To examine the association between different minimum important change (MIC) values for pain and disability and a successful response in global perception of improvement in patients with chronic ...nonspecific low back pain (CNLBP).
A prospective cohort study was conducted. At baseline, all participants completed a sociodemographic and clinical questionnaire, the Numeric Pain Rating Scale and the Quebec Back Pain Disability Scale (QBPDS). After a physiotherapy program, the Global Perceived Effect Scale (GPES) was completed together with pain and disability measures. The association of the different literature MIC values for pain and disability with a successful response on the GPES was analyzed using logistic regression models. The discrimination power, sensitivity, specificity and predictive values were computed.
A total of 183 patients with CNLBP participated in this study. A reduction of 30% on the QBPDS (OR = 7.8; area under the curve = 0.73; sensitivity = 0.72; specificity = 0.76) most accurately identified patients who perceived a global improvement on the GPES. Composite criteria using both pain and disability MIC values presented high odds ratios and specificity values, but failed to identify patients who perceived a meaningful improvement.
A 30% reduction on the QBPDS is recommended to identify patients with CNLBP who achieve a clinical improvement with physiotherapy treatment.
The use of TNF-inhibitors and/or the IL-6 receptor antagonist, tocilizumab, in rheumatoid arthritis (RA) have pleiotropic effects that also involve circulating B-cells. The main goal of this study ...was to assess the effect of TNF-inhibitors and tocilizumab on B-cell phenotype and gene expression in RA.
Blood samples were collected from untreated early RA (ERA) patients, established RA patients under methotrexate treatment, established RA patients before and after treatment with TNF-inhibitors and tocilizumab, and healthy donors. B-cell subpopulations were characterized by flow cytometry and B-cell gene expression was analyzed by real-time PCR on isolated B-cells. Serum levels of BAFF, CXCL13 and sCD23 were determined by ELISA.
The frequency of total CD19+ B cells in circulation was similar between controls and all RA groups, irrespective of treatment, but double negative (DN) IgD-CD27- memory B cells were significantly increased in ERA and established RA when compared to controls. Treatment with TNF-inhibitors and tocilizumab restored the frequency of IgD-CD27- B-cells to normal levels, but did not affect other B cell subpopulations. TACI, CD95, CD5, HLA-DR and TLR9 expression on B-cells significantly increased after treatment with either TNF-inhibitors and/ or tocilizumab, but no significant changes were observed in BAFF-R, BCMA, CD69, CD86, CXCR5, CD23, CD38 and IgM expression on B-cells when comparing baseline with post-treatment follow-ups. Alterations in B-cell gene expression of BAFF-R, TACI, TLR9, FcγRIIB, BCL-2, BLIMP-1 and β2M were found in ERA and established RA patients, but no significant differences were observed after TNF-inhibitors and tocilizumab treatment when comparing baseline and follow-ups. Serum levels of CXCL13, sCD23 and BAFF were not significantly affected by treatment with TNF-inhibitors and tocilizumab.
In RA patients, the use of TNF-inhibitors and/ or tocilizumab treatment affects B-cell phenotype and IgD-CD27- memory B cells in circulation, but not B-cell gene expression levels.
Summary
Osteoporosis-related fractures lead to high morbidity, mortality, and healthcare costs among post-menopausal women. This study showed that incident non-hip osteoporosis-related fractures are ...frequent among women aged 50 + in Portugal, leading to excessive healthcare costs of €74 million per year, in a conservative scenario.
Purpose
This study aimed to estimate the costs of incident non-hip osteoporosis-related fractures among postmenopausal women living in Portugal from a payer perspective.
Methods
The study includes women ≥ 50 years old who participated in the baseline assessment (2011–2013) and the first follow-up wave (2013–2015) of the Epidemiology of Chronic Diseases cohort, a Portuguese community-based longitudinal prospective study (
n
= 2,762). Incident non-hip osteoporosis-related fractures were defined as any self-reported low impact non-hip fractures since baseline. Healthcare resource utilization during the year following fracture was obtained from an informal panel of experts. The amounts of resources used were multiplied by the national tariffs practiced in the National Health Service (NHS) to obtain the cost per patient in the year following a wrist, vertebral, or other site fracture, which was subsequently multiplied by the estimated annual number of incident fractures to obtain the total annual cost of incident non-hip osteoporosis-related fractures among postmenopausal women.
