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Longitudinal, Interdisciplinary Home Visits vs. Usual Care for Homebound People with Advanced Parkinson's Disease (IN-HOME-PD): Study protocol for a controlled trial

Fleisher, Jori; Hess, Serena; Sennott, Brianna; Myrick, Erica; Wallace, Ellen Klostermann; Lee, Jeanette; Sanghvi, Maya; Woo, Katheryn; Ouyang, Bichun; Wilkinson, Jayne; Beck, James; Johnson, Tricia; Hall, Deborah; Chodosh, Joshua
BACKGROUND:Current understanding of advanced Parkinson's disease (PD) and its treatment is largely based on data from outpatient visits. The most advanced and disabled individuals become disconnected from both care and research. A previous pilot study among older, multimorbid patients with advanced PD demonstrated the feasibility of interdisciplinary home visits to reach the target population, improve care quality, and potentially avoid institutionalization. OBJECTIVE:The following protocol tests whether interdisciplinary home visits can 1) prevent decline in quality of life and 2) prevent worsening caregiver strain. Finally, the protocol explores whether program costs are offset by savings in healthcare use and institutionalization when compared with usual care. METHODS:In this single-center, controlled trial, 65 patient-caregiver dyads affected by advanced PD (Hoehn & Yahr stages 3-5 and homebound) are recruited to receive quarterly interdisciplinary home visits over one year. The one-year intervention is delivered by a nurse and research coordinator who travel to the home supported by a movement disorders specialist and social worker (both present by video). Each dyad is compared with age-, sex-, and Hoehn and Yahr stage-matched control dyads drawn from US participants in the longitudinal Parkinson's Outcome Project registry. The primary outcome measure is change in patient quality of life between baseline and one year. Secondary outcome measures include change in Hoehn & Yahr stage, caregiver strain, self-reported fall frequency, emergency room visits, hospital admissions, and time-to-institutionalization and/or death. Intervention costs and changes in healthcare utilization will be analyzed in a budget impact analysis exploring the potential for model adaptation and dissemination. RESULTS:The protocol was funded in September 2017 and approved by the Rush Institutional Review Board in October 2017. Recruitment began in May 2018 and closed in November 2019 with 65 patient-caregiver dyads enrolled. All study visits have been completed and analysis is underway. CONCLUSIONS:To our knowledge, this is the first controlled trial to investigate the effects of interdisciplinary home visits among homebound individuals with advanced Parkinson's disease and their caregivers. This study also establishes a unique cohort of patients from whom we can study the natural course of advanced PD, its treatments, and unmet needs. CLINICALTRIAL/UNASSIGNED:Clinicaltrials.gov, NCT03189459.
PMID: 34238753
ISSN: 1929-0748
CID: 4933512

Associations of maternal bisphenol urine concentrations during pregnancy with neonatal metabolomic profiles

Blaauwendraad, Sophia M; Voerman, Ellis; Trasande, Leonardo; Kannan, Kurunthachalam; Santos, Susana; Ruijter, George J G; Sol, Chalana M; Marchioro, Linda; Shokry, Engy; Koletzko, Berthold; Jaddoe, Vincent W V; Gaillard, Romy
BACKGROUND:Fetal exposure to bisphenols is associated with altered fetal growth, adverse birth outcomes and childhood cardio-metabolic risk factors. Metabolomics may serve as a tool to identify the mechanisms underlying these associations. We examined the associations of maternal bisphenol urinary concentrations in pregnancy with neonatal metabolite profiles from cord blood. METHODS:In a population-based prospective cohort study among 225 mother-child pairs, maternal urinary bisphenol A, S and F concentrations in first, second and third trimester were measured. LC-MS/MS was used to determine neonatal concentrations of amino acids, non-esterified fatty acids (NEFA), phospholipids (PL), and carnitines in cord blood. RESULTS:No associations of maternal total bisphenol concentrations with neonatal metabolite profiles were present. Higher maternal average BPA concentrations were associated with higher neonatal mono-unsaturated alkyl-lysophosphatidylcholine concentrations, whereas higher maternal average BPS was associated with lower neonatal overall and saturated alkyl-lysophosphatidylcholine (p-values < 0.05).Trimester-specific analyses showed that higher maternal BPA, BPS and BPF were associated with alterations in neonatal NEFA, diacyl-phosphatidylcholines, acyl-alkyl-phosphatidylcholines, alkyl-lysophosphatidylcholine, sphingomyelines and acyl-carnitines, with the strongest effects for third trimester maternal bisphenol and neonatal diacyl-phosphatidylcholine, sphingomyeline and acyl-carnitine metabolites (p-values < 0.05). Associations were not explained by maternal socio-demographic and lifestyle characteristics or birth characteristics. DISCUSSION/CONCLUSIONS:Higher maternal bisphenol A, F and S concentrations in pregnancy are associated with alterations in neonatal metabolite profile, mainly in NEFA, PL and carnitines concentrations. These findings provide novel insight into potential mechanisms underlying associations of maternal bisphenol exposure during pregnancy with adverse offspring outcomes but need to be replicated among larger, diverse populations.
PMID: 34518915
ISSN: 1573-3890
CID: 4996582

Depression and its associated factors: perceived stress, social support, substance use and related sociodemographic risk factors in medical school residents in Nairobi, Kenya

