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Michael J Fisch,1 Michael Grabner,2 Daniel S Mytelka,3 Amit D Raval,2 Lee Bowman,3 David M Kern,2 Collin Churchill,3 Joseph Singer,2 Stewart Wetmore,3 John Barron,2 Michael Eleff4 1AIM Specialty Health, Chicago, IL, USA; 2HealthCore, Inc., Wilmington, DE, USA; 3Eli Lilly and Company, Indianapolis, IN, USA; 4Anthem, Inc., Indianapolis, IN, USACorrespondence: Michael GrabnerHealthCore, Inc., 123 Justison St, Suite 200, Wilmington, DE 19801, USATel +1 302-230-2000Fax +1 302-230-2020Email mgrabner@healthcore.comObjective: Choosing chemotherapy for metastatic colorectal cancer (mCRC) requires balancing clinical effectiveness and risk of complications. This study characterized real-world inpatient/emergency department (ED) hospitalizations during first-line chemotherapy among individuals with mCRC.Methods: This retrospective cohort study used data from medical and pharmacy claims. All patients had mCRC with ≥ 1 claim for ≥ 1 of the 5 most frequently utilized first-line chemotherapy agents (fluorouracil, oxaliplatin, bevacizumab, irinotecan, capecitabine). The main outcome was all-cause hospitalizations (inpatient or ED setting) identified from claims via ICD-9/10-CM coding from index date until 30 days after the end of first-line chemotherapy or last available data.Results: A total of 717 individuals (mean age 55 years; 58% male; ECOG 0/1/2+/missing in 44%/39%/6%/11%; median follow-up 116 days) met study criteria. Thirty-four distinct chemotherapy regimens were used. Overall, 40% of patients had ≥ 1 hospitalization (n=285; total 415 hospitalizations); 12% (n=85) had ≥ 2 hospitalizations. The median time to first hospitalization was 52 days; median inpatient length of stay was 4 days; infections/neutropenia (21%) and bowel-related complications (17%) were the most common issues associated with inpatient hospitalizations. In univariate analyses, insurance plan type, geographical location, ECOG, and renal disease were associated with hospitalization. In multivariable analyses, ECOG ≥ 1 was associated with a 67% increase (p< 0.01) in the odds of hospitalization vs ECOG= 0.Conclusion: Approximately 40% of patients with mCRC were hospitalized during the study period. Hospital stays were typically short. Further research is needed to determine how many of these hospitalizations may be avoidable. We also observed a large amount of variation in regimens used in the first-line setting.Keywords: colorectal cancer, chemotherapy-associated hospitalization, outcomes research, observational study, claims analysis

Sinusitis due to unusual fungal pathogens is thought to occur primarily in immunocompromised individuals. However, the fungi Curvularia, Drechslera, and others produce sinusitis in healthy young adults. The signs and symptoms produced by these organisms are usually considered to be complications of sinusitis. Of the three cases that we report, two manifested decreased visual acuity, and the third presented with acute onset of seizures. Computed tomography scans were helpful in delineating the extent of disease and in following the results of therapy. Aggressive surgical treatment is necessary; indeed, two of our cases required a second operation to eradicate all disease. If histopathology shows tissue invasion by the fungus, intravenous amphotericin B is recommended. Fungal cultures and smears should be obtained when healthy patients present with complications of sinusitis. [ABSTRACT FROM AUTHOR]

Uvulopalatopharyngoplasty (UPPP) is an operation that is frequently performed for the treatment of obstructive sleep apnea (OSA). While UPPP usually eliminates or decreases snoring and often reduces excessive daytime sleepiness, the decrease in the number of episodes of apnea and hypopnea, and the improvement in oxygen saturation (SaO2) have been less predictable. We compared preoperative and postoperative polysomnography (PSG) in 27 patients with OSA and found that no single PSG parameter could accurately reflect the changes in respiration seen after UPPP. We suggest that a combination of indices including the apnea index, the apnea and hypopnea index, the frequency and severity of decreases in SaO2, and the lowest SaO2 be used to assess the effect of UPPP. Using this combination we determined that 30% of our patients were markedly improved, 33% were somewhat improved, and 37% were unimproved. To rely solely on the patient's subjective improvement often results in overestimating the therapeutic results of surgery, whereas to rely only on one PSG parameter may underestimate or overestimate the degree of improvement. [ABSTRACT FROM AUTHOR]

