance. The results were compared to a podiatry treatment. Participants were randomly allocated to one of three groups: potassium hydroxide (KOH, 40 %); trichloroacetic acid (TCA); and podiatry treatment. Participants were followed for 3 weeks after their initial intervention appointment (days 7, 14 and 21). The primary outcomes were the change from baseline in callus hydration, elasticity, texture, and size at each of the three time points. The secondary outcomes where: change in quality of life 21 days after treatment; resolution of calluses via visual inspection; and participant compliance and perception. Forty-six participants (61 ft) with plantar calluses were recruited. The podiatry treatment showed immediate and significant changes in all objective outcomes, associated foot pain and function (p <0.01). Lesser changes in skin quality and perceived pain and functional benefits occurred with TCA and KOH over 21 days. This is the first study where objective outcome measures have been used to measure changes in the nature of skin in response to callus treatments. We found significant differences in

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

Outcome Measurement in Economic Evaluations of Public Health Interventions: a Role for the Capability Approach?

PubMed Central

Lorgelly, Paula K.; Lawson, Kenny D.; Fenwick, Elisabeth A.L.; Briggs, Andrew H.

2010-01-01

Public health interventions have received increased attention from policy makers, and there has been a corresponding increase in the number of economic evaluations within the domain of public health. However, methods to evaluate public health interventions are less well established than those for medical interventions. Focusing on health as an outcome measure is likely to underestimate the impact of many public health interventions. This paper provides a review of outcome measures in public health; and describes the benefits of using the capability approach as a means to developing an all encompassing outcome measure. PMID:20623024

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

Measuring Outcomes in Children's Services.

ERIC Educational Resources Information Center

Christner, Anne Marshall, Ed.

Outcomes evaluation can provide program managers and clinical directors in child welfare, juvenile justice, child mental health, and child protective services the necessary tools for program quality assurance and accountability. This guide describes the outcomes evaluation process and provides a summary of articles and reports detailing current…

Porosity Measurements and Analysis for Metal Additive Manufacturing Process Control.

PubMed

Slotwinski, John A; Garboczi, Edward J; Hebenstreit, Keith M

2014-01-01

Additive manufacturing techniques can produce complex, high-value metal parts, with potential applications as critical metal components such as those found in aerospace engines and as customized biomedical implants. Material porosity in these parts is undesirable for aerospace parts - since porosity could lead to premature failure - and desirable for some biomedical implants - since surface-breaking pores allows for better integration with biological tissue. Changes in a part's porosity during an additive manufacturing build may also be an indication of an undesired change in the build process. Here, we present efforts to develop an ultrasonic sensor for monitoring changes in the porosity in metal parts during fabrication on a metal powder bed fusion system. The development of well-characterized reference samples, measurements of the porosity of these samples with multiple techniques, and correlation of ultrasonic measurements with the degree of porosity are presented. A proposed sensor design, measurement strategy, and future experimental plans on a metal powder bed fusion system are also presented.

Porosity Measurements and Analysis for Metal Additive Manufacturing Process Control

PubMed Central

Slotwinski, John A; Garboczi, Edward J; Hebenstreit, Keith M

2014-01-01

Additive manufacturing techniques can produce complex, high-value metal parts, with potential applications as critical metal components such as those found in aerospace engines and as customized biomedical implants. Material porosity in these parts is undesirable for aerospace parts - since porosity could lead to premature failure - and desirable for some biomedical implants - since surface-breaking pores allows for better integration with biological tissue. Changes in a part’s porosity during an additive manufacturing build may also be an indication of an undesired change in the build process. Here, we present efforts to develop an ultrasonic sensor for monitoring changes in the porosity in metal parts during fabrication on a metal powder bed fusion system. The development of well-characterized reference samples, measurements of the porosity of these samples with multiple techniques, and correlation of ultrasonic measurements with the degree of porosity are presented. A proposed sensor design, measurement strategy, and future experimental plans on a metal powder bed fusion system are also presented. PMID:26601041

Statistical inference for the additive hazards model under outcome-dependent sampling.

PubMed

Yu, Jichang; Liu, Yanyan; Sandler, Dale P; Zhou, Haibo

2015-09-01

Cost-effective study design and proper inference procedures for data from such designs are always of particular interests to study investigators. In this article, we propose a biased sampling scheme, an outcome-dependent sampling (ODS) design for survival data with right censoring under the additive hazards model. We develop a weighted pseudo-score estimator for the regression parameters for the proposed design and derive the asymptotic properties of the proposed estimator. We also provide some suggestions for using the proposed method by evaluating the relative efficiency of the proposed method against simple random sampling design and derive the optimal allocation of the subsamples for the proposed design. Simulation studies show that the proposed ODS design is more powerful than other existing designs and the proposed estimator is more efficient than other estimators. We apply our method to analyze a cancer study conducted at NIEHS, the Cancer Incidence and Mortality of Uranium Miners Study, to study the risk of radon exposure to cancer.

Statistical inference for the additive hazards model under outcome-dependent sampling

PubMed Central

Yu, Jichang; Liu, Yanyan; Sandler, Dale P.; Zhou, Haibo

2015-01-01

Cost-effective study design and proper inference procedures for data from such designs are always of particular interests to study investigators. In this article, we propose a biased sampling scheme, an outcome-dependent sampling (ODS) design for survival data with right censoring under the additive hazards model. We develop a weighted pseudo-score estimator for the regression parameters for the proposed design and derive the asymptotic properties of the proposed estimator. We also provide some suggestions for using the proposed method by evaluating the relative efficiency of the proposed method against simple random sampling design and derive the optimal allocation of the subsamples for the proposed design. Simulation studies show that the proposed ODS design is more powerful than other existing designs and the proposed estimator is more efficient than other estimators. We apply our method to analyze a cancer study conducted at NIEHS, the Cancer Incidence and Mortality of Uranium Miners Study, to study the risk of radon exposure to cancer. PMID:26379363

When do patient-reported outcome measures inform readmission risk?

PubMed

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

2015-05-01

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

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

Comparison of clinician-predicted to measured low vision outcomes.

PubMed

Chan, Tiffany L; Goldstein, Judith E; Massof, Robert W

2013-08-01

To compare low-vision rehabilitation (LVR) clinicians' predictions of the probability of success of LVR with patients' self-reported outcomes after provision of usual outpatient LVR services and to determine if patients' traits influence clinician ratings. The Activity Inventory (AI), a self-report visual function questionnaire, was administered pre-and post-LVR to 316 low-vision patients served by 28 LVR centers that participated in a collaborative observational study. The physical component of the Short Form-36, Geriatric Depression Scale, and Telephone Interview for Cognitive Status were also administered pre-LVR to measure physical capability, depression, and cognitive status. After patient evaluation, 38 LVR clinicians estimated the probability of outcome success (POS) using their own criteria. The POS ratings and change in functional ability were used to assess the effects of patients' baseline traits on predicted outcomes. A regression analysis with a hierarchical random-effects model showed no relationship between LVR physician POS estimates and AI-based outcomes. In another analysis, kappa statistics were calculated to determine the probability of agreement between POS and AI-based outcomes for different outcome criteria. Across all comparisons, none of the kappa values were significantly different from 0, which indicates that the rate of agreement is equivalent to chance. In an exploratory analysis, hierarchical mixed-effects regression models show that POS ratings are associated with information about the patient's cognitive functioning and the combination of visual acuity and functional ability, as opposed to visual acuity or functional ability alone. Clinicians' predictions of LVR outcomes seem to be influenced by knowledge of patients' cognitive functioning and the combination of visual acuity and functional ability-information clinicians acquire from the patient's history and examination. However, clinicians' predictions do not agree with observed

Comparison of Physician-Predicted to Measured Low Vision Outcomes

PubMed Central

Chan, Tiffany L.; Goldstein, Judith E.; Massof, Robert W.

2013-01-01

Purpose To compare low vision rehabilitation (LVR) physicians’ predictions of the probability of success of LVR to patients’ self-reported outcomes after provision of usual outpatient LVR services; and to determine if patients’ traits influence physician ratings. Methods The Activity Inventory (AI), a self-report visual function questionnaire, was administered pre and post-LVR to 316 low vision patients served by 28 LVR centers that participated in a collaborative observational study. The physical component of the Short Form-36, Geriatric Depression Scale, and Telephone Interview for Cognitive Status were also administered pre-LVR to measure physical capability, depression and cognitive status. Following patient evaluation, 38 LVR physicians estimated the probability of outcome success (POS), using their own criteria. The POS ratings and change in functional ability were used to assess the effects of patients’ baseline traits on predicted outcomes. Results A regression analysis with a hierarchical random effects model showed no relationship between LVR physician POS estimates and AI-based outcomes. In another analysis, Kappa statistics were calculated to determine the probability of agreement between POS and AI-based outcomes for different outcome criteria. Across all comparisons, none of the kappa values were significantly different from 0, which indicates the rate of agreement is equivalent to chance. In an exploratory analysis, hierarchical mixed effects regression models show that POS ratings are associated with information about the patient’s cognitive functioning and the combination of visual acuity and functional ability, as opposed to visual acuity or functional ability alone. Conclusions Physicians’ predictions of LVR outcomes appear to be influenced by knowledge of patients’ cognitive functioning and the combination of visual acuity and functional ability - information physicians acquire from the patient’s history and examination. However

Comparing the responsiveness of functional outcome assessment measures for trauma registries.

