1 INTRODUCTION
Greater than 1 million grownup Individuals are hospitalized for coronary heart failure (HF) yearly, accounting for six.5 million hospital days and the vast majority of the roughly $40 billion spent every year on HF-related care.1, 2 As well as, whereas per capita hospitalization charges could also be starting to say no, postdischarge readmission charges and mortality stay unacceptably excessive nationally.3 Thus, understanding the precipitants contributing to hospitalizations and readmissions for HF, significantly these which are probably avoidable, could facilitate more practical HF illness administration. A number of danger elements have been recognized together with arrhythmias, myocardial ischemia, respiratory infections, uncontrolled hypertension, nonadherence to medicines, and/or dietary indiscretion.4–8
The latter is especially related as a earlier examine in adults admitted for worsening HF estimated that nonadherence with HF-specific dietary suggestions probably contributed to >5% of hospitalizations.9 Curiously, a “heart-healthy” food regimen, significantly with respect to lowered sodium consumption, is arguably essentially the most incessantly beneficial self-care habits and is endorsed by the nationwide HF tips.10, 11 Nonetheless, dietary suggestions are primarily based largely on professional opinion and the restricted randomized managed trials which were performed to this point have both centered on a single dietary part and/or have produced inconsistent findings.12, 13 Thus, there may be an unmet medical want to raised perceive the impression of life-style decisions with respect to food regimen and diet in high-risk HF sufferers who’ve been just lately hospitalized.
Notably, there have been ongoing considerations that the novel coronavirus illness 2019 (COVID-19) pandemic and the general public well being response (i.e., mitigation methods) could have unintentionally restricted entry to group sources (e.g., contemporary and nutritious meals).14–18 Thus, to deal with this public well being difficulty, we performed a remotely administered survey utilizing beforehand derived and validated questionnaires to explain (1) meals safety, (2) dietary high quality and composition, (3) dietary understanding, and (4) attitudes in the direction of analysis amongst high-risk HF sufferers through the pandemic.
2 METHODS
2.1 Supply inhabitants
Kaiser Permanente Northern California (KPNC) is a big built-in healthcare supply system presently offering complete outpatient, emergency division, and inpatient care to >4.5 million members in northern and central California. The KPNC membership is very consultant of the native surrounding and statewide inhabitants when it comes to age, gender, race/ethnicity, and socioeconomic standing (SES). Practically all elements of care are captured via an built-in digital well being document (EHR) system, with key variables extracted and standardized for analysis within the Kaiser Permanente Digital Knowledge Warehouse.19, 20
This examine was authorized by the KPNC Institutional Assessment Board and affected person consent was obtained.
2.2 Research eligibility
We initially recognized all grownup (≥18 years) KPNC members with a recognized prognosis of HF on April 27, 2020 and no less than one hospitalization for HF inside the previous 12 months primarily based on EHR information. The discharge prognosis codes for HF have been validated in a number of healthcare supply techniques, with a optimistic predictive worth starting from ≥85% to 95%.21, 22 We excluded sufferers with <12 months of steady prior well being plan membership, a previous coronary heart transplant or left ventricular help gadget, admission to a talented nursing facility inside 30 days or hospice prior to now 180 days, prior kidney alternative remedy, or a mailing handle outdoors the KPNC geographic protection space.
2.3 Survey design and administration
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Meals Entry and Safety—Researchers on the Youngsters’s HealthWatch group developed the Two-Merchandise Quick Type of the Meals Safety Survey Module,23 which was first carried out in 1995 by The U.S. Division of Agriculture. Researchers have systematically evaluated the sensitivity, specificity, and bias of the Two-Merchandise Quick Type of the Meals Safety Module relative to the longer 18-item scale, and it supplies an appropriate substitute with the added benefits that food-insecure households might be extra effectively screened. Responses of “typically true” or “typically true” are coded as affirmative (sure) and an affirmative response to both query is taken into account to be ample proof of meals insecurity. Importantly, the Two-Merchandise Quick Type has been used efficiently in mail-out, take-home, and on-site self-administered surveys and has served as the premise for tons of of beforehand printed research.
