COSMIN Risk of Bias checklist for systematic reviews of Patient-Reported Outcome Measures

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.

     

Measurement properties of disease-specific questionnaires in patients with neck pain: a systematic review

Purpose  

To critically appraise and compare the measurement properties of the original versions of neck-specific questionnaires.     

A qualitative study investigating the meaning of participation to improve the measurement of this construct

Quality of Life Research - The purpose of this study was to improve the measurement of participation. Research questions were as follows: (1) What constitutes participation according to adults? (2)...     

A systematic review of instruments measuring foot function,foot pain,and foot‐related disability in patients with rheumatoid arthritis

Objective

To compose an inventory of instruments that have been described to measure foot function (i.e., pressure and/or gait parameters), foot pain, and foot‐related disability in rheumatoid arthritis (RA), and to investigate the clinimetric quality of these measures.

Methods

A systematic search was conducted in Medline, CINAHL, EMBase, and Sportdiscus. Standardized criteria, extended with levels of evidence, were applied to assess the quality of the clinimetric studies and the properties (i.e., reliability, validity, and responsiveness) of the described instruments.

Results

A variety of measurement instruments were identified. Only 16 instruments have been studied for their measurement properties in RA patients: 7 for assessing foot function, 3 for measuring foot‐related disability, and 6 for measuring both foot pain and foot‐related disability. Thirteen instruments were rated for reliability, of which 10 were rated positively on different levels of evidence. No positive rating for absolute measurement error was applicable for any of the tests. Internal consistency was reported for 7 instruments; 3 assigned a positive rating. For 2 instruments, Rasch analysis was used to assess the methodologic quality. A positive rating was reported for goodness‐of‐fit only, not for item calibration. Seven instruments were rated for construct validity, and 3 assigned a positive rating. Only 2 instruments were rated positively for responsiveness.

Conclusion

This review offers a basis for choosing the most appropriate instruments for measuring foot function, foot pain, and foot‐related disability in RA patients, both for clinical practice and for research. Further research on the quality of these measures is urgently needed.     

Comparison between direct volumetric and speckle tracking methodologies for left ventricular and left atrial chamber quantification by three-dimensional echocardiography

In an era of rapidly expanding and evolving 3-dimensional echocardiographic (3DE) technology, 1 of the issues facing the 3DE quantification of chamber volumes and function is that different software vendors use different methodologies and algorithms. The aim of this study was to evaluate the comparability and reproducibility of 3DE direct volumetric and speckle-tracking methods for left ventricular (LV) and left atrial (LA) chamber quantification. A total of 120 subjects (mean age 53 ± 17 years, 65% men), including 88 unselected patients and 32 healthy volunteers, underwent 3DE acquisitions and analysis using direct volumetric and speckle-tracking methods successively. Measurements of LV and LA volumes and LV function were compared between the 2 3DE methods. Additionally, intraobserver and interobserver reproducibility was assessed in 40 randomly selected patients. Measurements of LV end-diastolic volume, end-systolic volume, and ejection fraction by 3DE direct volumetric and 3DE speckle-tracking methods were comparable, with good correlations (r = 0.98, r = 0.98, and r = 0.87, respectively), small biases, and narrow limits of agreement (-1 ± 8 ml, -1 ± 8 ml, and 0 ± 6%, respectively). For measurements of LA end-systolic volume and end-diastolic volume, similar correlations (r = 0.96 for both), small biases, and narrow limits of agreement (-2 ± 6 and -1 ± 5 ml, respectively) were found between the 2 methods. Intraobserver and interobserver reproducibility for LV and LA quantification were comparable for the 2 methods. In conclusion, 3DE direct volumetric and speckle-tracking methods give comparable and reproducible quantification of LV and LA volumes and function, making interchangeable application a viable option in daily clinical practice.     

