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"Bouter, L. M."
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COSMIN Risk of Bias tool to assess the quality of studies on reliability or measurement error of outcome measurement instruments: a Delphi study
2020
Background
Scores on an outcome measurement instrument depend on the type and settings of the instrument used, how instructions are given to patients, how professionals administer and score the instrument, etc. The impact of all these sources of variation on scores can be assessed in studies on reliability and measurement error, if properly designed and analyzed. The aim of this study was to develop standards to assess the quality of studies on reliability and measurement error of clinician-reported outcome measurement instruments, performance-based outcome measurement instrument, and laboratory values.
Methods
We conducted a 3-round Delphi study involving 52 panelists.
Results
Consensus was reached on how a comprehensive research question can be deduced from the design of a reliability study to determine how the results of a study inform us about the quality of the outcome measurement instrument at issue. Consensus was reached on components of outcome measurement instruments, i.e. the potential sources of variation. Next, we reached consensus on standards on design requirements (
n
= 5), standards on preferred statistical methods for reliability (
n
= 3) and measurement error (
n
= 2), and their ratings on a four-point scale. There was one term for a component and one rating of one standard on which no consensus was reached, and therefore required a decision by the steering committee.
Conclusion
We developed a tool that enables researchers with and without thorough knowledge on measurement properties to assess the quality of a study on reliability and measurement error of outcome measurement instruments.
Journal Article
Deep learning-based single image super-resolution for low-field MR brain images
by
Remis, R. F.
,
de Leeuw den Bouter, M. L.
,
Ippolito, G.
in
639/705/1042
,
692/700/1421/1628
,
Brain - diagnostic imaging
2022
Low-field MRI scanners are significantly less expensive than their high-field counterparts, which gives them the potential to make MRI technology more accessible all around the world. In general, images acquired using low-field MRI scanners tend to be of a relatively low resolution, as signal-to-noise ratios are lower. The aim of this work is to improve the resolution of these images. To this end, we present a deep learning-based approach to transform low-resolution low-field MR images into high-resolution ones. A convolutional neural network was trained to carry out single image super-resolution reconstruction using pairs of noisy low-resolution images and their noise-free high-resolution counterparts, which were obtained from the publicly available NYU fastMRI database. This network was subsequently applied to noisy images acquired using a low-field MRI scanner. The trained convolutional network yielded sharp super-resolution images in which most of the high-frequency components were recovered. In conclusion, we showed that a deep learning-based approach has great potential when it comes to increasing the resolution of low-field MR images.
Journal Article
COSMIN Risk of Bias checklist for systematic reviews of Patient-Reported Outcome Measures
by
Mokkink, L. B.
,
Bouter, L. M.
,
Patrick, D. L.
in
Bias
,
Checklist - methods
,
Clinical outcomes
2018
Purpose The original COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist was developed to assess the methodological quality of single studies on measurement properties of Patient-Reported Outcome Measures (PROMs). Now it is our aim to adapt the COSMIN checklist and its four-point rating system into a version exclusively for use in systematic reviews of PROMs, aiming to assess risk of bias of studies on measurement properties. Methods For each standard (i.e., a design requirement or preferred statistical method), it was discussed within the COSMIN steering committee if and how it should be adapted. The adapted checklist was pilot-tested to strengthen content validity in a systematic review on the quality of PROMs for patients with hand osteoarthritis. Results Most important changes were the reordering of the measurement properties to be assessed in a systematic review of PROMs; the deletion of standards that concerned reporting issues and standards that not necessarily lead to biased results; the integration of standards on general requirements for studies on item response theory with standards for specific measurement properties; the recommendation to the review team to specify hypotheses for construct validity and responsiveness in advance, and subsequently the removal of the standards about formulating hypotheses; and the change in the labels of the four-point rating system. Conclusions The COSMIN Risk of Bias checklist was developed exclusively for use in systematic reviews of PROMs to distinguish this application from other purposes of assessing the methodological quality of studies on measurement properties, such as guidance for designing or reporting a study on the measurement properties.