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Dietary High quality and Composition—Understanding dietary range and high quality is crucial to assessing the dietary wants of the final inhabitants and sufferers with recognized heart problems. Nonetheless, most presently accessible dietary evaluation instruments are time-consuming, costly, and labor-intensive, and/or restricted by short-term recall. The Speedy Consuming Evaluation for Contributors—Shortened Model (REAP-S)24 was included as a simple, time-efficient, and cost-effective methodology to gather dietary info. The questionnaire consists of 13 objects, which give attention to consuming habits, willingness to alter, and particular person meals teams together with fiber-rich meals, fruits, greens, dairy merchandise, processed meats, and high-fat and high-sugar meals. The REAP-S inquires about meals and drinks that respondents may need over an common week and asks them to price the frequency as “normally/typically,” “typically,” “hardly ever/by no means,” or “doesn’t apply to me” for every merchandise. Responses of “normally/typically” obtain 1 level, “typically” obtain 2 factors, and “hardly ever/by no means” or “doesn’t apply to me” obtain 3 factors. Potential scores vary from 13 to 39 with a better rating indicating a better food regimen high quality.
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Dietary Understanding—Diet-related data addresses a person’s understanding of diet surrounding an individual’s consuming behaviors. Not too long ago printed meta-analyses and systematic critiques recommend that this area is considerably related to dietary habits and dietary consumption.25, 26 Diet-related data information was collected utilizing the Diet Information Questionnaire, which incorporates 13 objects on common diet data together with suggestions on complete caloric consumption and sources and consumption of chosen vitamins.27 All objects on the survey are closed-ended and dichotomous or a number of selection. A rating of 1 is assigned for every appropriate response and the whole rating is a sum starting from 0 to 13 factors with larger scores indicating higher nutrition-related data.
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Attitudes In direction of Analysis—A collection of 4 questions had been modified from the Nationwide Affected person-Centered Medical Analysis Community (PCORnet) and pilot examined to evaluate a respondent’s stage of curiosity and willingness to be approached, consented, and enrolled in analysis. The questions particularly addressed prior participation in analysis, future willingness to take part in various kinds of analysis, curiosity in serving as an advisor and/or affected person advocate for analysis research, and most well-liked contact methodology(s) concerning potential analysis alternatives. All objects had been closed-ended (i.e., dichotomous or a number of selection) and had been individually analyzed utilizing descriptive statistics.
The questionnaire was written in English and included each an digital model hosted on the REDCap platform and a hardcopy model. We offered respondents with a $10 present card to reimburse them for his or her time.
2.4 Dealing with of survey information
We despatched surveys to sufferers’ bodily mailing addresses via the U.S. Postal Service and electronically (i.e., through e mail addresses registered with our healthcare supply system), beginning on Might 18, 2020 for a complete of two sequential contacts. Commonplace high quality management measures had been carried out to make sure the respondent was the meant member for each accomplished on-line and print surveys. Print surveys had been edited by a examine group member and information had been entered right into a clone of the web questionnaire that was utilized by contributors who selected to finish the survey on-line. Our last cohort included sufferers who responded to the survey between Might 18 and September 30, 2020. The date every affected person’s survey response was acquired was assigned as their index date. We carried out a last exclusion of contributors who weren’t well being plan members on their assigned index date and people who had been recognized as having died earlier than receipt of survey response.
2.5 Baseline covariates and follow-up information
We additionally obtained information on demographic traits, comorbidities, very important indicators, laboratory outcomes, left ventricular ejection fraction (LVEF), and pharmacy shelling out utilizing Worldwide Classification of Illnesses ninth/tenth Version (ICD-9/10) and present procedural terminology codes and related EHR information primarily based on validated algorithms.21, 22
Medical occasions of curiosity had been all-cause and HF-specific hospitalizations and all-cause mortality occurring at 90 and 180 days after the index date. The reason for all hospitalizations was primarily based on the first discharge prognosis. These codes have been validated in a number of healthcare supply techniques and have a optimistic predictive worth that ranges from ≥85% to 95%.21, 22 As well as, at KPNC, there may be an unique relationship between the well being plan, members, and suppliers such that nonnetwork referrals are extraordinarily unusual total (i.e., <1% of medical encounters). In consequence, prior research have proven that occasion seize via the EHR (i.e., emergency room visits, unplanned hospitalizations, and dying) is >95%.22, 28, 29 Important standing was decided from a number of sources together with EHR information (for deaths occurring in well being plan amenities and member proxy reporting) and state dying certificates info.
2.6 Statistical method
We in contrast survey responses and baseline traits throughout SES, together with revenue and training stage, utilizing evaluation of variance for steady variables, and χ2 assessments for categorical variables. We performed Cox proportional hazards fashions to evaluate the affiliation between food regimen high quality and data survey instrument responses and every end result of curiosity at 90 and 180 days of follow-up, with adjustment for age, intercourse, race, revenue, LVEF, systolic blood strain, coronary heart price, b-type natriuretic peptide (BNP), blood urea nitrogen, comorbidity level rating—model 2,30 prior remedy use (angiotensin-converting-enzyme inhibitor/angiotensin receptor blocker/angiotensin receptor-neprilysin inhibitor [ACEi/ARBs/ARNIs], mineralocorticoid receptor antagonists [MRAs], β-blockers, and diuretics); and focused comorbidities (AF/AFL, acute myocardial infarction, unstable angina, and coronary revascularization). Every mixture of survey instrument, end result, and time level was modeled individually. We used SAS statistical software program, model 9.4 for all analyses, with a two-sided p < .05 as the brink for statistical significance.
