Engaging patients in designing a transmural allied health pathway: A qualitative exploration of hospital-to-home transitions.

INTRODUCTION: The transition from hospital to home is often suboptimal, resulting in patients not receiving the necessary allied healthcare after discharge. This may, in turn, lead to delayed recovery, a higher number of readmissions, more emergency department visits and an increase in mortality and healthcare costs. This study aimed to gain insight into patients' experiences, perceptions, and needs regarding hospital-to-home transition, focusing on allied healthcare as a first step towards the development of a transitional integrated allied healthcare pathway for patients with complex care needs after hospital discharge. METHODS: We conducted semistructured interviews with patients. Participants were recruited from universities and general hospitals in the Amsterdam region between May and July 2023. They were eligible if they (1) were discharged from the hospital minimally 3 and maximally 12 months after admission to an oncologic surgery department, internal medicine department, intensive care unit, or trauma centre, (2) received hospital-based care from at least one allied healthcare provider, who visited the patient at least twice during hospital admission, (3) spoke Dutch or English and (4) were 18 years or older. Interviews were audio-recorded and transcribed verbatim. We performed a thematic analysis of the interview data. RESULTS: Nineteen patients were interviewed. Three themes emerged from the analysis. 'Allied healthcare support during transition' depicts patients' positive experiences when they felt supported by allied health professionals during the hospital-to-home transition. 'Patient and family involvement' illustrates how much patients value the involvement of their family members during discharge planning. 'Information recall and processing' portrays the challenges of understanding and remembering overwhelming amounts of information, sometimes unclear and provided at the wrong moment. Overall, patients' experiences of transitional care were positive when they were involved in the discharge process. Negative experiences occurred when their preferences for postdischarge communication were ignored. CONCLUSIONS: This study suggests that allied health professionals need to continuously collaborate and communicate with each other to provide patients and their families with the personalized support they need. To provide high-quality and person-centred care, it is essential to consider how, when, and what information to provide to patients and their families to allow them to contribute to their recovery actively. PATIENT OR PUBLIC CONTRIBUTION: The interview guide for this manuscript was developed with the assistance of patients, who reviewed it and provided us with feedback. Furthermore, patients provided us with their valuable lived experiences by participating in the interviews conducted for this study.

Inspiratory muscle training for mechanically ventilated patients in the intensive care unit: Obstacles and facilitators for implementation. A mixed method quality improvement study.

BACKGROUND: Mechanically ventilated patients are at risk of developing inspiratory muscle weakness (IMW), which is associated with failure to wean and poor outcomes. Inspiratory muscle training (IMT) is a recommended intervention during and after extubation but has not been widely adopted in Dutch intensive care units (ICUs). OBJECTIVES: The objective of this study was to explore the potential, barriers, and facilitators for implementing IMT as treatment modality for mechanically ventilated patients. METHODS: This mixed-method, proof-of-concept study was conducted in a large academic hospital in the Netherlands. An evidence-based protocol for assessing IMW and training was applied to patients ventilated for ≥24 h in the ICU during an 8-month period in 2021. Quantitative data on completed measurements and interventions during and after ICU-stay were collected retrospectively and were analysed descriptively. Qualitative data were collected through semistructured interviews with physiotherapists executing the new protocol. Interview data were transcribed and thematically analysed. FINDINGS: Of the 301 screened patients, 11.6% (n = 35) met the inclusion criteria. Measurements were possible in 94.3% of the participants, and IMW was found in 78.8% of the participants. Ninety-six percent started training in the ICU, and 88.5% continued training after transfer to the ward. Follow-up measurements were achieved in 73.1% of the patients with respiratory muscle weakness. Twelve therapists were interviewed, of whom 41.7% regularly worked in the ICU. When exploring reasons for protocol deviation, three themes emerged: "professional barriers", "external factors", and "patient barriers". CONCLUSIONS: Implementation of measurements of and interventions for IMW showed to be challenging in this single centre study. Clinicians' willingness to change their handling was related to beliefs regarding usefulness, effectiveness, and availability of time and material. We recommend that hospitals aiming to implement IMT during or after ventilator weaning consider these professional and organisational barriers for implementation of novel, evidence-based interventions into daily clinical practice.

Recommendations for an exercise intervention and core outcome set for older patients after hospital discharge: Results of an international Delphi study.