Singer and Blom have recently reported a new surgical method for speech rehabilitation of the alaryngeal patient. The method consists of a tracheoesophageal, puncture (TEP) followed 2 to 3 days later by insertion of a silicone "duckbill" prosthesis which acts as a one-way valve allowing pulmonary air to enter and vibrate the esophagus but preventing aspiration. Along with more rapid acquisition of speech, the advantage of tracheoesophageal speech over esophageal speech is the greater volume of air flow through the vibrating segment of the esophagus, which allows smoother and more prolonged speech. Thirteen of our 18 patients (72%) who have undergone TEP are currently using tracheoesophageal speech. The complications associated with this procedure include the TEP tract closing, tracheal mucositis, stenosis of the tracheostoma, aspiration of the prosthesis, esophageal tear, and aspiration from the esophagus. Although we have encountered several problems, we enthusiastically endorse this procedure since it provides oral communication which is comparable to, and in many cases better than, that of the majority of esophageal speakers. [ABSTRACT FROM AUTHOR]

Abstracts from various medical journals are presented. "Endolymphatic Sac Surgery for Ménière's Disease: Long-term Results After Primary and Revision Surgery," from "Archives of Otolaryngology - Head and Neck Surgery" is presented. "Familial Predisposition for Psychiatric Disorder: Comparison of Subjects Treated for Cannabis-Induced Psychosis and Schizophrenia," from "Archives of General Psychiatry" is presented. "The Impact of a Vision Screening Law on Older Driver Fatality Rates," from "Archives of Opthalmology" is presented.

The aim of this study is to investigate the role of adenovirus and respiratory syncytial virus (RSV) in chronic sinusitis using the polymerase chain reaction (PCR) to assay for the viruses. PCR has proved to be more sensitive and specific than viral cultures and immunoassays in the detection of viruses. Adenovirus and RSV are among the most common viruses to cause upper respiratory tract infections. Sinus mucosa biopsies from 20 patients undergoing endoscopic sinus surgery were sterilely collected. Four specimens (20%) tested positive for RSV by PCR and none tested positive for adenovirus. Only one specimen tested positive for RSV and one for adenovirus by viral culture and immunofluorescence. Bacterial cultures tested positive in 40% of the 20 specimens. PCR can be used to detect RSV in patients with chronic sinusitis and PCR is more sensitive than viral culture and immunofluorescence techniques on sinus polyps and mucosa. [ABSTRACT FROM AUTHOR]

Introduction: Health system disruptions, caused by unexpected emergencies such as disease outbreaks, natural disasters, and cybercrimes, impact the delivery of routine preventative care. As comprehensive care providers, family physicians (FPs) devote significant time to prevention. However, without emergency and pandemic plans in place in primary care, FPs face added barriers to prioritizing and sustaining preventative care when health systems are strained, which was evident during the COVID-19 pandemic. This study aims to describe FPs' experiences providing preventative care during the COVID-19 pandemic and their perceptions of the impacts of disrupted preventative care in primary care settings., Methods: Using a qualitative descriptive approach, we conducted semistructured interviews with FPs across 4 provinces in Canada (i.e. Newfoundland and Labrador, Nova Scotia, Ontario, British Columbia) between October 2020 and June 2021 as part of a larger multiple case study. These interviews broadly explored the roles and responsibilities of FPs during the COVID-19 pandemic. Interviews were coded thematically and codes from the larger study were analysed further using an iterative, phased process of thematic analysis., Results: Interviews averaged 58 min in length (range 17-97 min) and FPs had a mean of 16.9 years of experience. We identified 4 major themes from interviews with FPs (n = 68): (i) lack of capacity and coordination across health systems, (ii) patient fear, (iii) impacts on patient care, and (iv) negative impacts on FPs. Physicians voiced concerns with managing patients' prevention needs when testing availability and coordination of services was limited. Early in the pandemic, patients were also missing or postponing their own primary care appointments. Change in the provision and coordination of routine preventative care had negative impacts on both patients and physicians, affecting disease incidence/progression, physician workload, and psychological wellbeing., Conclusion: During the COVID-19 pandemic, upstream care efforts were impacted, and FPs were forced to reduce their provision of preventative care. FPs contribute direct insight to primary care delivery that can support pandemic planning to ensure preventative care is sustained during future emergencies., (© The Author(s) 2022. Published by Oxford University Press.)

