Study Design
This prospective cohort study includes two parallel groups, with a detailed study procedure illustrated in Fig. 1. Baseline assessments will occur during participant recruitment, providing crucial cross-sectional data for evaluating the transition from mild cognitive impairment (MCI) to dementia. Due to the multicenter nature of this study, adherence to the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) guidelines is essential for ensuring scientific rigor.
Fig. 1 Flowchart of study procedure. Abbreviations: EMR, electronic medical records; K-MMSE, Korean version of the Mini-Mental State Examination; LTC, long-term care facility; MCI, mild cognitive impairment; S-CAM, Short Confusion Assessment Methods. The comprehensive plans for establishing participant cohorts from the first to third year are summarized below and depicted in Fig. 2.
Fig. 2 MDD Cohort protocol. Abbreviations: AI, artificial intelligence; LOS, length of stay; MCI, mild cognitive impairment; S-CAM, Short Confusion Assessment Methods. Participants will be recruited based on specific inclusion and exclusion criteria and will undergo initial assessments to facilitate their classification into delirium and non-delirium groups.
The study will involve checking for conversion to dementia and survival rates at 30-day intervals throughout the study duration. Data from the first year will undergo analysis, followed by a similar procedure for the second and third years, ultimately leading to the development of an artificial intelligence algorithm aimed at predicting the conversion of MCI to dementia.
Participants and Eligibility Criteria
Inclusion criteria stipulate that participants must be inpatients aged 65 years or older, diagnosed with MCI by a physician, and possess K-MMSE scores ranging from 18-23. Exclusions apply to individuals who cannot undergo the Short Confusion Assessment Method (S-CAM) due to severe sensory impairments, those with serious mental health or neurological issues, those who die or are transferred on the day of hospitalization, and those restricted from receiving emergency treatment during evaluation.
Sample Size and Data Collection
A detailed summary of data collection protocols and follow-up procedures is included in Table 1. Prior to initiating the study, a dedicated research team was assembled to establish the cohort. This team analyzed both domestic and international findings, set specific, measurable goals for each study phase, and produced a standardized manual containing comprehensive guidelines that will be disseminated before the study begins to standardize data collection and ensure quality control across participating hospitals.
Initial data collection will identify participants’ general characteristics through electronic medical records (EMR). This will encompass age, sex, education level, K-MMSE score, comorbidity index, hospitalization route, smoking and drinking habits, body mass index, and the number of prescriptions. Therapeutic factors such as falls, pressure ulcers, and various pain management modalities will be analyzed alongside other significant factors that could influence delirium risk, including strokes, sensory impairments, and nutritional status.
The geriatric depression scale and activities of daily living assessments will further enrich the dataset to identify additional risk factors for delirium.
Delirium Assessment
Delirium assessment will be conducted by trained research assistants using the Korean version of the S-CAM at two intervals daily (8–10 AM and 4–6 PM) for a duration of 30 days. To ensure consistency, experienced nurses from each participating long-term care facility will provide oversight, bolstered by three sessions of video training focused on S-CAM administration. An expert spot-checking protocol will also be instituted, where each assistant’s evaluations will be compared to a seasoned researcher’s assessments to rectify potential errors and facilitate training.
To qualify for independent delirium assessments, research assistants must achieve a minimum of 95% agreement with the expert for 20 consecutive trials and will classify participants based on their scores over the 36-month follow-up period.
The four primary symptoms of delirium, essential for diagnosis, include acute onset and fluctuating course, inattention, disorganized thinking, and altered consciousness levels.
Study Outcomes
In evaluating the study outcomes, we will calculate mortality rates at 30 days, 60 days, 12 months, 24 months, and 36 months for both delirium and non-delirium cohorts. Length of stay (LOS) will be analyzed in 12-month intervals. Direct medical costs accrued solely for treatment during hospitalization will also be tracked and analyzed in 12-month cycles, as detailed in Table 1, which outlines a comprehensive summary of data collection timelines.
Ethical Considerations
This study has received the necessary approval from the Institutional Review Board (IRB) of Keimyung University (approval number: 40525-202012-HR-073-02). The study has been registered with ClinicalTrials.gov, overseen by the US National Institutes of Health (NCT05113446). All employed methods will comply with pertinent guidelines and regulations. Participants will provide informed consent in writing prior to study involvement, with provisions allowing legal representatives to give consent for individuals with cognitive impairments. To ensure confidentiality, all collected data will be anonymized and associated with unique identification numbers to protect participant privacy.
Statistical Analysis
Statistical analyses will be conducted using SPSS software (version 24.0, IBM, Armonk, NY). General characteristics of participants will be articulated through descriptive statistics. Differences in the general characteristics, risk factors, and therapeutic factors will be assessed using chi-square tests and independent t-tests. Kaplan-Meier survival analysis and Cox proportional hazard regression will evaluate effects on mortality across specified timeframes. In addition, linear regression will be employed to assess length of stay and associated medical costs, ensuring a thorough analytical approach.
Unlocking the Secrets of MCI: A Study with a Twist!
Welcome, dear readers, to a journey through the fascinating realm of cognitive impairment! Today, we’ve got a little gem of a study that aims to tackle the notorious conversion of Mild Cognitive Impairment (MCI) to dementia. So, grab your tea, and let’s dive headfirst into the world of statistics, assessments, and—don’t forget—delirium!
The Study Design: Predicting the Future!
