Should you treat prediabetes? It’s complicated

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Should you treat prediabetes? It’s complicated

ILLUSTRATIVE CASE

A 51-year-old woman with a history of elevated cholesterol and a body mass index (BMI) of 31 presents to your clinic for a scheduled follow-up visit to review recent blood test results. Her A1C was elevated at 5.9%. She wants to know if she should start medication now.

Prediabetes is a high-risk state that ­confers increased risk for type 2 ­diabetes (T2D). It is identified by impaired fasting glucose (fasting plasma glucose [FPG], 100-125 mg/dL), impaired glucose tolerance (2-hour oral glucose tolerance test, 140-199 mg/dL), or an elevated A1C (between 5.7% and 6.4%).2

An estimated 96 million ­Americans—38% of the US adult population—have prediabetes, according to the Centers for Disease Control and Prevention.3 Family physicians frequently encounter this condition when screening for T2D in asymptomatic adults (ages 35 to 70 years) with overweight or obesity, as recommended by the US Preventive Services Task Force (grade “B”).4

To treat, or not? Studies have shown that interventions such as lifestyle modification and use of metformin by patients with prediabetes can decrease their risk for T2D.5,6 In the Diabetes Prevention Program (DPP) study, progression from prediabetes to T2D was reduced to 14% with lifestyle modification and 22% with metformin use, vs 29% with placebo.7

However, there is disagreement about whether to treat prediabetes, particularly with medication. Some argue that metformin is a safe, effective, and cost-saving treatment to prevent T2D and its associated health consequences.8 The current American Diabetes Association (ADA) guidelines suggest that metformin be considered in certain patients with prediabetes and high-risk factors, especially younger age, obesity or hyperglycemia, or a history of gestational diabetes.9 However, only an estimated 1% to 4% of adults with prediabetes are prescribed metformin.10

Others argue that treating a preclinical condition is not a patient-centered approach, especially since not all patients with prediabetes progress to T2D and the risk for development or progression of retinopathy and microalbuminuria is extremely low if A1C levels remain < 7.0%.11 By this standard, pharmacologic treatment should be initiated only if, or when, a patient develops T2D, with a focus on intensive lifestyle intervention for high-risk patients in the interim.11

Given the conflicting viewpoints, ongoing long-term studies on T2D prevention will help guide treatment decisions for patients with prediabetes. The study by Lee et al1 was the first to evaluate the effect of metformin or intensive lifestyle modification on all-cause and cause-specific mortality in patients at high risk for T2D.

Continue to: STUDY SUMMARY

 

 

STUDY SUMMARY

No mortality benefit from metformin or lifestyle modification

This secondary analysis evaluated mortality outcomes for patients at risk for T2D who were part of the DPP trial and then were ­followed long term in the Diabetes Prevention Program Outcomes Study (DPPOS).1 The initial DPP trial included 3234 adult patients at high risk for T2D (defined as having a BMI ≥ 24; an FPG of 95-125 mg/dL; and a 2-hour glucose level of 140-199 mg/dL). Participants were randomized into groups receiving either intensive lifestyle intervention (which focused on achieving ≥ 150 min/wk of exercise and ≥ 7% body weight loss), metformin 850 mg twice daily, or placebo twice daily; the latter 2 groups also received standard exercise and diet recommendations. Mean age was 51 years, mean BMI was 34, and 68% of participants were female.

Both the metformin and lifestyle intervention groups experienced decreases in weight and cardiovascular risk factors but not in mortality.

At the conclusion of the initial 5-year trial, treatment was unmasked and 86% of the patients continued to be followed for long-term outcomes. Patients in the lifestyle group were offered semiannual lifestyle reinforcement, while the metformin group continued to receive the twice-daily 850-mg dose unless a contraindication developed. If FPG levels increased to ≥ 140 mg/dL in the DPP study, or A1C increased to ≥ 7% in the DPPOS, study metformin was discontinued and management of the patient’s diabetes was transferred to their health care provider. By the end of the DPPOS, 53% of patients in the lifestyle group and 55% in the metformin group had progressed to T2D, compared with 60% in the placebo group (P = 0.003).

After a median 21-year follow-up interval, the investigators collected data on cause of death for patients and evaluated hazard ratios (HRs) for overall and cause-specific mortality. In total, 14% of the participants died, with no statistically significant difference in rates between the 3 groups. Cancer (37%) was the leading cause of death in all groups, followed by cardiovascular disease (CVD; 29%).

Compared with the placebo group, patients taking metformin did not have a decreased rate of overall mortality (HR = 0.99; 95% CI, 0.79-1.25), mortality from cancer (HR = 1.04; 95% CI, 0.72-1.52), or mortality due to CVD (HR = 1.08; 95% CI, 0.70-1.66). Similarly, compared with the placebo group, lifestyle intervention did not decrease overall mortality (HR = 1.02; 95% CI, 0.81-1.28), mortality from cancer (HR = 1.07; 95% CI, 0.74-1.55), or mortality due to CVD (HR = 1.18; 95% CI, 0.77-1.81). Results were similar when adjusted for other factors, including out-of-study metformin use, T2D status and duration, BMI change, and other cardiovascular risk factors.

WHAT’S NEW

Long-term data clarifylimits to interventions’ utility

This study looked at long-term follow-up data on mortality outcomes for patients with prediabetes treated with metformin or lifestyle intervention. Although these interventions did support weight loss, reduce the incidence of T2D, and lower cardiovascular risk factors (eg, hypertension, dyslipidemia), the comorbidity benefits did not affect risk for all-cause or cause-specific mortality, which were similar between the treatment and placebo groups.

Continue to: CAVEATS

 

 

CAVEATS

Exclusion criteria, residual confounding may limit the findings

Patients with significant cardiovascular or renal disease were excluded, so results may not apply to patients with these comorbidities. Additionally, there was a high amount of “drop-in” use of metformin prescribed by physicians once patients developed T2D, which may not have been controlled for completely. And while the intensive lifestyle intervention group had specific goals, the metformin and placebo groups also were encouraged to follow standard diet and lifestyle recommendations—and during a bridge period, all participants were offered a modified group lifestyle intervention. However, multivariable adjustment did not change the study conclusion.

CHALLENGES TO IMPLEMENTATION

Physicians may be unwilling to change their current prescribing habits

Physicians may not be willing to change their practice of prescribing metformin in prediabetes based on a singular study (with residual confounding) that showed no long-term mortality differences between the study groups. However, there may be long-term morbidity differences of interest to patients that were not specifically evaluated in this study—such as quality-of-life benefits from weight loss that may outweigh the risks (eg, gastrointestinal adverse effects such as diarrhea, nausea, and abdominal pain) of metformin for some patients. Therefore, a discussion of the risks and benefits of treatment for prediabetes should be had with patients at high risk who would prefer a pharmacologic intervention.

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References

1. Lee CG, Heckman-Stoddard B, et al; Diabetes Prevention Program Research Group. Effect of metformin and lifestyle interventions on mortality in the Diabetes Prevention Program and Diabetes Prevention Program Outcomes Study. Diabetes Care. 2021;44:2775-2782. doi: 10.2337/dc21-1046

2. American Diabetes Association. Understanding A1C: diagnosis. Accessed July 6, 2023. https://diabetes.org/diabetes/a1c/­diagnosis

3. CDC. National diabetes statistics report. Reviewed June 29, 2022. Accessed January 23, 2023. www.cdc.gov/diabetes/data/­statistics-report/index.html

4. USPSTF; Davidson KW, Barry MJ, Mangione CM, et al. Screening for prediabetes and type 2 diabetes: US Preventive Services Task Force recommendation statement. JAMA. 2021;326:736-743. doi: 10.1001/jama.2021.12531

5. Hostalek U, Campbell I. Metformin for diabetes prevention: update of the evidence base. Curr Med Res Opin. 2021;37:1705-1717. doi: 10.1080/03007995.2021.1955667

6. Aroda VR, Knowler WC, Crandall JP, et al; Diabetes Prevention Program Research Group. Metformin for diabetes prevention: insights gained from the Diabetes Prevention Program/Diabetes Prevention Program Outcomes Study. Diabetologia. 2017;60:1601-1611. doi: 10.1007/s00125-017-4361-9

7. Knowler WC, Barrett-Connor E, Fowler SE, et al; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002;346:393-403. doi: 10.1056/NEJMoa012512

8. Herman WH, Ratner RE. Metformin should be used to treat prediabetes in selected individuals. Diabetes Care. 2020;43:1988-1990. doi: 10.2337/dci20-0030

9. American Diabetes Association. 3. Prevention or delay of type 2 diabetes: standards of medical care in diabetes—2021. Diabetes Care. 2021;44(suppl 1):S34-S39. doi: 10.2337/dc21-S003

10. Tseng E, Yeh HC, Maruthur NM. Metformin use in prediabetes among US adults, 2005-2012. Diabetes Care. 2017;40:887-893. doi: 10.2337/dc16-1509

11. Davidson MB. Metformin should not be used to treat prediabetes. Diabetes Care. 2020;43:1983-1987. doi: 10.2337/dc19-2221

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Department of Family Medicine, University of Colorado, Denver

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Gary Asher, MD, MPH

University of North Carolina at Chapel Hill Family Medicine Residency Program

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DEPUTY EDITOR
Gary Asher, MD, MPH

University of North Carolina at Chapel Hill Family Medicine Residency Program

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ILLUSTRATIVE CASE

A 51-year-old woman with a history of elevated cholesterol and a body mass index (BMI) of 31 presents to your clinic for a scheduled follow-up visit to review recent blood test results. Her A1C was elevated at 5.9%. She wants to know if she should start medication now.

