Publications by authors named "Philip S����"

413 Publications

Future Care Planning: Concerns of Elderly Parents Caring for a Person With Serious Mental Illness.

Psychiatr Serv 2021 Jul 20:appips201900267. Epub 2021 Jul 20.

Department of Psychiatry, National Institute of Mental Health and Neurosciences, Bengaluru, India (Sivakumar, Philip, Chandra); Department of Psychiatry, All India Institute of Medical Sciences, Bhopal, India (Jain); Semel Institute on Neuroscience and Human Behavior, University of California, Los Angeles, and VA Greater Los Angeles Healthcare System at West Los Angeles, Los Angeles (Glynn).

Although recent advances in early treatment of people with serious mental illness have brought new hope to family members, parents of service users are still often left to worry about their loved one's future care. Without judicious planning, a parent''s death can be a catastrophic event that leaves an adult with serious mental illness without supports. This Open Forum emphasizes the benefits of mental health professionals being proactive and helping families and service users address concerns with future care planning. The active involvement of all stakeholders, including the person with mental illness, relatives, friends, mental health professionals, lawyers, and financial planners, can ensure proper care planning and promote better long-term outcomes.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1176/appi.ps.201900267DOI Listing
July 2021

Prospective Observational Study of Bisphosphonate-Related Osteonecrosis of the Jaw in Multiple Myeloma: Microbiota Profiling and Cytokine Expression.

Front Oncol 2021 24;11:704722. Epub 2021 Jun 24.

Institute for Genome Sciences, University of Maryland School of Medicine, Baltimore, MD, United States.

Purpose: Define incidence and risk factors of osteonecrosis of the jaw (ONJ) and explore oral microbial signatures and host immune response as reflected by cytokine changes in saliva and serum in multiple myeloma (MM) patients on bisphosphate (BP) therapy.

Patients And Methods: A single center observational prospective study of MM patients (n = 110) on >2 years of BP, none had ONJ at enrollment. Patients were followed every 3 months for 18 months with clinical/dental examination and serial measurements of inflammatory cytokines, bone turnover markers, and angiogenic growth factors. Oral microbiota was characterized by sequencing of 16S rRNA gene from saliva.

Results: Over the study period 14 patients (13%) developed BRONJ, at a median of 5.7 years (95% CI: 1.9-12.0) from MM diagnosis. Chronic periodontal disease was the main clinically observed risk factor. Oral microbial profiling revealed lower bacterial richness/diversity in BRONJ. , , and were abundant in controls; and were prevalent in BRONJ. In the saliva, at baseline patients who developed BRONJ had higher levels of MIP-1β; TNF-α and IL-6 compared to those without BRONJ, cytokine profile consistent with M-1 macrophage activation. In the serum, patients with BRONJ have significantly lower levels of TGF beta and VEGF over the study period.

Conclusion: Periodontal disease associated with low microbial diversity and predominance of invasive species with a proinflammatory cytokine profile leading to tissue damage and alteration of immunity seems to be the main culprit in pathogenesis of BRONJ.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.3389/fonc.2021.704722DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8263936PMC
June 2021

Sodium glucose-linked transport protein 2 inhibitors: An overview of genitourinary and perioperative implications.

Int J Urol 2021 Jun 22. Epub 2021 Jun 22.

Faculty of Medicine, The University of Queensland, Brisbane, Queensland, Australia.

Sodium glucose-linked transport protein 2 inhibitors are relatively novel drugs, used for the treatment of type 2 diabetes mellitus. Their use since Pharmaceutical Benefits Scheme approval in Australia has increased drastically, possibly due to the low risk of hypoglycemic events and their advertised cardiovascular mortality benefits. However, as with any novel drug, adverse effects regarding their use require medical practitioner awareness for optimal patient outcomes. This paper aims to cover the major urological implications, including those pertinent perioperatively, that concern this class of drugs. There is a clear risk of developing genital mycotic infections with the use of sodium glucose-linked transport protein 2 inhibitors, including serious infections such as Fournier's gangrene. Evidence for developing urinary tract infections has been mixed. Sodium glucose-linked transport protein 2 inhibitor-induced lower urinary tract symptoms may have impacts on quality of life via pollakiuria and nocturia, of which there are increased reports. Perioperative use increases the risk of euglycemic diabetic ketoacidosis. It is recommended that sodium glucose-linked transport protein 2 inhibitors be ceased perioperatively.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1111/iju.14624DOI Listing
June 2021

Impact of a targeted volume increase nutrition guideline on growth and body mass index (BMI) in premature infants: A retrospective review.

JPEN J Parenter Enteral Nutr 2021 Jun 11. Epub 2021 Jun 11.

University of Massachusetts Medical School, Department of Neonatology, Worcester, Massachusetts.

Background: The negative impact of disproportionate growth in premature infants is well documented, but optimal nutrition practices needed to prevent unhealthy body mass indices remains unclear.

Methods: An evidence-based volume increase guideline advanced feeding volumes from 150-160 to 170-180 milliliters per kilogram per day (ml/kg/d), between the post menstrual age (PMA) of 31 0/7 and 34 0/7 weeks was implemented in October 2017 for infants born ≤ 32 0/7 weeks GA. Data was collected on 262 infants' weight and length at birth and at discharge for 20 months before and 21 months after guideline implementation and retrospective analysis was conducted to determined disproportionate growth by comparing body mass indices [BMI (in g/cm )] at birth and at discharge. Changes in infants' body habitus were determined through bivariate analysis of weight and length z-scores from the Fenton growth curve.

Results: Implementation of a targeted volume nutrition guideline resulted in a reduction in infants with growth failure, defined as weight <10 percentile, (19.5% vs. 11.2% p = 0.06) at discharge. Infants who received the targeted nutrition guideline had a statistically significant reduction in disproportionally low BMI (8.6% vs. 2.5% p = 0.0380) and an increase in disproportionately high BMIs (4.3% vs. 12.3% p = 0.025). There was minor change in the percentage of disproportionately large infants who received the guidelines from birth to discharge (11.5% vs 12.3%).

