Efficacy of Trivalent Seasonal Influenza Vaccination in Reducing Mortality and Hospitalization in Chinese Nursing Home Older Adults

Objective

To examine the clinical efficacy of the trivalent seasonal influenza vaccination among Chinese older adults residing in a nursing home.

Design

A 12-month prospective cohort study. Participants were divided into 2 groups based on their own choice on vaccination of trivalent seasonal influenza vaccine: vaccinated group and unvaccinated group.

Setting

Fifty-eight nursing homes in Hong Kong.

Participants

A total of 1859 older adults residing in a nursing home.

Measurements

All-cause mortality, pneumonia-related mortality, all-cause hospitalization, and pneumonia-related hospitalization.

Results

A total of 1859 older adults residing in a nursing home were included: 1214 (65.3%) in the vaccinated group and 645 (34.7%) in the unvaccinated group. At 12 months of study, for all-cause mortality, 14.6% (177 of 1214) of the vaccinated group and 20.2% (130 of 645) of the unvaccinated group had died (P < .001). Multivariate analysis showed the hazard ratio for the vaccinated group was 0.72 (95% confidence interval [CI]: 0.54–0.95; P < .01). For pneumonia-related mortality, 9.4% (114 of 1214) of the vaccinated group and 12.7% (82 of 645) of the unvaccinated group died (P = .033). Multivariate analysis showed the hazard ratio for the vaccinated group was 0.80 (CI: 0.62–0.98; P < .05). The median number of all-cause hospitalizations per 1000 person-months was 55 (0–111) for the vaccinated group and 55 (0–167) for the unvaccinated group (P < .01). The median number of pneumonia-related hospitalizations per 1000 person-months was 0 (0–55) for the vaccinated group and 0 (0–111) for the unvaccinated group (P < .01).

Conclusions

Vaccination of trivalent seasonal influenza vaccine in Chinese nursing home older adults significantly reduced all-cause and pneumonia-related mortality and hospitalization.     

Effectiveness of Influenza Vaccination in Institutionalized Older Adults: A Systematic Review

IntroductionInfluenza infection is common among institutionalized older adults. Many nonrandomized observational studies on influenza vaccination suggested that it could reduce influenza-related hospitalizations and mortality in institutionalized older adults. Criticism regarding the effectiveness of influenza vaccine estimated by nonrandomized observational studies include the frailty selection bias and use of nonspecific outcome, such as all-cause mortality.MethodsWe conducted a systematic review of studies of influenza vaccination in institutionalized older adults to determine the effects on clinical outcomes. We searched for studies from 3 databases from 1946 to June 2013 assessing effectiveness against influenza infection. We selected studies with good comparability between vaccine group and control group. We expressed vaccine effectiveness (VE) as a proportion, using the formula VE = 1–relative risk or 1–odds ratio. We focused on the following outcomes: influenza-like illness (ILI), laboratory confirmed influenza, hospitalizations due to ILI, or pneumonia and death due to influenza or pneumonia. We did not include all-cause mortality.ResultsEleven studies that satisfied the inclusion criteria were identified, representing 11,262 institutionalized older adults. After meta-analysis, we found a significant reduction in pneumonia (VE: 37%, 95% confidence interval [CI]: 18%–53%, P = .001) and death due to pneumonia or influenza (VE: 34%, CI: 10%–53%, P = .01). There was no significant heterogeneity between studies. There was no significant publication bias.ConclusionInfluenza vaccination in institutionalized older adults could reduce pneumonia and death due to pneumonia or influenza. Influenza vaccination is recommended for institutionalized older adults.     

The Impact of Influenza Vaccination on Hospitalizations and Mortality Among Frail Older People

ObjectivesThe objective of this study was to evaluate the benefits of influenza vaccination against hospitalization and mortality on frail elderly people.DesignThe design was a population-based retrospective cohort study.SettingTaiwan's National Health Insurance claims data.ParticipantsParticipants were 5063 frail seniors, followed up for four years.MeasurementsMeasurements included age, gender, socioeconomic status, living areas, use of annual health examinations, comorbid conditions, use of influenza vaccine, frailty as defined by the Adjusted Clinical Group, hospitalization, and mortality in the observation period. The efficacy was presented as comparing ever versus never vaccinated people during the entire study period without regard to seasons.ResultsCompared with those without influenza vaccination, vaccinated elderly individuals were younger, more likely to be men, have higher socioeconomic status, live in rural areas, have a higher rate of receiving a health examination, and have similar medical conditions. In the Cox proportional hazards analysis, influenza vaccination reduced by 7% the risk of hospitalization (95% confidence interval [CI] 0.86–0.99) and by 44% the risk of mortality (95% CI 0.51–0.62).ConclusionInfluenza vaccination was effective against hospitalization and mortality among the frail elderly. These results uphold the current universal influenza vaccination policy, and encourage policymakers to adopt strategies to improve vaccination use.     