For older adults, acute hospitalization is a high-risk event with poor health outcomes, including functional decline. In absence of practical guidelines and high quality randomized controlled trials, this Delphi study was conducted. The aim of this study was to obtain consensus on an exercise intervention program, a core outcome set (COS) and handover information to prevent functional decline or restore physical function in acutely hospitalized older patients transitioning from hospital to home. An internal panel of experts in the field of exercise interventions for acutely hospitalized older adults were invited to join the study. In the Delphi study, relevant topics were recognized, statements were formulated and ranked on a 9-point Likert scale in two additional rounds. To reaching consensus, a score of 7-9 was classified as essential. Results were expressed as median and semi-interquartile range (SIQR), and consensus threshold was set at SIQR≤0.5. Fifteen international experts from eight countries participated in the panel. The response rate was 93%, 93% and 80% for the three rounds respectively. After three rounds, consensus was reached on 167 of the 185 (90.3%) statements, of which ninety-five (51.4%) were ranked as essential (median Likert-score ≥7.0, SIQR ≤0.5). This Delphi study provides starting points for developing an exercise intervention, a COS and handover information. The results of this Delphi study can assist physical therapists to provide a tailored exercise intervention for older patients with complex care needs after hospital discharge, to prevent functional decline and/or restore physical function.

Telerehabilitation Delivery in Canada and the Netherlands: Results of a Survey Study.

BACKGROUND: Following the onset of the COVID-19 pandemic, telerehabilitation (TR) has been expanding to address the challenges and risks of in-person delivery. It is likely that a level of TR delivery will continue after the pandemic because of its advantages, such as reducing geographical barriers to service. Many pandemic-related TR initiatives were put in place quickly. Therefore, we have little understanding of current TR delivery, barriers and facilitators, and how therapists anticipate integrating TR into current practice. Knowing this information will allow the incorporation of competencies specifically related to the use and provision of TR into professional profiles and entry-to-practice education, thereby promoting high-quality TR care. OBJECTIVE: This study aimed to obtain a descriptive overview of current TR practice among rehabilitation therapists in Canada and the Netherlands and identify perceived barriers to and facilitators of practice. METHODS: A web-based cross-sectional survey was conducted with occupational, physical, and respiratory therapists and dietitians in Canada (in French and English) and the Netherlands (in Dutch and English) between November 2021 and March 2022. Recruitment was conducted through advertisements on social media platforms and email invitations facilitated by regulatory and professional bodies. The survey included demographic and practice setting information; whether respondents delivered TR, and if so, components of delivery; confidence and satisfaction ratings with delivery; and barriers to and facilitators of use. TR satisfaction and uptake were measured using the Telehealth Usability Questionnaire and modified Technology Acceptance Model. Data were first summarized descriptively, and then, comparisons were conducted between professions. RESULTS: Overall, 723 survey responses were received, mostly from Canada (n=666, 92.1%) and occupational therapists (n=434, 60%). Only 28.1% (203/723) reported receiving specific training in TR, with 1.2% (9/723) indicating that it was part of their professional education. Approximately 19.5% (139/712) reported not using TR at all, whereas most participants (366/712, 51.4%) had been using this approach for 1 to 2 years. Services delivered were primarily teleconsultation and teletreatment with individuals. Respondents offering TR were moderately satisfied with their service delivery and found it to be effective; 90.1% (498/553) indicated that they were likely to continue offering TR after the pandemic. Technology access, confidence, and setup were rated the highest as facilitators, whereas technology issues and the clinical need for physical contact were the most common barriers. CONCLUSIONS: Professional practice and experience with TR were similar in both countries, suggesting the potential for common strategic approaches. The high prevalence of current practice and strong indicators of TR uptake suggest that therapists are likely to continue TR delivery after the pandemic; however, most therapists (461/712, 64.7%) felt ill prepared for practice, and the need to target TR competencies during professional and postprofessional education is critical. Future studies should explore best practice for preparatory and continuing education.

Association between anticholinergic activity and xerostomia and/ or xerophthalmia in the elderly: systematic review.

PURPOSE: The aim of this work was to investigate the association between anticholinergic burden or anticholinergic drug use and xerostomia and/or xerophtalmia in elderly through a systematic review of the published literature. METHODS: A search was carried out in 3 databases (CINAHL, Embase and Pubmed). Studies conducted in people ≥65 years of age, who took anticholinergic medications, and measured the association between the anticholinergic burden or the use of these medications with the prevalence of xerostomia and / or xerophthalmia, published up to August 2022, were selected. Studies published in languages other than Spanish and/or English were excluded. RESULTS: One thousand two hundred eleven articles were identified, 10 were selected for this review: six cross-sectional studies, two cohorts, one case-control and one randomized controlled clinical trial. A total of 3535 patients included in the different studies were studied. The most used scales were the Anticholinergic Drug Scale (ADS) and the Anticholinergic Risk Scale (ARS). Four articles studied the relationship between the use of anticholinergic medication and the prevalence of xerostomia and / or xerophthalmia, finding a positive relationship with xerostomia in all of them. Another 6 measured the relationship between anticholinergic burden and xerostomia and / or xerophthalmia. Four found a positive relationship between anticholinergic burden and xerostomia and/or xerophthalmia. CONCLUSIONS: Our findings suggest a clear relationship between the use of anticholinergic drugs or anticholinergic burden and the presence of xerostomia. This relationship was less conclusive in the case of xerophthalmia.

