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Open AccessConcept confirmation of the Treatment Administration Satisfaction Questionnaire (TASQ) in rare paroxysmal nocturnal hemoglobinuria
This study was conducted to evaluate content validity of the IntraVenous and SubCutaneous Treatment Administration Satisfaction Questionnaires (TASQ-IV and TASQ-SC), for use in a clinical trial population of p...
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Article
Open AccessValidation of the 5-domain Niemann-Pick type C Clinical Severity Scale
Niemann-Pick disease type C (NPC) is an ultra-rare, progressive, genetic disease leading to impaired lysosomal function and neurodegeneration causing serious morbidity and shortened life expectancy.
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Article
Open AccessValidation of a menstrual pictogram and a daily bleeding diary for assessment of uterine fibroid treatment efficacy in clinical studies
To evaluate the psychometric and measurement properties of two patient-reported outcome instruments, the menstrual pictogram superabsorbent polymer-containing version 3 (MP SAP-c v3) and Uterine Fibroid Daily ...
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Article
Open AccessRationale and study protocol of ACQUIRE, a prospective, observational study measuring quality of life, treatment preference and treatment satisfaction of autosomal dominant polycystic kidney disease (ADPKD) patients in Europe
Autosomal dominant polycystic kidney disease (ADPKD) is considered the most common inherited renal disease. Patient-Reported Outcomes (PROs) and patient experience in ADPKD are difficult to quantify and have n...
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Open AccessInterpreting change from patient reported outcome (PRO) endpoints: patient global ratings of concept versus patient global ratings of change, a case study among osteoporosis patients
Regulatory guidance recommends anchor-based methods for interpretation of treatment effects measured by PRO endpoints. Methodological pros and cons of patient global ratings of change vs. patient global rating...
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Article
Open AccessEquivalence of electronic and paper administration of patient-reported outcome measures: a systematic review and meta-analysis of studies conducted between 2007 and 2013
To conduct a systematic review and meta-analysis of the equivalence between electronic and paper administration of patient reported outcome measures (PROMs) in studies conducted subsequent to those included in...
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Open AccessChange in health status in long-term conditions over a one year period: a cohort survey using patient-reported outcome measures
Enhancing quality of life for people with long-term conditions by monitoring patient-reported outcome measure scores is a key domain of health care policy. This study investigated the responsiveness of patient...
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Article
Open AccessEffect of telehealth on glycaemic control: analysis of patients with type 2 diabetes in the Whole Systems Demonstrator cluster randomised trial
The Whole Systems Demonstrator was a large, pragmatic, cluster randomised trial that compared telehealth with usual care among 3,230 patients with long-term conditions in three areas of England. Telehealth inv...
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Open AccessMinimal important change or difference for the oxford hip and knee scores following joint replacement surgery
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Can pain and function be distinguished in the Oxford Knee Score in a meaningful way? An exploratory and confirmatory factor analysis
The purpose of this paper was to examine if pain and functioning can be distinguished in the Oxford Knee Score (OKS) in a meaningful way. This was done by (1) conducting exploratory factor analysis to explore ...
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Article
Open AccessImpact of telehealth on general practice contacts: findings from the whole systems demonstrator cluster randomised trial
Telehealth is increasingly used in the care of people with long term conditions. Whilst many studies look at the impacts of the technology on hospital use, few look at how it changes contacts with primary care...
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Open AccessTotal or Partial Knee Arthroplasty Trial - TOPKAT: study protocol for a randomised controlled trial
In the majority of patients with osteoarthritis of the knee the disease originates in the medial compartment. There are two fundamentally different approaches to knee replacement for patients with unicompartme...
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Open AccessCarer quality of life and experiences of health services: a cross-sectional survey across three neurological conditions
Neurological conditions have a substantial impact on carers, with carer well-being having been shown to be influenced by a number of demographic, patient and caregiving factors. Support given to carers can lea...
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Open AccessA comprehensive evaluation of the impact of telemonitoring in patients with long-term conditions and social care needs: protocol for the whole systems demonstrator cluster randomised trial
It is expected that increased demands on services will result from expanding numbers of older people with long-term conditions and social care needs. There is significant interest in the potential for technolo...
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Article
Internet Gamblers: A Latent Class Analysis of Their Behaviours and Health Experiences
In order to learn about the behaviours and health experiences of people who gamble on the Internet, we conducted an international online survey with respondents recruited via gambling and gambling-related webs...
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The Oxford Ankle Foot Questionnaire for children: responsiveness and longitudinal validity
To evaluate how scores from the Oxford Ankle Foot Questionnaire change over time and with treatment using both distribution-based and anchor-based approaches.
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Comparative responsiveness and minimal change for the Oxford Elbow Score following surgery
To assess the responsiveness and minimal change for the Oxford Elbow Score (OES) using anchor- and distribution-based approaches.
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Open Access2032 The relationship between electrocardiographic and cardiac magnetic resonance (CMR)-derived left ventricular parameters differs between physiologic and pathologic hypertrophy
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A patient-based questionnaire to assess outcomes of foot surgery: Validation in the context of surgery for hallux valgus
Background: A patient-based outcome measure with good measurement properties is urgently needed for use in clinical trials of foot surgery. Methods: We evaluated an existing foot pain and...
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The natural history of severe osteoarthritis of the knee in patients awaiting total knee arthroplasty
The disabling symptoms of osteoarthritis of the knee can be dramatically improved with joint replacement. The aim of this study was to examine the change in pain and physical function that occurs in patients w...