Feasibility and Clinical Efficacy of a Multidisciplinary Home-Telehealth Program to Prevent Falls in Older Adults: A Randomized Controlled Trial

Objectives

The aim of this study was to determine the feasibility and efficacy of a 6-month tele-rehabilitation home-based program, designed to prevent falls in older adults with 1 or more chronic diseases (cardiac, respiratory, neuromuscular or neurologic) returning home after in-hospital rehabilitation for their chronic condition. Patients were eligible for selection if they had experienced a fall during the previous year or were at high risk of falling.

Effects of a Multicomponent Frailty Prevention Program in Prefrail Community-Dwelling Older Persons: A Randomized Controlled Trial

ObjectiveTo examine the effects of a multicomponent frailty prevention program in community-dwelling older persons with prefrailty.DesignA randomized controlled trial.SettingA community elderly center in Hong Kong.ParticipantsPersons aged ≥50 years who scored 1-2 on a simple frailty questionnaire (FRAIL)MethodsParticipants (n = 127) were randomly assigned to a 12-week multicomponent frailty prevention program (exercise, cognitive training, board game activities) or to a wait-list control group. The primary outcomes were FRAIL scores, frailty status, and a combined frailty measure including subjective (FRAIL total score) and objective (grip strength, muscle endurance, balance, gait speed) measures. The secondary outcomes were verbal fluency assessed by dual-task gait speed, attention and memory assessed by digit span task, executive function assessed by the Frontal Assessment Battery, self-rated health, and life satisfaction. Assessments were conducted at baseline and at week 12.ResultsThe mean age of the participants was 62.2 years, and 88.2% were women. At week 12, the FRAIL score had decreased in the intervention group (−1.3, P < .001) but had increased in the control group (0.3, P < .01) (between-group differences P < .001). In addition, 83.3% and 1.6% of the intervention and control groups, respectively, had reversed from prefrailty to robust phenotype (between-group differences P < .001). Participants in the intervention group also had a greater reduction in the combined frailty score and greater improvements in muscle endurance, balance, verbal fluency, attention and memory, executive function, and self-rated health than those in the control group (all P < .05). There were no significant differences between the groups with respect to grip strength, gait speed, and life satisfaction.Conclusions and implicationsThe multicomponent frailty prevention program reduced frailty and improved physical and cognitive functions, and self-rated health in community-dwelling older persons with prefrailty. Findings can provide insights into the consideration of incorporating frailty prevention programs into the routine practice of community elderly services.     

Post Hoc Analyses of a Randomized Controlled Trial for the Effect of Pharmacist Deprescribing Intervention on the Anticholinergic Burden in Frail Community-Dwelling Older Adults

