International development of a patient-centered core outcome set for assessing health-related quality of life in metastatic breast cancer patients.

PURPOSE: For patients living with metastatic breast cancer (MBC), achieving best possible health-related quality of life, along with maximizing survival, is vital. Yet, we have no systemic way to determine if we achieve these goals. A Core Outcome Set (COS) that allows standardized measurement of outcomes important to patients, but also promotes discussing these outcomes during clinical encounters, is long overdue. METHODS: An international expert group (EG) of patient advocates, researchers, medical specialists, nurse specialists, and pharmaceutical industry representatives (n = 17) reviewed a list of relevant outcomes retrieved from the literature. A broader group (n = 141: patients/patient advocates (n = 45), health care professionals/researchers (n = 64), pharmaceutical industry representatives (n = 28), and health authority representatives (n = 4)) participated in a modified Delphi procedure, scoring the relevance of outcomes in two survey rounds. The EG finalized the COS in a consensus meeting. RESULTS: The final MBC COS includes 101 variables about: (1) health-related quality of life (HRQoL, n = 26) and adverse events (n = 24); (2) baseline patient characteristics (n = 9); and (3) clinical variables (n = 42). Many outcome that cover aspects of HRQoL relevant to MBC patients are included, e.g. daily functioning (including ability to work), psychosocial/emotional functioning, sexual functioning, and relationship with the medical team. CONCLUSION: The COS developed in this study contains important administrative data, clinical records, and clinician-reported measures that captures the impact of cancer. The COS is important for standardization of clinical research and implementation in daily practice and has received accreditation by the International Consortium for Health Outcomes Measurement (ICHOM).

Personal factors in systemic sclerosis and their coverage by patient-reported outcome measures. A multicentre European qualitative study and literature review.

BACKGROUND: Systemic sclerosis (SSc) is an autoimmune disease where thickening of the skin can lead to reduced body function and limitations in activities. Severe forms can also affect and seriously damage inner organs. Patient-centred rehabilitation emphasises considerations of patients' background, experience and behavior which highlights the need to know if patient-reported outcome measures (PROMs) include such personal factors. AIM: To identify and describe personal factors in the experiences of functioning and health of persons with SSc and to examine if and to what extent PROMs in SSc research cover these factors. DESIGN: Data from a qualitative study with focus group interviews were analysed. PROMs in SSc research were identified in a literature review between 2008-2013. SETTING: Participants were recruited from outpatient clinics at rheumatology department. POPULATION: Sixty-three patients with SSc from four European countries participated. METHODS: Data from interviews were analysed using a structure of personal factors developed by Geyh et al. Identified PROMs were analysed and linked to main concepts, related to the personal factors, found in the interview data. RESULTS: Nineteen main concepts were related to the area "patterns of experience and behaviour" in the personal factor structure, 16 to "thoughts and beliefs", nine to "feelings", one to "motives" and one to "personal history and biography", respectively. Among the 35 PROMs identified, 15 did not cover any of the identified concepts. Concepts within the area "feelings" were mostly covered by the PROMs. Five of the PROMs covered "patterns of experience and behaviour", while "motives" and "personal history and biography" were not covered at all. Four of the identified PROMs covered concepts within the areas "feelings", "thoughts and beliefs" and "patterns of experience and behaviour" in the same instrument. The Illness Cognition Questionnaire and Illness Behaviour Questionnaire were such PROMs. CONCLUSION: Patterns of experience and behaviour had the highest number of concepts related to personal factors, but few of the PROMs in SSc research covered these factors. Only a few PROMs covered several personal factors areas in the same instrument. CLINICAL REHABILITATION IMPACT: The results would be of value when developing core sets for outcome measurements in SSc.

Life stories of people with rheumatoid arthritis who retired early: how gender and other contextual factors shaped their everyday activities, including paid work.

OBJECTIVE: The aim of the present study was to explore how contextual factors affect the everyday activities of women and men with rheumatoid arthritis (RA), as evident in their life stories. METHODS: Fifteen people with RA, who had retired early due to the disease, were interviewed up to three times, according to a narrative biographic interview style. The life stories of the participants, which were reconstructed from the biographical data and from the transcribed 'told story' were analysed from the perspective of contextual factors, including personal and environmental factors. The rigour and accuracy of the analysis were enhanced by reflexivity and peer-review of the results. RESULTS: The life stories of the participants in this study reflected how contextual factors (such as gender, the healthcare system, the support of families and social and cultural values) shaped their everyday activities. In a society such as in Austria, which is based on traditional patriarchal values, men were presented with difficulties in developing a non-paid-work-related role. For women, if paid work had to be given up, they were more likely to engage in alternative challenging activities which enabled them to develop reflective skills, which in turn contributed to a positive and enriching perspective on their life stories. Health professionals may thus use some of the women's strategies to help men. CONCLUSION: Interventions by health professionals in people with RA may benefit from an approach sensitive to personal and environmental factors.