Shah, Sayed Shah Nur Hussein; Laving, Ahmed; Okech-Helu, Violet Caroline; Kumar, Manasi
BACKGROUND:Little data exists regarding depression and its associated factors in medical residents and doctors in Sub-Saharan Africa. Residents are at high risk of developing depression owing to the stressful nature of their medical practice and academic training. Depression in medical residents leads to decreased clinical efficiency, and poor academic performance; it can also lead to substance abuse and suicide. Our primary aim was to measure depression prevalence among medical residents in Kenya's largest national teaching and referral hospital. Secondary aims were to describe how depression was associated with perceived stress, perceived social support, substance use, and educational environment. METHODS:We sampled 338 residents belonging to 8 different specialties using self administered questionnaires in this cross-sectional survey between October 2019 and February 2020. Questionnaires included: sociodemographics, the Centres for Epidemiology Depression Scale - Revised, Perceived Stress Scale, Multidimensional Scale of Perceived Social Support, Alcohol, Smoking and Substance Involvement Screening Test, and Postgraduate Hospital Educational Environment Measure. Bivariate and multivariate linear regression were used to assess for risk factors for depression. RESULTS:Mean participant age was 31.8 years and 53.4% were males. Most residents (70.4%) reported no to mild depressive symptoms, 12.7% had moderate, and 16.9% had severe depressive symptoms. Most residents had high social support (71.8%) and moderate stress (61.6%). The educational environment was rated as more positive than negative by 46.3% of residents. Bivariate analyses revealed significant correlations between depressive symptoms, perceived stress, substance use, perceived social support, and educational environment. Multivariate analysis showed that depression was strongly associated with: fewer hours of sleep (β = - 0.683, p = 0.002), high perceived stress (β = 0.709, p < 0.001) and low perceived social support (β = - 2.19, p < 0.001). CONCLUSIONS:Only 30% of medical residents in our study had moderate and severe depressive symptoms. Most residents in our study reported high levels of social support, and moderate levels of stress. Though their overall appraisal of medical residency experience was positive, mental health support and self-care skills in the training of medical professionals needs prioritization.
PMCID:8425003
PMID: 34496834
ISSN: 1471-244x
CID: 5831252

Routine outcome measurement in adolescents seeking mental health services: standardization of HoNOSCA in Kenyan sample

Wambua, Grace Nduku; Kumar, Manasi; Falkenström, Fredrik; Cuijpers, Pim
BACKGROUND:The evaluation of treatment outcomes is important for service providers to assess if there is improvement or not. The Health of the Nation Outcome Scales for Children and Adolescents (HoNOSCA) was developed for this use in child and adolescent mental health services. Outcome measurement in routine mental health services is limited. This paper evaluates the psychometric properties of the self and clinician rated versions of the HoNOSCA for routine use in child and adolescent mental health services in Kenya. METHODS:Using a prospective design, the clinician- and self-rated versions of the HoNOSCA and the Paediatric Symptom Checklist (PSC) were administered at the Youth Centre at the Kenyatta National Hospital in Nairobi. Initial ratings were obtained from adolescents 12-17 years (n = 201). A sample of 98 paired ratings with 2 follow-ups were examined for measurement of change over time. RESULTS:Our findings showed good reliability with the self-rated version of the HoNOSCA score, correlating well with the self-reported version of the PSC (r = .74, p < .001). Both versions correlated well at follow-up and were sensitive to change. Using factor analysis, the maximum likelihood factoring and Promax rotation resulted in a four-factor structure, which with a Kaiser-Meyer-Olkin measure of sampling adequacy of 0.8 explained 54.74% of total variance. CONCLUSION:The HoNOSCA appears to be of value, and easy to use in routine settings. Our findings suggest further investigation with a larger sample.
PMCID:8422761
PMID: 34488702
ISSN: 1471-244x
CID: 5832072

Global, regional, and national progress towards Sustainable Development Goal 3.2 for neonatal and child health: all-cause and cause-specific mortality findings from the Global Burden of Disease Study 2019

