Article

Key clinical point: Patients receiving tenofovir disoproxil fumarate (TDF) vs. entecavir (ETV) after curative liver resection for hepatitis B virus (HBV)-related hepatocellular carcinoma (HCC) showed significantly better overall survival and protection of liver function but no significant difference in the cumulative incidences of HCC recurrence.

Major finding: Although patients receiving TDF vs. ETV showed no significant difference in recurrence-free survival after propensity-score matching (hazard ratio [HR] 0.91; P = .45), they had significantly better overall survival (HR 0.37; P = .002) and liver function (P = .001).

Study details: This retrospective, single-center study reviewed data on 1,173 adult patients with HBV-related HCC who had undergone liver resection and were initially treated with either TDF or ETV for chronic HBV infection.

Disclosures: The study was funded by Sun Yat-sen University Cancer Center physician-scientist funding and National Science and Technology Major Project of China. The authors reported having no conflict of interests.

Source: Wang XH et al. Tenofovir vs. entecavir on prognosis of hepatitis B virus-related hepatocellular carcinoma after curative resection. J Gastroenterol. 2022;57:185-198 (Feb 13). Doi: 10.1007/s00535-022-01855-x

Key clinical point: Patients receiving tenofovir disoproxil fumarate (TDF) vs. entecavir (ETV) after curative liver resection for hepatitis B virus (HBV)-related hepatocellular carcinoma (HCC) showed significantly better overall survival and protection of liver function but no significant difference in the cumulative incidences of HCC recurrence.

Major finding: Although patients receiving TDF vs. ETV showed no significant difference in recurrence-free survival after propensity-score matching (hazard ratio [HR] 0.91; P = .45), they had significantly better overall survival (HR 0.37; P = .002) and liver function (P = .001).

Study details: This retrospective, single-center study reviewed data on 1,173 adult patients with HBV-related HCC who had undergone liver resection and were initially treated with either TDF or ETV for chronic HBV infection.

Disclosures: The study was funded by Sun Yat-sen University Cancer Center physician-scientist funding and National Science and Technology Major Project of China. The authors reported having no conflict of interests.

Source: Wang XH et al. Tenofovir vs. entecavir on prognosis of hepatitis B virus-related hepatocellular carcinoma after curative resection. J Gastroenterol. 2022;57:185-198 (Feb 13). Doi: 10.1007/s00535-022-01855-x

Key clinical point: Patients receiving tenofovir disoproxil fumarate (TDF) vs. entecavir (ETV) after curative liver resection for hepatitis B virus (HBV)-related hepatocellular carcinoma (HCC) showed significantly better overall survival and protection of liver function but no significant difference in the cumulative incidences of HCC recurrence.

Major finding: Although patients receiving TDF vs. ETV showed no significant difference in recurrence-free survival after propensity-score matching (hazard ratio [HR] 0.91; P = .45), they had significantly better overall survival (HR 0.37; P = .002) and liver function (P = .001).

Study details: This retrospective, single-center study reviewed data on 1,173 adult patients with HBV-related HCC who had undergone liver resection and were initially treated with either TDF or ETV for chronic HBV infection.

Disclosures: The study was funded by Sun Yat-sen University Cancer Center physician-scientist funding and National Science and Technology Major Project of China. The authors reported having no conflict of interests.

Source: Wang XH et al. Tenofovir vs. entecavir on prognosis of hepatitis B virus-related hepatocellular carcinoma after curative resection. J Gastroenterol. 2022;57:185-198 (Feb 13). Doi: 10.1007/s00535-022-01855-x

Key clinical point: The risk for hepatocellular carcinoma (HCC) varies with underlying etiologies, with active hepatitis C virus (HCV) cirrhosis posing the highest and alcoholic or nonalcoholic fatty liver disease (NAFLD) cirrhosis posing the lowest risk of developing HCC.

Major finding: Patients with active HCV (3.36%) showed the highest annual HCC incidence rate, followed by those with cured HCV (1.71%), alcoholic liver disease (1.32%), and NAFLD cirrhosis (1.24%). Patients with active HCV vs. NAFLD were at a 2.1-fold higher risk for HCC (adjusted hazard ratio 2.16; 95% CI, 1.16-4.04).

Study details: This multicenter, prospective cohort study analyzed data from two multiethnic cohorts enrolling a total of 2,733 patients with cirrhosis.

Disclosures: The study received financial support from the National Cancer Institute; Cancer Prevention & Research Institute of Texas grant; and Center for Gastrointestinal Development, Infection, and Injury. No conflicts of interest were reported.

Source: Kanwal F et al. Risk factors for hepatocellular cancer in contemporary cohorts of patients with cirrhosis. Hepatology. 2022 (Mar 1). Doi: 10.1002/hep.32434

Key clinical point: The risk for hepatocellular carcinoma (HCC) varies with underlying etiologies, with active hepatitis C virus (HCV) cirrhosis posing the highest and alcoholic or nonalcoholic fatty liver disease (NAFLD) cirrhosis posing the lowest risk of developing HCC.

Major finding: Patients with active HCV (3.36%) showed the highest annual HCC incidence rate, followed by those with cured HCV (1.71%), alcoholic liver disease (1.32%), and NAFLD cirrhosis (1.24%). Patients with active HCV vs. NAFLD were at a 2.1-fold higher risk for HCC (adjusted hazard ratio 2.16; 95% CI, 1.16-4.04).

Study details: This multicenter, prospective cohort study analyzed data from two multiethnic cohorts enrolling a total of 2,733 patients with cirrhosis.

Disclosures: The study received financial support from the National Cancer Institute; Cancer Prevention & Research Institute of Texas grant; and Center for Gastrointestinal Development, Infection, and Injury. No conflicts of interest were reported.

Source: Kanwal F et al. Risk factors for hepatocellular cancer in contemporary cohorts of patients with cirrhosis. Hepatology. 2022 (Mar 1). Doi: 10.1002/hep.32434

Key clinical point: The risk for hepatocellular carcinoma (HCC) varies with underlying etiologies, with active hepatitis C virus (HCV) cirrhosis posing the highest and alcoholic or nonalcoholic fatty liver disease (NAFLD) cirrhosis posing the lowest risk of developing HCC.

Major finding: Patients with active HCV (3.36%) showed the highest annual HCC incidence rate, followed by those with cured HCV (1.71%), alcoholic liver disease (1.32%), and NAFLD cirrhosis (1.24%). Patients with active HCV vs. NAFLD were at a 2.1-fold higher risk for HCC (adjusted hazard ratio 2.16; 95% CI, 1.16-4.04).

Study details: This multicenter, prospective cohort study analyzed data from two multiethnic cohorts enrolling a total of 2,733 patients with cirrhosis.

Disclosures: The study received financial support from the National Cancer Institute; Cancer Prevention & Research Institute of Texas grant; and Center for Gastrointestinal Development, Infection, and Injury. No conflicts of interest were reported.

Source: Kanwal F et al. Risk factors for hepatocellular cancer in contemporary cohorts of patients with cirrhosis. Hepatology. 2022 (Mar 1). Doi: 10.1002/hep.32434

Key clinical point: Active hepatitis C virus (HCV) infection negatively affects overall and recurrence-free survival in patients with very early-stage hepatocellular carcinoma (HCC) after curative radiofrequency ablation (RFA).

Major finding: Active HCV infection was a significant risk factor for shorter overall survival (adjusted hazard ratio [aHR] 2.17; P = .003) and early recurrence of HCC (aHR 1.47; P = .022). Patients with vs. without active HCV infection had a shorter median overall (66 months vs. 145 months) and recurrence-free (20 months vs. 31 months) survival (both P < .001).

Study details: Findings are from a single-center retrospective study including 302 patients with very early-stage HCC (Barcelona Clinic Liver Cancer stage 0) who underwent RFA and had follow-up of >6 months, of which 195 had HCV infection, including 132 active infection cases.

Disclosures: M Kurosaki and N Izumi declared funding support from the Japan Agency for Medical Research and Development and Japanese Ministry of Health, Welfare, and Labor, respectively, and along with K Tsuchiya, receiving lecture fees from several sources.

Source: Takaura K et al. The impact of background liver disease on the long-term prognosis of very-early-stage HCC after ablation therapy. PLoS One. 2022;17(2):e0264075 (Feb 23). Doi:  10.1371/journal.pone.0264075

Key clinical point: Active hepatitis C virus (HCV) infection negatively affects overall and recurrence-free survival in patients with very early-stage hepatocellular carcinoma (HCC) after curative radiofrequency ablation (RFA).

Major finding: Active HCV infection was a significant risk factor for shorter overall survival (adjusted hazard ratio [aHR] 2.17; P = .003) and early recurrence of HCC (aHR 1.47; P = .022). Patients with vs. without active HCV infection had a shorter median overall (66 months vs. 145 months) and recurrence-free (20 months vs. 31 months) survival (both P < .001).

Study details: Findings are from a single-center retrospective study including 302 patients with very early-stage HCC (Barcelona Clinic Liver Cancer stage 0) who underwent RFA and had follow-up of >6 months, of which 195 had HCV infection, including 132 active infection cases.

Disclosures: M Kurosaki and N Izumi declared funding support from the Japan Agency for Medical Research and Development and Japanese Ministry of Health, Welfare, and Labor, respectively, and along with K Tsuchiya, receiving lecture fees from several sources.

Source: Takaura K et al. The impact of background liver disease on the long-term prognosis of very-early-stage HCC after ablation therapy. PLoS One. 2022;17(2):e0264075 (Feb 23). Doi:  10.1371/journal.pone.0264075

Key clinical point: Active hepatitis C virus (HCV) infection negatively affects overall and recurrence-free survival in patients with very early-stage hepatocellular carcinoma (HCC) after curative radiofrequency ablation (RFA).

Major finding: Active HCV infection was a significant risk factor for shorter overall survival (adjusted hazard ratio [aHR] 2.17; P = .003) and early recurrence of HCC (aHR 1.47; P = .022). Patients with vs. without active HCV infection had a shorter median overall (66 months vs. 145 months) and recurrence-free (20 months vs. 31 months) survival (both P < .001).

Study details: Findings are from a single-center retrospective study including 302 patients with very early-stage HCC (Barcelona Clinic Liver Cancer stage 0) who underwent RFA and had follow-up of >6 months, of which 195 had HCV infection, including 132 active infection cases.

Disclosures: M Kurosaki and N Izumi declared funding support from the Japan Agency for Medical Research and Development and Japanese Ministry of Health, Welfare, and Labor, respectively, and along with K Tsuchiya, receiving lecture fees from several sources.

Source: Takaura K et al. The impact of background liver disease on the long-term prognosis of very-early-stage HCC after ablation therapy. PLoS One. 2022;17(2):e0264075 (Feb 23). Doi:  10.1371/journal.pone.0264075

Key clinical point: Independent risk factors for postoperative recurrence among patients undergoing curative hepatic resection for early-stage hepatocellular carcinoma (HCC) include preoperative alpha-fetoprotein (AFP) level >400 µg/L, tumor size >5 cm, satellite nodules, multiple tumors, and microvascular invasion.

Major finding: Cirrhosis (adjusted hazard ratio [aHR] 1.49; P < .001), preoperative AFP level >400 µg/L (aHR 1.28; P = .004), tumor size >5 cm (aHR 1.74; P < .001), satellite nodules (aHR 1.35; P = .040), multiple tumors (aHR 1.63; P = .015), microvascular invasion (aHR 1.51; P < .001), and intraoperative blood transfusion (aHR 1.50; P = .013) were identified as independent risk factors associated with postoperative recurrence.

Study details: The data come from a large-scale, multicenter retrospective study including 1,424 adult patients who underwent curative hepatic resection for early-stage HCC (Barcelona Clinic Liver Cancer stage 0/A).