Now, before you roll your eyes, let’s talk about the design of this prospective cohort study. A two-parallel group masterpiece! Yes, that’s right, folks—think of it as the cognitive training wheels for the elderly. Baseline assessments will be your trusty GPS, helping researchers estimate how often one might transition from the everyday ‘senior moment’ to full-blown dementia. And as if that wasn’t enough, they’re sticking to the STROBE guidelines like a student eyeing their crush—committed and well-documented!
Participants: Who’s In and Who’s Out?
Speaking of rules, let’s chat about the guest list for this exclusive cognitive soirée. Inpatients aged 65 and above who “I’m-a-witness!” scored between 18 and 23 on the Korean MMSE get in. What about those who can’t tug at the S-CAM strings? Sorry, no entry! It’s like a club with a strict bouncer—no severe mental health issues or hearing troubles allowed—because we wouldn’t want any misunderstandings here, would we?
Data Collection: The Paper Trail
Let’s not kid ourselves, data collection is like assembling IKEA furniture: a little frustrating but oh-so-rewarding once it’s done! Researchers will be gathering vital stats like age, sex, and education level through electronic medical records. They’ll also dabble in assessing risk factors for delirium with fancy terms like “water-electrolyte imbalance” (sounds like a condition I had after a night out, doesn’t it?).
Delirium Assessment: The Lowdown
To bring clarity (pun intended), trained research assistants will assess delirium using S-CAM—a test so rigorous it makes boot camp look like a walk in the park! Twice daily, these assessors will channel their inner drill sergeant to ensure every participant is evaluated properly. Only the best of the best are allowed to score “pass” and continue the assessment.
Outcomes: What Will We Learn?
Alright, drum roll please! The primary outcomes will include mortality rates at various stages—30 days, 60 days, up to a whole three years. We’ll also get to analyze hospital length of stay and medical costs because nothing says “I care” like accounting for every Won spent!
Ethics in Research: Handshakes and High Fives!
But wait! Before we dive into the numbers and calculations, there’s the golden rule of research: ethics. Yes, this study has received the all-important nod from the Institutional Review Board. Informed consent is obtained, so don’t worry, folks—the participants are all in the loop, and their identities will be wrapped up tighter than a grandmother’s secret cookie recipe!
Statistical Shenanigans: The Final Act
Last but certainly not least, let’s touch on the magic of statistics. The team will employ SPSS software—because who doesn’t love fancy acronyms? They’ll use it to make sense of the data and figure out how, when, and why our dear participants might convert from MCI to dementia. Spoiler: it’s going to involve numbers, graphs, and maybe a few baffled looks!
Conclusion: A Study Worth Watching
So there you have it! A prospective cohort study that isn’t just a bunch of numbers and acute assessments—it’s the gateway to understanding and potentially changing the landscape of cognitive impairment! With a mix of rigorous research, ethical rigor, and a dash of humor, this study promises to shed light on the often murky waters of MCI and dementia. Who knows? It might even help us all prevent that daunting “where are my glasses?” moment in the future!
Until next time, keep those neurons firing, and remember—don’t just count the years, make the years count!
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As we journey through the outcomes of this meticulously designed study, we’ll be cracking the code of mortality rates—a heavy-duty assessment! Every 30 days, and then at 60 days, 12, 24, and 36 months, we’ll be quantifying how many participants are still in the game, both in the delirium and non-delirium cohorts. “How long do they stay in the hospital?” you might ask—great question! Length of stay will be analyzed in 12-month intervals, ensuring that we leave no stone (or bed) unturned.
And guess what? We’re not just tallying heads; we’ll also be tracking the direct medical costs associated with treating these lovely participants during their hospital stays. It’s like a financial audit, but with the added bonus of helping us understand the economic burden of MCI and its complications!
Ethical Considerations: The Good Stuff
Before we dive into the number-crunching like kids in a candy store, let’s take a moment for the ethical side of things. This research has received the nod from the Institutional Review Board (IRB) of Keimyung University—think of them as the wise elders who give the thumbs up for everything to be done right! Participants will provide informed consent, and legal representatives can step in for those with cognitive impairments. The confidentiality of all data? Safeguarded, of course, as each participant’s info will be anonymized with unique IDs. We’d like to keep things private and secure!
Statistical Analysis: Crunching the Numbers!
Now, let’s talk stats! Pulling out the heavy artillery, SPSS software will assist in filtering through the data to uncover meaningful insights. The researchers are armed with about every statistical test in the book—chi-square tests, independent t-tests, Kaplan-Meier survival analysis, Cox proportional hazard regression, and more! It’s truly a statistical buffet, ensuring that they analyze participants’ general characteristics, risk factors, and therapeutic interventions to their heart’s content. Length of stay and medical costs will be dissected using linear regression, rounding out this comprehensive analytical landmine of insights.
Conclusion: What Lies Ahead?
As we close the curtain on this captivating study, it’s hard not to get excited about the potential revelations that could stem from these assessments. Researchers aim to develop a robust artificial intelligence algorithm—a visionary endeavor that could set the standard for predicting the shift from mild cognitive impairment to dementia. So, dear readers, stay tuned! The unfolding journey of data collection, analysis, and ultimately the quest for better predictions in cognitive health is just beginning, and it’s bound to be a ride filled with surprises and valuable insights into our aging population. Who knew studying cognitive impairment could be this invigorating? Until next time!