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Defining CD4 T helper and T regulatory cell endotypes of progressive and remitting pulmonary sarcoidosis (BRITE): protocol for a US-based, multicentre, longitudinal observational bronchoscopy study

Por: Koth · L. L. · Harmacek · L. D. · White · E. K. · Arger · N. K. · Powers · L. · Werner · B. R. · Magallon · R. E. · Grewal · P. · Barkes · B. Q. · Li · L. · Gillespie · M. · Collins · S. E. · Cardenas · J. · Chen · E. S. · Maier · L. A. · Leach · S. M. · OConnor · B. P. · Hamzeh · N. Y.
Introduction

Sarcoidosis is a multiorgan granulomatous disorder thought to be triggered and influenced by gene–environment interactions. Sarcoidosis affects 45–300/100 000 individuals in the USA and has an increasing mortality rate. The greatest gap in knowledge about sarcoidosis pathobiology is a lack of understanding about the underlying immunological mechanisms driving progressive pulmonary disease. The objective of this study is to define the lung-specific and blood-specific longitudinal changes in the adaptive immune response and their relationship to progressive and non-progressive pulmonary outcomes in patients with recently diagnosed sarcoidosis.

Methods and analysis

The BRonchoscopy at Initial sarcoidosis diagnosis Targeting longitudinal Endpoints study is a US-based, NIH-sponsored longitudinal blood and bronchoscopy study. Enrolment will occur over four centres with a target sample size of 80 eligible participants within 18 months of tissue diagnosis. Participants will undergo six study visits over 18 months. In addition to serial measurement of lung function, symptom surveys and chest X-rays, participants will undergo collection of blood and two bronchoscopies with bronchoalveolar lavage separated by 6 months. Freshly processed samples will be stained and flow-sorted for isolation of CD4 +T helper (Th1, Th17.0 and Th17.1) and T regulatory cell immune populations, followed by next-generation RNA sequencing. We will construct bioinformatic tools using this gene expression to define sarcoidosis endotypes that associate with progressive and non-progressive pulmonary disease outcomes and validate the tools using an independent cohort.

Ethics and dissemination

The study protocol has been approved by the Institutional Review Boards at National Jewish Hospital (IRB# HS-3118), University of Iowa (IRB# 201801750), Johns Hopkins University (IRB# 00149513) and University of California, San Francisco (IRB# 17-23432). All participants will be required to provide written informed consent. Findings will be disseminated via journal publications, scientific conferences, patient advocacy group online content and social media platforms.

Physical activity and sedentary behaviour in current and former recreational and elite cricketers: a cross-sectional study

Por: Panagodage-Perera · N. K. · Bullock · G. S. · Arden · N. K. · Filbay · S. R.
Objective

Former sports participants do not necessarily maintain high levels of physical activity (PA) across their lifespan. Considering physical inactivity in former athletes is associated with an increased susceptibility to inactivity-related chronic diseases, research into PA behaviours in cricketers of all playing-standards is needed. The objective was to (1) describe PA and sedentary behaviour in current and former cricketers, and (2) determine the odds of current, former, recreational and elite cricketers meeting PA guidelines and health-enhancing PA (HEPA) compared with the general population.

Study design

Cross-sectional survey.

Setting

Questionnaire response, UK.

Participants

2267 current and former cricketers (age: 52±15 years, male: 97%, current: 59%, recreational: 45%) participated. Cricketers were recruited through the Cricket Health and Wellbeing Study and met eligibility requirements (aged ≥18 years; played ≥1 year of cricket).

Primary and secondary outcomes

Age-matched and sex-matched data from Health Survey for England 2015 (n=3201) was used as the general population-based sample. The International Physical Activity Questionnaire Short-Form assessed PA. Logistic regression, adjusted for age, sex, body mass index, alcohol consumption, smoking, education and ethnicity were used to meet the second aim.