PubMed

Williamson, Owen D; Gabbe, Belinda J; Sutherland, Ann M; Wolfe, Rory; Forbes, Andrew B; Cameron, Peter A

2011-07-01

Measuring long-term disability and functional outcomes after major trauma is not standardized across trauma registries. An ideal measure would be responsive to change but not have significant ceiling effects. The aim of this study was to compare the responsiveness of the Glasgow Outcome Scale (GOS), GOS-Extended (GOSE), Functional Independence Measure (FIM), and modified FIM in major trauma patients, with and without significant head injuries. Patients admitted to two adult Level I trauma centers in Victoria, Australia, who survived to discharge from hospital, were aged 15 years to 80 years with a blunt mechanism of injury, and had an estimated Injury Severity Score >15 on admission, were recruited for this prospective study. The instruments were administered at baseline (hospital discharge) and by telephone interview 6 months after injury. Measures of responsiveness, including effect sizes, were calculated. Bootstrapping techniques, and floor and ceiling effects, were used to compare the measures. Two hundred forty-three patients participated, of which 234 patients (96%) completed the study. The GOSE and GOS were the most responsive instruments in this major trauma population with effect sizes of 5.3 and 4.4, respectively. The GOSE had the lowest ceiling effect (17%). The GOSE was the instrument with greatest responsiveness and the lowest ceiling effect in a major trauma population with and without significant head injuries and is recommended for use by trauma registries for monitoring functional outcomes and benchmarking care. The results of this study do not support the use of the modified FIM for this purpose.

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.

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.

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,…

Heart Rate Variability as a Feeding Intervention Outcome Measure in the Preterm Infant.

PubMed

Pados, Britt F; Thoyre, Suzanne M; Knafl, George J; Nix, William Brant

2017-10-01

Feeding interventions for preterm infants aim to reduce the physiologic stress of feeding to promote growth. Heart rate variability (HRV) is a potential noninvasive measure of physiologic stress that may be useful for evaluating efficacy of feeding interventions. To evaluate whether HRV is a sensitive measure of physiologic stress compared with standard physiologic outcomes in the context of a feeding intervention study. This was a secondary analysis of a within-subjects, cross-over design study comparing usual care feeding with a gentle, coregulated (CoReg) feeding approach in 14 infants born less than 35 weeks' postmenstrual age. HRV indices were calculated from electrocardiogram data and compared with standard physiologic outcomes, including oxygen saturation (Spo2), respiratory rate (RR), apnea, heart rate (HR), and bradycardia. Data were analyzed using linear mixed modeling. Infants fed using the CoReg approach had fewer apneic events and higher RR, suggesting they were able to breathe more during feeding. No statistically significant differences were found in SpO2, HR, bradycardia, or high frequency power (the most commonly reported measure of HRV). Infants fed using the usual care approach had significantly higher SD12, a measure of HRV indicating randomness in the HR, which is a potential indicator of elevated stress. SD12 was more sensitive to stress than SpO2, HR, and bradycardia. The utility of HRV as a measure of feeding outcomes in clinical practice needs further exploration. Further exploration of HRV as an intervention outcome measure is needed, particularly evaluating nonlinear indices, such as SD12.

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

Textbook Outcome: A Composite Measure for Quality of Elective Aneurysm Surgery.

PubMed

Karthaus, Eleonora G; Lijftogt, Niki; Busweiler, Linde A D; Elsman, Bernard H P; Wouters, Michel W J M; Vahl, Anco C; Hamming, Jaap F

2017-11-01

To investigate a new composite quality measurement, which comprises a desirable outcome for elective aneurysm surgery, called "Textbook Outcome" (TO). Single-quality indicators in vascular surgery are often not distinctive and insufficiently reflect the quality of care. All patients undergoing elective abdominal aortic aneurysm repair, registered in the Dutch Surgical Aneurysm Audit between 2014 and 2015 were included. TO was defined as the percentage of patients who had abdominal aortic aneurysm-repair without intraoperative complications, postoperative surgical complications, reinterventions, prolonged hospital stay [endovascular aneurysm repair (EVAR) ≤4 d, open surgical repair (OSR) ≤10 d], readmissions, and postoperative mortality (≤30 d after surgery/at discharge). Case-mix adjusted TO rates were used to compare hospitals and to compare individual hospital results for different procedures. Five thousand one hundred seventy patients were included, of whom 4039 were treated with EVAR and 1131 with OSR. TO was achieved in 71% of EVAR and 53% of OSR. Important obstacles for achieving TO were a prolonged hospital stay, postoperative complications, and readmissions. Adjusted TO rates varied from 38% to 89% (EVAR) and from 0% to 97% (OSR) between individual hospitals. Hospitals with a high TO for OSR also had a high TO for EVAR; however, a high TO for EVAR did not implicate a high TO for OSR. TO generates additional information to evaluate the overall quality of the care of elective aneurysm surgery, which subsequently can be used by hospitals to improve the quality of their care.

Recommendations for a Core Outcome Set for Measuring Standing Balance in Adult Populations: A Consensus-Based Approach

PubMed Central

Sibley, Kathryn M.; Howe, Tracey; Lamb, Sarah E.; Lord, Stephen R.; Maki, Brian E.; Rose, Debra J.; Scott, Vicky; Stathokostas, Liza; Straus, Sharon E.; Jaglal, Susan B.

2015-01-01

Background Standing balance is imperative for mobility and avoiding falls. Use of an excessive number of standing balance measures has limited the synthesis of balance intervention data and hampered consistent clinical practice. Objective To develop recommendations for a core outcome set (COS) of standing balance measures for research and practice among adults. Methodology A combination of scoping reviews, literature appraisal, anonymous voting and face-to-face meetings with fourteen invited experts from a range of disciplines with international recognition in balance measurement and falls prevention. Consensus was sought over three rounds using pre-established criteria. Data sources The scoping review identified 56 existing standing balance measures validated in adult populations with evidence of use in the past five years, and these were considered for inclusion in the COS. Results Fifteen measures were excluded after the first round of scoring and a further 36 after round two. Five measures were considered in round three. Two measures reached consensus for recommendation, and the expert panel recommended that at a minimum, either the Berg Balance Scale or Mini Balance Evaluation Systems Test be used when measuring standing balance in adult populations. Limitations Inclusion of two measures in the COS may increase the feasibility of potential uptake, but poses challenges for data synthesis. Adoption of the standing balance COS does not constitute a comprehensive balance assessment for any population, and users should include additional validated measures as appropriate. Conclusions The absence of a gold standard for measuring standing balance has contributed to the proliferation of outcome measures. These recommendations represent an important first step towards greater standardization in the assessment and measurement of this critical skill and will inform clinical research and practice internationally. PMID:25768435

Patient population management: taking the leap from variance analysis to outcomes measurement.

PubMed

Allen, K M

1998-01-01

Case managers today at BCHS have a somewhat different role than at the onset of the Collaborative Practice Model. They are seen throughout the organization as: Leaders/participants on cross-functional teams. Systems change agents. Integrating/merging with quality services and utilization management. Outcomes managers. One of the major cross-functional teams is in the process of designing a Care Coordinator role. These individuals will, as one of their functions, assume responsibility for daily patient care management activities. A variance tracking program has come into the Utilization Management (UM) department as part of a software package purchased to automate UM work activities. This variance program could potentially be used by the new care coordinators as the role develops. The case managers are beginning to use a Decision Support software, (Transition Systems Inc.) in the collection of data that is based on a cost accounting system and linked to clinical events. Other clinical outcomes data bases are now being used by the case manager to help with the collection and measurement of outcomes information. Hoshin planning will continue to be a framework for defining and setting the targets for clinical and financial improvements throughout the organization. Case managers will continue to be involved in many of these system-wide initiatives. In the words of Galileo, 1579, "You need to count what's countable, measure what's measurable, and what's not measurable, make measurable."

Measuring public health practice and outcomes in chronic disease: a call for coordination.

PubMed

Porterfield, Deborah S; Rogers, Todd; Glasgow, LaShawn M; Beitsch, Leslie M

2015-04-01

A strategic opportunity exists to coordinate public health systems and services researchers' efforts to develop local health department service delivery measures and the efforts of divisions within the Centers for Disease Control and Prevention's National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP) to establish outcome indicators for public health practice in chronic disease. Several sets of outcome indicators developed by divisions within NCCDPHP and intended for use by state programs can be tailored to assess outcomes of interventions within smaller geographic areas or intervention settings. Coordination of measurement efforts could potentially allow information to flow from the local to the state to the federal level, enhancing program planning, accountability, and even subsequent funding for public health practice.