Results
Each year approximately 5,000 wrist, 3,500 vertebral, and 39,000 other-site osteoporosis-related fractures occur in women aged 50 + in Portugal. Healthcare costs per patient in the year following fracture vary from €2,709.52 for vertebral fractures to €3,096.35 for other fractures. Non-hip incident osteoporosis-related fractures among 50 + women cost approximately €74 million per year. Among all healthcare services, physiotherapy represents the bulk of costs.
Conclusions
This study pinpoints the relevance of preventing non-hip osteoporosis-related fractures, as these cost about €74 million per year in direct healthcare costs, a substantial impact on the budget of the Portuguese NHS.
We provide the first empirical exploration of disease-related innovation by patients and their caregivers. Our aims were to explore to what degree do patients develop innovative solutions; how many ...of these are unique developments; and do these solutions have positive perceived impact on the patients' overall quality of life? In addition, we explored the factors associated with patient innovation development, and sharing of the solutions that the patients developed.
We administered a questionnaire via telephone interviewing to a sample of 500 rare disease patients and caregivers. The solutions reported were pre-screened by the authors for their fit with the self-developed innovation aim of the study. All the reported solutions were then validated for their novelty by two medical professionals. Logistic regression models were used to test the relationships between our key variables, patient innovation and solution sharing.
263 (53%) of our survey respondents reported developing and using a solution to improve management of their diseases. An initial screening removed 81 (16%) solutions for being an obvious misfit to the self-developed innovation aim of the study. This lowered the sample of potentially innovative solutions to 182 (36%). Assessment of novelty and usefulness of the solutions, conducted by two medical evaluators, confirmed that 40 solutions (8%) were indeed novel, while the remaining 142 (28%) were already known to medicine. The likelihood of patient innovation increased as the education level increased (OR 2, p < 0.05), and as their perception of limitations imposed by their disease increased (OR 1.3, p < 0.05). 55 individuals diffused their solutions to some degree, with 50 of these sharing via direct diffusion to other patients. There is a positive relationship between the impact of a solution on the respondents' overall quality of life and likelihood of solution sharing.
Given that hundreds of millions of people worldwide are afflicted by rare diseases, patient and their caregivers can be a tremendous source of innovation for many who are similarly afflicted. Our findings suggest that many patients could be greatly assisted by improved diffusion of known solutions and best practices to and among patients and their caregivers.
Acute septic arthritis (SA) still remains a challenge with significant worldwide morbidity. In recent years, Kingella kingae has emerged and treatment regimens have become shorter. We aim to analyze ...trends in SA etiology and management and to identify risk factors for complications.
Longitudinal observational, single center study of children (<18 years old) with SA admitted to a tertiary care pediatric hospital, from 2003 to 2018, in 2 cohorts, before and after implementation of nucleic acid amplification assays (2014). Clinical, treatment and disease progression data were obtained.
A total of 247 children were identified, with an average annual incidence of 24.9/100,000, 57.9% males with a median age of 2 (1-6) years. In the last 5 years, a 1.7-fold increase in the annual incidence, a lower median age at diagnosis and an improved microbiologic yield (49%) was noticed. K. kingae became the most frequent bacteria (51.9%) followed by MSSA (19.2%) and S. pyogenes (9.6%). Children were more often treated for fewer intravenous days (10.7 vs. 13.2 days, P = 0.01) but had more complications (20.6% vs. 11.4%, P = 0.049) with a similar sequelae rate (3.7%). Risk factors for complications were C-reactive protein ≥80 mg/L and Staphylococcus aureus infection, and for sequelae at 6 months, age ≥4 years and CRP ≥ 80 mg/L.
The present study confirms that K. kingae was the most common causative organism of acute SA. There was a trend, although small, for decreasing antibiotic duration. Older children with high inflammatory parameters might be at higher risk of sequelae.
