Comparison of multimedia and printed patient education tools for patients with osteoporosis: a 6-month randomized controlled trial.

We conducted a randomized controlled trial to compare the efficacy of adding a video tool to a printed booklet on osteoporosis. Both strategies were effective in increasing knowledge and decreasing decisional conflict. There was no difference in the measured outcomes between the intervention and control groups. Patient preferences and learning styles are key factors in deciding a presentation format when educating patients with osteoporosis. INTRODUCTION: Innovative approaches to patient education about self-management in osteoporosis may improve outcomes. METHODS: We conducted a randomized controlled trial to compare the efficacy of adding a multimedia patient education tool involving video modeling to a printed educational booklet on osteoporosis. Participants were post-menopausal women with osteoporosis. We assessed osteoporosis knowledge, decisional conflict, self-efficacy, and effectiveness in disease management at baseline, immediately post-intervention, and at 3 and 6 months. Linear regression models were used to explore changes in outcomes at 6 months with respect to baseline characteristics. RESULTS: Two hundred and twenty-five women were randomized, 111 to receive the multimedia tool in addition to the booklet and 114 to receive the booklet alone. Knowledge and decisional conflict scores significantly improved in both groups at all post-intervention assessment points, but with no significant differences in score changes between the groups. Self-efficacy and disease management effectiveness showed no significant changes from baseline. In the entire cohort, younger age was associated with better effectiveness in disease management and Hispanic women had greater gains in knowledge at 6 months compared to White women. Women with limited health literacy who had received the multimedia tool in addition to the printed materials had higher decisional conflict than those who received printed materials alone. CONCLUSION: Both multimedia and printed tools increased knowledge and decreased decisional conflict to the same extent, neither of the educational materials proved to be better than the other. For women with limited health literacy, receiving the booklet alone was more effective in reducing decisional conflict after 6 months, than adding the multimedia tool.

Effect of beta-blockers on cancer recurrence and survival: a meta-analysis of epidemiological and perioperative studies.

BACKGROUND: The biological perturbation associated with psychological and surgical stress is implicated in cancer recurrence. Preclinical evidence suggests that beta-blockers can be protective against cancer progression. We undertook a meta-analysis of epidemiological and perioperative clinical studies to investigate the association between beta-blocker use and cancer recurrence (CR), disease-free survival (DFS), and overall survival (OS). METHODS: Databases were searched until September 2017, reported hazard ratios (HRs) pooled, and 95% confidence intervals (CIs) calculated. Comparative studies examining the effect of beta-blockers (selective and non-selective) on cancer outcomes were included. The Newcastle Ottawa Scale was used to assess methodological quality and bias. RESULTS: Of the 27 included studies, nine evaluated the incidental use of non-selective beta-blockers, and ten were perioperative studies. Beta-blocker use had no effect on CR. Within subgroups of cancer, melanoma was associated with improved DFS (HR 0.03, 95% CI 0.01-0.17) and OS (HR 0.04, 95% CI 0.00-0.38), while endometrial cancer had an associated reduction in DFS (HR 1.40, 95% CI 1.10-1.80) and OS (HR 1.50, 95% CI 1.12-2.00). There was also reduced OS seen with head and neck and prostate cancer. Non-selective beta-blocker use was associated with improved DFS and OS in ovarian cancer, improved DFS in melanoma, but reduced OS in lung cancer. Perioperative studies showed similar variable effects across cancer types, albeit from a limited data pool. CONCLUSION: Beta-blocker use had no evident effect on CR. The beneficial effect of beta-blockers on DFS and OS in the epidemiological or perioperative setting remains variable, tumour-specific, and of low-level evidence at present.

Risk of developing antiphospholipid antibodies following viral infection: a systematic review and meta-analysis.