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

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.

The STarT Back Screening Tool and Individual Psychological Measures: Evaluation of Prognostic Capabilities for Low Back Pain Clinical Outcomes in Outpatient Physical Therapy Settings

PubMed Central

Bishop, Mark D.; Fritz, Julie M.; Robinson, Michael E.; Asal, Nabih R.; Nisenzon, Anne N.

2013-01-01

Background Psychologically informed practice emphasizes routine identification of modifiable psychological risk factors being highlighted. Objective The purpose of this study was to test the predictive validity of the STarT Back Screening Tool (SBT) in comparison with single-construct psychological measures for 6-month clinical outcomes. Design This was an observational, prospective cohort study. Methods Patients (n=146) receiving physical therapy for low back pain were administered the SBT and a battery of psychological measures (Fear-Avoidance Beliefs Questionnaire physical activity scale and work scale [FABQ-PA and FABQ-W, respectively], Pain Catastrophizing Scale [PCS], 11-item version of the Tampa Scale of Kinesiophobia [TSK-11], and 9-item Patient Health Questionnaire [PHQ-9]) at initial evaluation and 4 weeks later. Treatment was at the physical therapist's discretion. Clinical outcomes consisted of pain intensity and self-reported disability. Prediction of 6-month clinical outcomes was assessed for intake SBT and psychological measure scores using multiple regression models while controlling for other prognostic variables. In addition, the predictive capabilities of intake to 4-week changes in SBT and psychological measure scores for 6-month clinical outcomes were assessed. Results Intake pain intensity scores (β=.39 to .45) and disability scores (β=.47 to .60) were the strongest predictors in all final regression models, explaining 22% and 24% and 43% and 48% of the variance for the respective clinical outcome at 6 months. Neither SBT nor psychological measure scores improved prediction of 6-month pain intensity. The SBT overall scores (β=.22) and SBT psychosocial scores (β=.25) added to the prediction of disability at 6 months. Four-week changes in TSK-11 scores (β=−.18) were predictive of pain intensity at 6 months. Four-week changes in FABQ-PA scores (β=−.21), TSK-11 scores (β=−.20) and SBT overall scores (β=−.18) were predictive of

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.

Development of an outcome measurement system for service planning for children and youth with special needs

PubMed Central

Kertoy, M K; Russell, D J; Rosenbaum, P; Jaffer, S; Law, M; McCauley, D; Gorter, J W

2013-01-01

Aim This study described the process used in developing an outcome measurement framework for system planning to improve services for children and youth with special needs and their families in a Canadian province. The study reports the results of several parent-completed measures, which would be useful in service planning as well as the acceptability and utility of these measures for use by families and service centres. Methods/results Development of a theoretical framework, consultation with key stakeholders, testing the utility of selected outcome measures and initial dissemination of results were critical elements in the successful development of an outcome system. Consultation with stakeholders confirmed use of the International Classification of Functioning, Disability and Health and the child-within-family-within community model as theoretical frameworks while building valuable partnerships and identifying potential barriers to implementation. Pilot testing showed three outcome measures were feasible for families to complete and the measures provided information about services for children that was valuable to families as well as service providers. Gaps in service delivery were identified and the need for better communication between service providers and communities to facilitate integrated services was highlighted. Conclusion The findings from this study can be used to implement an outcome measurement system for children with special needs and may serve as a resource for international researchers who are working to develop valid tools as well as outcome systems that are useful for system planning. PMID:22845889

The King's Outcome Scale for Childhood Head Injury and Injury Severity and Outcome Measures in Children with Traumatic Brain Injury

ERIC Educational Resources Information Center

Calvert, Sophie; Miller, Helen E.; Curran, Andrew; Hameed, Biju; McCarter, Renee; Edwards, Richard J.; Hunt, Linda; Sharples, Peta Mary

2008-01-01

The aim of this study was to relate discharge King's Outcome Scale for Childhood Head Injury (KOSCHI) category to injury severity and detailed outcome measures obtained in the first year post-traumatic brain injury (TBI). We used a prospective cohort study. Eighty-one children with TBI were studied: 29 had severe, 15 moderate, and 37 mild TBI. The…

Establishing a Core Outcome Measure for Graft Health: a Standardized Outcomes in Nephrology - Kidney Transplantation (SONG-Tx) Consensus Workshop Report.

PubMed

Tong, Allison; Sautenet, Benedicte; Poggio, Emilio D; Lentine, Krista L; Oberbauer, Rainer; Mannon, Roslyn; Murphy, Barbara; Padilla, Benita; Chow, Kai Ming; Marson, Lorna; Chadban, Steve; Craig, Jonathan C; Ju, Angela; Manera, Karine E; Hanson, Camilla S; Josephson, Michelle A; Knoll, Greg

2018-02-22

Graft loss, a critically important outcome for transplant recipients, is variably defined and measured, and incompletely reported in trials. We convened a consensus workshop on establishing a core outcome measure for graft loss for all trials in kidney transplantation. Twenty-five kidney transplant recipients/caregivers and 33 health professionals from eight countries participated. Transcripts were analyzed thematically. Five themes were identified. "Graft loss as a continuum" conceptualizes graft loss as a process, but requiring an endpoint defined as a discrete event. In "defining an event with precision and accuracy," loss of graft function requiring chronic dialysis (minimum 90 days) provided an objective and practical definition; re-transplant would capture preemptive transplantation; relisting was readily measured but would overestimate graft loss; and allograft nephrectomy was redundant in being preceded by dialysis. However, the thresholds for renal replacement therapy varied. Conservative management was regarded as too ambiguous and complex to use routinely. "Distinguishing death-censored graft loss" would ensure clarity and meaningfulness in interpreting results. "Consistent reporting for decision-making" by specifying time points and metrics (ie time to event) was suggested. "Ease of ascertainment and data collection" of the outcome from registries could support use of registry data to efficiently extend follow-up of trial participants. A practical and meaningful core outcome measure for graft loss may be defined as chronic dialysis or re-transplant, and distinguished from loss due to death. Consistent reporting of graft loss using standardized metrics and time points may improve the contribution of trials to decision-making in kidney transplantation.

The Search for an Early Intervention Outcome Measurement Tool in Autism

ERIC Educational Resources Information Center

Fletcher-Watson, S.; McConachie, H.

2017-01-01

Evidence is accumulating that early intervention can be effective in improving the skills of young children with autism spectrum disorder. However, the science is hampered by the lack of agreed "gold standard" tools for the measurement of progress and outcome. What is required is a reliable, valid, and sensitive measure of change in the…

Dignity Impact as a Primary Outcome Measure for Dignity Therapy.

PubMed

Scarton, Lisa; Oh, Sungho; Sylvera, Ashley; Lamonge, Ralph; Yao, Yingwei; Chochinov, Harvey; Fitchett, George; Handzo, George; Emanuel, Linda; Wilkie, Diana

2018-01-01

Feasibility of dignity therapy (DT) is well established in palliative care. Evidence of its efficacy, however, has been inconsistent and may stem from DT's primary effects differing from the outcomes measured in previous studies. We proposed that DT effects were in the spiritual domain and created a new outcome measure, Dignity Impact Scale (DIS), from items previously used in a large randomized controlled trial (RCT). The purpose of this secondary analysis study was to examine properties of a new measure of dignity impact. Using the DIS, we conducted reanalysis of posttest data from a large 3-arm, multi-site RCT study. Participants were receiving hospice/palliative care (n = 326, 50.6% female, mean age = 65.1 years, 89.3% white, all with a terminal illness with 6 months or less life expectancy). They had been randomized to standard palliative care (n = 111), client-centered care (n = 107), or DT (n = 108). The 7-item DIS was derived from selected items in a posttest DT Patient Feedback Questionnaire. The DIS had strong internal consistency (α = 0.85). The DT group mean DIS score (21.4 ± 5.0) was significantly higher than the usual care group mean score (17.7 ± 5.5; t = 5.2, df = 216, P < .001) and a client-centered intervention group mean score (17.9 ± 4.9; t = 5.2, df = 213, P < .001). We found that, compared to both other groups, patients who received DT reported significantly higher DIS ratings, which is consistent with the DT focus on meaning-making, preparation for death, and life completion tasks. We propose that the DIS be used as the primary outcome measure in evaluating the effects of DT.

Do Activity Level Outcome Measures Commonly Used in Neurological Practice Assess Upper-Limb Movement Quality?

