Elderly Patient Population Research Articles

Should Buprenorphine Be Considered a First-Line Opioid for the Treatment of Moderate to Severe Cancer Pain?

Cancer pain remains a significant problem worldwide, affecting more than half of patients receiving anti-cancer treatment and most patients with advanced disease. Opioids remain the cornerstone of therapy, and morphine, given its availability, multiple formulations, price, and evidence base, is typically considered the first-line treatment for moderate to severe cancer pain. Buprenorphine has emerged in recent decades as an alternative opioid for treating chronic pain and substance use disorder (SUD). However, it remains controversial whether buprenorphine should be considered a first-line opioid for moderate to severe cancer pain. In this "Controversies in Palliative Care" article, three expert clinicians independently answer this question. Specifically, each group provides a synopsis of the key studies that inform their thought process, share practical advice on their clinical approach, and highlight the opportunities for future research. All three groups agree that there is a place for the use of buprenorphine as a first-line opioid in cancer pain. Specifically, they mention populations of elderly patients, patients with renal failure, and those with (SUD). They also underscore many unique and favorable characteristics of buprenorphine, such as the low risk for respiratory depression, lack of adverse effects on testosterone levels in men, no risk of serotonin syndrome when combined with antidepressants, and ease of use given its transdermal, transmucosal, and sublingual formulations. However, further studies are needed to guide the use of buprenorphine for cancer pain-primarily randomized clinical trials (RCTs) comparing buprenorphine with other opioids in various pain syndromes.

Palliative Care for Patients With Heart Failure With Preserved Ejection Fraction.

Heart failure with preserved ejection fraction (HFpEF) has become the leading form of heart failure worldwide, particularly among elderly patient populations. HFpEF is associated with significant morbidity and mortality that may benefit from incorporation of palliative care (PC). Patients with HFpEF have similarly high mortality rates to patients with heart failure with reduced ejection fraction. PC trials for heart failure have shown improvement in quality of life, quality of death, and health care utilization, although most trials defined heart failure clinically without differentiating between HFpEF and heart failure with reduced ejection fraction. As such, the timing and role of PC for HFpEF care remains uncertain, and PC referral rates for HFpEF are very low despite potential improvements in important patient-centered outcomes. Specific barriers to referral include limited data, prognostic uncertainty, provider misconceptions about PC, inadequate specialty PC workforce, complexities of treating multimorbidity, and limited home care options for patients with heart failure. While there are many barriers to integration of PC into HFpEF care, there are multiple potential benefits to patients with HFpEF throughout their disease course. As this population continues to grow, targeted efforts to study and implement PC interventions are needed to improve patient quality of life and death.

Electrolyte Disturbances Related to Sodium and Potassium and Electroconvulsive Therapy: A Systematic Review.

Electrolyte disturbances related to sodium and potassium affect patients with mental disorders undergoing electroconvulsive therapy (ECT). The objective of this study was to systematically summarize the data regarding ECT and electrolyte disturbances related to sodium and potassium. A systematic literature review in accordance with PRISMA guidelines was conducted. Clinical studies of patients receiving ECT with electrolyte disturbances reported before or after treatment were included. We identified nine case reports and two retrospective studies describing electrolyte abnormalities occurring before or after ECT. ECT was effective and safe in patients with hyponatremia and hypernatremia, including the elderly patient population. This treatment was also effective in treating psychiatric symptoms that may persist after ionic equalization. Electrolyte disturbances after ECT were rare. Reports have suggested that succinylcholine used as a muscle relaxant was the main cause of hyperkalemia after ECT. Electrolyte control is a crucial aspect of guiding ECT therapy. In the context of sodium-related disorders, it is critical to control patient hydration as part of therapy. In addition, succinylcholine should not be used in patients with immobilization, such as catatonia or neuroleptic malignant syndrome. It is necessary to conduct further studies to clarify whether electrolyte concentration affects ECT parameters and clinical efficacy. In addition, it is necessary to assess the influence of various anesthetics on these conditions during ECT. The result of this review should be interpreted bearing in mind the small number of studies conducted to date and the low quality of the evidence they provide.

