Publications by authors named "Lisa Campbell"

97 Publications

SPIRIT-PRO Extension explanation and elaboration: guidelines for inclusion of patient-reported outcomes in protocols of clinical trials.

BMJ Open 2021 06 30;11(6):e045105. Epub 2021 Jun 30.

Value Evidence and Outcomes-Patient Centered Outcomes, GSK, Collegeville, Pennsylvania, USA.

Patient-reported outcomes (PROs) are used in clinical trials to provide valuable evidence on the impact of disease and treatment on patients' symptoms, function and quality of life. High-quality PRO data from trials can inform shared decision-making, regulatory and economic analyses and health policy. Recent evidence suggests the PRO content of past trial protocols was often incomplete or unclear, leading to research waste. To address this issue, international, consensus-based, PRO-specific guidelines were developed: the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT)-PRO Extension. The SPIRIT-PRO Extension is a 16-item checklist which aims to improve the content and quality of aspects of clinical trial protocols relating to PRO data collection to minimise research waste, and ultimately better inform patient-centred care. This SPIRIT-PRO explanation and elaboration (E&E) paper provides information to promote understanding and facilitate uptake of the recommended checklist items, including a comprehensive protocol template. For each SPIRIT-PRO item, we provide a detailed description, one or more examples from existing trial protocols and supporting empirical evidence of the item's importance. We recommend this paper and protocol template be used alongside the SPIRIT 2013 and SPIRIT-PRO Extension paper to optimise the transparent development and review of trial protocols with PROs.
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http://dx.doi.org/10.1136/bmjopen-2020-045105DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8246371PMC
June 2021

Guidelines for Reporting Trial Protocols and Completed Trials Modified Due to the COVID-19 Pandemic and Other Extenuating Circumstances: The CONSERVE 2021 Statement.

JAMA 2021 07;326(3):257-265

The Lancet , London, England.

Importance: Extenuating circumstances can trigger unplanned changes to randomized trials and introduce methodological, ethical, feasibility, and analytical challenges that can potentially compromise the validity of findings. Numerous randomized trials have required changes in response to the COVID-19 pandemic, but guidance for reporting such modifications is incomplete.

Objective: As a joint extension for the CONSORT and SPIRIT reporting guidelines, CONSERVE (CONSORT and SPIRIT Extension for RCTs Revised in Extenuating Circumstances) aims to improve reporting of trial protocols and completed trials that undergo important modifications in response to extenuating circumstances.

Evidence: A panel of 37 international trial investigators, patient representatives, methodologists and statisticians, ethicists, funders, regulators, and journal editors convened to develop the guideline. The panel developed CONSERVE following an accelerated, iterative process between June 2020 and February 2021 involving (1) a rapid literature review of multiple databases (OVID Medline, OVID EMBASE, and EBSCO CINAHL) and gray literature sources from 2003 to March 2021; (2) consensus-based panelist meetings using a modified Delphi process and surveys; and (3) a global survey of trial stakeholders.

Findings: The rapid review yielded 41 673 citations, of which 38 titles were relevant, including emerging guidance from regulatory and funding agencies for managing the effects of the COVID-19 pandemic on trials. However, no generalizable guidance for all circumstances in which trials and trial protocols might face unanticipated modifications were identified. The CONSERVE panel used these findings to develop a consensus reporting guidelines following 4 rounds of meetings and surveys. Responses were received from 198 professionals from 34 countries, of whom 90% (n = 178) indicated that they understood the concept definitions and 85.4% (n = 169) indicated that they understood and could use the implementation tool. Feedback from survey respondents was used to finalize the guideline and confirm that the guideline's core concepts were applicable and had utility for the trial community. CONSERVE incorporates an implementation tool and checklists tailored to trial reports and trial protocols for which extenuating circumstances have resulted in important modifications to the intended study procedures. The checklists include 4 sections capturing extenuating circumstances, important modifications, responsible parties, and interim data analyses.

Conclusions And Relevance: CONSERVE offers an extension to CONSORT and SPIRIT that could improve the transparency, quality, and completeness of reporting important modifications to trials in extenuating circumstances such as COVID-19.
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http://dx.doi.org/10.1001/jama.2021.9941DOI Listing
July 2021

New alleles in the mating type determination region of West Atlantic strains of Pseudo-nitzschia multistriata.

Harmful Algae 2021 03 20;103:101995. Epub 2021 Feb 20.

Stazione Zoologica Anton Dohrn, Villa Comunale, 80121 Naples, Italy. Electronic address:

The cosmopolitan, species-rich diatom genus Pseudo-nitzschia represents a good system for the study of speciation, evolution and diversity. Understanding elements linked to population dynamics and life cycle regulation for these species is of particular importance in view of their ability to produce the toxin domoic acid and cause harmful blooms. Pseudo-nitzschia multistriata, one of the toxic species that represents a model for the study of life cycle related questions, is the only diatom for which a sex determination mechanism has been described. Populations in the Gulf of Naples (Mediterranean Sea), can share four different allelic variants (A, M, B, N) of the mating type determination region, and one of them (A) is responsible for the determination of the mating type + (MT+), defined by the MT+ restricted expression of the gene MRP3. Here, we analysed the sex determination genomic region in three new strains isolated from the Gulf of Mexico and compared it to the alleles previously described in the Mediterranean strains. We first show that these geographically distant strains of P. multistriata belong to different populations but can interbreed. Next, we show that the two populations share an overall similar structure of the genomic locus although differences can be seen in the polymorphic regions upstream of MRP3. In strain P4-C1, we amplified and sequenced an allele (M) identical to one of those previously characterized in the Mediterranean strains. In the other two strains, P4-C2 and P4-C5, we identified three new alleles, which we named A2, B2 and N2. P4-C2 and P4-C5 are heterozygous and share the common allele A2 linked to the monoallelic expression of the MT+ specific sex determining gene MRP3. Our results expand information on the global distribution of P. multistriata and on the level of conservation of the sex determination region in different populations. The definition of the extent of intra- and inter-specific conservation of this region would be a relevant addition to our understanding of Pseudo-nitzschia diversity and evolution.
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http://dx.doi.org/10.1016/j.hal.2021.101995DOI Listing
March 2021

Fishing for food: Values and benefits associated with coastal infrastructure.

