Development of a new health-related quality of life measure for people with diabetes who experience hypoglycaemia: the Hypo-RESOLVE QoL.

Aims/hypothesis: Valid and reliable patient-reported outcome measures are vital for assessing disease impact, responsiveness to healthcare and the cost-effectiveness of interventions. A recent review has questioned the ability of existing measures to assess hypoglycaemia-related impacts on health-related quality of life for people with diabetes. This mixed-methods project was designed to produce a novel health-related quality of life patient-reported outcome measure in hypoglycaemia: the Hypo-RESOLVE QoL.

Assessment of the Psychometric Properties of the Danish VISA-P.

Purpose: The objective of the current study was to conduct a rigorous assessment of the psychometric properties of the Victorian Institute of Sports Assessment-patellar tendinopathy (VISA-P).

Methods: Rasch analysis, confirmatory factor analysis (CFA), and multivariable linear regression were used to assess the psychometric properties of the VISA-P questionnaire in 184 Danish patients with patellar tendinopathy who had symptoms ranging from under 3 months to over 1 year. A group of 100 healthy Danish persons was included as a reference for known-group validation.

Producing a preference-based quality of LIFE measure to quantify the impact of HYPOGLYCAEMIA on people living with diabetes: A mixed-methods research protocol.

Background: Assessment of patient-reported outcome measures (PROMs), including quality of life (QoL), is essential in diabetes research and care. However, a recent review concluded that current hypoglycaemia-specific PROMs have limited evidence of validity, reliability and responsiveness for assessing the impact of hypoglycaemia on QoL in people living with diabetes. None of the PROMs identified could be used directly to inform the cost-effectiveness of treatments and interventions.

Four of five frequently used orthopedic PROMs possess inadequate content validity: a COSMIN evaluation of the mHHS, HAGOS, IKDC-SKF, KOOS and KNEES-ACL.

Purpose: Content validity is the most important property of PROMs. The COSMIN initiative has published guidelines for evaluating the content validity of PROMs, but they have only sparsely been applied to relevant PROMs for musculoskeletal conditions. The aim of this study was to use the COSMIN Risk of Bias checklist to evaluate the content validity of five PROMs, that are highly relevant in musculoskeletal research and used by the arthroscopic surgery community: the modified Harris' Hip Score (mHHS), the Copenhagen Hip and Groin Outcome Score (HAGOS), the International Knee Documentation Committee Subjective Knee evaluation Form (IKDC-SKF), the Knee injury and Osteoarthritis Outcome Score (KOOS) and the Knee Numeric-Entity Evaluation Score ACL (KNEES-ACL).

Dual-panel translation to Danish and Rasch validation of the Foot and Ankle Ability Measure (FAAM-DK).

Background: The Foot and Ankle Ability Measure (FAAM) was developed by involvement of patients with chronic ankle instability (CAI) and has acceptable measurement properties, but is not available in Danish.

Methods: FAAM was translated and culturally adapted into Danish, and its measurement properties were assessed using Rasch analyses.

Results: A Danish version was produced with small adaptations, and content relevance was confirmed by Danish patients.

Patient reported outcome measures for ankle instability. An analysis of 17 existing questionnaires.

Background: Patient reported outcome measures (PROMs) are essential for evaluating treatment of ankle instability (AI). The aim was to assess the content validity and the measurement properties of all relevant PROMs for AI.

Methods: Relevant PROMs were identified from PubMed and SCOPUS.

Assessment of content validity and psychometric properties of VISA-A for Achilles tendinopathy.

A recent COSMIN review found that the Victorian Institute of Sports Assessment-Achilles tendinopathy questionnaire (VISA-A) has flawed construct validity. The objective of the current study was to assess specifically the process of how VISA-A was constructed and validated, and whether the Danish version of VISA-A is a valid patient-reported outcome measure (PROM) for measuring the perceived impact of Achilles tendinopathy. The original item generation strategy for content validity and the process for confirming the scaling properties (construct validity) were examined.

A catalogue of PROMs in sports science: Quality assessment of PROM development and validation.