Benefits and risks of revascularization in senile coronary artery disease patients: is there any optimal choice?

There has been an increase in the population of elderly patients with coronary artery disease (CAD) in recent years. Elderly and, especially, senile patients typically have comorbid conditions, multivessel coronary artery disease and coronary calcification, which make treatment more challenging. The available data from evidence-based medicine is not enough to determine the best treatment strategies for elderly patients, because large randomized clinical trials usually do not include elderly individuals with severe comorbidities. In the presented case, an 80-year-old patient with severe calcification and multivessel coronary artery disease experienced recurrent dissection of the left anterior descending artery (LAD) and stent thrombosis of the left main coronary artery (LMCA) during the second phase of percutaneous coronary intervention, which required the implantation of 8 stents and administration of glycoprotein IIb/IIIa inhibitors, leading to the clinical manifestation of gastrointestinal bleeding. An important feature of the presented case was the necessity to implant a large number of stents, which is a risk factor for restenosis. Various issues are discussed in this case, including the choice of optimal management strategy for an 80-year-old patient with multivessel coronary artery disease. Physicians had to make difficult decisions to achieve a balance between potential benefit and risk. In order to improve the management of elderly patients, further research is needed, as well as the accumulation and discussion of clinical data.

КАРЦИНОМА ИЗ КЛЕТОК МЕРКЕЛЯ: СОВРЕМЕННЫЕ ТЕНДЕНЦИИ ВРАЧЕБНОЙ ПРАКТИКИ

Merkel cell carcinoma (CM) is a rare but very dangerous (rapidly progressive) malignancy. The need for early detection of CM determines the importance and relevance of informing dermatologists, cosmetologists, doctors of other specialties about the current aspects of the diagnosis and treatment of this disease, despite its relatively rare occurrence. The review highlights modern approaches to the diagnosis and treatment of CM. Early treatment of CM is vital because the disease progresses extremely rapidly with the formation of distant metastases. For the treatment of CM at localized stages, positive results in terms of prognosis in patients are brought by the use of the standard of combined treatment: surgery with adjuvant radiation therapy. A good alternative is also to use of RT only. Effective therapy for late variants of CM includes the appointment of immune response checkpoint inhibitors. Immunotherapy provides a sustained response in a significant proportion of patients with metastatic or recurrent disease. However, in the population of elderly and debilitated patients, the use of immunotherapy is limited due to the development of adverse events. The tasks of determining the optimal therapy regimens with the best efficacy and drug safety profiles have been included in the programs for further clinical research and development.

Selecting cardiac magnetic resonance images suitable for annotation of pulmonary arteries using an active-learning based deep learning model

An increasing and aging patient population poses a growing burden on healthcare professionals. Automation of medical imaging diagnostics holds promise for enhancing patient care and reducing manpower required to accommodate an increasing patient-population. Deep learning, a subset of machine learning, has the potential to facilitate automated diagnostics, but commonly requires large-scaled labeled datasets. In medical domains, data is often abundant but labeling is a laborious and costly task. Active learning provides a method to optimize the selection of unlabeled samples that are most suitable for improvement of the model and incorporate them into the model training process. This approach proves beneficial when only a small number of labeled samples are available. Various selection methods currently exist, but most of them employ fixed querying schedules. There is limited research on how the timing of a query can impact performance in relation to the number of queried samples. This paper proposes a novel approach called dynamic querying, which aims to optimize the timing of queries to enhance model development while utilizing as few labeled images as possible. The performance of the proposed model is compared to a model trained utilizing a fully-supervised training method, and its effectiveness is assessed based on dataset size requirements and loss rates. Dynamic querying demonstrates a considerably faster learning curve in relation to the number of labeled samples used, achieving an accuracy of 70% using only 24 samples, compared to 82% for a fully-supervised model trained on the complete training dataset of 1017 images.

