a multicentre randomised Phase III non-inferiority trial comparing a positron emission tomographycomputerised tomography-guided watch-and-wait policy with planned neck dissection in the management of locally advanced (N2/N3) nodal metastases in patients with squamous cell head and neck cancer. Health Technol Assess 2017;21(17). This journal is a member of and subscribes to the principles of the Committee on Publication Ethics (COPE) (www.publicationethics.org/). Health Technology Assessment is indexed and abstracted inEditorial contact: journals.library@nihr.ac.ukThe full HTA archive is freely available to view online at www.journalslibrary.nihr.ac.uk/hta. Print-on-demand copies can be purchased from the report pages of the NIHR Journals Library website: www.journalslibrary.nihr.ac.uk Criteria for inclusion in the Health Technology Assessment journalReports are published in Health Technology Assessment (HTA) if (1) they have resulted from work for the HTA programme, and (2) they are of a sufficiently high scientific quality as assessed by the reviewers and editors.Reviews in Health Technology Assessment are termed 'systematic' when the account of the search appraisal and synthesis methods (to minimise biases and random errors) would, in theory, permit the replication of the review by others. HTA programmeThe HTA programme, part of the National Institute for Health Research (NIHR), was set up in 1993. It produces high-quality research information on the effectiveness, costs and broader impact of health technologies for those who use, manage and provide care in the NHS. 'Health technologies' are broadly defined as all interventions used to promote health, prevent and treat disease, and improve rehabilitation and long-term care.The journal is indexed in NHS Evidence via its abstracts included in MEDLINE and its Technology Assessment Reports inform National Institute for Health and Care Excellence (NICE) guidance. HTA research is also an important source of evidence for National Screening Committee (NSC) policy decisions.For more information about the HTA programme please visit the website: http://www.nets.nihr.ac.uk/programmes/hta This reportThe research reported in this issue of the journal was funded by the HTA programme as project number 06/302/129. The contractual start date was in April 2007. The draft report began editorial review in July 2015 and was accepted for publication in June 2016. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The HTA editors and publisher have tried to ensure the accuracy of the authors' report and would like to thank the reviewers for their constructive comments on the draft document. However, they do not accept liability for damages or losses arising from material published in this report.This report presents independent research funded by the National Institute for Health Research (NIHR). The views and opinions expressed by authors in this publication are those of the authors and do not necessarily ref...
Mobile technologies offer the potential to reduce the costs of conducting clinical trials by collecting high-quality information on health outcomes in real-world settings that are relevant to patients and clinicians. However, widespread use of mobile technologies in clinical trials has been impeded by their perceived challenges. To advance solutions to these challenges, the Clinical Trials Transformation Initiative (CTTI) has issued best practices and realistic approaches that clinical trial sponsors can now use. These include CTTI recommendations on technology selection; data collection, analysis, and interpretation; data management; protocol design and execution; and US Food and Drug Administration submission and inspection. The scientific principles underpinning the clinical trials enterprise continue to apply to studies using mobile technologies. These recommendations provide a framework for including mobile technologies in clinical trials that can lead to more efficient assessment of new therapies for patients.
Background: Chronic obstructive pulmonary disease (COPD) is a common, preventable and treatable disease that is characterised by persistent respiratory symptoms and airflow limitation that is due to airway and/ or alveolar abnormalities usually caused by significant exposure to noxious particles or gases. Tobacco smoking, occupational exposure to organic and inorganic dusts, chemical agents and fumes and biomass cooking are the risk factors for COPD. Chronic dyspnoea, cough, sputum production, wheezing and chest tightness are the common symptoms of COPD. The present study was undertaken to evaluate the clinical, radiological and spirometric parameters in patients with COPD and to demonstrate a correlation between them. Methods: This was a prospective study of 50 patients of COPD who presented to out-patient department. We included all patients above 40 years of age with a smoking index of 200 or more, or history of exposure to occupational dust, biomass fuel gas or exposure to other obnoxious gases; and who had history of dyspnoea and cough. Spirometry was performed to confirm the diagnosis and to grade the severity of airflow obstruction. History of dyspnoea, cough, sputum production, wheezing, chest tightness, fever, weight loss and the number of exacerbations in the previous year was noted. We then performed a detailed clinical examination. Blood was sent for haemogram and arterial blood gas analysis and all patients underwent an ECG, 2-D Echo and HRCT of the thorax. We then studied the correlation between the clinical, radiological and spirometric profiles in these patients. Results: Out of the 50 patients, majority was between 50-59 years of age, with male to female ratio of 1.94:1.00. History of smoking was present in 74% patients, exposure to biomass fuel in 12% and exposure to occupational dust in 6% patients. Commonest symptom was dyspnoea (in 100% patients) followed by cough (88%), sputum production (68%), wheezing (58%), chest tightness and fever (30%) and weight loss (28%). HRCT was positive in 75% patients, while ECG changes were seen in 42% patients and pulmonary hypertension was present in 54% patients. A significant association was observed between grade 5 dyspnoea on mMRC, hypoxia, hypercarbia, pulmonary hypertension and Gold-5 airflow obstruction. Conclusions: In the present study of 50 cases, COPD was seen predominantly in male patients, with a mean age of presentation between 50-59 years. Tobacco smoking was the commonest etiological factor. Clinical symptoms most commonly documented were dyspnoea, cough with or without expectoration, wheezing, chest tightness, fever and weight loss. A significant association was observed between grade 5 dyspnoea on mMRC, hypoxia, hypercarbia, pulmonary hypertension and Gold-5 airflow obstruction.
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