Journal Article
COSMIN methodology for evaluating the content validity of patient-reported outcome measures: a Delphi study
by
Bouter, L. M.
,
Mokkink, L. B.
,
Patrick, D. L.
in
Clinical outcomes
,
Consensus
,
Content validity
2018
Background Content validity is the most important measurement property of a patient-reported outcome measure (PROM) and the most challenging to assess. Our aims were to: (1) develop standards for evaluating the quality of PROM development; (2) update the original COSMIN standards for assessing the quality of content validity studies of PROMs; (3) develop criteria for what constitutes good content validity of PROMs, and (4) develop a rating system for summarizing the evidence on a PROM's content validity and grading the quality of the evidence in systematic reviews of PROMs. Methods An online 4-round Delphi study was performed among 159 experts from 21 countries. Panelists rated the degree to which they (dis)agreed to proposed standards, criteria, and rating issues on 5-point rating scales ('strongly disagree' to 'strongly agree'), and provided arguments for their ratings. Results Discussion focused on sample size requirements, recording and field notes, transcribing cognitive interviews, and data coding. After four rounds, the required 67% consensus was reached on all standards, criteria, and rating issues. After pilot-testing, the steering committee made some final changes. Ten criteria for good content validity were defined regarding item relevance, appropriateness of response options and recall period, comprehensiveness, and comprehensibility of the PROM. Discussion The consensus-based COSMIN methodology for content validity is more detailed, standardized, and transparent than earlier published guidelines, including the previous COSMIN standards. This methodology can contribute to the selection and use of high-quality PROMs in research and clinical practice.
Journal Article
Rheumatoid arthritis versus diabetes as a risk factor for cardiovascular disease: a cross-sectional study, the CARRÉ Investigation
by
Nijpels, G
,
Heine, R J
,
Lems, W F
in
Aged
,
Arthritis, Rheumatoid - complications
,
Arthritis, Rheumatoid - epidemiology
2009
Objectives:Patients with rheumatoid arthritis (RA) have an increased cardiovascular risk, but the magnitude of this risk is not known precisely. A study was undertaken to investigate the associations between RA and type 2 diabetes (DM2), a well-established cardiovascular risk factor, on the one hand, and cardiovascular disease (CVD) on the other.Methods:The prevalence of CVD (coronary, cerebral and peripheral arterial disease) was determined in 353 randomly selected outpatients with RA (diagnosed between 1989 and 2001, aged 50–75 years; the CARRÉ study) and in participants of a population-based cohort study on diabetes and CVD (the Hoorn study). Patients with RA with normal fasting glucose levels from the CARRÉ study (RA, n = 294) were compared with individuals from the Hoorn study with normal glucose metabolism (non-diabetic, n = 258) and individuals with DM2 (DM2, n = 194).Results:The prevalence of CVD was 5.0% (95% CI 2.3% to 7.7%) in the non-diabetic group, 12.4% (95% CI 7.5% to 17.3%) in the DM2 group and 12.9% (95% CI 8.8% to 17.0%) in those with RA. With non-diabetic individuals as the reference category, the age- and gender-adjusted prevalence odds ratio (OR) for CVD was 2.3 (95% CI 1.1 to 4.7) for individuals with DM2 and 3.1 (95% CI 1.6 to 6.1) for those with RA. There was an attenuation of the prevalences after adjustment for conventional cardiovascular risk factors (OR 2.0 (95% CI 0.9 to 4.5) and 2.7 (95% CI 1.2 to 5.9), respectively).Conclusions:The prevalence of CVD in RA is increased to an extent that is at least comparable to that of DM2. This should have implications for primary cardiovascular prevention strategies in RA.
Journal Article
A risk profile for identifying community-dwelling elderly with a high risk of recurrent falling: results of a 3-year prospective study
by
Tromp, E. A. M.
,
Bouter, L. M.