The role of medical speciality input in the management of older neurosurgical inpatients

Background With an increasing elderly population, the number of neurosurgical patients aged 65 and over is rising. Ageing is closely related to multimorbidity and frailty, which are both recognised risk factors for postoperative complications and mortality. Comanagement by geriatricians and surgeons has been shown to reduce the length of admission and improve postoperative outcomes in orthopaedics, but evidence for this in neurosurgical patients is limited. Aims To evaluate the demographics of the elderly neurosurgical population, and determine if input by medical teams or completion of frailty scores impacts patient outcomes. Methods A retrospective notes review and review of coding and HES data, including length of stay, number of comorbidities, and mortality rate, was collected for geriatric neurosurgery and spinal surgery patients 65 years and older who were discharged following inpatient admission from April 2019 – March 2020. Full medical notes were retrieved for patients with a length of stay exceeding 14 days, with data on frailty scores and involvement of medical teams collected. Statistical tests were applied to evaluate the difference in outcomes between those reviewed and those not reviewed by medical teams. Results Eighty-one patients had a length of stay over 14 days. 43% of these 81 patients were reviewed by medical teams during their admission. The mean length of stay was significantly shorter in those receiving medical input (22.8 ± 10.6 days vs 32.4 ± 16.0 days, p = 0.003). There was also a significant association between the completion of a frailty score and subsequent input by medical teams. Conclusions The reduction in length of stay observed when patients were reviewed by medical teams supports the role of elderly care physician comanagement in the elderly inpatient neurosurgical population.

A Fermented Wheat Germ Extract Contains Protein Components Active against NSCLC Xenografts In Vivo.

Non-small cell lung cancer (NSCLC) continues to be the leading cause of cancer-related deaths. Although advances have been made in the past decade to treat such tumors, most options induce multiple side effects, and many patients discontinue therapy due to toxicity. Thus, the need remains for non-toxic, effective NSCLC therapies, especially in an elderly patient population. Our lab has previously identified a protein fraction from the nutraceutical Avemar®-dubbed fermented wheat germ protein (FWGP)-with demonstrated efficacy in lymphoma models both in vitro and in vivo. Here, we show that FWGP also has anti-tumor activity in vitro and in vivo against lung cancer. In vitro cytotoxicity against multiple lung cancer cell lines yielded IC50 values comparable to those previously established with the parent product, Avemar. Further, significant A549 xenograft growth inhibition occurred in athymic nu/nu mice receiving FWGP in both pre-radiated and non-radiated models when compared to the untreated control. Encouragingly, mice treated with FWGP experienced no toxicities as detected by weight reduction or blood chemistry analysis. These data support the further study of FWGP as a potential non-toxic therapy for lung cancer and other oncologic indications.

A clinical trial of zosuquidar plus gemtuzumab ozogamicin (GO) in relapsed or refractory acute myeloid leukemia (RR AML): evidence of efficacy based on leukemic blast P-glycoprotein functional phenotype.

To evaluate safety, tolerability, potential efficacy, and pharmacodynamics (PD) of zosuquidar (Zos) in combination with gemtuzumab ozogamicin (GO) in elderly patients with relapsed or refractory (RR) acute myeloid leukemia (AML). Patients with RR AML (N = 41) were treated with Zos as a 48-h continuous intravenous infusion initiated 4h prior to a 2-h infusion of GO on days 1 and 15. P-glycoprotein (P-gp) status of the patients' leukemic blasts and PD determinations were assessed with ex vivo bioassays. Patient outcomes were analyzed for the total cohort and as stratified into P-gp-positive (P-gp +) and P-gp-negative (P-gp‒) subgroups. The eligible cohort exhibited a 34% overall remission rate (ORR), a composite of patients that exhibited complete remission (CR), CR with incomplete platelet recovery, or morphologic remission. Patients with 1st relapsed disease exhibited 40% ORR. P-gp phenotype did not significantly predict ORR. However, the P-gp + subgroup exhibited a greater median overall survival (OS) of 6.0months vs. 1.8months for patients in the P-gp‒ subgroup (p = 0.01). PD analyses revealed 90-95% inhibition of blast P-gp function during Zos infusion. Treatment related toxicities were observed and resolved with decrease or discontinued Zos or GO dosages. Zos plus GO elicited appreciable ORR for an elderly patient population with RR AML. The greater OS of the P-gp + subgroup vs. the P-gp‒ subgroup suggests that patients with P-gp + leukemic blasts were being more effectively targeted by GO with Zos co-therapy. The poorer OS of the P-gp‒ subgroup suggests activity of Zos-insensitive multidrug resistant mechanisms. NCT00233909; First posted October 06, 2005.

