Predicting EQ-5D index scores from Promis Profile 29 in the United Kingdom, France, And Germany

This is the author accepted manuscript. The final version is available from the publisher via the DOI in this recor

Predicting EQ-5D-5L crosswalk from the PROMIS-29 profile for the United Kingdom, France, and Germany

BACKGROUND: EQ-5D health state utilities (HSU) are commonly used in health economics to compute quality-adjusted life years (QALYs). The EQ-5D, which is country-specific, can be derived directly or by mapping from self-reported health-related quality of life (HRQoL) scales such as the PROMIS-29 profile. The PROMIS-29 from the Patient Reported Outcome Measures Information System is a comprehensive assessment of self-reported health with excellent psychometric properties. We sought to find optimal models predicting the EQ-5D-5L crosswalk from the PROMIS-29 in the United Kingdom, France, and Germany and compared the prediction performances with that of a US model. METHODS: We collected EQ-5D-5L and PROMIS-29 profiles and three samples representative of the general populations in the UK (n = 1509), France (n = 1501), and Germany (n = 1502). We used stepwise regression with backward selection to find the best models to predict the EQ-5D-5L crosswalk from all seven PROMIS-29 domains. We investigated the agreement between the observed and predicted EQ-5D-5L crosswalk in all three countries using various indices for the prediction performance, including Bland-Altman plots to examine the performance along the HSU continuum. RESULTS: The EQ-5D-5L crosswalk was best predicted in France (nRMSEFRA = 0.075, nMAEFRA = 0.052), followed by the UK (nRMSEUK = 0.076, nMAEUK = 0.053) and Germany (nRMSEGER = 0.079, nMAEGER = 0.051). The Bland-Altman plots show that the inclusion of higher-order effects reduced the overprediction of low HSU scores. CONCLUSIONS: Our models provide a valid method to predict the EQ-5D-5L crosswalk from the PROMIS-29 for the UK, France, and Germany

Predicting EQ-5D-5L crosswalk from the PROMIS-29 profile for the United Kingdom, France, and Germany

This is the final version. Available on open access from BMC via the DOI in this recordAvailability of data and materials: Data is available on reasonable request.Background: EQ-5D health state utilities (HSU) are commonly used in health economics to compute quality-adjusted life years (QALYs). The EQ-5D, which is country-specific, can be derived directly or by mapping from self-reported health-related quality of life (HRQoL) scales such as the PROMIS-29 profile. The PROMIS-29 from the Patient Reported Outcome Measures Information System is a comprehensive assessment of self-reported health with excellent psychometric properties. We sought to find optimal models predicting the EQ-5D-5L crosswalk from the PROMIS-29 in the United Kingdom, France, and Germany and compared the prediction performances with that of a US model. Methods: We collected EQ-5D-5L and PROMIS-29 profiles and three samples representative of the general populations in the UK (n = 1509), France (n = 1501), and Germany (n = 1502). We used stepwise regression with backward selection to find the best models to predict the EQ-5D-5L crosswalk from all seven PROMIS-29 domains. We investigated the agreement between the observed and predicted EQ-5D-5L crosswalk in all three countries using various indices for the prediction performance, including Bland–Altman plots to examine the performance along the HSU continuum. Results: The EQ-5D-5L crosswalk was best predicted in France (nRMSEFRA = 0.075, nMAEFRA = 0.052), followed by the UK (nRMSEUK = 0.076, nMAEUK = 0.053) and Germany (nRMSEGER = 0.079, nMAEGER = 0.051). The Bland–Altman plots show that the inclusion of higher-order effects reduced the overprediction of low HSU scores. Conclusions: Our models provide a valid method to predict the EQ-5D-5L crosswalk from the PROMIS-29 for the UK, France, and Germany.Centre Virchow-Villerm

Interventions for behaviour change and self-management in stroke secondary prevention: protocol for an overview of reviews