Conclusions: A targeted volume increase nutrition guideline may prevent growth failure with some effects on disproportionate growth in preterm infants born ≤ 32 0/7 weeks gestational age. This article is protected by copyright. All rights reserved.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1002/jpen.2204DOI Listing
June 2021

The SARS-CoV-2 pandemic: the race to trace: contact tracing scale-up in San Francisco-early lessons learned.

J Public Health Policy 2021 Jun 4;42(2):211-221. Epub 2021 Jun 4.

Population Health Division, San Francisco Department of Public of Health, San Francisco, USA.

In order to effectively control spread of coronavirus 2019 (COVID-19), it is essential that jurisdictions have the capacity to rapidly trace close contacts of each and every case. Best practice guidance on how to implement such programs is urgently needed. We describe the early experience in the City and County of San Francisco (CCSF), where the City's Department of Health expanded contact tracing capability in anticipation of changes in San Francisco's 'shelter in place' order between April and June 2020. Important prerequisites to successful scale-up included a rapid expansion of the COVID-19 response workforce, expansion of testing capability, and other containment resources. San Francisco's scale-up offers a model for how other jurisdictions can rapidly mobilize a workforce. We underscore the importance of an efficient digital case management system, effective training, and expansion of supportive service programs for those in quarantine or isolation, and metrics to ensure continuous performance improvement.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1057/s41271-021-00285-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8175931PMC
June 2021

Dome shaped macula with serous macular detachment in an elderly myopic woman: Case report and review of literature.

Oman J Ophthalmol 2021 Jan-Apr;14(1):45-48. Epub 2021 Feb 27.

Department of Ophthalmology, Armed Forces Hospital, Seeb, Muscat, Oman.

Dome-shaped macula (DSM) is a recently described entity characterized by convex protrusion of the macula within a posterior staphyloma. Serous macular detachment is the most common complication, but the condition often remains stable despite lack of intervention. Spontaneous resolution of the condition has also been reported in many cases. The condition may be observed with periodic review with optical coherence tomography (OCT). We report a 56-year-old Omani woman, a high myope without significant ocular complaints who was incidentally detected to have bilateral DSM with serous macular detachment and review the literature regarding its diagnosis, pathogenesis, and treatment options. As the patient was asymptomatic, she was followed with serial OCTs for 6 months and is stable in terms of visual acuity and subretinal fluid.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.4103/ojo.OJO_181_2020DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8095312PMC
February 2021

Admission of persons with disabilities into nursing and midwifery courses: Progress made by the Indian Nursing Council.

Indian J Med Ethics 2020 Oct-Dec;V(4):1-18

Professor of Psychiatry, NIMHANS, Bengaluru. 560 029 INDIA.

India's Persons with Disabilities Act, 1995 (PWD Act, 1995) mandated a minimum enrollment reservation of 3% for persons with disability (PwDs) across all educational courses supported by government funding. Following this, the Indian Nursing Council (INC) issued regulations limiting such an enrollment quota to PwDs with lower limb locomotor disability ranging between 40%-50%. The Medical Council of India (MCI) also restricted admissions under the PwD category to PwDs with a lower limb locomotor disability to comply with the Act. The Rights of Persons with Disabilities (RPwD) Act, 2016, which replaced the PwD Act, 1995, raised the minimum reservation to 5% for all government-funded institutions of higher education and extended this reservation to PwDs under 21 different clinical conditions, rather than the seven conditions included under the PwD Act, 1995. Following the enactment of the RPwD Act, 2016, the MCI issued regulations that allowed PwDs with locomotor disability and those with a few other types of disabilities in the range of 40%-80%, to pursue graduate and postgraduate medical courses, while the INC has not made any changes. This article addresses the complexities of inclusion of PwDs in the healthcare workforce, offers suggestions for inclusive measures; and compares the INC admission regulation released in 2019 to the MCI 2019 admission guidelines for graduate and postgraduate medical courses.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.20529/IJME.2020.111DOI Listing
May 2021

Lithium-Induced Gastroparesis in a Newly Diagnosed Bipolar Disorder Patient.

Am J Ther 2021 Apr 13. Epub 2021 Apr 13.

Department of Medicine, Albany Medical Center. Albany, NY Department of Gastroenterology, Albany Medical Center. Albany, NY.

View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1097/MJT.0000000000001374DOI Listing
April 2021

Challenges in psychiatry training in India: Perspectives of early career psychiatrists.

Asian J Psychiatr 2021 06 10;60:102657. Epub 2021 Apr 10.

Department of Psychiatry, National Institute of Mental Health and Neurosciences, Bangalore, 560029, India.

View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.ajp.2021.102657DOI Listing
June 2021

Portal Vein Thrombosis-a Rare Complication of SARS-CoV-2 Infection.

SN Compr Clin Med 2021 Apr 7:1-4. Epub 2021 Apr 7.

Military Hospital Ramgarh, Jharkand, India.

The SARS-CoV-2 is the causative organism for COVID-19 disease. It primarily affects the respiratory system. With time, some new extra-pulmonary manifestations of COVID-19 disease have been identified. Recent studies have shown that patients with SARS-CoV-2 infection may have a hypercoagulable state which explains the increased incidence of thrombotic events in these patients without any known risk factors. The most common thrombotic event described in these patients is pulmonary embolism. Intra-abdominal thrombosis is a rare thrombotic complication of COVID-19 disease. Here, we report a case of COVID-19 disease associated with acute portal vein thrombosis.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1007/s42399-021-00877-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8025736PMC
April 2021

A Quality Improvement Approach to Decreasing Postdischarge Acute Care Reuse Among Children With Asthma.

Hosp Pediatr 2021 May 6;11(5):478-484. Epub 2021 Apr 6.

Departments of Pediatrics.

Objectives: To reduce 7-day acute care reuse among children with asthma after discharge from an academic children's hospital by standardizing the delivery of clinical care and patient education.