Family physicians play important roles throughout all stages of a pandemic response; however, actionable descriptions outlining these roles are absent from current pandemic plans. Using a multiple case study design, we conducted a document analysis and interviewed 68 family physicians in four Canadian regions. We identified roles performed by family physicians in five distinct stages of pandemic response: pre-pandemic, phased closure and re-opening, acute care crisis, vaccination, and pandemic recovery. In addition to adopting public health guidance to ensure continued access to primary care services, family physicians were often expected to operationalize public health roles (eg, staffing assessment centres), modulate access to secondary/tertiary services, help provide surge capacity in acute care facilities, and enhance supports and outreach to vulnerable populations. Future pandemic plans should include family physicians in planning, explicitly incorporate family physician roles, and ensure needed resources are available to allow for an effective primary care response.

Objective: (1) Describe the presenting symptoms and tumor characteristics of patients who are diagnosed with a vestibular schwannoma (VS) with normal hearing or symmetric hearing loss, and (2) report the prospective growth and treatment of each tumor., Methods: This is a retrospective cohort study of acoustic neuroma patients who were found to have a VS and normal or symmetric hearing loss at a single tertiary care academic center from 1999 to 2012. Medical records were reviewed collecting the following information: patient demographics, symptoms, MRI characteristics, and treatment modality., Results: 15/195 (7.7%) patients met criteria for the study. Dizziness was the most common presenting symptom occurring in 9 subjects (60%), followed by headache in 6 (40%), vision changes in 5 (33%), tinnitus in 5 (33%), and unilateral hearing loss in 1 (7%). The average tumor size was 1.07 cm (range 0.3-2.2 cm). Eight (53%) patients presented with intracanalicular tumors. Growth was observed in 6 subjects (40%) with average growth rate in those who exhibited mean growth of 1.8 mm per year. Treatment consisted of surgical removal in 4 cases (27%), gamma knife therapy in 1 (7%), and observation or loss to follow-up in 10 (66%)., Conclusions: The incidence of VS with normal hearing was 7.7% Patients with VSs who do not exhibit unilateral hearing loss present most commonly with dizziness. Most of our patients had small, intracanalicular tumors with the largest tumor measuring 2.2 cm in greatest dimension. Of those who were managed conservatively with repeat imaging and observation, most showed tumor growth., (Copyright © 2021 Elsevier Inc. All rights reserved.)

The International Multimorbidity Symposium was held in November 2019 at Western University to achieve three main objectives: to discuss progress and findings from various jurisdictions; to facilitate collaboration through group discussion to identify strategies to move multimorbidity research forward; and to create concrete plans to ensure advances in multimorbidity research and knowledge can be achieved through cross-national partnership. This event included keynote presentations, elevator pitch presentations and breakout sessions and there was a total of 35 attendees from eight countries, representing diverse disciplines and training levels. The overall themes arising from the event were: the importance of integrating the study and management of multimorbidity from both the primary care and public health perspectives; meaningful engagement and collaboration with patients and caregivers to understand key dimensions of multimorbidity; the considerable benefit of collaborative international partnerships; and the need to spread and scale innovations for health care systems that can better respond to the complex needs of patients and caregivers who are living with multimorbidity. Finally, it was well-acknowledged among the attendees that expanding the collaboration and discussion among international colleagues via in-person and virtual events will be important to move multimorbidity research forward., Competing Interests: Declaration of conflicting interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article., (© The Author(s) 2020.)

