Federal Practitioner

Respiratory diseases have varied clinical presentations and are classified as restrictive, obstructive, mixed, or normal. Restrictive lung diseases have reduced lung volumes, either due to an alteration in lung parenchyma or a disease of the pleura, chest wall, or neuromuscular apparatus. If caused by parenchymal lung disease, restrictive lung disorders are accompanied by reduced gas transfer, which may be portrayed clinically by desaturation after exercise. Based on anatomical structures, the causes of lung volume reduction may be intrinsic or extrinsic. Intrinsic causes correspond to diseases of the lung parenchyma, such as idiopathic fibrotic diseases, connective-tissue diseases, drug-induced lung diseases, and other primary diseases of the lungs. Extrinsic causes refer to disorders outside the lungs or extra-pulmonary diseases such as neuromuscular and nonmuscular diseases of the chest wall.¹ For example, obesity and myasthenia gravis can cause restrictive lung diseases, one through mechanical interference of lung expansion and the other through neuromuscular impedance of thoracic cage expansion. All these diseases eventually result in lung restriction, impaired lung function, and respiratory failure. This heterogenicity of disease makes establishing a single severity criterion difficult.

Laboratory testing, imaging studies, and examinations are important for determining the pulmonary disease and its course and progression. The pulmonary function test (PFT), which consists of multiple procedures that are performed depending on the information needed, has been an essential tool in practice for the pulmonologist. The PFT includes spirometry, lung volume measurement, respiratory muscle strength, diffusion capacity, and a broncho-provocation test. Each test has a particular role in assisting the diagnosis and/or follow-up of the patient. Spirometry is frequently used due to its range of dynamic physiological parameters, ease of use, and accessibility. It is used for the diagnosis of pulmonary symptoms, in the assessment of disability, and preoperatory evaluation, including lung resection surgery, assisting in the diagnosis, monitoring, and therapy response of pulmonary diseases.

A systematic approach to PFT interpretation is recommended by several societies, such as the American Thoracic Society (ATS) and the European Respiratory Society (ERS).² The pulmonary function test results must be reproducible and meet established standards to ensure reliable and consistent clinical outcomes. A restrictive respiratory disease is defined by a decrease in total lung capacity (TLC) (< 5% of predicted value) and a normal forced expiratory volume in 1 second (FEV₁)/forced vital capacity (FVC) ratio.² Although other findings—such as a decrease in vital capacity—should prompt an investigation into whether the patient has a possible restrictive respiratory disease, the sole presence of this parameter is not definitive or diagnostic of a restrictive impairment.^2-4 The assessment of severity is typically determined by TLC. Unfortunately, the severity of a restrictive respiratory disease and the degree of patient discomfort do not always correlate when utilizing just TLC. Pulmonary sarcoidosis, for example, is a granulomatous lung disease with a restrictive PFT pattern and a disease burden that may vary over time. Having a more consistent method of grading the severity of the restrictive lung disease may help guide treatment. The modified Medical Research Council (mMRC) scale, a 5-point dyspnea scale, is widely used in assessing the severity of dyspnea in various respiratory conditions, including chronic obstructive pulmonary disease (COPD), where its scores have been associated with patient mortality.^1,5 The goal of this study was to document the associations between objective parameters obtained through PFT and other variables, with an established measurement of dyspnea to assess the severity grade of restrictive lung diseases.

Methods

This retrospective record review at the Veterans Affairs Caribbean Healthcare System (VACHS) in San Juan, Puerto Rico, wasconducted using the Veterans Health Information Systems and Technology Architecture to identify patients with a PFT, including spirometry, that indicated a restrictive ventilator pattern based on the current ATS/ERS Task Force on Lung Function Testing.² Patients were included if they were aged ≥ 21 years, PFT with TLC ≤ 80% predicted, mMRC score documented on PFT, and documented diffusing capacity of the lung for carbon monoxide (DLCO). Patients were excluded if their FEV₁/vital capacity (VC) was < 70% predicted using the largest VC, or no mMRC score was available. All patients meeting the inclusion criteria were considered regardless of comorbidities.

The PFT results of all adult patients, including those performed between June 1, 2013, and January 6, 2016, were submitted to spirometry, and lung volume measurements were analyzed. Sociodemographic information was collected, including sex, ethnicity, age, height, weight, and basal metabolic index. Other data found in PFTs, such as smoking status, smoking in packs/year, mMRC score, predicted TLC value, imaging present (chest X-ray, computed tomography), and hospitalizations and exacerbations within 1 year were collected. In addition, we examined the predicted values for FEV₁, DLCO, and DLCO/VA (calculated using the Ayer equation), FVC (calculated using the Knudson equation), expiratory reserve volume, inspiratory VC, and slow VC. PaO₂, PaCO₂, and Alveolar-arterial gradients also were collected.^6-9 Information about heart failure status was gathered through medical evaluation of notes and cardiac studies. All categorical variables were correlated with Spearman analysis and quantitative variables with average percentages. P values were calculated with analysis of variance.

 

 

Results

Of 6461 VACHS patient records reviewed, 415 met the inclusion criteria. Patients were divided according to their mMRC score: 65 had mMRC score of 0, 87 had an mMRC score of 1, 2 had an mMRC score of 2, 146 had an mMRC of 3, and 115 had an mMRC score of 4. The population was primarily male (98.6%) and of Hispanic ethnicity (96.4%), with a mean age of 72 years (Table 1). Most patients (n = 269, 64.0%) were prior smokers, while 135 patients (32.5%) had never smoked, and 11 (2.7%) were current smokers. At baseline, 169 patients (41.4%) had interstitial lung disease, 39 (9.6%) had chest wall disorders, 29 (7.1%) had occupational exposure, 25 (6.1%) had pneumonitis, and 14 (3.4%) had neuromuscular disorders.

There was a statistically significant relationship between mMRC score and hospitalization and FEV₁ but not TLC (Table 2). As mMRC increased, so did hospitalizations: a total of 168 patients (40.5%) were hospitalized; 24 patients (36.9%) had an mMRC score of 0, 30 patients (34.0%) had an mMRC score of 1, 2 patients (100%) had an mMRC score of 2, 54 patients (37.0%) had an mMRC score of 3, and 58 patients (50.0%) had an mMRC score of 4 (P = .04). Mean (SD) TLC values increased as mMRC scores increased. Mean (SD) TLC was 70.5% (33.0) for the entire population; 68.8% (7.2) for patients with an mMRC score of 0, 70.8% (5.8) for patients with an mMRC score of 1, 75.0% (1.4) for patients with an mMRC score of 2, 70.1% (7.2) for patients with an mMRC score of 3, and 71.5% (62.1) for patients with an mMRC score of 4 (P = .10) (Figure 1). There was an associated decrease in mean (SD) FEV₁ with mMRC. Mean (SD) FEV₁ was 76.2% (18.9) for the entire population; 81.7% (19.3) for patients with an mMRC score of 0, 80.9% (18) for patients with an mMRC score of 1, 93.5% (34.6) for patients with an mMRC score of 2, 76.2% (17.1) for patients with an mMRC score of 3, and 69.2% (19.4) for patients with an mMRC score of 4; (P < .001) (Figure 2).

The correlation between mMRC and FEV₁ (r = 0.25, P < .001) was stronger than the correlation between mMRC and TLC (r = 0.15, P < .001). The correlations for DLCO (P < .001), DLCO/VA (P < .001), hemoglobin (P < .02), and PaO₂ (P < .001) were all statistically significant (P < .005), but with no strong identifiable trend.

Discussion

The patient population of this study was primarily older males of Hispanic ethnicity with a history of smoking. There was no association between body mass index or smoking status with worsening dyspnea as measured with mMRC scores. We observed no significant correlation between mMRC scores and various factors such as comorbidities including heart conditions, and epidemiological factors like the etiology of lung disease, including both intrinsic and extrinsic causes. This lack of association was anticipated, as restrictive lung diseases in our study predominantly arose from intrinsic pulmonary etiologies, such as interstitial lung disease. A difference between more hospitalizations and worsening dyspnea was identified. There was a slightly higher correlation between FEV₁ and mMRC scores when compared with TLC and mMRC scores concerning worsening dyspnea, which could indicate that the use of FEV₁ should be preferred over previous recommendations to use TLC.¹⁰ Other guidelines have utilized exercise capacity via the 6-minute walk test as a marker of severity with spirometry values and found that DLCO was correlated with severity.¹¹

The latest ERS/ATS guidelines recommend z scores for grading the severity of obstructive lung diseases but do not recommend them for the diagnosis of restrictive lung diseases.¹² A z score encompasses diverse variables (eg, age, sex, and ethnicity) to provide more uniform and consistent results. Other studies have been done to relate z scores to other spirometry variables with restrictive lung disease. One such study indicates the potential benefit of using FVC alone to grade restrictive lung diseases.¹³ There continues to be great diversity in the interpretation of pulmonary function tests, and we believe the information gathered can provide valuable insight for managing patients with restrictive lung diseases.

Limitations

Only 2 patients reported an mMRC score of 2 in our study. This may have affected statistical outcomes. It also may reveal possible deficits in the efficacy of patient education on the mMRC scale. This study was also limited by its small sample size, single center location, and the distribution of patients that reported an mMRC favored either low or high values. The patients in this study, who were all veterans, may not be representative of other patient populations.