Methods: A diverse group of stakeholders from our tertiary care children's hospital and local community agencies used quality improvement methods to implement a series of interventions within inpatient, emergency department (ED), and outpatient settings. These interventions were designed to improve admission, inpatient care, and discharge processes for children hospitalized because of asthma and included a focus on (1) resident education, (2) patient access to medication and asthma education, and (3) gaps in existing asthma clinical care pathways in the ED and ICU. The primary outcome was the rate of 7-day acute care reuse (combined hospital readmissions and ED revisits) after discharge from an index hospitalization for asthma, measured through a monthly review of electronic health record data and compared with a 6-month baseline period of reuse data.

Results: The mean 7-day reuse rate for asthma after discharge was 3.7% during the 6 months baseline period ( = 107) and 1.0% during the 15-month intervention period ( = 302). This included a shift in our median from 3.3% to 0% with an 8-month period of no 7-day reuse.

Conclusions: An interprofessional quality improvement team successfully achieved and sustained a 73% reduction in mean 7-day asthma-related acute care reuse after discharge by standardizing provider training, care processes, and patient education.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1542/hpeds.2020-002824DOI Listing
May 2021

Discovery of a potent, highly selective, and orally bioavailable inhibitor of CDK8 through a structure-based optimisation.

Eur J Med Chem 2021 Jun 26;218:113391. Epub 2021 Mar 26.

Drug Discovery and Development, Cancer Research Institute, Clinical and Health Sciences, University of South Australia, Adelaide, South Australia, 5000, Australia. Electronic address:

CDK8 is deregulated in multiple types of human cancer and is viewed as a therapeutic target for the treatment of the disease. Accordingly, the search for small-molecule inhibitors of CDK8 is being intensified. Capitalising on our initial discovery of AU1-100, a potent CDK8 inhibitor yet with a limited degree of kinase selectivity, a structure-based optimisation was carried out, with a series of new multi-substituted pyridines rationally designed, chemically prepared and biologically evaluated. Such endeavour has culminated in the identification of 42, a more potent CDK8 inhibitor with superior kinomic selectivity and oral bioavailability. The mechanism underlying the anti-proliferative effect of 42 on MV4-11 cells was studied, revealing that the compound arrested the G1 cell cycle and triggered apoptosis. The low risk of hepato- and cardio-toxicity of 42 was estimated. These findings merit further investigation of 42 as a targeted cancer therapeutic.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.ejmech.2021.113391DOI Listing
June 2021

Cost-saving medication therapy management for outpatients.

Perspect Clin Res 2021 Jan-Mar;12(1):14-20. Epub 2019 Sep 5.

Department of Clinical Pharmacy, Aster Medcity, Kochi, Kerala, India.

Objective: Medication costs comprise the majority of health system budgets and continue to increase faster than other health-care expenditures. The objective of this study is to evaluate the causes and monetary value of cost-saving prescription interventions made by clinical pharmacists in outpatient pharmacy.

Materials And Methods: Outpatient prescriptions were randomly audited for a period of 11 months (August 2017-June 2018) using a customized outpatient prescription audit tool integrated with computerized physician order entry. Drug-related problems were communicated to respective prescribers, and their response to each intervention was documented in accordance with PCNE classification. Both unit dose cost and anticipated dose cost savings were calculated to evaluate the monetary benefit for patients.

Results: Unit dose cost of INR 4875.73 and anticipated dose cost of INR 26890.8 were saved from outpatients. Majority of the prescribing errors were associated with therapeutic duplication (43.4%) and drug interaction (25.7%) that account for anticipated dose cost savings of INR 17812.65 for patients. Major contributory drug classes that reduced the cost of therapy were antibiotics (24.23%), proton-pump inhibitors (13.27%), and analgesics (12.34%). Prescribers' response to pharmacist intervention varied, 53% responded to stop the drug, 21% responded to change the brand, and 20% changed the frequency of administration. Necessary instructions were verbally given to patients without making any modification in the prescription for 3.2% ( = 10) of cost-saving interventions.

Discussion And Conclusion: As clinical pharmacist has the expertise to detect, resolve, and prevent medication errors, the development of clinical pharmacy practice in a hospital outpatient pharmacy will have a significant impact on reducing prescription errors and health-care cost also.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.4103/picr.PICR_164_18DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8011525PMC
September 2019

Tinospora cordifolia chloroform extract inhibits LPS-induced inflammation via NF-κB inactivation in THP-1cells and improves survival in sepsis.

BMC Complement Med Ther 2021 Mar 20;21(1):97. Epub 2021 Mar 20.

Plant Based Bioactives and Disease Biology Laboratory, Rajiv Gandhi Centre for Biotechnology, Thiruvananthapuram, 695014, India.

Background: Tinospora cordifolia (Willd).Miers is a perennial climbing medicinal shrub that has been traditionally used for the treatment of chronic inflammatory ailments. Our previous pre- clinical studies on anti-inflammatory effects, proved that the chloroform extract of T. cordifolia (CETC) suppressed the LPS induced up-regulation of pro-inflammatory biomarkers, hence, further follow up study was carried out to evaluate whether CETC can exhibit a protective effect against LPS induced lethal endotoxemia in vivo and also to analyze the impact of CETC pre-treatment on the secretion of pro-inflammatory cytokines in vitro by THP-1 cells.

Methods: To corroborate our previous preclinical studies on inflammation, we investigated the mechanism of the anti-inflammatory effect of T. cordifolia on THP-cells which were pre-incubated with CETC (30 min) and stimulated subsequently with LPS (1 μg/ml) for 20 h. Levels as well as gene expressions of various cytokines were compared with that of LPS alone incubated cells. Alongside, in vivo oral anti-inflammatory efficacy against LPS induced endotoxemia study was effectuated, wherein rats were administered with CETC 48, 24, 12 and 1 h prior to the injection of LPS and the survival of rats were monitored upto 10 days. Cytokine levels were quantified by ELISA. Nitrite levels were measured using Griess reagent. Expression of pro-inflammatory proteins was inspected in rat tissues by histochemical and immuno -histochemical examinations.

Results: CETC was able to down-regulate the up-regulation of pro-inflammatory biomarkers in THP-1 macrophages though blockade of NF-κB nuclear translocation and could improve the survival rate during endotoxemic episodes with a marked suppression of the tissue expression of pro-inflammatory proteins.

