Risks, indications and technical aspects of colonoscopy in elderly or frail patients. Position paper of the Societat Catalana de Digestologia, the Societat Catalana de Geriatria i Gerontologia and the Societat Catalana de Medicina de Familia i Comunitaria. / Riesgos, indicaciones y aspectos técnicos de la colonoscopia en pacientes de edad avanzada o con fragilidad. Documento de posicionamiento de la Societat Catalana de Digestologia, la Societat Catalana de Geriatria i Gerontologia i la Societat Catalana de Medicina de Familia i Comunitaria.

Colonoscopy (CS) is an invasive diagnostic and therapeutic technique, allowing the study of the colon. It is a safe and well tolerated procedure. However, CS is associated with an increased risk of adverse events, insufficient preparation and incomplete examinations in the elderly or frail patient (PEA/F). The objective of this position paper was to develop a set of recommendations on risk assessment, indications and special care required for CS in the PEA/F. It was drafted by a group of experts appointed by the SCD, SCGiG and CAMFiC that agreed on eight statements and recommendations, between them to recommend against performing CS in patients with advanced frailty, to indicate CS only if the benefits clearly outweigh the risks in moderate frailty and to avoid repeating CS in patients with a previous normal procedure. We also recommended against performing screening CS in patients with moderate or advanced frailty.

The Phase II Study of Panitumumab in Chemotherapy-Naïve Frail or Elderly Patients with RAS Wild-type Colorectal Cancer: OGSG 1602 Final Results.

BACKGROUND: We previously reported the response rate of a phase II OGSG1602 study on panitumumab in chemotherapy-naive frail or elderly patients with RAS wild-type unresectable colorectal cancer (CRC) [Terazawa T, Kato T, Goto M, et al. Oncologist. 2021;26(1):17]. Herein, we report a survival analysis. METHODS: Patients aged ≥65 years and considered unsuitable for intensive chemotherapy or aged ≥76 years were enrolled. Primary tumors located from the cecum to the transverse colon were considered right-sided tumors (RSTs); those located from the splenic flexure to the rectum were considered left-sided tumors (LSTs). RESULTS: Among the 36 enrolled patients, 34 were included in the efficacy analysis, with 26 and 8 having LSTs and RSTs, respectively. The median progression-free survival (PFS) and overall survival (OS) were 6.0 [95% CI, 5.4-10.0] and 17.5 months (95% CI, 13.8-24.3), respectively. Although no significant differences existed in PFS between patients with LST and RST {6.6 (95% CI, 5.4-11.5) vs. 4.9 months [95% CI, 1.9-not available (NA), P = .120]}, there were significant differences in OS [19.3 (95% CI, 14.2-NA) vs.12.3 months (95% CI, 9.9-NA), P = .043]. CONCLUSION: Panitumumab showed favorable OS in frail or elderly patients with RAS wild-type CRC and no prior exposure to chemotherapy. Panitumumab may be optimal for patients with LSTs (UMIN Clinical Trials Registry Number UMIN000024528).

Weekly chemotherapy as first line treatment in frail head and neck cancer patients in the immunotherapy era.

OBJECTIVE: First-line therapy for metastatic squamous cell carcinoma of the head and neck (R/M HNSCC) has been revolutionized by the introduction of anti-checkpoint monoclonal antibodies, which have shown a significant improvement in overall survival (OS) gaining approval in a first line setting. Efficacy and safety of first-line weekly chemotherapy, compared to 3-weeks treatment, was retrospectively evaluated in a frail patient population with R/M HNSCC with the aim to evaluate its role as part of a personalized first-line approach. METHODS: A total of 124 patients with locally incurable R/M HNSCC receiving weekly (21) or three-weekly (103) chemotherapy plus cetuximab in a first line setting from December 2010 to September 2020 were retrospectively reviewed. Treatment outcomes in terms of objective response rate (ORR), progression-free survival (PFS), overall survival (OS) and toxicities were analysed. RESULTS: Patients in the three-week subgroup were ECOG PS 0 (39) and 1 (64) while patients in weekly group (21) were all PS 2. No significant differences were reported in terms of age, sex, smoking and previous alcohol abuse considering the two distinct subgroups. Moreover, no statistically significant difference was found in PFS and OS between the two treatment subgroups. The response rate was 35% (36 patients) and 34% (7 patients) in three-week and weekly treatment group, respectively. Seventy patients (68%) in the three-week group experienced chemotherapy-related toxicities, predominantly G3. In the weekly group a predominantly low-grade toxicity was found in a lower number of patients (52%). CONCLUSION: The weekly schedule appears to be an active and safe strategy in frail patients with R/M HNSCC. Based on these data, a weekly schedule could be considered as a first line treatment in all frail patients excluded from pembrolizumab treatment and a study on the combination of weekly chemotherapy and immunotherapy should be performed.