Prediabetes is a high-risk state that ­confers increased risk for type 2 ­diabetes (T2D). It is identified by impaired fasting glucose (fasting plasma glucose [FPG], 100-125 mg/dL), impaired glucose tolerance (2-hour oral glucose tolerance test, 140-199 mg/dL), or an elevated A1C (between 5.7% and 6.4%).2

An estimated 96 million ­Americans—38% of the US adult population—have prediabetes, according to the Centers for Disease Control and Prevention.3 Family physicians frequently encounter this condition when screening for T2D in asymptomatic adults (ages 35 to 70 years) with overweight or obesity, as recommended by the US Preventive Services Task Force (grade “B”).4

To treat, or not? Studies have shown that interventions such as lifestyle modification and use of metformin by patients with prediabetes can decrease their risk for T2D.5,6 In the Diabetes Prevention Program (DPP) study, progression from prediabetes to T2D was reduced to 14% with lifestyle modification and 22% with metformin use, vs 29% with placebo.7

However, there is disagreement about whether to treat prediabetes, particularly with medication. Some argue that metformin is a safe, effective, and cost-saving treatment to prevent T2D and its associated health consequences.8 The current American Diabetes Association (ADA) guidelines suggest that metformin be considered in certain patients with prediabetes and high-risk factors, especially younger age, obesity or hyperglycemia, or a history of gestational diabetes.9 However, only an estimated 1% to 4% of adults with prediabetes are prescribed metformin.10

Others argue that treating a preclinical condition is not a patient-centered approach, especially since not all patients with prediabetes progress to T2D and the risk for development or progression of retinopathy and microalbuminuria is extremely low if A1C levels remain < 7.0%.11 By this standard, pharmacologic treatment should be initiated only if, or when, a patient develops T2D, with a focus on intensive lifestyle intervention for high-risk patients in the interim.11

Given the conflicting viewpoints, ongoing long-term studies on T2D prevention will help guide treatment decisions for patients with prediabetes. The study by Lee et al1 was the first to evaluate the effect of metformin or intensive lifestyle modification on all-cause and cause-specific mortality in patients at high risk for T2D.

Continue to: STUDY SUMMARY

 

 

STUDY SUMMARY

No mortality benefit from metformin or lifestyle modification

This secondary analysis evaluated mortality outcomes for patients at risk for T2D who were part of the DPP trial and then were ­followed long term in the Diabetes Prevention Program Outcomes Study (DPPOS).1 The initial DPP trial included 3234 adult patients at high risk for T2D (defined as having a BMI ≥ 24; an FPG of 95-125 mg/dL; and a 2-hour glucose level of 140-199 mg/dL). Participants were randomized into groups receiving either intensive lifestyle intervention (which focused on achieving ≥ 150 min/wk of exercise and ≥ 7% body weight loss), metformin 850 mg twice daily, or placebo twice daily; the latter 2 groups also received standard exercise and diet recommendations. Mean age was 51 years, mean BMI was 34, and 68% of participants were female.

Both the metformin and lifestyle intervention groups experienced decreases in weight and cardiovascular risk factors but not in mortality.

At the conclusion of the initial 5-year trial, treatment was unmasked and 86% of the patients continued to be followed for long-term outcomes. Patients in the lifestyle group were offered semiannual lifestyle reinforcement, while the metformin group continued to receive the twice-daily 850-mg dose unless a contraindication developed. If FPG levels increased to ≥ 140 mg/dL in the DPP study, or A1C increased to ≥ 7% in the DPPOS, study metformin was discontinued and management of the patient’s diabetes was transferred to their health care provider. By the end of the DPPOS, 53% of patients in the lifestyle group and 55% in the metformin group had progressed to T2D, compared with 60% in the placebo group (P = 0.003).

After a median 21-year follow-up interval, the investigators collected data on cause of death for patients and evaluated hazard ratios (HRs) for overall and cause-specific mortality. In total, 14% of the participants died, with no statistically significant difference in rates between the 3 groups. Cancer (37%) was the leading cause of death in all groups, followed by cardiovascular disease (CVD; 29%).

Compared with the placebo group, patients taking metformin did not have a decreased rate of overall mortality (HR = 0.99; 95% CI, 0.79-1.25), mortality from cancer (HR = 1.04; 95% CI, 0.72-1.52), or mortality due to CVD (HR = 1.08; 95% CI, 0.70-1.66). Similarly, compared with the placebo group, lifestyle intervention did not decrease overall mortality (HR = 1.02; 95% CI, 0.81-1.28), mortality from cancer (HR = 1.07; 95% CI, 0.74-1.55), or mortality due to CVD (HR = 1.18; 95% CI, 0.77-1.81). Results were similar when adjusted for other factors, including out-of-study metformin use, T2D status and duration, BMI change, and other cardiovascular risk factors.

WHAT’S NEW

Long-term data clarifylimits to interventions’ utility

This study looked at long-term follow-up data on mortality outcomes for patients with prediabetes treated with metformin or lifestyle intervention. Although these interventions did support weight loss, reduce the incidence of T2D, and lower cardiovascular risk factors (eg, hypertension, dyslipidemia), the comorbidity benefits did not affect risk for all-cause or cause-specific mortality, which were similar between the treatment and placebo groups.

Continue to: CAVEATS

 

 

CAVEATS

Exclusion criteria, residual confounding may limit the findings

Patients with significant cardiovascular or renal disease were excluded, so results may not apply to patients with these comorbidities. Additionally, there was a high amount of “drop-in” use of metformin prescribed by physicians once patients developed T2D, which may not have been controlled for completely. And while the intensive lifestyle intervention group had specific goals, the metformin and placebo groups also were encouraged to follow standard diet and lifestyle recommendations—and during a bridge period, all participants were offered a modified group lifestyle intervention. However, multivariable adjustment did not change the study conclusion.

CHALLENGES TO IMPLEMENTATION

Physicians may be unwilling to change their current prescribing habits

Physicians may not be willing to change their practice of prescribing metformin in prediabetes based on a singular study (with residual confounding) that showed no long-term mortality differences between the study groups. However, there may be long-term morbidity differences of interest to patients that were not specifically evaluated in this study—such as quality-of-life benefits from weight loss that may outweigh the risks (eg, gastrointestinal adverse effects such as diarrhea, nausea, and abdominal pain) of metformin for some patients. Therefore, a discussion of the risks and benefits of treatment for prediabetes should be had with patients at high risk who would prefer a pharmacologic intervention.

ILLUSTRATIVE CASE

A 51-year-old woman with a history of elevated cholesterol and a body mass index (BMI) of 31 presents to your clinic for a scheduled follow-up visit to review recent blood test results. Her A1C was elevated at 5.9%. She wants to know if she should start medication now.

Prediabetes is a high-risk state that ­confers increased risk for type 2 ­diabetes (T2D). It is identified by impaired fasting glucose (fasting plasma glucose [FPG], 100-125 mg/dL), impaired glucose tolerance (2-hour oral glucose tolerance test, 140-199 mg/dL), or an elevated A1C (between 5.7% and 6.4%).2

An estimated 96 million ­Americans—38% of the US adult population—have prediabetes, according to the Centers for Disease Control and Prevention.3 Family physicians frequently encounter this condition when screening for T2D in asymptomatic adults (ages 35 to 70 years) with overweight or obesity, as recommended by the US Preventive Services Task Force (grade “B”).4

To treat, or not? Studies have shown that interventions such as lifestyle modification and use of metformin by patients with prediabetes can decrease their risk for T2D.5,6 In the Diabetes Prevention Program (DPP) study, progression from prediabetes to T2D was reduced to 14% with lifestyle modification and 22% with metformin use, vs 29% with placebo.7

However, there is disagreement about whether to treat prediabetes, particularly with medication. Some argue that metformin is a safe, effective, and cost-saving treatment to prevent T2D and its associated health consequences.8 The current American Diabetes Association (ADA) guidelines suggest that metformin be considered in certain patients with prediabetes and high-risk factors, especially younger age, obesity or hyperglycemia, or a history of gestational diabetes.9 However, only an estimated 1% to 4% of adults with prediabetes are prescribed metformin.10

Others argue that treating a preclinical condition is not a patient-centered approach, especially since not all patients with prediabetes progress to T2D and the risk for development or progression of retinopathy and microalbuminuria is extremely low if A1C levels remain < 7.0%.11 By this standard, pharmacologic treatment should be initiated only if, or when, a patient develops T2D, with a focus on intensive lifestyle intervention for high-risk patients in the interim.11

Given the conflicting viewpoints, ongoing long-term studies on T2D prevention will help guide treatment decisions for patients with prediabetes. The study by Lee et al1 was the first to evaluate the effect of metformin or intensive lifestyle modification on all-cause and cause-specific mortality in patients at high risk for T2D.

