424 results on '"Shelton RC"'
Search Results
2. Altered expression of genes involved in inflammation and apoptosis in frontal cortex in major depression
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Shelton, RC, Claiborne, J, Sidoryk-Wegrzynowicz, M, Reddy, R, Aschner, M, Lewis, DA, and Mirnics, K
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- 2011
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3. Factors associated with colorectal cancer screening among a low-income, multiethnic, highly insured population: does provider's understanding of the patient's social context matter?
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De Jesus M, Puleo E, Shelton RC, McNeill LH, Emmons KM, De Jesus, Maria, Puleo, Elaine, Shelton, Rachel C, McNeill, Lorna H, and Emmons, Karen M
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The primary aim of this paper was to explore whether provider's understanding of patient's social context is associated with screening uptake, independent of provider's recommendation. Baseline data were collected in 2004-2005 from a cluster randomized control trial in 12 low-income housing sites. Participants included 695 low-income, multiethnic adults aged 50 years and over who were primarily insured (97%). Provider's recommendation was significantly associated with current adherence to colorectal cancer (CRC) screening. Provider's understanding of patient's social context, as operationalized by how well participants felt that their provider knew (a) their responsibilities at work, home, or school; (b) their worries about health; and (c) them as a person and their values and beliefs, was also significantly associated with current adherence to screening, independent of provider's recommendation. Participants who reported that their provider knew them well on two or three items were significantly more likely to be current with CRC screening compared to those who reported their provider knew them well on only one or none of the items (odds ratio = 1.56; 95% confidence interval = 1.06, 2.29). Our findings indicate that provider's understanding of patient's social context, independent of provider's recommendation for CRC screening, contributed to adherence to CRC screening in this low-income, multiethnic population. [ABSTRACT FROM AUTHOR]
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- 2010
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4. Antidepressant drug effects and depression severity: a patient-level meta-analysis.
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Fournier JC, DeRubeis RJ, Hollon SD, Dimidjian S, Amsterdam JD, Shelton RC, Fawcett J, Fournier, Jay C, DeRubeis, Robert J, Hollon, Steven D, Dimidjian, Sona, Amsterdam, Jay D, Shelton, Richard C, and Fawcett, Jan
- Abstract
Context: Antidepressant medications represent the best established treatment for major depressive disorder, but there is little evidence that they have a specific pharmacological effect relative to pill placebo for patients with less severe depression.Objective: To estimate the relative benefit of medication vs placebo across a wide range of initial symptom severity in patients diagnosed with depression.Data Sources: PubMed, PsycINFO, and the Cochrane Library databases were searched from January 1980 through March 2009, along with references from meta-analyses and reviews.Study Selection: Randomized placebo-controlled trials of antidepressants approved by the Food and Drug Administration in the treatment of major or minor depressive disorder were selected. Studies were included if their authors provided the requisite original data, they comprised adult outpatients, they included a medication vs placebo comparison for at least 6 weeks, they did not exclude patients on the basis of a placebo washout period, and they used the Hamilton Depression Rating Scale (HDRS). Data from 6 studies (718 patients) were included.Data Extraction: Individual patient-level data were obtained from study authors.Results: Medication vs placebo differences varied substantially as a function of baseline severity. Among patients with HDRS scores below 23, Cohen d effect sizes for the difference between medication and placebo were estimated to be less than 0.20 (a standard definition of a small effect). Estimates of the magnitude of the superiority of medication over placebo increased with increases in baseline depression severity and crossed the threshold defined by the National Institute for Clinical Excellence for a clinically significant difference at a baseline HDRS score of 25.Conclusions: The magnitude of benefit of antidepressant medication compared with placebo increases with severity of depression symptoms and may be minimal or nonexistent, on average, in patients with mild or moderate symptoms. For patients with very severe depression, the benefit of medications over placebo is substantial. [ABSTRACT FROM AUTHOR]- Published
- 2010
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5. Racial discrimination and physical activity among low-income-housing residents.
