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.

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

PubMed

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

2009-01-01

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

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.

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

PubMed

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

2009-11-17

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

A Correlational Study on Critical Thinking in Nursing as an Outcome Variable for Success

ERIC Educational Resources Information Center

Porter, Rebecca Jean

2018-01-01

Critical thinking is a required curricular outcome for nursing education; however, the literature shows a gap related to valid and reliable tools to measure critical thinking specific to nursing and relating that critical thinking measurement to meaningful outcomes. This study examined critical thinking scores, as measured by Assessment…

Definition of delayed cerebral ischemia after aneurysmal subarachnoid hemorrhage as an outcome event in clinical trials and observational studies: proposal of a multidisciplinary research group.

PubMed

Vergouwen, Mervyn D I; Vermeulen, Marinus; van Gijn, Jan; Rinkel, Gabriel J E; Wijdicks, Eelco F; Muizelaar, J Paul; Mendelow, A David; Juvela, Seppo; Yonas, Howard; Terbrugge, Karel G; Macdonald, R Loch; Diringer, Michael N; Broderick, Joseph P; Dreier, Jens P; Roos, Yvo B W E M

2010-10-01

In clinical trials and observational studies there is considerable inconsistency in the use of definitions to describe delayed cerebral ischemia (DCI) after aneurysmal subarachnoid hemorrhage. A major cause for this inconsistency is the combining of radiographic evidence of vasospasm with clinical features of cerebral ischemia, although multiple factors may contribute to DCI. The second issue is the variability and overlap of terms used to describe each phenomenon. This makes comparisons among studies difficult. An international ad hoc panel of experts involved in subarachnoid hemorrhage research developed and proposed a definition of DCI to be used as an outcome measure in clinical trials and observational studies. We used a consensus-building approach. It is proposed that in observational studies and clinical trials aiming to investigate strategies to prevent DCI, the 2 main outcome measures should be: (1) cerebral infarction identified on CT or MRI or proven at autopsy, after exclusion of procedure-related infarctions; and (2) functional outcome. Secondary outcome measure should be clinical deterioration caused by DCI, after exclusion of other potential causes of clinical deterioration. Vasospasm on angiography or transcranial Doppler can also be used as an outcome measure to investigate proof of concept but should be interpreted in conjunction with DCI or functional outcome. The proposed measures reflect the most relevant morphological and clinical features of DCI without regard to pathogenesis to be used as an outcome measure in clinical trials and observational studies.

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

PubMed

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

2018-04-01

The purposes of this review were (1) to collate and synthesize research studies reporting any outcome measure on both open and arthroscopic surgical treatment of femoroacetabular impingement (FAI) syndrome and (2) to report the prevalence and consistency of outcomes across the included studies. A computer-assisted literature search of the MEDLINE, CINAHL (Cumulative Index to Nursing and Allied Health Literature), and Embase databases was conducted using keywords related to FAI syndrome and both open and arthroscopic surgical outcomes, resulting in 2,614 studies, with 163 studies involving 14,824 subjects meeting the inclusion criteria. Two authors independently reviewed study inclusion and data extraction with independent verification. The prevalence of reported outcomes was calculated and verified by separate authors. Between 2004 and 2016, there has been a 2,600% increase in the publication of surgical outcome studies. Patients had a mean duration of symptoms of 27.7 ± 21.5 months before surgery. Arthroscopy was the surgical treatment used in 71% of studies. The mean final follow-up period after surgery was 32.2 ± 17.3 months. Follow-up time frames were reported in 78% of studies. Ten different patient-reported outcome measures were reported. The alpha angle was reported to be measured 42% less frequently as a surgical outcome than as a surgical indication. Surgical complications were addressed in only 53% of studies and failures in 69%. Labral pathology (91% of studies reporting) and chondral pathology (61%) were the primary coexisting pathologies reported. Clinical signs, as defined by the Warwick Agreement on FAI syndrome, were reported in fewer than 25% of studies. Most FAI syndrome patients have longstanding pain and potential coexisting pathology. Patient-reported outcome measures and diagnostic imaging are the most frequently reported outcomes. Measures of hip strength and range of motion are under-reported. It is unclear whether the inconsistency in reporting is because of lack of measurement or lack of reporting of specific outcomes in these studies. Current surgical outcomes are limited to mid-term surgical follow-up time frames and inconsistent outcome reporting. Level IV, systematic review of Level I through IV studies. Copyright © 2017 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

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

PubMed

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

2014-05-13

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

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

PubMed Central

2014-01-01

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

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.

A core outcome set for clinical trials in acute diarrhoea.

PubMed

Karas, Jacek; Ashkenazi, Shai; Guarino, Alfredo; Lo Vecchio, Andrea; Shamir, Raanan; Vandenplas, Yvan; Szajewska, Hania

2015-04-01

Core outcome sets are the baseline for what should be measured in clinical research and, thus, should serve as a guide for what should be collected and reported. The Consensus Group on Outcome Measures Made in Pediatric Enteral Nutrition Clinical Trials, established in 2012, agreed that consensus on a core set of outcomes with agreed-upon definitions that should be measured and reported in clinical trials was needed. To achieve this goal, six working groups (WGs) were setup, including WG on acute diarrhoea, whose main goal was to develop a core outcome set for trials in acute diarrhoea. The first step identified how published outcomes related to acute diarrhoea were reported. The second focused on the methodology for determining which outcomes to measure in clinical trials. The third employed a two-phase questionnaire study using the Delphi technique to define clinically important outcomes to clinicians and parents. For therapeutic studies, the five most important outcome measures were diarrhoea duration, degree of dehydration, need for hospitalisation (or duration of hospitalisation for inpatients), the proportion of patients recovered by 48 h and adverse effects. The prophylactic core outcome set included prevention of diarrhoea, prevention of dehydration, prevention of hospitalisation and adverse effects. The outcome sets for therapy and prevention can be recommended for use in future trials of patients with gastroenteritis. Their envisioned goal is to decrease study heterogeneity and to ease the comparability of studies. WG's next step is to determine how to measure the outcomes included in the core set. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Outcomes of Interorganizational Networks in Canada for Chronic Disease Prevention: Insights From a Concept Mapping Study, 2015.

PubMed

Willis, Cameron; Kernoghan, Alison; Riley, Barbara; Popp, Janice; Best, Allan; Milward, H Brinton

2015-11-19

We conducted a mixed methods study from June 2014 to March 2015 to assess the perspectives of stakeholders in networks that adopt a population approach for chronic disease prevention (CDP). The purpose of the study was to identify important and feasible outcome measures for monitoring network performance. Participants from CDP networks in Canada completed an online concept mapping exercise, which was followed by interviews with network stakeholders to further understand the findings. Nine concepts were considered important outcomes of CDP networks: enhanced learning, improved use of resources, enhanced or increased relationships, improved collaborative action, network cohesion, improved system outcomes, improved population health outcomes, improved practice and policy planning, and improved intersectoral engagement. Three themes emerged from participant interviews related to measurement of the identified concepts: the methodological difficulties in measuring network outcomes, the dynamic nature of network evolution and function and implications for outcome assessment, and the challenge of measuring multisectoral engagement in CDP networks. Results from this study provide initial insights into concepts that can be used to describe the outcomes of networks for CDP and may offer foundations for strengthening network outcome-monitoring strategies and methodologies.

Outcomes of Interorganizational Networks in Canada for Chronic Disease Prevention: Insights From a Concept Mapping Study, 2015

PubMed Central

Kernoghan, Alison; Riley, Barbara; Popp, Janice; Best, Allan; Milward, H. Brinton

2015-01-01

Introduction We conducted a mixed methods study from June 2014 to March 2015 to assess the perspectives of stakeholders in networks that adopt a population approach for chronic disease prevention (CDP). The purpose of the study was to identify important and feasible outcome measures for monitoring network performance. Methods Participants from CDP networks in Canada completed an online concept mapping exercise, which was followed by interviews with network stakeholders to further understand the findings. Results Nine concepts were considered important outcomes of CDP networks: enhanced learning, improved use of resources, enhanced or increased relationships, improved collaborative action, network cohesion, improved system outcomes, improved population health outcomes, improved practice and policy planning, and improved intersectoral engagement. Three themes emerged from participant interviews related to measurement of the identified concepts: the methodological difficulties in measuring network outcomes, the dynamic nature of network evolution and function and implications for outcome assessment, and the challenge of measuring multisectoral engagement in CDP networks. Conclusion Results from this study provide initial insights into concepts that can be used to describe the outcomes of networks for CDP and may offer foundations for strengthening network outcome-monitoring strategies and methodologies. PMID:26583571

Osteoarthritis year in review: rehabilitation and outcomes.

PubMed

Davis, A M

2012-03-01

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

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

PubMed Central

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

2015-01-01

Objectives This paper aimed to systematically evaluate the mental health and well-being outcomes observed in previous community-based obesity prevention interventions in adolescent populations. Setting Systematic review of literature from database inception to October 2014. Articles were sourced from CINAHL, Global Health, Health Source: Nursing and Academic Edition, MEDLINE, PsycARTICLES and PsycINFO, all of which were accessed through EBSCOhost. The Cochrane Database was also searched to identify all eligible articles. PRISMA guidelines were followed and search terms and search strategy ensured all possible studies were identified for review. Participants Intervention studies were eligible for inclusion if they were: focused on overweight or obesity prevention, community-based, targeted adolescents (aged 10–19 years), reported a mental health or well-being measure, and included a comparison or control group. Studies that focused on specific adolescent groups or were treatment interventions were excluded from review. Quality of evidence was assessed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) guidelines. Primary and secondary outcome measures Primary outcomes were measures of mental health and well-being, including diagnostic and symptomatic measures. Secondary outcomes included adiposity or weight-related measures. Results Seven studies met the inclusion criteria; one reported anxiety/depressive outcomes, two reported on self-perception well-being measures such as self-esteem and self-efficacy, and four studies reported outcomes of quality of life. Positive mental health outcomes demonstrated that following obesity prevention, interventions included a decrease in anxiety and improved health-related quality of life. Quality of evidence was graded as very low. Conclusions Although positive outcomes for mental health and well-being do exist, controlled evaluations of community-based obesity prevention interventions have not often included mental health measures (n=7). It is recommended that future interventions incorporate mental health and well-being measures to identify any potential mechanisms influencing adolescent weight-related outcomes, and equally to ensure interventions are not causing harm to adolescent mental health. PMID:25564145

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.

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 emerge as widely used and clinically meaningful. These data support the need for a paradigm shift toward the consistent use of valid and reliable outcome measures for foot and ankle clinical research.

Hand therapist use of patient report outcome (PRO) in practice: a survey study.

PubMed

Valdes, Kristin; MacDermid, Joy; Algar, Lori; Connors, Brian; Cyr, Lisa M; Dickmann, Sharon; Lucado, Ann M; Naughton, Nancy

2014-01-01

The purpose of this survey was to gain greater insight into hand therapists' use of Patient Report Outcome (PRO) measures. An 11-question survey that evaluated therapists' perceptions, preferences, and patterns of use of patient report outcome measures was sent to members of ASHT. A total of 633 ASHT members participated in the survey study. A large majority of participants (92%) responded affirmatively to using a PRO measure in practice. The DASH was reported as the most frequently used measure (90%). The majority of therapists (84%) discuss the results of the outcome measurement score with their patients. Of the participants who use more than one outcome measure, 44% report that this allows them to better establish their patient's functional and physical limitations. The findings in this study suggest that a large percentage of hand therapists are currently including a PRO measure in their hand therapy practice. Copyright © 2014 Hanley & Belfus. Published by Elsevier Inc. All rights reserved.

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.

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…

Measurement error, time lag, unmeasured confounding: Considerations for longitudinal estimation of the effect of a mediator in randomised clinical trials.

PubMed

Goldsmith, K A; Chalder, T; White, P D; Sharpe, M; Pickles, A

2018-06-01

Clinical trials are expensive and time-consuming and so should also be used to study how treatments work, allowing for the evaluation of theoretical treatment models and refinement and improvement of treatments. These treatment processes can be studied using mediation analysis. Randomised treatment makes some of the assumptions of mediation models plausible, but the mediator-outcome relationship could remain subject to bias. In addition, mediation is assumed to be a temporally ordered longitudinal process, but estimation in most mediation studies to date has been cross-sectional and unable to explore this assumption. This study used longitudinal structural equation modelling of mediator and outcome measurements from the PACE trial of rehabilitative treatments for chronic fatigue syndrome (ISRCTN 54285094) to address these issues. In particular, autoregressive and simplex models were used to study measurement error in the mediator, different time lags in the mediator-outcome relationship, unmeasured confounding of the mediator and outcome, and the assumption of a constant mediator-outcome relationship over time. Results showed that allowing for measurement error and unmeasured confounding were important. Contemporaneous rather than lagged mediator-outcome effects were more consistent with the data, possibly due to the wide spacing of measurements. Assuming a constant mediator-outcome relationship over time increased precision.

Measurement error, time lag, unmeasured confounding: Considerations for longitudinal estimation of the effect of a mediator in randomised clinical trials

PubMed Central

Goldsmith, KA; Chalder, T; White, PD; Sharpe, M; Pickles, A

2016-01-01

Clinical trials are expensive and time-consuming and so should also be used to study how treatments work, allowing for the evaluation of theoretical treatment models and refinement and improvement of treatments. These treatment processes can be studied using mediation analysis. Randomised treatment makes some of the assumptions of mediation models plausible, but the mediator–outcome relationship could remain subject to bias. In addition, mediation is assumed to be a temporally ordered longitudinal process, but estimation in most mediation studies to date has been cross-sectional and unable to explore this assumption. This study used longitudinal structural equation modelling of mediator and outcome measurements from the PACE trial of rehabilitative treatments for chronic fatigue syndrome (ISRCTN 54285094) to address these issues. In particular, autoregressive and simplex models were used to study measurement error in the mediator, different time lags in the mediator–outcome relationship, unmeasured confounding of the mediator and outcome, and the assumption of a constant mediator–outcome relationship over time. Results showed that allowing for measurement error and unmeasured confounding were important. Contemporaneous rather than lagged mediator–outcome effects were more consistent with the data, possibly due to the wide spacing of measurements. Assuming a constant mediator–outcome relationship over time increased precision. PMID:27647810

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.

Progress on core outcome sets for critical care research.

PubMed

Blackwood, Bronagh; Marshall, John; Rose, Louise

2015-10-01

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

Outcome related to impact on daily living: preliminary validation of the ORIDL instrument.

PubMed

Reilly, David; Mercer, Stewart W; Bikker, Annemieke P; Harrison, Tansy

2007-09-02

The challenge of finding practical, patient-rated outcome measures is a key issue in the evaluation of health care systems and interventions. The ORIDL (Outcome in Relation to Impact on Daily Living) instrument (formerly referred to as the Glasgow Homoeopathic Hospital Outcomes Scale or GHHOS) has been developed to measure patient's views of the outcome of their care by asking about change, and relating this to impact on daily life. The aim of the present paper is to describe the background and potential uses of the ORIDL, and to report on its preliminary validation in a series of three studies in secondary and primary care. In the first study, 105 patients attending the Glasgow Homoeopathic Hospital (GHH) were followed-up at 12 months and changes in health status were measured by the EuroQol (EQOL) and the ORIDL. In the second study, 187 new patients at the GHH were followed-up at 3, 12, and 33 months, using the ORIDL, the Short Form 12 (SF-12), and the Measure Yourself Medical Outcome Profile (MYMOP). In study three, 323 patients in primary care were followed for 1 month post-consultation using the ORIDL and MYMOP. In all 3 studies the Patient Enablement Instrument (PEI) was also used as an outcome measure. Study 1 showed substantial improvements in main complaint and well-being over 12 months using the ORIDL, with two-thirds of patients reporting improvements in daily living. These improvements were not significantly correlated with changes in serial measures of the EQOL between baseline and 12 months, but were correlated with the EQOL transitions measure. Study 2 showed step-wise improvements in ORIDL scores between 3 and 33 months, which were only weakly associated with similar changes in SF-12 scores. However, MYMOP change scores correlated well with ORIDL scores at all time points. Study 3 showed similar high correlations between ORIDL scores and MYMOP scores. In all 3 studies, ORIDL scores were also significantly correlated with PEI-outcome scores. There is significant agreement between patient outcomes assessed by the ORIDL and the EQOL transition scale, the MYMOP, and the PEI-outcome instrument, suggesting that the ORIDL may be a valid and sensitive tool for measuring change in relation to impact on life.

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…

Measuring spine fracture outcomes: common scales and checklists.

PubMed

Schoenfeld, Andrew J; Bono, Christopher M

2011-03-01

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

A systematic review of oral herpetic viral infections in cancer patients: commonly used outcome measures and interventions.

PubMed

Elad, Sharon; Ranna, Vinisha; Ariyawardana, Anura; Correa, Maria Elvira Pizzigatti; Tilly, Vanessa; Nair, Raj G; Rouleau, Tanya; Logan, Richard M; Pinto, Andres; Charette, Veronica; Saunders, Debbie P; Jensen, Siri Beier

2017-02-01

To review the literature for outcome measures for oral viral infections in cancer patients. A secondary aim was to update the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO) clinical practice guidelines for the management of oral viral infections in cancer patients. Databases were searched for articles published in the English language, 1981-2013. Studies that met the eligibility criteria were reviewed systematically. The data about the outcome measures were classified according to the aim of the study: prevention, treatment, or non-interventional. The results of interventional studies were compared to the 2010 MASCC/ISOO publication. Multiple clinical and laboratory tests were used to measure oral viral infections, with great variability between studies. Most of the studies were about Herpes Simplex Virus (HSV). The outcome measure that was most commonly used was the presence of HSV infection diagnosed based on a combination of suggestive clinical presentation with a positive laboratory result. HSV culture was the most commonly reported laboratory outcome measure. Acyclovir and valacyclovir were consistently reported to be efficacious in the management of oral herpetic infections. No new data on the quality of life and economic aspects was found. Considering the variability in outcome measures reported to assess oral herpetic infections the researcher should select carefully the appropriate measures based on the objective of the study. Acyclovir and valacyclovir are effective in the management of oral herpetic infections in patients receiving treatment for cancer. Studies on newer anti-viral drugs may be useful to address the issue of anti-viral resistance.

Meta-Analysis of Treatment Outcomes Measured by the Y-OQ and Y-OQ-SR Comparing Wilderness and Non-Wilderness Treatment Programs

ERIC Educational Resources Information Center

Gillis, Harold L.; Speelman, Elizabeth; Linville, Noelle; Bailey, Emily; Kalle, Ashley; Oglesbee, Nathan; Sandlin, James; Thompson, Lauren; Jensen, Jennifer

2016-01-01

Background: Monitoring youth treatments requires outcome instruments sensitive to change. The Y-OQ and the Y-OQ-SR measure behavioral change during psychological treatment. Objective: The focus of this study was to compare treatment progress of youth in studies using the Youth Outcome Questionnaire (YOQ) or the Youth Outcome Questionnaire Self…

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

PubMed

Seymour, J; Newell, D; Shiell, A

1997-01-01

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

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.

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.

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

PubMed

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

2013-07-01

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

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

PubMed

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

2017-01-01

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

A multicenter study analyzing the relationship of a standardized radiographic scoring system of adolescent idiopathic scoliosis and the Scoliosis Research Society outcomes instrument.

PubMed

Wilson, Philip L; Newton, Peter O; Wenger, Dennis R; Haher, Thomas; Merola, Andrew; Lenke, Larry; Lowe, Thomas; Clements, David; Betz, Randy

2002-09-15

A multicenter study examining the association between radiographic and outcomes measures in adolescent idiopathic scoliosis. To evaluate the association between an objective radiographic scoring system and patient quality of life measures as determined by the Scoliosis Research Society outcomes instrument. Although surgical correction of scoliosis has been reported to be positively correlated with patient outcomes, studies to date have been unable to demonstrate an association between radiographic measures of deformity and outcomes measures in patients with adolescent idiopathic scoliosis. A standardized radiographic deformity scoring system and the Scoliosis Research Society outcome tool were used prospectively in seven scoliosis centers to collect data on patients with adolescent idiopathic scoliosis. A total of 354 data points for 265 patients consisting of those with nonoperative or preoperative curves >or=10 degrees, as well as those with surgically treated curves, were analyzed. Correlation analysis was performed to identify significant relationships between any of the radiographic measures, the Harms Study Group radiographic deformity scores (total, sagittal, coronal), and the seven Scoliosis Research Society outcome domains (Total Pain, General Self-Image, General Function, Activity, Postoperative Self-Image, Postoperative Function, and Satisfaction) as well as Scoliosis Research Society outcomes instrument total scores. Radiographic measures that were identified as significantly correlated with Scoliosis Research Society outcome scores were then entered into a stepwise regression analysis. The coronal measures of thoracic curve and lumbar curve magnitude were found to be significantly correlated with the Total Pain, General Self-Image, and total Scoliosis Research Society scores (P < 0.0001). The thoracic and upper thoracic curve magnitudes were also correlated with General Function (P < 0.002). The "coronal" subscore as well as the "total" score of the Harms Study Group radiographic scoring system were also significantly correlated with these Scoliosis Research Society domain and total scores. No radiographic measures taken after surgery were significantly correlated with the postoperative domains of the Scoliosis Research Society outcomes instrument. Stepwise regression analysis of these radiographic measures as predictors of Scoliosis Research Society scores resulted in adjusted R2 values of 0.03-0.07 (P < 0.0001). Although these results show that a significant association exists between the radiographic Cobb angle measure of the scoliosis and the Scoliosis Research Society outcomes scores, the low R2 values indicate that variables other than the radiographic appearance of the deformity (e.g., psychosocial, functional) must also be affecting these scores. The Cobb angle measure of the major deformity has a small, but statistically significant, correlation with the reported Total Pain, General Self-Image, and General Function as measured by the Scoliosis Research Society outcomes instrument. None of the radiographic measures in this population correlated with postoperative domain scores of the Scoliosis Research Society outcomes tool.

Liaison psychiatry for older adults in the general hospital: service activity, development and outcomes.

PubMed

Mujic, Fedza; Cairns, Ruth; Mak, Vivienne; Squire, Clare; Wells, Andrew; Al-Harrasi, Ahmed; Prince, Martin

2018-02-01

Aims and method This study used data collected to describe the activity, case-load characteristics and outcome measures for all patients seen during a 6-year period. The service reviewed 2153 patients over 6 years with referral rates and case-load characteristics comparable to those described in a previous study period. The team saw 82% of patients on the day they were referred. Data and outcome measures collected showed significant complexity in the cases seen and statistically significant improvement in Health of the Nation Outcome Scales (HoNOS) scores following service input. Clinical implications The outcome measures used were limited, but the study supports the need for specialist liaison psychiatry for older adults (LPOA) services in the general hospital. The Framework of Outcome Measures - Liaison Psychiatry has now been introduced, but it remains unclear how valid this is in LPOA. It is of note that cost-effectiveness secondary to service input and training activities are not adequately monitored. Declaration of interest None.

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

PubMed

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

2014-12-01

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

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

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

ERIC Educational Resources Information Center

Pasch, Marvin

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

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

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.

Computerised cognitive training in acquired brain injury: A systematic review of outcomes using the International Classification of Functioning (ICF).

PubMed

Sigmundsdottir, Linda; Longley, Wendy A; Tate, Robyn L

2016-10-01

Computerised cognitive training (CCT) is an increasingly popular intervention for people experiencing cognitive symptoms. This systematic review evaluated the evidence for CCT in adults with acquired brain injury (ABI), focusing on how outcome measures used reflect efficacy across components of the International Classification of Functioning, Disability and Health. Database searches were conducted of studies investigating CCT to treat cognitive symptoms in adult ABI. Scientific quality was rated using the PEDro-P and RoBiNT Scales. Ninety-six studies met the criteria. Most studies examined outcomes using measures of mental functions (93/96, 97%); fewer studies included measures of activities/participation (41/96, 43%) or body structures (8/96, 8%). Only 14 studies (15%) provided Level 1 evidence (randomised controlled trials with a PEDro-P score ≥ 6/10), with these studies suggesting strong evidence for CCT improving processing speed in multiple sclerosis (MS) and moderate evidence for improving memory in MS and brain tumour populations. There is a large body of research examining the efficacy of CCT, but relatively few Level 1 studies and evidence is largely limited to body function outcomes. The routine use of outcome measures of activities/participation would provide more meaningful evidence for the efficacy of CCT. The use of body structure outcome measures (e.g., neuroimaging) is a newly emerging area, with potential to increase understanding of mechanisms of action for CCT.

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.

Measurement of health outcomes.

PubMed

Thavorncharoensap, Montarat

2014-05-01

Health outcomes are one of the most important components of health technology assessments (HTAs). All HTA outcomes should be measured from a relevant sample using a properly designed study and method. A number of recommendations on health outcome measurements are made in this second edition of Thailand's HTA guidelines. In particular the use of final outcomes, rather than surrogate outcomes, in HTAs is stressed. Where surrogate outcomes are used, strong justification and evidence must be provided. Effectiveness is preferred over efficacy. The relative treatment effect (the difference between health outcome that would be experienced by patients receiving the technology and that experienced by the same group were they to receive an alternative technology) should be derived from a systematic review of head-to-head RCTs. Mixed treatment comparison (MTC) should be used only to provide supplementary data that cannot be obtained from a head-to-head comparison. Where no direct comparison evidence exists, indirect comparison and observational study data can be used.

Clinical Outcome Reporting in Youth ACL Literature Is Widely Variable

PubMed Central

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

2017-01-01

Background: Advances in anterior cruciate ligament (ACL) reconstruction procedures in pediatric and adolescent patients have resulted in an increase in recent clinical studies on this topic. However, the consistency with which outcome measures are reported in this demographic is unknown. Purpose: To document outcome reporting patterns of youth ACL reconstruction studies in high-impact journals. Study Design: Systematic review; Level of evidence, 4. Methods: All articles published in 5 high-impact orthopaedic journals from 2010 to 2016 were reviewed to identify those reporting clinical outcomes of young patients who underwent ACL reconstruction. Studies that were nonclinical, reported on patients older than 18 years, or included fewer than 10 patients were excluded. Outcome measures used in all included studies were recorded. Results: Seventeen studies encompassing 772 subjects (mean age, 14.3 years; range, 6.3-18.0 years) were analyzed. Eight studies (47%) reported on Tanner stage of subjects, while 1 study reported skeletal age. Ten studies (59%) clearly documented the presence or absence of surgical complications. Range of motion was reported in 65% of studies. Leg-length discrepancy and angular deformity were each reported in 76% of studies, with 12% quantifying results through radiographic measurements. Ligament testing was variably defined by inclusion of instrumented testing (65%), Lachman test (53%), and pivot-shift test (53%). Fourteen studies (82%) explicitly reported on the rate of ACL rerupture, while 71% reported on the rate of revision surgery. Rate of return to preinjury activity was reported in 8 studies (47%), of which 2 defined criteria for return to sport and 3 defined the level of competitive sport. Patient-reported outcome measures (PROMs) were used variably. For the 3 most commonly reported PROMs (Lysholm, International Knee Documentation Committee, and Tegner), 24% of studies reported all 3 PROMs, 35% of studies reported 2 PROMs, and 6% of studies reported 1 PROM in isolation. A pediatric-specific PROM was reported in 1 of the 17 studies. Conclusion: Studies on pediatric ACL reconstruction published in high-impact journals unreliably defined subjects’ skeletal maturity, inconsistently reported on objective outcome measures, and used disparate adult-validated PROMs to assess subjective outcomes. These findings highlight the need for standardized, pediatric-specific outcome measures to be applied in future studies evaluating ACL reconstruction in children and adolescents. PMID:28840156

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.

The Benchmarking Capacity of a General Outcome Measure of Academic Language in Science and Social Studies

ERIC Educational Resources Information Center

Mooney, Paul; Lastrapes, Renée E.

2016-01-01

The amount of research evaluating the technical merits of general outcome measures of science and social studies achievement is growing. This study targeted criterion validity for critical content monitoring. Questions addressed the concurrent criterion validity of alternate presentation formats of critical content monitoring and the measure's…

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

PubMed

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

2004-01-01

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

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 safety of care transitions, which makes interpretation or comparison of their results uncertain.

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.

Validity of the AusTOM scales: A comparison of the AusTOMs and EuroQol-5D

PubMed Central

Unsworth, Carolyn A; Duckett, Stephen J; Duncombe, Dianne; Perry, Alison; Skeat, Jemma; Taylor, Nicholas

2004-01-01

Background Clinicians require brief outcome measures in their busy daily practice to document global client outcomes. Based on the UK Therapy Outcome Measure, the Australian Therapy Outcome Measures were designed to capture global therapy outcomes of occupational therapy, physiotherapy and speech pathology in the Australian clinical context. The aim of this study was to investigate the construct (convergent) validity of the Australian Therapy Outcome Measures (AusTOMs) by comparing it with the EuroQuol-5D (EQ-5D). Methods The research was a prospective, longitudinal cohort study, with data collected over a seven month time period. The study was conducted at a total of 13 metropolitan and rural health-care sites including acute, sub-acute and community facilities. Two-hundred and five clients were asked to score themselves on the EQ-5D, and the same clients were scored by approximately 115 therapists (physiotherapists, speech pathologists and occupational therapists) using the AusTOMs at admission and discharge. Clients were consecutive admissions who agreed to participate in the study. Clients of all diagnoses, aged 18 years and over (a criteria of the EQ-5D), and able to give informed consent were scored on the measures. Spearman rank order correlation coefficients were used to analyze the relationships between scores from the two tools. The clients were scored on the AusTOMs and EQ-5D. Results There were many health care areas where correlations were expected and found between scores on the AusTOMs and the EQ-5D. Conclusion In the quest to measure the effectiveness of therapy services, managers, health care founders and clinicians are urgently seeking to undertake the first step by identifying tools that can measure therapy outcome. AusTOMs is one tool that can measure global client outcomes following therapy. In this study, it was found that on the whole, the AusTOMs and the EQ-5D measure similar constructs. Hence, although the validity of a tool is never 'proven', this study offers preliminary support for the construct validity of AusTOMs. PMID:15541181

The use of computer adaptive tests in outcome assessments following upper limb trauma.

PubMed

Jayakumar, P; Overbeek, C; Vranceanu, A-M; Williams, M; Lamb, S; Ring, D; Gwilym, S

2018-06-01

Aims Outcome measures quantifying aspects of health in a precise, efficient, and user-friendly manner are in demand. Computer adaptive tests (CATs) may overcome the limitations of established fixed scales and be more adept at measuring outcomes in trauma. The primary objective of this review was to gain a comprehensive understanding of the psychometric properties of CATs compared with fixed-length scales in the assessment of outcome in patients who have suffered trauma of the upper limb. Study designs, outcome measures and methodological quality are defined, along with trends in investigation. Materials and Methods A search of multiple electronic databases was undertaken on 1 January 2017 with terms related to "CATs", "orthopaedics", "trauma", and "anatomical regions". Studies involving adults suffering trauma to the upper limb, and undergoing any intervention, were eligible. Those involving the measurement of outcome with any CATs were included. Identification, screening, and eligibility were undertaken, followed by the extraction of data and quality assessment using the Consensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) criteria. The review is reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) criteria and reg istered (PROSPERO: CRD42016053886). Results A total of 31 studies reported trauma conditions alone, or in combination with non-traumatic conditions using CATs. Most were cross-sectional with varying level of evidence, number of patients, type of study, range of conditions and methodological quality. CATs correlated well with fixed scales and had minimal or no floor-ceiling effects. They required significantly fewer questions and/or less time for completion. Patient-Reported Outcomes Measurement Information System (PROMIS) CATs were the most frequently used, and the use of CATs is increasing. Conclusion Early studies show valid and reliable outcome measurement with CATs performing as well as, if not better than, established fixed scales. Superior properties such as floor-ceiling effects and ease of use support their use in the assessment of outcome after trauma. As CATs are being increasingly used in patient outcomes research, further psychometric evaluation, especially involving longitudinal studies and groups of patients with specific injuries are required to inform clinical practice using these contemporary measures. Cite this article: Bone Joint J 2018;100-B:693-702.

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.

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

Comparing contents of outcome measures in cerebral palsy using the International Classification of Functioning (ICF-CY): a systematic review.

PubMed

Schiariti, Veronica; Klassen, Anne F; Cieza, Alarcos; Sauve, Karen; O'Donnell, Maureen; Armstrong, Robert; Mâsse, Louise C

2014-01-01

The International Classification of Functioning children and youth version (ICF-CY) provides a universal framework for defining and classifying functioning and disability in children worldwide. To facilitate the application of the ICF in practice, ICF based-tools like the "ICF Core Sets" are being developed. In the context of the development of the ICF-CY Core Sets for children with Cerebral Palsy (CP), the aims of this study were as follows: to identify and compare the content of outcome measures used in studies of children with CP using the ICF-CY coding system; and to describe the most frequently addressed areas of functioning in those studies. We searched multiple databases likely to capture studies involving children with CP from January 1998 to March 2012. We included all English language articles that studied children aged 2-18 years and described an interventional or observational study. Constructs of the outcome measures identified in studies were linked to the ICF-CY by two trained professionals. We found 231 articles that described 238 outcome measures. The outcome measures contained 2193 concepts that were linked to the ICF-CY and covered 161 independent ICF-CY categories. Out of the 161 categories, 53 (33.5%) were related to body functions, 75 (46%) were related to activities/participation, 26 (16.1%) were related to environmental factors, and 7 (4.3%) were related to body structures. This systematic review provides information about content of measures that may guide researchers and clinicians in their selection of an outcome measure for use in a study and/or clinical practice with children with CP. Copyright © 2013 European Paediatric Neurology Society. Published by Elsevier Ltd. All rights reserved.

Measuring outcomes of community aged care programs: challenges, opportunities and the Australian Community Outcomes Measurement ACCOM tool.

PubMed

Cardona, Beatriz

2018-05-29

Measuring health and wellbeing outcomes of community aged care programs is a complex task given the diverse settings in which care takes place and the intersection of numerous factors affecting an individual's quality of life outcomes. Knowledge of a strong causal relationship between services provided and the final outcome enables confidence in assuming the care provided was largely responsible for the outcome achieved (Courtney et al., Aust J Adv Nurs 26:49-57, 2009). The Department of Health has recently reported on the findings of The National Aged Care Quality Indicator Program - Home Care Pilot (KPMG, National Aged Care Quality Indicator Program - Home Care Pilot, 2017). The Program sought to test various tools to measure quality of life outcomes of their community aged care programs. Some of the key issues raised in the study reiterate the findings from The Australian Community Care Outcome Measurement (ACCOM) pilot study (Cardona et al., Australas J Ageing 36: 69-71, 2017), including the value of the ASCOT SCT4 tool (Adult Social care Outcomes Toolkit, http://www.pssru.ac.uk/ascot/downloads/questionnaires/sct4.pdf ) to measure social care related quality of life (SCRQoL) in community aged care programs in the Australian context, the collection of additional data to map the relationship of various variables such as functional ability, demographic characteristics and quality of life scores and the governance and administration of measurement tools for the purpose of quality reporting and consumer choice.

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

PubMed

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

2015-10-01

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

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

PubMed

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

2015-12-02

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

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

PubMed

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

2017-12-19

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

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

PubMed

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

2014-02-01

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

Evidence on the Effectiveness of Water, Sanitation, and Hygiene (WASH) Interventions on Health Outcomes in Humanitarian Crises: A Systematic Review.

PubMed

Ramesh, Anita; Blanchet, Karl; Ensink, Jeroen H J; Roberts, Bayard

2015-01-01

Water, sanitation, and hygiene (WASH) interventions are amongst the most crucial in humanitarian crises, although the impact of the different WASH interventions on health outcomes remains unclear. To examine the quantity and quality of evidence on WASH interventions on health outcomes in humanitarian crises, as well as evaluate current evidence on their effectiveness against health outcomes in these contexts. A systematic literature review was conducted of primary and grey quantitative literature on WASH interventions measured against health outcomes in humanitarian crises occurring from 1980-2014. Populations of interest were those in resident in humanitarian settings, with a focus on acute crisis and early recovery stages of humanitarian crises in low and middle-income countries. Interventions of interest were WASH-related, while outcomes of interest were health-related. Study quality was assessed via STROBE/CONSORT criteria. Results were analyzed descriptively, and PRISMA reporting was followed. Of 3963 studies initially retrieved, only 6 published studies measured a statistically significant change in health outcome as a result of a WASH intervention. All 6 studies employed point-of-use (POU) water quality interventions, with 50% using safe water storage (SWS) and 35% using household water treatment (HWT). All 6 studies used self-reported diarrhea outcomes, 2 studies also reported laboratory confirmed outcomes, and 2 studies reported health treatment outcomes (e.g. clinical admissions). 1 study measured WASH intervention success in relation to both health and water quality outcomes; 1 study recorded uptake (use of soap) as well as health outcomes. 2 studies were unblinded randomized-controlled trials, while 4 were uncontrolled longitudinal studies. 2 studies were graded as providing high quality evidence; 3 studies provided moderate and 1 study low quality evidence. The current evidence base on the impact of WASH interventions on health outcomes in humanitarian crises is extremely limited, and numerous methodological limitations limit the ability to determine associative, let alone causal, relationships.

Evidence on the Effectiveness of Water, Sanitation, and Hygiene (WASH) Interventions on Health Outcomes in Humanitarian Crises: A Systematic Review

PubMed Central

Ramesh, Anita; Blanchet, Karl; Ensink, Jeroen H. J.; Roberts, Bayard

2015-01-01

Background Water, sanitation, and hygiene (WASH) interventions are amongst the most crucial in humanitarian crises, although the impact of the different WASH interventions on health outcomes remains unclear. Aim To examine the quantity and quality of evidence on WASH interventions on health outcomes in humanitarian crises, as well as evaluate current evidence on their effectiveness against health outcomes in these contexts. Methods A systematic literature review was conducted of primary and grey quantitative literature on WASH interventions measured against health outcomes in humanitarian crises occurring from 1980–2014. Populations of interest were those in resident in humanitarian settings, with a focus on acute crisis and early recovery stages of humanitarian crises in low and middle-income countries. Interventions of interest were WASH-related, while outcomes of interest were health-related. Study quality was assessed via STROBE/CONSORT criteria. Results were analyzed descriptively, and PRISMA reporting was followed. Results Of 3963 studies initially retrieved, only 6 published studies measured a statistically significant change in health outcome as a result of a WASH intervention. All 6 studies employed point-of-use (POU) water quality interventions, with 50% using safe water storage (SWS) and 35% using household water treatment (HWT). All 6 studies used self-reported diarrhea outcomes, 2 studies also reported laboratory confirmed outcomes, and 2 studies reported health treatment outcomes (e.g. clinical admissions). 1 study measured WASH intervention success in relation to both health and water quality outcomes; 1 study recorded uptake (use of soap) as well as health outcomes. 2 studies were unblinded randomized-controlled trials, while 4 were uncontrolled longitudinal studies. 2 studies were graded as providing high quality evidence; 3 studies provided moderate and 1 study low quality evidence. Conclusion The current evidence base on the impact of WASH interventions on health outcomes in humanitarian crises is extremely limited, and numerous methodological limitations limit the ability to determine associative, let alone causal, relationships. PMID:26398228

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

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

ERIC Educational Resources Information Center

Marshall, Keith; Willoughby-Booth, Simon

2007-01-01

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

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.

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

PubMed

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

2014-07-01

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

The impact of patient support programs on adherence, clinical, humanistic, and economic patient outcomes: a targeted systematic review

PubMed Central

Ganguli, Arijit; Clewell, Jerry; Shillington, Alicia C

2016-01-01

Background Patient support programs (PSPs), including medication management and counseling, have the potential to improve care in chronic disease states with complex therapies. Little is known about the program’s effects on improving clinical, adherence, humanistic, and cost outcomes. Purpose To conduct a targeted review describing medical conditions in which PSPs have been implemented; support delivery components (eg, face-to-face, phone, mail, and internet); and outcomes associated with implementation. Data sources MEDLINE – 10 years through March 2015 with supplemental handsearching of reference lists. Study selection English-language trials and observational studies of PSPs providing at minimum, counseling for medication management, measurement of ≥1 clinical outcome, and a 3-month follow-up period during which outcomes were measured. Data extraction Program characteristics and related clinical, adherence, humanistic, and cost outcomes were abstracted. Study quality and the overall strength of evidence were reviewed using standard criteria. Data synthesis Of 2,239 citations, 64 studies met inclusion criteria. All targeted chronic disease processes and the majority (48 [75%]) of programs offered in-clinic, face-to-face support. All but 9 (14.1%) were overseen by allied health care professionals (eg, nurses, pharmacists, paraprofessionals). Forty-one (64.1%) reported at least one significantly positive clinical outcome. The most frequent clinical outcome impacted was adherence, where 27 of 41 (66%) reported a positive outcome. Of 42 studies measuring humanistic outcomes (eg, quality of life, functional status), 27 (64%) reported significantly positive outcomes. Only 15 (23.4%) programs reported cost or utilization-related outcomes, and, of these, 12 reported positive impacts. Conclusion The preponderance of evidence suggests a positive impact of PSPs on adherence, clinical and humanistic outcomes. Although less often measured, health care utilization and costs are also reduced following PSP implementation. Further research is needed to better quantify which support programs, delivery methods, and components offer the greatest value for any particular medical condition. PMID:27175071

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.

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.

Identification of desired outcomes for school nursing practice.

PubMed

Selekman, Janice; Guilday, Patricia

2003-12-01

The Scope and Standards of Professional School Nursing Practice states that school nurses should evaluate the quality and effectiveness of their practice. School nurses have not yet identified and adopted outcomes by which this effectiveness can be measured. This study used focus groups during a national meeting of school nurse leaders to identify the desired outcomes that could be used to measure the efficacy of school nursing practice. Ten desired outcome themes were identified with numerous specific indicators as possible ways to measure the desired outcome in each theme. The student-, school-, and nurse-focused outcome themes were as follows: (a) increased student seat time, (b) receipt of first aid and acute care measures, (c) receipt of competent health-related interventions or skills, (d) meeting of the comprehensive needs of children with chronic conditions, (e) enhanced school health via wellness promotion and disease prevention measures, (f) referrals, (g) safe environment, (h) enhanced school health via community outreach, (i) cost-effective school nurse services, and (j) student, parent, and staff satisfaction. The school nurse participants were supportive of having potential outcomes identified and unanimously endorsed the findings at the conclusion of the study. They have provided a comprehensive framework from which evaluation tools can be developed to measure the efficacy of school nursing.

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

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

PubMed

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

2015-01-05

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

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.

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 tools was combined with information about their accessibility and presentation. Twelve tools were identified as having the strongest supporting evidence, the majority measuring autism characteristics and problem behaviour. The patchy evidence and limited scope of outcomes measured mean these tools do not constitute a 'recommended battery' for use. In particular, there is little evidence that the identified tools would be good at detecting change in intervention studies. The obvious gaps in available outcome measurement include well-being and participation outcomes for children, and family quality-of-life outcomes, domains particularly valued by our informants (young people with ASD and parents). This is the first systematic review of the quality and appropriateness of tools designed to monitor progress and outcomes of young children with ASD. Although it was not possible to recommend fully robust tools at this stage, the review consolidates what is known about the field and will act as a benchmark for future developments. With input from parents and other stakeholders, recommendations are made about priority targets for research. Priorities include development of a tool to measure child quality of life in ASD, and validation of a potential primary outcome tool for trials of early social communication intervention. This study is registered as PROSPERO CRD42012002223. The National Institute for Health Research Health Technology Assessment programme.

A comparison of time taken to return to baseline erectile function following focal and whole gland ablative therapies for localized prostate cancer: A systematic review.

PubMed

Faure Walker, Nicholas A; Norris, Joseph M; Shah, Taimur T; Yap, Tet; Cathcart, Paul; Moore, Caroline M; Ahmed, Hashim U; Emberton, Mark; Minhas, Suks

2018-02-01

To systematically review erectile function (EF) outcomes following primary whole gland (WG) and focal ablative therapies for localized prostate cancer to ascertain whether the treatment modality or intended treatment volume affects the time taken to recover baseline EF. A systematic review was performed according to the preferred reporting items for systematic review and meta-analysis statement. Inclusion criteria were men with localized prostate cancer treated with primary, ablative therapy. Primary outcome was the return to baseline EF measured with objective, validated symptoms scores. Secondary outcome was use of phosphodiesterase inhibitors or erectile aids. Meta-analysis was not performed owing to heterogenous outcome measures. Of 222 articles identified in February 2017, 55 studies which reported EF after ablative therapy were identified but only 17 used validated outcome measures and met inclusion criteria. WG cryotherapy was used in 2 studies, WG high-intensity focused ultrasound (HIFU) in 5, focal cryotherapy in 2, focal HIFU in 3, focal phototherapy or laser therapy in 4, vascular-targeted photodynamic therapy in 3, and irreversible electroporation in 2. WG cryotherapy was associated with a significant decline in EF at 6 months with minimal improvement at 36 months. Baseline IIEF-15 of patients undergoing focal HIFU fell 30 points at 1 month but returned to baseline by 6 months. The remaining focal therapies demonstrated minimal or no effect on EF, but the men in these studies had small foci of disease. The review is limited by lack of randomized studies and heterogenous outcome measures. Most studies assessing the outcomes of focal therapy on sexual function were not of high quality, used heterogenous outcomes, and had relatively short follow up, highlighting the need for more robustly designed studies using validated patient reported outcome measures  for comparison. However, FT in general resulted in less effect on EF than WG ablation. Copyright © 2018 Elsevier Inc. All rights reserved.

Validating Multidimensional Outcome Assessment Using the TBI Common Data Elements: An Analysis of the TRACK-TBI Pilot Sample.

PubMed

Nelson, Lindsay D; Ranson, Jana; Ferguson, Adam R; Giacino, Joseph; Okonkwo, David O; Valadka, Alex; Manley, Geoffrey; McCrea, Michael

2017-06-08

The Glasgow Outcome Scale-Extended (GOSE) is often the primary outcome measure in clinical trials for traumatic brain injury (TBI). Although the GOSE's capture of global function outcome has several strengths, concerns have been raised about its limited ability to identify mild disability and failure to capture the full scope of problems patients exhibit after TBI. This analysis examined the convergence of disability ratings across a multidimensional set of outcome domains in the Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) Pilot study. The study collected measures recommended by the TBI Common Data Elements (CDE) Workgroup. Patients presenting to 3 emergency departments with a TBI of any severity enrolled in TRACK-TBI prospectively after injury; outcome measures were collected at 3 and six months postinjury. Analyses examined frequency of impairment and overlap between impairment status across the CDE outcome domains of Global Level of Functioning (GOSE), Neuropsychological (cognitive) Impairment, Psychological Status, TBI Symptoms, and Quality of Life. GOSE score correlated in the expected direction with other outcomes (M Spearman's rho = .21 and .49 with neurocognitive and self-report outcomes, respectively). The subsample in the Upper Good Recovery (GOSE 8) category appeared quite healthy across most other outcomes, although 19.0% had impaired executive functioning (Trail Making Test Part B). A significant minority of participants in the Lower Good Recovery subgroup (GOSE 7) met criteria for impairment across numerous other outcome measures. The findings highlight the multidimensional nature of TBI recovery and the limitations of applying only a single outcome measure.

The development and preliminary psychometric properties of two positive psychology outcome measures for people with dementia: the PPOM and the EID-Q.

PubMed

Stoner, Charlotte R; Orrell, Martin; Long, Maria; Csipke, Emese; Spector, Aimee

2017-03-21

Positive psychology research in dementia care has largely been confined to the qualitative literature because of the lack of robust outcome measures. The aim of this study was to develop positive psychology outcome measures for people with dementia. Two measures were each developed in four stages. Firstly, literature reviews were conducted to identify and operationalise salient positive psychology themes in the qualitative literature and to examine existing measures of positive psychology. Secondly, themes were discussed within a qualitative study to add content validity for identified concepts (n = 17). Thirdly, draft measures were submitted to a panel of experts for feedback (n = 6). Finally, measures were used in a small-scale pilot study (n = 33) to establish psychometric properties. Salient positive psychology themes were identified as hope, resilience, a sense of independence and social engagement. Existing measures of hope and resilience were adapted to form the Positive Psychology Outcome Measure (PPOM). Due to the inter-relatedness of independence and engagement for people with dementia, 28 items were developed for a new scale of Engagement and Independence in Dementia Questionnaire (EID-Q) following extensive qualitative work. Both measures demonstrated acceptable internal consistency (α = .849 and α = .907 respectively) and convergent validity. Two new positive psychology outcome measures were developed using a robust four-stage procedure. Preliminary psychometric data was adequate and the measures were easy to use, and acceptable for people with dementia.

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

PubMed

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

2018-06-21

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

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

PubMed

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

2016-02-09

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

Development of a core outcome set for clinical trials in squamous cell carcinoma: study protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey.

PubMed

Schlessinger, Daniel I; Iyengar, Sanjana; Yanes, Arianna F; Chiren, Sarah G; Godinez-Puig, Victoria; Chen, Brian R; Kurta, Anastasia O; Schmitt, Jochen; Deckert, Stefanie; Furlan, Karina C; Poon, Emily; Cartee, Todd V; Maher, Ian A; Alam, Murad; Sobanko, Joseph F

2017-07-12

Squamous cell carcinoma (SCC) is a common skin cancer that poses a risk of metastasis. Clinical investigations into SCC treatment are common, but the outcomes reported are highly variable, omitted, or clinically irrelevant. The outcome heterogeneity and reporting bias of these studies leave clinicians unable to accurately compare studies. Core outcome sets (COSs) are an agreed minimum set of outcomes recommended to be measured and reported in all clinical trials of a given condition or disease. Although COSs are under development for several dermatologic conditions, work has yet to be done to identify core outcomes specific for SCC. Outcome extraction for COS generation will occur via four methods: (1) systematic literature review; (2) patient interviews; (3) other published sources; and (4) input from stakeholders in medicine, pharmacy, and other relevant industries. The list of outcomes will be revaluated by the Measuring PRiority Outcome Variables via Excellence in Dermatologic surgery (IMPROVED) Steering Committee. Delphi processes will be performed separately by expert clinicians and patients to condense the list of outcomes generated. A consensus meeting with relevant stakeholders will be conducted after the Delphi exercise to further select outcomes, taking into account participant scores. At the end of the meeting, members will vote and decide on a final recommended set of core outcomes. The Core Outcome Measures in Effectiveness Trials (COMET) organization and the Cochrane Skin Group - Core Outcome Set Initiative (CSG-COUSIN) will serve as advisers throughout the COS generation process. Comparison of clinical trials via systematic reviews and meta-analyses is facilitated when investigators study outcomes that are relevant and similar. The aim of this project is to develop a COS to guide use for future clinical trials.

Food environments and dietary intakes among adults: does the type of spatial exposure measurement matter? A systematic review.

PubMed

Bivoltsis, Alexia; Cervigni, Eleanor; Trapp, Gina; Knuiman, Matthew; Hooper, Paula; Ambrosini, Gina Leslie

2018-06-09

The relationships between food environments and dietary intake have been assessed via a range of methodologically diverse measures of spatial exposure to food outlets, resulting in a largely inconclusive body of evidence, limiting informed policy intervention. This systematic review aims to evaluate the influence of methodological choice on study outcomes by examining the within-study effect of availability (e.g., counts) versus accessibility (e.g., proximity) spatial exposure measures on associations with diet. (PROSPERO registration: CRD42018085250). PubMed, Web of Science, Scopus and ScienceDirect databases were searched for empirical studies from 1980 to 2017, in the English language, involving adults and reporting on the statistical association between a dietary outcome and spatial exposure measures of both availability and accessibility. Studies were appraised using an eight-point quality criteria with a narrative synthesis of results. A total of 205 associations and 44 relationships (i.e., multiple measures of spatial exposure relating to a particular food outlet type and dietary outcome) were extracted from 14 eligible articles. Comparative measures were dominated by counts (availability) and proximity (accessibility). Few studies compared more complex measures and all counts were derived from place-based measures of exposure. Sixteen of the 44 relationships had a significant effect involving an availability measure whilst only 8 had a significant effect from an accessibility measure. The largest effect sizes in relationships were mostly for availability measures. After stratification by scale, availability measure had the greatest effect size in 139 of the 176 pairwise comparisons. Of the 33% (68/205) of associations that reached significance, 53/68 (78%) were from availability measures. There was no relationship between study quality and reported study outcomes. The limited evidence suggests that availability measures may produce significant and greater effect sizes than accessibility measures. However, both availability and accessibility measures may be important concepts of spatial exposure depending on the food outlet type and dietary outcome examined. More studies reporting on multi-method effects are required to differentiate findings by the type of spatial exposure assessment and build an evidence base regarding the appropriateness and robustness of measures under different circumstances.

The 'Outcome Reporting in Brief Intervention Trials: Alcohol' (ORBITAL) framework: protocol to determine a core outcome set for efficacy and effectiveness trials of alcohol screening and brief intervention.

PubMed

Shorter, G W; Heather, N; Bray, Jeremy W; Giles, E L; Holloway, A; Barbosa, C; Berman, A H; O'Donnell, A J; Clarke, M; Stockdale, K J; Newbury-Birch, D

2017-12-22

The evidence base to assess the efficacy and effectiveness of alcohol brief interventions (ABI) is weakened by variation in the outcomes measured and by inconsistent reporting. The 'Outcome Reporting in Brief Intervention Trials: Alcohol' (ORBITAL) project aims to develop a core outcome set (COS) and reporting guidance for its use in future trials of ABI in a range of settings. An international Special Interest Group was convened through INEBRIA (International Network on Brief Interventions for Alcohol and Other Drugs) to inform the development of a COS for trials of ABI. ORBITAL will incorporate a systematic review to map outcomes used in efficacy and effectiveness trials of ABI and their measurement properties, using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) criteria. This will support a multi-round Delphi study to prioritise outcomes. Delphi panellists will be drawn from a range of settings and stakeholder groups, and the Delphi study will also be used to determine if a single COS is relevant for all settings. A consensus meeting with key stakeholder representation will determine the final COS and associated guidance for its use in trials of ABI. ORBITAL will develop a COS for alcohol screening and brief intervention trials, with outcomes stratified into domains and guidance on outcome measurement instruments. The standardisation of ABI outcomes and their measurement will support the ongoing development of ABI studies and a systematic synthesis of emerging research findings. We will track the extent to which the COS delivers on this promise through an exploration of the use of the guidance in the decade following COS publication.

Variation of clinical outcomes used in glaucoma randomised controlled trials: a systematic review.

PubMed

Ismail, Rehab; Azuara-Blanco, Augusto; Ramsay, Craig R

2014-04-01

In randomised clinical trials (RCTs) the selection of appropriate outcomes is crucial to the assessment of whether one intervention is better than another. The purpose of this review is to identify different clinical outcomes reported in glaucoma trials. We conducted a systematic review of glaucoma RCTs. A sample or selection of glaucoma trials were included bounded by a time frame (between 2006 and March 2012). Only studies in English language were considered. All clinical measured and reported outcomes were included. The possible variations of clinical outcomes were defined prior to data analysis. Information on reported clinical outcomes was tabulated and analysed using descriptive statistics. Other data recorded included type of intervention and glaucoma, duration of the study, defined primary outcomes, and outcomes used for sample size calculation, if nominated. The search strategy identified 4323 potentially relevant abstracts. There were 315 publications retrieved, of which 233 RCTs were included. A total of 967 clinical measures were reported. There were large variations in the definitions used to describe different outcomes and their measures. Intraocular pressure was the most commonly reported outcome (used in 201 RCTs, 86%) with a total of 422 measures (44%). Safety outcomes were commonly reported in 145 RCTs (62%) whereas visual field outcomes were used in 38 RCTs (16%). There is a large variation in the reporting of clinical outcomes in glaucoma RCTs. This lack of standardisation may impair the ability to evaluate the evidence of glaucoma interventions.

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

PubMed Central

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

2016-01-01

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

Use of continuous glucose monitoring as an outcome measure in clinical trials.

PubMed

Beck, Roy W; Calhoun, Peter; Kollman, Craig

2012-10-01

Although developed to be a management tool for individuals with diabetes, continuous glucose monitoring (CGM) also has potential value for the assessment of outcomes in clinical studies. We evaluated using CGM as such an outcome measure. Data were analyzed from six previously completed inpatient studies in which both CGM (Freestyle Navigator™ [Abbott Diabetes Care, Alameda, CA] or Guardian(®) [Medtronic, Northridge, CA]) and reference glucose measurements were available. The analyses included 97 days of data from 93 participants with type 1 diabetes (age range, 5-57 years; mean, 18 ± 12 years). Mean glucose levels per day were similar for the CGM and reference measurements (median, 148 mg/dL vs. 143 mg/dL, respectively; P = 0.92), and the correlation of the two was high (r = 0.89). Similarly, most glycemia metrics showed no significant differences comparing CGM and reference values, except that the nadir glucose tended to be slightly lower and peak glucose slightly higher with reference measurements than CGM measurements (respective median, 59 mg/dL vs. 66 mg/dL [P = 0.05] and 262 mg/dL vs. 257 mg/dL [P = 0.003]) and glucose variability as measured with the coefficient of variation was slightly lower with CGM than reference measurements (respective median, 31% vs. 35%; P<0.001). A reasonably high degree of concordance exists when comparing outcomes based on CGM measurements with outcomes based on reference blood glucose measurements. CGM inaccuracy and underestimation of the extremes of hyperglycemia and hypoglycemia can be accounted for in a clinical trial's study design. Thus, in appropriate settings, CGM can be a very meaningful and feasible outcome measure for clinical trials.