Continue to: STUDY SUMMARY

 

 

STUDY SUMMARY

No mortality benefit from metformin or lifestyle modification

This secondary analysis evaluated mortality outcomes for patients at risk for T2D who were part of the DPP trial and then were ­followed long term in the Diabetes Prevention Program Outcomes Study (DPPOS).1 The initial DPP trial included 3234 adult patients at high risk for T2D (defined as having a BMI ≥ 24; an FPG of 95-125 mg/dL; and a 2-hour glucose level of 140-199 mg/dL). Participants were randomized into groups receiving either intensive lifestyle intervention (which focused on achieving ≥ 150 min/wk of exercise and ≥ 7% body weight loss), metformin 850 mg twice daily, or placebo twice daily; the latter 2 groups also received standard exercise and diet recommendations. Mean age was 51 years, mean BMI was 34, and 68% of participants were female.

Both the metformin and lifestyle intervention groups experienced decreases in weight and cardiovascular risk factors but not in mortality.

At the conclusion of the initial 5-year trial, treatment was unmasked and 86% of the patients continued to be followed for long-term outcomes. Patients in the lifestyle group were offered semiannual lifestyle reinforcement, while the metformin group continued to receive the twice-daily 850-mg dose unless a contraindication developed. If FPG levels increased to ≥ 140 mg/dL in the DPP study, or A1C increased to ≥ 7% in the DPPOS, study metformin was discontinued and management of the patient’s diabetes was transferred to their health care provider. By the end of the DPPOS, 53% of patients in the lifestyle group and 55% in the metformin group had progressed to T2D, compared with 60% in the placebo group (P = 0.003).

After a median 21-year follow-up interval, the investigators collected data on cause of death for patients and evaluated hazard ratios (HRs) for overall and cause-specific mortality. In total, 14% of the participants died, with no statistically significant difference in rates between the 3 groups. Cancer (37%) was the leading cause of death in all groups, followed by cardiovascular disease (CVD; 29%).

Compared with the placebo group, patients taking metformin did not have a decreased rate of overall mortality (HR = 0.99; 95% CI, 0.79-1.25), mortality from cancer (HR = 1.04; 95% CI, 0.72-1.52), or mortality due to CVD (HR = 1.08; 95% CI, 0.70-1.66). Similarly, compared with the placebo group, lifestyle intervention did not decrease overall mortality (HR = 1.02; 95% CI, 0.81-1.28), mortality from cancer (HR = 1.07; 95% CI, 0.74-1.55), or mortality due to CVD (HR = 1.18; 95% CI, 0.77-1.81). Results were similar when adjusted for other factors, including out-of-study metformin use, T2D status and duration, BMI change, and other cardiovascular risk factors.

WHAT’S NEW

Long-term data clarifylimits to interventions’ utility

This study looked at long-term follow-up data on mortality outcomes for patients with prediabetes treated with metformin or lifestyle intervention. Although these interventions did support weight loss, reduce the incidence of T2D, and lower cardiovascular risk factors (eg, hypertension, dyslipidemia), the comorbidity benefits did not affect risk for all-cause or cause-specific mortality, which were similar between the treatment and placebo groups.

Continue to: CAVEATS

 

 

CAVEATS

Exclusion criteria, residual confounding may limit the findings

Patients with significant cardiovascular or renal disease were excluded, so results may not apply to patients with these comorbidities. Additionally, there was a high amount of “drop-in” use of metformin prescribed by physicians once patients developed T2D, which may not have been controlled for completely. And while the intensive lifestyle intervention group had specific goals, the metformin and placebo groups also were encouraged to follow standard diet and lifestyle recommendations—and during a bridge period, all participants were offered a modified group lifestyle intervention. However, multivariable adjustment did not change the study conclusion.

CHALLENGES TO IMPLEMENTATION

Physicians may be unwilling to change their current prescribing habits

Physicians may not be willing to change their practice of prescribing metformin in prediabetes based on a singular study (with residual confounding) that showed no long-term mortality differences between the study groups. However, there may be long-term morbidity differences of interest to patients that were not specifically evaluated in this study—such as quality-of-life benefits from weight loss that may outweigh the risks (eg, gastrointestinal adverse effects such as diarrhea, nausea, and abdominal pain) of metformin for some patients. Therefore, a discussion of the risks and benefits of treatment for prediabetes should be had with patients at high risk who would prefer a pharmacologic intervention.

References

1. Lee CG, Heckman-Stoddard B, et al; Diabetes Prevention Program Research Group. Effect of metformin and lifestyle interventions on mortality in the Diabetes Prevention Program and Diabetes Prevention Program Outcomes Study. Diabetes Care. 2021;44:2775-2782. doi: 10.2337/dc21-1046

2. American Diabetes Association. Understanding A1C: diagnosis. Accessed July 6, 2023. https://diabetes.org/diabetes/a1c/­diagnosis

3. CDC. National diabetes statistics report. Reviewed June 29, 2022. Accessed January 23, 2023. www.cdc.gov/diabetes/data/­statistics-report/index.html

4. USPSTF; Davidson KW, Barry MJ, Mangione CM, et al. Screening for prediabetes and type 2 diabetes: US Preventive Services Task Force recommendation statement. JAMA. 2021;326:736-743. doi: 10.1001/jama.2021.12531

5. Hostalek U, Campbell I. Metformin for diabetes prevention: update of the evidence base. Curr Med Res Opin. 2021;37:1705-1717. doi: 10.1080/03007995.2021.1955667

6. Aroda VR, Knowler WC, Crandall JP, et al; Diabetes Prevention Program Research Group. Metformin for diabetes prevention: insights gained from the Diabetes Prevention Program/Diabetes Prevention Program Outcomes Study. Diabetologia. 2017;60:1601-1611. doi: 10.1007/s00125-017-4361-9

7. Knowler WC, Barrett-Connor E, Fowler SE, et al; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002;346:393-403. doi: 10.1056/NEJMoa012512

8. Herman WH, Ratner RE. Metformin should be used to treat prediabetes in selected individuals. Diabetes Care. 2020;43:1988-1990. doi: 10.2337/dci20-0030

9. American Diabetes Association. 3. Prevention or delay of type 2 diabetes: standards of medical care in diabetes—2021. Diabetes Care. 2021;44(suppl 1):S34-S39. doi: 10.2337/dc21-S003

10. Tseng E, Yeh HC, Maruthur NM. Metformin use in prediabetes among US adults, 2005-2012. Diabetes Care. 2017;40:887-893. doi: 10.2337/dc16-1509

11. Davidson MB. Metformin should not be used to treat prediabetes. Diabetes Care. 2020;43:1983-1987. doi: 10.2337/dc19-2221

References

1. Lee CG, Heckman-Stoddard B, et al; Diabetes Prevention Program Research Group. Effect of metformin and lifestyle interventions on mortality in the Diabetes Prevention Program and Diabetes Prevention Program Outcomes Study. Diabetes Care. 2021;44:2775-2782. doi: 10.2337/dc21-1046

2. American Diabetes Association. Understanding A1C: diagnosis. Accessed July 6, 2023. https://diabetes.org/diabetes/a1c/­diagnosis

3. CDC. National diabetes statistics report. Reviewed June 29, 2022. Accessed January 23, 2023. www.cdc.gov/diabetes/data/­statistics-report/index.html

4. USPSTF; Davidson KW, Barry MJ, Mangione CM, et al. Screening for prediabetes and type 2 diabetes: US Preventive Services Task Force recommendation statement. JAMA. 2021;326:736-743. doi: 10.1001/jama.2021.12531

5. Hostalek U, Campbell I. Metformin for diabetes prevention: update of the evidence base. Curr Med Res Opin. 2021;37:1705-1717. doi: 10.1080/03007995.2021.1955667

6. Aroda VR, Knowler WC, Crandall JP, et al; Diabetes Prevention Program Research Group. Metformin for diabetes prevention: insights gained from the Diabetes Prevention Program/Diabetes Prevention Program Outcomes Study. Diabetologia. 2017;60:1601-1611. doi: 10.1007/s00125-017-4361-9

7. Knowler WC, Barrett-Connor E, Fowler SE, et al; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002;346:393-403. doi: 10.1056/NEJMoa012512

8. Herman WH, Ratner RE. Metformin should be used to treat prediabetes in selected individuals. Diabetes Care. 2020;43:1988-1990. doi: 10.2337/dci20-0030

9. American Diabetes Association. 3. Prevention or delay of type 2 diabetes: standards of medical care in diabetes—2021. Diabetes Care. 2021;44(suppl 1):S34-S39. doi: 10.2337/dc21-S003

10. Tseng E, Yeh HC, Maruthur NM. Metformin use in prediabetes among US adults, 2005-2012. Diabetes Care. 2017;40:887-893. doi: 10.2337/dc16-1509

11. Davidson MB. Metformin should not be used to treat prediabetes. Diabetes Care. 2020;43:1983-1987. doi: 10.2337/dc19-2221