Conclusion: These findings concomitantly reveal the anti-inflammatory mechanism of CETC and support us to move forward for the development of drugs against disorders resulting from deregulated immune reactions.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1186/s12906-021-03244-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7980548PMC
March 2021

Community engagement to control dengue and other vector-borne diseases in Alappuzha municipality, Kerala, India.

Pathog Glob Health 2021 Jun 18;115(4):258-266. Epub 2021 Mar 18.

TD Medical College, Alappuzha, India.

Vector-borne diseases (VBDs) are a serious threat in many Indian states, including Kerala. Community-based decentralized planning and engagement are effective strategies that can make positive behavioral changes to control VBDs. This community-based implementation research was conducted during November 2016 - October 2018 in Alappuzha municipality in Kerala, India. It was conducted in two phases. In the first phase, formative research was conducted to know the community's profile and perceptions and thus to plan and develop an appropriate intervention. Baseline data on some entomological indicators were also collected. These data were used to assess the impact of the intervention by comparing with the post-intervention data. In the second phase, an intervention through the community's engagement was implemented in selected wards. The activities included the formation of community committees and the vector control and source reduction activities with the community engagement and inter-sectoral coordination. The intervention resulted in a positive change among the community to engage in vector control activities. These efforts along with inter-sectoral coordination resulted in successfully implementing vector source reduction activities. In both wards, pre- and post-intervention entomological data (house index: 16.7 vs 6.0 and 64.2 vs. 8.6; container index: 24.8 vs. 12.1 and 37.7 vs. 18.1; and Breteau index: 21.3 vs. 7.3 and 47.7 vs. 8.6) revealed a considerable vector source reduction. The findings of this study suggest considering and including community engagement in public health policy as the main thrust to control VBDs.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1080/20477724.2021.1890886DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8168773PMC
June 2021

Marked improvements in glycaemic outcomes following insulin pump therapy initiation in people with type 1 diabetes: a nationwide observational study in Scotland.

Diabetologia 2021 Jun 8;64(6):1320-1331. Epub 2021 Mar 8.

MRC Institute of Genetic and Molecular Medicine, University of Edinburgh, Edinburgh, UK.

Aims/hypothesis: Our aim was to assess the use of continuous subcutaneous insulin infusion (CSII) in people with type 1 diabetes in Scotland and its association with glycaemic control, as measured by HbA levels, frequency of diabetic ketoacidosis (DKA) and severe hospitalised hypoglycaemia (SHH), overall and stratified by baseline HbA.

Methods: We included 4684 individuals with type 1 diabetes from the national Scottish register, who commenced CSII between 2004 and 2019. We presented crude within-person differences from baseline HbA over time since initiation, crude DKA and SHH event-rates pre-/post-CSII exposure. We then used mixed models to assess the significance of CSII exposure, taking into account: (1) the diffuse nature of the intervention (i.e. structured education often precedes initiation); (2) repeated within-person measurements; and (3) background time-trends occurring pre-intervention.

Results: HbA decreased after CSII initiation, with a median within-person change of -5.5 mmol/mol (IQR -12.0, 0.0) (-0.5% [IQR -1.1, 0.0]). Within-person changes were most substantial in those with the highest baseline HbA, with median -21.0 mmol/mol (-30.0, -11.0) (-1.9% [-2.7, -1.0]) change in those with a baseline >84 mmol/mol (9.8%) within a year of exposure, that was sustained: -19.0 mmol/mol (-27.6, -6.5) (-1.7% [-2.5, -0.6]) at ≥5 years. Statistical significance and magnitude of change were supported by the mixed models results. The crude DKA event-rate was significantly lower in post-CSII person-time compared with pre-CSII person-time: 49.6 events (95% CI 46.3, 53.1) per 1000 person-years vs 67.9 (64.1, 71.9); rate ratio from Bayesian mixed models adjusting for pre-exposure trend: 0.61 (95% credible interval [CrI] 0.47, 0.77; posterior probability of reduction pp = 1.00). The crude overall SHH event-rate in post-CSII vs pre-CSII person-time was also lower: 17.8 events (95% CI 15.8, 19.9) per 1000 person-years post-exposure vs 25.8 (23.5, 28.3) pre-exposure; rate ratio from Bayesian mixed models adjusting for pre-exposure trend: 0.67 (95% CrI 0.45, 1.01; pp = 0.97).

Conclusions/interpretation: CSII therapy was associated with marked falls in HbA especially in those with high baseline HbA. CSII was independently associated with reduced DKA and SHH rates. CSII appears to be an effective option for intensive insulin therapy in people with diabetes for improving suboptimal glycaemic control.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1007/s00125-021-05413-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8099793PMC
June 2021

Interventions for preventing type 2 diabetes in adults with mental disorders in low- and middle-income countries.

Cochrane Database Syst Rev 2021 02 16;2:CD013281. Epub 2021 Feb 16.

Department of Health Sciences, University of York, York, UK.

Background: The prevalence of type 2 diabetes is increased in individuals with mental disorders. Much of the burden of disease falls on the populations of low- and middle-income countries (LMICs).

Objectives: To assess the effects of pharmacological, behaviour change, and organisational interventions versus active and non-active comparators in the prevention or delay of type 2 diabetes among people with mental illness in LMICs.

Search Methods: We searched the Cochrane Common Mental Disorders Controlled Trials Register, CENTRAL, MEDLINE, Embase and six other databases, as well as three international trials registries. We also searched conference proceedings and checked the reference lists of relevant systematic reviews. Searches are current up to 20 February 2020.

Selection Criteria: Randomized controlled trials (RCTs) of pharmacological, behavioural or organisational interventions targeting the prevention or delay of type 2 diabetes in adults with mental disorders in LMICs.

Data Collection And Analysis: Pairs of review authors working independently performed data extraction and risk of bias assessments. We conducted meta-analyses using random-effects models.

