Patient-reported outcome measures in severe asthma: an expert consensus.

OBJECTIVE: The study aimed to reach a consensus on the most relevant patient-reported outcomes (PROs), the corresponding measures (PROMs), and measurement frequency during severe asthma patient follow-up. METHODS: Two Delphi rounds were conducted. The questionnaire was developed based on a systematic literature review, a focus group with patients, and a nominal group with experts. It assessed PROs' relevance and the appropriateness (A) and feasibility (F) of PROMs using a Likert scale (1=totally agree; 9=totally disagree). The consensus was established when ≥75% of participants agreed (1-3) or disagreed (7-9). RESULTS: Sixty-three professionals (25 hospital pharmacists, 14 allergists, 13 pulmonologists, and 11 nurses) and 5 patients answered the Delphi questionnaire. A consensus was reached on all PROs regarding their relevance. Experts agreed on the use of ACT (A:95.24%; F:95.24%), mini AQLQ (A:93.65; F:79.37%), mMRC dyspnea scale (A:85.71%; F:85.71%), TAI (A:92.06%; F:85.71%), MMAS (A:75.40%; F:82%), and the dispensing register (A:96.83%; F:92.06%). Also considered suitable were: SNOT-22 (A:90.48%; F:73.80%), PSQI (A:82.54; F:63.90%), HADS (A:82.54; F:64%), WPAI (A:77.78%; F:49.20%), TSQM-9 (A:79.37; F:70.50%) and knowledge of asthma questionnaire (A:77%; F:68.80%); however, their use in clinical practice was considered unfeasible. Panelists also agreed on the appropriateness of EQ-5D, which was finally included despite being considered unfeasible (A: 84.13%; F:67.20%) in clinical practice. Agreement was reached on using ACT, TAI, mMRC, and a dispensing register every three months; mini-AQLQ and MMAS every six months; and EQ-5D every twelve months. CONCLUSION: This consensus paves the way toward patient-centered care, promoting the development of strategies supporting routine assessment of PROs in severe asthma management.

Cytokine profiles in cord blood in relation to prenatal traffic-related air pollution: The NELA cohort.

BACKGROUND: Outdoor air pollution may disturb immune system development. We investigated whether gestational exposure to traffic-related air pollutants (TRAP) is associated with unstimulated cytokine profiles in newborns. METHODS: Data come from 235 newborns of the NELA cohort. Innate response-related cytokines (IL-6, IFN-α, IL1-ß, and TNF-α), Th1-related (IFN-γ and IL-2), Th2-related (IL-4, IL-5, and IL-13), Th17-related (IL-17 and IL-23), and immunomodulatory cytokine IL-10 were quantified in the supernatant of unstimulated whole umbilical cord blood cells after 7 days of culture using the Luminex technology. Dispersion/chemical transport modeling was used to estimate long-term (whole pregnancy and trimesters) and short-term (15 days before delivery) residential exposures to traffic-related nitrogen dioxide (NO2 ), particulate matter (PM2.5 and PM10 ), and ozone (O3 ). We fitted multivariable logistic regression, Bayesian kernel machine regression (BKMR), and weighted quantile sum (WQS) regression models. RESULTS: NO2 during the whole pregnancy increased the odds of detection of IL-1ß (OR per 10 µg/m3 increase = 1.37; 95% CI, 1.02, 1.85) and IL-6 (OR per 10 µg/m3 increase = 1.32; 95% CI 1.00, 1.75). Increased odds of detected concentrations of IL-10 was found in newborns exposed during whole pregnancy to higher levels of NO2 (OR per 10 µg/m3 increase = 1.30; 95% CI 0.99, 1.69), PM10 (OR per 10 µg/m3 increase = 1.49; 95% CI 0.95, 2.33), and PM2.5 (OR per 5 µg/m3 increase = 1.56; 95% CI 0.97, 2.51). Exposure to O3 during the whole pregnancy increased the odds of detected IL-13 (OR per 10 µg/m3 increase = 1.22; 95% CI 1.01, 1.49). WQS model revealed first and third trimesters of gestation as windows of higher susceptibility. CONCLUSIONS: Gestational exposure to TRAP may increase detection of pro-inflammatory, Th2-related, and T regulatory cytokines in newborns. These changes might influence immune system responses later in life.

Air pollution from traffic during pregnancy impairs newborn's cord blood immune cells: The NELA cohort.