Use of Continuous Glucose Monitoring as an Outcome Measure in Clinical Trials

PubMed Central

Calhoun, Peter; Kollman, Craig

2012-01-01

Abstract Objective Although developed to be a management tool for individuals with diabetes, continuous glucose monitoring (CGM) also has potential value for the assessment of outcomes in clinical studies. We evaluated using CGM as such an outcome measure. Research Design and Methods Data were analyzed from six previously completed inpatient studies in which both CGM (Freestyle Navigator™ [Abbott Diabetes Care, Alameda, CA] or Guardian® [Medtronic, Northridge, CA]) and reference glucose measurements were available. The analyses included 97 days of data from 93 participants with type 1 diabetes (age range, 5–57 years; mean, 18±12 years). Results Mean glucose levels per day were similar for the CGM and reference measurements (median, 148 mg/dL vs. 143 mg/dL, respectively; P=0.92), and the correlation of the two was high (r=0.89). Similarly, most glycemia metrics showed no significant differences comparing CGM and reference values, except that the nadir glucose tended to be slightly lower and peak glucose slightly higher with reference measurements than CGM measurements (respective median, 59 mg/dL vs. 66 mg/dL [P=0.05] and 262 mg/dL vs. 257 mg/dL [P=0.003]) and glucose variability as measured with the coefficient of variation was slightly lower with CGM than reference measurements (respective median, 31% vs. 35%; P<0.001). Conclusions A reasonably high degree of concordance exists when comparing outcomes based on CGM measurements with outcomes based on reference blood glucose measurements. CGM inaccuracy and underestimation of the extremes of hyperglycemia and hypoglycemia can be accounted for in a clinical trial's study design. Thus, in appropriate settings, CGM can be a very meaningful and feasible outcome measure for clinical trials. PMID:23013201

Negative control exposure studies in the presence of measurement error: implications for attempted effect estimate calibration

PubMed Central

Sanderson, Eleanor; Macdonald-Wallis, Corrie; Davey Smith, George

2018-01-01

Abstract Background Negative control exposure studies are increasingly being used in epidemiological studies to strengthen causal inference regarding an exposure-outcome association when unobserved confounding is thought to be present. Negative control exposure studies contrast the magnitude of association of the negative control, which has no causal effect on the outcome but is associated with the unmeasured confounders in the same way as the exposure, with the magnitude of the association of the exposure with the outcome. A markedly larger effect of the exposure on the outcome than the negative control on the outcome strengthens inference that the exposure has a causal effect on the outcome. Methods We investigate the effect of measurement error in the exposure and negative control variables on the results obtained from a negative control exposure study. We do this in models with continuous and binary exposure and negative control variables using analysis of the bias of the estimated coefficients and Monte Carlo simulations. Results Our results show that measurement error in either the exposure or negative control variables can bias the estimated results from the negative control exposure study. Conclusions Measurement error is common in the variables used in epidemiological studies; these results show that negative control exposure studies cannot be used to precisely determine the size of the effect of the exposure variable, or adequately adjust for unobserved confounding; however, they can be used as part of a body of evidence to aid inference as to whether a causal effect of the exposure on the outcome is present. PMID:29088358

Negative control exposure studies in the presence of measurement error: implications for attempted effect estimate calibration.

PubMed

Sanderson, Eleanor; Macdonald-Wallis, Corrie; Davey Smith, George

2018-04-01

Negative control exposure studies are increasingly being used in epidemiological studies to strengthen causal inference regarding an exposure-outcome association when unobserved confounding is thought to be present. Negative control exposure studies contrast the magnitude of association of the negative control, which has no causal effect on the outcome but is associated with the unmeasured confounders in the same way as the exposure, with the magnitude of the association of the exposure with the outcome. A markedly larger effect of the exposure on the outcome than the negative control on the outcome strengthens inference that the exposure has a causal effect on the outcome. We investigate the effect of measurement error in the exposure and negative control variables on the results obtained from a negative control exposure study. We do this in models with continuous and binary exposure and negative control variables using analysis of the bias of the estimated coefficients and Monte Carlo simulations. Our results show that measurement error in either the exposure or negative control variables can bias the estimated results from the negative control exposure study. Measurement error is common in the variables used in epidemiological studies; these results show that negative control exposure studies cannot be used to precisely determine the size of the effect of the exposure variable, or adequately adjust for unobserved confounding; however, they can be used as part of a body of evidence to aid inference as to whether a causal effect of the exposure on the outcome is present.

Variable reporting of functional outcomes and return to play in superior labrum anterior and posterior tear.

PubMed

Steinhaus, Michael E; Makhni, Eric C; Lieber, Adam C; Kahlenberg, Cynthia A; Gulotta, Lawrence V; Romeo, Anthony A; Verma, Nikhil N

2016-11-01

Outcomes assessments after superior labrum anterior and posterior (SLAP) tear/repair are highly varied, making it difficult to draw comparisons across the literature. This study examined the inconsistency in outcomes reporting in the SLAP tear literature. We hypothesize that there is significant variability in outcomes reporting and that although most studies may report return to play, time to return reporting will be highly variable. The PubMed, Medline, Scopus, and Embase databases were systematically reviewed for studies from January 2000 to December 2014 reporting outcomes after SLAP tear/repair. Two reviewers assessed each study, and those meeting inclusion criteria were examined for pertinent data. Outcomes included objective (range of motion, strength, clinical examinations, and imaging) and subjective (patient-reported outcomes, satisfaction, activities of daily living, and return to play) measures. Of the 56 included studies, 43% documented range of motion, 14% reported strength, and 16% noted postoperative imaging. There was significant variation in use of patient-reported outcomes measures, with the 3 most commonly noted measures reported in 20% to 55% of studies. Return to play was noted in 75% of studies, and 23% reported time to return, with greater rates in elite athletes. Eleven studies (20%) did not report follow-up or noted data with <12 months of follow-up. The SLAP literature is characterized by substantial variability in outcomes reporting, with time to return to play noted in few studies. Efforts to standardize outcomes reporting would facilitate comparisons across the literature and improve our understanding of the prognosis of this injury. Copyright © 2016 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.

Lest we forget: comparing retrospective and prospective assessments of adverse childhood experiences in the prediction of adult health.

PubMed

Reuben, Aaron; Moffitt, Terrie E; Caspi, Avshalom; Belsky, Daniel W; Harrington, Honalee; Schroeder, Felix; Hogan, Sean; Ramrakha, Sandhya; Poulton, Richie; Danese, Andrea

2016-10-01

Adverse childhood experiences (ACEs; e.g. abuse, neglect, and parental loss) have been associated with increased risk for later-life disease and dysfunction using adults' retrospective self-reports of ACEs. Research should test whether associations between ACEs and health outcomes are the same for prospective and retrospective ACE measures. We estimated agreement between ACEs prospectively recorded throughout childhood (by Study staff at Study member ages 3, 5, 7, 9, 11, 13, and 15) and retrospectively recalled in adulthood (by Study members when they reached age 38), in the population-representative Dunedin cohort (N = 1,037). We related both retrospective and prospective ACE measures to physical, mental, cognitive, and social health at midlife measured through both objective (e.g. biomarkers and neuropsychological tests) and subjective (e.g. self-reported) means. Dunedin and U.S. Centers for Disease Control ACE distributions were similar. Retrospective and prospective measures of adversity showed moderate agreement (r = .47, p < .001; weighted Kappa = .31, 95% CI: .27-.35). Both associated with all midlife outcomes. As compared to prospective ACEs, retrospective ACEs showed stronger associations with life outcomes that were subjectively assessed, and weaker associations with life outcomes that were objectively assessed. Recalled ACEs and poor subjective outcomes were correlated regardless of whether prospectively recorded ACEs were evident. Individuals who recalled more ACEs than had been prospectively recorded were more neurotic than average, and individuals who recalled fewer ACEs than recorded were more agreeable. Prospective ACE records confirm associations between childhood adversity and negative life outcomes found previously using retrospective ACE reports. However, more agreeable and neurotic dispositions may, respectively, bias retrospective ACE measures toward underestimating the impact of adversity on objectively measured life outcomes and overestimating the impact of adversity on self-reported outcomes. Associations between personality factors and the propensity to recall adversity were extremely modest and warrant further investigation. Risk predictions based on retrospective ACE reports should utilize objective outcome measures. Where objective outcome measurements are difficult to obtain, correction factors may be warranted. © 2016 Association for Child and Adolescent Mental Health.

Lest we forget: Comparing retrospective and prospective assessments of adverse childhood experiences in the prediction of adult health

PubMed Central

Reuben, Aaron; Moffitt, Terrie E.; Caspi, Avshalom; Belsky, Daniel W.; Harrington, Honalee; Schroeder, Felix; Hogan, Sean; Ramrakha, Sandhya; Poulton, Richie; Danese, Andrea

2017-01-01

Background Adverse childhood experiences (ACEs; e.g., abuse, neglect, parental loss, etc.) have been associated with increased risk for later-life disease and dysfunction using adults’ retrospective self-reports of ACEs. Research should test whether associations between ACEs and health outcomes are the same for prospective and retrospective ACE measures. Methods We estimated agreement between ACEs prospectively-recorded throughout childhood (by Study staff at Study member ages 3, 5, 7, 9, 11, 13, and 15) and retrospectively-recalled in adulthood (by Study members when they reached age 38), in the population-representative Dunedin cohort (N=1,037). We related both retrospective and prospective ACE measures to physical, mental, cognitive, and social health at midlife measured through both objective (e.g., biomarkers and neuropsychological tests) and subjective (e.g., self-reported) means. Results Dunedin and CDC ACE distributions were similar. Retrospective and prospective measures of adversity showed moderate agreement (r=.47, p<.001; weighted Kappa = .31, 95% CI: .27–.35). Both associated with all midlife outcomes. As compared to prospective ACEs, retrospective ACEs showed stronger associations with life outcomes that were subjectively assessed, and weaker associations with life outcomes that were objectively assessed. Recalled ACEs and poor subjective outcomes were correlated regardless of whether prospectively-recorded ACEs were evident. Individuals who recalled more ACEs than had been prospectively recorded were more neurotic than average, and individuals who recalled fewer ACEs than recorded were more agreeable. Conclusions Prospective ACE records confirm associations between childhood adversity and negative life outcomes found previously using retrospective ACE reports. However, more agreeable and neurotic dispositions may respectively bias retrospective ACE measures toward underestimating the impact of adversity on objectively-measured life outcomes and overestimating the impact of adversity on self-reported outcomes. Associations between personality factors and the propensity to recall adversity were extremely modest and warrant further investigation. Risk predictions based on retrospective ACE reports should utilize objective outcome measures. Where objective outcome measurements are difficult to obtain, correction factors may be warranted. PMID:27647050

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 that data-driven outcome definitions can provide better sensitivity to change than does the ACR20 or DDAS. Using such methods would improve power, but at the expense of trial standardization. The studies also show how patient population and treatment characteristics affect the power of specific outcome measures in RA clinical trials, and provide quantification of those effects.

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

PubMed

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

2018-05-17

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

Moving toward a standard for spinal fusion outcomes assessment.

PubMed

Blount, Kevin J; Krompinger, W Jay; Maljanian, Rose; Browner, Bruce D

2002-02-01

Previous spinal fusion outcomes assessment studies have been complicated by inconsistencies in evaluative criteria and consequent variations in results. As a result, a general consensus is lacking on how to achieve comprehensive outcomes assessment for spinal fusion surgeries. The purpose of this article is to report the most validated and frequently used assessment measures to facilitate comparable outcomes studies in the future. Twenty-seven spinal fusion outcomes studies published between 1990 and 2000 were retrospectively reviewed. Study characteristics such as design, evaluative measures, and assessment tools were recorded and analyzed. Based on the reviewed literature, an outcomes assessment model is proposed including the Short Form-36 Health Survey, the Oswestry Disability Questionnaire, the North American Spine Society Patient Satisfaction Index, the Prolo Economic Scale, a 0-10 analog pain scale, medication use, radiographically assessed fusion status, and a generalized complication rate.

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.

Methodological Issues in Monitoring Health Services and Outcomes for Stroke Survivors: A Case Study

PubMed Central

Stuart, Mary; Papini, Donato; Benvenuti, Francesco; Nerattini, Marco; Roccato, Enrico; Macellari, Velio; Stanhope, Steven; Macko, Richard; Weinrich, Michael

2010-01-01

Background Obtaining comprehensive health outcomes and health services utilization data on stroke patients has been difficult. This research grew out of a memorandum of understanding between the NIH and the ISS (its Italian equivalent) to foster collaborative research on rehabilitation. Objective The purpose of this study was to pilot a methodology using administrative data to monitor and improve health outcomes for stroke survivors in Tuscany. Methods This study used qualitative and quantitative methods to study health resources available to and utilized by stroke survivors during the first 12 months post-stroke in two Italian health authorities (AUSL10 and 11). Mortality rates were used as an outcome measure. Results Number of inpatient days, number of prescriptions, and prescription costs were significantly higher for patients in AUSL 10 compared to AUSL 11. There was no significant difference between mortality rates. Conclusion Using administrative data to monitor process and outcomes for chronic stroke has the potential to save money and improve outcomes. However, measures of functional impairment and more sensitive outcome measures than mortality are important. Additional recommendations for enhanced data collection and reporting are discussed. PMID:21057665

Individual and Composite Study Endpoints: Separating the Wheat from the Chaff

PubMed Central

Goldberg, Robert; Gore, Joel M.; Barton, Bruce; Gurwitz, Jerry

2014-01-01

We provide an overview of the individual and combined clinical endpoints and patient reported outcomes typically used in clinical trials and prospective epidemiological investigations. We discuss the strengths and limitations associated with the utilization of aggregated study endpoints and surrogate measures of important clinical endpoints and patient-centered outcomes. We hope that the points raised in this overview will lead to the collection of clinically rich, relevant, measurable, and cost-efficient study outcomes. PMID:24486289

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

PubMed Central

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

2016-01-01

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

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

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

PubMed

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

2018-05-15

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

NETS1HD: study protocol for development of a core outcome set for use in determining the overall success of Hirschsprung's disease treatment.

PubMed

Allin, Benjamin; Bradnock, Timothy; Kenny, Simon; Walker, Gregor; Knight, Marian

2016-12-07

Use of core outcome sets in research has been proposed as a method for countering the problems caused by heterogeneity of outcome measure reporting. Heterogeneity of outcome measure reporting occurs in Hirschsprung's disease (HD) research and is limiting the development of a robust evidence base to support clinical practice. Candidate outcome measures have been identified through a systematic review. These outcome measures will form the starting point for a three-phase online Delphi process to be carried out in parallel by three panels of experts. Panel 1 is a neonatal panel; panel 2 is a non-neonatal panel; and panel 3 is a lay panel. In round 1, experts will be asked to score the previously identified outcome measures from 1 to 9 based on how important they think the measures are in determining the overall success of their/their child's/their patient's HD. In round 2, experts will be presented with the same list of outcome measures and graphical representations of how their panel scored that outcome in round 1. They will be asked to re-score the outcome measure, taking into account how important other members of their panel felt it to be. In round 3, experts will again be asked to re-score each outcome measure, but this time they will receive a graphical representation of the distribution of scores from all three panels, which they should take into account when re-scoring. Following round 3 of the Delphi process, 40 experts will be invited to attend a face-to-face consensus meeting. Participants will be invited in a purposive manner to obtain balance between the different panels. Results of the Delphi process will be discussed, and outcomes will be re-scored. Outcome measures where >70% of participants at the meeting scored it 7-9 and <15% scored it 1-3 will form the core outcome set. Development of a core outcome set will help to reduce heterogeneity of outcome measure reporting in HD. This will increase the quality of research taking place and ultimately improve care provided to infants with HD.

Assessment of the Incorporation of Patient-Centric Outcomes in Studies of Minimally Invasive Glaucoma Surgical Devices

PubMed Central

Le, Jimmy T.; Viswanathan, Shilpa; Tarver, Michelle E.; Eydelman, Malvina; Li, Tianjing

2017-01-01

IMPORTANCE Minimally invasive glaucoma surgical (MIGS) devices are one option for lowering intraocular pressure in patients with glaucoma. OBJECTIVE To examine how often existing clinical studies of MIGS devices registered on ClinicalTrials.gov measure patient-centric outcomes that patients value directly. DESIGN, SETTING, AND PARTICIPANTS We searched ClinicalTrials.gov, a registry of publicly and privately supported clinical studies, on February 20, 2015, for records of MIGS device studies involving patients with glaucoma. Two investigators independently abstracted study design and outcome details from eligible records. We classified outcomes as patient-centric or not patient-centric using a prespecified definition. MAIN OUTCOMES AND MEASURES Proportion of patient-centric and nonpatient-centric outcomes registered on ClinicalTrials.gov. RESULTS We identified 51 eligible studies specifying 127 outcomes. Reduction in intraocular pressure was the most frequent outcome specified (78/127; 61%) and a primary outcome in 41 studies. Patient-centric outcomes—such as adverse events (n = 19; 15%), topical medication use (n = 16; 13%), visual acuity (n = 4; 3%), and health-related quality of life (n = 1; 1%)—were less frequently specified (n = 40; 32%) and a primary outcome in only 12 studies. CONCLUSION AND RELEVANCE Patient-centric outcomes that provide insight into the relative desirability and acceptability of the benefits and risks of MIGS devices are not well represented in current clinical studies. PMID:27389667

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.

The Challenge Course Experience Questionnaire: A Facilitator's Assessment Tool

ERIC Educational Resources Information Center

Schary, David P.; Waldron, Alexis L.

2017-01-01

Challenge course programs influence a variety of psychological, social, and educational outcomes. Yet, many challenges exist when measuring challenge course outcomes like logistical constraints and a lack of specific assessment tools. This study piloted and tested an assessment tool designed for facilitators to measure participant outcomes in…

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

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

PubMed Central

McKnight, Patrick E.; Kashdan, Todd B.

2009-01-01

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

Do the EULAR Sjögren's syndrome outcome measures correlate with health status in primary Sjögren's syndrome?

PubMed

Lendrem, Dennis; Mitchell, Sheryl; McMeekin, Peter; Gompels, Luke; Hackett, Katie; Bowman, Simon; Price, Elizabeth; Pease, Colin T; Emery, Paul; Andrews, Jacqueline; Lanyon, Peter; Hunter, John; Gupta, Monica; Bombardieri, Michele; Sutcliffe, Nurhan; Pitzalis, Costantino; McLaren, John; Cooper, Annie; Regan, Marian; Giles, Ian; Isenberg, David; Saravanan, Vadivelu; Coady, David; Dasgupta, Bhaskar; McHugh, Neil; Young-Min, Steven; Moots, Robert; Gendi, Nagui; Akil, Mohammed; Griffiths, Bridget; Ng, Wan-Fai

2015-04-01

This study sets out to investigate the relationship between health status [EuroQol five-dimensions questionnaire (EQ-5D)] in primary SS and three of the European League Against Rheumatism (EULAR) SS outcome measures-the disease activity index (ESSDAI), the patient reported index (ESSPRI) and the sicca score. In particular, the goal was to establish whether there is a relationship between the EULAR outcome measures and quality of life. Health status was evaluated using a standardized measure developed by the EuroQol Group-the EQ5D. This permits calculation of two measures of health status: time trade-off (TTO) values and the EQ-5D visual analogue scale (VAS) scores. We used Spearman's rank correlation analysis to investigate the strength of association between health status and three EULAR measures of physician- and patient-reported disease activity in 639 patients from the UK primary SS registry (UKPSSR) cohort. This study demonstrates that the EULAR SS disease-specific outcome measures are significantly correlated with health outcome values (P < 0.001). Higher scores on the ESSDAI, EULAR sicca score and ESSPRI are associated with poorer health states-i.e. lower TTO values and lower VAS scores. While all three are significantly correlated with TTO values and EQ-5D VAS scores, the effect is strongest for the ESSPRI. This study provides further evidence supporting the use of ESSDAI, EULAR sicca score and ESSPRI measures in the clinic. We also discuss the need for disease-specific measures of health status and their comparison with standardized health outcome measures. © The Author 2014. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

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.

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

PubMed

Alarab, H; Dubert, T

2015-02-01

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

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

PubMed

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

2017-07-01

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

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

PubMed Central

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

2015-01-01

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

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

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

PubMed

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

2014-01-01

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

Patient Reported Outcomes in Preoperative and Postoperative Patients with Hypospadias.

PubMed

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

2016-04-01

Current outcome tools for hypospadias have limited focus on the caregiver or patient perspective of important patient centered outcomes. In this study we collaborated with patients, caregivers, and lay and medical experts to develop and pilot a patient reported outcome measure for hypospadias. We developed a patient reported outcome measure based on systematic review of the literature and focus group input. The patient reported outcome measure was piloted in caregivers for boys younger than 8 years and in patients older than 8 years who presented for urology consultation before meeting with the surgeon. Patients were classified with uncorrected hypospadias, successful repair or failed repair based on the presence or absence of complications (fistula, diverticulum, meatal stenosis/stricture, greater than 30-degree recurrent curvature, glans dehiscence and/or skin reoperation). A patient reported outcome measure was developed and administered to 347 patients and/or caregivers-proxies, including 105 uncorrected cases, 162 successful repair cases and 80 failed cases. Satisfaction with appearance was highest in those with successful hypospadias repair compared to failed repair and uncorrected hypospadias (93% vs 77% and 67%, respectively). Voiding symptoms such as spraying or a deviated stream were highest in failed and uncorrected cases (39% and 37%, respectively). Overall dissatisfaction with voiding was highest for uncorrected hypospadias and failed repair compared to successful cases (54% and 47%, respectively, vs 15%). The evaluation of patient and caregiver-proxy reported outcomes in preoperative and postoperative patients with hypospadias allows for the quantification of benefits derived from hypospadias repair and may ultimately represent the gold standard outcome measure for hypospadias. This pilot study identified preliminary patient centered themes and demonstrated the feasibility of administering hypospadias patient reported outcome measures in clinical practice. Copyright © 2016 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

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

PubMed

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

2014-05-01

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

Mind-Body Medicine and Immune System Outcomes: A Systematic Review.

PubMed

Wahbeh, Helané; Haywood, Ashley; Kaufman, Karen; Zwickey, Heather

2009-01-01

This study is a systematic review of mind-body interventions that used immune outcomes in order to: 1) characterize mind-body medicine studies that assessed immune outcomes, 2) evaluate the quality of mind-body medicine studies measuring immune system effects, and 3) systematically evaluate the evidence for mind-body interventions effect on immune system outcomes using existing formal tools. 111 studies with 4,777 subjects were reviewed. The three largest intervention type categories were Relaxation Training (n=25), Cognitive Based Stress Management (n=22), and Hypnosis (n=21). Half the studies were conducted with healthy subjects (n=51). HIV (n=18), cancer (n=13) and allergies (n=7) were the most prominent conditions examined in the studies comprising of non-healthy subjects. Natural killer cell and CD4 T lymphocyte measures were the most commonly studied outcomes. Most outcome and modality categories had limited or inconclusive evidence. Relaxation training had the strongest scientific evidence of a mind-body medicine affecting immune outcomes. Immunoglobulin A had the strongest scientific evidence for positive effects from mind-body medicine. Issues for mind-body medicine studies with immune outcomes are discussed and recommendations are made to help improve future clinical trials.

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

PubMed Central

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

2015-01-01

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

Measuring outcomes in adult spinal deformity surgery: a systematic review to identify current strengths, weaknesses and gaps in patient-reported outcome measures.

PubMed

Faraj, Sayf S A; van Hooff, Miranda L; Holewijn, Roderick M; Polly, David W; Haanstra, Tsjitske M; de Kleuver, Marinus

2017-08-01

Adult spinal deformity (ASD) causes severe disability, reduces overall quality of life, and results in a substantial societal burden of disease. As healthcare is becoming more value based, and to facilitate global benchmarking, it is critical to identify and standardize patient-reported outcome measures (PROMs). This study aims to identify the current strengths, weaknesses, and gaps in PROMs used for ASD. Studies were included following a systematic search in multiple bibliographic databases between 2000 and 2015. PROMs were extracted and linked to the outcome domains of WHO's International Classification of Functioning and Health (ICF) framework. Subsequently, the clinimetric quality of identified PROMs was evaluated. The literature search identified 144 papers that met the inclusion criteria, and nine frequently used PROMs were identified. These covered 29 ICF outcome domains, which could be grouped into three of the four main ICF chapters: body function (n = 7), activity and participation (n = 19), environmental factors (n = 3), and body structure (n = 0). A low quantity (n = 3) of papers was identified that studied the clinimetric quality of PROMs. The Scoliosis Research Society (SRS)-22 has the highest level of clinimetric quality for ASD. Outcome domains related to mobility and pain were well represented. We identified a gap in current outcome measures regarding neurological and pulmonary function. In addition, no outcome domains were measured in the ICF chapter body structure. These results will serve as a foundation for the process of seeking international consensus on a standard set of outcome domains, accompanied PROMs and contributing factors to be used in future clinical trials and spine registries.

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 cognitive outcome after ATL. The results are encouraging with regard to the clinical relevance of using graph-theory measures in presurgical algorithms in the setting of TLE. Wiley Periodicals, Inc. © 2015 International League Against Epilepsy.

Staff perceptions of using outcome measures in stroke rehabilitation.

PubMed

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

2013-05-01

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

Outcome Measures Used to Report Kidney Function in Studies Investigating Surgical Management of Kidney Tumours: A Systematic Review.

PubMed

Ellis, Robert J; Cho, Yeoungjee; Del Vecchio, Sharon J; McStea, Megan; Morais, Christudas; Coombes, Jeff S; Wood, Simon T; Gobe, Glenda C; Francis, Ross S

2018-05-01

Most practice decisions relevant to preserving kidney function in patients managed surgically for kidney tumours are driven by observational studies. A wide range of outcome measures are used in these studies, which reduces comparability and increases the risk of reporting bias. To comprehensively and succinctly describe the outcomes used to evaluate kidney function in studies evaluating surgical management of kidney tumours. Electronic search of the PubMed database was conducted to identify studies with at least one measure of kidney function in patients managed surgically for kidney tumours, published between January 2000 and September 2017. Abstracts were initially screened for eligibility. Full texts of articles were then evaluated in more detail for inclusion. A narrative synthesis of the evidence was conducted. A total of 312 studies, involving 127905 participants, were included in this review. Most were retrospective (n=274) studies and conducted in a single centre (n=264). Overall, 78 unique outcome measures were identified, which were grouped into six outcome categories. Absolute postoperative kidney function (n=187), relative kidney function (n=181), and postoperative chronic kidney disease (n=131) were most frequently reported. Kidney function was predominantly quantified using estimated glomerular filtration rate or creatinine clearance (n=255), most using the modification of diet in renal disease equation (n=182). Only 70 studies provided rationale for specific outcome measures used. There is significant variability in the reporting and quantification of kidney function in studies evaluating patients managed surgically for kidney tumours. A standardised approach to measuring and reporting kidney function will increase the effectiveness of outcomes reported and improve relevance of research findings within a clinical context. Although we know that the removal of a kidney can reduce kidney function, clinical significance of various approaches is a matter of debate. This article demonstrates significant variability in the way kidney function was reported across all studies of patients with kidney cancer undergoing surgery, indicating a need for standardisation. Copyright © 2018 European Association of Urology. All rights reserved.

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

PubMed

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

2018-05-09

We aimed to map the physiotherapy practice in Sweden of clinical tests and patient-reported outcome measures in low-back pain (LBP), and to study advantages and barriers in using patient-reported outcome measures. An online survey was mailed to 4934 physiotherapists in primary health care in Sweden. Multiple choice questions investigated the use of clinical tests and patient-reported outcome measures in assessing patients with LBP. Open questions investigating the advantages and barriers to the use of patient-reported outcome measures were analyzed with content analysis. The response rate was 25% (n = 1217). Clinical tests were used "always/often" by >60% of the participants, while most patient-reported outcome measures were used by <15%. Advantages in using patient-reported outcome measures were: the clinical reasoning process, to increase the quality of assessment, to get the patient's voice, education and motivation of patients, and communication with health professionals. Barriers were lack of time and knowledge, administrative aspects, the interaction between physiotherapist and patient and, the applicability and validity of the patient-reported outcome measures. Our findings show that physiotherapists working in primary health care use clinical testing in LBP to a great extent, while various patient-reported outcome measures are used to a low-to-very-low extent. Several barriers to the use of patient-reported outcome measures were reported such as time, knowledge, and administrative issues, while important findings on advantages were to enhance the clinical reasoning process and to educate and motivate the patient. Barriers might be changed through education or organizational change-work. To enhance the use of patient-reported outcome measures and thus person-centered care in low-back pain, recommendation, and education on various patient-reported outcome measures need to be advocated. Implications for rehabilitation To increase the effects of 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.

Cell assisted lipotransfer in breast augmentation and reconstruction: A systematic review of safety, efficacy, use of patient reported outcomes and study quality.

PubMed

Arshad, Zeeshaan; Karmen, Lindsey; Choudhary, Rajan; Smith, James A; Branford, Olivier A; Brindley, David A; Pettitt, David; Davies, Benjamin M

2016-12-01

Cell assisted lipotransfer serves as a novel technique for both breast reconstruction and breast augmentation. This systematic review assesses the efficacy, safety and use of patient reported outcome measures in studies involving cell assisted lipotransfer. We also carry out an objective assessment of study quality focussing on recruitment, follow-up and provide an up-to-date clinical trial landscaping analysis. Key electronic databases were searched according to PRISMA guidelines and pre-defined inclusion and exclusion criteria. Two independent reviewers examined the retrieved publications and performed data extraction. 3980 publications were identified. Following screening, 11 studies were included for full review, representing a total of 336 patients with a follow-up time ranging from six to 42 months. A degree of variation was noted in graft retention and reported satisfaction levels, although there were only three comparative studies with conflicting results. Complications occurred at a rate of 37%. Additionally, there was a paucity of objective outcomes assessments (e.g. 3D assessment modalities or validated patient reported outcome measures) in the selected studies. Cell assisted lipotransfer is a surgical technique that is currently employed sparingly within the plastic & reconstructive surgery community. Presently, further technical and outcome standardization is required, in addition to rigorous randomized controlled trials and supporting long-term follow-up data to better determine procedural safety and efficacy. Routine use of more objective outcome measures, particularly 3D assessments and validated patient reported outcome measures, will also help facilitate wider clinical adoption and establish procedural utility.

Teamwork and communication in the operating room: relationship to discrete outcomes and research challenges.

PubMed

Nurok, Michael; Sundt, Thoralf M; Frankel, Allan

2011-03-01

The literature defining and addressing teamwork and communication is abundant; however, few studies have analyzed the relationship between measures of teamwork and communication and quantifiable outcomes. The objectives of this review are: (1) to identify studies addressing teamwork and communication in the operating room in relation to discrete measures of outcome, (2) to create a classification of studies of the relationship between teamwork and communication and outcomes, (3) to assess the implications of these studies, (4) to explore the methodological challenges of teamwork and communication studies in the perioperative setting, and (5) to suggest future research directions.studies in the perioperative setting, and (5) to suggest future research directions. Copyright © 2011 Elsevier Inc. All rights reserved.

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

PubMed

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

2015-09-01

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

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

PubMed

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

2018-02-22

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

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…

Relationship between Learning Outcomes and Online Accesses

ERIC Educational Resources Information Center

Suanpang, Pannee; Petocz, Peter; Reid, Anna

2004-01-01

This paper reports on a study carried out in Thailand investigating the relationship between students' use of an e-learning system and their learning outcomes in a course on Business Statistics. The results show a clear relationship between accesses to the e-learning system, as measured by number of "hits", and outcomes, as measured by…

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

PubMed

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

2018-06-30

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

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

PubMed

Schlessinger, Daniel I; Iyengar, Sanjana; Yanes, Arianna F; Henley, Jill K; Ashchyan, Hovik J; Kurta, Anastasia O; Patel, Payal M; Sheikh, Umar A; Franklin, Matthew J; Hanna, Courtney C; Chen, Brian R; Chiren, Sarah G; Schmitt, Jochen; Deckert, Stefanie; Furlan, Karina C; Poon, Emily; Maher, Ian A; Cartee, Todd V; Sobanko, Joseph F; Alam, Murad

2017-08-01

Facial aging is a concern for many patients. Wrinkles, loss of volume, and discoloration are common physical manifestations of aging skin. Genetic heritage, prior ultraviolet light exposure, and Fitzpatrick skin type may be associated with the rate and type of facial aging. Although many clinical trials assess the correlates of skin aging, there is heterogeneity in the outcomes assessed, which limits the quality of evaluation and comparison of treatment modalities. To address the inconsistency in outcomes, in this project we will develop a core set of outcomes that are to be evaluated in all clinical trials relevant to facial aging. A long list of measureable outcomes will be created from four sources: (1) systematic medical literature review, (2) patient interviews, (3) other published sources, and (4) stakeholder involvement. Two rounds of Delphi processes with homogeneous groups of physicians and patients will be performed to prioritize and condense the list. At a consensus meeting attended by physicians, patients, and stakeholders, outcomes will be further condensed on the basis of participant scores. By the end of the meeting, members will vote and decide on a final recommended set of core outcomes. Subsequent to this, specific measures will be selected or created to assess these outcomes. The aim of this study is to develop a core outcome set and relevant measures for clinical trials relevant to facial aging. We hope to improve the reliability and consistency of outcome reporting of skin aging, thereby enabling improved evaluation of treatment efficacy and patient satisfaction. Core Outcome Measures in Effectiveness Trials (COMET) Initiative, accessible at http://www.comet-initiative.org/studies/details/737 . Core Outcomes Set Initiative, (CSG-COUSIN) accessible at https://www.uniklinikum-dresden.de/de/das-klinikum/universitaetscentren/zegv/cousin/meet-the-teams/project-groups/core-outcome-set-for-the-appearance-of-facial-aging . Protocol version date is 28 July 2016.

Unmet reproductive health needs among women in some West African countries: a systematic review of outcome measures and determinants.

PubMed

Ayanore, Martin Amogre; Pavlova, Milena; Groot, Wim

2016-01-16

Identifying relevant measures of women's reproductive health needs is critical to improve women's chances of service utilization. The study aims to systematically review and analyze the adequacy of outcome measures and determinants applied in previous studies for assessing women reproductive health needs across West Africa. Evidence on outcomes and determinants of unmet reproductive health needs among women of childbearing age in diverse multicultural, religious, and ethnic settings in West African countries was systematically reviewed. The review included recent English language publications (from January 2009 - March 2014). Clinical studies particularly on obstetric care services and reproductive services in relation to HIV/AIDS were excluded. We acknowledge the possibility to have excluded non-English publications and yet-to-be-published articles related to the study aim and objectives. Outcomes and determinants were assessed and defined at three main levels; contraceptive use, obstetric care, and antenatal care utilization. Results show increasing unmet need for women's reproductive health needs. Socio-cultural norms and practices resulting in discontinuation of service use, economic constraints, travel distance to access services and low education levels of women were found to be key predictors of service utilization for contraception, antenatal and obstetric care services. Outcome measures were mainly assessed based on service utilization, satisfaction, cost, and quality of services available as core measures across the three levels assessed in this review. Evidence from this review indicates that currently applied measures of women's reproductive health needs might be inadequate in attaining best maternal outcomes since they appear rather broad. More support and research for developing and advancing context-related measures may help to improve women's maternal health.

Orthodontic trial outcomes: Plentiful, inconsistent, and in need of uniformity? A scoping review.

PubMed

Tsichlaki, Aliki; O'Brien, Kevin; Johal, Ama; Fleming, Padhraig S

2018-06-01

The selection of appropriate outcomes that matter to both patients and operators is increasingly appreciated, with core outcome sets in clinical trials gaining in popularity. The first step in core outcome set development is the generation of a list of possible important outcomes based on a scoping literature review. Moreover, outcome heterogeneity is known to detract from the findings of systematic reviews and meta-analyses. The aim of this study was to identify the range of outcome domains and specific outcome measures in contemporary orthodontic research. Multiple electronic databases were searched from December 31, 2012, to December 31, 2016, to identify clinical trials of orthodontic interventions, with no language restrictions. Abstracts, eligible full texts, and reference lists were screened, and all reported primary and nonprimary outcomes and methods of measurement were recorded. The search identified 1267 abstracts, of which 189 full-text articles were retrieved, and 164 studies were included in the analysis. A total of 54 outcomes were identified and categorized into 14 outcome domains. The most frequently measured outcomes were patient-reported pain, periodontal health, tooth angulation/inclination changes, and treatment duration, followed by rate of tooth movement and skeletal changes. Outcomes that followed the overall course of treatment were assessed in only 14 studies. Patient perspectives are increasingly being accounted for in orthodontic trials; however, there is little consistency in outcome selection among them. The identified list of outcomes will be used to inform a ranking exercise with service users and providers to establish an agreed core outcome set for future orthodontic clinical trials. Copyright © 2018 American Association of Orthodontists. Published by Elsevier Inc. All rights reserved.

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

Narrative review. To identify suitable outcome measures that can be used to quantify neurological and functional impairment in the management of cervical spondylotic myelopathy (CSM). CSM is the leading cause of acquired spinal cord disability, causing varying degrees of neurological impairment which impact on independence and quality of life. Because this impairment can have a heterogeneous presentation, a single outcome measure cannot define the broad range of deficits seen in this population. Therefore, it is necessary to define outcome measures that characterize the deficits with greater validity and sensitivity. This review was conducted in 3 stages. Stage I: To evaluate the current use of outcome measures in CSM, PubMed was searched using the name of the outcome measure and the common abbreviation combined with "CSM" or "myelopathy." Stage II: Having identified a lack of appropriate outcome measures, we constructed criteria by which measures appropriate for assessing the various aspects of CSM could be identified. Stage III: A second literature search was then conducted looking at specified outcomes that met these criteria. All literature was reviewed to determine specificity and psychometric properties of outcomes for CSM. Nurick grade, modified Japanese Orthopaedic Association Scale, visual analogue scale (VAS) for pain, Short Form (36) Health Survey (SF-36), and Neck Disability Index were the most commonly cited measures. The Short-Form 36 Health Survey and Myelopathy Disability Index have been validated in the CSM population with multiple studies, whereas the modified Japanese Orthopaedic Association Scale score, Nurick grade, and European Myelopathy Scale each had only one study assessing psychometric characteristics. No validity, reliability, or responsiveness studies were found for the VAS or Neck Disability Index in the CSM population. We recommend that the modified Japanese Orthopaedic Association Scale, Nurick grade, Myelopathy Disability Index, 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.

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 Authors for a complete description of levels of evidence.

The nature and outcomes of work: a replication and extension of interdisciplinary work-design research.

PubMed

Edwards, J R; Scully, J A; Brtek, M D

2000-12-01

Research into the changing nature of work requires comprehensive models of work design. One such model is the interdisciplinary framework (M. A. Campion, 1988), which integrates 4 work-design approaches (motivational, mechanistic, biological, perceptual-motor) and links each approach to specific outcomes. Unfortunately, studies of this framework have used methods that disregard measurement error, overlook dimensions within each work-design approach, and treat each approach and outcome separately. This study reanalyzes data from M. A. Campion (1988), using structural equation models that incorporate measurement error, specify multiple dimensions for each work-design approach, and examine the work-design approaches and outcomes jointly. Results show that previous studies underestimate relationships between work-design approaches and outcomes and that dimensions within each approach exhibit relationships with outcomes that differ in magnitude and direction.

The design and methodology of premature ejaculation interventional studies

PubMed Central

2016-01-01

Large well-designed clinical efficacy and safety randomized clinical trials (RCTs) are required to achieve regulatory approval of new drug treatments. The objective of this article is to make recommendations for the criteria for defining and selecting the clinical trial study population, design and efficacy outcomes measures which comprise ideal premature ejaculation (PE) interventional trial methodology. Data on clinical trial design, epidemiology, definitions, dimensions and psychological impact of PE was reviewed, critiqued and incorporated into a series of recommendations for standardisation of PE clinical trial design, outcome measures and reporting using the principles of evidence based medicine. Data from PE interventional studies are only reliable, interpretable and capable of being generalised to patients with PE, when study populations are defined by the International Society for Sexual Medicine (ISSM) multivariate definition of PE. PE intervention trials should employ a double-blind RCT methodology and include placebo control, active standard drug control, and/or dose comparison trials. Ejaculatory latency time (ELT) and subject/partner outcome measures of control, personal/partner/relationship distress and other study-specific outcome measures should be used as outcome measures. There is currently no published literature which identifies a clinically significant threshold response to intervention. The ISSM definition of PE reflects the contemporary understanding of PE and represents the state-of-the-art multi-dimensional definition of PE and is recommended as the basis of diagnosis of PE for all PE clinical trials. PMID:27652224

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.

'It will get even better': preliminary findings from a trauma-focused psychotherapy effectiveness study reveal false positive patients' long-term outcome expectations after the treatment.

PubMed

Kazlauskas, Evaldas; Jovarauskaite, Lina; Mazulyte, Egle; Skruibis, Paulius; Dovydaitiene, Migle; Eimontas, Jonas; Zelviene, Paulina

2017-05-01

There is considerable evidence that outcome expectations may predict psychotherapy outcomes. However, little is known about the long-term outcome expectations following the end of the treatment. The aim of this study was to evaluate patients' long-term outcome expectations after trauma-focused post-traumatic stress disorder (PTSD) psychotherapy in a single group effectiveness study. Twenty participants with various traumatic experiences who completed the Brief Eclectic Psychotherapy for Post-Traumatic Stress Disorder (BEPP) and all the assessments were included into the study. Self-report measures were used to evaluate the therapeutic outcomes: Impact of Event Scale-Revised (IES-R), Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) at pre-treatment, post-treatment, and 6-month follow-up. Subjective Units of Distress Scale was used to measure long-term outcome expectations at post-treatment, asking participants to measure the expected distress in 6 months following the treatment. Assessments at 6-month follow-up were used to estimate the accuracy of patients' expectations of their distress at previous post-treatment assessment. Significant decline of PTSD symptoms at post-treatment with large effect sizes was observed. At post-treatment assessment participants expected significant improvement of their condition in 6 months after the treatment. However, therapeutic effects remained stable at the 6-month follow-up. It is concluded that the PTSD patients, even after successful trauma-focused treatment, tend to expect further significant positive changes. However, therapeutic effects were stable half a year after the psychotherapy, and patients tend to have false expectations about further improvement of their condition.

Comparing current definitions of return to work: a measurement approach.

PubMed

Steenstra, I A; Lee, H; de Vroome, E M M; Busse, J W; Hogg-Johnson, S J

2012-09-01

Return-to-work (RTW) status is an often used outcome in work and health research. In low back pain, work is regarded as a normal activity a worker should return to in order to fully recover. Comparing outcomes across studies and even jurisdictions using different definitions of RTW can be challenging for readers in general and when performing a systematic review in particular. In this study, the measurement properties of previously defined RTW outcomes were examined with data from two studies from two countries. Data on RTW in low back pain (LBP) from the Canadian Early Claimant Cohort (ECC); a workers' compensation based study, and the Dutch Amsterdam Sherbrooke Evaluation (ASE) study were analyzed. Correlations between outcomes, differences in predictive validity when using different outcomes and construct validity when comparing outcomes to a functional status outcome were analyzed. In the ECC all definitions were highly correlated and performed similarly in predictive validity. When compared to functional status, RTW definitions in the ECC study performed fair to good on all time points. In the ASE study all definitions were highly correlated and performed similarly in predictive validity. The RTW definitions, however, failed to compare or compared poorly with functional status. Only one definition compared fairly on one time point. Differently defined outcomes are highly correlated, give similar results in prediction, but seem to differ in construct validity when compared to functional status depending on societal context or possibly birth cohort. Comparison of studies using different RTW definitions appears valid as long as RTW status is not considered as a measure of functional status.

Early childhood growth and cognitive outcomes: Findings from the MAL-ED study.

PubMed

Scharf, Rebecca J; Rogawski, Elizabeth T; Murray-Kolb, Laura E; Maphula, Angelina; Svensen, Erling; Tofail, Fahmida; Rasheed, Muneera; Abreu, Claudia; Vasquez, Angel Orbe; Shrestha, Rita; Pendergast, Laura; Mduma, Estomih; Koshy, Beena; Conaway, Mark R; Platts-Mills, James A; Guerrant, Richard L; DeBoer, Mark D

2018-02-02

Although many studies around the world hope to measure or improve developmental progress in children to promote community flourishing and productivity, growth is sometimes used as a surrogate because cognitive skills are more difficult to measure. Our objective was to assess how childhood measures of anthropometry correlate with measures of child development in low-income settings with high prevalence of poor nutrition and enteric disease, to inform studies considering growth outcomes in the absence of direct child developmental skill assessment. Children from the MAL-ED study were followed from birth to 24 months of age in field sites in 8 low- and middle-income countries across 3 continents. Monthly weight, length, and head circumference measurements were performed. At 24 months, the Bayley Scales of Infant and Toddler Development was administered. We correlated cognitive measures at 24 months with anthropometric measurements from birth to 2 years comparing 3 constructs: absolute attained monthly measures, summative difference in measures from the mean growth curve, and rate of change in measures. Growth faltering at multiple time periods is related to Bayley cognitive outcomes at 24 months. Birthweight, overall growth by 18-24 months, and rate of growth in the 6- to 18-month period were most associated with 24-month developmental scores. In this study, head circumference measurements, compared with length, was more closely linked to cognitive scores at 24 months. Notably, all studies between growth and cognitive outcomes exhibited low r 2 values (0.001-0.049). Anthropometric measures, particularly head circumference, were related to cognitive development, although explaining a low percent of variance. When feasible, direct measures of child development may be more useful. © 2018 John Wiley & Sons Ltd.

Methodological issues in the design and evaluation of supported communication for aphasia training: a cluster-controlled feasibility study

PubMed Central

Horton, Simon; Clark, Allan; Barton, Garry; Lane, Kathleen; Pomeroy, Valerie M

2016-01-01

Objective To assess the feasibility and acceptability of training stroke service staff to provide supported communication for people with moderate–severe aphasia in the acute phase; assess the suitability of outcome measures; collect data to inform sample size and Health Economic evaluation in a definitive trial. Design Phase II cluster-controlled, observer-blinded feasibility study. Settings In-patient stroke rehabilitation units in the UK matched for bed numbers and staffing were assigned to control and intervention conditions. Participants 70 stroke rehabilitation staff from all professional groups, excluding doctors, were recruited. 20 patients with moderate-severe aphasia were recruited. Intervention Supported communication for aphasia training, adapted to the stroke unit context versus usual care. Training was supplemented by a staff learning log, refresher sessions and provision of communication resources. Main outcome measures Feasibility of recruitment and acceptability of the intervention and of measures required to assess outcomes and Health Economic evaluation in a definitive trial. Staff outcomes: Measure of Support in Conversation; patient outcomes: Stroke and Aphasia Quality of Life Scale; Communicative Access Measure for Stroke; Therapy Outcome Measures for aphasia; EQ-5D-3L was used to assess health outcomes. Results Feasibility of staff recruitment was demonstrated. Training in the intervention was carried out with 28 staff and was found to be acceptable in qualitative reports. 20 patients consented to take part, 6 withdrew. 18 underwent all measures at baseline; 16 at discharge; and 14 at 6-month follow-up. Of 175 patients screened 71% were deemed to be ineligible, either lacking capacity or too unwell to participate. Poor completion rates impacted on assessment of patient outcomes. We were able to collect sufficient data at baseline, discharge and follow-up for economic evaluation. Conclusions The feasibility study informed components of the intervention and implementation in day-to-day practice. Modifications to the design are needed before a definitive cluster-randomised trial can be undertaken. Trial registration number ISRCTN37002304; Results. PMID:27091825

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

PubMed Central

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

2010-01-01

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

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

PubMed

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

2016-10-01

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

Predictive performance of four frailty measures in an older Australian population

PubMed Central

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

2015-01-01

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

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

PubMed

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

2017-07-20

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

Nervous System Sensitization as a Predictor of Outcome in the Treatment of Peripheral Musculoskeletal Conditions: A Systematic Review.

PubMed

O'Leary, Helen; Smart, Keith M; Moloney, Niamh A; Doody, Catherine M

2017-02-01

Research suggests that peripheral and central nervous system sensitization can contribute to the overall pain experience in peripheral musculoskeletal (MSK) conditions. It is unclear, however, whether sensitization of the nervous system results in poorer outcomes following the treatment. This systematic review investigated whether nervous system sensitization in peripheral MSK conditions predicts poorer clinical outcomes in response to a surgical or conservative intervention. Four electronic databases were searched to identify the relevant studies. Eligible studies had a prospective design, with a follow-up assessing the outcome in terms of pain or disability. Studies that used baseline indices of nervous system sensitization were included, such as quantitative sensory testing (QST) or questionnaires that measured centrally mediated symptoms. Thirteen studies met the inclusion criteria, of which six were at a high risk of bias. The peripheral MSK conditions investigated were knee and hip osteoarthritis, shoulder pain, and elbow tendinopathy. QST parameters indicative of sensitization (lower electrical pain thresholds, cold hyperalgesia, enhanced temporal summation, lower punctate sharpness thresholds) were associated with negative outcome (more pain or disability) in 5 small exploratory studies. Larger studies that accounted for multiple confounders in design and analysis did not support a predictive relationship between QST parameters and outcome. Two studies used self-report measures to capture comorbid centrally mediated symptoms, and found higher questionnaire scores were independently predictive of more persistent pain following a total joint arthroplasty. This systematic review found insufficient evidence to support an independent predictive relationship between QST measures of nervous system sensitization and treatment outcome. Self-report measures demonstrated better predictive ability. Further high-quality prognostic research is warranted. © 2016 World Institute of Pain.

Empirical evidence about inconsistency among studies in a pair‐wise meta‐analysis

PubMed Central

Turner, Rebecca M.; Higgins, Julian P. T.

2015-01-01

This paper investigates how inconsistency (as measured by the I2 statistic) among studies in a meta‐analysis may differ, according to the type of outcome data and effect measure. We used hierarchical models to analyse data from 3873 binary, 5132 continuous and 880 mixed outcome meta‐analyses within the Cochrane Database of Systematic Reviews. Predictive distributions for inconsistency expected in future meta‐analyses were obtained, which can inform priors for between‐study variance. Inconsistency estimates were highest on average for binary outcome meta‐analyses of risk differences and continuous outcome meta‐analyses. For a planned binary outcome meta‐analysis in a general research setting, the predictive distribution for inconsistency among log odds ratios had median 22% and 95% CI: 12% to 39%. For a continuous outcome meta‐analysis, the predictive distribution for inconsistency among standardized mean differences had median 40% and 95% CI: 15% to 73%. Levels of inconsistency were similar for binary data measured by log odds ratios and log relative risks. Fitted distributions for inconsistency expected in continuous outcome meta‐analyses using mean differences were almost identical to those using standardized mean differences. The empirical evidence on inconsistency gives guidance on which outcome measures are most likely to be consistent in particular circumstances and facilitates Bayesian meta‐analysis with an informative prior for heterogeneity. © 2015 The Authors. Research Synthesis Methods published by John Wiley & Sons, Ltd. © 2015 The Authors. Research Synthesis Methods published by John Wiley & Sons, Ltd. PMID:26679486

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…

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

PubMed

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

2017-12-01

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

A Cross-Sectional Review of Reporting Variation in Postoperative Bowel Dysfunction After Rectal Cancer Surgery.

PubMed

Chapman, Stephen J; Bolton, William S; Corrigan, Neil; Young, Neville; Jayne, David G

2017-02-01

Postoperative bowel dysfunction affects quality of life after sphincter-preserving rectal cancer surgery, but the extent of the problem is not clearly defined because of inconsistent outcome measures used to characterize the condition. The purpose of this study was to assess variation in the reporting of postoperative bowel dysfunction and to make recommendations for standardization in future studies. If possible, a quantitative synthesis of bowel dysfunction symptoms was planned. MEDLINE and EMBASE databases, as well as the Cochrane Library, were queried systematically between 2004 and 2015. The studies selected reported at least 1 component of bowel dysfunction after resection of rectal cancer. The main outcome measures were reporting, measurement, and definition of postoperative bowel dysfunction. Of 5428 studies identified, 234 met inclusion criteria. Widely reported components of bowel dysfunction were incontinence to stool (227/234 (97.0%)), frequency (168/234 (71.8%)), and incontinence to flatus (158/234 (67.5%)). Urgency and stool clustering were reported less commonly, with rates of 106 (45.3%) of 234 and 61 (26.1%) of 234. Bowel dysfunction measured as a primary outcome was associated with better reporting (OR = 3.49 (95% CI, 1.99-6.23); p < 0.001). Less than half of the outcomes were assessed using a dedicated research tool (337/720 (46.8%)), and the remaining descriptive measures were infrequently defined (56/383 (14.6%)). Heterogeneity in the reporting, measurement, and definition of postoperative bowel dysfunction precluded pooling of results and limited interpretation. Considerable variation exists in the reporting, measurement, and definition of postoperative bowel dysfunction. These inconsistencies preclude reliable estimates of incidence and meta-analysis. A broadly accepted outcome measure may address this deficit in future studies.

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

PubMed

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

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

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

PubMed

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

2014-06-01

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

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

PubMed Central

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

2017-01-01

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

Size and consistency of problem-solving consultation outcomes: an empirical analysis.

PubMed

Hurwitz, Jason T; Kratochwill, Thomas R; Serlin, Ronald C

2015-04-01

In this study, we analyzed extant data to evaluate the variability and magnitude of students' behavior change outcomes (academic, social, and behavioral) produced by consultants through problem-solving consultation with teachers. Research questions were twofold: (a) Do consultants produce consistent and sizeable positive student outcomes across their cases as measured through direct and frequent assessment? and (b) What proportion of variability in student outcomes is attributable to consultants? Analyses of extant data collected from problem-solving consultation outcome studies that used single-case, time-series AB designs with multiple participants were analyzed. Four such studies ultimately met the inclusion criteria for the extant data, comprising 124 consultants who worked with 302 school teachers regarding 453 individual students. Consultants constituted the independent variable, while the primary dependent variable was a descriptive effect size based on student behavior change as measured by (a) curriculum-based measures, (b) permanent products, or (c) direct observations. Primary analyses involved visual and statistical evaluation of effect size magnitude and variability observed within and between consultants and studies. Given the nested nature of the data, multilevel analyses were used to assess consultant effects on student outcomes. Results suggest that consultants consistently produced positive effect sizes on average across their cases, but outcomes varied between consultants. Findings also indicated that consultants, teachers, and the corresponding studies accounted for a significant proportion of variability in student outcomes. This investigation advances the use of multilevel and integrative data analyses to evaluate consultation outcomes and extends research on problem-solving consultation, consultant effects, and meta-analysis of case study AB designs. Practical implications for evaluating consultation service delivery in school settings are also discussed. Copyright © 2015 Society for the Study of School Psychology. Published by Elsevier Ltd. All rights reserved.

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

PubMed Central

2012-01-01

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

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

PubMed

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

2012-11-26

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

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

PubMed

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

2017-04-21

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

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…

Quality Control/Assurance in Post Secondary Education: An Outcomes Approach. AIR 1988 Annual Forum Paper.

ERIC Educational Resources Information Center

Birch, Derek W.; Johnson, F. Craig

A study was conducted using quality control and quality assurance models to examine student outcomes. The purpose was to investigate current quality control and quality assurance practices in six colleges, to evaluate the relationship between quantitative effectiveness measures and qualitative outcomes measure and to assess the readiness of each…

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

PubMed

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

2017-08-04

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

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

PubMed

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

2017-07-18

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

Hospital Nurses' Work Environment Characteristics and Patient Safety Outcomes: A Literature Review.

PubMed

Lee, Seung Eun; Scott, Linda D

2018-01-01

This integrative literature review assesses the relationship between hospital nurses' work environment characteristics and patient safety outcomes and recommends directions for future research based on examination of the literature. Using an electronic search of five databases, 18 studies published in English between 1999 and 2016 were identified for review. All but one study used a cross-sectional design, and only four used a conceptual/theoretical framework to guide the research. No definition of work environment was provided in most studies. Differing variables and instruments were used to measure patient outcomes, and findings regarding the effects of work environment on patient outcomes were inconsistent. To clarify the relationship between nurses' work environment characteristics and patient safety outcomes, researchers should consider using a longitudinal study design, using a theoretical foundation, and providing clear operational definitions of concepts. Moreover, given the inconsistent findings of previous studies, they should choose their measurement methodologies with care.

Wound healing outcomes: Using big data and a modified intent-to-treat method as a metric for reporting healing rates.

PubMed

Ennis, William J; Hoffman, Rachel A; Gurtner, Geoffrey C; Kirsner, Robert S; Gordon, Hanna M

2017-08-01

Chronic wounds are increasing in prevalence and are a costly problem for the US healthcare system and throughout the world. Typically outcomes studies in the field of wound care have been limited to small clinical trials, comparative effectiveness cohorts and attempts to extrapolate results from claims databases. As a result, outcomes in real world clinical settings may differ from these published studies. This study presents a modified intent-to-treat framework for measuring wound outcomes and measures the consistency of population based outcomes across two distinct settings. In this retrospective observational analysis, we describe the largest to date, cohort of patient wound outcomes derived from 626 hospital based clinics and one academic tertiary care clinic. We present the results of a modified intent-to-treat analysis of wound outcomes as well as demographic and descriptive data. After applying the exclusion criteria, the final analytic sample includes the outcomes from 667,291 wounds in the national sample and 1,788 wounds in the academic sample. We found a consistent modified intent to treat healing rate of 74.6% from the 626 clinics and 77.6% in the academic center. We recommend that a standard modified intent to treat healing rate be used to report wound outcomes to allow for consistency and comparability in measurement across providers, payers and healthcare systems. © 2017 by the Wound Healing Society.