Paulson, Katherine R; Kamath, Aruna M; Alam, Tahiya; Bienhoff, Kelly; Abady, Gdiom Gebreheat; Abbas, Jaffar; Abbasi-Kangevari, Mohsen; Abbastabar, Hedayat; Abd-Allah, Foad; Abd-Elsalam, Sherief M; Abdoli, Amir; Abedi, Aidin; Abolhassani, Hassan; Abreu, Lucas Guimarães; Abu-Gharbieh, Eman; Abu-Rmeileh, Niveen Me; Abushouk, Abdelrahman I; Adamu, Aishatu L; Adebayo, Oladimeji M; Adegbosin, Adeyinka Emmanuel; Adekanmbi, Victor; Adetokunboh, Olatunji O; Adeyinka, Daniel Adedayo; Adsuar, Jose C; Afshari, Khashayar; Aghaali, Mohammad; Agudelo-Botero, Marcela; Ahinkorah, Bright Opoku; Ahmad, Tauseef; Ahmadi, Keivan; Ahmed, Muktar Beshir; Aji, Budi; Akalu, Yonas; Akinyemi, Oluwaseun Oladapo; Aklilu, Addis; Al-Aly, Ziyad; Alam, Khurshid; Alanezi, Fahad Mashhour; Alanzi, Turki M; Alcalde-Rabanal, Jacqueline Elizabeth; Al-Eyadhy, Ayman; Ali, Tilahun; Alicandro, Gianfranco; Alif, Sheikh Mohammad; Alipour, Vahid; Alizade, Hesam; Aljunid, Syed Mohamed; Almasi-Hashiani, Amir; Almasri, Nihad A; Al-Mekhlafi, Hesham M; Alonso, Jordi; Al-Raddadi, Rajaa M; Altirkawi, Khalid A; Alumran, Arwa Khalid; Alvis-Guzman, Nelson; Alvis-Zakzuk, Nelson J; Ameyaw, Edward Kwabena; Amini, Saeed; Amini-Rarani, Mostafa; Amit, Arianna Maever L; Amugsi, Dickson A; Ancuceanu, Robert; Anderlini, Deanna; Andrei, Catalina Liliana; Ansari, Fereshteh; Ansari-Moghaddam, Alireza; Antonio, Carl Abelardo T; Antriyandarti, Ernoiz; Anvari, Davood; Anwer, Razique; Aqeel, Muhammad; Arabloo, Jalal; Arab-Zozani, Morteza; Aripov, Timur; Ärnlöv, Johan; Artanti, Kurnia Dwi; Arzani, Afsaneh; Asaad, Malke; Asadi-Aliabadi, Mehran; Asadi-Pooya, Ali A; Asghari Jafarabadi, Mohammad; Athari, Seyyed Shamsadin; Athari, Seyyede Masoume; Atnafu, Desta Debalkie; Atreya, Alok; Atteraya, Madhu Sudhan; Ausloos, Marcel; Awan, Asma Tahir; Ayala Quintanilla, Beatriz Paulina; Ayano, Getinet; Ayanore, Martin Amogre; Aynalem, Yared Asmare; Azari, Samad; Azarian, Ghasem; Azene, Zelalem Nigussie; B, Darshan B; Babaee, Ebrahim; Badiye, Ashish D; Baig, Atif Amin; Banach, Maciej; Banik, Palash Chandra; Barker-Collo, Suzanne Lyn; Barqawi, Hiba Jawdat; Bassat, Quique; Basu, Sanjay; Baune, Bernhard T; Bayati, Mohsen; Bedi, Neeraj; Beghi, Ettore; Beghi, Massimiliano; Bell, Michelle L; Bendak, Salaheddine; Bennett, Derrick A; Bensenor, Isabela M; Berhe, Kidanemaryam; Berman, Adam E; Bezabih, Yihienew Mequanint; Bhagavathula, Akshaya Srikanth; Bhandari, Dinesh; Bhardwaj, Nikha; Bhardwaj, Pankaj; Bhattacharyya, Krittika; Bhattarai, Suraj; Bhutta, Zulfiqar A; Bikbov, Boris; Biondi, Antonio; Birihane, Binyam Minuye; Biswas, Raaj Kishore; Bohlouli, Somayeh; Bragazzi, Nicola Luigi; Breusov, Alexey V; Brunoni, Andre R; Burkart, Katrin; Burugina Nagaraja, Sharath; Busse, Reinhard; Butt, Zahid A; Caetano Dos Santos, Florentino Luciano; Cahuana-Hurtado, Lucero; Camargos, Paulo; Cámera, Luis Alberto; Cárdenas, Rosario; Carreras, Giulia; Carrero, Juan J; Carvalho, Felix; Castaldelli-Maia, Joao Mauricio; Castañeda-Orjuela, Carlos A; Castelpietra, Giulio; Cerin, Ester; Chang, Jung-Chen; Chanie, Wagaye Fentahun; Charan, Jaykaran; Chatterjee, Souranshu; Chattu, Soosanna Kumary; Chattu, Vijay Kumar; Chaturvedi, Sarika; Chen, Simiao; Cho, Daniel Youngwhan; Choi, Jee-Young Jasmine; Chu, Dinh-Toi; Ciobanu, Liliana G; Cirillo, Massimo; Conde, Joao; Costa, Vera Marisa; Couto, Rosa A S; Dachew, Berihun Assefa; Dahlawi, Saad M A; Dai, Hancheng; Dai, Xiaochen; Dandona, Lalit; Dandona, Rakhi; Daneshpajouhnejad, Parnaz; Darmstadt, Gary L; Das, Jai K; Dávila-Cervantes, Claudio Alberto; Davis, Adrian C; Davletov, Kairat; De la Hoz, Fernando Pio; De Leo, Diego; Deeba, Farah; Denova-Gutiérrez, Edgar; Dervenis, Nikolaos; Desalew, Assefa; Deuba, Keshab; Dey, Sagnik; Dharmaratne, Samath Dhamminda; Dhingra, Sameer; Dhungana, Govinda Prasad; Dias da Silva, Diana; Diaz, Daniel; Dorostkar, Fariba; Doshmangir, Leila; Dubljanin, Eleonora; Duraes, Andre Rodrigues; Eagan, Arielle Wilder; Edinur, Hisham Atan; Efendi, Ferry; Eftekharzadeh, Sahar; El Sayed, Iman; El Tantawi, Maha; Elbarazi, Iffat; Elgendy, Islam Y; El-Jaafary, Shaimaa I; Emami, Amir; Enany, Shymaa; Eyawo, Oghenowede; Ezzikouri, Sayeh; Faris, Pawan Sirwan; Farzadfar, Farshad; Fattahi, Nazir; Fauk, Nelsensius Klau; Fazlzadeh, Mehdi; Feigin, Valery L; Ferede, Tomas Y; Fereshtehnejad, Seyed-Mohammad; Fernandes, Eduarda; Ferrara, Pietro; Filip, Irina; Fischer, Florian; Fisher, James L; Foigt, Nataliya A; Folayan, Morenike Oluwatoyin; Foroutan, Masoud; Franklin, Richard Charles; Freitas, Marisa; Friedman, Sara D; Fukumoto, Takeshi; Gad, Mohamed M; Gaidhane, Abhay Motiramji; Gaidhane, Shilpa; Gaihre, Santosh; Gallus, Silvano; Garcia-Basteiro, Alberto L; Garcia-Gordillo, M A; Gardner, William M; Gaspar Fonseca, Mariana; Gebremedhin, Ketema Bizuwork; Getacher, Lemma; Ghashghaee, Ahmad; Gholamian, Asadollah; Gilani, Syed Amir; Gill, Tiffany K; Giussani, Giorgia; Gnedovskaya, Elena V; Godinho, Myron Anthony; Goel, Amit; Golechha, Mahaveer; Gona, Philimon N; Gopalani, Sameer Vali; Goudarzi, Houman; Grivna, Michal; Gugnani, Harish Chander; Guido, Davide; Guimarães, Rafael Alves; Gupta, Rajat Das; Gupta, Rajeev; Hafezi-Nejad, Nima; Haider, Mohammad Rifat; Haj-Mirzaian, Arvin; Hamidi, Samer; Hanif, Asif; Hankey, Graeme J; Hargono, Arief; Hasaballah, Ahmed I; Hasan, Md Mehedi; Hasan, Syed Shahzad; Hassan, Amr; Hassanipour, Soheil; Hassankhani, Hadi; Havmoeller, Rasmus J; Hayat, Khezar; Heidari-Soureshjani, Reza; Henry, Nathaniel J; Herteliu, Claudiu; Hole, Michael K; Holla, Ramesh; Hossain, Naznin; Hosseini, Mostafa; Hosseinzadeh, Mehdi; Hostiuc, Mihaela; Hostiuc, Sorin; Househ, Mowafa; Huang, Junjie; Humayun, Ayesha; Hwang, Bing-Fang; Iavicoli, Ivo; Ibitoye, Segun Emmanuel; Ikuta, Kevin S; Ilesanmi, Olayinka Stephen; Ilic, Irena M; Ilic, Milena D; Inamdar, Sumant; Inbaraj, Leeberk Raja; Iqbal, Khalid; Iqbal, Usman; Islam, M Mofizul; Islam, Sheikh Mohammed Shariful; Iso, Hiroyasu; Iwagami, Masao; Iwu, Chidozie C D; Jaafari, Jalil; Jacobsen, Kathryn H; Jagnoor, Jagnoor; Jain, Vardhmaan; Janodia, Manthan Dilipkumar; Javaheri, Tahereh; Javanmardi, Fatemeh; Jayaram, Shubha; Jayatilleke, Achala Upendra; Jenabi, Ensiyeh; Jha, Ravi Prakash; Ji, John