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High-Dose Vitamin D Supplementation May Lead to Increased Risk of Falls
Study Overview
Objective. To determine the effectiveness of high-dose vitamin D versus low-dose vitamin D in reducing the risk of functional decline in older adults.
Design. Double-blind randomized controlled trial.
Setting and participants. This single-center study was conducted at the University of Zurich. Home-dwelling adults aged 70 and over were recruited through newspaper advertisement in Zurich from December 2009 to May 2010. Inclusion criteria included maintenance of mobility with or without a walking aid, having the ability to use public transportation to attend clinic visits, and scoring at least 27 on the Mini-Mental State Examination. Exclusion criteria include supplemental vitamin D use exceeding 800 IU per day and unwillingness to discontinue additional calcium and vitamin D supplementation, current cancer, malabsorption syndrome, heavy alcohol consumption, uncontrolled hypocalcemia, severe visual or hearing impairment, use of medications affecting calcium metabolism, diseases causing hypercalcemia, planned travel to sunny locations for longer than 2 months per year, maximum calcium supplement dose of 250 mg/day, use of medications affecting serum 25-hydroxyvitamin D (25[OH]D) level, body mass index ≥ 40, diseases predisposing to falls, hypercalcemia, kidney disease with creatinine clearance < 15, or kidney stone within 10 years prior to enrollment.
Intervention. Participants were randomized to receive either monthly supplementation of 24,000 IU of vitamin D3 per month (low-dose group), 60,000 IU of vitamin D3 once per month (high-dose group), or 24,000 IU of vitamin D3 plus 300 µg of calcifediol once per month. It was hypothesized that higher monthly doses of vitamin D or in combination with calcifediol, which is a liver metabolite approximately 2 to 3 times more potent than vitamin D3, will increase levels of 25(OH)D and reduce the risk of functional decline.
Main outcome measures. Lower extremity function using the Short Physical Performance Battery and 25(OH)D levels at 6 and 12 months. Study nurses called participants monthly to assess falls, adverse events, and adherence to study medications.
Main results. A total of 200 participants were enrolled. Average age was 78 years (SD = 5) and 67% were female; all had a history of falls in the previous year and average baseline 25(OH)D levels ranged from 18.4 to 20.9 ng/mL in the three groups. Adherence to the study medication exceeded 94% throughout the study trial in all treatment groups.
At 6 and 12 months, 25(OH)D levels increased by an average of 12.7 and 11.7 ng/mL in the low-dose group, an average of 18.3 and 19.2 ng/mL in the high-dose group, and an average of 27.6 and 25.8 ng/mL in the calcifediol-added group. The mean changes in physical performance score indicating lower extremity function did not differ significantly among treatment groups (P = 0.26), but for one measure—the 5 successive chair stands—the 2 high-dose groups had less improvement when compared with the low-dose group. At 12 months, 66.9% of the high-dose group and 66.1% in the group with calcifediol fell during the study period, which was more than the low-dose group (47.9%, P = 0.048). The mean number of falls was also higher among the high-dose and calcifediol groups when compared with the low-dose group.
Conclusion. Higher doses of vitamin D were not better than lower doses of vitamin D in improving lower extremity function and were associated with higher risk of falls.
Commentary
Vitamin D deficiency is common among older adults and is associated with sarcopenia, functional decline, falls, and fractures [1,2]. Prior meta-analysis has supported that supplementation with vitamin D may lead to improved outcomes in fracture prevention [3]. However, the US Preventive Services Task Force, using more recent evidence reviews and an updated meta-analysis [4], found evidence lacking regarding the benefit of supplementation with vitamin D in community-dwelling postmenopausal women at doses > 400 IU, found no benefit in this group for doses ≤ 400, and found evidence lacking for supplementation in men or premenopausal women at any dose [5]. At the same time, the USPSTF also recommends exercise or physical therapy and vitamin D supplementation (800 IU daily) to prevent falls in community-dwelling adults ≥ 65 years at increased risk for falls [6]. This is consistent with the Institute of Medicine’s recommendation of 800 IU per day for older adults [7].
The current study attempted to elucidate the potential impact of high-dose vitamin D supplementation, hypothesizing that higher doses will achieve improvement in vitamin D levels and better outcomes in terms of lower extremity function and falls. However, the investigators found that rather than lowering risk of falls, higher-dose vitamin D was associated with elevated risk of falls without the benefit of improving lower extremity function. This is not the first study that has demonstrated that higher doses of vitamin D supplementation may be associated with harm. A prior randomized controlled trial utilizing a different dosing strategy of annual high- dose vitamin D supplementation also found that higher doses were associated with increased risks of falls [8]. Nonetheless, it helps support the notion that in vitamin D supplementation, more is not necessarily better.
The study is not without its drawbacks. The sample size was relatively small and the trial may have been underpowered to detect whether there may be certain patients for whom high-dose vitamin D supplementation may have a role. Also, the study was based in Zurich, which has a relatively uniform population, and study results may not be generalizable to populations in other countries.
Applications for Clinical Practice
The study lends support to the current recommendation of the Institute of Medicine—800 IU a day—for fall prevention, which is equivalent in dose to the 24,000 IU per month utilized in the trial. One of the questions not answered by the study is whether high-dose supplementation for adults who have severe deficiency in vitamin D is beneficial or harmful when compared with lower-dose supplementation. In clinical practice, clinicians often check an initial level of vitamin D and aim for a target level with supplementation. Among those patients with extremely low baseline levels, a lower-dose regimen of 800 IU a day may not yield a normalized level of vitamin D. Further studies are needed to elucidate whether there may be a role for higher-dose supplementation in these individuals. Nonetheless, it is clear that the current evidence does not support the routine use of high-dose vitamin D supplementation; it does not lead to better lower extremity function and may cause harm.
—William Hung, MD, MPH
1. Visser M, Deeg DJ, Lips P; Longitudinal Aging Study Amsterdam. Low vitamin D and high parathyroid hormone levels as determinants of loss of muscle strength and muscle mass (sarcopenia): the Longitudinal Aging Study Amsterdam. J Clin Endocrinol Metab 2003;88:5766–72.
2. Cauley JA, Lacroix AZ, Wu L, et al. Serum 25-hydroxy-vitamin D concentrations and risk for hip fractures. Ann Intern Med 2008;149:242–50.
3. Bischoff-Ferrari HA, Willett WC, Wong JB, et al. Fracture prevention with vitamin D supplementation: a meta-analysis of randomized controlled trials. JAMA 2005;293:2257–64.
4. Chung M, Lee J, Terasawa T, et al. Vitamin D with or without calcium supplementation for prevention of cancer and fractures: an updated meta-analysis for the U.S. Preventive Services Task Force. Ann Intern Med 2011;155:827–38.
5. Moyer VA, on behalf of the U.S. Preventive Services Task Force. Vitamin D and calcium supplementation to prevent fractures in adults: U.S. Preventive Services Task Force Recommendation Statement. Ann Intern Med 2013;158:691–6.
6. Moyer VA et al. Prevention of falls in community-dwelling older adults: U.S. Prevention Services Task Force Recommendation statement. Ann Intern Med 2012; 157:197–204.
7. Institute of Medicine. Dietary reference intakes for calcium and vitamin D. Washington, DC: National Academies Press; 2010.
8. Sanders KM, Stuart AL, Williamson EJ, et al. Annual high-dose oral vitamin D and falls and fractures in older women: a randomized controlled trial. JAMA 2010;303:1815.
Study Overview
Objective. To determine the effectiveness of high-dose vitamin D versus low-dose vitamin D in reducing the risk of functional decline in older adults.
Design. Double-blind randomized controlled trial.
Setting and participants. This single-center study was conducted at the University of Zurich. Home-dwelling adults aged 70 and over were recruited through newspaper advertisement in Zurich from December 2009 to May 2010. Inclusion criteria included maintenance of mobility with or without a walking aid, having the ability to use public transportation to attend clinic visits, and scoring at least 27 on the Mini-Mental State Examination. Exclusion criteria include supplemental vitamin D use exceeding 800 IU per day and unwillingness to discontinue additional calcium and vitamin D supplementation, current cancer, malabsorption syndrome, heavy alcohol consumption, uncontrolled hypocalcemia, severe visual or hearing impairment, use of medications affecting calcium metabolism, diseases causing hypercalcemia, planned travel to sunny locations for longer than 2 months per year, maximum calcium supplement dose of 250 mg/day, use of medications affecting serum 25-hydroxyvitamin D (25[OH]D) level, body mass index ≥ 40, diseases predisposing to falls, hypercalcemia, kidney disease with creatinine clearance < 15, or kidney stone within 10 years prior to enrollment.
Intervention. Participants were randomized to receive either monthly supplementation of 24,000 IU of vitamin D3 per month (low-dose group), 60,000 IU of vitamin D3 once per month (high-dose group), or 24,000 IU of vitamin D3 plus 300 µg of calcifediol once per month. It was hypothesized that higher monthly doses of vitamin D or in combination with calcifediol, which is a liver metabolite approximately 2 to 3 times more potent than vitamin D3, will increase levels of 25(OH)D and reduce the risk of functional decline.
Main outcome measures. Lower extremity function using the Short Physical Performance Battery and 25(OH)D levels at 6 and 12 months. Study nurses called participants monthly to assess falls, adverse events, and adherence to study medications.
Main results. A total of 200 participants were enrolled. Average age was 78 years (SD = 5) and 67% were female; all had a history of falls in the previous year and average baseline 25(OH)D levels ranged from 18.4 to 20.9 ng/mL in the three groups. Adherence to the study medication exceeded 94% throughout the study trial in all treatment groups.
At 6 and 12 months, 25(OH)D levels increased by an average of 12.7 and 11.7 ng/mL in the low-dose group, an average of 18.3 and 19.2 ng/mL in the high-dose group, and an average of 27.6 and 25.8 ng/mL in the calcifediol-added group. The mean changes in physical performance score indicating lower extremity function did not differ significantly among treatment groups (P = 0.26), but for one measure—the 5 successive chair stands—the 2 high-dose groups had less improvement when compared with the low-dose group. At 12 months, 66.9% of the high-dose group and 66.1% in the group with calcifediol fell during the study period, which was more than the low-dose group (47.9%, P = 0.048). The mean number of falls was also higher among the high-dose and calcifediol groups when compared with the low-dose group.
Conclusion. Higher doses of vitamin D were not better than lower doses of vitamin D in improving lower extremity function and were associated with higher risk of falls.
Commentary
Vitamin D deficiency is common among older adults and is associated with sarcopenia, functional decline, falls, and fractures [1,2]. Prior meta-analysis has supported that supplementation with vitamin D may lead to improved outcomes in fracture prevention [3]. However, the US Preventive Services Task Force, using more recent evidence reviews and an updated meta-analysis [4], found evidence lacking regarding the benefit of supplementation with vitamin D in community-dwelling postmenopausal women at doses > 400 IU, found no benefit in this group for doses ≤ 400, and found evidence lacking for supplementation in men or premenopausal women at any dose [5]. At the same time, the USPSTF also recommends exercise or physical therapy and vitamin D supplementation (800 IU daily) to prevent falls in community-dwelling adults ≥ 65 years at increased risk for falls [6]. This is consistent with the Institute of Medicine’s recommendation of 800 IU per day for older adults [7].
The current study attempted to elucidate the potential impact of high-dose vitamin D supplementation, hypothesizing that higher doses will achieve improvement in vitamin D levels and better outcomes in terms of lower extremity function and falls. However, the investigators found that rather than lowering risk of falls, higher-dose vitamin D was associated with elevated risk of falls without the benefit of improving lower extremity function. This is not the first study that has demonstrated that higher doses of vitamin D supplementation may be associated with harm. A prior randomized controlled trial utilizing a different dosing strategy of annual high- dose vitamin D supplementation also found that higher doses were associated with increased risks of falls [8]. Nonetheless, it helps support the notion that in vitamin D supplementation, more is not necessarily better.
The study is not without its drawbacks. The sample size was relatively small and the trial may have been underpowered to detect whether there may be certain patients for whom high-dose vitamin D supplementation may have a role. Also, the study was based in Zurich, which has a relatively uniform population, and study results may not be generalizable to populations in other countries.
Applications for Clinical Practice
The study lends support to the current recommendation of the Institute of Medicine—800 IU a day—for fall prevention, which is equivalent in dose to the 24,000 IU per month utilized in the trial. One of the questions not answered by the study is whether high-dose supplementation for adults who have severe deficiency in vitamin D is beneficial or harmful when compared with lower-dose supplementation. In clinical practice, clinicians often check an initial level of vitamin D and aim for a target level with supplementation. Among those patients with extremely low baseline levels, a lower-dose regimen of 800 IU a day may not yield a normalized level of vitamin D. Further studies are needed to elucidate whether there may be a role for higher-dose supplementation in these individuals. Nonetheless, it is clear that the current evidence does not support the routine use of high-dose vitamin D supplementation; it does not lead to better lower extremity function and may cause harm.
—William Hung, MD, MPH
Study Overview
Objective. To determine the effectiveness of high-dose vitamin D versus low-dose vitamin D in reducing the risk of functional decline in older adults.
Design. Double-blind randomized controlled trial.
Setting and participants. This single-center study was conducted at the University of Zurich. Home-dwelling adults aged 70 and over were recruited through newspaper advertisement in Zurich from December 2009 to May 2010. Inclusion criteria included maintenance of mobility with or without a walking aid, having the ability to use public transportation to attend clinic visits, and scoring at least 27 on the Mini-Mental State Examination. Exclusion criteria include supplemental vitamin D use exceeding 800 IU per day and unwillingness to discontinue additional calcium and vitamin D supplementation, current cancer, malabsorption syndrome, heavy alcohol consumption, uncontrolled hypocalcemia, severe visual or hearing impairment, use of medications affecting calcium metabolism, diseases causing hypercalcemia, planned travel to sunny locations for longer than 2 months per year, maximum calcium supplement dose of 250 mg/day, use of medications affecting serum 25-hydroxyvitamin D (25[OH]D) level, body mass index ≥ 40, diseases predisposing to falls, hypercalcemia, kidney disease with creatinine clearance < 15, or kidney stone within 10 years prior to enrollment.
Intervention. Participants were randomized to receive either monthly supplementation of 24,000 IU of vitamin D3 per month (low-dose group), 60,000 IU of vitamin D3 once per month (high-dose group), or 24,000 IU of vitamin D3 plus 300 µg of calcifediol once per month. It was hypothesized that higher monthly doses of vitamin D or in combination with calcifediol, which is a liver metabolite approximately 2 to 3 times more potent than vitamin D3, will increase levels of 25(OH)D and reduce the risk of functional decline.