Post-injury personality in the prediction of outcome following severe acquired brain injury.

PubMed

Cattran, Charlotte Jane; Oddy, Michael; Wood, Rodger Llewellyn; Moir, Jane Frances

2011-01-01

The aim of the study was to examine the utility of five measures of non-cognitive neurobehavioural (NCNB) changes that often occur following acquired brain injury, in predicting outcome (measured in terms of participation and social adaptation) at 1-year follow-up. The study employed a longitudinal, correlational design. Multiple regression was employed to investigate the value of five new NCNB measures of social perception, emotional regulation, motivation, impulsivity and disinhibition in the prediction of outcome as measured by the Mayo-Portland Adaptability Inventory (MPAI). Two NCNB measures (motivation and emotional regulation) were found to significantly predict outcome at 1-year follow-up, accounting for 53% of the variance in MPAI total scores. These measures provide a method of quantifying the extent of NCNB changes following brain injury. The predictive value of the measures indicates that they may represent a useful tool which could aid clinicians in identifying early-on those whose symptoms are likely to persist and who may require ongoing intervention. This could facilitate the planning of rehabilitation programmes.

Impact of Molecular Diagnostics for Tuberculosis on Patient-Important Outcomes: A Systematic Review of Study Methodologies

PubMed Central

Schumacher, Samuel G.; Sohn, Hojoon; Qin, Zhi Zhen; Gore, Genevieve; Davis, J. Lucian; Denkinger, Claudia M.; Pai, Madhukar

2016-01-01

Background Several reviews on the accuracy of Tuberculosis (TB) Nucleic Acid Amplification Tests (NAATs) have been performed but the evidence on their impact on patient-important outcomes has not been systematically reviewed. Given the recent increase in research evaluating such outcomes and the growing list of TB NAATs that will reach the market over the coming years, there is a need to bring together the existing evidence on impact, rather than accuracy. We aimed to assess the approaches that have been employed to measure the impact of TB NAATs on patient-important outcomes in adults with possible pulmonary TB and/or drug-resistant TB. Methods We first develop a conceptual framework to clarify through which mechanisms the improved technical performance of a novel TB test may lead to improved patient outcomes and outline which designs may be used to measure them. We then systematically review the literature on studies attempting to assess the impact of molecular TB diagnostics on such outcomes and provide a narrative synthesis of designs used, outcomes assessed and risk of bias across different study designs. Results We found 25 eligible studies that assessed a wide range of outcomes and utilized a variety of experimental and observational study designs. Many potentially strong design options have never been used. We found that much of the available evidence on patient-important outcomes comes from a small number of settings with particular epidemiological and operational context and that confounding, time trends and incomplete outcome data receive insufficient attention. Conclusions A broader range of designs should be considered when designing studies to assess the impact of TB diagnostics on patient outcomes and more attention needs to be paid to the analysis as concerns about confounding and selection bias become relevant in addition to those on measurement that are of greatest concern in accuracy studies. PMID:26954678

Toddlers' Verb Lexicon Diversity and Grammatical Outcomes

ERIC Educational Resources Information Center

Hadley, Pamela A.; Rispoli, Matthew; Hsu, Ning

2016-01-01

Purpose: The goals of this study were to quantify longitudinal expectations for verb lexicon growth and to determine whether verb lexicon measures were better predictors of later grammatical outcomes than noun lexicon measures. Method: Longitudinal parent-report measures from the MacArthur-Bates Communicative Development Inventory (Fenson et al.,…

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…

HRM and its effect on employee, organizational and financial outcomes in health care organizations

PubMed Central

2014-01-01

Background One of the main goals of Human Resource Management (HRM) is to increase the performance of organizations. However, few studies have explicitly addressed the multidimensional character of performance and linked HR practices to various outcome dimensions. This study therefore adds to the literature by relating HR practices to three outcome dimensions: financial, organizational and employee (HR) outcomes. Furthermore, we will analyze how HR practices influence these outcome dimensions, focusing on the mediating role of job satisfaction. Methods This study uses a unique dataset, based on the ‘ActiZ Benchmark in Healthcare’, a benchmark study conducted in Dutch home care, nursing care and care homes. Data from autumn 2010 to autumn 2011 were analyzed. In total, 162 organizations participated during this period (approximately 35% of all Dutch care organizations). Employee data were collected using a questionnaire (61,061 individuals, response rate 42%). Clients were surveyed using the Client Quality Index for long-term care, via stratified sampling. Financial outcomes were collected using annual reports. SEM analyses were conducted to test the hypotheses. Results It was found that HR practices are - directly or indirectly - linked to all three outcomes. The use of HR practices is related to improved financial outcomes (measure: net margin), organizational outcomes (measure: client satisfaction) and HR outcomes (measure: sickness absence). The impact of HR practices on HR outcomes and organizational outcomes proved substantially larger than their impact on financial outcomes. Furthermore, with respect to HR and organizational outcomes, the hypotheses concerning the full mediating effect of job satisfaction are confirmed. This is in line with the view that employee attitudes are an important element in the ‘black box’ between HRM and performance. Conclusion The results underscore the importance of HRM in the health care sector, especially for HR and organizational outcomes. Further analyses of HRM in the health care sector will prove to be a productive endeavor for both scholars and HR managers. PMID:24938460

HRM and its effect on employee, organizational and financial outcomes in health care organizations.

PubMed

Vermeeren, Brenda; Steijn, Bram; Tummers, Lars; Lankhaar, Marcel; Poerstamper, Robbert-Jan; van Beek, Sandra

2014-06-17

One of the main goals of Human Resource Management (HRM) is to increase the performance of organizations. However, few studies have explicitly addressed the multidimensional character of performance and linked HR practices to various outcome dimensions. This study therefore adds to the literature by relating HR practices to three outcome dimensions: financial, organizational and employee (HR) outcomes. Furthermore, we will analyze how HR practices influence these outcome dimensions, focusing on the mediating role of job satisfaction. This study uses a unique dataset, based on the 'ActiZ Benchmark in Healthcare', a benchmark study conducted in Dutch home care, nursing care and care homes. Data from autumn 2010 to autumn 2011 were analyzed. In total, 162 organizations participated during this period (approximately 35% of all Dutch care organizations). Employee data were collected using a questionnaire (61,061 individuals, response rate 42%). Clients were surveyed using the Client Quality Index for long-term care, via stratified sampling. Financial outcomes were collected using annual reports. SEM analyses were conducted to test the hypotheses. It was found that HR practices are - directly or indirectly - linked to all three outcomes. The use of HR practices is related to improved financial outcomes (measure: net margin), organizational outcomes (measure: client satisfaction) and HR outcomes (measure: sickness absence). The impact of HR practices on HR outcomes and organizational outcomes proved substantially larger than their impact on financial outcomes. Furthermore, with respect to HR and organizational outcomes, the hypotheses concerning the full mediating effect of job satisfaction are confirmed. This is in line with the view that employee attitudes are an important element in the 'black box' between HRM and performance. The results underscore the importance of HRM in the health care sector, especially for HR and organizational outcomes. Further analyses of HRM in the health care sector will prove to be a productive endeavor for both scholars and HR managers.

Measurement issues in the evaluation of chronic disease self-management programs.

PubMed

Nolte, Sandra; Elsworth, Gerald R; Newman, Stanton; Osborne, Richard H

2013-09-01

To provide an in-depth analysis of outcome measures used in the evaluation of chronic disease self-management programs consistent with the Stanford curricula. Based on a systematic review on self-management programs, effect sizes derived from reported outcome measures are categorized according to the quality of life appraisal model developed by Schwartz and Rapkin which classifies outcomes from performance-based measures (e.g., clinical outcomes) to evaluation-based measures (e.g., emotional well-being). The majority of outcomes assessed in self-management trials are based on evaluation-based methods. Overall, effects on knowledge--the only performance-based measure observed in selected trials--are generally medium to large. In contrast, substantially more inconsistent results are found for both perception- and evaluation-based measures that mostly range between nil and small positive effects. Effectiveness of self-management interventions and resulting recommendations for health policy makers are most frequently derived from highly variable evaluation-based measures, that is, types of outcomes that potentially carry a substantial amount of measurement error and/or bias such as response shift. Therefore, decisions regarding the value and efficacy of chronic disease self-management programs need to be interpreted with care. More research, especially qualitative studies, is needed to unravel cognitive processes and the role of response shift bias in the measurement of change.

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

PubMed

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

2017-07-11

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

Cost-effectiveness with multiple outcomes.

PubMed

Bjørner, Jakob; Keiding, Hans

2004-12-01

In a large number of situations, activities in health care have to be measured in terms of outcome and cost. However, the cases where outcome is fully captured by a single measure are rather few, so that one uses some index for outcome, computed by weighing together several outcome measures using subjective and somewhat arbitrary weights. In the paper we propose an approach to cost-effectiveness analysis where such artificial aggregation is avoided. This is achieved by assigning to each activity the weights which are the most favourable in a comparison with the other options available, so that activities which have a poor score in this method are guaranteed to be inferior. The method corresponds to applying Data envelopment analysis, known from the theory of productivity, to the context of health economic evaluations. The method is applied to an analysis of the cost-effectiveness of alternative health plans using data from the Medical Outcome Study (JAMA 1996; 276: 1039-1047), where outcome is measured as improvement in mental and physical health. 2004 John Wiley & Sons, Ltd.

Improving the power of an efficacy study of a social and emotional learning program: application of generalizability theory to the measurement of classroom-level outcomes.

PubMed

Mashburn, Andrew J; Downer, Jason T; Rivers, Susan E; Brackett, Marc A; Martinez, Andres

2014-04-01

Social and emotional learning programs are designed to improve the quality of social interactions in schools and classrooms in order to positively affect students' social, emotional, and academic development. The statistical power of group randomized trials to detect effects of social and emotional learning programs and other preventive interventions on setting-level outcomes is influenced by the reliability of the outcome measure. In this paper, we apply generalizability theory to an observational measure of the quality of classroom interactions that is an outcome in a study of the efficacy of a social and emotional learning program called The Recognizing, Understanding, Labeling, Expressing, and Regulating emotions Approach. We estimate multiple sources of error variance in the setting-level outcome and identify observation procedures to use in the efficacy study that most efficiently reduce these sources of error. We then discuss the implications of using different observation procedures on both the statistical power and the monetary costs of conducting the efficacy study.

The Assessment of Protective Behavioral Strategies: Comparing the Absolute Frequency and Contingent Frequency Response Scales

PubMed Central

Kite, Benjamin A.; Pearson, Matthew R.; Henson, James M.

2016-01-01

The purpose of the present studies was to examine the effects of response scale on the observed relationships between protective behavioral strategies (PBS) measures and alcohol-related outcomes. We reasoned that an ‘absolute frequency’ scale (stem: “how many times…”; response scale: 0 times to 11+ times) conflates the frequency of using PBS with the frequency of consuming alcohol; thus, we hypothesized that the use of an absolute frequency response scale would result in positive relationships between types of PBS and alcohol-related outcomes. Alternatively, a ‘contingent frequency’ scale (stem: “When drinking…how often…”; response scale: never to always) does not conflate frequency of alcohol use with use of PBS; therefore, we hypothesized that use of a contingent frequency scale would result in negative relationships between use of PBS and alcohol-related outcomes. Two published measures of PBS were used across studies: the Protective Behavioral Strategies Survey (PBSS) and the Strategy Questionnaire (SQ). Across three studies, we demonstrate that when measured using a contingent frequency response scale, PBS measures relate negatively to alcohol-related outcomes in a theoretically consistent manner; however, when PBS measures were measured on an absolute frequency response scale, they were non-significantly or positively related to alcohol-related outcomes. We discuss the implications of these findings for the assessment of PBS. PMID:23438243

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 measure domains is an area of top priority and should urgently inform a proper process leading to a consensus on outcome measures in dental implant research. © 2012 John Wiley & Sons A/S.

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.

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.

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…

Influences on Labor Market Outcomes of African American College Graduates: A National Study

ERIC Educational Resources Information Center

Strayhorn, Terrell L.

2008-01-01

Using an expanded econometric model, this study sought to estimate more precisely the net effect of independent variables (i.e., attending an HBCU) on three measures of labor market outcomes for African American college graduates. Findings reveal a statistically significant, albeit moderate, relationship between measures of background, human and…

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

PubMed Central

Krishna, Santosh; Boren, Suzanne Austin

2008-01-01

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

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

PubMed

Krishna, Santosh; Boren, Suzanne Austin

2008-05-01

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

Influence of study approaches on academic outcomes during pre-clinical medical education.

PubMed

Ward, Peter J

2011-01-01

Different approaches to study lead to differing academic outcomes. Deep and strategic approaches have been linked to academic success while surface approaches lead to poorer understandings. This study sought to characterize how the approaches to study used by medical students impacted their academic success as measured by three outcomes: cumulative grades at the end of the first year, cumulative grades at the end of the second year, and performance on a medical licensing examination. The approaches and study skills inventory for students was administered to medical students to determine their predominant study approach (deep, strategic, superficial) at the beginning of their first year, end of first year, and end of second year. Each group's mean performance on each outcome measure was compared by ANOVA to find significant differences. For all three outcome measures, strategic approaches to study were associated with high performance while surface approaches with a poor one. Deep approaches were most popular at all times and were largely associated with adequate performance. Deep approaches to study are sufficient for success in the current paradigm of medical education but strategic ones may offer a selective advantage to those who use them. Surface approaches to study must be discouraged by instructors through deliberate course design.

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

PubMed

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

2018-05-31

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

Measurement properties of gait-related outcomes in youth with neuromuscular diagnoses: a systematic review.

PubMed

Ammann-Reiffer, Corinne; Bastiaenen, Caroline H G; de Bie, Rob A; van Hedel, Hubertus J A

2014-08-01

Sound measurement properties of outcome tools are essential when evaluating outcomes of an intervention, in clinical practice and in research. The purpose of this study was to review the evidence on reliability, measurement error, and responsiveness of measures of gait function in children with neuromuscular diagnoses. The MEDLINE, CINAHL, EMBASE, and PsycINFO databases were searched up to June 15, 2012. Studies evaluating reliability, measurement error, or responsiveness of measures of gait function in 1- to 18-year-old children and youth with neuromuscular diagnoses were included. Quality of the studies was independently rated by 2 raters using a modified COnsensus-based Standards for the selection of health status Measurement INstruments (COSMIN) checklist. Studies with a fair quality rating or better were considered for best evidence synthesis. Regarding the methodological quality, 32 out of 35 reliability studies, all of the 13 measurement error studies, and 5 out of 10 responsiveness studies were of fair or good quality. Best evidence synthesis revealed moderate to strong evidence for reliability for several measures in children and youth with cerebral palsy (CP) but was limited or unknown in other diagnoses. The Functional Mobility Scale (FMS) and the Gross Motor Function Measure (GMFM) dimension E showed limited positive evidence for responsiveness in children with CP, but it was unknown or controversial in other diagnoses. No information was reported on the minimal important change; thus, evidence on measurement error remained undetermined. As studies on validity were not included in the review, a comprehensive appraisal of the best available gait-related outcome measure per diagnosis is not possible. There is moderate to strong evidence on reliability for several measures of gait function in children and youth with CP, whereas evidence on responsiveness exists only for the FMS and the GMFM dimension E. © 2014 American Physical Therapy Association.

Recommendations for Self-Report Outcome Measures in Vulvodynia Clinical Trials.

PubMed

Pukall, Caroline F; Bergeron, Sophie; Brown, Candace; Bachmann, Gloria; Wesselmann, Ursula

2017-08-01

Vulvodynia (idiopathic chronic vulvar pain) is a prevalent condition associated with significant and negative impacts in many areas of function. Despite the increased research interest in vulvodynia in recent years, recommendations for outcome measures for use in clinical trials are missing. The purpose of this paper, therefore, was to provide recommendations for outcome measures for vulvodynia clinical trials so that consistent measures are used across trials to facilitate between-study comparisons and the conduct of large multicenter trials, and to improve measurement of the multiple dimensions of vulvodynia. Given that provoked vestibulodynia (PVD)-characterized by provoked pain localized to the vaginal opening-is the most common subtype of vulvodynia and the current main focus of clinical trials, this paper focused on recommended outcome measures in PVD clinical trials. The framework used to guide the selection of outcome measures was based on the one proposed by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT). The IMMPACT framework provided a well-suited guideline for outcome measure recommendations in PVD clinical trials. However, given the provoked presentation of PVD and the significant impact it has on sexuality, modifications to some of the IMMPACT recommendations were made and specific additional measures were suggested. Measures that are specific to vulvovaginal pain are ideal for adoption in PVD clinical trials, and many such measures currently exist that allow the relevant IMMPACT domains to be captured.

The enduring effects of psychodynamic treatments vis-a-vis alternative treatments: A multilevel longitudinal meta-analysis

NASA Astrophysics Data System (ADS)

Kivlighan, D. Martin, III

Although evidence suggests that the benefits of psychodynamic treatments are sustained over time, presently it is unclear whether these sustained benefits are superior to non-psychodynamic treatments. Additionally, the extant literature comparing the sustained benefits of psychodynamic treatments compared to alternative treatments is limited with methodological shortcomings. The purpose of the current study was to conduct a rigorous test of the growth of the benefits of psychodynamic treatments relative to alternative treatments across distinct domains of change (i.e., all outcome measures, targeted outcome measures, non-targeted outcome measures, and personality outcome measures). To do so, the study employed strict inclusion criteria to identify randomized clinical trials that directly compared at least one bona fide psychodynamic treatment and one bona fide non-psychodynamic treatment. Hierarchical linear modeling (Raudenbush, Bryk, Cheong & Congdon, du Toit, 2011) was used to longitudinally model the impact of psychodynamic treatments compared to non-psychodynamic treatments at post-treatment and to compare the growth (i.e., slope) of effects beyond treatment completion. Findings from the present meta-analysis indicated that psychodynamic treatments and non-psychodynamic treatments were equally efficacious at post-treatment and at follow-up for combined outcomes ( k = 20), targeted outcomes (k =19), non-targeted outcomes (k =17), and personality outcomes (k =6). Clinical implications, directions for future research, and limitations are discussed.

Cultural Mistrust, Academic Outcome Expectations, and Outcome Values among African American Adolescent Men

ERIC Educational Resources Information Center

Irving, Miles Anthony; Hudley, Cynthia

2005-01-01

This study measured the relationship between outcome expectations, outcome value, and cultural mistrust among African American male high school students (N = 75) attending an urban, Southern California school. We hypothesized that a negative perception of the dominant culture would negatively affect academic outcome expectations and academic…

Does the extended Glasgow Outcome Scale add value to the conventional Glasgow Outcome Scale?

PubMed

Weir, James; Steyerberg, Ewout W; Butcher, Isabella; Lu, Juan; Lingsma, Hester F; McHugh, Gillian S; Roozenbeek, Bob; Maas, Andrew I R; Murray, Gordon D

2012-01-01

The Glasgow Outcome Scale (GOS) is firmly established as the primary outcome measure for use in Phase III trials of interventions in traumatic brain injury (TBI). However, the GOS has been criticized for its lack of sensitivity to detect small but clinically relevant changes in outcome. The Glasgow Outcome Scale-Extended (GOSE) potentially addresses this criticism, and in this study we estimate the efficiency gain associated with using the GOSE in place of the GOS in ordinal analysis of 6-month outcome. The study uses both simulation and the reanalysis of existing data from two completed TBI studies, one an observational cohort study and the other a randomized controlled trial. As expected, the results show that using an ordinal technique to analyze the GOS gives a substantial gain in efficiency relative to the conventional analysis, which collapses the GOS onto a binary scale (favorable versus unfavorable outcome). We also found that using the GOSE gave a modest but consistent increase in efficiency relative to the GOS in both studies, corresponding to a reduction in the required sample size of the order of 3-5%. We recommend that the GOSE be used in place of the GOS as the primary outcome measure in trials of TBI, with an appropriate ordinal approach being taken to the statistical analysis.

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.

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.

Contextualized Measurement of Self-Efficacy and College Students' Perceived Sources of Self-Efficacy in Introductory Plant Science Courses

ERIC Educational Resources Information Center

Keefe, Lisa Madalon

2013-01-01

Institutions of higher learning are recently being held more accountable for the learning outcomes of their students. As such, universities have begun to actively measure and evaluate student learning and motivational outcomes in an effort to improve the successful outcomes of their students. To support this work, two studies were conducted to…

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.

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.

The effects of a psychological intervention directed at optimizing immune function: study protocol for a randomized controlled trial.

PubMed

Schakel, Lemmy; Veldhuijzen, Dieuwke S; van Middendorp, Henriët; Prins, Corine; Joosten, Simone A; Ottenhoff, Tom H M; Visser, Leo G; Evers, Andrea W M

2017-05-26

Previous research has provided evidence for the link between psychological processes and psychophysiological health outcomes. Psychological interventions, such as face-to-face or online cognitive behavioral therapy (CBT) and serious games aimed at improving health, have shown promising results in promoting health outcomes. Few studies so far, however, have examined whether Internet-based CBT combined with serious gaming elements is effective in modulating health outcomes. Moreover, studies often did not incorporate psychophysiological or immunological challenges in order to gain insight into physiological responses to real-life challenges after psychological interventions. The overall aim of this study is to investigate the effects of a psychological intervention on self-reported and physiological health outcomes in response to immune and psychophysiological challenges. In a randomized controlled trial, 60 healthy men are randomly assigned to either an experimental condition, receiving guided Internet-based (e-health) CBT combined with health-related serious gaming elements for 6 weeks, or a control condition receiving no intervention. After the psychological intervention, self-reported vitality is measured, and participants are given an immunological challenge in the form of a Mycobacterium bovis Bacillus Calmette-Guérin (BCG) vaccination. One day after the vaccination, participants are asked to perform several psychophysiological tasks in order to explore the effects of the psychological intervention on participants' stress response following the immune challenge. To assess the delayed effects of vaccination on self-reported and physiological health outcomes, a follow-up visit is planned 4 weeks later. Total study duration is approximately 14 weeks. The primary outcome measure is self-reported vitality measured directly after the intervention. Secondary outcome measures include inflammatory and endocrine markers, as well as psychophysiological measures of heart rate and skin conductance in response to the psychophysiological tasks after the BCG vaccination. The innovative design features of this study - e.g., combining guided e-health CBT with health-related serious gaming elements and incorporating immunological and psychophysiological challenges - will provide valuable information on the effects of a psychological intervention on both self-reported and physiological health outcomes. This study will offer further insights into the mechanisms underlying the link between psychological factors and health outcomes and is anticipated to contribute to the optimization of health care strategies. Nederlands Trial Register, NTR5610 . Registered on 4 January 2016.

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.

Empirical evidence about inconsistency among studies in a pair-wise meta-analysis.

PubMed

Rhodes, Kirsty M; Turner, Rebecca M; Higgins, Julian P T

2016-12-01

This paper investigates how inconsistency (as measured by the I 2 statistic) among studies in a meta-analysis may differ, according to the type of outcome data and effect measure. We used hierarchical models to analyse data from 3873 binary, 5132 continuous and 880 mixed outcome meta-analyses within the Cochrane Database of Systematic Reviews. Predictive distributions for inconsistency expected in future meta-analyses were obtained, which can inform priors for between-study variance. Inconsistency estimates were highest on average for binary outcome meta-analyses of risk differences and continuous outcome meta-analyses. For a planned binary outcome meta-analysis in a general research setting, the predictive distribution for inconsistency among log odds ratios had median 22% and 95% CI: 12% to 39%. For a continuous outcome meta-analysis, the predictive distribution for inconsistency among standardized mean differences had median 40% and 95% CI: 15% to 73%. Levels of inconsistency were similar for binary data measured by log odds ratios and log relative risks. Fitted distributions for inconsistency expected in continuous outcome meta-analyses using mean differences were almost identical to those using standardized mean differences. The empirical evidence on inconsistency gives guidance on which outcome measures are most likely to be consistent in particular circumstances and facilitates Bayesian meta-analysis with an informative prior for heterogeneity. © 2015 The Authors. Research Synthesis Methods published by John Wiley & Sons, Ltd. © 2015 The Authors. Research Synthesis Methods published by John Wiley & Sons, Ltd. © 2015 The Authors. Research Synthesis Methods published by John Wiley & Sons, Ltd.

Structural equation modeling of motor impairment, gross motor function, and the functional outcome in children with cerebral palsy.

PubMed

Park, Eun-Young; Kim, Won-Ho

2013-05-01

Physical therapy intervention for children with cerebral palsy (CP) is focused on reducing neurological impairments, improving strength, and preventing the development of secondary impairments in order to improve functional outcomes. However, relationship between motor impairments and functional outcome has not been proved definitely. This study confirmed the construct of motor impairment and performed structural equation modeling (SEM) between motor impairment, gross motor function, and functional outcomes of regarding activities of daily living in children with CP. 98 children (59 boys, 39 girls) with CP participated in this cross-sectional study. Mean age was 11 y 5 mo (SD 1 y 9 mo). The Manual Muscle Test (MMT), the Modified Ashworth Scale (MAS), range of motion (ROM) measurement, and the selective motor control (SMC) scale were used to assess motor impairments. Gross motor function and functional outcomes were measured using the Gross Motor Function Measure (GMFM) and the Functional Skills domain of the Pediatric Evaluation of Disability Inventory (PEDI) respectively. Measurement of motor impairment was consisted of strength, spasticity, ROM, and SMC. The construct of motor impairment was confirmed though an examination of a measurement model. The proposed SEM model showed good fit indices. Motor impairment effected gross motor function (β=-.0869). Gross motor function and motor impairment affected functional outcomes directly (β=0.890) and indirectly (β=-0.773) respectively. We confirmed that the construct of motor impairment consist of strength, spasticity, ROM, and SMC and it was identified through measurement model analysis. Functional outcomes are best predicted by gross motor function and motor impairments have indirect effects on functional outcomes. Copyright © 2013 Elsevier Ltd. All rights reserved.

Pharmacists' interventions on clinical asthma outcomes: a systematic review.

PubMed

Garcia-Cardenas, Victoria; Armour, Carol; Benrimoj, Shalom I; Martinez-Martinez, Fernando; Rotta, Inajara; Fernandez-Llimos, Fernando

2016-04-01

The objective of this systematic review was to evaluate the impact of pharmacists' interventions on clinical asthma outcomes on adult patients and to identify the outcome indicators used.PubMed, Scopus, Web of Science and Scielo were searched. Studies addressing pharmacists' interventions on adult asthma patients reporting clinical asthma outcomes were incorporated.11 clinical outcomes were identified in 21 studies. 10 studies measured the impact of the intervention on asthma control. Randomised controlled trials (RCT) and non-RCTs found positive results in percentages of controlled patients and Asthma Control Questionnaire (ACQ) scores. Discordant results were found for Asthma Control Test results. Asthma severity was assessed in four studies. One RCT found a significant decrease in the percentage of severe patients; two non-RCTs found significant improvements in severity scores. 11 studies reported pulmonary function indicators, showing inconsistent results. Eight studies measured asthma symptoms; three RCTs and four non-RCTs showed significant improvements.RCTs and non-RCTs generated similar results for most outcomes. Based on the evidence generated by RCTs, pharmacists' have a positive impact on the percentage of controlled patients, ACQ scores, severity and symptoms. Future research should report using the core outcome set of indicators established for asthma (PROSPERO CRD42014007019). Copyright ©ERS 2016.

Parent and family impact of raising a child with perinatal stroke

PubMed Central

2014-01-01

Background Perinatal stroke is a leading cause of early brain injury, cerebral palsy, and lifelong neurological morbidity. No study to date has examined the impact of raising a child with perinatal stroke on parents and families. However, a large breadth of research suggests that parents, especially mothers, may be at increased risk for psychological concerns. The primary aim of this study was to examine the impact of raising a child with perinatal stroke on mothers’ wellbeing. A secondary aim was to examine how caring for a child with perinatal stroke differentially affects mothers and fathers. Methods In Study I, a matched case-control design was used to compare the wellbeing of mothers of children with perinatal stroke and mothers of children with typical development. In Study II, a matched case-control design was used to compare mother-father dyads. Participants completed validated measures of anxiety and depression, stress, quality of life and family functioning, marital satisfaction, and marital distress. Parents of children with perinatal stroke also completed a recently validated measure of the psychosocial impact of perinatal stroke including guilt and blame outcomes. Disease severity was categorized by parents, validated by the Pediatric Stroke Outcome Measure (PSOM), and compared across the above outcomes in Study I. Results A total of 112 mothers participated in Study I (n = 56 per group; mean child age = 7.42 years), and 56 parents participated in Study II (n = 28 per group; mean child age = 8.25 years). In Study I, parent assessment of disease severity was correlated with PSOM scores (γ = 0.75, p < .001) and associated with parent outcomes. Mothers of children with mild conditions were indistinguishable from controls on the outcome measures. However, mothers of children with moderate/severe conditions had poorer outcomes on measures of depression, marital satisfaction, quality of life, and family functioning. In Study II, mothers and fathers had similar outcomes except mothers demonstrated a greater burden of guilt and higher levels of anxiety. Conclusions Although most mothers of children with perinatal stroke adapt well, mothers of children with moderate/severe conditions appear to be at higher risk for psychological concerns. PMID:25018138

Parent and family impact of raising a child with perinatal stroke.

PubMed

Bemister, Taryn B; Brooks, Brian L; Dyck, Richard H; Kirton, Adam

2014-07-14

Perinatal stroke is a leading cause of early brain injury, cerebral palsy, and lifelong neurological morbidity. No study to date has examined the impact of raising a child with perinatal stroke on parents and families. However, a large breadth of research suggests that parents, especially mothers, may be at increased risk for psychological concerns. The primary aim of this study was to examine the impact of raising a child with perinatal stroke on mothers' wellbeing. A secondary aim was to examine how caring for a child with perinatal stroke differentially affects mothers and fathers. In Study I, a matched case-control design was used to compare the wellbeing of mothers of children with perinatal stroke and mothers of children with typical development. In Study II, a matched case-control design was used to compare mother-father dyads. Participants completed validated measures of anxiety and depression, stress, quality of life and family functioning, marital satisfaction, and marital distress. Parents of children with perinatal stroke also completed a recently validated measure of the psychosocial impact of perinatal stroke including guilt and blame outcomes. Disease severity was categorized by parents, validated by the Pediatric Stroke Outcome Measure (PSOM), and compared across the above outcomes in Study I. A total of 112 mothers participated in Study I (n = 56 per group; mean child age = 7.42 years), and 56 parents participated in Study II (n = 28 per group; mean child age = 8.25 years). In Study I, parent assessment of disease severity was correlated with PSOM scores (γ = 0.75, p < .001) and associated with parent outcomes. Mothers of children with mild conditions were indistinguishable from controls on the outcome measures. However, mothers of children with moderate/severe conditions had poorer outcomes on measures of depression, marital satisfaction, quality of life, and family functioning. In Study II, mothers and fathers had similar outcomes except mothers demonstrated a greater burden of guilt and higher levels of anxiety. Although most mothers of children with perinatal stroke adapt well, mothers of children with moderate/severe conditions appear to be at higher risk for psychological concerns.

Powered exoskeletons for bipedal locomotion after spinal cord injury

NASA Astrophysics Data System (ADS)

Contreras-Vidal, Jose L.; Bhagat, Nikunj A.; Brantley, Justin; Cruz-Garza, Jesus G.; He, Yongtian; Manley, Quinn; Nakagome, Sho; Nathan, Kevin; Tan, Su H.; Zhu, Fangshi; Pons, Jose L.

2016-06-01

Objective. Powered exoskeletons promise to increase the quality of life of people with lower-body paralysis or weakened legs by assisting or restoring legged mobility while providing health benefits across multiple physiological systems. Here, a systematic review of the literature on powered exoskeletons addressed critical questions: What is the current evidence of clinical efficacy for lower-limb powered exoskeletons? What are the benefits and risks for individuals with spinal cord injury (SCI)? What are the levels of injury considered in such studies? What are their outcome measures? What are the opportunities for the next generation exoskeletons? Approach. A systematic search of online databases was performed to identify clinical trials and safety or efficacy studies with lower-limb powered exoskeletons for individuals with SCI. Twenty-two studies with eight powered exoskeletons thus selected, were analyzed based on the protocol design, subject demographics, study duration, and primary/secondary outcome measures for assessing exoskeleton's performance in SCI subjects. Main results. Findings show that the level of injury varies across studies, with T10 injuries being represented in 45.4% of the studies. A categorical breakdown of outcome measures revealed 63% of these measures were gait and ambulation related, followed by energy expenditure (16%), physiological improvements (13%), and usability and comfort (8%). Moreover, outcome measures varied across studies, and none had measures spanning every category, making comparisons difficult. Significance. This review of the literature shows that a majority of current studies focus on thoracic level injury as well as there is an emphasis on ambulatory-related primary outcome measures. Future research should: 1) develop criteria for optimal selection and training of patients most likely to benefit from this technology, 2) design multimodal gait intention detection systems that engage and empower the user, 3) develop real-time monitoring and diagnostic capabilities, and 4) adopt comprehensive metrics for assessing safety, benefits, and usability.

Elicited and Spontaneous Communicative Functions and Stability of Conversational Measures with Children Who Have Pragmatic Language Impairments

ERIC Educational Resources Information Center

Adams, Catherine; Lloyd, Julian

2005-01-01

Background: The preliminary phase of a project aimed at establishing appropriate outcome measures for intervention with children who have pragmatic language impairments (PLI) is reported. Assessment methods for children with PLI are considered in the context of developing outcome measures for intervention studies. Communicative function…

Ethnic Composition and Heterogeneity in the Classroom: Their Measurement and Relationship with Student Outcomes

ERIC Educational Resources Information Center

Rjosk, Camilla; Richter, Dirk; Lüdtke, Oliver; Eccles, Jacquelynne Sue

2017-01-01

This study explores various measures of the ethnic makeup in a classroom and their relationship with student outcomes. We examine whether measures of ethnic diversity are related to achievement (mathematics, reading) and feeling of belonging with one's peers over and above commonly investigated composition characteristics. Multilevel analyses were…

Value of intracochlear electrically evoked auditory brainstem response after cochlear implantation in patients with narrow internal auditory canal.

PubMed

Song, Mee Hyun; Bae, Mi Ran; Kim, Hee Nam; Lee, Won-Sang; Yang, Won Sun; Choi, Jae Young

2010-08-01

Cochlear implantation in patients with narrow internal auditory canal (IAC) can result in variable outcomes; however, preoperative evaluations have limitations in accurately predicting outcomes. In this study, we analyzed the outcomes of cochlear implantation in patients with narrow IAC and correlated the intracochlear electrically evoked auditory brainstem response (EABR) findings to postoperative performance to determine the prognostic significance of intracochlear EABR. Retrospective case series at a tertiary hospital. Thirteen profoundly deaf patients with narrow IAC who received cochlear implantation from 2002 to 2008 were included in this study. Postoperative performance was evaluated after at least 12 months of follow-up, and postoperative intracochlear EABR was measured to determine its correlation with outcome. The clinical significance of electrically evoked compound action potential (ECAP) was also analyzed. Patients with narrow IAC showed postoperative auditory performances ranging from CAP 0 to 4 after cochlear implantation. Intracochlear EABR measured postoperatively demonstrated prognostic value in the prediction of long-term outcomes, whereas ECAP measurements failed to show a significant correlation with outcome. Consistent with the advantages of intracochlear EABR over extracochlear EABR, this study demonstrates that intracochlear EABR has prognostic significance in predicting long-term outcomes in patients with narrow IAC. Intracochlear EABR measured either intraoperatively or in the early postoperative period may play an important role in deciding whether to continue with auditory rehabilitation using a cochlear implant or to switch to an auditory brainstem implant so as not to miss the optimal timing for language development.

Sample size and number of outcome measures of veterinary randomised controlled trials of pharmaceutical interventions funded by different sources, a cross-sectional study.

PubMed

Wareham, K J; Hyde, R M; Grindlay, D; Brennan, M L; Dean, R S

2017-10-04

Randomised controlled trials (RCTs) are a key component of the veterinary evidence base. Sample sizes and defined outcome measures are crucial components of RCTs. To describe the sample size and number of outcome measures of veterinary RCTs either funded by the pharmaceutical industry or not, published in 2011. A structured search of PubMed identified RCTs examining the efficacy of pharmaceutical interventions. Number of outcome measures, number of animals enrolled per trial, whether a primary outcome was identified, and the presence of a sample size calculation were extracted from the RCTs. The source of funding was identified for each trial and groups compared on the above parameters. Literature searches returned 972 papers; 86 papers comprising 126 individual trials were analysed. The median number of outcomes per trial was 5.0; there were no significant differences across funding groups (p = 0.133). The median number of animals enrolled per trial was 30.0; this was similar across funding groups (p = 0.302). A primary outcome was identified in 40.5% of trials and was significantly more likely to be stated in trials funded by a pharmaceutical company. A very low percentage of trials reported a sample size calculation (14.3%). Failure to report primary outcomes, justify sample sizes and the reporting of multiple outcome measures was a common feature in all of the clinical trials examined in this study. It is possible some of these factors may be affected by the source of funding of the studies, but the influence of funding needs to be explored with a larger number of trials. Some veterinary RCTs provide a weak evidence base and targeted strategies are required to improve the quality of veterinary RCTs to ensure there is reliable evidence on which to base clinical decisions.

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

PubMed

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

2018-03-01

Many randomized controlled trials have been performed with the goal of improving outcomes related to hemodialysis vascular access. If the reported outcomes are relevant and measured consistently to allow comparison of interventions across trials, such trials can inform decision making. This study aimed to assess the scope and consistency of vascular access outcomes reported in contemporary hemodialysis trials. Systematic review. Adults requiring maintenance hemodialysis. All randomized controlled trials and trial protocols reporting vascular access outcomes identified from ClinicalTrials.gov, Embase, MEDLINE, and the Cochrane Kidney and Transplant Specialized Register from January 2011 to June 2016. Any hemodialysis-related intervention. The frequency and characteristics of vascular access outcome measures were analyzed and classified. From 168 relevant trials, 1,426 access-related outcome measures were extracted and classified into 23 different outcomes. The 3 most common outcomes were function (136 [81%] trials), infection (63 [38%]), and maturation (31 [18%]). Function was measured in 489 different ways, but most frequently reported as "mean access blood flow (mL/min)" (37 [27%] trials) and "number of thromboses" (30 [22%]). Infection was assessed in 136 different ways, with "number of access-related infections" being the most common measure. Maturation was assessed in 44 different ways at 15 different time points and most commonly characterized by vein diameter and blood flow. Patient-reported outcomes, including pain (19 [11%]) and quality of life (5 [3%]), were reported infrequently. Only a minority of trials used previously standardized outcome definitions. Restricted sampling frame for feasibility and focus on contemporary trials. The reporting of access outcomes in hemodialysis trials is very heterogeneous, with limited patient-reported outcomes and infrequent use of standardized outcome measures. Efforts to standardize outcome reporting for vascular access are critical to optimizing the comparability, reliability, and value of trial evidence to improve outcomes for patients requiring hemodialysis. Copyright © 2017 National Kidney Foundation, Inc. All rights reserved.

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 not required as no primary data will be collected. Outcomes will be disseminated to stakeholders via reports, journal articles and presentations at meetings and conferences. PROSPERO registration number CRD42017057871. PMID:29678991

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.

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.

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

PubMed

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

2010-11-02

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

Outcome of first-episode schizophrenia in India: longitudinal study of effect of insight and psychopathology.

PubMed

Saravanan, Balasubramanian; Jacob, K S; Johnson, Shanthi; Prince, Martin; Bhugra, Dinesh; David, Anthony S

2010-06-01

Transcultural studies have found lack of insight to be an almost invariable feature of acute and chronic schizophrenia, but its influence on prognosis is unclear. To investigate the relationship between insight, psychopathology and outcome of first-episode schizophrenia in Vellore, India. Patients with a DSM-IV diagnosis of schizophrenia (n = 131) were assessed prospectively at baseline and at 6-month and 12-month follow-up. Demographic and clinical measures included insight, psychopathology, duration of untreated psychosis (DUP) and social functioning. Linear and logistic regression was used to measure predictors of outcome. Follow-up data were available for 115 patients at 1 year. All achieved remission, half of them with and half without residual symptoms. Changes in psychopathology and insight during the first 6 months and DUP strongly predicted outcome (relapse or functional impairment), controlling for baseline measures. Outcome of schizophrenia in this setting is driven by early symptomatic improvement and is relatively favourable, in line with other studies from low- and middle-income countries. Early improvement in insight might be a useful clinical guide to future outcome. Reduction of DUP should be a target for intervention.

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 is valuable to replicate if other organisations wish to select an outcome measure for use in their own practice.

The use of errorless learning strategies for patients with Alzheimer's disease: a literature review.

PubMed

Li, Ruijie; Liu, Karen P Y

2012-12-01

The aim of this article was to review the evidence of errorless learning on learning outcomes in patients with early-stage Alzheimer's disease. A computer-aided literature search from 1999 to 2011 was carried out using MEDLINE, Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycINFO and PsycArticles. Keywords included 'errorless learning or practice' and 'Alzheimer's disease'. Four studies that fulfilled the inclusion criteria were selected and reviewed. Two of the studies were clinical controlled trials: one was a single-group pretest-post-test trial and the other was a multiple single-participant study. Demographic variables, design, treatment and outcome measures were summarized. Recall trials were used as the primary outcome measure. Results indicate that the use of errorless learning promotes better retention of specific types of information. Errorless learning is effective in memory rehabilitation of older adults with Alzheimer's disease. However, it would require more studies with unified outcome measures to allow for the formulation of standardized clinical protocol and recommendations.

Random measurement error: Why worry? An example of cardiovascular risk factors.

PubMed

Brakenhoff, Timo B; van Smeden, Maarten; Visseren, Frank L J; Groenwold, Rolf H H

2018-01-01

With the increased use of data not originally recorded for research, such as routine care data (or 'big data'), measurement error is bound to become an increasingly relevant problem in medical research. A common view among medical researchers on the influence of random measurement error (i.e. classical measurement error) is that its presence leads to some degree of systematic underestimation of studied exposure-outcome relations (i.e. attenuation of the effect estimate). For the common situation where the analysis involves at least one exposure and one confounder, we demonstrate that the direction of effect of random measurement error on the estimated exposure-outcome relations can be difficult to anticipate. Using three example studies on cardiovascular risk factors, we illustrate that random measurement error in the exposure and/or confounder can lead to underestimation as well as overestimation of exposure-outcome relations. We therefore advise medical researchers to refrain from making claims about the direction of effect of measurement error in their manuscripts, unless the appropriate inferential tools are used to study or alleviate the impact of measurement error from the analysis.

Change Processes in Residential Cognitive and Interpersonal Psychotherapy for Social Phobia: A Process-Outcome Study

ERIC Educational Resources Information Center

Hoffart, Asle; Borge, Finn-Magnus; Sexton, Harold; Clark, David M.

2009-01-01

The purpose of this study was to test cognitive and interpersonal models for improving social phobia. Eighty patients with social phobia were randomized to 10-week residential cognitive (RCT) or residential interpersonal psychotherapy (RIPT). They completed process measures every Thursday and a sub-outcome measure every Monday. The ratings were…

Design and baseline data from the Gratitude Research in Acute Coronary Events (GRACE) study

PubMed Central

Huffman, Jeff C.; Beale, Eleanor E.; Beach, Scott R.; Celano, Christopher M.; Belcher, Arianna M.; Moore, Shannon V.; Suarez, Laura; Gandhi, Parul U.; Motiwala, Shweta R.; Gaggin, Hanna; Januzzi, James L.

2015-01-01

Background Positive psychological constructs, especially optimism, have been linked with superior cardiovascular health. However, there has been minimal study of positive constructs in patients with acute coronary syndrome (ACS), despite the prevalence and importance of this condition. Furthermore, few studies have examined multiple positive psychological constructs and multiple cardiac-related outcomes within the same cohort to determine specifically which positive construct may affect a particular cardiac outcome. Materials and methods The Gratitude Research in Acute Coronary Events (GRACE) study examines the association between optimism/gratitude 2 weeks post-ACS and subsequent clinical outcomes. The primary outcome measure is physical activity at 6 months, measured via accelerometer, and key secondary outcome measures include levels of prognostic biomarkers and rates of nonelective cardiac rehospitalization at 6 months. These relationships will be analyzed using multivariate linear regression, controlling for sociodemographic, medical, and negative psychological factors; associations between baseline positive constructs and subsequent rehospitalizations will be assessed via Cox regression. Results Overall, 164 participants enrolled and completed the baseline 2-week assessment; the cohort had a mean age of 61.5 +/− 10.5 years and was 84% men; this was the first ACS for 58% of participants. Conclusion The GRACE study will determine whether optimism and gratitude are prospectively and independently associated with physical activity and other critical outcomes in the 6 months following an ACS. If these constructs are associated with superior outcomes, this may highlight the importance of these constructs as independent prognostic factors post-ACS. PMID:26166171

Design and baseline data from the Gratitude Research in Acute Coronary Events (GRACE) study.

PubMed

Huffman, Jeff C; Beale, Eleanor E; Beach, Scott R; Celano, Christopher M; Belcher, Arianna M; Moore, Shannon V; Suarez, Laura; Gandhi, Parul U; Motiwala, Shweta R; Gaggin, Hanna; Januzzi, James L

2015-09-01

Positive psychological constructs, especially optimism, have been linked with superior cardiovascular health. However, there has been minimal study of positive constructs in patients with acute coronary syndrome (ACS), despite the prevalence and importance of this condition. Furthermore, few studies have examined multiple positive psychological constructs and multiple cardiac-related outcomes within the same cohort to determine specifically which positive construct may affect a particular cardiac outcome. The Gratitude Research in Acute Coronary Events (GRACE) study examines the association between optimism/gratitude 2weeks post-ACS and subsequent clinical outcomes. The primary outcome measure is physical activity at 6months, measured via accelerometer, and key secondary outcome measures include levels of prognostic biomarkers and rates of nonelective cardiac rehospitalization at 6months. These relationships will be analyzed using multivariable linear regression, controlling for sociodemographic, medical, and negative psychological factors; associations between baseline positive constructs and subsequent rehospitalizations will be assessed via Cox regression. Overall, 164 participants enrolled and completed the baseline 2-week assessment; the cohort had a mean age of 61.5+/?10.5years and was 84% men; this was the first ACS for 58% of participants. The GRACE study will determine whether optimism and gratitude are prospectively and independently associated with physical activity and other critical outcomes in the 6months following an ACS. If these constructs are associated with superior outcomes, this may highlight the importance of these constructs as independent prognostic factors post-ACS. Copyright © 2015 Elsevier Inc. All rights reserved.

Effect of Treatment Modality on Long-Term Outcomes in Attention-Deficit/Hyperactivity Disorder: A Systematic Review

PubMed Central

Arnold, L. Eugene; Hodgkins, Paul; Caci, Hervé; Kahle, Jennifer; Young, Susan

2015-01-01

Background Evaluation of treatments for attention-deficit/hyperactivity disorder (ADHD) previously focused on symptom control, but attention has shifted to functional outcomes. The effect of different ADHD treatment periods and modalities (pharmacological, non-pharmacological, and combination) on long-term outcomes needs to be more comprehensively understood. Methods A systematic search of 12 literature databases using Cochrane’s guidelines yielded 403 English-language peer-reviewed, primary studies reporting long-term outcomes (≥2 years). We evaluated relative effects of treatment modalities and durations and effect sizes of outcomes reported as statistically significantly improved with treatment. Results The highest proportion of improved outcomes was reported with combination treatment (83% of outcomes). Among significantly improved outcomes, the largest effect sizes were found for combination treatment. The greatest improvements were associated with academic, self-esteem, or social function outcomes. A majority of outcomes improved regardless of age of treatment initiation (60%–75%) or treatment duration (62%–72%). Studies with short treatment duration had shorter follow-up times (mean 3.2 years total study length) than those with longer treatment durations (mean 7.1 years total study length). Studies with follow-up times <3 years reported benefit with treatment for 93% of outcomes, whereas those with follow-up times ≥3 years reported treatment benefit for 57% of outcomes. Post-hoc analysis indicated that this result was related to the measurement of outcomes at longer periods (3.2 versus 0.4 years) after treatment cessation in studies with longer total study length. Conclusions While the majority of long-term outcomes of ADHD improve with all treatment modalities, the combination of pharmacological and non-pharmacological treatment was most consistently associated with improved long-term outcomes and large effect sizes. Older treatment initiation age or longer durations did not markedly affect proportion of improved outcomes reported, but measurement of outcomes long periods after treatment cessation may attenuate results. PMID:25714373

Use of cancer performance measures in population health: a macro-level perspective.

PubMed

Clauser, Steven B

2004-01-01

The use of performance measurement to inform macro-level studies of cancer control and quality of care is receiving increasing interest at the state, national, and international level. This article describes the use of these measures to inform health policy and monitor cancer disparities and disease burden. Applications are discussed in clinical and provider-reported outcomes such as cancer incidence, mortality and survival, and outcome-linked processes of care, and patient-reported outcomes such as health-related quality of life and patient satisfaction/experience with care. The use of economic measures to monitor and evaluate the burden of illness is also discussed. The growing demand for surveillance capability coupled with the need to expand both the quality and breadth of available measure sets, suggests that there is a need to supplement traditional clinical and provider-reported process and outcomes measures with patient-reported outcomes measures such as health-related quality of life and patient satisfaction and experience with care. In addition, there is also a need to broaden and standardize outcome-linked process-of-care measures to improve the ability to measure and monitor incremental progress in improving cancer care. Finally, better measures of indirect costs of cancer care, such as loss productivity and caregiver burden among the aged, would improve national estimates of the cost of illness associated with cancer.

Consensus for tinnitus patient assessment and treatment outcome measurement: Tinnitus Research Initiative meeting, Regensburg, July 2006

PubMed Central

Langguth, B.; Goodey, R.; Azevedo, A.; Bjorne, A.; Cacace, A.; Crocetti, A.; Del Bo, L.; De Ridder, D.; Diges, I.; Elbert, T.; Flor, H.; Herraiz, C.; Sanchez, T. Ganz; Eichhammer, P.; Figueiredo, R.; Hajak, G.; Kleinjung, T.; Landgrebe, M.; Londero, A.; Lainez, M.J.A.; Mazzoli, M.; Meikle, M.B.; Melcher, J.; Rauschecker, J.P.; Sand, P.G.; Struve, M.; Van de Heyning, P.; Van Dijk, P.; Vergara, R.

2014-01-01

There is widespread recognition that consistency between research centres in the ways that patients with tinnitus are assessed and outcomes following interventions are measured would facilitate more effective co-operation and more meaningful evaluations and comparisons of outcomes. At the first Tinnitus Research Initiative meeting held in Regensburg in July 2006 an attempt was made through workshops to gain a consensus both for patient assessments and for outcome measurements. It is hoped that this will contribute towards better cooperation between research centres in finding and evaluating treatments for tinnitus by allowing better comparability between studies. PMID:17956816

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

Using an Accountability Tool to Improve the Quality of Outcomes on Individual Family Service Plans

ERIC Educational Resources Information Center

Votava, Kristen M.; Johnson, Carol; Chiasson, Kari

2011-01-01

This study investigated using a state's Part C early intervention accountability tool to increase the number of outcomes meeting compliance within IFSPs. The Case Review Tool (CRT) was used to examine differences from year one to year three on three measures of quality outcomes. There was no evidence of change in two of the measures, but there was…

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 across the field. © 2017 The Authors. Addiction published by John Wiley & Sons Ltd on behalf of Society for the Study of Addiction.

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

PubMed Central

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

2015-01-01

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

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

PubMed Central

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

2016-01-01

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

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

PubMed

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

2017-01-01

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

Tests examining skill outcomes in sport: a systematic review of measurement properties and feasibility.

PubMed

Robertson, Samuel J; Burnett, Angus F; Cochrane, Jodie

2014-04-01

A high level of participant skill is influential in determining the outcome of many sports. Thus, tests assessing skill outcomes in sport are commonly used by coaches and researchers to estimate an athlete's ability level, to evaluate the effectiveness of interventions or for the purpose of talent identification. The objective of this systematic review was to examine the methodological quality, measurement properties and feasibility characteristics of sporting skill outcome tests reported in the peer-reviewed literature. A search of both SPORTDiscus and MEDLINE databases was undertaken. Studies that examined tests of sporting skill outcomes were reviewed. Only studies that investigated measurement properties of the test (reliability or validity) were included. A total of 22 studies met the inclusion/exclusion criteria. A customised checklist of assessment criteria, based on previous research, was utilised for the purpose of this review. A range of sports were the subject of the 22 studies included in this review, with considerations relating to methodological quality being generally well addressed by authors. A range of methods and statistical procedures were used by researchers to determine the measurement properties of their skill outcome tests. The majority (95%) of the reviewed studies investigated test-retest reliability, and where relevant, inter and intra-rater reliability was also determined. Content validity was examined in 68% of the studies, with most tests investigating multiple skill domains relevant to the sport. Only 18% of studies assessed all three reviewed forms of validity (content, construct and criterion), with just 14% investigating the predictive validity of the test. Test responsiveness was reported in only 9% of studies, whilst feasibility received varying levels of attention. In organised sport, further tests may exist which have not been investigated in this review. This could be due to such tests firstly not being published in the peer-review literature and secondly, not having their measurement properties (i.e., reliability or validity) examined formally. Of the 22 studies included in this review, items relating to test methodological quality were, on the whole, well addressed. Test-retest reliability was determined in all but one of the reviewed studies, whilst most studies investigated at least two aspects of validity (i.e., content, construct or criterion-related validity). Few studies examined predictive validity or responsiveness. While feasibility was addressed in over half of the studies, practicality and test limitations were rarely addressed. Consideration of study quality, measurement properties and feasibility components assessed in this review can assist future researchers when developing or modifying tests of sporting skill outcomes.

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

ERIC Educational Resources Information Center

Martin, Frank H.

2010-01-01

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

Use of IMMPACT domains in clinical trials of acupuncture for chronic pain: a protocol for a methodological survey.

PubMed

Mazzei, Lauren Giustti; Bergamaschi, Cristiane de Cássia; Silva, Marcus Tolentino; Lopes, Luciane Cruz

2017-09-27

Pain is one of the most common and most debilitating complaints among patients. It affects the individual, their relationship with friends and family, their ability to function at work, and their sociability. Acupuncture is one of the therapeutic resources for managing chronic pain. Given the variability of outcome measures in controlled randomised clinical trials on non-oncologicchronic pain (CRCT-NOCP), the Initiative in Methods, Measurements and Pain Assessment in Clinical Trials (IMMPACT) recommends six domains to be covered in evaluating the effectiveness of treatments for chronic pain. To check whether the methodological quality of outcome reporting in published trials has used IMMPACT recommendations in measuring CRCT-NOCP outcomes when acupuncture was used as a treatment. This is a methodological study. We will systematically search for eligible studies in specific databases with a defined strategy. We will use the MeSHterms of 'acupuncture', 'chronic pain' and similar terms, without restrictions on idiom. Eligible studies will include those which are randomised and chose NOCP patients to be treated with acupuncture or control (sham acupuncture or no acupuncture), recruited after September 2004, with ≥100 patients. The measured outcomes are to be the presence of outcome domains recommended by IMMPACT, domains reported by the patient or clinician, tools used to measure such domains, as well as other features of the studies. We shall conduct a regression analysis to explore factors which can be associated with the presence of outcome domains according to IMMPACT recommendations. This survey will be submitted for presentation at congresses and for publication in a scientific journal. The findings obtained in this study will allow us to measure the quality of the evidence and provide greater transparency in decisions regarding the use of acupuncture as a viable alternative to managing chronic pain. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Mismatch negativity is a stronger indicator of functional outcomes than neurocognition or theory of mind in patients with schizophrenia.

PubMed

Lee, Seung-Hwan; Sung, Kyongae; Lee, Kyong-Sang; Moon, Eunok; Kim, Chang-Gyu

2014-01-03

Mismatch negativity (MMN) is known to be associated with neurocognition, social cognition, and functional outcomes. The present study explored the relationships of MMN with neurocognition, theory of mind, and functional outcomes in patients with schizophrenia, first-degree relatives of patients with schizophrenia, and healthy controls. Twenty-five patients with schizophrenia, 21 first-degree relatives of patients with schizophrenia, and 29 healthy controls were recruited. We examined symptom severity, neurocognition, theory of mind, functional outcomes, and MMN. MMN amplitudes decreased in order of patients with schizophrenia, then first-degree relatives, then healthy controls. MMN amplitude was significantly correlated with measures of neurocognition, theory of mind, and functional outcome measurements in patients with schizophrenia. However, the most powerful correlations were those between MMN in the frontal region and measures of functional outcomes. The power and frequency of the correlations were weaker in first-degree relatives and healthy controls than in patients with schizophrenia. Hierarchical regression analysis revealed that functional outcomes (relative to measures of neurocognition and theory of mind) constituted the most powerful predictor of MMN. Our results suggest that MMN reflects functional outcomes more efficiently than do measures of neurocognition and theory of mind in patients with schizophrenia. © 2013.

The reliability of eyetracking to assess attentional bias to threatening words in healthy individuals.

