COnsensus-based Standards For The Selection Of Health Status Measurement INstruments Research Articles

Pain and Its Clinical Associations in Individuals With COPD: A Systematic Review

Pain is emerging as a clinical complication in COPD, but the clinical impact of this comorbidity and the measurement properties of instruments used to assess pain require evaluation. Electronic searches of five databases were performed up to September 2014 for the two phases of this review. To be included in phase 1, studies reported the clinical associations of pain and prevalence in individuals with COPD. To be included in phase 2, studies reported measurement properties of an instrument assessing pain in COPD. Two independent reviewers rated the quality of quantitative and qualitative evidence (phase 1) and the measurement properties using the four-point Consensus-Based Standards for the Selection of Health Status Measurement Instruments (COSMIN) checklist (phase 2). Of the 358 studies identified in the literature, nine met the inclusion criteria for phase 1 and five for phase 2. The mean (SD) quality score (of 16) for the quantitative studies was 13.1 (1.7). The pooled prevalence of pain in moderate to very severe COPD was 66% (95% CI, 44%-85%). Higher pain intensity was associated with increased dyspnea, fatigue, poorer quality of life, and a greater quantity of specific comorbidities. Of the two identified instruments (Brief Pain Inventory and McGill Pain Questionnaire), the measurement properties analyzed were construct validity, internal consistency, and criterion-predictive validity, with variable findings based on "fair" or "poor" quality studies. In people with COPD, pain has negative clinical associations with symptoms and quality-of-life measures. Further research exploring the measurement properties of instruments assessing pain is required.

Pain and Physical Functioning in Neuropathic Pain: A Systematic Review of Psychometric Properties of Various Outcome Measures.

A range of outcome measures across various domains are used to evaluate change following an intervention in clinical trials on chronic neuropathic pain (NeP). However, to capture a real change in the variable of interest, the psychometric properties of a particular measure should demonstrate appropriate methodological quality. Various outcome measures in the domains of pain and physical functioning have been used in the literature for NeP, for which individual properties (eg, reliability/validity) have been reported. To date, there is no definitive synthesis of evidence on the psychometric properties of those outcome measures; thus, the aim of this systematic review was to evaluate the methodological quality [COnsensus-based Standards for the selection of health status Measurement INstruments (COSMIN) guidelines] of studies that evaluated psychometric properties of pain and physical functioning outcome measures used for NeP. Specific MeSH/keywords related to 3 areas (pain and/or physical functioning, psychometric properties, and NeP) were used to retrieve relevant studies (English language) in key electronic databases (MEDLINE (Ovid), CINAHL (EBSCO), Scopus, AMED, and Web of Science) from database inception-July 2012. Articles retrieval/screening and quality analysis (COSMIN) were carried out by 2 independent reviewers. Twenty-four pain and thirty-seven physical functioning outcome measures were identified, varying in methodological quality from poor-excellent. Although a variety of pain and physical functioning outcome measures have been reported in the literature, few have demonstrate methodologically strong psychometric properties. Thus, future research is required to further investigate the psychometric properties of existing pain and physical functioning outcome measures used for clinical and research purposes.

Protocol for a systematic review of screening tools for fear of recurrent illness in common life-threatening diseases.

BackgroundA myocardial infarction (MI) (‘heart attack’) can be intensely stressful, and the impact of this event can leave patients with clinically significant post-MI stress symptoms. Untreated stress can make heart disease worse. Few tools are available that screen for specific thoughts or beliefs that can trigger post-MI stress responses. In other life-threatening illnesses, fear of recurrence (FoR) of illness has been identified as a key stressor, and screening tools have been developed to identify this. The aim of this review is to identify FoR screening tools used in other common life-threatening diseases that report on the development of the tool, to assess if there are any that can be adapted for use in MI survivors so that those with high levels of FoR can be identified and helped.Methods/DesignThe review will evaluate full FoR screening tools and methods of measurement used in common life-threatening disease clinical populations. The Campbell and Cochrane Libraries, Cumulative Index of Nursing and Allied Health Literature (CINAHL), PsycINFO, MEDLINE, Embase, Applied Social Sciences Index and s (ASSIA), Published International Literature on Traumatic Stress (PILOTS), Social Services s, Sociological s, Web of Knowledge, Health and Psychosocial Instruments and SCOPUS databases will be searched for relevant studies published from database inception. Reference lists and published reviews/meta-analyses will also be searched. All titles and abstracts will be screened and relevant full-text versions retrieved by two reviewers, who will then extract all the data. Each will independently review all data extracted by the other. Selected studies will also be assessed by two independent researchers using the COnsensus-based standards for the Selection of health status measurement INstruments (COSMIN) checklist and other quality criteria. This will be done to evaluate the degree to which their measurement properties meet the standards for good methodological quality. Disagreement will be resolved through consensus.DiscussionUntreated post-MI stress has a considerable psychological and physical impact on MI survivors. Therefore, there is a critical need to develop a screening tool to identify fear of recurrent MI so that those affected can be identified and directed to appropriate support interventions. This proposed research will enable a tool to be developed and adapted for use in the MI survivor patient population.Systematic review registrationPROSPERO: CRD42014010500