Disclosures: The study was supported by the National Natural Science Foundation of China. The authors reported no conflict of interests.

Source: Yao L-Q et al. Clinical features of recurrence after hepatic resection for early-stage hepatocellular carcinoma and long-term survival outcomes of patients with recurrence: A multi-institutional analysis. Ann Surg Oncol. 2022 Feb 22. Doi: 10.1245/s10434-022-11454-y

Key clinical point: Independent risk factors for postoperative recurrence among patients undergoing curative hepatic resection for early-stage hepatocellular carcinoma (HCC) include preoperative alpha-fetoprotein (AFP) level >400 µg/L, tumor size >5 cm, satellite nodules, multiple tumors, and microvascular invasion.

Major finding: Cirrhosis (adjusted hazard ratio [aHR] 1.49; P < .001), preoperative AFP level >400 µg/L (aHR 1.28; P = .004), tumor size >5 cm (aHR 1.74; P < .001), satellite nodules (aHR 1.35; P = .040), multiple tumors (aHR 1.63; P = .015), microvascular invasion (aHR 1.51; P < .001), and intraoperative blood transfusion (aHR 1.50; P = .013) were identified as independent risk factors associated with postoperative recurrence.

Study details: The data come from a large-scale, multicenter retrospective study including 1,424 adult patients who underwent curative hepatic resection for early-stage HCC (Barcelona Clinic Liver Cancer stage 0/A).

Disclosures: The study was supported by the National Natural Science Foundation of China. The authors reported no conflict of interests.

Source: Yao L-Q et al. Clinical features of recurrence after hepatic resection for early-stage hepatocellular carcinoma and long-term survival outcomes of patients with recurrence: A multi-institutional analysis. Ann Surg Oncol. 2022 Feb 22. Doi: 10.1245/s10434-022-11454-y

Key clinical point: Independent risk factors for postoperative recurrence among patients undergoing curative hepatic resection for early-stage hepatocellular carcinoma (HCC) include preoperative alpha-fetoprotein (AFP) level >400 µg/L, tumor size >5 cm, satellite nodules, multiple tumors, and microvascular invasion.

Major finding: Cirrhosis (adjusted hazard ratio [aHR] 1.49; P < .001), preoperative AFP level >400 µg/L (aHR 1.28; P = .004), tumor size >5 cm (aHR 1.74; P < .001), satellite nodules (aHR 1.35; P = .040), multiple tumors (aHR 1.63; P = .015), microvascular invasion (aHR 1.51; P < .001), and intraoperative blood transfusion (aHR 1.50; P = .013) were identified as independent risk factors associated with postoperative recurrence.

Study details: The data come from a large-scale, multicenter retrospective study including 1,424 adult patients who underwent curative hepatic resection for early-stage HCC (Barcelona Clinic Liver Cancer stage 0/A).

Disclosures: The study was supported by the National Natural Science Foundation of China. The authors reported no conflict of interests.

Source: Yao L-Q et al. Clinical features of recurrence after hepatic resection for early-stage hepatocellular carcinoma and long-term survival outcomes of patients with recurrence: A multi-institutional analysis. Ann Surg Oncol. 2022 Feb 22. Doi: 10.1245/s10434-022-11454-y

Key clinical point: Hampered ultrasound visualization in patients with cirrhosis receiving hepatocellular carcinoma (HCC) surveillance is associated with worse test performance, negatively affecting both sensitivity and specificity of surveillance.

Major finding: Patients with cirrhosis and HCC having severely impaired ultrasound visualization before HCC diagnosis showed increased odds of false-negative results (adjusted odds ratio [aOR] 7.94; 95% CI 1.23-51.16), whereas those with only cirrhosis having moderately impaired visualization showed increased odds of false-positive results (aOR 1.60; 95% CI 1.13-2.27).

Study details: This was a retrospective cohort study involving 2,238 patients with cirrhosis, with (n = 186) or without (n = 2,052) HCC, who underwent at least one abdominal ultrasound examination.

Disclosures: The study was supported by the United States National Institute of Health. A Singal and D Fetzer declared serving as consultants or advisory board members of or having research agreements with various organizations.

Source: Chong N et al. Association between ultrasound quality and test performance for HCC surveillance in patients with cirrhosis: a retrospective cohort study. Aliment Pharmacol Ther. 2022;55(6):683-690 (Feb 15). Doi: 10.1111/apt.16779

Key clinical point: Hampered ultrasound visualization in patients with cirrhosis receiving hepatocellular carcinoma (HCC) surveillance is associated with worse test performance, negatively affecting both sensitivity and specificity of surveillance.

Major finding: Patients with cirrhosis and HCC having severely impaired ultrasound visualization before HCC diagnosis showed increased odds of false-negative results (adjusted odds ratio [aOR] 7.94; 95% CI 1.23-51.16), whereas those with only cirrhosis having moderately impaired visualization showed increased odds of false-positive results (aOR 1.60; 95% CI 1.13-2.27).

Study details: This was a retrospective cohort study involving 2,238 patients with cirrhosis, with (n = 186) or without (n = 2,052) HCC, who underwent at least one abdominal ultrasound examination.

Disclosures: The study was supported by the United States National Institute of Health. A Singal and D Fetzer declared serving as consultants or advisory board members of or having research agreements with various organizations.

Source: Chong N et al. Association between ultrasound quality and test performance for HCC surveillance in patients with cirrhosis: a retrospective cohort study. Aliment Pharmacol Ther. 2022;55(6):683-690 (Feb 15). Doi: 10.1111/apt.16779

Key clinical point: Hampered ultrasound visualization in patients with cirrhosis receiving hepatocellular carcinoma (HCC) surveillance is associated with worse test performance, negatively affecting both sensitivity and specificity of surveillance.

Major finding: Patients with cirrhosis and HCC having severely impaired ultrasound visualization before HCC diagnosis showed increased odds of false-negative results (adjusted odds ratio [aOR] 7.94; 95% CI 1.23-51.16), whereas those with only cirrhosis having moderately impaired visualization showed increased odds of false-positive results (aOR 1.60; 95% CI 1.13-2.27).

Study details: This was a retrospective cohort study involving 2,238 patients with cirrhosis, with (n = 186) or without (n = 2,052) HCC, who underwent at least one abdominal ultrasound examination.

Disclosures: The study was supported by the United States National Institute of Health. A Singal and D Fetzer declared serving as consultants or advisory board members of or having research agreements with various organizations.

Source: Chong N et al. Association between ultrasound quality and test performance for HCC surveillance in patients with cirrhosis: a retrospective cohort study. Aliment Pharmacol Ther. 2022;55(6):683-690 (Feb 15). Doi: 10.1111/apt.16779

Key clinical point: Magnetic resonance elastography (MRE)-based shear strain mapping may serve as a noninvasive biomarker enabling the characterization of the tumor-liver interface and preoperative prediction of microvascular invasion (MVI) in patients with hepatocellular carcinoma (HCC).

Major finding: The positive MVI vs. negative MVI group displayed a significantly higher octahedral shear strain (OSS) percentage of low-shear-strain length (pLSL) at three evaluation frequencies (60 Hz: 75% vs. 40%, 40 Hz: 85% vs. 40%, and 30 Hz: 70% vs. 20%; all P < .01). The peritumor OSS-pLSL area under the receiver operating characteristic curve (0.73-0.90) for MVI prediction was good/excellent at all frequencies.

Study details: The data are derived from a retrospective study of 59 patients with HCC, all of whom underwent the conventional 60 Hz MRE examination; of these, 29 patients also underwent 40 and 30 Hz MRE examinations.

Disclosures: The study was funded by the National Natural Science Foundation of China, among others. The authors declared no conflict of interests.

Source: Li M et al. MR elastography-based shear strain mapping for assessment of microvascular invasion in hepatocellular carcinoma. Eur Radiol. 2022 (Feb 11). Doi: 10.1007/s00330-022-08578-w

Key clinical point: Magnetic resonance elastography (MRE)-based shear strain mapping may serve as a noninvasive biomarker enabling the characterization of the tumor-liver interface and preoperative prediction of microvascular invasion (MVI) in patients with hepatocellular carcinoma (HCC).

Major finding: The positive MVI vs. negative MVI group displayed a significantly higher octahedral shear strain (OSS) percentage of low-shear-strain length (pLSL) at three evaluation frequencies (60 Hz: 75% vs. 40%, 40 Hz: 85% vs. 40%, and 30 Hz: 70% vs. 20%; all P < .01). The peritumor OSS-pLSL area under the receiver operating characteristic curve (0.73-0.90) for MVI prediction was good/excellent at all frequencies.

Study details: The data are derived from a retrospective study of 59 patients with HCC, all of whom underwent the conventional 60 Hz MRE examination; of these, 29 patients also underwent 40 and 30 Hz MRE examinations.

Disclosures: The study was funded by the National Natural Science Foundation of China, among others. The authors declared no conflict of interests.

Source: Li M et al. MR elastography-based shear strain mapping for assessment of microvascular invasion in hepatocellular carcinoma. Eur Radiol. 2022 (Feb 11). Doi: 10.1007/s00330-022-08578-w

Key clinical point: Magnetic resonance elastography (MRE)-based shear strain mapping may serve as a noninvasive biomarker enabling the characterization of the tumor-liver interface and preoperative prediction of microvascular invasion (MVI) in patients with hepatocellular carcinoma (HCC).

Major finding: The positive MVI vs. negative MVI group displayed a significantly higher octahedral shear strain (OSS) percentage of low-shear-strain length (pLSL) at three evaluation frequencies (60 Hz: 75% vs. 40%, 40 Hz: 85% vs. 40%, and 30 Hz: 70% vs. 20%; all P < .01). The peritumor OSS-pLSL area under the receiver operating characteristic curve (0.73-0.90) for MVI prediction was good/excellent at all frequencies.

Study details: The data are derived from a retrospective study of 59 patients with HCC, all of whom underwent the conventional 60 Hz MRE examination; of these, 29 patients also underwent 40 and 30 Hz MRE examinations.

Disclosures: The study was funded by the National Natural Science Foundation of China, among others. The authors declared no conflict of interests.

Source: Li M et al. MR elastography-based shear strain mapping for assessment of microvascular invasion in hepatocellular carcinoma. Eur Radiol. 2022 (Feb 11). Doi: 10.1007/s00330-022-08578-w

As we transition out of the Omicron surge, the lessons we’ve learned from the prior surges carry forward and add to our knowledge foundation. Medical journals have published numerous research and perspectives manuscripts on all aspects of COVID-19 over the past 2 years, adding much-needed knowledge to our clinical practice during the pandemic. However, the story does not stop there, as the pandemic has impacted the usual, non-COVID-19 clinical care we provide. The value-based health care delivery model accounts for both COVID-19 clinical care and the usual care we provide our patients every day. Clinicians, administrators, and health care workers will need to know how to balance both worlds in the years to come.

In this issue of JCOM, the work of balancing the demands of COVID-19 care with those of system improvement continues. Two original research articles address the former, with Liesching et al¹ reporting data on improving clinical outcomes of patients with COVID-19 through acute care oxygen therapies, and Ali et al² explaining the impact of COVID-19 on STEMI care delivery models. Liesching et al’s study showed that patients admitted for COVID-19 after the first surge were more likely to receive high-flow nasal cannula and had better outcomes, while Ali et al showed that patients with STEMI yet again experienced worse outcomes during the first wave.