PubMed

Skinner, Ian W; Hübscher, Markus; Moseley, G Lorimer; Lee, Hopin; Wand, Benedict M; Traeger, Adrian C; Gustin, Sylvia M; McAuley, James H

2017-08-15

Eyetracking is commonly used to investigate attentional bias. Although some studies have investigated the internal consistency of eyetracking, data are scarce on the test-retest reliability and agreement of eyetracking to investigate attentional bias. This study reports the test-retest reliability, measurement error, and internal consistency of 12 commonly used outcome measures thought to reflect the different components of attentional bias: overall attention, early attention, and late attention. Healthy participants completed a preferential-looking eyetracking task that involved the presentation of threatening (sensory words, general threat words, and affective words) and nonthreatening words. We used intraclass correlation coefficients (ICCs) to measure test-retest reliability (ICC > .70 indicates adequate reliability). The ICCs(2, 1) ranged from -.31 to .71. Reliability varied according to the outcome measure and threat word category. Sensory words had a lower mean ICC (.08) than either affective words (.32) or general threat words (.29). A longer exposure time was associated with higher test-retest reliability. All of the outcome measures, except second-run dwell time, demonstrated low measurement error (<6%). Most of the outcome measures reported high internal consistency (α > .93). Recommendations are discussed for improving the reliability of eyetracking tasks in future research.

Quantitative outcome measures for systemic sclerosis-related Microangiopathy - Reliability of image acquisition in Nailfold Capillaroscopy.

PubMed

Dinsdale, Graham; Moore, Tonia; O'Leary, Neil; Berks, Michael; Roberts, Christopher; Manning, Joanne; Allen, John; Anderson, Marina; Cutolo, Maurizio; Hesselstrand, Roger; Howell, Kevin; Pizzorni, Carmen; Smith, Vanessa; Sulli, Alberto; Wildt, Marie; Taylor, Christopher; Murray, Andrea; Herrick, Ariane L

2017-09-01

Nailfold capillaroscopic parameters hold increasing promise as outcome measures for clinical trials in systemic sclerosis (SSc). Their inclusion as outcomes would often naturally require capillaroscopy images to be captured at several time points during any one study. Our objective was to assess repeatability of image acquisition (which has been little studied), as well as of measurement. 41 patients (26 with SSc, 15 with primary Raynaud's phenomenon) and 10 healthy controls returned for repeat high-magnification (300×) videocapillaroscopy mosaic imaging of 10 digits one week after initial imaging (as part of a larger study of reliability). Images were assessed in a random order by an expert blinded observer and 4 outcome measures extracted: (1) overall image grade and then (where possible) distal vessel locations were marked, allowing (2) vessel density (across the whole nailfold) to be calculated (3) apex width measurement and (4) giant vessel count. Intra-rater, intra-visit and intra-rater inter-visit (baseline vs. 1week) reliability were examined in 475 and 392 images respectively. A linear, mixed-effects model was used to estimate variance components, from which intra-class correlation coefficients (ICCs) were determined. Intra-visit and inter-visit reliability estimates (ICCs) were (respectively): overall image grade, 0.97 and 0.90; vessel density, 0.92 and 0.65; mean vessel width, 0.91 and 0.79; presence of giant capillary, 0.68 and 0.56. These estimates were conditional on each parameter being measurable. Within-operator image analysis and acquisition are reproducible. Quantitative nailfold capillaroscopy, at least with a single observer, provides reliable outcome measures for clinical studies including randomised controlled trials. Copyright © 2017 Elsevier Inc. All rights reserved.

Estimating scaled treatment effects with multiple outcomes.

PubMed

Kennedy, Edward H; Kangovi, Shreya; Mitra, Nandita

2017-01-01

In classical study designs, the aim is often to learn about the effects of a treatment or intervention on a single outcome; in many modern studies, however, data on multiple outcomes are collected and it is of interest to explore effects on multiple outcomes simultaneously. Such designs can be particularly useful in patient-centered research, where different outcomes might be more or less important to different patients. In this paper, we propose scaled effect measures (via potential outcomes) that translate effects on multiple outcomes to a common scale, using mean-variance and median-interquartile range based standardizations. We present efficient, nonparametric, doubly robust methods for estimating these scaled effects (and weighted average summary measures), and for testing the null hypothesis that treatment affects all outcomes equally. We also discuss methods for exploring how treatment effects depend on covariates (i.e., effect modification). In addition to describing efficiency theory for our estimands and the asymptotic behavior of our estimators, we illustrate the methods in a simulation study and a data analysis. Importantly, and in contrast to much of the literature concerning effects on multiple outcomes, our methods are nonparametric and can be used not only in randomized trials to yield increased efficiency, but also in observational studies with high-dimensional covariates to reduce confounding bias.

Asthma Outcomes: Healthcare Utilization and Costs

PubMed Central

Akinbami, Lara J.; Sullivan, Sean D.; Campbell, Jonathan D.; Grundmeier, Robert W.; Hartert, Tina V.; Lee, Todd A.; Smith, Robert A.

2014-01-01

Background Measures of healthcare utilization and indirect impact of asthma morbidity are used to assess clinical interventions and estimate cost. Objective National Institutes of Health (NIH) institutes and other federal agencies convened an expert group to propose standardized measurement, collection, analysis, and reporting of healthcare utilization and cost outcomes in future asthma studies. Methods We used comprehensive literature reviews and expert opinion to compile a list of asthma healthcare utilization outcomes that we classified as core (required in future studies), supplemental (used according to study aims and standardized) and emerging (requiring validation and standardization). We also have identified methodology to assign cost to these outcomes. This work was discussed at an NIH-organized workshop in March 2010 and finalized in September 2011. Results We identified 3 ways to promote comparability across clinical trials for measures of healthcare utilization, resource use, and cost: (1) specify the study perspective (patient, clinician, payer, society), (2) standardize the measurement period (ideally, 12 months), and (3) use standard units to measure healthcare utilization and other asthma-related events. Conclusions Large clinical trials and observational studies should collect and report detailed information on healthcare utilization, intervention resources, and indirect impact of asthma, so that costs can be calculated and cost-effectiveness analyses can be conducted across several studies. Additional research is needed to develop standard, validated survey instruments for collection of provider-reported and participant-reported data regarding asthma-related health care. PMID:22386509

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

PubMed

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

2017-01-01

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

Interventions to improve communication between people with dementia and nursing staff during daily nursing care: A systematic review.

PubMed

Machiels, Mariska; Metzelthin, Silke F; Hamers, Jan P H; Zwakhalen, Sandra M G

2017-01-01

To provide adequate nursing care it is important for nursing staff to communicate effectively with people with dementia. Due to their limited communication skills, people with dementia have difficulties in understanding communication and expressing themselves verbally. Nursing staff members often report communication difficulties with people with dementia, which emphasises the urgent need for interventions to improve their communication with people in this specific target group. To provide an up-to-date overview of communication interventions that are applicable during daily nursing care activities, irrespective of care setting, and to describe the effects on communication outcomes in people with dementia and nursing staff. Systematic literature review DATA SOURCES: The Cochrane Library, CINAHL, PsycINFO, and Pubmed databases were searched for all articles published until the 23rd of February 2016. Papers were included, if: (1) interventions focused on communication between nursing staff and people with dementia and were applicable during daily nursing care; (2) studies were (randomised) controlled trials; (3) papers were written in English, Dutch, or German. Data were extracted on content and communication outcomes of interventions, and on methodological quality of the studies. The data extraction form and methodological quality checklist were based on the Method Guidelines for Systematic Reviews for the Cochrane Back Review Group. Six studies on communication interventions were included. All of the studies incorporated a communication skills training for nursing staff with a broad range in frequency, duration and content. In addition, there was wide variation in the communication outcome measures used. Four studies measured non-verbal communication, all found positive effects on at least some of the communication outcomes. Four studies measured verbal communication, of which three found positive effects on at least one of the measured outcomes. Methodological quality assessment demonstrated a high risk of bias in five of the six studies. Few studies have been identified with wide variation in interventions and outcome measures. In addition, the methodological shortcomings make it difficult, to draw conclusions about the effectiveness. More research is needed to develop and evaluate communication interventions. Additionally, it is useful to reach consensus on defining and measuring communication. Copyright © 2017 Elsevier Ltd. All rights reserved.

Los Angeles County Juvenile Justice Crime Prevention Act: Fiscal Year 2005-2006. Report Summary

ERIC Educational Resources Information Center

Turner, Susan; Fain, Terry; Sehgal, Amber

2007-01-01

This document summarizes a study relating to California counties receiving state funds for Juvenile Justice Crime Prevention Act (JJCPA) programs. These counties are required to report six outcome measures to the California State Legislature on an annual basis to measure the success of the program. These outcome measures are (1) successful…

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

ERIC Educational Resources Information Center

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

2017-01-01

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

Action Research: Measuring Literacy Programme Participants' Learning Outcomes. Results of the Final Phase (2011-2014)

ERIC Educational Resources Information Center

Bolly, Madina; Jonas, Nicolas

2015-01-01

Action Research on Measuring Literacy Programme Participants' Learning Outcomes (RAMAA) aims to develop, implement and collaborate on the creation of a methodological approach to measure acquired learning and study the various factors that influence its development. This report examines how RAMAA I has been implemented over the past four years in…

Core Outcome Domains for early phase clinical trials of sound-, psychology-, and pharmacology-based interventions to manage chronic subjective tinnitus in adults: the COMIT'ID study protocol for using a Delphi process and face-to-face meetings to establish consensus.

PubMed

Fackrell, Kathryn; Smith, Harriet; Colley, Veronica; Thacker, Brian; Horobin, Adele; Haider, Haúla F; Londero, Alain; Mazurek, Birgit; Hall, Deborah A

2017-08-23

The reporting of outcomes in clinical trials of subjective tinnitus indicates that many different tinnitus-related complaints are of interest to investigators, from perceptual attributes of the sound (e.g. loudness) to psychosocial impacts (e.g. quality of life). Even when considering one type of intervention strategy for subjective tinnitus, there is no agreement about what is critically important for deciding whether a treatment is effective. The main purpose of this observational study is, therefore to, develop Core Outcome Domain Sets for the three different intervention strategies (sound, psychological, and pharmacological) for adults with chronic subjective tinnitus that should be measured and reported in every clinical trial of these interventions. Secondary objectives are to identify the strengths and limitations of our study design for recruiting and reducing attrition of participants, and to explore uptake of the core outcomes. The 'Core Outcome Measures in Tinnitus: International Delphi' (COMIT'ID) study will use a mixed-methods approach that incorporates input from health care users at the pre-Delphi stage, a modified three-round Delphi survey and final consensus meetings (one for each intervention). The meetings will generate recommendations by stakeholder representatives on agreed Core Outcome Domain Sets specific to each intervention. A subsequent step will establish a common cross-cutting Core Outcome Domain Set by identifying the common outcome domains included in all three intervention-specific Core Outcome Domain Sets. To address the secondary objectives, we will gather feedback from participants about their experience of taking part in the Delphi process. We aspire to conduct an observational cohort study to evaluate uptake of the core outcomes in published studies at 7 years following Core Outcome Set publication. The COMIT'ID study aims to develop a Core Outcome Domain Set that is agreed as critically important for deciding whether a treatment for subjective tinnitus is effective. Such a recommendation would help to standardise future clinical trials worldwide and so we will determine if participation increases use of the Core Outcome Set in the long term. This project has been registered (November 2014) in the database of the Core Outcome Measures in Effectiveness Trials (COMET) initiative.

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.

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

PubMed Central

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

2014-01-01

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

A Systematic Review and Meta-Analysis of a Measure of Staff/Child Interaction Quality (the Classroom Assessment Scoring System) in Early Childhood Education and Care Settings and Child Outcomes.

PubMed

Perlman, Michal; Falenchuk, Olesya; Fletcher, Brooke; McMullen, Evelyn; Beyene, Joseph; Shah, Prakesh S

2016-01-01

The quality of staff/child interactions as measured by the Classroom Assessment Scoring System (CLASS) in Early Childhood Education and Care (ECEC) programs is thought to be important for children's outcomes. The CLASS is made of three domains that assess Emotional Support, Classroom Organization and Instructional Support. It is a relatively new measure that is being used increasingly for research, quality monitoring/accountability and other applied purposes. Our objective was to evaluate the association between the CLASS and child outcomes. Searches of Medline, PsycINFO, ERIC, websites of large datasets and reference sections of all retrieved articles were conducted up to July 3, 2015. Studies that measured association between the CLASS and child outcomes for preschool-aged children who attended ECEC programs were included after screening by two independent reviewers. Searches and data extraction were conducted by two independent reviewers. Thirty-five studies were systematically reviewed of which 19 provided data for meta-analyses. Most studies had moderate to high risk of bias. Of the 14 meta-analyses we conducted, associations between Classroom Organization and Pencil Tapping and between Instructional Support and SSRS Social Skills were significant with pooled correlations of .06 and .09 respectively. All associations were in the expected direction. In the systematic review, significant correlations were reported mainly from one large dataset. Substantial heterogeneity in use of the CLASS, its dimensions, child outcomes and statistical measures was identified. Greater consistency in study methodology is urgently needed. Given the multitude of factors that impact child development it is encouraging that our analyses revealed some, although small, associations between the CLASS and children's outcomes.

A Systematic Review and Meta-Analysis of a Measure of Staff/Child Interaction Quality (the Classroom Assessment Scoring System) in Early Childhood Education and Care Settings and Child Outcomes

PubMed Central

Perlman, Michal; Falenchuk, Olesya; Fletcher, Brooke; McMullen, Evelyn; Beyene, Joseph; Shah, Prakesh S.

2016-01-01

The quality of staff/child interactions as measured by the Classroom Assessment Scoring System (CLASS) in Early Childhood Education and Care (ECEC) programs is thought to be important for children’s outcomes. The CLASS is made of three domains that assess Emotional Support, Classroom Organization and Instructional Support. It is a relatively new measure that is being used increasingly for research, quality monitoring/accountability and other applied purposes. Our objective was to evaluate the association between the CLASS and child outcomes. Searches of Medline, PsycINFO, ERIC, websites of large datasets and reference sections of all retrieved articles were conducted up to July 3, 2015. Studies that measured association between the CLASS and child outcomes for preschool-aged children who attended ECEC programs were included after screening by two independent reviewers. Searches and data extraction were conducted by two independent reviewers. Thirty-five studies were systematically reviewed of which 19 provided data for meta-analyses. Most studies had moderate to high risk of bias. Of the 14 meta-analyses we conducted, associations between Classroom Organization and Pencil Tapping and between Instructional Support and SSRS Social Skills were significant with pooled correlations of .06 and .09 respectively. All associations were in the expected direction. In the systematic review, significant correlations were reported mainly from one large dataset. Substantial heterogeneity in use of the CLASS, its dimensions, child outcomes and statistical measures was identified. Greater consistency in study methodology is urgently needed. Given the multitude of factors that impact child development it is encouraging that our analyses revealed some, although small, associations between the CLASS and children’s outcomes. PMID:28036333

Does injury compensation lead to worse health after whiplash? A systematic review.

PubMed

Spearing, Natalie M; Connelly, Luke B; Gargett, Susan; Sterling, Michele

2012-06-01

One might expect that injury compensation would leave injured parties better off than they would otherwise have been, yet many believe that compensation does more harm than good. This study systematically reviews the evidence on this "compensation hypothesis" in relation to compensable whiplash injuries. PubMed, CINAHL, EMBASE, PEDro, PsycInfo, CCTR, Lexis, and EconLit were searched from the date of their inception to April 2010 to locate longitudinal studies, published in English, comparing the health outcomes of adults exposed/not exposed to compensation-related factors. Studies concerning serious neck injuries, using claimants only, or using proxy measures of health outcomes were excluded. Eleven studies were included. These examined the effect of lawyer involvement, litigation, claim submission, or previous claims on pain and other health outcomes. Among the 16 results reported were 9 statistically significant negative associations between compensation-related factors and health outcomes. Irrespective of the compensation-related factor involved and the health outcome measured, the quality of these studies was similar to studies that did not find a significant negative association: most took some measures to address selection bias, confounding, and measurement bias, and none resolved the potential for reverse causality bias that arises in the relationship between compensation-related factors and health. Unless ambiguous causal pathways are addressed, one cannot draw conclusions from statistical associations, regardless of their statistical significance and the extent of measures to address other sources of bias. Consequently, there is no clear evidence to support the idea that compensation and its related processes lead to worse health. Copyright © 2012 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.

Patient value: its nature, measurement, and role in real world evidence studies and outcomes-based reimbursement.

PubMed

McKenna, Stephen P; Wilburn, Jeanette

2018-05-01

The assessment of "patient value" is fundamental to clinical trials, real world evidence studies, and outcomes-based reimbursement schemes. Measures of health-related quality-of-life (HRQoL) are widely used in health research. Such measures are effective in determining the presence or absence of symptoms and functional ability. However, HRQoL measures were not intended, nor designed, to determine the value to patients of alternative health states. Functions have no intrinsic value-they are a means to fulfil human needs. However, needs can be met in a variety of ways, for example by adopting different functions or by the provision of social services. It is possible to analyze all functions in terms of the needs they satisfy. A needs model has been applied in health research since the 1990s. It is concerned with the extent to which human needs are fulfilled in the presence of disease and its treatment. It is argued that this is the major concern of the patient. Needs-based measures are patient-centric and produce a valid unidimensional index of outcome. Consequently, they provide a direct means of measuring patient value. This approach provides the possibility of evaluating health services in terms of the value they provide to consumers and payers. It also has a role to play in real-world evidence studies and outcomes-based reimbursement. It is recommended that greater attention is given in future to the development of patient-reported outcome measures that provide direct assessments of patient value.

"It's the skin you're in": African-American women talk about their experiences of racism. an exploratory study to develop measures of racism for birth outcome studies.

PubMed

Nuru-Jeter, Amani; Dominguez, Tyan Parker; Hammond, Wizdom Powell; Leu, Janxin; Skaff, Marilyn; Egerter, Susan; Jones, Camara P; Braveman, Paula

2009-01-01

Stress due to experiences of racism could contribute to African-American women's adverse birth outcomes, but systematic efforts to measure relevant experiences among childbearing women have been limited. We explored the racism experiences of childbearing African-American women to inform subsequent development of improved measures for birth outcomes research. Six focus groups were conducted with a total of 40 socioeconomically diverse African-American women of childbearing age in four northern California cities. Women reported experiencing racism (1) throughout the lifecourse, with childhood experiences seeming particularly salient and to have especially enduring effects (2) directly and vicariously, particularly in relation to their children; (3) in interpersonal, institutional, and internalized forms; (4) across different life domains; (5) with active and passive responses; and (6) with pervasive vigilance, anticipating threats to themselves and their children. This exploratory study's findings support the need for measures reflecting the complexity of childbearing African-American women's racism experiences. In addition to discrete, interpersonal experiences across multiple domains and active/passive responses, which have been measured, birth outcomes research should also measure women's childhood experiences and their potentially enduring impact, perceptions of institutionalized racism and internalized negative stereotypes, vicarious experiences related to their children, vigilance in anticipating future racism events, as well as the pervasiveness and chronicity of racism exposure, all of which could be sources of ongoing stress with potentially serious implications for birth outcomes. Measures of racism addressing these issues should be developed and formally tested.

“It's The Skin You're In”: African-American Women Talk About Their Experiences of Racism. An Exploratory Study to Develop Measures of Racism for Birth Outcome Studies

PubMed Central

Nuru-Jeter, Amani; Dominguez, Tyan Parker; Hammond, Wizdom Powell; Leu, Janxin; Skaff, Marilyn; Egerter, Susan; Jones, Camara P.; Braveman, Paula

2011-01-01

Objectives Stress due to experiences of racism could contribute to African-American women's adverse birth outcomes, but systematic efforts to measure relevant experiences among childbearing women have been limited. We explored the racism experiences of childbearing African-American women to inform subsequent development of improved measures for birth outcomes research. Methods Six focus groups were conducted with a total of 40 socioeconomically diverse African-American women of childbearing age in four northern California cities. Results Women reported experiencing racism (1) throughout the lifecourse, with childhood experiences seeming particularly salient and to have especially enduring effects (2) directly and vicariously, particularly in relation to their children; (3) in interpersonal, institutional, and internalized forms; (4) across different life domains; (5) with active and passive responses; and (6) with pervasive vigilance, anticipating threats to themselves and their children. Conclusions This exploratory study's findings support the need for measures reflecting the complexity of childbearing African-American women's racism experiences. In addition to discrete, interpersonal experiences across multiple domains and active/passive responses, which have been measured, birth outcomes research should also measure women's childhood experiences and their potentially enduring impact, perceptions of institutionalized racism and internalized negative stereotypes, vicarious experiences related to their children, vigilance in anticipating future racism events, as well as the pervasiveness and chronicity of racism exposure, all of which could be sources of ongoing stress with potentially serious implications for birth outcomes. Measures of racism addressing these issues should be developed and formally tested. PMID:18463971

The Mayo Portland Adaptability Inventory-4 outcome measure is superior to UK FIM+FAM in a British military population.

PubMed

McGilloway, Emer; Mitchell, James; Dharm-Datta, Shreshth; Roberts, Andrew; Tilley, Haydn; Etherington, John

2016-01-01

The aim of this study was to identify the most appropriate rehabilitation outcome measure for use in a young adult population with acquired brain injury. A 2-year prospective study of patients admitted to a UK military neuro-rehabilitation unit with acquired brain injury to compare the appropriateness of the Functional Independence Measure/Functional Assessment Measure (FIM+FAM) vs the Mayo-Portland Adaptability Inventory Version 4 (MPAI-4) in assessing outcomes. Patients were assessed at admission, discharge and at 4-month follow-up using FIM+FAM and MPAI-4. The FIM+FAM total motor score showed a marked ceiling affect, 42% of patients scored the maximum on admission rising to 80% at discharge. The MPAI-4 did not show significant ceiling effects. The other sub-scales of FIM+FAM and MPAI-4 were generally comparable, no more than 17% achieved ceiling at follow-up. This is the first comparative study of FIM+FAM and MPAI-4 in a young adult military population following acquired brain injury. All patients showed improvements in both outcome measures following intensive inpatient rehabilitation. However, the MPAI-4 did not show ceiling effects in motor scores. This measure was, therefore, found to be more appropriate in the cohort.

Cardiopulmonary resuscitation quality and beyond: the need to improve real-time feedback and physiologic monitoring.

PubMed

Lin, Steve; Scales, Damon C

2016-06-28

High-quality cardiopulmonary resuscitation (CPR) has been shown to improve survival outcomes after cardiac arrest. The current standard in studies evaluating CPR quality is to measure CPR process measures-for example, chest compression rate, depth, and fraction. Published studies evaluating CPR feedback devices have yielded mixed results. Newer approaches that seek to optimize CPR by measuring physiological endpoints during the resuscitation may lead to individualized patient care and improved patient outcomes.

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

Does the Extended Glasgow Outcome Scale Add Value to the Conventional Glasgow Outcome Scale?

PubMed Central

Weir, James; Steyerberg, Ewout W.; Butcher, Isabella; Lu, Juan; Lingsma, Hester F.; McHugh, Gillian S.; Roozenbeek, Bob; Maas, Andrew I.R.

2012-01-01

Abstract The Glasgow Outcome Scale (GOS) is firmly established as the primary outcome measure for use in Phase III trials of interventions in traumatic brain injury (TBI). However, the GOS has been criticized for its lack of sensitivity to detect small but clinically relevant changes in outcome. The Glasgow Outcome Scale-Extended (GOSE) potentially addresses this criticism, and in this study we estimate the efficiency gain associated with using the GOSE in place of the GOS in ordinal analysis of 6-month outcome. The study uses both simulation and the reanalysis of existing data from two completed TBI studies, one an observational cohort study and the other a randomized controlled trial. As expected, the results show that using an ordinal technique to analyze the GOS gives a substantial gain in efficiency relative to the conventional analysis, which collapses the GOS onto a binary scale (favorable versus unfavorable outcome). We also found that using the GOSE gave a modest but consistent increase in efficiency relative to the GOS in both studies, corresponding to a reduction in the required sample size of the order of 3–5%. We recommend that the GOSE be used in place of the GOS as the primary outcome measure in trials of TBI, with an appropriate ordinal approach being taken to the statistical analysis. PMID:22026476

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

PubMed

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

2017-01-01

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

Outcome scores in spinal surgery quantified: excellent, good, fair and poor in terms of patient-completed tools.

PubMed

Tafazal, Suhayl I; Sell, Philip J

2006-11-01

Outcome scores are very useful tools in the field of spinal surgery as they allow us to assess a patient's progress and the effect of various treatments. The clinical importance of a score change is not so clear. Although previous studies have looked at the minimum clinically important score change, the degree of score change varies considerably. Our study is a prospective cohort study of 193 patients undergoing discectomy, decompression and fusion procedures with minimum 2-year follow-up. We have used three standard outcome measures in common usage, the oswestry disability index (ODI), the low back outcome score (LBOS) and the visual analogue score (VAS). We have defined each of these scores according to a global measure of outcome graded by the patient as excellent, good, fair or poor. We have also graded patient perception and classified excellent and good as success and fair and poor as failure. Our results suggest that a median 24-point change in the ODI equates with a good outcome or is the minimum change needed for success. We have also found that different surgical disorders have very different minimal clinically important differences as perceived by patient perception. We found that for a discectomy a minimum 27-point change in the ODI would be classed as a success, for a decompression the change in ODI needed to class it as a success would be 16 points, whereas for a fusion the change in the ODI would be only 13 points. We believe that patient-rated global measures of outcome are of value and we have quantified them in terms of the standard outcome measures used in spinal surgery.

The Effect of Childbirth Self-Efficacy on Perinatal Outcomes

PubMed Central

Tilden, Ellen L.; Caughey, Aaron B.; Lee, Christopher S.; Emeis, Cathy

2016-01-01

Objective To synthesize and critique the quantitative literature on measuring childbirth self-efficacy and the effect of childbirth self-efficacy on perinatal outcomes. Data Sources Eligible studies were identified through searching MEDLINE, CINAHL, Scopus, and Google Scholar databases. Study Selection Published research using a tool explicitly intended to measure childbirth self-efficacy and also examining outcomes within the perinatal period were included. All manuscripts were in English and published in peer-reviewed journals. Data Extraction First author, country, year of publication, reference and definition of childbirth self-efficacy, measurement of childbirth self-efficacy, sample recruitment and retention, sample characteristics, study design, interventions (with experimental and quasi-experimental studies), and perinatal outcomes were extracted and summarized. Data Synthesis Of 619 publications, 23 studies published between 1983 and 2015 met inclusion criteria and were critiqued and synthesized in this review. Conclusions There is overall consistency in how childbirth self-efficacy is defined and measured among studies, facilitating comparison and synthesis. Our findings suggest that increased childbirth self-efficacy is associated with a wide variety of improved perinatal outcomes. Moreover, there is evidence that childbirth self-efficacy is a psychosocial factor that can be modified through various efficacy-enhancing interventions. Future researchers will be able to build knowledge in this area through: (a) utilization of experimental and quasi-experimental design; (b) recruitment and retention of more diverse samples; (c) explicit reporting of definitions of terms (e.g. ‘high risk’); (d) investigation of interventions that increase childbirth self-efficacy during pregnancy; and, (e) investigation regarding how childbirth self-efficacy enhancing interventions might lead to decreased active labor pain and suffering. Exploratory research should continue to examine the potential association between higher prenatal childbirth self-efficacy and improved early parenting outcomes. PMID:27290918

PREDICTING ADHERENCE TO TREATMENT FOR METHAMPHETAMINE DEPENDENCE FROM NEUROPSYCHOLOGICAL AND DRUG USE VARIABLES*

PubMed Central

Dean, Andy C.; London, Edythe D.; Sugar, Catherine A.; Kitchen, Christina M. R.; Swanson, Aimee-Noelle; Heinzerling, Keith G.; Kalechstein, Ari D.; Shoptaw, Steven

2009-01-01

Although some individuals who abuse methamphetamine have considerable cognitive deficits, no prior studies have examined whether neurocognitive functioning is associated with outcome of treatment for methamphetamine dependence. In an outpatient clinical trial of bupropion combined with cognitive behavioral therapy and contingency management (Shoptaw et al., 2008), 60 methamphetamine-dependent adults completed three tests of reaction time and working memory at baseline. Other variables that were collected at baseline included measures of drug use, mood/psychiatric functioning, employment, social context, legal status, and medical status. We evaluated the relative predictive value of all baseline measures for treatment outcome using Classification and Regression Trees (CART; Breiman, 1984), a nonparametric statistical technique that produces easily interpretable decision rules for classifying subjects that are particularly useful in clinical settings. Outcome measures were whether or not a participant completed the trial and whether or not most urine tests showed abstinence from methamphetamine abuse. Urine-verified methamphetamine abuse at the beginning of the study was the strongest predictor of treatment outcome; two psychosocial measures (e.g., nicotine dependence and Global Assessment of Functioning) also offered some predictive value. A few reaction time and working memory variables were related to treatment outcome, but these cognitive measures did not significantly aid prediction after adjusting for methamphetamine usage at the beginning of the study. On the basis of these findings, we recommend that research groups seeking to identify new predictors of treatment outcome compare the predictors to methamphetamine usage variables to assure that unique predictive power is attained. PMID:19608354

Observational Study of Preschool Education and Care for Disadvantaged Children: Recommendations for Measuring Cognitive and Social-Emotional Outcomes among Chapter 1 Children.

ERIC Educational Resources Information Center

Seppanen, Patricia S.; Love, John M.

This paper presents recommendations about measures for assessing cognitive and social-emotional outcomes of children in Chapter 1 preschool and kindergarten programs. Section I explains the purpose and design of the study, giving special attention to the Chapter 1 substudy. Section II covers critical issues related to cognitive and…

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

Evaluation of the measurement properties of symptom measurement instruments for atopic eczema: a systematic review.

PubMed

Gerbens, L A A; Prinsen, C A C; Chalmers, J R; Drucker, A M; von Kobyletzki, L B; Limpens, J; Nankervis, H; Svensson, Å; Terwee, C B; Zhang, J; Apfelbacher, C J; Spuls, P I

2017-01-01

Symptoms have been identified as a core outcome domain for atopic eczema (AE) trials. Various instruments exist to measure symptoms in AE, but they vary in quality and there is a lack of standardization between clinical trials. Our objective was to systematically evaluate the quality of the evidence on the measurement properties of AE symptom instruments, thereby informing consensus discussions within the Harmonising Outcome Measures for Eczema (HOME) initiative regarding the most appropriate instruments for the core outcome domain symptoms. Using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist and predefined criteria for good measurement properties on identified development and validation studies of AE symptom instruments, a best evidence synthesis was performed to draw an overall conclusion on quality of the instruments and to provide recommendations. Eighteen instruments were identified and evaluated. When the quality and results of the studies were considered, only five of these instruments had sufficient validation data to consider them for the core outcome set for the core outcome domain symptoms. These were the paediatric Itch Severity Scale (ISS), Patient-Oriented Eczema Measure (POEM), Patient-Oriented SCOring Atopic Dermatitis (PO-SCORAD), Self-Administered Eczema Area and Severity Index (SA-EASI) and adapted SA-EASI. ISS (paediatric version), POEM, PO-SCORAD, SA-EASI and adapted SA-EASI are currently the most appropriate instruments and therefore have the potential to be recommended as core symptom instrument in future clinical trials. These findings will be utilized for the development of a core outcome set for AE. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

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

PubMed Central

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

2011-01-01

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

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

PubMed

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

2011-05-01

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

The Outcome and Assessment Information Set (OASIS): A Review of Validity and Reliability

PubMed Central

O’CONNOR, MELISSA; DAVITT, JOAN K.

2015-01-01

The Outcome and Assessment Information Set (OASIS) is the patient-specific, standardized assessment used in Medicare home health care to plan care, determine reimbursement, and measure quality. Since its inception in 1999, there has been debate over the reliability and validity of the OASIS as a research tool and outcome measure. A systematic literature review of English-language articles identified 12 studies published in the last 10 years examining the validity and reliability of the OASIS. Empirical findings indicate the validity and reliability of the OASIS range from low to moderate but vary depending on the item studied. Limitations in the existing research include: nonrepresentative samples; inconsistencies in methods used, items tested, measurement, and statistical procedures; and the changes to the OASIS itself over time. The inconsistencies suggest that these results are tentative at best; additional research is needed to confirm the value of the OASIS for measuring patient outcomes, research, and quality improvement. PMID:23216513

Protocol for the development of a Core Outcome Set (COS) for hemorrhoidal disease: an international Delphi study.

PubMed

van Tol, R R; Melenhorst, J; Dirksen, C D; Stassen, L P S; Breukink, S O

2017-07-01

Over the last decade, many studies were performed regarding treatment options for hemorrhoidal disease. Randomised controlled trials (RCTs) should have well-defined primary and secondary outcomes. However, the reported outcome measures are numerous and diverse. The heterogeneity of outcome definition in clinical trials limits transparency and paves the way for bias. The development of a core outcome set (COS) helps minimizing this problem. A COS is an agreed minimum set of outcomes that should be measured and reported in all clinical trials of a specific disease. The aim of this project is to generate a COS regarding the outcome of treatment after hemorrhoidal disease. A Delphi study will be performed by an international steering group healthcare professionals and patients with the intention to create a standard outcome set for future clinical trials for the treatment of hemorrhoidal disease. First, a literature review will be conducted to establish which outcomes are used in clinical trials for hemorrhoidal disease. Secondly, both healthcare professionals and patients will participate in several consecutive rounds of online questionnaires and a face-to-face meeting to refine the content of the COS. Development of a COS for hemorrhoidal disease defines a minimum outcome-reporting standard and will improve the quality of research in the future.

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

PubMed Central

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

2016-01-01

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

Influence of Study Design on Outcomes Following Reflexology Massage: An Integrative and Critical Review of Interventional Studies.

PubMed

McVicar, Andrew; Greenwood, Christina; Ellis, Carol; LeForis, Chantelle

2016-09-01

Interpretation of the efficacy of reflexology is hindered by inconsistent research designs and complicated by professional views that criteria of randomized controlled trials (RCTs)are not ideal to research holistic complementary and alternative medicine practice. The influence of research designs on study outcomes is not known. This integrative review sought to evaluate this possibility. Thirty-seven interventional studies (2000-2014) were identified; they had RCT or non-RCT design and compared reflexology outcomes against a control/comparison group. Viability of integrating RCT and non-RCT studies into a single database was first evaluated by appraisal of 16 reporting fields related to study setting and objectives, sample demographics, methodologic design, and treatment fidelity and assessment against Jadad score quality criteria for RCTs. For appraisal, the database was stratified into RCT/non-RCT or Jadad score of 3 or more or less than 3. Deficits in reporting were identified for blind assignment of participants, dropout/completion rate, and School of Reflexology. For comparison purposes, these fields were excluded from subsequent analysis for evidence of association between design fields and of fields with study outcomes. Thirty-one studies applied psychometric tools and 20 applied biometric tools (14 applied both). A total of 116 measures were used. Type of measure was associated with study objectives (p < 0.001; chi-square), in particular of psychometric measures with a collated "behavioral/cognitive" objective. Significant outcomes were more likely (p < 0.001; chi-square) for psychometric than for biometric measures. Neither type of outcome was associated with choice of RCT or non-RCT method, but psychometric responses were associated (p = 0.007) with a nonmassage control strategy. The review supports psychometric responses to reflexology when study design uses a nonmassage control strategy. Findings suggest that an evaluation of outcomes against sham reflexology massage and other forms of massage, as well as a narrower focus of study objective, may clarify whether there is a relationship between study design and efficacy of reflexology.

Challenges in Measuring Outcomes Following Digital Replantation

PubMed Central

Sebastin, Sandeep J.; Chung, Kevin C.

2013-01-01

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

Linear Combinations of Multiple Outcome Measures to Improve the Power of Efficacy Analysis ---Application to Clinical Trials on Early Stage Alzheimer Disease

PubMed Central

Xiong, Chengjie; Luo, Jingqin; Morris, John C; Bateman, Randall

2018-01-01

Modern clinical trials on Alzheimer disease (AD) focus on the early symptomatic stage or even the preclinical stage. Subtle disease progression at the early stages, however, poses a major challenge in designing such clinical trials. We propose a multivariate mixed model on repeated measures to model the disease progression over time on multiple efficacy outcomes, and derive the optimum weights to combine multiple outcome measures by minimizing the sample sizes to adequately power the clinical trials. A cross-validation simulation study is conducted to assess the accuracy for the estimated weights as well as the improvement in reducing the sample sizes for such trials. The proposed methodology is applied to the multiple cognitive tests from the ongoing observational study of the Dominantly Inherited Alzheimer Network (DIAN) to power future clinical trials in the DIAN with a cognitive endpoint. Our results show that the optimum weights to combine multiple outcome measures can be accurately estimated, and that compared to the individual outcomes, the combined efficacy outcome with these weights significantly reduces the sample size required to adequately power clinical trials. When applied to the clinical trial in the DIAN, the estimated linear combination of six cognitive tests can adequately power the clinical trial. PMID:29546251

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.

Perinatal and maternal outcomes in planned home and obstetric unit births in women at ‘higher risk’ of complications: secondary analysis of the Birthplace national prospective cohort study

PubMed Central

Li, Y; Townend, J; Rowe, R; Brocklehurst, P; Knight, M; Linsell, L; Macfarlane, A; McCourt, C; Newburn, M; Marlow, N; Pasupathy, D; Redshaw, M; Sandall, J; Silverton, L; Hollowell, J

2015-01-01

Objective To explore and compare perinatal and maternal outcomes in women at ‘higher risk’ of complications planning home versus obstetric unit (OU) birth. Design Prospective cohort study. Setting OUs and planned home births in England. Population 8180 ‘higher risk’ women in the Birthplace cohort. Methods We used Poisson regression to calculate relative risks adjusted for maternal characteristics. Sensitivity analyses explored possible effects of differences in risk between groups and alternative outcome measures. Main outcome measures Composite perinatal outcome measure encompassing ‘intrapartum related mortality and morbidity’ (intrapartum stillbirth, early neonatal death, neonatal encephalopathy, meconium aspiration syndrome, brachial plexus injury, fractured humerus or clavicle) and neonatal admission within 48 hours for more than 48 hours. Two composite maternal outcome measures capturing intrapartum interventions/adverse maternal outcomes and straightforward birth. Results The risk of ‘intrapartum related mortality and morbidity’ or neonatal admission for more than 48 hours was lower in planned home births than planned OU births [adjusted relative risks (RR) 0.50, 95% CI 0.31–0.81]. Adjustment for clinical risk factors did not materially affect this finding. The direction of effect was reversed for the more restricted outcome measure ‘intrapartum related mortality and morbidity’ (RR adjusted for parity 1.92, 95% CI 0.97–3.80). Maternal interventions were lower in planned home births. Conclusions The babies of ‘higher risk’ women who plan birth in an OU appear more likely to be admitted to neonatal care than those whose mothers plan birth at home, but it is unclear if this reflects a real difference in morbidity. Rates of intrapartum related morbidity and mortality did not differ statistically significantly between settings at the 5% level but a larger study would be required to rule out a clinically important difference between the groups. PMID:25603762

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

PubMed Central

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

2014-01-01

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

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

PubMed Central

Herrington, Lee

2014-01-01

Objective. A systematic scoping review of the literature to identify functional performance tests and patient reported outcomes for patients who undergo anterior cruciate ligament (ACL) reconstruction and rehabilitation that are used in clinical practice and research during the last decade. Methods. A literature search was conducted. Electronic databases used included Medline, PubMed, Cochrane Library, EMBASE, CINAHL, SPORTDiscus, PEDro, and AMED. The inclusion criteria were English language, publication between April 2004 and April 2014, and primary ACL reconstruction with objective and/or subjective outcomes used. Two authors screened the selected papers for title, abstract, and full-text in accordance with predefined inclusion and exclusion criteria. The methodological quality of all papers was assessed by a checklist of the Critical Appraisal Skills Programme (CASP). Results. A total of 16 papers were included with full-text. Different authors used different study designs for functional performance testing which led to different outcomes that could not be compared. All papers used a measurement for quantity of functional performance except one study which used both quantity and quality outcomes. Several functional performance tests and patient reported outcomes were identified in this review. Conclusion. No extensive research has been carried out over the past 10 years to measure the quality of functional performance testing and control stability of patients following ACL reconstruction. However this study found that the measurement of functional performance following ACL reconstruction consisting of a one-leg hop for a set distance or a combination of different hops using limb symmetry index (LSI) was a main outcome parameter of several studies. A more extensive series of tests is suggested to measure both the quantitative and qualitative aspects of functional performance after the ACL reconstruction. The KOOS and the IKDC questionnaires are both measures that are increasingly being used for ACL reconstruction throughout the last decade. PMID:27379330

The influence of individual, group, and relative self-esteem on outcome for patients undergoing group cognitive-behavioural therapy treatment.

PubMed

Parker, Thomas J; Page, Andrew C; Hooke, Geoff R

2013-11-01

Despite a strong association between individual self-esteem and treatment outcome in group cognitive-behavioural therapy (GCBT), no study has investigated how patient outcomes might be influenced by an individual's self-esteem relative to other group members. The study comprised a retrospective examination of patients' data and used a multiple regression analysis to identify predictors of treatment outcome. Patients' pre-treatment self-esteem scores were assessed on a continuum and assigned to be low, medium, or high. Therapy groups were assigned to be either low, balanced or high self-esteem groups based on averaged self-esteem scores of participants. In this study, 3,878 patients who had completed a 10-day intensive cognitive behavioural group therapy programme at a private psychiatric facility were included in the study. The Rosenberg Self-Esteem measure was chosen to assess self-esteem. The three subscales of the Depression Anxiety Stress Scales were used as the outcome measures. Patient outcomes were influenced by pre-treatment self-esteem scores, such that higher initial self-esteem was associated with better treatment outcomes. Low group self-esteem was predictive of significantly better outcomes for depression, relative to higher self-esteem groups. Additionally, the combined influence of high individual self-esteem and low group self-esteem was associated with significantly enhanced depression improvement. High self-esteem patients perform better on outcome measures following completion of GCBT. Low self-esteem groups show greater improvement in depression symptoms. Similar results for depression are achieved when patients with high self-esteem complete treatment in low self-esteem groups. © 2013 The British Psychological Society.

Outcome of Vaginoplasty in Male-to-Female Transgenders: A Systematic Review of Surgical Techniques.

PubMed

Horbach, Sophie E R; Bouman, Mark-Bram; Smit, Jan Maerten; Özer, Müjde; Buncamper, Marlon E; Mullender, Margriet G

2015-06-01

Gender reassignment surgery is the keystone of the treatment of transgender patients. For male-to-female transgenders, this involves the creation of a neovagina. Many surgical methods for vaginoplasty have been opted. The penile skin inversion technique is the method of choice for most gender surgeons. However, the optimal surgical technique for vaginoplasty in transgender women has not yet been identified, as outcomes of the different techniques have never been compared. With this systematic review, we aim to give a detailed overview of the published outcomes of all currently available techniques for vaginoplasty in male-to-female transgenders. A PubMed and EMBASE search for relevant publications (1995-present), which provided data on the outcome of techniques for vaginoplasty in male-to-female transgender patients. Main outcome measures are complications, neovaginal depth and width, sexual function, patient satisfaction, and improvement in quality of life (QoL). Twenty-six studies satisfied the inclusion criteria. The majority of these studies were retrospective case series of low to intermediate quality. Outcome of the penile skin inversion technique was reported in 1,461 patients, bowel vaginoplasty in 102 patients. Neovaginal stenosis was the most frequent complication in both techniques. Sexual function and patient satisfaction were overall acceptable, but many different outcome measures were used. QoL was only reported in one study. Comparison between techniques was difficult due to the lack of standardization. The penile skin inversion technique is the most researched surgical procedure. Outcome of bowel vaginoplasty has been reported less frequently but does not seem to be inferior. The available literature is heterogeneous in patient groups, surgical procedure, outcome measurement tools, and follow-up. Standardized protocols and prospective study designs are mandatory for correct interpretation and comparability of data. © 2015 International Society for Sexual Medicine.

Excellent Patient Care Processes in Poor Hospitals? Why Hospital-Level and Patient-Level Care Quality-Outcome Relationships Can Differ.

PubMed

Finney, John W; Humphreys, Keith; Kivlahan, Daniel R; Harris, Alex H S

2016-04-01

Studies finding weak or nonexistent relationships between hospital performance on providing recommended care and hospital-level clinical outcomes raise questions about the value and validity of process of care performance measures. Such findings may cause clinicians to question the effectiveness of the care process presumably captured by the performance measure. However, one cannot infer from hospital-level results whether patients who received the specified care had comparable, worse or superior outcomes relative to patients not receiving that care. To make such an inference has been labeled the "ecological fallacy," an error that is well known among epidemiologists and sociologists, but less so among health care researchers and policy makers. We discuss such inappropriate inferences in the health care performance measurement field and illustrate how and why process measure-outcome relationships can differ at the patient and hospital levels. We also offer recommendations for appropriate multilevel analyses to evaluate process measure-outcome relationships at the patient and hospital levels and for a more effective role for performance measure bodies and research funding organizations in encouraging such multilevel analyses.

An Investigation of the Relationship Between the Alliance Negotiation Scale and Psychotherapy Process and Outcome.

PubMed

Doran, Jennifer M; Safran, Jeremy D; Muran, J Christopher

2017-04-01

This study examines the validity of the Alliance Negotiation Scale (ANS) in a psychotherapy research program. Analyses were designed to evaluate the relationship between the ANS and psychotherapy process and outcome variables. Data were collected in a metropolitan psychotherapy research program. Participants completed 30 sessions of therapy, postsession assessments, and a battery of measures at intake and termination. Relationships were found between the ANS and session outcome, working alliance, and the presence of ruptures and their resolution. Relationships emerged between the ANS and treatment outcome on measures of psychiatric distress and interpersonal problems. The ANS demonstrated relationships with several psychotherapy process and outcome variables. The ANS was the most differentiated from the working alliance on measures of interpersonal functioning and in discriminating personality disorder pathology. These results extend previous findings on the ANS' psychometric integrity, and offer new data on the relationship between negotiation and treatment outcome. © 2016 Wiley Periodicals, Inc.

Family Structure, Family Stability, and Outcomes of Five-Year-Old Children

PubMed Central

Brooks-Gunn, Jeanne; Waldfogel, Jane

2013-01-01

This study exploits data from the Fragile Families and Child Wellbeing Study, a birth cohort study of a diverse sample of children from twenty U.S. cities (N = 3,676), to examine how cognitive, behavioural, and health outcomes of five-year old children differ according to their family structure and family stability. We define three models: one that measures family structure at birth only, a second that measures current family structure at year five conditional on family structure at birth, and a third that measures changes in family structure from birth to age five. We find that while family structure has persistent links to child outcomes, the effects are significantly altered by stability of the family structure over time. These findings remain robust even after addressing selection. PMID:24163735

Separable Attentional Predictors of Language Outcome

ERIC Educational Resources Information Center

Salley, Brenda; Panneton, Robin K.; Colombo, John

2013-01-01

The aim of this study was to examine the combined influences of infants' attention and use of social cues in the prediction of their language outcomes. This longitudinal study measured infants' visual attention on a distractibility task (11 months), joint attention (14 months), and language outcomes (word-object association, 14 months; MBCDI…

TAFE Diploma Graduates: Personal Capital Investments and Returns

ERIC Educational Resources Information Center

van der Linde, Chris

2008-01-01

TAFE currently uses the NCVER Student Outcomes Survey (SOS) to determine outcomes related to TAFE diploma programs. The SOS measures TAFE outcomes in terms of three major categories: skills development, employment and further study. This study introduces the notion of personal capital as distinct from human capital. It argues that, while valuable,…

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

PubMed

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

2017-01-01

A clinician-reported outcome (ClinRO) assessment is a type of clinical outcome assessment (COA). ClinRO assessments, like all COAs (patient-reported, observer-reported, or performance outcome assessments), are used to 1) measure patients' health status and 2) define end points that can be interpreted as treatment benefits of medical interventions on how patients feel, function, or survive in clinical trials. Like other COAs, ClinRO assessments can be influenced by human choices, judgment, or motivation. A ClinRO assessment is conducted and reported by a trained health care professional and requires specialized professional training to evaluate the patient's health status. This is the second of two reports by the ISPOR Clinical Outcomes Assessment-Emerging Good Practices for Outcomes Research Task Force. The first report provided an overview of COAs including definitions important for an understanding of COA measurement practices. This report focuses specifically on issues related to ClinRO assessments. In this report, we define three types of ClinRO assessments (readings, ratings, and clinician global assessments) and describe emerging good measurement practices in their development and evaluation. The good measurement practices include 1) defining the context of use; 2) identifying the concept of interest measured; 3) defining the intended treatment benefit on how patients feel, function, or survive reflected by the ClinRO assessment and evaluating the relationship between that intended treatment benefit and the concept of interest; 4) documenting content validity; 5) evaluating other measurement properties once content validity is established (including intra- and inter-rater reliability); 6) defining study objectives and end point(s) objectives, and defining study end points and placing study end points within the hierarchy of end points; 7) establishing interpretability in trial results; and 8) evaluating operational considerations for the implementation of ClinRO assessments used as end points in clinical trials. Applying good measurement practices to ClinRO assessment development and evaluation will lead to more efficient and accurate measurement of treatment effects. This is important beyond regulatory approval in that it provides evidence for the uptake of new interventions into clinical practice and provides justification to payers for reimbursement on the basis of the clearly demonstrated added value of the new intervention. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Modeling Deficits from Early Auditory Information Processing to Psychosocial Functioning in Schizophrenia

PubMed Central

Thomas, Michael L.; Green, Michael F.; Hellemann, Gerhard; Sugar, Catherine A.; Tarasenko, Melissa; Calkins, Monica E.; Greenwood, Tiffany A.; Gur, Raquel E.; Gur, Ruben C.; Lazzeroni, Laura C.; Nuechterlein, Keith H.; Radant, Allen D.; Seidman, Larry J.; Shiluk, Alexandra L.; Siever, Larry J.; Silverman, Jeremy M.; Sprock, Joyce; Stone, William S.; Swerdlow, Neal R.; Tsuang, Debby W.; Tsuang, Ming T.; Turetsky, Bruce I.; Braff, David L.; Light, Gregory A.

2017-01-01

Importance Neurophysiological measures of early auditory information processing (EAP) are used as endophenotypes in genomic studies and biomarkers in clinical intervention studies. Research in schizophrenia has established correlations among measures of EAP, cognition, clinical symptoms, and functional outcome. Clarifying these relationships by determining the pathways through which deficits in EAP affect functioning would suggest when and where to therapeutically intervene. Objective We sought to characterize the pathways from EAP to outcome and to estimate the extent to which enhancement of basic information processing might improve both cognition and psychosocial functioning in schizophrenia. Design Cross-sectional data were analyzed using structural equation modeling to examine the associations between EAP, cognition, negative symptoms, and functional outcome. Setting Participants were recruited from the community at five geographically distributed laboratories as part of the Consortium on the Genetics of Schizophrenia-2 (COGS-2). Participants This well-characterized cohort of schizophrenia patients (N = 1,415) underwent EAP and cognitive testing as well as thorough clinical and functional assessment. Main Outcome and Measures EAP was measured by mismatch negativity, P3a, and reorienting negativity. Cognition was measured by the Letter Number Span test and scales from the California Verbal Learning Test - Second Edition, the Wechsler Memory Scale Third Edition, and the Penn Computerized Neurocognitive Battery. Negative symptoms were measured by the Scale for the Assessment of Negative Symptoms. Functional outcome was measured by the Role Functioning Scale. Results EAP had a direct effect on cognition (β = 0.37, p < .001), cognition had a direct effect on negative symptoms (β = −0.16, p < .001), and both cognition (β = 0.26, p < .001) and experiential negative symptoms (β = −0.75, p < .001) had direct effects on functional outcome. Overall, EAP had a fully mediated effect on functional outcome, engaging general rather than modality-specific cognition, with separate pathways that either involved or bypassed negative symptoms. Conclusions and Relevance The data support a model where EAP deficits lead to poor functional outcome via impaired cognition and increased negative symptoms. Results can be used to help guide mechanistically informed, personalized treatments, and support the strategy of using EAP measures as surrogate endpoints in early stage pro-cognitive intervention studies. PMID:27926742

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

PubMed Central

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

2015-01-01

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

The development of leadership outcome-indicators evaluating the contribution of clinical specialists and advanced practitioners to health care: a secondary analysis.

PubMed

Elliott, Naomi; Begley, Cecily; Kleinpell, Ruth; Higgins, Agnes

2014-05-01

To report a secondary analysis of data collected from the case study phase of a national study of advanced practitioners and to develop leadership outcome-indicators appropriate for advanced practitioners. In many countries, advanced practitioners in nursing and midwifery have responsibility as leaders for health care development, but without having leadership outcome measures available they are unable to demonstrate the results of their activities. In Ireland, a sequential mixed method research study was used to develop a validated tool for the evaluation of clinical specialists and advanced practitioners. Despite strong evidence of leadership activities, few leadership-specific outcomes were generated from the primary analysis. Secondary analysis of a multiple case study data set. Data set comprised 23 case studies of advanced practitioner/clinical specialists from 13 sites across each region in Ireland from all divisions of the Nursing Board Register. Data were collected 2008-2010. Data sources included non-participant observation (n = 92 hours) of advanced practitioners in practice, interviews with clinicians (n = 21), patients (n = 20) and directors of nursing/midwifery (n = 13) and documents. Analysis focused on leadership outcome-indicator development in line with the National Health Service's Good Indicators Guide. The four categories of leadership outcomes for advanced practitioner developed were as follows: (i) capacity and capability building of multidisciplinary team; (ii) measure of esteem; (iii) new initiatives for clinical practice and healthcare delivery; and (iv) clinical practice based on evidence. The proposed set of leadership outcome-indicators derived from a secondary analysis captures the complexity of leadership in practice. They add to existing clinical outcomes measuring advanced practice. © 2013 John Wiley & Sons Ltd.

What counts: outcome assessment after distal radius fractures in aged patients.

PubMed

Goldhahn, Jörg; Angst, Felix; Simmen, Beat R

2008-09-01

Outcome of surgical interventions at the distal radius does not only depend on the type of intervention used, it also depends on the way the outcome is measured. Substantial differences in outcome assessment between different measurement tools and poor correlation among them result in the question about the best instrument for the evaluation of treatment after distal radius fractures. The aim of the review is to discuss pros and cons of the parameters that are available to assess the outcome after distal radius fractures. The review should help to choose the appropriate instruments for a given research question in aged patients with distal radius fractures. Objective and subjective measures were reviewed with respect to their suitability in outcome assessment. Radiological parameters like inclination, palmar slope, and length of the radius are most common and used to determine especially surgical success. Grip strength and range of motion are considered objective and used as study endpoints in many studies. Functional tests like the Jebsen test provide a realistic feedback about disability but require special skills and resources of the testing personnel. Patient self-assessment adds perceived patient benefit. The patient-rated wrist evaluation (PRWE) provides a reliable and valid instrument for subjective outcome assessment. A combination of objective and subjective parameters should be used to assess the outcome of different treatment strategies due to the known discrepancies. Objective parameters like shortening, radial shift, or others should be clearly defined in the study methodology.

A systematic literature search to identify performance measure outcomes used in clinical studies of racehorses.

PubMed

Wylie, C E; Newton, J R

2018-05-01

Racing performance is often used as a measurable outcome variable in research studies investigating clinical diagnoses or interventions. However, the use of many different performance measures largely precludes conduct of meaningful comparative studies and, to date, those being used have not been collated. To systematically review the veterinary scientific literature for the use of racing performance as a measurable outcome variable in clinical studies of racehorses, collate and identify those most popular, and identify their advantages and disadvantages. Systematic literature search. The search criteria "((racing AND performance) AND (horses OR equidae))" were adapted for both MEDLINE and CAB Abstracts databases. Data were collected in standardised recording forms for binary, categorical and quantitative measures, and the use of performance indices. In total, 217 studies that described racing performance were identified, contributing 117 different performance measures. No one performance measure was used in all studies, despite 90.3% using more than one variable. Data regarding race starts and earnings were used most commonly, with 88.0% and 54.4% of studies including at least one measure of starts and earnings, respectively. Seventeen variables were used 10 times or more, with the top five comprising: 'return to racing', 'number of starts', 'days to first start', 'earnings per period of time' and 'earnings per start'. The search strategies may not have identified all relevant papers, introducing bias to the review. Performance indices have been developed to improve assessment of interventions; however, they are not widely adopted in the scientific literature. Use of the two most commonly identified measures, whether the horse returned to racing and number of starts over a defined period of time, would best facilitate future systematic reviews and meta-analyses in advance of the development of a gold-standard measure of race performance outcome. © 2017 EVJ Ltd.