BACKGROUND: Hazards of traffic-related air pollution (TRAP) on the developing immune system are poorly understood. We sought to investigate the effects of prenatal exposure to TRAP on cord blood immune cell distributions; and to identify gestational windows of susceptibility. METHODS: In-depth immunophenotyping of cord blood leukocyte and lymphocyte subsets was performed by flow cytometry in 190 newborns embedded in the Nutrition in Early Life and Asthma (NELA) birth cohort (2015-2018). Long-term (whole pregnancy and trimesters) and short-term (15-days before delivery) residential exposures to traffic-related nitrogen dioxide (NO2), particulate matter (PM2.5 and PM10), and ozone (O3) were estimated using dispersion/chemical transport modelling. Associations between TRAP concentrations and cord blood immune cell counts were assessed using multivariate Poisson regression models. RESULTS: Mean number of natural killer (NK) cells decreased 15% in relation to higher NO2 concentrations (≥36.4 µg/m3) during whole pregnancy (incidence relative risk (IRR), 0.85; 95% CI, 0.72, 0.99), with stronger associations in the first trimester. Higher PM2.5 concentrations (≥13.3 µg/m3) during whole pregnancy associated with a reduced mean number of cytotoxic T cells (IRR, 0.88; 95% CI, 0.78, 0.99). Newborns exposed to higher PM10 (≥23.6 µg/m3) and PM2.5 concentrations during the first and third trimester showed greater mean number of helper T type 1 (Th1) cells (P < 0.05). Decreased number of regulatory T (Treg) cells was associated with greater short-term NO2 (IRR, 0.90; 95% CI, 0.80, 1.01) and PM10 (IRR, 0.88; 95% CI, 0.77, 0.99) concentrations. CONCLUSIONS: Prenatal exposure to TRAP, particularly in early and late gestation, impairs fetal immune system development through disturbances in cord blood leukocyte and lymphocyte distributions.

Efficacy and efficiency of a new therapeutic approach based on activity-oriented proprioceptive antiedema therapy (TAPA) for edema reduction and improved occupational performance in the rehabilitation of breast cancer-related arm lymphedema in women: a controlled, randomized clinical trial.

BACKGROUND: Breast cancer (BC) is a major public health issue. More than one out of five women treated for breast cancer will develop lymphedema in an upper extremity. Current evidence advocates transdisciplinary oncological rehabilitation. Therefore, research in this area is necessary since limited consensus having been reached with regard to the basic essential components of this rehabilitation. Consensus has, however, been reached on the use of decongestive lymphedema therapy (DLT), but due to a lack of tests, the necessary dosages are unknown and its level is moderately strong. This study attempts to verify both the efficacy of activity-oriented proprioceptive antiedema therapy (TAPA), as compared to conventional treatments such as DLT or Complex Physical Therapy (CPT), as well as its efficiency in terms of cost-effectiveness, for patients affected by breast cancer-related arm lymphedema. METHODS: Controlled, randomized clinical trial with dual stratification, two parallel arms, longitudinal and single blind. 64 women with breast cancer-related arm lymphedema will take part in the study. The experimental group intervention will be the same for stage I and II, and will consist of neuro-dynamic exercises oriented to the activity, proprioceptive neuromuscular facilitation activities and proprioceptive anti-edema bandaging. The control group intervention, depending on the stage, will consist of preventive measures, skin care and exercise-prescribed training in the lymphedema workshop as well as compression garments (Stage I) or conservative Complex Decongestive Therapy treatment (skin care, multi-layer bandaging, manual lymphatic drainage and massage therapy) (Stage II). RESULTS: Sociodemographic and clinical variables will be collected for the measurement of edema volume and ADL performance. Statistical analysis will be performed on intent to treat. DISCUSSION: It has been recommended that patient training be added to DLT, as well as a re-designing of patient lifestyles and the promotion of health-related aspects. In addition, clinical trials should be undertaken to assess neural mobilization techniques and proprioceptive neuromuscular facilitation should be included in the therapy. Cohesive bandaging will also be performed as an early form of pressotherapy. The proposed study combines all of these aspects in order to increased comfort and promote the participation of individuals with lymphedema in everyday situations. LIMITATIONS: The authors have proposed the assessment of the experimental treatment for stages I and II. One possible limitation is the lack of awareness of whether or not this treatment would be effective for other stages as well as the concern for proper hand cleansing during use of bandages, given the current COVID-19 pandemic situation. TRIAL REGISTRATION: This trial was registered in ClinicalTrials.gov ( NCT03762044 ). Date of registration: 23 November 2018. Prospectively Registered.