Main outcome measures. Lower extremity function using the Short Physical Performance Battery and 25(OH)D levels at 6 and 12 months. Study nurses called participants monthly to assess falls, adverse events, and adherence to study medications.
Main results. A total of 200 participants were enrolled. Average age was 78 years (SD = 5) and 67% were female; all had a history of falls in the previous year and average baseline 25(OH)D levels ranged from 18.4 to 20.9 ng/mL in the three groups. Adherence to the study medication exceeded 94% throughout the study trial in all treatment groups.
At 6 and 12 months, 25(OH)D levels increased by an average of 12.7 and 11.7 ng/mL in the low-dose group, an average of 18.3 and 19.2 ng/mL in the high-dose group, and an average of 27.6 and 25.8 ng/mL in the calcifediol-added group. The mean changes in physical performance score indicating lower extremity function did not differ significantly among treatment groups (P = 0.26), but for one measure—the 5 successive chair stands—the 2 high-dose groups had less improvement when compared with the low-dose group. At 12 months, 66.9% of the high-dose group and 66.1% in the group with calcifediol fell during the study period, which was more than the low-dose group (47.9%, P = 0.048). The mean number of falls was also higher among the high-dose and calcifediol groups when compared with the low-dose group.
Conclusion. Higher doses of vitamin D were not better than lower doses of vitamin D in improving lower extremity function and were associated with higher risk of falls.
Commentary
Vitamin D deficiency is common among older adults and is associated with sarcopenia, functional decline, falls, and fractures [1,2]. Prior meta-analysis has supported that supplementation with vitamin D may lead to improved outcomes in fracture prevention [3]. However, the US Preventive Services Task Force, using more recent evidence reviews and an updated meta-analysis [4], found evidence lacking regarding the benefit of supplementation with vitamin D in community-dwelling postmenopausal women at doses > 400 IU, found no benefit in this group for doses ≤ 400, and found evidence lacking for supplementation in men or premenopausal women at any dose [5]. At the same time, the USPSTF also recommends exercise or physical therapy and vitamin D supplementation (800 IU daily) to prevent falls in community-dwelling adults ≥ 65 years at increased risk for falls [6]. This is consistent with the Institute of Medicine’s recommendation of 800 IU per day for older adults [7].
The current study attempted to elucidate the potential impact of high-dose vitamin D supplementation, hypothesizing that higher doses will achieve improvement in vitamin D levels and better outcomes in terms of lower extremity function and falls. However, the investigators found that rather than lowering risk of falls, higher-dose vitamin D was associated with elevated risk of falls without the benefit of improving lower extremity function. This is not the first study that has demonstrated that higher doses of vitamin D supplementation may be associated with harm. A prior randomized controlled trial utilizing a different dosing strategy of annual high- dose vitamin D supplementation also found that higher doses were associated with increased risks of falls [8]. Nonetheless, it helps support the notion that in vitamin D supplementation, more is not necessarily better.
The study is not without its drawbacks. The sample size was relatively small and the trial may have been underpowered to detect whether there may be certain patients for whom high-dose vitamin D supplementation may have a role. Also, the study was based in Zurich, which has a relatively uniform population, and study results may not be generalizable to populations in other countries.
Applications for Clinical Practice
The study lends support to the current recommendation of the Institute of Medicine—800 IU a day—for fall prevention, which is equivalent in dose to the 24,000 IU per month utilized in the trial. One of the questions not answered by the study is whether high-dose supplementation for adults who have severe deficiency in vitamin D is beneficial or harmful when compared with lower-dose supplementation. In clinical practice, clinicians often check an initial level of vitamin D and aim for a target level with supplementation. Among those patients with extremely low baseline levels, a lower-dose regimen of 800 IU a day may not yield a normalized level of vitamin D. Further studies are needed to elucidate whether there may be a role for higher-dose supplementation in these individuals. Nonetheless, it is clear that the current evidence does not support the routine use of high-dose vitamin D supplementation; it does not lead to better lower extremity function and may cause harm.
—William Hung, MD, MPH
1. Visser M, Deeg DJ, Lips P; Longitudinal Aging Study Amsterdam. Low vitamin D and high parathyroid hormone levels as determinants of loss of muscle strength and muscle mass (sarcopenia): the Longitudinal Aging Study Amsterdam. J Clin Endocrinol Metab 2003;88:5766–72.
2. Cauley JA, Lacroix AZ, Wu L, et al. Serum 25-hydroxy-vitamin D concentrations and risk for hip fractures. Ann Intern Med 2008;149:242–50.
3. Bischoff-Ferrari HA, Willett WC, Wong JB, et al. Fracture prevention with vitamin D supplementation: a meta-analysis of randomized controlled trials. JAMA 2005;293:2257–64.
4. Chung M, Lee J, Terasawa T, et al. Vitamin D with or without calcium supplementation for prevention of cancer and fractures: an updated meta-analysis for the U.S. Preventive Services Task Force. Ann Intern Med 2011;155:827–38.
5. Moyer VA, on behalf of the U.S. Preventive Services Task Force. Vitamin D and calcium supplementation to prevent fractures in adults: U.S. Preventive Services Task Force Recommendation Statement. Ann Intern Med 2013;158:691–6.
6. Moyer VA et al. Prevention of falls in community-dwelling older adults: U.S. Prevention Services Task Force Recommendation statement. Ann Intern Med 2012; 157:197–204.
7. Institute of Medicine. Dietary reference intakes for calcium and vitamin D. Washington, DC: National Academies Press; 2010.
8. Sanders KM, Stuart AL, Williamson EJ, et al. Annual high-dose oral vitamin D and falls and fractures in older women: a randomized controlled trial. JAMA 2010;303:1815.
1. Visser M, Deeg DJ, Lips P; Longitudinal Aging Study Amsterdam. Low vitamin D and high parathyroid hormone levels as determinants of loss of muscle strength and muscle mass (sarcopenia): the Longitudinal Aging Study Amsterdam. J Clin Endocrinol Metab 2003;88:5766–72.
2. Cauley JA, Lacroix AZ, Wu L, et al. Serum 25-hydroxy-vitamin D concentrations and risk for hip fractures. Ann Intern Med 2008;149:242–50.
3. Bischoff-Ferrari HA, Willett WC, Wong JB, et al. Fracture prevention with vitamin D supplementation: a meta-analysis of randomized controlled trials. JAMA 2005;293:2257–64.
4. Chung M, Lee J, Terasawa T, et al. Vitamin D with or without calcium supplementation for prevention of cancer and fractures: an updated meta-analysis for the U.S. Preventive Services Task Force. Ann Intern Med 2011;155:827–38.
5. Moyer VA, on behalf of the U.S. Preventive Services Task Force. Vitamin D and calcium supplementation to prevent fractures in adults: U.S. Preventive Services Task Force Recommendation Statement. Ann Intern Med 2013;158:691–6.
6. Moyer VA et al. Prevention of falls in community-dwelling older adults: U.S. Prevention Services Task Force Recommendation statement. Ann Intern Med 2012; 157:197–204.
7. Institute of Medicine. Dietary reference intakes for calcium and vitamin D. Washington, DC: National Academies Press; 2010.
8. Sanders KM, Stuart AL, Williamson EJ, et al. Annual high-dose oral vitamin D and falls and fractures in older women: a randomized controlled trial. JAMA 2010;303:1815.
Dabigatran Adherence Among Nonvalvular Atrial Fibrillation Patients Is Associated with Pharmacist-Based Activities
Study Overview
Objective. To assess site level adherence to dabigatran among patients with atrial fibrillation and to determine if specific practices at the site level are associated with adherence.
Design. Mixed-methods study involving retrospective quantitative and cross-sectional qualitative data.
Setting and participants. 67 Veterans Health Administration sites with 20 or more patients with dabigatran prescription for nonvalvular atrial fibrillation between 2010 and 2012 were included. Among these sites, 41 sites participated in an inquiry about practices related to dabigatran use. A total of 47 pharmacists among the 41 sites were interviewed. The investigators identified from the interviews 3 specific practices related to dabigatran use: appropriate patient selection (review of indications, contradictions, and prior adherence to other medications), pharmacist-driven patient education, and pharmacist-led adverse event and adherence monitoring. Sites were characterized as having adopted these specific practices or not, based on the interviews.
Main outcome measure. Dabigatran adherence defined by proportion of days covered (ratio of days supplied by prescription to follow-up duration) of 80% or more. Site level variance in dabigatran adherence among the 67 sites were described. Site level adherence was adjusted by patient level factors and site level factors. The association between site level practice and adherence was examined with Poisson models using generalized estimate equation to account for clustering of patients within sites.
Main results. A total of 67 sites with 4863 patients with prescriptions of dabigatran for atrial fibrillation were included in the analysis. There was wide variation among sites on adherence rate, with a range of 42% to 93% (median, 74%). The sites were categorized as high performing if their site level adherence rate was at least 74%. Among the 41 sites that participated in the qualitative study that defined exposure variables, appropriate patient selection was performed at 31 sites, pharmacist-led education was provided at 30 sites, and pharmacist-led monitoring at 28 sites. There was variation in the duration of monitoring among sites, with 18 of 28 monitoring for 3 to 6 months while the rest of the sites monitor indefinitely. Site level practices differed between low and high performing sites, with high performing sites more likely to have adopted appropriate patient selection with review of adherence (83% vs. 65% in low-performing sites), have pharmacist-driven education (83% vs. 59%), and have pharmacist-led adverse event monitoring (92% vs. 35%). After adjustment for patient level and site level characteristics, the association between adherence and appropriate patient selection (adjusted risk ratio [RR], 1.14; 95% confidence interval [CI], 1.05–1.25) and pharmacist-led adverse event monitoring (RR, 1.25; 95% CI, 1.11–1.41) remained.
Conclusion. There is wide variability in dabigatran adherence among patients with atrial fibrillation at different VA sites. Site level pharmacist-based practices are associated with the level of adherence at the sites.
Commentary
Studies have demonstrated that in a clinical trial setting, dabigatran is as effective as warfarin in stroke prevention among patients with atrial fibrillation and is associated with a lower risk of major hemorrhage [1]. However, outside of clinical trials, effectiveness of a treatment regimen is highly related to whether treatment is adhered to. In contrast with warfarin treatment, where treatment adherence is regularly tracked through monitoring of blood levels and clinic visits, dabigatran does not require monitoring and thus, adherence to dabigatran may not be monitored. A recent study finds that poorer adherence likely contributes to increased risk of stroke and death among patients on dabigatran [2]. The current study examines the variation in adherence rates on a site level and identifies factors that are associated with better adherence. The findings suggest that better patient selection through examination of prior adherence to warfarin and other medications and pharmacist-led adverse event and adherence monitoring are practices that are associated with better adherence. These are potentially important findings that may impact care for patients with atrial fibrillation.
These results need to be interpreted cautiously because of the limitations of the observational study design. Several factors need to be considered when interpreting the study findings. First, despite the VA being a comprehensive system of care, veterans often use care outside of the VA, including obtaining medications outside of VA [3]. Because of the prevalent concurrent use of care outside of VA, examining adherence to medication with only VA records may be incomplete and may erroneously categorize patients as low adherence. Second, the number of patients on dabigatran per facility is rather small and quite variable as well, with some sites that have very few number of patients. Although the investigators have excluded sites with fewer than 20 patients on dabigatran, the variability in the use of dabigatran may reflect site-specific factors, some of which may affect patient selection on the site level, that ultimately may affect outcome. Finally, the interview of pharmacist at each site may reflect the view of one to two pharmacists at each site, and thus may not truly reflect practices at the site throughout the period where patients were selected and outcomes defined.
Applications for Clinical Practice
Although it is tempting to conclude that instituting the pharmacist-based activities in patient selection and adverse event monitoring will lead to better adherence to dabigatran and thus improved patient outcomes, considering the limitations in the study a follow-up intervention study where sites are randomized to institute-specific practices for dabigatran use will be very important to demonstrate definitively the impact of these interventions. Also, as the use of dabigatran and other novel anticoagulants become more prevalent [4], a follow-up study to include a larger sample of patients may also be valuable to demonstrate if the conclusions are upheld.
—William Hung, MD, MPH
1. Connolly SJ, Ezekowitz MD, Yusuf S, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 2009: 361:1139–50.
2. Shore S, Carey EP, Turakhia MP, et al. Adherence to dabigatran therapy and longitudinal patient outcomes: insights from the veterans health administration. Am Heart J 2014;167:810–7.
3. Hynes DM, Koelling K, Stroupe K, et al. Veterans’ access to and use of Medicare and veterans affairs health care. Med Care 2007:45:214–23.
4. Boyle AM. VA, army clinicians rapidly increase prescribing of novel anticoagulants. US Med Feb 2014. Available at www.usmedicine.com.
Study Overview
Objective. To assess site level adherence to dabigatran among patients with atrial fibrillation and to determine if specific practices at the site level are associated with adherence.
Design. Mixed-methods study involving retrospective quantitative and cross-sectional qualitative data.
Setting and participants. 67 Veterans Health Administration sites with 20 or more patients with dabigatran prescription for nonvalvular atrial fibrillation between 2010 and 2012 were included. Among these sites, 41 sites participated in an inquiry about practices related to dabigatran use. A total of 47 pharmacists among the 41 sites were interviewed. The investigators identified from the interviews 3 specific practices related to dabigatran use: appropriate patient selection (review of indications, contradictions, and prior adherence to other medications), pharmacist-driven patient education, and pharmacist-led adverse event and adherence monitoring. Sites were characterized as having adopted these specific practices or not, based on the interviews.
Main outcome measure. Dabigatran adherence defined by proportion of days covered (ratio of days supplied by prescription to follow-up duration) of 80% or more. Site level variance in dabigatran adherence among the 67 sites were described. Site level adherence was adjusted by patient level factors and site level factors. The association between site level practice and adherence was examined with Poisson models using generalized estimate equation to account for clustering of patients within sites.
Main results. A total of 67 sites with 4863 patients with prescriptions of dabigatran for atrial fibrillation were included in the analysis. There was wide variation among sites on adherence rate, with a range of 42% to 93% (median, 74%). The sites were categorized as high performing if their site level adherence rate was at least 74%. Among the 41 sites that participated in the qualitative study that defined exposure variables, appropriate patient selection was performed at 31 sites, pharmacist-led education was provided at 30 sites, and pharmacist-led monitoring at 28 sites. There was variation in the duration of monitoring among sites, with 18 of 28 monitoring for 3 to 6 months while the rest of the sites monitor indefinitely. Site level practices differed between low and high performing sites, with high performing sites more likely to have adopted appropriate patient selection with review of adherence (83% vs. 65% in low-performing sites), have pharmacist-driven education (83% vs. 59%), and have pharmacist-led adverse event monitoring (92% vs. 35%). After adjustment for patient level and site level characteristics, the association between adherence and appropriate patient selection (adjusted risk ratio [RR], 1.14; 95% confidence interval [CI], 1.05–1.25) and pharmacist-led adverse event monitoring (RR, 1.25; 95% CI, 1.11–1.41) remained.