ObjectivesAnticholinergic burden is detrimental to cognitive health. Multiple studies found that a high anticholinergic burden is associated with an increased risk for dementia, changes to the brain structure, function, and cognitive decline. We performed a post hoc analysis of a randomized controlled deprescribing trial. We compared the effect of the intervention on baseline anticholinergic burden across the treatment and control groups and the time of recruitment before and after a lockdown due to the COVID pandemic with subgroup analyses by baseline frailty index.DesignRandomized controlled trial.Settings and ParticipantsWe analyzed data from a de-prescribing trial of older adults (>65 years) previously conducted in New Zealand that was focused on reducing the Drug Burden Index (DBI).MethodsWe used the anticholinergic cognitive burden (ACB) to quantify the impact of the intervention on reducing the anticholinergic burden. Participants not taking anticholinergics at the start of the trial were excluded. The primary outcome for this subgroup analysis was a change in ACB, measured with the ĝ_Hedges statistic describing the difference in standard deviation units of this change between intervention and control. For this analysis, the trial participants were stratified into low, medium, and high frailty and timing into prior- and post-lockdown (public health measures for COVID-19).ResultsAmong the 295 participants in this analysis, the median (IQR) age was 79 (74, 85), and 67% were women. For the primary outcome ĝ_Hedges = −0.04 (95% CI −0.26 to 0.19) with a −0.23 mean reduction in ACB in the intervention arm and −0.19 in the control arm. Before lockdown ĝ_Hedges = −0.38 (95% CI −0.84 to 0.04) and post-lockdown ĝ_Hedges = 0.07 (95% CI −0.19 to 0.33). The mean change in ACB for each of the frailty strata was as follows: low frailty (−0.02; 95% CI −0.65 to 0.18); medium frailty (0.05; 95% CI −0.28 to 0.38); high frailty (0.08; 95% CI −0.40 to 0.56).Conclusions and ImplicationsThe study did not provide evidence for the effect of pharmacist deprescribing intervention on reducing the anticholinergic burden. However, this post hoc analysis examined the impact of COVID on the effectiveness of the intervention, and further research in this area may be warranted.     

Decomposing Racial and Ethnic Disparities in Nursing Home Influenza Vaccination

ObjectivesQuantify how observable characteristics contribute to influenza vaccination disparities among White, Black, and Hispanic nursing home (NH) residents.DesignRetrospective cohort.Setting and ParticipantsShort- and long-stay U.S. NH residents aged ≥65 years.MethodsWe linked Minimum Data Set (MDS) and Medicare data to LTCFocUS and other facility data. We included residents with 6-month continuous enrollment in Medicare and an MDS assessment between October 1, 2013, and March 31, 2014. Residents were classified as short-stay (<100 days in NH) or long-stay (≥100 days in NH). We fit multivariable logistic regression models to assess the relationships between 27 resident and NH-level characteristics and receipt of influenza vaccination. Using nonlinear Oaxaca-Blinder decomposition, we decomposed the disparity in influenza vaccination between White versus Black and White versus Hispanic NH residents. Analyses were repeated separately for short- and long-stay residents.ResultsOur study included 630,373 short-stay and 1,029,593 long-stay residents. Proportions vaccinated against influenza included 67.2% of White, 55.1% of Black, and 54.5% of Hispanic individuals among short-stay residents and 84.2%, 76.7%, and 80.8%, respectively among long-stay residents. Across 4 comparisons, the crude disparity in influenza vaccination ranged from 3.4 to 12.7 percentage points. By equalizing 27 prespecified characteristics, these disparities could be reduced 37.7% to 59.2%. Living in a predominantly White facility and proxies for NH quality were important contributors across all analyses. Characteristics unmeasured in our data (eg, NH staff attitudes and beliefs) may have also contributed significantly to the disparity.Conclusions and ImplicationsThe racial/ethnic disparity in influenza vaccination was most dramatic among short-stay residents. Intervening on factors associated with NH quality would likely reduce these disparities; however, future qualitative research is essential to explore potential contributors that were unmeasured in our data and to understand the degree to which these factors contribute to the overall disparity in influenza vaccination.     

Improvements in Antibiotic Appropriateness for Cystitis in Older Nursing Home Residents: A Quality Improvement Study With Randomized Assignment

