Effect of dual-acupoint and single-acupoint electric stimulation on postoperative outcomes in elderly patients subjected to gastrointestinal surgery: study protocol for a randomized controlled trial.

BACKGROUND: Transcutaneous electric acupoint stimulation (TEAS) has shown benefits when used peri-operatively. However, the role of numbers of areas with acupoint stimulation is still unclear. Therefore, we report the protocol of a randomized controlled trial of using TEAS in elderly patients subjected to gastrointestinal surgery, and comparing dual-acupoint and single-acupoint stimulation. METHODS/DESIGN: A multicenter, randomized, controlled, three-arm design, large-scale trial is currently undergoing in four hospitals in China. Three hundred and forty-five participants are randomly assigned to three groups in a 1:1:1 ratio, receiving dual-acupoint TEAS, single-acupoint TEAS, and no stimulation, respectively. The primary outcome is incidence of pulmonary complications at 30 days after surgery. The secondary outcomes include the incidence of pulmonary complications at 3 days after surgery; the all-cause mortality within 30 days and 1 year after surgery; admission to the intensive care unit (ICU) and length of ICU stay within 30 days after surgery; the length of postoperative hospital stay; and medical costs during hospitalization after surgery. DISCUSSION: The result of this trial (which will be available in September 2019) will confirm whether TEAS before and during anesthesia could alleviate the postoperative pulmonary complications after gastrointestinal surgery in elderly patients, and whether dual-acupoint stimulation is more effective than single-acupoint stimulation. TRIALS REGISTRATIONS: ClinicalTrials.gov, ID: NCT03230045 . Registered on 10 July 2017.

Acceptance, satisfaction and cost of an integrative anthroposophic program for pediatric respiratory diseases in a Swiss teaching hospital: An implementation report.

BACKGROUND: For the pilot phase of an integrative pediatric program, we defined inpatient treatment algorithms for bronchiolitis, asthma and pneumonia, using medications and nursing techniques from anthroposophic medicine (AM). Parents could choose AM treatment as add-on to conventional care. MATERIAL AND METHODS: To evaluate the 18-month pilot phase, parents of AM users were asked to complete the Client Satisfaction Questionnaire (CSQ-8) and a questionnaire on the AM treatment. Staff feedback was obtained through an open-ended questionnaire. Economic data for project set-up, medications and insurance reimbursements were collected. RESULTS: A total of 351 children with bronchiolitis, asthma and pneumonia were hospitalized. Of these, 137 children (39%) received AM treatment, with use increasing over time. 52 parents completed the questionnaire. Mean CSQ-8 score was 29.77 (95% CI 29.04-30.5) which is high in literature comparison. 96% of parents were mostly or very satisfied with AM; 96% considered AM as somewhat or very helpful for their child; 94% considered they learnt skills to better care for their child. The staff questionnaire revealed positive points about enlarged care offer, closer contact with the child, more relaxed children and greater role for parents; weak points included insufficient knowledge of AM and additional nursing time needed. Cost for staff training and medications were nearly compensated by AM related insurance reimbursements. CONCLUSIONS: Introduction of anthroposophic treatments were well-accepted and led to high parent satisfaction. Additional insurance reimbursements outweighed costs. The program has now been expanded into a center for integrative pediatrics.

Preclinical efficacy studies in investigator brochures: Do they enable risk-benefit assessment?

Human protection policies require favorable risk-benefit judgments prior to launch of clinical trials. For phase I and II trials, evidence for such judgment often stems from preclinical efficacy studies (PCESs). We undertook a systematic investigation of application materials (investigator brochures [IBs]) presented for ethics review for phase I and II trials to assess the content and properties of PCESs contained in them. Using a sample of 109 IBs most recently approved at 3 institutional review boards based at German Medical Faculties between the years 2010-2016, we identified 708 unique PCESs. We then rated all identified PCESs for their reporting on study elements that help to address validity threats, whether they referenced published reports, and the direction of their results. Altogether, the 109 IBs reported on 708 PCESs. Less than 5% of all PCESs described elements essential for reducing validity threats such as randomization, sample size calculation, and blinded outcome assessment. For most PCESs (89%), no reference to a published report was provided. Only 6% of all PCESs reported an outcome demonstrating no effect. For the majority of IBs (82%), all PCESs were described as reporting positive findings. Our results show that most IBs for phase I/II studies did not allow evaluators to systematically appraise the strength of the supporting preclinical findings. The very rare reporting of PCESs that demonstrated no effect raises concerns about potential design or reporting biases. Poor PCES design and reporting thwart risk-benefit evaluation during ethical review of phase I/II studies.

Secondhand smoke exposure, illness severity, and resource utilization in pediatric emergency department patients with respiratory illnesses.