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It’s complicated</title> <deck>While treatment with metformin or lifestyle modification reduces risk for T2D in patients with prediabetes, neither intervention ultimately offers a mortality benefit.</deck> </itemMeta> <itemContent> <h3>PRACTICE CHANGER</h3> <p><hl name="269"/>Adjust patient expectations when discussing metformin treatment and intensive lifestyle modification in patients with prediabetes. No long-term mortality benefit has been found with either, and it may be time to stop prescribing metformin in these patients. </p> <p class="sub4">STRENGTH OF RECOMMENDATION</p> <p><b>B: </b>Based on a long-term follow-up of a randomized controlled trial.<sup>1</sup></p> <p class="SOR">Lee CG, Heckman-Stoddard B, Dabelea D, et al; Diabetes Prevention Program Research Group. Effect of metformin and lifestyle interventions on mortality in the Diabetes Prevention Program and Diabetes Prevention Program Outcomes Study. <i>Diabetes Care</i>. 2021;44:2775-2782. doi: 10.2337/dc21-1046</p> <h2>ILLUSTRATIVE CASE</h2> <p>A 51-year-old woman with a history of elevated cholesterol and a body mass index (BMI) of 31 presents to your clinic for a scheduled follow-up visit to review recent blood test results. Her A1C was elevated at 5.9%. She wants to know if she should start medication now. </p> <p><span class="dropcap">P</span>rediabetes is a high-risk state that ­confers increased risk for type 2 ­diabetes (T2D). It is identified by impaired fasting glucose (fasting plasma glucose [FPG], 100-125 mg/dL), impaired glucose tolerance (2-hour oral glucose tolerance test, 140-199 mg/dL), or an elevated A1C (between 5.7% and 6.4%).<sup>2</sup> </p> <p>An estimated 96 million ­Americans—38% of the US adult population—have prediabetes, according to the Centers for Disease Control and Prevention.<sup>3</sup> Family physicians frequently encounter this condition when screening for T2D in asymptomatic adults (ages 35 to 70 years) with overweight or obesity, as recommended by the US Preventive Services Task Force (grade “B”).<sup>4</sup> <br/><br/><span class="dingbat3">❚</span><span class="intro"> To treat, or not?</span> Studies have shown that interventions such as lifestyle modification and use of metformin by patients with prediabetes can decrease their risk for T2D.<sup>5,6</sup> In the Diabetes Prevention Program (DPP) study, progression from prediabetes to T2D was reduced to 14% with lifestyle modification and 22% with metformin use, vs 29% with placebo.<sup>7</sup>However, there is disagreement about whether to treat prediabetes, particularly with medication. Some argue that metformin is a safe, effective, and cost-saving treatment to prevent T2D and its associated health consequences.<sup>8</sup> The current American Diabetes Association (ADA) guidelines suggest that metformin be considered in certain patients with prediabetes and high-risk factors, especially younger age, obesity or hyperglycemia, or a history of gestational diabetes.<sup>9</sup> However, only an estimated 1% to 4% of adults with prediabetes are prescribed metformin.<sup>10</sup> <br/><br/>Others argue that treating a preclinical condition is not a patient-centered approach, especially since not all patients with prediabetes progress to T2D and the risk for development or progression of retinopathy and microalbuminuria is extremely low if A1C levels remain &lt; 7.0%.<sup>11</sup> By this standard, pharmacologic treatment should be initiated only if, or when, a patient develops T2D, with a focus on intensive lifestyle intervention for high-risk patients in the interim.<sup>11<br/><br/></sup>Given the conflicting viewpoints, ongoing long-term studies on T2D prevention will help guide treatment decisions for patients with prediabetes. The study by Lee et al<sup>1</sup> was the first to evaluate the effect of metformin or intensive lifestyle modification on all-cause and cause-specific mortality in patients at high risk for T2D. </p> <h2>STUDY SUMMARY</h2> <h3>No mortality benefitfrom metformin or lifestyle modification </h3> <p>This secondary analysis evaluated mortality outcomes for patients at risk for T2D who were part of the DPP trial and then were ­followed long term in the Diabetes Prevention Program Outcomes Study (DPPOS).<sup>1</sup> The initial DPP trial included 3234 adult patients at high risk for T2D (defined as having a BMI ≥ 24; an FPG of 95-125 mg/dL; and a 2-hour glucose level of 140-199 mg/dL). Participants were randomized into groups receiving either intensive lifestyle intervention (which focused on achieving ≥ 150 min/wk of exercise and <ul>&gt;</ul> 7% body weight loss), metformin 850 mg twice daily, or placebo twice daily; the latter 2 groups also received standard exercise and diet recommendations. Mean age was 51 years, mean BMI was 34, and 68% of participants were female. </p> <p>At the conclusion of the initial 5-year trial, treatment was unmasked and 86% of the patients continued to be followed for long-term outcomes. Patients in the lifestyle group were offered semiannual lifestyle reinforcement, while the metformin group continued to receive the twice-daily 850-mg dose unless a contraindication developed. If FPG levels increased to ≥ 140 mg/dL in the DPP study, or A1C increased to ≥ 7% in the DPPOS, study metformin was discontinued and management of the patient’s diabetes was transferred to their health care provider. By the end of the DPPOS, 53% of patients in the lifestyle group and 55% in the metformin group had progressed to T2D, compared with 60% in the placebo group (<i>P</i> = 0.003). <br/><br/>After a median 21-year follow-up interval, the investigators collected data on cause of death for patients and evaluated hazard ratios (HRs) for overall and cause-specific mortality. In total, 14% of the participants died, with no statistically significant difference in rates between the 3 groups. Cancer (37%) was the leading cause of death in all groups, followed by cardiovascular disease (CVD; 29%). <br/><br/>Compared with the placebo group, patients taking metformin did not have a decreased rate of overall mortality (HR = 0.99; 95% CI, 0.79-1.25), mortality from cancer (HR = 1.04; 95% CI, 0.72-1.52), or mortality due to CVD (HR = 1.08; 95% CI, 0.70-1.66). Similarly, compared with the placebo group, lifestyle intervention did not decrease overall mortality (HR = 1.02; 95% CI, 0.81-1.28), mortality from cancer (HR = 1.07; 95% CI, 0.74-1.55), or mortality due to CVD (HR = 1.18; 95% CI, 0.77-1.81). Results were similar when adjusted for other factors, including out-of-study metformin use, T2D status and duration, BMI change, and other cardiovascular risk factors.</p> <h2>WHAT’S NEW</h2> <h3>Long-term data clarifylimits to interventions’ utility </h3> <p>This study looked at long-term follow-up data on mortality outcomes for patients with prediabetes treated with metformin or lifestyle intervention. Although these interventions did support weight loss, reduce the incidence of T2D, and lower cardiovascular risk factors (eg, hypertension, dyslipidemia), the comorbidity benefits did not affect risk for all-cause or cause-specific mortality, which were similar between the treatment and placebo groups.</p> <h2>CAVEATS</h2> <h3>Exclusion criteria, residual confoundingmay limit the findings</h3> <p>Patients with significant cardiovascular or renal disease were excluded, so results may not apply to patients with these comorbidities. Additionally, there was a high amount of “drop-in” use of metformin prescribed by physicians once patients developed T2D, which may not have been controlled for completely. And while the intensive lifestyle intervention group had specific goals, the metformin and placebo groups also were encouraged to follow standard diet and lifestyle recommendations—and during a bridge period, all participants were offered a modified group lifestyle intervention. However, multivariable adjustment did not change the study conclusion. </p> <h2>CHALLENGES TO IMPLEMENTATION</h2> <h3>Physicians may be unwilling to change their current prescribing habits</h3> <p>Physicians may not be willing to change their practice of prescribing metformin in prediabetes based on a singular study (with residual confounding) that showed no long-term mortality differences between the study groups. However, there may be long-term morbidity differences of interest to patients that were not specifically evaluated in this study—such as quality-of-life benefits from weight loss that may outweigh the risks (eg, gastrointestinal adverse effects such as diarrhea, nausea, and abdominal pain) of metformin for some patients. Therefore, a discussion of the risks and benefits of treatment for prediabetes should be had with patients at high risk who would prefer a pharmacologic intervention. <span class="end">JFP</span></p> <p class="reference"> 1. Lee CG, Heckman-Stoddard B, et al; Diabetes Prevention Program Research Group. Effect of metformin and lifestyle interventions on mortality in the Diabetes Prevention Program and Diabetes Prevention Program Outcomes Study. <i>Diabetes Care</i>. 2021;44:2775-2782. doi: 10.2337/dc21-1046<br/><br/> 2. American Diabetes Association. Understanding A1C: diagnosis. Accessed July 6, 2023. <a href="https://diabetes.org/diabetes/a1c/diagnosis">https://diabetes.org/diabetes/a1c/­diagnosis</a><br/><br/> 3. CDC. National diabetes statistics report. Reviewed June 29, 2022. Accessed January 23, 2023. <a href="http://www.cdc.gov/diabetes/data/statistics-report/index.html">www.cdc.gov/diabetes/data/­statistics-report/index.html</a><br/><br/> 4. USPSTF; Davidson KW, Barry MJ, Mangione CM, et al. Screening for prediabetes and type 2 diabetes: US Preventive Services Task Force recommendation statement. <i>JAMA</i>. 2021;326:736-743. doi: 10.1001/jama.2021.12531<br/><br/> 5. Hostalek U, Campbell I. Metformin for diabetes prevention: update of the evidence base. <i>Curr Med Res Opin</i>. 2021;37:1705-1717. doi: 10.1080/03007995.2021.1955667<br/><br/> 6. Aroda VR, Knowler WC, Crandall JP, et al; Diabetes Prevention Program Research Group. Metformin for diabetes prevention: insights gained from the Diabetes Prevention Program/Diabetes Prevention Program Outcomes Study. <i>Diabetologia</i>. 2017;60:1601-1611. doi: 10.1007/s00125-017-4361-9<br/><br/> 7. Knowler WC, Barrett-Connor E, Fowler SE, et al; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. <i>N Engl J Med</i>. 2002;346:393-403. doi: 10.1056/NEJMoa012512<br/><br/> 8. Herman WH, Ratner RE. Metformin should be used to treat prediabetes in selected individuals. <i>Diabetes Care</i>. 2020;43:1988-1990. doi: 10.2337/dci20-0030<br/><br/> 9. American Diabetes Association. 3. Prevention or delay of type 2 diabetes<i>: </i>s<span class="Emphasis">tandards of medical care in diabetes—2021</span><i>. </i><span class="Emphasis">Diabetes Care</span>. 2021;44(suppl 1):S34-S39. doi: 10.2337/dc21-S003 <br/><br/> 10. Tseng E, Yeh HC, Maruthur NM. Metformin use in prediabetes among US adults, 2005-2012. <i>Diabetes Care</i>. 2017;40:887-893. doi: 10.2337/dc16-1509<br/><br/> 11. Davidson MB. Metformin should not be used to treat prediabetes. <i>Diabetes Care</i>. 2020;43:1983-1987. doi: 10.2337/dc19-2221</p> </itemContent> </newsItem> </itemSet></root>
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Inside the Article