Feasibility of a home-based interdisciplinary rehabilitation program for patients with Post-Intensive Care Syndrome: the REACH study.

BACKGROUND: Survivors of critical illness experience long-term functional challenges, which are complex, heterogeneous, and multifactorial in nature. Although the importance of rehabilitation interventions after intensive care unit (ICU) discharge is universally recognized, evidence on feasibility and effectiveness of home-based rehabilitation programs is scarce and ambiguous. This study investigates the feasibility of an interdisciplinary rehabilitation program designed for patients with Post-Intensive Care Syndrome (PICS) who are discharged home. METHODS: A mixed method, non-randomized, prospective pilot feasibility study was performed with a 6-month follow-up, comparing the intervention (REACH) with usual care. REACH was provided by trained professionals and included a patient-centered, interdisciplinary approach starting directly after hospital discharge. Primary outcomes were patient safety, satisfaction, adherence, referral need and health care usage. Secondary outcomes, measured at 3 timepoints, were functional exercise capacity, self-perceived health status, health-related quality of life (HRQoL), return to work and psychotrauma. Risk of undernutrition was assessed at baseline. RESULTS: 43 patients with a median mechanical ventilation duration of 8 (IQR:10) days, were included in the study and 79.1% completed 6-month follow-up. 19 patients received the intervention, 23 received usual care. Groups were similar for gender distribution and ICU length of stay. No adverse events occurred. REACH participants showed higher satisfaction with treatment and reported more allied health professional visits, while the usual care group reported more visits to medical specialists. Qualitative analysis identified positive experiences among REACH-professionals related to providing state-of-the-art interventions and sharing knowledge and expertise within an interprofessional network. Similar recovery was seen between groups on all secondary outcomes, but neither group reached reference values for HRQoL at 6 months. Larger return to work rates were seen in the REACH group. Prevalence of undernutrition at hospital discharge was high in both groups (> 80%), warranting the need for careful tuning of physical therapy and nutritional interventions. CONCLUSIONS: This study shows that providing early, home-based rehabilitation interventions for patients with PICS-related symptoms is feasible and perceived positively by patients and professionals. When provided in an interdisciplinary collaborative network state of the art, person-centered interventions can be tailored to individual needs potentially increasing patient satisfaction, adherence, and efficacy. Registered in the Dutch Trial register: NL7792: https://www.trialregister.nl/trial/7792 , registered 7-06-2019.

[Failure mode effect analysis for safety improvement in the automatic drug dispensing systems]. / Aplicación de un análisis modal de fallos y efectos para la mejora de la seguridad en la utilización de los sistemas automatizados de dispensación de medicamentos.

OBJECTIVE: To identify the risks in automated dispensing cabinet use in order to improve routine procedure safety. METHODS: We used the Failure Mode Effect Analysis (FMEA) methodology. A multidisciplinary team identified potential failure modes of the procedure through a brainstorming session. We assessed the impact associated with each failure mode with the Risk Priority Number (RPN), which involves three variables: occurrence, severity, and detectability. Improvement measures were established for failure modes with RPN>100 considered critical. The final RPN (theoretical) that would result from the proposed measures was also calculated. RESULTS: The process was divided into five sub-processes: automatic delivery of order replacement, to prepare order in a pyramidal cart, transport of the pyramidal cart from the pharmacy service to the automated dispensing cabinet, replacement of the automated dispensing cabinet by the pharmacy technician and dispensing/returning by nursing staff. Twenty-two failure modes, with 25 cases and with varying effects (severity 2-8) were evaluated. The sub-process with more failure modes with NPR>100 was dispensing/returning by nursing staff. CONCLUSIONS: The FMEA methodology was a useful tool when applied to automated dispensing cabinet system use. The implementation of improvement actions significantly reduced the risk.