S; John, Oommen; Jonas, Jost B; Joo, Tamas; Joseph, Nitin; Joukar, Farahnaz; Jozwiak, Jacek Jerzy; Jürisson, Mikk; Kabir, Ali; Kabir, Zubair; Kalankesh, Leila R; Kamyari, Naser; Kanchan, Tanuj; Kapoor, Neeti; Karami Matin, Behzad; Karch, André; Karimi, Salah Eddin; Kassahun, Getinet; Kayode, Gbenga A; Kazemi Karyani, Ali; Kemmer, Laura; Khalid, Nauman; Khalilov, Rovshan; Khammarnia, Mohammad; Khan, Ejaz Ahmad; Khan, Gulfaraz; Khan, Maseer; Khan, Md Nuruzzaman; Khang, Young-Ho; Khatab, Khaled; Khater, Amir M; Khater, Mona M; Khayamzadeh, Maryam; Khosravi, Ardeshir; Kim, Daniel; Kim, Young-Eun; Kim, Yun Jin; Kimokoti, Ruth W; Kisa, Adnan; Kisa, Sezer; Kissoon, Niranjan; Kopec, Jacek A; Kosen, Soewarta; Koul, Parvaiz A; Koulmane Laxminarayana, Sindhura Lakshmi; Koyanagi, Ai; Krishan, Kewal; Krishnamoorthy, Vijay; Kuate Defo, Barthelemy; Kucuk Bicer, Burcu; Kulkarni, Vaman; Kumar, G Anil; Kumar, Manasi; Kumar, Nithin; Kurmi, Om P; Kusuma, Dian; La Vecchia, Carlo; Lacey, Ben; Lalloo, Ratilal; Lami, Faris Hasan; Landires, Iván; Larsson, Anders O; Lasrado, Savita; Lassi, Zohra S; Lauriola, Paolo; Lee, Paul H; Lee, Shaun Wen Huey; Lee, Yo Han; Leigh, James; Leonardi, Matilde; Lewycka, Sonia; Li, Bingyu; Li, Shanshan; Liang, Juan; Lim, Lee-Ling; Limenih, Miteku Andualem; Lin, Ro-Ting; Liu, Xuefeng; Lodha, Rakesh; Lopez, Alan D; Lozano, Rafael; Lugo, Alessandra; Lunevicius, Raimundas; Mackay, Mark T; Madhava Kunjathur, Shilpashree; Magnani, Francesca Giulia; Mahadeshwara Prasad, D R; Maheri, Mina; Mahmoudi, Morteza; Majeed, Azeem; Maled, Venkatesh; Maleki, Afshin; Maleki, Shokofeh; Malekzadeh, Reza; Malik, Ahmad Azam; Malta, Deborah Carvalho; Mamun, Abdullah A; Mansouri, Borhan; Mansournia, Mohammad Ali; Martinez, Gabriel; Martini, Santi; Martins-Melo, Francisco Rogerlândio; Masoumi, Seyedeh Zahra; Maulik, Pallab K; McAlinden, Colm; McGrath, John J; Medina-Solís, Carlo Eduardo; Mehrabi Nasab, Entezar; Mejia-Rodriguez, Fabiola; Memish, Ziad A; Mendoza, Walter; Menezes, Ritesh G; Mengesha, Endalkachew Worku; Mensah, George A; Meretoja, Atte; Meretoja, Tuomo J; Mersha, Abera M; Mestrovic, Tomislav; Miazgowski, Bartosz; Miazgowski, Tomasz; Michalek, Irmina Maria; Miller, Ted R; Mini, G K; Miri, Mohammad; Mirica, Andreea; Mirrakhimov, Erkin M; Mirzaei, Hamed; Mirzaei, Maryam; Moazen, Babak; Moghadaszadeh, Masoud; Mohajer, Bahram; Mohamad, Osama; Mohammad, Yousef; Mohammadi, Seyyede Momeneh; Mohammadian-Hafshejani, Abdollah; Mohammed, Shafiu; Mokdad, Ali H; Molokhia, Mariam; Monasta, Lorenzo; Mondello, Stefania; Moni, Mohammad Ali; Moore, Catrin E; Moradi, Ghobad; Moradi, Masoud; Moradzadeh, Rahmatollah; Moraga, Paula; Morawska, Lidia; Morrison, Shane Douglas; Mosser, Jonathan F; Mousavi Khaneghah, Amin; Mustafa, Ghulam; Naderi, Mehdi; Nagarajan, Ahamarshan Jayaraman; Nagaraju, Shankar Prasad; Naghavi, Mohsen; Naghshtabrizi, Behshad; Naimzada, Mukhammad David; Nangia, Vinay; Narasimha Swamy, Sreenivas; Nascimento, Bruno Ramos; Naveed, Muhammad; Nazari, Javad; Ndejjo, Rawlance; Negoi, Ionut; Negoi, Ruxandra Irina; Nena, Evangelia; Nepal, Samata; Netsere, Henok Biresaw; Nguefack-Tsague, Georges; Ngunjiri, Josephine W; Nguyen, Chi Thi Yen; Nguyen, Cuong Tat; Nguyen, Huong Lan Thi; Nigatu, Yeshambel T; Nigussie, Samuel Negash; Nixon, Molly R; Nnaji, Chukwudi A; Nomura, Shuhei; Noor, Nurulamin M; Noubiap, Jean Jacques; Nuñez-Samudio, Virginia; Nwatah, Vincent Ebuka; Oancea, Bogdan; Odukoya, Oluwakemi Ololade; Ogbo, Felix Akpojene; Olusanya, Bolajoko Olubukunola; Olusanya, Jacob Olusegun; Omar Bali, Ahmed; Onwujekwe, Obinna E; Ortiz, Alberto; Otoiu, Adrian; Otstavnov, Nikita; Otstavnov, Stanislav S; Owolabi, Mayowa O; P A, Mahesh; Padubidri, Jagadish Rao; Pakhale, Smita; Pakshir, Keyvan; Pal, Pramod Kumar; Palladino, Raffaele; Pana, Adrian; Panda-Jonas, Songhomitra; Pandey, Anamika; Pandey, Ashok; Pandi-Perumal, Seithikurippu R; Pangaribuan, Helena Ullyartha; Pardo-Montaño, Ana Melisa; Park, Eun-Kee; Patel, Sangram Kishor; Patton, George C; Pawar, Shrikant; Pazoki Toroudi, Hamidreza; Peden, Amy E; Pepito, Veincent Christian Filipino; Peprah, Emmanuel K; Pereira, Jeevan; Pérez-Gómez, Jorge; Perico, Norberto; Pesudovs, Konrad; Pilgrim, Thomas; Pinheiro, Marina; Piradov, Michael A; Pirsaheb, Meghdad; Platts-Mills, James A; Pokhrel, Khem Narayan; Postma, Maarten J; Pourjafar, Hadi; Prada, Sergio I; Prakash, Sanjay; Pupillo, Elisabetta; Quazi Syed, Zahiruddin; Rabiee, Navid; Radfar, Amir; Rafiee, Ata; Rafiei, Alireza; Raggi, Alberto; Rahimzadeh, Shadi; Rahman, Mohammad Hifz Ur; Rahmani, Amir Masoud; Ramezanzadeh, Kiana; Rana, Juwel; Ranabhat, Chhabi Lal; Rao, Sowmya J; Rasella, Davide; Rastogi, Prateek; Rathi, Priya; Rawaf, David Laith; Rawaf, Salman; Rawasia, Wasiq Faraz; Rawassizadeh, Reza; Reiner, Robert C Jr; Remuzzi, Giuseppe; Renzaho, Andre M N; Reshmi, Bhageerathy; Resnikoff, Serge; Rezaei, Negar; Rezaei, Nima; Rezapour, Aziz; Riahi, Seyed Mohammad; Ribeiro, Daniela; Rickard, Jennifer; Roever, Leonardo; Ronfani, Luca; Rothenbacher, Dietrich; Rubagotti, Enrico; Rumisha, Susan Fred; Ryan, Paul MacDaragh; Saddik, Basema; Sadeghi, Ehsan; Saeedi Moghaddam, Sahar; Sagar, Rajesh; Sahebkar, Amirhossein; Salahshoor, Mohammad Reza; Salehi, Sana; Salem, Marwa Rashad; Salimzadeh, Hamideh; Salomon, Joshua A; Samodra, Yoseph Leonardo; Samy, Abdallah M; Sanabria, Juan; Santric-Milicevic, Milena M; Saraswathy, Sivan Yegnanarayana Iyer; Sarker, Abdur Razzaque; Sarrafzadegan, Nizal; Sarveazad, Arash; Sathian, Brijesh; Sathish, Thirunavukkarasu; Sattin, Davide; Saxena, Sonia; Saya, Ganesh Kumar; Saylan, Mete; Schiavolin, Silvia; Schlaich, Markus P; Schwebel, David C; Schwendicke, Falk; Senthilkumaran, Subramanian; Sepanlou, Sadaf G; Serván-Mori, Edson; Sha, Feng; Shafaat, Omid; Shahabi, Saeed; Shahbaz, Mohammad; Shaheen, Amira A; Shahid, Izza; Shaikh, Masood Ali; Shakiba, Saeed; Shalash, Ali S; Shams-Beyranvand, Mehran; Shannawaz, Mohammed; Sharafi, Kiomars; Sheikh, Aziz; Sheikhbahaei, Sara; Shiferaw, Wondimeneh Shibabaw; Shigematsu, Mika; Shin, Jae Il; Shiri, Rahman; Shiue, Ivy; Shuval, Kerem; Siddiqi, Tariq Jamal; Sidemo, Negussie Boti; Sigfusdottir, Inga Dora; Sigurvinsdottir, Rannveig; Silva, João