PRACTICE CHANGER

Adjust patient expectations when discussing metformin treatment and intensive lifestyle modification in patients with prediabetes. No long-term mortality benefit has been found with either, and it may be time to stop prescribing metformin in these patients.

STRENGTH OF RECOMMENDATION

B: Based on a long-term follow-up of a randomized controlled trial.1

Lee CG, Heckman-Stoddard B, Dabelea D, et al; Diabetes Prevention Program Research Group. Effect of metformin and lifestyle interventions on mortality in the Diabetes Prevention Program and Diabetes Prevention Program Outcomes Study. Diabetes Care. 2021;44:2775-2782. doi: 10.2337/dc21-1046

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Put down the electronics after a concussion?

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Put down the electronics after a concussion?

ILLUSTRATIVE CASE

A 17-year-old high school football player presents to the emergency department (ED) after a helmet-to-helmet tackle in a game earlier that day. After the tackle, he experienced immediate confusion. Once he returned to his feet, he felt dizzy and nauseated and began to develop a headache. When his symptoms failed to resolve within a few hours, his mother brought him to the hospital for an evaluation. In the ED, he receives a diagnosis of concussion, and his mother asks for recommendations on how he can recover as quickly as possible.

Traumatic brain injuries account for an estimated 2.5 million ED visits annually in the United States.2 Concussions are the most common form of traumatic brain injury, with adolescents contributing to the highest incidence of concussions.3,4 An estimated 1.6 to 3.8 million people experience a sports-related concussion annually.5

Time to recovery is a clinical endpoint that matters greatly to our young, physically active patients, who are often eager to return to their daily activities as soon as possible. Guidelines frequently recommend cognitive and physical rest for 24 to 48 hours immediately following a concussion, but the use of screens during this cognitive rest period remains uncertain.6,7 International guidelines and the Centers for Disease Control and ­Prevention recommend symptom-limited activities—including screen time—during the initial period of a concussion.6,7 Although this gradual approach is standard of care, it has been unclear if abstaining completely from certain activities during the initial days of a concussion has any impact on recovery time.

Recent studies have examined physical activity to clarify the optimal timing of physical rest after a concussion. Among adolescents with concussions, strict rest for 5 days does not appear to improve symptoms compared with rest for 1 to 2 days.8 Additionally, physical activity within 7 days of acute head injury may help reduce symptoms and prevent postconcussive symptoms.9,10

This same level of clarity has been lacking for cognitive rest and screen time. The use of screens is a part of most patients’ daily activities, particularly among adolescents and young adults. One report found that students ages 8 to 18 years engage in approximately 7 hours of daily screen time, excluding that related to schoolwork.11 This trial evaluated the relationship between screen time abstinence within 48 hours of a concussion and time to symptom resolution.

STUDY SUMMARY

Symptom duration was significantly reduced by cutting screen time

This single-site, parallel-design, randomized clinical trial examined the effectiveness of limiting screen time exposure within the first 48 hours after a concussion in reducing the time to resolution of concussive symptoms in 125 patients. 1 Patients were included if they were 12 to 25 years old (mean age, 17 years) and presented within 24 hours of sustaining a concussion (as defined on the Acute Concussion Evaluation–Emergency Department tool) to the pediatric or adult ED at a US tertiary medical center.

A shared decision-making discussion should center on the idea that 48 hours of screen time abstinence could be well worth the increased likelihood of total recovery at Day 10.

Patients were randomized to either ­engage in screen time as tolerated or to abstain from screen time for 48 hours following their injury. Screen modalities included television, phones, video games, and computers/­tablets. The Post-Concussive Symptom Scale (PCSS; 0-132) was used to characterize 22 symptoms from 0 (absent) to 6 (severe) daily for 10 days. Patients also self-reported the amount of screen time they engaged in during Days 1 to 3 of the study period and completed an activity survey on Days 4 to 10. Among the participants, 76% completed the PCSS form until symptom resolution or until Day 10 (the end of the study period).

Continue to: The primary outcome...

 

 

The primary outcome was days to resolution of concussive symptoms, defined as a PCSS score ≤ 3. The median baseline PCSS score was 21 in the screen time–permitted group and 24.5 in the screen time–abstinent group. The screen time–permitted group reported a median screen time of 630 minutes during the intervention period, compared with 130 minutes in the screen time–abstinent group, and was less likely to recover during the study period than the screen time–­abstinent group (hazard ratio = 0.51; 95% CI, 0.29-0.90). The screen time–permitted group had a significantly longer median recovery time compared with the screen time–­abstinent group (8.0 vs 3.5 days; P = .03).

WHAT'S NEW?

Exploring the role of screen time during the cognitive rest period

This study provides evidence supporting the recommendation that adolescent and young adult patients abstain from screen time in the first 48 hours following a concussion to decrease time to symptom resolution, thus shortening the timeline to return to their usual daily activities.

CAVEATS

Self-reporting of data may introduce bias

This study used a self-reporting method to collect data, which could have resulted in underreporting or overreporting of screen time and potentially introduced recall and reporting bias. The screen timeabstinent group did not completely abstain from all screen time, with a self-reported average of 5 to 10 minutes of daily screen time to complete the required research surveys, so it is not immediately clear what extent of abstinence vs significant screen time reduction led to the clinical endpoints observed. Furthermore, this study did not ask patients to differentiate between active screen time (eg, texting and gaming) and passive screen time (eg, watching videos), which may differentially impact symptom resolution.

CHALLENGES TO IMPLEMENTATION

Turning off the ever-present screen may present obstacles

This intervention is easy to recommend, with few barriers to implementation. It’s worth noting that screens are often used in a patient’s school or job, and 48 hours of abstinence from these activities is a difficult ask when much of our society’s education, entertainment, and productivity revolve around the use of technology. When appropriate, a shared decision-making discussion between patient and physician should center on the idea that 48 hours of screen time abstinence could be well worth the increased likelihood of total recovery at Day 10, as opposed to the risk for persistent and prolonged symptoms that interfere with the patient’s lifestyle.

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References

1. Macnow T, Curran T, Tolliday C, et al. Effect of screen time on recovery from concussion: a randomized clinical trial. JAMA Pediatr. 2021;175:1124-1131. doi: 10.1001/jamapediat rics.2021.2782

2. Taylor CA, Bell JM, Breiding MJ, et al. Traumatic brain injury–related emergency department visits, hospitalizations, and deaths—United States, 2007 and 2013. MMWR Surveill Summ. 2017;66:1-16. doi: 10.15585/mmwr.ss6609a1

3. Vos PE, Battistin L, Birbamer G, et al; European Federation of Neurological Societies. EFNS guideline on mild traumatic brain injury: report of an EFNS task force. Eur J Neurol. 2002;9:207-219. doi: 10.1046/j.1468-1331.2002.00407.x

4. Zhang AL, Sing DC, Rugg CM, et al. The rise of concussions in the adolescent population. Orthop J Sports Med. 2016;4:2325967116662458. doi: 10.1177/2325967116662458

5. McKee AC, Cantu RC, Nowinski CJ, et al. Chronic traumatic encephalopathy in athletes: progressive tauopathy after repetitive head injury. J Neuropathol Exp Neurol. 2009;68:709-735. doi: 10.1097/NEN.0b013e3181a9d503

6. McCrory P, Meeuwisse W, Dvorák J, et al. Consensus statement on concussion in sport—the 5th international conference on concussion in sport held in Berlin, October 2016. Br J Sports Med. 2017;51:838-847. doi: 10.1136/bjsports-2017-097699

7. Lumba-Brown A, Yeates KO, Sarmiento K, et al. Centers for Disease Control and Prevention guideline on the diagnosis and management of mild traumatic brain injury among children. JAMA Pediatr. 2018;172:e182853. doi: 10.1001/jamapediat rics.2018.2853

8. Thomas DG, Apps JN, Hoffmann RG, et al. Benefits of strict rest after acute concussion: a randomized controlled trial. Pediatrics. 2015;135:213-223. doi: 10.1542/peds.2014-0966

9. Grool AM, Aglipay M, Momoli F, et al; Pediatric Emergency Research Canada (PERC) Concussion Team. Association between early participation in physical activity following acute concussion and persistent postconcussive symptoms in children and adolescents. JAMA. 2016;316:2504-2514. doi: 10.1001/jama.2016.17396

10. Lal A, Kolakowsky-Hayner SA, Ghajar J, et al. The effect of physical exercise after a concussion: a systematic review and meta-analysis. Am J Sports Med. 2018;46:743-752. doi: 10.1177/0363546517706137

11. Rideout V, Peebles A, Mann S, et al. The Common Sense Census: Media Use by Tweens and Teens, 2021. Common Sense Media; 2022. Accessed December 28, 2022. www.commonsensemedia.org/sites/default/files/research/report/8-18-census-integrated-report-final-web_0.pdf

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ILLUSTRATIVE CASE

A 17-year-old high school football player presents to the emergency department (ED) after a helmet-to-helmet tackle in a game earlier that day. After the tackle, he experienced immediate confusion. Once he returned to his feet, he felt dizzy and nauseated and began to develop a headache. When his symptoms failed to resolve within a few hours, his mother brought him to the hospital for an evaluation. In the ED, he receives a diagnosis of concussion, and his mother asks for recommendations on how he can recover as quickly as possible.