The use of databases for quality assessment in rheumatoid arthritis.

As resources in health care systems become increasingly scarce, rheumatologists may need to provide evidence that their quality of care uses the allocated resources effectively by achieving a good outcome for patients with rheumatoid arthritis (RA). In order to assess quality, it has been recommended in other areas of medicine to gather data according to appropriate outcome measures, preferably in electronic databases, enabling identification of benchmarks to compare the outcome quality of different clinical settings. Available electronic applications commonly comprise a database for data processing and storage, as well as a tool for regularly measuring and following disease activity in individual patients. Access to aggregated data makes it possible to monitor disease activity in individual patients over time in relation to treatment. In addition, electronic applications should allow the extraction of patient data according to special characteristics for analysis. In this way, such electronic applications can provide a central database that can be used for monitoring patients in routine care, case studies or general research, as well as facilitating comparisons of quality of care in different centres or in different countries for reference purposes.

Very recent onset rheumatoid arthritis: clinical and serological patient characteristics associated with radiographic progression over the first years of disease.

OBJECTIVES: Despite early recognition and disease modifying anti-rheumatic drug (DMARD) treatment, a sizable proportion of early rheumatoid arthritis (RA) patients show radiological progression. This study was performed to determine the frequency of erosive arthritis and the pace of radiological progression in an inception cohort of patients with very early RA (

ICF core sets: how to specify impairment and function in systemic lupus erythematosus.

The World Health Organization's International Classification of Function (ICF) is a tool to characterize and illuminate better the full of array of problems a patient faces when affected by disease. Specifying these problems is a particular challenge in a disease like systemic lupus erythematosus (SLE) because of the wide variety in organ systems involved, its variable activity and severity, and considerable ethnic and local differences. The authors of this manuscript believe, however, that a broader understanding will prove essential for optimal patient care, and that there is sufficient experience now in defining ICF Core Sets to successfully complete core sets for SLE. Therefore, we will embark on an international project for developing ICF Core Sets for SLE, which we here delineate. This development will include two versions: 1) The Brief ICF Core Set for SLE will be a very focused list of categories essential for SLE clinical trials; and 2) The Comprehensive ICF Core Set will be much broader and useful for guiding multidisciplinary assessment in patients with SLE. Both Core Sets will be developed in a formal decision-making and consensus process of health professionals integrating evidence gathered from preliminary studies. The final definition of the Core Sets will occur at a consensus conference which will integrate: i) a systematic review of the literature regarding the outcome measures used in clinical trials and selected observational studies; ii) focus groups or semi-structured interviews with SLE patients; iii) a Delphi exercise with world wide involvement of experts; and iv) the evidence from empirical studies. The development of these SLE ICF Core Sets is designed to be an inclusive, open, worldwide process. We therefore invite both SLE clinical experts and SLE patients to participate actively.

Clinical study on the effect of infrared radiation of a tiled stove on patients with hand osteoarthritis.

OBJECTIVE: To explore the effect of infrared radiation of a tiled stove on patients with hand osteoarthritis (OA). METHODS: A randomized controlled crossover study was performed with 45 patients with hand OA. This sample was randomly assigned to two groups: group A [first 3 hours spent three times a week during 3 weeks in a heated tiled stove room ('Stove Period') and after 2 weeks without treatment this group was observed for another 3 weeks ('Control Period')]; and group B (first assigned to the control period and the stove period following the treatment-free period). Assessments included the visual analogue scale (VAS) for general pain, pain in the hands, and global hand function, grip strength, the Moberg Picking-up Test (MPUT), the Australian/Canadian Osteoarthritis Hand Index (AUSCAN), and the Medical Outcomes Study (MOS) 36-item Short-Form Health Status Survey (SF-36). RESULTS: Fourteen (31%) patients improved on the VAS for general pain at the end of the tiled stove period as compared to 10 patients (22%) during the control period (p = 0.314, chi2-test). The AUSCAN pain domain showed a significant improvement after the tiled stove period (p = 0.034). Others pain parameters analysed (VAS for pain in hands and SF-36 bodily pain) showed moderate but not significant improvement (p = 0.682 and p = 0.237, respectively) compared to the control period. CONCLUSION: This study did not prove positive effects of the tiled stove exposure, although the numerical improvement in all pain measures suggests some possible positive effects on this symptom of hand OA.