Pedro; Silverberg, Jonathan I S; Simonetti, Biagio; Singh, Balbir Bagicha; Singh, Jasvinder A; Singhal, Deepika; Sinha, Dhirendra Narain; Skiadaresi, Eirini; Skryabin, Valentin Yurievich; Skryabina, Anna Aleksandrovna; Sleet, David A; Sobaih, Badr Hasan; Sobhiyeh, Mohammad Reza; Soltani, Shahin; Soriano, Joan B; Spurlock, Emma Elizabeth; Sreeramareddy, Chandrashekhar T; Steiropoulos, Paschalis; Stokes, Mark A; Stortecky, Stefan; Sufiyan, Mu'awiyyah Babale; Suliankatchi Abdulkader, Rizwan; Sulo, Gerhard; Swope, Carolyn B; Sykes, Bryan L; Szeto, Mindy D; Szócska, Miklós; Tabarés-Seisdedos, Rafael; Tadesse, Eyayou Girma; Taherkhani, Amir; Tamiru, Animut Tagele; Tareque, Md Ismail; Tehrani-Banihashemi, Arash; Temsah, Mohamad-Hani; Tesfay, Fisaha Haile; Tessema, Gizachew Assefa; Tessema, Zemenu Tadesse; Thankappan, Kavumpurathu Raman; Thapar, Rekha; Tolani, Musliu Adetola; Tovani-Palone, Marcos Roberto; Traini, Eugenio; Tran, Bach Xuan; Tripathy, Jaya Prasad; Tsapparellas, Giorgos; Tsatsakis, Aristidis; Tudor Car, Lorainne; Uddin, Riaz; Ullah, Anayat; Umeokonkwo, Chukwuma David; Unim, Brigid; Unnikrishnan, Bhaskaran; Upadhyay, Era; Usman, Muhammad Shariq; Vacante, Marco; Vaezi, Maryam; Valadan Tahbaz, Sahel; Valdez, Pascual R; Vasankari, Tommi Juhani; Venketasubramanian, Narayanaswamy; Verma, Madhur; Violante, Francesco S; Vlassov, Vasily; Vo, Bay; Vu, Giang Thu; Wado, Yohannes Dibaba; Waheed, Yasir; Wamai, Richard G; Wang, Yanping; Wang, Yanzhong; Wang, Yuan-Pang; Ward, Paul; Werdecker, Andrea; Westerman, Ronny; Wickramasinghe, Nuwan Darshana; Wilner, Lauren B; Wiysonge, Charles Shey; Wu, Ai-Min; Wu, Chenkai; Xie, Yang; Yahyazadeh Jabbari, Seyed Hossein; Yamagishi, Kazumasa; Yandrapalli, Srikanth; Yaya, Sanni; Yazdi-Feyzabadi, Vahid; Yip, Paul; Yonemoto, Naohiro; Yoon, Seok-Jun; Younis, Mustafa Z; Yousefi, Zabihollah; Yousefinezhadi, Taraneh; Yu, Chuanhua; Yusuf, Sifat Shahana; Zaidi, Syed Saoud; Zaman, Sojib Bin; Zamani, Mohammad; Zamanian, Maryam; Zastrozhin, Mikhail Sergeevich; Zastrozhina, Anasthasia; Zhang, Yunquan; Zhang, Zhi-Jiang; Zhao, Xiu-Ju George; Ziapour, Arash; Hay, Simon I; Murray, Christopher J L; Wang, Haidong; Kassebaum, Nicholas J
BACKGROUND:Sustainable Development Goal 3.2 has targeted elimination of preventable child mortality, reduction of neonatal death to less than 12 per 1000 livebirths, and reduction of death of children younger than 5 years to less than 25 per 1000 livebirths, for each country by 2030. To understand current rates, recent trends, and potential trajectories of child mortality for the next decade, we present the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2019 findings for all-cause mortality and cause-specific mortality in children younger than 5 years of age, with multiple scenarios for child mortality in 2030 that include the consideration of potential effects of COVID-19, and a novel framework for quantifying optimal child survival. METHODS:We completed all-cause mortality and cause-specific mortality analyses from 204 countries and territories for detailed age groups separately, with aggregated mortality probabilities per 1000 livebirths computed for neonatal mortality rate (NMR) and under-5 mortality rate (U5MR). Scenarios for 2030 represent different potential trajectories, notably including potential effects of the COVID-19 pandemic and the potential impact of improvements preferentially targeting neonatal survival. Optimal child survival metrics were developed by age, sex, and cause of death across all GBD location-years. The first metric is a global optimum and is based on the lowest observed mortality, and the second is a survival potential frontier that is based on stochastic frontier analysis of observed mortality and Healthcare Access and Quality Index. FINDINGS:Global U5MR decreased from 71·2 deaths per 1000 livebirths (95% uncertainty interval [UI] 68·3-74·0) in 2000 to 37·1 (33·2-41·7) in 2019 while global NMR correspondingly declined more slowly from 28·0 deaths per 1000 live births (26·8-29·5) in 2000 to 17·9 (16·3-19·8) in 2019. In 2019, 136 (67%) of 204 countries had a U5MR at or below the SDG 3.2 threshold and 133 (65%) had an NMR at or below the SDG 3.2 threshold, and the reference scenario suggests that by 2030, 154 (75%) of all countries could meet the U5MR targets, and 139 (68%) could meet the NMR targets. Deaths of children younger than 5 years totalled 9·65 million (95% UI 9·05-10·30) in 2000 and 5·05 million (4·27-6·02) in 2019, with the neonatal fraction of these deaths increasing from 39% (3·76 million [95% UI 3·53-4·02]) in 2000 to 48% (2·42 million; 2·06-2·86) in 2019. NMR and U5MR were generally higher in males than in females, although there was no statistically significant difference at the global level. Neonatal disorders remained the leading cause of death in children younger than 5 years in 2019, followed by lower respiratory infections, diarrhoeal diseases, congenital birth defects, and malaria. The global optimum analysis suggests NMR could be reduced to as low as 0·80 (95% UI 0·71-0·86) deaths per 1000 livebirths and U5MR to 1·44 (95% UI 1·27-1·58) deaths per 1000 livebirths, and in 2019, there were as many as 1·87 million (95% UI 1·35-2·58; 37% [95% UI 32-43]) of 5·05 million more deaths of children younger than 5 years than the survival potential frontier. INTERPRETATION:Global child mortality declined by almost half between 2000 and 2019, but progress remains slower in neonates and 65 (32%) of 204 countries, mostly in sub-Saharan Africa and south Asia, are not on track to meet either SDG 3.2 target by 2030. Focused improvements in perinatal and newborn care, continued and expanded delivery of essential interventions such as vaccination and infection prevention, an enhanced focus on equity, continued focus on poverty reduction and education, and investment in strengthening health systems across the development spectrum have the potential to substantially improve U5MR. Given the widespread effects of COVID-19, considerable effort will be required to maintain and accelerate progress. FUNDING:Bill & Melinda Gates Foundation.
PMID: 34416195
ISSN: 1474-547x
CID: 5266342