Long-term healthcare costs and functional outcomes associated with lack of remission in schizophrenia: a post-hoc analysis of a prospective observational study

PubMed Central

2012-01-01

Background Little is known about the long-term outcomes for patients with schizophrenia who fail to achieve symptomatic remission. This post-hoc analysis of a 3-year study compared the costs of mental health services and functional outcomes between individuals with schizophrenia who met or did not meet cross-sectional symptom remission at study enrollment. Methods This post-hoc analysis used data from a large, 3-year prospective, non-interventional observational study of individuals treated for schizophrenia in the United States conducted between July 1997 and September 2003. At study enrollment, individuals were classified as non-remitted or remitted using the Schizophrenia Working Group Definition of symptom remission (8 core symptoms rated as mild or less). Mental health service use was measured using medical records. Costs were based on the sites’ medical information systems. Functional outcomes were measured with multiple patient-reported measures and the clinician-rated Quality of Life Scale (QLS). Symptoms were measured using the Positive and Negative Syndrome Scale (PANSS). Outcomes for non-remitted and remitted patients were compared over time using mixed effects models for repeated measures or generalized estimating equations after adjusting for multiple baseline characteristics. Results At enrollment, most of the 2,284 study participants (76.1%) did not meet remission criteria. Non-remitted patients had significantly higher PANSS total scores at baseline, a lower likelihood of being Caucasian, a higher likelihood of hospitalization in the previous year, and a greater likelihood of a substance use diagnosis (all p < 0.05). Total mental health costs were significantly higher for non-remitted patients over the 3-year study (p = 0.008). Non-remitted patients were significantly more likely to be victims of crime, exhibit violent behavior, require emergency services, and lack paid employment during the 3-year study (all p < 0.05). Non-remitted patients also had significantly lower scores on the QLS, SF-12 Mental Component Summary Score, and Global Assessment of Functioning during the 3-year study. Conclusions In this post-hoc analysis of a 3-year prospective observational study, the failure to achieve symptomatic remission at enrollment was associated with higher subsequent healthcare costs and worse functional outcomes. Further examination of outcomes for schizophrenia patients who fail to achieve remission at initial assessment by their subsequent clinical status is warranted. PMID:23216976

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

PubMed

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

2018-05-01

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

Development and classification of a robust inventory of near real-time outcome measurements for assessing information technology interventions in health care.

PubMed

Colicchio, Tiago K; Del Fiol, Guilherme; Scammon, Debra L; Bowes, Watson A; Facelli, Julio C; Narus, Scott P

2017-09-01

To develop and classify an inventory of near real-time outcome measures for assessing information technology (IT) interventions in health care and assess their relevance as perceived by experts in the field. To verify the robustness and coverage of a previously published inventory of measures and taxonomy, we conducted semi-structured interviews with clinical and administrative leaders from a large care delivery system to collect suggestions of outcome measures that can be calculated with data available in electronic format for near real-time monitoring of EHR implementations. We combined these measures with the most commonly reported in the literature. We then conducted two online surveys with subject-matter experts to collect their perceptions of the relevance of the measures, and identify other potentially relevant measures. With input from experienced health care leaders and informaticists, we developed an inventory of 102 outcome measures. These measures were classified into a taxonomy of commonly used measures around the categories of quality, productivity, and safety. Safety measures were rated as most relevant by subject-matter experts, especially those measuring medication processes. Clinician satisfaction and measures assessing mean time to complete tasks and time spent on electronic documentation were also rated as highly relevant. By expanding the coverage of our previously published inventory and taxonomy, we expect to help providers, health IT vendors and researchers to more effectively and consistently monitor the impact of EHR implementations in near real-time, and report more standardized outcomes in future studies. We identified several measures not commonly assessed by previous studies of IT implementations, especially those of safety and productivity, which deserve more attention from the broader informatics community. Our inventory of measures and taxonomy will help researchers identify gaps in their measurement approaches and report more standardized measurements of IT interventions that could be shared among researchers, hopefully facilitating comparison across future studies and increasing our understanding of the impact of IT interventions in health care. Copyright © 2017 Elsevier Inc. All rights reserved.

Can psychotherapists function as their own controls? Meta-analysis of the crossed therapist design in comparative psychotherapy trials.

PubMed

Falkenström, Fredrik; Markowitz, John C; Jonker, Hanske; Philips, Björn; Holmqvist, Rolf

2013-05-01

Clinical trials sometimes have the same therapists deliver more than 1 psychotherapy, ostensibly to control for therapist effects. This "crossed therapist" design makes controlling for therapist allegiance imperative, as therapists may prefer one treatment they deliver to the other(s). Research has established a strong relationship between principal investigators' allegiances and treatment outcome. Study therapists' allegiances probably also influence outcome, yet this moderating factor on outcome has never been studied. English language abstracts in PsycINFO and MEDLINE from January 1985 to December 2011 were searched for keywords psychotherapy and randomized trial. The search yielded 990 abstracts that were searched manually. Trials using the same therapists in more than 1 condition were included. Thirty-nine studies fulfilled inclusion criteria. Meta-regression analyses assessed the influence of researchers' allegiance on treatment outcome, testing the hypothesis that studies poorly controlling for therapist allegiance would show stronger influence of researcher allegiance on outcome. A single-item measure assessed researchers' reported attempts to control for therapist allegiance. Only 1 of 39 studies (3%) measured therapist treatment allegiance. Another 5 (13%) mentioned controlling for, without formally assessing, therapist allegiance. Most publications (67%) did not even mention therapist allegiance. In studies not controlling for therapist allegiance, researcher allegiance strongly influenced outcome, whereas studies reporting control for therapist allegiance showed no differential researcher allegiance. Researchers with cognitive-behavioral therapy allegiance described controlling for therapist allegiance less frequently than other researchers. The crossed therapist design is subject to bias due to differential psychotherapist allegiance. Worrisome results suggest that researchers strongly allied to a treatment may ignore therapist allegiance, potentially skewing outcomes. All clinical trials, and especially crossed therapist designs, should measure psychotherapist allegiance to evaluate this possible bias. © Copyright 2013 Physicians Postgraduate Press, Inc.

A longitudinal analysis of nursing home outcomes.

PubMed Central

Porell, F; Caro, F G; Silva, A; Monane, M

1998-01-01

OBJECTIVE: To investigate resident and facility attributes associated with long-term care health outcomes in nursing homes. DATA SOURCES: Quarterly Management Minutes Questionnaire (MMQ) survey data for Medicaid case-mix reimbursement of nursing homes in Massachusetts from 1991 to 1994, for specification of outcomes and resident attributes. Facility attributes are specified from cost report data. STUDY DESIGN: Multivariate logistic and "state-dependence" regression models are estimated for survival, ADL functional status, incontinence status, and mental status outcomes from longitudinal residence histories of Medicaid residents spanning 3 to 36 months in length. Outcomes are specified to be a function of resident demographic and diagnostic attributes and facility-level operating and nurse staffing attributes. PRINCIPAL FINDINGS: The estimated parameters for resident demographic and diagnostic attributes showed a great deal of construct validity with respect to clinical expectations regarding risk factors for adverse outcomes. Few facility attributes were associated with outcomes generally, and none was significantly associated with all four outcomes. CONCLUSIONS: The absence of uniform associations between facility attributes and the various long-term care health outcomes studied suggests that strong facility performance on one health outcome may coexist with much weaker performance on other outcomes. This has implications for the aggregation of individual facility performance measures on multiple outcomes and the development of overall outcome performance measures. PMID:9776939

Towards measurement of the Healthy Ageing Phenotype in lifestyle-based intervention studies.

PubMed

Lara, Jose; Godfrey, Alan; Evans, Elizabeth; Heaven, Ben; Brown, Laura J E; Barron, Evelyn; Rochester, Lynn; Meyer, Thomas D; Mathers, John C

2013-10-01

Given the biological complexity of the ageing process, there is no single, simple and reliable measure of how healthily someone is ageing. Intervention studies need a panel of measures which capture key features of healthy ageing. To help guide our research in this area, we have adopted the concept of the "Healthy Ageing Phenotype" (HAP) and this study aimed to (i) identify the most important features of the HAP and (ii) identify/develop tools for measurement of those features. After a comprehensive assessment of the literature we selected the following domains: physiological and metabolic health, physical capability, cognitive function, social wellbeing, and psychological wellbeing which we hoped would provide a reasonably holistic characterisation of the HAP. We reviewed the literature and identified systematic reviews and/or meta-analysis of cohort studies, and clinical guidelines on outcome measures of these domains relevant to the HAP. Selection criteria for these measures included: frequent use in longitudinal studies of ageing; expected to change with age; evidence for strong association with/prediction of ageing-related phenotypes such as morbidity, mortality and lifespan; whenever possible, focus on studies measuring these outcomes in populations rather than on individuals selected on the basis of a particular disease; (bio)markers that respond to (lifestyle-based) intervention. Proposed markers were exposed to critique in a Workshop held in Newcastle, UK in October 2012. We have selected a tentative panel of (bio)markers of physiological and metabolic health, physical capability, cognitive function, social wellbeing, and psychological wellbeing which we propose may be useful in characterising the HAP and which may have utility as outcome measures in intervention studies. In addition, we have identified a number of tools which could be applied in community-based intervention studies designed to enhance healthy ageing. We have proposed, tentatively, a panel of outcome measures which could be deployed in community-based, lifestyle intervention studies. The evidence base for selection of measurement domains is less well developed in some areas e.g. social wellbeing (where the definition of the concept itself remains elusive) and this has implications for the identification of appropriate tools. Although we have developed this panel as potential outcomes for intervention studies, we recognise that broader agreement on the concept of the HAP and on tools for its measurement could have wider utility and e.g. could facilitate comparisons of healthy ageing across diverse study designs and populations. Copyright © 2013 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

Parents Suggest Which Indicators of Progress and Outcomes Should Be Measured in Young Children with Autism Spectrum Disorder

ERIC Educational Resources Information Center

McConachie, Helen; Livingstone, Nuala; Morris, Christopher; Beresford, Bryony; Le Couteur, Ann; Gringras, Paul; Garland, Deborah; Jones, Glenys; Macdonald, Geraldine; Williams, Katrina; Parr, Jeremy R.

2018-01-01

Evaluation of interventions for children with autism spectrum disorder (ASD) is hampered by the multitude of outcomes measured and tools used. Measurement in research with young children tends to focus on core impairments in ASD. We conducted a systematic review of qualitative studies of what matters to parents. Parent advisory groups completed…

Measures of Social Deprivation That Predict Health Care Access and Need within a Rational Area of Primary Care Service Delivery

PubMed Central

Butler, Danielle C; Petterson, Stephen; Phillips, Robert L; Bazemore, Andrew W

2013-01-01

Objective To develop a measure of social deprivation that is associated with health care access and health outcomes at a novel geographic level, primary care service area. Data Sources/Study Setting Secondary analysis of data from the Dartmouth Atlas, AMA Masterfile, National Provider Identifier data, Small Area Health Insurance Estimates, American Community Survey, Area Resource File, and Behavioural Risk Factor Surveillance System. Data were aggregated to primary care service areas (PCSAs). Study Design Social deprivation variables were selected from literature review and international examples. Factor analysis was used. Correlation and multivariate analyses were conducted between index, health outcomes, and measures of health care access. The derived index was compared with poverty as a predictor of health outcomes. Data Collection/Extraction Methods Variables not available at the PCSA level were estimated at block level, then aggregated to PCSA level. Principal Findings Our social deprivation index is positively associated with poor access and poor health outcomes. This pattern holds in multivariate analyses controlling for other measures of access. A multidimensional measure of deprivation is more strongly associated with health outcomes than a measure of poverty alone. Conclusions This geographic index has utility for identifying areas in need of assistance and is timely for revision of 35-year-old provider shortage and geographic underservice designation criteria used to allocate federal resources. PMID:22816561

PROMIS Physical Function Computer Adaptive Test Compared With Other Upper Extremity Outcome Measures in the Evaluation of Proximal Humerus Fractures in Patients Older Than 60 Years.

PubMed

Morgan, Jordan H; Kallen, Michael A; Okike, Kanu; Lee, Olivia C; Vrahas, Mark S

2015-06-01

To compare the PROMIS Physical Function Computer Adaptive Test (PROMIS PF CAT) to commonly used traditional PF measures for the evaluation of patients with proximal humerus fractures. Prospective. Two Level I trauma centers. Forty-seven patients older than 60 years with displaced proximal humerus fractures treated between 2006 and 2009. Evaluation included completion of the PROMIS PF CAT, the Constant Shoulder Score, the Disabilities of the Arm, Shoulder, and Hand (DASH) and the Short Musculoskeletal Functional Assessment (SMFA). Observed correlations among the administered PF outcome measures. On average, patients responded to 86 outcome-related items for this study: 4 for the PROMIS PF CAT (range: 4-8 items), 6 for the Constant Shoulder Score, 30 for the DASH, and 46 for the SMFA. Time to complete the PROMIS PF CAT (median completion time = 98 seconds) was significantly less than that for the DASH (median completion time = 336 seconds, P < 0.001) and for the SMFA (median completion time = 482 seconds, P < 0.001). PROMIS PF CAT scores correlated statistically significantly and were of moderate-to-high magnitude with all other PF outcome measure scores administered. This study suggests using the PROMIS PF CAT as a sole PF outcome measure can yield an assessment of upper extremity function similar to those provided by traditional PF measures, while substantially reducing patient assessment time.

Communication Competence, Leadership Behaviors, and Employee Outcomes in Supervisor-Employee Relationships

ERIC Educational Resources Information Center

Mikkelson, Alan C.; York, Joy A.; Arritola, Joshua

2015-01-01

Supervisor communication competence and leadership style were used to predict specific employee outcomes. In the study, 276 participants working in various industries completed measures of communication competence and leadership styles about their direct supervisor along with measures of their job satisfaction, motivation, and organizational…

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.

Predicting well-being longitudinally for mothers rearing offspring with intellectual and developmental disabilities.

PubMed

Grein, K A; Glidden, L M

2015-07-01

Well-being outcomes for parents of children with intellectual and developmental disabilities (IDD) may vary from positive to negative at different times and for different measures of well-being. Predicting and explaining this variability has been a major focus of family research for reasons that have both theoretical and applied implications. The current study used data from a 23-year longitudinal investigation of adoptive and birth parents of children with IDD to determine which early child, mother and family characteristics would predict the variance in maternal outcomes 20 years after their original measurement. Using hierarchical regression analyses, we tested the predictive power of variables measured when children were 7 years old on outcomes of maternal well-being when children were 26 years old. Outcome variables included maternal self-report measures of depression and well-being. Final models of well-being accounted for 20% to 34% of variance. For most outcomes, Family Accord and/or the personality variable of Neuroticism (emotional stability/instability) were significant predictors, but some variables demonstrated a different pattern. These findings confirm that (1) characteristics of the child, mother and family during childhood can predict outcomes of maternal well-being 20 years later; and (2) different predictor-outcome relationships can vary substantially, highlighting the importance of using multiple measures to gain a more comprehensive understanding of maternal well-being. These results have implications for refining prognoses for parents and for tailoring service delivery to individual child, parent and family characteristics. © 2014 MENCAP and International Association of the Scientific Study of Intellectual and Developmental Disabilities and John Wiley & Sons Ltd.

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

PubMed Central

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

2011-01-01

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

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

PubMed

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

2016-12-15

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

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

The Science of Salt: A focused review on salt-related knowledge, attitudes and behaviors, and gender differences.

PubMed

McKenzie, Briar; Santos, Joseph Alvin; Trieu, Kathy; Thout, Sudhir Raj; Johnson, Claire; Arcand, JoAnne; Webster, Jacqui; McLean, Rachael

2018-05-01

The aim of the current review was to examine the scope of studies published in the Science of Salt Weekly that contained a measure of self-reported knowledge, attitudes, and behavior (KAB) concerning salt. Specific objectives were to examine how KAB measures are used to evaluate salt reduction intervention studies, the questionnaires used, and whether any gender differences exist in self-reported KAB. Studies were reviewed from the commencement of Science of Salt Weekly, June 2013 to the end of August 2017. Seventy-five studies had relevant measures of KAB and were included in this review, 13 of these were salt-reduction intervention-evaluation studies, with the remainder (62) being descriptive KAB studies. The KAB questionnaires used were specific to the populations studied, without evidence of a best practice measure. 40% of studies used KAB alone as the primary outcome measure; the remaining studies used more quantitative measures of salt intake such as 24-hour urine. Only half of the descriptive studies showed KAB outcomes disaggregated by gender, and of those, 73% showed women had more favorable KAB related to salt. None of the salt intervention-evaluation studies showed disaggregated KAB data. Therefore, it is likely important that evaluation studies disaggregate, and are appropriately powered to disaggregate all outcomes by gender to address potential disparities. ©2018 Wiley Periodicals, Inc.

Do large-scale hospital- and system-wide interventions improve patient outcomes: a systematic review.

PubMed

Clay-Williams, Robyn; Nosrati, Hadis; Cunningham, Frances C; Hillman, Kenneth; Braithwaite, Jeffrey

2014-09-03

While health care services are beginning to implement system-wide patient safety interventions, evidence on the efficacy of these interventions is sparse. We know that uptake can be variable, but we do not know the factors that affect uptake or how the interventions establish change and, in particular, whether they influence patient outcomes. We conducted a systematic review to identify how organisational and cultural factors mediate or are mediated by hospital-wide interventions, and to assess the effects of those factors on patient outcomes. A systematic review was conducted and reported in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Database searches were conducted using MEDLINE from 1946, CINAHL from 1991, EMBASE from 1947, Web of Science from 1934, PsycINFO from 1967, and Global Health from 1910 to September 2012. The Lancet, JAMA, BMJ, BMJ Quality and Safety, The New England Journal of Medicine and Implementation Science were also hand searched for relevant studies published over the last 5 years. Eligible studies were required to focus on organisational determinants of hospital- and system-wide interventions, and to provide patient outcome data before and after implementation of the intervention. Empirical, peer-reviewed studies reporting randomised and non-randomised controlled trials, observational, and controlled before and after studies were included in the review. Six studies met the inclusion criteria. Improved outcomes were observed for studies where outcomes were measured at least two years after the intervention. Associations between organisational factors, intervention success and patient outcomes were undetermined: organisational culture and patient outcomes were rarely measured together, and measures for culture and outcome were not standardised. Common findings show the difficulty of introducing large-scale interventions, and that effective leadership and clinical champions, adequate financial and educational resources, and dedicated promotional activities appear to be common factors in successful system-wide change.The protocol has been registered in the international prospective register of systematic reviews, PROSPERO (Registration No. CRD42103003050).

[Benchmarking using different measurement instruments and the management of measurement variability].

PubMed

Blankers, M; Barendregt, M; Dekker, J J M

2016-01-01

In mental health care centres in the Netherlands outcome data are collected using a variety of outcome instruments. This may have implications for the comparability of outcome results between different centres. To discuss recent findings regarding the extent to which the eight instruments currently used in clinical practice report comparable results. Our study is based on a combination of literature review and empirical research. The results obtained with the eight instruments are not equivalent. Patients symptom reductions appear larger with some instruments than with others. The current practice of benchmarking in the Dutch mental health system would have greater validity if the number of different instruments would be reduced. State-of-the-art calibration studies are necessary to validate the comparability of the remaining instruments. Ideally, all mental health centres will soon use one instrument per care domain to measure treatment outcome.

A comparison between the clinical significance and growth mixture modelling early change methods at predicting negative outcomes.

PubMed

Flood, Nicola; Page, Andrew; Hooke, Geoff

2018-05-03

Routine outcome monitoring benefits treatment by identifying potential no change and deterioration. The present study compared two methods of identifying early change and their ability to predict negative outcomes on self-report symptom and wellbeing measures. 1467 voluntary day patients participated in a 10-day group Cognitive Behaviour Therapy (CBT) program and completed the symptom and wellbeing measures daily. Early change, as defined by (a) the clinical significance method and (b) longitudinal modelling, was compared on each measure. Early change, as defined by the simpler clinical significance method, was superior at predicting negative outcomes than longitudinal modelling. The longitudinal modelling method failed to detect a group of deteriorated patients, and agreement between the early change methods and the final unchanged outcome was higher for the clinical significance method. Therapists could use the clinical significance early change method during treatment to alert them of patients at risk for negative outcomes, which in turn could allow therapists to prevent those negative outcomes from occurring.

Methodology Series Module 3: Cross-sectional Studies.

PubMed

Setia, Maninder Singh

2016-01-01

Cross-sectional study design is a type of observational study design. In a cross-sectional study, the investigator measures the outcome and the exposures in the study participants at the same time. Unlike in case-control studies (participants selected based on the outcome status) or cohort studies (participants selected based on the exposure status), the participants in a cross-sectional study are just selected based on the inclusion and exclusion criteria set for the study. Once the participants have been selected for the study, the investigator follows the study to assess the exposure and the outcomes. Cross-sectional designs are used for population-based surveys and to assess the prevalence of diseases in clinic-based samples. These studies can usually be conducted relatively faster and are inexpensive. They may be conducted either before planning a cohort study or a baseline in a cohort study. These types of designs will give us information about the prevalence of outcomes or exposures; this information will be useful for designing the cohort study. However, since this is a 1-time measurement of exposure and outcome, it is difficult to derive causal relationships from cross-sectional analysis. We can estimate the prevalence of disease in cross-sectional studies. Furthermore, we will also be able to estimate the odds ratios to study the association between exposure and the outcomes in this design.

Methodology Series Module 3: Cross-sectional Studies

PubMed Central

Setia, Maninder Singh

2016-01-01

Cross-sectional study design is a type of observational study design. In a cross-sectional study, the investigator measures the outcome and the exposures in the study participants at the same time. Unlike in case–control studies (participants selected based on the outcome status) or cohort studies (participants selected based on the exposure status), the participants in a cross-sectional study are just selected based on the inclusion and exclusion criteria set for the study. Once the participants have been selected for the study, the investigator follows the study to assess the exposure and the outcomes. Cross-sectional designs are used for population-based surveys and to assess the prevalence of diseases in clinic-based samples. These studies can usually be conducted relatively faster and are inexpensive. They may be conducted either before planning a cohort study or a baseline in a cohort study. These types of designs will give us information about the prevalence of outcomes or exposures; this information will be useful for designing the cohort study. However, since this is a 1-time measurement of exposure and outcome, it is difficult to derive causal relationships from cross-sectional analysis. We can estimate the prevalence of disease in cross-sectional studies. Furthermore, we will also be able to estimate the odds ratios to study the association between exposure and the outcomes in this design. PMID:27293245

Racial disparities in African Americans with diabetes: process and outcome mismatch.

PubMed

Bulger, John B; Shubrook, Jay H; Snow, Richard

2012-08-01

Over the past 2 decades, numerous studies have demonstrated the existence of racial disparities in patient care in the United States. Specifically, African Americans with diabetes are less likely to have recommended process of care measures performed and outcome benchmarks for quality of care. To evaluate the delivery of diabetes care (processes and outcomes) associated with racial categories using a national web-based registry-the American Osteopathic Association Clinical Assessment Program (AOA-CAP). A retrospective analysis of data retrieved from the AOA-CAP database on outcomes and process measures for diabetes. A total of 10,699 Caucasian and African American patients who received diabetes care had data entered into the AOA-CAP registry between July 1, 2005, and October 30, 2010. African Americans represented 3123 patients (29%), Caucasians 7576 (71%). Demographic, process of care, and outcomes comparisons between ethnicities were carried out using ?2 and t tests. Composite measures of process and outcomes of diabetes care were created to investigate the effect of race on care. The process of care composite measure was significantly different among African American patients (P = .02) who were more likely to receive all indicated care than Caucasian patients (33.9% vs 31.6%). Evaluation of the composite outcome measure, which quantifies the percentage of patients achieving control of all 3 intermediate outcomes, was (P <.001) lower in African Americans than in Caucasians (8.1% vs 12.3%). African American patients with diabetes were as likely or more likely to have recommended process of care measures performed. In spite of this, intermediate diabetes outcomes were still poorer in the same African American population.

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

PubMed Central

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

2014-01-01

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

Guidelines for competency development and measurement in rehabilitation psychology postdoctoral training.

PubMed

Stiers, William; Barisa, Mark; Stucky, Kirk; Pawlowski, Carey; Van Tubbergen, Marie; Turner, Aaron P; Hibbard, Mary; Caplan, Bruce

2015-05-01

This study describes the results of a multidisciplinary conference (the Baltimore Conference) that met to develop consensus guidelines for competency specification and measurement in postdoctoral training in rehabilitation psychology. Forty-six conference participants were chosen to include representatives of rehabilitation psychology training and practice communities, representatives of psychology accreditation and certification bodies, persons involved in medical education practice and research, and consumers of training programs (students). Consensus education and training guidelines were developed that specify the key competencies in rehabilitation psychology postdoctoral training, and structured observation checklists were developed for their measurement. This study continues the development of more than 50 years of thinking about education and training in rehabilitation psychology and builds on the existing work to further advance the development of guidelines in this area. The conference developed aspirational guidelines for competency specification and measurement in rehabilitation psychology postdoctoral training (i.e., for studying the outcomes of these training programs). Structured observation of trainee competencies allows examination of actual training outcomes in relation to intended outcomes and provides a methodology for studying how program outcomes are related to program structures and processes so that program improvement can occur. Best practices in applying program evaluation research methods to the study of professional training programs are discussed. (c) 2015 APA, all rights reserved).

Frailty and Intellectual and Developmental Disabilities: a Scoping Review

PubMed Central

McKenzie, Katherine; Martin, Lynn; Ouellette-Kuntz, Hélène

2016-01-01

Background Individuals with intellectual and developmental disabilities (IDD) are both living longer than in previous generations and experiencing premature aging. Improved understanding of frailty in this aging population may inform community supports and avoid negative outcomes. Methods The objective of this study was to review the literature on frailty and IDD and determine areas for future research and application. The methodological framework for a scoping review as developed by H. Arksey and L. O’Malley was applied to identify and select original studies published since 2000. Results Seventeen studies were identified; these were based on the work of researchers from four research programs. The studies utilized six measures of frailty, including two frailty indices, the VFQ-ID(-R), the frailty phenotype, and the frailty marker. Frailty was equally studied as an outcome and as predictor for other outcomes (e.g., mobility, falls, care intensity, institutionalization, and survival). Conclusions There is evidence of a growing interest in the measurement of frailty in aging adults with IDD. As in the general population, frailty in this group is associated with many negative outcomes. While a few measures have emerged, more work is required to replicate results, validate tools, and test the feasibility of applying frailty measures in practice and to inform policy. PMID:27729949

Effects of person-centred care on health outcomes-A randomized controlled trial in patients with acute coronary syndrome.

PubMed

Pirhonen, Laura; Olofsson, Elisabeth Hansson; Fors, Andreas; Ekman, Inger; Bolin, Kristian

2017-02-01

To study the effects of person-centred care provided to patients with acute coronary syndrome, using four different health-related outcome measures. Also, to examine the performance of these outcomes when measuring person-centred care. The data used in this study consists of primary data from a multicentre randomized parallel group, controlled intervention study for patients with acute coronary syndrome at Sahlgrenska University Hospital in Gothenburg, Sweden. The intervention and control group consisted of 94 and 105 patients, respectively. The effect of the intervention on health-related outcomes was estimated, controlling for socio-economic and disease-related variables. Patients in the intervention group reported significantly higher general self-efficacy than those in the control group six months after intervention start-up. Moreover, the intervention group returned to work in a greater extent than controls; their physical activity level had increased more and they had a higher EQ-5D score, meaning higher health-related quality of life. These latter effects are not significant but are all pointing towards the beneficial effects of person-centred care. All the effects were estimated while controlling for important socio-economic and disease-related variables. The effectiveness of person-centred care varies between different outcomes considered. A statistically significant beneficial effect was found for one of the four outcome measures (self-efficacy). The other measures all captured beneficial, but not significant, effects. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Relationship between total quality management, critical paths, and outcomes management.

PubMed

Lynn, P A

1996-09-01

Total quality management (TQM), clinical paths, and outcomes management are high-profile strategies in today's health care environment. Each strategy is distinct, yet there are interrelationships among them. TQM supports a customer-focused organizational culture, providing tools and techniques to identify and solve problems. Clinical paths are tools for enhancing patient care coordination and for identifying system-wide and patient population specific issues. Outcomes management is an integrated system for measuring the results in patient populations over time. There is a recent shift in outcomes measurement towards expanding both the nature of the outcomes examined and the timeframes in which they are studied.

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.

Social and health outcomes following upgrades to a national housing standard: a multilevel analysis of a five-wave repeated cross-sectional survey.

PubMed

Poortinga, Wouter; Jones, Nikki; Lannon, Simon; Jenkins, Huw

2017-12-02

While existing research indicates that housing improvements are associated with health improvements, less is known about the wider social and health benefits of meeting national housing standards, as well as those of their specific constituent measures. This study evaluates the impacts of a managed housing upgrade programme through a repeated cross-sectional survey design. A five-wave repeated cross-sectional survey was conducted over a seven-year period from 2009 to 2016 (n = 2075; n = 2219; n = 2015; n = 1991; and n = 1709, respectively). The study followed a managed upgrade programme designed to meet a national social housing standard over an extended period. The data were analysed from a multilevel perspective to take account of the time-dependent nature of the observations and differences in socio-demographic composition. The installation of the majority of individual housing measures (new windows and doors; boilers; kitchens; bathrooms; electrics; loft insulation; and cavity/external wall insulation) were associated with improvements in several social (housing suitability, satisfaction, and quality; thermal comfort and household finances) and health (mental, respiratory and general health) outcomes; and analyses showed relationships between the number of measures installed and the total amount invested on the one hand and the social and health outcomes on the other. There were however a few exceptions. Most notably, the installation of cavity wall insulation was associated with poorer health outcomes, and did not lead to better social outcomes. Also, no association was found between the number of measures installed and respiratory health. The study suggests that substantial housing investments through a managed upgrade programme may result in better social and health outcomes, and that the size of the improvements are proportionate to the number of measures installed and amount invested. However, there may be risks associated with specific measures; and more attention is needed for mechanical ventilation when upgrading energy efficiency of houses through fabric work. In addition to providing new evidence regarding the wider social and health outcomes, the study provides an analytical approach to evaluate upgrade programmes that are delivered over multiple years.

Cardiovascular recovery from psychological and physiological challenge and risk for adverse cardiovascular outcomes and all-cause mortality

PubMed Central

Panaite, Vanessa; Salomon, Kristen; Jin, Alvin; Rottenberg, Jonathan

2015-01-01

Objective Exaggerated cardiovascular (CV) reactivity to laboratory challenge has been shown to predict future CV morbidity and mortality. CV recovery, has been less studied, and has yielded inconsistent findings, possibly due to presence of moderators. Reviews on the relationship between CV recovery and CV outcomes have been limited to cross-sectional studies and have not considered methodological factors. We performed a comprehensive meta-analytic review of the prospective literature investigating CV recovery to physical and psychological challenge and adverse cardiovascular outcomes. Methods We searched PsycINFO and PubMed for prospective studies investigating the relationship between CV recovery and adverse CV outcomes. Studies were coded for variables of interest and for effect sizes (ES). We conducted a random effects weighted meta-analysis. Moderators were examined with ANOVA-analog and meta-regression analyses. Results Thirty seven studies met inclusion criteria (N=125386). Impaired recovery from challenge predicted adverse cardiovascular outcomes (summary effect, r = .17, p < .001). Physical challenge was associated with larger predictive effects than psychological challenge. Moderator analyses revealed that recovery measured at 1 minute post-exercise, passive recovery, use of mortality as an outcome measure, and older sample age were associated with larger effects. Conclusions Poor recovery from laboratory challenges predicts adverse CV outcomes, with recovery from exercise serving as a particularly strong predictor of CV outcomes. The overall ES for recovery and CV outcomes is similar to that observed for CV reactivity and suggests that the study of recovery may have incremental value for understanding adverse CV outcomes. PMID:25829236

The Effect of Childbirth Self-Efficacy on Perinatal Outcomes.

PubMed

Tilden, Ellen L; Caughey, Aaron B; Lee, Christopher S; Emeis, Cathy

2016-01-01

To synthesize and critique the quantitative literature on measuring childbirth self-efficacy and the effect of childbirth self-efficacy on perinatal outcomes. Eligible studies were identified through searches of MEDLINE, CINAHL, Scopus, and Google Scholar databases. Published research articles that used a tool explicitly intended to measure childbirth self-efficacy and that examined outcomes within the perinatal period were included. All articles were in English and were published in peer-reviewed journals. First author, country, year of publication, reference and definition of childbirth self-efficacy, measurement of childbirth self-efficacy, sample recruitment and retention, sample characteristics, study design, interventions (with experimental and quasiexperimental studies), and perinatal outcomes were extracted and summarized. Of 619 publications, 23 studies published between 1983 and 2015 met inclusion criteria and were critiqued and synthesized in this review. There is overall consistency in how childbirth self-efficacy is defined and measured among studies, which facilitates comparison and synthesis. Our findings suggest that increased childbirth self-efficacy is associated with a wide variety of improved perinatal outcomes. Moreover, there is evidence that childbirth self-efficacy is a psychosocial factor that can be modified through various efficacy-enhancing interventions. Future researchers will be able to build knowledge in this area through (a) use of experimental and quasiexperimental design, (b) recruitment and retention of more diverse samples, (c) explicit reporting of definitions of terms (e.g., high risk), (d) investigation of interventions that increase childbirth self-efficacy during pregnancy, and (e) investigation about how childbirth self-efficacy-enhancing interventions might lead to decreased active labor pain and suffering. Exploratory research should continue to examine the potential association between higher prenatal childbirth self-efficacy and improved early parenting outcomes. Copyright © 2016 AWHONN, the Association of Women's Health, Obstetric and Neonatal Nurses. Published by Elsevier Inc. All rights reserved.

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

PubMed Central

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

2015-01-01

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

Appraising the uptake and use of recommendations for a common outcome data set for clinical trials: a case study in fall injury prevention.

PubMed

Copsey, Bethan; Hopewell, Sally; Becker, Clemens; Cameron, Ian D; Lamb, Sarah E

2016-03-10

Many researchers and professional bodies are seeking consensus for core outcomes for clinical trials. The Prevention of Falls Network Europe (ProFaNE) developed a common outcome data set for fall injury prevention trials 10 years ago. This study assesses the impact of these recommendations. A systematic search (up to 16 January 2015) was performed using Web of Science, Scopus and PubMed for articles citing the ProFaNE recommendations. Randomised trials on fall prevention in older people were selected for further analysis. Data were extracted on study characteristics and adherence to the key domains recommended by the ProFaNE consensus: falls, fall injury, physical activity, psychological consequences and health-related quality of life. Details of non-recommended outcome measures used were also recorded. The ProFaNE recommendations were cited in a total of 464 published articles, of which 34 were randomised trials on fall prevention in older people. Only one study (3 %) reported on all core domains. Most of the trials reported on falls (n = 32/34, 94 %) as a core outcome measure. Most of the recommendations within the falls domain were well-followed. Around half of the trials reported on fall-related injury (n = 16/34, 47 %). However, none reported the number of radiologically confirmed peripheral fracture events, which is the recommended outcome measure for injury. The other key domains (quality of life, physical activity and psychological consequences) were less frequently reported on, with a lack of consistency in the outcome measures used. The ProFaNE recommendations had a limited effect on standardising the reporting of outcomes in randomised trials on fall injury prevention in older people during the search period. Authors of consensus guidelines should consider maximising buy-in by including a diversity of geographic areas and academic disciplines at the development stage and using a solid dissemination strategy.

Outcome measures for oral health based on clinical assessments and claims data: feasibility evaluation in practice.

PubMed

Hummel, Riët; Bruers, Josef; van der Galiën, Onno; van der Sanden, Wil; van der Heijden, Geert

2017-10-05

It is well known that treatment variation exists in oral healthcare, but the consequences for oral health are unknown as the development of outcome measures is still in its infancy. The aim of this study was to identify and develop outcome measures for oral health and explore their performance using health insurance claims records and clinical data from general dental practices. The Dutch healthcare insurance company Achmea collaborated with researchers, oral health experts, and general dental practitioners (GDPs) in a proof of practice study to test the feasibility of measures in general dental practices. A literature search identified previously described outcome measures for oral healthcare. Using a structured approach, identified measures were (i) prioritized, adjusted and added to after discussion and then (ii) tested for feasibility of data collection, their face validity and discriminative validity. Data sources were claims records from Achmea, clinical records from dental practices, and prospective, pre-determined clinical assessment data obtained during routine consultations. In total eight measures (four on dental caries, one on tooth wear, two on periodontal health, one on retreatment) were identified, prioritized and tested. The retreatment measure and three measures for dental caries were found promising as data collection was feasible, they had face validity and discriminative validity. Deployment of these measures demonstrated variation in clinical practices of GDPs. Feedback of this data to GDPs led to vivid discussions on best practices and quality of care. The measure 'tooth wear' was not considered sufficiently responsive; 'changes in periodontal health score' was considered a controversial measure. The available data for the measures 'percentage of 18-year-olds with no tooth decay' and 'improvement in gingival bleeding index at reassessment' was too limited to provide accurate estimates per dental practice. The evaluated measures 'time to first restoration', 'distribution of risk categories for dental caries', 'filled-and-missing score' and 'retreatment after restoration', were considered valid and relevant measures and a proxy for oral health status. As such, they improve the transparency of oral health services delivery that can be related to oral health outcomes, and with time may serve to improve these oral health outcomes.

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

PubMed

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

2014-07-21

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

The development of Music in Dementia Assessment Scales (MiDAS)

PubMed Central

McDermott, Orii; Orrell, Martin; Ridder, Hanne Mette

2015-01-01

There is a need to develop an outcome measure specific to music therapy in dementia that reflects a holistic picture of the therapy process and outcome. This study aimed to develop a clinically relevant and scientifically robust music therapy outcome measure incorporating the values and views of people with dementia. Focus groups and interviews were conducted to obtain qualitative data on what music meant to people with dementia and the observed effects of music. Expert and peer consultations were conducted at each stage of the measure development to maximise its content validity. The new measure was field-tested by clinicians in a care home. Feedback from the clinicians and music therapy experts were incorporated during the review and refinement process of the measure. A review of the existing literature, the experiential results and the consensus process enabled the development of the new outcome measure “Music in Dementia Assessment Scales (MiDAS)”. Analysis of the qualitative data identified five key areas of the impact of music on people with dementia and they were transformed as the five Visual Analogue Scale (VAS) items: levels of Interest, Response, Initiation, Involvement and Enjoyment. MiDAS comprises the five VAS items and a supplementary checklist of notable positive and negative reactions from the individual. This study demonstrates that it is possible to design and develop an easy to apply and rigorous quantitative outcome measure which has a high level of clinical relevance for people with dementia, care home staff and music therapists. PMID:26246670

Measuring motivation in schizophrenia: Is a general state of motivation necessary for task-specific motivation?

PubMed Central

Choi, Jimmy; Choi, Kee-Hong; Reddy, Felice; Fiszdon, Joanna M.

2014-01-01

Despite the important role of motivation in rehabilitation and functional outcomes in schizophrenia, to date, there has been little emphasis on how motivation is assessed. This is important, since different measures may tap potentially discrete motivational constructs, which in turn may have very different associations to important outcomes. In the current study, we used baseline data from 71 schizophrenia spectrum outpatients enrolled in a rehabilitation program to examine the relationship between task-specific motivation, as measured by the Intrinsic Motivation Inventory (IMI), and a more general state of volition/initiation, as measured by the three item Quality of Life (QLS) motivation index. We also examined the relationship of these motivation measures to demographic, clinical and functional variables relevant to rehabilitation outcomes. The two motivation measures were not correlated, and participants with low general state motivation exhibited a full range of task-specific motivation. Only the QLS motivation index correlated with variables relevant to rehabilitation outcomes. The lack of associations between QLS motivation index and IMI subscales suggests that constructs tapped by these measures may be divergent in schizophrenia, and specifically that task-specific intrinsic motivation is not contingent on a general state of motivation. That is, even in individuals with a general low motivational state (i.e. amotivation), interventions aimed at increasing task-specific motivation may still be effective. Moreover, the pattern of interrelationships between the QLS motivation index and variables relevant to psychosocial rehabilitation supports its use in treatment outcome studies. PMID:24529609

The development of Music in Dementia Assessment Scales (MiDAS).

PubMed

McDermott, Orii; Orrell, Martin; Ridder, Hanne Mette

2015-07-03

There is a need to develop an outcome measure specific to music therapy in dementia that reflects a holistic picture of the therapy process and outcome. This study aimed to develop a clinically relevant and scientifically robust music therapy outcome measure incorporating the values and views of people with dementia. Focus groups and interviews were conducted to obtain qualitative data on what music meant to people with dementia and the observed effects of music. Expert and peer consultations were conducted at each stage of the measure development to maximise its content validity. The new measure was field-tested by clinicians in a care home. Feedback from the clinicians and music therapy experts were incorporated during the review and refinement process of the measure. A review of the existing literature, the experiential results and the consensus process enabled the development of the new outcome measure "Music in Dementia Assessment Scales (MiDAS)". Analysis of the qualitative data identified five key areas of the impact of music on people with dementia and they were transformed as the five Visual Analogue Scale (VAS) items: levels of Interest, Response, Initiation, Involvement and Enjoyment. MiDAS comprises the five VAS items and a supplementary checklist of notable positive and negative reactions from the individual. This study demonstrates that it is possible to design and develop an easy to apply and rigorous quantitative outcome measure which has a high level of clinical relevance for people with dementia, care home staff and music therapists.

Surrogate endpoints and competing risk of death in cardiac arrest research.

PubMed

McCredie, Victoria A; Scales, Damon C

2016-06-29

We urgently need new therapies to improve outcomes after cardiac arrest. Initial studies typically target surrogate endpoints, and these studies help to inform subsequent larger trials that are powered to measure more patient-orientated clinical outcomes such as survival. The competing risk of death and premature assessment of neurological prognosis pose significant challenges to measuring these surrogate endpoints after cardiac arrest.

Systematic review of the quality of prognosis studies in systemic lupus erythematosus.

PubMed

Lim, Lily S H; Lee, Senq J; Feldman, Brian M; Gladman, Dafna D; Pullenayegum, Eleanor; Uleryk, Elizabeth; Silverman, Earl D

2014-10-01

Prognosis studies examine outcomes and/or seek to identify predictors or factors associated with outcomes. Many prognostic factors have been identified in systemic lupus erythematosus (SLE), but few have been consistently found across studies. We hypothesized that this is due to a lack of rigor of study designs. This study aimed to systematically assess the methodologic quality of prognosis studies in SLE. A search of prognosis studies in SLE was performed using MEDLINE and Embase, from January 1990 to June 2011. A representative sample of 150 articles was selected using a random number generator and assessed by 2 reviewers. Each study was assessed by a risk of bias tool according to 6 domains: study participation, study attrition, measurement of prognostic factors, measurement of outcomes, measurement/adjustment for confounders, and appropriateness of statistical analysis. Information about missing data was also collected. A cohort design was used in 71% of studies. High risk of bias was found in 65% of studies for confounders, 57% for study participation, 56% for attrition, 36% for statistical analyses, 20% for prognostic factors, and 18% for outcome. Missing covariate or outcome information was present in half of the studies. Only 6 studies discussed reasons for missing data and 2 imputed missing data. Lack of rigorous study design, especially in addressing confounding, study participation and attrition, and inadequately handled missing data, has limited the quality of prognosis studies in SLE. Future prognosis studies should be designed with consideration of these factors to improve methodologic rigor. Copyright © 2014 by the American College of Rheumatology.

Worse self-reported outcomes but no limitations in performance-based measures in patients with long-standing hip and groin pain compared with healthy controls.

PubMed

Wörner, Tobias; Sigurðsson, Haraldur B; Pålsson, Anders; Kostogiannis, Ioannis; Ageberg, Eva

2017-01-01

This study aimed to evaluate patient-reported outcomes as well as lower extremity and trunk muscle function in patients with long-standing hip and groin pain, in comparison with matched, healthy controls. It was hypothesized that patients with long-standing hip and groin pain would report more deficiency on the Copenhagen Hip and Groin Outcome Score (HAGOS) and have worse outcomes on performance-based measures than healthy controls. Nineteen patients with long-standing hip and groin pain and 19 healthy, activity level-, age-, gender-, and weight-matched controls were assessed with the HAGOS for self-reported outcomes, and a parallel squat (w/kg), single-leg triple jump (cm), single-leg rise (n), barbell roll-out (% of height), and plank test (s) for performance-based measures. Independent sample t test was performed to assess between-group differences. The paired t test was used to analyse between-limb differences in unilateral performance tasks. The patients had worse scores than the controls in all HAGOS subscales (p ≤ 0.001), while no statistically significant differences were observed for any performance measure between groups or between symptomatic and non-symptomatic limbs. Despite significant self-reported functional limitations on the HAGOS, there were no significant differences between groups in performance-based strength or power measures. The results of this study highlight the need to identify performance-based measures, sensitive to functional deficiencies in patients with long-standing hip and groin pain in order to complement the clinical picture obtained by patient-reported outcomes such as the HAGOS. III.

Nursing Outcomes for Patients with Risk of Perioperative Positioning Injury.

PubMed

de Lima, Luciana Bjorklund; E Cardozo, Michelle Cardoso; Bernardes, Daniela de Souza; Rabelo-Silva, Eneida Rejane

2018-04-16

To select and refine the outcomes and indicators of Nursing Outcomes Classification for the diagnosis of risk for perioperative positioning injury. Validation study on expert consensus and refinement through pilot study. Eight outcomes and 35 indicators were selected in consensus. After clinical testing was performed, in which 10 patients were assessed at five different times. Eight outcomes and 33 indicators remained in the protocol. This study made it possible to select the most relevant outcomes and indicators to be measured for this diagnosis in clinical practice. Validation studies by consensus and clinical testing are important to promote the accuracy, creating opportunities to legitimize, and improve the concepts of taxonomies. © 2018 NANDA International, Inc.

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

PubMed

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

2016-06-01

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

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

PubMed

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

2010-12-01

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

Pretest Measures of the Study Outcome and the Elimination of Selection Bias: Evidence from Three Within Study Comparisons.

PubMed

Hallberg, Kelly; Cook, Thomas D; Steiner, Peter M; Clark, M H

2018-04-01

This paper examines how pretest measures of a study outcome reduce selection bias in observational studies in education. The theoretical rationale for privileging pretests in bias control is that they are often highly correlated with the outcome, and in many contexts, they are also highly correlated with the selection process. To examine the pretest's role in bias reduction, we use the data from two within study comparisons and an especially strong quasi-experiment, each with an educational intervention that seeks to improve achievement. In each study, the pretest measures are consistently highly correlated with post-intervention measures of themselves, but the studies vary the correlation between the pretest and the process of selection into treatment. Across the three datasets with two outcomes each, there are three cases where this correlation is low and three where it is high. A single wave of pretest always reduces bias across the six instances examined, and it eliminates bias in three of them. Adding a second pretest wave eliminates bias in two more instances. However, the pattern of bias elimination does not follow the predicted pattern-that more bias reduction ensues as a function of how highly the pretest is correlated with selection. The findings show that bias is more complexly related to the pretest's correlation with selection than we hypothesized, and we seek to explain why.

Implementation outcome assessment instruments used in physical healthcare settings and their measurement properties: a systematic review protocol

PubMed Central

Vitoratou, Silia; Sevdalis, Nick; Hull, Louise

2017-01-01

Introduction Over the past 10 years, research into methods that promote the uptake, implementation and sustainability of evidence-based interventions has gathered pace. However, implementation outcomes are defined in different ways and assessed by different measures; the extent to which these measures are valid and reliable is unknown. The aim of this systematic review is to identify and appraise studies that assess the measurement properties of quantitative implementation outcome instruments used in physical healthcare settings, to advance the use of precise and accurate measures. Methods and analysis The following databases will be searched from inception to March 2017: MEDLINE, EMBASE, PsycINFO, CINAHL and the Cochrane Library. Grey literature will be sought via HMIC, OpenGrey, ProQuest for theses and Web of Science Conference Proceedings Citation Index-Science. Reference lists of included studies and relevant reviews will be hand searched. Three search strings will be combined to identify eligible studies: (1) implementation literature, (2) implementation outcomes and (3) measurement properties. Screening of titles, abstracts and full papers will be assessed for eligibility by two reviewers independently and any discrepancies resolved via consensus with the wider team. The methodological quality of the studies will be assessed using the COnsensus-based Standards for the selection of health Measurement INstruments checklist. A set of bespoke criteria to determine the quality of the instruments will be used, and the relationship between instrument usability and quality will be explored. Ethics and dissemination Ethical approval is not necessary for systematic review protocols. Researchers and healthcare professionals can use the findings of this systematic review to guide the selection of implementation outcomes instruments, based on their psychometric quality, to assess the impact of their implementation efforts. The findings will also provide a useful guide for reviewers of papers and grants to determine the psychometric quality of the measures used in implementation research. Trial registration number International Prospective Register of Systematic Reviews (PROSPERO): CRD42017065348. PMID:28993392

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…

Consequential Validity of an Assistive Technology Supplement for the School Function Assessment

ERIC Educational Resources Information Center

Silverman, Michelle Kaye; Smith, Roger O.

2006-01-01

Educators and therapists implement assistive technology to maximize educational outcomes of students with disabilities. However, few measure the outcomes of interventions because of a lack of valid measurement tools. This study investigated whether an assistive technology supplement for the School Function Assessment demonstrates an important…

Sample Size Limits for Estimating Upper Level Mediation Models Using Multilevel SEM

ERIC Educational Resources Information Center

Li, Xin; Beretvas, S. Natasha

2013-01-01

This simulation study investigated use of the multilevel structural equation model (MLSEM) for handling measurement error in both mediator and outcome variables ("M" and "Y") in an upper level multilevel mediation model. Mediation and outcome variable indicators were generated with measurement error. Parameter and standard…

Measuring Economic Attitudes in High School.

ERIC Educational Resources Information Center

Walstad, William B.; Soper, John C.

This paper discusses a survey undertaken to assess the attitudes of over 2,000 high school students towards economic issues and economics courses. The premise of the survey was that more studies evaluating economics instruction at the high school level overemphasize achievement and knowledge outcomes and fail to measure attitude outcomes. The…

Disappearance of enlarged nuchal translucency before 14 weeks' gestation: relationship with chromosomal abnormalities and pregnancy outcome.

PubMed

Müller, M A; Pajkrt, E; Bleker, O P; Bonsel, G J; Bilardo, C M

2004-08-01

The aim of this study was to investigate the natural course of enlarged nuchal translucency (NT) and to determine if its disappearance before 14 weeks' gestation is a favorable prognostic sign in relation to fetal karyotype and pregnancy outcome. A total of 147 women with increased NT (> 95th centile) at first measurement were included in this study. A second measurement was performed in all cases, at an interval of at least 2 days. Both measurements were taken between 10 + 3 and 14 + 0 weeks. All women underwent chorionic villus sampling or amniocentesis for subsequent karyotyping. In those women with a normal karyotype, a fetal anomaly scan was performed at 20 weeks' gestation. Pregnancy outcome was recorded in all cases. The finding of persistent or disappearing NT enlargement was analyzed in relation to fetal karyotype and pregnancy outcome. Of the 147 paired measurements, NT remained enlarged at the second measurement in 121 (82%) cases. An abnormal karyotype was found in 35% of these cases. In 26 (18%) fetuses the NT measurement was found to be below the 95th percentile at the second measurement and in only two of them an abnormal karyotype was found (8%). In the 103 chromosomally normal fetuses an adverse outcome (i.e. fetal loss or structural defects) was recorded in 22 fetuses with persistent enlargement (28%) and in four fetuses with disappearing enlargement (17%). Disappearance of an enlarged NT before 14 weeks' gestation is not a rare phenomenon and seems to be a favorable prognostic sign with respect to fetal karyotype. Overall, no significant difference in pregnancy outcome was found between chromosomally normal fetuses with persisting or disappearing NT enlargement. Copyright 2004 ISUOG

Outcomes of total knee arthroplasty in relation to preoperative patient-reported and radiographic measures: data from the osteoarthritis initiative.

PubMed

Kahn, Timothy L; Soheili, Aydin; Schwarzkopf, Ran

2013-12-01

Total knee arthroplasty (TKA) is the preferred surgical treatment for end-stage osteoarthritis. However, substantial numbers of patients still experience poor outcomes. Consequently, it is important to identify which patient characteristics are predictive of outcomes in order to guide clinical decisions. Our hypothesis is that preoperative patient-reported outcome measures and radiographic measures may help to predict TKA outcomes. Using cohort data from the Osteoarthritis Initiative, we studied 172 patients who underwent TKA. For each patient, we compiled pre- and postoperative Western Ontario and McMaster University Arthritis Index (WOMAC) scores. Radiographs were measured for knee joint angles, femorotibial angles, anatomical lateral distal femoral angles, and anatomical medial proximal tibial angles; Kellgren and Lawrence (KL) grades were assigned to each compartment of the knee. All studied measurements were compared to WOMAC outcomes. Preoperative WOMAC disability, pain, and total scores were positively associated with postoperative WOMAC total scores (P = .010, P = .010, and P = .009, respectively) and were associated with improvement in WOMAC total scores (P < .001, P < .001, and P < .001, respectively). For radiographic measurements, preoperative joint angles were positively associated with improvements in postoperative WOMAC total scores (P = .044). Combined KL grades (medial and lateral compartments) were negatively correlated with postoperative WOMAC disability and pain scores (P = .045 and P = .044) and were positively correlated with improvements in WOMAC total scores (P = .001). All preoperative WOMAC scores demonstrated positive associations with postoperative WOMAC scores, while among the preoperative radiographic measurements only combined KL grades and joint angles showed any correlation with postoperative WOMAC scores. Higher preoperative KL grades and joint angles were associated with better (lower) postoperative WOMAC scores, demonstrating an inverse correlation.

Computer-assisted cognitive remediation therapy: cognition, self-esteem and quality of life in schizophrenia.

PubMed

Garrido, Gemma; Barrios, Maite; Penadés, Rafael; Enríquez, Maria; Garolera, Maite; Aragay, Núria; Pajares, Marta; Vallès, Vicenç; Delgado, Luis; Alberni, Joan; Faixa, Carlota; Vendrell, Josep M

2013-11-01

Quality of life (QoL) is an important outcome in the treatment of schizophrenia. Cognitive deficits have an impact on functional outcomes. Cognitive remediation therapy is emerging as a psychological intervention that targets cognitive impairment, but the effect of computer-assisted cognitive remediation on neuropsychology and social functioning and wellbeing remains unclear. The aim of the current study is to investigate the neurocognitive outcomes of computer-assisted cognitive remediation (CACR) therapy in a sample of schizophrenia patients, and to measure the quality of life and self-esteem as secondary outcomes. Sixty-seven people with schizophrenia were randomly assigned to computer-assisted cognitive remediation or an active control condition. The main outcomes were neuropsychological measures and secondary outcomes (self-esteem and quality of life). Measurements were recorded at baseline and post-treatment. The CACR therapy group improved in speed of processing, working memory and reasoning and problem-solving cognitive domains. QoL and self-esteem measures also showed significant improvements over time in this group. Computer-assisted cognitive remediation therapy for people with schizophrenia achieved improvements in neuropsychological performance and in QoL and self-esteem measurements. © 2013 Elsevier B.V. All rights reserved.

Rewarding healthy behaviors--pay patients for performance.

PubMed

Wu, Joanne

2012-01-01

Despite a considerable investment of resources into pay for performance, preliminary studies have found that it may not be significantly more effective in improving health outcome measures when compared with voluntary quality improvement programs. Because patient behaviors ultimately affect health outcomes, I would propose a novel pay-for-performance program that rewards patients directly for achieving evidence-based health goals. These rewards would be in the form of discounts towards co-payments for doctor's visits, procedures, and medications, thereby potentially reducing cost and compliance issues. A pilot study recruiting patients with diabetes or hypertension, diseases with clear and objective outcome measures, would be useful to examine true costs, savings, and health outcomes of such a reward program. Offering incentives to patients for reaching health goals has the potential to foster a stronger partnership between doctors and patients and improve health outcomes.

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

PubMed

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

2017-11-12

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

Characterizing smoking topography of cannabis in heavy users

PubMed Central

Stitzer, Maxine L.; Vandrey, Ryan

2013-01-01

Rationale Little is known about the smoking topography characteristics of heavy cannabis users. Such measures may be able to predict cannabis use-related outcomes and could be used to validate self-reported measures of cannabis use. Objectives The current study was conducted to measure cannabis smoking topography characteristics during periods of ad libitum use and to correlate topography assessments with measures of self-reported cannabis use, withdrawal and craving during abstinence, and cognitive task performance. Methods Participants (N=20) completed an inpatient study in which they alternated between periods of ad libitum cannabis use and abstinence. Measures of self-reported cannabis use, smoking topography, craving, withdrawal, and sleep measures were collected. Results Participants smoked with greater intensity (e.g., greater volume, longer duration) on initial cigarette puffs with a steady decline on subsequent puffs. Smoking characteristics were significantly correlated with severity of withdrawal, notably sleep quality and architecture, and craving during abstinence, suggesting dose-related effects of cannabis use on these outcomes. Smoking characteristics generally were not significantly associated with cognitive performance. Smoking topography measures were significantly correlated with self-reported measures of cannabis use, indicating validity of these assessments, but topography measures were more sensitive than self-report in predicting cannabis-related outcomes. Conclusions A dose–effect relationship between cannabis consumption and outcomes believed to be clinically important was observed. With additional research, smoking topography assessments may become a useful clinical tool. PMID:21922170

Validation of Patient-Reported Outcomes Measurement Information System Computerized Adaptive Tests Against the Foot and Ankle Outcome Score for 6 Common Foot and Ankle Pathologies.