91 Yaşındaki Aktif Hastada Unstabil Pertorakhanterik Kırık Nedeniyle Uygulanan Proksimal Femoral Çivinin (PFN) Proksimalden İki Kez Kırılması

With prolonged life expectancy in society and an increasing elderly patient population, pertrochanterıc hip fractures have become more common. Particularly in unstable pertrochanteric hip fractures, Proximal Femoral Nail (PFN) is often preferred for internal rigid fixation of the fracture and early mobilization of the patient. Implant failure findings such as relapse or fracture of the proximal sliding screw after PFN, fracture of the distal screw, and fracture of the PFN from the proximal or distal area are rare. We present the case of an advanced-age active female patient with an unstable pertrochanteric hip fracture who developed two proximal PFN fractures after PFN, and we document the two revisions with PFN+ graft we introduced for her. We present this case because in the literature we had not encountered any 91-year-old patient who developed proximal PFN fractures twice without falling or high-energy trauma and who achieved union of the fracture with through revisions performed twice with PFN and graft.

Risk factors affecting hip fracture patterns in an elderly Korean patient population.

Hip fracture in the elderly patient population, particularly the Korean patient cohort, is one of the most serious complications of osteoporosis and currently increasing alongside age. In this study, we attempted to identify various factors that could either indicate the risk for an intertrochanteric or femoral neck fracture in an osteoporotic Korean hip fracture patient cohort ≥ 65 years old. A retrospective analysis of 168 patients was performed for those who underwent surgical treatment for either an intertrochanteric or femoral neck fracture at Daegu Catholic University Medical Center from January 2013 to December 2015. Inclusion criteria included patients who sustained a intertrochanteric or femoral neck fracture between the designated time frame, ≥65 years old, and of Korean ethnicity. Differences between the T-score and Z-score regarding bone mineral density (BMD) and the relationship between BMD and subtype of the fracture for the intertrochanteric (n = 92) and femoral neck fracture (n = 76) groups were obtained. Demographical factors (age, sex, weight, height, and body mass index [BMI]) were analyzed as potential risk factors for intertrochanteric or femoral neck fractures using software. Of the total 168 patients, mean weight and BMI values were found to be lower in the intertrochanteric fracture group (P = .033) compared to the femoral neck fracture group (P = .044). Additionally, Z-scores for the intertrochanteric fracture group were lower in the trochanter (P = .030), intertrochanteric (P = .029), and Ward's triangle (P = .029) regions. Regarding the intertrochanteric fracture group, the A3 subgroup showed lower T-scores of the trochanteric region than the A1 fracture subgroup (P = .010). In an elderly Korean hip patient cohort, lower body weight, BMI, and BMD Z-scores are correlated with a higher incidence of intertrochanteric fractures when compared to femoral neck hip fractures.