,
Pluijm, S. M. F.
in
Accidental Falls - prevention & control
,
Aged
,
Aged, 80 and over
2006
The aim of the prospective study reported here was to develop a risk profile that can be used to identify community-dwelling elderly at a high risk of recurrent falling.
The study was designed as a 3-year prospective cohort study. A total of 1365 community-dwelling persons, aged 65 years and older, of the population-based Longitudinal Aging Study Amsterdam participated in the study. During an interview in 1995/1996, physical, cognitive, emotional and social aspects of functioning were assessed. A follow-up on the number of falls and fractures was conducted during a 3-year period using fall calendars that participants filled out weekly. Recurrent fallers were identified as those who fell at least twice within a 6-month period during the 3-year follow-up.
The incidence of recurrent falls at the 3-year follow-up point was 24.9% in women and 24.4% in men. Of the respondents, 5.5% reported a total of 87 fractures that resulted from a fall, including 20 hip fractures, 21 wrist fractures and seven humerus fractures. Recurrent fallers were more prone to have a fall-related fracture than those who were not defined as recurrent fallers (11.9% vs. 3.4%; OR: 3.8; 95% CI: 2.3-6.1). Backward logistic regression analysis identified the following predictors in the risk profile for recurrent falling: two or more previous falls, dizziness, functional limitations, weak grip strength, low body weight, fear of falling, the presence of dogs/cats in the household, a high educational level, drinking 18 or more alcoholic consumptions per week and two interaction terms (high education x 18 or more alcohol consumptions per week and two or more previous falls x fear of falling) (AUC=0.71).
At a cut-off point of 5 on the total risk score (range 0-30), the model predicted recurrent falling with a sensitivity of 59% and a specificity of 71%. At a cut-off point of 10, the sensitivity and specificity were 31% and 92%, respectively. A risk profile including nine predictors that can easily be assessed seems to be a useful tool for the identification of community-dwelling elderly with a high risk of recurrent falling.
Journal Article
Incidence and prevalence of complaints of the neck and upper extremity in general practice
2005
Objective: To study the incidence and prevalence of neck and upper extremity musculoskeletal complaints in Dutch general practice. Methods: Data were obtained from the second Dutch national survey of general practice. In all, 195 general practitioners (GPs) from 104 practices across the Netherlands recorded all contacts with patients during 12 consecutive months. Incidence densities and consultation rates were calculated. Results: The total number of contacts during the registration period of one year was 1 524 470. The most commonly reported complaint was neck symptoms (incidence 23.1 per 1000 person-years), followed by shoulder symptoms (incidence 19.0 per 1000 person-years). Sixty six GP consultations per 1000 person-years were attributable to a new complaint or new episode of complaint of the neck or upper extremity (incidence density). In all, the GPs were consulted 147 times per 1000 registered persons for complaints of the neck or upper extremity. For most complaints the incidence densities and consultation rates were higher for women than for men. Conclusions: Neck and upper extremity symptoms are common in Dutch general practice. The GP is consulted approximately seven times each week for a complaint relating to the neck or upper extremity; of these, three are new complaints or new episodes. Attention should be paid to training GPs to deal with neck and upper limb complaints, and to research on the prognosis and treatment of these common complaints in primary care.
Journal Article
COSMIN guideline for systematic reviews of patient-reported outcome measures
by
Mokkink, L. B.
,
Bouter, L. M.
,
Patrick, D. L.
