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Objectives To compare the effectiveness of oral versus intramuscular (IM) vitamin B12 (VB12) in patients aged ≥65 years with VB12 deficiency.Design Pragmatic, randomised, non-inferiority, multicentre trial in 22 primary healthcare centres in Madrid (Spain).Participants 283 patients ≥65 years with VB12 deficiency were randomly assigned to oral (n=140) or IM (n=143) treatment arm.Interventions The IM arm received 1 mg VB12 on alternate days in weeks 1–2, 1 mg/week in weeks 3–8 and 1 mg/month in weeks 9–52. The oral arm received 1 mg/day in weeks 1–8 and 1 mg/week in weeks 9–52.Main outcomes Serum VB12 concentration normalisation (≥211 pg/mL) at 8, 26 and 52 weeks. Non-inferiority would be declared if the difference between arms is 10% or less. Secondary outcomes included symptoms, adverse events, adherence to treatment, quality of life, patient preferences and satisfaction.Results The follow-up period (52 weeks) was completed by 229 patients (80.9%). At week 8, the percentage of patients in each arm who achieved normal B12 levels was well above 90%; the differences in this percentage between the oral and IM arm were −0.7% (133 out of 135 vs 129 out of 130; 95% CI: −3.2 to 1.8; p>0.999) by per-protocol (PPT) analysis and 4.8% (133 out of 140 vs 129 out of 143; 95% CI: −1.3 to 10.9; p=0.124) by intention-to-treat (ITT) analysis. At week 52, the percentage of patients who achieved normal B12 levels was 73.6% in the oral arm and 80.4% in the IM arm; these differences were −6.3% (103 out of 112 vs 115 out of 117; 95% CI: −11.9 to −0.1; p=0.025) and −6.8% (103 out of 140 vs 115 out of 143; 95% CI: −16.6 to 2.9; p=0.171), respectively. Factors affecting the success rate at week 52 were age, OR=0.95 (95% CI: 0.91 to 0.99) and having reached VB12 levels ≥281 pg/mL at week 8, OR=8.1 (95% CI: 2.4 to 27.3). Under a Bayesian framework, non-inferiority probabilities (Δ>−10%) at week 52 were 0.036 (PPT) and 0.060 (ITT). Quality of life and adverse effects were comparable across groups. 83.4% of patients preferred the oral route.Conclusions Oral administration was no less effective than IM administration at 8 weeks. Although differences were found between administration routes at week 52, the probability that the differences were below the non-inferiority threshold was very low.Trial registration numbers NCT 01476007; EUDRACT (2010-024129-20).

OBJECTIVE:Osteoarthritis of the lower limb (OALL) worsens health-related quality of life (HRQL), but this impact has not been quantified with standardized measures. We intend to evaluate the impact of OALL on HRQL through measures based on individual preferences in comparison to the general population. METHODS:A cross-sectional study was designed. A total of 6234 subjects aged 50 years or older without OALL were selected from the Spanish general population (National Health Survey 2011-12). An opportunistic sample of patients aged 50 years or older diagnosed with hip (n = 331) or knee osteoarthritis (n = 393), using the American Rheumatism Association criteria, was recruited from six hospitals and 21 primary care centers in Vizcaya, Madrid and Tenerife between January and December 2015. HRQL was measured with the EQ-5D-5L, and the results were transformed into utility scores. Sociodemographic variables (age, sex, social group, cohabitation), number of chronic diseases, and body mass index were considered. The clinical stage of OALL was collected using the Western Ontario and McMaster Universities Osteoarthritis Index and the Oxford hip score and Oxford knee score. Generalized linear models were constructed using the utility index as the dependent variable. RESULTS:HRQL expressed by OALL patients was significantly worse than this of the general population. After adjustment for sociodemographic and clinical characteristics, the mean utility loss was -0.347 (95% CI: -0.390, -0.303) for osteoarthritis of the hip and -0.295 (95% CI: -0.336, -0.255) for osteoarthritis of the knee. OALL patients who were treated at a hospital had an additional utility loss of -0.112 (95% CI: -0.158, -0.065). CONCLUSION:OALL has a great impact on HRQL. People with OALL perceive a utility loss of approximately 0.3 points compared to the general population without osteoarthritis, which is very high in relation to the utility loss reported for other chronic diseases and for arthritis in general.