Performance of prediction models for short term outcome in COVID-19 patients in the emergency department: a retrospective study

IntroductionCoronavirus disease 2019 (COVID-19) has a high burden on the healthcare system and demands information on the outcome early after admission to the emergency department (ED). Previously developed prediction models may assist in triaging patients when allocating healthcare resources. We aimed to assess the value of several prediction models when applied to COVID-19 patients in the ED. MethodsAll consecutive COVID-19 patients who visited the ED of a combined secondary/tertiary care center were included. Prediction models were selected based on their feasibility. The primary outcome was 30-day mortality, secondary outcomes were 14-day mortality, and a composite outcome of 30-day mortality and admission to the medium care unit (MCU) or the intensive care unit (ICU). The discriminatory performance of the prediction models was assessed using an area under the receiver operating characteristic curve (AUC). ResultsA total of 403 ED patients were diagnosed with COVID-19. Within 30 days, 95 patients died (23.6%), 14-day mortality was 19.1%. Forty-eight patients (11.9%) were admitted to the MCU, 66 patients (16.4%) to the ICU and 152 patients (37.7%) met the composite endpoint. Eleven models were included: RISE UP score, 4C mortality score, CURB-65, MEWS, REMS, abbMEDS, SOFA, APACHE II, CALL score, ACP index and Host risk factor score. The RISE UP score and 4C mortality score showed a very good discriminatory performance for 30-day mortality (AUC 0.83 and 0.84 respectively, 95% CI 0.79-0.88 for both), for 14-day mortality (AUC 0.83, 95% CI: 0.79-0.88, for both) and for the composite outcome (AUC 0.79 and 0.77 respectively, 95% CI 0.75-0.84). The discriminatory performance of the RISE UP score and 4C mortality score was significantly higher compared to that of the other models. ConclusionThe RISE UP score and 4C mortality score have good discriminatory performance in predicting adverse outcome in ED patients with COVID-19. These prediction models can be used to recognize patients at high risk for short-term poor outcome and may assist in guiding clinical decision-making and allocating healthcare resources.

Validating the RISE UP score for predicting prognosis in patients with COVID-19 in the emergency department, a retrospective study

ObjectiveTo mitigate the burden of COVID-19 on the healthcare system, information on the prognosis of the disease is needed. The recently developed RISE UP score has very good discriminatory value with respect to short-term mortality in older patients in the emergency department (ED). It consists of six items: age, abnormal vital signs, albumin, blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and bilirubin. We hypothesized that the RISE UP score could have discriminatory value with regard to 30-day mortality in ED patients with COVID-19. SettingTwo EDs of the Zuyderland Medical Centre (MC), secondary care hospital in the Netherlands. ParticipantsThe study sample consisted of 642 adult ED patients diagnosed with COVID-19 between March 3rd until May 25th 2020. Inclusion criteria were: 1) admission to the hospital with symptoms suggestive of COVID-19, and 2) positive result of the polymerase chain reaction (PCR), or (very) high suspicion of COVID-19 according to the chest computed tomography (CT) scan. OutcomePrimary outcome was 30-day mortality, secondary outcome was a composite of 30-day mortality and admission to intensive care unit (ICU). ResultsWithin 30 days after presentation, 167 patients (26.0%) died and 102 patients (15.9%) were admitted to ICU. The RISE UP score showed good discriminatory value with respect to 30-day mortality (AUC 0.77, 95% CI 0.73-0.81), and to the composite outcome (AUC 0.72, 95% CI 0.68-0.76). Patients with RISE UP scores below 10% (121 patients) had favourable outcome (0% mortality and 5% ICU admissions). Patients with a RISE UP score above 30% (221 patients) were at high risk of adverse outcome (46.6% mortality and 19% ICU admissions). ConclusionThe RISE UP score is an accurate prognostic model for adverse outcome in ED patients with COVID-19. It can be used to identify patients at risk of short-term adverse outcome, and may help guiding decision-making and allocating healthcare resources.

Preparing undergraduate students for clinical work in a complex environment: evaluation of an e-learning module on physiotherapy in the intensive care unit.

BACKGROUND: Intensive Care Units (ICUs) are daunting environments for physiotherapy (PT) students performing clinical rotations. To prepare students for this environment, a newly developed, evidence-based e-learning module was designed and implemented in the undergraduate curriculum. The aim of this study was to investigate whether e-learning is a feasible method in preparing PT students for clinical work in complex ICU environments, as perceived by students and experts. METHODS: A mixed methods proof of concept study was undertaken. Participants were final-year students of an international curriculum, and experts from didactic and clinical fields. An e-learning module consisting of 7 separate chapters based on the latest scientific evidence and clinical expertise was developed, piloted and incorporated into the undergraduate curriculum as a compulsory course to be completed prior to clinical ICU rotations. Data were collected through 3 focus group meetings and 5 semi-structured interviews; these meetings and interviews were audio recorded, transcribed verbatim and analyzed. RESULTS: The study sample comprised of 14 students and 5 experts. Thematic analysis revealed three themes: expected competencies of PT students in ICU, feeling prepared for ICU clinical work and dealing with local variety. The e-learning module enabled students to anticipate clinical situations and PT tasks in the ICU. Higher level clinical reasoning skills, handling of lines and wires and dealing with out-of-textbook situations could not be achieved with the e-learning module alone. CONCLUSIONS: An e-learning module can sufficiently prepare PT students for their clinical tasks in the ICU, as long as it is integrated with, or closely connected to, the students' clinical placement.