A personalized intervention to prevent depression in primary care: cost-effectiveness study nested into a clustered randomized trial.

BACKGROUND: Depression is viewed as a major and increasing public health issue, as it causes high distress in the people experiencing it and considerable financial costs to society. Efforts are being made to reduce this burden by preventing depression. A critical component of this strategy is the ability to assess the individual level and profile of risk for the development of major depression. This paper presents the cost-effectiveness of a personalized intervention based on the risk of developing depression carried out in primary care, compared with usual care. METHODS: Cost-effectiveness analyses are nested within a multicentre, clustered, randomized controlled trial of a personalized intervention to prevent depression. The study was carried out in 70 primary care centres from seven cities in Spain. Two general practitioners (GPs) were randomly sampled from those prepared to participate in each centre (i.e. 140 GPs), and 3326 participants consented and were eligible to participate. The intervention included the GP communicating to the patient his/her individual risk for depression and personal risk factors and the construction by both GPs and patients of a psychosocial programme tailored to prevent depression. In addition, GPs carried out measures to activate and empower the patients, who also received a leaflet about preventing depression. GPs were trained in a 10- to 15-h workshop. Costs were measured from a societal and National Health care perspective. Qualityadjustedlife years were assessed using the EuroQOL five dimensions questionnaire. The time horizon was 18 months. RESULTS: With a willingness-to-pay threshold of €10,000 (£8568) the probability of cost-effectiveness oscillated from 83% (societal perspective) to 89% (health perspective). If the threshold was increased to €30,000 (£25,704), the probability of being considered cost-effective was 94% (societal perspective) and 96%, respectively (health perspective). The sensitivity analysis confirmed these results. CONCLUSIONS: Compared with usual care, an intervention based on personal predictors of risk of depression implemented by GPs is a cost-effective strategy to prevent depression. This type of personalized intervention in primary care should be further developed and evaluated. TRIAL REGISTRATION: ClinicalTrials.gov, NCT01151982. Registered on June 29, 2010.

Intervention to Prevent Major Depression in Primary Care: A Cluster Randomized Trial.

BACKGROUND: Not enough is known about universal prevention of depression in adults. OBJECTIVE: To evaluate the effectiveness of an intervention to prevent major depression. DESIGN: Multicenter, cluster randomized trial with sites randomly assigned to usual care or an intervention. (ClinicalTrials.gov: NCT01151982). SETTING: 10 primary care centers in each of 7 cities in Spain. PARTICIPANTS: Two primary care physicians (PCPs) and 5236 nondepressed adult patients were randomly sampled from each center; 3326 patients consented and were eligible to participate. INTERVENTION: For each patient, PCPs communicated individual risk for depression and personal predictors of risk and developed a psychosocial program tailored to prevent depression. MEASUREMENTS: New cases of major depression, assessed every 6 months for 18 months. RESULTS: At 18 months, 7.39% of patients in the intervention group (95% CI, 5.85% to 8.95%) developed major depression compared with 9.40% in the control (usual care) group (CI, 7.89% to 10.92%) (absolute difference, -2.01 percentage points [CI, -4.18 to 0.16 percentage points]; P = 0.070). Depression incidence was lower in the intervention centers in 5 cities and similar between intervention and control centers in 2 cities. LIMITATION: Potential self-selection bias due to nonconsenting patients. CONCLUSION: Compared with usual care, an intervention based on personal predictors of risk for depression implemented by PCPs provided a modest but nonsignificant reduction in the incidence of major depression. Additional study of this approach may be warranted. PRIMARY FUNDING SOURCE: Institute of Health Carlos III.

'Management multiple myeloma during pregnancy: a case report and review'.

