Responsiveness and minimal important change of seven PROMIS computerized adaptive tests (CAT) in patients with advanced chronic kidney disease.

BACKGROUND: The Patient-Reported Outcomes Measurement Information System (PROMIS®) has the potential to harmonize the measurement of health-related quality of life (HRQL) across medical conditions. We evaluated responsiveness and minimal important change (MIC) of seven Dutch-Flemish PROMIS computerized adaptive tests (CAT) in Dutch patients with advanced chronic kidney disease (CKD). METHODS: CKD patients (eGFR < 30 ml/min.1.73m2) completed at baseline and after 6 months seven PROMIS CATs (assessing physical function, pain interference, fatigue, sleep disturbance, anxiety, depression, and ability to participate in social roles and activities), Short Form Health Survey 12 (SF-12), PROMIS Pain Intensity single item, Dialysis Symptom Index (DSI), and Global Rating Scales (GRS) of change. Responsiveness was assessed by testing predefined hypotheses about expected correlations among measures, area under the ROC Curve, and effect sizes. MIC was determined with predictive modelling. RESULTS: 207 patients were included; 186 (90%) completed the follow-up. Most results were in accordance with expectations (70-91% of hypotheses confirmed), with some exceptions for PROMIS Anxiety and Ability to Participate (60% and 42% of hypotheses confirmed, respectively). For PROMIS Anxiety and Depression correlations with the GRS were too low (0.04 and 0.20, respectively) to calculate a MIC. MIC values, representing minimal important deterioration, ranged from 0.4 to 2.5 T-score points for the other domains. CONCLUSION: We found sufficient responsiveness of PROMIS CATs Physical Function, Fatigue, Sleep Disturbance, and Depression. The results for PROMIS CATs Pain Interference were almost sufficient, but some results for Anxiety and Ability to Participate in Social Roles and Activities were not as expected. Reported MIC values should be interpreted with caution because most patients did not change.

Development of a standard set of PROs and generic PROMs for Dutch medical specialist care : Recommendations from the Outcome-Based Healthcare Program Working Group Generic PROMs.

PURPOSE: The added value of measuring patient-reported outcomes (PROs) for delivering patient-centered care and assessment of healthcare quality is increasingly evident. However, healthcare system wide data collection initiatives are hampered by the proliferation of patient-reported outcome measures (PROMs) and conflicting data collection standards. As part of a national initiative of the Dutch Ministry of Health, Welfare and Sport we developed a consensus-based standard set of generic PROs and PROMs to be implemented across Dutch medical specialist care. METHODS: A working group of mandated representatives of umbrella organizations involved in Dutch medical specialist care, together with PROM experts and patient organizations worked through a structured, consensus-driven co-creation process. This included literature reviews, online expert and working group meetings, and feedback from national patient- and umbrella organizations. The 'PROM-cycle' methodology was used to select feasible, valid, and reliable PROMs to obtain domain scores for each of the PROs included in the set. RESULTS: Eight PROs across different domains of health were ultimately endorsed: symptoms (pain & fatigue), functioning (physical, social/participation, mental [anxiety & depression]), and overarching (quality of life & perceived overall health). A limited number of generic PROMs was endorsed. PROMIS short forms were selected as the preferred instruments for all PROs. Several recommendations were formulated to facilitate healthcare system level adoption and implementation of the standard set. CONCLUSIONS: We developed a consensus-based standard set of Generic PROMs and a set of recommendations to facilitate healthcare system wide implementation across Dutch medical specialist care.

Validity and reliability of the Patient-Reported Outcomes Measurement Information System (PROMIS®) using computerized adaptive testing in patients with advanced chronic kidney disease.

BACKGROUND: The Patient-Reported Outcomes Measurement Information System (PROMIS®) has been recommended for computerized adaptive testing (CAT) of health-related quality of life. This study compared the content, validity, and reliability of seven PROMIS CATs to the 12-item Short-Form Health Survey (SF-12) in patients with advanced chronic kidney disease. METHODS: Adult patients with chronic kidney disease and an estimated glomerular filtration rate under 30 mL/min/1.73 m2 who were not receiving dialysis treatment completed seven PROMIS CATs (assessing physical function, pain interference, fatigue, sleep disturbance, anxiety, depression, and the ability to participate in social roles and activities), the SF-12, and the PROMIS Pain Intensity single item and Dialysis Symptom Index at inclusion and 2 weeks. A content comparison was performed between PROMIS CATs and the SF-12. Construct validity of PROMIS CATs was assessed using Pearson's correlations. We assessed the test-retest reliability of all patient-reported outcome measures by calculating the intraclass correlation coefficient and minimal detectable change. RESULTS: In total, 207 patients participated in the study. A median of 45 items (10 minutes) were completed for PROMIS CATs. All PROMIS CATs showed evidence of sufficient construct validity. PROMIS CATs, most SF-12 domains and summary scores, and Dialysis Symptom Index showed sufficient test-retest reliability (intraclass correlation coefficient ≥ 0.70). PROMIS CATs had a lower minimal detectable change compared with the SF-12 (range, 5.7-7.4 compared with 11.3-21.7 across domains, respectively). CONCLUSION: PROMIS CATs showed sufficient construct validity and test-retest reliability in patients with advanced chronic kidney disease. PROMIS CATs required more items but showed better reliability than the SF-12. Future research is needed to investigate the feasibility of PROMIS CATs for routine nephrology care.

A pragmatic approach for implementation of value-based healthcare in Amsterdam UMC, the Netherlands.