Physiotherapy treatment approaches for survivors of critical illness: a proposal from a Delphi study.

Purpose: The aim of this study was to develop practical recommendations for physiotherapy for survivors of critical illness after hospital discharge. Methods: A modified Delphi consensus study was performed. A scoping literature review formed the basis for three Delphi rounds. The first round was used to gather input from the panel to finalize the survey for the next two rounds in which the panel was asked to rank each of the statements on an ordinal scale with the objective to reach consensus. Consensus was defined as a SIQR of ≤ 0.5. Ten Dutch panelists participated in this study: three primary care physiotherapists, four intensive care physiotherapists, one occupational therapist, one ICU-nurse and one former ICU-patient. All involved professionals have treated survivors of critical illness. Our study was performed in parallel with an international Delphi study with hospital-based health-care professionals and researchers. Results: After three Delphi rounds, consensus was reached on 95.5% of the statements. This resulted in practical recommendations for physiotherapy for critical illness survivors in the primary care setting. The panel agreed that the handover should include information on 14 items. Physiotherapy treatment goals should be directed toward improvement of aerobic capacity, physical functioning, activities in daily living, muscle strength, respiratory and pulmonary function, fatigue, pain, and health-related quality of life. Physiotherapy measurements and interventions to improve these outcomes are suggested. Conclusion: This study adds to the knowledge on post-ICU physiotherapy with practical recommendations supporting clinical decision-making in the treatment of survivors of critical illness after hospital discharge.

Survivors of Critical Illness and Their Relatives. A Qualitative Study on Hospital Discharge Experience.

Rationale: To target rehabilitation needs of survivors of critical illness and their relatives in a timely and adequate manner, a thorough needs assessment is recommended when hospital discharge planning is initiated. In light of existing evidence on physical and psychological consequences of critical illness for patients and family, it is currently unclear if current hospital discharge procedures suffice to meet the needs of this group.Objectives: To explore hospital discharge experience and to identify perceived barriers and enablers for a positive transition experience from hospital to home or rehabilitation facility as perceived by survivors of critical illness and their families.Methods: We performed a grounded theory study with semi-structured interviews among a group of survivors of critical illness and their relatives (n = 35) discharged from 16 hospitals across the Netherlands. Interviews were audio recorded and transcribed verbatim. Using constant comparative methods, initial and focused coding was applied to the data, which were further labeled into major categories and subcategories, ultimately leading to the identification of key concepts. Triangulation was applied through several reflexivity meetings at different stages of the study.Results: Twenty-two former intensive care unit patients and 13 relatives were interviewed. The mean age was 53 (standard deviation ± 11.2) and 60% were female. Median intensive care unit and hospital length of stay were 14 days (interquartile range, 9.75-24.5) and 35 days (interquartile range, 21.75-57.25), respectively. Thematic analyses led to identification of seven key concepts, representing barriers and enablers to a positive transition experience. "Existing in a fragmented reality," "being overlooked," and "feeling disqualified" were identified barriers and "feeling empowered," "encountering empathic and expert professionals," "managing recovery expectations," and "family engagement" were identified as enablers for a positive perceived transition experience.Conclusions: Findings of this study suggest that current hospital discharge practice for survivors of critical illness is driven by speed and efficiency, rather than by individual needs assessments, despite advocacies for patient- and family-centered care. Discharge strategies should be customized to facilitate adequate and comprehensive assessment of aftercare needs, conducted at the right time and within the right context, encouraging empowerment and a positive perceived transition from hospital to home.

A novel heterozygous IGF-1 receptor mutation associated with hypoglycemia.