Abstract Background Stroke secondary prevention guidelines recommend medication prescription and adherence, active education and behavioural counselling regarding lifestyle risk factors. To impact on recurrent vascular events, positive behaviour/s must be adopted and sustained as a lifestyle choice, requiring theoretically informed behaviour change and self-management interventions. A growing number of systematic reviews have addressed complex interventions in stroke secondary prevention. Differing terminology, inclusion criteria and overlap of studies between reviews makes the mechanism/s that affect positive change difficult to identify or replicate clinically. Adopting a two-phase approach, this overview will firstly comprehensively summarise systematic reviews in this area and secondly identify and synthesise primary studies in these reviews which provide person-centred, theoretically informed interventions for stroke secondary prevention. Methods An overview of reviews will be conducted using a systematic search strategy across the Cochrane Database of Systematic Reviews, PubMed and Epistomonikas. Inclusion criteria: systematic reviews where the population comprises individuals post-stroke or TIA and where data relating to person-centred risk reduction are synthesised for evidence of efficacy when compared to standard care or no intervention. Primary outcomes of interest include mortality, recurrent stroke and other cardiovascular events. In phase 1, two reviewers will independently (1) assess the eligibility of identified reviews for inclusion; (2) rate the quality of included reviews using the ROBIS tool; (3) identify unique primary studies and overlap between reviews; (4) summarise the published evidence supporting person-centred behavioural change and self-management interventions in stroke secondary prevention and (5) identify evidence gaps in this field. In phase 2, two independent reviewers will (1) examine person-centred, primary studies in each review using the Template for Intervention Description and Replication (TIDieR checklist), itemising, where present, theoretical frameworks underpinning interventions; (2) group studies employing theoretically informed interventions by the intervention delivered and by the outcomes reported (3) apply GRADE quality of evidence for each intervention by outcome/s identified from theoretically informed primary studies. Disagreement between reviewers at each process stage will be discussed and a third reviewer consulted. Discussion This overview will comprehensively bring together the best available evidence supporting person-centred, stroke secondary prevention strategies in an accessible format, identifying current knowledge gaps

The FDA guidance for industry on PROs: the point of view of a pharmaceutical company

The importance of the patients point of view on their health status is widely recognised. Patient-reported outcomes is a broad term encompassing a large variety of different health data reported by patients, as symptoms, functional status, Quality of Life and Health-Related Quality of Life. Measurements of Health-Related Quality of Life have been developed during many years of researches, and a lot of validated questionnaires exist. However, few attempts have been made to standardise the evaluation of instruments characteristics, no recommendations are made about interpretation on Health-Related Quality of Life results, especially regarding the clinical significance of a change leading a therapeutic approach. Moreover, the true value of Health-Related Quality of Life evaluations in clinical trials has not yet been completely defined. An important step towards a more structured and frequent use of Patient-Reported Outcomes in drug development is represented by the FDA Guidance, issued on February 2006. In our paper we aim to report some considerations on this Guidance. Our comments focus especially on the characteristics of instruments to use, the Minimal Important Difference, and the methods to calculate it. Furthermore, we present the advantages and opportunities of using the Patient-Reported Outcomes in drug development, as seen by a pharmaceutical company. The Patient-Reported Outcomes can provide additional data to make a drug more competitive than others of the same pharmacological class, and a well demonstrated positive impact on the patient' health status and daily life might allow a higher price and/or the inclusion in a reimbursement list. Applying extensively the FDA Guidance in the next trials could lead to a wider culture of subjective measurement, and to a greater consideration for the patient's opinions on his/her care. Moreover, prescribing doctors and payers could benefit from subjective information to better define the value of drugs

Wake up, wake up! It's me! It's my life! patient narratives on person-centeredness in the integrated care context: a qualitative study

Person-centered care emphasizes a holistic, humanistic approach that puts patients first, at the center of medical care. Person-centeredness is also considered a core element of integrated care. Yet typologies of integrated care mainly describe how patients fit within integrated services, rather than how services fit into the patient's world. Patient-centeredness has been commonly defined through physician's behaviors aimed at delivering patient-centered care. Yet, it is unclear how 'person-centeredness' is realized in integrated care through the patient voice. We aimed to explore patient narratives of person-centeredness in the integrated care context

Evaluative and discriminative properties of the Portuguese MacNew Heart Disease Health‐related Quality of Life Questionnaire.

Qual Life Res. 2005 Dec;14(10):2335-41. Evaluative and discriminative properties of the Portuguese MacNew Heart Disease Health-related Quality of Life Questionnaire. Leal A, Paiva C, Höfer S, Amado J, Gomes L, Oldridge N. Cardiac Rehabilitation Unit, Hospital Sto António Porto, Largo Prof Abel Salazar 400, Portugal. [email protected] Abstract The aim of this study was to validate the Portuguese version of the self-administered MacNew Heart Disease Health-related Quality of Life (MacNew) questionnaire in patients after diagnosis of acute coronary syndrome. The MacNew, with a Global score and physical, emotional and social subscales, the Short Form SF-36 (SF-36) and the Hospital Anxiety and Depression Scale (HADS) were completed at baseline by 150 patients and again by 48 clinically stable patients 2-3 weeks later. A cohort of 50 different patients completed the same questionnaires before and after a cardiac rehabilitation program in order to examine responsiveness. Acceptance of the MacNew by the patients was good and the three factor model was substantiated and explained 52.2% of the variance. Internal consistency, intra-class-correlation, and test-retest reliability each exceeded 0.72. The predicted construct validity hypotheses were partially confirmed. The discriminative validity of the MacNew was confirmed with significantly higher MacNew scores for patients with normal left ventricular function, with improved health status, and who were not anxious or depressed. Even though MacNew scores improved significantly following cardiac rehabilitation, the evaluative validity of the MacNew was less robust with small responsiveness statistics. The Portuguese version of the MacNew HRQL questionnaire appears to be a reliable, valid, and moderately responsive instrument to evaluate health-related quality of life after diagnosis of acute coronary syndrome. PMID: 16328913 [PubMed - indexed for MEDLINE