PubMed

Demers, Marika; Levin, Mindy F

2017-07-01

Movement is described in terms of task-related end point characteristics in external space and movement quality (joint rotations in body space). Assessment of upper-limb (UL) movement quality can assist therapists in designing effective treatment approaches for retraining lost motor elements and provide more detailed measurements of UL motor improvements over time. To determine the extent to which current activity level outcome measures used in neurological practice assess UL movement quality. Outcome measures assessing arm/hand function at the International Classification of Function activity level recommended by neurological clinical practice guidelines were reviewed. Measures assessing the UL as part of a general mobility assessment, those strictly evaluating body function/structure or participation, and paediatric measures were excluded. In all, 15 activity level outcome measures were identified; 9 measures assess how movement is performed by measuring either end point characteristics or movement quality. However, except for the Reaching Performance Scale for Stroke and the Motor Evaluation Scale for Upper Extremity in Stroke Patients, these measures only account for deficits indirectly by giving a partial score if movements are slower or if the person experiences difficulties. Six outcome measures neither assess any parameters related to movement quality, nor distinguish between improvements resulting from motor compensation or recovery of desired movement strategies. Current activity measures may not distinguish recovery from compensation and adequately track changes in movement quality over time. Movement quality may be incorporated into clinical assessment using observational kinematics with or without low-cost motion tracking technology.

Outcome-driven thresholds for home blood pressure measurement: international database of home blood pressure in relation to cardiovascular outcome.

PubMed

Niiranen, Teemu J; Asayama, Kei; Thijs, Lutgarde; Johansson, Jouni K; Ohkubo, Takayoshi; Kikuya, Masahiro; Boggia, José; Hozawa, Atsushi; Sandoya, Edgardo; Stergiou, George S; Tsuji, Ichiro; Jula, Antti M; Imai, Yutaka; Staessen, Jan A

2013-01-01

The lack of outcome-driven operational thresholds limits the clinical application of home blood pressure (BP) measurement. Our objective was to determine an outcome-driven reference frame for home BP measurement. We measured home and clinic BP in 6470 participants (mean age, 59.3 years; 56.9% women; 22.4% on antihypertensive treatment) recruited in Ohasama, Japan (n=2520); Montevideo, Uruguay (n=399); Tsurugaya, Japan (n=811); Didima, Greece (n=665); and nationwide in Finland (n=2075). In multivariable-adjusted analyses of individual subject data, we determined home BP thresholds, which yielded 10-year cardiovascular risks similar to those associated with stages 1 (120/80 mm Hg) and 2 (130/85 mm Hg) prehypertension, and stages 1 (140/90 mm Hg) and 2 (160/100 mm Hg) hypertension on clinic measurement. During 8.3 years of follow-up (median), 716 cardiovascular end points, 294 cardiovascular deaths, 393 strokes, and 336 cardiac events occurred in the whole cohort; in untreated participants these numbers were 414, 158, 225, and 194, respectively. In the whole cohort, outcome-driven systolic/diastolic thresholds for the home BP corresponding with stages 1 and 2 prehypertension and stages 1 and 2 hypertension were 121.4/77.7, 127.4/79.9, 133.4/82.2, and 145.4/86.8 mm Hg; in 5018 untreated participants, these thresholds were 118.5/76.9, 125.2/79.7, 131.9/82.4, and 145.3/87.9 mm Hg, respectively. Rounded thresholds for stages 1 and 2 prehypertension and stages 1 and 2 hypertension amounted to 120/75, 125/80, 130/85, and 145/90 mm Hg, respectively. Population-based outcome-driven thresholds for home BP are slightly lower than those currently proposed in hypertension guidelines. Our current findings could inform guidelines and help clinicians in diagnosing and managing patients.

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.

Health Systems and Their Assessment: A Methodological Proposal of the Synthetic Outcome Measure

PubMed Central

Romaniuk, Piotr; Kaczmarek, Krzysztof; Syrkiewicz-Świtała, Magdalena; Holecki, Tomasz; Szromek, Adam R.

2018-01-01

The effectiveness of health systems is an area of constant interest for public health researchers and practitioners. The varied approach to effectiveness itself has resulted in numerous methodological proposals related to its measurement. The limitations of the currently used methods lead to a constant search for better tools for the assessment of health systems. This article shows the possibilities of using the health system synthetic outcome measure (SOM) for this purpose. It is an original tool using 41 indicators referring to the epidemiological situation, health behaviors, and factors related to the health-care system, which allows a relatively quick and easy assessment of the health system in terms of its effectiveness. Construction of the measure of health system functioning in such a way allowed its presentation in dynamic perspective, i.e., assessing not only the health system itself in a given moment of time but also changes in the value of the effectiveness measures. In order to demonstrate the cognitive value of the SOM, the analysis of the effectiveness of health systems in 21 countries of Central and Eastern Europe during the transformation period was carried out. The mean SOM values calculated on the basis of the component measures allowed to differentiate countries in terms of the effectiveness of their health systems. Considering the whole period, a similar level of health system effects can be observed in Slovenia, Croatia, Czech Republic, Slovakia, Poland, Macedonia, and Albania. In the middle group, Hungary, Romania, Latvia, Lithuania, Georgia, Estonia, Bulgaria, Belarus, and Armenia were found. The third group, weakest in terms of achieved effects, was formed by health systems in countries like Ukraine, Moldova, and Russia. The presented method allows for the analysis of the health system outcomes from a comparative angle, eliminating arbitrariness of pinpointing a model solution as a potential reference point in the assessment of the systems

Health Systems and Their Assessment: A Methodological Proposal of the Synthetic Outcome Measure.

PubMed

Romaniuk, Piotr; Kaczmarek, Krzysztof; Syrkiewicz-Świtała, Magdalena; Holecki, Tomasz; Szromek, Adam R

2018-01-01

The effectiveness of health systems is an area of constant interest for public health researchers and practitioners. The varied approach to effectiveness itself has resulted in numerous methodological proposals related to its measurement. The limitations of the currently used methods lead to a constant search for better tools for the assessment of health systems. This article shows the possibilities of using the health system synthetic outcome measure (SOM) for this purpose. It is an original tool using 41 indicators referring to the epidemiological situation, health behaviors, and factors related to the health-care system, which allows a relatively quick and easy assessment of the health system in terms of its effectiveness. Construction of the measure of health system functioning in such a way allowed its presentation in dynamic perspective, i.e., assessing not only the health system itself in a given moment of time but also changes in the value of the effectiveness measures. In order to demonstrate the cognitive value of the SOM, the analysis of the effectiveness of health systems in 21 countries of Central and Eastern Europe during the transformation period was carried out. The mean SOM values calculated on the basis of the component measures allowed to differentiate countries in terms of the effectiveness of their health systems. Considering the whole period, a similar level of health system effects can be observed in Slovenia, Croatia, Czech Republic, Slovakia, Poland, Macedonia, and Albania. In the middle group, Hungary, Romania, Latvia, Lithuania, Georgia, Estonia, Bulgaria, Belarus, and Armenia were found. The third group, weakest in terms of achieved effects, was formed by health systems in countries like Ukraine, Moldova, and Russia. The presented method allows for the analysis of the health system outcomes from a comparative angle, eliminating arbitrariness of pinpointing a model solution as a potential reference point in the assessment of the systems

Spatial cluster detection for repeatedly measured outcomes while accounting for residential history.

PubMed

Cook, Andrea J; Gold, Diane R; Li, Yi

2009-10-01

Spatial cluster detection has become an important methodology in quantifying the effect of hazardous exposures. Previous methods have focused on cross-sectional outcomes that are binary or continuous. There are virtually no spatial cluster detection methods proposed for longitudinal outcomes. This paper proposes a new spatial cluster detection method for repeated outcomes using cumulative geographic residuals. A major advantage of this method is its ability to readily incorporate information on study participants relocation, which most cluster detection statistics cannot. Application of these methods will be illustrated by the Home Allergens and Asthma prospective cohort study analyzing the relationship between environmental exposures and repeated measured outcome, occurrence of wheeze in the last 6 months, while taking into account mobile locations.

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

Measurement of additional shear during sludge conditioning and dewatering.

PubMed

Ormeci, Banu; Ahmad, Ayaz

2009-07-01

Optimum polymer dose is influenced both by the polymer demand of the sludge and the shear applied during conditioning. Sludge exposed to additional shear following conditioning will experience a decrease in cake solids concentration for the same polymer dose. Therefore, it is necessary to measure or quantify the additional shear in order to optimize the conditioning and dewatering. There is currently no direct or indirect method to achieve this. The main objective of this study was to develop a method based on torque rheology to measure the amount of shear that a sludge network experiences during conditioning and dewatering. Anaerobically digested sludge samples were exposed to increasing levels of mixing intensities and times, and rheological characteristics of samples were measured using a torque rheometer. Several rheological parameters were evaluated including the peak torque and totalized torque (area under the rheograms). The results of this study show that at the optimum polymer dose, a linear relationship exists between the applied shear and the area under the rheograms, and this relationship can be used to estimate an unknown amount of shear that the sludge was exposed to. The method is useful as a research tool to study the effect of shear on dewatering but also as an optimization tool in a dewatering automation system based on torque rheology.

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.

Outcome Measures in Myasthenia Gravis: Incorporation Into Clinical Practice.