Conclusion. There is wide variability in dabigatran adherence among patients with atrial fibrillation at different VA sites. Site level pharmacist-based practices are associated with the level of adherence at the sites.
Commentary
Studies have demonstrated that in a clinical trial setting, dabigatran is as effective as warfarin in stroke prevention among patients with atrial fibrillation and is associated with a lower risk of major hemorrhage [1]. However, outside of clinical trials, effectiveness of a treatment regimen is highly related to whether treatment is adhered to. In contrast with warfarin treatment, where treatment adherence is regularly tracked through monitoring of blood levels and clinic visits, dabigatran does not require monitoring and thus, adherence to dabigatran may not be monitored. A recent study finds that poorer adherence likely contributes to increased risk of stroke and death among patients on dabigatran [2]. The current study examines the variation in adherence rates on a site level and identifies factors that are associated with better adherence. The findings suggest that better patient selection through examination of prior adherence to warfarin and other medications and pharmacist-led adverse event and adherence monitoring are practices that are associated with better adherence. These are potentially important findings that may impact care for patients with atrial fibrillation.
These results need to be interpreted cautiously because of the limitations of the observational study design. Several factors need to be considered when interpreting the study findings. First, despite the VA being a comprehensive system of care, veterans often use care outside of the VA, including obtaining medications outside of VA [3]. Because of the prevalent concurrent use of care outside of VA, examining adherence to medication with only VA records may be incomplete and may erroneously categorize patients as low adherence. Second, the number of patients on dabigatran per facility is rather small and quite variable as well, with some sites that have very few number of patients. Although the investigators have excluded sites with fewer than 20 patients on dabigatran, the variability in the use of dabigatran may reflect site-specific factors, some of which may affect patient selection on the site level, that ultimately may affect outcome. Finally, the interview of pharmacist at each site may reflect the view of one to two pharmacists at each site, and thus may not truly reflect practices at the site throughout the period where patients were selected and outcomes defined.
Applications for Clinical Practice
Although it is tempting to conclude that instituting the pharmacist-based activities in patient selection and adverse event monitoring will lead to better adherence to dabigatran and thus improved patient outcomes, considering the limitations in the study a follow-up intervention study where sites are randomized to institute-specific practices for dabigatran use will be very important to demonstrate definitively the impact of these interventions. Also, as the use of dabigatran and other novel anticoagulants become more prevalent [4], a follow-up study to include a larger sample of patients may also be valuable to demonstrate if the conclusions are upheld.
—William Hung, MD, MPH
Study Overview
Objective. To assess site level adherence to dabigatran among patients with atrial fibrillation and to determine if specific practices at the site level are associated with adherence.
Design. Mixed-methods study involving retrospective quantitative and cross-sectional qualitative data.
Setting and participants. 67 Veterans Health Administration sites with 20 or more patients with dabigatran prescription for nonvalvular atrial fibrillation between 2010 and 2012 were included. Among these sites, 41 sites participated in an inquiry about practices related to dabigatran use. A total of 47 pharmacists among the 41 sites were interviewed. The investigators identified from the interviews 3 specific practices related to dabigatran use: appropriate patient selection (review of indications, contradictions, and prior adherence to other medications), pharmacist-driven patient education, and pharmacist-led adverse event and adherence monitoring. Sites were characterized as having adopted these specific practices or not, based on the interviews.
Main outcome measure. Dabigatran adherence defined by proportion of days covered (ratio of days supplied by prescription to follow-up duration) of 80% or more. Site level variance in dabigatran adherence among the 67 sites were described. Site level adherence was adjusted by patient level factors and site level factors. The association between site level practice and adherence was examined with Poisson models using generalized estimate equation to account for clustering of patients within sites.
Main results. A total of 67 sites with 4863 patients with prescriptions of dabigatran for atrial fibrillation were included in the analysis. There was wide variation among sites on adherence rate, with a range of 42% to 93% (median, 74%). The sites were categorized as high performing if their site level adherence rate was at least 74%. Among the 41 sites that participated in the qualitative study that defined exposure variables, appropriate patient selection was performed at 31 sites, pharmacist-led education was provided at 30 sites, and pharmacist-led monitoring at 28 sites. There was variation in the duration of monitoring among sites, with 18 of 28 monitoring for 3 to 6 months while the rest of the sites monitor indefinitely. Site level practices differed between low and high performing sites, with high performing sites more likely to have adopted appropriate patient selection with review of adherence (83% vs. 65% in low-performing sites), have pharmacist-driven education (83% vs. 59%), and have pharmacist-led adverse event monitoring (92% vs. 35%). After adjustment for patient level and site level characteristics, the association between adherence and appropriate patient selection (adjusted risk ratio [RR], 1.14; 95% confidence interval [CI], 1.05–1.25) and pharmacist-led adverse event monitoring (RR, 1.25; 95% CI, 1.11–1.41) remained.
Conclusion. There is wide variability in dabigatran adherence among patients with atrial fibrillation at different VA sites. Site level pharmacist-based practices are associated with the level of adherence at the sites.
Commentary
Studies have demonstrated that in a clinical trial setting, dabigatran is as effective as warfarin in stroke prevention among patients with atrial fibrillation and is associated with a lower risk of major hemorrhage [1]. However, outside of clinical trials, effectiveness of a treatment regimen is highly related to whether treatment is adhered to. In contrast with warfarin treatment, where treatment adherence is regularly tracked through monitoring of blood levels and clinic visits, dabigatran does not require monitoring and thus, adherence to dabigatran may not be monitored. A recent study finds that poorer adherence likely contributes to increased risk of stroke and death among patients on dabigatran [2]. The current study examines the variation in adherence rates on a site level and identifies factors that are associated with better adherence. The findings suggest that better patient selection through examination of prior adherence to warfarin and other medications and pharmacist-led adverse event and adherence monitoring are practices that are associated with better adherence. These are potentially important findings that may impact care for patients with atrial fibrillation.
These results need to be interpreted cautiously because of the limitations of the observational study design. Several factors need to be considered when interpreting the study findings. First, despite the VA being a comprehensive system of care, veterans often use care outside of the VA, including obtaining medications outside of VA [3]. Because of the prevalent concurrent use of care outside of VA, examining adherence to medication with only VA records may be incomplete and may erroneously categorize patients as low adherence. Second, the number of patients on dabigatran per facility is rather small and quite variable as well, with some sites that have very few number of patients. Although the investigators have excluded sites with fewer than 20 patients on dabigatran, the variability in the use of dabigatran may reflect site-specific factors, some of which may affect patient selection on the site level, that ultimately may affect outcome. Finally, the interview of pharmacist at each site may reflect the view of one to two pharmacists at each site, and thus may not truly reflect practices at the site throughout the period where patients were selected and outcomes defined.
Applications for Clinical Practice
Although it is tempting to conclude that instituting the pharmacist-based activities in patient selection and adverse event monitoring will lead to better adherence to dabigatran and thus improved patient outcomes, considering the limitations in the study a follow-up intervention study where sites are randomized to institute-specific practices for dabigatran use will be very important to demonstrate definitively the impact of these interventions. Also, as the use of dabigatran and other novel anticoagulants become more prevalent [4], a follow-up study to include a larger sample of patients may also be valuable to demonstrate if the conclusions are upheld.
—William Hung, MD, MPH
1. Connolly SJ, Ezekowitz MD, Yusuf S, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 2009: 361:1139–50.
2. Shore S, Carey EP, Turakhia MP, et al. Adherence to dabigatran therapy and longitudinal patient outcomes: insights from the veterans health administration. Am Heart J 2014;167:810–7.
3. Hynes DM, Koelling K, Stroupe K, et al. Veterans’ access to and use of Medicare and veterans affairs health care. Med Care 2007:45:214–23.
4. Boyle AM. VA, army clinicians rapidly increase prescribing of novel anticoagulants. US Med Feb 2014. Available at www.usmedicine.com.
1. Connolly SJ, Ezekowitz MD, Yusuf S, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 2009: 361:1139–50.
2. Shore S, Carey EP, Turakhia MP, et al. Adherence to dabigatran therapy and longitudinal patient outcomes: insights from the veterans health administration. Am Heart J 2014;167:810–7.
3. Hynes DM, Koelling K, Stroupe K, et al. Veterans’ access to and use of Medicare and veterans affairs health care. Med Care 2007:45:214–23.
4. Boyle AM. VA, army clinicians rapidly increase prescribing of novel anticoagulants. US Med Feb 2014. Available at www.usmedicine.com.
A Decision Aid Did Not Improve Patient Empowerment for Setting and Achieving Diabetes Treatment Goals
Study Overview
Objective. To determine if a patient-oriented decision aid for prioritizing treatment goals in diabetes leads to changes in patient empowerment for setting and achieving goals and in treatment.
Design. Randomized controlled trial.
Setting and participants. Study participants were recruited from 18 general practices in the north of the Netherlands between April 2011 and August 2012. Participants were included if they had a diagnosis of type 2 diabetes and were managed in primary care. Participants were identified from the electronic medical record system and at least 40 patients were selected from each practice to be contacted for participation. Subjects were excluded if they had myocardial infarction in the preceding year, experienced a stroke, had heart failure, angina, or a terminal illness, or were more than 65 years of age when they received their diabetes diagnosis. Other exclusion criteria include dementia, cognitive deficits, blindness, or an inability to read Dutch. Eligibility criteria were confirmed with the health care provider from each practice. Practices that were included in the study had several features: (1) each had an electronic medical record system supporting structured care protocols; (2) most practices have a nurse practitioner or specialized assistant for diabetes care who carries out the quarterly diabetes checks and is trained to conduct physical examinations, risk assessments, patient education, and counseling; (3) all practices received training in motivational interviewing.
The decision aid format was either a computer screen or printed version, and presented as either a short version, showing treatment effects on myocardial infarction risk only, or as an extended version, including effects on additional outcomes (stroke, amputation, blindness, renal failure). Practices were randomly assigned to use the computer screen or printed version, stratified by practice size (< 2500 patients or > 2500 patients) and number of GPs (solo or several). Within each practice, consenting patients were randomized to receive the short version aid, the extended version, or to the control group.
Intervention. The decision aid presents individually tailored information on risks and treatment options for multiple risk factors. The aid focuses on shared goal setting and decision making, particularly with respect to the drug treatment of risk factors including hemoglobin A1c, systolic blood pressure, low density lipoprotein cholesterol, and smoking. The decision aid is designed to be used by patients before a regular check-up and discussed with their health care provider during a visit to help prioritize treatment that will maximize outcomes; the aid helps to summarize effects of the various treatment options. The patients were asked to come to the practice 15 minutes in advance to go through the information, either in print or on the computer; health care providers were expected to support patients to think about treatment goals and options. Patients in the control received care as usual.
Main outcome measures. The primary outcome measure was the empowerment of patients for setting and achieving goals, which was measured with the Diabetes Empowerment Scale (DES-III). Other outcome measures included changes in treatment, including intensification of drug treatment and treatment with ACE inhibitors.
Main results. A total of 344 patients were included in the study and were randomized to the intervention (n = 225) or usual care group (n = 119). Patients in the intervention group were comparable to usual care patients in terms of age, sex, and educational level. However, there were several differences between the 2 groups: intervention patients were more likely to have well-controlled HbA1c level at baseline and less likely to have well-controlled blood pressure at baseline. Among participants in the intervention group, only 46% reported to have received the basic elements of the intervention. The mean empowerment score increased 0.1 point on a 5-point scale in the intervention group, which was not different from the control group (mean adjusted difference, 0.039 points [95% confidence interval {CI}], −0.056 to 0.134). Lipid lowering medication treatment was intensified in 25% of intervention and 12% of control participants (odds ratio [OR], 2.5 [95% CI, 0.89–7.23]). Explorative analyses comparing printed version of the aid with control did find that lipid lowering medication treatment was more intensified although the confidence interval was wide (OR, 3.90 [95% CI, 1.29–11.80]). No other differences in treatment plan were observed.
Conclusions. The treatment decision aid for diabetes did not improve patient empowerment or substantially alter treatment plan when compared to usual care. However, this finding is limited by the uptake of use of the decision aid during the study period.
Commentary
Patient engagement through shared decision making is an important element in chronic disease management, particularly in diseases such as diabetes where there are a number of significant tasks, including monitoring and administration of medication, that are key to its successful management. The use of decision aids is an innovation that has demonstrated effects in improving patient understanding of disease, and has potential downstream effect in improving management and control of the disease [1]. However, the use of decision aids is not without limitations—patients with poorer health literacy, and perhaps lower socioeconomic status, may derive less clinical benefit [2], and in older adults cognitive and physical limitations may also limit their use.
This study found that the decision aid used in the study did not significantly improve patient empowerment or alter treatment plan. In comparison with previous studies on decision aids for diabetes [3,4], this study is notable that it did not find any significant clinical impact of the decision aid when compared with usual care. However, it is important to consider reasons that may explain its null finding. First, the study has a rather complicated design, with 4 different intervention groups. The study design attempts to differentiate intervention groups with differences in its delivery (computer screen vs. printed) and content (focused information on myocardial infarction risk outcome only vs. all outcomes). The rationale was that it could provide evidence to perhaps suggest the most effective decision aid, but the drawback is that it has the potential to weaken the power of the study, increasing the likelihood of a false-negative finding. Second, in contrast to other studies, this study also uses a different measurement as its primary outcome—a measurement of patient empowerment. Though an important concept to measure, it is less clear what the expected impact and what the level of clinical significance would be. Third, as noted by the investigators, the decision aid had limited uptake in the intervention group; this may be related to its design and format. The challenge in design of a decision aid is that it needs to be simple and easy to use, consume little time, yet be adequately informative with helpful information for patients. Finally, another unique feature of the study is that the control group was an active control group, in that the providers in the practices had significant training in motivational interviewing and communication, which may have made it more challenging to demonstrate impact in intervention group.
Applications for Clinical Practice
Decision aids remain a potentially important addition for patients in the management of chronic diseases such as diabetes. Most studies have demonstrated significant impact. Despite the limitations of the current study, it does point out that different formats of decision aid may have different effects on patient outcomes. For practices that are adopting decision aids for chronic disease management, they need to take into account the format, the information, and the burden of use of the decision aid. Further studies may help to elucidate how decision aids can be optimized for maximizing clinical impact.
