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

Background: The Core Outcome Measures in Effectiveness Trials (COMET) initiative aims to facilitate the development and application of 'core outcome sets' (COS). A COS is an agreed minimum set of outcomes that should be measured and reported in all clinical trials of a specific disease or trial population. The overall aim of the Core Outcome Measurement Instrument Selection (COMIS) project is to develop a guideline on how to select outcome measurement instruments for outcomes included in a COS.

Mobile-bearing total knee arthroplasty: More rotation is evident during more demanding tasks.

Background: Some reports showed few but significant more axial femorotibial rotation in favor of mobile-bearing (MB) versus fixed-bearing (FB) total knee arthroplasty (TKA), mostly during knee bend fluoroscopic studies. The goal of the current study was to submit MB and FB groups of TKA patients to a turning activity, in which additional rotation was to be expected.

Methods: Two consecutive cohorts of patients after TKA (10 FB and 11 MB knees in a total of 18 patients) were assessed using motion analysis five year postoperatively, while performing gait and sit-to-walk (STW) movements with and without turning steps.

Measurement properties of the Western Ontario Shoulder Instability index in Dutch patients with shoulder instability.

Background: The Western Ontario Shoulder Instability index (WOSI) is a patient-reported outcome measure for patients with shoulder instability. The purpose of this study was to validate the WOSI in a Dutch population by evaluating its structural validity, internal consistency, measurement error, reliability, and construct validity. Floor and ceiling effects were also addressed.

Reliability, responsiveness and interpretability of the neck disability index-Dutch version in primary care.

Purpose: To establish an evidence-based recommendation for the pragmatic use of the Neck Disability Index-Dutch Version (NDI-DV) in primary care based on an assessment of the reliability, the responsiveness, and the interpretability of the NDI-DV.

Study Design And Setting/methods: At baseline, the NDI-DV was completed by 337 patients with neck pain presenting to 97 chiropractic clinics in Belgium and the Netherlands. Three months after inclusion, 265 patients provided data to assess the responsiveness and interpretability.

Validation of the Dutch language version of the Foot and Ankle Outcome Score.

Purpose: The aim of this study was to develop a Dutch language version of the Foot and Ankle Outcome Score (FAOS-DLV) and evaluate its measurement properties according to the definitions of the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN).

Methods: After a standard forward-backward translation procedure, the Dutch version of the FAOS was evaluated for reliability and validity in 110 patients with various hind foot and ankle complaints. Reliability was evaluated by calculation of intraclass correlation coefficients (ICC), Cronbach's alpha for internal consistency, and the smallest detectable change (SDC).

Calibration of the PROMIS physical function item bank in Dutch patients with rheumatoid arthritis.

Objective: To calibrate the Dutch-Flemish version of the PROMIS physical function (PF) item bank in patients with rheumatoid arthritis (RA) and to evaluate cross-cultural measurement equivalence with US general population and RA data.

Methods: Data were collected from RA patients enrolled in the Dutch DREAM registry. An incomplete longitudinal anchored design was used where patients completed all 121 items of the item bank over the course of three waves of data collection.

Dutch-Flemish translation of 17 item banks from the patient-reported outcomes measurement information system (PROMIS).

Background: The Patient-Reported Outcomes Measurement Information System (PROMIS(®)) is a new, state-of-the-art assessment system for measuring patient-reported health and well-being of adults and children that has the potential to be more valid, reliable and responsive than existing PROMs. The PROMIS items can be administered in short forms or, more efficiently, through computerized adaptive testing. This paper describes the translation of 563 items from 17 PROMIS item banks (domains) for adults from the English source into Dutch-Flemish.

The case for an international patient-reported outcomes measurement information system (PROMIS®) initiative.

Patient-reported outcomes (PROs) play an increasingly important role in clinical practice and research. Modern psychometric methods such as item response theory (IRT) enable the creation of item banks that support fixed-length forms as well as computerized adaptive testing (CAT), often resulting in improved measurement precision and responsiveness. Here we describe and discuss the case for developing an international core set of PROs building from the US PROMIS® network.

Determination and comparison of the smallest detectable change (SDC) and the minimal important change (MIC) of four-shoulder patient-reported outcome measures (PROMs).

Background: There is a need for better interpretation of orthopedic treatment effects. Patient-reported outcome measures (PROMs) are already commonly used for patient evaluation. PROMs can be used to determine treatment effects in research as well as in clinical settings by calculating change scores, with pre- and post-treatment evaluation.

Unsuccessful validation of 2004 model for predicting academic or behavioural limitations after childhood bacterial meningitis.

Aim: In 2004, a model identifying children at risk of academic or behavioural limitations after bacterial meningitis (BM) was presented. Risk factors were male gender, low birthweight, lower educational level of the father, Streptococcus pneumoniae, lower cerebrospinal fluid (CSF) leucocyte count, delay between admission and start of antibiotics, dexamethasone <2 days, seizures and prolonged fever. The aim of this study was to validate that prediction model in an independent cohort.

Development and validation of the computer-administered animated activity questionnaire to measure physical functioning of patients with hip or knee osteoarthritis.

Background: Physical functioning of patients with hip or knee osteoarthritis is measured by self-report questionnaires and performance-based tests. However, performance-based tests often are not feasible.

Objective: The aim of this study was to develop a computer-administered questionnaire (ie, the Animated Activity Questionnaire [AAQ]) to measure physical functioning in patients with hip or knee OA.

Social participation in older adults with joint pain and comorbidity; testing the measurement properties of the Dutch Keele Assessment of Participation.

Objective: The Keele Assessment of Participation (KAP) questionnaire measures person-perceived participation in 11 aspects of life. Participation allows fulfilment of valued life activities and social roles, which are important to older adults. Since we aimed to use the KAP in a larger Dutch cohort, we examined the measurement properties of KAP in a Dutch sample of older adults with joint pain and comorbidity.