On the system improvement front, Cusick et al³ report on a quality improvement (QI) project that addressed acute disease management of heparin-induced thrombocytopenia (HIT) during hospitalization, Sosa et al⁴ discuss efforts to improve comorbidity capture at their institution, and Uche et al⁵ present the results of a nonpharmacologic initiative to improve management of chronic pain among veterans. Cusick et al’s QI project showed that a HIT testing strategy could be safely implemented through an evidence-based process to nudge resource utilization using specific management pathways. While capturing and measuring the complexity of diseases and comorbidities can be challenging, accurate capture is essential, as patient acuity has implications for reimbursement and quality comparisons for hospitals and physicians; Sosa et al describe a series of initiatives implemented at their institution that improved comorbidity capture. Furthermore, Uche et al report on a 10-week complementary and integrative health program for veterans with noncancer chronic pain that reduced pain intensity and improved quality of life for its participants. These QI reports show that, though the health care landscape has changed over the past 2 years, the aim remains the same: to provide the best care for patients regardless of the diagnosis, location, or time.

Conducting QI projects during the COVID-19 pandemic has been difficult, especially in terms of implementing consistent processes and management pathways while contending with staff and supply shortages. The pandemic, however, has highlighted the importance of continuing QI efforts, specifically around infectious disease prevention and good clinical practices. Moreover, the recent continuous learning and implementation around COVID-19 patient care has been a significant achievement, as clinicians and administrators worked continuously to understand and improve processes, create a supporting culture, and redesign care delivery on the fly. The management of both COVID-19 care and our usual care QI efforts should incorporate the lessons learned from the pandemic and leverage system redesign for future steps. As we’ve seen, survival in COVID-19 improved dramatically since the beginning of the pandemic, as clinical trials became more adaptive and efficient and system upgrades like telemedicine and digital technologies in the public health response led to major advancements. The work to improve the care provided in the clinic and at the bedside will continue through one collective approach in the new normal.

Corresponding author: Ebrahim Barkoudah, MD, MPH, Department of Medicine Brigham and Women’s Hospital, Boston, MA; [email protected]

As we transition out of the Omicron surge, the lessons we’ve learned from the prior surges carry forward and add to our knowledge foundation. Medical journals have published numerous research and perspectives manuscripts on all aspects of COVID-19 over the past 2 years, adding much-needed knowledge to our clinical practice during the pandemic. However, the story does not stop there, as the pandemic has impacted the usual, non-COVID-19 clinical care we provide. The value-based health care delivery model accounts for both COVID-19 clinical care and the usual care we provide our patients every day. Clinicians, administrators, and health care workers will need to know how to balance both worlds in the years to come.

In this issue of JCOM, the work of balancing the demands of COVID-19 care with those of system improvement continues. Two original research articles address the former, with Liesching et al¹ reporting data on improving clinical outcomes of patients with COVID-19 through acute care oxygen therapies, and Ali et al² explaining the impact of COVID-19 on STEMI care delivery models. Liesching et al’s study showed that patients admitted for COVID-19 after the first surge were more likely to receive high-flow nasal cannula and had better outcomes, while Ali et al showed that patients with STEMI yet again experienced worse outcomes during the first wave.

On the system improvement front, Cusick et al³ report on a quality improvement (QI) project that addressed acute disease management of heparin-induced thrombocytopenia (HIT) during hospitalization, Sosa et al⁴ discuss efforts to improve comorbidity capture at their institution, and Uche et al⁵ present the results of a nonpharmacologic initiative to improve management of chronic pain among veterans. Cusick et al’s QI project showed that a HIT testing strategy could be safely implemented through an evidence-based process to nudge resource utilization using specific management pathways. While capturing and measuring the complexity of diseases and comorbidities can be challenging, accurate capture is essential, as patient acuity has implications for reimbursement and quality comparisons for hospitals and physicians; Sosa et al describe a series of initiatives implemented at their institution that improved comorbidity capture. Furthermore, Uche et al report on a 10-week complementary and integrative health program for veterans with noncancer chronic pain that reduced pain intensity and improved quality of life for its participants. These QI reports show that, though the health care landscape has changed over the past 2 years, the aim remains the same: to provide the best care for patients regardless of the diagnosis, location, or time.

Conducting QI projects during the COVID-19 pandemic has been difficult, especially in terms of implementing consistent processes and management pathways while contending with staff and supply shortages. The pandemic, however, has highlighted the importance of continuing QI efforts, specifically around infectious disease prevention and good clinical practices. Moreover, the recent continuous learning and implementation around COVID-19 patient care has been a significant achievement, as clinicians and administrators worked continuously to understand and improve processes, create a supporting culture, and redesign care delivery on the fly. The management of both COVID-19 care and our usual care QI efforts should incorporate the lessons learned from the pandemic and leverage system redesign for future steps. As we’ve seen, survival in COVID-19 improved dramatically since the beginning of the pandemic, as clinical trials became more adaptive and efficient and system upgrades like telemedicine and digital technologies in the public health response led to major advancements. The work to improve the care provided in the clinic and at the bedside will continue through one collective approach in the new normal.

Corresponding author: Ebrahim Barkoudah, MD, MPH, Department of Medicine Brigham and Women’s Hospital, Boston, MA; [email protected]

As we transition out of the Omicron surge, the lessons we’ve learned from the prior surges carry forward and add to our knowledge foundation. Medical journals have published numerous research and perspectives manuscripts on all aspects of COVID-19 over the past 2 years, adding much-needed knowledge to our clinical practice during the pandemic. However, the story does not stop there, as the pandemic has impacted the usual, non-COVID-19 clinical care we provide. The value-based health care delivery model accounts for both COVID-19 clinical care and the usual care we provide our patients every day. Clinicians, administrators, and health care workers will need to know how to balance both worlds in the years to come.

In this issue of JCOM, the work of balancing the demands of COVID-19 care with those of system improvement continues. Two original research articles address the former, with Liesching et al¹ reporting data on improving clinical outcomes of patients with COVID-19 through acute care oxygen therapies, and Ali et al² explaining the impact of COVID-19 on STEMI care delivery models. Liesching et al’s study showed that patients admitted for COVID-19 after the first surge were more likely to receive high-flow nasal cannula and had better outcomes, while Ali et al showed that patients with STEMI yet again experienced worse outcomes during the first wave.

On the system improvement front, Cusick et al³ report on a quality improvement (QI) project that addressed acute disease management of heparin-induced thrombocytopenia (HIT) during hospitalization, Sosa et al⁴ discuss efforts to improve comorbidity capture at their institution, and Uche et al⁵ present the results of a nonpharmacologic initiative to improve management of chronic pain among veterans. Cusick et al’s QI project showed that a HIT testing strategy could be safely implemented through an evidence-based process to nudge resource utilization using specific management pathways. While capturing and measuring the complexity of diseases and comorbidities can be challenging, accurate capture is essential, as patient acuity has implications for reimbursement and quality comparisons for hospitals and physicians; Sosa et al describe a series of initiatives implemented at their institution that improved comorbidity capture. Furthermore, Uche et al report on a 10-week complementary and integrative health program for veterans with noncancer chronic pain that reduced pain intensity and improved quality of life for its participants. These QI reports show that, though the health care landscape has changed over the past 2 years, the aim remains the same: to provide the best care for patients regardless of the diagnosis, location, or time.

Conducting QI projects during the COVID-19 pandemic has been difficult, especially in terms of implementing consistent processes and management pathways while contending with staff and supply shortages. The pandemic, however, has highlighted the importance of continuing QI efforts, specifically around infectious disease prevention and good clinical practices. Moreover, the recent continuous learning and implementation around COVID-19 patient care has been a significant achievement, as clinicians and administrators worked continuously to understand and improve processes, create a supporting culture, and redesign care delivery on the fly. The management of both COVID-19 care and our usual care QI efforts should incorporate the lessons learned from the pandemic and leverage system redesign for future steps. As we’ve seen, survival in COVID-19 improved dramatically since the beginning of the pandemic, as clinical trials became more adaptive and efficient and system upgrades like telemedicine and digital technologies in the public health response led to major advancements. The work to improve the care provided in the clinic and at the bedside will continue through one collective approach in the new normal.

Corresponding author: Ebrahim Barkoudah, MD, MPH, Department of Medicine Brigham and Women’s Hospital, Boston, MA; [email protected]

Key clinical point: Patients with advanced hepatocellular carcinoma (aHCC) and alpha-fetoprotein (AFP) levels ≥400 ng/mL experience a consistent survival benefit with ramucirumab therapy irrespective of baseline prognostic covariates.

Major finding: Ramucirumab vs. placebo improved overall survival in patients with viral (hazard ratio [HR] 0.76; 95% CI 0.60-0.97) and nonviral (HR 0.56; 95% CI 0.49-0.79) etiologies and in those with above-median AFP levels (≥4,081.5 ng/mL; HR 0.71; 95% CI 0.54-0.95).

Study details: Findings are from a post hoc meta-analysis of the phase 3 REACH and REACH-2 trials involving 542 patients with aHCC and AFP levels ≥400 ng/mL who were randomly assigned to receive ramucirumab (n = 316) or placebo (n = 226).

Disclosures: The study was sponsored by Eli Lilly and Company. JM Llovet, A Singal, A Villanueva, R Finn, M Kudo, P Galle, M Ikeda, and A Zhu reported receiving grants, personal/advisory board/consulting fees, or honoraria from various sources, including Eli Lilly. The other authors are employees or shareholders of Eli Lilly.

Source: Llovet JM et al. Prognostic and predictive factors in patients with advanced HCC and elevated alpha-fetoprotein treated with ramucirumab in two randomized phase III trial. Clin Cancer Res. 2022 (Mar 4). Doi: 10.1158/1078-0432.CCR-21-4000

Key clinical point: Patients with advanced hepatocellular carcinoma (aHCC) and alpha-fetoprotein (AFP) levels ≥400 ng/mL experience a consistent survival benefit with ramucirumab therapy irrespective of baseline prognostic covariates.

Major finding: Ramucirumab vs. placebo improved overall survival in patients with viral (hazard ratio [HR] 0.76; 95% CI 0.60-0.97) and nonviral (HR 0.56; 95% CI 0.49-0.79) etiologies and in those with above-median AFP levels (≥4,081.5 ng/mL; HR 0.71; 95% CI 0.54-0.95).

Study details: Findings are from a post hoc meta-analysis of the phase 3 REACH and REACH-2 trials involving 542 patients with aHCC and AFP levels ≥400 ng/mL who were randomly assigned to receive ramucirumab (n = 316) or placebo (n = 226).

Disclosures: The study was sponsored by Eli Lilly and Company. JM Llovet, A Singal, A Villanueva, R Finn, M Kudo, P Galle, M Ikeda, and A Zhu reported receiving grants, personal/advisory board/consulting fees, or honoraria from various sources, including Eli Lilly. The other authors are employees or shareholders of Eli Lilly.

Source: Llovet JM et al. Prognostic and predictive factors in patients with advanced HCC and elevated alpha-fetoprotein treated with ramucirumab in two randomized phase III trial. Clin Cancer Res. 2022 (Mar 4). Doi: 10.1158/1078-0432.CCR-21-4000

Key clinical point: Patients with advanced hepatocellular carcinoma (aHCC) and alpha-fetoprotein (AFP) levels ≥400 ng/mL experience a consistent survival benefit with ramucirumab therapy irrespective of baseline prognostic covariates.

Major finding: Ramucirumab vs. placebo improved overall survival in patients with viral (hazard ratio [HR] 0.76; 95% CI 0.60-0.97) and nonviral (HR 0.56; 95% CI 0.49-0.79) etiologies and in those with above-median AFP levels (≥4,081.5 ng/mL; HR 0.71; 95% CI 0.54-0.95).

Study details: Findings are from a post hoc meta-analysis of the phase 3 REACH and REACH-2 trials involving 542 patients with aHCC and AFP levels ≥400 ng/mL who were randomly assigned to receive ramucirumab (n = 316) or placebo (n = 226).