Conclusions

There continue to be few factors associated with the physiological severity of the defective oxygen delivery and reported dyspnea of a patient with restrictive lung disease that allows for an accurate, repeatable grading of severity. Using FEV₁ instead of TLC to determine the severity of a restrictive lung disease should be reconsidered. We could not find any other strong correlation among other factors studied. Further research should be conducted to continue looking for variables that more accurately depict patient dyspnea in restrictive lung disease.

Acknowledgments

This study is based upon work supported by the Veterans Affairs Caribbean Healthcare System in San Juan, Puerto Rico, and is the result of work supported by Pulmonary & Critical Care Medicine service, with resources and the use of its facilities.

Respiratory diseases have varied clinical presentations and are classified as restrictive, obstructive, mixed, or normal. Restrictive lung diseases have reduced lung volumes, either due to an alteration in lung parenchyma or a disease of the pleura, chest wall, or neuromuscular apparatus. If caused by parenchymal lung disease, restrictive lung disorders are accompanied by reduced gas transfer, which may be portrayed clinically by desaturation after exercise. Based on anatomical structures, the causes of lung volume reduction may be intrinsic or extrinsic. Intrinsic causes correspond to diseases of the lung parenchyma, such as idiopathic fibrotic diseases, connective-tissue diseases, drug-induced lung diseases, and other primary diseases of the lungs. Extrinsic causes refer to disorders outside the lungs or extra-pulmonary diseases such as neuromuscular and nonmuscular diseases of the chest wall.¹ For example, obesity and myasthenia gravis can cause restrictive lung diseases, one through mechanical interference of lung expansion and the other through neuromuscular impedance of thoracic cage expansion. All these diseases eventually result in lung restriction, impaired lung function, and respiratory failure. This heterogenicity of disease makes establishing a single severity criterion difficult.

Laboratory testing, imaging studies, and examinations are important for determining the pulmonary disease and its course and progression. The pulmonary function test (PFT), which consists of multiple procedures that are performed depending on the information needed, has been an essential tool in practice for the pulmonologist. The PFT includes spirometry, lung volume measurement, respiratory muscle strength, diffusion capacity, and a broncho-provocation test. Each test has a particular role in assisting the diagnosis and/or follow-up of the patient. Spirometry is frequently used due to its range of dynamic physiological parameters, ease of use, and accessibility. It is used for the diagnosis of pulmonary symptoms, in the assessment of disability, and preoperatory evaluation, including lung resection surgery, assisting in the diagnosis, monitoring, and therapy response of pulmonary diseases.

A systematic approach to PFT interpretation is recommended by several societies, such as the American Thoracic Society (ATS) and the European Respiratory Society (ERS).² The pulmonary function test results must be reproducible and meet established standards to ensure reliable and consistent clinical outcomes. A restrictive respiratory disease is defined by a decrease in total lung capacity (TLC) (< 5% of predicted value) and a normal forced expiratory volume in 1 second (FEV₁)/forced vital capacity (FVC) ratio.² Although other findings—such as a decrease in vital capacity—should prompt an investigation into whether the patient has a possible restrictive respiratory disease, the sole presence of this parameter is not definitive or diagnostic of a restrictive impairment.^2-4 The assessment of severity is typically determined by TLC. Unfortunately, the severity of a restrictive respiratory disease and the degree of patient discomfort do not always correlate when utilizing just TLC. Pulmonary sarcoidosis, for example, is a granulomatous lung disease with a restrictive PFT pattern and a disease burden that may vary over time. Having a more consistent method of grading the severity of the restrictive lung disease may help guide treatment. The modified Medical Research Council (mMRC) scale, a 5-point dyspnea scale, is widely used in assessing the severity of dyspnea in various respiratory conditions, including chronic obstructive pulmonary disease (COPD), where its scores have been associated with patient mortality.^1,5 The goal of this study was to document the associations between objective parameters obtained through PFT and other variables, with an established measurement of dyspnea to assess the severity grade of restrictive lung diseases.

Methods

This retrospective record review at the Veterans Affairs Caribbean Healthcare System (VACHS) in San Juan, Puerto Rico, wasconducted using the Veterans Health Information Systems and Technology Architecture to identify patients with a PFT, including spirometry, that indicated a restrictive ventilator pattern based on the current ATS/ERS Task Force on Lung Function Testing.² Patients were included if they were aged ≥ 21 years, PFT with TLC ≤ 80% predicted, mMRC score documented on PFT, and documented diffusing capacity of the lung for carbon monoxide (DLCO). Patients were excluded if their FEV₁/vital capacity (VC) was < 70% predicted using the largest VC, or no mMRC score was available. All patients meeting the inclusion criteria were considered regardless of comorbidities.

The PFT results of all adult patients, including those performed between June 1, 2013, and January 6, 2016, were submitted to spirometry, and lung volume measurements were analyzed. Sociodemographic information was collected, including sex, ethnicity, age, height, weight, and basal metabolic index. Other data found in PFTs, such as smoking status, smoking in packs/year, mMRC score, predicted TLC value, imaging present (chest X-ray, computed tomography), and hospitalizations and exacerbations within 1 year were collected. In addition, we examined the predicted values for FEV₁, DLCO, and DLCO/VA (calculated using the Ayer equation), FVC (calculated using the Knudson equation), expiratory reserve volume, inspiratory VC, and slow VC. PaO₂, PaCO₂, and Alveolar-arterial gradients also were collected.^6-9 Information about heart failure status was gathered through medical evaluation of notes and cardiac studies. All categorical variables were correlated with Spearman analysis and quantitative variables with average percentages. P values were calculated with analysis of variance.

 

 

Results

Of 6461 VACHS patient records reviewed, 415 met the inclusion criteria. Patients were divided according to their mMRC score: 65 had mMRC score of 0, 87 had an mMRC score of 1, 2 had an mMRC score of 2, 146 had an mMRC of 3, and 115 had an mMRC score of 4. The population was primarily male (98.6%) and of Hispanic ethnicity (96.4%), with a mean age of 72 years (Table 1). Most patients (n = 269, 64.0%) were prior smokers, while 135 patients (32.5%) had never smoked, and 11 (2.7%) were current smokers. At baseline, 169 patients (41.4%) had interstitial lung disease, 39 (9.6%) had chest wall disorders, 29 (7.1%) had occupational exposure, 25 (6.1%) had pneumonitis, and 14 (3.4%) had neuromuscular disorders.

There was a statistically significant relationship between mMRC score and hospitalization and FEV₁ but not TLC (Table 2). As mMRC increased, so did hospitalizations: a total of 168 patients (40.5%) were hospitalized; 24 patients (36.9%) had an mMRC score of 0, 30 patients (34.0%) had an mMRC score of 1, 2 patients (100%) had an mMRC score of 2, 54 patients (37.0%) had an mMRC score of 3, and 58 patients (50.0%) had an mMRC score of 4 (P = .04). Mean (SD) TLC values increased as mMRC scores increased. Mean (SD) TLC was 70.5% (33.0) for the entire population; 68.8% (7.2) for patients with an mMRC score of 0, 70.8% (5.8) for patients with an mMRC score of 1, 75.0% (1.4) for patients with an mMRC score of 2, 70.1% (7.2) for patients with an mMRC score of 3, and 71.5% (62.1) for patients with an mMRC score of 4 (P = .10) (Figure 1). There was an associated decrease in mean (SD) FEV₁ with mMRC. Mean (SD) FEV₁ was 76.2% (18.9) for the entire population; 81.7% (19.3) for patients with an mMRC score of 0, 80.9% (18) for patients with an mMRC score of 1, 93.5% (34.6) for patients with an mMRC score of 2, 76.2% (17.1) for patients with an mMRC score of 3, and 69.2% (19.4) for patients with an mMRC score of 4; (P < .001) (Figure 2).

The correlation between mMRC and FEV₁ (r = 0.25, P < .001) was stronger than the correlation between mMRC and TLC (r = 0.15, P < .001). The correlations for DLCO (P < .001), DLCO/VA (P < .001), hemoglobin (P < .02), and PaO₂ (P < .001) were all statistically significant (P < .005), but with no strong identifiable trend.

Discussion

The patient population of this study was primarily older males of Hispanic ethnicity with a history of smoking. There was no association between body mass index or smoking status with worsening dyspnea as measured with mMRC scores. We observed no significant correlation between mMRC scores and various factors such as comorbidities including heart conditions, and epidemiological factors like the etiology of lung disease, including both intrinsic and extrinsic causes. This lack of association was anticipated, as restrictive lung diseases in our study predominantly arose from intrinsic pulmonary etiologies, such as interstitial lung disease. A difference between more hospitalizations and worsening dyspnea was identified. There was a slightly higher correlation between FEV₁ and mMRC scores when compared with TLC and mMRC scores concerning worsening dyspnea, which could indicate that the use of FEV₁ should be preferred over previous recommendations to use TLC.¹⁰ Other guidelines have utilized exercise capacity via the 6-minute walk test as a marker of severity with spirometry values and found that DLCO was correlated with severity.¹¹

The latest ERS/ATS guidelines recommend z scores for grading the severity of obstructive lung diseases but do not recommend them for the diagnosis of restrictive lung diseases.¹² A z score encompasses diverse variables (eg, age, sex, and ethnicity) to provide more uniform and consistent results. Other studies have been done to relate z scores to other spirometry variables with restrictive lung disease. One such study indicates the potential benefit of using FVC alone to grade restrictive lung diseases.¹³ There continues to be great diversity in the interpretation of pulmonary function tests, and we believe the information gathered can provide valuable insight for managing patients with restrictive lung diseases.