Mutation in the insulin-like growth factor-1 receptor (IGF1R) gene is a rare cause for intrauterine and postnatal growth disorders. Patients identified with IGF1R mutations present with either normal or impaired glucose tolerance. None of the cases described so far showed hypoglycemia. We aimed to identify the genetic basis for small for gestational age, short stature and hypoglycemia over three generations in one family. The proband, a 9-year-old male, presented in infancy with recurrent hypoglycemic episodes, symmetric intrauterine growth retardation and postnatal growth retardation. Blood DNA samples from the patient, his parents, a maternal sister and maternal grandmother underwent Sanger sequencing of the IGF1R gene. Primary skin fibroblast cultures of the patient, his mother and age- and sex-matched control donors were used for gene expression and receptor functional analyses. We found a novel heterozygous mutation (c.94 + 1g > a, D1105E) affecting the splicing site of the IGF1R mRNA in the patient, his mother and his grandmother. Primary fibroblast cultures derived from the patient and his mother showed reduced proliferation and impaired activation of the IGF1R, evident by reduced IGF1R and AKT phosphorylation upon ligand binding. In conclusion, the newly identified heterozygous missense mutation in exon 1 of IGF1R (D1105E) results in impaired IGF1R function and is associated with small for gestational age, microcephaly and abnormal glucose metabolism. Further studies are required to understand the mechanisms by which this mutation leads to hypoglycemia.

Utilización y efectividad de cinacalcet en pacientes con hiperparatiroidismo secundario sometidos a hemodiálisis / Use and effectiveness of cinacalcet in hemodialysis patients with secondary hyperparatiroidism

Objetivo: describir la efectividad y seguridad de cinacalcet en situaciones reales así como la identificación de factores que puedan interferir en la eficacia del tratamiento con cinacalcet. Método: estudio retrospectivo que evaluó el perfil de uso de cinacalcet durante 12 meses, en pacientes con hiperparatiroidismo secundario a insuficiencia renal crónica, durante el periodo de tiempo noviembre 2014 - marzo 2016. Se evaluó la eficacia de cinacalcet en un contexto real. Se valoró la incidencia de hipocalcemias como principal reacción adversa. Resultados: se estudiaron un total de 38 pacientes con hiperparatiroidismo secundario sometidos a hemodiálisis. A los 12 meses cinacalcet logró controlar la paratohormona intacta (PTHi) del 58% de los pacientes. Se observó que los pacientes con niveles de PTHi al inicio del tratamiento > 800 pg/dl tenían mayor dificultad en alcanzar niveles inferiores a 250 pg/dl. Los niveles de calcio, fósforo y producto fosfocálcico se normalizaron en la totalidad de los pacientes estudiados a partir del 3 mes de tratamiento. En cuanto al perfil de uso de cinacalcet, al tercer mes de tratamiento el 50% de los pacientes estaban infradosificados. Conclusiones: a pesar de que cinacalcet ha demostrado ser efectivo en la práctica real, el aumento de dosis según los niveles de PTHi no se realiza según las recomendaciones establecidas en la ficha técnica del medicamento. El seguimiento farmacoterapéutico de estos pacientes mejoraría los resultados de control de la PTHi y la efectividad del tratamiento (AU)

Objective: To describe the effectiveness and safety of cinacalcet in real situations and to identify factors that may interfere with the effectiveness of cinacalcet treatment. Method: It was carried out a retrospective study evaluating the usage profile of cinacalcet during 12 months in patients with secondary hyperparathyroidism to chronic renal failure during the time period November 2014 to March 2016. The efficacy of cinacalcet was evaluated in a real context. It was evaluated the incidence of hypocalcemias as the main adverse reaction. Results: A total of 38 hemodialysis patients with secondary hyperparathyroidism were studied. Over 12 months, cinacalcet was able to control PTHi in 58% of patients. Patients with PTH levels at baseline > 800 pg / dl had greater difficulty to reach levels below 250 pg / dl. The levels of calcium, phosphorus and phosphocalcic products were normalized in all studied patients after 3 months of treatment. Regarding the profile of cinacalcet use, at the third month of treatment 50% of the patients were under-treated. Conclusions: Although cinacalcet has shown to be effective in the management of hyperparathyroidism, the increase of doses according to the levels of PTHi is not carried out according to the recommendations established in the summary of product characteristics. The pharmacotherapeutic follow-up of these patients would improve the results of PTHi and the effectiveness of the treatment (AU)

Management of LBP at primary care level in South Africa: up to standards?

BACKGROUND: Primary Health Care (PHC) is well suited for management of low back pain (LBP). Prevalence of (chronic) LBP is suspected to be high among visitors of the South African primary care centers, but currently no information exists on prevalence or guideline adherence. OBJECTIVES: To establish if treatment received for LBP in public PHC in the Cape Town area compares with international evidence based guidelines. METHODS: Cluster randomization determined the 8 community health centres where the study took place. A measurement tool was developed and validated for this population. Descriptive analysis and logistic regression analytical techniques were applied. RESULTS: 489 participants (mean age: 44.8) were included in this study. Lifetime prevalence was 73.2% and 26.3% suffered from chronic low back pain (CLBP) . Pain medication was the only form of treatment received by 90% of the sample. Interventions received seemed to be unrelated to type of LBP (acute, sub acute and chronic). Referral to physiotherapy, education and advice to stay active were rarely done. Participants expressed low satisfaction with treatment. CONCLUSIONS: Current management of LBP at PHC level appears to be ineffective and not conform guidelines. Further South African research should focus on barriers as well as measures to be taken for implementation of LBP guidelines.