Autoantibody profiling as early diagnostic and prognostic tool for rheumatoid arthritis.

BACKGROUND: Early treatment prevents progression of joint damage in rheumatoid arthritis (RA), but diagnosis in early disease is impeded by lack of appropriate diagnostic criteria. OBJECTIVE: To study the value of rheumatoid factor (RF), anti-cyclic citrullinated peptide autoantibodies (anti-CCP), and anti-RA33 autoantibodies for diagnosis of RA and prediction of outcome in patients with very early arthritis. METHODS: The prospective follow up inception cohort included 200 patients with very early (<3 months) inflammatory joint disease. Autoantibodies were measured at baseline and analysed in a tree based model which aimed at determining the added diagnostic value of testing for anti-CCP and anti-RA33 as compared with RF alone. RESULTS: RA was diagnosed in 102 patients, while 98 developed other inflammatory arthropathies. Receiver operator curve analysis showed an optimum cut off level for RF at 50 U/ml, above which anti-CCP and anti-RA33 had no additional diagnostic value. Remarkably, RF >or=50 U/ml and anti-CCP showed similar sensitivity and high specificity for RA, but overlapped considerably. Anti-RA33 was less specific and did not correlate with RF or anti-CCP. Among patients with RA, 72% showed at least one of these three autoantibodies, compared with 15% of non-RA patients. RF >or=50 U/ml and anti-CCP were predictors of erosive disease, whereas anti-RA33 was associated with mild disease. CONCLUSIONS: Stepwise autoantibody testing in early inflammatory joint disease, starting with RF, followed by anti-CCP (in patients with RF <50 U/ml), and finally anti-RA33, should be used as a sensitive and effective strategy for distinguishing patients with RA at high risk for poor outcome.

Benefit of very early referral and very early therapy with disease-modifying anti-rheumatic drugs in patients with early rheumatoid arthritis.

OBJECTIVE: Delay of disease-modifying anti-rheumatic drug (DMARD) therapy is a major contributing factor for poor outcome in rheumatoid arthritis (RA). Although early therapy has been shown to be particularly effective, there is still uncertainty about the optimal time point of DMARD introduction. We wanted to test if a therapeutic window of opportunity may exist within the first few months of the disease. METHODS: In this case-control parallel-group study, 20 very early RA (VERA) patients with median disease duration of 3 months were age and gender matched to a group of 20 late early RA (LERA) patients with median disease duration of 12 months until first DMARD initiation. Follow-up time was 36 months. Primary outcome measures were the disease activity score (DAS28) and radiological joint destruction using the Larsen method. RESULTS: Already after 3 months of DMARD therapy we found a significant difference of improvement in favour of the VERA patients in the DAS28. This trend continued over the study period. At study end the DAS28 showed an improvement of 2.8+/-1.5 in the VERA vs 1.7+/-1.2 in the LERA group (P(c)<0.05). The Larsen scores showed a statistically significant retardation of progression in the VERA compared with the LERA. CONCLUSION: Our results indicate that there is a window of opportunity for highly successful treatment of RA in the first year, and especially within the first 3 months of therapy. Thus, early diagnosis and therapy may be the crucial step in achieving optimal control of disease progression and prognosis in RA.

The Austrian Early Arthritis Registry.

The Austrian Early Arthritis Registry (Austrian Early Arthritis Action, EAA) enrols and follows patients with inflammatory arthritis of very short (< 12 weeks) duration. Currently, data on 375 patients (almost 2000 individual follow-up examinations) have been entered into the EA database. Evaluations of data from 182 patients with a follow-up of at least one year are available. 65% of these patients have RA, as diagnosed using the ACR classification criteria in a cumulative fashion. Approximately 15% of these patients still have no established diagnosis and are being carried forward and observed as cases of "undifferentiated arthritis". In RA patients, the mean DAS 28 decreased significantly from an initial mean score of 5.5 (high disease activity) into the range of low disease activity. At the end of one year a DAS 28 of < 3.2 was observed in 52% of the RA patients. Radiological progression in these RA patients, who also received treatment very early, appears to be less severe than in other cohorts, although direct comparisons are impossible due to different methods of patient selection. In addition, the serological data from our cohort in cooperation with other study groups will allow development and validation of possible prediction algorithms for early arthritis patients which could improve the diagnostic and therapeutic approach to this patient group.