ObjectiveTo determine the impact of an educational quality improvement initiative on the appropriateness of antibiotic prescribing restricted to uncomplicated cystitis in older noncatheterized nursing home residents.DesignQuality improvement study with randomized assignment.Settings and ParticipantsTwenty-five nursing homes in United States were randomized to the intervention or usual care group by strata that included state, urban/rural status, bed size, and geographic separation.MethodsA 12-month trial of a low-intensity multifaceted antimicrobial stewardship intervention focused on uncomplicated cystitis in nursing home residents vs usual care. The outcome was the modified Medication Appropriateness Index as assessed by a blinded geriatric clinical pharmacist and consisted of an assessment of antibiotic effectiveness, dosage, drug-drug interactions, and duration.ResultsThere were 75 cases (0.15/1000 resident days) in intervention and 92 (0.22/1000 resident days) in control groups with a probable cystitis per consensus guidelines. Compared with controls, there was a statistically nonsignificant 21% reduction in the risk of inappropriate antibiotic prescribing (nonzero Medication Appropriateness Index score rate 0.13 vs 0.21/1000 person days; adjusted incident rate ratio 0.79; 95% confidence interval 0.45?1.38). There was a favorable comparison in inappropriateness of duration (77% vs 89% for intervention vs control groups, respectively; P = .0394). However, the intervention group had more problems with drug-drug interactions than the control group (8% vs 1%, respectively; P = .0463). Similarly, the intervention group had a nonsignificant trend toward more problems with dosage (primarily because of the lack of adjustment for decreased renal function) than the control group (32% vs 25%, respectively; P = .3170). Both groups had similar rates of problems with choice/effectiveness (44% vs 45%; P = .9417). The most common class of antibiotics prescribed inappropriately was quinolones (25% vs 23% for intervention versus control groups, respectively; P = .7057).Conclusions and ImplicationsA low-intensity intervention showed a trend toward improved appropriate antibiotic prescribing in nursing home residents with likely uncomplicated cystitis. Efforts to improve antibiotic prescribing in addition to the low-intensity intervention might include a consultant pharmacist in a nursing home to identify inappropriate prescribing practices.     

A Randomized Controlled Trial of Heart Failure Disease Management in Skilled Nursing Facilities

ObjectivePatients discharged from the hospital to a skilled nursing facility (SNF) are not typically part of a heart failure disease management program (HF-DMP). The objective of this study is to determine if an HF-DMP in SNF improves outcomes for patients with HF.DesignCluster-randomized controlled trial.ParticipantsThe trial was conducted in 47 SNFs, and 671 patients were enrolled (329 HF-DMP; 342 to usual care).MethodsThe HF-DMP included documentation of ejection fraction, symptoms, weights, diet, medication optimization, education, and 7-day visit post SNF discharge. The composite outcome was all-cause hospitalization, emergency department visits, or mortality at 60 days. Secondary outcomes included the composite endpoint at 30 days, change in the Kansas City Cardiomyopathy Questionnaire and the Self-care of HF Index at 60 days. Rehospitalization and mortality rates were calculated as an exploratory outcome.ResultsMean age of the patients was 79 ± 10 years, 58% were women, and the mean ejection fraction was 51% ± 16%. At 30 and 60 days post SNF admission, the composite endpoint was not significant between DMP (29%) and usual care (32%) at 30 days and 60 days (43% vs 47%, respectively). The Kansas City Cardiomyopathy Questionnaire significantly improved in the HF-DMP vs usual care for the Physical Limitation (11.3 ± 2.9 vs 20.8 ± 3.6; P = .039) and Social Limitation subscales (6.0 ± 3.1 vs 17.9 ± 3.8; P = .016). Self-care of HF Index was not significant. The total number of events (composite endpoint) totaled 517 (231 in HF-DMP and 286 in usual care). Differences in the 60-day hospitalization rate [mean HF-DMP rate 0.43 (SE 0.03) vs usual care 0.54 (SE 0.05), P = .04] and mortality rate (HF-DMP 5.2% vs usual care 10.8%, P < .001) were significant.Conclusions and ImplicationsThe composite endpoint was high for patients with HF in SNF regardless of group. Rehospitalization and mortality rates were reduced by the HF-DMP. HF-DMPs in SNFs may be beneficial to the outcomes of patients with HF. SNFs should consider structured HF-DMPs for their patients.     

Non-pharmacological Interventions in Hypertension: A Community-based Cross-over Randomized Controlled Trial

Background:

Hypertension is the most prevalent non-communicable disease causing significant morbidity/mortality through cardiovascular, cerebrovascular, and renal complications.

Objectives:

This community-based study tested the efficacy of non-pharmacological interventions in preventing/controlling hypertension.

Materials and Methods:

This is a cross-over randomized controlled trial (RCT) of the earlier RCT (2007) of non-pharmacological interventions in hypertension, conducted in the urban service area of our Institute. The subjects, prehypertensive and hypertensive young adults (98 subjects: 25, 23, 25, 25 in four groups) were randomly allotted into a group that he/she had not belonged to in the earlier RCT: Control (New Group I), Physical Exercise (NG II)-brisk walking for 50 to 60 minutes, three to four days/week, Salt Intake Reduction (NG III) to at least half of their previous intake, Yoga (NG IV) for 30 to 45 minutes/day, five days/week. Blood pressure was measured before and after eight weeks of intervention. Analysis was by ANOVA with a Games-Howell post hoc test.