Prevalence of fibromyalgia in France: a multi-step study research combining national screening and clinical confirmation: The DEFI study (Determination of Epidemiology of FIbromyalgia)

<p>Abstract</p> <p>Background</p> <p>Fibromyalgia is a common disease, but little is known on its real prevalence in France. This epidemiological study aimed to assess fibromyalgia (FM) prevalence in the French metropolitan population, based on a multi-step sampling analysis, combining national screening and clinical confirmation by trained specialists.</p> <p>Methods</p> <p>a sampling method on the entire national territory was used: patients over 18 years of age accepting to take part in the study were contacted by telephone using the LFES Questionnaire, a screening test for FM. The, for patients detected by the LFESQ, a visit with a FM-trained rheumatologist was proposed to confirm FM, based on 1990 ACR criteria. Each detected patient completed the following self-questionnaires: SF36, HADS, stress VAS, Co-morbidities and Regional pain score.</p> <p>Results</p> <p>3081 patients were contacted in 5 representative French regions, of which 232 patients were screened for FM. A fibromyalgia diagnosis was then confirmed by rheumatologist in 20 cases (17 female and 3 male, 56.9 ± 13.2 years). The final estimated FM prevalence was 1.6 (CI95: 1.2%; 2.0%). No significant difference was detected between the patients accepting (CS+) and refusing (CS-) rheumatologist visit for the SF36 score, regional pain score, stress VAS scale and co-morbidities. In patients detected for FM by the LFESQ, we found a statistically significant decrease in quality of life and a statistically significant increase in stress level in patients with a confirmed diagnosis (FM+) (6.3 ± 1.9) compared to patients with an invalidated diagnosis (FM-) (4.4 ± 2.8; p = 0.007). The study also demonstrated a significant association, independently of ACR criteria, between the diagnosis of FM and several factors such as regional pain score > 10, elevated stress level, low SF36 scale score and presence of gastro-intestinal disorder co-morbidities.</p> <p>Conclusion</p> <p>Fibromyalgia is a common condition; the 1.6% prevalence calculated in the French population in our study corroborates the figures published in the European literature. Our results also suggest that criteria such as regional pain score, stress level or SF36 quality of life, could represent useful tools in fibromyalgia diagnosis.</p

A Rasch analysis of the Person-Centred Climate Questionnaire – staff version

Background: Person-centred care is the bedrock of modern dementia services, yet the evidence-base to support its implementation is not firmly established. Research is hindered by a need for more robust measurement instruments. The 14-item Person-Centred Climate Questionnaire - Staff version (PCQ-S) is one of the most established scales and has promising measurement properties. However, its construction under classical test theory methods leaves question marks over its rigour and the need for evaluation under more modern testing procedures. Methods: The PCQ-S was self-completed by nurses and other care staff working across nursing homes in 35 Swedish municipalities in 2013/14. A Rasch analysis was undertaken in RUMM2030 using a partial credit model suited to the Likert-type items. Three subscales of the PCQ-S were evaluated against common thresholds for overall fit to the Rasch model; ordering of category thresholds; unidimensionality; local dependency; targeting; and Differential Item Functioning. Three subscales were evaluated separately as unidimensional models and then combined as subtests into a single measure. Due to large number of respondents (n = 4381), two random sub-samples were drawn, with a satisfactory model established in the first ('evaluation') and confirmed in the second ('validation'). Final item locations and a table converting raw scores to Rasch-transformed values were created using the full sample. Results: All three subscales had disordered thresholds for some items, which were resolved by collapsing categories. The three subscales fit the assumptions of the Rasch model after the removal of two items, except for subscale 3, where there was evidence of local dependence between two items. By forming subtests, the 3 subscales were combined into a single Rasch model which had satisfactory fit statistics. The Rasch form of the instrument (PCQ-S-R) had an adequate but modest Person Separation Index (&lt; 0.80) and some evidence of mistargeting due to a low number of `difficult-to-endorse' items. Conclusions: The PCQ-S-R has 12 items and can be used as a unidimensional scale with interval level properties, using the nomogram presented within this paper. The scale is reliable but has some inefficiencies due to too few high-end thresholds inhibiting discrimination amongst populations who already perceive that person-centred care is very good in their environment