Main Results: One hospital-based RCT with 150 participants (99 participants with schizophrenia) addressed our review's primary outcome of prevention or delay of type 2 diabetes onset. Low-certainty evidence from this study did not show a difference between atypical and typical antipsychotics in the development of diabetes at six weeks (risk ratio (RR) 0.46, 95% confidence interval (CI) 0.03 to 7.05) (among a total 99 participants with schizophrenia, 68 were in atypical and 31 were in typical antipsychotic groups; 55 participants without mental illness were not considered in the analysis). An additional 29 RCTs with 2481 participants assessed one or more of the review's secondary outcomes. All studies were conducted in hospital settings and reported on pharmacological interventions. One study, which we could not include in our meta-analysis, included an intervention with pharmacological and behaviour change components. We identified no studies of organisational interventions. Low- to moderate-certainty evidence suggests there may be no difference between the use of atypical and typical antipsychotics for the outcomes of drop-outs from care (RR 1.31, 95% CI 0.63 to 2.69; two studies with 144 participants), and fasting blood glucose levels (mean difference (MD) 0.05 lower, 95% CI 0.10 to 0.00; two studies with 211 participants). Participants who receive typical antipsychotics may have a lower body mass index (BMI) at follow-up than participants who receive atypical antipsychotics (MD 0.57, 95% CI 0.33 to 0.81; two studies with 141 participants; moderate certainty of evidence), and may have lower total cholesterol levels eight weeks after starting treatment (MD 0.35, 95% CI 0.27 to 0.43; one study with 112 participants). There was moderate certainty evidence suggesting no difference between the use of metformin and placebo for the outcomes of drop-outs from care (RR 1.22, 95% CI 0.09 to 16.35; three studies with 158 participants). There was moderate-to-high certainty evidence of no difference between metformin and placebo for fasting blood glucose levels (endpoint data: MD -0.35, 95% CI -0.60 to -0.11; change from baseline data: MD 0.01, 95% CI -0.21 to 0.22; five studies with 264 participants). There was high certainty evidence that BMI was lower for participants receiving metformin compared with those receiving a placebo (MD -1.37, 95% CI -2.04 to -0.70; five studies with 264 participants; high certainty of evidence). There was no difference between metformin and placebo for the outcomes of waist circumference, blood pressure and cholesterol levels. Low-certainty evidence from one study (48 participants) suggests there may be no difference between the use of melatonin and placebo for the outcome of drop-outs from care (RR 1.00, 95% CI 0.38 to 2.66). Fasting blood glucose is probably reduced more in participants treated with melatonin compared with placebo (endpoint data: MD -0.17, 95% CI -0.35 to 0.01; change from baseline data: MD -0.24, 95% CI -0.39 to -0.09; three studies with 202 participants, moderate-certainty evidence). There was no difference between melatonin and placebo for the outcomes of waist circumference, blood pressure and cholesterol levels. Very low-certainty evidence from one study (25 participants) suggests that drop-outs may be higher in participants treated with a tricyclic antidepressant (TCA) compared with those receiving a selective serotonin reuptake inhibitor (SSRI) (RR 0.34, 95% CI 0.11 to 1.01). It is uncertain if there is no difference in fasting blood glucose levels between these groups (MD -0.39, 95% CI -0.88 to 0.10; three studies with 141 participants, moderate-certainty evidence). It is uncertain if there is no difference in BMI and depression between the TCA and SSRI antidepressant groups.

Authors' Conclusions: Only one study reported data on our primary outcome of interest, providing low-certainty evidence that there may be no difference in risk between atypical and typical antipsychotics for the outcome of developing type 2 diabetes. We are therefore not able to draw conclusions on the prevention of type 2 diabetes in people with mental disorders in LMICs. For studies reporting on secondary outcomes, there was evidence of risk of bias in the results. There is a need for further studies with participants from LMICs with mental disorders, particularly on behaviour change and on organisational interventions targeting prevention of type 2 diabetes in these populations.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1002/14651858.CD013281.pub2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8092639PMC
February 2021

Potent and orally bioavailable CDK8 inhibitors: Design, synthesis, structure-activity relationship analysis and biological evaluation.

Eur J Med Chem 2021 Mar 3;214:113248. Epub 2021 Feb 3.

Drug Discovery and Development, Cancer Research Institute, Clinical and Health Sciences, University of South Australia, Adelaide, South Australia, 5000, Australia. Electronic address:

CDK8 regulates transcription either by phosphorylation of transcription factors or, as part of a four-subunit kinase module, through a reversible association of the kinase module with the Mediator complex, a highly conserved transcriptional coactivator. Deregulation of CDK8 has been found in various types of human cancer, while the role of CDK8 in supressing anti-cancer response of natural killer cells is being understood. Currently, CDK8-targeting cancer drugs are highly sought-after. Herein we detail the discovery of a series of novel pyridine-derived CDK8 inhibitors. Medicinal chemistry optimisation gave rise to 38 (AU1-100), a potent CDK8 inhibitor with oral bioavailability. The compound inhibited the proliferation of MV4-11 acute myeloid leukaemia cells with the kinase activity of cellular CDK8 dampened. No systemic toxicology was observed in the mice treated with 38. These results warrant further pre-clinical studies of 38 as an anti-cancer agent.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.ejmech.2021.113248DOI Listing
March 2021

Commentary on Impact of COVID-19 and Lockdown on Children with ADHD and Their Families-An Online Survey and a Continuity Care Model.

Authors:
Sharad Philip

J Neurosci Rural Pract 2021 Jan 1;12(1):222. Epub 2021 Feb 1.

Department of Psychiatry, NIMHANS, Bangalore, Karnataka, India.

View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1055/s-0040-1721542DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7850914PMC
January 2021

Rationale and design of the pragmatic randomized trial of icosapent ethyl for high cardiovascular risk adults (MITIGATE).

Am Heart J 2021 05 28;235:54-64. Epub 2021 Jan 28.

Division of Research, Kaiser Permanente Northern California, Oakland, CA; Department of Health Systems Science, Kaiser Permanente Bernard J. Tyson School of Medicine, Pasadena, CA; Departments of Medicine (Nephrology), Epidemiology, and Biostatistics, University of California, San Francisco, San Francisco, CA; Department of Medicine (Nephrology), Stanford University, Palo Alto, CA.