BACKGROUND: The emphasis on implementation of value-based healthcare (VBHC) has increased in the Dutch healthcare system. Yet, the translation of the theoretical principles of VBHC towards actual implementation in daily practice has been rarely described. Our aim is to present a pragmatic step-by-step approach for VBHC implementation, developed and applied in Amsterdam UMC, to share our key elements. The approach may inspire others and can be used as a template for implementing VBHC principles in other hospitals. METHODS: The local approach is developed in a major academic hospital in the Netherlands, based at two locations with 15,000 employees in total. Experience-based co-design is used, building on our learning experiences from implementing VBHC for 14 specific patient groups. The described steps and activities devolved from iterative and participative co-design sessions with various experienced stakeholders involved in the implementation of one or more VBHC pathways. RESULTS: The approach includes five phases; preparation, design (team introduction, outcome selection, action agenda), building (outcome set integration in daily practice), implementation (training, outcome registration and implementation) and the continuous improvement cycle. We described two cases for illustration of the approach; the Cleft Lip and Palate and the Chronic Kidney Disease patient groups. For a good start, involvement of a clinical leader as driving force, ensuring participation of patient representatives and sufficient resources are needed. CONCLUSION: We have experienced that several defining features of the development and implementation of this approach may have contributed to its completeness and applicability. Key elements for success have been organisational readiness and clinical leadership. In conclusion, the approach has provided a first step towards VBHC in our hospital. Further research is needed for evaluation of its effectiveness including impact on value for patients.

Relation between Red Cell Distribution Width and Fibroblast Growth Factor 23 Cleaving in Patients with Chronic Kidney Disease and Heart Failure.

OBJECTIVE: In chronic kidney disease (CKD), both anemia and deregulated phosphate metabolism are common and predictive of adverse outcome. Previous studies suggest that iron status influences phosphate metabolism by modulating proteolytic cleavage of FGF23 into C-terminal fragments. Red cell distribution width (RDW) was recently identified as a strong prognostic determinant for cardiovascular morbidity and mortality, independently of iron status. We assessed whether RDW is associated with FGF23 cleaving in CKD patients with heart failure. MATERIALS AND METHODS: The associations between RDW and either intact FGF23 (iFGF23), C-terminal FGF23 (cFGF23, reflecting iFGF23 and C-terminal fragments together) and the iFGF23/cFGF23 ratio were analyzed in 52 patients with CKD (eGFR 34,9 ± 13.9 ml/min/1.73m2) and chronic heart failure (CHF). Associations between RDW and FGF23 forms were studied by linear regression analysis adjusted for parameters of renal function, iron metabolism, phosphate metabolism and inflammation. RESULTS: Median cFGF23 levels were 197.5 [110-408.5] RU/ml, median iFGF23 levels were 107.3 [65.1-162.2] pg/ml and median FGF23 ratio was 0.80 [0.37-0.86]. Mean RDW was 14.1 ± 1.2%. cFGF23 and RDW were associated (ß = 1.63 x 10(-3), P < 0.001), whereas iFGF23 and RDW were not (ß = -1.38 x 10(-3), P = 0.336). The iFGF23/cFGF23 ratio was inversely associated with RDW. The difference between cFGF23 and iFGF23 (cFGF23- iFGF23) was positively associated with RDW (ß = 1.74 x 10(-3), P < 0.001). The association between cFGF23 and RDW persisted upon multivariable linear regression analysis, adjusted for parameters of renal function, phosphate metabolism, iron metabolism and inflammation (ß = 0.97 x 10(-3), P = 0.047). CONCLUSION: RDW is associated with cFGF23 but not with iFGF23 levels in patients with CKD and CHF. This suggests a connection between RDW and FGF23 catabolism, independent of iron status and inflammation. Future studies are needed to unravel underlying mechanisms and whether these pertain to the link between RDW and outcome.

Assessing the prevalence of modifiable risk factors in older patients visiting an ED due to a fall using the CAREFALL Triage Instrument.

OBJECTIVE: Falls in older people are a common presenting complaint. Knowledge of modifiable risk factors may lead to a more tailored approach to prevent recurrent falls and/or fractures. We investigated prevalence of 8 modifiable risk factors for recurrent falling and/or a serious consequence of the fall among older patients visiting the emergency department after a fall with the Combined Amsterdam and Rotterdam Evaluation of Falls Triage Instrument (CTI), a self-administrated questionnaire that consists of questions concerning demographics, possible cause(s) of the fall, and questions relating to (modifiable) risk factors for falling. METHODS: After treatment for their injuries, 1077 consecutive patients 65 years or older visiting the accident and emergency department due to a fall were evaluated by the CTI. The following were assessed: impaired vision, mobility disorder, fear of falling, mood disorder, high risk of osteoporosis, orthostatic hypotension, incontinence, and polypharmacy. RESULTS: The percentage of respondents who returned the questionnaire was 59.3%. The mean (SD) age was 78.5 (7.5) years, and 57.8% experienced a fall with serious consequences. There were 60.9% of patients with a recurrent fall versus 51% with a first fall who experienced with a serious consequence (P = .025). Age and risk factors mobility disorder (odds ratio [OR], 1.9; 95% confidence interval [CI], 1.1-3.3), high risk of osteoporosis (OR, 2.0; 95% CI, 1.2-3.2), incontinence (OR, 1.7; 95% CI, 1.0-2.7), fear of falling (OR, 2.2; 95% CI, 1.3-3.7), and orthostatic hypotension (OR, 2.4; 95% CI, 1.4-4.2) were independently associated with a recurrent fall. Age and high risk of osteoporosis were the only risk factors predicting a serious consequence of a fall (OR, 4.6; 95% CI, 2.9-7.2). CONCLUSIONS: Age and 5 modifiable risk factors assessed with the CTI were independently associated with a recurrent fall. Only high risk of osteoporosis was associated with a serious consequence.