PLoS One 2021 15;16(4):e0249725. Epub 2021 Apr 15.

Duke University Marine Lab, Nicholas School of the Environment, Duke University, Beaufort, North Carolina, United States of America.

While there is substantial literature about the socio-cultural characteristics and values associated with recreational and commercial fisheries in the U.S., studies directed at those who 'fish for food'-those who depend on consuming their catch to various degrees-are relatively sparse. Using qualitative data collected through 80 semi-structured interviews with fishers in the summer and fall of 2018 in Carteret County, North Carolina, this study aims to better understand the group of recreational fishers who consume their catch by describing social and cultural dimensions and values associated with fishing for food, examining the role of infrastructure in facilitating access to benefits associated with this activity, and considering how knowledge of existing licensing regulations surrounding subsistence license waivers affect this fishing community. Interviews conducted at free public fishing structures in the region revealed that fishers derive a variety of values and benefits from fishing at these sites, including access to recreation, nutrition, a social community, and mental health benefits, which were found to be negatively impacted by Hurricane Florence in September 2018. We also found an informal economy of sharing catch on- and off-site that extends the reach and benefits facilitated by public infrastructure to people beyond those using it directly. Overall, we call for conceptualizations of 'fishing for food' that include aspects that go beyond traditional definitions of 'subsistence' or 'recreational' fishing such as food security, access, and less obvious social and cultural motivations behind the activity. These findings are a compelling rationalization for the creation and maintenance of formal and informal fishing places locally and, by extension, in other coastal areas, given the array of benefits provided by access to these types of locations.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0249725PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8049240PMC
April 2021

Discrimination Experiences and Depressive Symptoms among African Americans with Osteoarthritis Enrolled in a Pain Coping Skills Training Randomized Controlled Trial.

J Health Care Poor Underserved 2021 ;32(1):145-155

African Americans are more likely than members of other racial groups to report perceived discrimination in health care settings, and discrimination is linked to depression. Using data from a randomized controlled trial of pain coping skills training (PCST) for African Americans with osteoarthritis (N=164), we evaluated the interaction between discrimination experiences and experimental condition (PCST or control group) in linear regression models predicting depressive symptoms. There was a significant interaction between personal discrimination and experimental condition on depressive symptoms (interaction term coefficient: b=-3.2, 95% CI [- 6.4, - .02], p=.05). Discrimination was associated with depressive symptoms among those in the control group but not among those who received PCST. Participation in a PCST intervention may have reduced the association between discrimination experiences and depressive symptoms among participants in this sample. Future research should explore whether interventions aimed at teaching coping skills may be effective in ameliorating the harmful mental health effects of perceived discrimination.
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http://dx.doi.org/10.1353/hpu.2021.0014DOI Listing
September 2021

Assessing civility at an academic health science center: Implications for employee satisfaction and well-being.

PLoS One 2021 26;16(2):e0247715. Epub 2021 Feb 26.

College of Media & Communication, Texas Tech University, Lubbock, Texas, United States of America.

Incivilities are pervasive among workers in healthcare institutions. Previously identified effects include deterioration of employee physical and mental health, absenteeism, burnout, and turnover, as well as reduced patient safety and quality of care. This study documented factors related to organizational civility at an academic health sciences center (AHSC) as the basis for future intervention work. We used a cross-sectional research design to conduct an online survey at four of five campuses of an AHSC. Using the Organizational Civility Scale (OCS), we assessed differences across gender, race (White and non-White) and job type (faculty or staff) in the eleven subscales (frequency of incivility, perceptions of organizational climate, existence of civility resources, importance of civility resources, feelings about current employment, employee satisfaction, sources of stress, coping strategies, overall levels of stress/coping ability, and overall civility rating). Significant gender differences were found in six of the eleven subscales: perception of organizational climate (p < .001), existence of civility resources (p = .001), importance of civility resources (p < .001), frequency of incivilities (p < .001), employee satisfaction (p = .002), and overall civility rating (p = .007). Significant differences between respondents by self-identified race were found only in one subscale: existence of civility resources (p = .048). Significant differences were found between faculty and staff in four subscales: perception of organizational climate (p = .001), importance of civility resources (p = .02), employee satisfaction (p = .01), and overall levels of stress (p = .03). Results suggest that gender and employment type differences exist in the perception of organizational climate at the academic health center, while significant racial differences only occurred in reference to reported existence of civility resources. Attention to these differences should be incorporated into the development of programs to address the problem.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0247715PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7909676PMC
August 2021

Application of a convolutional neural network to improve automated early warning of harmful algal blooms.

Environ Sci Pollut Res Int 2021 Jun 5;28(22):28544-28555. Epub 2021 Feb 5.

Department of Oceanography, Texas A&M University, College Station, TX, 77843-3146, USA.

Continuous monitoring and early warning together represent an important mitigation strategy for harmful algal blooms (HAB). The coast of Texas experiences periodic blooms of three HAB dinoflagellates: Karenia brevis, Dinophysis ovum, and Prorocentrum texanum. A plankton image data set acquired by an Imaging FlowCytobot over a decade of operation was used to train and evaluate two new automated image classifiers. A 112 class, random forest classifier (RF_112) and a 112 class, convolutional neural network classifier (CNN_112) were developed and compared with an existing, 54 class, random forest classifier (RF_54) already in use as an early warning notification system. Both 112 class classifiers exhibited improved performance over the RF_54 classifier when tested on three different HAB species with the CNN_112 classifier producing fewer false positives and false negatives in most of the cases tested. For K. brevis and P. texanum, the current threshold of 2 cellsmL was identified as the best threshold to minimize the number of false positives and false negatives. For D. ovum, a threshold of 1 cellmL was found to produce the best results with regard to the number of false positives/negatives. A lower threshold will result in earlier notification of an increase in cell concentration and will provide state health managers with increased lead time to prepare for an impending HAB.
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http://dx.doi.org/10.1007/s11356-021-12471-2DOI Listing
June 2021

Recognize fish as food in policy discourse and development funding.