Objective The objective of this paper is to conduct a systematic review and meta-analysis on the risk of developing elevated antiphospholipid (aPL) antibodies and related thromboembolic and/or pregnancy events following a viral infection. Method We searched Medline, EMBASE, Web of Science, PubMed ePubs, and Cochrane Central Register of Controlled Trials through June 2016. Independent observational studies of elevated aPL antibodies in patients with a viral infection compared with controls or patients with lupus were included. Results We analyzed 73 publications for 60 studies. Human immunodeficiency virus (HIV) and hepatitis C virus (HCV) were most commonly reported. Compared with healthy controls, patients with HIV were more likely to develop elevated anticardiolipin (aCL) antibodies (risk ratio (RR) 10.5, 95% confidence interval (CI) 5.6-19.4), as were those with HCV (RR 6.3, 95% CI 3.9-10.1), hepatitis B virus (HBV) (RR 4.2, 95% CI 1.8-9.5), and Epstein-Barr virus (EBV) (RR 10.9 95% CI 5.4-22.2). The only statistically significant increased risk for anti-ß2-glycoprotein I (anti-ß2-GPI) antibodies was observed in patients with HCV (RR 4.8 95% CI 1.0-22.3). Compared with patients with lupus, patients with HIV were more likely to develop elevated aCL antibodies (RR 1.8, 95% CI 1.3-2.6), and those with EBV, elevated anti-ß2-GPI antibodies (RR 2.2, 95% CI 1.3-3.9). Thromboembolic events were most prevalent in patients with elevated aPL antibodies who had HCV (9.1%, 95% CI 3.0-18.1), and HBV (5.9%, 95% CI 2.0-11.9) infections, and pregnancy events were most prevalent in those with parvovirus B19 (16.3%, 95% CI 0.78-45.7). However, compared to virus-infected patients with negative aPL antibodies, the only statistically significant increased risk was observed in those with HCV and positive aPL. Conclusions Viral infection can increase the risk of developing elevated aPL antibodies and associated thromboembolic events. Results are contingent on the reported information.

Systematic review: cost-effectiveness of direct-acting antivirals for treatment of hepatitis C genotypes 2-6.

BACKGROUND: The availability of direct-acting antivirals (DAAs) has dramatically changed the landscape of hepatitis C virus (HCV) therapy; however, the cost and budget requirements for DAA treatment have been widely debated. AIMS: To systematically review published studies evaluating the cost-effectiveness of DAAs for HCV genotype 2-6 infections, and synthesise and re-evaluate results with updated drug prices. METHODS: We conducted a systematic search of various electronic databases, including Medline, EMBASE, Cochrane library and EconLit for cost-effectiveness studies published from 2011 to 2016. Studies evaluating DAAs for genotypes 2-6 were included. Reported costs, quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratios (ICERs) were abstracted. We re-estimated ICERs by varying the price of DAAs from $20 000 to $100 000, and estimated the threshold price at which DAA regimens would be deemed cost-effective (ICER≤$100 000/QALY). RESULTS: A total of 92 ICERs for 7 different DAA regimens from 10 published articles were included. Among the abstracted 92 ICERs, 20 were for genotype 2, 40 for genotype 3, 30 for genotype 4, 2 for genotype 5 and none for genotype 6; therefore, only genotypes 2-5 were analysed. At the discounted price of $40 000, 87.0% analyses found DAA regiments to be cost-effective, and 7.6% found to be cost-saving. The median threshold price below which DAAs would be deemed cost-effective was between $144 400 and $225 000, and cost-saving between $17 300 and $25 400. CONCLUSIONS: HCV treatment with DAAs is highly cost-effective in patients with HCV genotypes 2-5 at a $100 000/QALY threshold. Timely HCV treatment would be an optimal strategy from both a public health and economic perspective.

Prevention and treatment of bone loss and fractures in patients undergoing a hematopoietic stem cell transplant: a systematic review and meta-analysis.

The most effective method to prevent and treat bone loss following hematopoietic stem cell transplantation (HSCT) remains uncertain. We conducted a comprehensive search in four electronic databases until August 2015. We retrieved articles describing patients with bone loss or fractures who received HSCT. Controlled trials, with a follow-up period of at least 12 months, were included. Twelve studies (19 publications) met our inclusion criteria. A total of 643 participants underwent HSCT (85.7% allogeneic HSCT). There was a statistically significant lower mean bone mineral density (g/cm2) percentage change of the lumbar spine (mean difference (MD) 7.8, 95% confidence interval (CI) 5.6-10.0) and femoral neck (MD 6.7, 95% CI 5.6-7.9) in the bisphosphonate therapy group compared with the control group with no bisphosphonate therapy at 12 months. In a subgroup analysis, seven different comparison groups were evaluated. The rate of fractures or X-ray findings of subclinical vertebral fractures was similar between groups. Bisphosphonates are promising in the prevention and treatment of bone loss following HSCT. Additional research is required to determine whether they reduce long-term fracture risk.

Systematic review of case reports of antiphospholipid syndrome following infection.