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Shelton RC, Puleo E, Bennett GG, McNeill LH, Goldman RE, Emmons KM, Shelton, Rachel C, Puleo, Elaine, Bennett, Gary G, McNeill, Lorna H, Goldman, Roberta E, and Emmons, Karen M
- Abstract
Background: Although discrimination has been identified as a potential determinant of existing racial/ethnic health disparities, no studies have investigated whether racial discrimination contributes to disparities in physical activity.Purpose: The primary aim of the current study was to examine the association between interpersonal racial discrimination and physical activity.Methods: Baseline data were collected during 2004-2005 among a predominately black and Hispanic sample of adult residents living in 12 low-income-housing sites in Boston MA (n=1055). Residents reported experiences of lifetime racial discrimination during interviewer-administered surveys and wore a pedometer for 5 days to measure physical activity. For analyses, performed in 2009, linear regression models with a cluster design were conducted to predict physical activity, measured as steps per day.Results: Nearly 48% of participants reported ever experiencing racial discrimination, and discrimination was most commonly experienced on the street or in a public setting. No association was found between discrimination and physical activity, when examined in bivariate, multivariable, or race-stratified models.Conclusions: The current results indicate that self-reported racial discrimination is not a key determinant of physical activity among residents living in low-income housing. However, additional research is warranted to address current limitations of this study. [ABSTRACT FROM AUTHOR]- Published
- 2009
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6. The association between racial and gender discrimination and body mass index among residents living in lower-income housing.
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Shelton RC, Puleo E, Bennett GG, McNeill LH, Sorensen G, Emmons KM, Shelton, Rachel C, Puleo, Elaine, Bennett, Gary G, McNeill, Lorna H, Sorensen, Glorian, and Emmons, Karen M
- Abstract
Background: Research on the association between self-reported racial or gender discrimination and body mass index (BMI) has been limited and inconclusive to date, particularly among lower-income populations.Objectives: The aim of the current study was to examine the association between self-reported racial and gender discrimination and BMI among a sample of adult residents living in 12 urban lower-income housing sites in Boston, Masschusetts (USA).Methods: Baseline survey data were collected among 1,307 (weighted N = 1907) study participants. For analyses, linear regression models with a cluster design were conducted using SUDAAN and SAS statistical software.Results: Our sample was predominately Black (weighted n = 956) and Hispanic (weighted n = 857), and female (weighted n = 1420), with a mean age of 49.3 (SE: .40) and mean BMI of 30.2 kg m(-2) (SE: .19). Nearly 47% of participants reported ever experiencing racial discrimination, and 24.8% reported ever experiencing gender discrimination. In bivariate and multivariable linear regression models, no main effect association was found between either racial or gender discrimination and BMI.Conclusions: While our findings suggest that self-reported discrimination is not a key determinant of BMI among lower-income housing residents, these results should be considered in light of study limitations. Future researchers may want to investigate this association among other relevant samples, and other social contextual and cultural factors should be explored to understand how they contribute to disparities. [ABSTRACT FROM AUTHOR]- Published
- 2009
7. Symbyax® (olanzapine and fluoxetine HCl) for the acute treatment of treatment-resistant depression.
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Shelton RC
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- 2009
8. Treatment-resistant depression: understanding its nature and the burden of care.
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Shelton RC
- Published
- 2009
9. Follow-up of abnormal screening mammograms among low-income ethnically diverse women: findings from a qualitative study.
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Allen JD, Shelton RC, Harden E, Goldman RE, Allen, Jennifer D, Shelton, Rachel C, Harden, Elizabeth, and Goldman, Roberta E
- Abstract
Objective: To understand factors that women feel facilitate or hinder their receipt of diagnostic services following an abnormal screening mammogram.Methods: This qualitative study used a purposive sampling strategy to identify low-income, ethnically diverse women aged 40 or over who had a recent abnormal mammogram. Working with a community health center, breast evaluation center, and mobile mammography van, 64 women were interviewed to identify salient themes that differentiated women who received timely follow-up from those who did not.Results: Prominent themes among women who delayed follow-up included dissatisfaction with communication of results; perceived disrespect on the part of providers and clinic staff; logistical barriers to access of diagnostic services; anxiety and fear about a possible cancer diagnosis; and a lack of information about breast cancer screening and symptoms. Women who received timely care more often reported an appreciation of efforts by providers and clinic staff to support their prompt follow-up; availability of social support that facilitated appointment-keeping; confidence in their ability to advocate for their health; and a high priority placed on self-care.Conclusion: A comprehensive approach to improving timely diagnostic follow-up among underserved groups must address patient beliefs and attitudes, provider practices and communication, and practices at the health care systems level.Practice Implications: Implications and strategies for improving patient education, patient-provider communication, and organizational practices are discussed. [ABSTRACT FROM AUTHOR]- Published
- 2008
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10. Effectiveness of St John's wort in major depression: a randomized controlled trial.