Choosing the most adequate PROM for a study is a non-trivial process. The aim of this study was to provide a catalogue with analyses of content and construct validity of PROMs relevant to research in sports science, including all published local translations. The most commonly used PROMs in sports research were selected from a PubMed search "patient reported outcome measures sports", identifying 439 articles and 194 different PROMs.

Choosing the most appropriate PROM for clinical studies in sports medicine.

Choosing the most appropriate patient-reported outcome measure (PROM) for a clinical study is essential in order to achieve trustworthy results. This choice will depend on (a) the objective of the study and hence the research question; (b) the choice of a theoretical framework, such as the World Health Organization's International Classification of Functioning, Disability, and Health (ICF); (c) whether there currently is a PROM that possesses high content validity and high construct validity for the specific patient group and objective, and if not; (d) the decision on whether to use a suboptimal PROM or develop and validate a new PROM. This paper presents the steps that should be followed in order to assess the relevance of PROMs and suggests ways to enhance the choice depending on the goal of the study.

Psychometric validation of PROM instruments.

The aim was to provide an overview of the different statistical methods for validation of patient-reported outcome measures, ranging from simple statistical methods available in all software packages to advanced statistical models that require specialized software. A non-technical summary of classical test theory (CTT) and modern test theory (MTT) is provided. Specifically, confirmatory factor analysis, item response theory, and Rasch analysis is outlined.

Are adequate PROMs used as outcomes in randomized controlled trials? an analysis of 54 trials.

Results by patient-reported outcome measures (PROMs) from randomized controlled trials (RCTs) in musculoskeletal research often influence healthcare strategies. We aimed to evaluate to which extent these RCTs use adequate PROMs, and how this influences the results and conclusions. We identified RCTs of sports research relevance with PROMs as primary outcomes published in 13 preselected journals between January 1, 2008, and November 1, 2019; all journals regularly publish results from musculoskeletal research.

What is a PROM and why do we need it?

The purpose of this article was to introduce the reader to the nature of patient-reported outcome measures (PROMs) and pitfalls in their use. PROMs collect subjective information directly from the patient regarding specific or general conditions and add to clinical and functional outcomes, and turn unmeasurable subjective qualities into quantitative measures. PROMs are questionnaires consisting of items: questions or statements with predefined response options.

Potential problems in the use of patient reported outcome measures (PROMs) and reporting of PROM data in sports science.

To use an inadequate patient reported outcome measure (PROM) or use a PROM in an inappropriate way potentially influences the quality of measurement. The objectives of this study were to define potential inadequate uses of PROMs in sports research studies and estimate how often they occur. A consensus group consisting of medical researchers, statisticians, and psychometricians identified and defined potentially irregular applications of PROMs.

Are PROMs used adequately in sports research? An analysis of 54 randomized controlled trials with PROMs as endpoint.

Deviations from adequate use and reporting of PROMs may be problematic and misleading. The aim of this study was to investigate the extent of such problems in randomized clinical trials (RCTs). RCTs involving sports medicine research that used PROMs as primary outcomes were identified in 13 preselected journals.

How to develop a condition-specific PROM.

Developing new patient-reported outcome measures (PROMs) for application in clinical studies can be necessary if an adequate PROM does not exist. For adequate measurement, it is essential that the PROM has face validity (ie, is perceived to be relevant by clinicians and researchers) and has high content validity (ie, content relevance and content coverage for the targeted patient group). The steps needed to create PROMs that possess face and content validity for a specific condition are described in this paper.

Patient-reported outcome measures for patients with hand-specific impairments-A scoping review.

Background: Patient-reported outcome measures (PROMs) are increasingly used to provide evidence for treatment effects and to guide rehabilitation. To our knowledge, no disease-specific PROM exists for the assessment of patients with flexor tendon lesions of the hand. We believe that PROMs used to assess hand function, regardless of diagnosis, contain relevant items for patients with flexor tendon lesions of the hand.

How to translate and locally adapt a PROM. Assessment of cross-cultural differential item functioning.