Traumatic brain injuries account for an estimated 2.5 million ED visits annually in the United States.2 Concussions are the most common form of traumatic brain injury, with adolescents contributing to the highest incidence of concussions.3,4 An estimated 1.6 to 3.8 million people experience a sports-related concussion annually.5

Time to recovery is a clinical endpoint that matters greatly to our young, physically active patients, who are often eager to return to their daily activities as soon as possible. Guidelines frequently recommend cognitive and physical rest for 24 to 48 hours immediately following a concussion, but the use of screens during this cognitive rest period remains uncertain.6,7 International guidelines and the Centers for Disease Control and ­Prevention recommend symptom-limited activities—including screen time—during the initial period of a concussion.6,7 Although this gradual approach is standard of care, it has been unclear if abstaining completely from certain activities during the initial days of a concussion has any impact on recovery time.

Recent studies have examined physical activity to clarify the optimal timing of physical rest after a concussion. Among adolescents with concussions, strict rest for 5 days does not appear to improve symptoms compared with rest for 1 to 2 days.8 Additionally, physical activity within 7 days of acute head injury may help reduce symptoms and prevent postconcussive symptoms.9,10

This same level of clarity has been lacking for cognitive rest and screen time. The use of screens is a part of most patients’ daily activities, particularly among adolescents and young adults. One report found that students ages 8 to 18 years engage in approximately 7 hours of daily screen time, excluding that related to schoolwork.11 This trial evaluated the relationship between screen time abstinence within 48 hours of a concussion and time to symptom resolution.

STUDY SUMMARY

Symptom duration was significantly reduced by cutting screen time

This single-site, parallel-design, randomized clinical trial examined the effectiveness of limiting screen time exposure within the first 48 hours after a concussion in reducing the time to resolution of concussive symptoms in 125 patients. 1 Patients were included if they were 12 to 25 years old (mean age, 17 years) and presented within 24 hours of sustaining a concussion (as defined on the Acute Concussion Evaluation–Emergency Department tool) to the pediatric or adult ED at a US tertiary medical center.

A shared decision-making discussion should center on the idea that 48 hours of screen time abstinence could be well worth the increased likelihood of total recovery at Day 10.

Patients were randomized to either ­engage in screen time as tolerated or to abstain from screen time for 48 hours following their injury. Screen modalities included television, phones, video games, and computers/­tablets. The Post-Concussive Symptom Scale (PCSS; 0-132) was used to characterize 22 symptoms from 0 (absent) to 6 (severe) daily for 10 days. Patients also self-reported the amount of screen time they engaged in during Days 1 to 3 of the study period and completed an activity survey on Days 4 to 10. Among the participants, 76% completed the PCSS form until symptom resolution or until Day 10 (the end of the study period).

Continue to: The primary outcome...

 

 

The primary outcome was days to resolution of concussive symptoms, defined as a PCSS score ≤ 3. The median baseline PCSS score was 21 in the screen time–permitted group and 24.5 in the screen time–abstinent group. The screen time–permitted group reported a median screen time of 630 minutes during the intervention period, compared with 130 minutes in the screen time–abstinent group, and was less likely to recover during the study period than the screen time–­abstinent group (hazard ratio = 0.51; 95% CI, 0.29-0.90). The screen time–permitted group had a significantly longer median recovery time compared with the screen time–­abstinent group (8.0 vs 3.5 days; P = .03).

WHAT'S NEW?

Exploring the role of screen time during the cognitive rest period

This study provides evidence supporting the recommendation that adolescent and young adult patients abstain from screen time in the first 48 hours following a concussion to decrease time to symptom resolution, thus shortening the timeline to return to their usual daily activities.

CAVEATS

Self-reporting of data may introduce bias

This study used a self-reporting method to collect data, which could have resulted in underreporting or overreporting of screen time and potentially introduced recall and reporting bias. The screen timeabstinent group did not completely abstain from all screen time, with a self-reported average of 5 to 10 minutes of daily screen time to complete the required research surveys, so it is not immediately clear what extent of abstinence vs significant screen time reduction led to the clinical endpoints observed. Furthermore, this study did not ask patients to differentiate between active screen time (eg, texting and gaming) and passive screen time (eg, watching videos), which may differentially impact symptom resolution.

CHALLENGES TO IMPLEMENTATION

Turning off the ever-present screen may present obstacles

This intervention is easy to recommend, with few barriers to implementation. It’s worth noting that screens are often used in a patient’s school or job, and 48 hours of abstinence from these activities is a difficult ask when much of our society’s education, entertainment, and productivity revolve around the use of technology. When appropriate, a shared decision-making discussion between patient and physician should center on the idea that 48 hours of screen time abstinence could be well worth the increased likelihood of total recovery at Day 10, as opposed to the risk for persistent and prolonged symptoms that interfere with the patient’s lifestyle.

ILLUSTRATIVE CASE

A 17-year-old high school football player presents to the emergency department (ED) after a helmet-to-helmet tackle in a game earlier that day. After the tackle, he experienced immediate confusion. Once he returned to his feet, he felt dizzy and nauseated and began to develop a headache. When his symptoms failed to resolve within a few hours, his mother brought him to the hospital for an evaluation. In the ED, he receives a diagnosis of concussion, and his mother asks for recommendations on how he can recover as quickly as possible.

Traumatic brain injuries account for an estimated 2.5 million ED visits annually in the United States.2 Concussions are the most common form of traumatic brain injury, with adolescents contributing to the highest incidence of concussions.3,4 An estimated 1.6 to 3.8 million people experience a sports-related concussion annually.5

Time to recovery is a clinical endpoint that matters greatly to our young, physically active patients, who are often eager to return to their daily activities as soon as possible. Guidelines frequently recommend cognitive and physical rest for 24 to 48 hours immediately following a concussion, but the use of screens during this cognitive rest period remains uncertain.6,7 International guidelines and the Centers for Disease Control and ­Prevention recommend symptom-limited activities—including screen time—during the initial period of a concussion.6,7 Although this gradual approach is standard of care, it has been unclear if abstaining completely from certain activities during the initial days of a concussion has any impact on recovery time.

Recent studies have examined physical activity to clarify the optimal timing of physical rest after a concussion. Among adolescents with concussions, strict rest for 5 days does not appear to improve symptoms compared with rest for 1 to 2 days.8 Additionally, physical activity within 7 days of acute head injury may help reduce symptoms and prevent postconcussive symptoms.9,10

This same level of clarity has been lacking for cognitive rest and screen time. The use of screens is a part of most patients’ daily activities, particularly among adolescents and young adults. One report found that students ages 8 to 18 years engage in approximately 7 hours of daily screen time, excluding that related to schoolwork.11 This trial evaluated the relationship between screen time abstinence within 48 hours of a concussion and time to symptom resolution.

STUDY SUMMARY

Symptom duration was significantly reduced by cutting screen time

This single-site, parallel-design, randomized clinical trial examined the effectiveness of limiting screen time exposure within the first 48 hours after a concussion in reducing the time to resolution of concussive symptoms in 125 patients. 1 Patients were included if they were 12 to 25 years old (mean age, 17 years) and presented within 24 hours of sustaining a concussion (as defined on the Acute Concussion Evaluation–Emergency Department tool) to the pediatric or adult ED at a US tertiary medical center.

A shared decision-making discussion should center on the idea that 48 hours of screen time abstinence could be well worth the increased likelihood of total recovery at Day 10.

Patients were randomized to either ­engage in screen time as tolerated or to abstain from screen time for 48 hours following their injury. Screen modalities included television, phones, video games, and computers/­tablets. The Post-Concussive Symptom Scale (PCSS; 0-132) was used to characterize 22 symptoms from 0 (absent) to 6 (severe) daily for 10 days. Patients also self-reported the amount of screen time they engaged in during Days 1 to 3 of the study period and completed an activity survey on Days 4 to 10. Among the participants, 76% completed the PCSS form until symptom resolution or until Day 10 (the end of the study period).