Objective: To examine the relationship between multimorbidity and mortality, and whether relationship varied by material deprivation/rural location and by age., Methods: Retrospective population-based cohort study conducted using 2013-14 data from previously created cohort of Ontario, Canada residents classified according to whether or not they had multimorbidity, defined as having 3+ of 17 chronic conditions. Adjusted rate ratios were calculated to compare mortality rates for those with and without multimorbidity, comparing rates by material deprivation/rural location, and by age group., Results: There were 13,581,191 people in the cohort ages 0 to 105 years; 15.2% had multimorbidity. Median length of observation was 365 days. Adjusted mortality rate ratios did not vary by material deprivation/rural location; overall adjusted mortality rate ratio was 2.41 (95% CI 2.37-2.45). Adjusted mortality rate ratios varied by age with ratios decreasing as age increased. Overall rate ratio was 14.7 (95% CI 14.48-14.91). Children (0-17 years) had highest ratio, 40.06 (95% CI 26.21-61.22). Youngest adult age group (18-24 years) had rate ratio of 9.96 (95% CI 7.18-13.84); oldest age group (80+ years) had rate ratio of 1.97 (95% CI 1.94-2.04)., Conclusion: Compared to people without multimorbidity, multimorbidity conferred higher risk of death in this study at all age groups. Risk was greater in early and middle adulthood than in older ages. Results reinforce the fact multimorbidity is not just a problem of aging, and multimorbidity leads not only to poorer health and higher health care utilization, but also to a higher risk of death at a younger age., Competing Interests: Declaration of conflicting interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article., (© The Author(s) 2020.)

Aptamers are functional nucleic acids that bind to a range of targets (small molecules, proteins or cells) with a high affinity and specificity. Chemically-modified aptamers are of interest because the incorporation of novel nucleobase components can enhance aptamer binding to target proteins, while fluorescent base analogues permit the design of functional aptasensors that signal target binding. However, since optimally modified nucleoside designs have yet to be identified, information about how to fine tune aptamer stability and target binding affinity is required. The present work uses molecular dynamics (MD) simulations to investigate modifications to the prototypical thrombin-binding aptamer (TBA), which is a 15-mer DNA sequence that folds into a G-quadruplex structure connected by two TT loops and one TGT loop. Specifically, we modeled a previously synthesized thymine (T) analog, namely 5-furyl-2'-deoxyuridine (5FurU), into each of the six aptamer locations occupied by a thymine base in the TT or TGT loops of unbound and thrombin bound TBA. This modification and aptamer combination were chosen as a proof-of-principle because previous experimental studies have shown that TBA displays emissive sensitivity to target binding based on the local environment polarity at different 5FurU modification sites. Our simulations reveal that the chemically-modified base imparts noticeable structural changes to the aptamer without affecting the global conformation. Depending on the modification site, 5FurU performance is altered due to changes in the local environment, including the modification site structural dynamics, degree of solvent exposure, stacking with neighboring bases, and interactions with thrombin. Most importantly, these changes directly correlate with the experimentally-observed differences in the stability, binding affinity and emissive response of the modified aptamers. Therefore, the computational protocols implemented in the present work can be used in subsequent studies in a predictive way to aid the fine tuning of aptamer target recognition for use as biosensors (aptasensors) and/or therapeutics.