Disclosures: The study was sponsored by Eli Lilly and Company. JM Llovet, A Singal, A Villanueva, R Finn, M Kudo, P Galle, M Ikeda, and A Zhu reported receiving grants, personal/advisory board/consulting fees, or honoraria from various sources, including Eli Lilly. The other authors are employees or shareholders of Eli Lilly.

Source: Llovet JM et al. Prognostic and predictive factors in patients with advanced HCC and elevated alpha-fetoprotein treated with ramucirumab in two randomized phase III trial. Clin Cancer Res. 2022 (Mar 4). Doi: 10.1158/1078-0432.CCR-21-4000

From Neurology/Chronic Pain Management Services, Department of Veterans Affairs (VA) Maryland Health Care System, Baltimore VA Medical Center, Baltimore, MD (Dr. Uche), and School of Nursing, Washburn University, Topeka, KS (Drs. Jamison and Waugh).

Abstract

Objective: The purpose of this quality improvement project was to abstract and analyze previously collected data from veterans with high-impact chronic pain who attended the Empower Veterans Program (EVP) offered by a Veterans Administration facility in the northeastern United States.

Methods: This quality improvement project used data collected from veterans with chronic pain who completed the veterans health care facility’s EVP between August 2017 and August 2019. Pre- and post-intervention data on pain intensity, pain interference, quality of life, and pain catastrophizing were compared using paired t-tests.

Results: Although data were abstracted from 115 patients, the final sample included 67 patients who completed both pre-and postintervention questionnaires. Baseline measures of completers and noncompleters were similar. Comparison of pre and post mean scores on completers showed statistically significant findings (P = .004) based on the Bonferroni correction. The medium and large effect sizes (Cohen’s d) indicated clinically significant improvements for veterans who completed the program. Veterans reported high levels of satisfaction with the program.

Conclusion: Veterans with chronic high-impact noncancer pain who completed the EVP had reduced pain intensity, pain interference, pain catastrophizing as well as improved quality of life and satisfaction with their health.

Keywords: musculoskeletal pain, Veterans Affairs, complementary and integrative health, acceptance and commitment therapy, mind-body therapies, whole health, multidisciplinary pain management.

More than 100 million American adults suffer from chronic pain; costs associated with managing chronic pain are approximately $635 billion each year.¹ Chronic pain is prevalent among military veterans, affecting one-third of the 9 million veterans who receive care from Veterans Health Administration (VHA) facilities.² The biopsychosocial impact of chronic pain on the general population, and specifically on veterans, has been compounded by the opioid crisis. The effects of chronic pain and the opioid crisis have fueled interest in the use of complementary and integrative health (CIH) modalities in the management of chronic noncancer pain. Providers are increasingly developing treatment programs that incorporate CIH in their management of chronic noncancer pain.

One such program is the Empower Veterans Program (EVP). Originally developed at the Atlanta Veterans Affairs Health Care System, the EVP is a CIH modality based on the biopsychosocial model of pain developed by psychiatrist George Engel in 1977.³ The biopsychosocial model of pain recognizes that pain is a complex, multidimensional, biopsychosocial experience. Under this model, the mind and body work in unison as interconnected entities. Because the model acknowledges biological, psychological, and social components of pain and illness,⁴ treatment focuses on all aspects of a person’s health, life, and relationships.

The EVP fits into the VHA Pain Management Stepped Care Model and is an adjunctive complement for that model.^5-7 The EVP complements care at the first step, where patient/family provide self-care and where care is provided by patient-aligned primary care teams, at the second step, which includes secondary consultation with multidisciplinary pain medicine specialty teams and other specialists, and at the third step, with the addition of tertiary interdisciplinary pain centers.

The VA Maryland Health Care System (VAMHCS) implemented the EVP as part of a quality improvement project for the management of chronic pain. The objectives of the program were to reduce pain intensity, pain catastrophizing, and pain interference, as well as improve functionality and quality of life among veterans with chronic high-impact noncancer pain. More than 2 years after the program was implemented, collected data had not been analyzed. The purpose of this quality improvement project was to abstract and analyze the previously collected data from veterans with high-impact chronic pain who attended an EVP offered by the VAMHCS. The results of the data analysis were used to inform decisions regarding the future of the program.

Methods

This quality improvement project used the Plan-Do-Study-Act (PDSA) process.⁸ The first 2 phases of the PDSA cycle (Plan and Do) were completed by a team of VA employees from the VAMHCS, who donated their time to establish and implement the program at the project site. This team consisted of psychologists, a physical therapist, a social worker, and a chaplain, and included support from medical administrative staff. This team planned and implemented the EVP at the VA facility based on the model developed at the Atlanta VA Health Care System. During the “Do” phase, the team collected data on pain intensity, pain interference, quality of life, and pain negative cognition (catastrophizing) before the intervention and post intervention. They also collected data on program outcome (patient treatment satisfaction) post intervention. Because these employees did not have time to retrieve and analyze the data, they welcomed the opportunity to have the data analyzed by the investigators during the Study phase of the PDSA cycle. Based on the results of the analysis, recommendations for program changes were made during the Act phase of the cycle.

Intervention

The EVP was developed as a 10-week (30 hours) interdisciplinary CIH approach that coached veterans with chronic pain to live fuller lives based on their individual values and what matters to them. EVP is the “What Else” management modality for the 5% of veterans with high-impact chronic pain.⁹ The EVP provided functional restoration through its components of whole health, mindfulness training, coaching calls, acceptance and commitment therapy, and mindful movement. It used the Wheel of Health with the 4 key components of me, self-care, professional care, and community.^10,11

Veterans who had a diagnosis of chronic nonmalignant pain for 3 months or more and who agreed to participate in the EVP at this facility attended 3-hour classes every Tuesday with a cohort of 8 to 12 peers and engaged in one-on-one coaching with interdisciplinary team members. During the class sessions, veterans were coached to understand and accept their pain and commit to maintaining function despite their pain. Mindful movement by the physical therapist emphasized the pivotal place of exercise in pain management. The therapist used the mantra “Motion is Lotion.”⁹ The guiding principle of the EVP was that small incremental changes can have a big impact on the individual’s whole life. Emphasis was placed on increasing self-efficacy and mindful awareness for veterans with high-impact pain by giving them “Skills before Pills.”⁹

Outcome Measures

Outcome measures included the Numerical Pain Rating Scale (NPRS), the Multidimensional Pain Inventory (MPI), the World Health Organization Quality of Life assessment (WHOQOL-BREF), the Pain Catastrophizing Scale (PCS), and the Pain Treatment Satisfaction Scale (PTSS). Cronbach alpha coefficients were calculated to assess internal consistency reliability of these measures in the sample of veterans who completed the EVP.

NPRS. The NPRS is ubiquitous as a screening tool in many health care environments and its use is mandated by the VA health care system.¹² The choice of the NPRS as the tool for pain screening in the VA health care system was based on a large body of research that supports the reliability and validity of the NPRS as a single index of pain intensity or severity. Studies suggest that the NPRS is valid for use in the assessment of acute, cancer, or chronic nonmalignant pain and in varied clinical settings.¹³ The NPRS has 4 items, each on a scale of 0 to 10. For the purpose of this project, only 3 items were used. The 3 items assessed the worst pain, usual pain, and the current pain (right now). The higher the score, the higher the pain intensity. Cronbach alpha coefficients on the NPRS obtained from the current sample of veterans were 0.85 on both pre- and postintervention assessments.

MPI. The MPI is an easily accessible, reliable, and valid self-report questionnaire that measures the impact of pain on an individual’s life, quality of social support, and general activity.¹⁴ This instrument is a short version of the West Haven-Yale MPI.¹⁵ The MPI contains 9 items rated on a scale from 0 to 6. The higher the score, the greater pain interference a person is experiencing. The MPI produces reliable, valid information for diagnostic purposes and for therapy outcome studies.¹⁶ The MPI had a Cronbach alpha of 0.90 on pre-intervention and 0.92 on postintervention assessments in the current sample.

WHOQOL-BREF. The WHOQOL-BREF is a measure of quality of life and is an abbreviated version of the WHOQOL-100. Quality of life is defined by the World Health Organization¹⁷ “as an individuals’ perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns.” The WHOQOL-BREF contains 26 items. The first 2 items were examined separately; the first item asks individuals to rate their overall quality of life and the second asks individuals how satisfied they are with their health. The remaining 24 items were used to calculate the following 4 domain scores: physical health, psychological health, social relationship, and environment.¹⁸ Each item is measured on a scale of 1 to 5. Higher scores denote higher or better quality of life. Domain scores have demonstrated good reliability and validity.^19-21 Cronbach alpha coefficients for the domain subscales ranged from 0.63 to 0.84 in the current sample, with the lowest alphas for the 3-item Social Relationships Domain.

PCS. The PCS is a widely used measure of catastrophic thinking related to pain. Catastrophizing has been conceived by Sullivan and colleagues as “an exaggerated negative mental set brought to bear during actual or anticipated painful experience.”²² The PCS provides a total score and scores for the following subscales: rumination, magnification, and helplessness.²³ It has been used in a variety of chronic pain populations and has demonstrated good reliability and validity in clinical as well as nonclinical samples.^24-26 The PCS has 13 items rated on a scale of 0 to 4. Higher scores mean greater negative pain cognition (catastrophizing). In the current sample, the PCS total scale had a Cronbach alpha coefficient of 0.95 and 0.94 on the 2 assessments. The coefficients for the subscales ranged from 0.81 to 0.90.

PTSS. The PTSS is a 5-item tool that measures patient satisfaction with pain treatment. It includes items that address overall satisfaction, staff warmth, staff skill level, ease of scheduling appointments, and recommendation of the program to other veterans. It was derived from the post-treatment version of The Pain Outcome Questionnaire-VA and has demonstrated reliability and validity.²⁷ The questions are scaled from 0 to 10. High scores on the PTSS denote high patient satisfaction with the EVP. The Cronbach alpha coefficient on the PTSS obtained from the current sample was 0.80.

Data Gathering and Analysis

Prior to starting the Study phase, Washburn University’s Institutional Review Board (IRB) and the VA IRB approved the project. The VA IRB, through its affiliate, gave a Not Human Research Determination and granted a waiver of informed consent and the Health Insurance Portability and Accountability Act authorization. The VA facility’s Research and Development department also approved the quality improvement project.

Once these approvals were obtained, the Study phase began with the abstraction of retrospective data obtained from veterans who participated in the VA health care facility’s EVP between August 2017 and August 2019. Most of the measurement tools changed in August 2019, and for this reason data abstraction was limited to the time period August 2017 to August 2019. The first author (JUU) abstracted data for both program completers and noncompleters. The second (MJ) and third (SW) authors analyzed the data in SPSS 24 and calculated effect sizes.

Veterans who completed the program were compared to veterans who did not complete the program on age, gender, and baseline measures. The investigators used independent samples t-tests to compare completers and noncompleters on age, pain intensity, pain interference, quality of life, and pain catastrophizing. They used the chi-square test of independence to analyze the association between gender and program completion.

Data were included in the pre- and postintervention analysis if the veteran completed the NPRS, MPI, WHOQOL-BREF, and PCS pre and post intervention. This became an important eligibility requirement as some of the tools/measures were changed towards the end of the review period in 2019. Pre- and postintervention data on pain intensity, pain interference, quality of life, pain catastrophizing, and patient satisfaction were compared using paired samples t-test at .004 level of significance based on the Bonferroni correction.²⁸ Data on patient satisfaction with pain treatment were collected at program completion (week 8 or 10) and were analyzed using descriptive statistics.

