Introduction: PROMs are increasingly used by clinicians to evaluate recovery after distal radius fractures, but can also be used as benchmark data to help patients managing their expectations about... Show moreIntroduction: PROMs are increasingly used by clinicians to evaluate recovery after distal radius fractures, but can also be used as benchmark data to help patients managing their expectations about recovery after DRF. Purpose of the Study: The study aimed to determine the general course of patient-reported functional recovery and complaints during 1 year after a DRF, depending on fracture type and age. The study aimed to determine the general course of patient-reported functional recovery and complaints during one year after a DRF, depending on fracture type and age. Methods: Retrospectively analyzed PROMs of 326 patients with DRF from a prospective cohort at baseline and at 6, 12, 26 and 52 weeks included PRWHE questionnaire for measuring functional outcome, VAS for pain during movement, and items of the DASH for measuring complaints (tingling, weakness, stiffness) and limitations in work and daily activities. The effect of age and fracture type on outcomes were assessed using repeated measures analysis. Results: PRWHE scores after one year were on average 5.4 points higher compared to the patients' prefracture scores. Patients with type B DRF had significantly better function and less pain than those with types A or C at every time point. After six months, more than 80% of the patients reported mild or no pain. Tingling, weakness or stiffness were reported by 55-60% of the overall cohort after six weeks, while 10-15% had persisting complaints at one year. Older patients reported worse function and more pain, complaints and limitations. Conclusions: Functional recovery after a DRF is predictable in time with functional outcome scores after one-year follow-up that are similar to pre-fracture values. Some outcomes after DRF differ between age and fracture type groups. (c) 2022 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY license ( http://creativecommons.org/licenses/by/4.0/ ) Show less
Gelderblom, H.; Jones, R.L.; Blay, J.Y.; George, S.; Mehren, M. von; Zalcberg, J.R.; ... ; Bauer, S. 2023
PurposeIn the INTRIGUE trial, ripretinib showed no significant difference versus sunitinib in progression-free survival for patients with advanced gastrointestinal stromal tumour (GIST) previously... Show morePurposeIn the INTRIGUE trial, ripretinib showed no significant difference versus sunitinib in progression-free survival for patients with advanced gastrointestinal stromal tumour (GIST) previously treated with imatinib. We compared the impact of these treatments on health-related quality of life (HRQoL).Patients and methodsPatients were randomised 1:1 to once-daily ripretinib 150 mg or once-daily sunitinib 50 mg (4 weeks on/2 weeks off). Patient-reported outcomes were assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer-30 (EORTC QLQ-C30) questionnaire at day (D)1, and D29 of all cycles until treatment discontinuation. Change from baseline was calculated. Time without symptoms or toxicity (TWiST) was estimated as the mean number of days without progression, death, or grade ≥3 treatment-emergent adverse events per patient over 1 year of follow-up.ResultsQuestionnaire completion at baseline was 88.1% (199/226) for ripretinib and 87.7% (199/227) for sunitinib and remained high for enrolled patients throughout treatment. Patients receiving sunitinib demonstrated within-cycle variation in self-reported HRQoL, corresponding to the on/off dosing regimen. Patients receiving ripretinib reported better HRQoL at D29 assessments than patients receiving sunitinib on all scales except constipation. HRQoL was similar between treatments at D1 assessments, following 2 weeks without treatment for sunitinib patients. TWiST was greater for ripretinib patients (173 versus 126 days).ConclusionPatients receiving ripretinib experienced better HRQoL than patients receiving sunitinib during the dosing period and similar HRQoL to patients who had not received sunitinib for 2 weeks for all QLQ-C30 domains except constipation. Ripretinib may provide clinically meaningful benefit to patients with advanced GIST previously treated with imatinib. Show less
Albers, E.A.C.; Fraterman, I.; Walraven, I.; Wilthagen, E.; Schagen, S.B.; Ploeg, I.M. van der; ... ; Ligt, K.M. de 2022
Purpose The use of Patient-Reported Outcome Measures (PROMs) for individual patient management within clinical practice is becoming increasingly important. New evidence about graphic visualization... Show morePurpose The use of Patient-Reported Outcome Measures (PROMs) for individual patient management within clinical practice is becoming increasingly important. New evidence about graphic visualization formats for PROMs scores has become available. This systematic literature review evaluated evidence for graphic visualization formats of PROMs data in clinical practice for patients and clinicians, for both individual and group level PROMs data. Methods Studies published between 2000 and 2020 were extracted from CINAHL, PubMed, PsychInfo, and Medline. Studies included patients >= 18 years old in daily clinical practice. Papers not available in English, without full-text access, or that did not specifically describe visualization of PROMs data were excluded. Outcomes were: visualization preferences; interpretation