Limitations

Only 2 patients reported an mMRC score of 2 in our study. This may have affected statistical outcomes. It also may reveal possible deficits in the efficacy of patient education on the mMRC scale. This study was also limited by its small sample size, single center location, and the distribution of patients that reported an mMRC favored either low or high values. The patients in this study, who were all veterans, may not be representative of other patient populations.

Conclusions

There continue to be few factors associated with the physiological severity of the defective oxygen delivery and reported dyspnea of a patient with restrictive lung disease that allows for an accurate, repeatable grading of severity. Using FEV₁ instead of TLC to determine the severity of a restrictive lung disease should be reconsidered. We could not find any other strong correlation among other factors studied. Further research should be conducted to continue looking for variables that more accurately depict patient dyspnea in restrictive lung disease.

Acknowledgments

This study is based upon work supported by the Veterans Affairs Caribbean Healthcare System in San Juan, Puerto Rico, and is the result of work supported by Pulmonary & Critical Care Medicine service, with resources and the use of its facilities.

Respiratory diseases have varied clinical presentations and are classified as restrictive, obstructive, mixed, or normal. Restrictive lung diseases have reduced lung volumes, either due to an alteration in lung parenchyma or a disease of the pleura, chest wall, or neuromuscular apparatus. If caused by parenchymal lung disease, restrictive lung disorders are accompanied by reduced gas transfer, which may be portrayed clinically by desaturation after exercise. Based on anatomical structures, the causes of lung volume reduction may be intrinsic or extrinsic. Intrinsic causes correspond to diseases of the lung parenchyma, such as idiopathic fibrotic diseases, connective-tissue diseases, drug-induced lung diseases, and other primary diseases of the lungs. Extrinsic causes refer to disorders outside the lungs or extra-pulmonary diseases such as neuromuscular and nonmuscular diseases of the chest wall.¹ For example, obesity and myasthenia gravis can cause restrictive lung diseases, one through mechanical interference of lung expansion and the other through neuromuscular impedance of thoracic cage expansion. All these diseases eventually result in lung restriction, impaired lung function, and respiratory failure. This heterogenicity of disease makes establishing a single severity criterion difficult.

Laboratory testing, imaging studies, and examinations are important for determining the pulmonary disease and its course and progression. The pulmonary function test (PFT), which consists of multiple procedures that are performed depending on the information needed, has been an essential tool in practice for the pulmonologist. The PFT includes spirometry, lung volume measurement, respiratory muscle strength, diffusion capacity, and a broncho-provocation test. Each test has a particular role in assisting the diagnosis and/or follow-up of the patient. Spirometry is frequently used due to its range of dynamic physiological parameters, ease of use, and accessibility. It is used for the diagnosis of pulmonary symptoms, in the assessment of disability, and preoperatory evaluation, including lung resection surgery, assisting in the diagnosis, monitoring, and therapy response of pulmonary diseases.

A systematic approach to PFT interpretation is recommended by several societies, such as the American Thoracic Society (ATS) and the European Respiratory Society (ERS).² The pulmonary function test results must be reproducible and meet established standards to ensure reliable and consistent clinical outcomes. A restrictive respiratory disease is defined by a decrease in total lung capacity (TLC) (< 5% of predicted value) and a normal forced expiratory volume in 1 second (FEV₁)/forced vital capacity (FVC) ratio.² Although other findings—such as a decrease in vital capacity—should prompt an investigation into whether the patient has a possible restrictive respiratory disease, the sole presence of this parameter is not definitive or diagnostic of a restrictive impairment.^2-4 The assessment of severity is typically determined by TLC. Unfortunately, the severity of a restrictive respiratory disease and the degree of patient discomfort do not always correlate when utilizing just TLC. Pulmonary sarcoidosis, for example, is a granulomatous lung disease with a restrictive PFT pattern and a disease burden that may vary over time. Having a more consistent method of grading the severity of the restrictive lung disease may help guide treatment. The modified Medical Research Council (mMRC) scale, a 5-point dyspnea scale, is widely used in assessing the severity of dyspnea in various respiratory conditions, including chronic obstructive pulmonary disease (COPD), where its scores have been associated with patient mortality.^1,5 The goal of this study was to document the associations between objective parameters obtained through PFT and other variables, with an established measurement of dyspnea to assess the severity grade of restrictive lung diseases.

Methods

This retrospective record review at the Veterans Affairs Caribbean Healthcare System (VACHS) in San Juan, Puerto Rico, wasconducted using the Veterans Health Information Systems and Technology Architecture to identify patients with a PFT, including spirometry, that indicated a restrictive ventilator pattern based on the current ATS/ERS Task Force on Lung Function Testing.² Patients were included if they were aged ≥ 21 years, PFT with TLC ≤ 80% predicted, mMRC score documented on PFT, and documented diffusing capacity of the lung for carbon monoxide (DLCO). Patients were excluded if their FEV₁/vital capacity (VC) was < 70% predicted using the largest VC, or no mMRC score was available. All patients meeting the inclusion criteria were considered regardless of comorbidities.

The PFT results of all adult patients, including those performed between June 1, 2013, and January 6, 2016, were submitted to spirometry, and lung volume measurements were analyzed. Sociodemographic information was collected, including sex, ethnicity, age, height, weight, and basal metabolic index. Other data found in PFTs, such as smoking status, smoking in packs/year, mMRC score, predicted TLC value, imaging present (chest X-ray, computed tomography), and hospitalizations and exacerbations within 1 year were collected. In addition, we examined the predicted values for FEV₁, DLCO, and DLCO/VA (calculated using the Ayer equation), FVC (calculated using the Knudson equation), expiratory reserve volume, inspiratory VC, and slow VC. PaO₂, PaCO₂, and Alveolar-arterial gradients also were collected.^6-9 Information about heart failure status was gathered through medical evaluation of notes and cardiac studies. All categorical variables were correlated with Spearman analysis and quantitative variables with average percentages. P values were calculated with analysis of variance.

 

 

Results

Of 6461 VACHS patient records reviewed, 415 met the inclusion criteria. Patients were divided according to their mMRC score: 65 had mMRC score of 0, 87 had an mMRC score of 1, 2 had an mMRC score of 2, 146 had an mMRC of 3, and 115 had an mMRC score of 4. The population was primarily male (98.6%) and of Hispanic ethnicity (96.4%), with a mean age of 72 years (Table 1). Most patients (n = 269, 64.0%) were prior smokers, while 135 patients (32.5%) had never smoked, and 11 (2.7%) were current smokers. At baseline, 169 patients (41.4%) had interstitial lung disease, 39 (9.6%) had chest wall disorders, 29 (7.1%) had occupational exposure, 25 (6.1%) had pneumonitis, and 14 (3.4%) had neuromuscular disorders.

There was a statistically significant relationship between mMRC score and hospitalization and FEV₁ but not TLC (Table 2). As mMRC increased, so did hospitalizations: a total of 168 patients (40.5%) were hospitalized; 24 patients (36.9%) had an mMRC score of 0, 30 patients (34.0%) had an mMRC score of 1, 2 patients (100%) had an mMRC score of 2, 54 patients (37.0%) had an mMRC score of 3, and 58 patients (50.0%) had an mMRC score of 4 (P = .04). Mean (SD) TLC values increased as mMRC scores increased. Mean (SD) TLC was 70.5% (33.0) for the entire population; 68.8% (7.2) for patients with an mMRC score of 0, 70.8% (5.8) for patients with an mMRC score of 1, 75.0% (1.4) for patients with an mMRC score of 2, 70.1% (7.2) for patients with an mMRC score of 3, and 71.5% (62.1) for patients with an mMRC score of 4 (P = .10) (Figure 1). There was an associated decrease in mean (SD) FEV₁ with mMRC. Mean (SD) FEV₁ was 76.2% (18.9) for the entire population; 81.7% (19.3) for patients with an mMRC score of 0, 80.9% (18) for patients with an mMRC score of 1, 93.5% (34.6) for patients with an mMRC score of 2, 76.2% (17.1) for patients with an mMRC score of 3, and 69.2% (19.4) for patients with an mMRC score of 4; (P < .001) (Figure 2).

The correlation between mMRC and FEV₁ (r = 0.25, P < .001) was stronger than the correlation between mMRC and TLC (r = 0.15, P < .001). The correlations for DLCO (P < .001), DLCO/VA (P < .001), hemoglobin (P < .02), and PaO₂ (P < .001) were all statistically significant (P < .005), but with no strong identifiable trend.

Discussion

The patient population of this study was primarily older males of Hispanic ethnicity with a history of smoking. There was no association between body mass index or smoking status with worsening dyspnea as measured with mMRC scores. We observed no significant correlation between mMRC scores and various factors such as comorbidities including heart conditions, and epidemiological factors like the etiology of lung disease, including both intrinsic and extrinsic causes. This lack of association was anticipated, as restrictive lung diseases in our study predominantly arose from intrinsic pulmonary etiologies, such as interstitial lung disease. A difference between more hospitalizations and worsening dyspnea was identified. There was a slightly higher correlation between FEV₁ and mMRC scores when compared with TLC and mMRC scores concerning worsening dyspnea, which could indicate that the use of FEV₁ should be preferred over previous recommendations to use TLC.¹⁰ Other guidelines have utilized exercise capacity via the 6-minute walk test as a marker of severity with spirometry values and found that DLCO was correlated with severity.¹¹

The latest ERS/ATS guidelines recommend z scores for grading the severity of obstructive lung diseases but do not recommend them for the diagnosis of restrictive lung diseases.¹² A z score encompasses diverse variables (eg, age, sex, and ethnicity) to provide more uniform and consistent results. Other studies have been done to relate z scores to other spirometry variables with restrictive lung disease. One such study indicates the potential benefit of using FVC alone to grade restrictive lung diseases.¹³ There continues to be great diversity in the interpretation of pulmonary function tests, and we believe the information gathered can provide valuable insight for managing patients with restrictive lung diseases.