The incidences of and consultation rate for lower extremity complaints in general practice

OBJECTIVE: To estimate the incidence and consultation rate of lower extremity complaints in general practice. METHODS: Data were obtained from the Second Dutch National Survey of General Practice, in which 195 general practitioners (GPs) in 104 practices recorded all contacts with patients during 12 consecutive months in computerised patient records. GPs classified the symptoms and diagnosis for each patient at each consultation according to the International Classification of Primary Care (ICPC). Incidence densities and consultation rates for different complaints were calculated. RESULTS: During the registration period 63.2 GP consultations per 1000 person-years were attributable to a new complaint of the lower extremities. Highest incidence densities were seen for knee complaints: 21.4 per 1000 person-years for women and 22.8 per 1000 person-years for men. The incidence of most lower extremity complaints was higher for women than for men and higher in older age. CONCLUSIONS: Both incidences of and consultation rates for lower extremity complaints are substantial in general practice. This implies a considerable impact on the workload of the GP.     

Measuring disease activity to predict therapeutic outcome in Graves' ophthalmopathy

OBJECTIVE: The concept of disease activity in Graves' ophthalmopathy (GO) might explain why as many as one-third of patients do not respond to immunosuppressive treatment, because only patients in the active stage of disease are expected to respond. The hypothesis was adopted that a parameter used to measure disease activity should be able to predict a response to immunosuppressive treatment. The aim of this study was to develop a multivariate prediction model in which all previous tested activity parameters are integrated. DESIGN AND PATIENTS: We included 66 consecutive patients with untreated moderately severe GO who had been euthyroid for at least 2 months. All patients were treated with radiotherapy. Measurements Treatment efficacy after 6 months follow-up was used as the primary outcome measure. Disease severity and 15 different disease activity parameters were assessed before treatment. Univariate and multivariate logistic regression models were used to predict response (model 1) or no change (model 2). RESULTS: In multivariate analyses, we found that duration of GO, soft tissue involvement, elevation, soluble interleukin-2 receptor (sIL-2R), soluble CD30 (sCD30), eye muscle reflectivity and octreotide uptake ratio were significant predictors of a response to radiotherapy. Gender, duration of GO, soft tissue involvement, eye muscle reflectivity, IL-6 and urinary glycosaminoglycan (GAG) excretion were significant predictors of no change upon radiotherapy. Prognostic score charts were developed for use in clinical practice to calculate the probability of response (model 1) and the probability of no change (model 2) for each new patient. Finally we used a combination of both models to define a recommended treatment modality for each individual patient, based on both the predicted probabilities of response and no change. We were able to identify the correct treatment (based on a comparison with the observed response) in 89% of the patients. CONCLUSIONS: Although we strongly recommend that our results should be confirmed in other studies, our findings are the first evidence for the idea that disease (in)activity should determine which kind of treatment should be used.     

Interobserver reproducibility of the visual estimation of range of motion of the shoulder

OBJECTIVES: To assess interobserver reproducibility (agreement and reliability) of visually estimated shoulder range of motion (ROM) and to study the influence of clinical characteristics on the reproducibility. DESIGN: Test-retest analyses. SETTING: Various health care settings in the Netherlands. PARTICIPANTS: Consecutive patients with shoulder complaints (N = 201) referred by 20 general practitioners, 2 orthopedic physicians, and 20 rheumatologists. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Independent visual estimation by 2 physiotherapists of the ROM. Agreement was calculated as the mean difference in visual estimation between examiners +/-1.96 x standard deviations of this mean difference. The intraclass correlation coefficient (ICC) was calculated as a measure of reliability, based on a 2-way random effects analysis of variance. RESULTS: The lowest level of agreement was for visual estimation of active and passive elevation (limits of agreement, -43.4 to 39.8 and -46.7 to 41.5, respectively, for the difference between the affected and contralateral sides), for which the level of agreement was most clearly associated with pain severity and disability. The ability to differentiate between subjects was acceptable for all movements for the difference between the affected and contralateral sides (ICCs, > .70) except for horizontal adduction (ICC = .49). CONCLUSIONS: Interobserver agreement was low for the assessment of active and passive elevation, especially for patients with a high pain severity and disability. Except for horizontal adduction, visual estimation seems suitable for distinguishing differences between affected and contralateral ROM between subjects.