OBJECTIVE: Hospital-based data reveal that children who have secondhand smoke exposure (SHSe) experience severe respiratory illnesses and greater resource utilization. Our objective was to assess the relationship between SHSe and illness severity/resource utilization among children presenting to the pediatric emergency department (PED) with three common respiratory conditions-asthma, bronchiolitis, and pneumonia. METHODS: A retrospective review of a yearlong consecutive sample of PED patients with SHSe status documentation and asthma, bronchiolitis, or pneumonia diagnoses was performed. PED illness severity/resource utilization variables included triage categorization, initial oxygen saturation, evaluation/testing (influenza A & B, respiratory syncytial virus, chest X-ray), procedures/interventions performed (supplemental oxygen, suctioning, intubation), medications administered, and disposition. Logistic and linear regression models were conducted to determine differences in each diagnosis group while controlling for sociodemographics, medical history, seasonality, and insurance type. RESULTS: There were 3,229 children with documentation of SHSe status and an asthma (41%), bronchiolitis (36%), or pneumonia (23%) diagnosis. Across diagnosis groups, approximately 1/4 had positive documentation of SHSe. Asthmatic children with SHSe were more likely to receive corticosteroids (odds ratio (OR) = 1.71, 95% confidence interval (CI) = 1.19, 2.44) and/or magnesium sulfate (OR = 1.66, 95% CI = 1.14, 2.40). Children with SHSe and bronchiolitis were more likely to receive racemic epinephrine (OR = 2.48, 95% CI = 1.21, 5.08), have a chest X-ray (OR = 1.36, 95% CI = 1.00, 1.85), and/or be admitted (OR = 1.46, 95% CI = 1.09, 1.95). No differences in illness severity/resource utilization were identified for children with pneumonia. CONCLUSIONS: SHS-exposed children with asthma or bronchiolitis have greater illness severity/resource utilization. Our findings highlight the importance of SHSe assessment, cessation, and research efforts in the PED setting.

Managing comorbidities in COPD.

Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality worldwide. Age and smoking are common risk factors for COPD and other illnesses, often leading COPD patients to demonstrate multiple coexisting comorbidities. COPD exacerbations and comorbidities contribute to the overall severity in individual patients. Clinical trials investigating the treatment of COPD routinely exclude patients with multiple comorbidities or advanced age. Clinical practice guidelines for a specific disease do not usually address comorbidities in their recommendations. However, the management and the medical intervention in COPD patients with comorbidities need a holistic approach that is not clearly established worldwide. This holistic approach should include the specific burden of each comorbidity in the COPD severity classification scale. Further, the pharmacological and nonpharmacological management should also include optimal interventions and risk factor modifications simultaneously for all diseases. All health care specialists in COPD management need to work together with professionals specialized in the management of the other major chronic diseases in order to provide a multidisciplinary approach to COPD patients with multiple diseases. In this review, we focus on the major comorbidities that affect COPD patients. We present an overview of the problems faced, the reasons and risk factors for the most commonly encountered comorbidities, and the burden on health care costs. We also provide a rationale for approaching the therapeutic options of the COPD patient afflicted by comorbidity.

Descripción de los resultados y costes de una intervención preventiva a nivel respiratorio en el anciano institucionalizado: ensayo controlado aleatorizado / Cost-consequence analysis of respiratory preventive intervention among institutionalized older people: Randomized controlled trial

Introducción. En el anciano institucionalizado con limitación funcional se evidencia una mayor reducción de la funcionalidad de la musculatura respiratoria (MR). Los objetivos de este estudio son evaluar los resultados y costes de una intervención de entrenamiento de la MR mediante Pranayama en población anciana institucionalizada con limitación funcional. Material y métodos. Estudio controlado aleatorizado desarrollado en ancianos institucionalizados con limitación para la deambulación (n = 54). La intervención consistió en el entrenamiento de la MR mediante Pranayama, durante 6 semanas (5 sesiones/semana). Los resultados se midieron en relación con la función de la MR mediante las presiones inspiratoria y espiratoria máximas y la ventilación máxima voluntaria, en 4 tiempos. También se valoró la satisfacción percibida por el grupo experimental (GE) a través de un cuestionario ad hoc. Se estimaron los costes directos e indirectos de la intervención desde la perspectiva social. Resultados. El GE reveló una mejora significativa de la fuerza (presiones inspiratoria y espiratoria máximas) y de la resistencia (ventilación máxima voluntaria) de la MR. Además, un 92% del GE refirió una satisfacción alta. Los costes sociales totales, directos e indirectos, ascendieron a 21.678 Euros. Conclusiones. Esta evaluación revela que los resultados en términos de la función de la MR son significativos, que la intervención es bien tolerada y valorada por el residente, y los costes de la intervención son moderados (AU)

Introduction. The institutionalized elderly with functional impairment show a greater decline in respiratory muscle (RM) function. The aims of the study are to evaluate outcomes and costs of RM training using Pranayama in institutionalized elderly people with functional impairment. Material and methods. A randomized controlled trial was conducted on institutionalized elderly people with walking limitation (n = 54). The intervention consisted of 6 weeks of Pranayama RM training (5 times/week). The outcomes were measured at 4 time points, and were related to RM function: the maximum respiratory pressures and the maximum voluntary ventilation. Perceived satisfaction in the experimental group (EG) was assessed by means of an ad hoc questionnaire. Direct and indirect costs were estimated from the social perspective. Results. The GE showed a significant improvement related with strength (maximum respiratory pressures) and endurance (maximum voluntary ventilation) of RM. Moreover, 92% of the EG reported a high satisfaction. The total social costs, direct and indirect, amounted to Euros 21,678. Conclusions. This evaluation reveals that RM function improvement is significant, that intervention is well tolerated and appreciated by patients, and the intervention costs are moderate (AU)

Climate change. A global threat to cardiopulmonary health.

Recent changes in the global climate system have resulted in excess mortality and morbidity, particularly among susceptible individuals with preexisting cardiopulmonary disease. These weather patterns are projected to continue and intensify as a result of rising CO2 levels, according to the most recent projections by climate scientists. In this Pulmonary Perspective, motivated by the American Thoracic Society Committees on Environmental Health Policy and International Health, we review the global human health consequences of projected changes in climate for which there is a high level of confidence and scientific evidence of health effects, with a focus on cardiopulmonary health. We discuss how many of the climate-related health effects will disproportionally affect people from economically disadvantaged parts of the world, who contribute relatively little to CO2 emissions. Last, we discuss the financial implications of climate change solutions from a public health perspective and argue for a harmonized approach to clean air and climate change policies.