A systematic review of measurement properties of patient-reported outcome measures for use in patients with foot or ankle diseases

Recently, an increasing number of systematic reviews have been published in which the measurement properties of health status questionnaires are compared. For a meaningful comparison, quality criteria for measurement properties are needed. Our aim was to develop quality criteria for design, methods, and outcomes of studies on the development and evaluation of health status questionnaires. Quality criteria for content validity, internal consistency, criterion validity, construct validity, reproducibility, longitudinal validity, responsiveness, floor and ceiling effects, and interpretability were derived from existing guidelines and consensus within our research group. For each measurement property a criterion was defined for a positive, negative, or indeterminate rating, depending on the design, methods, and outcomes of the validation study. Our criteria make a substantial contribution toward defining explicit quality criteria for measurement properties of health status questionnaires. Our criteria can be used in systematic reviews of health status questionnaires, to detect shortcomings and gaps in knowledge of measurement properties, and to design validation studies. The future challenge will be to refine and complete the criteria and to reach broad consensus, especially on quality criteria for good measurement properties.

To study risk factors for falling, we conducted a one-year prospective investigation, using a sample of 336 persons at least 75 years of age who were living in the community. All subjects underwent detailed clinical evaluation, including standardized measures of mental status, strength, reflexes, balance, and gait; in addition, we inspected their homes for environmental hazards. Falls and their circumstances were identified during bimonthly telephone calls. During one year of follow-up, 108 subjects (32 percent) fell at least once; 24 percent of those who fell had serious injuries and 6 percent had fractures. Predisposing factors for falls were identified in linear-logistic models. The adjusted odds ratio for sedative use was 28.3; for cognitive impairment, 5.0; for disability of the lower extremities, 3.8; for palmomental reflex, 3.0; for abnormalities of balance and gait, 1.9; and for foot problems, 1.8; the lower bounds of the 95 percent confidence intervals were 1 or more for all variables. The risk of falling increased linearly with the number of risk factors, from 8 percent with none to 78 percent with four or more risk factors (P less than 0.0001). About 10 percent of the falls occurred during acute illness, 5 percent during hazardous activity, and 44 percent in the presence of environmental hazards. We conclude that falls among older persons living in the community are common and that a simple clinical assessment can identify the elderly persons who are at the greatest risk of falling.

Background Aim of the COSMIN study (COnsensus-based Standards for the selection of health status Measurement INstruments) was to develop a consensus-based checklist to evaluate the methodological quality of studies on measurement properties. We present the COSMIN checklist and the agreement of the panel on the items of the checklist. Methods A four-round Delphi study was performed with international experts (psychologists, epidemiologists, statisticians and clinicians). Of the 91 invited experts, 57 agreed to participate (63%). Panel members were asked to rate their (dis)agreement with each proposal on a five-point scale. Consensus was considered to be reached when at least 67% of the panel members indicated ‘agree’ or ‘strongly agree’. Results Consensus was reached on the inclusion of the following measurement properties: internal consistency, reliability, measurement error, content validity (including face validity), construct validity (including structural validity, hypotheses testing and cross-cultural validity), criterion validity, responsiveness, and interpretability. The latter was not considered a measurement property. The panel also reached consensus on how these properties should be assessed. Conclusions The resulting COSMIN checklist could be useful when selecting a measurement instrument, peer-reviewing a manuscript, designing or reporting a study on measurement properties, or for educational purposes.