Objective: The MITIGATE study aims to evaluate the real-world clinical effectiveness of pre-treatment with icosapent ethyl (IPE), compared with usual care, on laboratory-confirmed viral upper respiratory infection (URI)-related morbidity and mortality in adults with established atherosclerotic cardiovascular disease (ASCVD).

Background: IPE is a highly purified and stable omega-3 fatty acid prescription medication that is approved for cardiovascular risk reduction in high-risk adults on statin therapy with elevated triglycerides. Preclinical data and clinical observations suggest that IPE may have pleiotropic effects including antiviral and anti-inflammatory properties that may prevent or reduce the downstream sequelae and cardiopulmonary consequences of viral URIs.

Methods: MITIGATE is a virtual, electronic health record-based, open-label, randomized, pragmatic clinical trial enrolling ∼16,500 participants within Kaiser Permanente Northern California - a fully integrated and learning health care delivery system with 21 hospitals and >255 ambulatory clinics serving ∼4.5 million members. Adults ≥50 years with established ASCVD and no prior history of coronavirus disease 2019 (COVID-19) will be prospectively identified and pre-randomized in a 1:10 allocation ratio (∼ 1,500 IPE: ∼15,000 usual care) stratified by age and previous respiratory health status to the intervention (IPE 2 grams by mouth twice daily with meals) vs the control group (usual care) for a minimum follow-up duration of 6 months. The co-primary endpoints are moderate-to-severe laboratory-confirmed viral URI and worst clinical status due to a viral URI at any point in time.

Conclusion: The MITIGATE study will inform clinical practice by providing evidence on the real-world clinical effectiveness of pretreatment with IPE to prevent and/or reduce the sequelae of laboratory-confirmed viral URIs in a high-risk cohort of patients with established ASCVD.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.ahj.2021.01.018DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7843090PMC
May 2021

Experiential account of risk mitigation strategies in a tertiary care psychiatric setting during COVID-19 pandemic.

Asian J Psychiatr 2021 02 12;56:102556. Epub 2021 Jan 12.

Department of Psychiatry, National Institute of Mental Health and Neuro Sciences (NIMHANS), Hosur Road, Bengaluru, 560029, India; National Institute of Mental Health and Neuro Sciences (NIMHANS), Hosur Road, Bengaluru, 560029, India.

View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.ajp.2021.102556DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7834503PMC
February 2021

Reasonable Accommodation at the Workplace for Professionals with Severe Mental Illness: A Qualitative Study of Needs.

Indian J Psychol Med 2020 Sep 11;42(5):445-450. Epub 2020 Aug 11.

Psychiatric Rehabilitation Services, Dept. of Psychiatry, National Institute of Mental Health and Neurosciences, Bengaluru, Karnataka, India.

Background: Professionals with Severe Mental Illness (PwSMI) often face challenges in obtaining and retaining employment. For equal and effective participation, they may require reasonable workplace adjustments. The recently legislated Rights of Persons With Disabilities Act 2016 in India defines such adjustments as reasonable accommodations.

Methods: In-depth qualitative interviews were conducted with 15 consenting PwSMI availing psychiatric rehabilitation services at a tertiary mental health institute in India, five mental health professionals, and five employers. The audio-recorded interviews were transcribed and coded manually by two independent investigators. Inductive content analysis approach was used for qualitative analysis.

Results: The detected themes included modifications in work schedule, supports to improve work efficiency, modifications in the work environment, modifications in the work-related appraisal, supportive employer policy, and integration of services. The participants described the term "undue burden" to be ambiguous.

Conclusions: The reported reasonable accommodations are non-structural and mainly dependent on human assistance. Vocational rehabilitation and job reintegration efforts can focus on guided negotiations between employers and PwSMI. This is dependent on at least some degree of disclosure. Awareness regarding reasonable accommodation and stigma reduction is necessary for successful implementation.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1177/0253717620939771DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7750859PMC
September 2020

Early COVID-19 Successes in Skilled Nursing Facilities in San Francisco.

J Am Geriatr Soc 2020 12 8;68(12):2744-2745. Epub 2020 Sep 8.

San Francisco Department of Public Health, San Francisco, California, USA.

View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1111/jgs.16765DOI Listing
December 2020

Risks of and risk factors for COVID-19 disease in people with diabetes: a cohort study of the total population of Scotland.

Lancet Diabetes Endocrinol 2021 02 23;9(2):82-93. Epub 2020 Dec 23.

Health Protection Scotland, College of Medicine and Veterinary Medicine, University of Edinburgh, Edinburgh, UK.

Background: We aimed to ascertain the cumulative risk of fatal or critical care unit-treated COVID-19 in people with diabetes and compare it with that of people without diabetes, and to investigate risk factors for and build a cross-validated predictive model of fatal or critical care unit-treated COVID-19 among people with diabetes.

Methods: In this cohort study, we captured the data encompassing the first wave of the pandemic in Scotland, from March 1, 2020, when the first case was identified, to July 31, 2020, when infection rates had dropped sufficiently that shielding measures were officially terminated. The participants were the total population of Scotland, including all people with diabetes who were alive 3 weeks before the start of the pandemic in Scotland (estimated Feb 7, 2020). We ascertained how many people developed fatal or critical care unit-treated COVID-19 in this period from the Electronic Communication of Surveillance in Scotland database (on virology), the RAPID database of daily hospitalisations, the Scottish Morbidity Records-01 of hospital discharges, the National Records of Scotland death registrations data, and the Scottish Intensive Care Society and Audit Group database (on critical care). Among people with fatal or critical care unit-treated COVID-19, diabetes status was ascertained by linkage to the national diabetes register, Scottish Care Information Diabetes. We compared the cumulative incidence of fatal or critical care unit-treated COVID-19 in people with and without diabetes using logistic regression. For people with diabetes, we obtained data on potential risk factors for fatal or critical care unit-treated COVID-19 from the national diabetes register and other linked health administrative databases. We tested the association of these factors with fatal or critical care unit-treated COVID-19 in people with diabetes, and constructed a prediction model using stepwise regression and 20-fold cross-validation.