—William Hung, MD, MPH
1. Stacey D, Légaré F, Col NF, et al. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev 2014;1:CD001431.
2. Coylewright M, Branda M, Inselman JW, et al. Impact of sociodemographic patient characteristics on the efficacy of decision AIDS: a patient-level meta-analysis of 7 randomized trials. Circ Cardiovasc Qual Outcomes 2014;7:360–7.
3. Mathers N, Ng CJ, Campbell MJ, et al. Clinical effectiveness of a patient decision aid to improve decision quality and glycaemic control in people with diabetes making treatment choices: a cluster randomized controlled trial (PANDAs) in general practice. BMJ Open 2012;2:e001469.
4. Branda ME, LeBlanc A, Shah ND, et al. Shared decision making for patients with type 2 diabetes: a randomized trial in primary care. BMC Health Serv Res 2013;13:301.
Study Overview
Objective. To determine if a patient-oriented decision aid for prioritizing treatment goals in diabetes leads to changes in patient empowerment for setting and achieving goals and in treatment.
Design. Randomized controlled trial.
Setting and participants. Study participants were recruited from 18 general practices in the north of the Netherlands between April 2011 and August 2012. Participants were included if they had a diagnosis of type 2 diabetes and were managed in primary care. Participants were identified from the electronic medical record system and at least 40 patients were selected from each practice to be contacted for participation. Subjects were excluded if they had myocardial infarction in the preceding year, experienced a stroke, had heart failure, angina, or a terminal illness, or were more than 65 years of age when they received their diabetes diagnosis. Other exclusion criteria include dementia, cognitive deficits, blindness, or an inability to read Dutch. Eligibility criteria were confirmed with the health care provider from each practice. Practices that were included in the study had several features: (1) each had an electronic medical record system supporting structured care protocols; (2) most practices have a nurse practitioner or specialized assistant for diabetes care who carries out the quarterly diabetes checks and is trained to conduct physical examinations, risk assessments, patient education, and counseling; (3) all practices received training in motivational interviewing.
The decision aid format was either a computer screen or printed version, and presented as either a short version, showing treatment effects on myocardial infarction risk only, or as an extended version, including effects on additional outcomes (stroke, amputation, blindness, renal failure). Practices were randomly assigned to use the computer screen or printed version, stratified by practice size (< 2500 patients or > 2500 patients) and number of GPs (solo or several). Within each practice, consenting patients were randomized to receive the short version aid, the extended version, or to the control group.
Intervention. The decision aid presents individually tailored information on risks and treatment options for multiple risk factors. The aid focuses on shared goal setting and decision making, particularly with respect to the drug treatment of risk factors including hemoglobin A1c, systolic blood pressure, low density lipoprotein cholesterol, and smoking. The decision aid is designed to be used by patients before a regular check-up and discussed with their health care provider during a visit to help prioritize treatment that will maximize outcomes; the aid helps to summarize effects of the various treatment options. The patients were asked to come to the practice 15 minutes in advance to go through the information, either in print or on the computer; health care providers were expected to support patients to think about treatment goals and options. Patients in the control received care as usual.
Main outcome measures. The primary outcome measure was the empowerment of patients for setting and achieving goals, which was measured with the Diabetes Empowerment Scale (DES-III). Other outcome measures included changes in treatment, including intensification of drug treatment and treatment with ACE inhibitors.
Main results. A total of 344 patients were included in the study and were randomized to the intervention (n = 225) or usual care group (n = 119). Patients in the intervention group were comparable to usual care patients in terms of age, sex, and educational level. However, there were several differences between the 2 groups: intervention patients were more likely to have well-controlled HbA1c level at baseline and less likely to have well-controlled blood pressure at baseline. Among participants in the intervention group, only 46% reported to have received the basic elements of the intervention. The mean empowerment score increased 0.1 point on a 5-point scale in the intervention group, which was not different from the control group (mean adjusted difference, 0.039 points [95% confidence interval {CI}], −0.056 to 0.134). Lipid lowering medication treatment was intensified in 25% of intervention and 12% of control participants (odds ratio [OR], 2.5 [95% CI, 0.89–7.23]). Explorative analyses comparing printed version of the aid with control did find that lipid lowering medication treatment was more intensified although the confidence interval was wide (OR, 3.90 [95% CI, 1.29–11.80]). No other differences in treatment plan were observed.
Conclusions. The treatment decision aid for diabetes did not improve patient empowerment or substantially alter treatment plan when compared to usual care. However, this finding is limited by the uptake of use of the decision aid during the study period.
Commentary
Patient engagement through shared decision making is an important element in chronic disease management, particularly in diseases such as diabetes where there are a number of significant tasks, including monitoring and administration of medication, that are key to its successful management. The use of decision aids is an innovation that has demonstrated effects in improving patient understanding of disease, and has potential downstream effect in improving management and control of the disease [1]. However, the use of decision aids is not without limitations—patients with poorer health literacy, and perhaps lower socioeconomic status, may derive less clinical benefit [2], and in older adults cognitive and physical limitations may also limit their use.
This study found that the decision aid used in the study did not significantly improve patient empowerment or alter treatment plan. In comparison with previous studies on decision aids for diabetes [3,4], this study is notable that it did not find any significant clinical impact of the decision aid when compared with usual care. However, it is important to consider reasons that may explain its null finding. First, the study has a rather complicated design, with 4 different intervention groups. The study design attempts to differentiate intervention groups with differences in its delivery (computer screen vs. printed) and content (focused information on myocardial infarction risk outcome only vs. all outcomes). The rationale was that it could provide evidence to perhaps suggest the most effective decision aid, but the drawback is that it has the potential to weaken the power of the study, increasing the likelihood of a false-negative finding. Second, in contrast to other studies, this study also uses a different measurement as its primary outcome—a measurement of patient empowerment. Though an important concept to measure, it is less clear what the expected impact and what the level of clinical significance would be. Third, as noted by the investigators, the decision aid had limited uptake in the intervention group; this may be related to its design and format. The challenge in design of a decision aid is that it needs to be simple and easy to use, consume little time, yet be adequately informative with helpful information for patients. Finally, another unique feature of the study is that the control group was an active control group, in that the providers in the practices had significant training in motivational interviewing and communication, which may have made it more challenging to demonstrate impact in intervention group.
Applications for Clinical Practice
Decision aids remain a potentially important addition for patients in the management of chronic diseases such as diabetes. Most studies have demonstrated significant impact. Despite the limitations of the current study, it does point out that different formats of decision aid may have different effects on patient outcomes. For practices that are adopting decision aids for chronic disease management, they need to take into account the format, the information, and the burden of use of the decision aid. Further studies may help to elucidate how decision aids can be optimized for maximizing clinical impact.
—William Hung, MD, MPH
Study Overview
Objective. To determine if a patient-oriented decision aid for prioritizing treatment goals in diabetes leads to changes in patient empowerment for setting and achieving goals and in treatment.
Design. Randomized controlled trial.
Setting and participants. Study participants were recruited from 18 general practices in the north of the Netherlands between April 2011 and August 2012. Participants were included if they had a diagnosis of type 2 diabetes and were managed in primary care. Participants were identified from the electronic medical record system and at least 40 patients were selected from each practice to be contacted for participation. Subjects were excluded if they had myocardial infarction in the preceding year, experienced a stroke, had heart failure, angina, or a terminal illness, or were more than 65 years of age when they received their diabetes diagnosis. Other exclusion criteria include dementia, cognitive deficits, blindness, or an inability to read Dutch. Eligibility criteria were confirmed with the health care provider from each practice. Practices that were included in the study had several features: (1) each had an electronic medical record system supporting structured care protocols; (2) most practices have a nurse practitioner or specialized assistant for diabetes care who carries out the quarterly diabetes checks and is trained to conduct physical examinations, risk assessments, patient education, and counseling; (3) all practices received training in motivational interviewing.
The decision aid format was either a computer screen or printed version, and presented as either a short version, showing treatment effects on myocardial infarction risk only, or as an extended version, including effects on additional outcomes (stroke, amputation, blindness, renal failure). Practices were randomly assigned to use the computer screen or printed version, stratified by practice size (< 2500 patients or > 2500 patients) and number of GPs (solo or several). Within each practice, consenting patients were randomized to receive the short version aid, the extended version, or to the control group.
Intervention. The decision aid presents individually tailored information on risks and treatment options for multiple risk factors. The aid focuses on shared goal setting and decision making, particularly with respect to the drug treatment of risk factors including hemoglobin A1c, systolic blood pressure, low density lipoprotein cholesterol, and smoking. The decision aid is designed to be used by patients before a regular check-up and discussed with their health care provider during a visit to help prioritize treatment that will maximize outcomes; the aid helps to summarize effects of the various treatment options. The patients were asked to come to the practice 15 minutes in advance to go through the information, either in print or on the computer; health care providers were expected to support patients to think about treatment goals and options. Patients in the control received care as usual.
Main outcome measures. The primary outcome measure was the empowerment of patients for setting and achieving goals, which was measured with the Diabetes Empowerment Scale (DES-III). Other outcome measures included changes in treatment, including intensification of drug treatment and treatment with ACE inhibitors.
Main results. A total of 344 patients were included in the study and were randomized to the intervention (n = 225) or usual care group (n = 119). Patients in the intervention group were comparable to usual care patients in terms of age, sex, and educational level. However, there were several differences between the 2 groups: intervention patients were more likely to have well-controlled HbA1c level at baseline and less likely to have well-controlled blood pressure at baseline. Among participants in the intervention group, only 46% reported to have received the basic elements of the intervention. The mean empowerment score increased 0.1 point on a 5-point scale in the intervention group, which was not different from the control group (mean adjusted difference, 0.039 points [95% confidence interval {CI}], −0.056 to 0.134). Lipid lowering medication treatment was intensified in 25% of intervention and 12% of control participants (odds ratio [OR], 2.5 [95% CI, 0.89–7.23]). Explorative analyses comparing printed version of the aid with control did find that lipid lowering medication treatment was more intensified although the confidence interval was wide (OR, 3.90 [95% CI, 1.29–11.80]). No other differences in treatment plan were observed.
Conclusions. The treatment decision aid for diabetes did not improve patient empowerment or substantially alter treatment plan when compared to usual care. However, this finding is limited by the uptake of use of the decision aid during the study period.
Commentary
Patient engagement through shared decision making is an important element in chronic disease management, particularly in diseases such as diabetes where there are a number of significant tasks, including monitoring and administration of medication, that are key to its successful management. The use of decision aids is an innovation that has demonstrated effects in improving patient understanding of disease, and has potential downstream effect in improving management and control of the disease [1]. However, the use of decision aids is not without limitations—patients with poorer health literacy, and perhaps lower socioeconomic status, may derive less clinical benefit [2], and in older adults cognitive and physical limitations may also limit their use.
This study found that the decision aid used in the study did not significantly improve patient empowerment or alter treatment plan. In comparison with previous studies on decision aids for diabetes [3,4], this study is notable that it did not find any significant clinical impact of the decision aid when compared with usual care. However, it is important to consider reasons that may explain its null finding. First, the study has a rather complicated design, with 4 different intervention groups. The study design attempts to differentiate intervention groups with differences in its delivery (computer screen vs. printed) and content (focused information on myocardial infarction risk outcome only vs. all outcomes). The rationale was that it could provide evidence to perhaps suggest the most effective decision aid, but the drawback is that it has the potential to weaken the power of the study, increasing the likelihood of a false-negative finding. Second, in contrast to other studies, this study also uses a different measurement as its primary outcome—a measurement of patient empowerment. Though an important concept to measure, it is less clear what the expected impact and what the level of clinical significance would be. Third, as noted by the investigators, the decision aid had limited uptake in the intervention group; this may be related to its design and format. The challenge in design of a decision aid is that it needs to be simple and easy to use, consume little time, yet be adequately informative with helpful information for patients. Finally, another unique feature of the study is that the control group was an active control group, in that the providers in the practices had significant training in motivational interviewing and communication, which may have made it more challenging to demonstrate impact in intervention group.
Applications for Clinical Practice
Decision aids remain a potentially important addition for patients in the management of chronic diseases such as diabetes. Most studies have demonstrated significant impact. Despite the limitations of the current study, it does point out that different formats of decision aid may have different effects on patient outcomes. For practices that are adopting decision aids for chronic disease management, they need to take into account the format, the information, and the burden of use of the decision aid. Further studies may help to elucidate how decision aids can be optimized for maximizing clinical impact.
—William Hung, MD, MPH
1. Stacey D, Légaré F, Col NF, et al. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev 2014;1:CD001431.
2. Coylewright M, Branda M, Inselman JW, et al. Impact of sociodemographic patient characteristics on the efficacy of decision AIDS: a patient-level meta-analysis of 7 randomized trials. Circ Cardiovasc Qual Outcomes 2014;7:360–7.
3. Mathers N, Ng CJ, Campbell MJ, et al. Clinical effectiveness of a patient decision aid to improve decision quality and glycaemic control in people with diabetes making treatment choices: a cluster randomized controlled trial (PANDAs) in general practice. BMJ Open 2012;2:e001469.
4. Branda ME, LeBlanc A, Shah ND, et al. Shared decision making for patients with type 2 diabetes: a randomized trial in primary care. BMC Health Serv Res 2013;13:301.
1. Stacey D, Légaré F, Col NF, et al. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev 2014;1:CD001431.
2. Coylewright M, Branda M, Inselman JW, et al. Impact of sociodemographic patient characteristics on the efficacy of decision AIDS: a patient-level meta-analysis of 7 randomized trials. Circ Cardiovasc Qual Outcomes 2014;7:360–7.
3. Mathers N, Ng CJ, Campbell MJ, et al. Clinical effectiveness of a patient decision aid to improve decision quality and glycaemic control in people with diabetes making treatment choices: a cluster randomized controlled trial (PANDAs) in general practice. BMJ Open 2012;2:e001469.
4. Branda ME, LeBlanc A, Shah ND, et al. Shared decision making for patients with type 2 diabetes: a randomized trial in primary care. BMC Health Serv Res 2013;13:301.
Self-Monitoring and Self-Titration of Antihypertensive Medications Result in Better Systolic Blood Pressure Control
Study Overview
Objective. To examine the effect of self-monitoring of blood pressure and self-titration of antihypertensive medications among hypertensive patients with cardiovascular disease, diabetes, or chronic kidney disease.
Design. Unblinded randomized controlled trial.
