Statistics for the Non-Statistician: How to Read the Respiratory Care Literature.

Statistical analysis is an important part of the research process. Researchers are advised to include a statistician from the moment that the study is being planned. The statistical plan informs the research process, including sample size requirements and the most robust data collection. Once the data are collected, descriptive and inferential statistical analyses are performed. The results of this analysis determine whether the findings are significant, which leads to an interpretation of the findings. The importance of the statistical plan and analysis for the researcher is self-evident. However, it is also important for the reader of published papers to have some knowledge of statistical analysis. This allows critical review of all aspects of the published manuscript. The intent of this paper is to review some basic statistical concepts and thus allow the reader to become a better consumer of the literature.

AARC Clinical Practice Guideline: Spontaneous Breathing Trials for Liberation From Adult Mechanical Ventilation.

Despite prior publications of clinical practice guidelines related to ventilator liberation, some questions remain unanswered. Many of these questions relate to the details of bedside implementation. We, therefore, formed a guidelines committee of individuals with experience and knowledge of ventilator liberation as well as a medical librarian. Using Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology, we make the following recommendations: (1) We suggest that calculation of a rapid shallow breathing index is not needed to determine readiness for a spontaneous breathing trial (SBT) (conditional recommendation; moderate certainty); (2) We suggest that SBTs can be conducted with or without pressure support ventilation (conditional recommendation, moderate certainty); (3) We suggest a standardized approach to assessment and, if appropriate, completion of an SBT before noon each day (conditional recommendation, very low certainty); and (4) We suggest that FIO2 should not be increased during an SBT (conditional recommendation, very low certainty). These recommendations are intended to assist bedside clinicians to liberate adult critically ill patients more rapidly from mechanical ventilation.

How to Write an Effective Discussion.

Explaining the meaning of the results to the reader is the purpose of the discussion section of a research paper. There are elements of the discussion section that should be included and pitfalls that should be avoided. Always write the discussion section for the reader. Remember that the focus is to help the reader understand the study and that the focus should be on the study data.

Observational Studies.

Studies can be observational or experimental. With an observational study, the investigator does not determine the assignment of subjects, and there might not be a control group. If there is a control group, assignment of the independent variable (exposure or intervention) is not under the control of the investigator. Observational studies can be rigorously conducted, but the lack of random assignment of the exposure/intervention introduces confounding and bias. Thus, the quality of evidence resulting from observational studies is lower than that of experimental randomized controlled trials (RCTs). An observational study might be performed if an RCT is unethical, impractical, or outside the control of the investigator. There are many types of prospective and retrospective observational study designs. However, an observational study design should be avoided if an experimental study is possible. Sophisticated statistical approaches can be used, but this does not elevate an observational study to the level of an RCT. Regardless of quality, an observational study cannot establish causality.

Respiratory Care Management of COPD Exacerbations.

A COPD exacerbation is characterized by an increase in symptoms such as dyspnea, cough, and sputum production that worsens over a period of 2 weeks. Exacerbations are common. Respiratory therapists and physicians in an acute care setting often treat these patients. Targeted O2 therapy improves outcomes and should be titrated to an SpO2 of 88-92%. Arterial blood gases remain the standard approach to assessing gas exchange in patients with COPD exacerbation. The limitations of arterial blood gas surrogates (pulse oximetry, capnography, transcutaneous monitoring, peripheral venous blood gases) should be appreciated so that they can be used wisely. Inhaled short-acting bronchodilators can be provided by nebulizer (jet or mesh), pressurized metered-dose inhaler (pMDI), pMDI with spacer or valved holding chamber, soft mist inhaler, or dry powder inhaler. The available evidence for the use of heliox for COPD exacerbation is weak. Noninvasive ventilation (NIV) is standard therapy for patients who present with COPD exacerbation and is supported by clinical practice guidelines. Robust high-level evidence with patient important outcomes is lacking for the use of high-flow nasal cannula in patients with COPD exacerbation. Management of auto-PEEP is the priority in mechanically ventilated patients with COPD. This is achieved by reducing airway resistance and decreasing minute ventilation. Trigger asynchrony and cycle asynchrony are addressed to improve patient-ventilator interaction. Patients with COPD should be extubated to NIV. Additional high-level evidence is needed before widespread use of extracorporeal CO2 removal. Care coordination can improve the effectiveness of care for patients with COPD exacerbation. Evidence-based practices improve outcomes in patients with COPD exacerbation.

Research and Publication in Respiratory Care.

The evidence that informs respiratory care practice arises from research that generates facts based on the scientific method. A simple definition of research is that it is a method for finding answers to questions. The Common Rule establishes guidelines related to human subjects research, but there are many types of research not subject to the Common Rule. Although conducting research can elevate the stature of investigators, more importantly, it is an essential attribute of a profession to generate research to support clinical practice.

Analysis of shared cognitive tasks in the application of non-invasive ventilation to patients with COPD exacerbation.