PubMed

Muppidi, Srikanth

2017-03-01

The development of validated assessment tools for evaluating disease status and response to interventions in patients with myasthenia gravis (MG) has been driven by clinical studies of emerging MG therapies. However, only a small proportion of MG-focused neurology practices have adopted these assessment tools for routine clinical use. This article reviews the suitability of 5 assessment instruments for incorporation into clinical practice, which should be driven by their ability to contribute to improved patient outcomes, and to be implemented within practice personnel and resource constraints. It is recommended that assessments based on both physician-evaluated and patient-reported outcomes be selected, to adequately evaluate both point-in-time symptom load and functional impact of MG symptoms over time. Provider resource allocation and reimbursement issues may be the most significant roadblocks to successful ongoing use of these tools; to that end, the addition of regular assessments to MG standards of care is recommended.

Additional Risk Minimisation Measures for Medicinal Products in the European Union: A Review of the Implementation and Effectiveness of Measures in the United Kingdom by One Marketing Authorisation Holder.

PubMed

Agyemang, Elaine; Bailey, Lorna; Talbot, John

2017-01-01

Additional risk minimisation measures (aRMMs) for medicinal products are necessary to address specific important safety issues which may not be practically achieved through routine risk management measures alone. The implementation and determination of effectiveness for aRMMs can be a challenge as it involves multiple stakeholders. It is therefore important to have concise objectives to avoid undue burden on patients, healthcare professionals and the healthcare system. The aim of this study was to examine how aRMMs are implemented and how effectiveness is assessed in the European Union (EU) using practical examples from Roche Products Limited in the United Kingdom (UK) (referred to as the 'Company'). Three centrally authorised products were selected from the Company's portfolio, each of which had aRMMs to address important safety concerns; specifically, teratogenicity, medication error and infections. The implementation of EU aRMMs, effectiveness checks and specific UK activities were analysed. Hard copy folders and electronic sites for Company aRMMs were used to assess process indicators. Periodic benefit-risk evaluation reports for specified time intervals and the Company safety database was used in checking safety outcomes for the selected products. For each product, the effectiveness of aRMMs was analysed based on specific process indicators and the subsequent safety outcomes. Literature searches were performed on scientific databases for the purposes of the broader study. The main process indicators in measuring effectiveness of Company aRMMs were distribution metrics for educational materials, assessment of awareness and clinical actions among healthcare professionals (HCPs). Case reports of pregnancy, medication errors and progressive multifocal leukoencephalopathy (PML) were the outcome indicators for Erivedge ® ▼, Kadcyla ® ▼ and MabThera ® (the latter specifically in autoimmune indications: rheumatoid arthritis, granulomatosis with polyangiitis and

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

Skeletal Muscle Quantitative Nuclear Magnetic Resonance Imaging and Spectroscopy as an Outcome Measure for Clinical Trials

PubMed Central

Carlier, Pierre G.; Marty, Benjamin; Scheidegger, Olivier; Loureiro de Sousa, Paulo; Baudin, Pierre-Yves; Snezhko, Eduard; Vlodavets, Dmitry

2016-01-01

Recent years have seen tremendous progress towards therapy of many previously incurable neuromuscular diseases. This new context has acted as a driving force for the development of novel non-invasive outcome measures. These can be organized in three main categories: functional tools, fluid biomarkers and imagery. In the latest category, nuclear magnetic resonance imaging (NMRI) offers a considerable range of possibilities for the characterization of skeletal muscle composition, function and metabolism. Nowadays, three NMR outcome measures are frequently integrated in clinical research protocols. They are: 1/ the muscle cross sectional area or volume, 2/ the percentage of intramuscular fat and 3/ the muscle water T2, which quantity muscle trophicity, chronic fatty degenerative changes and oedema (or more broadly, “disease activity”), respectively. A fourth biomarker, the contractile tissue volume is easily derived from the first two ones. The fat fraction maps most often acquired with Dixon sequences have proven their capability to detect small changes in muscle composition and have repeatedly shown superior sensitivity over standard functional evaluation. This outcome measure will more than likely be the first of the series to be validated as an endpoint by regulatory agencies. The versatility of contrast generated by NMR has opened many additional possibilities for characterization of the skeletal muscle and will result in the proposal of more NMR biomarkers. Ultra-short TE (UTE) sequences, late gadolinium enhancement and NMR elastography are being investigated as candidates to evaluate skeletal muscle interstitial fibrosis. Many options exist to measure muscle perfusion and oxygenation by NMR. Diffusion NMR as well as texture analysis algorithms could generate complementary information on muscle organization at microscopic and mesoscopic scales, respectively. 31P NMR spectroscopy is the reference technique to assess muscle energetics non-invasively during and

Heart rate variability measured early in patients with evolving acute coronary syndrome and 1-year outcomes of rehospitalization and mortality.

PubMed

Harris, Patricia R E; Stein, Phyllis K; Fung, Gordon L; Drew, Barbara J

2014-01-01

This study sought to examine the prognostic value of heart rate variability (HRV) measurement initiated immediately after emergency department presentation for patients with acute coronary syndrome (ACS). Altered HRV has been associated with adverse outcomes in heart disease, but the value of HRV measured during the earliest phases of ACS related to risk of 1-year rehospitalization and death has not been established. Twenty-four-hour Holter recordings of 279 patients with ACS were initiated within 45 minutes of emergency department arrival; recordings with ≥18 hours of sinus rhythm were selected for HRV analysis (number [N] =193). Time domain, frequency domain, and nonlinear HRV were examined. Survival analysis was performed. During the 1-year follow-up, 94 patients were event-free, 82 were readmitted, and 17 died. HRV was altered in relation to outcomes. Predictors of rehospitalization included increased normalized high frequency power, decreased normalized low frequency power, and decreased low/high frequency ratio. Normalized high frequency >42 ms(2) predicted rehospitalization while controlling for clinical variables (hazard ratio [HR] =2.3; 95% confidence interval [CI] =1.4-3.8, P=0.001). Variables significantly associated with death included natural logs of total power and ultra low frequency power. A model with ultra low frequency power <8 ms(2) (HR =3.8; 95% CI =1.5-10.1; P=0.007) and troponin >0.3 ng/mL (HR =4.0; 95% CI =1.3-12.1; P=0.016) revealed that each contributed independently in predicting mortality. Nonlinear HRV variables were significant predictors of both outcomes. HRV measured close to the ACS onset may assist in risk stratification. HRV cut-points may provide additional, incremental prognostic information to established assessment guidelines, and may be worthy of additional study.

Scope and design of the Following Rehabilitation, Economics and Everyday-Dialysis Outcome Measurements (FREEDOM) Study.

PubMed

Jaber, Bertrand L; Finkelstein, Fredric O; Glickman, Joel D; Hull, Alan R; Kraus, Michael A; Leypoldt, John K; Liu, Jiannong; Gilbertson, David; McCarthy, James; Miller, Brent W; Moran, John; Collins, Allan J

2009-02-01

Conventional thrice-weekly hemodialysis (HD) has limited the ability to generate further improvements in patient quality of life, morbidity, and mortality. Daily HD (DHD) offers the promise of providing clinical and economic benefits. The objectives of the Following Rehabilitation, Economics and Everyday-Dialysis Outcome Measurements Study are to evaluate outcomes of DHD (6 times/wk) with the NxStage System One (NxStage Medical Inc, Lawrence, MA) device. Cohort study with matched control group. The DHD group will include up to 500 participants at 70 clinical sites, enrolling for 3 years with a minimum of 1-year follow-up. Study candidates include adult patients (age >or= 18 years) with end-stage renal disease who are considered suitable candidates for DHD with the NxStage System One device by the treating physician and who have Medicare as their primary insurance payer. The control group will consist of a matched thrice-weekly in-center HD cohort derived from the US Renal Data System database using a 10:1 ratio, totaling 5,000 patients. Treatment with DHD and "standard of care" thrice-weekly HD. The primary intent-to-treat analysis compares hospitalization days/patient-year between the DHD and thrice-weekly HD groups. Other outcomes recorded in both groups include non-treatment-related medical expenditures. In addition, in the DHD cohort, changes in quality-of-life measures (baseline, 4 and 12 months, and every 6 months thereafter); urea kinetics; parameters related to anemia, bone and mineral metabolism, and nutrition; vascular access interventions; and use of medications will be examined. This study has the potential to elucidate the health and economic benefits of DHD and complement results of current clinical trials.

Worker productivity outcome measures: OMERACT filter evidence and agenda for future research.