Epidemiology and treatment of proximal femoral fractures in the elderly U.S. population

Proximal femoral fractures are a serious complication, especially for elderly patients. Detailed epidemiological analyzes provide a valuable resource for stakeholders in the health care system in order to foresee future development possibly influenceable by adaption of therapeutic procedures and prevention strategies. This work aimed at answering the following research questions: (1) What are the incidence rates of proximal femoral fractures in the elderly U.S. population? (2) What is the preferred treatment procedure for these fractures? Proximal femoral fractures occurred between January 1, 2009 and December 31, 2019 in patients ≥ 65 years were identified from the Medicare Physician Service Records Data Base. The 5% sample of Medicare beneficiaries, equivalent to the records from approximately 2.5 million enrollees formed the basis of this study. Fractures were grouped into head/neck, intertrochanteric, and subtrochanteric fractures. The overall incidence rate, age and sex specific incidence rates as well as incidence rate ratios were calculated. Common Procedural Terminology (CPT) codes were used to identify procedures and operations. In 2019, a total number of 7982 femoral head/neck fractures was recorded. In comparison to 9588 cases in 2009, the incidence substantially decreased by 26.6% from 666.7/100,000 inhabitants to 489.3/100,000 inhabitants (z = − 5.197, p < 0.001). Also, in intertrochanteric fractures, a significant decline in the incidence by 17.3% was evident over the years from 367.7/100,000 inhabitants in 2009 to 304.0 cases per 100,000 inhabitants in 2019 (z = − 2.454, p = 0.014). A similar picture was observable for subtrochanteric fractures, which decreased by 29.6% (51.0 cases per 100,000 to 35.9 cases per 100,000) over the time period (z = − 1.612, p = 0.107). Head/neck fractures were mainly treated with an arthroplasty (n = 36,301, 40.0%). The majority of intertrochanteric fractures and subtrochanteric fractures received treatment with an intramedullary device (n = 34,630, 65.5% and n = 5870, 77.1%, respectively). The analysis indicated that the incidence of all types of proximal femoral neck fractures decreased for the population of elderly patients in the U.S. within the last decade. Treatment of head and neck fractures was mainly conducted through arthroplasty, while intertrochanteric and subtrochanteric fractures predominantly received an intramedullary nailing.

Fate After the Mustard Procedure for d-Transposition of the Great Arteries: Impact of Age, Complexity, and Atrial Tachyarrhythmias: A Single Center Experience

Patients with dextro transposition of the great arteries (d-TGA) after atrial switch procedure are at risk to develop heart failure and arrhythmias during long-term follow-up. The present study aims to add knowledge on the fate of subjects after Mustard procedure during long-term follow-up into adulthood. A single center, retrospective chart review analysis was conducted. All subjects who had Mustard-type atrial switch procedure between 1969 and 1994 at our institution were included. A total of 92 subjects were included. Early postoperative death was reported in 2 subjects. Long-term follow-up was available in 49 survivors. Of those, 6 individuals died during further follow-up. Sudden cardiac death was the most prevalent cause for fatal outcome. Mortality during long-term follow-up was associated with the presence of additional cardiovascular malformations (complex d-TGA). Sinus node dysfunction was observed in 65% of the patients and atrial tachyarrhythmias were common in adult survivors (63%). Implantation of a pacemaker or a cardioverter defibrillator was required in 31% and 45% of those surviving into adulthood. Complications were frequently observed during follow-up after either pacemaker or cardioverter defibrillator implantation (43%) with lead failure being the most frequent complication. The aging population of patients after Mustard procedure is facing challenging problems mainly resulting from a failing systemic right ventricle, presence of associated cardiac malformations and the presence of atrial baffles associated with relevant atrial scars. Age, associated cardiac malformations, and atrial tachyarrhythmias seem to play a major role in determining the fate of patients with d-TGA after atrial switch procedures.

