Protocol for a randomized controlled study of Iyengar yoga for youth with irritable bowel syndrome

<p>Abstract</p> <p>Introduction</p> <p>Irritable bowel syndrome affects as many as 14% of high school-aged students. Symptoms include discomfort in the abdomen, along with diarrhea and/or constipation and other gastroenterological symptoms that can significantly impact quality of life and daily functioning. Emotional stress appears to exacerbate irritable bowel syndrome symptoms suggesting that mind-body interventions reducing arousal may prove beneficial. For many sufferers, symptoms can be traced to childhood and adolescence, making the early manifestation of irritable bowel syndrome important to understand. The current study will focus on young people aged 14-26 years with irritable bowel syndrome. The study will test the potential benefits of Iyengar yoga on clinical symptoms, psychospiritual functioning and visceral sensitivity. Yoga is thought to bring physical, psychological and spiritual benefits to practitioners and has been associated with reduced stress and pain. Through its focus on restoration and use of props, Iyengar yoga is especially designed to decrease arousal and promote psychospiritual resources in physically compromised individuals. An extensive and standardized teacher-training program support Iyengar yoga's reliability and safety. It is hypothesized that yoga will be feasible with less than 20% attrition; and the yoga group will demonstrate significantly improved outcomes compared to controls, with physiological and psychospiritual mechanisms contributing to improvements.</p> <p>Methods/Design</p> <p>Sixty irritable bowel syndrome patients aged 14-26 will be randomly assigned to a standardized 6-week twice weekly Iyengar yoga group-based program or a wait-list usual care control group. The groups will be compared on the primary clinical outcomes of irritable bowel syndrome symptoms, quality of life and global improvement at post-treatment and 2-month follow-up. Secondary outcomes will include visceral pain sensitivity assessed with a standardized laboratory task (water load task), functional disability and psychospiritual variables including catastrophizing, self-efficacy, mood, acceptance and mindfulness. Mechanisms of action involved in the proposed beneficial effects of yoga upon clinical outcomes will be explored, and include the mediating effects of visceral sensitivity, increased psychospiritual resources, regulated autonomic nervous system responses and regulated hormonal stress response assessed via salivary cortisol.</p> <p>Trial registration</p> <p>ClinicalTrials.gov <a href="http://www.clinicaltrials.gov/ct2/show/NCT01107977">NCT01107977</a>.</p

Mortality from gastrointestinal congenital anomalies at 264 hospitals in 74 low-income, middle-income, and high-income countries: a multicentre, international, prospective cohort study

Background: Congenital anomalies are the fifth leading cause of mortality in children younger than 5 years globally. Many gastrointestinal congenital anomalies are fatal without timely access to neonatal surgical care, but few studies have been done on these conditions in low-income and middle-income countries (LMICs). We compared outcomes of the seven most common gastrointestinal congenital anomalies in low-income, middle-income, and high-income countries globally, and identified factors associated with mortality. // Methods: We did a multicentre, international prospective cohort study of patients younger than 16 years, presenting to hospital for the first time with oesophageal atresia, congenital diaphragmatic hernia, intestinal atresia, gastroschisis, exomphalos, anorectal malformation, and Hirschsprung's disease. Recruitment was of consecutive patients for a minimum of 1 month between October, 2018, and April, 2019. We collected data on patient demographics, clinical status, interventions, and outcomes using the REDCap platform. Patients were followed up for 30 days after primary intervention, or 30 days after admission if they did not receive an intervention. The primary outcome was all-cause, in-hospital mortality for all conditions combined and each condition individually, stratified by country income status. We did a complete case analysis. // Findings: We included 3849 patients with 3975 study conditions (560 with oesophageal atresia, 448 with congenital diaphragmatic hernia, 681 with intestinal atresia, 453 with gastroschisis, 325 with exomphalos, 991 with anorectal malformation, and 517 with Hirschsprung's disease) from 264 hospitals (89 in high-income countries, 166 in middle-income countries, and nine in low-income countries) in 74 countries. Of the 3849 patients, 2231 (58·0%) were male. Median gestational age at birth was 38 weeks (IQR 36–39) and median bodyweight at presentation was 2·8 kg (2·3–3·3). Mortality among all patients was 37 (39·8%) of 93 in low-income countries, 583 (20·4%) of 2860 in middle-income countries, and 50 (5·6%) of 896 in high-income countries (p<0·0001 between all country income groups). Gastroschisis had the greatest difference in mortality between country income strata (nine [90·0%] of ten in low-income countries, 97 [31·9%] of 304 in middle-income countries, and two [1·4%] of 139 in high-income countries; p≤0·0001 between all country income groups). Factors significantly associated with higher mortality for all patients combined included country income status (low-income vs high-income countries, risk ratio 2·78 [95% CI 1·88–4·11], p<0·0001; middle-income vs high-income countries, 2·11 [1·59–2·79], p<0·0001), sepsis at presentation (1·20 [1·04–1·40], p=0·016), higher American Society of Anesthesiologists (ASA) score at primary intervention (ASA 4–5 vs ASA 1–2, 1·82 [1·40–2·35], p<0·0001; ASA 3 vs ASA 1–2, 1·58, [1·30–1·92], p<0·0001]), surgical safety checklist not used (1·39 [1·02–1·90], p=0·035), and ventilation or parenteral nutrition unavailable when needed (ventilation 1·96, [1·41–2·71], p=0·0001; parenteral nutrition 1·35, [1·05–1·74], p=0·018). Administration of parenteral nutrition (0·61, [0·47–0·79], p=0·0002) and use of a peripherally inserted central catheter (0·65 [0·50–0·86], p=0·0024) or percutaneous central line (0·69 [0·48–1·00], p=0·049) were associated with lower mortality. // Interpretation: Unacceptable differences in mortality exist for gastrointestinal congenital anomalies between low-income, middle-income, and high-income countries. Improving access to quality neonatal surgical care in LMICs will be vital to achieve Sustainable Development Goal 3.2 of ending preventable deaths in neonates and children younger than 5 years by 2030