Results:

Ninety-four participants (25, 23, 21, 25) completed the study. All three intervention groups showed significant reduction in BP (SBP/DBP mmHg: 5.3/6.0 in NG II, 2.5/2.0 in NG III, and 2.3/2.4 in NG IV, respectively), while the Control Group showed no significant difference. Persistence of significant reduction in BP in the three intervention groups after cross-over confirmed the biological plausibility of these non-pharmacological interventions. This study reconfirmed that physical exercise was more effective than Salt Reduction or Yoga. Salt Reduction, and Yoga were equally effective.

Conclusion:

Physical exercise, salt intake reduction, and yoga are effective non-pharmacological methods for reducing blood pressure in young pre-hypertensive and hypertensive adults.     

Community-based Randomized Controlled Trial of Non-pharmacological Interventions in Prevention and Control of Hypertension among Young Adults

Context:

Hypertension is a major chronic lifestyle disease. Several non-pharmacological interventions are effective in bringing down the blood pressure (BP). This study focuses on the effectiveness of such interventions among young adults.

Aims:

To measure the efficacy of physical exercise, reduction in salt intake, and yoga, in lowering BP among young (20-25) pre-hypertensives and hypertensives, and to compare their relative efficacies.

Settings and Design:

The study was done in the urban service area of JIPMER. Pre-hypertensives and hypertensives, identified from previous studies, constituted the universe. The participants were randomized into one control and three interventional groups.

Materials and Methods:

A total of 113 subjects: 30, 28, 28 and 27 in four groups respectively participated for eight weeks: control (I), physical exercise (II) - brisk walking for 50-60 minutes, four days/week, salt intake reduction (III) - to at least half of their previous intake, and practice of yoga (IV) - for 30-45 minutes/day on at least five days/week.

Statistical Analysis Used:

Efficacy was assessed using paired t test and ANOVA with Games Howell post hoc test. An intention to treat analysis was also performed.

Results:

A total of 102 participants (29, 27, 25 and 21 in groups I, II, III and IV) completed the study. All three intervention groups showed a significant reduction in BP (SBP/DBP: 5.3/6.0 in group II, 2.6/3.7 in III, and 2.0/2.6 mm Hg in IV respectively). There was no significant change (SBP/DBP: 0.2/0.5 mmHg) of BP in control group (I). Physical exercise was most effective (considered individually); salt intake reduction and yoga were also effective.

Conclusions:

Physical exercise, salt intake reduction, and yoga are effective non-pharmacological interventions in significantly reducing BP among young hypertensives and pre-hypertensives. These can therefore be positively recommended for hypertensives. There is also a case to deploy these interventions in the general population.     

Effect of Berberine on Cardiovascular Disease Risk Factors: A Mechanistic Randomized Controlled Trial

Cardiovascular disease (CVD) is a major contributor to the global burden of disease. Berberine, a long-standing, widely used, traditional Chinese medicine, is thought to have beneficial effects on CVD risk factors and in women with polycystic ovary syndrome. The mechanisms and effects, specifically in men, possibly via testosterone, have not been examined previously. To assess the effect of berberine on CVD risk factors and any potential pathway via testosterone in men, we conducted a randomized, double-blind, placebo-controlled, parallel trial in Hong Kong. In total, 84 eligible Chinese men with hyperlipidemia were randomized to berberine (500 mg orally, twice a day) or placebo for 12 weeks. CVD risk factors (lipids, thromboxane A2, blood pressure, body mass index and waist–hip ratio) and testosterone were assessed at baseline, and 8 and 12 weeks after intervention. We compared changes in CVD risk factors and testosterone after 12 weeks of intervention using analysis of variance, and after 8 and 12 weeks using generalized estimating equations (GEE). Of the 84 men randomized, 80 men completed the trial. Men randomized to berberine had larger reductions in total cholesterol (−0.39 mmol/L, 95% confidence interval (CI) −0.70 to −0.08) and high-density lipoprotein cholesterol (−0.07 mmol/L, 95% CI −0.13 to −0.01) after 12 weeks. Considering changes after 8 and 12 weeks together, berberine lowered total cholesterol and possibly low-density lipoprotein-cholesterol (LDL-c), and possibly increased testosterone. Changes in triglycerides, thromboxane A2, blood pressure, body mass index and waist–hip ratio after the intervention did not differ between the berberine and placebo groups. No serious adverse event was reported. Berberine is a promising treatment for lowering cholesterol. Berberine did not lower testosterone but instead may increase testosterone in men, suggesting sex-specific effects of berberine. Exploring other pathways and assessing sex differences would be worthwhile, with relevance to drug repositioning and healthcare.     