Results

90% of current and 82% of former cricketers met UK PA guidelines. Current (OR 1.26, 95% CI 1.06 to 1.49)) and elite (OR 1.35, 95% CI 1.01 to 1.78) cricketers had greater odds of meeting UK PA guidelines, and elite cricketers had greater odds of HEPA (OR 1.19, 95% CI 1.02 to 1.42), compared with the general population. Former cricketers had reduced odds (OR 0.78, 95% CI 0.62 to 0.99) of meeting the UK PA guidelines compared with the general population.

Conclusions

Elite cricketers had a greater odds of meeting the PA guidelines and HEPA, compared with the general population. Former cricketers demonstrated reduced odds of meeting the PA guidelines compared with the general population. Strategies are needed to transition cricketers to an active lifestyle after retirement, since former cricketers demonstrated reduced odds of meeting the PA guidelines compared with the general population.

Study protocol for yoga-based lifestyle intervention for healthy ageing phenotype in the older adults (yHAP): a two-armed, waitlist randomised controlled trial with multiple primary outcomes

Por: Majumdar · V. · Snigdha · A. · Manjunath · N. K. · Nagarathna · R. · Mavathur · R. · Singh · A. · S R · K. · H R · N.
Introduction

The conceptualisation of healthy ageing phenotype (HAP) and the availability of a tentative panel for HAP biomarkers raise the need to test the efficacy of potential interventions to promote health in older adults. This study protocol reports the methodology for a 24-week programme to explore the holistic influence of the yoga-based intervention on the (bio)markers of HAP.

Methods and analysis

The study is a two-armed, randomised waitlist controlled trial with blinded outcome assessors and multiple primary outcomes. We aim to recruit 250 subjects, aged 60–80 years from the residential communities and old age clubs in Bangalore city, India, who will undergo randomisation into intervention or control arms (1:1). The intervention will include a yoga-based programme tailored for the older adults, 1 hour per day for 6 days a week, spread for 24 weeks. Data would be collected at the baseline and post-intervention, the 24th week. The multiple primary outcomes of the study are the (bio)markers of HAP: glycated haemoglobin, low-density lipoprotein cholesterol (LDL-C), systolic blood pressure, and forced expiratory volume in 1 s for physiological and metabolic health; Digit Symbol Substitution Test, Trail Making Tests A and B for cognition; hand grip strength and gait speed for physical capability; loneliness for social well-being and WHO Quality of Life Instrument-Short Form for quality of life. The secondary outcomes include inflammatory markers, tumour necrosis factor-alpha receptor II, C reactive protein, interleukin 6 and serum Klotho levels. Analyses will be by intention-to-treat and the holistic impact of yoga on HAP will be assessed using global statistical test.

Ethics and dissemination

The study is approved by the Institutional Ethics Committee of Swami Vivekananda Yoga Anusandhana Samsthana University, Bangalore (ID: RES/IEC-SVYASA/143/2019). Written informed consent will be obtained from each participant prior to inclusion. Results will be available through research articles and conferences.

Trial registration number

CTRI/2021/02/031373.

Impact of bed height on the biomechanics of healthcare professionals during chest compressions on the neonate: a descriptive pilot study

Por: Parent-Nichols · J. · Perez · J. · Witherell · B. · McWilliam · P. · Halamek · L. P. · Kent · N. · Varnum · W. · Yamada · N. K.
Objectives

The biomechanics of the healthcare professionals (HCPs) performing the life-saving intervention of chest compressions in the neonatal population is poorly understood. The aim of this pilot study was to describe the variations in body position at a self-selected and a predetermined bed height during neonatal chest compressions. Measures of joint angles, time to postural sway and number of postural adjustments were chosen as indices for the stability of the HCP’s position.

Setting

Data were collected at a simulation-based research centre in which the patient care environment was replicated.

Participants

HCPs with varying roles working in the neonatal intensive care unit and holding a current Neonatal Resuscitation Program Provider certification were recruited for this study.