in
Clinical outcomes
,
COSMIN
,
Guidelines as Topic
2018
Purpose Systematic reviews of patient-reported outcome measures (PROMs) differ from reviews of interventions and diagnostic test accuracy studies and are complex. In fact, conducting a review of one or more PROMs comprises of multiple reviews (i.e., one review for each measurement property of each PROM). In the absence of guidance specifically designed for reviews on measurement properties, our aim was to develop a guideline for conducting systematic reviews of PROMs. Methods Based on literature reviews and expert opinions, and in concordance with existing guidelines, the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) steering committee developed a guideline for systematic reviews of PROMs. Results A consecutive ten-step procedure for conducting a systematic review of PROMs is proposed. Steps 1-4 concern preparing and performing the literature search, and selecting relevant studies. Steps 5-8 concern the evaluation of the quality of the eligible studies, the measurement properties, and the interpretability and feasibility aspects. Steps 9 and 10 concern formulating recommendations and reporting the systematic review. Conclusions The COSMIN guideline for systematic reviews of PROMs includes methodology to combine the methodological quality of studies on measurement properties with the quality of the PROM itself (i.e., its measurement properties). This enables reviewers to draw transparent conclusions and making evidence-based recommendations on the quality of PROMs, and supports the evidence-based selection of PROMs for use in research and in clinical practice.
Journal Article
High physical work load and low job satisfaction increase the risk of sickness absence due to low back pain: results of a prospective cohort study
by
Bongers, P M
,
de Vet, H C W
,
Bouter, L M
in
9th revision of the international classification of diseases
,
Absenteeism
,
Adolescent
2002
Objective: To determine whether physical and psychosocial load at work influence sickness absence due to low back pain. Methods: The research was a part of the study on musculoskeletal disorders, absenteeism, stress, and health (SMASH), a 3 year prospective cohort study on risk factors for musculoskeletal disorders. Workers from 21 companies located throughout The Netherlands participated in the part of this study on sickness absence due to low back pain. The study population consisted of 732 workers with no sickness absences of 3 days or longer due to low back pain in the 3 months before the baseline survey and complete data on the reasons for absences during the follow up period. The mean (range) period of follow up in this group was 37 (7–44) months. Physical load at work was assessed by analyses of video recordings. Baseline information on psychosocial work characteristics was obtained by a questionnaire. Data on sickness absence were collected from company records. The main outcome measure was the rate of sickness absences of 3 days or longer due to low back pain during the follow up period. Results: After adjustment of the work related physical and psychosocial factors for each other and for other potential determinants, significant rate ratios ranging from 2.0 to 3.2 were found for trunk flexion, trunk rotation, lifting, and low job satisfaction. A dose-response relation was found for trunk flexion, but not for trunk rotation or lifting. Non-significant rate ratios of about 1.4 were found for low supervisor support and low coworker support. Quantitative job demands, conflicting demands, decision authority, and skill discretion showed no relation with sickness absence due to low back pain. Conclusions: Flexion and rotation of the trunk, lifting, and low job satisfaction are risk factors for sickness absence due to low back pain. Some indications of a relation between low social support, either from supervisors or coworkers, and sickness absence due to low back pain are also present.
Journal Article
A one season prospective cohort study of volleyball injuries
2004
Objective: To estimate the overall incidence of acute and overuse volleyball injuries, and to describe factors associated with ankle sprains. Methods: 486 players from the second and third Dutch national volleyball divisions participated in the study and were followed prospectively during a whole season. Three measurements were made during the season (baseline, follow up 1, and follow up 2), where all players completed a questionnaire on demographic variables (only at baseline), sports participation, use of preventive measures, and previous injuries. Volleyball exposure during training and matches was recorded for each individual player by the coach on a weekly exposure form. In case of injury the coach provided the injured player with an injury registration form, which had to be completed within one week after the onset of injury. Results: 100 injuries were reported, resulting in an overall injury incidence of 2.6 injuries/1000 hours. The incidence of acute injuries was 2.0/1000 hours. Ankle sprains (n = 41) accounted for most of the acute injuries, and 31 (75%) of all players with an ankle sprain reported a previous ankle sprain. Twenty five overuse injuries were reported. The overall incidence of overuse injuries was 0.6/1000 hours; the back and the shoulder were the most common sites. Conclusions: Ankle sprain is the most common injury in volleyball, accounting for 41% of all volleyball related injuries. Previous injury seems to be an important risk factor for an ankle sprain. Injury prevention programmes should focus on ankle sprains and concentrate on players with previous ankle sprains.
Journal Article