Long-term outcomes in patients presenting with optic neuritis: Analyses of the MSBase registry

Kenney, Rachel; Liu, Mengling; Patil, Sachi; Alroughani, Raed; Ampapa, Radek; Bergamaschi, Roberto; Boz, Cavit; Butzkueven, Helmut; Gomez, Jose Cabrera; Cartechini, Elisabetta; Madueño, Sara Eichau; Ferraro, Diana; Grand-Maison, Francois; Granella, Franco; Horakova, Dana; Izquierdo Ayuso, Guillermo; Kalincik, Tomas; Lizrova Preiningerova, Jana; Lugaresi, Alessandra; Onofrj, Marco; Ozakbas, Serkan; Patti, Francesco; Sola, Patrizia; Soysal, Aysun; Spitaleri, Daniele Litterio A; Terzi, Murat; Turkoglu, Recai; van Pesch, Vincent; Saidha, Shiv; Thorpe, Lorna E; Galetta, Steven L; Balcer, Laura J; Kister, Ilya; Spelman, Tim
BACKGROUND:Short-term outcomes of optic neuritis (ON) have been well characterized. Limited data exists on longer-term visual outcomes in patients who present with ON. The large MSBase registry allows for characterization of long-term visual outcomes after ON. METHODS:Via the MSBase Registry, data on patients from 41 centers was collected during routine clinical and research visits. Physical and visual disability were measured using the expanded disability status scale (EDSS) and the visual function score (VFS). Inclusion criteria for this analysis included age ≥ 18 years, clinically isolated syndrome (CIS), ON-onset, baseline visit within 6 months of onset, and at least one follow-up visit. Survival analysis was used to evaluate the association of disease-modifying treatment with time to conversion to clinically definite MS or sustained EDSS/VFS progression. RESULTS:Data from 60,933 patients were obtained from the MSBase registry in July 2019. Of these, 1317 patients met inclusion criteria; 935 were treated at some point in disease course, while 382 were never treated. At baseline, mean age was 32.3 ± 8.8 years, 74% were female, median EDSS was 2 (IQR 1-2), and median VFS was 1 (IQR 0-2). Median follow-up time was 5.2 years (IQR 2.4-9.3). Treatment was associated with reduced risk and delayed conversion to clinically definite MS (HR = 0.70, p < 0.001), sustained EDSS progression (HR = 0.46, p < 0.0001) and sustained VFS (HR = 0.41, p < 0.001) progression. CONCLUSIONS:In the MSBase cohort, treatment after ON was associated with better visual and neurological outcomes compared to no treatment. These results support early treatment for patients presenting with ON as the first manifestation of MS.
PMID: 34537678
ISSN: 1878-5883
CID: 5012512