Continue to: The primary outcome...

 

 

The primary outcome was days to resolution of concussive symptoms, defined as a PCSS score ≤ 3. The median baseline PCSS score was 21 in the screen time–permitted group and 24.5 in the screen time–abstinent group. The screen time–permitted group reported a median screen time of 630 minutes during the intervention period, compared with 130 minutes in the screen time–abstinent group, and was less likely to recover during the study period than the screen time–­abstinent group (hazard ratio = 0.51; 95% CI, 0.29-0.90). The screen time–permitted group had a significantly longer median recovery time compared with the screen time–­abstinent group (8.0 vs 3.5 days; P = .03).

WHAT'S NEW?

Exploring the role of screen time during the cognitive rest period

This study provides evidence supporting the recommendation that adolescent and young adult patients abstain from screen time in the first 48 hours following a concussion to decrease time to symptom resolution, thus shortening the timeline to return to their usual daily activities.

CAVEATS

Self-reporting of data may introduce bias

This study used a self-reporting method to collect data, which could have resulted in underreporting or overreporting of screen time and potentially introduced recall and reporting bias. The screen timeabstinent group did not completely abstain from all screen time, with a self-reported average of 5 to 10 minutes of daily screen time to complete the required research surveys, so it is not immediately clear what extent of abstinence vs significant screen time reduction led to the clinical endpoints observed. Furthermore, this study did not ask patients to differentiate between active screen time (eg, texting and gaming) and passive screen time (eg, watching videos), which may differentially impact symptom resolution.

CHALLENGES TO IMPLEMENTATION

Turning off the ever-present screen may present obstacles

This intervention is easy to recommend, with few barriers to implementation. It’s worth noting that screens are often used in a patient’s school or job, and 48 hours of abstinence from these activities is a difficult ask when much of our society’s education, entertainment, and productivity revolve around the use of technology. When appropriate, a shared decision-making discussion between patient and physician should center on the idea that 48 hours of screen time abstinence could be well worth the increased likelihood of total recovery at Day 10, as opposed to the risk for persistent and prolonged symptoms that interfere with the patient’s lifestyle.

References

1. Macnow T, Curran T, Tolliday C, et al. Effect of screen time on recovery from concussion: a randomized clinical trial. JAMA Pediatr. 2021;175:1124-1131. doi: 10.1001/jamapediat rics.2021.2782

2. Taylor CA, Bell JM, Breiding MJ, et al. Traumatic brain injury–related emergency department visits, hospitalizations, and deaths—United States, 2007 and 2013. MMWR Surveill Summ. 2017;66:1-16. doi: 10.15585/mmwr.ss6609a1

3. Vos PE, Battistin L, Birbamer G, et al; European Federation of Neurological Societies. EFNS guideline on mild traumatic brain injury: report of an EFNS task force. Eur J Neurol. 2002;9:207-219. doi: 10.1046/j.1468-1331.2002.00407.x

4. Zhang AL, Sing DC, Rugg CM, et al. The rise of concussions in the adolescent population. Orthop J Sports Med. 2016;4:2325967116662458. doi: 10.1177/2325967116662458

5. McKee AC, Cantu RC, Nowinski CJ, et al. Chronic traumatic encephalopathy in athletes: progressive tauopathy after repetitive head injury. J Neuropathol Exp Neurol. 2009;68:709-735. doi: 10.1097/NEN.0b013e3181a9d503

6. McCrory P, Meeuwisse W, Dvorák J, et al. Consensus statement on concussion in sport—the 5th international conference on concussion in sport held in Berlin, October 2016. Br J Sports Med. 2017;51:838-847. doi: 10.1136/bjsports-2017-097699

7. Lumba-Brown A, Yeates KO, Sarmiento K, et al. Centers for Disease Control and Prevention guideline on the diagnosis and management of mild traumatic brain injury among children. JAMA Pediatr. 2018;172:e182853. doi: 10.1001/jamapediat rics.2018.2853

8. Thomas DG, Apps JN, Hoffmann RG, et al. Benefits of strict rest after acute concussion: a randomized controlled trial. Pediatrics. 2015;135:213-223. doi: 10.1542/peds.2014-0966

9. Grool AM, Aglipay M, Momoli F, et al; Pediatric Emergency Research Canada (PERC) Concussion Team. Association between early participation in physical activity following acute concussion and persistent postconcussive symptoms in children and adolescents. JAMA. 2016;316:2504-2514. doi: 10.1001/jama.2016.17396

10. Lal A, Kolakowsky-Hayner SA, Ghajar J, et al. The effect of physical exercise after a concussion: a systematic review and meta-analysis. Am J Sports Med. 2018;46:743-752. doi: 10.1177/0363546517706137

11. Rideout V, Peebles A, Mann S, et al. The Common Sense Census: Media Use by Tweens and Teens, 2021. Common Sense Media; 2022. Accessed December 28, 2022. www.commonsensemedia.org/sites/default/files/research/report/8-18-census-integrated-report-final-web_0.pdf

References

1. Macnow T, Curran T, Tolliday C, et al. Effect of screen time on recovery from concussion: a randomized clinical trial. JAMA Pediatr. 2021;175:1124-1131. doi: 10.1001/jamapediat rics.2021.2782

2. Taylor CA, Bell JM, Breiding MJ, et al. Traumatic brain injury–related emergency department visits, hospitalizations, and deaths—United States, 2007 and 2013. MMWR Surveill Summ. 2017;66:1-16. doi: 10.15585/mmwr.ss6609a1

3. Vos PE, Battistin L, Birbamer G, et al; European Federation of Neurological Societies. EFNS guideline on mild traumatic brain injury: report of an EFNS task force. Eur J Neurol. 2002;9:207-219. doi: 10.1046/j.1468-1331.2002.00407.x

4. Zhang AL, Sing DC, Rugg CM, et al. The rise of concussions in the adolescent population. Orthop J Sports Med. 2016;4:2325967116662458. doi: 10.1177/2325967116662458

5. McKee AC, Cantu RC, Nowinski CJ, et al. Chronic traumatic encephalopathy in athletes: progressive tauopathy after repetitive head injury. J Neuropathol Exp Neurol. 2009;68:709-735. doi: 10.1097/NEN.0b013e3181a9d503

6. McCrory P, Meeuwisse W, Dvorák J, et al. Consensus statement on concussion in sport—the 5th international conference on concussion in sport held in Berlin, October 2016. Br J Sports Med. 2017;51:838-847. doi: 10.1136/bjsports-2017-097699

7. Lumba-Brown A, Yeates KO, Sarmiento K, et al. Centers for Disease Control and Prevention guideline on the diagnosis and management of mild traumatic brain injury among children. JAMA Pediatr. 2018;172:e182853. doi: 10.1001/jamapediat rics.2018.2853

8. Thomas DG, Apps JN, Hoffmann RG, et al. Benefits of strict rest after acute concussion: a randomized controlled trial. Pediatrics. 2015;135:213-223. doi: 10.1542/peds.2014-0966

9. Grool AM, Aglipay M, Momoli F, et al; Pediatric Emergency Research Canada (PERC) Concussion Team. Association between early participation in physical activity following acute concussion and persistent postconcussive symptoms in children and adolescents. JAMA. 2016;316:2504-2514. doi: 10.1001/jama.2016.17396

10. Lal A, Kolakowsky-Hayner SA, Ghajar J, et al. The effect of physical exercise after a concussion: a systematic review and meta-analysis. Am J Sports Med. 2018;46:743-752. doi: 10.1177/0363546517706137

11. Rideout V, Peebles A, Mann S, et al. The Common Sense Census: Media Use by Tweens and Teens, 2021. Common Sense Media; 2022. Accessed December 28, 2022. www.commonsensemedia.org/sites/default/files/research/report/8-18-census-integrated-report-final-web_0.pdf