Effect sizes (Cohen’s d) were calculated to determine the substantive significance or magnitude of the mean differences in scores. Effect sizes (expressed as absolute values of Cohen’s d) were calculated as the mean difference divided by the standard deviation. Values of 0.2 were considered a small effect size, 0.5 a medium effect size, and 0.8 a large effect size.²⁹

Data were abstracted for 115 veterans who started the EVP. Of these, 48 left the program, leaving 67 veterans (58%) who completed the program. Completers and noncompleters were similar in age, gender, and baseline measures (Table 1). Fifty-three (79%) completers and 35 (73%) noncompleters were male. A chi-square test of independence showed no significant association between gender and program completion (χ^2₁ [N = 115] = .595, P = .440).

Comparison of pre-and postintervention mean scale scores resulted in statistically significant differences for all comparisons (Table 2). These comparisons yielded improvements in the desired direction. For example, the scores on the NPRS, the MPI, and the PCS (along with its subscales) decreased, revealing reductions in pain severity, the impact of pain on the veterans’ lives, and pain catastrophizing. The 2 individual item scores on the WHOQOL-BREF increased, indicating improvements in perceived quality of life and satisfaction with health. The domain scores on the WHOQOL-BREF increased, revealing improvements in pain-related quality of life. The moderate to large effect sizes indicated clinically significant improvements for veterans with chronic high-impact pain who completed the EVP.

Analysis of data obtained using the PTSS yielded high mean scores for items that focused on patient satisfaction with treatment (Table 3). Scaled statistics yielded a mean (SD) of 46.95 (4.40). These results denoted overall patient satisfaction with the EVP.

Discussion

The purpose of this quality improvement project was to abstract and analyze previously collected data from veterans with high-impact chronic pain who attended the EVP. Comparison of pre-intervention and postintervention data obtained from 67 veterans who completed the program revealed improvements in pain intensity, pain interference, negative cognition (catastrophizing), and quality of life. The differences were statistically significant and clinically meaningful, with medium and large effect sizes. In addition, veterans reported high satisfaction with the EVP.

The EVP includes CIH approaches that have demonstrated effectiveness among veterans and other populations with chronic pain. A wealth of studies, for example, support the effectiveness of CIH approaches among veterans.^30-34 Other studies focus on specific CIH approaches that are components of the EVP. Evidence supports, for example, the efficacy of mindfulness-based stress reduction,^35-39 acceptance and commitment therapy,^40-43 brief peer support intervention,⁴⁴ and interdisciplinary biopsychosocial rehabilitation.^45,46

While empirical evidence supports components of the EVP, only one study focused on the outcomes of the Atlanta VA EVP among veterans with chronic pain. Results of a qualitative study conducted by Penney and Haro⁴⁷ described the experience of veterans with the EVP. Those veterans reported adopting new self-care or lifestyle practices for pain management and health, accepting pain, being better able to adjust and set boundaries, feeling more in control, participating in life, and changing their medication use.

The mean baseline scores from the current sample were similar to samples of patients with chronic pain in other studies (NPRS,⁴⁸ MPI,⁴⁸ and PCS^48-51). After converting scores on the WHOQOL-BREF from those that ranged from 4 to 20 to those that ranged from 0 to 100,¹⁸ the scores from the current sample were similar to those of other studies of patients with chronic pain.^48,52,53Several strengths of the project should be noted. Data were collected using well established measurement tools that had previously demonstrated reliability and validity. All the tools used in data collection demonstrated good internal consistency reliabilities in the current sample of veterans. Weaknesses of the project include the use of a convenience sample of veterans and small sample size. Data were not available on the number of veterans who were offered participation or on how many veterans declined enrollment. The sample of veterans who chose to participate in the EVP may or may not have been representative of the population of veterans with high-impact chronic pain. As a pre- and postintervention design with no comparison group, the results are subject to multiple threats to internal validity, including the Hawthorne effect, maturation in the form of healing, and attrition. Reasons for leaving the program had not been recorded, so the investigators had no way of knowing factors that may have contributed to attrition. Also, data on when veterans left the program were unavailable. Research is needed with a control group to reduce the effect of confounding variables on the outcome measures. This project used data collected at a single VA facility, which limits its generalizability.

While completers and noncompleters of the EVP were similar on age, gender, and baseline measures, there may have been unidentified characteristics that influenced program completion. The investigators noticed the presence of more missing data among noncompleters compared to completers on the pre-intervention PCS; thus, noncompleters may have scored lower than completers on this instrument simply because there were more individual items that were unanswered/missing among this group of noncompleters.

Data were analyzed using a limited number of outcome measures that had previously been collected. Other outcome measures might include whether EVP participants reduced their use of medications, clinical resources, and personnel. Future projects, for example, could determine whether the EVP is effective in reducing opioid analgesic medication use and decreasing primary care and emergency department visits. Cost-benefit analyses could be completed to determine whether EVP is associated with financial savings.

Because no follow-up assessments were made to determine whether improvements were maintained over time, the project focus was limited to an evaluation of the short-term changes in the outcome measures. Future projects could include a follow-up assessment of the veterans 1- or 2-years post completion of the EVP.

Data for the project were collected prior to the COVID-19 pandemic, when the EVP was implemented through face-to-face meetings with participants and their peers. It is not clear how changes to the delivery of the program (such as offering it through telehealth) might impact veterans’ satisfaction with the program, willingness to complete it, and other variables of interest.

The results of this project were made available to stakeholders with recommendations for program expansion both at the current location and at other VA facilities, including the recommendation to hire additional personnel that would implement the program. As the VA network of facilities expand the EVP program and adapt it for telehealth delivery, the investigators recommended a similar analysis of data be performed following telehealth delivery. If delivery through telehealth is shown to improve outcome measures, the EVP could provide pain management treatment options for patients challenged by transportation barriers, including rural veterans.

Conclusion

This quality improvement project provided evidence of improvement in measures of pain severity, pain interference, negative cognition (catastrophizing), quality of life, and patient treatment satisfaction among veterans with chronic high-impact pain. Findings have been well received by the northeastern VA as well as the Veterans Integrated Systems Network 5. The results of the analyses were used to inform decisions regarding the future of the program.

Disclaimer: This material is the result of work supported with resources and the use of facilities at the VA Maryland Health Care System, Baltimore, Maryland. The views expressed are those of the authors and do not necessarily represent the views of the Department of Veterans Affairs or the United States Government.

Acknowledgments: The authors thank Dr. Arianna Perra, the recent past coordinator of the Empower Veterans Program (EVP), who provided initial insights and support that motivated the decision to evaluate the program. We also thank the veterans and VA EVP clinicians who contributed data for the evaluation, and Dr. Michael Saenger (Director, TelePain-EVP: EVP) and Dr. Robert Lavin for their ongoing support, care, and concern for veteran patients. We also thank Dr. Beverly Bradley and the neurology service administrative team for their guidance in the process of obtaining necessary VA approvals for this project.

Corresponding author: Jessica U. Uche, DNP, CRNP-Family; [email protected]

doi:10.12788/jcom.0089

From Neurology/Chronic Pain Management Services, Department of Veterans Affairs (VA) Maryland Health Care System, Baltimore VA Medical Center, Baltimore, MD (Dr. Uche), and School of Nursing, Washburn University, Topeka, KS (Drs. Jamison and Waugh).

Abstract

Objective: The purpose of this quality improvement project was to abstract and analyze previously collected data from veterans with high-impact chronic pain who attended the Empower Veterans Program (EVP) offered by a Veterans Administration facility in the northeastern United States.

Methods: This quality improvement project used data collected from veterans with chronic pain who completed the veterans health care facility’s EVP between August 2017 and August 2019. Pre- and post-intervention data on pain intensity, pain interference, quality of life, and pain catastrophizing were compared using paired t-tests.

Results: Although data were abstracted from 115 patients, the final sample included 67 patients who completed both pre-and postintervention questionnaires. Baseline measures of completers and noncompleters were similar. Comparison of pre and post mean scores on completers showed statistically significant findings (P = .004) based on the Bonferroni correction. The medium and large effect sizes (Cohen’s d) indicated clinically significant improvements for veterans who completed the program. Veterans reported high levels of satisfaction with the program.

Conclusion: Veterans with chronic high-impact noncancer pain who completed the EVP had reduced pain intensity, pain interference, pain catastrophizing as well as improved quality of life and satisfaction with their health.

Keywords: musculoskeletal pain, Veterans Affairs, complementary and integrative health, acceptance and commitment therapy, mind-body therapies, whole health, multidisciplinary pain management.

More than 100 million American adults suffer from chronic pain; costs associated with managing chronic pain are approximately $635 billion each year.¹ Chronic pain is prevalent among military veterans, affecting one-third of the 9 million veterans who receive care from Veterans Health Administration (VHA) facilities.² The biopsychosocial impact of chronic pain on the general population, and specifically on veterans, has been compounded by the opioid crisis. The effects of chronic pain and the opioid crisis have fueled interest in the use of complementary and integrative health (CIH) modalities in the management of chronic noncancer pain. Providers are increasingly developing treatment programs that incorporate CIH in their management of chronic noncancer pain.

One such program is the Empower Veterans Program (EVP). Originally developed at the Atlanta Veterans Affairs Health Care System, the EVP is a CIH modality based on the biopsychosocial model of pain developed by psychiatrist George Engel in 1977.³ The biopsychosocial model of pain recognizes that pain is a complex, multidimensional, biopsychosocial experience. Under this model, the mind and body work in unison as interconnected entities. Because the model acknowledges biological, psychological, and social components of pain and illness,⁴ treatment focuses on all aspects of a person’s health, life, and relationships.

The EVP fits into the VHA Pain Management Stepped Care Model and is an adjunctive complement for that model.^5-7 The EVP complements care at the first step, where patient/family provide self-care and where care is provided by patient-aligned primary care teams, at the second step, which includes secondary consultation with multidisciplinary pain medicine specialty teams and other specialists, and at the third step, with the addition of tertiary interdisciplinary pain centers.

The VA Maryland Health Care System (VAMHCS) implemented the EVP as part of a quality improvement project for the management of chronic pain. The objectives of the program were to reduce pain intensity, pain catastrophizing, and pain interference, as well as improve functionality and quality of life among veterans with chronic high-impact noncancer pain. More than 2 years after the program was implemented, collected data had not been analyzed. The purpose of this quality improvement project was to abstract and analyze the previously collected data from veterans with high-impact chronic pain who attended an EVP offered by the VAMHCS. The results of the data analysis were used to inform decisions regarding the future of the program.

Methods

This quality improvement project used the Plan-Do-Study-Act (PDSA) process.⁸ The first 2 phases of the PDSA cycle (Plan and Do) were completed by a team of VA employees from the VAMHCS, who donated their time to establish and implement the program at the project site. This team consisted of psychologists, a physical therapist, a social worker, and a chaplain, and included support from medical administrative staff. This team planned and implemented the EVP at the VA facility based on the model developed at the Atlanta VA Health Care System. During the “Do” phase, the team collected data on pain intensity, pain interference, quality of life, and pain negative cognition (catastrophizing) before the intervention and post intervention. They also collected data on program outcome (patient treatment satisfaction) post intervention. Because these employees did not have time to retrieve and analyze the data, they welcomed the opportunity to have the data analyzed by the investigators during the Study phase of the PDSA cycle. Based on the results of the analysis, recommendations for program changes were made during the Act phase of the cycle.