Ambio 2021 May 16;50(5):981-989. Epub 2021 Jan 16.

World Food Policy Center, Duke University, 1201 Pennsylvania Avenue NW, Suite 500, Washington, DC, 20004, USA.

The international development community is off-track from meeting targets for alleviating global malnutrition. Meanwhile, there is growing consensus across scientific disciplines that fish plays a crucial role in food and nutrition security. However, this 'fish as food' perspective has yet to translate into policy and development funding priorities. We argue that the traditional framing of fish as a natural resource emphasizes economic development and biodiversity conservation objectives, whereas situating fish within a food systems perspective can lead to innovative policies and investments that promote nutrition-sensitive and socially equitable capture fisheries and aquaculture. This paper highlights four pillars of research needs and policy directions toward this end. Ultimately, recognizing and working to enhance the role of fish in alleviating hunger and malnutrition can provide an additional long-term development incentive, beyond revenue generation and biodiversity conservation, for governments, international development organizations, and society more broadly to invest in the sustainability of capture fisheries and aquaculture.
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http://dx.doi.org/10.1007/s13280-020-01451-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7811336PMC
May 2021

Ectopic pregnancy and epithelial to mesenchymal transition: is there a link?

Reproduction 2021 03;161(3):V11-V14

Biomedical Sciences, University of Edinburgh, Edinburgh, Scotland.

Ectopic pregnancy (EP) is defined as the implantation of an embryo outside of the uterus and is a leading cause of first trimester maternal mortality and morbidity. This article discusses a possible role for epithelial to mesenchymal transition in the pathogenesis of EP, given the notable similarity of protein expression between the two processes.
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http://dx.doi.org/10.1530/REP-20-0542DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7923141PMC
March 2021

Growth response of Dinophysis, Mesodinium, and Teleaulax cultures to temperature, irradiance, and salinity.

Harmful Algae 2020 09 29;98:101896. Epub 2020 Aug 29.

Department of Oceanography, Texas A&M University, College Station, TX 77843, USA. Electronic address:

Mixotrophic Dinophysis species threaten human health and coastal economies through the production of toxins which cause diarrhetic shellfish poisoning (DSP) in humans. Novel blooms of Dinophysis acuminata and Dinophysis ovum have occurred in North American waters in recent decades, resulting in the closure of shellfish harvesting. Understanding the ecology of Dinophysis species and their prey is essential to predicting and mitigating the impact of blooms of these dinoflagellates. The growth response of two new isolates of Dinophysis species, one isolate of Mesodinium rubrum, and two strains of Teleaulax amphioxeia were evaluated at a range of temperature, salinity, and irradiance treatments to identify possible environmental drivers of Dinophysis blooms in the Gulf of Mexico. Results showed optimal growth of T. amphioxeia and M. rubrum at 24 °C, salinity 30 - 34, and irradiances between 300 and 400 µmol quanta m  s  . Optimal Dinophysis growth was observed at salinity 22 and temperatures between 18 and 24 °C. Mesodinium and both Dinophysis responded differently to experimental treatments, which may be due to the suitability of prey and different handling of kleptochloroplasts. Dinophysis bloom onset may be initiated by warming surface waters between winter and spring in the Gulf of Mexico. Toxin profiles for these two North American isolates were distinct; Dinophysis acuminata produced okadaic acid, dinophysistoxin-1, and pectenotoxin-2 while D. ovum produced only okadaic acid. Toxin per cell for D. ovum was two orders of magnitude greater than D. acuminata. Phylogenies based on the cox1 and cob genes did not distinguish these two Dinophysis species within the D. acuminata complex.
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http://dx.doi.org/10.1016/j.hal.2020.101896DOI Listing
September 2020

Targeting colony stimulating factor-1 receptor signalling to treat ectopic pregnancy.

Sci Rep 2020 09 24;10(1):15638. Epub 2020 Sep 24.

MRC Centre for Reproductive Health, University of Edinburgh, Queen's Medical Research Institute, Edinburgh, EH16 4TJ, UK.

1-2% of pregnancies are ectopic, the majority implanting in the Fallopian tube. A single, systemic dose of methotrexate, a DNA-synthesis (S phase) inhibitor, has been used since 1991 for outpatient treatment of women with stable EP. However, methotrexate has limited clinical and cost effectiveness, restricting its use to 25-30% of these women. There is an unmet need for better medical treatment for EP. Colony stimulating factor-1 (CSF-1) promotes placentation and creates a pro-inflammatory environment that is fundamental for the maintenance of a normal pregnancy. We hypothesised that CSF-1 is also involved in the placentation and maintenance of an EP. Herein, we demonstrate the immunolocalisation of the CSF-1 receptor (CSF-1R) as well as its ligand (CSF-1) in immortalised first trimester trophoblast cells. We show that a specific CSF-1R kinase inhibitor, GW2580, abolishes CSF-1 induced trophoblast cell proliferation and migration and can be cytotoxic. We then demonstrate the expression of CSF-1R and CSF-1 in the cytotrophoblast and syncytiotrophoblast within ectopic implantation sites from women with EP. Our data suggests that CSF-1 is involved in the survival and proliferation of trophoblast cells in EP. This suggests that pharmacological disruption of CSF-1/CSF-1R signaling axis could be the basis of a new therapeutic for EP.
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http://dx.doi.org/10.1038/s41598-020-72785-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7519033PMC
September 2020

Stakeholder perspectives on large-scale marine protected areas.