Limitations

Only 2 patients reported an mMRC score of 2 in our study. This may have affected statistical outcomes. It also may reveal possible deficits in the efficacy of patient education on the mMRC scale. This study was also limited by its small sample size, single center location, and the distribution of patients that reported an mMRC favored either low or high values. The patients in this study, who were all veterans, may not be representative of other patient populations.

Conclusions

There continue to be few factors associated with the physiological severity of the defective oxygen delivery and reported dyspnea of a patient with restrictive lung disease that allows for an accurate, repeatable grading of severity. Using FEV₁ instead of TLC to determine the severity of a restrictive lung disease should be reconsidered. We could not find any other strong correlation among other factors studied. Further research should be conducted to continue looking for variables that more accurately depict patient dyspnea in restrictive lung disease.

Acknowledgments

This study is based upon work supported by the Veterans Affairs Caribbean Healthcare System in San Juan, Puerto Rico, and is the result of work supported by Pulmonary & Critical Care Medicine service, with resources and the use of its facilities.

Increasing complexities within health care systems are significant impediments to the consistent delivery of safe and effective patient care. These impediments include an increase in specialization of care, staff shortages, burnout, poor coordination of services and access to care, as well as rising costs.¹ High reliability organizations (HROs) provide safe, high-quality, and effective care in highly complex and risk-prone environments without causing harm or experiencing catastrophic events.²

Within the US Department of Veterans Affairs (VA), the Veterans Health Administration (VHA) operates the nation’s largest integrated health care system, providing care to > 9 million veterans. The VHA formally launched plans for an enterprise-wide HRO in February 2019. During the first year, 18 medical facilities comprised cohort1 of the journey to high reliability. Cohort 2 began in October 2020 and consisted of 54 facilities. Cohort 3 started in October 2021 with 67 facilities.³

Health care organizations seeking high reliability exercise a philosophy aimed at learning from errors and addressing system failures. High reliability is accomplished by implementing 5 principles: (1) sensitivity to operations (a heightened understanding of the current state of systems); (2) preoccupation with failure (striving to anticipate risks that might suggest a much larger system problem); (3) reluctance to simplify (avoiding making any assumptions regarding the causes of failures); (4) commitment to resilience (preparing for potential failures and bouncing back when they occur); and (5) deference to expertise (deferring to individuals with the skills and proficiency to make the best decisions).² The VHA also recognized that a successful journey to high reliability—in addition to achieving a culture of safety—relies on the implementation of foundational HRO practices: leader rounding, visual management systems, safety forums, and safety huddles. This article describes an initiative for how these foundational practices were implemented in a large integrated health care system.

BACKGROUND

The VHA has focused on 4 foundational components as part of its enterprise activities and support structure to implement HRO principles and practices. These components were selected based on pilot activities that preceded the enterprise-wide effort, reviews of the literature, and expert consultation with both government and private sector health systems. To support the implementation of these practices, the VHA provided training, toolkits, HRO executive leader coaching, and peer-to-peer mentoring. As the VHA enters its fifth year seeking high reliability, we undertook an initiative to reflect on our own experiences and refine our practices based on an updated literature review.

As part of this enterprise-wide initiative, we conducted a literature review from 2018 to March 2023 seeking recent evidence describing the value of implementing the 4 foundational HRO practices to advance high reliability and improve patient safety. A 5-year period was used to ensure recency and value of evidence.

Eligible literature was identified in PubMed, PsycINFO, the Cumulative Index to Nursing and Allied Health Literature, ScienceDirect, Scopus, the Cochrane Library, and ProQuest Dissertations & Theses Global. Inclusion and exclusion criteria were peer-reviewed interdisciplinary documents(eg, publications, dissertations, conference proceedings, and grey literature) written in English. Search terms included high reliability organizations, foundational practices, and patient safety. Boolean operators (AND, OR) were also used in the search. The search resulted in a dearth of evidence that addressed implementation of all 4 foundational practices across a health care system. Retrieved evidence focused on the implementation of only 1 particular foundational practice in a specific health care setting. In addition to describing the formal processes for the implementation of each foundational HRO practice, a brief description of representative examples of strong practices within the VHA is provided.

To support the implementation of HROs, the VHA paired HRO executive leader coaches with select medical center directors and their leadership teams. Executive leader coaches also support an organization’s HRO Lead and HRO Champion. The HRO Lead coordinates and facilitates the implementation of HRO principles and practices in pursuit of no harm across an organization. The HRO Champion supports the same as the HRO Lead, but typically has a different specialty background. For example, if the HRO Lead has an administrative background, the HRO Champion would have a clinical background.

Coaching focuses heavily on supporting site-specific implementation and sustainment of the 4 HRO foundational practices. The aim is to accelerate change, build enduring capacity, foster a safety culture, and accelerate HRO maturity. To measure change, HRO executive leader coaches track the progress of their aligned VA medical centers (VAMCs) using the Organizational Learning Tool (OLT). This tool was developed to provide information such as a facility summary and relationships between a medical center director, HRO Lead, HRO Champion, and the executive leader coach (Figure 1). The OLT also serves as a structured process to measure leader coaching performance against mutually agreed upon objectives that ultimately contribute to enterprise outcomes. It also collects data on the progress in implementing foundational practices, strong practices, needs and gaps, and more (Figure 2). Data collected from facilities supported by HRO executive leader coaches on whether foundational practices are in place are briefly described.

Leader Rounding

Leader rounding for high reliability ensures effective, bidirectional communication and collaboration among all disciplines to improve patient safety. It is an essential feature of a robust patient safety culture and an important method for demonstrating leadership engagement with high reliability.^4,5 These rounds are conducted by organizational leadership (eg, executive teams, department/service chiefs, or unit managers) and frontline staff from different areas. They are specifically focused on high reliability, patient and staff safety, and improvement efforts. The aim is to learn about daily challenges that may contribute to patient harm.⁴

Leader rounding has been found to be highly effective at improving leadership visibility across the organization. It enhances interaction and open communication with frontline staff, fostering leader-staff collaboration and shared decision-making, as well as promoting leadership understanding of operational, clinical, nonclinical (eg, administrative, nutrition services, or facilities management), and patient/family experience issues.⁴ Collaboration among team members fosters the delivery of more effective and efficient care, increases staff satisfaction, and improves employee retention.⁶ Leader rounding for high reliability significantly contributes to the breakdown of power barriers by giving team members voice and agency, ultimately leading to deeper engagement.⁷

It is important that leader rounding for high reliability occurs as planned and when possible, scheduled in advance. This helps to avoid rounding at peak times when care activities are being performed.^4,6 When scheduling conflicts arise, another leader should be sent to participate in rounds.⁴ Developing a list of questions in advance allows leadership to prepare messaging to share with staff as it relates to high reliability and patient safety (Table).^4,6,8

Closing the loop improves bidirectional communication and is critical to leader rounding for high reliability. Closed-loop communication and following up on and/or closing out issues raised during rounding empowers the sharing of information, which is critical for advancing a culture of safety.^4,8 Enhanced feedback is also associated with greater workforce engagement, staff feeling more connected to quality improvement activities, and lower rates of employee burnout.⁷ It is important to recognize that senior leaders are not responsible for resolving all issues. If a team or manager can resolve concerns that are raised, this should be encouraged and supported. Maintaining accountability at the lowest level of the organization promotes principles and practices of high reliability (Figure 3).^4,8

The VA Bedford Healthcare System created and implemented a strong practice for leader rounding for high reliability. This phased implementation involved creating an evidence-based process, deciding on an appropriate cadence, developing a tracking tool, and measuring impact to determine the overall effectiveness of leader rounding for high reliability.⁴

 

 

Visual Management Systems

A visual management system (VMS) displays clinical and operational performance aligned with HRO goals and practices. It is used to view and guide discussions between interdisciplinary teams during tiered safety huddles, leader rounds for high reliability, and frontline staff on the current status and safety trends in a particular area.^8,9 A VMS is highly effective in creating an environment where all staff members, especially frontline workers, feel empowered to voice their concerns related to safety or to identify improvement opportunities.^8,10 Increased leader engagement in patient safety and heightened transparency of information associated with the use of a VMS improves staff morale and professional satisfaction.¹⁰

A VMS may be a dry-erase or whiteboard display, paper-based display, or electronic status board.⁸ VMSs are usually located in or near work settings (eg, nurses’ station, staff break room, or conference room).⁸ Although they can take different forms and display several types of information, a VMS should be easy to update and meet the specific needs of a work area. In the VHA, a VMS displays: (1) essential information for staff members to effectively perform their work; (2) improvement project ideas; (3) current work in progress; (4) tracking of implemented improvement activities; (5) strong practices that have been effective; and (6) staff recognition for those who have enhanced patient safety, including the reporting of close calls and near misses.