Abstract Background Low back pain (LBP) is a common health condition and the leading cause of years lived with disability worldwide. Most LBP episodes have a favourable prognosis, but recurrences ...within a year are common. Despite the individual and societal impact related to LBP recurrences, there is limited evidence on effective strategies for secondary prevention of LBP and successful implementation of intervention programmes in a real-world context. The aim of this study is to analyse the effectiveness of a tailored exercise and behavioural change programme (MyBack programme) in the secondary prevention of LBP; and evaluate acceptability, feasibility and determinants of implementation by the different stakeholders, as well as the implementation strategy of the MyBack programme in real context. Methods This protocol describes a hybrid type I, randomized controlled trial to evaluate the effectiveness and implementation of MyBack programme in the context of primary health care. The Behaviour Change Wheel framework and FITT-VP principles will inform the development of the behaviour change and exercise component of MyBack programme, respectively. Patients who have recently recovered from an episode of non-specific LBP will be randomly assigned to MyBack and usual care group or usual care group. The primary outcome will be the risk of LBP recurrence. The secondary outcomes will include disability, pain intensity, musculoskeletal health, and health-related quality of life. Participants will be followed monthly for 1 year. Costs data related to health care use and the MyBack programme will be also collected. Implementation outcomes will be assessed in parallel with the effectiveness study using qualitative methods (focus groups with participants and health providers) and quantitative data (study enrolment and participation data; participants adherence). Discussion To our knowledge, this is the first study assessing the effectiveness and implementation of a tailored exercise and behaviour change programme for prevention of LBP recurrences. Despite challenges related to hybrid design, it is expected that data on the effectiveness, cost-effectiveness, and implementation of the MyBack programme may contribute to improve health care in patients at risk of LBP recurrences, contributing to direct and indirect costs reduction for patients and the health system. Trial registration number NCT05841732.
Non-specific low back pain (NSLBP) is the most prevalent musculoskeletal condition in western countries and is associated with persistent disability and high consumption of health care resources. ...NSLBP patients first seek primary health care services but the outcomes are often uncertain. This study aimed to examine the clinical course of the outcomes and to identify prognostic indicators for poor outcomes in NSLBP patients who consulted primary care.
A prospective cohort study of 115 patients seeking treatment for NSLBP in primary care was conducted. Participants were consecutively recruited by their General Practitioners (GPs) and then assessed at baseline and 2 and 6 months later. Baseline assessment included socio-demographic and clinical data, psychosocial factors, pain, disability, and health related quality of life (HRQoL). Pain, disability, HRQoL and global perception of change were also assessed at 2 and 6-months' follow-up. In addition, information regarding the GP' practice was collected. Poor outcomes were determined according to the cut-off point used to define a persistent disabling condition and the minimal important change established for disability, pain and for global perception of change. The relationship between variables on baseline and poor outcomes was modulated through binary logistic regression analysis. The significance of associations was evaluated at ≤ 0.05 p-value with 95% confidence intervals (CI) and adjusted odds ratios (AOR).
110 (94.8%) and 104 (89.7%) participants completed the follow-up assessment at 2 and 6 months, respectively. The mean age (±SD) was 48.06 ± 11.41, with 53.9%, (N = 62) reporting an acute presentation of NSLBP. Six months after GP consultation, 53.8% (N = 56) of the participants reported a persistent disabling condition. An "LBP episode of less than 12 weeks" AOR: 0.26; 95% CI (0.10, 0.65); AOR: 0.34; 95% CI (0.14, 0.81); AOR: 0.21; 95% CI (0.09, 0.53),"maladaptive psychosocial factors" AOR: 2.06; 95% CI (1.40, 3.04); AOR: 1.82; 95% CI (1.27, 2.59); AOR: 1.72; 95% CI (1.20, 2.47) were significantly associated with poor outcomes on disability, pain and global perception of change, respectively. Besides these factors, being employed reduces the chances of poor outcomes on disability AOR 0.31; 95% CI (0.11, 0.92).
A large proportion of LBP patients seeking primary health care reported poor outcomes 6 months after GP consultation. Patients who report chronic LBP, maladaptive psychosocial factors and are unemployed have a significant increase in the risk of poor outcome. These findings suggest the need of implementing effective models of care able to provide early screening and appropriate treatment to those at greatest risk of a poor outcome.
Current Controlled Trials NCT04046874 (August 6, 2019). Retrospectively registered.
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