PLoS One 2020 2;15(9):e0238574. Epub 2020 Sep 2.

Department of Geography, Environment and Geomatics, University of Guelph, Guelph, Ontario, Canada.

Large-scale marine protected areas (LSMPAs), MPAs greater than 100,000km2, have proliferated in the past decade. However, the value of LSMPAs as conservation tools is debated, in both global scientific and policy venues as well as in particular sites. To add nuance and more diverse voices to this debate, this research examines the perspectives of stakeholders directly engaged with LSMPAs. We conducted a Q Method study with forty LSMPA stakeholders at five sites, including three established LSMPAs (the Marianas Trench Marine National Monument, United States; the Phoenix Islands Protected Area, Kiribati; the National Marine Sanctuary, Palau) and two sites where LSMPAs had been proposed at the time of research (Bermuda and Rapa Nui (Easter Island), Chile). The analysis reveals five distinct viewpoints of LSMPAs. These include three more optimistic views of LSMPAs we have named Enthusiast, Purist, and Relativist. It also depicts two more cautious views of LSMPAs, which we have named Critic and Skeptic. The findings demonstrate the multi-dimensionality of stakeholder viewpoints on LSMPAs. These shared viewpoints have implications for the global LSMPA debate and LSMPA decision-makers, including highlighting the need to focus on LSMPA consultation processes. Better understanding of these viewpoints, including stakeholder beliefs, perspectives, values and concerns, may help to facilitate more nuanced dialogue amongst LSMPA stakeholders and, in turn, promote better governance of LSMPAs.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0238574PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7467253PMC
October 2020

Acceptability of telephone-based pain coping skills training among African Americans with osteoarthritis enrolled in a randomized controlled trial: a mixed methods analysis.

BMC Musculoskelet Disord 2020 Aug 14;21(1):545. Epub 2020 Aug 14.

Department of Medicine, University of North Carolina, Chapel Hill, NC, USA.

Background: Osteoarthritis (OA) disproportionately impacts African Americans compared to Caucasians, including greater pain severity. The Pain Coping Skills Training for African Americans with Osteoarthritis (STAART) study examined a culturally enhanced Pain Coping Skills Training (CST) program among African Americans with OA. This mixed methods study evaluated the acceptability of the Pain CST program among STAART participants.

Methods: STAART was a randomized controlled trial evaluating the effectiveness of an 11-session, telephone-based pain CST program, compared to a usual care control group. Participants were from the University of North Carolina and Durham Veterans Affairs Healthcare Systems. The present analyses included 93 participants in the CST group who completed a questionnaire about experiences with the program. Descriptive statistics of the questionnaire responses were calculated using SAS software. Thematic analysis was applied to open-response data using Dedoose software.

Results: Participants' mean rating of overall helpfulness of the pain CST program for managing arthritis symptoms was 8.0 (SD = 2.2) on a scale of 0-10. A majority of participants reported the program made a positive difference in their experience with arthritis (83.1%). Mean ratings of helpfulness of the specific skills ranged from 7.7 to 8.8 (all scales 0-10). Qualitative analysis of the open-response data identified four prominent themes: Improved Pain Coping, Mood and Emotional Benefits, Improved Physical Functioning, and experiences related to Intervention Delivery.

Conclusions: The high ratings of helpfulness demonstrate acceptability of this culturally enhanced pain CST program by African Americans with OA. Increasing access to cognitive-behavioral therapy-based programs may be a promising strategy to address racial disparities in OA-related pain and associated outcomes.

Trial Registration: NCT02560922 , registered September 25, 2015.
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http://dx.doi.org/10.1186/s12891-020-03578-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7427940PMC
August 2020

A call to action for public health nurses during the COVID-19 pandemic.

Public Health Nurs 2020 05 16;37(3):323-324. Epub 2020 Apr 16.

School of Nursing, Texas Tech University Health Sciences Center, San Antonio, TX, USA.

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http://dx.doi.org/10.1111/phn.12733DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7262140PMC
May 2020

Moving Upstream From the Individual to the Community: Addressing Social Determinants of Health.

NASN Sch Nurse 2020 May 2;35(3):152-157. Epub 2020 Feb 2.

Professor, Robert and Kathleen Scanlon Endowed Chair in Values Based Health Care, Director, Mid-Atlantic Center for Children's Health and the Environment (Region 3 PEHSU), Georgetown University, School of Nursing & Health Studies, Washington, DC.

School nurses are often the primary health professional promoting children's health-and address not just individuals, but communities. This article, featuring the key principle of community/public health, is the first in a series focusing on The Framework for 21st Century School Nursing Practice™ and presents a case study on asthma and air quality issues comparing the more traditional individual approaches to health (labeled downstream and midstream) with population-level approaches (labeled upstream). Through collaboration with key community stakeholders, school nurses can successfully implement policies and programs to address social determinants of health and, in turn, improve the health of the entire community. As we look to advance school nursing and support best practices, concentrating on population-level, upstream approaches align with recommendations outlined in the Framework for 21st Century School Nursing Practice™.
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http://dx.doi.org/10.1177/1942602X20902462DOI Listing
May 2020

Society for Developmental and Behavioral Pediatrics Clinical Practice Guideline for the Assessment and Treatment of Children and Adolescents with Complex Attention-Deficit/Hyperactivity Disorder.

J Dev Behav Pediatr 2020 Feb/Mar;41 Suppl 2S:S35-S57

Division of Developmental Medicine, Boston Children's Hospital, Harvard Medical School, Boston, MA.

