Publications by authors named "Alexandra Zizzi"

6 Publications

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The Pediatric Obesity Microbiome and Metabolism Study (POMMS): Methods, Baseline Data, and Early Insights.

Obesity (Silver Spring) 2021 Mar;29(3):569-578

Department of Pediatrics, Duke University, Durham, North Carolina, USA.

Objective: The purpose of this study was to establish a biorepository of clinical, metabolomic, and microbiome samples from adolescents with obesity as they undergo lifestyle modification.

Methods: A total of 223 adolescents aged 10 to 18 years with BMI ≥95th percentile were enrolled, along with 71 healthy weight participants. Clinical data, fasting serum, and fecal samples were collected at repeated intervals over 6 months. Herein, the study design, data collection methods, and interim analysis-including targeted serum metabolite measurements and fecal 16S ribosomal RNA gene amplicon sequencing among adolescents with obesity (n = 27) and healthy weight controls (n = 27)-are presented.

Results: Adolescents with obesity have higher serum alanine aminotransferase, C-reactive protein, and glycated hemoglobin, and they have lower high-density lipoprotein cholesterol when compared with healthy weight controls. Metabolomics revealed differences in branched-chain amino acid-related metabolites. Also observed was a differential abundance of specific microbial taxa and lower species diversity among adolescents with obesity when compared with the healthy weight group.

Conclusions: The Pediatric Metabolism and Microbiome Study (POMMS) biorepository is available as a shared resource. Early findings suggest evidence of a metabolic signature of obesity unique to adolescents, along with confirmation of previously reported findings that describe metabolic and microbiome markers of obesity.
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http://dx.doi.org/10.1002/oby.23081DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7927749PMC
March 2021

Rationale and design of "Hearts & Parks": study protocol for a pragmatic randomized clinical trial of an integrated clinic-community intervention to treat pediatric obesity.

BMC Pediatr 2020 06 26;20(1):308. Epub 2020 Jun 26.

Duke Clinical Research Institute, Duke University, Durham, NC, 27710, USA.

Background: The prevalence of child and adolescent obesity and severe obesity continues to increase despite decades of policy and research aimed at prevention. Obesity strongly predicts cardiovascular and metabolic disease risk; both begin in childhood. Children who receive intensive behavioral interventions can reduce body mass index (BMI) and reverse disease risk. However, delivering these interventions with fidelity at scale remains a challenge. Clinic-community partnerships offer a promising strategy to provide high-quality clinical care and deliver behavioral treatment in local park and recreation settings. The Hearts & Parks study has three broad objectives: (1) evaluate the effectiveness of the clinic-community model for the treatment of child obesity, (2) define microbiome and metabolomic signatures of obesity and response to lifestyle change, and (3) inform the implementation of similar models in clinical systems.

Methods: Methods are designed for a pragmatic randomized, controlled clinical trial (n = 270) to test the effectiveness of an integrated clinic-community child obesity intervention as compared with usual care. We are powered to detect a difference in body mass index (BMI) between groups at 6 months, with follow up to 12 months. Secondary outcomes include changes in biomarkers for cardiovascular disease, psychosocial risk, and quality of life. Through collection of biospecimens (serum and stool), additional exploratory outcomes include microbiome and metabolomics biomarkers of response to lifestyle modification.

Discussion: We present the study design, enrollment strategy, and intervention details for a randomized clinical trial to measure the effectiveness of a clinic-community child obesity treatment intervention. This study will inform a critical area in child obesity and cardiovascular risk research-defining outcomes, implementation feasibility, and identifying potential molecular mechanisms of treatment response.

Clinical Trial Registration: NCT03339440 .
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http://dx.doi.org/10.1186/s12887-020-02190-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7318397PMC
June 2020

Middle managers' role in implementing evidence-based practices in healthcare: a systematic review.

Implement Sci 2018 12 12;13(1):149. Epub 2018 Dec 12.

Center for Healthcare Organization and Implementation Research (CHOIR), VA Boston Healthcare System, 150 South Huntington Avenue (152M), Jamaica Plain Campus, Building 9, Boston, MA, 02130, USA.

Background: Middle managers are in a unique position to promote the implementation of evidence-based practices (EBPs) in healthcare organizations, yet knowledge of middle managers' role in implementation and determinants (e.g., individual-, organizational-, and system-level factors) which influence their role remains fractured, spanning decades and disciplines. To synthesize understanding, we undertook a systematic review of studies of middle managers' role in healthcare EBP implementation and determinants of that role.

Methods: We searched MEDLINE/PubMed and Business Source Complete (Ebsco) for literature on middle managers' role in healthcare EBP implementation and its determinants. We abstracted data from records that met inclusion criteria (i.e., written in English, peer-reviewed, and reporting either a protocol or results of an empirical study) into a matrix for analysis. We summarized categorical variables using descriptive statistics. To analyze qualitative data, we used a priori codes and then allowed additional themes to emerge.