accuracy; guidance for clinical interpretation. Results Twenty-five out of 789 papers were included for final analysis. Most frequently studied formats were: bar charts, line graphs, and pie charts. Patients preferred bar charts and line graphs as these were easy and quick for retrieving information about their PROMs scores over time. Clinicians' interpretation accuracy and preferences were similar among graphic visualization formats. Scores were most often compared with patients' own previous scores; to further guide clinical interpretation, scores were compared to norm population scores. Different 'add-ons' improved interpretability for patients and clinicians, e.g. using colors, descriptions of measurement scale directionality, descriptive labels, and brief definitions. Conclusion There was no predominant graphical visualization format approach in terms of preferences or interpretation accuracy for both patients and clinicians. Detailed clarification of graph content is essential.Plain English summary Patient-Reported Outcome Measures (PROMs) capture patients' self-reported health through the use of questionnaires. PROMs measure health related quality of life, daily functioning, and symptom experience, which are becoming increasingly important to incorporate in clinical practice for individual patient management. To present PROMs within clinical practice, raw or summarized PROMs scores can be visualized in graphical formats. To be useful during clinical encounters, both patients and clinicians ought to interpret such formats correctly. New evidence about graphic visualization formats for PROMs scores has become available. Therefore, we systematically reviewed the literature to evaluate evidence for graphic visualization formats of PROMs data in clinical practice. In 25 included papers, most studies used graphical formats like bar charts, line graphs, and pie charts for presenting PROMs scores. There was no predominant graphical visualization format approach in terms of preferences or interpretation accuracy for both patients and clinicians. Patients preferred bar charts and line graphs as these were easy and quick for retrieving information about their PROMs scores over time. Clinicians' interpretation accuracy and preferences were similar among graphic visualization formats. The graphical interpretation of PROMs data for patients and clinicians can be improved by using colors, descriptions of measurement scale directionality, descriptive labels, and brief definitions. Show less
Graaf, J.A. de; Visser-Meily, J.M.; Schepers, V.P.; Baars, A.; Kappelle, L.J.; Passier, P.E.; ... ; Post, M.W. 2021
BACKGROUND: Although the use of patient-reported outcome measures to assess Health-Related Quality of Life (HRQoL) has been advocated, it is still open to debate which patient-reported outcome... Show moreBACKGROUND: Although the use of patient-reported outcome measures to assess Health-Related Quality of Life (HRQoL) has been advocated, it is still open to debate which patient-reported outcome measure should be preferred to evaluate HRQoL after stroke.AIM: To compare the measurement properties (including concurrent validity and discriminant ability) between the 5-dimensional 5-level Euro-Qol (EQ-5D-5L) and the Patient-Reported Outcomes Measurement Information System 10-Question Global Health Short Form (PROMIS-10) to evaluate HRQoL 3 months after stroke.DESIGN: Cross-sectional study.SETTING: Neurology outpatient clinics in 6 Dutch hospitals.POPULATION: The participants 360 consecutive individuals with stroke. Their median age was 71 years, 143 (39.7%) were female and 335 (93.0%) had suffered an ischemic stroke.METHODS: The EQ-5D-5L, PROMIS-10, modified Rankin Scale and two items on experienced decrease in health and activities post-stroke were administered by a stroke nurse or nurse practitioner through a telephone interview 3 months after stroke. The internal consistency, distribution, floor/ceiling effects, inter-correlations and discriminant ability (using the modified Rankin Scale and experienced decrease in health and in activities post-stroke as external anchors) were calculated for both the EQ-5D-5L and PROMIS-10.RESULTS: Ninety-six percent of the participants were living at home and 50.9% experienced minimal or no disabilities (modified Rankin Scale 0-1) 3 months after stroke. A ceiling effect and a non-normal left skewed distribution were observed in the EQ-5D-5L. The PROMIS-10 showed higher internal consistency (alpha=0.90) compared to the EQ-5D-5L (alpha=0.75). Both the EQ-5D-5L and the PROMIS-10 were strongly correlated with the modified Rankin Scale (r=0.62 and 0.60 respectively). The PROMIS-10 showed better discriminant ability in less affected individuals with stroke, whereas the EQ-5D-5L showed slightly better discriminant ability in more affected individuals with stroke.CONCLUSIONS: Both EQ-5D-5L and PROMIS-10 prove to be useful instruments to evaluate HRQoL in patients who are living at home 3 months after stroke.CLINICAL REHABILITATION IMPACT: The clinical rehabilitation impact depended on the setting and underlying goal which patient-reported outcome measure is preferred to evaluate HRQoL 3 months after stroke. The PROMIS-10 should be preferred to detect differences in less affected stroke patients, whereas the EQ-5D-5L provides slightly more information in more affected stroke patients. Show less