PubMed

Koltsov, Jayme C B; Greenfield, Stephen T; Soukup, Dylan; Do, Huong T; Ellis, Scott J

2017-08-01

The field of foot and ankle surgery lacks a widely accepted gold-standard patient-reported outcome instrument. With the changing infrastructure of the medical profession, more efficient patient-reported outcome tools are needed to reduce respondent burden and increase participation while providing consistent and reliable measurement across multiple pathologies and disciplines. The primary purpose of the present study was to validate 3 Patient-Reported Outcomes Measurement Information System computer adaptive tests (CATs) most relevant to the foot and ankle discipline against the Foot and Ankle Outcome Score (FAOS) and the Short Form 12 general health status survey in patients with 6 common foot and ankle pathologies. Patients (n = 240) indicated for operative treatment for 1 of 6 common foot and ankle pathologies completed the CATs, FAOS, and Short Form 12 at their preoperative surgical visits, 1 week subsequently (before surgery), and at 6 months postoperatively. The psychometric properties of the instruments were assessed and compared. The Patient-Reported Outcomes Measurement Information System CATs each took less than 1 minute to complete, whereas the FAOS took 6.5 minutes, and the Short Form 12 took 3 minutes. CAT scores were more normally distributed and had fewer floor and ceiling effects than those on the FAOS, which reached as high as 24%. The CATs were more precise than the FAOS and had similar responsiveness and test-retest reliability. The physical function and mobility CATs correlated strongly with the activities subscale of the FAOS, and the pain interference CAT correlated strongly with the pain subscale of the FAOS. The CATs and FAOS were responsive to changes with operative treatment for 6 common foot and ankle pathologies. The CATs performed as well as or better than the FAOS in all aspects of psychometric validity. The Patient-Reported Outcomes Measurement Information System CATs show tremendous potential for improving the study of patient outcomes in foot and ankle research through improved precision and reduced respondent burden. Level II, prospective comparative study.

Examining the Error of Mis-Specifying Nonlinear Confounding Effect With Application on Accelerometer-Measured Physical Activity.

PubMed

Lee, Paul H

2017-06-01

Some confounders are nonlinearly associated with dependent variables, but they are often adjusted using a linear term. The purpose of this study was to examine the error of mis-specifying the nonlinear confounding effect. We carried out a simulation study to investigate the effect of adjusting for a nonlinear confounder in the estimation of a causal relationship between the exposure and outcome in 3 ways: using a linear term, binning into 5 equal-size categories, or using a restricted cubic spline of the confounder. Continuous, binary, and survival outcomes were simulated. We examined the confounder across varying measurement error. In addition, we performed a real data analysis examining the 3 strategies to handle the nonlinear effects of accelerometer-measured physical activity in the National Health and Nutrition Examination Survey 2003-2006 data. The mis-specification of a nonlinear confounder had little impact on causal effect estimation for continuous outcomes. For binary and survival outcomes, this mis-specification introduced bias, which could be eliminated using spline adjustment only when there is small measurement error of the confounder. Real data analysis showed that the associations between high blood pressure, high cholesterol, and diabetes and mortality adjusted for physical activity with restricted cubic spline were about 3% to 11% larger than their counterparts adjusted with a linear term. For continuous outcomes, confounders with nonlinear effects can be adjusting with a linear term. Spline adjustment should be used for binary and survival outcomes on confounders with small measurement error.

Bimodal benefits on objective and subjective outcomes for adult cochlear implant users.

PubMed

Heo, Ji-Hye; Lee, Jae-Hee; Lee, Won-Sang

2013-09-01

Given that only a few studies have focused on the bimodal benefits on objective and subjective outcomes and emphasized the importance of individual data, the present study aimed to measure the bimodal benefits on the objective and subjective outcomes for adults with cochlear implant. Fourteen listeners with bimodal devices were tested on the localization and recognition abilities using environmental sounds, 1-talker, and 2-talker speech materials. The localization ability was measured through an 8-loudspeaker array. For the recognition measures, listeners were asked to repeat the sentences or say the environmental sounds the listeners heard. As a subjective questionnaire, three domains of Korean-version of Speech, Spatial, Qualities of Hearing scale (K-SSQ) were used to explore any relationships between objective and subjective outcomes. Based on the group-mean data, the bimodal hearing enhanced both localization and recognition regardless of test material. However, the inter- and intra-subject variability appeared to be large across test materials for both localization and recognition abilities. Correlation analyses revealed that the relationships were not always consistent between the objective outcomes and the subjective self-reports with bimodal devices. Overall, this study supports significant bimodal advantages on localization and recognition measures, yet the large individual variability in bimodal benefits should be considered carefully for the clinical assessment as well as counseling. The discrepant relations between objective and subjective results suggest that the bimodal benefits in traditional localization or recognition measures might not necessarily correspond to the self-reported subjective advantages in everyday listening environments.

Interprofessional education: effects on professional practice and healthcare outcomes (update).

PubMed

Reeves, Scott; Perrier, Laure; Goldman, Joanne; Freeth, Della; Zwarenstein, Merrick

2013-03-28

The delivery of effective, high-quality patient care is a complex activity. It demands health and social care professionals collaborate in an effective manner. Research continues to suggest that collaboration between these professionals can be problematic. Interprofessional education (IPE) offers a possible way to improve interprofessional collaboration and patient care. To assess the effectiveness of IPE interventions compared to separate, profession-specific education interventions; and to assess the effectiveness of IPE interventions compared to no education intervention. For this update we searched the Cochrane Effective Practice and Organisation of Care Group specialised register, MEDLINE and CINAHL, for the years 2006 to 2011. We also handsearched the Journal of Interprofessional Care (2006 to 2011), reference lists of all included studies, the proceedings of leading IPE conferences, and websites of IPE organisations. Randomised controlled trials (RCTs), controlled before and after (CBA) studies and interrupted time series (ITS) studies of IPE interventions that reported objectively measured or self reported (validated instrument) patient/client or healthcare process outcomes. At least two review authors independently assessed the eligibility of potentially relevant studies. For included studies, at least two review authors extracted data and assessed study quality. A meta-analysis of study outcomes was not possible due to heterogeneity in study designs and outcome measures. Consequently, the results are presented in a narrative format. This update located nine new studies, which were added to the six studies from our last update in 2008. This review now includes 15 studies (eight RCTs, five CBA and two ITS studies). All of these studies measured the effectiveness of IPE interventions compared to no educational intervention. Seven studies indicated that IPE produced positive outcomes in the following areas: diabetes care, emergency department culture and patient satisfaction; collaborative team behaviour and reduction of clinical error rates for emergency department teams; collaborative team behaviour in operating rooms; management of care delivered in cases of domestic violence; and mental health practitioner competencies related to the delivery of patient care. In addition, four of the studies reported mixed outcomes (positive and neutral) and four studies reported that the IPE interventions had no impact on either professional practice or patient care. This updated review reports on 15 studies that met the inclusion criteria (nine studies from this update and six studies from the 2008 update). Although these studies reported some positive outcomes, due to the small number of studies and the heterogeneity of interventions and outcome measures, it is not possible to draw generalisable inferences about the key elements of IPE and its effectiveness. To improve the quality of evidence relating to IPE and patient outcomes or healthcare process outcomes, the following three gaps will need to be filled: first, studies that assess the effectiveness of IPE interventions compared to separate, profession-specific interventions; second, RCT, CBA or ITS studies with qualitative strands examining processes relating to the IPE and practice changes; third, cost-benefit analyses.

Identification of key outcome measures when using the instrumented timed up and go and/or posturography for fall screening.

PubMed

Sample, Renee Beach; Kinney, Allison L; Jackson, Kurt; Diestelkamp, Wiebke; Bigelow, Kimberly Edginton

2017-09-01

The Timed Up and Go (TUG) has been commonly used for fall risk assessment. The instrumented Timed Up and Go (iTUG) adds wearable sensors to capture sub-movements and may be more sensitive. Posturography assessments have also been used for determining fall risk. This study used stepwise logistic regression models to identify key outcome measures for the iTUG and posturography protocols. The effectiveness of the models containing these measures in differentiating fallers from non-fallers were then compared for each: iTUG total time duration only, iTUG, posturography, and combined iTUG and posturography assessments. One hundred and fifty older adults participated in this study. The iTUG measures were calculated utilizing APDM Inc.'s Mobility Lab software. Traditional and non-linear posturography measures were calculated from center of pressure during quiet-standing. The key outcome measures incorporated in the iTUG assessment model (sit-to-stand lean angle and height) resulted in a model sensitivity of 48.1% and max re-scaled R 2 value of 0.19. This was a higher sensitivity, indicating better differentiation, compared to the model only including total time duration (outcome of the traditional TUG), which had a sensitivity of 18.2%. When the key outcome measures of the iTUG and the posturography assessments were combined into a single model, the sensitivity was approximately the same as the iTUG model alone. Overall the findings of this study support that the iTUG demonstrates greater sensitivity than the total time duration, but that carrying out both iTUG and posturography does not greatly improve sensitivity when used as a fall risk screening tool. Copyright © 2017 Elsevier B.V. All rights reserved.

Childhood self-control and adult outcomes: results from a 30-year longitudinal study.

PubMed

Fergusson, David M; Boden, Joseph M; Horwood, L John

2013-07-01

A study by Moffitt et al. reported pervasive associations between childhood self-control and adult outcomes. The current study attempts to replicate the findings reported by Moffitt et al., adjusting these results for the confounding influence of childhood conduct problems. Data were gathered from the Christchurch Health and Development Study, a longitudinal birth cohort studied to age 30 years. Self-control during ages 6 to 12 years was measured analogously to that in Moffitt et al., using parent-, teacher-, and self-report methods. Outcome measures to age 30 included criminal offending, substance use, education/employment, sexual behavior, and mental health. Associations between self-control and outcomes were adjusted for possible confounding by gender, socioeconomic status (SES), IQ, and childhood conduct problems (ages 6-10). In confirmation of the findings of Moffitt et al., all outcomes except major depression were significantly (p < .05) associated with childhood self-control. Adjustment for gender, SES, and IQ reduced to some extent the magnitude of the associations. However, adjustment for childhood conduct disorder further reduced the magnitude of many of these associations, with only 4 of the 14 outcomes remaining statistically significantly (p < .05) associated with self-control. After adjustment for gender, SES, IQ, and conduct problems, those individuals who scored higher in self-control had lower odds of violent offending and welfare dependence, were more likely to have obtained a university degree, and had higher income levels. The findings from this study suggest that observed linkages between a measure of childhood self-control and outcomes in adulthood were largely explained by the correlated effects of childhood conduct problems, SES, IQ, and gender. Copyright © 2013 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.

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 disseminated to stakeholders via reports, journal articles and presentations at meetings and conferences. CRD42017057871. © 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.

Measuring Family Outcomes Early Intervention: Findings from a Large-Scale Assessment

ERIC Educational Resources Information Center

Raspa, Melissa; Bailey, Donald B., Jr.; Olmsted, Murrey G.; Nelson, Robin; Robinson, Nyle; Simpson, Mary Ellen; Guillen, Chelsea; Houts, Renate

2010-01-01

This article reports data from a large-scale assessment using the Family Outcomes Survey with families participating in early intervention. The study was designed to determine how families describe themselves with regard to outcomes achieved, the extent to which outcomes are interrelated, and the extent to which child, family, and program factors…

Modern psychometrics applied in rheumatology--a systematic review.

PubMed

Siemons, Liseth; Ten Klooster, Peter M; Taal, Erik; Glas, Cees Aw; Van de Laar, Mart Afj

2012-10-31

Although item response theory (IRT) appears to be increasingly used within health care research in general, a comprehensive overview of the frequency and characteristics of IRT analyses within the rheumatic field is lacking. An overview of the use and application of IRT in rheumatology to date may give insight into future research directions and highlight new possibilities for the improvement of outcome assessment in rheumatic conditions. Therefore, this study systematically reviewed the application of IRT to patient-reported and clinical outcome measures in rheumatology. Literature searches in PubMed, Scopus and Web of Science resulted in 99 original English-language articles which used some form of IRT-based analysis of patient-reported or clinical outcome data in patients with a rheumatic condition. Both general study information and IRT-specific information were assessed. Most studies used Rasch modeling for developing or evaluating new or existing patient-reported outcomes in rheumatoid arthritis or osteoarthritis patients. Outcomes of principle interest were physical functioning and quality of life. Since the last decade, IRT has also been applied to clinical measures more frequently. IRT was mostly used for evaluating model fit, unidimensionality and differential item functioning, the distribution of items and persons along the underlying scale, and reliability. Less frequently used IRT applications were the evaluation of local independence, the threshold ordering of items, and the measurement precision along the scale. IRT applications have markedly increased within rheumatology over the past decades. To date, IRT has primarily been applied to patient-reported outcomes, however, applications to clinical measures are gaining interest. Useful IRT applications not yet widely used within rheumatology include the cross-calibration of instrument scores and the development of computerized adaptive tests which may reduce the measurement burden for both the patient and the clinician. Also, the measurement precision of outcome measures along the scale was only evaluated occasionally. Performed IRT analyses should be adequately explained, justified, and reported. A global consensus about uniform guidelines should be reached concerning the minimum number of assumptions which should be met and best ways of testing these assumptions, in order to stimulate the quality appraisal of performed IRT analyses.

Association between changes on the Negative Symptom Assessment scale (NSA-16) and measures of functional outcome in schizophrenia.

PubMed

Velligan, Dawn I; Alphs, Larry; Lancaster, Scott; Morlock, Robert; Mintz, Jim

2009-09-30

We examined whether changes in negative symptoms, as measured by scores on the 16-item Negative Symptom Assessment scale (NSA-16), were associated with changes in functional outcome. A group of 125 stable outpatients with schizophrenia were assessed at baseline and at 6 months using the NSA-16, the Brief Psychiatric Rating Scale, and multiple measures of functional outcome. Baseline adjusted regression coefficients indicated moderate correlations between negative symptoms and functional outcomes when baseline values of both variables were controlled. Results were nearly identical when we controlled for positive symptoms. Cross-lag panel correlations and Structural Equation Modeling were used to examine whether changes in negative symptoms drove changes in functional outcomes over time. Results indicated that negative symptoms drove the changes in the Social and Occupational Functioning Scale (SOFAS) rather than the reverse. Measures of Quality of Life and measures of negative symptoms may be assessing overlapping constructs or changes in both may be driven by a third variable. Negative symptoms were unrelated over time to scores on a performance-based measure of functional capacity. This study indicates that the relationship between negative symptom change and the change in functional outcomes is complex, and points to potential issues in selection of assessments.

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

PubMed Central

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

2014-01-01

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

Developmental Outcome of Childhood Leukemia.

ERIC Educational Resources Information Center

Coniglio, Susan J.; Blackman, James A.

1995-01-01

Literature on developmental and psychosocial outcomes of childhood leukemia is reviewed, focusing on preschool-age children. Studies are categorized in terms of outcome measures: intelligence/achievement, neuropsychological, memory/attention, and psychosocial tests. Evidence suggests that preschool children with leukemia are at high risk for…

Outcome expectations and use of smokeless tobacco (snus): a cross-sectional study among young Norwegian snus users.

PubMed

Wiium, Nora; Aarø, Leif E

2011-02-01

In this study, measures of outcome expectancies related to use of snus (wet snuff) were used to predict reported frequency of snus use. Data stem from a nation-wide survey in Norway among 16- to 20-year-olds. Only users of snus were included in the statistical analyses (n = 589). The main outcome measure, frequency of snus use, was measured as a categorical variable - occasional, weekly and daily use. Four dimensions of outcome expectancies (mood regulation, smoking control, weight control and negative health outcomes) were measured and confirmed in a confirmatory factor analysis. Informants tended to believe that snus use is harmful to health, but still they supported the idea of snus as a way to control own cigarette smoking. In a SEM model, two of the four dimensions of outcome expectancies turned out to be particularly significant predictors of frequency of snus use - mood regulation and smoking control. No significant interactions with gender were found. Males scored higher than females on "mood regulation", and "smoking control", while females scored higher than males on "negative health outcomes". If more smokers were convinced that snus use is a less harmful alternative, more of them might start using snus, not only because there is some association between health outcome expectancies and snus use, but also because snus use by many is perceived as a remedy to stop smoking and as a way to gain some of the mood regulation benefits which are usually associated with smoking. © 2010 The Authors. Scandinavian Journal of Psychology © 2010 The Scandinavian Psychological Associations.

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

PubMed

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

2018-04-01

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

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

PubMed

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

2017-07-14

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

Diffusion Tensor Imaging in Relation to Cognitive and Functional Outcome of Traumatic Brain Injury in Children

PubMed Central

Levin, Harvey S.; Wilde, Elisabeth A.; Chu, Zili; Yallampalli, Ragini; Hanten, Gerri R.; Li, Xiaoqi; Chia, Jon; Vasquez, Carmen; Hunter, Jill V.

2008-01-01

Objective To investigate the relation of white matter integrity using diffusion tensor imaging (DTI) to cognitive and functional outcome of moderate to severe traumatic brain injury (TBI) in children. Design Prospective observational study of children who had sustained moderate to severe TBI and a comparison group of children who had sustained orthopedic injury (OI). Participants Thirty-two children who had sustained moderate to severe TBI and 36 children with OI were studied. Methods Fiber tracking analysis of DTI acquired at 3-month postinjury and assessment of global outcome and cognitive function within 2 weeks of brain imaging. Global outcome was assessed using the Glasgow Outcome Scale and the Flanker task was used to measure cognitive processing speed and resistance to interference. Results Fractional anisotropy and apparent diffusion coefficient values differentiated the groups and both cognitive and functional outcome measures were related to the DTI findings. Dissociations were present wherein the relation of Fractional anisotropy to cognitive performance differed between the TBI and OI groups. A DTI composite measure of white matter integrity was related to global outcome in the children with TBI. Conclusions DTI is sensitive to white matter injury at 3 months following moderate to severe TBI in children, including brain regions that appear normal on conventional magnetic resonance imaging. DTI measures reflecting diffusion of water parallel and perpendicular to white matter tracts as calculated by fiber tracking analysis are related to global outcome, cognitive processing speed, and speed of resolving interference in children with moderate to severe TBI. Longitudinal data are needed to determine whether these relations between DTI and neurobehavioral outcome of TBI in children persist at longer follow-up intervals. PMID:18650764

Associations between Motivational Orientations and Chronically Accessible Outcomes in Leisure-Time Physical Activity: Are Appearance-Related Outcomes Controlling in Nature?

ERIC Educational Resources Information Center

McLachlan, Sarah; Hagger, Martin S.

2010-01-01

This study aimed to explore relations between chronically accessible outcomes in physical activity and scaled measures of motivational orientations from a self-determination perspective. Methods from construct and attitude accessibility research and the Levesque and Pelletier (2003) study were used to identify participants' chronically accessible…

Male Perpetrators of Intimate Partner Violence and Implicit Attitudes toward Violence: Associations with Treatment Outcomes

PubMed Central

Eckhardt, Christopher I.; Crane, Cory A.

2014-01-01

The present study examined the associations among implicit attitudes toward factors related to intimate partner violence (IPV) and objective, behavioral outcomes of participants legally mandated to attend partner violence interventions. Twenty-six male offenders, adjudicated within the past month on IPV charges, completed three sets of gender and violence themed implicit associations tests (IATs) to evaluate the relationships between implicit evaluations of women and violence and three key outcome measures assessed six months after enrollment in the study: self-reported prior year IPV perpetration, completion of a court-mandated partner abuse program, and criminal reoffending. IAT results indicated that more rapid associations between violence-related words and positive valences, rather than gender evaluations or associations between gender and violence, were associated with greater IPV perpetration during the year prior to involvement in the study as well as with poorer outcomes (i.e., greater treatment non-compliance and criminal recidivism) at the 6-month follow-up. Among explicit measures, only negative partner violence outcome expectancies were marginally associated with treatment compliance. None of the explicit measures predicted previous violence or recidivism. The findings are discussed in the context of reducing violence through promoting implicit cognitive change. PMID:25598562

Measuring masculinity in research on men of color: findings and future directions.

PubMed

Griffith, Derek M; Gunter, Katie; Watkins, Daphne C

2012-05-01

The purpose of this study was to examine the association between masculinity and the health of US men of color aged 18 years and older. We identified 22 population-based studies that included a measure of masculinity and a measure of health behavior, mental health, or physical health. The associations between masculinity and health were complex and varied by construct and health outcome, though they generally were significant in the hypothesized directions. Future research should explore the centrality of masculinity versus other identities and characteristics, how the relationship between masculinity and health varies by health outcome, and the identification of the conceptions and aspects of masculinity that are most relevant to and associated with specific health behaviors and health outcomes.

Measuring Masculinity in Research on Men of Color: Findings and Future Directions

PubMed Central

Gunter, Katie; Watkins, Daphne C.

2012-01-01

The purpose of this study was to examine the association between masculinity and the health of US men of color aged 18 years and older. We identified 22 population-based studies that included a measure of masculinity and a measure of health behavior, mental health, or physical health. The associations between masculinity and health were complex and varied by construct and health outcome, though they generally were significant in the hypothesized directions. Future research should explore the centrality of masculinity versus other identities and characteristics, how the relationship between masculinity and health varies by health outcome, and the identification of the conceptions and aspects of masculinity that are most relevant to and associated with specific health behaviors and health outcomes. PMID:22401519

Relative risk reduction is useful metric to standardize effect size for public heath interventions for translational research.

PubMed

Mirzazadeh, Ali; Malekinejad, Mohsen; Kahn, James G

2015-03-01

Heterogeneity of effect measures in intervention studies undermines the use of evidence to inform policy. Our objective was to develop a comprehensive algorithm to convert all types of effect measures to one standard metric, relative risk reduction (RRR). This work was conducted to facilitate synthesis of published intervention effects for our epidemic modeling of the health impact of human immunodeficiency virus [HIV testing and counseling (HTC)]. We designed and implemented an algorithm to transform varied effect measures to RRR, representing the proportionate reduction in undesirable outcomes. Our extraction of 55 HTC studies identified 473 effect measures representing unique combinations of intervention-outcome-population characteristics, using five outcome metrics: pre-post proportion (70.6%), odds ratio (14.0%), mean difference (10.2%), risk ratio (4.4%), and RRR (0.9%). Outcomes were expressed as both desirable (29.5%, eg, consistent condom use) and undesirable (70.5%, eg, inconsistent condom use). Using four examples, we demonstrate our algorithm for converting varied effect measures to RRR and provide the conceptual basis for advantages of RRR over other metrics. Our review of the literature suggests that RRR, an easily understood and useful metric to convey risk reduction associated with an intervention, is underused by original and review studies. Copyright © 2015 Elsevier Inc. All rights reserved.

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

PubMed

Wigham, Sarah; McConachie, Helen

2014-01-01

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

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

PubMed Central

Wigham, Sarah; McConachie, Helen

2014-01-01

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

Occurrences and sources of Differential Item Functioning (DIF) in patient-reported outcome measures: Description of DIF methods, and review of measures of depression, quality of life and general health

PubMed Central

Teresi, Jeanne A.; Ramirez, Mildred; Lai, Jin-Shei; Silver, Stephanie

2009-01-01

Examination of the equivalence of measures involves several levels, including conceptual equivalence of meaning, as well as quantitative tests of differential item functioning (DIF). The purpose of this review is to examine DIF in patient-reported outcomes. Reviewed were measures of self-reported depression, quality of life (QoL) and general health. Most measures of depression contained large amounts of DIF, and the impact of DIF at the scale level was typically sizeable. The studies of QoL and health measures identified a moderate amount of DIF; however, many of these studies examined only one type of DIF (uniform). Relative to DIF analyses of depression measures, less analysis of the impact of DIF on QoL and health measures was performed, and the authors of these analyses generally did not recommend remedial action, with one notable exception. While these studies represent good beginning efforts to examine measurement equivalence in patient-reported outcome measures, more cross-validation work is required using other (often larger) samples of different ethnic and language groups, as well as other methods that permit more extensive analyses of the type of DIF, together with magnitude and impact. PMID:20165561

The Impact of Information Technology on Patient Engagement and Health Behavior Change: A Systematic Review of the Literature

PubMed Central

Rashrash, Mohamed; Phalakornkule, Kanitha; Carpenter, Janet S; Jones, Josette F

2016-01-01

Background Advancements in information technology (IT) and its increasingly ubiquitous nature expand the ability to engage patients in the health care process and motivate health behavior change. Objective Our aim was to systematically review the (1) impact of IT platforms used to promote patients’ engagement and to effect change in health behaviors and health outcomes, (2) behavior theories or models applied as bases for developing these interventions and their impact on health outcomes, (3) different ways of measuring health outcomes, (4) usability, feasibility, and acceptability of these technologies among patients, and (5) challenges and research directions for implementing IT platforms to meaningfully impact patient engagement and health outcomes. Methods PubMed, Web of Science, PsycINFO, and Google Scholar were searched for studies published from 2000 to December 2014. Two reviewers assessed the quality of the included papers, and potentially relevant studies were retrieved and assessed for eligibility based on predetermined inclusion criteria. Results A total of 170 articles met the inclusion criteria and were reviewed in detail. Overall, 88.8% (151/170) of studies showed positive impact on patient behavior and 82.9% (141/170) reported high levels of improvement in patient engagement. Only 47.1% (80/170) referenced specific behavior theories and only 33.5% (57/170) assessed the usability of IT platforms. The majority of studies used indirect ways to measure health outcomes (65.9%, 112/170). Conclusions In general, the review has shown that IT platforms can enhance patient engagement and improve health outcomes. Few studies addressed usability of these interventions, and the reason for not using specific behavior theories remains unclear. Further research is needed to clarify these important questions. In addition, an assessment of these types of interventions should be conducted based on a common framework using a large variety of measurements; these measurements should include those related to motivation for health behavior change, long-standing adherence, expenditure, satisfaction, and health outcomes. PMID:26795082

Monthly oral methylprednisolone pulse treatment in progressive multiple sclerosis.

PubMed

Ratzer, Rikke; Iversen, Pernille; Börnsen, Lars; Dyrby, Tim B; Romme Christensen, Jeppe; Ammitzbøll, Cecilie; Madsen, Camilla Gøbel; Garde, Ellen; Lyksborg, Mark; Andersen, Birgit; Hyldstrup, Lars; Sørensen, Per Soelberg; Siebner, Hartwig R; Sellebjerg, Finn

2016-06-01

There is a large unmet need for treatments for patients with progressive multiple sclerosis (MS). Phase 2 studies with cerebrospinal fluid (CSF) biomarker outcomes may be well suited for the initial evaluation of efficacious treatments. To evaluate the effect of monthly oral methylprednisolone pulse treatment on intrathecal inflammation in progressive MS. In this open-label phase 2A study, 15 primary progressive and 15 secondary progressive MS patients received oral methylprednisolone pulse treatment for 60 weeks. Primary outcome was changes in CSF concentrations of osteopontin. Secondary outcomes were other CSF biomarkers of inflammation, axonal damage and demyelination; clinical scores; magnetic resonance imaging measures of disease activity, magnetization transfer ratio (MTR) and diffusion tensor imaging (DTI); motor evoked potentials; and bone density scans. We found no change in the CSF concentration of osteopontin, but we observed significant improvement in clinical scores, MTR, DTI and some secondary CSF outcome measures. Adverse events were well-known side effects to methylprednisolone. Monthly methylprednisolone pulse treatment was safe, but had no effect on the primary outcome. However, improvements in secondary clinical and MRI outcome measures suggest that this treatment regimen may have a beneficial effect in progressive MS. © The Author(s), 2015.

Relative Risk Reduction as a Metric to Standardize Effect Size for Public Heath Interventions for Translational Research: Methods and Applications

PubMed Central

Mirzazadeh, A; Malekinejad, M; Kahn, JG

2018-01-01

Objective Heterogeneity of effect measures in intervention studies undermines the use of evidence to inform policy. Our objective was to develop a comprehensive algorithm to convert all types of effect measures to one standard metric, relative risk reduction (RRR). Study Design and Setting This work was conducted to facilitate synthesis of published intervention effects for our epidemic modeling of the health impact of HIV Testing and Counseling (HTC). We designed and implemented an algorithm to transform varied effect measures to RRR, representing the proportionate reduction in undesirable outcomes. Results Our extraction of 55 HTC studies identified 473 effect measures representing unique combinations of intervention-outcome-population characteristics, using five outcome metrics: pre-post proportion (70.6%), odds ratio (14.0%), mean difference (10.2%), risk ratio (4.4%), and RRR (0.9%). Outcomes were expressed as both desirable (29.5%, e.g., consistent condom use) and undesirable (70.5% e.g., inconsistent condom use). Using four examples, we demonstrate our algorithm for converting varied effect measures to RRR, and provide the conceptual basis for advantages of RRR over other metrics. Conclusion Our review of the literature suggests that RRR, an easily understood and useful metric to convey risk reduction associated with an intervention, is underutilized by original and review studies. PMID:25726522

Sustain talk predicts poorer outcomes among mandated college student drinkers receiving a brief motivational intervention.

PubMed

Apodaca, Timothy R; Borsari, Brian; Jackson, Kristina M; Magill, Molly; Longabaugh, Richard; Mastroleo, Nadine R; Barnett, Nancy P

2014-09-01

Within-session client language that represents a movement toward behavior change (change talk) has been linked to better treatment outcomes in the literature on motivational interviewing (MI). There has been somewhat less study of the impact of client language against change (sustain talk) on outcomes following an MI session. This study examined the role of both client change talk and sustain talk, as well as therapist language, occurring during a brief motivational intervention (BMI) session with college students who had violated college alcohol policy (N = 92). Audiotapes of these sessions were coded using a therapy process coding system. A series of hierarchical regressions were used to examine the relationships among therapist MI-consistent and MI-inconsistent language, client change talk and sustain talk, as well as global measures of relational variables, and drinking outcomes. Contrary to prior research, sustain talk, but not change talk, predicted poorer alcohol use outcomes following the BMI at 3- and 12-month follow-up assessments. Higher levels of client self-exploration during the session also predicted improved drinking outcomes. Therapist measures of MI-consistent and MI-inconsistent language, and global measures of therapist acceptance and MI spirit were unrelated to client drinking outcomes. Results suggest that client sustain talk and self-exploration during the session play an important role in determining drinking outcomes among mandated college students receiving a BMI addressing alcohol use.

Hyperglycemia and Adverse Pregnancy Outcome (HAPO) Study: associations of maternal A1C and glucose with pregnancy outcomes.

PubMed

Lowe, Lynn P; Metzger, Boyd E; Dyer, Alan R; Lowe, Julia; McCance, David R; Lappin, Terence R J; Trimble, Elisabeth R; Coustan, Donald R; Hadden, David R; Hod, Moshe; Oats, Jeremy J N; Persson, Bengt

2012-03-01

To compare associations of maternal glucose and A1C with adverse outcomes in the multinational Hyperglycemia and Adverse Pregnancy Outcome (HAPO) Study and determine, based on those comparisons, if A1C measurement can provide an alternative to an oral glucose tolerance test (OGTT) in pregnant women. Eligible pregnant women underwent a 75-g OGTT at 24-32 weeks' gestation. A sample for A1C was also collected. Neonatal anthropometrics and cord serum C-peptide were measured. Associations with outcomes were assessed using multiple logistic regression with adjustment for potential confounders. Among 23,316 HAPO Study participants with glucose levels blinded to caregivers, 21,064 had a nonvariant A1C result. The mean ± SD A1C was 4.79 ± 0.40%. Associations were significantly stronger with glucose measures than with A1C for birth weight, sum of skinfolds, and percent body fat >90th percentile and for fasting and 1-h glucose for cord C-peptide (all P < 0.01). For example, in fully adjusted models, odds ratios (ORs) for birth weight >90th percentile for each measure higher by 1 SD were 1.39, 1.45, and 1.38, respectively, for fasting, 1-, and 2-h plasma glucose and 1.15 for A1C. ORs for cord C-peptide >90th percentile were 1.56, 1.45, and 1.35 for glucose, respectively, and 1.32 for A1C. ORs were similar for glucose and A1C for primary cesarean section, preeclampsia, and preterm delivery. On the basis of associations with adverse outcomes, these findings suggest that A1C measurement is not a useful alternative to an OGTT in pregnant women.

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.

The Association between Outpatient Buprenorphine Detoxification Duration and Clinical Treatment Outcomes: A Review

PubMed Central

Sigmon, Stacey C.; Strain, Eric C.; Heil, Sarah H.; Higgins, Stephen T.

2011-01-01

Background The association between buprenorphine taper duration and treatment outcomes is not well understood. This review evaluated whether duration of outpatient buprenorphine taper is significantly associated with treatment outcomes. Methods Studies that were published in peer-reviewed journals, administered buprenorphine as an outpatient taper to opioid-dependent participants, and provided data on at least one of three primary treatment outcome measures (opioid abstinence, retention, peak withdrawal severity) were reviewed. Primary treatment outcomes were evaluated as a function of taper duration using hierarchical linear regressions using pre-taper maintenance as a cofactor. Results Twenty-eight studies were reviewed. Taper duration significantly predicted percent of opioid-negative samples provided during treatment, however pre-taper maintenance period predicted percent participants abstinent on the final day of treatment. High rates of relapse were reported. No significant association between taper duration and retention in treatment or peak withdrawal severity was observed. Conclusion The data reviewed here suggest taper duration is associated with opioid abstinence achieved during detoxification but not with other markers of treatment outcome. The reviewed studies varied widely on several parameters (e.g., frequency of urinalysis testing, provision of ancillary medications) that may influence treatment outcome and thus could have interfered with the ability to identify relationships between taper duration and outcomes. Future studies evaluating opioid detoxification should utilize rigorous experimental methods and report a wider range of outcome measures in order to help advance our understanding of the association between taper duration and treatment outcomes. PMID:21741781

Glasgow Coma Scale score, mortality, and functional outcome in head-injured patients.

PubMed

Udekwu, Pascal; Kromhout-Schiro, Sharon; Vaslef, Steven; Baker, Christopher; Oller, Dale

2004-05-01

Preresuscitation Glasgow Coma Scale (P-GCS) score is frequently obtained in injured patients and incorporated into mortality prediction. Data on functional outcome in head injury is sparse. A large group of patients with head injuries was analyzed to assess relationships between P-GCS score, mortality, and functional outcome as measured by the Functional Independence Measure (FIM). Records for patients with International Classification of Diseases, Ninth Revision diagnosis codes indicating head injury in a statewide trauma registry between 1994 and 2002 were selected. P-GCS score, mortality, and FIM score at hospital discharge were integrated and analyzed. Of 138,750 patients, 22,924 patients were used for the mortality study and 7,150 patients for the FIM study. A good correlation exists between P-GCS score and FIM, as determined by rank correlation coefficients, whereas mortality falls steeply between a P-GCS score of 3 and a P-GCS score of 7 followed by a shallow fall. Although P-GCS score is related to mortality in head-injured patients, its relationship is nonlinear, which casts doubt on its use as a continuous measure or an equivalent set of categorical measures incorporated into outcome prediction models. The average FIM scores indicate substantial likelihood of good outcomes in survivors with low P-GCS scores, further complicating the use of the P-GCS score in the prediction of poor outcome at the time of initial patient evaluation. Although the P-GCS score is related to functional outcome as measured by the FIM score and mortality in head injury, current mortality prediction models may need to be modified to account for the nonlinear relationship between P-GCS score and mortality. The P-GCS score is not a good clinical tool for outcome prediction in individual head-injured patients, given the variability in mortality rates and functional outcomes at all scores.

Accreditation standards for undergraduate forensic science programs

NASA Astrophysics Data System (ADS)

Miller, Marilyn Tebbs

Undergraduate forensic science programs are experiencing unprecedented growth in numbers of programs offered and, as a result, student enrollments are increasing. Currently, however, these programs are not subject to professional specialized accreditation. This study sought to identify desirable student outcome measures for undergraduate forensic science programs that should be incorporated into such an accreditation process. To determine desirable student outcomes, three types of data were collected and analyzed. All the existing undergraduate forensic science programs in the United States were examined with regard to the input measures of degree requirements and curriculum content, and for the output measures of mission statements and student competencies. Accreditation procedures and guidelines for three other science-based disciplines, computer science, dietetics, and nursing, were examined to provide guidance on accreditation processes for forensic science education programs. Expert opinion on outcomes for program graduates was solicited from the major stakeholders of undergraduate forensic science programs-forensic science educators, crime laboratory directors, and recent graduates. Opinions were gathered by using a structured Internet-based survey; the total response rate was 48%. Examination of the existing undergraduate forensic science programs revealed that these programs do not use outcome measures. Of the accreditation processes for other science-based programs, nursing education provided the best model for forensic science education, due primarily to the balance between the generality and the specificity of the outcome measures. From the analysis of the questionnaire data, preliminary student outcomes, both general and discipline-specific, suitable for use in the accreditation of undergraduate forensic science programs were determined. The preliminary results were reviewed by a panel of experts and, based on their recommendations, the outcomes identified were revised and refined. The results of this study were used to identify student outcomes and to suggest accreditation standards and an accreditation process for undergraduate forensic science programs based on those outcomes.

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

PubMed

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

2008-05-01

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

Early Postoperative Measures Predict 1- and 2-Year Outcomes After Unilateral Total Knee Arthroplasty: Importance of Contralateral Limb Strength

PubMed Central

Snyder-Mackler, Lynn

2010-01-01

Background Total knee arthroplasty (TKA) has been shown to be an effective surgical intervention for people with end-stage knee osteoarthritis. However, recovery of function is variable, and not all people have successful outcomes. Objective The aim of this study was to discern which early postoperative functional measures could predict functional ability at 1 year and 2 years after surgery. Design and Methods One hundred fifty-five people who underwent unilateral TKA participated in the prospective longitudinal study. Functional evaluations were performed at the initial outpatient physical therapy appointment and at 1 and 2 years after surgery. Evaluations consisted of measurements of height, weight, quadriceps muscle strength (force-generating capacity), and knee range of motion; the Timed “Up & Go” Test (TUG); the stair-climbing task (SCT); and the Knee Outcome Survey (KOS) questionnaire. The ability to predict 1- and 2-year outcomes on the basis of early postoperative measures was analyzed with a hierarchical regression. Differences in functional scores were evaluated with a repeated-measures analysis of variance. Results The TUG, SCT, and KOS scores at 1 and 2 years showed significant improvements over the scores at the initial evaluation (P<.001). A weaker quadriceps muscle in the limb that did not undergo surgery (“nonoperated limb”) was related to poorer 1- and 2-year outcomes even after the influence of the other early postoperative measures was accounted for in the regression. Older participants with higher body masses also had poorer outcomes at 1 and 2 years. Postoperative measures were better predictors of TUG and SCT times than of KOS scores. Conclusions Rehabilitation regimens after TKA should include exercises to improve the strength of the nonoperated limb as well as to treat the deficits imposed by the surgery. Emphasis on treating age-related impairments and reducing body mass also might improve long-term outcomes. PMID:19959653

Routine educational outcome measures in health studies: Key Stage 1 in the ORACLE Children Study follow-up of randomised trial cohorts.

PubMed

Jones, David R; Pike, Katie; Kenyon, Sara; Pike, Laura; Henderson, Brian; Brocklehurst, Peter; Marlow, Neil; Salt, Alison; Taylor, David J

2011-01-01

Statutory educational attainment measures are rarely used as health study outcomes, but Key Stage 1 (KS1) data formed secondary outcomes in the long-term follow-up to age 7 years of the ORACLE II trial of antibiotic use in preterm babies. This paper describes the approach, compares different approaches to analysis of the KS1 data and compares use of summary KS1 (level) data with use of individual question scores. 3394 children born to women in the ORACLE Children Study and resident in England at age 7. Analysis of educational achievement measured by national end of KS1 data (KS1) using Poisson regression modelling and anchoring of the KS1 data using external standards. KS1 summary level data were obtained for 3239 (95%) eligible children; raw individual question scores were obtained for 1899 (54%). Use of individual question scores where available did not change the conclusion of no evidence of treatment effects based on summary KS1 outcome data. When accessible for medical research purposes, routinely collected educational outcome data may have advantages of low cost and standardised definition. Here, summary scores lead to similar conclusions to raw (individual question) scores and so are attractive and cost-effective alternatives.

Acute effects of tea constituents L-theanine, caffeine, and epigallocatechin gallate on cognitive function and mood: a systematic review and meta-analysis.

PubMed

Camfield, David A; Stough, Con; Farrimond, Jonathon; Scholey, Andrew B

2014-08-01

A systematic review and meta-analysis was conducted on 11 randomized placebo-controlled human studies of acute effects of tea constituents L-theanine and epigallocatechin gallate, administered alone or in combination with caffeine, on cognitive function and mood. The outcome measures of mood were alertness, calmness, and contentedness, derived from the Bond-Lader scales, and state anxiety, from the State-Trait Anxiety Inventory. Cognitive measures assessed were attentional switch, intersensory attention, and rapid visual information processing. Standardized mean differences between placebo and treatment groups are presented for each study and outcome measure. Meta-analysis using a random-effects model was conducted when data were available for three or more studies. Evidence of moderate effect sizes in favor of combined caffeine and L-theanine in the first 2 hours postdose were found for outcome measures Bond-Lader alertness, attentional switching accuracy, and, to a lesser extent, some unisensory and multisensory attentional outcomes. Moderator analysis of caffeine and L-theanine doses revealed trends toward greater change in effect size for caffeine dose than for L-theanine dose, particularly during the first hour postdose. © 2014 International Life Sciences Institute.

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

PubMed

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

2018-05-08

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

Responsiveness of performance-based outcome measures for mobility, balance, muscle strength and manual dexterity in adults with myotonic dystrophy type 1.

PubMed

Kierkegaard, Marie; Petitclerc, Émilie; Hébert, Luc J; Mathieu, Jean; Gagnon, Cynthia

2018-02-28

To assess changes and responsiveness in outcome measures of mobility, balance, muscle strength and manual dexterity in adults with myotonic dystrophy type 1. A 9-year longitudinal study conducted with 113 patients. The responsiveness of the Timed Up and Go test, Berg Balance Scale, quantitative muscle testing, grip and pinch-grip strength, and Purdue Pegboard Test was assessed using criterion and construct approaches. Patient-reported perceived changes (worse/stable) in balance, walking, lower-limb weakness, stair-climbing and hand weakness were used as criteria. Predefined hypotheses about expected area under the receiver operating characteristic curves (criterion approach) and correlations between relative changes (construct approach) were explored. The direction and magnitude of median changes in outcome measures corresponded with patient-reported changes. Median changes in the Timed Up and Go test, grip strength, pinch-grip strength and Purdue Pegboard Test did not, in general, exceed known measurement errors. Most criterion (72%) and construct (70%) approach hypotheses were supported. Promising responsiveness was found for outcome measures of mobility, balance and muscle strength. Grip strength and manual dexterity measures showed poorer responsiveness. The performance-based outcome measures captured changes over the 9-year period and responsiveness was promising. Knowledge of measurement errors is needed to interpret the meaning of these longitudinal changes.

A core outcome set for evaluating self-management interventions in people with comorbid diabetes and severe mental illness: study protocol for a modified Delphi study and systematic review.

PubMed

Taylor, Johanna; Böhnke, Jan R; Wright, Judy; Kellar, Ian; Alderson, Sarah L; Hughes, Tom; Holt, Richard I G; Siddiqi, Najma

2017-02-14

People with diabetes and comorbid severe mental illness (SMI) form a growing population at risk of increased mortality and morbidity compared to those with diabetes or SMI alone. There is increasing interest in interventions that target diabetes in SMI in order to help to improve physical health and reduce the associated health inequalities. However, there is a lack of consensus about which outcomes are important for this comorbid population, with trials differing in their focus on physical and mental health. A core outcome set, which includes outcomes across both conditions that are relevant to patients and other key stakeholders, is needed. This study protocol describes methods to develop a core outcome set for use in effectiveness trials of self-management interventions for adults with comorbid type-2 diabetes and SMI. We will use a modified Delphi method to identify, rank, and agree core outcomes. This will comprise a two-round online survey and multistakeholder workshops involving patients and carers, health and social care professionals, health care commissioners, and other experts (e.g. academic researchers and third sector organisations). We will also select appropriate measurement tools for each outcome in the proposed core set and identify gaps in measures, where these exist. The proposed core outcome set will provide clear guidance about what outcomes should be measured, as a minimum, in trials of interventions for people with coexisting type-2 diabetes and SMI, and improve future synthesis of trial evidence in this area. We will also explore the challenges of using online Delphi methods for this hard-to-reach population, and examine differences in opinion about which outcomes matter to diverse stakeholder groups. COMET registration: http://www.comet-initiative.org/studies/details/911 . Registered on 1 July 2016.

Assessing the quality of the volume-outcome relationship in uro-oncology.

PubMed

Mayer, Erik K; Purkayastha, Sanjay; Athanasiou, Thanos; Darzi, Ara; Vale, Justin A

2009-02-01

To assess systematically the quality of evidence for the volume-outcome relationship in uro-oncology, and thus facilitate the formulating of health policy within this speciality, as 'Implementation of Improving Outcome Guidance' has led to centralization of uro-oncology based on published studies that have supported a 'higher volume-better outcome' relationship, but improved awareness of methodological drawbacks in health service research has questioned the strength of this proposed volume-outcome relationship. We systematically searched previous relevant reports and extracted all articles from 1980 onwards assessing the volume-outcome relationship for cystectomy, prostatectomy and nephrectomy at the institution and/or surgeon level. Studies were assessed for their methodological quality using a previously validated rating system. Where possible, meta-analytical methods were used to calculate overall differences in outcome measures between low and high volume healthcare providers. In all, 22 studies were included in the final analysis; 19 of these were published in the last 5 years. Only four studies appropriately explored the effect of both the institution and surgeon volume on outcome measures. Mortality and length of stay were the most frequently measured outcomes. The median total quality scores within each of the operation types were 8.5, 9 and 8 for cystectomy, prostatectomy and nephrectomy, respectively (possible maximum score 18). Random-effects modelling showed a higher risk of mortality in low-volume institutions than in higher-volume institutions for both cystectomy and nephrectomy (odds ratio 1.88, 95% confidence interval 1.54-2.29, and 1.28, 1.10-1.49, respectively). The methodological quality of volume-outcome research as applied to cystectomy, prostatectomy and nephrectomy is only modest at best. Accepting several limitations, pooled analysis confirms a higher-volume, lower-mortality relationship for cystectomy and nephrectomy. Future research should focus on the development of a quality framework with a validated scoring system for the bench-marking of data to improve validity and facilitate rational policy-making within the speciality of uro-oncology.

Dimensional personality traits and alcohol treatment outcome: a systematic review and meta-analysis.

PubMed

Foulds, James; Newton-Howes, Giles; Guy, Nicola H; Boden, Joseph M; Mulder, Roger T

2017-08-01

To identify dimensional personality traits associated with treatment outcome for patients with an alcohol use disorder (AUD). Systematic review and meta-analysis of clinical trials and longitudinal studies of ≥ 8 weeks in patients receiving treatment for AUD, in which the association between personality dimensions and treatment outcome was reported. Primary outcomes were relapse and alcohol consumption measures. Treatment retention was a secondary outcome. Eighteen studies, including 4783 subjects, were identified. Twelve studies used Cloninger's Temperament and Personality Questionnaire (TPQ) or Temperament and Character Inventory (TCI). Remaining studies used a broad range of other personality measures. Compared with non-relapsers, patients who relapsed had higher novelty-seeking [standardized mean difference in novelty-seeking score 0.28; 95% confidence interval (CI) = 0.12, 0.44], lower persistence (-0.30, 95% = CI -0.48, -0.12), lower reward dependence (-0.16, 95% CI = -0.31, -0.01) and lower cooperativeness (-0.23, 95% CI = -0.41, -0.04). Few studies reported on alcohol consumption outcomes, therefore findings for those outcomes were inconclusive. Lower novelty-seeking predicted better retention in treatment in two of three studies. Most studies reported findings only for those retained in treatment, and did not attempt to account for missing data; therefore, findings for the primary outcomes cannot be generalized to patients who dropped out of treatment. Studies using personality instruments other than the TCI or TPQ reported no consistent findings on the association between personality variables and treatment outcome. Among patients receiving treatment for an alcohol use disorder, those who relapse during follow-up have higher novelty-seeking, lower persistence, lower reward dependence and lower cooperativeness than those who do not relapse. © 2017 Society for the Study of Addiction.

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

PubMed

Fujii, Daryl E; Wylie, A Michael

2003-02-01

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

The selection of core International Classification of Functioning, Disability, and Health (ICF) categories for patient-reported outcome measurement in spine trauma patients-results of an international consensus process.

PubMed

Sadiqi, Said; Lehr, A Mechteld; Post, Marcel W; Jacobs, Wilco C H; Aarabi, Bizhan; Chapman, Jens R; Dunn, Robert N; Dvorak, Marcel F; Fehlings, Michael G; Rajasekaran, S; Vialle, Luiz R; Vaccaro, Alexander R; Oner, F Cumhur

2016-08-01

There is no outcome instrument specifically designed and validated for spine trauma patients without complete paralysis, which makes it difficult to compare outcomes of different treatments of the spinal column injury within and between studies. The paper aimed to report on the evidence-based consensus process that resulted in the selection of core International Classification of Functioning, Disability, and Health (ICF) categories, as well as the response scale for use in a universal patient-reported outcome measure for patients with traumatic spinal column injury. The study used a formal decision-making and consensus process. The sample includes patients with a primary diagnosis of traumatic spinal column injury, excluding completely paralyzed and polytrauma patients. The wide array of function and health status of patients with traumatic spinal column injury was explored through the identification of all potentially meaningful ICF categories. A formal decision-making and consensus process integrated evidence from four preparatory studies. Three studies aimed to identify relevant ICF categories from three different perspectives. The research perspective was covered by a systematic literature review identifying outcome measures focusing on the functioning and health of spine trauma patients. The expert perspective was explored through an international web-based survey among spine surgeons from the five AOSpine International world regions. The patient perspective was investigated in an international empirical study. A fourth study investigated various response scales for their potential use in the future universal outcome instrument. This work was supported by AOSpine. AOSpine is a clinical division of the AO Foundation, an independent medically guided non-profit organization. The AOSpine Knowledge Forums are pathology-focused working groups acting on behalf of AOSpine in their domain of scientific expertise. Combining the results of the preparatory studies, the list of ICF categories presented at the consensus conference included 159 different ICF categories. Based on voting and discussion, 11 experts from 6 countries selected a total of 25 ICF categories as core categories for patient-reported outcome measurement in adult traumatic spinal column injury patients (9 body functions, 14 activities and participation, and 2 environmental factors). The experts also agreed to use the Numeric Rating Scale 0-100 as response scale in the future universal outcome instrument. A formal consensus process integrating evidence and expert opinion led to a set of 25 core ICF categories for patient-reported outcome measurement in adult traumatic spinal column injury patients, as well as the response scale for use in the future universal disease-specific outcome instrument. The adopted core ICF categories could also serve as a benchmark for assessing the content validity of existing and future outcome instruments used in this specific patient population. Copyright © 2016 Elsevier Inc. All rights reserved.

Should Schools Expect Poor Physical and Mental Health, Social Adjustment, and Participation Outcomes in Students with Disability?

PubMed Central

Vaz, Sharmila; Cordier, Reinie; Falkmer, Marita; Ciccarelli, Marina; Parsons, Richard; McAuliffe, Tomomi; Falkmer, Torbjorn

2015-01-01

The literature on whether students with disabilities have worse physical and mental health, social adjustment, and participation outcomes when compared to their peers without disabilities is largely inconclusive. While the majority of case control studies showed significantly worse outcomes for students with disabilities; the proportion of variance accounted for is rarely reported. The current study used a population cross-sectional approach to determine the classification ability of commonly used screening and outcome measures in determining the disability status. Furthermore, the study aimed to identify the variables, if any, that best predicted the presence of disability. Results of univariate discriminant function analyses suggest that across the board, the sensitivity of the outcome/screening tools to correctly identify students with a disability was 31.9% higher than the related Positive Predictive Value (PPV). The lower PPV and Positive Likelihood Ratio (LR+) scores suggest that the included measures had limited discriminant ability (17.6% to 40.3%) in accurately identifying students at-risk for further assessment. Results of multivariate analyses suggested that poor health and hyperactivity increased the odds of having a disability about two to three times, while poor close perceived friendship and academic competences predicted disability with roughly the same magnitude. Overall, the findings of the current study highlight the need for researchers and clinicians to familiarize themselves with the psychometric properties of measures, and be cautious in matching the function of the measures with their research and clinical needs. PMID:25965845

Should schools expect poor physical and mental health, social adjustment, and participation outcomes in students with disability?

PubMed

Vaz, Sharmila; Cordier, Reinie; Falkmer, Marita; Ciccarelli, Marina; Parsons, Richard; McAuliffe, Tomomi; Falkmer, Torbjorn

2015-01-01

The literature on whether students with disabilities have worse physical and mental health, social adjustment, and participation outcomes when compared to their peers without disabilities is largely inconclusive. While the majority of case control studies showed significantly worse outcomes for students with disabilities; the proportion of variance accounted for is rarely reported. The current study used a population cross-sectional approach to determine the classification ability of commonly used screening and outcome measures in determining the disability status. Furthermore, the study aimed to identify the variables, if any, that best predicted the presence of disability. Results of univariate discriminant function analyses suggest that across the board, the sensitivity of the outcome/screening tools to correctly identify students with a disability was 31.9% higher than the related Positive Predictive Value (PPV). The lower PPV and Positive Likelihood Ratio (LR+) scores suggest that the included measures had limited discriminant ability (17.6% to 40.3%) in accurately identifying students at-risk for further assessment. Results of multivariate analyses suggested that poor health and hyperactivity increased the odds of having a disability about two to three times, while poor close perceived friendship and academic competences predicted disability with roughly the same magnitude. Overall, the findings of the current study highlight the need for researchers and clinicians to familiarize themselves with the psychometric properties of measures, and be cautious in matching the function of the measures with their research and clinical needs.

Characteristics of clinical shoulder research over the last decade: a review of shoulder articles in The Journal of Bone & Joint Surgery from 2004 to 2014.

PubMed

Gartsman, Gary M; Morris, Brent J; Unger, R Zackary; Laughlin, Mitzi S; Elkousy, Hussein A; Edwards, T Bradley

2015-03-04

The purpose of this study was to determine characteristics and trends in published shoulder research over the last decade in a leading orthopaedic journal. We examined all clinical shoulder articles published in The Journal of Bone & Joint Surgery from 2004 to 2014. The number of citations, authorship, academic degrees of the authors, country and institution of origin, topic, level of evidence, positive or nonpositive outcome, and inclusion of validated patient-reported outcome measures were assessed for each article. Shoulder articles that included an author with an advanced research degree (MD [Doctor of Medicine] with a PhD [Doctor of Philosophy] or other advanced degree) increased during the study period (p = 0.047). Level-I, II, and III studies were more likely to have an author with an advanced research degree, and Level-IV studies were more likely to have MDs only (p = 0.03). Overall, there was great variability of outcome measures, with at least thirty-nine different validated or nonvalidated outcome measures reported. Over the last decade, there was an improvement in the level of evidence of shoulder articles published in The Journal of Bone & Joint Surgery that corresponds with recent emphasis on evidence-based medicine. A consensus is needed in shoulder research for more consistent application of validated patient-reported outcome measurement tools. Copyright © 2015 by The Journal of Bone and Joint Surgery, Incorporated.

Cultural specificity of emotional overinvolvement: a systematic review.

PubMed

Singh, Swaran P; Harley, Kath; Suhail, Kausar

2013-03-01

Understanding cross-cultural aspects of emotional overinvolvement (EOI) on psychosis outcomes is important for ensuring cultural appropriateness of family interventions. This systematic review explores whether EOI has similar impact in different cultural groups and whether the same norms can be used to measure EOI across cultures. Thirty-four studies were found that have investigated the impact of EOI on outcomes across cultures or culturally adapted EOI measures. The relationship between high EOI and poor outcome is inconsistent across cultures. Attempts to improve predictive ability by post hoc adjustment of EOI norms have had varied success. Few studies have attempted a priori adaptations or development of culture-specific norms. Methodological differences such as use of different expressed emotions (EE) measures and varying definitions of relapse across studies may explain a lack of EOI outcome relationship across cultures. However, our findings suggest that the construct and measurement of EOI itself are culture-specific. EOI may not necessarily be detrimental in all cultures. The effect of high EOI may be moderated by the unexplored dimension of warmth and high levels of mutual interdependence in kin relationships. Researchers should reevaluate the prevailing concepts of the impact of family relations on the course and outcome of psychotic disorders, specifically focusing on the protective aspects of family involvement. Clinically, family interventions based on EE reduction should take cultural differences into account when treating families from different ethnocultural groups.

Analysis of subarachnoid hemorrhage using the Nationwide Inpatient Sample: the NIS-SAH Severity Score and Outcome Measure.