PubMed

Tang, Kenneth; Boonen, Annelies; Verstappen, Suzanne M M; Escorpizo, Reuben; Luime, Jolanda J; Lacaille, Diane; Fautrel, Bruno; Bosworth, Ailsa; Cifaldi, Mary; Gignac, Monique A M; Hofstetter, Cathy; Leong, Amye; Montie, Pam; Petersson, Ingemar F; Purcaru, Oana; Bombardier, Claire; Tugwell, Peter S; Beaton, Dorcas E

2014-01-01

The objective of the Outcome Measures in Rheumatology (OMERACT) Worker Productivity working group is to identify worker productivity outcome measures that meet the requirements of the OMERACT filter. At the OMERACT 11 Workshop, we focused on the at-work limitations/productivity component of worker productivity (i.e., presenteeism) - an area with diverse conceptualization and instrumentation approaches. Various approaches to quantify at-work limitations/productivity (e.g., single-item global and multi-item measures) were examined, and available evidence pertaining to OMERACT truth, discrimination, and feasibility were presented to conference participants. Four candidate global measures of presenteeism were put forth for a plenary vote to determine whether current evidence meets the OMERACT filter requirements. Presenteeism globals from the Work Productivity and Activity Impairment Questionnaire (72% support) and Rheumatoid Arthritis-specific Work Productivity Survey (71% support) were endorsed by conference participants; however, neither the presenteeism global item from the Health and Work Performance Questionnaire nor the Quantity and Quality method achieved the level of support required for endorsement at the present time. The plenary was also asked whether the central item from the Work Ability Index should also be considered as a candidate measure for potential endorsement in the future. Of participants at the plenary, 70% supported this presenteeism global measure. Progress was also made in other areas through discussions at individual breakout sessions. Topics examined include the merits of various multi-item measures of at-work limitations/productivity, methodological issues related to interpretability of outcome scores, and approaches to appraise and classify contextual factors of worker productivity. Feedback gathered from conference participants will inform the future research agenda of the working group.

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

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

Estimating the Error of an Analog Quantum Simulator by Additional Measurements

NASA Astrophysics Data System (ADS)

Schwenk, Iris; Zanker, Sebastian; Reiner, Jan-Michael; Leppäkangas, Juha; Marthaler, Michael

2017-12-01

We study an analog quantum simulator coupled to a reservoir with a known spectral density. The reservoir perturbs the quantum simulation by causing decoherence. The simulator is used to measure an operator average, which cannot be calculated using any classical means. Since we cannot predict the result, it is difficult to estimate the effect of the environment. Especially, it is difficult to resolve whether the perturbation is small or if the actual result of the simulation is in fact very different from the ideal system we intend to study. Here, we show that in specific systems a measurement of additional correlators can be used to verify the reliability of the quantum simulation. The procedure only requires additional measurements on the quantum simulator itself. We demonstrate the method theoretically in the case of a single spin connected to a bosonic environment.

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.

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

Longitudinal Multicenter Analysis of Outcomes After Cessation of Control Measures for Vancomycin-Resistant Enterococci.

PubMed

Lemieux, Camille; Gardam, Michael; Evans, Gerald; John, Michael; Suh, Kathryn N; vanWalraven, Carl; Vicencio, Elisa; Coulby, Cameron; Roth, Virginia; Hota, Susy

2017-01-01

OBJECTIVE To assess clinically relevant outcomes after complete cessation of control measures for vancomycin-resistant enterococci (VRE). DESIGN Quasi-experimental ecological study over 3.5 years. METHODS All VRE screening and isolation practices at 4 large academic hospitals in Ontario, Canada, were stopped on July 1, 2012. In total, 618 anonymized abstracted charts of patients with VRE-positive clinical isolates identified between July 1, 2010, and December 31, 2013, were reviewed to determine whether the case was a true VRE infection, a VRE colonization or contaminant, or a true VRE bacteremia. All deaths within 30 days of the last VRE infection were also reviewed to determine whether the death was fully or partially attributable to VRE. All-cause mortality was evaluated over the study period. Generalized estimating equation methods were used to cluster outcome rates within hospitals, and negative binomial models were created for each outcome. RESULTS The incidence rate ratio (IRR) for VRE infections was 0.59 and the associated P value was .34. For VRE bacteremias, the IRR was 0.54 and P=.38; for all-cause mortality the IRR was 0.70 and P=.66; and for VRE attributable death, the IRR was 0.35 and P=.49. VRE control measures were not significantly associated with any of the outcomes. Rates of all outcomes appeared to increase during the 18-month period after cessation of VRE control measures, but none reached statistical significance. CONCLUSION Clinically significant VRE outcomes remain rare. Cessation of all control measures for VRE had no significant attributable adverse clinical impact. Infect Control Hosp Epidemiol 2016;1-7.

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.

No common denominator: a review of outcome measures in IVF RCTs.

PubMed

Wilkinson, Jack; Roberts, Stephen A; Showell, Marian; Brison, Daniel R; Vail, Andy

2016-12-01

Which outcome measures are reported in RCTs for IVF? Many combinations of numerator and denominator are in use, and are often employed in a manner that compromises the validity of the study. The choice of numerator and denominator governs the meaning, relevance and statistical integrity of a study's results. RCTs only provide reliable evidence when outcomes are assessed in the cohort of randomised participants, rather than in the subgroup of patients who completed treatment. Review of outcome measures reported in 142 IVF RCTs published in 2013 or 2014. Trials were identified by searching the Cochrane Gynaecology and Fertility Specialised Register. English-language publications of RCTs reporting clinical or preclinical outcomes in peer-reviewed journals in the period 1 January 2013 to 31 December 2014 were eligible. Reported numerators and denominators were extracted. Where they were reported, we checked to see if live birth rates were calculated correctly using the entire randomised cohort or a later denominator. Over 800 combinations of numerator and denominator were identified (613 in no more than one study). No single outcome measure appeared in the majority of trials. Only 22 (43%) studies reporting live birth presented a calculation including all randomised participants or only excluding protocol violators. A variety of definitions were used for key clinical numerators: for example, a consensus regarding what should constitute an ongoing pregnancy does not appear to exist at present. Several of the included articles may have been secondary publications. Our categorisation scheme was essentially arbitrary, so the frequencies we present should be interpreted with this in mind. The analysis of live birth denominators was post hoc. There is massive diversity in numerator and denominator selection in IVF trials due to its multistage nature, and this causes methodological frailty in the evidence base. The twin spectres of outcome reporting bias and analysis of non

How do aggregated patient-reported outcome measures data stimulate health care improvement? A realist synthesis

PubMed Central

Dalkin, Sonia; Gibbons, Elizabeth; Wright, Judy; Valderas, Jose Maria; Meads, David; Black, Nick

2017-01-01

Objectives Internationally, there has been considerable debate about the role of data in supporting quality improvement in health care. Our objective was to understand how, why and in what circumstances the feedback of aggregated patient-reported outcome measures data improved patient care. Methods We conducted a realist synthesis. We identified three main programme theories underlying the use of patient-reported outcome measures as a quality improvement strategy and expressed them as nine ‘if then’ propositions. We identified international evidence to test these propositions through searches of electronic databases and citation tracking, and supplemented our synthesis with evidence from similar forms of performance data. We synthesized this evidence through comparing the mechanisms and impact of patient-reported outcome measures and other performance data on quality improvement in different contexts. Results Three programme theories were identified: supporting patient choice, improving accountability and enabling providers to compare their performance with others. Relevant contextual factors were extent of public disclosure, use of financial incentives, perceived credibility of the data and the practicality of the results. Available evidence suggests that patients or their agents rarely use any published performance data when selecting a provider. The perceived motivation behind public reporting is an important determinant of how providers respond. When clinicians perceived that performance indicators were not credible but were incentivized to collect them, gaming or manipulation of data occurred. Outcome data do not provide information on the cause of poor care: providers needed to integrate and interpret patient-reported outcome measures and other outcome data in the context of other data. Lack of timeliness of performance data constrains their impact. Conclusions Although there is only limited research evidence to support some widely held theories of how

Patient-reported outcomes (PROs): the significance of using humanistic measures in clinical trial and clinical practice.

PubMed

Refolo, P; Minacori, R; Mele, V; Sacchini, D; Spagnolo, A G

2012-10-01

Patient-reported outcome (PRO) is an "umbrella term" that covers a whole range of potential types of measurement but it is used specifically to refer to all measures quantifying the state of health through the evaluation of outcomes reported by the patient himself/herself. PROs are increasingly seen as complementary to biomedical measures and they are being incorporated more frequently into clinical trials and clinical practice. After considering the cultural background of PROs - that is the well known patient-centered model of medicine -, their historical profile (since 1914, the year of the first outcome measure) and typologies, the paper aims at debating their methodological complexity and implementation into practice. Some clinical trials and therapeutic managements utilizing patient-centered measures will be also analyzed.

Actigraphy scoring for sleep outcome measures in chronic obstructive pulmonary disease.