Sodium Reduction in Restaurant Food: A Randomized Controlled Trial in China

Restaurant food is one of the important sources of sodium intake in China. We aimed to determine whether a restaurant-based comprehensive intervention program may induce lower sodium content in restaurant food. A randomized controlled trial was implemented between 2019 and 2020 in 192 restaurants in China. After baseline assessment, the restaurants were randomly assigned to either an intervention or a control group (1:1). Comprehensive activities designed for intervention restaurants were conducted for one year. The primary outcome was the difference in change of sodium content estimated by the mean values of five best-selling dishes for each restaurant, from baseline to the end of the trial between groups. In total, 66 control restaurants and 80 intervention restaurants completed the follow-up assessment. The average sodium content of dishes at baseline was 540.9 ± 176.8 mg/100 g in control and 551.9 ± 149.0 mg/100 g in intervention restaurants. The mean effect of intervention after adjusting for confounding factors was −43.63 mg/100 g (95% CI: from −92.94 to 5.66, p = 0.08), representing an 8% reduction in sodium content. The restaurant-based intervention led to a modest but not significant reduction in the sodium content of restaurant food. There is great urgency for implementing effective and sustainable salt reduction programs, due to the rapid increase in the consumption of restaurant food in China.     

Dextrose Prolotherapy for Knee Osteoarthritis: A Randomized Controlled Trial

PURPOSEKnee osteoarthritis is a common, debilitating chronic disease. Prolotherapy is an injection therapy for chronic musculoskeletal pain. We conducted a 3-arm, blinded (injector, assessor, injection group participants), randomized controlled trial to assess the efficacy of prolotherapy for knee osteoarthritis.METHODSNinety adults with at least 3 months of painful knee osteoarthritis were randomized to blinded injection (dextrose prolotherapy or saline) or at-home exercise. Extra- and intra-articular injections were done at 1, 5, and 9 weeks with as-needed additional treatments at weeks 13 and 17. Exercise participants received an exercise manual and in-person instruction. Outcome measures included a composite score on the Western Ontario McMaster University Osteoarthritis Index (WOMAC; 100 points); knee pain scale (KPS; individual knee), post-procedure opioid medication use, and participant satisfaction. Intention-to-treat analysis using analysis of variance was used.RESULTSNo baseline differences existed between groups. All groups reported improved composite WOMAC scores compared with baseline status (P <.01) at 52 weeks. Adjusted for sex, age, and body mass index, WOMAC scores for patients receiving dextrose prolotherapy improved more (P <.05) at 52 weeks than did scores for patients receiving saline and exercise (score change: 15.3 ± 3.5 vs 7.6 ± 3.4, and 8.2 ± 3.3 points, respectively) and exceeded the WOMAC-based minimal clinically important difference. Individual knee pain scores also improved more in the prolotherapy group (P = .05). Use of prescribed postprocedure opioid medication resulted in rapid diminution of injection-related pain. Satisfaction with prolotherapy was high. There were no adverse events.CONCLUSIONSProlotherapy resulted in clinically meaningful sustained improvement of pain, function, and stiffness scores for knee osteoarthritis compared with blinded saline injections and at-home exercises.     