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In a randomized clinical trial, symptom duration was reduced when teens and young adults observed a certain screen-time hiatus.</deck> </itemMeta> <itemContent> <h3>PRACTICE CHANGER</h3> <p> <span class="normaltextrun">Advise your teenaged and young adult patients with concussion to avoid electronic screens in the first 48 hours after a concussion to minimize time to symptom resolution.</span> </p> <p class="sub4">STRENGTH OF RECOMMENDATION</p> <p><strong>B</strong><b>:</b> Based on a single randomized clinical trial.<span class="normaltextrun"><sup>1</sup></span></p> <p class="SOR">Macnow T, Curran T, Tolliday C, et al. Effect of screen time on recovery from concussion: a randomized clinical trial. <i>JAMA Pediatr</i>. 2021;175:1124-1131. doi: 10.1001/jamapediatrics.2021.2782</p> <h2>Illustrative case</h2> <p>A 17-year-old high school football player presents to the emergency department (ED) after a helmet-to-helmet tackle in a game earlier that day. After the tackle, he experienced immediate confusion. Once he returned to his feet, he felt dizzy and nauseated and began to develop a headache. When his symptoms failed to resolve within a few hours, his mother brought him to the hospital for an evaluation. In the ED, he receives a diagnosis of concussion, and his mother asks for recommendations on how he can recover as quickly as possible.</p> <p><span class="dropcap">T</span>raumatic brain injuries account for an estimated 2.5 million ED visits annually in the United States.<sup>2</sup> Concussions are the most common form of traumatic brain injury, with adolescents contributing to the highest incidence of concussions.<sup>3,4</sup> An estimated 1.6 to 3.8 million people experience a sports-related concussion annually.<sup>5</sup> </p> <p>Time to recovery is a clinical endpoint that matters greatly to our young, physically active patients, who are often eager to return to their daily activities as soon as possible. Guidelines frequently recommend cognitive and physical rest for 24 to 48 hours immediately following a concussion, but the use of screens during this cognitive rest period remains uncertain<span class="Annotation">.</span><sup>6,7</sup> International guidelines and the Centers for Disease Control and ­Prevention recommend symptom-limited activities—including screen time—during the initial period of a concussion.<sup>6,7</sup> Although this gradual approach is standard of care, it has been unclear if abstaining completely from certain activities during the initial days of a concussion has any impact on recovery time. <br/><br/>Recent studies have examined physical activity to clarify the optimal timing of physical rest after a concussion. Among adolescents with concussions, strict rest for 5 days does not appear to improve symptoms compared with rest for 1 to 2 days.<sup>8</sup> Additionally, physical activity within 7 days of acute head injury may help reduce symptoms and prevent postconcussive symptoms.<sup>9,10</sup> This same level of clarity has been lacking for cognitive rest and screen time. The use of screens is a part of most patients’ daily activities, particularly among adolescents and young adults. One report found that students ages 8 to 18 years engage in approximately 7 hours of daily screen time, excluding that related to <hl name="268"/>schoolwork.<sup>11</sup> This trial evaluated the relationship between screen time abstinence within 48 hours of a concussion and time to symptom resolution.</p> <h2>Study summary</h2> <h3> <span class="normaltextrun">Symptom duration was significantly reduced by cutting screen time</span> </h3> <p> <span class="normaltextrun">This single-site, parallel-design, randomized clinical trial examined the effectiveness of limiting screen time exposure within the first 48 hours after a concussion in reducing the time to resolution of concussive symptoms in 125 patients.</span> <span class="normaltextrun"> <sup>1</sup> </span> <span class="normaltextrun"> Patients were included if they were 12 to 25 years old (mean age, 17 years) and presented within 24 hours of sustaining a concussion (as defined on the Acute Concussion Evaluation–Emergency Department tool) to the pediatric or adult ED at a US tertiary medical center. </span> </p> <p><span class="normaltextrun">Patients were randomized to either ­engage in screen time as tolerated or to abstain from screen time for 48 hours following their injury.</span> <span class="normaltextrun">Screen modalities included television, phones, video games, and computers/­tablets. The Post-Concussive Symptom Scale (PCSS; 0-132) was used to characterize 22 symptoms from 0 (absent) to 6 (severe) daily for 10 days. Patients also self-reported the amount of screen time they engaged in during</span> <span class="normaltextrun">Days 1 to 3 of the study period</span> <span class="normaltextrun">and completed an activity survey on Days 4 to 10. Among the participants, 76% completed the PCSS form until symptom resolution or until Day 10 (the end of the study period). <br/><br/></span><span class="normaltextrun">The primary outcome was days to resolution of concussive symptoms, defined as a PCSS score ≤ 3. The median baseline PCSS score was 21 in the screen time–permitted group and 24.5 in the screen time–abstinent group. The screen time–permitted group reported a median screen time of 630 minutes during the intervention period, compared with 130 minutes in the screen time–abstinent group, and was less likely to recover during the study period than the screen time–­abstinent group (hazard ratio = 0.51; 95% CI, 0.29-0.90). The screen time–permitted group had a significantly longer median recovery time compared with the screen time–­abstinent group (8.0 vs 3.5 days; </span><em>P</em><span class="normaltextrun"> = .03).</span></p> <h2>What’s new?</h2> <h3>Exploring the role of screen time during the cognitive rest period </h3> <p>This study provides evidence supporting the recommendation that adolescent and young adult patients abstain from screen time in the first 48 hours following a concussion to decrease time to symptom resolution, thus shortening the timeline to return to their usual daily activities. </p> <h2>Caveats</h2> <h3>Self-reporting of data may introduce bias </h3> <p>This study used a self-reporting method to collect data, which could have resulted in underreporting or overreporting of screen time and potentially introduced recall and reporting bias. The screen time<span class="normaltextrun">–</span>abstinent group did not completely abstain from all screen time, with a self-reported average of 5 to 10 minutes of daily screen time to complete the required research surveys, so it is not immediately clear what extent of abstinence vs significant screen time reduction led to the clinical endpoints observed. Furthermore, this study did not ask patients to differentiate between active screen time (eg, texting and gaming) and passive screen time (eg, watching videos), which may differentially impact symptom resolution. </p> <h2>Challenges to implementation</h2> <h3>Turning off the ever-present screen may present obstacles </h3> <p>This intervention is easy to recommend, with few barriers to implementation. It’s worth noting that screens are often used in a patient’s school or job, and 48 hours of abstinence from these activities is a difficult ask when much of our society’s education, entertainment, and productivity revolve around the use of technology. When appropriate, a shared decision-making discussion between patient and physician should center on the idea that 48 hours of screen time abstinence could be well worth the increased likelihood of total recovery at Day 10, as opposed to the risk for persistent and prolonged symptoms that interfere with the patient’s lifestyle. <span class="end">JFP</span></p> <p class="References"> 1. Macnow T, Curran T, Tolliday C, et al. Effect of screen time on recovery from concussion: a randomized clinical trial. <span class="ireference">JAMA Pediatr</span>. 2021;175:1124-1131. doi: 10.1001/jamapediat rics.2021.2782<br/><br/> 2. Taylor CA, Bell JM, Breiding MJ, et al. Traumatic brain injury–related emergency department visits, hospitalizations, and deaths—United States, 2007 and 2013. <span class="ireference">MMWR Surveill Summ</span>. 2017;66:1-16. doi: 10.15585/mmwr.ss6609a1<br/><br/> 3. Vos PE, Battistin L, Birbamer G, et al; European Federation of Neurological Societies. EFNS guideline on mild traumatic brain injury: report of an EFNS task force. <span class="ireference">Eur J Neurol</span>. 2002;9:207-219. doi: 10.1046/j.1468-1331.2002.00407.x <br/><br/> 4. Zhang AL, Sing DC, Rugg CM, et al. The rise of concussions in the adolescent population. <span class="ireference">Orthop J Sports Med</span>. 2016;4:2325967116662458. doi: 10.1177/2325967116662458<br/><br/> 5. McKee AC, Cantu RC, Nowinski CJ, et al. Chronic traumatic encephalopathy in athletes: progressive tauopathy after repetitive head injury. <span class="ireference">J Neuropathol Exp Neurol</span>. 2009;68:709-735. doi: 10.1097/NEN.0b013e3181a9d503<br/><br/> 6. McCrory P, Meeuwisse W, Dvorák J, et al. Consensus statement on concussion in sport—the 5th international conference on concussion in sport held in Berlin, October 2016. <span class="ireference">Br J Sports Med</span>. 2017;51:838-847. doi: 10.1136/bjsports-2017-097699<br/><br/> 7. Lumba-Brown A, Yeates KO, Sarmiento K, et al. Centers for Disease Control and Prevention guideline on the diagnosis and management of mild traumatic brain injury among children. <span class="ireference">JAMA Pediatr</span>. 2018;172:e182853. doi: 10.1001/jamapediat rics.2018.2853<br/><br/> 8. Thomas DG, Apps JN, Hoffmann RG, et al. Benefits of strict rest after acute concussion: a randomized controlled trial. <span class="ireference">Pediatrics</span>. 2015;135:213-223. doi: 10.1542/peds.2014-0966<br/><br/> 9. Grool AM, Aglipay M, Momoli F, et al; Pediatric Emergency Research Canada (PERC) Concussion Team. Association between early participation in physical activity following acute concussion and persistent postconcussive symptoms in children and adolescents. <span class="ireference">JAMA</span>. 2016;316:2504-2514. doi: 10.1001/jama.2016.17396<br/><br/> 10. Lal A, Kolakowsky-Hayner SA, Ghajar J, et al. The effect of physical exercise after a concussion: a systematic review and meta-analysis. <span class="ireference">Am J Sports Med</span>. 2018;46:743-752. doi: 10.1177/0363546517706137 <br/><br/> 11. Rideout V, Peebles A, Mann S, et al. <span class="ireference">The Common Sense Census: Media Use by Tweens and Teens, 2021</span>. Common Sense Media; 2022. Accessed December 28, 2022. <a href="http://www.commonsensemedia.org/sites/default/files/research/report/8-18-census-integrated-report-final-web_0.pdf">www.commonsensemedia.org/sites/default/files/research/report/8-18-census-integrated-report-final-web_0.pdf</a> </p> </itemContent> </newsItem> </itemSet></root>
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Inside the Article

PRACTICE CHANGER

Advise your teenaged and young adult patients with concussion to avoid electronic screens in the first 48 hours after a concussion to minimize time to symptom resolution.

STRENGTH OF RECOMMENDATION

B: Based on a single randomized clinical trial.1

Macnow T, Curran T, Tolliday C, et al. Effect of screen time on recovery from concussion: a randomized clinical trial. JAMA Pediatr. 2021;175:1124-1131. doi: 10.1001/jamapediatrics.2021.2782

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