Background: Late-life depression (LLD) is a disabling disorder and antidepressants are ineffective in as many as 60% of cases. Converging evidence shows a strong correlation between LLD and subsequent risk of cardiovascular disease. There is a need for new, well-tolerated, non-pharmacological augmentation interventions that can treat depressive symptoms as well as improve heart rate variability (HRV), an important prognostic marker for development of subsequent cardiovascular disease. Meditation-based techniques are of interest based on positive findings in other samples.AimsWe aimed to assess the efficacy of Sahaj Samadhi meditation (SSM), an underevaluated, standardised and manualised meditation intervention, on HRV and depressive symptoms., Method: Eighty-three men and women aged 60-85 years, with mild to moderate depression and receiving treatment as usual (TAU) were randomised to either the SSM or TAU arm. Those allocated to SSM attended 4 consecutive days of group meditation training, using personalised mantras followed by 11 weekly reinforcement sessions. HRV and Hamilton Rating Scale for Depression (HRSD; 17-item) score were measured at baseline and 12 weeks., Results: All time and frequency domain measures of HRV did not significantly change in either arm. However, there was significant improvement in the SSM arm, compared with TAU, on the HRSD (difference in mean, 2.66; 95% CI 0.26-5.05; P = 0.03)., Conclusions: Compared with TAU, SSM is associated with improvements in depressive symptoms but does not significantly improve HRV in patients with LLD. These results need to be replicated in subsequent studies incorporating a group-based, active control arm.Declaration of interestR.I.N. is the Director of Research and Health Promotion for the Art of Living Foundation, Canada and supervised the staff providing Sahaj Samadhi meditation. S.R. has received research funding from Satellite Healthcare for a mindfulness meditation trial in patients on haemodialysis. The remaining authors report no financial or other relationship relevant to the subject of this article.

Introduction: Targeted therapies, including tyrosine kinase inhibitors (TKIs) that target the sensitizing epidermal growth factor receptor (EGFR) gene are recommended for patients with non-small cell lung cancer (NSCLC). Most patients with NSCLC who test positive for the EGFR mutation and receive TKIs develop resistance to these drugs. Questions remain regarding which treatment sequence is optimal for patients with EGFR-mutant NSCLC, and few studies have evaluated patterns of TKI treatment use in NSCLC, irrespective of EGFR mutation status, in a real-world setting. This population-based study aimed to evaluate treatment patterns at a national level in the USA., Methods: This retrospective observational study used data from the US Oncology Network's iKnowMed database. Patients with advanced NSCLC who initiated first-line therapy with erlotinib and/or intravenous chemotherapy between January 1, 2012 and June 30, 2015 and met all other study criteria were included. Descriptive analyses assessed demographic and clinical characteristics and treatment patterns among the overall study cohort, as well as for specific erlotinib treatment subgroups, stratified by EGFR status., Results: Among the 3108 patients identified, 18.5% were EGFR positive, 49.8% were EGFR negative, and 31.7% were EGFR documented unknown. For the overall cohort, 18.4% received first-line erlotinib monotherapy, fewer than 1% received first-line combination therapy (erlotinib plus chemotherapy), 4.7% received second-line erlotinib monotherapy, and 3.3% received second-line combination therapy. First-line erlotinib monotherapy was used in 77.8% of all EGFR positive patients. Almost two-thirds of the overall cohort were not observed to have advanced to second-line therapy., Conclusions: As treatment options evolve, this study provides real-world treatment patterns that suggest concordance with NCCN guidelines and confirm the remaining need to understand sequencing of therapies and related outcomes., Funding: Eli Lilly and Company.