Patient perspectives on telemedicine during the COVID-19 pandemic: a mixed-methods community-based study

BackgroundDetailed community-based perspectives on patient experiences with telemedicine are currently lacking, yet essential to assess clinical applicability of telemedicine during and beyond pandemics, alike COVID-19. The aim of this study was to expose patient perspectives on virtual compared to in-person consultations, including determinants of these preferences.MethodsWe invited 5864 participants of the population-based Rotterdam Study to fill in a validated questionnaire using both close-ended and free-text questions. The questionnaire was sent on 30 July 2020, following a period of lockdowns and closures of non-essential workplaces. It assessed preferences for physician contact, healthcare utilisation, socioeconomic factors, and overall health. Those who experienced at least one virtual consultation (telephone or video call) between March 2020 and the beginning of July 2020 were asked whether those consultations were more, equally or less pleasant than in-person consultations, and to detail their experiences through free-text comments. These narrative data were examined using thematic analysis.Results4514 participants completed the questionnaire (response rate 77.0%, 58.7% women, mean age 70.8 ± 10.5 years). 1103 participants (24.4%) reported having had experience with virtual consultations. Half of these participants considered virtual consultations less pleasant than in-person consultations (N = 556; 50.4%), while 11.5% found it more pleasant. In total, we coded free-text comments of 752 participants. Prominent themes behind patient preferences for virtual or in-person consultations were lack of nonverbal communication, lack of physical examination, consultation scheduling, personal circumstances, and the presence of somatic and/or language barriers.ConclusionsBased on the experiences of a large elderly patient population, we showed that preference for virtual or in-person consultations is dependent on personal and situational variety, and their interplay. Healthcare providers should consider patients’ complex care needs and evaluate the potential added value of nonverbal communication and physical examination before scheduling a virtual consultation.

Modified Supine Percutaneous Nephrolithotomy in the Elderly: Outcomes and Safety.

With increases in the aging population, conditions affecting older people and relevant surgical techniques are becoming more pertinent. Modified supine percutaneous nephrolithotomy (PCNL) is increasingly being adopted. There are limited data on the safety of this position in the elderly patient population. We describe our experience of the modified supine position in patients aged 70 years and older. Between April 2011 and March 2021, patients aged 70 years and older undergoing a modified supine PCNL performed by a single surgeon were prospectively evaluated. Data including patient age, operative time, complications, stone clearance, and length of stay were collected and analysed. Sixty-nine procedures were performed on 67 patients with a mean age was 76.5 years. Median total operative time was 95 min with 20 (29%) patients having a combined procedure with ureterorenoscopy. Preoperative mean stone burden was 23.5 mm and complete stone clearance was achieved in 46 (66.7%) patients. Twelve (17.4%) patients had complications during their hospitalisation. Six were Clavien-Dindo class II or less and one Clavien-Dindo class V. The modified supine position for PCNL is safe in the elderly patient population and has advantages including reduced handling of patients and achieving adequate stone-free rates. These benefits are particularly important in the elderly population, which frequently has a reduced tolerance to adaptation.

Coincidence of normal pressure hydrocephalus and Alzheimer`s disease: therapeutic implications and open questions

Normal pressure hydrocephalus (NPH) is prevalent in aging patient populations. Despite its clinical relevance, many patients with NPH may not receive adequate treatment. Because of the frequency of Alzheimer`s disease in these patients, there could be overlapping pathophysiological mechanisms that are as yet incompletely understood. Cerebral comorbidities seem to have negative effects on therapeutic response to ventriculoperitoneal shunting. In order to avoid unnecessary and unsuccessful surgery in highly vulnerable elderly patients, they have to be taken into consideration in the diagnostic process.

Role of statins in clinical evolution of octogenarian patients admitted due to COVID-19

Introduction and objectivesCOVID-19 (Coronavirus disease 2019) causes high mortality in elderly patients. Some studies have shown a benefit of statin treatment in the evolution of this disease. Since there are no similar publications in this population group, the aim of this study is to analyze in-hospital mortality in relation to preadmission treatment with statins in an exclusively elderly population of octogenarian patients. Materials and methodsA single-center retrospective cohort study was performed including a total of 258 patients ≥80 years with hospital admission for confirmed COVID-19 between March 1 and May 31, 2020. They were divided into two groups: taking statins prior to admission (n = 129) or not (n = 129). ResultsIn-hospital mortality due to COVID-19 in patients ≥80 years (86.13 ± 4.40) during the first wave was 35.7% (95% CI: 30.1%–41.7%). Mortality in patients previously taking statins was 25.6% while in those not taking statins was 45.7%. Female sex (RR 0.62 [0.44–0.89]; P = .008), diabetes (RR 0.61 [0.41–0.92]; P = .017) and pre-admission treatment with statins (RR 0.58 CI 95% [0.41–0.83]; P = .003) were associated with lower in-hospital mortality. Severe lung involvement was associated with increased in-hospital mortality (RR 1.45 IC95% [1.04–2.03]; P = .028). Hypertension, obesity, age, cardiovascular disease and a higher Charlson index did not, however, show influence on in-hospital mortality. ConclusionsIn octogenarian patients treated with statins prior to admission for COVID-19 in the first wave, lower in-hospital mortality was observed.