Detection of asymptomatic renal Leptospira infection in abattoir slaughtered cattle in southeastern Georgia, United States.

OBJECTIVES: Leptospirosis is one of the most widespread zoonotic infectious diseases affecting humans and animals. Several animal species, including cattle, can act as potential asymptomatic carriers facilitating zoonotic transmission of Leptospira. This study was conducted to assess the occurrence of asymptomatic renal Leptospira carriers among cattle slaughtered in southeastern Georgia, United States. METHODS: A battery of diagnostic tests, including dark field microscopy, direct fluorescent antibody staining, polymerase chain reaction, and culture, were performed on a set of bovine kidneys (n = 37) collected from an abattoir in southeastern Georgia, United States. Virulence of a field isolate obtained from this study was tested in a hamster experimental model. RESULTS: Motile spirochete-like structures were observed by dark field microscopy in 23 (59%) out of 37 kidney samples tested. In all, 29 samples (78%) were positive by direct fluorescent antibody staining. Only 11 (29.7%) samples by polymerase chain reaction and 3 (8.1%) by culture were positive for Leptospira sp. The isolates obtained by culture were confirmed as Leptospira borgpetersenii. Hamsters experimentally infected with one of the Leptospira field isolates obtained from this study did not show clinical signs but developed renal infection with interstitial nephritis and tubular necrosis. CONCLUSIONS: This study confirms that asymptomatic Leptospira renal infection is present among cattle in the region. Our findings underscore the need for future studies to assess the potential environmental contamination and transmission to humans in contact with infected cattle.

Effect of calf age and administration route of initial multivalent modified-live virus vaccine on humoral and cell-mediated immune responses following subsequent administration of a booster vaccination at weaning in beef calves.

OBJECTIVE: To compare immune responses following modified-live virus (MLV) vaccination at weaning after intranasal or SC administration of an MLV vaccine to beef calves at 2 or 70 days of age. ANIMALS: 184 calves. PROCEDURES: Calves were allocated to 1 of 5 groups. The IN2 (n = 37) and IN70 (37) groups received an MLV vaccine containing bovine herpesvirus 1 (BHV1), bovine viral diarrhea virus (BVDV) types 1 and 2, bovine respiratory syncytial virus (BRSV), and parainfluenza 3 virus intranasally and a Mannheimia haemolytica and Pasteurella multocida bacterin SC at median ages of 2 and 70 days, respectively. The SC2 (n = 36) and SC70 (37) groups received a 7-way MLV vaccine containing BHV1, BVDV1, BVDV2, BRSV, parainfluenza 3 virus, M haemolytica, and P multocida SC at median ages of 2 and 70 days, respectively; the control group (37) remained unvaccinated until weaning. All calves received the 7-way MLV vaccine SC at median ages of 217 (weaning) and 231 days. Serum neutralizing antibody (SNA) titers against BHV1, BVDV1, and BRSV and intranasal IgA concentrations were determined at median ages of 2, 70, 140, 217, and 262 days. Cell-mediated immunity (CMI) against BHV1, BRSV, BVDV1, and P multocida was determined for 16 calves/group. RESULTS: At median ages of 140 and 217 days, BVDV1 SNA titers were significantly higher for the SC70 group than those for the other groups. Intranasal IgA concentrations and CMI increased over time for all groups. Vaccination at weaning increased SNA titers and CMI in all groups. CONCLUSIONS AND CLINICAL RELEVANCE: SC administration of an MLV vaccine to 70-day-old calves significantly increased BVDV1 antibody titers before weaning.

Humoral immunity and injection-site reactions in cattle vaccinated with a multivalent clostridial vaccine administered via subcutaneous injection or via transdermal needle-free injection.