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Shelton RC, Keller MB, Gelenberg A, Dunner DL, Hirschfeld R, Thase ME, Russell J, Lydiard RB, Crits-Cristoph P, Gallop R, Todd L, Hellerstein D, Goodnick P, Keitner G, Stahl SM, Halbreich U, Shelton, R C, Keller, M B, Gelenberg, A, and Dunner, D L
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Context: Extracts of St John's wort are widely used to treat depression. Although more than 2 dozen clinical trials have been conducted with St John's wort, most have significant flaws in design and do not enable meaningful interpretation.Objective: To compare the efficacy and safety of a standardized extract of St John's wort with placebo in outpatients with major depression.Design and Setting: Randomized, double-blind, placebo-controlled clinical trial conducted between November 1998 and January 2000 in 11 academic medical centers in the United States.Participants: Two hundred adult outpatients (mean age, 42.4 years; 67.0% female; 85.9% white) diagnosed as having major depression and having a baseline Hamilton Rating Scale for Depression (HAM-D) score of at least 20.Intervention: Participants completed a 1-week, single-blind run-in of placebo, then were randomly assigned to receive either St John's wort extract (n = 98; 900 mg/d for 4 weeks, increased to 1200 mg/d in the absence of an adequate response thereafter) or placebo (n = 102) for 8 weeks.Main Outcome Measures: The primary outcome measure was rate of change on the HAM-D over the treatment period. Secondary measures included the Beck Depression Inventory (BDI), Hamilton Rating Scale for Anxiety (HAM-A), the Global Assessment of Function (GAF) scale, and the Clinical Global Impression-Severity and -Improvement scales (CGI-S and CGI-I).Results: The random coefficient analyses for the HAM-D, HAM-A, CGI-S, and CGI-I all showed significant effects for time but not for treatment or time-by-treatment interaction (for HAM-D scores, P<.001, P =.16, and P =.58, respectively). Analysis of covariance showed nonsignificant effects for BDI and GAF scores. The proportion of participants achieving an a priori definition of response did not differ between groups. The number reaching remission of illness was significantly higher with St John's wort than with placebo (P =.02), but the rates were very low in the full intention-to-treat analysis (14/98 [14.3%] vs 5/102 [4.9%], respectively). St John's wort was safe and well tolerated. Headache was the only adverse event that occurred with greater frequency with St John's wort than placebo (39/95 [41%] vs 25/100 [25%], respectively).Conclusion: In this study, St John's wort was not effective for treatment of major depression. [ABSTRACT FROM AUTHOR]- Published
- 2001
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11. Chronic depression: now, a treatable condition.
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D'Epiro NW, Howland RH, Shelton RC, and Trivedi MH
- Abstract
Once thought to reflect an 'unhappy temperament,' chronic depression is now known to be a mood disorder amenable to drug treatment. The therapeutic implications are profound--particularly because many of these patients have been depressed for decades, if not for their entire adult lives. [ABSTRACT FROM AUTHOR]
- Published
- 2000
12. Fine-tuning the treatment of depression.
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D'Epiro NW, Shelton RC, Simon GE, Stahl SM, Treisman GJ, and Williams JW Jr.
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In the 4 decades that antidepressant drugs have been available, treatment has improved-but it's still imperfect. Even the newest agents are associated with adverse effects, so the goal is to make drug side effects work for, rather than against, the patient. [ABSTRACT FROM AUTHOR]
- Published
- 1999
13. Understanding treatment-resistant depression.
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Cohen LJ, Shelton RC, Jackson WC, and Thase ME
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- 2009
14. Psychosocial outcomes in patients with recurrent major depressive disorder during 2 years of maintenance treatment with venlafaxine extended release.