The measurement properties of the IKDC-subjective knee form.

To evaluate the methodological quality of studies reporting on the measurement properties of the International Knee Documentation Committee subjective knee form (IKDC-SKF) and to evaluate their results following the COnsensus-based Standards for the selection of health status Measurement INstruments (COSMIN) guidelines. Systematic search of articles published about the measurement properties of the IKDC-SKF, review of the studies' methodological quality, and synthesis of the results using the COSMIN guidelines. Twenty-six studies were identified and reviewed. There was strong evidence for good internal consistency, test-retest reliability, and responsiveness. There was moderate evidence for good content and structural validity. With the SF36 as a gold standard, the level of evidence for criterion validity was indeterminate. There was conflicting evidence for hypothesis testing and not enough evidence to evaluate measurement error and cross-cultural validity. There were no floor or ceiling effects. This review shows that the IKDC-SKF is a measurement instrument with good internal consistency, test-retest reliability, content and structural validity, and responsiveness and interpretability (no floor and ceiling effects). Further evaluation of measurement error, minimal important change, and hypotheses testing is recommended. The IKDC-SKF seems to be useful as a general instrument for all kinds of knee injuries, which might facilitate its clinical use in situations in which time is a factor. Systematic review, Level III.

Instruments measuring meaningful learning in undergraduate healthcare students: a systematic review protocol.

To establish the psychometric properties of instruments to measure learning outcomes in healthcare students. Meaningful learning is an active process that promotes a wider and deeper understanding of concepts. It is the result of an interaction between new and previous knowledge. Meaningful learning produces a long-term change in knowledge and skills, which is underpinned by willingness to learn and experience and it is exclusively built by the learner. Systematic psychometric review protocol developed from Cochrane Effective Practice and Organization of Care guidance. Searches of MEDLINE, CINAHL, SCOPUS, ERIC, PsycINFO, Cochrane Library, Psychology & Behavioral Sciences Collection Database between 1990-2013. Selected studies will be evaluated with the Consensus-based Standards for the selection of health status Measurement INstruments (COSMIN) checklist. Funding for the review was confirmed on January 2011 by the Centre of Excellence for Nursing Scholarship in Rome. The systematic review will produce a synthesis of the data related to the instruments that measure learning outcomes. These data will help us decide which tools to use and identify the state of knowledge in this field. Measuring learning outcomes is very important for the large amount of human and financial resources employed in educating and training health professionals and this requires reliable and valid instruments.

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

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.

Systematic review of studies on measurement properties of instruments for adults published in the American Journal of Occupational Therapy, 2009-2013.

We describe the methodological quality of recent studies on instrument development and testing published in the American Journal of Occupational Therapy (AJOT). We conducted a systematic review using the COnsensus-based Standards for the selection of health status Measurement INstruments (COSMIN) checklist to appraise 48 articles on measurement properties of assessments for adults published in AJOT between 2009 and 2013. Most studies had adequate methodological quality in design and statistical analysis. Common methodological limitations included that methods used to examine internal consistency were not consistently linked to the theoretical constructs underpinning assessments; participants in some test-retest reliability studies were not stable during the interim period; and in several studies of reliability and convergent validity, sample sizes were inadequate. AJOT's dissemination of psychometric research evidence has made important contributions to moving the profession toward the American Occupational Therapy Association's Centennial Vision. This study's results provide a benchmark by which to evaluate future accomplishments.