The Effects of a Low Sodium Meal Plan on Blood Pressure in Older Adults: The SOTRUE Randomized Feasibility Trial

Reduced sodium meal plans are recommended by the Centers of Disease Control to lower blood pressure in older adults; however, this strategy has not been tested in a clinical trial. The Satter House Trial of Reduced Sodium Meals (SOTRUE) was an individual-level, double-blind, randomized controlled pilot study of adults living in a congregate living facility subsidized by the Federal Department of Housing and Urban Development (HUD). Adults over age 60 years ate 3 isocaloric meals with two snacks daily for 14 days. The meal plans differed in sodium density (<0.95 vs. >2 mg/kcal), but were equivalent in potassium and macronutrients. Seated systolic BP (SBP) was the primary outcome, while urine sodium-creatinine ratio was used to measure compliance. Twenty participants were randomized (95% women; 95% white; mean age 78 ± 8 years), beginning in 7 October 2019. Retention was 100% with the last participant ending 4 November 2019. Mean baseline SBP changed from 121 to 116 mmHg with the typical sodium diet (−5 mmHg; 95% CI: −18, 8) and from 123 to 112 mmHg with the low sodium diet (−11 mmHg; 95% CI: −15.2, −7.7). Compared to the typical sodium meal plan, the low sodium meal plan lowered SBP by 4.8 mmHg (95% CI: −14.4, 4.9; p = 0.31) and urine sodium-creatinine ratio by 36% (−36.0; 95% CI: −60.3, 3.4; p = 0.07), both non-significant. SOTRUE demonstrates the feasibility of sodium reduction in federally mandated meal plans. A longer and larger study is needed to establish the efficacy and safety of low sodium meals in older adults.     

A Randomized Trial of Alerting to Low Glycated Hemoglobin Level in Older Adults: Results of the Low Indexes of Metabolism Intervention Trial B (LIMIT-B)

ObjectivesThe benefit of alerting clinical staff to low plasma glycated hemoglobin (HbA1c) in patients aged 75 years and older who receive antidiabetic drugs remains uncertain.Design, Setting, and ParticipantsIn a randomized controlled trial, 1684 patients with HbA1c ≤ 6.5% who received antidiabetic drugs were assigned to have an e-mail alert sent to their physician, and 1643 were assigned to have no such alert (control group). The primary outcome of the trial was annual death. Secondary outcomes included antidiabetic drug dose reduction and HbA1c change.ResultsIn the first quarter, antidiabetic drug-defined daily doses were reduced on average by 10.4 ± 35.8 (16% ± 55%) in the intervention group and by 6.4 ± 36.1 (10% ± 56%) in the control group (difference −4.1 ± 1.2, 95% confidence interval [CI] −6.5 to −1.6; P = .001). Measured HbA1c levels were raised by a mean (± standard deviation) of 0.28 ± 0.77 in the intervention group and by 0.18 ± 0.57 in the control group (difference 0.10 ± 0.02, 95% CI –0.15 to −0.059, P < .001). One year after the alerts, 121 patients (7.2%) died in the intervention group and 107 patients (6.5%) died in the control group (relative risk 1.1, 95% CI 0.86-1.42; P = .44).Conclusions and ImplicationsIn this trial, alerting clinical staff to low HbA1c in patients aged 75 years and older treated with antidiabetic medicines was associated with mildly reduced antidiabetic doses and increased HbA1c but was not associated with a significant difference in survival rate compared with usual clinical care.     

Effect of Individual Nutrition Therapy and Exercise Regime on Gait Speed,Physical Function,Strength and Balance,Body Composition,Energy and Protein,in Injured,Vulnerable Elderly: A Multisite Randomized Controlled Trial (INTERACTIVE)

It is imperative that the surgical treatment of hip fractures is followed up with rehabilitation to enhance recovery and quality of life. This randomized controlled trial aimed to determine if an individualised, combined exercise–nutrition intervention significantly improved health outcomes in older adults, after proximal femoral fracture. We commenced the community extended therapy while in hospital, within two weeks post-surgery. The primary outcome was gait speed and secondary outcomes included physical function, strength and balance, body composition, energy and protein intake. Eighty-six and 89 participants were randomized into six months individualised exercise and nutrition intervention and attention-control groups, respectively. There were no statistically significant differences in gait speed between the groups at six and 12 months. There were no major differences between groups with respect to the secondary outcomes, except estimated energy and protein intake. This may be explained by the sample size achieved. Participants in the intervention group had greater increment in energy (235 kcal; 95% CI, 95 to 375; p = 0.01) and protein intake (9.1 g; 95% CI, 1.5 to 16.8; p = 0.02), compared with those in the control group at six months but not significant at 12 months. This study has demonstrated that providing early, combined exercise and nutrition therapy can improve dietary energy and protein intake in older adults with hip fractures.