Findings: Of the total Scottish population on March 1, 2020 (n=5 463 300), the population with diabetes was 319 349 (5·8%), 1082 (0·3%) of whom developed fatal or critical care unit-treated COVID-19 by July 31, 2020, of whom 972 (89·8%) were aged 60 years or older. In the population without diabetes, 4081 (0·1%) of 5 143 951 people developed fatal or critical care unit-treated COVID-19. As of July 31, the overall odds ratio (OR) for diabetes, adjusted for age and sex, was 1·395 (95% CI 1·304-1·494; p<0·0001, compared with the risk in those without diabetes. The OR was 2·396 (1·815-3·163; p<0·0001) in type 1 diabetes and 1·369 (1·276-1·468; p<0·0001) in type 2 diabetes. Among people with diabetes, adjusted for age, sex, and diabetes duration and type, those who developed fatal or critical care unit-treated COVID-19 were more likely to be male, live in residential care or a more deprived area, have a COVID-19 risk condition, retinopathy, reduced renal function, or worse glycaemic control, have had a diabetic ketoacidosis or hypoglycaemia hospitalisation in the past 5 years, be on more anti-diabetic and other medication (all p<0·0001), and have been a smoker (p=0·0011). The cross-validated predictive model of fatal or critical care unit-treated COVID-19 in people with diabetes had a C-statistic of 0·85 (0·83-0·86).

Interpretation: Overall risks of fatal or critical care unit-treated COVID-19 were substantially elevated in those with type 1 and type 2 diabetes compared with the background population. The risk of fatal or critical care unit-treated COVID-19, and therefore the need for special protective measures, varies widely among those with diabetes but can be predicted reasonably well using previous clinical history.

Funding: None.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/S2213-8587(20)30405-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7832778PMC
February 2021

Physical activity monitoring to assess disability progression in multiple sclerosis.

Mult Scler J Exp Transl Clin 2020 Oct-Dec;6(4):2055217320975185. Epub 2020 Dec 7.

Clinical Neurosciences, Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.

Background: Clinical outcome measurement in multiple sclerosis (MS) usually requires a physical visit. Remote activity monitoring (RAM) using wearable technology provides a rational alternative, especially desirable when distance is involved or in a pandemic setting.

Objective: To validate RAM in progressive MS using (1) traditional psychometric methods (2) brain atrophy.

Methods: 56 people with progressive MS participated in a longitudinal study over 2.5 years. An arm-worn RAM device measured activity over six days, every six months, and incorporated triaxial accelerometry and transcutaneous physiological variable measurement. Five RAM variables were assessed: physical activity duration, step count, active energy expenditure, metabolic equivalents and a composite RAM score incorporating all four variables. Other assessments every six months included EDSS, MSFC, MSIS-29, Chalder Fatigue Scale and Beck's Depression Inventory. Annualized brain atrophy was measured using SIENA.

Results: RAM was tolerated well by people with MS; the device was worn 99.4% of the time. RAM had good convergent and divergent validity and was responsive, especially with respect to step count. Measurement of physical activity over one day was as responsive as six days. The composite RAM score positively correlated with brain volume loss.

Conclusion: Remote activity monitoring is a valid and acceptable outcome measure in MS.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1177/2055217320975185DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7727071PMC
December 2020

"We've got through hard times before: acute mental distress and coping among disadvantaged groups during COVID-19 lockdown in North India - a qualitative study".

Int J Equity Health 2020 12 17;19(1):224. Epub 2020 Dec 17.

Nossal Institute, University of Melbourne and Australia- India Institute, Melbourne, Australia.

Background: The COVID-19 crisis in India negatively impacted mental health due to both the disease and the harsh lockdown, yet there are almost no qualitative studies describing mental health impacts or the strategies of resilience used, and in particular, no reports from the most vulnerable groups. This study aimed to examine the acute mental health impacts of the COVID-19 crisis as well as coping strategies employed by disadvantaged community members in North India.

Methods: We used an intersectional lens for this qualitative study set in rural Tehri Garwhal and urban Dehradun districts of Uttarakhand, India. In-depth interviews were conducted in May 2020 during lockdown, by phone and in person using purposive selection, with people with disabilities, people living in slums with psychosocial disabilities and widows (total n = 24). We used the framework method for analysis following steps of transcription and translation, familiarisation, coding, developing and then applying a framework, charting and then interpreting data.

Findings: The participants with compounded disadvantage had almost no access to mobile phones, health messaging or health care and experienced extreme mental distress and despair, alongside hunger and loss of income. Under the realms of intrapersonal, interpersonal and social, six themes related to mental distress emerged: feeling overwhelmed and bewildered, feeling distressed and despairing, feeling socially isolated, increased events of othering and discrimination, and experiencing intersectional disadvantage. The six themes summarising coping strategies in the COVID-19 crisis were: finding sense and meaning, connecting with others, looking for positive ways forward, innovating with new practices, supporting others individually and collectively, and engaging with the natural world.

Conclusions: People intersectionally disadvantaged by their social identity experienced high levels of mental distress during the COVID-19 crisis, yet did not collapse, and instead described diverse and innovative strategies which enabled them to cope through the COVID-19 lockdown. This study illustrates that research using an intersectional lens is valuable to design equitable policy such as the need for access to digital resources, and that disaggregated data is needed to address social inequities at the intersection of poverty, disability, caste, religious discrimination and gender inherent in the COVID-19 pandemic in India.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1186/s12939-020-01345-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7745174PMC
December 2020

Unilateral Tessier 7 cleft: Case report of Z-plasty with geometric broken line repair and literature review.

Int J Pediatr Otorhinolaryngol 2021 Jan 3;140:110546. Epub 2020 Dec 3.

Department of Otolaryngology-Head and Neck Surgery, Texas Tech University Health Sciences Center, Lubbock, TX, 79430-8312, USA; Division of Facial Plastics Reconstruction. Electronic address:

Tessier 7 clefts are a rare congenital anomaly, usually surgically repaired with Z-plasty or other reconstructive methods, although undesirable scars may result. We present a review of the literature and a case of unilateral Tessier 7 cleft repaired with a novel reconstruction technique using a combined Z-plasty and geometric broken line closure (GBLC) to camouflage and irregularize the otherwise linear scar. We present this case to expand the armamentarium of surgical options to address Tessier 7 clefts and to review techniques for repair.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.ijporl.2020.110546DOI Listing
January 2021

Timely intervention and control of a novel coronavirus (COVID-19) outbreak at a large skilled nursing facility-San Francisco, California, 2020.