Reliability and validity of the Pragmatics Observational Measure (POM): a new observational measure of pragmatic language for children.

There is a need for a reliable and valid assessment of childhood pragmatic language skills during peer-peer interactions. This study aimed to evaluate the psychometric properties of a newly developed pragmatic assessment, the Pragmatic Observational Measure (POM). The psychometric properties of the POM were investigated from observational data of two studies - study 1 involved 342 children aged 5-11 years (108 children with ADHD; 108 typically developing playmates; 126 children in the control group), and study 2 involved 9 children with ADHD who attended a 7-week play-based intervention. The psychometric properties of the POM were determined based on the COnsensus-based Standards for the selection of health status Measurement INstruments (COSMIN) taxonomy of psychometric properties and definitions for health-related outcomes; the Pragmatic Protocol was used as the reference tool against which the POM was evaluated. The POM demonstrated sound psychometric properties in all the reliability, validity and interpretability criteria against which it was assessed. The findings showed that the POM is a reliable and valid measure of pragmatic language skills of children with ADHD between the age of 5 and 11 years and has clinical utility in identifying children with pragmatic language difficulty.

Responsiveness of the Work Role Functioning Questionnaire (Spanish Version) in a General Working Population

To examine the responsiveness of the Work Role Functioning Questionnaire (Spanish version) (WRFQ-SpV) so that it could be used in evaluative studies. A longitudinal survey was performed. Combinations of distribution- and anchor-based approaches were used. Five hypotheses were tested, examining validity of change scores. The consensus-based standards for the selection of health status measurement instruments (COSMIN) guided the study design. One hundred two participants (mean age, 47.3 years; SD = 10.3 years) completed the WRFQ-SpV twice, within a mean interval of 3.7 (SD = 1.8) months. Four hypotheses were confirmed and one was rejected. It was verified that the WRFQ-SpV was able to detect (true) changes over time. Suggestive evidence about the possible use of the WRFQ-SpV with evaluative purposes was provided. More research is needed to examine the instrument responsiveness for groups whose health is stable or deteriorates.

Upper Extremity Strength Measurement for Children With Cerebral Palsy: A Systematic Review of Available Instruments

In order to make inferences about strength related to development or treatment interventions, it is important to use measurement instruments that have sound clinimetric properties. The objective of this review is to systematically evaluate the level of evidence of the clinimetric properties of instruments for measuring upper extremity muscle strength at the "body functions & structures" level of the International Classification of Functioning, Disability and Health for Children and Youth (ICF-CY) for children with cerebral palsy (CP). A systematic search of the PubMed, EMBASE, OTseeker, CINAHL, PEDro, and MEDLINE databases up to November 2012 was performed. Two independent raters identified and examined studies that reported the use of upper extremity strength measurement instruments and methods for children and adolescents with CP aged 0 to 18 years. The COSMIN (COnsensus-based Standards for the selection of health status Measurement INstruments) checklist with 4-point rating scale was used by 2 independent raters to evaluate the methodological quality of the included studies. Best evidence synthesis was performed using COSMIN outcomes and the quality of the clinimetric properties. Six different measurement instruments or methods were identified. Test-retest, interrater, and intrarater reliability were investigated. Two test-retest reliability studies were rated as "fair" for the level of evidence. All other studies were rated as "unknown" for the level of evidence. The paucity of literature describing clinimetric properties, especially other than reliability, of upper limb strength measurement instruments for children with CP was a limitation of the study. For measuring grip strength, the Jamar dynamometer is recommended. For other muscle groups, handheld dynamometry is recommended. Manual muscle testing (MMT) can be used in case of limited (below MMT grade 4) wrist strength or for total upper limb muscle strength. Based on lacking information regarding other clinimetric properties, caution is advised regarding interpretation of the results.

Expert Panels: Can They Be Trusted?

Van Meer et al.1 recently compared the Knee Injury and Osteoarthritis Outcome Score (KOOS)2 with the International Knee Documentation Committee (IKDC) Subjective Knee Form3 to investigate which of the instruments is most useful after anterior cruciate ligament reconstruction (ACLR). Following the COSMIN (COnsensus-based Standards for the selection of health status Measurement INstruments) checklist, an expert panel reached consensus on a priori hypotheses regarding responsiveness and construct validity.