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Trivedi MH, Dunner DL, Kornstein SG, Thase ME, Zajecka JM, Rothschild AJ, Friedman ES, Shelton RC, Keller MB, Kocsis JH, Gelenberg A, Trivedi, Madhukar H, Dunner, David L, Kornstein, Susan G, Thase, Michael E, Zajecka, John M, Rothschild, Anthony J, Friedman, Edward S, Shelton, Richard C, and Keller, Martin B
- Abstract
Background: Psychosocial outcomes from the Prevention of Recurrent Episodes of Depression with Venlafaxine ER for Two Years (PREVENT) study were evaluated.Methods: Adult outpatients with recurrent major depressive disorder (MDD) and response or remission following 6-month continuation treatment with venlafaxine extended release (ER) were randomized to receive venlafaxine ER or placebo for 1 year. Patients without recurrence on venlafaxine ER during year 1 were randomized to venlafaxine ER or placebo for year 2. Psychosocial functioning was assessed using the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q), Life Enjoyment Scale-Short Version (LES-S), Social Adjustment Scale-Self-Report (SAS-SR) total and individual factors, Short Form Health Survey (SF-36) (vitality, social functioning, and role function-emotional items), and Longitudinal Interval Follow-up Evaluation (LIFE).Results: At year 1 end, better overall psychosocial functioning was seen among patients randomly assigned to venlafaxine ER (n=129) vs placebo (n=129), with significant differences at end point on SF-36 role function-emotional, Q-LES-Q, and SAS-SR total, and work, house work, social/leisure, and extended-family factor scores (p≤0.05). At year 2 end, significant differences favored venlafaxine ER (n=43) vs placebo (n=40) on SF-36 vitality and role function-emotional, Q-LES-Q, LES-S, LIFE, and SAS-SR total, social/leisure, and extended-family factor scores (p≤0.05).Limitations: Patients with chronic MDD or treatment resistance were excluded and long-term specialist care was a financial incentive for treatment compliance. Discontinuation-related adverse events may have compromised the integrity of the treatment blind.Conclusions: For patients with recurrent MDD, 2 years' maintenance therapy with venlafaxine ER may improve psychosocial functioning vs placebo. [ABSTRACT FROM AUTHOR]- Published
- 2010
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15. Comparative effectiveness research trial for antidepressant incomplete and non-responders with treatment resistant depression (ASCERTAIN-TRD) a randomized clinical trial.
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Papakostas GI, Trivedi MH, Shelton RC, Iosifescu DV, Thase ME, Jha MK, Mathew SJ, DeBattista C, Dokucu ME, Brawman-Mintzer O, Currier GW, McCall WV, Modirrousta M, Macaluso M, Bystritsky A, Rodriguez FV, Nelson EB, Yeung AS, Feeney A, MacGregor LC, Carmody T, and Fava M
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- Humans, Male, Female, Middle Aged, Adult, Treatment Outcome, Duloxetine Hydrochloride therapeutic use, Comparative Effectiveness Research, Psychiatric Status Rating Scales, Combined Modality Therapy methods, Depressive Disorder, Treatment-Resistant drug therapy, Depressive Disorder, Treatment-Resistant therapy, Venlafaxine Hydrochloride therapeutic use, Transcranial Magnetic Stimulation methods, Aripiprazole therapeutic use, Aripiprazole pharmacology, Antidepressive Agents therapeutic use
- Abstract
Further research is needed to help improve both the standard of care and the outcome for patients with treatment-resistant depression. A particularly critical evidence gap exists with respect to whether pharmacological or non-pharmacological augmentation is superior to antidepressant switch, or vice-versa. The objective of this study was to compare the effectiveness of augmentation with aripiprazole or repetitive transcranial magnetic stimulation versus switching to the antidepressant venlafaxine XR (or duloxetine for those not eligible to receive venlafaxine) for treatment-resistant depression. In this multi-site, 8-week, randomized, open-label study, 278 subjects (196 females and 82 males, mean age 45.6 years (SD 15.3)) with treatment-resistant depression were assigned in a 1:1:1 fashion to treatment with either of these three interventions; 235 subjects completed the study. 260 randomized subjects with at least one post-baseline Montgomery-Asberg Depression Rating (MADRS) assessment were included in the analysis. Repetitive transcranial magnetic stimulation (score change (standard error (se)) = -17.39 (1.3) (p = 0.015) but not aripiprazole augmentation (score change (se) = -14.9 (1.1) (p = 0.069) was superior to switch (score change (se) = -13.22 (1.1)) on the MADRS. Aripiprazole (mean change (se) = -37.79 (2.9) (p = 0.003) but not repetitive transcranial magnetic stimulation augmentation (mean change (se) = -42.96 (3.6) (p = 0.031) was superior to switch (mean change (se) = -34.45 (3.0)) on the symptoms of depression questionnaire. Repetitive transcranial magnetic stimulation augmentation was shown to be more effective than switching antidepressants in treatment-resistant depression on the study primary measure. In light of these findings, clinicians should consider repetitive transcranial magnetic stimulation augmentation early-on for treatment-resistant depression.Trial registration: ClinicalTrials.gov, NCT02977299., (© 2024. The Author(s).)