Setting and participants. The study was conducted in central and east England. Patients with poorly controlled blood pressure with a last recorded systolic blood pressure of at least 145 mm Hg at 59 UK primary care practices were invited to participate. Patients had to be at least 35 years old and have at least 1 of the following comorbidities: transient ischemic attack or stroke, stage 3 chronic kidney disease, or history of coronary artery bypass graft surgery, myocardial infarction, or angina. Patients were excluded if they could not self-monitor blood pressure, had dementia or failed a cognitive screen using the short-orientation memory concentration test, had postural hypotension, took more than 3 antihypertensive medications, had an acute cardiovascular event within the previous 3 months, were receiving care from a specialist for their hypertension, were pregnant, or had a terminal disease. Participants were randomized to the self-management intervention or usual care.
Intervention. Patients in the self-management group were asked to monitor their blood pressure using an automated blood pressure monitor and to titrate their blood pressure medications using an individualized 3-step plan devised by the patient with their family physician. They were trained to do these tasks in 2- or 3-hour sessions. Patients were instructed to take their blood pressure twice each morning for the first week of each month; if 4 or more blood pressure readings during the measurement week for 2 consecutive months were higher than the target blood pressure, patients were to follow their individualized plan to change their medications. The target blood pressure was 120/75 mm Hg, following British guidelines for patients with stroke, diabetes, chronic kidney disease, or coronary heart disease. If patients exhausted all 3 steps for medication titration, they were to return to their family physician for additional instructions. Patients in the usual care group had a routine blood pressure check and medication review appointment with their family physician, which was followed by follow-up care at the discretion of the family physician for blood pressure measurement, blood pressure targets, or adjustment of medication.
Main outcome measure. The primary outcome was systolic blood pressure at 12 months. The difference in outcomes between the intervention and usual care groups was examined while accounting for baseline blood pressure and other clinical factors. 6 blood pressures were taken at 1-minute intervals after an initial 5 minutes of rest. Blood pressure was taken by an electronic automated blood pressure machine. The mean of the second and third readings were used as primary outcome. Outcome assessor was not blinded to group assignment. The primary analysis included all cases with complete data, and a sensitivity analysis with multiple imputations was also performed. Preplanned subgroup analyses included older vs. younger age-groups, men vs. women, and other risk groups.
Main results. Among 10,764 patients assessed for eligibility, 3353 were excluded as they were considered by their family physician to be housebound, have a terminal illness, or not be a suitable candidate. Among the 7411 invited to participate, 4207 did not respond to the invitation and 2003 declined participation (with a third who did not want to alter their own medications, and a third who did not want to measure their own blood pressure). Among the 1201 who attended the baseline clinic, 138 withdrew their consent and 508 were deemed ineligible. A total of 555 were randomized, and 220 in the intervention group and 230 in the control group completed the study and provided outcome data (81%). Patients in the self-management group had a 9.2 mm Hg–lower systolic blood pressure at 12 months (95% CI, 5.7–12.7) compared with the usual care group. The self-management group also had a larger increase in the intake of antihypertensive drugs compared with controls, with an increase in both doses and number of medications. Although adverse symptoms were common in both groups, there were no significant differences in adverse symptoms between groups.
Conclusions. Self-management of hypertension among patients with stroke, cardiovascular disease, and other high-risk conditions is safe and effective in achieving better blood pressure control.
Commentary
Hypertension is a major public health problem. Significant resources have been devoted to advance hypertension management through research, practice improvements, and guideline developments; however, blood pressure control among those with hypertension in the United States remains suboptimal—with only about half achieving adequate control [1].
Advances in technology have made home blood pressure monitoring possible. It offers several advantages to traditional office-based blood pressure management [2], and several studies have shown home blood pressure telemonitoring and team care can achieve better outcomes than office-based management [3]. A significant contribution of the current study is that it demonstrated that the self-management approach is both safe and effective even in high-risk patients, who are perhaps the most likely to have adverse events from treatment but also the most likely to derive benefit from adequate treatment of hypertension.
Although the self-management approach has promise, it also has potential drawbacks. Specifically, as demonstrated by the low enrollment rate in this study, this intervention may not be suitable for all patients. About two-thirds of those who responded to the initial enrollment attempt ultimately declined participation because they did not want to modify their own medications or did not want to perform the tasks of home blood pressure monitoring. This perhaps is a realistic assessment of who may ultimately benefit from this approach—patients who wish to have an active role in managing their medical problems and have the ability to do so. For the clinician, it is important to identify patients who are able to manage the complex task of adjusting their medication regimen; otherwise, the potential for harm may be magnified.
Engaging patients in the management of their chronic disease is a growing trend in chronic disease management. Bringing management of hypertension to patients’ homes, as the accompanying editorial in the issue pointed out, reflects patient-centeredness at its best and represents an important step toward the adaptation of treatment for patients who want to actively take part in their own care [2].
Applications for Clinical Practice
Self-management of blood pressure in patients at high risk of cardiovascular disease appears feasible. As the editorialists note, this study is an important step toward adaptation of treatment for patients who want to actively take part in their own risk-factor control [2]. More research is needed to study the effects of self-titration on long-term outcomes and to identify the appropriate protocols that can be applied by clinicians in the community, both for patient selection and education and medication adjustment.
—William Hung, MD, MPH
1. Egan BM, Zhao Y, Axon RN. US trends in prevalence, awareness, treatment, and control of hypertension, 1988-2008. JAMA 2010;303:2043–50.
2. Nilsson PM, Nystrom FH. Self-titration of antihypertensive therapy in high-risk patients. Bringing it home. JAMA 2014;312:795–6.
3. Margolis KL, Asche SE, Bergdall AR, et al. Effect of home blood pressure telemonitoring and pharmacist management on blood pressure control. a cluster randomized clinical trial. JAMA 2013;310:46–56.
Study Overview
Objective. To examine the effect of self-monitoring of blood pressure and self-titration of antihypertensive medications among hypertensive patients with cardiovascular disease, diabetes, or chronic kidney disease.
Design. Unblinded randomized controlled trial.
Setting and participants. The study was conducted in central and east England. Patients with poorly controlled blood pressure with a last recorded systolic blood pressure of at least 145 mm Hg at 59 UK primary care practices were invited to participate. Patients had to be at least 35 years old and have at least 1 of the following comorbidities: transient ischemic attack or stroke, stage 3 chronic kidney disease, or history of coronary artery bypass graft surgery, myocardial infarction, or angina. Patients were excluded if they could not self-monitor blood pressure, had dementia or failed a cognitive screen using the short-orientation memory concentration test, had postural hypotension, took more than 3 antihypertensive medications, had an acute cardiovascular event within the previous 3 months, were receiving care from a specialist for their hypertension, were pregnant, or had a terminal disease. Participants were randomized to the self-management intervention or usual care.
Intervention. Patients in the self-management group were asked to monitor their blood pressure using an automated blood pressure monitor and to titrate their blood pressure medications using an individualized 3-step plan devised by the patient with their family physician. They were trained to do these tasks in 2- or 3-hour sessions. Patients were instructed to take their blood pressure twice each morning for the first week of each month; if 4 or more blood pressure readings during the measurement week for 2 consecutive months were higher than the target blood pressure, patients were to follow their individualized plan to change their medications. The target blood pressure was 120/75 mm Hg, following British guidelines for patients with stroke, diabetes, chronic kidney disease, or coronary heart disease. If patients exhausted all 3 steps for medication titration, they were to return to their family physician for additional instructions. Patients in the usual care group had a routine blood pressure check and medication review appointment with their family physician, which was followed by follow-up care at the discretion of the family physician for blood pressure measurement, blood pressure targets, or adjustment of medication.
Main outcome measure. The primary outcome was systolic blood pressure at 12 months. The difference in outcomes between the intervention and usual care groups was examined while accounting for baseline blood pressure and other clinical factors. 6 blood pressures were taken at 1-minute intervals after an initial 5 minutes of rest. Blood pressure was taken by an electronic automated blood pressure machine. The mean of the second and third readings were used as primary outcome. Outcome assessor was not blinded to group assignment. The primary analysis included all cases with complete data, and a sensitivity analysis with multiple imputations was also performed. Preplanned subgroup analyses included older vs. younger age-groups, men vs. women, and other risk groups.
Main results. Among 10,764 patients assessed for eligibility, 3353 were excluded as they were considered by their family physician to be housebound, have a terminal illness, or not be a suitable candidate. Among the 7411 invited to participate, 4207 did not respond to the invitation and 2003 declined participation (with a third who did not want to alter their own medications, and a third who did not want to measure their own blood pressure). Among the 1201 who attended the baseline clinic, 138 withdrew their consent and 508 were deemed ineligible. A total of 555 were randomized, and 220 in the intervention group and 230 in the control group completed the study and provided outcome data (81%). Patients in the self-management group had a 9.2 mm Hg–lower systolic blood pressure at 12 months (95% CI, 5.7–12.7) compared with the usual care group. The self-management group also had a larger increase in the intake of antihypertensive drugs compared with controls, with an increase in both doses and number of medications. Although adverse symptoms were common in both groups, there were no significant differences in adverse symptoms between groups.
Conclusions. Self-management of hypertension among patients with stroke, cardiovascular disease, and other high-risk conditions is safe and effective in achieving better blood pressure control.
Commentary
Hypertension is a major public health problem. Significant resources have been devoted to advance hypertension management through research, practice improvements, and guideline developments; however, blood pressure control among those with hypertension in the United States remains suboptimal—with only about half achieving adequate control [1].
Advances in technology have made home blood pressure monitoring possible. It offers several advantages to traditional office-based blood pressure management [2], and several studies have shown home blood pressure telemonitoring and team care can achieve better outcomes than office-based management [3]. A significant contribution of the current study is that it demonstrated that the self-management approach is both safe and effective even in high-risk patients, who are perhaps the most likely to have adverse events from treatment but also the most likely to derive benefit from adequate treatment of hypertension.
Although the self-management approach has promise, it also has potential drawbacks. Specifically, as demonstrated by the low enrollment rate in this study, this intervention may not be suitable for all patients. About two-thirds of those who responded to the initial enrollment attempt ultimately declined participation because they did not want to modify their own medications or did not want to perform the tasks of home blood pressure monitoring. This perhaps is a realistic assessment of who may ultimately benefit from this approach—patients who wish to have an active role in managing their medical problems and have the ability to do so. For the clinician, it is important to identify patients who are able to manage the complex task of adjusting their medication regimen; otherwise, the potential for harm may be magnified.
Engaging patients in the management of their chronic disease is a growing trend in chronic disease management. Bringing management of hypertension to patients’ homes, as the accompanying editorial in the issue pointed out, reflects patient-centeredness at its best and represents an important step toward the adaptation of treatment for patients who want to actively take part in their own care [2].
Applications for Clinical Practice
Self-management of blood pressure in patients at high risk of cardiovascular disease appears feasible. As the editorialists note, this study is an important step toward adaptation of treatment for patients who want to actively take part in their own risk-factor control [2]. More research is needed to study the effects of self-titration on long-term outcomes and to identify the appropriate protocols that can be applied by clinicians in the community, both for patient selection and education and medication adjustment.
—William Hung, MD, MPH
Study Overview
Objective. To examine the effect of self-monitoring of blood pressure and self-titration of antihypertensive medications among hypertensive patients with cardiovascular disease, diabetes, or chronic kidney disease.
Design. Unblinded randomized controlled trial.
Setting and participants. The study was conducted in central and east England. Patients with poorly controlled blood pressure with a last recorded systolic blood pressure of at least 145 mm Hg at 59 UK primary care practices were invited to participate. Patients had to be at least 35 years old and have at least 1 of the following comorbidities: transient ischemic attack or stroke, stage 3 chronic kidney disease, or history of coronary artery bypass graft surgery, myocardial infarction, or angina. Patients were excluded if they could not self-monitor blood pressure, had dementia or failed a cognitive screen using the short-orientation memory concentration test, had postural hypotension, took more than 3 antihypertensive medications, had an acute cardiovascular event within the previous 3 months, were receiving care from a specialist for their hypertension, were pregnant, or had a terminal disease. Participants were randomized to the self-management intervention or usual care.
Intervention. Patients in the self-management group were asked to monitor their blood pressure using an automated blood pressure monitor and to titrate their blood pressure medications using an individualized 3-step plan devised by the patient with their family physician. They were trained to do these tasks in 2- or 3-hour sessions. Patients were instructed to take their blood pressure twice each morning for the first week of each month; if 4 or more blood pressure readings during the measurement week for 2 consecutive months were higher than the target blood pressure, patients were to follow their individualized plan to change their medications. The target blood pressure was 120/75 mm Hg, following British guidelines for patients with stroke, diabetes, chronic kidney disease, or coronary heart disease. If patients exhausted all 3 steps for medication titration, they were to return to their family physician for additional instructions. Patients in the usual care group had a routine blood pressure check and medication review appointment with their family physician, which was followed by follow-up care at the discretion of the family physician for blood pressure measurement, blood pressure targets, or adjustment of medication.
Main outcome measure. The primary outcome was systolic blood pressure at 12 months. The difference in outcomes between the intervention and usual care groups was examined while accounting for baseline blood pressure and other clinical factors. 6 blood pressures were taken at 1-minute intervals after an initial 5 minutes of rest. Blood pressure was taken by an electronic automated blood pressure machine. The mean of the second and third readings were used as primary outcome. Outcome assessor was not blinded to group assignment. The primary analysis included all cases with complete data, and a sensitivity analysis with multiple imputations was also performed. Preplanned subgroup analyses included older vs. younger age-groups, men vs. women, and other risk groups.
Main results. Among 10,764 patients assessed for eligibility, 3353 were excluded as they were considered by their family physician to be housebound, have a terminal illness, or not be a suitable candidate. Among the 7411 invited to participate, 4207 did not respond to the invitation and 2003 declined participation (with a third who did not want to alter their own medications, and a third who did not want to measure their own blood pressure). Among the 1201 who attended the baseline clinic, 138 withdrew their consent and 508 were deemed ineligible. A total of 555 were randomized, and 220 in the intervention group and 230 in the control group completed the study and provided outcome data (81%). Patients in the self-management group had a 9.2 mm Hg–lower systolic blood pressure at 12 months (95% CI, 5.7–12.7) compared with the usual care group. The self-management group also had a larger increase in the intake of antihypertensive drugs compared with controls, with an increase in both doses and number of medications. Although adverse symptoms were common in both groups, there were no significant differences in adverse symptoms between groups.
Conclusions. Self-management of hypertension among patients with stroke, cardiovascular disease, and other high-risk conditions is safe and effective in achieving better blood pressure control.