Características da tuberculose pulmonar em área hiperendêmica: município de Santos (SP) Characteristics of pulmonary tuberculosis in a hyperendemic area: the city of Santos, Brasil

OBJETIVO: Caracterizar o perfil dos pacientes com tuberculose pulmonar (TBP) no município de Santos (SP) segundo fatores biológicos, ambientais e institucionais. MÉTODOS: Estudo descritivo, com dados obtidos na vigilância da TB, abrangendo pacientes com TBP maiores de 15 anos de idade, residentes em Santos (SP) e com tratamento iniciado entre 2000 e 2004. RESULTADOS: Foram identificados 2.176 casos, e 481 apresentavam história prévia de TB. Desses, 29,3% curaram-se no episódio anterior, e 70,7% abandonaram o tratamento. Em 61,6% e em 33,8% dos casos, o diagnóstico foi confirmado por baciloscopia e por critérios clínico-radiológicos, respectivamente; 69.0% eram homens, e 69,5% situavam-se entre 20 a 49 anos. Houve 732 hospitalizações, com tempo médio de permanência de 32 dias na primeira internação. A prevalência de alcoolismo, diabetes e coinfecção TB/HIV foi de, respectivamente, 11,7%, 8,2% e 16,2%, com declínio dessa última de 20,7% para 12,9% no período de estudo. O desfecho do tratamento para 71,0%, 12,1%, 3,2% e 3,3% foi, respectivamente, cura, abandono, óbito por TB e óbito por TB/HIV. O tratamento supervisionado de curta duração foi aplicado em 63,4% dos casos, e não houve diferenças nos desfechos entre os tipos de tratamento (p > 0,05). A incidência anual média de TBP foi de 127,9/100.000habitantes (variação: 72,8-272,92/100.000 conforme a região). A taxa anual média de mortalidade por TBP foi de 6,9/100.000 habitantes. CONCLUSÕES: Em áreas hiperendêmicas de TB, o tratamento supervisionado de curta duração deve ser priorizado para os grupos de risco para o abandono de tratamento ou óbito, e a busca de TB entre contatos deve ser intensificada.<br>OBJECTIVE: To characterize the profile of patients with pulmonary tuberculosis (PTB) in the city of Santos, Brazil, according to biological, environmental and institutional factors. METHODS: Descriptive study, using the TB surveillance database, including patients with PTB, aged 15 years or older, residing in the city of Santos and whose treatment was initiated between 2000 and 2004. RESULTS: We identified 2,176 cases, of which 481 presented a history of TB. Of those 481 patients, 29.3% were cured, and 70.7% abandoned treatment. In 61.6% of the cases, the diagnosis was confirmed by sputum smear microscopy, whereas it was confirmed based on clinical and radiological criteria in 33.8%; 69.0% were male; and 69.5% were between 20 and 49 years of age. There were 732 hospitalizations, and the mean length of hospital stay was 32 days (first hospitalization). The prevalence of alcoholism, diabetes and TB/HIV coinfection was, respectively, 11.7%, 8.2% and 16.2%. The prevalence of TB/HIV coinfection decreased from 20.7% to 12.9% during the study period. The treatment outcome was cure, abandonment, death from TB and death attributed to TB/HIV coinfection in 71.0%, 12.1%, 3.9% and 2.5%, respectively. The directly observed treatment, short-course (DOTS) was adopted in 63.4% of cases, and there were no significant differences between DOTS and the conventional treatment approach in terms of outcomes (p > 0.05). The mean annual incidence of PTB was 127.9/100,000 population (range: 72.8-272.92/100,000 population, varying by region). The mean annual mortality rate for PTB was 6.9/100,000 population. CONCLUSIONS: In areas hyperendemic for TB, DOTS should be prioritized for groups at greater risk of treatment abandonment or death, and the investigation of TB contacts should be intensified