Validity and Reliability of Tools to Measure Muscle Mass, Strength, and Physical Performance in Community-Dwelling Older People: A Systematic Review

This study critically appraises the measurement properties of tools to measure muscle mass, strength, and physical performance in community-dwelling older people. This can support the selection of a valid and reliable set of tools that is feasible for future screening and identification of sarcopenia. The databases PubMed, Cumulative Index to Nursing and Allied Health Literature (CINAHL), and Cochrane were systematically searched (January 11, 2012). Studies were included if they investigated the measurement properties or feasibility, or both, of tools to measure muscle mass, strength, and physical performance in community-dwelling older people aged ≥60 years. The consensus-based standards for the selection of health status measurement instruments (COSMIN) checklist was used for quality appraisal of the studies. Sixty-two publications were deemed eligible, including tools for muscle mass (n= 16), muscle strength (n= 15), and physical performance (n= 31). Magnetic resonance imaging, computed tomography, and a 4-compartment model were used as gold standards for muscle mass assessment. Other frequently used measures of muscle mass are dual-energy x-ray and the bioelectrical impedance (BIA); however, reliability data of the BIA are lacking. Handheld dynamometry and gait speed or a short physical performance battery provide a valid and reliable measurement of muscle strength and physical performance, respectively. It can be concluded that several tools are available for valid and reliable measurements of muscle mass, strength, and performance in clinical settings. For a home-setting BIA, handheld dynamometry and gait speed or a short physical performance battery are the most valid, reliable, and feasible. The combination of selected instruments and its use for the screening and identification of sarcopenia in community-dwelling older people need further evaluation.

Measurement Properties of Outcome Measures for Vitiligo

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.

Clinimetric properties of observer‐assessed impairment tests used to evaluate hip and groin impairments: A systematic review

To recommend the most suitable observer-assessed impairment tests in people with hip and/or groin pathologies by conducting a systematic review of the clinimetric properties of these tests. Electronic searches were performed in the Cochrane, PubMed, CINAHL, Embase, SPORTDiscus, and PsycINFO databases up to August 2011. Two reviewers independently rated the measurement properties of clinical tests of impairments, defined by the International Classification of Functioning, Disability and Health as problems in body structure or body function, using the Consensus-Based Standards for the Selection of Health Status Measurement Instruments (COSMIN). "Best evidence synthesis" was made using COSMIN outcomes and the quality of findings was assessed using a purpose criteria system. Fifteen of 2,588 publications were eligible for inclusion. Impairments evaluated were range of motion (ROM; 9 studies), muscle strength (6 studies), tenderness (3 studies), leg length discrepancy (2 studies), balance (2 studies), and muscle length (2 studies) in people with hip osteoarthritis (OA), hip fractures, and mixed hip/groin pathologies. Measurement properties evaluated included reliability, measurement error, construct validity, and criterion validity. Responsiveness and interpretability were not assessed. Intrarater reliability of ROM tests (intraclass correlation coefficient [ICC] 0.82-0.97) and strength tests (ICC 0.84-0.98) for hip OA and of strength tests (ICC 0.66-0.86) and balance tests (ICC 0.73-0.94) for hip fractures was demonstrated. This systematic review highlighted a paucity of literature evaluating the clinimetric properties of impairment tests for people with hip and/or groin pathology. A large number of inconclusive findings were found and as such, many clinical impairment tests should be used with caution in people with hip and/or groin pathologies until further clinimetric evidence becomes available.