Intervention

The EVP was developed as a 10-week (30 hours) interdisciplinary CIH approach that coached veterans with chronic pain to live fuller lives based on their individual values and what matters to them. EVP is the “What Else” management modality for the 5% of veterans with high-impact chronic pain.⁹ The EVP provided functional restoration through its components of whole health, mindfulness training, coaching calls, acceptance and commitment therapy, and mindful movement. It used the Wheel of Health with the 4 key components of me, self-care, professional care, and community.^10,11

Veterans who had a diagnosis of chronic nonmalignant pain for 3 months or more and who agreed to participate in the EVP at this facility attended 3-hour classes every Tuesday with a cohort of 8 to 12 peers and engaged in one-on-one coaching with interdisciplinary team members. During the class sessions, veterans were coached to understand and accept their pain and commit to maintaining function despite their pain. Mindful movement by the physical therapist emphasized the pivotal place of exercise in pain management. The therapist used the mantra “Motion is Lotion.”⁹ The guiding principle of the EVP was that small incremental changes can have a big impact on the individual’s whole life. Emphasis was placed on increasing self-efficacy and mindful awareness for veterans with high-impact pain by giving them “Skills before Pills.”⁹

Outcome Measures

Outcome measures included the Numerical Pain Rating Scale (NPRS), the Multidimensional Pain Inventory (MPI), the World Health Organization Quality of Life assessment (WHOQOL-BREF), the Pain Catastrophizing Scale (PCS), and the Pain Treatment Satisfaction Scale (PTSS). Cronbach alpha coefficients were calculated to assess internal consistency reliability of these measures in the sample of veterans who completed the EVP.

NPRS. The NPRS is ubiquitous as a screening tool in many health care environments and its use is mandated by the VA health care system.¹² The choice of the NPRS as the tool for pain screening in the VA health care system was based on a large body of research that supports the reliability and validity of the NPRS as a single index of pain intensity or severity. Studies suggest that the NPRS is valid for use in the assessment of acute, cancer, or chronic nonmalignant pain and in varied clinical settings.¹³ The NPRS has 4 items, each on a scale of 0 to 10. For the purpose of this project, only 3 items were used. The 3 items assessed the worst pain, usual pain, and the current pain (right now). The higher the score, the higher the pain intensity. Cronbach alpha coefficients on the NPRS obtained from the current sample of veterans were 0.85 on both pre- and postintervention assessments.

MPI. The MPI is an easily accessible, reliable, and valid self-report questionnaire that measures the impact of pain on an individual’s life, quality of social support, and general activity.¹⁴ This instrument is a short version of the West Haven-Yale MPI.¹⁵ The MPI contains 9 items rated on a scale from 0 to 6. The higher the score, the greater pain interference a person is experiencing. The MPI produces reliable, valid information for diagnostic purposes and for therapy outcome studies.¹⁶ The MPI had a Cronbach alpha of 0.90 on pre-intervention and 0.92 on postintervention assessments in the current sample.

WHOQOL-BREF. The WHOQOL-BREF is a measure of quality of life and is an abbreviated version of the WHOQOL-100. Quality of life is defined by the World Health Organization¹⁷ “as an individuals’ perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns.” The WHOQOL-BREF contains 26 items. The first 2 items were examined separately; the first item asks individuals to rate their overall quality of life and the second asks individuals how satisfied they are with their health. The remaining 24 items were used to calculate the following 4 domain scores: physical health, psychological health, social relationship, and environment.¹⁸ Each item is measured on a scale of 1 to 5. Higher scores denote higher or better quality of life. Domain scores have demonstrated good reliability and validity.^19-21 Cronbach alpha coefficients for the domain subscales ranged from 0.63 to 0.84 in the current sample, with the lowest alphas for the 3-item Social Relationships Domain.

PCS. The PCS is a widely used measure of catastrophic thinking related to pain. Catastrophizing has been conceived by Sullivan and colleagues as “an exaggerated negative mental set brought to bear during actual or anticipated painful experience.”²² The PCS provides a total score and scores for the following subscales: rumination, magnification, and helplessness.²³ It has been used in a variety of chronic pain populations and has demonstrated good reliability and validity in clinical as well as nonclinical samples.^24-26 The PCS has 13 items rated on a scale of 0 to 4. Higher scores mean greater negative pain cognition (catastrophizing). In the current sample, the PCS total scale had a Cronbach alpha coefficient of 0.95 and 0.94 on the 2 assessments. The coefficients for the subscales ranged from 0.81 to 0.90.

PTSS. The PTSS is a 5-item tool that measures patient satisfaction with pain treatment. It includes items that address overall satisfaction, staff warmth, staff skill level, ease of scheduling appointments, and recommendation of the program to other veterans. It was derived from the post-treatment version of The Pain Outcome Questionnaire-VA and has demonstrated reliability and validity.²⁷ The questions are scaled from 0 to 10. High scores on the PTSS denote high patient satisfaction with the EVP. The Cronbach alpha coefficient on the PTSS obtained from the current sample was 0.80.

Data Gathering and Analysis

Prior to starting the Study phase, Washburn University’s Institutional Review Board (IRB) and the VA IRB approved the project. The VA IRB, through its affiliate, gave a Not Human Research Determination and granted a waiver of informed consent and the Health Insurance Portability and Accountability Act authorization. The VA facility’s Research and Development department also approved the quality improvement project.

Once these approvals were obtained, the Study phase began with the abstraction of retrospective data obtained from veterans who participated in the VA health care facility’s EVP between August 2017 and August 2019. Most of the measurement tools changed in August 2019, and for this reason data abstraction was limited to the time period August 2017 to August 2019. The first author (JUU) abstracted data for both program completers and noncompleters. The second (MJ) and third (SW) authors analyzed the data in SPSS 24 and calculated effect sizes.

Veterans who completed the program were compared to veterans who did not complete the program on age, gender, and baseline measures. The investigators used independent samples t-tests to compare completers and noncompleters on age, pain intensity, pain interference, quality of life, and pain catastrophizing. They used the chi-square test of independence to analyze the association between gender and program completion.

Data were included in the pre- and postintervention analysis if the veteran completed the NPRS, MPI, WHOQOL-BREF, and PCS pre and post intervention. This became an important eligibility requirement as some of the tools/measures were changed towards the end of the review period in 2019. Pre- and postintervention data on pain intensity, pain interference, quality of life, pain catastrophizing, and patient satisfaction were compared using paired samples t-test at .004 level of significance based on the Bonferroni correction.²⁸ Data on patient satisfaction with pain treatment were collected at program completion (week 8 or 10) and were analyzed using descriptive statistics.

Effect sizes (Cohen’s d) were calculated to determine the substantive significance or magnitude of the mean differences in scores. Effect sizes (expressed as absolute values of Cohen’s d) were calculated as the mean difference divided by the standard deviation. Values of 0.2 were considered a small effect size, 0.5 a medium effect size, and 0.8 a large effect size.²⁹

Data were abstracted for 115 veterans who started the EVP. Of these, 48 left the program, leaving 67 veterans (58%) who completed the program. Completers and noncompleters were similar in age, gender, and baseline measures (Table 1). Fifty-three (79%) completers and 35 (73%) noncompleters were male. A chi-square test of independence showed no significant association between gender and program completion (χ^2₁ [N = 115] = .595, P = .440).

Comparison of pre-and postintervention mean scale scores resulted in statistically significant differences for all comparisons (Table 2). These comparisons yielded improvements in the desired direction. For example, the scores on the NPRS, the MPI, and the PCS (along with its subscales) decreased, revealing reductions in pain severity, the impact of pain on the veterans’ lives, and pain catastrophizing. The 2 individual item scores on the WHOQOL-BREF increased, indicating improvements in perceived quality of life and satisfaction with health. The domain scores on the WHOQOL-BREF increased, revealing improvements in pain-related quality of life. The moderate to large effect sizes indicated clinically significant improvements for veterans with chronic high-impact pain who completed the EVP.

Analysis of data obtained using the PTSS yielded high mean scores for items that focused on patient satisfaction with treatment (Table 3). Scaled statistics yielded a mean (SD) of 46.95 (4.40). These results denoted overall patient satisfaction with the EVP.

Discussion

The purpose of this quality improvement project was to abstract and analyze previously collected data from veterans with high-impact chronic pain who attended the EVP. Comparison of pre-intervention and postintervention data obtained from 67 veterans who completed the program revealed improvements in pain intensity, pain interference, negative cognition (catastrophizing), and quality of life. The differences were statistically significant and clinically meaningful, with medium and large effect sizes. In addition, veterans reported high satisfaction with the EVP.

The EVP includes CIH approaches that have demonstrated effectiveness among veterans and other populations with chronic pain. A wealth of studies, for example, support the effectiveness of CIH approaches among veterans.^30-34 Other studies focus on specific CIH approaches that are components of the EVP. Evidence supports, for example, the efficacy of mindfulness-based stress reduction,^35-39 acceptance and commitment therapy,^40-43 brief peer support intervention,⁴⁴ and interdisciplinary biopsychosocial rehabilitation.^45,46

While empirical evidence supports components of the EVP, only one study focused on the outcomes of the Atlanta VA EVP among veterans with chronic pain. Results of a qualitative study conducted by Penney and Haro⁴⁷ described the experience of veterans with the EVP. Those veterans reported adopting new self-care or lifestyle practices for pain management and health, accepting pain, being better able to adjust and set boundaries, feeling more in control, participating in life, and changing their medication use.

The mean baseline scores from the current sample were similar to samples of patients with chronic pain in other studies (NPRS,⁴⁸ MPI,⁴⁸ and PCS^48-51). After converting scores on the WHOQOL-BREF from those that ranged from 4 to 20 to those that ranged from 0 to 100,¹⁸ the scores from the current sample were similar to those of other studies of patients with chronic pain.^48,52,53Several strengths of the project should be noted. Data were collected using well established measurement tools that had previously demonstrated reliability and validity. All the tools used in data collection demonstrated good internal consistency reliabilities in the current sample of veterans. Weaknesses of the project include the use of a convenience sample of veterans and small sample size. Data were not available on the number of veterans who were offered participation or on how many veterans declined enrollment. The sample of veterans who chose to participate in the EVP may or may not have been representative of the population of veterans with high-impact chronic pain. As a pre- and postintervention design with no comparison group, the results are subject to multiple threats to internal validity, including the Hawthorne effect, maturation in the form of healing, and attrition. Reasons for leaving the program had not been recorded, so the investigators had no way of knowing factors that may have contributed to attrition. Also, data on when veterans left the program were unavailable. Research is needed with a control group to reduce the effect of confounding variables on the outcome measures. This project used data collected at a single VA facility, which limits its generalizability.

While completers and noncompleters of the EVP were similar on age, gender, and baseline measures, there may have been unidentified characteristics that influenced program completion. The investigators noticed the presence of more missing data among noncompleters compared to completers on the pre-intervention PCS; thus, noncompleters may have scored lower than completers on this instrument simply because there were more individual items that were unanswered/missing among this group of noncompleters.

Data were analyzed using a limited number of outcome measures that had previously been collected. Other outcome measures might include whether EVP participants reduced their use of medications, clinical resources, and personnel. Future projects, for example, could determine whether the EVP is effective in reducing opioid analgesic medication use and decreasing primary care and emergency department visits. Cost-benefit analyses could be completed to determine whether EVP is associated with financial savings.

Because no follow-up assessments were made to determine whether improvements were maintained over time, the project focus was limited to an evaluation of the short-term changes in the outcome measures. Future projects could include a follow-up assessment of the veterans 1- or 2-years post completion of the EVP.

Data for the project were collected prior to the COVID-19 pandemic, when the EVP was implemented through face-to-face meetings with participants and their peers. It is not clear how changes to the delivery of the program (such as offering it through telehealth) might impact veterans’ satisfaction with the program, willingness to complete it, and other variables of interest.