Objective: To determine the range of services and procedures offered by family physicians who define themselves as comprehensive practitioners and compare responses across 3 generations of alumni of a single family practice program., Design: Cross-sectional survey., Setting: Western University in London, Ont., Participants: All graduates of the family medicine program between 1985 and 2012., Main Outcome Measures: Self-reported provision of the following types of care: in-office care, in-hospital care, intrapartum obstetrics, housecalls, palliative care, after-hours care, nursing home care, minor surgery, emergency department care, sport medicine, and walk-in care. Sex, training site (urban or rural), size of community of practice, practice model, and satisfaction with practice were also reported., Results: Participants practised in 7 provinces and 1 territory across Canada, but principally in Ontario. A small number were located in the United States. There was a decline in the number of services provided across 3 generations of graduates, with newer graduates providing fewer services than the older graduates. Significant decreases across the 3 groups were observed in provision of housecalls ( P = .004), palliative care ( P = .028), and nursing home care ( P < .001). Non-significant changes were seen in provision of intrapartum obstetrics across the 3 alumni groups, with an initial decline and then increase in reported activity. Most respondents were in a family health organization or family health network practice model and those in such models reported offering significantly more services than those in family health group or salary models ( P < .001)., Conclusion: The normative definition of comprehensive care varies across 3 generations of graduates of this family medicine program, with newer physicians reporting fewer overall services and procedures than older graduates. Greater understanding of the forces (institutional, regulatory, economic, and personal) that determine the meaning of comprehensive primary care is necessary if this foundational element of family medicine is to be preserved., (Copyright© the College of Family Physicians of Canada.)

Objective: Determine the effect of complete malleus removal during canal wall up tympanomastoidectomy for cholesteatoma on ossiculoplasty success and rate of residual cholesteatoma., Methods: We reviewed the operative, audiogram, and clinical reports of patients who underwent canal wall up tympanomastoidectomy for cholesteatoma between 2009 and 2016 at a tertiary academic medical center with at least 8 months of follow-up after surgery. To control for extent of disease, we independently catalogued the subsites of the middle ear and mastoid that cholesteatoma involved from each operation. We performed multivariate logistic regression to determine the independent effect of complete removal of the malleus on the rate of residual disease and success of ossiculoplasty., Results: One hundred eighty surgeries were included in the analysis. For ossiculoplasty success, the adjusted odds ratio of complete malleus removal was 1.7 (95% CI, 0.43-7.0, P = .43), which was not statistically significant. For residual disease, the adjusted odds ratio of complete malleus removal versus not was 0.29 (95% CI, 0.074-1.1, P = .076), which approached but did not meet statistical significance., Conclusion: Though complete malleus removal does not independently decrease the rate of residual cholesteatoma, it may be a safe technique as it did not compromise ossiculoplasty success.

Aim: To assess the cost-effectiveness of first-line pemetrexed/platinum and other commonly administered regimens in a representative US elderly population with advanced non-squamous non-small cell lung cancer (NSCLC)., Materials and Methods: This study utilized the Surveillance Epidemiology and End Results (SEER) cancer registry linked to Medicare claims records. The study population included all SEER-Medicare patients diagnosed in 2008-2009 with advanced non-squamous NSCLC (stages IIIB-IV) as their only primary cancer and who started chemotherapy within 90 days of diagnosis. The study evaluated the four most commonly observed first-line regimens: paclitaxel/carboplatin, platinum monotherapy, pemetrexed/platinum, and paclitaxel/carboplatin/bevacizumab. Overall survival and total healthcare cost comparisons as well as incremental cost-effectiveness ratios (ICERs) were calculated for pemetrexed/platinum vs each of the other three. Unstratified analyses and analyses stratified by initial disease stage were conducted., Results: The final study population consisted of 2,461 patients. Greater administrative censorship of pemetrexed recipients at the end of the study period disproportionately reduced the observed mean survival for pemetrexed/platinum recipients. The disease stage-stratified ICER analysis found that the pemetrexed/platinum incurred total Medicare costs of $536,424 and $283,560 per observed additional year of life relative to platinum monotherapy and paclitaxel/carboplatin, respectively. The pemetrexed/platinum vs triplet comparator analysis indicated that pemetrexed/platinum was associated with considerably lower total Medicare costs, with no appreciable survival difference., Limitations: Limitations included differential censorship of the study regimen recipients and differential administration of radiotherapy., Conclusions: Pemetrexed/platinum yielded either improved survival at increased cost or similar survival at reduced cost relative to comparator regimens in the treatment of advanced non-squamous NSCLC. Limitations in the study methodology suggest that the observed pemetrexed survival benefit was likely conservative.

