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.
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.
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.
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.
We conducted a 3-round Delphi study involving 52 panelists.
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.
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.
Objective: Individual work performance is differently conceptualized and operationalized in different disciplines. The aim of the current review was twofold: (1) identifying conceptual frameworks of ...individual work performance and (2) integrating these to reach a heuristic conceptual framework. Methods: A systematic review was conducted in medical, psychological, and management databases. Studies were selected independently by two researchers and included when they presented a conceptual framework of individual work performance. Results: A total of 17 generic frameworks (applying across occupations) and 18 job-specific frameworks (applying to specific occupations) were identified. Dimensions frequently used to describe individual work performance were task performance, contextual performance, counterproductive work behavior, and adaptive performance. Conclusion: On the basis of the literature, a heuristic conceptual framework of individual work performance was proposed. This framework can serve as a theoretical basis for future research and practice.
Background The COSMIN checklist is a standardized tool for assessing the methodological quality of studies on measurement properties. It contains 9 boxes, each dealing with one measurement property, ...with 5-18 items per box about design aspects and statistical methods. Our aim was to develop a scoring system for the COSMIN checklist to calculate quality scores per measurement property when using the checklist in systematic reviews of measurement properties. Methods The scoring system was developed based on discussions among experts and testing of the scoring system on 46 articles from a systematic review. Four response options were defined for each COSMIN item (excellent, good, fair, and poor). A quality score per measurement property is obtained by taking the lowest rating of any item in a box ("worst score counts"). Results Specific criteria for excellent, good, fair, and poor quality for each COSMIN item are described. In defining the criteria, the "worst score counts" algorithm was taken into consideration. This means that only fatal flaws were defined as poor quality. The scores of the 46 articles show how the scoring system can be used to provide an overview of the methodological quality of studies included in a systematic review of measurement properties. Conclusions Based on experience in testing this scoring system on 46 articles, the COSMIN checklist with the proposed scoring system seems to be a useful tool for assessing the methodological quality of studies included in systematic reviews of measurement properties.
Background
Work disability has serious consequences for individuals as well as society. It is possible to facilitate resumption of work by reducing barriers to return to work (RTW) and promoting ...collaboration with key stakeholders. This review was first published in 2009 and has now been updated to include studies published up to February 2015.
Objectives
To determine the effectiveness of workplace interventions in preventing work disability among sick‐listed workers, when compared to usual care or clinical interventions.
Search methods
We searched the Cochrane Work Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and PsycINFO databases on 2 February 2015.
Selection criteria
We included randomised controlled trials (RCTs) of workplace interventions that aimed to improve RTW for disabled workers. We only included studies where RTW or conversely sickness absence was reported as a continuous outcome.
Data collection and analysis
Two review authors independently extracted data and assessed risk of bias of the studies. We performed meta‐analysis where possible, and we assessed the quality of evidence according to GRADE criteria. We used standard methodological procedures expected by Cochrane.
Main results
We included 14 RCTs with 1897 workers. Eight studies included workers with musculoskeletal disorders, five workers with mental health problems, and one workers with cancer. We judged six studies to have low risk of bias for the outcome sickness absence.
Workplace interventions significantly improved time until first RTW compared to usual care, moderate‐quality evidence (hazard ratio (HR) 1.55, 95% confidence interval (CI) 1.20 to 2.01). Workplace interventions did not considerably reduce time to lasting RTW compared to usual care, very low‐quality evidence (HR 1.07, 95% CI 0.72 to 1.57). The effect on cumulative duration of sickness absence showed a mean difference of ‐33.33 (95% CI ‐49.54 to ‐17.12), favouring the workplace intervention, high‐quality evidence. One study assessed recurrences of sick leave, and favoured usual care, moderate‐quality evidence (HR 0.42, 95% CI 0.21 to 0.82). Overall, the effectiveness of workplace interventions on work disability showed varying results.
In subgroup analyses, we found that workplace interventions reduced time to first and lasting RTW among workers with musculoskeletal disorders more than usual care (HR 1.44, 95% CI 1.15 to 1.82 and HR 1.77, 95% CI 1.37 to 2.29, respectively; both moderate‐quality evidence). In studies of workers with musculoskeletal disorders, pain also improved (standardised mean difference (SMD) ‐0.26, 95% CI ‐0.47 to ‐0.06), as well as functional status (SMD ‐0.33, 95% CI ‐0.58 to ‐0.08). In studies of workers with mental health problems, there was a significant improvement in time until first RTW (HR 2.64, 95% CI 1.41 to 4.95), but no considerable reduction in lasting RTW (HR 0.79, 95% CI 0.54 to 1.17). One study of workers with cancer did not find a considerable reduction in lasting RTW (HR 0.88, 95% CI 0.53 to 1.47).
In another subgroup analysis, we did not find evidence that offering a workplace intervention in combination with a cognitive behavioural intervention (HR 1.93, 95% CI 1.27 to 2.93) is considerably more effective than offering a workplace intervention alone (HR 1.35, 95% CI 1.01 to 1.82, test for subgroup differences P = 0.17).
Workplace interventions did not considerably reduce time until first RTW compared with a clinical intervention in workers with mental health problems in one study (HR 2.65, 95% CI 1.42 to 4.95, very low‐quality evidence).