Results: One hundred five records, spanning across several countries and healthcare settings and relating to a range of EBPs, met our inclusion criteria. Studies of middle managers' role in healthcare EBP implementation and its determinants substantially increased from 1996 to 2015. Results from included studies suggest that middle managers shape implementation climate in addition to fulfilling the four roles hypothesized in extant theory of middle managers' role in implementation. However, extant studies offered little understanding of determinants of middle managers' role.

Conclusions: Our findings suggest that middle managers may play an important role in facilitating EBP implementation. Included studies offered little understanding regarding the relative importance of various roles, potential moderators of the relationship between middle managers' roles and EBP implementation, or determinants of middle managers' role in EBP implementation. Future studies should seek to understand determinants and moderators of middle managers' role. Clearer understanding may facilitate the translation of evidence into practice.
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http://dx.doi.org/10.1186/s13012-018-0843-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6292008PMC
December 2018

Correction to: Survivorship Care Plan Implementation in US Cancer Programs: a National Survey of Cancer Care Providers.

J Cancer Educ 2019 Jun;34(3):623

Institute for Patient-Centered Initiatives & Health Equity, The George Washington University Cancer Center, Washington, DC, USA.

The original version of this article contained an error. Citation 17 in the original publication referenced the wrong article.
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http://dx.doi.org/10.1007/s13187-018-1450-5DOI Listing
June 2019

Survivorship Care Plan Implementation in US Cancer Programs: a National Survey of Cancer Care Providers.

J Cancer Educ 2019 06;34(3):614-622

Institute for Patient-Centered Initiatives & Health Equity, The George Washington University Cancer Center, Washington, DC, USA.

Survivorship care plans (SCPs)-documents intended to improve care for cancer survivors who have completed active treatment-are required, yet implementation is poor. We sought to understand SCP implementation in cancer programs in the USA with the objective of identifying opportunities for improvement. We recruited cancer care providers in the USA via several cancer care networks to participate in a survey regarding SCP implementation. We used descriptive statistics to analyze the data. Three hundred ninety-five providers from diverse cancer programs in 47 states and Washington, DC responded to the survey. The timing of SCP implementation varied across and within cancer programs, with approximately 40% of respondents reporting developing SCPs more than 3 months after primary treatment or adjuvant therapy completion. Nurse navigators were responsible for 48-58% of each stage of SCP implementation. Processes that could have been automated often occurred in-person or via phone and vice versa. Respondents reported spending more than 2 h per SCP to complete all stages of implementation, of which less than a third was reimbursed by third-party payers. We identified several opportunities for improving SCP implementation, including broadening the base of responsibility, optimizing modes of communication, decreasing the time required and increasing the funding available, and limiting variation in SCP implementation across and within cancer programs. Future work should assess the influence of approaches to SCP implementation on desired outcomes.
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http://dx.doi.org/10.1007/s13187-018-1374-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6294719PMC
June 2019

Survivorship care plans: are randomized controlled trials assessing outcomes that are relevant to stakeholders?

J Cancer Surviv 2018 08 23;12(4):495-508. Epub 2018 Mar 23.

Department of Research and Evaluation, Kaiser Permanente Research, Pasadena, CA, USA.

Purpose: The purpose of this study was to compare outcomes assessed in extant randomized controlled trials (RCTs) to outcomes that stakeholders expect from survivorship care plans (SCPs). To facilitate the transition from active treatment to follow-up care for the 15.5 million US cancer survivors, many organizations require SCP use. However, results of several RCTs of SCPs' effectiveness have been null, possibly because they have evaluated outcomes on which SCPs should be expected to have limited influence. Stakeholders (e.g., survivors, oncologists) may expect outcomes that differ from RCTs' outcomes.

Methods: We identified RCTs' outcomes using a PubMed literature review. We identified outcomes that stakeholders expect from SCPs using semistructured interviews with stakeholders in three healthcare systems in the USA and Canada. Finally, we mapped RCTs' outcomes onto stakeholder-identified outcomes.

Results: RCT outcomes did not fully address outcomes that stakeholders expected from SCPs, and RCTs assessed outcomes that stakeholders did not expect from SCPs. RCTs often assessed outcomes only from survivors' perspectives.

Conclusions: RCTs of SCPs' effectiveness have not assessed outcomes that stakeholders expect. To better understand SCPs' effectiveness, future RCTs should assess outcomes of SCP use that are relevant from the perspective of multiple stakeholders.

Implications For Cancer Survivors: SCPs' effectiveness may be optimized when used with an eye toward outcomes that stakeholders expect from SCPs. For survivors, this means using SCPs as a map to guide them with respect to what kind of follow-up care they should seek, when they should seek it, and from whom they should seek it.
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http://dx.doi.org/10.1007/s11764-018-0688-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6054562PMC
August 2018