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- 2024
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16. Closing the gap: advancing implementation science through training and capacity building.
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Brownson RC, Cabassa LJ, Drake BF, and Shelton RC
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- Humans, Capacity Building organization & administration, Implementation Science
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In their article on "Navigating the Field of Implementation Science Towards Maturity: Challenges and Opportunities," Chambers and Emmons describe the rapid growth of implementation science along with remaining challenges. A significant gap remains in training and capacity building. Formats for capacity building include university degree programs, summer training institutes, workshops, and conferences. In this letter, we describe and amplify on five key areas, including the need to (1) identify advanced competencies, (2) increase the volume and reach of trainings, (3) sustain trainings, (4) build equity focused trainings, and (5) develop global capacity. We hope that the areas we highlight will aid in addressing several key challenges to prioritize in future efforts to build greater capacity in implementation science., (© 2024. The Author(s).)
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- 2024
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17. Clinician- and Patient-Directed Communication Strategies for Patients With Cancer at High Mortality Risk: A Cluster Randomized Trial.
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Takvorian SU, Gabriel P, Wileyto EP, Blumenthal D, Tejada S, Clifton ABW, Asch DA, Buttenheim AM, Rendle KA, Shelton RC, Chaiyachati KH, Fayanju OM, Ware S, Schuchter LM, Kumar P, Salam T, Lieberman A, Ragusano D, Bauer AM, Scott CA, Shulman LN, Schnoll R, Beidas RS, Bekelman JE, and Parikh RB
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- Humans, Female, Male, Middle Aged, Aged, Communication, Adult, Cluster Analysis, Pennsylvania, Neoplasms mortality, Neoplasms psychology, Neoplasms therapy, Physician-Patient Relations
- Abstract
Importance: Serious illness conversations (SICs) that elicit patients' values, goals, and care preferences reduce anxiety and depression and improve quality of life, but occur infrequently for patients with cancer. Behavioral economic implementation strategies (nudges) directed at clinicians and/or patients may increase SIC completion., Objective: To test the independent and combined effects of clinician and patient nudges on SIC completion., Design, Setting, and Participants: A 2 × 2 factorial, cluster randomized trial was conducted from September 7, 2021, to March 11, 2022, at oncology clinics across 4 hospitals and 6 community sites within a large academic health system in Pennsylvania and New Jersey among 163 medical and gynecologic oncology clinicians and 4450 patients with cancer at high risk of mortality (≥10% risk of 180-day mortality)., Interventions: Clinician clusters and patients were independently randomized to receive usual care vs nudges, resulting in 4 arms: (1) active control, operating for 2 years prior to trial start, consisting of clinician text message reminders to complete SICs for patients at high mortality risk; (2) clinician nudge only, consisting of active control plus weekly peer comparisons of clinician-level SIC completion rates; (3) patient nudge only, consisting of active control plus a preclinic electronic communication designed to prime patients for SICs; and (4) combined clinician and patient nudges., Main Outcomes and Measures: The primary outcome was a documented SIC in the electronic health record within 6 months of a participant's first clinic visit after randomization. Analysis was performed on an intent-to-treat basis at the patient level., Results: The study accrued 4450 patients (median age, 67 years [IQR, 59-75 years]; 2352 women [52.9%]) seen by 163 clinicians, randomized to active control (n = 1004), clinician nudge (n = 1179), patient nudge (n = 997), or combined nudges (n = 1270). Overall patient-level rates of 6-month SIC completion were 11.2% for the active control arm (112 of 1004), 11.5% for the clinician nudge arm (136 of 1179), 11.5% for the patient nudge arm (115 of 997), and 14.1% for the combined nudge arm (179 of 1270). Compared with active control, the combined nudges were associated with an increase in SIC rates (ratio of hazard ratios [rHR], 1.55 [95% CI, 1.00-2.40]; P = .049), whereas the clinician nudge (HR, 0.95 [95% CI, 0.64-1.41; P = .79) and patient nudge (HR, 0.99 [95% CI, 0.73-1.33]; P = .93) were not., Conclusions and Relevance: In this cluster randomized trial, nudges combining clinician peer comparisons with patient priming questionnaires were associated with a marginal increase in documented SICs compared with an active control. Combining clinician- and patient-directed nudges may help to promote SICs in routine cancer care., Trial Registration: ClinicalTrials.gov Identifier: NCT04867850.