Teleassistance for frail elderly people: A usability and customer satisfaction study.

Scientific advances and new information and communication technologies have facilitated the development of services that allow older people to stay at home as long as possible. In this study, we evaluated the usability and the patient satisfaction of a novel telemedicine system. All enrolled participants underwent a teleassistance program, which included remote surveillance and tele-counselling services with different health-care professionals, including nurses. We administered a specific questionnaire to assess the quality of the service and the patient satisfaction, whereas the System Usability Scale was used to evaluate the patient's usability of the system. Our findings showed that telemedicine might be useful in improving health and quality of life of disadvantaged older people, especially if affected by severe comorbidity and living far from health services. Moreover, the patient satisfaction concerning the service was rated as good by the majority of the participants, although the usability rate was not so high.

First-line single-agent panitumumab in frail elderly patients with wild-type RAS unresectable colorectal cancer: a phase II study protocol OGSG 1602.

BACKGROUND: A cytotoxic chemotherapeutic regimen is not routinely recommended for frail elderly patients with unresectable colorectal cancer (CRC) because of susceptibility to treatment. Panitumumab is a monoclonal antibody targeting the epidermal growth factor receptor (EGFR). Use of panitumumab as first-line therapy is expected to be well tolerated and to improve survival rates, even in patients who are not eligible for intensive chemotherapy. However, the efficacy and safety of panitumumab as the first-line therapy for the frail elderly patients with unresectable CRC have not been yet studied. METHODS: We plan to conduct a prospective multi-center phase II study. Patients with wild-type RAS unresectable CRC aged ≥76 years or ≥ 65 who are not considered eligible for intensive chemotherapy will be included in the study. A total of 36 patients will be enrolled from Osaka Gastrointestinal Cancer Chemotherapy Study Group for over 2 years. Panitumumab 6 mg/kg IV infusion will be administered every 2 weeks. The purpose of this trial is to assess the efficacy of panitumumab as first-line therapy for patients with unresectable CRC. The primary endpoint is to determine the disease control rate. Secondary endpoints include progression-free survival, overall survival, response rate, time to treatment failure, and the incidence of grade 3/4 toxicities. DISCUSSION: This is a prospective phase II trial assessing the efficacy of panitumumab monotherapy in the elderly patients with wild-type RAS unresectable CRC. TRIAL REGISTRATION: The ethics committee of the Osaka Medical College approved this study on November 7, 2016. The trial registration number of the government was UMIN000024528 on December 1, 2016. It was registered prospectively (the day of enrollment of the first participant was February 9, 2017).

Awake robotic liver surgery: A case report.

BACKGROUND: In recent years, minimally invasive liver resection has become a standard of care for liver tumors. Considering the need to treat increasingly fragile patients, general anesthesia is sometimes avoided due to respiratory complications. Therefore, surgical treatment with curative intent is abandoned in favor of a less invasive and less radical approach. Epidural anesthesia has been shown to reduce respiratory complications, especially in elderly patients with pre-existing lung disease. CASE SUMMARY: A 77-year-old man with hepatitis-C-virus-related chronic liver disease underwent robotic liver resection for hepatocellular carcinoma. The patient was suffering from hypertension, diabetes and chronic obstructive pulmonary disease. The National Surgical Quality Improvement Program score for developing pneumonia was 9.2%. We planned a combined spinal-epidural anesthesia with conscious sedation to avoid general anesthesia. No modification of the standard surgical technique was necessary. Hemodynamics were stable and bleeding was minimal. The postoperative course was uneventful. CONCLUSION: Robotic surgery in locoregional anesthesia with conscious sedation could be considered a safe and suitable approach in specialized centers and in selected patients.

Subcutaneous Emphysema as a Life-Threatening Complication of Metastatic Renal Cancer: A Case Report.

Subcutaneous emphysema (SE) could present as an emergency situation requiring appropriate management because of possible serious complications. While the diagnosis can be well established, its classification and treatment are not yet standardized. Herein we report the case of SE occurred in a young man after positioning of a thorax drainage because of a hydro-pneumothorax developed as a consequence of pulmonary metastases from clear cell renal carcinoma. Since there are no data correlating anatomo-clinical categorization with outcome and treatment of patients with SE, a "tailored- treatment" may be considered.