3 RESULTS
3.1 Cohort meeting and survey response
We recognized 51 352 adults with identified HF as of April 27, 2020, with 5632 having been hospitalized for HF inside the final 12 months earlier than their index date (Determine 1). After making use of the remaining exclusion standards, the eligible cohort included 3777 people. There was a complete of 1212 survey respondents (32.5% of eligible cohort) between Might 18, 2020 and September 30, 2020. In comparison with nonrespondents, survey respondents had been older and had a better burden of chosen comorbidities however had been in any other case related when it comes to baseline sociodemographic and medical traits (Desk S1).
Consort diagram displaying cohort meeting for survey eligibility and participant response following survey administration. HF coronary heart failure; KPNC, Kaiser Permanente Northern California
3.2 Baseline traits of survey respondents
The imply ± SD age of survey respondents was 77.9 ± 11.4% and 50.1% had been ladies (Desk S2). The median (interquartile vary [IQR]) LVEF was 55% (40%–60%) and 42.2% of the cohort had a preserved LVEF. The median (IQR) BNP was 401 pg/ml (215–789 pg/ml). The burden of cardiac and noncardiac comorbidities was excessive, with 60.6% having AF/AFL, 52.7% had diabetes mellitus, and 50.7% with persistent kidney illness. Sufferers had been well-treated with β-blockers, ACEis/ARBs/ARNis, and MRAs regardless of a low proportion of HF sufferers with a lowered LVEF. Variations in baseline medical traits throughout SES (i.e., revenue and training stage) are proven in Tables S3 and S4.
3.3 Meals entry and safety
Primarily based on the 2-Merchandise Quick Type of the meals safety survey module, 15.1% of respondents reported being meals safe, with 0.8% who didn’t reply (Desk S2). The proportion of respondents reporting to be meals insecure was larger for these with decrease revenue (i.e., ≤$50 000 vs. >$50 000) and amongst contributors for whom the very best stage of training achieved was “lower than highschool” or “highschool” in comparison with “some school” and “school graduate” (Tables S3 and S4).
3.4 Dietary high quality and composition
The distribution of scores for the REAP-S ranged from 13 to 39 (i.e., with larger scores indicating a better food regimen high quality) and are proven in Determine 2. There was an total slender distribution of scores primarily based on SES (Tables S3 and S4).
Distribution of scores amongst respondents for the speedy consuming evaluation for contributors—a shortened model
3.5 Dietary understanding
The median (IQR) vary of questions answered accurately was 8 (6–9) out of 13 questions for the general cohort (Desk S2 and Determine 3). Generally, respondents who had an revenue >$50 000 and better training stage tended to reply extra questions accurately (Tables S3 and S4).
Distribution of variety of questions answered accurately amongst respondents for the Dietary Information Questionnaire
3.6 Attitudes in the direction of analysis
Total, solely 24.0% of survey respondents had beforehand participated within the analysis (Desk S2). Though 65.0% of respondents had been prepared to contemplate taking part in a future analysis survey, the proportion of respondents was prepared to contemplate giving blood for analysis (32.2%), taking remedy for analysis (14.4%), and altering habits for analysis (27.1%) was considerably decrease. As well as, solely 7.6% and 25.5%, respectively, indicated they might both “Sure” or “Perhaps” be keen on serving as a analysis advisor. Survey respondents indicated their most well-liked contact from most to least as the next: mailed letter (40.0%), e-mail (22.0%), dwell cellphone name (13.3%), in-person clinic go to (10.1%), textual content message (9.3%), and recorded cellphone name (2.8%). Total, respondents with larger revenue and training ranges expressed extra willingness to take part and are contacted sooner or later concerning analysis alternatives (Tables S3 and S4).
3.7 Outcomes and interplay analyses
The incidence of HF hospitalizations, all-cause hospitalizations, and dying as a result of any trigger at 90 and 180 days, respectively, had been 4.1%/8.1%, 13.9%/25.2%, and three.2%/7.9%. Solely poor/honest versus glorious/superb/good (reference) self-reported dietary well being was related to elevated danger of all-cause hospitalization at 90 and 180 days (Desk 1). After multivariable adjustment, meals safety, dietary behaviors, and dietary data weren’t independently related to SES.