Commentary
Hypertension is a major public health problem. Significant resources have been devoted to advance hypertension management through research, practice improvements, and guideline developments; however, blood pressure control among those with hypertension in the United States remains suboptimal—with only about half achieving adequate control [1].
Advances in technology have made home blood pressure monitoring possible. It offers several advantages to traditional office-based blood pressure management [2], and several studies have shown home blood pressure telemonitoring and team care can achieve better outcomes than office-based management [3]. A significant contribution of the current study is that it demonstrated that the self-management approach is both safe and effective even in high-risk patients, who are perhaps the most likely to have adverse events from treatment but also the most likely to derive benefit from adequate treatment of hypertension.
Although the self-management approach has promise, it also has potential drawbacks. Specifically, as demonstrated by the low enrollment rate in this study, this intervention may not be suitable for all patients. About two-thirds of those who responded to the initial enrollment attempt ultimately declined participation because they did not want to modify their own medications or did not want to perform the tasks of home blood pressure monitoring. This perhaps is a realistic assessment of who may ultimately benefit from this approach—patients who wish to have an active role in managing their medical problems and have the ability to do so. For the clinician, it is important to identify patients who are able to manage the complex task of adjusting their medication regimen; otherwise, the potential for harm may be magnified.
Engaging patients in the management of their chronic disease is a growing trend in chronic disease management. Bringing management of hypertension to patients’ homes, as the accompanying editorial in the issue pointed out, reflects patient-centeredness at its best and represents an important step toward the adaptation of treatment for patients who want to actively take part in their own care [2].
Applications for Clinical Practice
Self-management of blood pressure in patients at high risk of cardiovascular disease appears feasible. As the editorialists note, this study is an important step toward adaptation of treatment for patients who want to actively take part in their own risk-factor control [2]. More research is needed to study the effects of self-titration on long-term outcomes and to identify the appropriate protocols that can be applied by clinicians in the community, both for patient selection and education and medication adjustment.
—William Hung, MD, MPH
1. Egan BM, Zhao Y, Axon RN. US trends in prevalence, awareness, treatment, and control of hypertension, 1988-2008. JAMA 2010;303:2043–50.
2. Nilsson PM, Nystrom FH. Self-titration of antihypertensive therapy in high-risk patients. Bringing it home. JAMA 2014;312:795–6.
3. Margolis KL, Asche SE, Bergdall AR, et al. Effect of home blood pressure telemonitoring and pharmacist management on blood pressure control. a cluster randomized clinical trial. JAMA 2013;310:46–56.
1. Egan BM, Zhao Y, Axon RN. US trends in prevalence, awareness, treatment, and control of hypertension, 1988-2008. JAMA 2010;303:2043–50.
2. Nilsson PM, Nystrom FH. Self-titration of antihypertensive therapy in high-risk patients. Bringing it home. JAMA 2014;312:795–6.
3. Margolis KL, Asche SE, Bergdall AR, et al. Effect of home blood pressure telemonitoring and pharmacist management on blood pressure control. a cluster randomized clinical trial. JAMA 2013;310:46–56.
Light Intensity Physical Activity May Reduce Risk of Disability Among Adults with or At Risk For Knee Osteoarthritis
Study Overview
Objective. To determine if time spent in light intensity physical activity is related to incident disability and disability progression.
Design. Prospective cohort study.
Setting and participants. This study uses a subcohort from the Osteoarthritis Initiative, a longitudinal study that enrolled 4796 men and women aged 45 to 79 years with or at high risk of developing knee osteoarthritis. Inclusion criteria for the main cohort study were: (1) presence of osteoarthritis with symptoms in at least 1 knee (with a definite tibiofemoral osteophyte) and pain, aching, or stiffness on most days for at least 1 month during the previous 12 months; or (2) presence of at least 1 from a set of established risk factors for knee osteoarthritis: knee symptoms in the previous 12 months; overweight; knee injury causing difficulty walking for at least a week; history of knee surgery; family history of a total knee replacement for osteoarthritis; Heberden’s nodes; repetitive knee bending at work or outside work; and age 70–79 years. The subcohort of the current study draws from the 2127 participants that enrolled in the substudy with accelerometer monitoring, included those without disability at study onset; exclusion criteria include insufficient baseline accelerometer monitoring, incomplete outcome or covariate data, decedents and those lost to follow up. A total of 1680 were included in the main analysis, and an additional 134 participants (for a total of 1814) with baseline mild or moderate disability were included in a secondary analysis. between September 2008 to December 2012 at 4 sites (Baltimore, Pittsburgh, Columbus, Ohio, and Pawtucket, Rhode Island)
Main outcome measure. Disability at the 2-year follow-up visit among those without disability at baseline. Disability was ascertained by using a set of questions asking if participants have any difficulty performing each basic or instrumental activity of daily living because of a health or memory problem. Basic activities include walking across a room, dressing, bathing, eating, using the toilet and bed transfer. Instrumental activities of daily living include preparing hot meals, grocery shopping, making telephone calls, taking drugs, and managing money. Disability levels were defined as none, mild (only instrumental activities limitations), moderate (1–2 basic activities limitations), and severe (more than 2 basic activities limitations).
Statistical analysis. Main predictor variable was physical activity monitored using accelerometers measured at baseline. Participants wear the accelerometer for 7 consecutive days on a belt from arising in the morning until retiring, except during water activities. Participants also recorded on a daily log the time spent in water and cycling. Intensity thresholds were applied on a minute by minute basis to identify non-sedentary activity of light intensity and moderate to vigorous intensity. The primary variable was the accelerometer assessment of physical activity measured as daily minutes spent in light or moderate-vigorous activity. The time spent was divided in quartiles; the quartile cut-points for light activity were 229, 277, and 331 minutes, and the cut-points for moderate-vigorous activity were 4.3, 12.2, and 28.2 average minutes per day. Other covariates were socioeconomic factors including race and ethnicity, age, sex education and income, health factors including chronic conditions by self report, body mass index, knee-specific health factors and symptoms, smoking, and gait speed. The main analysis of the relationship between baseline physical activity and the development of disability was done using survival analysis techniques and hazard ratios. Secondary analysis using the larger cohort evaluated hazard ratios for disability progression as defined by progression to a more severe level among the 1814 participants.
Main results. In the main analysis, with 1680 participants without disability at baseline, 149 participants had new disability over the 2 years of follow-up. Average age of the cohort was 65 years, the majority (85%) were white, and approximately 54% were female. The cohort averaged 302 minutes a day of non-sedentary activity, the majority of which was light-intensity activities (284 minutes). Older age was associated with lower physical activity (P < 0.001), as was male sex (P < 0.001), higher body mass index, a number of chronic medical conditions (cancer, cerebrovascular disease, congestive heart failure), lower extremity pain, and higher grade of knee osteoarthritis severity. Onset of disability was associated with daily light-intensity activity times, even after adjusting for covariates. Using the group with the lowest quartile of light intensity activity time as reference, groups with higher quartiles of activity level had lower hazard ratios for onset of disability—hazard ratios were 0.64, 0.51, and 0.67 for the second, third, and highest quartile, respectively. Using daily moderate to vigorous activity time–defined quartile, longer duration of moderate-vigorous activity time was associated with delayed onset of disability. In the secondary analysis using the cohort with and without disability at baseline (n = 1814), similar results were found. Participants who spent more time in light intensity activity were associated with less incident disability.
Conclusion. Greater daily time spent in light intensity physical activity was associated with lower risk of onset and progression of disability among adults with knee osteoarthritis and those with risk factors for knee osteoarthritis.
Commentary
Disability, such as the inability to dress, bathe, or manage one’s medications, is prevalent among older adults in the United States [1,2]. The development of such disability among older adults is often complex and multifactorial. One significant contributor is osteoarthritis of the knee [3]. Although prior observational and randomized controlled trials have established that moderate to vigorous physical activity reduces disability incidence and progression [4,5], less is known about light intensity physical activity—activities that may be more realistically introduced for adults with symptomatic knee arthritis.
The current prospective cohort study included adults with and at risk for knee osteoarthritis; the authors found that physical activity, even if it is of light intensity, is associated with lower risk of disability onset and progression. A major strength of the study is the objective measurements of physical activity using an accelerometer rather than relying on recall or diaries, which are more subject to bias. Another strength is the long follow-up period, which allowed for the examination of incident disability or disability progression over 2 years. The results confirm that even light intensity activity is associated with reduced risk of incident disability.
It is important to note that causation cannot be inferred in this study. As the authors stated, those who can do longer periods of physical activity may be at lower risk of developing incident disability because of factors other than the physical activity itself. A different study design, such as a randomized trial, is needed to demonstrate that light intensity physical activity, when introduced to adults with or at risk for knee arthritis, may lead to reduced risk of disability.
Applications for Clinical Practice
Prior studies suggest that introducing regular exercise have significant health benefits. The recommendation for exercise for adults with knee arthritis remains the same. Whether introducing light intensity activity, particularly for those who are unable to perform more vigorous exercises, yields similar benefits will need further studies that are designed to determine therapeutic effect.
—William Hung, MD, MPH
1. Manton KG, Gu XL, Lamb VL. Change in chronic disability from 1982 to 2004/2005 as measured by long-term changes in function and health in the U.S. elderly population. PNAS 2006;103:18374–9.
2. Hung WW, Ross JS, Boockvar KS, Siu AL. Recent trends in chronic disease, impairment and disability among older adults in the United States. BMC Geriatrics 2011;11:47.
3. Ettinger, WH, Davis MA, Neuhaus JM, Mallon KP. Long-term physical functioning in persons with knee osteoarthritis from NHANES I: Effects of comorbid medical conditions. J Clin Epidemiol 1994;47:809–15.
4. Penninx BW, Messier SP, Rejesko WJ, et al. Physical exercise and the prevention of disability in activities of daily living in older persons with osteoarthritis. Arch Intern Med 2001;161:2309–16.
5. Ettinger WH, Burns R, Messier SP, et al. A randomized trial comparing aerobic exercise and resistance exercise with a health education program in older adults with knee osteoarthritis. The Fitness Arthritis and Seniors Trial (FAST). JAMA 1997;277:25–31.
Study Overview
Objective. To determine if time spent in light intensity physical activity is related to incident disability and disability progression.
Design. Prospective cohort study.
Setting and participants. This study uses a subcohort from the Osteoarthritis Initiative, a longitudinal study that enrolled 4796 men and women aged 45 to 79 years with or at high risk of developing knee osteoarthritis. Inclusion criteria for the main cohort study were: (1) presence of osteoarthritis with symptoms in at least 1 knee (with a definite tibiofemoral osteophyte) and pain, aching, or stiffness on most days for at least 1 month during the previous 12 months; or (2) presence of at least 1 from a set of established risk factors for knee osteoarthritis: knee symptoms in the previous 12 months; overweight; knee injury causing difficulty walking for at least a week; history of knee surgery; family history of a total knee replacement for osteoarthritis; Heberden’s nodes; repetitive knee bending at work or outside work; and age 70–79 years. The subcohort of the current study draws from the 2127 participants that enrolled in the substudy with accelerometer monitoring, included those without disability at study onset; exclusion criteria include insufficient baseline accelerometer monitoring, incomplete outcome or covariate data, decedents and those lost to follow up. A total of 1680 were included in the main analysis, and an additional 134 participants (for a total of 1814) with baseline mild or moderate disability were included in a secondary analysis. between September 2008 to December 2012 at 4 sites (Baltimore, Pittsburgh, Columbus, Ohio, and Pawtucket, Rhode Island)
Main outcome measure. Disability at the 2-year follow-up visit among those without disability at baseline. Disability was ascertained by using a set of questions asking if participants have any difficulty performing each basic or instrumental activity of daily living because of a health or memory problem. Basic activities include walking across a room, dressing, bathing, eating, using the toilet and bed transfer. Instrumental activities of daily living include preparing hot meals, grocery shopping, making telephone calls, taking drugs, and managing money. Disability levels were defined as none, mild (only instrumental activities limitations), moderate (1–2 basic activities limitations), and severe (more than 2 basic activities limitations).
Statistical analysis. Main predictor variable was physical activity monitored using accelerometers measured at baseline. Participants wear the accelerometer for 7 consecutive days on a belt from arising in the morning until retiring, except during water activities. Participants also recorded on a daily log the time spent in water and cycling. Intensity thresholds were applied on a minute by minute basis to identify non-sedentary activity of light intensity and moderate to vigorous intensity. The primary variable was the accelerometer assessment of physical activity measured as daily minutes spent in light or moderate-vigorous activity. The time spent was divided in quartiles; the quartile cut-points for light activity were 229, 277, and 331 minutes, and the cut-points for moderate-vigorous activity were 4.3, 12.2, and 28.2 average minutes per day. Other covariates were socioeconomic factors including race and ethnicity, age, sex education and income, health factors including chronic conditions by self report, body mass index, knee-specific health factors and symptoms, smoking, and gait speed. The main analysis of the relationship between baseline physical activity and the development of disability was done using survival analysis techniques and hazard ratios. Secondary analysis using the larger cohort evaluated hazard ratios for disability progression as defined by progression to a more severe level among the 1814 participants.
Main results. In the main analysis, with 1680 participants without disability at baseline, 149 participants had new disability over the 2 years of follow-up. Average age of the cohort was 65 years, the majority (85%) were white, and approximately 54% were female. The cohort averaged 302 minutes a day of non-sedentary activity, the majority of which was light-intensity activities (284 minutes). Older age was associated with lower physical activity (P < 0.001), as was male sex (P < 0.001), higher body mass index, a number of chronic medical conditions (cancer, cerebrovascular disease, congestive heart failure), lower extremity pain, and higher grade of knee osteoarthritis severity. Onset of disability was associated with daily light-intensity activity times, even after adjusting for covariates. Using the group with the lowest quartile of light intensity activity time as reference, groups with higher quartiles of activity level had lower hazard ratios for onset of disability—hazard ratios were 0.64, 0.51, and 0.67 for the second, third, and highest quartile, respectively. Using daily moderate to vigorous activity time–defined quartile, longer duration of moderate-vigorous activity time was associated with delayed onset of disability. In the secondary analysis using the cohort with and without disability at baseline (n = 1814), similar results were found. Participants who spent more time in light intensity activity were associated with less incident disability.
Conclusion. Greater daily time spent in light intensity physical activity was associated with lower risk of onset and progression of disability among adults with knee osteoarthritis and those with risk factors for knee osteoarthritis.
Commentary
Disability, such as the inability to dress, bathe, or manage one’s medications, is prevalent among older adults in the United States [1,2]. The development of such disability among older adults is often complex and multifactorial. One significant contributor is osteoarthritis of the knee [3]. Although prior observational and randomized controlled trials have established that moderate to vigorous physical activity reduces disability incidence and progression [4,5], less is known about light intensity physical activity—activities that may be more realistically introduced for adults with symptomatic knee arthritis.