Background: Surgical aortic valve replacement (SAVR) via limited access approaches ('mini-AVR') have proven to be safe alternative for the surgical treatment of aortic valve disease. However, it... Show moreBackground: Surgical aortic valve replacement (SAVR) via limited access approaches ('mini-AVR') have proven to be safe alternative for the surgical treatment of aortic valve disease. However, it remains unclear whether these less invasive approaches are associated with improved quality of life and/or reduced postoperative pain when compared to conventional SAVR via full median sternotomy (FMS).Study design: The LImited access Aortic valve Replacement (LIAR) trial is a single-center, single blind randomized controlled clinical trial comparing 2 arms of 80 patients undergoing limited access SAVR via J-shaped upper hemi-sternotomy (UHS) or conventional SAVR through FMS. In all randomized patients, the diseased native aortic valve is planned to be replaced with a rapid deployment stented bioprosthesis. Patients unwilling or unable to participate in the randomized trial will be treated conventionally via SAVR via FMS and with implantation of a sutured valve prosthesis. These patients will participate in a prospective registry.Study methods: Primary outcome is improvement in cardiac-specific quality of life, measured by two domains of the Kansas City Cardiomyopathy Questionnaire up to one year after surgery. Secondary outcomes include, but are not limited to: generic quality of life measured with the Short Form-36, postoperative pain, perioperative (technical success rate, operating time) and postoperative outcomes (30-day and one-year mortality), complication rate and hospital length of stay.Conclusion: The LIAR trial is designed to determine whether a limited access approach for SAVR ("mini-AVR") is associated with improved quality of life and/or reduced postoperative pain compared with conventional SAVR through FMS. Show less
Mulligen, E. van; Weel, A.E.A.M.; Kuijper, T.M.; Hazes, J.M.W.; Helm-van Mil, A.H.M. van der; Jong, P.H.P. de 2020
Objectives: To determine the impact of a disease flare on patient reported outcome measures (PROMs) in rheumatoid arthritis (RA) patients, who are tapering treatment.Methods: Data were used from... Show moreObjectives: To determine the impact of a disease flare on patient reported outcome measures (PROMs) in rheumatoid arthritis (RA) patients, who are tapering treatment.Methods: Data were used from the TARA trial; a multicenter, randomized controlled trial in which RA patients, with a well-controlled disease (DAS <= 2.4 and SJC <= 1) for at least 6 months, gradually tapered their DMARDs. PROMs of patients with a flare (DAS>2.4 and/or SJC>1) were compared every three months before and after a flare with their own norm values. Linear Mixed Models were used to investigate whether a disease flare influenced functional ability (HAQ-DI), fatigue (BRAF-MDQ), quality of life (EQ-5D and SF36), anxiety and depression (HADS), morning stiffness, general health (GH) and worker productivity, and if so, the duration was determined. For unemployment and sick leave we used descriptive statistics.Results: A flare negatively influenced GH, morning stiffness, HAQ-DI, EQ-5D, BRAF-MDQ and the SF36 physical component scale and this effect lasted >3 months. Except for the HAQ-DI, effect sizes exceeded the minimum clinically important differences (MCIDs). For the physical outcomes effects lasted >6 months. Worker productivity was not significantly affected by a flare.Conclusion: A disease flare influenced patients' lives, the largest effect was seen in the physical outcomes, and lasted 6 months. Although on a group level effect sizes for the separate PROMs were not always significant or larger than specific MCIDs, a disease flare can still be of great importance for individual patients. (C) 2020 The Author(s). Published by Elsevier Inc. Show less
With increasing life expectancy, the incidence and burden of osteoarthritis on society increases. Currently, no treatment for end-stage symptomatic osteoarthritis is available and when symptoms... Show moreWith increasing life expectancy, the incidence and burden of osteoarthritis on society increases. Currently, no treatment for end-stage symptomatic osteoarthritis is available and when symptoms become too severe arthroplasty surgery will be performed, replacing the affected joint with a prosthesis. Although replacement surgery of the hip or knee is safe and commonly performed, up to 20% of the patients are unsatisfied with the outcome. The exact reasons for this dissatisfaction are unknown but may vary from the type of surgical procedure itself, expectancy of the outcome surgery to the patient’s preoperative state of overall metabolic health. We aimed to evaluate some of these aspects related to outcome, from patient perspectives to molecular profiling (e.g. metabolic health). Characteristics of different nature were included: material of prosthesis, physical activity, questionnaires, clinical measures and metabolomics. This holistic approach enables the assessment of more patient specific targets such as advices on treatment modalities. Ultimately, selection of patients, both from a patient’s as well as orthopaedic surgeon’s perspective, will be optimised for the best intervention for the patient. Since osteoarthritis is the major driver for performing arthroplasty, the conclusion of this thesis will spark future studies into OA and its overall effect on disability. Show less