Addition of host genetic variants in a prediction rule for post meningitis hearing loss in childhood: a model updating study.

Background: Sensorineural hearing loss is the most common sequela in survivors of bacterial meningitis (BM). In the past we developed a validated prediction model to identify children at risk for post-meningitis hearing loss. It is known that host genetic variations, besides clinical factors, contribute to severity and outcome of BM.

Diagnostic value of patient characteristics, history, and six clinical tests for traumatic anterior shoulder instability.

Background: It is unknown which combination of patient information and clinical tests might be optimal for the diagnosis of traumatic anterior shoulder instability. This study aimed to determine the diagnostic value of individual clinical tests and to develop a prediction model that combined patient characteristics, history, and clinical tests for diagnosis of traumatic anterior shoulder instability.

Materials And Methods: This prospective cohort study included 169 consecutive patients with shoulder complaints who were examined at an orthopaedic outpatient clinic.

Bioelectrical impedance analysis to estimate body composition in children and adolescents: a systematic review and evidence appraisal of validity, responsiveness, reliability and measurement error.

Bioelectrical impedance analysis (BIA) is a practical method to estimate percentage body fat (%BF). In this systematic review, we aimed to assess validity, responsiveness, reliability and measurement error of BIA methods in estimating %BF in children and adolescents.We searched for relevant studies in Pubmed, Embase and Cochrane through November 2012.

What is a clinically relevant change on the HIT-6 questionnaire? An estimation in a primary-care population of migraine patients.

Objective: To interpret questionnaire scores, clinicians and researchers need to know what change in score reflects a meaningful change in the condition of an individual patient, and what difference reflects a meaningful difference between groups. These values differ between different populations. We determined the within-person minimally important change (MIC) and the between-group minimally important difference (MID) of the Headache Impact Test-6 (HIT-6) questionnaire in a primary-care population of migraine patients.

Instruments measuring externalizing mental health problems in immigrant ethnic minority youths: a systematic review of measurement properties.

Background: Little is known about reliability and validity of instruments measuring externalizing mental health problems in immigrant ethnic minority youths.

Aims: To provide an overview of studies on measurement properties of instruments measuring these problems in immigrant ethnic minority youths, their methodological quality and results.

Methods: A systematic review of the literature in MEDLINE, EMbase, PsycINFO and Cochrane Library was performed.

Definition of the construct to be measured is a prerequisite for the assessment of validity. The Neck Disability Index as an example.

Objective: To determine the content, structural, and construct validity of the Dutch version of the Neck Disability Index (NDI).

Study Design And Setting: To assess content validity, 11 neck pain experts and 10 patients commented on the construct, comprehensiveness, and relevance of the NDI. Structural validity was assessed by item factor analysis (FA) and item response theory modeling using the generalized partial credit model.

Clinicians are right not to like Cohen's κ.

Clinicians are interested in observer variation in terms of the probability of other raters (interobserver) or themselves (intraobserver) obtaining the same answer. Cohen's κ is commonly used in the medical literature to express such agreement in categorical outcomes. The value of Cohen's κ, however, is not sufficiently informative because it is a relative measure, while the clinician's question of observer variation calls for an absolute measure.

Independent validation of an existing model enables prediction of hearing loss after childhood bacterial meningitis.

Objective: This study aimed external validation of a formerly developed prediction model identifying children at risk for hearing loss after bacterial meningitis (BM). Independent risk factors included in the model are: duration of symptoms prior to admission, petechiae, cerebral spinal fluid (CSF) glucose level, Streptococcus pneumoniae and ataxia. Validation helps to evaluate whether the model has potential in clinical practice.

Knee injury and Osteoarthritis Outcome Score or International Knee Documentation Committee Subjective Knee Form: which questionnaire is most useful to monitor patients with an anterior cruciate ligament rupture in the short term?

Purpose: To evaluate which questionnaire, the Knee Injury and Osteoarthritis Outcome Score (KOOS) or the International Knee Documentation Committee Subjective Knee Form (IKDC subjective), is most useful to evaluate patients with recent anterior cruciate ligament (ACL) ruptures or those within 1 year of an ACL reconstruction.

Methods: Patients with recent (0-6 months) ACL ruptures or those with indications for ACL reconstruction were included. All patients completed the questionnaires shortly after trauma or preoperatively and again 1 year later.

ISOQOL recommends minimum standards for patient-reported outcome measures used in patient-centered outcomes and comparative effectiveness research.

Purpose: An essential aspect of patient-centered outcomes research (PCOR) and comparative effectiveness research (CER) is the integration of patient perspectives and experiences with clinical data to evaluate interventions. Thus, PCOR and CER require capturing patient-reported outcome (PRO) data appropriately to inform research, healthcare delivery, and policy. This initiative's goal was to identify minimum standards for the design and selection of a PRO measure for use in PCOR and CER.

Spinal manipulative therapy for acute low back pain: an update of the cochrane review.

Study Design: Systematic review of interventions.

Objective: To assess the effects of spinal manipulative therapy (SMT) for acute low back pain.

Summary Of Background Data: SMT is one of many therapies for the treatment of low back pain, which is a worldwide, extensively practiced intervention.

The six-minute walk test in chronic pediatric conditions: a systematic review of measurement properties.

Background: The Six-Minute Walk Test (6MWT) is increasingly being used as a functional outcome measure for chronic pediatric conditions. Knowledge about its measurement properties is needed to determine whether it is an appropriate test to use.

Purpose: The purpose of this study was to systematically review all published clinimetric studies on the 6MWT in chronic pediatric conditions.