Adjusted associations between survey information and outcomes
| Dying | Any hospitalization | HF hospitalization | ||||
|---|---|---|---|---|---|---|
| HR (95% CI) | p Worth | HR (95% CI) | p Worth | HR (95% CI) | p Worth | |
| Outcomes at 90 days | ||||||
| Meals insecurity | ||||||
| No meals insecurity famous | (ref) | (ref) | (ref) | |||
| Meals insecurity famous | 0.79 (0.24–2.58) | 0.69 | 1.09 (0.71–1.69) | 0.69 | 1.54 (0.78–3.05) | 0.22 |
| Dietary data | ||||||
| Rating at or over median | 0.65 (0.29–1.45) | 0.29 | 1.17 (0.85–1.63) | 0.34 | 0.65 (0.33–1.28) | 0.22 |
| Rating beneath median | (ref) | (ref) | (ref) | |||
| Dietary behaviors (REAP) | ||||||
| Rating at or over median | 0.88 (0.44–1.74) | 0.70 | 1.23 (0.89–1.69) | 0.20 | 1.04 (0.57–1.89) | 0.91 |
| Rating beneath median | (ref) | (ref) | (ref) | |||
| Outcomes at 180 days | ||||||
| Meals insecurity | ||||||
| No meals insecurity famous | (ref) | (ref) | (ref) | |||
| Meals insecurity famous | 0.75 (0.38–1.49) | 0.41 | 0.92 (0.65–1.30) | 0.63 | 1.02 (0.59–1.74) | 0.96 |
| Dietary data | ||||||
| Rating at or over median | 0.92 (0.58–1.47) | 0.73 | 1.15 (0.90–1.47) | 0.26 | 0.97 (0.62–1.52) | 0.88 |
| Rating beneath median | (ref) | (ref) | (ref) | |||
| Dietary behaviors (REAP) | ||||||
| Rating at or over median | 0.84 (0.54–1.29) | 0.42 | 0.98 (0.78–1.24) | 0.87 | 1.00 (0.66–1.51) | 0.99 |
| Rating beneath median | (ref) | (ref) | (ref) | |||
- Abbreviations: CI, confidence interval; HF, coronary heart failure; HR, hazard ratio.
4 DISCUSSION
To our data, that is the primary complete survey addressing meals entry, food regimen high quality and composition, dietary understanding, and attitudes in the direction of analysis in older adults with a excessive burden of cardiac and noncardiac comorbidities through the COVID-19 pandemic. Notably, upwards of 15% of respondents screened optimistic for meals insecurity, and solely roughly 65% of respondents answered greater than half of the objects accurately on a questionnaire assessing dietary understanding. As well as, though the vast majority of respondents indicated that may be prepared to contemplate taking part in future analysis, that proportion declined markedly for research requiring blood attracts, examine medicine, and/or habits change. As well as, decrease revenue was related to larger charges of meals insecurity, and contributors with a decrease SES had a worse dietary understanding. Lastly, not one of the purposeful domains assessed by this survey had been independently related to medical outcomes in our cohort.
It could be sudden that in an insured inhabitants roughly 15% of survey respondents screened optimistic for meals insecurity. That is clinically related as a result of there could also be a misperception that well-insured sufferers are much less delicate to modest fluctuations in out-of-pocket expenditures, however our information recommend {that a} sizable minority of sufferers could have problem affording fundamental requirements. We discovered that decrease revenue and training ranges had the strongest affiliation with meals insecurity. As well as, respondents who had a decrease revenue and training stage demonstrated a poorer understanding of fundamental dietary ideas. In combination, these outcomes recommend that even inside a well-insured inhabitants, there may be room for enchancment, and interventions directed at bettering entry to meals, food regimen high quality, and dietary understanding could selectively goal high-risk populations, significantly these of decrease SES.
These preliminary information on attitudes in the direction of analysis additionally provide a glimpse into public perceptions at a time when lay people had been partaking with the scientific course of (i.e., COVID-19 unfold, rising therapeutics, vaccine growth, and so on.) on an virtually every day foundation. Inside this context, though lower than 1 / 4 of respondents had beforehand participated in a analysis examine, practically 65% indicated they might be prepared to take part in one other survey-based examine. Nonetheless, there was a lot decrease curiosity in taking part in analysis involving giving blood (∼30%), taking a examine remedy (∼15%), or behavioral change (∼30%); nevertheless, these estimates should still be thought of comparatively excessive given the superior age and excessive multimorbidity burden amongst survey respondents. It’s noteworthy that the popular preliminary mode of communication amongst contributors was a mailed letter or e mail two-to-four-fold versus a dwell cellphone name or in-person clinic go to. This desire could also be partly a mirrored image of the shelter-in-place orders that had been in impact throughout many of the survey interval however is probably going nonetheless a generalizable discovering given the magnitude of the distinction. A last actionable perception is that respondents who had a better revenue and training stage had been extra prone to specific a willingness to take part in future analysis alternatives. That is vital as experimental protocols are a part of the usual of care in lots of fields (i.e., oncology) and this may increasingly contribute to disparities in entry, high quality, and outcomes.