The results of this project were made available to stakeholders with recommendations for program expansion both at the current location and at other VA facilities, including the recommendation to hire additional personnel that would implement the program. As the VA network of facilities expand the EVP program and adapt it for telehealth delivery, the investigators recommended a similar analysis of data be performed following telehealth delivery. If delivery through telehealth is shown to improve outcome measures, the EVP could provide pain management treatment options for patients challenged by transportation barriers, including rural veterans.

Conclusion

This quality improvement project provided evidence of improvement in measures of pain severity, pain interference, negative cognition (catastrophizing), quality of life, and patient treatment satisfaction among veterans with chronic high-impact pain. Findings have been well received by the northeastern VA as well as the Veterans Integrated Systems Network 5. The results of the analyses were used to inform decisions regarding the future of the program.

Disclaimer: This material is the result of work supported with resources and the use of facilities at the VA Maryland Health Care System, Baltimore, Maryland. The views expressed are those of the authors and do not necessarily represent the views of the Department of Veterans Affairs or the United States Government.

Acknowledgments: The authors thank Dr. Arianna Perra, the recent past coordinator of the Empower Veterans Program (EVP), who provided initial insights and support that motivated the decision to evaluate the program. We also thank the veterans and VA EVP clinicians who contributed data for the evaluation, and Dr. Michael Saenger (Director, TelePain-EVP: EVP) and Dr. Robert Lavin for their ongoing support, care, and concern for veteran patients. We also thank Dr. Beverly Bradley and the neurology service administrative team for their guidance in the process of obtaining necessary VA approvals for this project.

Corresponding author: Jessica U. Uche, DNP, CRNP-Family; [email protected]

doi:10.12788/jcom.0089

From Neurology/Chronic Pain Management Services, Department of Veterans Affairs (VA) Maryland Health Care System, Baltimore VA Medical Center, Baltimore, MD (Dr. Uche), and School of Nursing, Washburn University, Topeka, KS (Drs. Jamison and Waugh).

Abstract

Objective: The purpose of this quality improvement project was to abstract and analyze previously collected data from veterans with high-impact chronic pain who attended the Empower Veterans Program (EVP) offered by a Veterans Administration facility in the northeastern United States.

Methods: This quality improvement project used data collected from veterans with chronic pain who completed the veterans health care facility’s EVP between August 2017 and August 2019. Pre- and post-intervention data on pain intensity, pain interference, quality of life, and pain catastrophizing were compared using paired t-tests.

Results: Although data were abstracted from 115 patients, the final sample included 67 patients who completed both pre-and postintervention questionnaires. Baseline measures of completers and noncompleters were similar. Comparison of pre and post mean scores on completers showed statistically significant findings (P = .004) based on the Bonferroni correction. The medium and large effect sizes (Cohen’s d) indicated clinically significant improvements for veterans who completed the program. Veterans reported high levels of satisfaction with the program.

Conclusion: Veterans with chronic high-impact noncancer pain who completed the EVP had reduced pain intensity, pain interference, pain catastrophizing as well as improved quality of life and satisfaction with their health.

Keywords: musculoskeletal pain, Veterans Affairs, complementary and integrative health, acceptance and commitment therapy, mind-body therapies, whole health, multidisciplinary pain management.

More than 100 million American adults suffer from chronic pain; costs associated with managing chronic pain are approximately $635 billion each year.¹ Chronic pain is prevalent among military veterans, affecting one-third of the 9 million veterans who receive care from Veterans Health Administration (VHA) facilities.² The biopsychosocial impact of chronic pain on the general population, and specifically on veterans, has been compounded by the opioid crisis. The effects of chronic pain and the opioid crisis have fueled interest in the use of complementary and integrative health (CIH) modalities in the management of chronic noncancer pain. Providers are increasingly developing treatment programs that incorporate CIH in their management of chronic noncancer pain.

One such program is the Empower Veterans Program (EVP). Originally developed at the Atlanta Veterans Affairs Health Care System, the EVP is a CIH modality based on the biopsychosocial model of pain developed by psychiatrist George Engel in 1977.³ The biopsychosocial model of pain recognizes that pain is a complex, multidimensional, biopsychosocial experience. Under this model, the mind and body work in unison as interconnected entities. Because the model acknowledges biological, psychological, and social components of pain and illness,⁴ treatment focuses on all aspects of a person’s health, life, and relationships.

The EVP fits into the VHA Pain Management Stepped Care Model and is an adjunctive complement for that model.^5-7 The EVP complements care at the first step, where patient/family provide self-care and where care is provided by patient-aligned primary care teams, at the second step, which includes secondary consultation with multidisciplinary pain medicine specialty teams and other specialists, and at the third step, with the addition of tertiary interdisciplinary pain centers.

The VA Maryland Health Care System (VAMHCS) implemented the EVP as part of a quality improvement project for the management of chronic pain. The objectives of the program were to reduce pain intensity, pain catastrophizing, and pain interference, as well as improve functionality and quality of life among veterans with chronic high-impact noncancer pain. More than 2 years after the program was implemented, collected data had not been analyzed. The purpose of this quality improvement project was to abstract and analyze the previously collected data from veterans with high-impact chronic pain who attended an EVP offered by the VAMHCS. The results of the data analysis were used to inform decisions regarding the future of the program.

Methods

This quality improvement project used the Plan-Do-Study-Act (PDSA) process.⁸ The first 2 phases of the PDSA cycle (Plan and Do) were completed by a team of VA employees from the VAMHCS, who donated their time to establish and implement the program at the project site. This team consisted of psychologists, a physical therapist, a social worker, and a chaplain, and included support from medical administrative staff. This team planned and implemented the EVP at the VA facility based on the model developed at the Atlanta VA Health Care System. During the “Do” phase, the team collected data on pain intensity, pain interference, quality of life, and pain negative cognition (catastrophizing) before the intervention and post intervention. They also collected data on program outcome (patient treatment satisfaction) post intervention. Because these employees did not have time to retrieve and analyze the data, they welcomed the opportunity to have the data analyzed by the investigators during the Study phase of the PDSA cycle. Based on the results of the analysis, recommendations for program changes were made during the Act phase of the cycle.

Intervention

The EVP was developed as a 10-week (30 hours) interdisciplinary CIH approach that coached veterans with chronic pain to live fuller lives based on their individual values and what matters to them. EVP is the “What Else” management modality for the 5% of veterans with high-impact chronic pain.⁹ The EVP provided functional restoration through its components of whole health, mindfulness training, coaching calls, acceptance and commitment therapy, and mindful movement. It used the Wheel of Health with the 4 key components of me, self-care, professional care, and community.^10,11

Veterans who had a diagnosis of chronic nonmalignant pain for 3 months or more and who agreed to participate in the EVP at this facility attended 3-hour classes every Tuesday with a cohort of 8 to 12 peers and engaged in one-on-one coaching with interdisciplinary team members. During the class sessions, veterans were coached to understand and accept their pain and commit to maintaining function despite their pain. Mindful movement by the physical therapist emphasized the pivotal place of exercise in pain management. The therapist used the mantra “Motion is Lotion.”⁹ The guiding principle of the EVP was that small incremental changes can have a big impact on the individual’s whole life. Emphasis was placed on increasing self-efficacy and mindful awareness for veterans with high-impact pain by giving them “Skills before Pills.”⁹

Outcome Measures

Outcome measures included the Numerical Pain Rating Scale (NPRS), the Multidimensional Pain Inventory (MPI), the World Health Organization Quality of Life assessment (WHOQOL-BREF), the Pain Catastrophizing Scale (PCS), and the Pain Treatment Satisfaction Scale (PTSS). Cronbach alpha coefficients were calculated to assess internal consistency reliability of these measures in the sample of veterans who completed the EVP.

NPRS. The NPRS is ubiquitous as a screening tool in many health care environments and its use is mandated by the VA health care system.¹² The choice of the NPRS as the tool for pain screening in the VA health care system was based on a large body of research that supports the reliability and validity of the NPRS as a single index of pain intensity or severity. Studies suggest that the NPRS is valid for use in the assessment of acute, cancer, or chronic nonmalignant pain and in varied clinical settings.¹³ The NPRS has 4 items, each on a scale of 0 to 10. For the purpose of this project, only 3 items were used. The 3 items assessed the worst pain, usual pain, and the current pain (right now). The higher the score, the higher the pain intensity. Cronbach alpha coefficients on the NPRS obtained from the current sample of veterans were 0.85 on both pre- and postintervention assessments.

MPI. The MPI is an easily accessible, reliable, and valid self-report questionnaire that measures the impact of pain on an individual’s life, quality of social support, and general activity.¹⁴ This instrument is a short version of the West Haven-Yale MPI.¹⁵ The MPI contains 9 items rated on a scale from 0 to 6. The higher the score, the greater pain interference a person is experiencing. The MPI produces reliable, valid information for diagnostic purposes and for therapy outcome studies.¹⁶ The MPI had a Cronbach alpha of 0.90 on pre-intervention and 0.92 on postintervention assessments in the current sample.

WHOQOL-BREF. The WHOQOL-BREF is a measure of quality of life and is an abbreviated version of the WHOQOL-100. Quality of life is defined by the World Health Organization¹⁷ “as an individuals’ perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns.” The WHOQOL-BREF contains 26 items. The first 2 items were examined separately; the first item asks individuals to rate their overall quality of life and the second asks individuals how satisfied they are with their health. The remaining 24 items were used to calculate the following 4 domain scores: physical health, psychological health, social relationship, and environment.¹⁸ Each item is measured on a scale of 1 to 5. Higher scores denote higher or better quality of life. Domain scores have demonstrated good reliability and validity.^19-21 Cronbach alpha coefficients for the domain subscales ranged from 0.63 to 0.84 in the current sample, with the lowest alphas for the 3-item Social Relationships Domain.

PCS. The PCS is a widely used measure of catastrophic thinking related to pain. Catastrophizing has been conceived by Sullivan and colleagues as “an exaggerated negative mental set brought to bear during actual or anticipated painful experience.”²² The PCS provides a total score and scores for the following subscales: rumination, magnification, and helplessness.²³ It has been used in a variety of chronic pain populations and has demonstrated good reliability and validity in clinical as well as nonclinical samples.^24-26 The PCS has 13 items rated on a scale of 0 to 4. Higher scores mean greater negative pain cognition (catastrophizing). In the current sample, the PCS total scale had a Cronbach alpha coefficient of 0.95 and 0.94 on the 2 assessments. The coefficients for the subscales ranged from 0.81 to 0.90.

PTSS. The PTSS is a 5-item tool that measures patient satisfaction with pain treatment. It includes items that address overall satisfaction, staff warmth, staff skill level, ease of scheduling appointments, and recommendation of the program to other veterans. It was derived from the post-treatment version of The Pain Outcome Questionnaire-VA and has demonstrated reliability and validity.²⁷ The questions are scaled from 0 to 10. High scores on the PTSS denote high patient satisfaction with the EVP. The Cronbach alpha coefficient on the PTSS obtained from the current sample was 0.80.

Data Gathering and Analysis

Prior to starting the Study phase, Washburn University’s Institutional Review Board (IRB) and the VA IRB approved the project. The VA IRB, through its affiliate, gave a Not Human Research Determination and granted a waiver of informed consent and the Health Insurance Portability and Accountability Act authorization. The VA facility’s Research and Development department also approved the quality improvement project.

Once these approvals were obtained, the Study phase began with the abstraction of retrospective data obtained from veterans who participated in the VA health care facility’s EVP between August 2017 and August 2019. Most of the measurement tools changed in August 2019, and for this reason data abstraction was limited to the time period August 2017 to August 2019. The first author (JUU) abstracted data for both program completers and noncompleters. The second (MJ) and third (SW) authors analyzed the data in SPSS 24 and calculated effect sizes.