Multiple myeloma (MM) is a hematologic neoplasm characterized by plasma tumor cell proliferation in the bone marrow. It's a rare malignancy before a 40-year-old and it is extremely uncommon during pregnancy. We report the case of a 37-year-old woman with a newly diagnosed IgG λ MM (Durie-Salmon stage IIIA, International Staging System II and good prognosis cytogenetic) at the 27th week of her pregnancy. Our management during pregnancy, the delivery, and initiation of anti-myeloma treatment with bortezomib, lenalidomide, and dexamethasone are published. There are a few reviews reporting the most common features and management of MM during pregnancy. We perform a comprehensive review of all 32 cases reported between 1965 and 2014 in which a MM was diagnosed during pregnancy including score, cytogenetic results, labor characteristics, and response to therapy. About 53% of pregnant women did not start treatment before partum. Cesarean section was the most common form of delivery (82%). About 88% of newborns were healthy, although most of them were premature (73%). Management of a MM diagnosed during pregnancy should be based on the presence of myeloma-related organ damage to secure survival of the mother without fetal adverse effects related to treatment. Serial fetal ultrasound may be helpful in order to avoid complications. The cesarean section may be preferred depending on maternal and fetus prognosis. Whole-body diffusion-weighted imaging minimal response could be an appropriate technique to discard plasmacytomas during pregnancy in critical situations such as the appearance of symptoms of spinal cord compression. Therapeutic choices should be agreed with the pregnant after a thorough discussion of the prognostic factors of the disease and the potential risk for the fetus and the patient. While awaiting partum, dexamethasone is a non-toxic treatment. Triple therapy including a proteasome inhibitor should be started quickly after delivery. Copyright © 2014 John Wiley & Sons, Ltd.

Concomitant administration of seasonal influenza and COVID-19 mRNA vaccines.

Current clinical guidelines support the concomitant administration of seasonal influenza vaccines and COVID-19 mRNA boosters vaccine. Whether dual vaccination may impact vaccine immunogenicity due to an interference between influenza or SARS-CoV-2 antigens is unknown. We aimed to understand the impact of mRNA COVID-19 vaccines administered concomitantly on the immune response to influenza vaccines. For this, 128 volunteers were vaccinated during the 22-23 influenza season. Three groups of vaccination were assembled: FLU vaccine only (46, 35%) versus volunteers that received the mRNA bivalent COVID-19 vaccines concomitantly to seasonal influenza vaccines, FluCOVID vaccine in the same arm (42, 33%) or different arm (40, 31%), respectively. Sera and whole blood were obtained the day of vaccination, +7, and +28 days after for antibody and T cells response quantification. As expected, side effects were increased in individuals who received the FluCOVID vaccine as compared to FLU vaccine only based on the known reactogenicity of mRNA vaccines. In general, antibody levels were high at 4 weeks post-vaccination and differences were found only for the H3N2 virus when administered in different arms compared to the other groups at day 28 post-vaccination. Additionally, our data showed that subjects that received the FluCOVID vaccine in different arm tended to have better antibody induction than those receiving FLU vaccines for H3N2 virus in the absence of pre-existing immunity. Furthermore, no notable differences in the influenza-specific cellular immune response were found for any of the vaccination groups. Our data supports the concomitant administration of seasonal influenza and mRNA COVID-19 vaccines.

Myofascial trigger points, pain, disability, and sleep quality in patients with chronic nonspecific low back pain.

OBJECTIVE: To investigate the difference in the presence of trigger points (TrPs) between patients with chronic nonspecific low back pain (LBP) and healthy people, and to determine the relationship of TrPs with the intensity of ongoing pain, disability, and sleep quality. DESIGN: A cross-sectional study. SETTING: The role of TrPs in LBP has not been determined. PATIENTS: Forty-two patients with nonspecific LBP (50% women), aged 23-55 years old, and 42 age- and sex-matched controls participated. OUTCOME MEASURES: TrPs were bilaterally explored within the quadratus lumborum, iliocostalis lumborum, psoas, piriformis, gluteus minimus, and gluteus medius muscles in a blinded design. TrPs were considered active if the subject recognized the local and referred pain as familiar symptoms, and TrPs were considered latent if the pain was not recognized as a familiar symptom. Pain measures were collected with a numerical pain rate scale, disability was assessed with the Roland-Morris questionnaire, and sleep quality was determined with the Pittsburgh Sleep Quality Index. RESULTS: Patients with nonspecific LBP exhibited a greater disability and worse sleep quality than healthy controls (P < 0.001). Patients with nonspecific LBP exhibited a mean of 3.5 ± 2.3 active TrPs. Further, patients with nonspecific LBP showed a greater (P < 0.001) number of latent TrPs (mean: 2.0 ± 1.5) than healthy controls (mean: 1.0 ± 1.5). Active TrPs in the quadratus lumborum, iliocostalis lumborum, and gluteus medius muscles were the most prevalent in patients with nonspecific LBP. A greater number of active TrPs was associated with higher pain intensity (rs = 0.602; P < 0.001) and worse sleep quality (rs = 0.338; P = 0.03). CONCLUSIONS: The local and referred pain elicited by active TrPs in the back and hip muscles contributes to pain symptoms in nonspecific LBP. Patients had higher disability and worse sleep quality than controls. The number of active TrPs was associated with pain intensity and sleep quality. It is possible that a complex interaction among these factors is present in patients with nonspecific LBP.