The current prospective cohort study included adults with and at risk for knee osteoarthritis; the authors found that physical activity, even if it is of light intensity, is associated with lower risk of disability onset and progression. A major strength of the study is the objective measurements of physical activity using an accelerometer rather than relying on recall or diaries, which are more subject to bias. Another strength is the long follow-up period, which allowed for the examination of incident disability or disability progression over 2 years. The results confirm that even light intensity activity is associated with reduced risk of incident disability.
It is important to note that causation cannot be inferred in this study. As the authors stated, those who can do longer periods of physical activity may be at lower risk of developing incident disability because of factors other than the physical activity itself. A different study design, such as a randomized trial, is needed to demonstrate that light intensity physical activity, when introduced to adults with or at risk for knee arthritis, may lead to reduced risk of disability.
Applications for Clinical Practice
Prior studies suggest that introducing regular exercise have significant health benefits. The recommendation for exercise for adults with knee arthritis remains the same. Whether introducing light intensity activity, particularly for those who are unable to perform more vigorous exercises, yields similar benefits will need further studies that are designed to determine therapeutic effect.
—William Hung, MD, MPH
Study Overview
Objective. To determine if time spent in light intensity physical activity is related to incident disability and disability progression.
Design. Prospective cohort study.
Setting and participants. This study uses a subcohort from the Osteoarthritis Initiative, a longitudinal study that enrolled 4796 men and women aged 45 to 79 years with or at high risk of developing knee osteoarthritis. Inclusion criteria for the main cohort study were: (1) presence of osteoarthritis with symptoms in at least 1 knee (with a definite tibiofemoral osteophyte) and pain, aching, or stiffness on most days for at least 1 month during the previous 12 months; or (2) presence of at least 1 from a set of established risk factors for knee osteoarthritis: knee symptoms in the previous 12 months; overweight; knee injury causing difficulty walking for at least a week; history of knee surgery; family history of a total knee replacement for osteoarthritis; Heberden’s nodes; repetitive knee bending at work or outside work; and age 70–79 years. The subcohort of the current study draws from the 2127 participants that enrolled in the substudy with accelerometer monitoring, included those without disability at study onset; exclusion criteria include insufficient baseline accelerometer monitoring, incomplete outcome or covariate data, decedents and those lost to follow up. A total of 1680 were included in the main analysis, and an additional 134 participants (for a total of 1814) with baseline mild or moderate disability were included in a secondary analysis. between September 2008 to December 2012 at 4 sites (Baltimore, Pittsburgh, Columbus, Ohio, and Pawtucket, Rhode Island)
Main outcome measure. Disability at the 2-year follow-up visit among those without disability at baseline. Disability was ascertained by using a set of questions asking if participants have any difficulty performing each basic or instrumental activity of daily living because of a health or memory problem. Basic activities include walking across a room, dressing, bathing, eating, using the toilet and bed transfer. Instrumental activities of daily living include preparing hot meals, grocery shopping, making telephone calls, taking drugs, and managing money. Disability levels were defined as none, mild (only instrumental activities limitations), moderate (1–2 basic activities limitations), and severe (more than 2 basic activities limitations).
Statistical analysis. Main predictor variable was physical activity monitored using accelerometers measured at baseline. Participants wear the accelerometer for 7 consecutive days on a belt from arising in the morning until retiring, except during water activities. Participants also recorded on a daily log the time spent in water and cycling. Intensity thresholds were applied on a minute by minute basis to identify non-sedentary activity of light intensity and moderate to vigorous intensity. The primary variable was the accelerometer assessment of physical activity measured as daily minutes spent in light or moderate-vigorous activity. The time spent was divided in quartiles; the quartile cut-points for light activity were 229, 277, and 331 minutes, and the cut-points for moderate-vigorous activity were 4.3, 12.2, and 28.2 average minutes per day. Other covariates were socioeconomic factors including race and ethnicity, age, sex education and income, health factors including chronic conditions by self report, body mass index, knee-specific health factors and symptoms, smoking, and gait speed. The main analysis of the relationship between baseline physical activity and the development of disability was done using survival analysis techniques and hazard ratios. Secondary analysis using the larger cohort evaluated hazard ratios for disability progression as defined by progression to a more severe level among the 1814 participants.
Main results. In the main analysis, with 1680 participants without disability at baseline, 149 participants had new disability over the 2 years of follow-up. Average age of the cohort was 65 years, the majority (85%) were white, and approximately 54% were female. The cohort averaged 302 minutes a day of non-sedentary activity, the majority of which was light-intensity activities (284 minutes). Older age was associated with lower physical activity (P < 0.001), as was male sex (P < 0.001), higher body mass index, a number of chronic medical conditions (cancer, cerebrovascular disease, congestive heart failure), lower extremity pain, and higher grade of knee osteoarthritis severity. Onset of disability was associated with daily light-intensity activity times, even after adjusting for covariates. Using the group with the lowest quartile of light intensity activity time as reference, groups with higher quartiles of activity level had lower hazard ratios for onset of disability—hazard ratios were 0.64, 0.51, and 0.67 for the second, third, and highest quartile, respectively. Using daily moderate to vigorous activity time–defined quartile, longer duration of moderate-vigorous activity time was associated with delayed onset of disability. In the secondary analysis using the cohort with and without disability at baseline (n = 1814), similar results were found. Participants who spent more time in light intensity activity were associated with less incident disability.
Conclusion. Greater daily time spent in light intensity physical activity was associated with lower risk of onset and progression of disability among adults with knee osteoarthritis and those with risk factors for knee osteoarthritis.
Commentary
Disability, such as the inability to dress, bathe, or manage one’s medications, is prevalent among older adults in the United States [1,2]. The development of such disability among older adults is often complex and multifactorial. One significant contributor is osteoarthritis of the knee [3]. Although prior observational and randomized controlled trials have established that moderate to vigorous physical activity reduces disability incidence and progression [4,5], less is known about light intensity physical activity—activities that may be more realistically introduced for adults with symptomatic knee arthritis.
The current prospective cohort study included adults with and at risk for knee osteoarthritis; the authors found that physical activity, even if it is of light intensity, is associated with lower risk of disability onset and progression. A major strength of the study is the objective measurements of physical activity using an accelerometer rather than relying on recall or diaries, which are more subject to bias. Another strength is the long follow-up period, which allowed for the examination of incident disability or disability progression over 2 years. The results confirm that even light intensity activity is associated with reduced risk of incident disability.
It is important to note that causation cannot be inferred in this study. As the authors stated, those who can do longer periods of physical activity may be at lower risk of developing incident disability because of factors other than the physical activity itself. A different study design, such as a randomized trial, is needed to demonstrate that light intensity physical activity, when introduced to adults with or at risk for knee arthritis, may lead to reduced risk of disability.
Applications for Clinical Practice
Prior studies suggest that introducing regular exercise have significant health benefits. The recommendation for exercise for adults with knee arthritis remains the same. Whether introducing light intensity activity, particularly for those who are unable to perform more vigorous exercises, yields similar benefits will need further studies that are designed to determine therapeutic effect.
—William Hung, MD, MPH
1. Manton KG, Gu XL, Lamb VL. Change in chronic disability from 1982 to 2004/2005 as measured by long-term changes in function and health in the U.S. elderly population. PNAS 2006;103:18374–9.
2. Hung WW, Ross JS, Boockvar KS, Siu AL. Recent trends in chronic disease, impairment and disability among older adults in the United States. BMC Geriatrics 2011;11:47.
3. Ettinger, WH, Davis MA, Neuhaus JM, Mallon KP. Long-term physical functioning in persons with knee osteoarthritis from NHANES I: Effects of comorbid medical conditions. J Clin Epidemiol 1994;47:809–15.
4. Penninx BW, Messier SP, Rejesko WJ, et al. Physical exercise and the prevention of disability in activities of daily living in older persons with osteoarthritis. Arch Intern Med 2001;161:2309–16.
5. Ettinger WH, Burns R, Messier SP, et al. A randomized trial comparing aerobic exercise and resistance exercise with a health education program in older adults with knee osteoarthritis. The Fitness Arthritis and Seniors Trial (FAST). JAMA 1997;277:25–31.
1. Manton KG, Gu XL, Lamb VL. Change in chronic disability from 1982 to 2004/2005 as measured by long-term changes in function and health in the U.S. elderly population. PNAS 2006;103:18374–9.
2. Hung WW, Ross JS, Boockvar KS, Siu AL. Recent trends in chronic disease, impairment and disability among older adults in the United States. BMC Geriatrics 2011;11:47.
3. Ettinger, WH, Davis MA, Neuhaus JM, Mallon KP. Long-term physical functioning in persons with knee osteoarthritis from NHANES I: Effects of comorbid medical conditions. J Clin Epidemiol 1994;47:809–15.
4. Penninx BW, Messier SP, Rejesko WJ, et al. Physical exercise and the prevention of disability in activities of daily living in older persons with osteoarthritis. Arch Intern Med 2001;161:2309–16.
5. Ettinger WH, Burns R, Messier SP, et al. A randomized trial comparing aerobic exercise and resistance exercise with a health education program in older adults with knee osteoarthritis. The Fitness Arthritis and Seniors Trial (FAST). JAMA 1997;277:25–31.
Declining Adverse Event Rates Among Patients With Cardiac Conditions But Not With Pneumonia or Surgical Conditions
Study Overview
Objective. To examine changes in adverse event rates among Medicare patients with common medical conditions and conditions requiring surgery hospitalized in acute care hospitals.
Design. Retrospective review utilizing the Medicare Patient Safety Monitoring System (MPSMS) [1], a large database of information abstracted from medical records of a random sample of hospitalized patients in the United States. The database was established in by the Centers for Medicare and Medicaid Services in 2001 to track adverse events in hospitals among Medicare patients, with data collected from every year thereafter except for 2008. The MPSMS tracks 21 indicators of safety that can be reliably abstracted from medical records. Among these are inpatients falls, hospital-acquired pressure ulcers, catheter-associated urinary tract infections, selected hospital-acquired infections, selected adverse events related to high-risk medications, operative events and postoperative events for certain conditions.
Setting and participants. Medicare patients aged 65 and older who had been hospitalized for acute myocardial infarction, congestive heart failure, pneumonia, or conditions requiring surgery from 2005 to 2007 and 2009 to 2011. A total of 61,523 patients were included in the final study sample—11,399 with acute myocardial infarction, 15,374 with congestive heart failure, 18,269 with pneumonia, and 16,481 with conditions requiring surgery from a total of 4372 hospitals.
Main outcome measures. The rate of occurrence of adverse events for which patients were at risk, the proportion of patients with 1 or more adverse events, and the number of adverse events per 1000 hospitalizations.
Statistical analysis. Outcome rates were described and reported in 2-year intervals: 2005–2006, 2007–2009, and 2010–2011. Trends in the number of adverse events per 1000 hospitalizations were modeled using a linear mixed-effects model with Poisson link function. Other composite outcomes were also modeled using linear mixed models for trend analysis.
Main results. Adverse event rates among patients with myocardial infarction and congestive heart failure declined significantly. Among patients with myocardial infarction, rate of adverse event among patients at risk for events declined from 5% to 3.7% (rate difference 1.3%; 95% confidence interval [CI], 0.7 to 1.9) and among patients with congestive heart failure, the rate declined from 3.7% to 2.7% (rate difference 1%; 95% CI, 0.5 to 1.4). Proportion of patients with 1 or more adverse events declined by 6.6% (95% CI, 3.3 to 10.2) among patients with myocardial infarction, and 3.3% (95% CI, 1.0 to 5.5) among patients with congestive heart failure. Number of adverse events per 1000 hospitalizations also declined by 139.7 among patients with myocardial infarction and by 68.3 among patients with congestive heart failure. On the other hand, among patients admitted for pneumonia or for conditions requiring surgery, adverse events rates remained the same. Rate of adverse events among patients admitted for pneumonia remained the same at 3.4% in 2005–2006 and 3.5% in 2010–2011; and for patients admitted for conditions requiring surgery, rate of adverse events remained the same at 3.2% in 2005–2006 and 3.3% in 2010–2011. Similarly, proportion of patients with 1 or more events in the hospital also remained the same in patients with pneumonia (a proportion of 17.1% in 2005–2006 and 17.5% in 2010–11) and conditions requiring surgery (a proportion of 21.6% in 2005–2006 and 22.7% in 2010–2011). Number of events per 1000 hospitalizations also did not change over time. When accounting for patient characteristics and geographic differences in the models, the results also did not substantially change.
Conclusions. In a large nationally representative sample of older adults aged 65 and above, adverse event rates declined among patients admitted for cardiac conditions, including myocardial infarction and congestive heart failure, but did not decline among patients admitted for other medical (pneumonia) or surgical conditions.
Commentary
Patient safety in inpatient hospital care is of paramount importance, and the Affordable Care Act has placed significant emphasis on improving patient safety by aligning incentives and disincentives with patient outcomes on the hospital level [2,3].These measures, including adverse event rates, are reported publicly in reports such as Hospital Compare [3–5].The current study reports on the recent national trends in safety and adverse events using data abstracted from medical records among older Medicare patients with 4 common conditions. The demonstration of the trends in adverse events represent an important first step towards understanding the current environment and trends in patient safety. The finding that in-hospital adverse event rates have improved in patients admitted for cardiac conditions is reassuring given that there were substantial nationwide efforts in promoting patient safety in hospitals, but the lack of progress in other conditions both medical and surgical is rather disappointing.
There is good quality evidence suggesting how hospitals may make changes to improve patient safety; these steps may include adopting care practices and protocols such as pressure ulcer monitoring and prevention protocols, fall prevention protocols, safety checklists, models for older adults inpatient care such as Mobile Acute Care of Elderly teams [6] and Acute Care for the Elderly models [7], quality improvement initiatives, and incorporation of information systems for data tracking and reporting, to name a few. How hospitals adopt different practices for the care of patients with different conditions may explain the study findings. The challenge is to figure out why noncardiac conditions do not have improving trends in patient safety and to demonstrate what works (and what doesn’t) on the hospital level. Understanding how care is delivered on the hospital level and correlating hospital level practices with patient outcomes from databases such as MPSMS may yield clues as to what specific steps hospitals have taken that have yielded changes in patient safety.
Applications for Clinical Practice
This study highlights trends in adverse events among hospitalized older adults that demonstrated improvements for patients with cardiac conditions but not for others. Future studies need to focus on understanding what works and what doesn’t so that hospitals can adopt safety practices that improve outcomes for older hospitalized patients.