PubMed

Washington, Chad W; Derdeyn, Colin P; Dacey, Ralph G; Dhar, Rajat; Zipfel, Gregory J

2014-08-01

Studies using the Nationwide Inpatient Sample (NIS), a large ICD-9-based (International Classification of Diseases, Ninth Revision) administrative database, to analyze aneurysmal subarachnoid hemorrhage (SAH) have been limited by an inability to control for SAH severity and the use of unverified outcome measures. To address these limitations, the authors developed and validated a surrogate marker for SAH severity, the NIS-SAH Severity Score (NIS-SSS; akin to Hunt and Hess [HH] grade), and a dichotomous measure of SAH outcome, the NIS-SAH Outcome Measure (NIS-SOM; akin to modified Rankin Scale [mRS] score). Three separate and distinct patient cohorts were used to define and then validate the NIS-SSS and NIS-SOM. A cohort (n = 148,958, the "model population") derived from the 1998-2009 NIS was used for developing the NIS-SSS and NIS-SOM models. Diagnoses most likely reflective of SAH severity were entered into a regression model predicting poor outcome; model coefficients of significant factors were used to generate the NIS-SSS. Nationwide Inpatient Sample codes most likely to reflect a poor outcome (for example, discharge disposition, tracheostomy) were used to create the NIS-SOM. Data from 716 patients with SAH (the "validation population") treated at the authors' institution were used to validate the NIS-SSS and NIS-SOM against HH grade and mRS score, respectively. Lastly, 147,395 patients (the "assessment population") from the 1998-2009 NIS, independent of the model population, were used to assess performance of the NIS-SSS in predicting outcome. The ability of the NIS-SSS to predict outcome was compared with other common measures of disease severity (All Patient Refined Diagnosis Related Group [APR-DRG], All Payer Severity-adjusted DRG [APS-DRG], and DRG). RESULTS The NIS-SSS significantly correlated with HH grade, and there was no statistical difference between the abilities of the NIS-SSS and HH grade to predict mRS-based outcomes. As compared with the APR-DRG, APSDRG, and DRG, the NIS-SSS was more accurate in predicting SAH outcome (area under the curve [AUC] = 0.69, 0.71, 0.71, and 0.79, respectively). A strong correlation between NIS-SOM and mRS was found, with an agreement and kappa statistic of 85% and 0.63, respectively, when poor outcome was defined by an mRS score > 2 and 95% and 0.84 when poor outcome was defined by an mRS score > 3. Data in this study indicate that in the analysis of NIS data sets, the NIS-SSS is a valid measure of SAH severity that outperforms previous measures of disease severity and that the NIS-SOM is a valid measure of SAH outcome. It is critically important that outcomes research in SAH using administrative data sets incorporate the NIS-SSS and NIS-SOM to adjust for neurology-specific disease severity.

Comparison of Associations of Urine Protein-Creatinine Ratio Versus Albumin-Creatinine Ratio With Complications of CKD: A Cross-sectional Analysis

PubMed Central

Fisher, Herrick; Hsu, Chi-yuan; Vittinghoff, Eric; Lin, Feng; Bansal, Nisha

2013-01-01

Background Urine albumin-creatinine ratio (ACR) and protein-creatinine ratio (PCR) are important markers of kidney damage and are utilized for prognosis in persons with chronic kidney disease (CKD). Despite how commonly these measurements are done in clinical practice, relatively few studies have directly compared the performance of these two measures with regard to associations with clinical outcomes, which may inform clinicians about which measure of urinary protein excretion is best. We studied the association of ACR and PCR with common complications of CKD. Study Design Cross-sectional study. Setting & Participants 3,481 participants with CKD in the Chronic Renal Insufficiency Cohort (CRIC) study. Predictors ACR and PCR. Outcomes We examined the association between ACR and PCR with measures of common CKD complications: serum hemoglobin, bicarbonate, parathyroid hormone, phosphorus, potassium and albumin. Measurements Restricted cubic spline analyses adjusted for estimated glomerular filtration rate (eGFR; calculated by the MDRD [Modification of Diet in Renal Disease] Study Equation) were performed to study the continuous association with our predictors with each outcome. Results Mean eGFR was 43 ± 13 (SD) ml/min/1.73 m2 and median levels of PCR and ACR were 140 and 46 mg/g, respectively. In continuous analyses adjusted for eGFR, higher ACR and PCR were comparable and both were associated with lower levels of serum hemoglobin, bicarbonate, and albumin and higher levels of parathyroid hormone, phosphorus, and potassium. Across all outcomes, the associations of ACR and PCR were comparable with only small, absolute differences in the outcome measure. Similar associations were seen in patients with diabetes mellitus. Limitations Participants largely had moderate CKD with low levels of ACR and PCR, so results may not be generalizable to all CKD populations. Conclusions In persons with CKD, ACR and PCR are relatively comparable in their associations with common complications of CKD. Thus routine measurement of PCR may provide similar information as ACR in managing immediate complications of CKD. PMID:24041612

Kinematic measures for upper limb motor assessment during robot-mediated training in patients with severe sub-acute stroke.

PubMed

Duret, Christophe; Courtial, Ophélie; Grosmaire, Anne Gaelle

2016-01-01

Kinematic assessments are increasingly used as motor outcome measures during upper limb robot-assisted training, in addition to clinical scales. However, their relevance has not been evaluated much. Thirty-eight patients with severe sub-acute stroke (age 56 ± 17 [19-87] years; time since stroke, 55 ± 22 days) carried out 16 sessions (average 3/week, 35 ± 15 days) of upper limb robot-assisted training combined with standard therapy. Pre/post motor performance was evaluated using the Fugl-Meyer Assessment scale, Motor Status Scale (MSS) and kinematic measures. Motor outcomes were compared and relationships between clinical and kinematic outcomes were analyzed. All clinical and kinematic outcomes improved after training (p <  0.01). FM score increased from 17.7 ± 10.0 to 28.6 ± 15.4. All baseline kinematic measures were strongly correlated with clinical scores. Correlations between clinical and kinematic changes were moderate (r = -0.65 for change in FM Proximal score and change in accuracy measure). However, smoothness and accuracy indicators were shown to be responsive measures. This study demonstrated that baseline kinematic measures and their pre/post training changes were significantly correlated with clinical motor outcome measures. However, even if kinematic measures are valid for the evaluation of motor impairment we cannot propose to substitute common clinical measures of motor function which also evaluate functional abilities of the upper limb.

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.

Effect of analgesic therapy on clinical outcome measures in a randomized controlled trial using client-owned dogs with hip osteoarthritis.

PubMed

Malek, Sarah; Sample, Susannah J; Schwartz, Zeev; Nemke, Brett; Jacobson, Peer B; Cozzi, Elizabeth M; Schaefer, Susan L; Bleedorn, Jason A; Holzman, Gerianne; Muir, Peter

2012-10-04

Pain and impaired mobility because of osteoarthritis (OA) is common in dogs and humans. Efficacy studies of analgesic drug treatment of dogs with naturally occurring OA may be challenging, as a caregiver placebo effect is typically evident. However, little is known about effect sizes of common outcome-measures in canine clinical trials evaluating treatment of OA pain. Forty-nine client-owned dogs with hip OA were enrolled in a randomized, double-blinded placebo-controlled prospective trial. After a 1 week baseline period, dogs were randomly assigned to a treatment (ABT-116 - transient receptor potential vanilloid 1 (TRPV1) antagonist, Carprofen - non-steroidal anti-inflammatory drug (NSAID), Tramadol - synthetic opiate, or Placebo) for 2 weeks. Outcome-measures included physical examination parameters, owner questionnaire, activity monitoring, gait analysis, and use of rescue medication. Acute hyperthermia developed after ABT-116 treatment (P < 0.001). Treatment with carprofen (P ≤ 0.01) and tramadol (P ≤ 0.001) led to improved mobility assessed by owner questionnaire. Nighttime activity was increased after ABT-116 treatment (P = 0.01). Kinetic gait analysis did not reveal significant treatment effects. Use of rescue treatment decreased with treatment in the ABT-116 and Carprofen groups (P < 0.001). Questionnaire score and activity count at the end of treatment were correlated with age, clinical severity at trial entry, and outcome measure baseline status (SR ≥ ±0.40, P ≤ 0.005). Placebo treatment effects were evident with all variables studied. Treatment of hip OA in client-owned dogs is associated with a placebo effect for all variables that are commonly used for efficacy studies of analgesic drugs. This likely reflects caregiver bias or the phenomenon of regression to the mean. In the present study, outcome measures with significant effects also varied between groups, highlighting the value of using multiple outcome measures, as well as an a priori analysis of effect size associated with each measure. Effect size data from the present study could be used to inform design of future trials studying analgesic treatment of canine OA. Our results suggest that analgesic treatment with ABT-116 is not as effective as carprofen or tramadol for treatment of hip arthritis pain in client-owned dogs.

Effect of analgesic therapy on clinical outcome measures in a randomized controlled trial using client-owned dogs with hip osteoarthritis

PubMed Central

2012-01-01

Background Pain and impaired mobility because of osteoarthritis (OA) is common in dogs and humans. Efficacy studies of analgesic drug treatment of dogs with naturally occurring OA may be challenging, as a caregiver placebo effect is typically evident. However, little is known about effect sizes of common outcome-measures in canine clinical trials evaluating treatment of OA pain. Forty-nine client-owned dogs with hip OA were enrolled in a randomized, double-blinded placebo-controlled prospective trial. After a 1 week baseline period, dogs were randomly assigned to a treatment (ABT-116 – transient receptor potential vanilloid 1 (TRPV1) antagonist, Carprofen – non-steroidal anti-inflammatory drug (NSAID), Tramadol - synthetic opiate, or Placebo) for 2 weeks. Outcome-measures included physical examination parameters, owner questionnaire, activity monitoring, gait analysis, and use of rescue medication. Results Acute hyperthermia developed after ABT-116 treatment (P < 0.001). Treatment with carprofen (P ≤ 0.01) and tramadol (P ≤ 0.001) led to improved mobility assessed by owner questionnaire. Nighttime activity was increased after ABT-116 treatment (P = 0.01). Kinetic gait analysis did not reveal significant treatment effects. Use of rescue treatment decreased with treatment in the ABT-116 and Carprofen groups (P < 0.001). Questionnaire score and activity count at the end of treatment were correlated with age, clinical severity at trial entry, and outcome measure baseline status (SR ≥ ±0.40, P ≤ 0.005). Placebo treatment effects were evident with all variables studied. Conclusion Treatment of hip OA in client-owned dogs is associated with a placebo effect for all variables that are commonly used for efficacy studies of analgesic drugs. This likely reflects caregiver bias or the phenomenon of regression to the mean. In the present study, outcome measures with significant effects also varied between groups, highlighting the value of using multiple outcome measures, as well as an a priori analysis of effect size associated with each measure. Effect size data from the present study could be used to inform design of future trials studying analgesic treatment of canine OA. Our results suggest that analgesic treatment with ABT-116 is not as effective as carprofen or tramadol for treatment of hip arthritis pain in client-owned dogs. PMID:23035739

A Qualitative Study of US Clinical Ethics Services: Objectives and Outcomes.

PubMed

McClimans, Leah; Pressgrove, Geah; Rhea, James

2016-01-01

The quality of clinical ethics services in health care organizations is increasingly seen as an important aspect of the overall quality of care. But measuring this quality is difficult because there is a lack of clarity and consensus regarding the objectives of clinical ethics and the best outcome domains to measure. The aim of this qualitative study is to explore the views of experts about the objectives and outcomes of clinical ethics services in the US. We interviewed 19 experts in clinical ethics, focusing on the appropriate objectives and outcomes of a clinical ethics service (CES). Participants were selected using a purposive snowball sampling strategy. The development of the interview protocol was informed by the clinical ethics literature as well as by research and theories that inform clinical ethics practice. Interviews were conducted by phone, recorded, and transcribed for individual analysis. Analysis proceeded through the development of a codebook of categories using QDA Miner software. Our experts identified 12 objectives and nine outcomes. Some of these identifications were familiar (e.g., mediation and satisfaction) and some were novel (e.g., be of service and transformation). We found that experts are divided in their emphasis on the kinds of objectives that are most important. In terms of outcomes, our experts were concerned with the appropriateness of different proxy and direct measures. This study provides the perspectives of a select group of experts on the objectives and outcomes appropriate for a CES in the United States. The themes identified will be used in future research to inform a Delphi study to refine and obtain expert consensus.

Acculturation and Bicultural Efficacy Effects on Chinese American Immigrants’ Diabetes and Health Management

PubMed Central

Chun, Kevin M.; Kwan, Christine M. L.; Strycker, Lisa A.; Chesla, Catherine A.

2016-01-01

The primary goal of this study was to examine effects of bicultural efficacy, or perceived confidence in dealing with bicultural acculturation stressors, on type 2 diabetes management and health for first-generation, Cantonese-speaking, Chinese American immigrants (N=162) recruited for a larger community-based diabetes intervention study (Chesla et al., 2013). The current study also tested whether a new Bicultural Efficacy in Health Management (BEFF-HM) scale is a more robust predictor of diabetes and health outcomes than proxy (years in the U.S.) and general acculturation measures. Hierarchical regression analyses of cross-sectional data revealed that high BEFF-HM was significantly related to positive outcomes on five of six diabetes and health measures as hypothesized after accounting for participant characteristics, proxy and general acculturation measures, and social support. Proxy and general acculturation measures failed to predict any study outcome supporting our secondary hypothesis that BEFF-HM is a better predictor of Chinese American immigrants’ diabetes and health management. An immigrant-focused research approach advances understanding of acculturation and bicultural efficacy effects on health by identifying key acculturation domains for study. PMID:27412776

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

PubMed

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

2010-04-01

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

Adherence to cognitive behavioral therapy for insomnia: a systematic review.

PubMed

Matthews, Ellyn E; Arnedt, J Todd; McCarthy, Michaela S; Cuddihy, Leisha J; Aloia, Mark S

2013-12-01

Chronic insomnia is a significant public health problem worldwide, and insomnia has considerable personal and social costs associated with serious health conditions, greater healthcare utilization, work absenteeism, and motor-vehicle accidents. Cognitive behavioral therapy for insomnia (CBTI) is an efficacious treatment, yet attrition and suboptimal adherence may diminish its impact. Despite the increasing use of CBTI, surprisingly little attention has been devoted to understanding the role of adherence. This review describes a comprehensive literature search of adherence to CBTI. The search revealed 15 studies that evaluated adherence to CBTI in adults using valid and reliable measures of sleep, and measure of adherence other than study withdrawals. The primary purposes of this review were to 1) synthesize current study characteristics, methodology, adherence rates, contributing factors, and impact on outcomes, 2) discuss measurement issues, and 3) identify future practice and research directions that may lead to improved outcomes. Strong patterns and inconsistencies were identified among the studies, which complicate an evaluation of the role of adherence as a factor and outcome of CBTI success. The importance of standardized adherence and outcome measures is discussed. In light of the importance of adherence to behavior change, this systematic review may better inform future intervention efforts. Copyright © 2013 Elsevier Ltd. All rights reserved.

Developing a Web-Based Nursing Practice and Research Information Management System: A Pilot Study.

PubMed

Choi, Jeeyae; Lapp, Cathi; Hagle, Mary E

2015-09-01

Many hospital information systems have been developed and implemented to collect clinical data from the bedside and have used the information to improve patient care. Because of a growing awareness that the use of clinical information improves quality of care and patient outcomes, measuring tools (electronic and paper based) have been developed, but most of them require multiple steps of data collection and analysis. This necessitated the development of a Web-based Nursing Practice and Research Information Management System that processes clinical nursing data to measure nurses' delivery of care and its impact on patient outcomes and provides useful information to clinicians, administrators, researchers, and policy makers at the point of care. This pilot study developed a computer algorithm based on a falls prevention protocol and programmed the prototype Web-based Nursing Practice and Research Information Management System. It successfully measured performance of nursing care delivered and its impact on patient outcomes successfully using clinical nursing data from the study site. Although Nursing Practice and Research Information Management System was tested with small data sets, results of study revealed that it has the potential to measure nurses' delivery of care and its impact on patient outcomes, while pinpointing components of nursing process in need of improvement.

Evaluation of interventions for informed consent for randomised controlled trials (ELICIT): protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey.

PubMed

Gillies, Katie; Entwistle, Vikki; Treweek, Shaun P; Fraser, Cynthia; Williamson, Paula R; Campbell, Marion K

2015-10-27

The process of obtaining informed consent for participation in randomised controlled trials (RCTs) was established as a mechanism to protect participants against undue harm from research and allow people to recognise any potential risks or benefits associated with the research. A number of interventions have been put forward to improve this process. Outcomes reported in trials of interventions to improve the informed consent process for decisions about trial participation tend to focus on the 'understanding' of trial information. However, the operationalization of understanding as a concept, the tools used to measure it and the timing of the measurements are heterogeneous. A lack of clarity exists regarding which outcomes matter (to whom) and why. This inconsistency between studies results in difficulties when making comparisons across studies as evidenced in two recent systematic reviews of informed consent interventions. As such, no optimal method for measuring the impact of these interventions aimed at improving informed consent for RCTs has been identified. The project will adopt and adapt methodology previously developed and used in projects developing core outcome sets for assessment of clinical treatments. Specifically, the work will consist of three stages: 1) A systematic methodology review of existing outcome measures of trial informed consent interventions; 2) Interviews with key stakeholders to explore additional outcomes relevant for trial participation decisions; and 3) A Delphi study to refine the core outcome set for evaluation of trial informed consent interventions. All stages will include the stakeholders involved in the various aspects of RCT consent: users (that is, patients), developers (that is, trialists), deliverers (focusing on research nurses) and authorisers (that is, ethics committees). A final consensus meeting including all stakeholders will be held to review outcomes. The ELICIT study aims to develop a core outcome set for the evaluation of interventions intended to improve informed consent for RCTs for use in future RCTs and reviews, thereby improving the reliability and consistency of research in this area.

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

PubMed

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

2015-09-16

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

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.

The impact of poverty reduction and development interventions on non-communicable diseases and their behavioural risk factors in low and lower-middle income countries: A systematic review

PubMed Central

Pullar, Jessie; Allen, Luke; Townsend, Nick; Williams, Julianne; Foster, Charlie; Roberts, Nia; Rayner, Mike; Mikkelsen, Bente; Branca, Francesco

2018-01-01

Introduction Non-communicable diseases (NCDs) disproportionately affect low- and lower-middle income countries (LLMICs) where 80% of global NCD related deaths occur. LLMICs are the primary focus of interventions to address development and poverty indicators. We aimed to synthesise the evidence of these interventions' impact on the four primary NCDs (cardiovascular disease, diabetes, chronic respiratory disease and cancer) and their common behavioural risk factors (unhealthy diets, physical inactivity, tobacco and alcohol use). Methods We systematically searched four online databases (Medline, Embase, Web of Science and Global Health) for primary research conducted in LLMICS, published between January 1st 1990 and February 15th 2016. Studies involved development or poverty interventions which reported on outcomes relating to NCDs. We extracted summary level data on study design, population, health outcomes and potential confounders. Results From 6383 search results, 29 studies from 24 LLMICs published between 1999 and 2015 met our inclusion criteria. The quality of included studies was limited and heterogeneity of outcome measures required narrative synthesis. One study measured impact on NCD prevalence, one physical activity and 27 dietary components. The majority of papers (23), involved agricultural interventions. Primary outcome measures tended to focus on undernutrition. Intensive agricultural interventions were associated with improved calorie, vitamin, fruit and vegetable intake. However, positive impacts were reliant on participant's land ownership, infection status and limited in generalisability. Just three studies measured adult obesity; two indicated increased income and consequential food affordability had the potential to increase obesity. Overall, there was poor alignment between included studies outcome measures and the key policy options and objectives of the Global Action Plan on NCDs. Conclusions Though many interventions addressing poverty and development have great potential to impact on NCD prevalence and risk, most fail to measure or report these outcomes. Current evidence is limited to behavioural risk factors, namely diet and suggests a positive impact of agricultural-based food security programmes on dietary indicators. However, studies investigating the impact of improved income on obesity tend to show an increased risk. Embedding NCD impact evaluation into development programmes is crucial in the context of the Sustainable Development Goals and the rapid epidemiological transitions facing LLMICs. PMID:29474454

The impact of poverty reduction and development interventions on non-communicable diseases and their behavioural risk factors in low and lower-middle income countries: A systematic review.

PubMed

Pullar, Jessie; Allen, Luke; Townsend, Nick; Williams, Julianne; Foster, Charlie; Roberts, Nia; Rayner, Mike; Mikkelsen, Bente; Branca, Francesco; Wickramasinghe, Kremlin

2018-01-01

Non-communicable diseases (NCDs) disproportionately affect low- and lower-middle income countries (LLMICs) where 80% of global NCD related deaths occur. LLMICs are the primary focus of interventions to address development and poverty indicators. We aimed to synthesise the evidence of these interventions' impact on the four primary NCDs (cardiovascular disease, diabetes, chronic respiratory disease and cancer) and their common behavioural risk factors (unhealthy diets, physical inactivity, tobacco and alcohol use). We systematically searched four online databases (Medline, Embase, Web of Science and Global Health) for primary research conducted in LLMICS, published between January 1st 1990 and February 15th 2016. Studies involved development or poverty interventions which reported on outcomes relating to NCDs. We extracted summary level data on study design, population, health outcomes and potential confounders. From 6383 search results, 29 studies from 24 LLMICs published between 1999 and 2015 met our inclusion criteria. The quality of included studies was limited and heterogeneity of outcome measures required narrative synthesis. One study measured impact on NCD prevalence, one physical activity and 27 dietary components. The majority of papers (23), involved agricultural interventions. Primary outcome measures tended to focus on undernutrition. Intensive agricultural interventions were associated with improved calorie, vitamin, fruit and vegetable intake. However, positive impacts were reliant on participant's land ownership, infection status and limited in generalisability. Just three studies measured adult obesity; two indicated increased income and consequential food affordability had the potential to increase obesity. Overall, there was poor alignment between included studies outcome measures and the key policy options and objectives of the Global Action Plan on NCDs. Though many interventions addressing poverty and development have great potential to impact on NCD prevalence and risk, most fail to measure or report these outcomes. Current evidence is limited to behavioural risk factors, namely diet and suggests a positive impact of agricultural-based food security programmes on dietary indicators. However, studies investigating the impact of improved income on obesity tend to show an increased risk. Embedding NCD impact evaluation into development programmes is crucial in the context of the Sustainable Development Goals and the rapid epidemiological transitions facing LLMICs.

Treatment of trauma-affected refugees with venlafaxine versus sertraline combined with psychotherapy - a randomised study.

PubMed

Sonne, Charlotte; Carlsson, Jessica; Bech, Per; Elklit, Ask; Mortensen, Erik Lykke

2016-11-08

The prevalence of trauma-related psychiatric disorders is high among refugees. Despite this, little is known about the effect of pharmacological treatment for this patient group. The objective of the present study was therefore to examine differences in the effects of venlafaxine and sertraline on Post-Traumatic Stress Disorder (PTSD), depression and functional impairment in trauma-affected refugees. The study was a randomised pragmatic trial comparing venlafaxine and sertraline in combination with psychotherapy and social counselling. PTSD symptoms were measured on the Harvard Trauma Questionnaire - part IV, which was the primary outcome measure. Other outcome measures included: Hopkins Symptom Check List-25 (depression and anxiety), Social Adjustment Scale - short version (social functioning), WHO-5 Well-being Index (quality of life), Crisis Support Scale (support from social network), Sheehan Disability Scale (disability in three areas of functioning), Hamilton Depression and Anxiety scale, the somatisation items of the Symptoms Checklist-90, Global Assessment of Functioning scales and the summarised score of pain in four body areas rated on visual analogue scales. Two hundred seven adult refugee patients were included in the trial (98 in the venlafaxine and 109 in the sertraline group). Of these, 195 patients were eligible for intention-to-treat analyses. Small but significant pre-treatment to post-treatment differences were found on the Harvard Trauma Questionnaire and a number of other ratings in both groups. On the primary outcome measure, no difference was found in treatment effect between the sertraline and venlafaxine group. A significant group difference was found in favour of sertraline on the Sheehan Disability Scale. Sertraline had a slightly better outcome than venlafaxine on some of the secondary outcome measures, but not on the primary outcome measure. Furthermore, a higher percentage of dropouts was found in the venlafaxine group compared to the sertraline group. Although this could indicate that sertraline was better tolerated, which is supported by other studies, a final conclusion on tolerability cannot be drawn from the current study due to lack of systematic reporting of side effects. ClinicalTrials.gov NCT01569685 . Registration date: 28/2/12.

Towards a Unified Testing Framework for Single-Sided Deafness Studies: A Consensus Paper

PubMed Central

Van de Heyning, Paul; Távora-Vieira, Dayse; Mertens, Griet; Van Rompaey, Vincent; Rajan, Gunesh P.; Müller, Joachim; Hempel, John Martin; Leander, Daniel; Polterauer, Daniel; Marx, Mathieu; Usami, Shin-ichi; Kitoh, Ryosuke; Miyagawa, Maiko; Moteki, Hideaki; Smilsky, Kari; Baumgartner, Wolf-Dieter; Keintzel, Thomas Georg; Sprinzl, Georg Mathias; Wolf-Magele, Astrid; Arndt, Susan; Wesarg, Thomas; Zirn, Stefan; Baumann, Uwe; Weissgerber, Tobias; Rader, Tobias; Hagen, Rudolf; Kurz, Anja; Rak, Kristen; Stokroos, Robert; George, Erwin; Polo, Ruben; Medina, María del Mar; Henkin, Yael; Hilly, Ohad; Ulanovski, David; Rajeswaran, Ranjith; Kameswaran, Mohan; Di Gregorio, Maria Fernanda; Zernotti, Mario E.

2017-01-01

Background While hearing aids for a contralateral routing of signals (CROS-HA) and bone conduction devices have been the traditional treatment for single-sided deafness (SSD) and asymmetric hearing loss (AHL), in recent years, cochlear implants (CIs) have increasingly become a viable treatment choice, particularly in countries where regulatory approval and reimbursement schemes are in place. Part of the reason for this shift is that the CI is the only device capable of restoring bilateral input to the auditory system and hence of possibly reinstating binaural hearing. Although several studies have independently shown that the CI is a safe and effective treatment for SSD and AHL, clinical outcome measures in those studies and across CI centers vary greatly. Only with a consistent use of defined and agreed-upon outcome measures across centers can high-level evidence be generated to assess the safety and efficacy of CIs and alternative treatments in recipients with SSD and AHL. Methods This paper presents a comparative study design and minimum outcome measures for the assessment of current treatment options in patients with SSD/AHL. The protocol was developed, discussed, and eventually agreed upon by expert panels that convened at the 2015 APSCI conference in Beijing, China, and at the CI 2016 conference in Toronto, Canada. Results A longitudinal study design comparing CROS-HA, BCD, and CI treatments is proposed. The recommended outcome measures include (1) speech in noise testing, using the same set of 3 spatial configurations to compare binaural benefits such as summation, squelch, and head shadow across devices; (2) localization testing, using stimuli that rove in both level and spectral content; (3) questionnaires to collect quality of life measures and the frequency of device use; and (4) questionnaires for assessing the impact of tinnitus before and after treatment, if applicable. Conclusion A protocol for the assessment of treatment options and outcomes in recipients with SSD and AHL is presented. The proposed set of minimum outcome measures aims at harmonizing assessment methods across centers and thus at generating a growing body of high-level evidence for those treatment options. PMID:28319951

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

PubMed

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

2017-04-01

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

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.

Impact of Health Literacy in Patients with Chronic Musculoskeletal Disease–Systematic Review

PubMed Central

Loke, Yoon K.; Hinz, Ina; Wang, Xia; Rowlands, Gill; Scott, David; Salter, Charlotte

2012-01-01

Objectives To estimate the prevalence of low health literacy, and evaluate the impact of low health literacy on outcomes in patients with chronic musculoskeletal conditions. Data Sources We searched Embase, Pubmed, PsycInfo, and CINAHL in January 2011 for relevant studies, restricted to English-language articles. Study Selection and Data Extraction Studies were included if they measured health literacy and/or reported on the link between outcomes and health literacy levels in patients with osteoporosis, osteoarthritis, or rheumatoid arthritis. We assessed risk of bias from participant selection, methods of measuring health literacy and functional outcomes, missing data, and potential for confounding. Data Synthesis We reviewed 1863 citations and judged 8 studies to be relevant. Most were cross-sectional in nature, and five were based in the United States. Diversity in measurements, participant characteristics, and settings meant that results had to be synthesized narratively. Prevalence of low health literacy varied from 7% to 42%. Of the five studies that reported on musculoskeletal outcomes, only one showed an association (unadjusted) between low health literacy and greater pain and limitations in physical functioning. However, other studies, including those with multivariate analyses, found no significant relationship between health literacy and measures of pain or disease specific questionnaires. One clinical trial found short-term improvements in the mental health of patients with musculoskeletal conditions after an intervention to improve health literacy. Limitations Most of the studies were cross-sectional in nature, which precludes interpretation of a causal relationship. The sample sizes may not have been sufficiently large to enable detection of significant associations. Conclusions The current evidence does not show a consistent association between low health literacy and poorer functional outcomes in patients with chronic musculoskeletal conditions. In the absence of a definite link, efforts to develop interventions to improve health literacy would not necessarily improve health service or patient-related outcomes. PMID:22792242

Psychological effects of belonging to a Facebook weight management group in overweight and obese adults: Results of a randomised controlled trial.

PubMed

Jane, Monica; Foster, Jonathan; Hagger, Martin; Ho, Suleen; Kane, Robert; Pal, Sebely

2018-05-18

This study was conducted to test whether the weight outcomes in an online social networking group were mediated by changes to psychological outcome measures in overweight and obese individuals, following a weight management programme delivered via Facebook. The data analysed in this study were collected during a three-armed, randomised, controlled clinical weight management trial conducted with overweight and obese adults over 24 weeks. Two intervention groups were given the same weight management programme: one within a Facebook group, along with peer support from other group members (the Facebook Group); the other group received the same programme in a pamphlet (the Pamphlet Group). A Control Group was given standard care. The primary outcome was weight; secondary outcomes included the following domains from self-reported questionnaires: energy intake and expenditure; psychological health, social relationships, physical health, quality of life, depression, anxiety, stress, health anxiety, happiness, as well as Facebook Group participants' opinion of this group. The Facebook Group experienced a reduction in their baseline weight measurement by week 24, significantly compared to the Control Group (p = .016). The Facebook Group recorded a significant increase in the psychological health domain during the trial (at week 12) relative to their baseline measurement, and significant compared to the Control Group (p = .022). Mediation analysis indicated a statistical trend, but not statistical significance, for psychological health as a mediator to weight loss in the Facebook Group. While both intervention groups showed significant changes in psychological outcome measures, the Facebook Group was the only group to experience statistically significant weight loss by the end of the 24 weeks. Therefore, an examination of other psychological and/or behavioural outcome measures undertaken in larger studies in the future may help to identify significant mediators to improved weight loss outcomes in online social networking groups. © 2018 John Wiley & Sons Ltd.

Evaluating Willingness-to-Pay Thresholds for Dementia Caregiving Interventions: Application to the Tailored Activity Program

PubMed Central

Jutkowitz, Eric; Gitlin, Laura N.; Pizzi, Laura T.

2017-01-01

Objectives The study aims to apply willingness-to-pay (WTP) values derived from the literature to inform decision-makers of the cost-effectiveness of the Tailored Activity Program (TAP), an intervention proven to reduce caregiver burden. Methods TAP and other caregiver interventions employ an individual perspective and non–quality-adjusted life-year (QALY) outcome measure where the primary objective is to determine caregiver burden from an individual perspective. Therefore, standard cost/QALY thresholds are not appropriate. To identify relevant WTP values, we searched for studies that: 1) were published in the past 5 years and used contingent valuation methodology to identify WTP; 2) assessed WTP for a dementia-related intervention requiring out-of-pocket expenditure; and 3) asked caregivers their WTP for an outcome related to reducing caregiver burden. Three studies were identified utilizing four WTP values. We also assessed potential financial savings that caregivers could achieve from purchasing TAP. To assess the probability of TAP being cost-effective, we built a Monte Carlo simulation to test the four WTP values applied to two TAP outcome measures: reduction in caregiver hours “on duty;” and “doing things.” Results For outcome measure “on duty,” WTP varied between $1.06/hour and $4.58/hour. For outcome measure “doing things,” WTP varied between $2.21/hour and $9.57/hour. Applying the four identified WTP values from the literature to TAP outcomes resulted in TAP cost-effectiveness varying between 50% and 80% for both outcome measures. Conclusions When WTP data are not collected prospectively or conventional metrics cannot be applied, retrospectively assessing literature-derived WTP may be acceptable for informing decision-makers of potential cost-effectiveness of a proven program. Application of WTP to TAP shows potential cost-effectiveness that can be expected under the tested WTP scenarios. PMID:20561331

Effects of mental demands during dispensing on perceived medication safety and employee well being: A study of workload in pediatric hospital pharmacies

PubMed Central

Holden, Richard J.; Patel, Neal R.; Scanlon, Matthew C.; Shalaby, Theresa M.; Arnold, Judi M.; Karsh, Ben-Tzion

2009-01-01

Background Pharmacy workload is a modifiable work system factor believed to affect both medication safety outcomes and employee outcomes such as job satisfaction. Objectives This study sought to measure the effect of workload on safety and employee outcomes in two pediatric hospitals and to do so using a novel approach to pharmacy workload measurement. Methods Rather than measuring prescription volume or other similar indicators, this study measured the type and intensity of mental demands experienced during the medication dispensing tasks. The effects of external (interruptions, divided attention, rushing) and internal (concentration, effort) task demands on perceived medication error likelihood, adverse drug event likelihood, job dissatisfaction, and burnout were statistically estimated using multiple linear and logistic regression. Results Pharmacists and pharmacy technicians reported high levels of external and internal mental demands during dispensing. The study supported the hypothesis that external demands (interruptions, divided attention, rushing) negatively impacted medication safety and employee well being outcomes. However, as hypothesized, increasing levels of internal demands (concentration and effort) were not associated with greater perceived likelihood of error, adverse drug events, or burnout, and even had a positive effect on job satisfaction. Conclusion Replicating a prior study in nursing, this study shows that new conceptualizations and measures of workload can generate important new findings about both detrimental and beneficial effects of workload on patient safety and employee well being. This study discusses what those findings imply for policy, management, and design concerning automation, cognition, and staffing. PMID:21111387

Effects of mental demands during dispensing on perceived medication safety and employee well-being: a study of workload in pediatric hospital pharmacies.

PubMed

Holden, Richard J; Patel, Neal R; Scanlon, Matthew C; Shalaby, Theresa M; Arnold, Judi M; Karsh, Ben-Tzion

2010-12-01

Pharmacy workload is a modifiable work system factor believed to affect both medication safety outcomes and employee outcomes, such as job satisfaction. This study sought to measure the effect of workload on safety and employee outcomes in 2 pediatric hospitals and to do so using a novel approach to pharmacy workload measurement. Rather than measuring prescription volume or other similar indicators, this study measured the type and intensity of mental demands experienced during the medication dispensing tasks. The effects of external (interruptions, divided attention, and rushing) and internal (concentration and effort) task demands on perceived medication error likelihood, adverse drug event likelihood, job dissatisfaction, and burnout were statistically estimated using multiple linear and logistic regression. Pharmacists and pharmacy technicians reported high levels of external and internal mental demands during dispensing. The study supported the hypothesis that external demands (interruptions, divided attention, and rushing) negatively impacted medication safety and employee well-being outcomes. However, as hypothesized, increasing levels of internal demands (concentration and effort) were not associated with greater perceived likelihood of error, adverse drug events, or burnout and even had a positive effect on job satisfaction. Replicating a prior study in nursing, this study shows that new conceptualizations and measures of workload can generate important new findings about both detrimental and beneficial effects of workload on patient safety and employee well-being. This study discusses what those findings imply for policy, management, and design concerning automation, cognition, and staffing. Copyright © 2010 Elsevier Inc. All rights reserved.

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.

A thick placenta: a predictor of adverse pregnancy outcomes.

PubMed

Miwa, Ichiro; Sase, Masakatsu; Torii, Mayumi; Sanai, Hiromi; Nakamura, Yasuhiko; Ueda, Kazuyuki

2014-01-01

The aim of this study is to evaluate the efficacy of an ultrasonographic measurement of placental thickness and the correlation of a thick placenta with adverse perinatal outcome. Placental thickness was measured in single gravidas, 16 to 40 weeks of gestation, between 2005 and 2009. Placentas were considered to be thick if their measured thickness were above the 95th percentile for gestational age. The incidence of thick placentas was 4.3% (138/3,183). Perinatal morbidity and neonatal conditions were worse in cases with thick placenta rather than without thick placenta. Ultrasonographic measurement of placental thickness is a simple method to estimate placental size. Thick placenta may be a useful predictor of adverse pregnancy outcomes.

Are K-12 learners motivated in physical education? A meta-analysis.

PubMed

Chen, Senlin; Chen, Ang; Zhu, Xihe

2012-03-01

Previous studies devoted to K-12 learner motivation in physical education share a general assumption that students may lack motivation. This meta-analytic study examined published original studies (n = 79) to determine students' motivation level and the association between motivation and outcomes. Original means of motivation measures were converted and aggregated to determine motivation levels. Correlation effect sizes were calculated to determine the association between motivation and outcome measures. The analyses revealed that K-12 students are motivated regardless of the theoretical constructs used in the studies (M > 50). The correlation effect sizes (r = .20-.30, p < .05) indicate a weak association between motivation and outcome. The findings suggest a need to involve meaningful learning and pedagogy variables in motivation research.

Self-selection and bias in a large prospective pregnancy cohort in Norway.

PubMed

Nilsen, Roy M; Vollset, Stein Emil; Gjessing, Håkon K; Skjaerven, Rolv; Melve, Kari K; Schreuder, Patricia; Alsaker, Elin R; Haug, Kjell; Daltveit, Anne Kjersti; Magnus, Per

2009-11-01

Self-selection in epidemiological studies may introduce selection bias and influence the validity of study results. To evaluate potential bias due to self-selection in a large prospective pregnancy cohort in Norway, the authors studied differences in prevalence estimates and association measures between study participants and all women giving birth in Norway. Women who agreed to participate in the Norwegian Mother and Child Cohort Study (43.5% of invited; n = 73 579) were compared with all women giving birth in Norway (n = 398 849) using data from the population-based Medical Birth Registry of Norway in 2000-2006. Bias in the prevalence of 23 exposure and outcome variables was measured as the ratio of relative frequencies, whereas bias in exposure-outcome associations of eight relationships was measured as the ratio of odds ratios. Statistically significant relative differences in prevalence estimates between the cohort participants and the total population were found for all variables, except for maternal epilepsy, chronic hypertension and pre-eclampsia. There was a strong under-representation of the youngest women (<25 years), those living alone, mothers with more than two previous births and with previous stillbirths (relative deviation 30-45%). In addition, smokers, women with stillbirths and neonatal death were markedly under-represented in the cohort (relative deviation 22-43%), while multivitamin and folic acid supplement users were over-represented (relative deviation 31-43%). Despite this, no statistically relative differences in association measures were found between participants and the total population regarding the eight exposure-outcome associations. Using data from the Medical Birth Registry of Norway, this study suggests that prevalence estimates of exposures and outcomes, but not estimates of exposure-outcome associations are biased due to self-selection in the Norwegian Mother and Child Cohort Study.

Evaluation of a nurse-led disease management programme for chronic kidney disease: a randomized controlled trial.

PubMed

Wong, Frances Kam Yuet; Chow, Susan Ka Yee; Chan, Tony Moon Fai

2010-03-01

Patients with end stage renal failure require dialysis and strict adherence to treatment plans to sustain life. However, non-adherence is a common and serious problem among patients with chronic kidney disease. There is a scarcity of studies in examining the effects of disease management programmes on patients with chronic kidney disease. This paper examines whether the study group receiving the disease management programme have better improvement than the control group, comparing outcomes at baseline (O1), at 7 weeks at the completion of the programme (O2) and at 13 weeks (O3). This is a randomized controlled trial. The outcome measures were non-adherence in diet, fluid, dialysis and medication, quality of life, satisfaction, symptom control, complication control and health service utilisation. There was no significant difference between the control and study group for the baseline measures, except for sleep. Significant differences (p<0.05) were found between the control and study group at O2 in the outcome measures of diet degree non-adherence, sleep, symptom, staff encouragement, overall health and satisfaction. Sustained effects at O3 were noted in the outcome measures of continuous ambulatory peritoneal dialysis (CAPD) non-adherence degree, sleep, symptom, and effect of kidney disease. Many studies exploring chronic disease management have neglected the group with end stage renal failure and this study fills this gap. This study has employed an innovative model of skill mix using specialist and general nurses and demonstrated patient improvement in diet non-adherence, CAPD non-adherence, aspects of quality of life and satisfaction with care. Redesigning chronic disease management programmes helps to optimize the use of different levels of skills and resources to bring about positive outcomes. Copyright 2009 Elsevier Ltd. All rights reserved.

The Impact of Children's Social Adjustment on Academic Outcomes

ERIC Educational Resources Information Center

DeRosier, Melissa E.; Lloyd, Stacey W.

2011-01-01

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

Symptoms versus neurocognition as predictors of change in life skills in schizophrenia after outpatient rehabilitation.

PubMed

Kurtz, Matthew M; Wexler, Bruce E; Fujimoto, Marco; Shagan, Dana S; Seltzer, James C

2008-07-01

A growing body of literature has shown that neurocognitive deficits in schizophrenia account for 20-60% of the variance in measures of outcome, and in many studies are more closely related to outcome than symptoms [Green, M.F., Kern, R.S., Braff, D.L., Mintz, J., 2000. Neurocognitive deficits and functional outcome in schizophrenia: are we measuring the "right stuff"? Schizophr. Bull. 26(1), 119-136; Green, M.F., Kern, R.S., Heaton, R.K., 2004. Longitudinal studies of cognition and functional outcome in schizophrenia: implications for MATRICS. Schizophr. Res. 72(1), 41-51]. Most of these studies have been cross-sectional, few longitudinal studies have investigated the degree to which neurocognition and symptoms predict ability to benefit from outpatient rehabilitation, and no longitudinal studies use measures of everyday life skills that are performance-based. In the current study we investigated the relationship between five measures of neurocognitive function, crystallized verbal ability, visual sustained vigilance, verbal learning, problem-solving, and processing speed, and two measures of symptoms, total positive and negative symptoms, and change on a performance-based measure of everyday life skills after a year of outpatient rehabilitation. Rehabilitation consisted of both psychosocial and cognitive interventions. Forty-six patients with schizophrenia or schizoaffective disorder were studied. Results of a linear regression model revealed that verbal learning predicted a significant amount of the variance in change in performance-based measures of everyday life skills after outpatient rehabilitation, even when variance for all other variables in the model was accounted for. Measures of crystallized verbal ability, sustained visual vigilance, problem-solving, processing speed and symptoms were not linked to functional status change. These findings emphasize the importance of verbal learning for benefiting from psychosocial and cognitive rehabilitation interventions, and suggest the development of alternative rehabilitation strategies for those who do not benefit.

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.

The Effect of Financial Compensation on Health Outcomes following Musculoskeletal Injury: Systematic Review

PubMed Central

Murgatroyd, Darnel F.; Casey, Petrina P.; Cameron, Ian D.; Harris, Ian A.

2015-01-01

The effect of financial compensation on health outcomes following musculoskeletal injury requires further exploration because results to date are varied and controversial. This systematic review identifies compensation related factors associated with poorer health outcomes following musculoskeletal injury. Searches were conducted using electronic medical journal databases (Medline, CINAHL, Embase, Informit, Web of Science) for prospective studies published up to October 2012. Selection criteria included: prognostic factors associated with validated health outcomes; six or more months follow up; and multivariate statistical analysis. Studies solely measuring return to work outcomes were excluded. Twenty nine articles were synthesised and then assessed using GRADE (Grading of Recommendations Assessment, Development and Evaluation) methodology to determine evidence levels. The results were mixed. There was strong evidence of an association between compensation status and poorer psychological function; and legal representation and poorer physical function. There was moderate evidence of an association between compensation status and poorer physical function; and legal representation and poorer psychological function. There was limited evidence of an association between compensation status and increased pain. In seven studies the association depended on the outcome measured. No studies reported an association between compensation related factors and improved health outcomes. Further research is needed to find plausible reasons why compensation related factors are associated with poorer health following musculoskeletal injury. PMID:25680118

A Pilot Study of a Mindfulness Intervention for Adolescents and the Potential Role of Self-Compassion in Reducing Stress.

PubMed

Bluth, Karen; Roberson, Patricia N E; Gaylord, Susan A

2015-01-01

In this pilot study, we sought to investigate the effects of a mindfulness intervention for adolescents on a community sample of teens. Specifically, we explored the effects of mindfulness training on emotional well-being outcomes. Also, we examined the relationship between mindfulness and self-compassion at baseline-predicted outcome measures. This design was a pre-/post-pilot intervention study. Paired t-tests were conducted to examine change in outcome measures before and after the mindfulness intervention. Multiple regression was also conducted to investigate the influence of baseline mindfulness and self-compassion on outcome measures. The study took place after school in a classroom at a local university. Overall 28 adolescents age 10-18 years from two different cohorts participated in this study. Learning to BREATHE, a mindfulness curriculum designed specifically for adolescents and taught in six 1.5h sessions, was implemented. The outcome measures, life satisfaction and perceived stress, were included in an online survey before and after the mindfulness intervention. Results indicated that mindfulness, self-compassion, perceived stress, and life satisfaction improved from pre-intervention to post-intervention. Further, self-compassion (taught within the mindfulness intervention) was negatively related to perceived stress post-intervention while controlling for baseline stress. These findings suggest that mindfulness may be an effective intervention for improving indicators of emotional well-being among an adolescent population. Additionally, self-compassion may be a pathway through which youth can lower stress. Future research should examine self-compassion as a potential factor in promoting emotional well-being. Copyright © 2015 Elsevier Inc. All rights reserved.

Predicting Outcome of Face-to-Face and Telephone Counselling for Occupational Stress

ERIC Educational Resources Information Center

Karatzias, Thanos; Chouliara, Zoe; Power, Kevin; Kilfedder, Catherine

2011-01-01

The aim of the present study was to investigate predictors of outcome of counselling, using mean change scores of three outcome measures, at treatment completion and at 4-months follow-up, in a randomised trial of face-to-face (n = 30) versus telephone counselling (n = 30) for occupational stress. Factors associated with treatment outcome were…

Exploring the Link between Experienced Teachers' Learning Outcomes and Individual and Professional Learning Community Characteristics

ERIC Educational Resources Information Center

Vanblaere, Bénédicte; Devos, Geert

2016-01-01

The continuous professional development of teachers is crucial in our current knowledge-based society, yet empirical research on experienced teachers' learning outcomes is scarce. In this study, we examine perceived changes in classroom practices and in competence as outcomes. By making these outcomes measurable, we can relate them to several…

The relationship between the Early Childhood Environment Rating Scale and its revised form and child outcomes: A systematic review and meta-analysis.

PubMed

Brunsek, Ashley; Perlman, Michal; Falenchuk, Olesya; McMullen, Evelyn; Fletcher, Brooke; Shah, Prakesh S

2017-01-01

The Early Childhood Environment Rating Scale (ECERS) and its revised version (ECERS-R) were designed as global measures of quality that assess structural and process aspects of Early Childhood Education and Care (ECEC) programs. Despite frequent use of the ECERS/ECERS-R in research and applied settings, associations between it and child outcomes have not been systematically reviewed. The objective of this research was to evaluate the association between the ECERS/ECERS-R and children's wellbeing. Searches of Medline, PsycINFO, ERIC, websites of large datasets and reference sections of all retrieved articles were completed up to July 3, 2015. Eligible studies provided a statistical link between the ECERS/ECERS-R and child outcomes for preschool-aged children in ECEC programs. Of the 823 studies selected for full review, 73 were included in the systematic review and 16 were meta-analyzed. The combined sample across all eligible studies consisted of 33, 318 preschool-aged children. Qualitative systematic review results revealed that ECERS/ECERS-R total scores were more generally associated with positive outcomes than subscales or factors. Seventeen separate meta-analyses were conducted to assess the strength of association between the ECERS/ECERS-R and measures that assessed children's language, math and social-emotional outcomes. Meta-analyses revealed a small number of weak effects (in the expected direction) between the ECERS/ECERS-R total score and children's language and positive behavior outcomes. The Language-Reasoning subscale was weakly related to a language outcome. The enormous heterogeneity in how studies operationalized the ECERS/ECERS-R, the outcomes measured and statistics reported limited our ability to meta-analyze many studies. Greater consistency in study methodology is needed in this area of research. Despite these methodological challenges, the ECERS/ECERS-R does appear to capture aspects of quality that are important for children's wellbeing; however, the strength of association is weak.

The relationship between the Early Childhood Environment Rating Scale and its revised form and child outcomes: A systematic review and meta-analysis

PubMed Central

Brunsek, Ashley; Perlman, Michal; Falenchuk, Olesya; McMullen, Evelyn; Fletcher, Brooke; Shah, Prakesh S.

2017-01-01

The Early Childhood Environment Rating Scale (ECERS) and its revised version (ECERS-R) were designed as global measures of quality that assess structural and process aspects of Early Childhood Education and Care (ECEC) programs. Despite frequent use of the ECERS/ECERS-R in research and applied settings, associations between it and child outcomes have not been systematically reviewed. The objective of this research was to evaluate the association between the ECERS/ECERS-R and children’s wellbeing. Searches of Medline, PsycINFO, ERIC, websites of large datasets and reference sections of all retrieved articles were completed up to July 3, 2015. Eligible studies provided a statistical link between the ECERS/ECERS-R and child outcomes for preschool-aged children in ECEC programs. Of the 823 studies selected for full review, 73 were included in the systematic review and 16 were meta-analyzed. The combined sample across all eligible studies consisted of 33, 318 preschool-aged children. Qualitative systematic review results revealed that ECERS/ECERS-R total scores were more generally associated with positive outcomes than subscales or factors. Seventeen separate meta-analyses were conducted to assess the strength of association between the ECERS/ECERS-R and measures that assessed children’s language, math and social-emotional outcomes. Meta-analyses revealed a small number of weak effects (in the expected direction) between the ECERS/ECERS-R total score and children’s language and positive behavior outcomes. The Language-Reasoning subscale was weakly related to a language outcome. The enormous heterogeneity in how studies operationalized the ECERS/ECERS-R, the outcomes measured and statistics reported limited our ability to meta-analyze many studies. Greater consistency in study methodology is needed in this area of research. Despite these methodological challenges, the ECERS/ECERS-R does appear to capture aspects of quality that are important for children’s wellbeing; however, the strength of association is weak. PMID:28586399

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

PubMed

Nancarrow, Susan A

2013-01-01

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

Who Gets the Most Out of Cognitive-Behavioral Therapy for Anxiety Disorders?

PubMed Central

Glenn, Daniel; Golinelli, Daniela; Rose, Raphael D.; Roy-Byrne, Peter; Stein, Murray B.; Sullivan, Greer; Bystritksy, Alexander; Sherbourne, Cathy; Craske, Michelle G.

2013-01-01

Objective The present study explored treatment dose and patient engagement as predictors of treatment outcome in cognitive behavioral therapy (CBT) for anxiety disorders. Method Measures of high versus low treatment dose, and high versus low patient engagement in CBT were compared as predictors of 12 and 18 month outcomes for patients being treated for anxiety disorders with CBT (with or without concurrent pharmacotherapy) in primary care settings as part of a randomized controlled effectiveness trial of the Coordinated Anxiety Learning and Management (CALM) intervention. Measures of dose (attendance, exposure completion) and engagement in CBT (homework adherence, commitment) were collected throughout treatment, and blinded follow-up phone assessments of outcome measures (12-item Brief Symptom Inventory, Patient Health Questionnaire 8, Sheehan Disability Scale) were completed at 12 and 18 months. Propensity score weighting controlled for baseline differences in demographics and symptom severity between patients with high and low dose and engagement. These analyses included the 439 patients that selected CBT as treatment modality. Results Completing exposures, high attendance, and being more homework adherent predicted better outcomes across all measures at 12 and 18 months, and high CBT commitment predicted better outcomes on all measures at 18 months. Conclusions This study found that higher treatment dose and patient engagement in CBT for anxiety disorders were stable and robust predictors of greater reductions in anxiety symptoms, depression symptoms, and functional disability. PMID:23750465

How Do We Value Postoperative Recovery?: A Systematic Review of the Measurement Properties of Patient-reported Outcomes After Abdominal Surgery.

PubMed

Fiore, Julio F; Figueiredo, Sabrina; Balvardi, Saba; Lee, Lawrence; Nauche, Bénédicte; Landry, Tara; Mayo, Nancy E; Feldman, Liane S

2018-04-01

To appraise the level of evidence supporting the measurement properties of patient-reported outcome measures (PROMs) in the context of postoperative recovery after abdominal surgery. There is growing interest in using PROMs to support value-based care in abdominal surgery; however, to draw valid conclusions regarding patient-reported outcomes data, PROMs with robust measurement properties are required. Eight databases (MEDLINE, EMBASE, Biosis, PsycINFO, The Cochrane Library, CINAHL, Scopus, Web of Science) were searched for studies focused on the measurement properties of PROMs in the context of recovery after abdominal surgery. The methodological quality of individual studies was evaluated using the consensus-based COSMIN checklist. Evidence supporting the measurement properties of each PROM was synthetized according to standardized criteria and compared against the International Society of Quality of Life Research minimum standards for the selection of PROMs for outcomes research. We identified 35 studies evaluating 22 PROMs [12 focused on nonspecific surgical populations (55%), 4 focused on abdominal surgery (18%), and 6 generic PROMs (27%)]. The great majority of the studies (74%) received only poor or fair quality ratings. Measurement properties of PROMs were predominantly supported by limited or unknown evidence. None of the PROMs fulfilled International Society of Quality of Life Research's minimum standards, hindering specific recommendations. There is very limited evidence supporting the measurement properties of existing PROMs used in the context of recovery after abdominal surgery. This precludes the use of these PROMs to support value-based surgical care. Further research is required to bridge this major knowledge gap. International Prospective Register of Systematic Reviews (PROSPERO): CRD42014014349.

Adult Outcomes, Reported Self-Aptitude, and Perceived Training: A Follow-Up Study of Individuals with Visual Impairment

ERIC Educational Resources Information Center

Lawson, Holly Michelle

2010-01-01

The purpose of this study was to examine factors that relate to successful adult outcomes for 28 individuals with visual impairment ages 23-30. The primary dependent variable was current employment. Independent living and completion of postsecondary educational program were secondary, related outcome measures. A secondary goal of this research was…

[Is it beneficial to involve family member? A literature review to psychosocial interventions in family-centered nursing].

PubMed

Mahrer-Imhof, Romy; Bruylands, Michelle

2014-10-01

Families influence the wellbeing of patients and are influenced by illness themselves. Involving caregivers in patient care was examined in multiple studies. The aim of this literature review was to investigate the different approaches to family-centered interventions (FI) and to evaluate the tested outcomes as well as the detected effect sizes. This search for a systematic literature review of randomized controlled trials and metaanalyses revealed three Meta Analyses with studies until 2007 and six randomized controlled studies from 2007 to 2012. FI showed small to middle positive effects on the outcomes depression, mental health, anxiety of patients and family members and on caregiver burden. A conclusive effect on physical health could not be shown. The results strongly depend on the enrolled patient population, the targeted participants of FI, as well as the focus, type and dose of FI. The studies showed vast differences in the length and type of intervention, the target population and the selection of outcomes. Comparing outcomes was difficult due to the use of different outcome measures. Further research with various populations, different FI intensity but with same, valid outcome measures is needed.

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

PubMed

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

2015-06-01

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

Abbreviated neuropsychological assessment in schizophrenia

PubMed Central

Harvey, Philip D.; Keefe, Richard S. E.; Patterson, Thomas L.; Heaton, Robert K.; Bowie, Christopher R.

2008-01-01

The aim of this study was to identify the best subset of neuropsychological tests for prediction of several different aspects of functioning in a large (n = 236) sample of older people with schizophrenia. While the validity of abbreviated assessment methods has been examined before, there has never been a comparative study of the prediction of different elements of cognitive impairment, real-world outcomes, and performance-based measures of functional capacity. Scores on 10 different tests from a neuropsychological assessment battery were used to predict global neuropsychological (NP) performance (indexed with averaged scores or calculated general deficit scores), performance-based indices of everyday-living skills and social competence, and case-manager ratings of real-world functioning. Forward entry stepwise regression analyses were used to identify the best predictors for each of the outcomes measures. Then, the analyses were adjusted for estimated premorbid IQ, which reduced the magnitude, but not the structure, of the correlations. Substantial amounts (over 70%) of the variance in overall NP performance were accounted for by a limited number of NP tests. Considerable variance in measures of functional capacity was also accounted for by a limited number of tests. Different tests constituted the best predictor set for each outcome measure. A substantial proportion of the variance in several different NP and functional outcomes can be accounted for by a small number of NP tests that can be completed in a few minutes, although there is considerable unexplained variance. However, the abbreviated assessments that best predict different outcomes vary across outcomes. Future studies should determine whether responses to pharmacological and remediation treatments can be captured with brief assessments as well. PMID:18720182

Measures and procedures utilized to determine the added value of microprocessor-controlled prosthetic knee joints: a systematic review

PubMed Central

2013-01-01

Background The effectiveness of microprocessor-controlled prosthetic knee joints (MPKs) has been assessed using a variety of outcome measures in a variety of health and health-related domains. However, if the patient is to receive a prosthetic knee joint that enables him to function optimally in daily life, it is vital that the clinician has adequate information about the effects of that particular component on all aspects of persons’ functioning. Especially information concerning activities and participation is of high importance, as this component of functioning closely describes the person’s ability to function with the prosthesis in daily life. The present study aimed to review the outcome measures that have been utilized to assess the effects of microprocessor-controlled prosthetic knee joints (MPK), in comparison with mechanically controlled prosthetic knee joints, and aimed to classify these measures according to the components and categories of functioning defined by the International Classification of Functioning, Disability and Health (ICF). Subsequently, the gaps in the scientific evidence regarding the effectiveness of MPKs were determined. Methods A systematic literature search in 6 databases (i.e. PubMed, CINAHL, Cochrane Library, Embase, Medline and PsychInfo) identified scientific studies that compared the effects of using MPKs with mechanically controlled prosthetic knee joints on persons’ functioning. The outcome measures that have been utilized in those studies were extracted and categorized according to the ICF framework. Also, a descriptive analysis regarding all studies has been performed. Results A total of 37 studies and 72 outcome measures have been identified. The majority (67%) of the outcome measures that described the effects of using an MPK on persons’ actual performance with the prosthesis covered the ICF body functions component. Only 31% of the measures on persons’ actual performance investigated how an MPK may affect performance in daily life. Research also typically focused on young, fit and active persons. Conclusions Scientifically valid evidence regarding the performance of persons with an MPK in everyday life is limited. Future research should specifically focus on activities and participation to increase the understanding of the possible functional added value of MPKs. PMID:24279314

Measures and procedures utilized to determine the added value of microprocessor-controlled prosthetic knee joints: a systematic review.