Preventing the onset of major depression based on the level and profile of risk of primary care attendees: protocol of a cluster randomised trial (the predictD-CCRT study).

BACKGROUND: The 'predictD algorithm' provides an estimate of the level and profile of risk of the onset of major depression in primary care attendees. This gives us the opportunity to develop interventions to prevent depression in a personalized way. We aim to evaluate the effectiveness, cost-effectiveness and cost-utility of a new intervention, personalized and implemented by family physicians (FPs), to prevent the onset of episodes of major depression. METHODS/DESIGN: This is a multicenter randomized controlled trial (RCT), with cluster assignment by health center and two parallel arms. Two interventions will be applied by FPs, usual care versus the new intervention predictD-CCRT. The latter has four components: a training workshop for FPs; communicating the level and profile of risk of depression; building up a tailored bio-psycho-family-social intervention by FPs to prevent depression; offering a booklet to prevent depression; and activating and empowering patients. We will recruit a systematic random sample of 3286 non-depressed adult patients (1643 in each trial arm), nested in 140 FPs and 70 health centers from 7 Spanish cities. All patients will be evaluated at baseline, 6, 12 and 18 months. The level and profile of risk of depression will be communicated to patients by the FPs in the intervention practices at baseline, 6 and 12 months. Our primary outcome will be the cumulative incidence of major depression (measured by CIDI each 6 months) over 18 months of follow-up. Secondary outcomes will be health-related quality of life (SF-12 and EuroQol), and measurements of cost-effectiveness and cost-utility. The inferences will be made at patient level. We shall undertake an intention-to-treat effectiveness analysis and will handle missing data using multiple imputations. We will perform multi-level logistic regressions and will adjust for the probability of the onset of major depression at 12 months measured at baseline as well as for unbalanced variables if appropriate. The economic evaluation will be approached from two perspectives, societal and health system. DISCUSSION: To our knowledge, this will be the first RCT of universal primary prevention for depression in adults and the first to test a personalized intervention implemented by FPs. We discuss possible biases as well as other limitations. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01151982.

Deglufarm: Mobile application with recommendations for safety drug administration in patients with dysphagia or deglution disorders. / Deglufarm: aplicación móvil con recomendaciones para la administración segura de medicamentos en pacientes con disfagia o problemas de deglución.

OBJECTIVE: Develop an App to use in healthcare practice, with updated and accurate information on the handling of medications in patients with dysphagia or deglution disorders, as well as their compatibility with food and thickeners. METHODS: The development of the Deglufarm® App was based on the CRONOS, Nutrition and Techno working groups of the Sociedad Española de Farmacia Hospitalaria. A group of specialist pharmacists was created from different care areas for patients with dysphagia. The creation of Deglufarm® consisted of several stages: Selection of active drugs, literature review, content development, design (an expert company in App design was contacted), testing, launch, content update and follow-up. RESULTS: Deglufarm® is available for Android and IOS free of charge from July 2022. It has been tested among the members of the research group and collaborators, currently, 540 monographs of active drugs have been reviewed and registered in Deglufarm. The first version is aimed at healthcare professionals. CONCLUSIONS: Deglufarm® is an easy tool to consult, with the most current evidence on handling the medicines it contains.

[Translated article] Deglufarm: Mobile application with recommendations for the safe administration of drugs in patients with dysphagia or swallowing disorders.

OBJECTIVE: Develop an App to use in healthcare practice, with updated and accurate information on the handling of medications in patients with dysphagia or deglution disorders, as well as their compatibility with food and thickeners. METHODS: The development of the Deglufarm® App was based on the CRONOS, Nutrition and Techno working groups of the Sociedad Española de Farmacia Hospitalaria. A group of specialist pharmacists was created from different care areas for patients with dysphagia. The creation of Deglufarm® consisted of several stages: selection of active drugs, literature review, content development, design (an expert company in App design was contacted), testing, launch, content update and follow-up. RESULTS: Deglufarm® is available for Android and IOS free of charge from July 2022. It has been tested among the members of the research group and collaborators, Currently, 540 monographs of active drugs have been reviewed and registered in Deglufarm. The first version is aimed at healthcare professionals. CONCLUSIONS: Deglufarm® is an easy tool to consult, with the most current evidence on handling the medicines it contains.

