scholarly journals Towards compatibility of EUnetHTA JCA methodology and German HTA: a systematic comparison and recommendations from an industry perspective

2021 ◽  
Author(s):  
Agnes Kisser ◽  
Joschua Knieriemen ◽  
Annette Fasan ◽  
Karolin Eberle ◽  
Sara Hogger ◽  
...  
Keyword(s):  
Data Extraction ◽  
Relative Effectiveness ◽  
Patient Reported Outcome ◽  
Added Value ◽  
Relative Safety ◽  
Patient Reported ◽  
Related Quality ◽  
Health Related ◽  
Definition Of

Abstract Objective The transferability of the EU joint clinical assessment (JCA) reports for pharmaceuticals for the German benefit assessment was evaluated by systematically comparing EU JCA and German clinical assessments (CA) based on established assessment elements for HTA and assessing the potential impact of differences on Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA) ability to derive the therapeutic added value. Methods Identification of all pharmaceuticals undergoing both, EU JCA and German CA between January 2016–June 2020. Qualitative review and data extraction from the assessments, assessment of methodological differences using a hierarchical model. Recommendations for harmonisation were developed and consented with pharmaceutical industry stakeholders. Results Differences with potentially major impact: (1) View on differing treatment algorithms and definition of corresponding subpopulations/respective comparators. (2) Clinical relevance of surrogate/intermediate endpoints. Inclusion of different/surrogate morbidity endpoints resulting in different relative effectiveness conclusions. (3) Tolerance of study interventions not used according to marketing authorisation. (4) Different operationalisation and/or weighting of individual safety endpoints leading to differing relative safety conclusions. Differences with potentially minor impact: (1) Disagreement in risk of bias assessment for overall survival and its robustness against study limitations. (2) Use of patient-reported outcome symptom scales as measurements for health-related quality of life instruments. Conclusion While many synergies between EU JCA and German CA exist, we identified several aspects in HTA methodology that would benefit of harmonisation and ensure the transferability of future EU JCA to the German HTA process without duplicated evaluation requirements. For those, a set of recommendations was developed.

Patient Reported Outcome Measures of Health-Related Quality of Life and Asthenia after Thyroidectomy

2021 ◽  
Vol 264 ◽  
pp. 394-401
Author(s):  
Mary Kate Luddy ◽  
Rachel Vetter ◽  
Jessica Shank ◽  
Whitney Goldner ◽  
Anery Patel ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Outcome Measures ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Health Related Quality ◽  
Patient Reported ◽  
Related Quality ◽  
Health Related

scholarly journals Patient-reported outcome measures as a new application in the Swedish Renal Registry: health-related quality of life through RAND-36

2019 ◽  
Author(s):  
Agneta A Pagels ◽  
Maria Stendahl ◽  
Marie Evans
Keyword(s):  
Age Groups ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Age Group ◽  
Patient Reported ◽  
Related Quality ◽  
Centered Care ◽  
Health Related ◽  
Impaired Health

AbstractBackgroundAlthough patient-reported outcome measures (PROMs) are gaining increased interest in developing health care quality and are a useful tool in person-centered care, their use in routine care is still limited. The aim of this study is to describe the implementation and initial results of PROMs via the Swedish Renal Registry (SRR) on a national level.MethodsAfter testing and piloting the electronic PROM application, nationwide measures were carried out in 2017 for completing the RAND-36 questionnaire online or by paper in a wide range of chronic kidney disease (CKD) patients (Stages 3–5, dialysis and transplantation) through the SRR. Cross-sectional results during the first year were analyzed by descriptive statistics and stratified by treatment modality.ResultsA total of 1378 patients from 26 of 68 renal units (39%) completed the questionnaire. The response rate for all participating hemodialysis units was 38.9%. The CKD patients had an impaired health profile compared with a Swedish general population, especially regarding physical functions and assessed general health (GH). Transplanted patients had the highest scores, whereas patients on dialysis treatment had the lowest scores. The youngest age group assessed their physical function higher and experienced fewer physical limitations and less bodily pain than the other age groups but assessed their GH and vitality (VT) relatively low. The oldest age group demonstrated the lowest health profile but rated their mental health higher than the other age groups. The older the patient, the smaller the difference compared with persons of the same age in the general population.ConclusionsNationwide, routine collection of PROMs is feasible in Sweden. However, greater emphasis is needed on motivating clinical staff to embrace the tool and its possibilities in executing person-centered care. CKD patients demonstrate impaired health-related quality of life, especially regarding limitations related to physical problems, GH and VT/energy/fatigue.

What Matters to Patients With Cleft Lip and/or Palate

2017 ◽  
Vol 55 (3) ◽  
pp. 442-450 ◽  
Author(s):  
Karen W. Y. Wong Riff ◽  
Elena Tsangaris ◽  
Timothy E. E. Goodacre ◽  
Christopher R. Forrest ◽  
Jessica Lawson ◽  
...  
Keyword(s):  
Conceptual Framework ◽  
Qualitative Methodology ◽  
Cleft Lip ◽  
Patient Reported Outcome ◽  
Patient Reported ◽  
Related Quality ◽  
Health Related ◽  
Changes Over Time ◽  
What Matters

Objective: The goal of treatment for individuals with cleft lip and/or palate (CL/P) is to improve physical, psychological, and social health. Outcomes of treatment are rarely measured from the patient’s perspective. The aim of the study was to develop a conceptual framework for a patient-reported outcome (PRO) instrument for individuals with clefts (CLEFT-Q) by developing an in-depth understanding of issues that individuals consider to be important. Design: The qualitative methodology of interpretive description was used. Setting, Participants, and Intervention: We performed 136 individual in-depth interviews with participants with clefts of any age, presenting for cleft care, across 6 countries. Parents were involved if the child was more comfortable. Interviews were audio-recorded, transcribed verbatim, and coded using constant comparison. The data were used to develop a refined conceptual framework. Results: Participants described concepts of interest in 3 top-level domains, each of which included subdomains: appearance (face, nose, nostrils, teeth, lips, jaw, cleft lip scar), health-related quality of life (psychological, social, school, speech-related distress), and facial function (speech, eating/drinking). Participants were able to describe changes over time with regard to the 3 domains. Conclusions: A conceptual framework of concepts of interest to individuals with CL/P formed the basis of the scales in the CLEFT-Q. Each subdomain represents an independently functioning scale. Understanding what matters to patients is essential in guiding PRO measurement.

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