PubMed

Theeven, Patrick J R; Hemmen, Bea; Brink, Peter R G; Smeets, Rob J E M; Seelen, Henk A M

2013-11-27

The effectiveness of microprocessor-controlled prosthetic knee joints (MPKs) has been assessed using a variety of outcome measures in a variety of health and health-related domains. However, if the patient is to receive a prosthetic knee joint that enables him to function optimally in daily life, it is vital that the clinician has adequate information about the effects of that particular component on all aspects of persons' functioning. Especially information concerning activities and participation is of high importance, as this component of functioning closely describes the person's ability to function with the prosthesis in daily life. The present study aimed to review the outcome measures that have been utilized to assess the effects of microprocessor-controlled prosthetic knee joints (MPK), in comparison with mechanically controlled prosthetic knee joints, and aimed to classify these measures according to the components and categories of functioning defined by the International Classification of Functioning, Disability and Health (ICF). Subsequently, the gaps in the scientific evidence regarding the effectiveness of MPKs were determined. A systematic literature search in 6 databases (i.e. PubMed, CINAHL, Cochrane Library, Embase, Medline and PsychInfo) identified scientific studies that compared the effects of using MPKs with mechanically controlled prosthetic knee joints on persons' functioning. The outcome measures that have been utilized in those studies were extracted and categorized according to the ICF framework. Also, a descriptive analysis regarding all studies has been performed. A total of 37 studies and 72 outcome measures have been identified. The majority (67%) of the outcome measures that described the effects of using an MPK on persons' actual performance with the prosthesis covered the ICF body functions component. Only 31% of the measures on persons' actual performance investigated how an MPK may affect performance in daily life. Research also typically focused on young, fit and active persons. Scientifically valid evidence regarding the performance of persons with an MPK in everyday life is limited. Future research should specifically focus on activities and participation to increase the understanding of the possible functional added value of MPKs.

Pulmonary function outcomes for assessing cystic fibrosis care.

PubMed

Wagener, Jeffrey S; Elkin, Eric P; Pasta, David J; Schechter, Michael S; Konstan, Michael W; Morgan, Wayne J

2015-05-01

Assessing cystic fibrosis (CF) patient quality of care requires the choice of an appropriate outcome measure. We looked systematically and in detail at pulmonary function outcomes that potentially reflect clinical practice patterns. Epidemiologic Study of Cystic Fibrosis data were used to evaluate six potential outcome variables (2002 best FVC, FEV(1), and FEF(25-75) and rate of decline for each from 2000 to 2002). We ranked CF care sites by outcome measure and then assessed any association with practice patterns and follow-up pulmonary function. Sites ranked in the top quartile had more frequent monitoring, treatment of exacerbations, and use of chronic therapies and oral corticosteroids. The follow-up rate of pulmonary function decline was not predicted by site ranking. Different pulmonary function outcomes associate slightly differently with practice patterns, although annual FEV(1) is at least as good as any other measure. Current site ranking only moderately predicts future ranking. Copyright © 2014 European Cystic Fibrosis Society. Published by Elsevier B.V. All rights reserved.

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

PubMed Central

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

2017-01-01

A clinician-reported outcome (ClinRO) assessment is a type of clinical outcome assessment (COA). ClinRO assessments, like all COAs (patient-reported, observer-reported, or performance outcome assessments), are used to 1) measure patients’ health status and 2) define end points that can be interpreted as treatment benefits of medical interventions on how patients feel, function, or survive in clinical trials. Like other COAs, ClinRO assessments can be influenced by human choices, judgment, or motivation. A ClinRO assessment is conducted and reported by a trained health care professional and requires specialized professional training to evaluate the patient’s health status. This is the second of two reports by the ISPOR Clinical Outcomes Assessment—Emerging Good Practices for Outcomes Research Task Force. The first report provided an overview of COAs including definitions important for an understanding of COA measurement practices. This report focuses specifically on issues related to ClinRO assessments. In this report, we define three types of ClinRO assessments (readings, ratings, and clinician global assessments) and describe emerging good measurement practices in their development and evaluation. The good measurement practices include 1) defining the context of use; 2) identifying the concept of interest measured; 3) defining the intended treatment benefit on how patients feel, function, or survive reflected by the ClinRO assessment and evaluating the relationship between that intended treatment benefit and the concept of interest; 4) documenting content validity; 5) evaluating other measurement properties once content validity is established (including intra- and inter-rater reliability); 6) defining study objectives and end point(s) objectives, and defining study end points and placing study end points within the hierarchy of end points; 7) establishing interpretability in trial results; and 8) evaluating operational considerations for the implementation of ClinRO assessments used as end points in clinical trials. Applying good measurement practices to ClinRO assessment development and evaluation will lead to more efficient and accurate measurement of treatment effects. This is important beyond regulatory approval in that it provides evidence for the uptake of new interventions into clinical practice and provides justification to payers for reimbursement on the basis of the clearly demonstrated added value of the new intervention. PMID:28212963

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.

Pilot Study to Evaluate Hearing Aid Service Delivery Model and Measure Benefit Using Self-Report Outcome Measures Using Community Hearing Workers in a Developing Country

PubMed Central

Emerson, Lingamdenne Paul; Job, Anand; Abraham, Vinod

2013-01-01

Hearing loss is a major handicap in developing countries with paucity of trained audiologists and limited resources. In this pilot study trained community health workers were used to provide comprehensive hearing aid services in the community. One hundred and eleven patients were fitted with semi-digital hearing aid and were evaluated over a period of six months. They were assessed using self-report outcome measure APHAB. Results show that trained CHWs are effective in detecting disabling hearing loss and in providing HAs. APHAB can identify and pick up significant improvements in communication in daily activities and provides a realistic expectation of the benefits of a hearing aid. The model of using trained CHWs to provide rehabilitative services in audiology along with self-report outcome measures can be replicated in other developing countries. PMID:23724277

Identifying thresholds for relationships between impacts of rationing of nursing care and nurse- and patient-reported outcomes in Swiss hospitals: a correlational study.

PubMed

Schubert, Maria; Clarke, Sean P; Glass, Tracy R; Schaffert-Witvliet, Bianca; De Geest, Sabina

2009-07-01

In the Rationing of Nursing Care in Switzerland Study, implicit rationing of care was the only factor consistently significantly associated with all six studied patient outcomes. These results highlight the importance of rationing as a new system factor regarding patient safety and quality of care. Since at least some rationing of care appears inevitable, it is important to identify the thresholds of its influences in order to minimize its negative effects on patient outcomes. To describe the levels of implicit rationing of nursing care in a sample of Swiss acute care hospitals and to identify clinically meaningful thresholds of rationing. Descriptive cross-sectional multi-center study. Five Swiss-German and three Swiss-French acute care hospitals. 1338 nurses and 779 patients. Implicit rationing of nursing care was measured using the newly developed Basel Extent of Rationing of Nursing Care (BERNCA) instrument. Other variables were measured using survey items from the International Hospital Outcomes Study battery. Data were summarized using appropriate descriptive measures, and logistic regression models were used to define a clinically meaningful rationing threshold level. For the studied patient outcomes, identified rationing threshold levels varied from 0.5 (i.e., between 0 ('never') and 1 ('rarely') to 2 ('sometimes')). Three of the identified patient outcomes (nosocomial infections, pressure ulcers, and patient satisfaction) were particularly sensitive to rationing, showing negative consequences anywhere it was consistently reported (i.e., average BERNCA scores of 0.5 or above). In other cases, increases in negative outcomes were first observed from the level of 1 (average ratings of rarely). Rationing scores generated using the BERNCA instrument provide a clinically meaningful method for tracking the correlates of low resources or difficulties in resource allocation on patient outcomes. Thresholds identified here provide parameters for administrators to respond to whenever rationing reports exceed the determined level of '0.5' or '1'. Since even very low levels of rationing had negative consequences on three of the six studied outcomes, it is advisable to treat consistent evidence of any rationing as a significant threat to patient safety and quality of care.

Alternative outcome definitions and their effect on the performance of methods for observational outcome studies.

PubMed

Reich, Christian G; Ryan, Patrick B; Schuemie, Martijn J

2013-10-01

A systematic risk identification system has the potential to test marketed drugs for important Health Outcomes of Interest or HOI. For each HOI, multiple definitions are used in the literature, and some of them are validated for certain databases. However, little is known about the effect of different definitions on the ability of methods to estimate their association with medical products. Alternative definitions of HOI were studied for their effect on the performance of analytical methods in observational outcome studies. A set of alternative definitions for three HOI were defined based on literature review and clinical diagnosis guidelines: acute kidney injury, acute liver injury and acute myocardial infarction. The definitions varied by the choice of diagnostic codes and the inclusion of procedure codes and lab values. They were then used to empirically study an array of analytical methods with various analytical choices in four observational healthcare databases. The methods were executed against predefined drug-HOI pairs to generate an effect estimate and standard error for each pair. These test cases included positive controls (active ingredients with evidence to suspect a positive association with the outcome) and negative controls (active ingredients with no evidence to expect an effect on the outcome). Three different performance metrics where used: (i) Area Under the Receiver Operator Characteristics (ROC) curve (AUC) as a measure of a method's ability to distinguish between positive and negative test cases, (ii) Measure of bias by estimation of distribution of observed effect estimates for the negative test pairs where the true effect can be assumed to be one (no relative risk), and (iii) Minimal Detectable Relative Risk (MDRR) as a measure of whether there is sufficient power to generate effect estimates. In the three outcomes studied, different definitions of outcomes show comparable ability to differentiate true from false control cases (AUC) and a similar bias estimation. However, broader definitions generating larger outcome cohorts allowed more drugs to be studied with sufficient statistical power. Broader definitions are preferred since they allow studying drugs with lower prevalence than the more precise or narrow definitions while showing comparable performance characteristics in differentiation of signal vs. no signal as well as effect size estimation.

An organizing framework for informal caregiver interventions: detailing caregiving activities and caregiver and care recipient outcomes to optimize evaluation efforts

PubMed Central

2011-01-01

Background Caregiver interventions may help improve the quality of informal care. Yet the lack of a systematic framework specifying the targets and outcomes of caregiver interventions hampers our ability to understand what has been studied, to evaluate existing programs, and to inform the design of future programs. Our goal was to develop an organizing framework detailing the components of the caregiving activities and the caregiver and care recipient outcomes that should be affected by an intervention. In so doing, we characterize what has been measured in the published literature to date and what should be measured in future studies to enable comparisons across interventions and across time. Methods Our data set comprises 121 reports of caregiver interventions conducted in the United States and published between 2000 and 2009. We extracted information on variables that have been examined as primary and secondary outcomes. These variables were grouped into categories, which then informed the organizing framework. We calculated the frequency with which the interventions examined each framework component to identify areas about which we have the most knowledge and under-studied areas that deserve attention in future research. Results The framework stipulates that caregiver interventions seek to change caregiving activities, which in turn affect caregiver and care recipient outcomes. The most frequently assessed variables have been caregiver psychological outcomes (especially depression and burden) and care recipient physical and health care use outcomes. Conclusions Based on the organizing framework, we make three key recommendations to guide interventions and inform research and policy. First, all intervention studies should assess quality and/or quantity of caregiving activities to help understand to what extent and how well the intervention worked. Second, intervention studies should assess a broad range of caregiver and care recipient outcomes, including considering whether expanding to economic status and health care use of the caregiver can be accommodated, to ease subsequent economic evaluations of caregiving. Third, intervention studies should measure a common set of outcomes to facilitate cross-time and cross-study comparisons of effectiveness. PMID:22107600

New agreement measures based on survival processes

PubMed Central

Guo, Ying; Li, Ruosha; Peng, Limin; Manatunga, Amita K.

2013-01-01

Summary The need to assess agreement arises in many scenarios in biomedical sciences when measurements were taken by different methods on the same subjects. When the endpoints are survival outcomes, the study of agreement becomes more challenging given the special characteristics of time-to-event data. In this paper, we propose a new framework for assessing agreement based on survival processes that can be viewed as a natural representation of time-to-event outcomes. Our new agreement measure is formulated as the chance-corrected concordance between survival processes. It provides a new perspective for studying the relationship between correlated survival outcomes and offers an appealing interpretation as the agreement between survival times on the absolute distance scale. We provide a multivariate extension of the proposed agreement measure for multiple methods. Furthermore, the new framework enables a natural extension to evaluate time-dependent agreement structure. We develop nonparametric estimation of the proposed new agreement measures. Our estimators are shown to be strongly consistent and asymptotically normal. We evaluate the performance of the proposed estimators through simulation studies and then illustrate the methods using a prostate cancer data example. PMID:23844617

Hippocampal Mismatch Signals Are Modulated by the Strength of Neural Predictions and Their Similarity to Outcomes.

PubMed

Long, Nicole M; Lee, Hongmi; Kuhl, Brice A

2016-12-14

The hippocampus is thought to compare predicted events with current perceptual input, generating a mismatch signal when predictions are violated. However, most prior studies have only inferred when predictions occur without measuring them directly. Moreover, an important but unresolved question is whether hippocampal mismatch signals are modulated by the degree to which predictions differ from outcomes. Here, we conducted a human fMRI study in which subjects repeatedly studied various word-picture pairs, learning to predict particular pictures (outcomes) from the words (cues). After initial learning, a subset of cues was paired with a novel, unexpected outcome, whereas other cues continued to predict the same outcome. Critically, when outcomes changed, the new outcome was either "near" to the predicted outcome (same visual category as the predicted picture) or "far" from the predicted outcome (different visual category). Using multivoxel pattern analysis, we indexed cue-evoked reactivation (prediction) within neocortical areas and related these trial-by-trial measures of prediction strength to univariate hippocampal responses to the outcomes. We found that prediction strength positively modulated hippocampal responses to unexpected outcomes, particularly when unexpected outcomes were close, but not identical, to the prediction. Hippocampal responses to unexpected outcomes were also associated with a tradeoff in performance during a subsequent memory test: relatively faster retrieval of new (updated) associations, but relatively slower retrieval of the original (older) associations. Together, these results indicate that hippocampal mismatch signals reflect a comparison between active predictions and current outcomes and that these signals are most robust when predictions are similar, but not identical, to outcomes. Although the hippocampus is widely thought to signal "mismatches" between memory-based predictions and outcomes, previous research has not linked hippocampal mismatch signals directly to neural measures of prediction strength. Here, we show that hippocampal mismatch signals increase as a function of the strength of predictions in neocortical regions. This increase in hippocampal mismatch signals was particularly robust when outcomes were similar, but not identical, to predictions. These results indicate that hippocampal mismatch signals are driven by both the active generation of predictions and the similarity between predictions and outcomes. Copyright © 2016 the authors 0270-6474/16/3612677-11$15.00/0.

Systematic literature review of patient-reported outcome measures used in assessment and measurement of sleep disorders in chronic obstructive pulmonary disease.

PubMed

Garrow, Adam P; Yorke, Janelle; Khan, Naimat; Vestbo, Jørgen; Singh, Dave; Tyson, Sarah

2015-01-01

Sleep problems are common in patients with chronic obstructive pulmonary disease (COPD), but the validity of patient-reported outcome measures (PROMs) that measure sleep dysfunction has not been evaluated. We have reviewed the literature to identify disease-specific and non-disease-specific sleep PROMs that have been validated for use in COPD patients. The review also examined the psychometric properties of identified sleep outcome measures and extracted point and variability estimates of sleep instruments used in COPD studies. The online EMBASE, MEDLINE, PsycINFO, and SCOPUS databases for all years to May 2014 were used to source articles for the review. The review was performed according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Criteria from the Medical Outcomes Trust Scientific Advisory Committee guidelines were used to evaluate the psychometric properties of all sleep PROMs identified. One COPD-specific and six non-COPD-specific sleep outcome measures were identified and 44 papers met the review selection criteria. We only identified one instrument, the COPD and Asthma Sleep Impact Scale, which was developed specifically for use in COPD populations. Ninety percent of the identified studies used one of two non-disease-specific sleep scales, ie, the Pittsburgh Sleep Quality Index and/or the Epworth Sleep Scale, although neither has been tested for reliability or validity in people with COPD. The results highlight a need for existing non-disease-specific instruments to be validated in COPD populations and also a need for new disease-specific measures to assess the impact of sleep problems in COPD.

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.

Physical and mental health outcomes of prenatal maternal stress in human and animal studies: a review of recent evidence.

PubMed

Beydoun, Hind; Saftlas, Audrey F

2008-09-01

Prenatal maternal stress (PNMS) has been linked with adverse health outcomes in the offspring through experimental studies using animal models and epidemiological studies of human populations. The purpose of this review article is to establish a parallel between animal and human studies, while focusing on methodological issues and gaps in knowledge. The review examines the quality of recent evidence for prevailing PNMS theoretical models, namely the biopsychosocial model for adverse pregnancy outcomes and the fetal programming model for chronic diseases. The investigators used PubMed (2000-06) to identify recently published original articles in the English language literature. A total of 103 (60 human and 43 animal) studies were examined. Most human studies originated from developed countries, thus limiting generalisability to developing nations. Most animal studies were conducted on non-primates, rendering extrapolation of findings to pregnant women less straightforward. PNMS definition and measurement were heterogeneous across studies examining similar research questions, thus precluding the conduct of meta-analyses. In human studies, physical health outcomes were often restricted to birth complications while mental health outcomes included postnatal developmental disorders and psychiatric conditions in children, adolescents and adults. Diverse health outcomes were considered in animal studies, some being useful models for depression, schizophrenia or attention deficit hyperactivity disorder in human populations. The overall evidence is consistent with independent effects of PNMS on perinatal and postnatal outcomes. Intervention studies and large population-based cohort studies combining repeated multi-dimensional and standardised PNMS measurements with biomarkers of stress are needed to further understand PNMS aetiology and pathophysiology in human populations.

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 Directors in Surgery. Published by Elsevier Inc. All rights reserved.

Measuring disaster-resilient communities: a case study of coastal communities in Indonesia.

PubMed

Kafle, Shesh Kanta

2012-01-01

Vulnerability reduction and resilience building of communities are central concepts in recent policy debates. Although there are fundamental linkages, and complementarities exist between the two concepts, recent policy and programming has focused more on the latter. It is assumed here that reducing underlying causes of vulnerabilities and their interactions with resilience elements is a prerequisite for obtaining resilience capabilities. An integrated approach, incorporating both the vulnerability and resilience considerations, has been taken while developing an index for measuring disaster-resilient communities. This study outlines a method for measuring community resilience capabilities using process and outcome indicators in 43 coastal communities in Indonesia. An index was developed using ten process and 25 outcome indicators, selected on the basis of the ten steps of the Integrated Community Based Risk Reduction (ICBRR) process, and key characteristics of disaster resilient communities were taken from various literatures. The overall index value of all 43 communities was 63, whereas the process and outcome indicator values were measured as 63 and 61.5 respectively. The core components of this index are process and outcome indicators. The tool has been developed with an assumption that both the process and outcome indicators are equally important in building disaster-resilient communities. The combination of both indicators is an impetus to quality change in the community. Process indicators are important for community understanding, ownership and the sustainability of the programme; whereas outcome indicators are important for the real achievements in terms of community empowerment and capacity development. The process of ICBRR approach varies by country and location as per the level of community awareness and organisational strategy. However, core elements such as the formation of community groups, mobilising those groups in risk assessment and planning should be present in all the countries or locations. As this study shows, community resiliency can be measured but any such measurement must be both location- and hazard-specific.

Post-Discharge Care of Pediatric Traumatic Brain Injury in Argentina: A Multi-Center Randomized Controlled Trial

PubMed Central

Carney, Nancy A.; Petroni, Gustavo J.; Luján, Silvia B.; Ballarini, Nicolás M.; Faguaga, Gabriela A.; du Coudray, Hugo E. M.; Huddleston, Amy E.; Baggio, Gloria M.; Becerra, Juan M.; Busso, Leonardo O.; Dikmen, Sureyya S.; Falcone, Roberto; García, Mirta E.; Carrillo, Osvaldo R. González; Medici, Paula L.; Quaglino, Marta B.; Randisi, Carina A.; Sáenz, Silvia S.; Temkin, Nancy R.; Vanella, Elida E.

2016-01-01

Objective To develop, in partnership with families of children with traumatic brain injury (TBI), a post-discharge intervention that is effective, simple and sustainable. Design Randomized Controlled Trial Setting Seven Level 1 Pediatric Trauma Centers in Argentina. Patients Persons less than 19 years of age admitted to one of the study hospitals with a diagnosis of severe, moderate, or complicated mild TBI, and were discharged alive. Interventions Patients were randomly assigned to either the Intervention or Standard Care group. A specially trained Community Resource Coordinator (CRC) was assigned to each family in the Intervention group. We hypothesized that children with severe, moderate, and complicated mild TBI who received the intervention would have significantly better functional outcomes at 6-months post-discharge than those who received standard care. We further hypothesized there would be a direct correlation between patient outcome and measures of family function. Measurements and Main Results The primary outcome measure was a composite measured at 6-months post-injury. There were 308 patients included in the study; 61% male. Forty-four percent sustained a complicated mild TBI, 18% moderate, and 38% severe. Sixty-five percent of the patients were 8 years old or younger, and over 70% were transported to the hospital without ambulance assistance. There was no significant difference between groups on the primary outcome measure. There was a statistically significant correlation between the primary outcome measure and scores on the Family Impact Module of the PedsQL (ρ= 0.57; p < 0.0001). Children with better outcomes lived with families reporting better function at 6-months post-injury. Conclusions While no significant effect of the intervention was demonstrated, this study represents the first conducted in Latin America that documents the complete course of treatment for pediatric patients with TBI spanning hospital transport through hospital care and into the post-discharge setting. PMID:27243414

Do personality traits predict outcome of psychodynamically oriented psychosomatic inpatient treatment beyond initial symptoms?

PubMed

Steinert, Christiane; Klein, Susanne; Leweke, Frank; Leichsenring, Falk

2015-03-01

Whether personality characteristics have an impact on treatment outcome is an important question in psychotherapy research. One of the most common approaches for the description of personality is the five-factor model of personality. Only few studies investigated whether patient personality as measured with the NEO-Five-Factor Inventory (NEO-FFI, Costa & McCrae [1992b]. Revised NEO-PI-R and NEO-FFI. Professional manual. Odessa, FL: Psychological Assessment Recources) predicts outcome. Results were inconsistent. Studies reporting personality to be predictive of outcome did not control for baseline symptoms, while studies controlling initial symptoms could not support these findings. We hypothesized that after taking into account baseline symptoms, the NEO-FFI would not predict outcome and tested this in a large sample of inpatients at a psychosomatic clinic. Naturalistic, non-controlled study using patients' data for multiple regression analysis to identify predictors of outcome. Data of 254 inpatients suffering primarily from depressive, anxiety, stress, and somatoform disorders were analysed. Personality was assessed at the beginning of therapy. For psychotherapy outcome, changes in anxiety and depression (Hospital Anxiety and Depression Scale; HADS), overall psychopathology (Symptom Checklist-90-R Global Severity Index [GSI]), and interpersonal problems (Inventory of Interpersonal Problems; IIP) were measured. The treatment resulted in significant decreases on all outcome measures corresponding to moderate to large effect sizes (HADS: d = 1.03; GSI: d = 0.90; IIP: d = 0.38). Consistent with our hypothesis, none of the personality domains predicted outcome when baseline symptoms were controlled for. Personality assessment at baseline does not seem to have an added value in the prediction of inpatient psychotherapy outcome beyond initial symptoms. Clinical implications Personality dimensions overlap with symptomatic distress. Rather than serve as predictors of outcome, the domains tapped by the NEO-FFI reflect current psychological symptomatology in inpatients with depressive, anxiety, stress or somatoform disorders. From a clinician's point of view monitoring individual progress by using actuarial measures is more valuable than trying to predict who will benefit from treatment using personality assessments. Limitations of the study Diagnostic assessment was solely based on clinical evaluation rather than structured interviews. Twenty-five per cent of the original sample had to be excluded due to missing data. There was a focus on only one set of client characteristics (i.e., five-factor model personality traits). Assessment of personality domains in the acute phase of a mental disorder may be problematic and could have influenced findings. © 2014 The British Psychological Society.

Assessing Medication Effects in the MTA Study Using Neuropsychological Outcomes

ERIC Educational Resources Information Center

Epstein, Jeffery N.; Conners, C. Keith; Hervey, Aaron S.; Tonev, Simon T.; Arnold, L. Eugene; Abikoff, Howard B.; Elliott, Glen; Greenhill, Laurence L.; Hechtman, Lily; Hoagwood, Kimberly; Hinshaw, Stephen P.; Hoza, Betsy; Jensen, Peter S.; March, John S.; Newcorn, Jeffrey H.; Pelham, William E.; Severe, Joanne B.; Swanson, James M.; Wells, Karen; Vitiello, Benedetto; Wigal, Timothy

2006-01-01

Background: While studies have increasingly investigated deficits in reaction time (RT) and RT variability in children with attention deficit/hyperactivity disorder (ADHD), few studies have examined the effects of stimulant medication on these important neuropsychological outcome measures. Methods: 316 children who participated in the Multimodal…

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

PubMed Central

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

2018-01-01

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

Can a future choice affect a past measurement’s outcome?

DOE Office of Scientific and Technical Information (OSTI.GOV)

Aharonov, Yakir; Schmid College of Science, Chapman University, Orange, CA 92866; Iyar, The Israeli Institute for Advanced Research, Rehovot

2015-04-15

An EPR experiment is studied where each particle within the entangled pair undergoes a few weak measurements (WMs) along some pre-set spin orientations, with the outcomes individually recorded. Then the particle undergoes one strong measurement along an orientation chosen at the last moment. Bell-inequality violation is expected between the two final measurements within each EPR pair. At the same time, statistical agreement is expected between these strong measurements and the earlier weak ones performed on that pair. A contradiction seemingly ensues: (i) Bell’s theorem forbids spin values to exist prior to the choice of the orientation measured; (ii) A weakmore » measurement is not supposed to determine the outcome of a successive strong one; and indeed (iii) Almost no disentanglement is inflicted by the WMs; and yet (iv) The outcomes of weak measurements statistically agree with those of the strong ones, suggesting the existence of pre-determined values, in contradiction with (i). Although the conflict can be solved by mere mitigation of the above restrictions, the most reasonable resolution seems to be that of the Two-State-Vector Formalism (TSVF), namely, that the choice of the experimenter has been encrypted within the weak measurement’s outcomes, even before the experimenters themselves know what their choice will be.« less

Differences between seven measures of self-reported numbers of clients of female sex workers in southern India: implications for individual- and population-level analysis.

PubMed

Deering, Kathleen N; Vickerman, P; Pickles, M; Moses, S; Blanchard, J F; Ramesh, B M; Isac, S; Boily, M-C

2013-02-01

Quantifying sexual activity of sub-populations with high-risk sexual behaviour is important in understanding HIV epidemiology. This study examined inconsistency of seven outcomes measuring self-reported clients per month (CPM) of female sex workers (FSWs) in southern India and implications for individual/population-level analysis. Multivariate negative binomial regression was used to compare key social/environmental factors associated with each outcome. A transmission dynamics model was used to assess the impact of differences between outcomes on population-level FSW/client HIV prevalence. Outcomes based on 'clients per last working day' produced lower estimates than those based on 'clients per typical day'. Although the outcomes were strongly correlated, their averages differed by approximately two-fold (range 39.0-79.1 CPM). The CPM measure chosen did not greatly influence standard epidemiological 'risk factor' analysis. Differences across outcomes influenced HIV prevalence predictions. Due to this uncertainty, we recommend basing population-based estimates on the range of outcomes, particularly when assessing the impact of interventions.

Core Health Outcomes In Childhood Epilepsy (CHOICE): protocol for the selection of a core outcome set.

PubMed

Morris, Christopher; Dunkley, Colin; Gibbon, Frances M; Currier, Janet; Roberts, Deborah; Rogers, Morwenna; Crudgington, Holly; Bray, Lucy; Carter, Bernie; Hughes, Dyfrig; Tudur Smith, Catrin; Williamson, Paula R; Gringras, Paul; Pal, Deb K

2017-11-28

There is increasing recognition that establishing a core set of outcomes to be evaluated and reported in trials of interventions for particular conditions will improve the usefulness of health research. There is no established core outcome set for childhood epilepsy. The aim of this work is to select a core outcome set to be used in evaluative research of interventions for children with rolandic epilepsy, as an exemplar of common childhood epilepsy syndromes. First we will identify what outcomes should be measured; then we will decide how to measure those outcomes. We will engage relevant UK charities and health professional societies as partners, and convene advisory panels for young people with epilepsy and parents of children with epilepsy. We will identify candidate outcomes from a search for trials of interventions for childhood epilepsy, statutory guidance and consultation with our advisory panels. Families, charities and health, education and neuropsychology professionals will be invited to participate in a Delphi survey following recommended practices in the development of core outcome sets. Participants will be able to recommend additional outcome domains. Over three rounds of Delphi survey participants will rate the importance of candidate outcome domains and state the rationale for their decisions. Over the three rounds we will seek consensus across and between families and health professionals on the more important outcomes. A face-to-face meeting will be convened to ratify the core outcome set. We will then review and recommend ways to measure the shortlisted outcomes using clinical assessment and/or patient-reported outcome measures. Our methodology is a proportionate and pragmatic approach to expediently produce a core outcome set for evaluative research of interventions aiming to improve the health of children with epilepsy. A number of decisions have to be made when designing a study to develop a core outcome set including defining the scope, choosing which stakeholders to engage, most effective ways to elicit their views, especially children and a potential role for qualitative research.

"Family Matters": A Systematic Review of the Evidence For Family Psychoeducation For Major Depressive Disorder.

PubMed

Brady, Pamela; Kangas, Maria; McGill, Katherine

2017-04-01

The first aim of this systematic review was to evaluate the evidence for family psychoeducation (FPE) interventions for major depressive disorder (MDD). A second aim was to compare the efficacy of different modes of delivering face-to-face FPE interventions. Ten studies (based on nine distinct samples) were identified comprising four single-family studies, four multifamily studies, one single versus multifamily comparative study, and one peer-led, mixed-diagnosis study. Seven studies measured patient functioning and six reported positive outcomes. Six studies measured carer's well-being and four reported positive outcomes. Results provide preliminary evidence that FPE leads to improved outcomes for patient functioning and family-carer's well-being for persons with depression. The implications for future development and delivery of FPE interventions for MDD are discussed. © 2016 American Association for Marriage and Family Therapy.

Political efficacy in adolescence: Development, gender differences, and outcome relations.

PubMed

Arens, A Katrin; Watermann, Rainer

2017-05-01

The present study focuses on political efficacy in terms of students' competence self-perceptions related to the domain of politics. The investigation addresses the mean level development and longitudinal relations to outcome variables including gender differences. Drawing on a sample of N = 2,504 German students, political efficacy, along with meaningful outcome variables (i.e., political information behavior, political knowledge, and interest in politics), was measured at 2 measurement points, once in Grade 7 and once in Grade 10. Students' mean levels of political efficacy increased from the first to the second measurement point, and boys consistently displayed higher levels. Political efficacy demonstrated reciprocal relations to political information behavior and political knowledge, and showed a unidirectional relation to interest in politics across time. The pattern of outcome relations was invariant across gender. This study contributes to research and theory on political socialization in adolescence as it outlines temporal relations among, and gender differences in, facets of political socialization. Therefore, this study also offers new practical insights into effectively facilitating political education in adolescent students. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

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

PubMed

Irwin, P; Rudd, A

1998-01-01

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

A randomized trial of face-to-face counselling versus telephone counselling versus bibliotherapy for occupational stress.

PubMed

Kilfedder, Catherine; Power, Kevin; Karatzias, Thanos; McCafferty, Aileen; Niven, Karen; Chouliara, Zoë; Galloway, Lisa; Sharp, Stephen

2010-09-01

The aim of the present study was to compare the effectiveness and acceptability of three interventions for occupational stress. A total of 90 National Health Service employees were randomized to face-to-face counselling or telephone counselling or bibliotherapy. Outcomes were assessed at post-intervention and 4-month follow-up. Clinical Outcomes in Routine Evaluation (CORE), General Health Questionnaire (GHQ-12), and Perceived Stress Scale (PSS-10) were used to evaluate intervention outcomes. An intention-to-treat analyses was performed. Repeated measures analysis revealed significant time effects on all measures with the exception of CORE Risk. No significant group effects were detected on all outcome measures. No time by group significant interaction effects were detected on any of the outcome measures with the exception of CORE Functioning and GHQ total. With regard to acceptability of interventions, participants expressed a preference for face-to-face counselling over the other two modalities. Overall, it was concluded that the three intervention groups are equally effective. Given that bibliotherapy is the least costly of the three, results from the present study might be considered in relation to a stepped care approach to occupational stress management with bibliotherapy as the first line of intervention, followed by telephone and face-to-face counselling as required.

Gender identity and substance use among students in two high schools in Monterrey, Mexico

PubMed Central

Kulis, Stephen; Marsiglia, Flavio Francisco; Lingard, Erin Chase; Nieri, Tanya; Nagoshi, Julieann

2011-01-01

This study explored relationships between several hypothesized dimensions of gender identity and substance use outcomes within a non-probability sample of adolescents in Monterrey, Mexico. Based on Mexican concepts of machismo and marianismo, four gender identity constructs were measured: aggressive masculinity, assertive masculinity, affective femininity and submissive femininity. The study assessed how well these gender identity measures predicted substance use behaviors, substance use intentions, expectancies, and normative approval, and exposure and vulnerability to substance offers. Data were drawn from questionnaires completed by 327 students from 2 Monterrey secondary schools. Multivariate ordered logistic and linear regression analyses, adjusted for school level effects, indicated that aggressive masculinity was associated with higher risk of drug use on most outcomes, while affective femininity was associated with lower risk on selected outcomes. Assertive masculinity was associated with only one of the outcomes examined and submissive femininity with none of them. Most gender identity effects persisted after controlling for biological sex, academic performance, age, and other gender identity measures. For two of the outcomes, the gender identity measures had significantly stronger effects for males than for females. The findings are interpreted in light of males’ higher risk for drug use and changes in gender roles and gendered behavior that are now occurring in Mexico as in the U.S. PMID:18329826

Gender identity and substance use among students in two high schools in Monterrey, Mexico.

PubMed

Kulis, Stephen; Marsiglia, Flavio Francisco; Lingard, Erin Chase; Nieri, Tanya; Nagoshi, Julieann

2008-06-01

This study explored relationships between several hypothesized dimensions of gender identity and substance use outcomes within a non-probability sample of adolescents in Monterrey, Mexico. Based on Mexican concepts of machismo and marianismo, four gender identity constructs were measured: aggressive masculinity, assertive masculinity, affective femininity and submissive femininity. The study assessed how well these gender identity measures predicted substance use behaviors, substance use intentions, expectancies, and normative approval, and exposure and vulnerability to substance offers. Data were drawn from questionnaires completed by 327 students from 2 Monterrey secondary schools. Multivariate ordered logistic and linear regression analyses, adjusted for school level effects, indicated that aggressive masculinity was associated with higher risk of drug use on most outcomes, while affective femininity was associated with lower risk on selected outcomes. Assertive masculinity was associated with only one of the outcomes examined and submissive femininity with none of them. Most gender identity effects persisted after controlling for biological sex, academic performance, age, and other gender identity measures. For two of the outcomes, the gender identity measures had significantly stronger effects for males than for females. The findings are interpreted in light of males' higher risk for drug use and changes in gender roles and gendered behavior that are now occurring in Mexico as in the U.S.

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 another when applied to subjects with knee OA. We believe that all 3 instruments are appropriate outcome measures to examine change in functional status of patients with knee OA.

The effect of work-based mentoring on patient outcome in musculoskeletal physiotherapy: study protocol for a randomised controlled trial.

PubMed

Williams, Aled L; Phillips, Ceri J; Watkins, Alan; Rushton, Alison B

2014-10-25

Despite persistent calls to measure the effectiveness of educational interventions on patient outcomes, few studies have been conducted. Within musculoskeletal physiotherapy, the effects of postgraduate clinical mentoring on physiotherapist performance have been assessed, but the impact of this mentoring on patient outcomes remains unknown. The objective of this trial is to assess the effectiveness of a work-based mentoring programme to facilitate physiotherapist clinical reasoning on patient outcomes in musculoskeletal physiotherapy. A stepped wedge cluster randomised controlled trial (CRCT) has been designed to recruit a minimum of 12 senior physiotherapists who work in musculoskeletal outpatient departments of a large National Health Service (NHS) organization. Participating physiotherapists will be randomised by cluster to receive the intervention at three time periods. Patients will be blinded to whether their physiotherapist has received the intervention. The primary outcome measure will be the Patient-Specific Functional Scale; secondary outcome measures will include the EQ-5D, patient activation, patient satisfaction and physiotherapist performance. Sample size considerations used published methods describing stepped wedge designs, conventional values of 0.80 for statistical power and 0.05 for statistical significance, and pragmatic groupings of 12 participating physiotherapists in three clusters. Based on an intergroup difference of 1.0 on the PSFS with a standard deviation of 2.0, 10 patients are required to complete outcome measures per physiotherapist, at time period 1 (prior to intervention roll-out) and at each of time periods 2, 3 and 4, giving a sample size of 480 patients. To account for the potential loss to follow-up of 33%, 720 sets of patient outcomes will be collected.All physiotherapist participants will receive 150 hours of mentored clinical practice as the intervention and usual in-service training as control. Consecutive, consenting patients attending treatment by the participating physiotherapists during data collection periods will complete outcome measures at baseline, discharge and 12 months post-baseline. The lead researcher will be blinded to the allocation of the physiotherapist when analyzing outcome data; statistical analysis will involve classical linear models incorporating both an intervention effect and a random intercept term to reflect systematic differences among clusters. Assigned 31 July 2012: ISRCTN79599220.

Can Psychotherapists Function as Their Own Controls? Meta-Analysis of the “Crossed Therapist” Design in Comparative Psychotherapy Trials

PubMed Central

Falkenström, Fredrik; Markowitz, John C.; Jonker, Hanske; Philips, Björn; Holmqvist, Rolf

2013-01-01

Objective Clinical trials sometimes have the same therapists deliver more than one psychotherapy, ostensibly to control for therapist effects. This “crossed therapists” design makes controlling for therapist allegiance imperative, as therapists may prefer one treatment they deliver to the other(s). Research has established a strong relationship between principal investigators’ allegiances and treatment outcome. Study therapists’ allegiances probably also influence outcome, yet this moderating factor on outcome has never been studied. Data Sources English language abstracts in Psychinfo and MedLine from January 1985 to December 2011 were searched for keywords “psychotherapy” and “randomized trial.” Study Selection The search yielded 990 abstracts that were searched manually. Trials using the same therapists in more than one condition were included. Data extraction Thirty-nine studies fulfilled inclusion criteria. Meta-regression analyses assessed the influence of researchers’ allegiance on treatment outcome, testing the hypothesis that studies poorly controlling for therapist allegiance would show stronger influence of researcher allegiance on outcome. A single-item measure assessed researchers’ reported attempts to control for therapist allegiance. Results Only one (3%) of 39 studies measured therapist treatment allegiance. Another five (13%) mentioned controlling for, without formally assessing, therapist allegiance. Most publications (64%) did not even mention therapist allegiance. In studies not controlling for therapist allegiance, researcher allegiance strongly influenced outcome, whereas studies reporting control for therapist allegiance showed no differential researcher allegiance. Cognitive-behavioral trials less frequently described controlling for therapist allegiance. Conclusions The “crossed therapist” design is subject to bias due to differential psychotherapist allegiance. Worrisome results suggest that researchers strongly allied to a treatment may ignore therapist allegiance, potentially skewing outcomes. All clinical trials, and especially “crossed therapist” designs, should measure psychotherapist allegiance to evaluate this possible bias. One of the sacrosanct assumptions of a client is that their therapist believes in the treatment being delivered. -- Wampold, 2001 (1, p159) PMID:23146326

Toward spanning the quality chasm: an examination of team functioning measures.

PubMed

Strasser, Dale C; Burridge, Andrea Backscheider; Falconer, Judith A; Uomoto, Jay M; Herrin, Jeph

2014-11-01

To examine the effect of 5 measures of team functioning on patient outcomes. Observational, exploratory, measurement. Team functioning surveys and patient outcomes collected 1 year apart in a clinical trial were analyzed. The findings are discussed in context of the domains of team functioning, team effectiveness, and quality improvement. 27 Veterans Affairs medical centers. Staff (t1: N=356; t2: N=273) on inpatient teams and patients (t1: N=4266; t2: N=3213) treated by the teams. Not applicable. Five measures of team functioning (Physician Engagement, Shared Leadership, Supervisor Team Support, Teamness, and Team Effectiveness scales) and 3 measures of patient outcomes (functional improvement, discharge destination, and length of stay) were assessed at 2 time points with hierarchical generalized linear models to evaluate the association between team functioning measures and changes in patient outcomes. Associations (P<.05) between team functioning measures and patient outcomes were found for 3 of the 15 analyses over the study period. Higher Physician Engagement scale score was associated with lower length of stay (P=.017), and increased scores on Teamness and Team Effectiveness scales correlated with higher rates of community discharge (P=.044 and .049, respectively). This exploratory analysis revealed trends that team functioning corresponds with patient outcomes in clinically relevant patterns. An increase in community discharge and a decrease in length of stay were associated with higher scores of team functioning. Here, we find evidence that modifiable attributes of team functioning have a measurable effect on patient outcomes. Such findings are promising and support the need for further research on team effectiveness. Copyright © 2014 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Outcome expectations for exercise scale: utility and psychometrics.

PubMed

Resnick, B; Zimmerman, S I; Orwig, D; Furstenberg, A L; Magaziner, J

2000-11-01

The purpose of this study was to develop a measure of outcome expectations for exercise specifically for the older adult (The Outcome Expectations for Exercise [OEE] Scale), and to test the reliability and validity of this measure in a sample of older individuals. This scale was developed based on Bandura's theory of self-efficacy and the work of prior researchers in the development of measures of outcome expectations. The OEE scale, which was completed during a face-to-face interview, was tested in a sample of 175 residents in a continuing care retirement community. There was support for the internal consistency of the OEE scale (alpha coefficient of .89), and some support for reliability based on a structural equation modeling approach that used R2 estimates, although less than half of these were greater than 0.5. There was evidence of validity of the measure based on: (a) a confirmatory factor analysis in which the model fit the data (normed fit index [NFI] = .99, root mean square error of approximation [RMSEA] - .07, chi2/df = 2.8); (b) support for the hypothesis that those who exercised regularly had higher OEE scores than those who did not (F = 31.3, p < .05, eta squared = .15); and (c) a statistically significant relationship between outcome expectations and self-efficacy expectations (r = .66). This study provides some initial support for the reliability and validity of the OEE scale. Outcome expectations for exercise were related to exercise behavior in the older adult, and the OEE scale can help identify older adults with low outcome expectations for exercise. Interventions can then be implemented to help these individuals strengthen their outcome expectations, which may subsequently improve exercise behavior.

Associations between loneliness and perceived social support and outcomes of mental health problems: a systematic review.

PubMed

Wang, Jingyi; Mann, Farhana; Lloyd-Evans, Brynmor; Ma, Ruimin; Johnson, Sonia

2018-05-29

The adverse effects of loneliness and of poor perceived social support on physical health and mortality are established, but no systematic synthesis is available of their relationship with the outcomes of mental health problems over time. In this systematic review, we aim to examine the evidence on whether loneliness and closely related concepts predict poor outcomes among adults with mental health problems. We searched six databases and reference lists for longitudinal quantitative studies that examined the relationship between baseline measures of loneliness and poor perceived social support and outcomes at follow up. Thirty-four eligible papers were retrieved. Due to heterogeneity among included studies in clinical populations, predictor measures and outcomes, a narrative synthesis was conducted. We found substantial evidence from prospective studies that people with depression who perceive their social support as poorer have worse outcomes in terms of symptoms, recovery and social functioning. Loneliness has been investigated much less than perceived social support, but there is some evidence that greater loneliness predicts poorer depression outcome. There is also some preliminary evidence of associations between perceived social support and outcomes in schizophrenia, bipolar disorder and anxiety disorders. Loneliness and quality of social support in depression are potential targets for development and testing of interventions, while for other conditions further evidence is needed regarding relationships with outcomes.

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

PubMed

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

2016-04-01

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

Participation in Pre-High School Football and Neurological, Neuroradiological, and Neuropsychological Findings in Later Life: A Study of 45 Retired National Football League Players.

PubMed

Solomon, Gary S; Kuhn, Andrew W; Zuckerman, Scott L; Casson, Ira R; Viano, David C; Lovell, Mark R; Sills, Allen K

2016-05-01

A recent study found that an earlier age of first exposure (AFE) to tackle football was associated with long-term neurocognitive impairment in retired National Football League (NFL) players. To assess the association between years of exposure to pre-high school football (PreYOE) and neuroradiological, neurological, and neuropsychological outcome measures in a different sample of retired NFL players. Cross-sectional study; Level of evidence, 3. Forty-five former NFL players were included in this study. All participants prospectively completed extensive history taking, a neurological examination, brain magnetic resonance imaging, and a comprehensive battery of neuropsychological tests. To measure the associations between PreYOE and these outcome measures, multiple regression models were utilized while controlling for several covariates. After applying a Bonferroni correction for multiple comparisons, none of the neurological, neuroradiological, or neuropsychological outcome measures yielded a significant relationship with PreYOE. A second Bonferroni-corrected analysis of a subset of these athletes with self-reported learning disability yielded no significant relationships on paper-and-pencil neurocognitive tests but did result in a significant association between learning disability and computerized indices of visual motor speed and reaction time. The current study failed to replicate the results of a prior study, which concluded that an earlier AFE to tackle football might result in long-term neurocognitive deficits. In 45 retired NFL athletes, there were no associations between PreYOE and neuroradiological, neurological, and neuropsychological outcome measures. © 2016 The Author(s).

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.

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

PubMed

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

2017-10-01

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

A core outcome set for clinical trials on non-specific low back pain: study protocol for the development of a core domain set.

PubMed

Chiarotto, Alessandro; Terwee, Caroline B; Deyo, Richard A; Boers, Maarten; Lin, Chung-Wei Christine; Buchbinder, Rachelle; Corbin, Terry P; Costa, Leonardo O P; Foster, Nadine E; Grotle, Margreth; Koes, Bart W; Kovacs, Francisco M; Maher, Chris G; Pearson, Adam M; Peul, Wilco C; Schoene, Mark L; Turk, Dennis C; van Tulder, Maurits W; Ostelo, Raymond W

2014-12-26

Low back pain (LBP) is one of the most disabling and costly disorders affecting modern society, and approximately 90% of patients are labelled as having non-specific LBP (NSLBP). Several interventions for patients with NSLBP have been assessed in clinical trials, but heterogeneous reporting of outcomes in these trials has hindered comparison of results and performance of meta-analyses. Moreover, there is a risk of selective outcome reporting bias. To address these issues, the development of a core outcome set (COS) that should be measured in all clinical trials for a specific health condition has been recommended. A standardized set of outcomes for LBP was proposed in 1998, however, with evolution in COS development methodology, new instruments, interventions, and understanding of measurement properties, it is appropriate to update that proposal. This protocol describes the methods used in the initial step in developing a COS for NSLBP, namely, establishing a core domain set that should be measured in all clinical trials. An International Steering Committee including researchers, clinicians, and patient representatives from four continents was formed to guide the development of this COS. The approach of initiatives like Core Outcome Measures in Effectiveness Trials (COMET) and Outcome Measures in Rheumatology (OMERACT) was followed. Participants were invited to participate in a Delphi study aimed at generating a consensus-based core domain set for NSLBP. A list of potential core domains was drafted and presented to the Delphi participants who were asked to judge which domains were core. Participant suggestions about overlap, aggregation, or addition of potential core domains were addressed during the study. The patients' responses were isolated to assess whether there was substantial disagreement with the rest of the Delphi panel. A priori thresholds for consensus were established before each Delphi round. All participants' responses were analysed from a quantitative and qualitative perspective to ascertain that no substantial discrepancies between the two approaches emerged. We present the initial step in developing a COS for NSLBP. The next step will be to determine which measurement instruments adequately cover the domains.

Methodological issues in the design and evaluation of supported communication for aphasia training: a cluster-controlled feasibility study.

PubMed

Horton, Simon; Clark, Allan; Barton, Garry; Lane, Kathleen; Pomeroy, Valerie M

2016-04-18

To assess the feasibility and acceptability of training stroke service staff to provide supported communication for people with moderate-severe aphasia in the acute phase; assess the suitability of outcome measures; collect data to inform sample size and Health Economic evaluation in a definitive trial. Phase II cluster-controlled, observer-blinded feasibility study. In-patient stroke rehabilitation units in the UK matched for bed numbers and staffing were assigned to control and intervention conditions. 70 stroke rehabilitation staff from all professional groups, excluding doctors, were recruited. 20 patients with moderate-severe aphasia were recruited. Supported communication for aphasia training, adapted to the stroke unit context versus usual care. Training was supplemented by a staff learning log, refresher sessions and provision of communication resources. Feasibility of recruitment and acceptability of the intervention and of measures required to assess outcomes and Health Economic evaluation in a definitive trial. Staff outcomes: Measure of Support in Conversation; patient outcomes: Stroke and Aphasia Quality of Life Scale; Communicative Access Measure for Stroke; Therapy Outcome Measures for aphasia; EQ-5D-3L was used to assess health outcomes. Feasibility of staff recruitment was demonstrated. Training in the intervention was carried out with 28 staff and was found to be acceptable in qualitative reports. 20 patients consented to take part, 6 withdrew. 18 underwent all measures at baseline; 16 at discharge; and 14 at 6-month follow-up. Of 175 patients screened 71% were deemed to be ineligible, either lacking capacity or too unwell to participate. Poor completion rates impacted on assessment of patient outcomes. We were able to collect sufficient data at baseline, discharge and follow-up for economic evaluation. The feasibility study informed components of the intervention and implementation in day-to-day practice. Modifications to the design are needed before a definitive cluster-randomised trial can be undertaken. ISRCTN37002304; Results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

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

PubMed

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

2014-08-01

Improving clinical performance using measurement and payment incentives, including pay for performance (or P4P), has, so far, shown modest to no benefit on patient outcomes. Our objective was to assess the impact of a P4P programme on paediatric health outcomes in the Philippines. We used data from the Quality Improvement Demonstration Study. In this study, the P4P intervention, introduced in 2004, was randomly assigned to 10 community district hospitals, which were matched to 10 control sites. At all sites, physician quality was measured using Clinical Performance Vignettes (CPVs) among randomly selected physicians every 6 months over a 36-month period. In the hospitals randomized to the P4P intervention, physicians received bonus payments if they met qualifying scores on the CPV. We measured health outcomes 4-10 weeks after hospital discharge among children 5 years of age and under who had been hospitalized for diarrhoea and pneumonia (the two most common illnesses affecting this age cohort) and had been under the care of physicians participating in the study. Health outcomes data collection was done at baseline/pre-intervention and 2 years post-intervention on the following post-discharge outcomes: (1) age-adjusted wasting, (2) C-reactive protein in blood, (3) haemoglobin level and (4) parental assessment of child's health using general self-reported health (GSRH) measure. To evaluate changes in health outcomes in the control vs intervention sites over time (baseline vs post-intervention), we used a difference-in-difference logistic regression analysis, controlling for potential confounders. We found an improvement of 7 and 9 percentage points in GSRH and wasting over time (post-intervention vs baseline) in the intervention sites relative to the control sites (P ≤ 0.001). The results from this randomized social experiment indicate that the introduction of a performance-based incentive programme, which included measurement and feedback, led to improvements in two important child health outcomes. Published by Oxford University Press in association with The London School of Hygiene and Tropical Medicine © The Author 2013; all rights reserved.

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

PubMed

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

2017-06-09

Crohn's disease (CD) and ulcerative colitis (UC), the main forms of inflammatory bowel disease (IBD), are chronic, progressive and disabling disorders of the gastrointestinal tract. Although data from randomised controlled trials (RCTs) provide the foundation of evidence that validates medical therapy for IBD, considerable heterogeneity exists in the measured outcomes used in these studies. Furthermore, in recent years, there has been a paradigm shift in IBD treatment targets, moving from symptom-based scoring to improvement or normalisation of objective measures of inflammation such as endoscopic appearance, inflammatory biomarkers and histological and radiographic end points. The abundance of new treatment options and evolving end points poses opportunities and challenges for all stakeholders involved in drug development. Accordingly, there exists a need to harmonise measures used in clinical trials through the development of a core outcome set (COS). The development of an IBD-specific COS includes four steps. First, a systematic literature review is performed to identify outcomes previously used in IBD RCTs. Second, semistructured qualitative interviews are conducted with key stakeholders, including patients, clinicians, researchers, pharmaceutical industry representatives, healthcare payers and regulators to identify additional outcomes of importance. Using the outcomes generated from literature review and stakeholder interviews, an international two-round Delphi survey is conducted to prioritise outcomes for inclusion in the COS. Finally, a consensus meeting is held to ratify the COS and disseminate findings for application in future IBD trials. Given that over 30 novel therapeutic compounds are in development for IBD treatment, the design of robust clinical trials measuring relevant and standardised outcomes is crucial. Standardising outcomes through a COS will reduce heterogeneity in trial reporting, facilitate valid comparisons of new therapies and improve clinical trial quality. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

BIOMARKERS S100B AND NSE PREDICT OUTCOME IN HYPOTHERMIA-TREATED ENCEPHALOPATHIC NEWBORNS

PubMed Central

Massaro, An N.; Chang, Taeun; Baumgart, Stephen; McCarter, Robert; Nelson, Karin B.; Glass, Penny

2014-01-01

Objective To evaluate if serum S100B protein and neuron specific enolase (NSE) measured during therapeutic hypothermia are predictive of neurodevelopmental outcome at 15 months in children with neonatal encephalopathy (NE). Design Prospective longitudinal cohort study Setting A level IV neonatal intensive care unit in a free-standing children’s hospital. Patients Term newborns with moderate to severe NE referred for therapeutic hypothermia during the study period. Interventions Serum NSE and S100B were measured at 0, 12, 24 and 72 hrs of hypothermia. Measurements and Main Reseults Of the 83 infants were enrolled, fifteen (18%) died in the newborn period. Survivors were evaluated by the Bayley Scales of Infant Development (BSID-II) at 15 months of age. Outcomes were assessed in 49/68 (72%) survivors at a mean age of 15.2±2.7 months. Neurodevelopmental outcome was classified by BSID-II Mental (MDI) and Psychomotor (PDI) Developmental Index scores, reflecting cognitive and motor outcomes respectively. Four-level outcome classifications were defined a priori: normal= MDI/PDI within 1SD (>85), mild= MDI/PDI <1SD (70–85), moderate/severe= MDI/PDI <2SD (<70), or died. Elevated serum S100B and NSE levels measured during hypothermia were associated with increasing outcome severity after controlling for baseline and soceioeconomic characteristics in ordinal regression models. Adjusted odds ratios for cognitive outcome were: S100B 2.5 (95% CI 1.3–4.8) and NSE 2.1 (1.2–3.6); for motor outcome: S100B 2.6 (1.2–5.6) and NSE 2.1 (1.2–3.6). Conclusions Serum S100B and NSE levels in babies with NE are associated with neurodevelopmental outcome at 15 months. These putative biomarkers of brain injury may help direct care during therapeutic hypothermia. PMID:24777302

Bimodal Benefits on Objective and Subjective Outcomes for Adult Cochlear Implant Users

PubMed Central

Heo, Ji-Hye; Lee, Won-Sang

2013-01-01

Background and Objectives Given that only a few studies have focused on the bimodal benefits on objective and subjective outcomes and emphasized the importance of individual data, the present study aimed to measure the bimodal benefits on the objective and subjective outcomes for adults with cochlear implant. Subjects and Methods Fourteen listeners with bimodal devices were tested on the localization and recognition abilities using environmental sounds, 1-talker, and 2-talker speech materials. The localization ability was measured through an 8-loudspeaker array. For the recognition measures, listeners were asked to repeat the sentences or say the environmental sounds the listeners heard. As a subjective questionnaire, three domains of Korean-version of Speech, Spatial, Qualities of Hearing scale (K-SSQ) were used to explore any relationships between objective and subjective outcomes. Results Based on the group-mean data, the bimodal hearing enhanced both localization and recognition regardless of test material. However, the inter- and intra-subject variability appeared to be large across test materials for both localization and recognition abilities. Correlation analyses revealed that the relationships were not always consistent between the objective outcomes and the subjective self-reports with bimodal devices. Conclusions Overall, this study supports significant bimodal advantages on localization and recognition measures, yet the large individual variability in bimodal benefits should be considered carefully for the clinical assessment as well as counseling. The discrepant relations between objective and subjective results suggest that the bimodal benefits in traditional localization or recognition measures might not necessarily correspond to the self-reported subjective advantages in everyday listening environments. PMID:24653909