The VHA uses the MESS (methods, equipment, staffing, and supplies) VMS format. This format empowers staff to identify whether proper procedures and practices are in place, essential equipment and supplies are readily available in the quantity needed, and appropriate staffing is on hand to provide safe, high-quality patient care.⁸ Colored magnets are used as visual cues in a stoplight classification system to identify low or no safety risks (green), at risk (yellow), or high risk (red). Green coded issues are addressed locally by a manager or supervisor. Yellow coded concerns require increased staff and leadership vigilance. Red coded issues indicate that patient care would be impacted that day and therefore need to be immediately escalated and addressed with senior leaders to mitigate the threat.^4,11 Dayton VAMC successfully implemented a VMS, using both physical and electronic visual management boards. The Dayton VAMC VMS boards are closely tied to tiered safety huddles and leader rounding for high reliability.   

Safety Forums

Safety forums are another foundational practice of VHA health care organizations seeking high reliability. Recurring monthly, safety forums focus on reinforcing HRO principles and practices, safety programs, the importance and appreciation of reporting, and just culture. The emphasis on just culture reminds staff that adverse events in the organization are viewed as valuable learning opportunities to understand the factors leading to the situation as opposed to immediately assigning blame.¹²

Psychological safety is another important focus. When individuals feel psychologically safe, they are more likely to voice concerns and act without fear of reprisal, which supports a culture of safety.¹³ Safety forums are open to all members of the health care organization, including both clinical and nonclinical staff. Forums can be conducted by an HRO Lead, HRO Champion, Patient Safety Manager, or even executive leadership. Rotating the responsibility of leading these forums demonstrates that high reliability and safety are everyone’s responsibility.

Safety forums publicly review and discuss errors, adverse events, close calls, and near misses. Time is also spent discussing root cause analysis trends and highlighting continuous process improvement principles and current projects. During safety forums, leaders should recognize individuals for safety behaviors and reward reporting through a safety awards program.¹⁴ All forums should conclude with a question-and-answer session. Forums typically occur in virtual 30-minute sessions but can last up to 60 minutes when guest speakers attend and continuing education credit is offered.

The Jesse Brown VAMC in Chicago developed an interactive monthly safety forum appealing to a broad audience. Each forum is attended by about 200 staff members and includes leader engagement and panel discussions led by the chief medical officer, with topics on both patient and team safety connecting with HRO principles. A planning committee prepares guest speakers and offers continuing education credits.

 

 

Tiered Safety Huddles

Based on the processes of high reliability industries like aviation and nuclear power, tiered safety huddles have been increasingly adopted in health care. Huddles (health care, utilizing, deliberate, discussion,linking, and events) are department-level interdisciplinary meetings that last no more than 15 minutes.¹⁵ Their purpose is to improve communication by sharing day-to-day information across multiple disciplines, identify issues that may impact the delivery of care (eg, patient and staff safety concerns, staffing issues, or inadequate supplies) and resolve problems.

Tiered safety huddles are gaining popularity, especially in organizations seeking high reliability. They are more complex than traditional huddles because of the mechanics of elevating safety issues (eg, bedside to executive leadership teams), feedback loops, and sequencing, among other factors.^15,16

Tiered safety huddles are focused, transparent forums with multidisciplinary staff, including frontline workers, along with senior leadership.^15,16 When initially implemented, tiered safety huddles may take longer than the suggested 15 minutes; however, as teams become more experienced, huddles become more efficient.¹⁵ The goal of tiered safety huddles is to proactively identify, share, address, and resolve problems that have the potential to impact the delivery of safe and quality patient care. This may include addressing staffing shortfalls, inadequate allocation of supplies and equipment, operational issues, etc.^8,15 Critical to theeffective utilization of tiered safety huddles is the appropriate escalation of issues between tiers. The most critical issues are elevated to higher tiers so they are addressed by the most qualified person in the organization.

Deciding on the number of tiers typically depends on the size and scope of services provided by the health care organization or integrated system. For example, tiered huddles in the VHA originate at the point of service (eg, critical care unit). Tier 1 includes staff members at the unit/team level along with immediate supervisors/managers. Tier 2 involves departments and service lines (eg, pharmacy, podiatry, or internal medicine) including their respective leadership. Tier 3 is the executive leadership team. This process allows for bidirectional communication instead of the traditional hierarchical communication pathway (Figure 4). Issues identified that cannot be addressed at a particular tier are elevated to the next tier. Elevated issues typically involve systems or processes requiring attention and resolution by senior leadership.¹⁵ Tier 4 huddles at the Veterans Integrated Services Network level and Tier 5 huddles at the VHA Central Office level are being initiated. These additional levels will more effectively identify system-level risks and issues that may impact multiple VHA facilities and may be addressed through centralized functions and resources.

Tiered safety huddles have been found to be instrumental to ensuring the flow of information across organizations, improving multidisciplinary and leadership engagement and collaboration, as well as increasing accountability for safety. Tiered safety huddles increase situational awareness, which improves an organization’s ability to appropriately respond to safety concerns. Furthermore, tiered safety huddles enhance teamwork and interprofessional collaboration, and have been found to significantly increase the reporting of patient safety events.^15-19

The VA Connecticut Healthcare System tiered huddles followed a pilot testing implementation process. After receiving executive-level commitment, an evidence-based process was enacted, including staff education, selecting a VMS, determining tier interaction, and deciding on metrics to track.¹⁵

Implementing Foundational Practices

To examine the progress of the implementation of the 4 foundational HRO practices, quarterly metrics derived from the OLT are reviewed to determine whether each is being implemented and sustained. The OLT also tracks progress over time. For example, at the 27 cohort 2 and lead sites that initiated leader coaching in 2021 and continued through 2022, coaches observed a 27% increase in leader rounding for high reliability and a 46% increase in the use of VMSs. For the 66 cohort 3 sites that began leader coaching in 2022, coaches documented similar changes, ranging from a 40% increase in leader rounding for high reliability to a 66% increase in the use of safety forums. Additional data continue to be collected and analyzed to publish more comprehensive findings.

DISCUSSION

Incorporating leader rounding for high reliability, VMSs, safety forums, and tiered safety huddles into daily operations is critical to building and sustaining a robust culture of safety.⁸ The 4 foundational HRO practices are instrumental in providing psychologically safe forums for staff to share concerns and actively participate. These practices also promote continual, efficient bidirectional communication throughout organizational lines and across services. The increased visibility and transparency of leaders demonstrate the importance of fostering trust, enhancing closed-loop communication with issues that arise, and building momentum to achieve high reliability. The interconnectedness of the foundational HRO practices identified and implemented by the VHA helps foster teamwork and collaboration built on trust, respect, enthusiasm for improvement, and the delivery of exceptional patient care.

CONCLUSIONS

Incorporating the 4 foundational practices into daily operations is beneficial to the delivery of safe, high-quality health care. This effective and sustained application can strengthen a health care organization on its journey to high reliability and establishing a culture of safety. To be effective, these foundational practices should be personalized to support the unique circumstances of every health care environment. While the exact methodology by which organizations implement these practices may differ, they will help organizations approach patient safety in a more transparent and thoughtful manner.

Acknowledgments

The authors thank Aaron M. Sawyer, PhD, PMP, and Jessica Fankhauser, MA, for their unwavering administrative support, and Jeff Wright for exceptional graphic design support.

Increasing complexities within health care systems are significant impediments to the consistent delivery of safe and effective patient care. These impediments include an increase in specialization of care, staff shortages, burnout, poor coordination of services and access to care, as well as rising costs.¹ High reliability organizations (HROs) provide safe, high-quality, and effective care in highly complex and risk-prone environments without causing harm or experiencing catastrophic events.²

Within the US Department of Veterans Affairs (VA), the Veterans Health Administration (VHA) operates the nation’s largest integrated health care system, providing care to > 9 million veterans. The VHA formally launched plans for an enterprise-wide HRO in February 2019. During the first year, 18 medical facilities comprised cohort1 of the journey to high reliability. Cohort 2 began in October 2020 and consisted of 54 facilities. Cohort 3 started in October 2021 with 67 facilities.³

Health care organizations seeking high reliability exercise a philosophy aimed at learning from errors and addressing system failures. High reliability is accomplished by implementing 5 principles: (1) sensitivity to operations (a heightened understanding of the current state of systems); (2) preoccupation with failure (striving to anticipate risks that might suggest a much larger system problem); (3) reluctance to simplify (avoiding making any assumptions regarding the causes of failures); (4) commitment to resilience (preparing for potential failures and bouncing back when they occur); and (5) deference to expertise (deferring to individuals with the skills and proficiency to make the best decisions).² The VHA also recognized that a successful journey to high reliability—in addition to achieving a culture of safety—relies on the implementation of foundational HRO practices: leader rounding, visual management systems, safety forums, and safety huddles. This article describes an initiative for how these foundational practices were implemented in a large integrated health care system.

BACKGROUND

The VHA has focused on 4 foundational components as part of its enterprise activities and support structure to implement HRO principles and practices. These components were selected based on pilot activities that preceded the enterprise-wide effort, reviews of the literature, and expert consultation with both government and private sector health systems. To support the implementation of these practices, the VHA provided training, toolkits, HRO executive leader coaching, and peer-to-peer mentoring. As the VHA enters its fifth year seeking high reliability, we undertook an initiative to reflect on our own experiences and refine our practices based on an updated literature review.