[Spanish version of the STOPP/START 3 criteria: Advances in the detection of inappropriate prescribing medication in the older people]. / Versión en español de los criterios STOPP/START 3. Avances en la detección de la prescripción inapropiada de medicamentos en personas mayores.

The STOPP/START criteria are explicit physiologic systems-based criteria that summarize evidence on clinically relevant prescribing problems related to the use of potentially inappropriate medications (STOPP criteria) and potential prescribing omissions (START criteria). The two previous versions of the STOPP/START criteria were published in 2008 and 2015, and their Spanish versions in 2009 and 2015. Version3 of these criteria has just been published in 2023. The aim of this article is to present the Spanish translated version, and to review the use and impact that version2 of 2015 has had in our language. A translation from English to Spanish was performed by expert professionals with a high level of English of version3 of the STOPP/START criteria, which incorporates the evidence published from April 2014 to March 2022. In addition, a systematic review of publications that have used the Spanish translation of the previous version (version2 of 2015) of the STOPP/START criteria was performed. The new version, presented in this article, has 190 STOPP/START criteria (133 STOPP criteria and 57 START criteria), which is a 40% increase in the number of criteria compared to the previous version. The review found 37 studies (21 observational, 11 interventional and 5 other) that used the Spanish version instead of the international version. The Spanish version 3 of the STOPP/START criteria is an updated explicit list of potentially inappropriate medications and possible omissions in prescribing that aims to optimize medication and minimize adverse drug reactions during medication review in the elderly, particularly those with multimorbidity and polypharmacy. With this new version, the original criteria are intended to be more widely disseminated within the Spanish-speaking healthcare community. The Spanish version2 of the STOPP/START has been widely used, so we consider that the translation into Spanish has helped to improve pharmacotherapy in older patients with polypharmacy and multimorbidity in our linguistic environment.

Optimisation of the quality of care for patients with severe asthma: ASfarMA project.

Severe asthma has an important impact on patients and healthcare resources. Recently, the new specific treatments have defined a new scenario in which person-focused care and specialist multidisciplinary teams are necessary. Our Severe Asthma Unit (SAU) started the ASfarMA project along with an external human-centered design company to understand patients' vision of their illness, treatment, and healthcare experience, and to define the ideal SAU by performing a core group session, in-depth semistructured interviews and co-creation workshop. Herein, a series of tips classified as either 'transformative solutions' or 'quick wins', according to a value versus effort matrix are presented. Successful implementation of the proposed solutions will be valuable for patients and healthcare professionals, optimising patient care and resources. These findings can also be helpful to other SAUs or other humanisation projects involving complex, chronic and multidisciplinary pathologies.

Myofascial trigger points, pain, disability, and sleep quality in individuals with mechanical neck pain.

OBJECTIVE: The purpose of this study was to investigate the presence of active myofascial trigger points (MTrPs) in a greater number of muscles than previous studies and the relation between the presence of MTrPs, the intensity of pain, disability, and sleep quality in mechanical neck pain. METHODS: Fifteen patients with mechanical neck pain (80% women) and 12 comparable controls participated. Myofascial trigger points were bilaterally explored in the upper trapezius, splenius capitis, semispinalis capitis, sternocleidomastoid, levator scapulae, and scalene muscles in a blinded design. Myofascial trigger points were considered active if the subject recognized the elicited referred pain as a familiar symptom. Myofascial trigger points were considered latent if the elicited referred pain was not recognized as a symptom. Pain was collected with a numerical pain rate scale (0-10); disability was assessed with Neck Disability Index; and sleep quality, with the Pittsburgh Sleep Quality Index. RESULTS: Patients exhibited a greater disability and worse sleep quality than controls (P < .001). The Pittsburgh Sleep Quality Index score was associated with the worst intensity of pain (r = 0.589; P = .021) and disability (r = 0.552; P = .033). Patients showed a greater (P = .002) number of active MTrPs (mean, 2 ± 2) and similar number (P = .505) of latent MTrPs (1.6 ± 1.4) than controls (latent MTrPs, 1.3 ± 1.4). No significant association between the number of latent or active MTrPs and pain, disability, or sleep quality was found. CONCLUSIONS: The referred pain elicited by active MTrPs in the neck and shoulder muscles contributed to symptoms in mechanical neck pain. Patients exhibited higher disability and worse sleep quality than controls. Sleep quality was associated with pain intensity and disability. No association between active MTrPs and the intensity of pain, disability, or sleep quality was found.