Short course radiotherapy and delayed surgery for locally advanced rectal cancer in frail patients: is it a valid option?

OBJECTIVE: The endpoint of the present study was to evaluate the outcomes of short-course radiotherapy (SCRT) and SCRT with delayed surgery (SCRT-DS) on a selected subgroup of frail patients with locally advanced middle/low rectal adenocarcinoma. METHODS: From January 2008 to December 2018, a total of 128 frail patients with locally advanced middle-low rectal adenocarcinoma underwent SCRT and subsequent restaging for eventual delayed surgery. Rates of complete pathological response, down-staging, disease free survival (DFS) and overall survival (OS) were analyzed. RESULTS: 128 patients completed 5 × 5 Gy pelvic radiotherapy. 69 of these were unfit for surgery; 59 underwent surgery 8 weeks (average time: 61 days) after radiotherapy. Downstaging of T occurred in 64% and down-staging of N in 50%. The median overall survival (OS) of SCRT alone was 19.5 months. The 1-year, 2-year, 3-year and 5-year OS was 48%, 22%, 14% and 0% respectively. In the surgical group, the median disease-free survival (DFS) and median OS were, respectively, 67 months (95% CI 49.8-83.1 months) and 72.1 months (95% CI 57.5-86.7 months). The 1, 2, 3, 5-year OS was 88%, 75%, 51%, 46%, respectively. Post-operative morbidity was 22%, mortality was 3.4%. CONCLUSIONS: Frail patients with advanced rectal cancer are often "unfit" for long-term neoadjuvant chemoradiation. A SCRT may be considered a valid option for this group of patients. Once radiotherapy is completed, patients can be re-evaluated for surgery. If feasible, SCRT and delayed surgery is the best option for frail patients.

Screening of the frail patient in the emergency department: A systematic review.

BACKGROUND: Several frailty rating scales have been developed to detect and screen for the level of frailty. It is uncertain what diagnostic value screening of frailty level have in the emergency department. AIM: To assess the accuracy of the screening tools used in the emergency department to detect frailty in patients≥65years by their ability to identify the risk of adverse outcomes. METHODS: An extensive medical literature search of Embase and PubMed was conducted, to identify studies using frailty screening scales in the emergency department. Data was subsequently extracted and evaluated from the results of the included studies. RESULTS: Four studies met the exact inclusion criteria. Four different frailty screening scales: Clinical Frailty Scale, Deficit Accumulation Index, Identification of Seniors At Risk and The Study of Osteoporotic Fracture frailty index used in the emergency department were described and compared. Predictive values for various outcomes are represented and discussed. CONCLUSIONS: The results suggest that frailty successfully predicts increased risk of hospitalization, nursing home admission, mortality and prolonged length of stay after an initial emergency department visit. Frailty does however not predict increased risk of 30day emergency department revisit. Further research highlighting the value of screening for frailty level in elderly emergency department patients is needed. LEARNING POINTS: Although frail elders in need of further geriatric assessment should be identified as soon as possible, this systematic review only identified four cohort studies of frailty assessment in emergency departments. Although frailty screening appeared to predict the risk of mortality and of admission to hospital/nursing home, these four studies did not show that it could predict return visits to emergency departments within 30days. Randomized clinical trials of frailty screening tools compared to usual care or other methods of assessment are clearly needed.

A novel organizational model to face the challenge of multimorbid elderly patients in an internal medicine setting: a case study from Parma Hospital, Italy.

Continuous increase of elderly patients with multimorbidity and Emergency Department (ED) overcrowding are great challenges for modern medicine. Traditional hospital organizations are often too rigid to solve them without consistently rising healthcare costs. In this paper we present a new organizational model achieved at Internal Medicine and Critical Subacute Care Unit of Parma University Hospital, Italy, a 106-bed internal medicine area organized by intensity of care and specifically dedicated to such patients. The unit is partitioned into smaller wards, each with a specific intensity level of care, including a rapid-turnover ward (mean length of stay <4 days) admitting acutely ill patients from the ED, a subacute care ward for chronic critically ill subjects and a nurse-managed ward for stable patients who have socio-economic trouble preventing discharge. A very-rapid-turnover ("come'n'go") ward has also been instituted to manage sudden ED overflows. Continuity, effectiveness, safety and appropriateness of care are guaranteed by an innovative figure called "flow manager," with skilled clinical experience and managerial attitude, and by elaboration of an early personalized discharge plan anticipating every patient's needs according to lean methodology principles. In 2012-2014, this organizational model, compared with other peer units of the hospital and of other teaching hospitals of the region, showed a better performance, efficacy and effectiveness indexes calculated on Regional Hospital Discharge Records database system, allowing a capacity to face a massive (+22 %) rise in medical admissions from the ED. Further studies are needed to validate this model from a patient outcome point of view.