As part of this enterprise-wide initiative, we conducted a literature review from 2018 to March 2023 seeking recent evidence describing the value of implementing the 4 foundational HRO practices to advance high reliability and improve patient safety. A 5-year period was used to ensure recency and value of evidence.

Eligible literature was identified in PubMed, PsycINFO, the Cumulative Index to Nursing and Allied Health Literature, ScienceDirect, Scopus, the Cochrane Library, and ProQuest Dissertations & Theses Global. Inclusion and exclusion criteria were peer-reviewed interdisciplinary documents(eg, publications, dissertations, conference proceedings, and grey literature) written in English. Search terms included high reliability organizations, foundational practices, and patient safety. Boolean operators (AND, OR) were also used in the search. The search resulted in a dearth of evidence that addressed implementation of all 4 foundational practices across a health care system. Retrieved evidence focused on the implementation of only 1 particular foundational practice in a specific health care setting. In addition to describing the formal processes for the implementation of each foundational HRO practice, a brief description of representative examples of strong practices within the VHA is provided.

To support the implementation of HROs, the VHA paired HRO executive leader coaches with select medical center directors and their leadership teams. Executive leader coaches also support an organization’s HRO Lead and HRO Champion. The HRO Lead coordinates and facilitates the implementation of HRO principles and practices in pursuit of no harm across an organization. The HRO Champion supports the same as the HRO Lead, but typically has a different specialty background. For example, if the HRO Lead has an administrative background, the HRO Champion would have a clinical background.

Coaching focuses heavily on supporting site-specific implementation and sustainment of the 4 HRO foundational practices. The aim is to accelerate change, build enduring capacity, foster a safety culture, and accelerate HRO maturity. To measure change, HRO executive leader coaches track the progress of their aligned VA medical centers (VAMCs) using the Organizational Learning Tool (OLT). This tool was developed to provide information such as a facility summary and relationships between a medical center director, HRO Lead, HRO Champion, and the executive leader coach (Figure 1). The OLT also serves as a structured process to measure leader coaching performance against mutually agreed upon objectives that ultimately contribute to enterprise outcomes. It also collects data on the progress in implementing foundational practices, strong practices, needs and gaps, and more (Figure 2). Data collected from facilities supported by HRO executive leader coaches on whether foundational practices are in place are briefly described.

Leader Rounding

Leader rounding for high reliability ensures effective, bidirectional communication and collaboration among all disciplines to improve patient safety. It is an essential feature of a robust patient safety culture and an important method for demonstrating leadership engagement with high reliability.^4,5 These rounds are conducted by organizational leadership (eg, executive teams, department/service chiefs, or unit managers) and frontline staff from different areas. They are specifically focused on high reliability, patient and staff safety, and improvement efforts. The aim is to learn about daily challenges that may contribute to patient harm.⁴

Leader rounding has been found to be highly effective at improving leadership visibility across the organization. It enhances interaction and open communication with frontline staff, fostering leader-staff collaboration and shared decision-making, as well as promoting leadership understanding of operational, clinical, nonclinical (eg, administrative, nutrition services, or facilities management), and patient/family experience issues.⁴ Collaboration among team members fosters the delivery of more effective and efficient care, increases staff satisfaction, and improves employee retention.⁶ Leader rounding for high reliability significantly contributes to the breakdown of power barriers by giving team members voice and agency, ultimately leading to deeper engagement.⁷

It is important that leader rounding for high reliability occurs as planned and when possible, scheduled in advance. This helps to avoid rounding at peak times when care activities are being performed.^4,6 When scheduling conflicts arise, another leader should be sent to participate in rounds.⁴ Developing a list of questions in advance allows leadership to prepare messaging to share with staff as it relates to high reliability and patient safety (Table).^4,6,8

Closing the loop improves bidirectional communication and is critical to leader rounding for high reliability. Closed-loop communication and following up on and/or closing out issues raised during rounding empowers the sharing of information, which is critical for advancing a culture of safety.^4,8 Enhanced feedback is also associated with greater workforce engagement, staff feeling more connected to quality improvement activities, and lower rates of employee burnout.⁷ It is important to recognize that senior leaders are not responsible for resolving all issues. If a team or manager can resolve concerns that are raised, this should be encouraged and supported. Maintaining accountability at the lowest level of the organization promotes principles and practices of high reliability (Figure 3).^4,8

The VA Bedford Healthcare System created and implemented a strong practice for leader rounding for high reliability. This phased implementation involved creating an evidence-based process, deciding on an appropriate cadence, developing a tracking tool, and measuring impact to determine the overall effectiveness of leader rounding for high reliability.⁴

 

 

Visual Management Systems

A visual management system (VMS) displays clinical and operational performance aligned with HRO goals and practices. It is used to view and guide discussions between interdisciplinary teams during tiered safety huddles, leader rounds for high reliability, and frontline staff on the current status and safety trends in a particular area.^8,9 A VMS is highly effective in creating an environment where all staff members, especially frontline workers, feel empowered to voice their concerns related to safety or to identify improvement opportunities.^8,10 Increased leader engagement in patient safety and heightened transparency of information associated with the use of a VMS improves staff morale and professional satisfaction.¹⁰

A VMS may be a dry-erase or whiteboard display, paper-based display, or electronic status board.⁸ VMSs are usually located in or near work settings (eg, nurses’ station, staff break room, or conference room).⁸ Although they can take different forms and display several types of information, a VMS should be easy to update and meet the specific needs of a work area. In the VHA, a VMS displays: (1) essential information for staff members to effectively perform their work; (2) improvement project ideas; (3) current work in progress; (4) tracking of implemented improvement activities; (5) strong practices that have been effective; and (6) staff recognition for those who have enhanced patient safety, including the reporting of close calls and near misses.

The VHA uses the MESS (methods, equipment, staffing, and supplies) VMS format. This format empowers staff to identify whether proper procedures and practices are in place, essential equipment and supplies are readily available in the quantity needed, and appropriate staffing is on hand to provide safe, high-quality patient care.⁸ Colored magnets are used as visual cues in a stoplight classification system to identify low or no safety risks (green), at risk (yellow), or high risk (red). Green coded issues are addressed locally by a manager or supervisor. Yellow coded concerns require increased staff and leadership vigilance. Red coded issues indicate that patient care would be impacted that day and therefore need to be immediately escalated and addressed with senior leaders to mitigate the threat.^4,11 Dayton VAMC successfully implemented a VMS, using both physical and electronic visual management boards. The Dayton VAMC VMS boards are closely tied to tiered safety huddles and leader rounding for high reliability.   

Safety Forums

Safety forums are another foundational practice of VHA health care organizations seeking high reliability. Recurring monthly, safety forums focus on reinforcing HRO principles and practices, safety programs, the importance and appreciation of reporting, and just culture. The emphasis on just culture reminds staff that adverse events in the organization are viewed as valuable learning opportunities to understand the factors leading to the situation as opposed to immediately assigning blame.¹²

Psychological safety is another important focus. When individuals feel psychologically safe, they are more likely to voice concerns and act without fear of reprisal, which supports a culture of safety.¹³ Safety forums are open to all members of the health care organization, including both clinical and nonclinical staff. Forums can be conducted by an HRO Lead, HRO Champion, Patient Safety Manager, or even executive leadership. Rotating the responsibility of leading these forums demonstrates that high reliability and safety are everyone’s responsibility.

Safety forums publicly review and discuss errors, adverse events, close calls, and near misses. Time is also spent discussing root cause analysis trends and highlighting continuous process improvement principles and current projects. During safety forums, leaders should recognize individuals for safety behaviors and reward reporting through a safety awards program.¹⁴ All forums should conclude with a question-and-answer session. Forums typically occur in virtual 30-minute sessions but can last up to 60 minutes when guest speakers attend and continuing education credit is offered.

The Jesse Brown VAMC in Chicago developed an interactive monthly safety forum appealing to a broad audience. Each forum is attended by about 200 staff members and includes leader engagement and panel discussions led by the chief medical officer, with topics on both patient and team safety connecting with HRO principles. A planning committee prepares guest speakers and offers continuing education credits.

 

 

Tiered Safety Huddles

Based on the processes of high reliability industries like aviation and nuclear power, tiered safety huddles have been increasingly adopted in health care. Huddles (health care, utilizing, deliberate, discussion,linking, and events) are department-level interdisciplinary meetings that last no more than 15 minutes.¹⁵ Their purpose is to improve communication by sharing day-to-day information across multiple disciplines, identify issues that may impact the delivery of care (eg, patient and staff safety concerns, staffing issues, or inadequate supplies) and resolve problems.

Tiered safety huddles are gaining popularity, especially in organizations seeking high reliability. They are more complex than traditional huddles because of the mechanics of elevating safety issues (eg, bedside to executive leadership teams), feedback loops, and sequencing, among other factors.^15,16

Tiered safety huddles are focused, transparent forums with multidisciplinary staff, including frontline workers, along with senior leadership.^15,16 When initially implemented, tiered safety huddles may take longer than the suggested 15 minutes; however, as teams become more experienced, huddles become more efficient.¹⁵ The goal of tiered safety huddles is to proactively identify, share, address, and resolve problems that have the potential to impact the delivery of safe and quality patient care. This may include addressing staffing shortfalls, inadequate allocation of supplies and equipment, operational issues, etc.^8,15 Critical to theeffective utilization of tiered safety huddles is the appropriate escalation of issues between tiers. The most critical issues are elevated to higher tiers so they are addressed by the most qualified person in the organization.