PubMed

Kapella, Mary C; Vispute, Sachin; Zhu, Bingqian; Herdegen, James J

2017-09-01

Actigraphy is commonly used to measure sleep outcomes so that sleep can be measured conveniently at home over multiple nights. Actigraphy has been validated in people with sleep disturbances; however, the validity of scoring settings in people with chronic medical illnesses such as chronic obstructive pulmonary disease remains unclear. The purpose of this secondary analysis was to compare actigraphy-customized scoring settings with polysomnography (PSG) for the measurement of sleep outcomes in people with chronic obstructive pulmonary disease who have insomnia. Participants underwent overnight sleep assessment simultaneously by PSG and actigraphy at the University of Illinois of Chicago Sleep Science Center. Fifty participants (35 men and 15 women) with mild-to-severe chronic obstructive pulmonary disease and co-existing insomnia were included in the analysis. Sleep onset latency, total sleep time (TST), wake after sleep onset (WASO), and sleep efficiency (SE) were calculated independently from data derived from PSG and actigraphy. Actigraphy sleep outcome scores obtained at the default setting and several customized actigraphy settings were compared to the scored PSG results. Although no single setting was optimal for all sleep outcomes, the combination of 10 consecutive immobile minutes for sleep onset or end and an activity threshold of 10 worked well. Actigraphy overestimated TST and SE and underestimated WASO, but there was no difference in variance between PSG and actigraphy in TST and SE when the 10 × 10 combination was used. As the average TST and SE increased, the agreement between PSG and actigraphy appeared to increase, and as the average WASO decreased, the agreement between PSG and actigraphy appeared to increase. Results support the conclusion that the default actigraphy settings may not be optimal for people with chronic obstructive pulmonary disease and co-existing insomnia. Copyright © 2017 The Author(s). Published by Elsevier B.V. All rights

Measuring what matters to patients: Using goal content to inform measure choice and development.

PubMed

Jacob, Jenna; Edbrooke-Childs, Julian; Law, Duncan; Wolpert, Miranda

2017-04-01

Personalised care requires personalised outcomes and ways of feeding back clinically useful information to clinicians and practitioners, but it is not clear how to best personalise outcome measurement and feedback using existing standardised outcome measures. The constant comparison method of grounded theory was used to compare goal themes derived from goals set at the outset of therapy for 180 children aged between 4 and 17 years, visiting eight child and adolescent mental health services, to existing standardised outcome measures used as part of common national datasets. In all, 20 out of 27 goal themes corresponded to items on at least one commonly used outcome measure. Consideration of goal themes helped to identify potential relevant outcome measures. However, there were several goal themes that were not captured by items on standardised outcome measures. These seemed to be related to existential factors such as understanding, thinking about oneself and future planning. This presents a powerful framework for how clinicians can use goals to help select a standardised outcome measure (where this is helpful) in addition to the use of a goal-based outcome measure and personalise choices. There may be areas not captured by standardised outcome measures that may be important for children and young people and which may only be currently captured in goal measurement. There is an indication that we may not be measuring what is important to children and young people. We may need to develop or look for new measures that capture these areas.

Alzheimer Disease Biomarkers as Outcome Measures for Clinical Trials in MCI.

PubMed

Caroli, Anna; Prestia, Annapaola; Wade, Sara; Chen, Kewei; Ayutyanont, Napatkamon; Landau, Susan M; Madison, Cindee M; Haense, Cathleen; Herholz, Karl; Reiman, Eric M; Jagust, William J; Frisoni, Giovanni B

2015-01-01

The aim of this study was to compare the performance and power of the best-established diagnostic biological markers as outcome measures for clinical trials in patients with mild cognitive impairment (MCI). Magnetic resonance imaging, F-18 fluorodeoxyglucose positron emission tomography markers, and Alzheimer's Disease Assessment Scale-cognitive subscale were compared in terms of effect size and statistical power over different follow-up periods in 2 MCI groups, selected from Alzheimer's Disease Neuroimaging Initiative data set based on cerebrospinal fluid (abnormal cerebrospinal fluid Aβ1-42 concentration-ABETA+) or magnetic resonance imaging evidence of Alzheimer disease (positivity to hippocampal atrophy-HIPPO+). Biomarkers progression was modeled through mixed effect models. Scaled slope was chosen as measure of effect size. Biomarkers power was estimated using simulation algorithms. Seventy-four ABETA+ and 51 HIPPO+ MCI patients were included in the study. Imaging biomarkers of neurodegeneration, especially MR measurements, showed highest performance. For all biomarkers and both MCI groups, power increased with increasing follow-up time, irrespective of biomarker assessment frequency. These findings provide information about biomarker enrichment and outcome measurements that could be employed to reduce MCI patient samples and treatment duration in future clinical trials.

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

Review of patient-reported outcome measures in chronic hepatitis C

PubMed Central

2012-01-01

Background Chronic hepatitis C (CHC) and its treatment are associated with a variety of patient-reported symptoms and impacts. Some CHC symptoms and impacts may be difficult to evaluate through objective clinical testing, and more easily measured through patient self-report. This literature review identified concepts raised by CHC patients related to symptoms, impacts, and treatment effects, and evaluated integration of these concepts within patient-reported outcome (PRO) measures. The goal of this work was to provide recommendations for incorporation of PRO measurement of concepts that are relevant to the CHC experience into CHC clinical trial design. Methods A three-tiered literature search was conducted. This included searches on concepts of importance, PRO measures used in clinical trials, and existing PRO measures. The PRO Concept Search focused on reviewing issues raised by CHC patients about CHC symptoms, disease impact, and treatment effects. The CHC Trials with PRO Endpoints Search reviewed clinical trials with PRO endpoints to assess differences between treatments over time. The PRO Measure Search reviewed existing PRO measures associated with the concepts of interest. Results This multi-tiered approach identified five key concepts of interest: depression/anxiety, fatigue, flu-like symptoms, cognitive function, insomnia. Comparing these five concepts of interest to the PRO measures in published CHC clinical trials showed that, while treatment of CHC may decrease health-related quality of life in a number of mental and physical domains, the PRO measures that were utilized in published clinical trials inadequately covered the concepts of interest. Further review of 18 existing PRO measures of the concepts of interest showed only four of the 18 were validated in CHC populations. Conclusions This review identified several gaps in the literature regarding assessment of symptoms and outcomes reported as important by CHC patients. Further research is needed to

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

PubMed

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

2012-04-01

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

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

PubMed Central

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

2013-01-01

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

Goal achievement as a patient‐generated outcome measure for stress urinary incontinence

PubMed Central

Milne, Jill L.; Robert, Magali; Tang, Selphee; Drummond, Neil; Ross, Sue

2009-01-01

Abstract Objectives  To explore women’s goals and goal attainment for the conservative and surgical treatment of stress urinary incontinence (SUI), and to examine the feasibility of Goal Attainment Scaling (GAS) as an outcome measure in this population. Background  Despite the range of treatments for SUI, little is known about the outcomes patients consider important. Current instruments measure the impact of SUI on the ability to live a ‘normal’ life without addressing what normal looks like for the patient. Patient‐generated measures that address what a patient aims to achieve may fill this gap. Design  A mixed‐methods exploratory design combined semi‐structured interviews with validated questionnaires and individualized rating of goal achievement. Setting and participants  Participants with SUI (n = 18) were interviewed in their homes prior to initiation of treatment and 3–6 months afterwards. Main variables  Participants reported individualized goals pre‐treatment and rated goal attainment after surgical and conservative therapy. Quality of life impact and change were measured using short forms of the Incontinence Impact Questionnaire and Urinary Distress Inventory. Results  Women expressed a median of four highly individualized treatment‐related goals but goal achievement following conservative treatment was poor. GAS was not feasible as an outcome measure; women readily identified personal goals but could not independently identify graded levels of attainment for each goal. Conclusions  Although further work is needed to examine the most feasible, valid, and reliable method of measuring goal achievement in research, asking patients with UI to identify pre‐treatment goals may provide useful information to guide treatment‐related decision making. PMID:19754692

Evaluation of outcome measures for use in clinical practice for adults with musculoskeletal conditions of the knee: a systematic review.

PubMed

Howe, Tracey E; Dawson, Lesley J; Syme, Grant; Duncan, Louise; Reid, Judith

2012-04-01

This systematic review reported on the clinimetric properties of outcome measures for use in clinical practice for adults with musculoskeletal conditions of the knee. A systematic search was performed in Medline, EMBASE, Cinahl and AMED to identify studies examining the clinimetric properties of outcome measures for adults undergoing conservative treatment of ligament injuries, meniscal lesions, patellofemoral pain and osteoarthritis of the knee. Outcomes measures taking less than 20 min to administer and requiring minimal equipment and space were included. Pairs of authors used a checklist to record the characteristics of the outcome measures, their reported clinimetric properties and the demographics of the study populations. The OMERACT filters of 'truth' and 'discrimination' were applied to the data for each outcome measure by an expert panel. Forty-seven studies were included evaluating 37 outcome measures. Ten outcome measures had adequate supporting evidence for 'truth' and 'discrimination': AAOS, AKPS, goniometer measurement, IKDC, KOOS, LEFS, Lysholm, Tegner, WOMAC and WOMET. However none of the outcome measures had been comprehensively tested across all clinimetric properties. Despite the widespread use of some outcome measures in clinical practice and primary research, data on the clinimetric properties were available for only 37 and of these only 10 had adequate supporting evidence for use in this population. However, before a core set of outcome measures can be recommended use in clinical practice, for adults with musculoskeletal conditions of the knee, consensus should be obtained on 'feasibility' in terms of burden on the clinician and the participant. Copyright © 2011 Elsevier Ltd. All rights reserved.