OBJECTIVE: The objective of this study was to conduct a systematic review of case reports documenting the development of antiphospholipid syndrome or antiphospholipid syndrome-related features after an infection. METHODS: We searched Medline, EMBASE, Web of Science, PubMed ePubs, and The Cochrane Library - CENTRAL through March 2015 without restrictions. Studies reporting cases of antiphospholipid syndrome or antiphospholipid syndrome-related features following an infection were included. RESULTS: Two hundred and fifty-nine publications met inclusion criteria, reporting on 293 cases. Three different groups of patients were identified; group 1 included patients who fulfilled the criteria for definitive antiphospholipid syndrome (24.6%), group 2 included patients who developed transient antiphospholipid antibodies with thromboembolic phenomena (43.7%), and group 3 included patients who developed transient antiphospholipid antibodies without thromboembolic events (31.7%). The most common preceding infection was viral (55.6%). In cases that developed thromboembolic events Human immunodeficiency and Hepatitis C viruses were the most frequently reported. Parvovirus B19 was the most common in cases that developed antibodies without thromboembolic events. Hematological manifestations and peripheral thrombosis were the most common clinical manifestations. Positive anticardiolipin antibodies were the most frequent antibodies reported, primarily coexisting IgG and IgM isotypes. Few patients in groups 1 and 2 had persistent antiphospholipid antibodies for more than 6 months. Outcome was variable with some cases reporting persistent antiphospholipid syndrome features and others achieving complete resolution of clinical events. CONCLUSIONS: Development of antiphospholipid antibodies with all traditional manifestations of antiphospholipid syndrome were observed after variety of infections, most frequently after chronic viral infections with Human immunodeficiency and Hepatitis C. The causal relationship between infection and antiphospholipid syndrome cannot be established, but the possible contribution of various infections in the pathogenesis of antiphospholipid syndrome need further longitudinal and controlled studies to establish the incidence, and better quantify the risk and the outcomes of antiphospholipid-related events after infection.

Multi-language translation and cross-cultural adaptation of the OARSI/OMERACT measure of intermittent and constant osteoarthritis pain (ICOAP).

AIM: To conduct a multi-language translation and cross-cultural adaptation of the Intermittent and Constant OsteoArthritis Pain (ICOAP) questionnaire for hip and knee osteoarthritis (OA). METHODS: The questionnaires were translated and cross-culturally adapted in parallel, using a common protocol, into the following languages: Czech, Dutch, French (France), German, Italian, Norwegian, Spanish (Castillan), North and Central American Spanish, Swedish. The process was conducted following five steps: (1)--independent translation into the target language by two or three persons; (2)--consensus meeting to obtain a single preliminary translated version; (3)--backward translation by an independent bilingual native English speaker, blinded to the English original version; (4)--final version produced by a multidisciplinary consensus committee; (5)--pre-testing of the final version with 10-20 target-language-native hip and knee OA patients. RESULTS: The process could be followed and completed in all countries. Only slight differences were identified in the structure of the sentences between the original and the translated versions. A large majority of the patients felt that the questionnaire was easy to understand and complete. Only a few minor criticisms were expressed. Moreover, a majority of patients found the concepts of constant pain and pain that comes and goes to be of a great pertinence and were very happy with the distinction. CONCLUSION: The ICOAP questionnaire is now available for multi-center international studies.

Comparative evaluation of three semi-quantitative radiographic grading techniques for knee osteoarthritis in terms of validity and reproducibility in 1759 X-rays: report of the OARSI-OMERACT task force.

OBJECTIVE: The objective of this work was to compare the measurement properties of three categorical X-ray scoring methods of knee osteoarthritis (OA), both on semiflexed and extended views. METHODS: In data obtained from trials and cohorts, X-rays were graded using Kellgren and Lawrence (KL), the OA Research Society International (OARSI) joint space narrowing score, and measurement of joint space width (JSW). JSW was analyzed as a categorical variable. Construct validity was assessed through logistic regression between X-ray stages and Western Ontario and McMaster Universities OA Index. Inter-observer reliability was assessed in 50 subjects for extended views by weighted kappa. Intra-observer reliability and sensitivity to change were assessed separately for extended and semiflexed views in 50 patients who had both views performed, over a 30-month interval, by weighted kappa and standardized response mean (SRM). RESULTS: Extended views were available from three trials and two cohorts (1759 X-rays), including one trial in which both extended and semiflexed views (antero-posterior) were obtained. Correlation with clinical parameters was low for the three scoring methods, except for the single community-based cohort. Inter-rater reliability was higher for categorical JSW in extended views (kappa, 0.86 vs 0.56 and 0.48 for KL and OARSI, respectively). Intra-rater reliability was higher for categorical JSW, both in extended views (0.83 vs 0.61 and 0.71) and in semiflexed views (0.89 vs 0.50 and 0.67). Sensitivity to change was also higher for categorical JSW, particularly in semiflexed views (SRM, 0.49 vs 0.22 and 0.34). CONCLUSION: These results indicate categorical JSW, in particular on semiflexed views, may be the preferred method to evaluate structural severity in knee OA clinical trials.

Developing guidelines in musculoskeletal disorders.