Deciding on the number of tiers typically depends on the size and scope of services provided by the health care organization or integrated system. For example, tiered huddles in the VHA originate at the point of service (eg, critical care unit). Tier 1 includes staff members at the unit/team level along with immediate supervisors/managers. Tier 2 involves departments and service lines (eg, pharmacy, podiatry, or internal medicine) including their respective leadership. Tier 3 is the executive leadership team. This process allows for bidirectional communication instead of the traditional hierarchical communication pathway (Figure 4). Issues identified that cannot be addressed at a particular tier are elevated to the next tier. Elevated issues typically involve systems or processes requiring attention and resolution by senior leadership.¹⁵ Tier 4 huddles at the Veterans Integrated Services Network level and Tier 5 huddles at the VHA Central Office level are being initiated. These additional levels will more effectively identify system-level risks and issues that may impact multiple VHA facilities and may be addressed through centralized functions and resources.

Tiered safety huddles have been found to be instrumental to ensuring the flow of information across organizations, improving multidisciplinary and leadership engagement and collaboration, as well as increasing accountability for safety. Tiered safety huddles increase situational awareness, which improves an organization’s ability to appropriately respond to safety concerns. Furthermore, tiered safety huddles enhance teamwork and interprofessional collaboration, and have been found to significantly increase the reporting of patient safety events.^15-19

The VA Connecticut Healthcare System tiered huddles followed a pilot testing implementation process. After receiving executive-level commitment, an evidence-based process was enacted, including staff education, selecting a VMS, determining tier interaction, and deciding on metrics to track.¹⁵

Implementing Foundational Practices

To examine the progress of the implementation of the 4 foundational HRO practices, quarterly metrics derived from the OLT are reviewed to determine whether each is being implemented and sustained. The OLT also tracks progress over time. For example, at the 27 cohort 2 and lead sites that initiated leader coaching in 2021 and continued through 2022, coaches observed a 27% increase in leader rounding for high reliability and a 46% increase in the use of VMSs. For the 66 cohort 3 sites that began leader coaching in 2022, coaches documented similar changes, ranging from a 40% increase in leader rounding for high reliability to a 66% increase in the use of safety forums. Additional data continue to be collected and analyzed to publish more comprehensive findings.

DISCUSSION

Incorporating leader rounding for high reliability, VMSs, safety forums, and tiered safety huddles into daily operations is critical to building and sustaining a robust culture of safety.⁸ The 4 foundational HRO practices are instrumental in providing psychologically safe forums for staff to share concerns and actively participate. These practices also promote continual, efficient bidirectional communication throughout organizational lines and across services. The increased visibility and transparency of leaders demonstrate the importance of fostering trust, enhancing closed-loop communication with issues that arise, and building momentum to achieve high reliability. The interconnectedness of the foundational HRO practices identified and implemented by the VHA helps foster teamwork and collaboration built on trust, respect, enthusiasm for improvement, and the delivery of exceptional patient care.

CONCLUSIONS

Incorporating the 4 foundational practices into daily operations is beneficial to the delivery of safe, high-quality health care. This effective and sustained application can strengthen a health care organization on its journey to high reliability and establishing a culture of safety. To be effective, these foundational practices should be personalized to support the unique circumstances of every health care environment. While the exact methodology by which organizations implement these practices may differ, they will help organizations approach patient safety in a more transparent and thoughtful manner.

Acknowledgments

The authors thank Aaron M. Sawyer, PhD, PMP, and Jessica Fankhauser, MA, for their unwavering administrative support, and Jeff Wright for exceptional graphic design support.

Increasing complexities within health care systems are significant impediments to the consistent delivery of safe and effective patient care. These impediments include an increase in specialization of care, staff shortages, burnout, poor coordination of services and access to care, as well as rising costs.¹ High reliability organizations (HROs) provide safe, high-quality, and effective care in highly complex and risk-prone environments without causing harm or experiencing catastrophic events.²

Within the US Department of Veterans Affairs (VA), the Veterans Health Administration (VHA) operates the nation’s largest integrated health care system, providing care to > 9 million veterans. The VHA formally launched plans for an enterprise-wide HRO in February 2019. During the first year, 18 medical facilities comprised cohort1 of the journey to high reliability. Cohort 2 began in October 2020 and consisted of 54 facilities. Cohort 3 started in October 2021 with 67 facilities.³

Health care organizations seeking high reliability exercise a philosophy aimed at learning from errors and addressing system failures. High reliability is accomplished by implementing 5 principles: (1) sensitivity to operations (a heightened understanding of the current state of systems); (2) preoccupation with failure (striving to anticipate risks that might suggest a much larger system problem); (3) reluctance to simplify (avoiding making any assumptions regarding the causes of failures); (4) commitment to resilience (preparing for potential failures and bouncing back when they occur); and (5) deference to expertise (deferring to individuals with the skills and proficiency to make the best decisions).² The VHA also recognized that a successful journey to high reliability—in addition to achieving a culture of safety—relies on the implementation of foundational HRO practices: leader rounding, visual management systems, safety forums, and safety huddles. This article describes an initiative for how these foundational practices were implemented in a large integrated health care system.

BACKGROUND

The VHA has focused on 4 foundational components as part of its enterprise activities and support structure to implement HRO principles and practices. These components were selected based on pilot activities that preceded the enterprise-wide effort, reviews of the literature, and expert consultation with both government and private sector health systems. To support the implementation of these practices, the VHA provided training, toolkits, HRO executive leader coaching, and peer-to-peer mentoring. As the VHA enters its fifth year seeking high reliability, we undertook an initiative to reflect on our own experiences and refine our practices based on an updated literature review.

As part of this enterprise-wide initiative, we conducted a literature review from 2018 to March 2023 seeking recent evidence describing the value of implementing the 4 foundational HRO practices to advance high reliability and improve patient safety. A 5-year period was used to ensure recency and value of evidence.

Eligible literature was identified in PubMed, PsycINFO, the Cumulative Index to Nursing and Allied Health Literature, ScienceDirect, Scopus, the Cochrane Library, and ProQuest Dissertations & Theses Global. Inclusion and exclusion criteria were peer-reviewed interdisciplinary documents(eg, publications, dissertations, conference proceedings, and grey literature) written in English. Search terms included high reliability organizations, foundational practices, and patient safety. Boolean operators (AND, OR) were also used in the search. The search resulted in a dearth of evidence that addressed implementation of all 4 foundational practices across a health care system. Retrieved evidence focused on the implementation of only 1 particular foundational practice in a specific health care setting. In addition to describing the formal processes for the implementation of each foundational HRO practice, a brief description of representative examples of strong practices within the VHA is provided.

To support the implementation of HROs, the VHA paired HRO executive leader coaches with select medical center directors and their leadership teams. Executive leader coaches also support an organization’s HRO Lead and HRO Champion. The HRO Lead coordinates and facilitates the implementation of HRO principles and practices in pursuit of no harm across an organization. The HRO Champion supports the same as the HRO Lead, but typically has a different specialty background. For example, if the HRO Lead has an administrative background, the HRO Champion would have a clinical background.

Coaching focuses heavily on supporting site-specific implementation and sustainment of the 4 HRO foundational practices. The aim is to accelerate change, build enduring capacity, foster a safety culture, and accelerate HRO maturity. To measure change, HRO executive leader coaches track the progress of their aligned VA medical centers (VAMCs) using the Organizational Learning Tool (OLT). This tool was developed to provide information such as a facility summary and relationships between a medical center director, HRO Lead, HRO Champion, and the executive leader coach (Figure 1). The OLT also serves as a structured process to measure leader coaching performance against mutually agreed upon objectives that ultimately contribute to enterprise outcomes. It also collects data on the progress in implementing foundational practices, strong practices, needs and gaps, and more (Figure 2). Data collected from facilities supported by HRO executive leader coaches on whether foundational practices are in place are briefly described.