Interprofessional teamwork plays a key role in the uptake of evidence-based interventions, such as noninvasive ventilation (NIV) for patients with exacerbated Chronic Obstructive Pulmonary Disease (COPD). We aimed to identify the shared cognitive tasks in interprofessional teams using NIV for patients with COPD exacerbation. We used a cognitive task analysis approach (CTA) to engage nurses, rapid response team members, respiratory therapists, and physicians involved in the use of NIV to treat patients with COPD exacerbation. Clinicians participated in a semi-structured interview (n = 21) that elicited cognitions needed to treat COPD exacerbation. Three shared cognitive tasks were identified: Complete a thorough assessment, Formulate a care plan, and Continuously monitor patient status. Findings attest to the importance of having access to up-to-date information and expertise necessary to make accurate clinical inferences for patient assessment. Shared understanding of the formulated care plan among all members of the care team was important to its execution. Continuous monitoring was crucial; however, this cognitive task relied on patient assessment skills and ongoing collaboration within the clinical care team. Application of NIV for patients with COPD exacerbation may require enhancing collaboration through nontechnical skills and interprofessional training.

Exploring the Patient Experience with Noninvasive Ventilation: A Human-Centered Design Analysis to Inform Planning for Better Tolerance.

BACKGROUND: This study brings a human-centered design (HCD) perspective to understanding the patient experience when using noninvasive ventilation (NIV) with the goal of creating better strategies to improve NIV comfort and tolerance. METHODS: Using an HCD motivational approach, we created a semi-structured interview to uncover the patients' journey while being treated with NIV. We interviewed 16 patients with chronic obstructive pulmonary disease (COPD) treated with NIV while hospitalized. Patients' experiences were captured in a stepwise narrative creating a journey map as a framework describing the overall experience and highlighting the key processes, tensions, and flows. We broke the journey into phases, steps, emotions, and themes to get a clear picture of the overall experience levers for patients. RESULTS: The following themes promoted NIV tolerance: trust in the providers, the favorable impression of the facility and staff, understanding why the mask was needed, how NIV works and how long it will be needed, immediate relief of the threatening suffocating sensation, familiarity with similar treatments, use of meditation and mindfulness, and the realization that treatment was useful. The following themes deterred NIV tolerance: physical and psychological discomfort with the mask, impaired control, feeling of loss of control, and being misinformed. CONCLUSIONS: Understanding the reality of patients with COPD treated with NIV will help refine strategies that can improve their experience and tolerance with NIV. Future research should test ideas with the best potential and generate prototypes and design iterations to be tested with patients.

Noninvasive respiratory support for COVID-19 patients: when, for whom, and how?

The significant mortality rate and prolonged ventilator days associated with invasive mechanical ventilation (IMV) in patients with severe COVID-19 have incited a debate surrounding the use of noninvasive respiratory support (NIRS) (i.e., HFNC, CPAP, NIV) as a potential treatment strategy. Central to this debate is the role of NIRS in preventing intubation in patients with mild respiratory disease and the potential beneficial effects on both patient outcome and resource utilization. However, there remains valid concern that use of NIRS may prolong time to intubation and lung protective ventilation in patients with more advanced disease, thereby worsening respiratory mechanics via self-inflicted lung injury. In addition, the risk of aerosolization with the use of NIRS has the potential to increase healthcare worker (HCW) exposure to the virus. We review the existing literature with a focus on rationale, patient selection and outcomes associated with the use of NIRS in COVID-19 and prior pandemics, as well as in patients with acute respiratory failure due to different etiologies (i.e., COPD, cardiogenic pulmonary edema, etc.) to understand the potential role of NIRS in COVID-19 patients. Based on this analysis we suggest an algorithm for NIRS in COVID-19 patients which includes indications and contraindications for use, monitoring recommendations, systems-based practices to reduce HCW exposure, and predictors of NIRS failure. We also discuss future research priorities for addressing unanswered questions regarding NIRS use in COVID-19 with the goal of improving patient outcomes.

Update to the study protocol for an implementation-effectiveness trial comparing two education strategies for improving the uptake of noninvasive ventilation in patients with severe COPD exacerbation.

BACKGROUND: There is strong evidence that noninvasive ventilation (NIV) improves the outcomes of patients hospitalized with severe COPD exacerbation, and NIV is recommended as the first-line therapy for these patients. Yet, several studies have demonstrated substantial variation in NIV use across hospitals, leading to preventable morbidity and mortality. In addition, prior studies suggested that efforts to increase NIV use in COPD need to account for the complex and interdisciplinary nature of NIV delivery and the need for team coordination. Therefore, our initial project aimed to compare two educational strategies: online education (OLE) and interprofessional education (IPE), which targets complex team-based care in NIV delivery. Due to the impact of the COVID-19 pandemic on recruitment and planned intervention, we had made several changes in the study design, statistical analysis, and implementation strategies delivery as outlined in the methods. METHODS: We originally proposed a two-arm, pragmatic, cluster, randomized hybrid implementation-effectiveness trial comparing two education strategies to improve NIV uptake in patients with severe COPD exacerbation in 20 hospitals with a low baseline rate of NIV use. Due to logistical constrains and slow recruitment, we changed the study design to an opened cohort stepped-wedge design with three steps which will allow the institutions to enroll when they are ready to participate. Only the IPE strategy will be implemented, and the education will be provided in an online virtual format. Our primary outcome will be the hospital-level risk-standardized NIV proportion for the period post-IPE training, along with the change in rate from the period prior to training. Aim 1 will compare the change over time of NIV use among patients with COPD in the step-wedged design. Aim 2 will explore the mediators' role (respiratory therapist autonomy and team functionality) on the relationship between the implementation strategies and effectiveness. Finally, in Aim 3, through interviews with providers, we will assess the acceptability and feasibility of the educational training. CONCLUSION: The changes in study design will result in several limitation. Most importantly, the hospitals in the three cohorts are not randomized as they enroll based on their readiness. Second, the delivery of the IPE is virtual, and it is not known if remote education is conducive to team building. However, this study will be among the first to test the impact of IPE in the inpatient setting carefully and may generalize to other interventions directed to seriously ill patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT04206735 . Registered on December 20, 2019.