Clinical practice guidelines (CPGs) are systematically developed statements to assist practitioners and patients on healthcare decisions. They provide recommendations for the average patient, which should take into account individual clinical judgment and the patient's values and expectations. Quality benchmarks differ from CPGs in that they are best practices that are medically necessary under almost all circumstances, and constitute a standard by which quality of care can be measured. Scientifically rigorous CPGs should be evidence-based and evolve from multidisciplinary and systematic development processes. To maximize their validity, the available evidence must be graded according to its methodological quality and the strength of the recommendations should be based on these ratings. We conducted a systematic review of the literature and relevant websites, which identified 276 CPGs for the diagnosis and/or treatment of musculoskeletal disorders. Of these, 61 were retrieved from 3 sources: 1) the American College of Rheumatology (ACR); 2) the European League against Rheumatism (EULAR); and 3) musculoskeletal CPGs retrieved from the National Guideline Clearinghouse. While use of scientific evidence was commonly cited in the discussion, methodological information was often lacking, without specification as to whether the evidence had been systematically reviewed and graded. We also observed substantial overlap between organizations in the development of CPGs for a given disease.CPGs can improve quality of care by providing evidence-based recommendations. However, it is imperative that they be developed with the utmost transparency, and using a careful and systematic appraisal of the totality of evidence, with recommendations graded according a systematic approach to avoid bias. While many CPGs exist in the rheumatology field, the consensus processes followed in their development is not always explicit, leading to limitations in their interpretations that can hamper broader acceptance and adoption.

Factors associated with hyperhomocysteinaemia in Mexican patients with rheumatoid arthritis.

BACKGROUND: Hyperhomocysteinaemia is a factor related to the development of atherosclerosis in rheumatoid arthritis (RA). However, Hispanics with RA develop high rates of coronary disease; there are no studies about the frequency and factors related to high levels of homocysteine in Mexican patients. OBJECTIVE: To evaluate the prevalence and characteristics associated with hyperhomocysteinaemia in Mexican patients with RA. METHODS: One hundred and fifty-two patients with RA were compared with 153 controls. The assessment in RA included clinical characteristics, disease activity (RADAR), functioning (HAQ-Di and global functional status), comorbidity, and radiological damage. Laboratory determinations included total serum homocysteine (tHcy), erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), rheumatoid factor (RF), and lipid profile. RESULTS: Median levels of homocysteine were higher in RA compared with controls (11.3 vs. 9.3, p<0.001). Twenty per cent of the patients with RA had hyperhomocysteinaemia (>15 micromol/L) compared with 6% in controls (p<0.001). There was statistical association between hyperhomocysteinaemia in RA with male gender (p<0.001), impairment in the global functional status (p = 0.004), higher radiological damage (p = 0.001), and CRP (p = 0.04). There was no association with RADAR, HAQ-Di, or RF, methotrexate dose or duration of use. In the adjusted multivariate model, the two variables associated with higher risk for hyperhomocysteinaemia were male gender (OR = 4.2, 95% CI 2 to 12, p = 0.006) and higher radiological damage (III-IV) (OR = 3.4, 95% CI 1.3 to 9, p = 0.01). CONCLUSIONS: Our data show a high prevalence of hyperhomocysteinaemia in Mexican patients with RA. More effort is required to evaluate and treat earlier this coronary risk factor.

[Patterns of health care in an out patient rheumatologic clinic]. / La atención médica en reumatología en un hospital de segundo nivel de atención.

INTRODUCTION: Studies evaluating the pattern of diseases evaluated by rheumatology services are required to improve the planning of healthcare resource distribution. AIM: To describe the pattern of diseases motivating consultations in an outpatient clinic of a secondary care center in Guadalajara, Mexico. MATERIAL AND METHODS: A cross-sectional, descriptive study was performed. Data on the diseases evaluated in the rheumatology service and other healthcare indicators were obtained through a search of the hospital's computerized database. The number of initial and repeat consultations, their distribution by age and sex, the mean monthly number of prescriptions, and other indicators of performance were identified. RESULTS: There were 5,790 consultations in 1 year (26% were initial visits). The three most frequent diseases were: rheumatoid arthritis (47.1%, 95% CI 46-48%), systemic lupus erythematosus (12.7%, 95% CI 12-14%), and ankylosing spondylitis (7.7%, 95% CI 7-8%). Four women were attended for each man. Consultations were most frequent in the group aged 30-59 years old. The mean number of consultations per rheumatologist/month was 242, with a mean of 2.5 prescriptions per patient. The rate of compliance with appointments was 85%. A mean of 7.5 were diagnosed with temporary work disability for each rheumatologist/month. CONCLUSIONS: The most prevalent disorders in our outpatient rheumatology clinic were inflammatory joint diseases and systemic autoimmune diseases. These disorders required a high proportion of health-care resource. Further studies are required to evaluate the costs of these resources with the aim of establising better strategies for the health care needs in these patients.