Veterans who completed the program were compared to veterans who did not complete the program on age, gender, and baseline measures. The investigators used independent samples t-tests to compare completers and noncompleters on age, pain intensity, pain interference, quality of life, and pain catastrophizing. They used the chi-square test of independence to analyze the association between gender and program completion.

Data were included in the pre- and postintervention analysis if the veteran completed the NPRS, MPI, WHOQOL-BREF, and PCS pre and post intervention. This became an important eligibility requirement as some of the tools/measures were changed towards the end of the review period in 2019. Pre- and postintervention data on pain intensity, pain interference, quality of life, pain catastrophizing, and patient satisfaction were compared using paired samples t-test at .004 level of significance based on the Bonferroni correction.²⁸ Data on patient satisfaction with pain treatment were collected at program completion (week 8 or 10) and were analyzed using descriptive statistics.

Effect sizes (Cohen’s d) were calculated to determine the substantive significance or magnitude of the mean differences in scores. Effect sizes (expressed as absolute values of Cohen’s d) were calculated as the mean difference divided by the standard deviation. Values of 0.2 were considered a small effect size, 0.5 a medium effect size, and 0.8 a large effect size.²⁹

Data were abstracted for 115 veterans who started the EVP. Of these, 48 left the program, leaving 67 veterans (58%) who completed the program. Completers and noncompleters were similar in age, gender, and baseline measures (Table 1). Fifty-three (79%) completers and 35 (73%) noncompleters were male. A chi-square test of independence showed no significant association between gender and program completion (χ^2₁ [N = 115] = .595, P = .440).

Comparison of pre-and postintervention mean scale scores resulted in statistically significant differences for all comparisons (Table 2). These comparisons yielded improvements in the desired direction. For example, the scores on the NPRS, the MPI, and the PCS (along with its subscales) decreased, revealing reductions in pain severity, the impact of pain on the veterans’ lives, and pain catastrophizing. The 2 individual item scores on the WHOQOL-BREF increased, indicating improvements in perceived quality of life and satisfaction with health. The domain scores on the WHOQOL-BREF increased, revealing improvements in pain-related quality of life. The moderate to large effect sizes indicated clinically significant improvements for veterans with chronic high-impact pain who completed the EVP.

Analysis of data obtained using the PTSS yielded high mean scores for items that focused on patient satisfaction with treatment (Table 3). Scaled statistics yielded a mean (SD) of 46.95 (4.40). These results denoted overall patient satisfaction with the EVP.

Discussion

The purpose of this quality improvement project was to abstract and analyze previously collected data from veterans with high-impact chronic pain who attended the EVP. Comparison of pre-intervention and postintervention data obtained from 67 veterans who completed the program revealed improvements in pain intensity, pain interference, negative cognition (catastrophizing), and quality of life. The differences were statistically significant and clinically meaningful, with medium and large effect sizes. In addition, veterans reported high satisfaction with the EVP.

The EVP includes CIH approaches that have demonstrated effectiveness among veterans and other populations with chronic pain. A wealth of studies, for example, support the effectiveness of CIH approaches among veterans.^30-34 Other studies focus on specific CIH approaches that are components of the EVP. Evidence supports, for example, the efficacy of mindfulness-based stress reduction,^35-39 acceptance and commitment therapy,^40-43 brief peer support intervention,⁴⁴ and interdisciplinary biopsychosocial rehabilitation.^45,46

While empirical evidence supports components of the EVP, only one study focused on the outcomes of the Atlanta VA EVP among veterans with chronic pain. Results of a qualitative study conducted by Penney and Haro⁴⁷ described the experience of veterans with the EVP. Those veterans reported adopting new self-care or lifestyle practices for pain management and health, accepting pain, being better able to adjust and set boundaries, feeling more in control, participating in life, and changing their medication use.

The mean baseline scores from the current sample were similar to samples of patients with chronic pain in other studies (NPRS,⁴⁸ MPI,⁴⁸ and PCS^48-51). After converting scores on the WHOQOL-BREF from those that ranged from 4 to 20 to those that ranged from 0 to 100,¹⁸ the scores from the current sample were similar to those of other studies of patients with chronic pain.^48,52,53Several strengths of the project should be noted. Data were collected using well established measurement tools that had previously demonstrated reliability and validity. All the tools used in data collection demonstrated good internal consistency reliabilities in the current sample of veterans. Weaknesses of the project include the use of a convenience sample of veterans and small sample size. Data were not available on the number of veterans who were offered participation or on how many veterans declined enrollment. The sample of veterans who chose to participate in the EVP may or may not have been representative of the population of veterans with high-impact chronic pain. As a pre- and postintervention design with no comparison group, the results are subject to multiple threats to internal validity, including the Hawthorne effect, maturation in the form of healing, and attrition. Reasons for leaving the program had not been recorded, so the investigators had no way of knowing factors that may have contributed to attrition. Also, data on when veterans left the program were unavailable. Research is needed with a control group to reduce the effect of confounding variables on the outcome measures. This project used data collected at a single VA facility, which limits its generalizability.

While completers and noncompleters of the EVP were similar on age, gender, and baseline measures, there may have been unidentified characteristics that influenced program completion. The investigators noticed the presence of more missing data among noncompleters compared to completers on the pre-intervention PCS; thus, noncompleters may have scored lower than completers on this instrument simply because there were more individual items that were unanswered/missing among this group of noncompleters.

Data were analyzed using a limited number of outcome measures that had previously been collected. Other outcome measures might include whether EVP participants reduced their use of medications, clinical resources, and personnel. Future projects, for example, could determine whether the EVP is effective in reducing opioid analgesic medication use and decreasing primary care and emergency department visits. Cost-benefit analyses could be completed to determine whether EVP is associated with financial savings.

Because no follow-up assessments were made to determine whether improvements were maintained over time, the project focus was limited to an evaluation of the short-term changes in the outcome measures. Future projects could include a follow-up assessment of the veterans 1- or 2-years post completion of the EVP.

Data for the project were collected prior to the COVID-19 pandemic, when the EVP was implemented through face-to-face meetings with participants and their peers. It is not clear how changes to the delivery of the program (such as offering it through telehealth) might impact veterans’ satisfaction with the program, willingness to complete it, and other variables of interest.

The results of this project were made available to stakeholders with recommendations for program expansion both at the current location and at other VA facilities, including the recommendation to hire additional personnel that would implement the program. As the VA network of facilities expand the EVP program and adapt it for telehealth delivery, the investigators recommended a similar analysis of data be performed following telehealth delivery. If delivery through telehealth is shown to improve outcome measures, the EVP could provide pain management treatment options for patients challenged by transportation barriers, including rural veterans.

Conclusion

This quality improvement project provided evidence of improvement in measures of pain severity, pain interference, negative cognition (catastrophizing), quality of life, and patient treatment satisfaction among veterans with chronic high-impact pain. Findings have been well received by the northeastern VA as well as the Veterans Integrated Systems Network 5. The results of the analyses were used to inform decisions regarding the future of the program.

Disclaimer: This material is the result of work supported with resources and the use of facilities at the VA Maryland Health Care System, Baltimore, Maryland. The views expressed are those of the authors and do not necessarily represent the views of the Department of Veterans Affairs or the United States Government.

Acknowledgments: The authors thank Dr. Arianna Perra, the recent past coordinator of the Empower Veterans Program (EVP), who provided initial insights and support that motivated the decision to evaluate the program. We also thank the veterans and VA EVP clinicians who contributed data for the evaluation, and Dr. Michael Saenger (Director, TelePain-EVP: EVP) and Dr. Robert Lavin for their ongoing support, care, and concern for veteran patients. We also thank Dr. Beverly Bradley and the neurology service administrative team for their guidance in the process of obtaining necessary VA approvals for this project.

Corresponding author: Jessica U. Uche, DNP, CRNP-Family; [email protected]

doi:10.12788/jcom.0089

Key clinical point: Compared with patients with hepatocellular carcinoma (HCC) due to other causes, a higher proportion of those with nonalcoholic fatty liver disease (NAFLD)-related HCC do not have cirrhosis and lack an indication for HCC surveillance, thus calling for surveillance strategies for patients with NAFLD without cirrhosis but at high risk for HCC.

Major finding: The proportion of patients without cirrhosis was higher among those with NAFLD-related HCC vs. HCC due to other causes (38.5% vs. 14.6%; P < .0001). Before cancer diagnosis, only 32.8% of patients with NAFLD-related HCC underwent HCC surveillance relative to 55.7% of those with HCC due to other causes (odds ratio 0.36; P < .0001).

Study details: This was a meta-analysis of 61 studies including 94,636 patients with HCC related to either NAFLD (n = 15,377) or other causes (n = 79,259).

Disclosures: No funding was received for the study. Some authors declared having stock options from, serving as paid/unpaid consultants or advisory board members for, and receiving royalties or research grants from various organizations.

Source: Tan DJH et al. Clinical characteristics, surveillance, treatment allocation, and outcomes of non-alcoholic fatty liver disease-related hepatocellular carcinoma: a systematic review and meta-analysis. Lancet Oncol. 2022 (Mar 4). Doi: 10.1016/S1470-2045(22)00078-X

Key clinical point: Compared with patients with hepatocellular carcinoma (HCC) due to other causes, a higher proportion of those with nonalcoholic fatty liver disease (NAFLD)-related HCC do not have cirrhosis and lack an indication for HCC surveillance, thus calling for surveillance strategies for patients with NAFLD without cirrhosis but at high risk for HCC.

Major finding: The proportion of patients without cirrhosis was higher among those with NAFLD-related HCC vs. HCC due to other causes (38.5% vs. 14.6%; P < .0001). Before cancer diagnosis, only 32.8% of patients with NAFLD-related HCC underwent HCC surveillance relative to 55.7% of those with HCC due to other causes (odds ratio 0.36; P < .0001).

Study details: This was a meta-analysis of 61 studies including 94,636 patients with HCC related to either NAFLD (n = 15,377) or other causes (n = 79,259).

Disclosures: No funding was received for the study. Some authors declared having stock options from, serving as paid/unpaid consultants or advisory board members for, and receiving royalties or research grants from various organizations.

Source: Tan DJH et al. Clinical characteristics, surveillance, treatment allocation, and outcomes of non-alcoholic fatty liver disease-related hepatocellular carcinoma: a systematic review and meta-analysis. Lancet Oncol. 2022 (Mar 4). Doi: 10.1016/S1470-2045(22)00078-X

Key clinical point: Compared with patients with hepatocellular carcinoma (HCC) due to other causes, a higher proportion of those with nonalcoholic fatty liver disease (NAFLD)-related HCC do not have cirrhosis and lack an indication for HCC surveillance, thus calling for surveillance strategies for patients with NAFLD without cirrhosis but at high risk for HCC.

Major finding: The proportion of patients without cirrhosis was higher among those with NAFLD-related HCC vs. HCC due to other causes (38.5% vs. 14.6%; P < .0001). Before cancer diagnosis, only 32.8% of patients with NAFLD-related HCC underwent HCC surveillance relative to 55.7% of those with HCC due to other causes (odds ratio 0.36; P < .0001).

Study details: This was a meta-analysis of 61 studies including 94,636 patients with HCC related to either NAFLD (n = 15,377) or other causes (n = 79,259).

Disclosures: No funding was received for the study. Some authors declared having stock options from, serving as paid/unpaid consultants or advisory board members for, and receiving royalties or research grants from various organizations.

Source: Tan DJH et al. Clinical characteristics, surveillance, treatment allocation, and outcomes of non-alcoholic fatty liver disease-related hepatocellular carcinoma: a systematic review and meta-analysis. Lancet Oncol. 2022 (Mar 4). Doi: 10.1016/S1470-2045(22)00078-X