Background: The cost of cancer care is increasing, and tools are needed to understand the economic impact of new drugs on the hospital pharmacy budget., Objective: To develop an interactive budget impact model (BIM) through a collaborative effort of industry, academia, and modeling experts to evaluate the use of a new agent in non-small cell lung cancer (NSCLC); this BIM included an institutional module specific to the needs of practices that purchase medications for use in institutional settings., Methods: Treatment regimens, doses, duration of therapy, toxicity, and cost data are from published sources. All input data may be modified to match the local population. Outputs include cost of care, reimbursement, and margin overall and by treatment regimen., Results: The base case assumes 20 NSCLC patients progressing after initial therapy (3 receiving ramucirumab+docetaxel, 2 bevacizumab+erlotinib, 3 docetaxel, 6 erlotinib, and 6 pemetrexed), wholesale acquisition cost (WAC) purchase price, and reimbursement at WAC+4.3%. The model estimated the total cost and reimbursement for the institutional oncology pharmacy to be $699,413 and $729,487, respectively, resulting in a margin of $30,075 (difference due to rounding) for the year for regimens utilized in the treatment of NSCLC in the post-progression setting. Results will vary depending on the input data., Conclusions: There is an increasing need for institutional pharmacies to plan ahead and anticipate the impact of new drugs on their oncology budgets. This interactive Excel-based institutional BIM may provide evidence-based support for pharmacy decision making.

Late-life depression affects 2-6% of seniors aged 60 years and above. Patients are increasingly embracing non-pharmacological therapies, many of which have not been scientifically evaluated. This study aimed to evaluate a category of meditation, automatic self-transcending meditation (ASTM), in alleviating symptoms of depression when augmenting treatment as usual (NCT02149810). The preliminary results of an ongoing single-blind randomised controlled trial comparing a training programme involving ASTM with a wait-list control indicate that a 12-week ASTM programme may lead to significantly greater reductions in depression and anxiety severity. As such, ASTM may be an effective adjunctive therapy in the treatment of late-life depression., Declaration of Interest: R.I.N. is Director of Research and Health Promotion for the Art of Living Foundation, Canada and supervised the staff providing ASTM training., Copyright and Usage: © The Royal College of Psychiatrists 2016. This is an open access article distributed under the terms of the Creative Commons Non-Commercial, No Derivatives (CC BY-NC-ND) licence.

Background: The prevalence and socioeconomic cost of late life depression (LLD) is on the rise, while the response rate to antidepressant trials remains poor. Various mind-body therapies are being embraced by patients as they are considered safe and potentially effective, yet little is known regarding the effectiveness of such therapies to improve LLD symptoms. Among the mind-body therapies currently in practice, the results of our pilot study have shown that a particular meditation technique called Sahaj Samadhi Meditation, which belongs to the category of meditation termed automatic self-transcending meditation (ASTM) may have some promise in improving cardiovascular autonomic disturbances associated with LLD as well as ameliorating symptoms of depression and anxiety., Methods/design: Patients between the ages of 60 and 85 with LLD will be randomized either to ASTM plus treatment as usual (TAU) or TAU alone to assess changes in cardiovascular autonomic parameters, neuropsychological symptoms of depression and anxiety as well as quality of life. The instructional phase of the intervention consists of 4 consecutive days of meditation training, after which participants are encouraged to meditate twice daily for twenty minutes each time at home. The intervention also includes once weekly follow up sessions for the subsequent 11 weeks. The planned study has one and a half year recruitment period. Participants will be assessed at baseline and at 4, 8, 12 and 24 weeks post intervention., Discussion: This study should provide a unique data source from a randomized, controlled, longitudinal trial to investigate the effects of a form of ASTM on cardiovascular autonomic and neuropsychological health in LLD., Trial Registration: Clinicaltrials.gov NCT02149810, date registered: 05/28/2014.