Human-centered implementation research: a new approach to develop and evaluate implementation strategies for strengthening referral networks for hypertension in western Kenya

Pillsbury, Mc Kinsey M; Mwangi, Eunice; Andesia, Josephine; Njuguna, Benson; Bloomfield, Gerald S; Chepchumba, Agneta; Kamano, Jemima; Mercer, Tim; Miheso, Juliet; Pastakia, Sonak D; Pathak, Shravani; Thakkar, Aarti; Naanyu, Violet; Akwanalo, Constantine; Vedanthan, Rajesh
BACKGROUND:Human-centered design (HCD) is an increasingly recognized approach for engaging stakeholders and developing contextually appropriate health interventions. As a component of the ongoing STRENGTHS study (Strengthening Referral Networks for Management of Hypertension Across the Health System), we report on the process and outcomes of utilizing HCD to develop the implementation strategy prior to a cluster-randomized controlled trial. METHODS:We organized a design team of 15 local stakeholders to participate in an HCD process to develop implementation strategies. We tested prototypes for acceptability, appropriateness, and feasibility through focus group discussions (FGDs) with various community stakeholder groups and a pilot study among patients with hypertension. FGD transcripts underwent content analysis, and pilot study data were analyzed for referral completion and reported barriers to referral. Based on this community feedback, the design team iteratively updated the implementation strategy. During each round of updates, the design team reflected on their experience through FGDs and a Likert-scale survey. RESULTS:The design team developed an implementation strategy consisting of a combined peer navigator and a health information technology (HIT) package. Overall, community participants felt that the strategy was acceptable, appropriate, and feasible. During the pilot study, 93% of referrals were completed. FGD participants felt that the implementation strategy facilitated referral completion through active peer engagement; enhanced communication between clinicians, patients, and health administrators; and integrated referral data into clinical records. Challenges included referral barriers that were not directly addressed by the strategy (e.g. transportation costs) and implementation of the HIT package across multiple health record systems. The design team reflected that all members contributed significantly to the design process, but emphasized the need for more transparency in how input from study investigators was incorporated into design team discussions. CONCLUSIONS:The adaptive process of co-creation, prototyping, community feedback, and iterative redesign aligned our implementation strategy with community stakeholder priorities. We propose a new framework of human-centered implementation research that promotes collaboration between community stakeholders, study investigators, and the design team to develop, implement, and evaluate HCD products for implementation research. Our experience provides a feasible and replicable approach for implementation research in other settings. TRIAL REGISTRATION/BACKGROUND:Clinicaltrials.gov, NCT02501746 , registration date: July 17, 2015.
PMCID:8414706
PMID: 34479556
ISSN: 1472-6963
CID: 5011342

Egocentric social network characteristics and cardiovascular risk among patients with hypertension or diabetes in western Kenya: a cross-sectional analysis from the BIGPIC trial

Ruchman, Samuel G; Delong, Allison K; Kamano, Jemima H; Bloomfield, Gerald S; Chrysanthopoulou, Stavroula A; Fuster, Valentin; Horowitz, Carol R; Kiptoo, Peninah; Matelong, Winnie; Mugo, Richard; Naanyu, Violet; Orango, Vitalis; Pastakia, Sonak D; Valente, Thomas W; Hogan, Joseph W; Vedanthan, Rajesh
OBJECTIVES:Management of cardiovascular disease (CVD) is an urgent challenge in low-income and middle-income countries, and interventions may require appraisal of patients' social networks to guide implementation. The purpose of this study is to determine whether egocentric social network characteristics (SNCs) of patients with chronic disease in western Kenya are associated with overall CVD risk and individual CVD risk factors. DESIGN:Cross-sectional analysis of enrollment data (2017-2018) from the Bridging Income Generation with GrouP Integrated Care trial. Non-overlapping trust-only, health advice-only and multiplex (trust and health advice) egocentric social networks were elicited for each participant, and SNCs representing social cohesion were calculated. SETTING:24 communities across four counties in western Kenya. PARTICIPANTS:Participants (n=2890) were ≥35 years old with diabetes (fasting glucose ≥7 mmol/L) or hypertension. PRIMARY AND SECONDARY OUTCOMES:We hypothesised that SNCs would be associated with CVD risk status (QRISK3 score). Secondary outcomes were individual CVD risk factors. RESULTS:Among the 2890 participants, 2020 (70%) were women, and mean (SD) age was 60.7 (12.1) years. Forty-four per cent of participants had elevated QRISK3 score (≥10%). No relationship was observed between QRISK3 level and SNCs. In unadjusted comparisons, participants with any individuals in their trust network were more likely to report a good than a poor diet (41% vs 21%). SNCs for the trust and multiplex networks accounted for a substantial fraction of variation in measures of dietary quality and physical activity (statistically significant via likelihood ratio test, adjusted for false discovery rate). CONCLUSION:SNCs indicative of social cohesion appear to be associated with individual behavioural CVD risk factors, although not with overall CVD risk score. Understanding how SNCs of patients with chronic diseases relate to modifiable CVD risk factors could help inform network-based interventions. TRIAL REGISTRATION NUMBER:ClinicalTrials.gov identifier: NCT02501746; https://clinicaltrials.gov/ct2/show/NCT02501746.
PMCID:8413931
PMID: 34475172
ISSN: 2044-6055
CID: 5011302