Attention-deficit/hyperactivity disorder (ADHD) is the most common childhood neurodevelopmental disorder and is associated with an array of coexisting conditions that complicate diagnostic assessment and treatment. ADHD and its coexisting conditions may impact function across multiple settings (home, school, peers, community), placing the affected child or adolescent at risk for adverse health and psychosocial outcomes in adulthood. Current practice guidelines focus on the treatment of ADHD in the primary care setting. The Society for Developmental and Behavioral Pediatrics has developed this practice guideline to facilitate integrated, interprofessional assessment and treatment of children and adolescents with "complex ADHD" defined by age (<4 years or presentation at age >12 years), presence of coexisting conditions, moderate to severe functional impairment, diagnostic uncertainty, or inadequate response to treatment.
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http://dx.doi.org/10.1097/DBP.0000000000000770DOI Listing
January 2020

Supplementary Evidence Tables for Treatment of Complex Attention-Deficit/Hyperactivity Disorder.

J Dev Behav Pediatr 2020 Feb/Mar;41 Suppl 2S:s111-s148

Division of Developmental Medicine, Boston Children's Hospital, Harvard Medical School, Boston, MA.

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http://dx.doi.org/10.1097/DBP.0000000000000768DOI Listing
January 2020

Characterization of Dinophysis spp. (Dinophyceae, Dinophysiales) from the mid-Atlantic region of the United States.

J Phycol 2020 04 10;56(2):404-424. Epub 2020 Feb 10.

Center for Food Safety and Applied Nutrition, Office of Regulatory Science, US Food and Drug Administration, College Park, Maryland, 20740, USA.

Due to the increasing prevalence of Dinophysis spp. and their toxins on every US coast in recent years, the need to identify and monitor for problematic Dinophysis populations has become apparent. Here, we present morphological analyses, using light and scanning electron microscopy, and rDNA sequence analysis, using a ~2-kb sequence of ribosomal ITS1, 5.8S, ITS2, and LSU DNA, of Dinophysis collected in mid-Atlantic estuarine and coastal waters from Virginia to New Jersey to better characterize local populations. In addition, we analyzed for diarrhetic shellfish poisoning (DSP) toxins in water and shellfish samples collected during blooms using liquid-chromatography tandem mass spectrometry and an in vitro protein phosphatase inhibition assay and compared this data to a toxin profile generated from a mid-Atlantic Dinophysis culture. Three distinct morphospecies were documented in mid-Atlantic surface waters: D. acuminata, D. norvegica, and a "small Dinophysis sp." that was morphologically distinct based on multivariate analysis of morphometric data but was genetically consistent with D. acuminata. While mid-Atlantic D. acuminata could not be distinguished from the other species in the D. acuminata-complex (D. ovum from the Gulf of Mexico and D. sacculus from the western Mediterranean Sea) using the molecular markers chosen, it could be distinguished based on morphometrics. Okadaic acid, dinophysistoxin 1, and pectenotoxin 2 were found in filtered water and shellfish samples during Dinophysis blooms in the mid-Atlantic region, as well as in a locally isolated D. acuminata culture. However, DSP toxins exceeded regulatory guidance concentrations only a few times during the study period and only in noncommercial shellfish samples.
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http://dx.doi.org/10.1111/jpy.12966DOI Listing
April 2020

Accurate assessment of functional abilities in pre-schoolers for diagnostic and funding purposes: A comparison of the Vineland-3 and the PEDI-CAT.

Aust Occup Ther J 2020 02 27;67(1):31-38. Epub 2019 Oct 27.

Child Developmental Assessment Service, Campbelltown Hospital, Campbelltown, NSW, Australia.

Aim: Assessment of functional abilities is an essential component in the diagnosis of neurodevelopmental disorders in young children. Functional abilities, assessed using the Pediatric Evaluation of Disability Inventory-Computer Adapted Test (PEDI-CAT), are used to determine eligibility for early intervention funded under the National Disability Insurance Scheme in Australia (NDIS). This study aims to compare the use of the PEDI-CAT with the Vineland-3, a comprehensive parent interview for the determination of support needs, diagnosis, and eligibility for funding.

Method: Seventy-five preschool aged children referred for formal diagnosis were assessed with the Vineland-3, and subscale scores reviewed for clinical judgement. These children were also assessed on the PEDI-CAT speedy version and the results on the two tests compared.

Results: The PEDI-CAT was less sensitive than the Vineland-3 to the functional difficulties being experienced in this population of preschool aged children. The Vineland-3 had floor effects on some scales and deficits masked by skills in other areas in the same domain, but standard subscale scores allowed skills and areas needing support to be defined. Overall 25% of children clinically in need of support were not identified on the Pedi-cat compared to only 4% using Vineland Domain scores and 3% using Vineland-3 subscale scores. The PEDI-CAT also identified significantly lower levels of support required with only 32% of children found to need very substantial support compared to 40% of children on the Vineland Domain scores, and 59% using subscale scores.

Conclusion: Based on the results of this study, the Vineland-3 comprehensive interview interpreted using subscale scores as well as domain scores is more sensitive than the PEDI-CAT in identifying young children in need of support as well as the areas and degree of support required.
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http://dx.doi.org/10.1111/1440-1630.12619DOI Listing
February 2020

Quad Council Coalition community/public health nursing competencies: Building consensus through collaboration.

Public Health Nurs 2020 01 7;37(1):96-112. Epub 2019 Oct 7.

North Carolina Division of Public Health, Raleigh, North Carolina, USA.

Background: The changing professional environment for community/public health nursing practice necessitates competencies grounded in current evidence-based practice. The Quad Council Coalition (QCC) appointed a Task Force to revise the 2011 QCC Competencies for Public Health Nursing. The goal of the competencies is to guide professional nursing practice, curricula, research, and policy development. This paper describes the process used to develop the revised 2018 Competencies.

Methods: A biphasic Delphi technique was used to conduct a detailed examination and build consensus. Four individuals representing community/public health practice and education collaborated to identify and implement a systematic process for revising the QCC Competencies. The process included multiple iterations of review and feedback using consistent methods and tools to analyze and synthesize themes.

