Conservative management versus invasive management of significant traumatic pneumothoraces in the emergency department (the CoMiTED trial): a study protocol for a randomised non-inferiority trial.

INTRODUCTION: Traumatic pneumothoraces are present in one of five victims of severe trauma. Current guidelines advise chest drain insertion for most traumatic pneumothoraces, although very small pneumothoraces can be managed with observation at the treating clinician's discretion. There remains a large proportion of patients in whom there is clinical uncertainty as to whether an immediate chest drain is required, with no robust evidence to inform practice. Chest drains carry a high risk of complications such as bleeding and infection. The default to invasive treatment may be causing potentially avoidable pain, distress and complications. We are evaluating the clinical and cost-effectiveness of an initial conservative approach to the management of patients with traumatic pneumothoraces. METHODS AND ANALYSIS: The CoMiTED (Conservative Management in Traumatic Pneumothoraces in the Emergency Department) trial is a multicentre, pragmatic parallel group, individually randomised controlled non-inferiority trial to establish whether initial conservative management of significant traumatic pneumothoraces is non-inferior to invasive management in terms of subsequent emergency pleural interventions, complications, pain, breathlessness and quality of life. We aim to recruit 750 patients from at least 40 UK National Health Service hospitals. Patients allocated to the control (invasive management) group will have a chest drain inserted in the emergency department. For those in the intervention (initial conservative management) group, the treating clinician will be advised to manage the participant without chest drain insertion and undertake observation. The primary outcome is a binary measure of the need for one or more subsequent emergency pleural interventions within 30 days of randomisation. Secondary outcomes include complications, cost-effectiveness, patient-reported quality of life and patient and clinician views of the two treatment options; participants are followed up for 6 months. ETHICS AND DISSEMINATION: This trial received approval from the Wales Research Ethics Committee 4 (reference: 22/WA/0118) and the Health Research Authority. Results will be submitted for publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: ISRCTN35574247.

A comprehensive electronic health record-enabled smoking treatment program: Evaluating reach and effectiveness in primary care in a multiple baseline design.

Effective treatments for smoking cessation exist but are underused. Proactive chronic care approaches may enhance the reach of cessation treatment and reduce the prevalence of smoking in healthcare systems. This pragmatic study evaluated a population-based Comprehensive Tobacco Intervention Program (CTIP) implemented in all (6) adult primary care clinics in a Madison, Wisconsin, USA healthcare cooperative, assessing treatment reach, reach equity, and effectiveness in promoting smoking cessation. CTIP launched in 3 waves of 2 clinics each in a multiple baseline design. Electronic health record (EHR) tools facilitated clinician-delivered pharmacotherapy and counseling; guiding tobacco care managers in phone outreach to all patients who smoke; and prompting multimethod bulk outreach to all patients on a smoking registry using an opt-out approach. EHR data were analyzed to assess CTIP reach and effectiveness among 6894 adult patients between January 2018 and February 2020. Cessation treatment reach increased significantly after CTIP launch in 5 of 6 clinics and was significantly higher when clinics were active vs. inactive in CTIP [Odds Ratio (OR) range = 2.0-3.0]. Rates of converting from current to former smoking status were also higher in active vs. inactive clinics (OR range = 2.2-10.5). Telephone treatment reach was particularly high in historically underserved groups, including African-American, Hispanic, and Medicaid-eligible patients. Implementation of a comprehensive, opt-out, chronic-care program aimed at all patients who smoke was associated with increases in the rates of pharmacotherapy and counseling delivery and quitting smoking. Proactive outreach may help reduce disparities in treatment access.