Leader Rounding

Leader rounding for high reliability ensures effective, bidirectional communication and collaboration among all disciplines to improve patient safety. It is an essential feature of a robust patient safety culture and an important method for demonstrating leadership engagement with high reliability.^4,5 These rounds are conducted by organizational leadership (eg, executive teams, department/service chiefs, or unit managers) and frontline staff from different areas. They are specifically focused on high reliability, patient and staff safety, and improvement efforts. The aim is to learn about daily challenges that may contribute to patient harm.⁴

Leader rounding has been found to be highly effective at improving leadership visibility across the organization. It enhances interaction and open communication with frontline staff, fostering leader-staff collaboration and shared decision-making, as well as promoting leadership understanding of operational, clinical, nonclinical (eg, administrative, nutrition services, or facilities management), and patient/family experience issues.⁴ Collaboration among team members fosters the delivery of more effective and efficient care, increases staff satisfaction, and improves employee retention.⁶ Leader rounding for high reliability significantly contributes to the breakdown of power barriers by giving team members voice and agency, ultimately leading to deeper engagement.⁷

It is important that leader rounding for high reliability occurs as planned and when possible, scheduled in advance. This helps to avoid rounding at peak times when care activities are being performed.^4,6 When scheduling conflicts arise, another leader should be sent to participate in rounds.⁴ Developing a list of questions in advance allows leadership to prepare messaging to share with staff as it relates to high reliability and patient safety (Table).^4,6,8

Closing the loop improves bidirectional communication and is critical to leader rounding for high reliability. Closed-loop communication and following up on and/or closing out issues raised during rounding empowers the sharing of information, which is critical for advancing a culture of safety.^4,8 Enhanced feedback is also associated with greater workforce engagement, staff feeling more connected to quality improvement activities, and lower rates of employee burnout.⁷ It is important to recognize that senior leaders are not responsible for resolving all issues. If a team or manager can resolve concerns that are raised, this should be encouraged and supported. Maintaining accountability at the lowest level of the organization promotes principles and practices of high reliability (Figure 3).^4,8

The VA Bedford Healthcare System created and implemented a strong practice for leader rounding for high reliability. This phased implementation involved creating an evidence-based process, deciding on an appropriate cadence, developing a tracking tool, and measuring impact to determine the overall effectiveness of leader rounding for high reliability.⁴

 

 

Visual Management Systems

A visual management system (VMS) displays clinical and operational performance aligned with HRO goals and practices. It is used to view and guide discussions between interdisciplinary teams during tiered safety huddles, leader rounds for high reliability, and frontline staff on the current status and safety trends in a particular area.^8,9 A VMS is highly effective in creating an environment where all staff members, especially frontline workers, feel empowered to voice their concerns related to safety or to identify improvement opportunities.^8,10 Increased leader engagement in patient safety and heightened transparency of information associated with the use of a VMS improves staff morale and professional satisfaction.¹⁰

A VMS may be a dry-erase or whiteboard display, paper-based display, or electronic status board.⁸ VMSs are usually located in or near work settings (eg, nurses’ station, staff break room, or conference room).⁸ Although they can take different forms and display several types of information, a VMS should be easy to update and meet the specific needs of a work area. In the VHA, a VMS displays: (1) essential information for staff members to effectively perform their work; (2) improvement project ideas; (3) current work in progress; (4) tracking of implemented improvement activities; (5) strong practices that have been effective; and (6) staff recognition for those who have enhanced patient safety, including the reporting of close calls and near misses.

The VHA uses the MESS (methods, equipment, staffing, and supplies) VMS format. This format empowers staff to identify whether proper procedures and practices are in place, essential equipment and supplies are readily available in the quantity needed, and appropriate staffing is on hand to provide safe, high-quality patient care.⁸ Colored magnets are used as visual cues in a stoplight classification system to identify low or no safety risks (green), at risk (yellow), or high risk (red). Green coded issues are addressed locally by a manager or supervisor. Yellow coded concerns require increased staff and leadership vigilance. Red coded issues indicate that patient care would be impacted that day and therefore need to be immediately escalated and addressed with senior leaders to mitigate the threat.^4,11 Dayton VAMC successfully implemented a VMS, using both physical and electronic visual management boards. The Dayton VAMC VMS boards are closely tied to tiered safety huddles and leader rounding for high reliability.   

Safety Forums

Safety forums are another foundational practice of VHA health care organizations seeking high reliability. Recurring monthly, safety forums focus on reinforcing HRO principles and practices, safety programs, the importance and appreciation of reporting, and just culture. The emphasis on just culture reminds staff that adverse events in the organization are viewed as valuable learning opportunities to understand the factors leading to the situation as opposed to immediately assigning blame.¹²

Psychological safety is another important focus. When individuals feel psychologically safe, they are more likely to voice concerns and act without fear of reprisal, which supports a culture of safety.¹³ Safety forums are open to all members of the health care organization, including both clinical and nonclinical staff. Forums can be conducted by an HRO Lead, HRO Champion, Patient Safety Manager, or even executive leadership. Rotating the responsibility of leading these forums demonstrates that high reliability and safety are everyone’s responsibility.

Safety forums publicly review and discuss errors, adverse events, close calls, and near misses. Time is also spent discussing root cause analysis trends and highlighting continuous process improvement principles and current projects. During safety forums, leaders should recognize individuals for safety behaviors and reward reporting through a safety awards program.¹⁴ All forums should conclude with a question-and-answer session. Forums typically occur in virtual 30-minute sessions but can last up to 60 minutes when guest speakers attend and continuing education credit is offered.

The Jesse Brown VAMC in Chicago developed an interactive monthly safety forum appealing to a broad audience. Each forum is attended by about 200 staff members and includes leader engagement and panel discussions led by the chief medical officer, with topics on both patient and team safety connecting with HRO principles. A planning committee prepares guest speakers and offers continuing education credits.

 

 

Tiered Safety Huddles

Based on the processes of high reliability industries like aviation and nuclear power, tiered safety huddles have been increasingly adopted in health care. Huddles (health care, utilizing, deliberate, discussion,linking, and events) are department-level interdisciplinary meetings that last no more than 15 minutes.¹⁵ Their purpose is to improve communication by sharing day-to-day information across multiple disciplines, identify issues that may impact the delivery of care (eg, patient and staff safety concerns, staffing issues, or inadequate supplies) and resolve problems.

Tiered safety huddles are gaining popularity, especially in organizations seeking high reliability. They are more complex than traditional huddles because of the mechanics of elevating safety issues (eg, bedside to executive leadership teams), feedback loops, and sequencing, among other factors.^15,16

Tiered safety huddles are focused, transparent forums with multidisciplinary staff, including frontline workers, along with senior leadership.^15,16 When initially implemented, tiered safety huddles may take longer than the suggested 15 minutes; however, as teams become more experienced, huddles become more efficient.¹⁵ The goal of tiered safety huddles is to proactively identify, share, address, and resolve problems that have the potential to impact the delivery of safe and quality patient care. This may include addressing staffing shortfalls, inadequate allocation of supplies and equipment, operational issues, etc.^8,15 Critical to theeffective utilization of tiered safety huddles is the appropriate escalation of issues between tiers. The most critical issues are elevated to higher tiers so they are addressed by the most qualified person in the organization.

Deciding on the number of tiers typically depends on the size and scope of services provided by the health care organization or integrated system. For example, tiered huddles in the VHA originate at the point of service (eg, critical care unit). Tier 1 includes staff members at the unit/team level along with immediate supervisors/managers. Tier 2 involves departments and service lines (eg, pharmacy, podiatry, or internal medicine) including their respective leadership. Tier 3 is the executive leadership team. This process allows for bidirectional communication instead of the traditional hierarchical communication pathway (Figure 4). Issues identified that cannot be addressed at a particular tier are elevated to the next tier. Elevated issues typically involve systems or processes requiring attention and resolution by senior leadership.¹⁵ Tier 4 huddles at the Veterans Integrated Services Network level and Tier 5 huddles at the VHA Central Office level are being initiated. These additional levels will more effectively identify system-level risks and issues that may impact multiple VHA facilities and may be addressed through centralized functions and resources.

Tiered safety huddles have been found to be instrumental to ensuring the flow of information across organizations, improving multidisciplinary and leadership engagement and collaboration, as well as increasing accountability for safety. Tiered safety huddles increase situational awareness, which improves an organization’s ability to appropriately respond to safety concerns. Furthermore, tiered safety huddles enhance teamwork and interprofessional collaboration, and have been found to significantly increase the reporting of patient safety events.^15-19

The VA Connecticut Healthcare System tiered huddles followed a pilot testing implementation process. After receiving executive-level commitment, an evidence-based process was enacted, including staff education, selecting a VMS, determining tier interaction, and deciding on metrics to track.¹⁵

Implementing Foundational Practices

To examine the progress of the implementation of the 4 foundational HRO practices, quarterly metrics derived from the OLT are reviewed to determine whether each is being implemented and sustained. The OLT also tracks progress over time. For example, at the 27 cohort 2 and lead sites that initiated leader coaching in 2021 and continued through 2022, coaches observed a 27% increase in leader rounding for high reliability and a 46% increase in the use of VMSs. For the 66 cohort 3 sites that began leader coaching in 2022, coaches documented similar changes, ranging from a 40% increase in leader rounding for high reliability to a 66% increase in the use of safety forums. Additional data continue to be collected and analyzed to publish more comprehensive findings.

DISCUSSION

Incorporating leader rounding for high reliability, VMSs, safety forums, and tiered safety huddles into daily operations is critical to building and sustaining a robust culture of safety.⁸ The 4 foundational HRO practices are instrumental in providing psychologically safe forums for staff to share concerns and actively participate. These practices also promote continual, efficient bidirectional communication throughout organizational lines and across services. The increased visibility and transparency of leaders demonstrate the importance of fostering trust, enhancing closed-loop communication with issues that arise, and building momentum to achieve high reliability. The interconnectedness of the foundational HRO practices identified and implemented by the VHA helps foster teamwork and collaboration built on trust, respect, enthusiasm for improvement, and the delivery of exceptional patient care.

CONCLUSIONS

Incorporating the 4 foundational practices into daily operations is beneficial to the delivery of safe, high-quality health care. This effective and sustained application can strengthen a health care organization on its journey to high reliability and establishing a culture of safety. To be effective, these foundational practices should be personalized to support the unique circumstances of every health care environment. While the exact methodology by which organizations implement these practices may differ, they will help organizations approach patient safety in a more transparent and thoughtful manner.

Acknowledgments

The authors thank Aaron M. Sawyer, PhD, PMP, and Jessica Fankhauser, MA, for their unwavering administrative support, and Jeff Wright for exceptional graphic design support.