Interventions

Fifteen HCPs performed two trials of chest compressions, each lasting 2 min, at a predetermined bed height and a self-selected bed height. Trials were video recorded, capturing upper and lower body movements. Videos were analysed for time to postural sway and number of postural adjustments. Joint angles were measured at the start and end of each trial.

Results

A statistically significant difference was found between the two bed height conditions for number of postural adjustments (p=0.02). While not statistically significant, time postural sway was increased in the choice bed height condition (85 s) compared with the predetermined bed height (45 s). After 30 s of chest compressions, mean shoulder and knee angles were smaller for choice bed height (p=0.03, 95% CI Lower=–12.14, Upper=–0.68 and p=0.05, 95% CI Lower=3.43, Upper=0.01, respectively). After 1 min and 45 s of chest compressions, mean wrist angles were smaller in the choice bed height condition (p=0.01, 95% CI Lower=–9.20, Upper=–1.22), stride length decreased between the 30 s and 1 min 45 s marks of the chest compressions in the predetermined height condition (p=0.02).

SYMptom monitoring with Patient-Reported Outcomes using a web application among patients with Lung cancer in the Netherlands (SYMPRO-Lung): study protocol for a stepped-wedge randomised controlled trial

Por: Billingy · N. E. · Tromp · V. N. M. F. · Veldhuijzen · E. · Belderbos · J. · Aaronson · N. K. · Feldman · E. · Hoek · R. J. A. · Bogaard · H.-J. · Onwuteaka-Philipsen · B. D. · van de Poll-Franse · L. · Hugtenburg · J. G. · van den Hurk · C. J. G. · Becker-Commissaris · A. · Walr
Introduction

Lung cancer and its treatment cause a wide range of symptoms impacting the patients’ health-related quality of life (HRQoL). The use of patient-reported outcomes (PRO) to monitor symptoms during and after cancer treatment has been shown not only to improve symptom management but also to improve HRQoL and overall survival (OS). Collectively, these results favour implementation of PRO-symptom monitoring in daily clinical care. However, these promising outcomes have been obtained under trial conditions in which patients were selected based on stringent inclusion criteria, and in countries with a dissimilar healthcare system than in the Netherlands.

The primary aim of the SYMptom monitoring with Patient-Reported Outcomes using a web application among patients with Lung cancer in the Netherlands (SYMPRO-Lung) study is to evaluate the effect of PRO-symptom monitoring during and after lung cancer treatment on HRQoL in daily clinical practice. Secondary objectives include assessing the effect of PRO-symptom monitoring on progression-free survival, OS, the incidence and grade of PRO symptoms, medication adherence, implementation fidelity and cost-effectiveness.

Methods and analysis

The SYMPRO-Lung study is a prospective, multicentre trial with a stepped wedge cluster randomised design. Study participants (n=292 intervention, n=292 controls) include patients with lung cancer (stages I–IV) starting treatment with surgery, systemic treatment, targeted treatment and/or radiotherapy.

Every participating centre will consecutively switch from the control period to the intervention period, in which patients report their symptoms weekly via an online tool. In the intervention group, we evaluate two alert approaches: the active and reactive approach. If the symptoms exceed a predefined threshold, an alert is sent to the healthcare provider (active approach) or to the patient (reactive approach). Both the control and intervention group complete HRQoL questionnaires at 4 time points: at baseline, 15 weeks, 6 months and 1-year post treatment). Differences in HRQoL between the groups will be compared using linear mixed modelling analyses, accounting for within-centre clustering, potential time effects and confounding.

Ethics and dissemination

The study protocol was approved by the Institutional Review Board and the Medical Ethics Committee of the Amsterdam UMC (under number NL 68440.029.18) and the institutional review boards of the participating study sites. The dissemination of the results will be conducted through publication in peer-reviewed journals and through scientific conferences.

Trial registration number

Trial register identifier: Netherlands Trial register Trial NL7897. Date of registration: 24 July 2019. https://www.trialregister.nl/trial/7897.

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