Activity-Oriented Antiedema Proprioceptive Therapy (TAPA) for Shoulder Mobility Improvement in Women with Upper Limb Lymphedema Secondary to Breast Cancer: A Multicenter Controlled Clinical Trial.

BACKGROUND: Lymphedema, secondary to breast cancer (BCRL), is the abnormal accumulation of protein-rich fluid in the interstitium caused by a malfunction of the lymphatic system. It causes swelling, deficiencies in upper limb functions and structures, sensory pain and emotional alterations, which have a chronic course and affect the upper limb's functionality. This study aims to verify the efficacy and efficiency in the upper limb´s functionality of a protocolized experimental approach based on occupational therapy, TAPA (activity-oriented proprioceptive antiedema therapy), in the rehabilitation of BCRL in stages I and II, comparing it with the conservative treatment considered as the standard, complex decongestive therapy (CDT), through a multicenter randomized clinical trial. METHODS: a randomized and prospective clinical trial was conducted with experimental and control groups. Women diagnosed with BCRL belonging to institutions in Córdoba and Aragon (Spain) participated. Sociodemographic variables and those related to the functionality of the affected upper limb were evaluated before and after the intervention. RESULTS: The results showed statistically significant differences in the analysis of covariance performed for the variable joint balance of the shoulder´s external rotation (p = 0.045) that could be attributed to the intervention performed; however, the effect size was minimal (η2 ≤ 0.080). In the rest of the variables, no significant differences were found. CONCLUSIONS: TAPA may be an alternative to the conservative treatment of women with BCRL. It was shown to be just as effective for volume reduction and activity performance as CDT but more effective in improving external rotation in shoulder joint balance.

Impact of Activity-Oriented Propioceptive Antiedema Therapy on the Health-Related Quality of Life of Women with Upper-Limb Lymphedema Secondary to Breast Cancer-A Randomized Clinical Trial.

BACKGROUND: Alterations derived from lymphedema in the upper-limb secondary to breast cancer-related lymphedema (BCRL) decrease the health-related quality of life (HRQoL), but there is limited evidence of the impact of the different interventions on it. The aim of this research was to compare the effect of conventional treatment with another treatment based on Activity-Oriented Antiedema Proprioceptive Therapy (TAPA) on HRQoL in women diagnosed with BCRL. METHODS: A prospective clinical study was designed with two parallel arms. The study population consisted of women diagnosed with BCRL in stage I and II, belonging to different institutions in Córdoba and Aragon, Spain. Sociodemographic and HRQoL-related variables, pain, tightness, heaviness and functionality were obtained before and after treatments. RESULTS: 51 women participated in the study, 25 received the conventional treatment and 26 the TAPA, with a mean age of 59.24 ± 9.55 years. HRQoL was significantly related to upper-limb function and pain on the participants' affected side. In addition, covariance analysis (ANCOVA) showed that the TAPA treatment interfered less in the performance of activities of daily life and produced significant improvements in the social dimension of HRQoL. CONCLUSIONS: the non-use of compressive elements in the rehabilitative treatment of the BCRL that is proposed with TAPA improves aspects such as self-image and participation in social and recreational activities.

Intervention study for the reduction of medication errors in elderly trauma patients.

OBJECTIVE: To analyse the impact of a set of measures designed by a working group to reduce medication errors (MEs) during the care transition of elderly trauma patients. The secondary objectives were to classify MEs and determine their location. METHODS: A 43-month pre-post prospective intervention study in a university hospital. A working group was set up in the Trauma Service. A pharmacist analysed the pharmacotherapeutic processes of all patients admitted to the Trauma Service in different healthcare locations from Monday to Friday. To detect MEs, the pharmacist reviewed this process at the following points: reconciliation, prescription, validation, dispensing, and administration records. Errors were classified according to the Ruiz Jarabo classification. Subsequently, the working group designed a set of measures that were implemented with the incorporation into the Acute Care Team and the intervention of a pharmacist. Data on MEs were again collected in a post-implementation phase. RESULTS: There was a statistically significant reduction in MEs between phases. A total of 132 (31.3%) patients experienced MEs during the pre-implementation phase and 75 (16.2%) during the post-implementation phase. Among the measures implemented, the incorporation of the pharmacist to the team, as well as training sessions and design of medication protocols. During the pre-implementation and post-implementation phases, the ME rates were respectively as follows: reconciliation 31.6% (172) vs 14.8% (91); prescription 7.7% (79) vs 1.9% (23); dispensing 1% (10) vs 0.3% (3); administration record 0.4% (4) vs 0.0% (0); and validation 0.3% (3) vs 0.1% (1). There were significant reductions in reconciliation, prescription, and dispensing errors. The majority of the MEs occurred in the Trauma Service. CONCLUSIONS: The implementation of specific measures by a Multidisciplinary Safety Group reduced MEs in the care transition of elderly trauma patients, particularly those MEs that occurred during reconciliation. The greatest reduction in MEs occurred in the Trauma Service.