Abstract Background Osteoarthritis (OA) of the hip is a disease that entails a major burden for patients and the society as a whole. One way of measuring this burden for the patient is through impact on Health-related Quality of Life (HRQL). The Oxford Hip Score (OHS) is a well-known tool to measure HRQL in patients with OA of the hip. This study aims to assess the psychometric properties of the Spanish-adapted version of the OHS, including its reliability, validity, and sensitivity to change. Methods Prospective observational study that included 361 patients diagnosed with hip OA (according to the criterion of the American College of Rheumatology) from 3 different Spanish regions. Their HRQL was assessed using a generic questionnaire, the EQ-5D-5 L, and two specific ones (the Western Ontario and McMaster Universities Osteoarthritis Index, WOMAC, and the OHS) adapted to Spanish. There was a follow-up period of 6 months, and the acceptability, psychometric properties, presence of ceiling and floor effects, validity, reliability, and sensitivity to changes of the OHS were measured. Results The OHS was fully answered in 99.4% of cases with no indication of ceiling or floor effects. Its factor structure can be explained in a single dimension. Its discriminative capacity was very good compared to the groups generated by the WOMAC and the EQ-5D-5 L. The correlation between the OHS and dimensions of the WOMAC or EQ-5D-5 L utilities was ≥0.7. Excellent test-retest reliability (ICC = 0.992; CI95%: 0.994–0.998) and internal consistency (Cronbach’s α = 0.928) were observed. The minimal clinically important difference (MCID) was 7.0 points, and the minimum detectable change (MDC) was 5.5 points. The effect size for moderate improvement in perceived HRQL was 0.73, similar to that of WOMAC dimensions and higher than the EQ-5D-5 L. Conclusions The Spanish-adapted version of the OHS is a useful, acceptable tool for the assessment of perceived HRQL in patients with hip OA, and has psychometric properties similar to those of the WOMAC that allow for discriminating both a patient’s condition at a given moment and changes that can occur over time.

Aim: To analyze worker burnout and the prevalence of psychiatric illness among primary care physicians, and to determine how burnout is related with sociodemographic and work-related factors., Design: Cross-sectional, descriptive study., Setting: Primary care centers in Area 8, Madrid (central Spain).Subjects. All 244 physicians (family medicine and pediatrics) who provided care at centers in Area 8 at the time of the study.Method. Anonymous, self-administered questionnaire that included the Maslach Burnout Inventory (worker burnout); GHQ-28 (possible mental illness); survey of sociodemographic and work-related factors, unhealthy behaviors, use of medications, and perceived quality of care and risk of medical errors in relation with work-related pressures; open question regarding causes of work-related stress., Results: Response rate, 80.3%. Burnout was detected in 69.2% of the physicians (95% CI, 62.1%-75.4%) and was severe in 12.3%. The prevalence of possible psychiatric illness was 36.7%. Burnout was found to be related with possible psychiatric illness (P<.01); perception that work-related pressures frequently led to diminished quality of care and medical errors (P<.o1); permanent employment status (P<.05); more than 1700 patients on the patient list (P<.05); age between 37 and 46 years (P<.01) and patient load of 35 to 47 patients/day (P<.05)., Conclusions: The prevalence of worker burnout and possible psychiatric illness was high, and the two variables were related. A large percentage of participants perceived that work-related pressures diminished the quality of care provided.

A study was made of the routes of transmission of HCV in 106 carrier patients and the prevalence of antibodies to HCV antigen (HCV Ab) in 132 family contacts (mothers, sexual partners and children of carrier women) attended at a Primary Care Center in Madrid. The following data were obtained through a personal interview: age, gender and possible routes of contagion. Also, ALT and serologic status to HBV. Household contacts were interviewed and HCV Ab status obtained. Only in 21 patients (19.8%) was no risk factor found ("sporadic cases"). Eighty-one individuals (76.4%) and 13 (12.3%) had percutaneous transmission and sexual transmission risk factors, respectively. Out of 18 studied mothers, two (11.1%) had HCV Ab. The prevalence of HCV Ab in household contacts was 8.35%. These results suggest that the proportion of sporadic cases decreases significantly when a thorough investigation is carried out in carrier patients. The percutaneous route is responsible for most of HCV infections. The prevalence of HCV Ab among household contacts appears to be higher than among general population.