It is usually value noting that we didn’t observe an unbiased affiliation between meals entry, food regimen high quality, and dietary data, and all-cause and HF-related morbidity and mortality. Nonetheless, there are a number of caveats to this statement. First, the purpose estimates of the hazard ratios had been constantly within the course of elevated hurt with meals insecurity, poor dietary high quality, and worse dietary data, and we could have been underpowered to detect statistically vital variations. Second, for a few of the content material areas lined by the survey comparable to meals entry, the proportion of irregular values (i.e., meals insecure) could have been too small and impeded our capacity to seek out vital between-group variations. Third, the proportion of survey respondents was unexpectedly decrease given our organizations’ intensive expertise surveying members and the traditionally excessive response charges sometimes seen in an older demographic and sufferers with persistent medical situations.31 In consequence, this seemingly contributed as nicely to decrease than anticipated occasion charges and lowered energy in our examine. Lastly, it needs to be famous that meals entry is a related patient-centered end result and the affiliation between food regimen and different life-style elements (i.e., train) has been strongly correlated with long-term cardiovascular danger.32, 33
There are a number of limitations of the examine. First, the examine pattern was recruited from a big built-in healthcare supply system in northern California, and the outcomes might not be generalizable to all different populations and observe settings. Nonetheless, KPNC membership is various and extremely consultant of the native surrounding and statewide inhabitants when it comes to age, gender, race/ethnicity, and SES. Second, the general response price was decrease than anticipated introducing the opportunity of choice bias. Regardless of this potential limitation, we had been reassured that the baseline sociodemographic and medical traits of the examine pattern had been corresponding to the supply inhabitants. Third, some parts of the survey (i.e., attitudes in the direction of analysis) haven’t been beforehand validated and needs to be thought of hypothesis-generating till they’ve been rigorously evaluated in numerous populations.
In conclusion, we recognized potential obstacles to meals entry, food regimen high quality and composition, and dietary understanding in a various and modern inhabitants of older adults with a excessive burden of medical comorbidities through the COVID-19 pandemic. These findings had been most outstanding amongst people with decrease SES. As well as, though most respondents indicated a willingness to contemplate taking part in future analysis, the bulk most well-liked observational reasonably than experimental (i.e., medical trials) research and mail and/or e-mail as the first mode of contact versus cellphone or in-person. Primarily based on these insights, future efforts to enhance entry to wholesome and nutritious meals sources ought to leverage distant recruitment with a versatile and culturally delicate intervention and selectively goal at-risk teams.
ACKNOWLEDGMENTS
The authors want to thank Nancy P. Gordon, ScD, Teresa Y. Lin, MPH, and Pete Bogdanos, BS for his or her help with survey administration and information assortment. This examine was funded by the KPNC Group Profit Program (Oakland, CA).
CONFLICT OF INTERESTS
Andrew P. Ambrosy is supported by a Mentored Affected person-Oriented Analysis Profession Growth Award (K23HL150159) via the Nationwide Coronary heart, Lung, and Blood Institute and has acquired related analysis help via grants to his establishment from Amarin Pharma, Inc., Abbott, and Novartis. Alan S. Go has acquired related analysis help via grants to his establishment from the Nationwide Coronary heart, Lung and Blood Institute; Nationwide Institute of Diabetes, Digestive and Kidney Illnesses; Nationwide Institute on Getting older; Amarin Pharma, Inc.; Novartis; Janssen Analysis & Growth; and CSL Behring. All different authors have declared no battle of pursuits.
AUTHOR CONTRIBUTIONS
Andrew P. Ambrosy: Conceptualization, methodology, investigation, writing (authentic draft), writing (reviewing and modifying), and supervision. Umar I. Malik: Investigation, writing (authentic draft), writing (reviewing and modifying). Thomas Okay. Leong: Investigation, formal analyses, and information curation. Amanda R. Allen: Knowledge assortment (growth and administration), writing (reviewing and modifying). Sue Hee Sung: Undertaking administration, supervision, investigation, and writing (reviewing and modifying). Alan S. Go: Conceptualization, methodology, writing (authentic draft), writing (reviewing and modifying), and supervision.