Are validated outcome measures used in distal radial fractures truly valid?

PubMed Central

Nienhuis, R. W.; Bhandari, M.; Goslings, J. C.; Poolman, R. W.; Scholtes, V. A. B.

2016-01-01

Objectives Patient-reported outcome measures (PROMs) are often used to evaluate the outcome of treatment in patients with distal radial fractures. Which PROM to select is often based on assessment of measurement properties, such as validity and reliability. Measurement properties are assessed in clinimetric studies, and results are often reviewed without considering the methodological quality of these studies. Our aim was to systematically review the methodological quality of clinimetric studies that evaluated measurement properties of PROMs used in patients with distal radial fractures, and to make recommendations for the selection of PROMs based on the level of evidence of each individual measurement property. Methods A systematic literature search was performed in PubMed, EMbase, CINAHL and PsycINFO databases to identify relevant clinimetric studies. Two reviewers independently assessed the methodological quality of the studies on measurement properties, using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist. Level of evidence (strong / moderate / limited / lacking) for each measurement property per PROM was determined by combining the methodological quality and the results of the different clinimetric studies. Results In all, 19 out of 1508 identified unique studies were included, in which 12 PROMs were rated. The Patient-rated wrist evaluation (PRWE) and the Disabilities of Arm, Shoulder and Hand questionnaire (DASH) were evaluated on most measurement properties. The evidence for the PRWE is moderate that its reliability, validity (content and hypothesis testing), and responsiveness are good. The evidence is limited that its internal consistency and cross-cultural validity are good, and its measurement error is acceptable. There is no evidence for its structural and criterion validity. The evidence for the DASH is moderate that its responsiveness is good. The evidence is limited that its reliability and the

The use of routine outcome measures in two child and adolescent mental health services: a completed audit cycle

PubMed Central

2013-01-01

Background Routine outcome measurement (ROM) is important for assessing the clinical effectiveness of health services and for monitoring patient outcomes. Within Child and Adolescent Mental Health Services (CAMHS) in the UK the adoption of ROM in CAMHS has been supported by both national and local initiatives (such as government strategies, local commissioning policy, and research). Methods With the aim of assessing how these policies and initiatives may have influenced the uptake of ROM within two different CAMHS we report the findings of two case-note audits: a baseline audit conducted in January 2011 and a re-audit conducted two years later in December 2012-February 2013. Results The findings show an increase in both the single and repeated use of outcome measures from the time of the original audit, with repeated use (baseline and follow-up) of the Health of the Nation Outcome Scale for Children and Adolescents (HoNOSCA) scale increasing from 10% to 50% of cases. Re-audited case-notes contained more combined use of different outcome measures, with greater consensus on which measures to use. Outcome measures that were applicable across a wide range of clinical conditions were more likely to be used than symptom-specific measures, and measures that were completed by the clinician were found more often than measures completed by the service user. Conclusions The findings show a substantial improvement in the use of outcome measures within CAMHS. These increases in use were found across different service organisations which were subject to different types of local service priorities and drivers. PMID:24139139

Patient Reported Outcome Measure of Spiritual Care as Delivered by Chaplains.

PubMed

Snowden, Austyn; Telfer, Iain

2017-01-01

Chaplains are employed by health organizations around the world to support patients in recognizing and addressing their spiritual needs. There is currently no generalizable measure of the impact of these interventions and so the clinical and strategic worth of chaplaincy is difficult to articulate. This article introduces the Scottish PROM, an original five-item patient reported outcome measure constructed specifically to address this gap. It describes the validation process from its conceptual grounding in the spiritual care literature through face and content validity cycles. It shows that the Scottish PROM is internally consistent and unidimensional. Responses to the Scottish PROM show strong convergent validity with responses to the Warwick and Edinburgh Mental Well-Being Scale, a generic well-being scale often used as a proxy for spiritual well-being. In summary, the Scottish PROM is fit for purpose. It measures the outcomes of spiritual care as delivered by chaplains in this study. This novel project introduces an essential and original breakthrough; the possibility of generalizable international chaplaincy research.

Patient-reported outcome measures in arthroplasty registries

PubMed Central

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

2016-01-01

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

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

No effect of additional screw fixation of a cementless, all-polyethylene press-fit socket on migration, wear, and clinical outcome.

PubMed

Minten, Michiel J M; Heesterbeek, Petra J C; Spruit, Maarten

2016-08-01

Background and purpose - Additional screw fixation of the all-polyethylene press-fit RM cup (Mathys) has no additional value for migration, in the first 2 years after surgery. However, the medium-term and long-term effects of screw fixation remain unclear. We therefore evaluated the influence of screw fixation on migration, wear, and clinical outcome at 6.5 years using radiostereometric analysis (RSA). Patients and methods - This study involved prolonged follow-up from a previous randomized controlled trial (RCT). We analyzed RSA radiographs taken at baseline and at 1-, 2-, and 6.5-year follow-up. Cup migration and wear were assessed using model-based RSA software. Wear was calculated as translation of the femoral head model in relation to the cup model. Total translation, rotation, and wear were calculated mathematically from results of the orthogonal components. Results - 27 patients (15 with screw fixation and 12 without) were available for follow-up at 6.5 (5.6-7.2) years. Total translation (0.50 mm vs. 0.56 mm) and rotation (1.01 degrees vs. 1.33 degrees) of the cup was low, and was not significantly different between the 2 groups. Wear increased over time, and was similar between the 2 groups (0.58 mm vs. 0.53 mm). Wear rate (0.08 mm/year vs. 0.09 mm/year) and clinical outcomes were also similar. Interpretation - Our results indicate that additional screw fixation of all-polyethylene press-fit RM cups has no additional value regarding medium-term migration and clinical outcome. The wear rate was low in both groups.

Initial constructs for patient-centered outcome measures to evaluate brain-computer interfaces.

PubMed

Andresen, Elena M; Fried-Oken, Melanie; Peters, Betts; Patrick, Donald L

2016-10-01

The authors describe preliminary work toward the creation of patient-centered outcome (PCO) measures to evaluate brain-computer interface (BCI) as an assistive technology (AT) for individuals with severe speech and physical impairments (SSPI). In Phase 1, 591 items from 15 existing measures were mapped to the International Classification of Functioning, Disability and Health (ICF). In Phase 2, qualitative interviews were conducted with eight people with SSPI and seven caregivers. Resulting text data were coded in an iterative analysis. Most items (79%) were mapped to the ICF environmental domain; over half (53%) were mapped to more than one domain. The ICF framework was well suited for mapping items related to body functions and structures, but less so for items in other areas, including personal factors. Two constructs emerged from qualitative data: quality of life (QOL) and AT. Component domains and themes were identified for each. Preliminary constructs, domains and themes were generated for future PCO measures relevant to BCI. Existing instruments are sufficient for initial items but do not adequately match the values of people with SSPI and their caregivers. Field methods for interviewing people with SSPI were successful, and support the inclusion of these individuals in PCO research. Implications for Rehabilitation Adapted interview methods allow people with severe speech and physical impairments to participate in patient-centered outcomes research. Patient-centered outcome measures are needed to evaluate the clinical implementation of brain-computer interface as an assistive technology.

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...

The importance of patient-reported outcome measures in reconstructive urology.

PubMed

Jackson, Matthew J; N'Dow, James; Pickard, Rob

2010-11-01

Patient-reported outcome measures (PROMs) are now recognised as the most appropriate instruments to assess the effectiveness of healthcare interventions from the patient's perspective. The purpose of this review was to identify recent publications describing the use of PROMs following reconstructive urological surgery. A wide systematic search identified only three original articles published in the last 2 years that prospectively assessed effectiveness using a patient-completed condition-specific or generic health-related quality of life (HRQoL) instrument. These publications illustrate the need to administer PROMs at a postoperative interval relevant to the anticipated recovery phase of individual procedures. They also highlight the difference in responsiveness of generic HRQoL instruments to symptomatic improvement between straightforward conditions such as pelviureteric junction obstruction and complex multidimensional conditions such as meningomyelocele. PROMs uptake and awareness is increasing in reconstructive urology but more work is required to demonstrate the effectiveness of surgical procedures for patients and healthcare funders alike. Healthcare policy-makers now rely on these measures to determine whether specific treatments are worth financing and to compare outcomes between institutions.

Developing a General Outcome Measure of Growth in Movement for Infants and Toddlers.

ERIC Educational Resources Information Center

Greenwood, Charles R.; Luze, Gayle J.; Cline, Gabriel; Kuntz, Susan; Leitschuh, Carol

2002-01-01

The development of an experimental measure for assessing growth in movement in children (ages birth-3) is described. Results from the use of the Movement General Outcome Measurement with 29 infants and toddlers demonstrated the feasibility of the measure. The 6-minute assessment was found reliable in terms of inter-observer agreement. (Contains…

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.