Infect Control Hosp Epidemiol 2020 Dec 14:1-8. Epub 2020 Dec 14.

California Department of Public Health, Richmond, California.

Objective: To describe epidemiologic and genomic characteristics of a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) outbreak in a large skilled-nursing facility (SNF), and the strategies that controlled transmission.

Design, Setting, And Participants: This cohort study was conducted during March 22-May 4, 2020, among all staff and residents at a 780-bed SNF in San Francisco, California.

Methods: Contact tracing and symptom screening guided targeted testing of staff and residents; respiratory specimens were also collected through serial point prevalence surveys (PPSs) in units with confirmed cases. Cases were confirmed by real-time reverse transcription-polymerase chain reaction testing for SARS-CoV-2, and whole-genome sequencing (WGS) was used to characterize viral isolate lineages and relatedness. Infection prevention and control (IPC) interventions included restricting from work any staff who had close contact with a confirmed case; restricting movement between units; implementing surgical face masking facility-wide; and the use of recommended PPE (ie, isolation gown, gloves, N95 respirator and eye protection) for clinical interactions in units with confirmed cases.

Results: Of 725 staff and residents tested through targeted testing and serial PPSs, 21 (3%) were SARS-CoV-2 positive: 16 (76%) staff and 5 (24%) residents. Fifteen cases (71%) were linked to a single unit. Targeted testing identified 17 cases (81%), and PPSs identified 4 cases (19%). Most cases (71%) were identified before IPC interventions could be implemented. WGS was performed on SARS-CoV-2 isolates from 4 staff and 4 residents: 5 were of Santa Clara County lineage and the 3 others were distinct lineages.

Conclusions: Early implementation of targeted testing, serial PPSs, and multimodal IPC interventions limited SARS-CoV-2 transmission within the SNF.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1017/ice.2020.1375DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8144818PMC
December 2020

Real-world analyses of patients with elevated atherosclerotic cardiovascular disease risk from the Optum Research Database.

Future Cardiol 2021 Jul 4;17(4):743-755. Epub 2020 Dec 4.

Amarin Pharma, Inc., Bridgewater, NJ 08807, USA.

More than 56 million Americans have hypertriglyceridemia, including over 12 million statin-treated individuals. However, the contribution of elevated and high triglyceride levels to cardiovascular disease and death has not been extensively studied using real-world analyses. We review recent analyses of the Optum Research Database, which included patients aged ≥45 years with diabetes and/or atherosclerotic cardiovascular disease and on statin therapy. Triglyceride levels ≥150 and 200-499 mg/dl were significantly associated with a 25.8 and 34.9% increased relative risk of cardiovascular events, respectively, versus patients with triglyceride levels <150 mg/dl. In addition, hypertriglyceridemia predicted peripheral arterial revascularization, new heart failure diagnosis and new-onset renal disease. Increased triglyceride levels were also significantly associated with increased healthcare resource utilization and costs. Interventions such as icosapent ethyl reduce triglycerides and associated cardiovascular disease risk.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.2217/fca-2020-0123DOI Listing
July 2021

Performance of a single-use, rapid, point-of-care PCR device for the detection of Neisseria gonorrhoeae, Chlamydia trachomatis, and Trichomonas vaginalis: a cross-sectional study.

Lancet Infect Dis 2021 05 23;21(5):668-676. Epub 2020 Nov 23.

Department of Medicine, University of California Los Angeles, Los Angeles, CA, USA; Department of Epidemiology, University of California Los Angeles, Los Angeles, CA, USA.

Background: Timely detection and treatment are important for the control of Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis. The objective of this study was to measure the performance of the Visby Medical Sexual Health Test, a single-use, point-of-care PCR device.

Methods: Women aged 14 years and older who presented consecutively to ten clinical sites across seven US states were enrolled for a cross-sectional, single-visit study. Patients who consented to participate, and who had not used any exclusionary products in the genital area in the previous 48 h, provided self-collected vaginal swabs for testing with the investigational device. Untrained operators received the specimens and ran the device using the guide provided. Specimens had to be run within 2 h of collection to be considered valid. For comparison, patient-infected status was derived by testing clinician-collected vaginal specimens with the Hologic Aptima Combo 2 Assay and Aptima Trichomonas vaginalis Assay, as well as the BD ProbeTec CT/GC Q Amplified DNA Assay and BD ProbeTec Trichomonas vaginalis Q Assay. If the results of those assays did not match, the BD MAX CT/GC/TV was used as a tiebreaker. The primary outcomes were the sensitivity and specificity of the investigational device for the detection of C trachomatis, N gonorrhoeae, and T vaginalis compared with patient-infected status.

Findings: Between Feb 25, 2019, and Jan 6, 2020, 1585 participants aged between 14 years and 80 years (mean 34·8 [SD 14·2]) were enrolled. 1555 participants had tests run with the investigational device, of whom 1532 (98·5%) had a valid result on either the first or repeat test. Among the patients with evaluable results (including a determinate patient-infected status), the device had a sensitivity of 97·6% (95% CI 93·2-99·2) and specificity of 98·3% (97·5-98·9) for C trachomatis (n=1457), sensitivity of 97·4% (86·5-99·5) and specificity of 99·4% (98·9-99·7) for N gonorrhoeae (n=1468), and sensitivity of 99·2% (95·5-99·9) and specificity of 96·9% (95·8-97·7) for T vaginalis (n=1449).

Interpretation: This innovative, rapid, easy-to-use, single-use, point-of-care device to detect C trachomatis, N gonorrhoeae, and T vaginalis infections showed excellent sensitivity and specificity, and could represent an important advance in the development of rapid diagnostics for sexually transmitted infections and other infectious diseases.

Funding: Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/S1473-3099(20)30734-9DOI Listing
May 2021