Results: The primary result of this project is the 2018 QCC Competencies document that has strong consensus and provides a coherent voice from professionals on the practice of community/public health nursing.

Discussion: Use of current QCC Competencies will strengthen the community/public health nursing capacity to positively impact the health and well-being of populations.
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http://dx.doi.org/10.1111/phn.12666DOI Listing
January 2020

Trends in Dinophysis abundance and diarrhetic shellfish toxin levels in California mussels (Mytilus californianus) from Monterey Bay, California.

Harmful Algae 2019 09 20;88:101641. Epub 2019 Aug 20.

Ocean Sciences Department, 1156 High Street, University of California, Santa Cruz, CA, 95064, United States.

Diarrhetic shellfish toxins (DSTs) are produced by the marine dinoflagellate, Dinophysis, as well as select species of benthic Prorocentrum. The DSTs can bioaccumulate in shellfish and cause gastrointestinal illness when humans consume high levels of this toxin. Although not routinely monitored throughout the U.S., recent studies in Washington, Texas, and New York suggest DSTs may be widespread throughout U.S. coastal waters. This study describes a four-year time series (2013-2016) of Dinophysis concentration and DST level in California mussels (Mytilus californianus) from Santa Cruz Municipal Wharf (SCMW) in Monterey Bay, California. Results show a maximum Dinophysis concentration of 9404 cells/L during this study and suggest Dinophysis persists as a member of the background phytoplankton community throughout the year. In California mussels, DSTs were found at persistent low levels throughout the course of this study, and exceeded the FDA guidance level of 160 ng/g 19 out of 192 weeks sampled. Concentrations of Dinophysis alone are a positive but weak predictor of DST level in California mussels, and basic environmental variables (temperature, salinity, and nutrients) do not sufficiently explain variation in Dinophysis concentration at SCMW. This study demonstrates that Dinophysis in Monterey Bay are producing DSTs that accumulate in local shellfish throughout the year, occasionally reaching levels of concern.
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http://dx.doi.org/10.1016/j.hal.2019.101641DOI Listing
September 2019

Characterization of putative DD-carboxypeptidase-encoding genes in Mycobacterium smegmatis.

Sci Rep 2019 03 26;9(1):5194. Epub 2019 Mar 26.

DST/NRF Centre of Excellence for Biomedical TB Research, School of Pathology, Faculty of Health Sciences, University of the Witwatersrand and the National Health Laboratory Service, P.O. Box 1038, Johannesburg, 2000, South Africa.

Penicillin binding proteins (PBPs) are the target of numerous antimicrobial agents that disrupt bacterial cell wall synthesis. In mycobacteria, cell elongation occurs through insertion of nascent cell wall material in the sub-polar region, a process largely driven by High Molecular Weight PBPs. In contrast, the function of DD-carboxypeptidases (DD-CPases), which are Low Molecular Weight Class 1C PBPs, in mycobacteria remains poorly understood. Mycobacterium smegmatis encodes four putative DD-CPase homologues, which display homology to counterparts in Escherichia coli. Herein, we demonstrate that these are expressed in varying abundance during growth. Deletion of MSMEG_1661, MSMEG_2433 or MSMEG_2432, individually resulted in no defects in growth, cell morphology, drug susceptibility or spatial incorporation of new peptidoglycan. In contrast, deletion of MSMEG_6113 (dacB) was only possible in a merodiploid strain expressing the homologous M. tuberculosis operon encoding Rv3627c (dacB), Rv3626c, Rv3625c (mesJ) and Rv3624c (hpt), suggestive of essentiality. To investigate the role of this operon in mycobacterial growth, we depleted gene expression using anhydrotetracycline-responsive repressors and noted reduced bipolar peptidoglycan synthesis. These data point to a possible role for this four gene operon, which is highly conserved across all mycobacterial species, in regulating spatial localization of peptidoglycan synthesis.
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http://dx.doi.org/10.1038/s41598-019-41001-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6435803PMC
March 2019

Pain coping skills training for African Americans with osteoarthritis: results of a randomized controlled trial.

Pain 2019 06;160(6):1297-1307

Department of Psychiatry and Behavioral Science, Duke University, Durham, NC, United States.

African Americans bear a disproportionate burden of osteoarthritis (OA), but they have been underrepresented in trials of behavioral interventions for pain. This trial examined a culturally tailored pain coping skills training (CST) program, compared to a wait list control group, among 248 African Americans with knee or hip OA. The pain CST program involved 11 telephone-based sessions over 3 months. Outcomes were assessed at baseline, 3 months (primary), and 9 months, and included the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale (primary outcome), WOMAC total score and function subscale, PROMIS Pain Interference, Short-Form 12 Mental and Physical Composite Subscales, Coping Strategies Questionnaire-Total Coping Attempts, Pain Catastrophizing Scale, Patient Health Questionnaire-8, Arthritis Self-Efficacy Scale, and Patient Global Impression of Arthritis Symptom Change. Linear mixed models were fit for all outcomes. There were no significant between-group differences in WOMAC pain score at 3 months (-0.63 [95% confidence interval -1.45, 0.18]; P = 0.128) or 9 months (-0.84 [95% confidence interval -1.73, 0.06]; P = 0.068). Among secondary outcomes, at 3 months, there were significant differences, in favor of the CST group, for Coping Strategies Questionnaire Total Coping Attempts, Pain Catastrophizing Scale, Arthritis Self-Efficacy, and Patient Global Impression of Arthritis Symptom Change (P < 0.01). Coping Strategies Questionnaire Total Coping Attempts, Arthritis Self-Efficacy, and Patient Global Assessment Change were also significantly improved at 9 months in the CST group, compared with wait list (P < 0.01). The culturally tailored pain CST program did not significantly reduce pain severity but did improve key measures of pain coping and perceived ability to manage pain among African Americans with OA.
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http://dx.doi.org/10.1097/j.pain.0000000000001525DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6719680PMC
June 2019

Literacy-Adapted Cognitive Behavioral Therapy Versus Education for Chronic Pain.