Development and Validation of a Delirium Risk Prediction Model for Elderly Patients Undergoing Elective Orthopedic Surgery.

This study aimed to develop and validate a post-operative delirium (POD) nomogram in a population of elderly patients undergoing elective orthopedic surgery. A predictive model was developed based on a training dataset of 474 elderly patients undergoing elective orthopedic surgery from March 2021 to May 2022. POD was identified using the Confusion Assessment Methods (CAM). The least absolute shrinkage and selection operator (LASSO) method was used to screen risk factors, and prediction models were created by combining the outcomes with logistic regression analysis. We employ bootstrap validation for internal validation to examine the model's repeatability. The results were validated using a prospective study on 153 patients operated on from January 2022 to May 2022 at another institution. The predictors in the POD nomogram included age, the Mini-Mental State Examination(MMSE), sleep disorder, neurological disorders, preoperative serum creatinine (Pre-SCR), and ASA classification. The c-index of the model was 0.928 (95% confidence interval 0.898 ~ 0.957) and the bootstrap validation still achieved a high c-index of 0.912. The c-index of the external validation was 0.921. The calibration curve for the diagnostic probability showed good agreement between prediction by nomogram and actual observation. By combining preoperative and intraoperative clinical risk factors, we created a POD risk nomogram to predict the probability of POD in elderly patients who undergo elective orthopedic surgery. It could be a tool for guiding individualized interventions.

Geriatric assessment scores: Predictors of prognosis and premature end of treatment in the MARTA and MARiTA study population of elderly PCNSL patients &gt;65 years

Geriatric assessment scores: Predictors of prognosis and premature end of treatment in the MARTA and MARiTA study population of elderly PCNSL patients &gt;65 years

Telephone informed consent in a pragmatic point-of-care clinical trial embedded in primary care

BackgroundOne benefit of pragmatic clinical trials is reduction of the burden on patients and clinical staff while facilitating a learning healthcare system. One way to decrease the work of clinical staff is through decentralized telephone consent. MethodsThe Diuretic Comparison Project (DCP) was a nationwide Point of Care pragmatic clinical trial conducted by the VA Cooperative Studies Program. The purpose of the trial was to compare the clinical effectiveness on major CV outcomes of two commonly used diuretics, hydrochlorothiazide and chlorthalidone, in an elderly patient population. Telephone consent was allowed for this study because of its minimal risk designation. Telephone consent was more difficult than initially anticipated and the study team constantly adjusted methods to find timely solutions. ResultsThe major challenges can be categorized as call center-related, telecommunications, operational, and study population based. In particular, the possible technical and operational pitfalls are rarely discussed. By presenting hurdles here, future studies may avoid these challenges and start studies with a more effective system in place. ConclusionsDCP is a novel study designed to answer an important clinical question. The lessons learned from implementing a centralized call center for the Diuretic Comparison Project helped the study reach enrollment goals and develop a centralized telephone consent system that can be utilized for future pragmatic and explanatory clinical trials. Clinical trial registrationThe study is registered on ClinicalTrials.gov; NCT02185417 [https://clinicaltrials.gov/ct2/show/NCT02185417].The contents do not represent the views of the U.S. Department of Veterans Affairs or the United States Government.