Authors' conclusions
We found moderate‐quality evidence that workplace interventions reduce time to first RTW, high‐quality evidence that workplace interventions reduce cumulative duration of sickness absence, very low‐quality evidence that workplace interventions reduce time to lasting RTW, and moderate‐quality evidence that workplace interventions increase recurrences of sick leave. Overall, the effectiveness of workplace interventions on work disability showed varying results. Workplace interventions reduce time to RTW and improve pain and functional status in workers with musculoskeletal disorders. We found no evidence of a considerable effect of workplace interventions on time to RTW in workers with mental health problems or cancer.
We found moderate‐quality evidence to support workplace interventions for workers with musculoskeletal disorders. The quality of the evidence on the effectiveness of workplace interventions for workers with mental health problems and cancer is low, and results do not show an effect of workplace interventions for these workers. Future research should expand the range of health conditions evaluated with high‐quality studies.
Background. Low body mass index is a general measure of thinness. However, its measurement can be cumbersome in older persons and other simple anthropometric measures may be more strongly associated ...with mortality. Therefore, associations of low mid-upper arm circumference, calf circumference, and body mass index with mortality were examined in older persons. Methods. Data of the Longitudinal Aging Study Amsterdam, a population-based cohort study in the Netherlands, were used. The present study included community-dwelling persons 65 years and older in 1992–1993 (n = 1,667), who were followed until 2007 for their vital status. Associations between anthropometric measures and 15-year mortality were examined by spline regression models and, below the nadir, Cox regression models, transforming all measures to sex-specific Z scores. Results. Mortality rates were 599 of 826 (73%) in men and 479 of 841 (57%) in women. Below the nadir, the hazard ratio of mortality per 1 standard deviation lower mid-upper arm circumference was 1.79 (95% confidence interval, 1.48–2.16) in men and 2.26 (1.71–3.00) in women. For calf circumference, the hazard ratio was 1.45 (1.22–1.71) in men and 1.30 (1.15–1.48) in women and for body mass index 1.38 (1.17–1.61) in men and 1.56 (1.10–2.21) in women. Excluding deaths within the first 3 years after baseline did not change these associations. Excluding those with a smoking history, obstructive lung disease, or cancer attenuated the associations of calf circumference (men) and body mass index (women). Conclusions. Based on the stronger association with mortality and given a more easy assessment in older persons, mid-upper arm circumference seems a more feasible and valid anthropometric measure of thinness than body mass index in older men and women.
Purpose
Anorexia is a frequently observed symptom in patients with cancer and is associated with limited food intake and decreased quality of life. Diagnostic instruments such as the ...Anorexia/Cachexia Subscale (A/CS) of the Functional Assessment of Anorexia/Cachexia Therapy (FAACT) questionnaire and the visual analog scale (VAS) for appetite have been recommended in the assessment of anorexia, but validated cut-off values are lacking. This study aimed to obtain cut-off values of these instruments for the assessment of anorexia in patients with cancer.
Methods
The FAACT–A/CS and the VAS for appetite were administered to patients with cancer before start of chemotherapy. As reference standard for anorexia, two external criteria were used: (1) a cut-off value of ≥2 on the anorexia symptom scale of the EORTC QLQ C-30 and (2) the question “Do you experience a decreased appetite?” (yes/no). ROC curves were used to examine the optimal cut-off values for the FAACT–A/CS and VAS.
Results
A total of 273 patients (58 % male; 64.0 ± 10.6 years) were included. The median score on the FAACT–A/CS was 38 (IQR 32–42) points and 77 (IQR 47–93) points on the VAS. Considering both external criteria, the optimal cut-off value for the FAACT–A/CS was ≤37 (sensitivity (se) 80 %, specificity (sp) 81 %, positive predictive value (PV
+
) 79 %, negative predictive value (PV
−
) 82 %) and for the VAS was ≤70 (se 76 %, sp 83 %, PV
+
80 %, PV
−
79 %).
Conclusions
For the assessment of anorexia in patients with cancer, our study suggests cut-off values of ≤37 for the FAACT–A/CS and ≤70 for the VAS. Future studies should confirm our findings in other patient samples.
Colorectal cancer is diagnosed progressively in employed patients due to screening programs and increasing retirement age. The objective of this study was to identify prognostic factors for return to ...work and work disability in patients with colorectal cancer.
The research protocol was published at PROSPERO with registration number CRD42017049757. A systematic review of cohort and case-control studies in colorectal cancer patients above 18 years, who were employed when diagnosed, and who had a surgical resection with curative intent were included. The primary outcome was return to work or work disability. Potentially prognostic factors were included in the analysis if they were measured in at least three studies. Risk of bias was assessed according to the QUality In Prognosis Studies tool. A qualitative synthesis analysis was performed due to heterogeneity between studies. Quality of evidence was evaluated according to Grading of Recommendation Assessment, Development and Evaluation.
Eight studies were included with a follow-up period of 26 up to 520 weeks. (Neo)adjuvant therapy, higher age, and more comorbidities had a significant negative influence on return to work. A previous period of unemployment, extensive surgical resection and postoperative complications significantly increased the risk of work disability. The quality of evidence for these prognostic factors was considered very low to moderate.
Health care professionals need to be aware of these prognostic factors to select patients eligible for timely intensified rehabilitation in order to optimize the return to work process and prevent work disability.
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