Author's Reply

Author's Reply

How Should We Measure Arm Exercise Capacity in Patients With COPD?: A Systematic Review

There are no recommendations on how to measure arm exercise capacity in individuals with COPD. The objectives of this study were (1) to synthesize the literature on measures of arm exercise capacity in individuals with COPD, (2) to describe the psychometric properties and the target construct of each measure, and (3) to make recommendations for clinical practice and research.Studies conducted in patients with COPD that included a measure of arm exercise capacity were identified after searches of five electronic databases (PubMed, CINAHL, EMBASE, PEDro, and Cochrane Library) and reference lists of pertinent articles. One reviewer performed data extraction, and two assessed the quality of the studies that described measurement properties, using the Consensus-based Standards for the Selection of Health Status Measurement Instruments (COSMIN) checklist.Of 654 reports, 41 met the study criteria. Five types of arm exercise tests were identified: arm ergometry, ring shifts, dowel lifts, proprioceptive neuromuscular facilitation, and activities of daily living. Four studies assessed the measurement properties of the unsupported upper-limb exercise test (UULEX), the 6-min pegboard and ring test (6PBRT), a test involving weight shifts, and the grocery-shelving task (GST). Validity studies were of fair to good quality, whereas reliability studies were of poor quality.Arm ergometry may be the best method for measuring peak supported arm exercise capacity and endurance. The UULEX, 6PBRT, and GST may better reflect activities of daily living and should be the tests of choice to measure peak unsupported arm exercise capacity (UULEX) and arm function (6PBRT and GST).

Evaluation of the measurement properties of self-reported health-related work-functioning instruments among workers with common mental disorders

During the past decade, common mental disorders (CMD) have emerged as a major public and occupational health problem in many countries. Several instruments have been developed to measure the influence of health on functioning at work. To select appropriate instruments for use in occupational health practice and research, the measurement properties (eg, reliability, validity, responsiveness) must be evaluated. The objective of this study is to appraise critically and compare the measurement properties of self-reported health-related work-functioning instruments among workers with CMD. A systematic review was performed searching three electronic databases. Papers were included that: (i) mainly focused on the development and/or evaluation of the measurement properties of a self-reported health-related work-functioning instrument; (ii) were conducted in a CMD population; and (iii) were fulltext original papers. Quality appraisal was performed using the consensus-based standards for the selection of health status measurement instruments (COSMIN) checklist. Five papers evaluating measurement properties of five self-reported health-related work-functioning instruments in CMD populations were included. There is little evidence available for the measurement properties of the identified instruments in this population, mainly due to low methodological quality of the included studies. The available evidence on measurement properties is based on studies of poor-to-fair methodological quality. Information on a number of measurement properties, such as measurement error, content validity, and cross-cultural validity is still lacking. Therefore, no evidence-based decisions and recommendations can be made for the use of health-related work functioning instruments. Studies of high methodological quality are needed to properly assess the existing instruments' measurement properties.

Inter-rater agreement and reliability of the COSMIN (COnsensus-based Standards for the selection of health status Measurement Instruments) checklist.

BackgroundThe COSMIN checklist is a tool for evaluating the methodological quality of studies on measurement properties of health-related patient-reported outcomes. The aim of this study is to determine the inter-rater agreement and reliability of each item score of the COSMIN checklist (n = 114).Methods75 articles evaluating measurement properties were randomly selected from the bibliographic database compiled by the Patient-Reported Outcome Measurement Group, Oxford, UK. Raters were asked to assess the methodological quality of three articles, using the COSMIN checklist. In a one-way design, percentage agreement and intraclass kappa coefficients or quadratic-weighted kappa coefficients were calculated for each item.Results88 raters participated. Of the 75 selected articles, 26 articles were rated by four to six participants, and 49 by two or three participants. Overall, percentage agreement was appropriate (68% was above 80% agreement), and the kappa coefficients for the COSMIN items were low (61% was below 0.40, 6% was above 0.75). Reasons for low inter-rater agreement were need for subjective judgement, and accustom to different standards, terminology and definitions.ConclusionsResults indicated that raters often choose the same response option, but that it is difficult on item level to distinguish between articles. When using the COSMIN checklist in a systematic review, we recommend getting some training and experience, completing it by two independent raters, and reaching consensus on one final rating. Instructions for using the checklist are improved.

Imported Tropical Diseases

<h3>Background</h3> Sound measurement properties of outcome tools are essential when evaluating outcomes of an intervention, in clinical practice and in research. <h3>Purpose</h3> 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. <h3>Data Sources</h3> The MEDLINE, CINAHL, EMBASE, and PsycINFO databases were searched up to June 15, 2012. <h3>Study Selection</h3> 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. <h3>Data Extraction</h3> 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. <h3>Data Synthesis</h3> 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. <h3>Limitations</h3> 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. <h3>Conclusions</h3> 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.