OBJECTIVE: To evaluate injection-site reactions and serum antibody titers in cattle vaccinated with a clostridial vaccine administered SC or via needle-free transdermal injection. ANIMALS: Sixteen 11-to 12-month-old Herefords. PROCEDURES: Cattle in 2 groups were vaccinated on days 0 and 28 with a commercially available multivalent clostridial vaccine administered SC or transdermally Injection sites and serum antibody titers were evaluated at several time points after vaccination. Serum antibody titers against Clostridium perfringens beta toxin, Clostridium novyi alpha toxin, and Clostridium septicum alpha toxin were determined with an ELISA; Clostridium sordellii lethal toxin titers were determined with a toxin neutralization assay. RESULTS: Firm injection site swellings developed in cattle vaccinated via either route; however, at several observation times, swellings were significantly smaller in cattle vaccinated transdermally. Serum titers against C perfringens beta toxin and C septicum alpha toxin did not differ significantly between groups after vaccination; serum titers against C novyi alpha toxin were not significantly different between groups, except on days 10 and 56, when they were significantly higher in cattle vaccinated SC. Titers against C sordellii lethal toxin were significantly higher in cattle vaccinated SC on several days after vaccination, but titers were not significantly different after day 49. CONCLUSIONS AND CLINICAL RELEVANCE: Transdermal vaccination of cattle resulted in serum antibody titers that were similar to those induced via SC vaccination and caused injection-site reactions that were significantly smaller. Transdermal vaccination may be an effective technique for vaccinating cattle against clostridial diseases while minimizing local reactions that often develop after clostridial vaccination.

Safety and U.S. Regulatory considerations in the nonclinical use of medical ultrasound devices.

Ultrasound imaging has been used for medical purposes for over 50 years and has an excellent safety record. Ultrasonic fetal scanning is generally considered safe and is properly used when medical information on a pregnancy is needed. However, ultrasound energy delivered to the fetus cannot be regarded as completely innocuous. Even though there are no demonstrated risks from ultrasound imaging, it can produce effects on the body. Laboratory studies have demonstrated that diagnostic levels of ultrasound can produce physical effects in tissue, such as mechanical vibrations, rise in temperature and cavitation. A number of in vitro and in vivo (animal and human) biologic effects have been reported following exposure to diagnostic ultrasound devices and low intensity ultrasound used for therapeutic purposes. Most public health experts, clinicians and industry agree that exposure of the fetus to ultrasound for nonmedical purposes should be avoided. The U.S. Food and Drug Administration (FDA) supports this position.

Análisis del proceso de selección de nuevos medicamentos en un hospital terciario. Años 2004–07 / Analysis of the selection process for new drugs in a tertiary hospital 2004–2007

Objetivo Describir la estructura de la Comisión de Farmacia y Terapéutica y el proceso de selección de nuevos medicamentos de un hospital terciario. Material y métodos Se revisan todas las actas de la Comisión de Farmacia y Terapéutica y las Guías para la Incorporación de Nuevos Fármacos recibidas en el periodo 2004–2007 en el Hospital Universitario Virgen del Rocío. Se realiza un estudio descriptivo que recoge variables relacionadas con el fármaco (grupo terapéutico, vía de registro, vía de administración y categoría legal), con el solicitante (servicio al que pertenece, categoría profesional y tipo de petición) y con el resultado de la evaluación (decisión final adoptada y tiempo de retraso entre la petición y la decisión).Resultados De los 72 medicamentos solicitados, se aprobaron 45 (62,5%), 6 como equivalentes terapéuticos, 36 (80%) con recomendaciones específicas y 3 (4,2%) sin ninguna restricción. De los fármacos no incluidos, en 12 (81,1%) fue por insuficiente evidencia de su eficacia comparada con el tratamiento actual. El grupo terapéutico solicitado con más frecuencia fue el de los antineoplásicos, destacando Oncología y Hematología entre los peticionarios. Destaca el alto porcentaje de solicitantes que aportaron ensayos clínicos (97,2%) y datos referentes al coste (84,7%).Conclusiones Existe un alto grado cumplimentación de la Guía para la Incorporación de Nuevos Fármacos en nuestro centro que garantiza una decisión final por parte de la Comisión de Farmacia y Terapéutica basada en la evidencia científica (AU)

Material and methods All annals of the P&TC and the New Drug Incorporation Guides (GINF) to incorporate new drugs received at Hospital Virgen del Rocío between 2004 and 2007 were reviewed. We carried out a descriptive study which collected variables having to do with the drug (drug type, type of register, route of administration and legal category), the petitioner (responsible division, professional category and request type) and the result of the evaluation (final decision, elapsed time between the request and the decision). Results Of the 72 requested drugs, 45 (62.5%) were approved: six as equivalent treatments, 36 (80%) with specific recommendations, and three (4.2%) with no restrictions. Twelve drugs (81.1%) were not included due to insufficient evidence of their effectiveness compared with the current treatment. The most frequently-requested drug type was the antineoplastics, most commonly requested by Oncology and Haematology divisions. We highlight the fact that many of the petitioners included clinical trials (97.2%) and data referring to costs (84.7%) (AU)