Seriousness of medication reconciliation errors in patients of advanced age in the emergency department. / Gravedad de los errores de conciliación producidos en el servicio de urgencias en pacientes ancianos.

OBJECTIVES: To analyze the seriousness of medication reconciliation errors (MREs) in the treatment of older patients admitted to an emergency department's acute geriatric unit. To identify and describe discrepancies, including the drug groups involved, and to explore risk factors. MATERIAL AND METHODS: Prospective, observational 6-month study. A pharmacist recorded medications in each patient's history and compared the patient's usual treatment to the regimen prescribed in the emergency department; discrepancies were flagged for evaluation as possible MREs. A geriatric medicine specialist evaluated MRE seriousness. RESULTS: Three hundred twenty-eight discrepancies were detected (93.8% of the total of 351 patients); 151 patients (43.02%) had at least 1 MRE. Three hundred MREs were identified, 248 (82.7%) reached the patient, and 27 (9%) caused reversible injury. No errors led to prolonged injury or death. CONCLUSION: MREs were common but not serious, and the injuries caused were reversible.

OBJETIVO: Analizar la gravedad de los errores de conciliación (EC) producidos en el servicio de urgencias (SU) en pacientes que ingresan en una unidad de agudos de geriatría. Cuantificar y describir las discrepancias y los EC. Analizar los grupos farmacológicos y los factores de riesgo. METODO: Estudio observacional prospectivo. Un farmacéutico realizó la historia farmacoterapéutica y comparó el tratamiento habitual con el prescrito en el SU, identificó discrepancias y posibles EC y un geriatra evaluó su gravedad. RESULTADOS: Se incluyeron 351 pacientes, de los que 328 (93,8%) presentaron discrepancias, 151 pacientes (43,02%) presentaron al menos 1 EC. Se observaron 300 EC de los que 248 (82,7%) alcanzaron al paciente, y 27 EC (9%) produjeron daño reversible. No hubo ningún error que causase daño prolongado o mortal. CONCLUSIONES: Los EC fueron frecuentes pero de escasa gravedad, y los daños que ocasionaron fueron reversibles.

High-activity variants of the uMAOA polymorphism increase the risk for depression in a large primary care sample.

Studies on the association between the functional uMAOA polymorphism and depression have yielded non-conclusive results up till now. One thousand two hundred twenty eight consecutive Spanish primary care attendees, participating in the PREDICT study, agreed to take part in this genetic PREDICT-Gene study. We explored the association between depression and either high-activity uMAOA alleles or genotypes. Depression was diagnosed using the Composite International Diagnostic Interview (CIDI) to establish three different depressive outcomes (ICD-10 Depressive Episode (DE), ICD-10 Severe Depressive Episode (SDE) and DSM-IV Major Depression (MD)). uMAOA genetic variation was determined by PCR amplification and subsequent electrophoresis. Crude and adjusted (gender and/or age) odds ratios, with 95% confidence intervals, were calculated for the associations between allele or genotype frequencies and all three depressive outcomes. We found associations between all three depressive phenotypes and either high-activity alleles or high-activity genotypes in both sexes. The associations were statistically significant for females but not for males. Testing the same associations on the entire sample (males and females) also yielded significant associations between depression and either high-activity alleles or high-activity genotype distribution that were independent of age and/or gender (ICD-10 DE: OR = 1.98; 95% CI: 1.42-1.77; P = 0.00002; ICD-10-SDE: OR = 2.05; 95% CI: 1.38-3.05; P = 0.0002; DSM-IV MD: OR = 1.91; 95% CI: (1.26-2.91); P = 0.0014). Our results provide fairly consistent evidence that high-activity variants of the MAOA promoter polymorphism confer a modestly higher risk for depression.