Enhancing Implementation of Complex Critical Care Interventions through Interprofessional Education.

Background: Many critical care interventions that require teamwork are adopted slowly and variably despite strong evidence supporting their use. We hypothesize that educational interventions that target the entire interprofessional team (rather than professions in isolation) are one effective way to enhance implementation of complex interventions in the intensive care unit (ICU). Objective: As a first step toward testing this hypothesis, we sought to qualitatively solicit opinions about team dynamics, evidence translation, and interprofessional education as well as current knowledge, attitudes, and practices surrounding the use of one example of a team-based practice in the ICU-preventive postextubation noninvasive ventilation (NIV). Methods: We conducted a qualitative evaluation using semistructured interviews and focus groups with nurses, respiratory therapists, and physicians working in four ICUs in four hospitals within an integrated health system. ICUs were selected based on variation in academic versus community status. We iteratively analyzed transcripts using a thematic content analysis approach. Results: From December 2018 to January 2019, we conducted 32 interviews (34 people) and 3 focus groups (20 people). Participants included 31 nurses, 15 respiratory therapists, and 8 physicians. Participants had favorable views of how their teams work together but discussed ways team dynamics (e.g., leader inclusiveness) impact care coordination. Participants viewed interprofessional education favorably and shared suggestions regarding preferred content and delivery (e.g., include both profession-specific and team-oriented content). Though participants reported frequently using NIV as a treatment, they described rarely using NIV as a preventive strategy, and nurses and respiratory therapists described challenges to use such as perceived patient discomfort. There were ICU-specific differences in management of patients at a high risk for respiratory failure after extubation, with some preferring to delay extubation. Conclusion: Participants reported optimism that interprofessional education can be an acceptable and effective way to improve translation of evidence into practice. Participants also detailed patient-specific and ICU-wide barriers to the implementation of preventive postextubation NIV. This information about teamwork in the ICU, suggestions for interprofessional education, and barriers and facilitators to use of a target evidence-based practice can inform the development of novel educational strategies in ways that increase acceptability, appropriateness, and feasibility of the intervention.

Optimal NIV Medicare Access Promotion: Patients With Thoracic Restrictive Disorders: A Technical Expert Panel Report From the American College of Chest Physicians, the American Association for Respiratory Care, the American Academy of Sleep Medicine, and the American Thoracic Society.

The existing coverage criteria for noninvasive ventilation (NIV) do not recognize the benefits of early initiation of NIV for those with thoracic restrictive disorders and do not address the unique needs for daytime support as the patients progress to ventilator dependence. This document summarizes the work of the thoracic restrictive disorder Technical Expert Panel working group. The most pressing current coverage barriers identified were: (1) delays in implementing NIV treatment; (2) lack of coverage for many nonprogressive neuromuscular diseases; and (3) lack of clear policy indications for home mechanical ventilation (HMV) support in thoracic restrictive disorders. To best address these issues, we make the following key recommendations: (1) given the need to encourage early initiation of NIV with bilevel positive airway pressure devices, we recommend that symptoms be considered as a reason to initiate therapy even at mildly reduced FVCs; (2) broaden CO2 measurements to include surrogates such as transcutaneous, end-tidal, or venous blood gas; (3) expand the diagnostic category to include phrenic nerve injuries and disorders of central drive; (4) allow a bilevel positive airway pressure device to be advanced to an HMV when the vital capacity is < 30% or to address severe daytime respiratory symptoms; and (5) provide additional HMV when the patient is ventilator dependent with use > 18 h per day. Adoption of these proposed recommendations would result in the right device, at the right time, for the right type of patients with thoracic restrictive disorders.

Evidence-Based Respiratory Care.

Evidence-based medicine is the integration of individual clinical expertise with the best available research and the patient's values and expectations. The efficient approach to finding the best evidence is to identify systematic reviews or evidence-based clinical practice guidelines. Respiratory therapies that are supported by evidence include lung-protective ventilation and noninvasive ventilation for individuals with COPD. Evidence does not support postoperative incentive spirometry or intermittent mandatory ventilation. The principles of evidence-based medicine are a valuable approach to respiratory care practice.