Survival of patients ≥70 years with advanced chronic kidney disease: Dialysis vs. conservative care. / Supervivencia de pacientes de edad avanzada (≥70 años) con enfermedad crónica estadios 4-5: diálisis vs tratamiento conservador.

INTRODUCTION: The number of elderly patients with advanced chronic kidney disease (ACKD) has increased in recent years, and the best therapeutic approach has not been determined due to a lack of evidence. OBJECTIVES: To observe the progression of elderly patients with ACKD (stages 4 and 5) and to compare the survival of stage 5 CKD patients with and without dialysis treatment. MATERIAL AND METHODS: All patients ≥70 years who began ACKD follow-up from 01/01/2007 to 31/12/2008 were included, and their progression was observed until 31/12/2013. Demographic data, the Charlson comorbidity index, history of ischaemic heart disease (IHD) and diabetes mellitus (DM) were assessed. RESULTS: A total of 314 patients ≥70 years with stages 4 and 5 CKD were studied. Of these patients, 162 patients had stage 5 CKD at the beginning of follow-up or progressed to stage 5 during the study, and 69 of these patients were treated with dialysis. In the stage 5 group: median age was 77 years (74-81); 48% had IHD; 50% had DM, Charlson 7 (6-9). Kaplan-Meier survival analysis: ≥70 years (93 vs. 69 patients with dialysis, log rank: 15 P<.001); patients ≥75 years (74 vs. 46 patients with dialysis, log rank: 8.9 P=.003); patients ≥80 (40 vs. 15 patients with dialysis) and p=0,2. Patients receiving dialysis were younger, with a lower Charlson comorbidity index and shorter follow-up time. CONCLUSIONS: Our study shows that dialysis treatment improves survival, although this benefit is lost in patients ≥80 years.

Reducing the risk of hospital admission: a call to action from the Italian Society of Internal Medicine.

The belief that hospital stays may constitute per se a risk for patients is not widespread among patients and health care professionals. In the balance between advantages and disadvantages of admission, we rarely take into account the impact of the hospital stay itself on the well-being of the patient. In a society that is getting older the hospital may become a hostile environment for the complex and frail patient. Reducing the risks associated with hospital admission implies a radical cultural change accepted and shared by all health care professionals. The critical reconsideration of admission is a way of reasoning not only on hospitalisation but also on what the correct health outcome paradigms should be.

Frailty and risk in proximal aortic surgery.

OBJECTIVES: Although frailty has recently been examined in various populations as a predictor of morbidity and mortality, its effect on thoracic aortic surgery outcomes has not been studied. The objective of the present study was to evaluate the role of frailty in predicting postoperative morbidity and mortality in patients undergoing proximal aortic replacement surgery. METHODS: A retrospective analysis of a prospectively maintained database was performed for all patients undergoing elective and nonelective proximal aortic operations (root, ascending aorta, and/or arch) at a single-referral institution from June 2005 to December 2012. A total of 581 patients underwent proximal aortic surgery, of whom 574 (98.8%) were included in the present analysis; 7 were excluded because of incomplete data. Frailty was evaluated using an index consisting of age >70 years, body mass index <18.5 kg/m(2), anemia, history of stroke, hypoalbuminemia, and total psoas volume in the bottom quartile of the population. One point was given for each criterion met to determine a frailty score of 0 to 6. Frailty was defined as a score of ≥2. Risk models for length of stay >14 days, discharge to other than home, 30-day composite major morbidity, 30-day composite major morbidity/mortality, and 30-day and 1-year mortality were calculated using multivariate regression modeling. RESULTS: Of the 574 patients, 148 (25.7%) were defined as frail (frailty score ≥2). The unadjusted 30-day/in-hospital and long-term outcomes were significantly worse for the frail versus nonfrail patients in all but 1 of the outcomes analyzed; no difference was found in the 30-day readmission rates between the 2 groups. In the multivariate model, a frailty score of ≥2 was associated with discharge to other than home and 30-day and 1-year mortality. CONCLUSIONS: Frailty, as defined using a 6-component frailty index, can serve as an independent predictor of discharge disposition and early and late mortality risk in patients undergoing proximal aortic surgery. These frailty markers, all of which are easily assessed preoperatively, could provide valuable information for patient counseling and risk stratification before proximal aortic replacement.