Ann Intern Med 2018 09;169(6):422-423

The University of Alabama, Tuscaloosa, Alabama (B.E.T., A.K.N., C.A.T.).

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http://dx.doi.org/10.7326/L18-0348DOI Listing
September 2018

Pain coping skills training for African Americans with osteoarthritis study: baseline participant characteristics and comparison to prior studies.

BMC Musculoskelet Disord 2018 Sep 19;19(1):337. Epub 2018 Sep 19.

Department of Psychology, East Carolina University, Greenville, NC, USA.

Background: The Pain Coping Skills Training for African Americans with OsteoaRTthritis (STAART) trial is examining the effectiveness of a culturally enhanced pain coping skills training (CST) program for African Americans with osteoarthritis (OA). This disparities-focused trial aimed to reach a population with greater symptom severity and risk factors for poor pain-related outcomes than previous studies. This paper compares characteristics of STAART participants with prior studies of CST or cognitive behavioral therapy (CBT)-informed training in pain coping strategies for OA.

Methods: A literature search identified 10 prior trials of pain CST or CBT-informed pain coping training among individuals with OA. We descriptively compared characteristics of STAART participants with other studies, in 3 domains of the National Institutes of Minority Health and Health Disparities' Research Framework: Sociocultural Environment (e.g., age, education, marital status), Biological Vulnerability and Mechanisms (e.g, pain and function, body mass index), and Health Behaviors and Coping (e.g., pain catastrophizing). Means and standard deviations (SDs) or proportions were calculated for STAART participants and extracted from published manuscripts for comparator studies.

Results: The mean age of STAART participants, 59 years (SD = 10.3), was lower than 9 of 10 comparator studies; the proportion of individuals with some education beyond high school, 75%, was comparable to comparator studies (61-86%); and the proportion of individuals who are married or living with a partner, 42%, was lower than comparator studies (62-66%). Comparator studies had less than about 1/3 African American participants. Mean scores on the Western Ontario and McMaster Universities Osteoarthritis Index pain and function scales were higher (worse) for STAART participants than for other studies, and mean body mass index of STAART participants, 35.2 kg/m (SD = 8.2), was higher than all other studies (30-34 kg/m). STAART participants' mean score on the Pain Catastrophizing scale, 19.8 (SD = 12.3), was higher (worse) than other studies reporting this measure (7-17).

Conclusions: Compared with prior studies with predominantly white samples, STAART participants have worse pain and function and more risk factors for negative pain-related outcomes across several domains. Given STAART participants' high mean pain catastrophizing scores, this sample may particularly benefit from the CST intervention approach.

Trial Registration: NCT02560922.
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http://dx.doi.org/10.1186/s12891-018-2249-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6145122PMC
September 2018

Pelvic Chlamydial Infection Predisposes to Ectopic Pregnancy by Upregulating Integrin β1 to Promote Embryo-tubal Attachment.

EBioMedicine 2018 Mar 23;29:159-165. Epub 2018 Feb 23.

MRC Centre for Reproductive Health, University of Edinburgh, Edinburgh, UK. Electronic address:

Tubal ectopic pregnancies are a leading cause of global maternal morbidity and mortality. Previous infection with Chlamydia trachomatis is a major risk factor for tubal embryo implantation but the biological mechanism behind this association is unclear. Successful intra-uterine embryo implantation is associated with increased expression of endometrial "receptivity" integrins (cell adhesion molecules). We examined integrin expression in Fallopian tubes of women with previous C. trachomatis infection, in mice experimentally infected with C. trachomatis, in immortalised human oviductal epithelial cells (OE-E6/E7) and in an in vitro model of human embryo attachment (trophoblast spheroid-OE-E6/7 cell co-culture). Previous exposure with C. trachomatis increased Fallopian tube/oviduct integrin-subunit beta-1 (ITGB1) in women and mice compared to controls. C. trachomatis increased OE-E6/E7 cell ITGB1 expression and promoted trophoblast attachment to OE-E6/E7 cells which was negated by anti-ITGB1-antibody. We demonstrate that infection with C. trachomatis increases tubal ITGB1 expression, predisposing to tubal embryo attachment and ectopic pregnancy.
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http://dx.doi.org/10.1016/j.ebiom.2018.02.020DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5925620PMC
March 2018

Literacy-Adapted Cognitive Behavioral Therapy Versus Education for Chronic Pain at Low-Income Clinics: A Randomized Controlled Trial.

Ann Intern Med 2018 04 27;168(7):471-480. Epub 2018 Feb 27.

Whatley Health Services, Tuscaloosa, Alabama (R.B., T.T.B., C.S.E., D.H.T.).

Background: Chronic pain is common and challenging to treat. Although cognitive behavioral therapy (CBT) is efficacious, its benefit in disadvantaged populations is largely unknown.

Objective: To evaluate the efficacy of literacy-adapted and simplified group CBT versus group pain education (EDU) versus usual care.

Design: Randomized controlled trial. (ClinicalTrials.gov: NCT01967342).

Setting: Community health centers serving low-income patients in Alabama.

Patients: Adults (aged 19 to 71 years) with mixed chronic pain.

Interventions: CBT and EDU delivered in 10 weekly 90-minute group sessions.

Measurements: Self-reported, postintervention pain intensity (primary outcome) and physical function and depression (secondary outcomes).