Translating patient-reported outcome measures (PROMs) can alter the meaning of items and undermine the PROM's psychometric properties (quantified as cross-cultural differential item functioning [DIF]). The aim of this paper was to present the theoretical background for PROM translation, adaptation, and cross-cultural validation, and assess how PROMs used in sports medicine research have been translated and adapted. We also assessed DIF for the Knee Injury and Osteoarthritis Outcome Score (KOOS) across Danish, Norwegian, and Swedish versions.

Responsiveness, minimal important difference, minimal relevant difference, and optimal number of patients for a study.

Several terms are used to describe changes in PROM scores in relation to treatments. Whether the change is small, large, or relevant is defined in different ways, yet these change scores are used to recommend or oppose treatments. They are also used to calculate the necessary number of patients for a study.

Psychometric Validation of the Danish Version of the Oswestry Disability Index in Patients With Chronic Low Back Pain.

Study Design: Registry-based repeated-measures psychometric validation of the Danish Oswestry Disability Index (ODI).

Objective: The goal was to use classical and modern psychometric validation methods to assess the measurement properties and the minimally clinical important difference (MCID) of the ODI in a Danish cohort of patients with chronic low back pain being treated with spinal surgery.

Summary Of Background Data: Scores for the ODI, EQ-5D, SF-36, leg pain, back pain, and a general rating of pain item from 800 patients with chronic low back pain were extracted from the National Danish Spine Registry (DaneSpine) at baseline and 1-year postspine surgery.

Comparison of Ibuprofen vs Acetaminophen and Severe Bleeding Risk After Pediatric Tonsillectomy: A Noninferiority Randomized Clinical Trial.

Importance: Ibuprofen is an effective analgesic after tonsillectomy alone or tonsillectomy with adenoidectomy, but concerns remain about whether it increases postoperative hemorrhage.

Objective: To investigate the effect of ibuprofen compared with acetaminophen on posttonsillectomy bleeding (PTB) requiring surgical intervention in children.

Design, Setting, And Participants: A multicenter, randomized, double-blind noninferiority trial was conducted at 4 tertiary medical centers (Massachusetts Eye and Ear Infirmary, Boston; Naval Medical Center, San Diego, California; Naval Medical Center, Portsmouth, Virginia; Madigan Army Medical Center, Tacoma, Washington).

Validation of a health screening questionnaire for primary care using Rasch models.

Background: Health inequality is on the rise due to various social and individual factors. While preventive health checks (PHC) aim to counteract health inequality, there is robust evidence against the use of PHC in general practice. It is unknown which factors can identify persons who will benefit from preventive interventions that are more beneficial than harmful.

KNEES-ACL has superior responsiveness compared to the most commonly used patient-reported outcome measures for anterior cruciate ligament injury.

Purpose: For clinical trials, it is essential that measures are sensitive to change. The aim of this study was to conduct a head-to-head comparison of responsiveness of four PROMs used to measure outcome after anterior cruciate ligament (ACL) reconstruction. The PROMs compared were the knee injury osteoarthritis outcome score (KOOS), the international knee documentation committee subjective form (IKDC), the Lysholm score, and the knee numeric-entity evaluation score (KNEES-ACL).

Adaptation of the Activity Measure Post-Acute Care (AM-PAC) from English to Mandarin using the dual-panel translation approach.

Purpose: The aims of this study were to translate and adapt the Activity Measure Post-Acute Care (AM-PAC) from US English to Mandarin using the dual-panel method, and to assess its psychometric properties in an outpatient rehabilitation setting.

Methods: The AM-PAC outpatient short forms were translated using the dual-panel method. The translated AM-PAC was tested in 550 Chinese-speaking rehabilitation outpatients.

Cited references and Medical Subject Headings (MeSH) as two different knowledge representations: clustering and mappings at the paper level.

For the biomedical sciences, the Medical Subject Headings (MeSH) make available a rich feature which cannot currently be merged properly with widely used citing/cited data. Here, we provide methods and routines that make MeSH terms amenable to broader usage in the study of science indicators: using Web-of-Science (WoS) data, one can generate the matrix of citing versus cited documents; using PubMed/MEDLINE data, a matrix of the citing documents versus MeSH terms can be generated analogously. The two matrices can also be reorganized into a 2-mode matrix of MeSH terms versus cited references.