Immunogenicity and Reactogenicity After SARS-CoV-2 mRNA Vaccination in Kidney Transplant Recipients Taking Belatacept

Ou, Michael T; Boyarsky, Brian J; Chiang, Teresa P Y; Bae, Sunjae; Werbel, William A; Avery, Robin K; Tobian, Aaron A R; Massie, Allan B; Segev, Dorry L; Garonzik-Wang, Jacqueline M
BACKGROUND:Belatacept may impair humoral immunity, impacting the effectiveness of SARS-CoV-2 mRNA vaccines in transplant recipients. We investigated immunogenicity after SARS-CoV-2 mRNA vaccines in kidney transplant recipients who are and are not taking belatacept. METHODS:Participants were recruited between December 9, 2020, and April 1, 2021. Blood samples were collected after dose 1 and dose 2 (D1, D2) and analyzed using either an anti-SARS-CoV-2 enzyme immunoassay against the S1 domain of the SARS-CoV-2 spike protein or immunoassay against the receptor-binding domain of the SARS-CoV-2 spike protein. Stabilized inverse probability of treatment weights was used to compare immunogenicity, and a weighted logistics regression was used to calculate fold change of positive response. RESULTS:Among the 609 participants studied, 24 (4%) were taking belatacept. After dose 1, 0/24 (0%) belatacept patients had detectable antibodies, compared with 77 of 568 (14%) among the equivalent nonbelatacept population (P = 0.06). After dose 2, 1/19 (5%) belatacept patients had detectable antibodies, compared with 190/381 (50%) among the equivalent nonbelatacept population (P < 0.001). Belatacept use was associated with 16.7-fold lower odds of having a positive post-D2 titer result (P < 0.01). CONCLUSIONS:Additional measures need to be explored to protect kidney transplant recipients taking belatacept. Best safety practices should be continued despite vaccination among this population.
PMCID:8380692
PMID: 34028386
ISSN: 1534-6080
CID: 5127202

Comparison of Treatment Retention of Adults With Opioid Addiction Managed With Extended-Release Buprenorphine vs Daily Sublingual Buprenorphine-Naloxone at Time of Release From Jail

Lee, Joshua D; Malone, Mia; McDonald, Ryan; Cheng, Anna; Vasudevan, Kumar; Tofighi, Babak; Garment, Ann; Porter, Barbara; Goldfeld, Keith S; Matteo, Michael; Mangat, Jasdeep; Katyal, Monica; Giftos, Jonathan; MacDonald, Ross
Importance/UNASSIGNED:Extended-release buprenorphine (XRB), a monthly injectable long-acting opioid use disorder (OUD) treatment, has not been studied for use in corrections facilities. Objective/UNASSIGNED:To compare treatment retention following release from jail among adults receiving daily sublingual buprenorphine-naloxone (SLB) vs those receiving XRB. Design, Setting, and Participants/UNASSIGNED:This open-label, randomized comparative effectiveness study included 52 incarcerated adults in New York City observed for 8 weeks postrelease between June 2019 and May 2020. Participants were soon-to-be-released volunteers from 1 men's and 1 women's jail facility who had OUDs already treated with SLB. Follow-up treatment was received at a primary care clinic in Manhattan. Data were analyzed between June 2020 and December 2020. Interventions/UNASSIGNED:XRB treatment was offered prior to release and continued monthly through 8 weeks after release. SLB participants continued to receive daily directly observed in-jail SLB administration, were provided a 7-day SLB supply at jail release, and followed up at a designated clinic (or other preferred clinics). Main Outcomes and Measures/UNASSIGNED:Buprenorphine treatment retention at 8 weeks postrelease. Results/UNASSIGNED:A total of 52 participants were randomized 1:1 to XRB (26 participants) and SLB (26 participants). Participants had a mean (SD) age of 42.6 (10.0) years; 45 participants (87%) were men; and 40 (77%) primarily used heroin prior to incarceration. Most participants (30 [58%]) reported prior buprenorphine use; 18 (35%) reported active community buprenorphine treatment prior to jail admission. Twenty-one of 26 assigned to XRB received 1 or more XRB injection prior to release; 3 initiated XRB postrelease; and 2 did not receive XRB. Patients in the XRB arm had fewer jail medical visits compared with daily SLB medication administration (mean [SD] visits per day: XRB, 0.11 [0.03] vs SLB, 1.06 [0.08]). Community buprenorphine treatment retention at week 8 postrelease was 18 participants in the XRB group (69.2%) vs 9 in the SLB group (34.6%), and rates of opioid-negative urine tests were 72 of 130 tests in the XRB group (55.3%) and 50 of 130 tests in the SLB group (38.4%). There were no differences in rates of serious adverse events, no overdoses, and no deaths. Conclusions and Relevance/UNASSIGNED:XRB was acceptable among patients currently receiving SLB, and patients had fewer in-jail clinic visits and increased community buprenorphine treatment retention when compared with standard daily SLB treatment. These results support wider use and further study of XRB as correctional and reentry OUD treatment. Trial Registration/UNASSIGNED:ClinicalTrials.gov Identifier: NCT03604159.
PMCID:8427378
PMID: 34495340
ISSN: 2574-3805
CID: 5011982