—William Hung, MD, MPH
1. Hunt DR, Verzier N, Abend SL, et al. Fundamentals of Medicare patient safety surveillance: intent, relevance and transparency. Rockville, MD: Agency for Healthcare Research and Quality. Available at archive.ahrq.gov/qual/nhqr05/fullreport/Mpsms.htm.
2. Rosenbaum S. The Patient Protection and Affordable Care Act: implications for public health policy and practice. Public Health Rep 2011;126:130–5.
3. Werner RM, Bradlow ET. Relationship between Medicare’s hospital compare performance measures and mortality rates. JAMA 2006;296:2694–702.
4. Werner RM, Bradlow ET. Public reporting on hospital process improvements is linked to better patient outcomes. Health Aff (Millwood) 2010;29:1319–24.
5. Kruse GB, Polsky D, Stuart EA, Werner RM. The impact of hospital pay-for-performance on hospital and Medicare costs. Health Serv Res 2012;47:2118–36.
6. Hung WW, Ross JS, Farber J, Siu AL. Evaluation of the Mobile Acute Care of the Elderly (MACE) service. JAMA Intern Med 2013:1–7.
7. Landefeld CS, Palmer RM, Kresevic DM, Fortinsky RH, Kowal J. A randomized trial of care in a hospital medical unit especially designed to improve the functional outcomes of acutely ill older patients. N Engl J Med 1995;332:1338–44
Study Overview
Objective. To examine changes in adverse event rates among Medicare patients with common medical conditions and conditions requiring surgery hospitalized in acute care hospitals.
Design. Retrospective review utilizing the Medicare Patient Safety Monitoring System (MPSMS) [1], a large database of information abstracted from medical records of a random sample of hospitalized patients in the United States. The database was established in by the Centers for Medicare and Medicaid Services in 2001 to track adverse events in hospitals among Medicare patients, with data collected from every year thereafter except for 2008. The MPSMS tracks 21 indicators of safety that can be reliably abstracted from medical records. Among these are inpatients falls, hospital-acquired pressure ulcers, catheter-associated urinary tract infections, selected hospital-acquired infections, selected adverse events related to high-risk medications, operative events and postoperative events for certain conditions.
Setting and participants. Medicare patients aged 65 and older who had been hospitalized for acute myocardial infarction, congestive heart failure, pneumonia, or conditions requiring surgery from 2005 to 2007 and 2009 to 2011. A total of 61,523 patients were included in the final study sample—11,399 with acute myocardial infarction, 15,374 with congestive heart failure, 18,269 with pneumonia, and 16,481 with conditions requiring surgery from a total of 4372 hospitals.
Main outcome measures. The rate of occurrence of adverse events for which patients were at risk, the proportion of patients with 1 or more adverse events, and the number of adverse events per 1000 hospitalizations.
Statistical analysis. Outcome rates were described and reported in 2-year intervals: 2005–2006, 2007–2009, and 2010–2011. Trends in the number of adverse events per 1000 hospitalizations were modeled using a linear mixed-effects model with Poisson link function. Other composite outcomes were also modeled using linear mixed models for trend analysis.
Main results. Adverse event rates among patients with myocardial infarction and congestive heart failure declined significantly. Among patients with myocardial infarction, rate of adverse event among patients at risk for events declined from 5% to 3.7% (rate difference 1.3%; 95% confidence interval [CI], 0.7 to 1.9) and among patients with congestive heart failure, the rate declined from 3.7% to 2.7% (rate difference 1%; 95% CI, 0.5 to 1.4). Proportion of patients with 1 or more adverse events declined by 6.6% (95% CI, 3.3 to 10.2) among patients with myocardial infarction, and 3.3% (95% CI, 1.0 to 5.5) among patients with congestive heart failure. Number of adverse events per 1000 hospitalizations also declined by 139.7 among patients with myocardial infarction and by 68.3 among patients with congestive heart failure. On the other hand, among patients admitted for pneumonia or for conditions requiring surgery, adverse events rates remained the same. Rate of adverse events among patients admitted for pneumonia remained the same at 3.4% in 2005–2006 and 3.5% in 2010–2011; and for patients admitted for conditions requiring surgery, rate of adverse events remained the same at 3.2% in 2005–2006 and 3.3% in 2010–2011. Similarly, proportion of patients with 1 or more events in the hospital also remained the same in patients with pneumonia (a proportion of 17.1% in 2005–2006 and 17.5% in 2010–11) and conditions requiring surgery (a proportion of 21.6% in 2005–2006 and 22.7% in 2010–2011). Number of events per 1000 hospitalizations also did not change over time. When accounting for patient characteristics and geographic differences in the models, the results also did not substantially change.
Conclusions. In a large nationally representative sample of older adults aged 65 and above, adverse event rates declined among patients admitted for cardiac conditions, including myocardial infarction and congestive heart failure, but did not decline among patients admitted for other medical (pneumonia) or surgical conditions.
Commentary
Patient safety in inpatient hospital care is of paramount importance, and the Affordable Care Act has placed significant emphasis on improving patient safety by aligning incentives and disincentives with patient outcomes on the hospital level [2,3].These measures, including adverse event rates, are reported publicly in reports such as Hospital Compare [3–5].The current study reports on the recent national trends in safety and adverse events using data abstracted from medical records among older Medicare patients with 4 common conditions. The demonstration of the trends in adverse events represent an important first step towards understanding the current environment and trends in patient safety. The finding that in-hospital adverse event rates have improved in patients admitted for cardiac conditions is reassuring given that there were substantial nationwide efforts in promoting patient safety in hospitals, but the lack of progress in other conditions both medical and surgical is rather disappointing.
There is good quality evidence suggesting how hospitals may make changes to improve patient safety; these steps may include adopting care practices and protocols such as pressure ulcer monitoring and prevention protocols, fall prevention protocols, safety checklists, models for older adults inpatient care such as Mobile Acute Care of Elderly teams [6] and Acute Care for the Elderly models [7], quality improvement initiatives, and incorporation of information systems for data tracking and reporting, to name a few. How hospitals adopt different practices for the care of patients with different conditions may explain the study findings. The challenge is to figure out why noncardiac conditions do not have improving trends in patient safety and to demonstrate what works (and what doesn’t) on the hospital level. Understanding how care is delivered on the hospital level and correlating hospital level practices with patient outcomes from databases such as MPSMS may yield clues as to what specific steps hospitals have taken that have yielded changes in patient safety.
Applications for Clinical Practice
This study highlights trends in adverse events among hospitalized older adults that demonstrated improvements for patients with cardiac conditions but not for others. Future studies need to focus on understanding what works and what doesn’t so that hospitals can adopt safety practices that improve outcomes for older hospitalized patients.
—William Hung, MD, MPH
Study Overview
Objective. To examine changes in adverse event rates among Medicare patients with common medical conditions and conditions requiring surgery hospitalized in acute care hospitals.
Design. Retrospective review utilizing the Medicare Patient Safety Monitoring System (MPSMS) [1], a large database of information abstracted from medical records of a random sample of hospitalized patients in the United States. The database was established in by the Centers for Medicare and Medicaid Services in 2001 to track adverse events in hospitals among Medicare patients, with data collected from every year thereafter except for 2008. The MPSMS tracks 21 indicators of safety that can be reliably abstracted from medical records. Among these are inpatients falls, hospital-acquired pressure ulcers, catheter-associated urinary tract infections, selected hospital-acquired infections, selected adverse events related to high-risk medications, operative events and postoperative events for certain conditions.
Setting and participants. Medicare patients aged 65 and older who had been hospitalized for acute myocardial infarction, congestive heart failure, pneumonia, or conditions requiring surgery from 2005 to 2007 and 2009 to 2011. A total of 61,523 patients were included in the final study sample—11,399 with acute myocardial infarction, 15,374 with congestive heart failure, 18,269 with pneumonia, and 16,481 with conditions requiring surgery from a total of 4372 hospitals.
Main outcome measures. The rate of occurrence of adverse events for which patients were at risk, the proportion of patients with 1 or more adverse events, and the number of adverse events per 1000 hospitalizations.
Statistical analysis. Outcome rates were described and reported in 2-year intervals: 2005–2006, 2007–2009, and 2010–2011. Trends in the number of adverse events per 1000 hospitalizations were modeled using a linear mixed-effects model with Poisson link function. Other composite outcomes were also modeled using linear mixed models for trend analysis.
Main results. Adverse event rates among patients with myocardial infarction and congestive heart failure declined significantly. Among patients with myocardial infarction, rate of adverse event among patients at risk for events declined from 5% to 3.7% (rate difference 1.3%; 95% confidence interval [CI], 0.7 to 1.9) and among patients with congestive heart failure, the rate declined from 3.7% to 2.7% (rate difference 1%; 95% CI, 0.5 to 1.4). Proportion of patients with 1 or more adverse events declined by 6.6% (95% CI, 3.3 to 10.2) among patients with myocardial infarction, and 3.3% (95% CI, 1.0 to 5.5) among patients with congestive heart failure. Number of adverse events per 1000 hospitalizations also declined by 139.7 among patients with myocardial infarction and by 68.3 among patients with congestive heart failure. On the other hand, among patients admitted for pneumonia or for conditions requiring surgery, adverse events rates remained the same. Rate of adverse events among patients admitted for pneumonia remained the same at 3.4% in 2005–2006 and 3.5% in 2010–2011; and for patients admitted for conditions requiring surgery, rate of adverse events remained the same at 3.2% in 2005–2006 and 3.3% in 2010–2011. Similarly, proportion of patients with 1 or more events in the hospital also remained the same in patients with pneumonia (a proportion of 17.1% in 2005–2006 and 17.5% in 2010–11) and conditions requiring surgery (a proportion of 21.6% in 2005–2006 and 22.7% in 2010–2011). Number of events per 1000 hospitalizations also did not change over time. When accounting for patient characteristics and geographic differences in the models, the results also did not substantially change.
Conclusions. In a large nationally representative sample of older adults aged 65 and above, adverse event rates declined among patients admitted for cardiac conditions, including myocardial infarction and congestive heart failure, but did not decline among patients admitted for other medical (pneumonia) or surgical conditions.
Commentary
Patient safety in inpatient hospital care is of paramount importance, and the Affordable Care Act has placed significant emphasis on improving patient safety by aligning incentives and disincentives with patient outcomes on the hospital level [2,3].These measures, including adverse event rates, are reported publicly in reports such as Hospital Compare [3–5].The current study reports on the recent national trends in safety and adverse events using data abstracted from medical records among older Medicare patients with 4 common conditions. The demonstration of the trends in adverse events represent an important first step towards understanding the current environment and trends in patient safety. The finding that in-hospital adverse event rates have improved in patients admitted for cardiac conditions is reassuring given that there were substantial nationwide efforts in promoting patient safety in hospitals, but the lack of progress in other conditions both medical and surgical is rather disappointing.
There is good quality evidence suggesting how hospitals may make changes to improve patient safety; these steps may include adopting care practices and protocols such as pressure ulcer monitoring and prevention protocols, fall prevention protocols, safety checklists, models for older adults inpatient care such as Mobile Acute Care of Elderly teams [6] and Acute Care for the Elderly models [7], quality improvement initiatives, and incorporation of information systems for data tracking and reporting, to name a few. How hospitals adopt different practices for the care of patients with different conditions may explain the study findings. The challenge is to figure out why noncardiac conditions do not have improving trends in patient safety and to demonstrate what works (and what doesn’t) on the hospital level. Understanding how care is delivered on the hospital level and correlating hospital level practices with patient outcomes from databases such as MPSMS may yield clues as to what specific steps hospitals have taken that have yielded changes in patient safety.
Applications for Clinical Practice
This study highlights trends in adverse events among hospitalized older adults that demonstrated improvements for patients with cardiac conditions but not for others. Future studies need to focus on understanding what works and what doesn’t so that hospitals can adopt safety practices that improve outcomes for older hospitalized patients.
—William Hung, MD, MPH
1. Hunt DR, Verzier N, Abend SL, et al. Fundamentals of Medicare patient safety surveillance: intent, relevance and transparency. Rockville, MD: Agency for Healthcare Research and Quality. Available at archive.ahrq.gov/qual/nhqr05/fullreport/Mpsms.htm.
2. Rosenbaum S. The Patient Protection and Affordable Care Act: implications for public health policy and practice. Public Health Rep 2011;126:130–5.
3. Werner RM, Bradlow ET. Relationship between Medicare’s hospital compare performance measures and mortality rates. JAMA 2006;296:2694–702.
4. Werner RM, Bradlow ET. Public reporting on hospital process improvements is linked to better patient outcomes. Health Aff (Millwood) 2010;29:1319–24.
5. Kruse GB, Polsky D, Stuart EA, Werner RM. The impact of hospital pay-for-performance on hospital and Medicare costs. Health Serv Res 2012;47:2118–36.
6. Hung WW, Ross JS, Farber J, Siu AL. Evaluation of the Mobile Acute Care of the Elderly (MACE) service. JAMA Intern Med 2013:1–7.
7. Landefeld CS, Palmer RM, Kresevic DM, Fortinsky RH, Kowal J. A randomized trial of care in a hospital medical unit especially designed to improve the functional outcomes of acutely ill older patients. N Engl J Med 1995;332:1338–44
1. Hunt DR, Verzier N, Abend SL, et al. Fundamentals of Medicare patient safety surveillance: intent, relevance and transparency. Rockville, MD: Agency for Healthcare Research and Quality. Available at archive.ahrq.gov/qual/nhqr05/fullreport/Mpsms.htm.
2. Rosenbaum S. The Patient Protection and Affordable Care Act: implications for public health policy and practice. Public Health Rep 2011;126:130–5.
3. Werner RM, Bradlow ET. Relationship between Medicare’s hospital compare performance measures and mortality rates. JAMA 2006;296:2694–702.
4. Werner RM, Bradlow ET. Public reporting on hospital process improvements is linked to better patient outcomes. Health Aff (Millwood) 2010;29:1319–24.
5. Kruse GB, Polsky D, Stuart EA, Werner RM. The impact of hospital pay-for-performance on hospital and Medicare costs. Health Serv Res 2012;47:2118–36.
6. Hung WW, Ross JS, Farber J, Siu AL. Evaluation of the Mobile Acute Care of the Elderly (MACE) service. JAMA Intern Med 2013:1–7.
7. Landefeld CS, Palmer RM, Kresevic DM, Fortinsky RH, Kowal J. A randomized trial of care in a hospital medical unit especially designed to improve the functional outcomes of acutely ill older patients. N Engl J Med 1995;332:1338–44