Results: 290 participants were enrolled (70.7% of whom were women, 66.9% minority group members, 72.4% at or below the poverty level, and 35.8% reading below the fifth grade level); 241 (83.1%) participated in posttreatment assessments. Linear mixed models included all randomly assigned participants. Members of the CBT and EDU groups had larger decreases in pain intensity scores between baseline and posttreatment than participants receiving usual care (estimated differences in change scores-CBT: -0.80 [95% CI -1.48 to -0.11]; P = 0.022; EDU: -0.57 [CI, -1.04 to -0.10]; P = 0.018). At 6-month follow-up, treatment gains were not maintained in the CBT group but were still present in the EDU group. With regard to physical function, participants in the CBT and EDU interventions had greater posttreatment improvement than those receiving usual care, and this progress was maintained at 6-month follow-up. Changes in depression (secondary outcome) did not differ between either the CBT or EDU group and the usual care group.

Limitations: Participants represented a single health care system. Self-selection bias may have been present.

Conclusion: Simplified group CBT and EDU interventions delivered at low-income clinics significantly improved pain and physical function compared with usual care.

Primary Funding Source: Patient-Centered Outcomes Research Institute.
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http://dx.doi.org/10.7326/M17-0972DOI Listing
April 2018

Vinorelbine Potently Induces Placental Cell Death, Does Not Harm Fertility and is a Potential Treatment for Ectopic Pregnancy.

EBioMedicine 2018 Mar 2;29:166-176. Epub 2018 Feb 2.

Translational Obstetrics Group, Department of Obstetrics and Gynecology, Mercy Hospital for Women, University of Melbourne, Heidelberg, Victoria 3084, Australia; Mercy Perinatal, Mercy Hospital for Women, Victoria, Australia.

Ectopic pregnancies complicate 1-2 pregnancies and are a leading cause of maternal death. An effective oral drug therapy that replaces surgery might make its treatment safer, cheaper, simpler and therefore more widely accessible. The only current medical treatment offered to women is intramuscular methotrexate, but this only reliably resolves smaller ectopic pregnancies. As such, many ectopic pregnancies require surgical excision. We show that vinorelbine, an orally available chemotherapeutic agent, potently induced placental cell death but did not harm fertility in mice. Vinorelbine was 100-1000 times more potent than methotrexate in inducing placental cell death in vitro, and more potent than combination methotrexate and gefitinib (another proposed treatment for ectopic pregnancy being evaluated in phase III trials). Mechanistically, it caused microtubule condensation, blocked mitosis and activated the apoptosis cascade in placental cells. Vinorelbine was more efficacious than methotrexate±gefitinib in reducing the volume of placental cell tumors xenografted subcutaneously in SCID mice. Mice exposed to vinorelbine and allowed to breed, following a four week washout period, displayed normal fertility, however long-term fertility was not assessed. Human Fallopian tubes treated with vinorelbine did not exhibit up-regulation of apoptosis molecules. Our findings show that placental cells appear sensitive to vinorelbine and it has potential as a tablet-only approach to treat ectopic pregnancy.
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http://dx.doi.org/10.1016/j.ebiom.2018.01.041DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5925452PMC
March 2018

Guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols: The SPIRIT-PRO Extension.

JAMA 2018 02;319(5):483-494

Patient Partner, Centre for Patient Reported Outcome Research, Institute of Applied Health Research, University of Birmingham, Birmingham, England.

Importance: Patient-reported outcome (PRO) data from clinical trials can provide valuable evidence to inform shared decision making, labeling claims, clinical guidelines, and health policy; however, the PRO content of clinical trial protocols is often suboptimal. The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement was published in 2013 and aims to improve the completeness of trial protocols by providing evidence-based recommendations for the minimum set of items to be addressed, but it does not provide PRO-specific guidance.

Objective: To develop international, consensus-based, PRO-specific protocol guidance (the SPIRIT-PRO Extension).

Design, Setting, And Participants: The SPIRIT-PRO Extension was developed following the Enhancing Quality and Transparency of Health Research (EQUATOR) Network's methodological framework for guideline development. This included (1) a systematic review of existing PRO-specific protocol guidance to generate a list of potential PRO-specific protocol items (published in 2014); (2) refinements to the list and removal of duplicate items by the International Society for Quality of Life Research (ISOQOL) Protocol Checklist Taskforce; (3) an international stakeholder survey of clinical trial research personnel, PRO methodologists, health economists, psychometricians, patient advocates, funders, industry representatives, journal editors, policy makers, ethicists, and researchers responsible for evidence synthesis (distributed by 38 international partner organizations in October 2016); (4) an international Delphi exercise (n = 137 invited; October 2016 to February 2017); and (5) consensus meeting (n = 30 invited; May 2017). Prior to voting, consensus meeting participants were informed of the results of the Delphi exercise and given data from structured reviews evaluating the PRO protocol content of 3 defined samples of trial protocols.

Results: The systematic review identified 162 PRO-specific protocol recommendations from 54 sources. The ISOQOL Taskforce (n = 21) reduced this to 56 items, which were considered by 138 international stakeholder survey participants and 99 Delphi panelists. The final wording of the SPIRIT-PRO Extension was agreed on at a consensus meeting (n = 29 participants) and reviewed by external group of experts during a consultation period. Eleven extensions and 5 elaborations to the SPIRIT 2013 checklist were recommended for inclusion in clinical trial protocols in which PROs are a primary or key secondary outcome. Extension items focused on PRO-specific issues relating to the trial rationale, objectives, eligibility criteria, concepts used to evaluate the intervention, time points for assessment, PRO instrument selection and measurement properties, data collection plan, translation to other languages, proxy completion, strategies to minimize missing data, and whether PRO data will be monitored during the study to inform clinical care.

Conclusions And Relevance: The SPIRIT-PRO guidelines provide recommendations for items that should be addressed and included in clinical trial protocols in which PROs are a primary or key secondary outcome. Improved design of clinical trials including PROs could help ensure high-quality data that may inform patient-centered care.
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http://dx.doi.org/10.1001/jama.2017.21903DOI Listing
February 2018
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