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- 2024
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18. Impact of Nicotine Replacement Therapy Sampling on Cessation-Related Processes.
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Sisson ML, Gajos JM, Wolford-Clevenger C, Chichester KR, Hawes ES, Hill SV, Shelton RC, Hendricks PS, Businelle MS, Carpenter MJ, and Cropsey KL
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- Humans, Male, Female, Adult, Middle Aged, Motivation, Poverty, Counseling methods, Nicotine Replacement Therapy, Smoking Cessation methods, Substance Withdrawal Syndrome, Tobacco Use Cessation Devices, Craving
- Abstract
Objectives: Smoking prevalence remains high among low-income smokers. Understanding processes (eg, withdrawal, craving, motivation) in early smoking cessation is crucially important for designing effective interventions for this population., Methods: This is a secondary analysis of a novel, in-session sampling intervention (ie, In Vivo) as compared with standard care behavioral smoking cessation counseling (SC) among community-dwelling low-income smokers (n = 83). This analysis examined the effect of 5 in-session sampling interventions on cessation-related processes and perceived advantages or disadvantages of nicotine replacement therapy (NRT) products over time using daily diaries., Results: The In Vivo treatment had an early positive impact in terms of decreasing withdrawal symptoms and cravings, and increasing perceived advantages to NRT, with moderate to large effect sizes. Results also showed that the treatment effectively reduced withdrawal symptoms and cravings in-session, with small-to-medium and medium-to-large effect sizes, respectively. In-session reduction of withdrawal symptoms and cravings did not occur for the SC group, with the exception of decreased withdrawal symptoms occurring during week 4. The In Vivo treatment did not impact quit goal, desire to quit, abstinence self-efficacy, perceived difficulty in quitting, motivational engagement, or perceived disadvantages to NRT. The In Vivo group reported less daily cigarette use relative to the SC group, in addition to reporting less cigarette use on days they reported greater combination NRT use., Conclusions: There is preliminary support for this In Vivo treatment over SC in reducing withdrawal, craving, and the number of cigarettes smoked per day, as well as promoting perceived advantages of NRT among low-income smokers., (Copyright © 2024 American Society of Addiction Medicine.)
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- 2024
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19. Integrated Measure of PRogram Element SuStainability in Childcare Settings (IMPRESS-C): development and psychometric evaluation of a measure of sustainability determinants in the early childhood education and care setting.
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Shoesmith A, Nathan N, Lum M, Yoong S, Nolan E, Wolfenden L, Shelton RC, Cooper B, Lane C, Grady A, Imad N, Riley-Gibson E, McCarthy N, Pearson N, and Hall A
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- Humans, Child, Preschool, Australia, Reproducibility of Results, Child Day Care Centers standards, Child Day Care Centers organization & administration, Female, Surveys and Questionnaires standards, Male, Child Care standards, Child, Psychometrics, Program Evaluation
- Abstract
Background: There is a need for valid and reliable measures of determinants of sustainability of public health interventions in early childhood education and care (ECEC) settings. This study aimed to develop and evaluate the psychometric and pragmatic properties of such a measure - the Integrated Measure of PRogram Element SuStainability in Childcare Settings (IMPRESS-C)., Methods: We undertook a two-phase process guided by the COnsensus-based Standards for the selection of health status Measurement INstruments checklist (COSMIN) and Psychometric and Pragmatic Evidence Rating Scale (PAPERS). Phase 1 involved measure development; i.e., determining items and scales through an iterative process and assessment of face and content validity. Phase 2 involved the evaluation of psychometric and pragmatic properties. The 29-item measure completed by service executives (directors and nominated supervisors) was embedded in a larger survey from a national sample of Australian ECEC services assessing their implementation of nutrition and physical activity programs. Structural validity, concurrent validity, known groups validity, internal consistency, floor and ceiling effects, norms, and pragmatic qualities of the measure were assessed according to the PAPERS criteria., Results: The final measure contained 26 items, with respondents reporting how strongly they agreed or disagreed on a five-point Likert scale. Phase 1 assessments confirmed the relevance, and face and content validity of the scale. In Phase 2, we obtained 482 completed surveys, of which 84% (n = 405) completed the entire measure across 405 ECEC settings (one executive per service). Three of the four fit indices for the confirmatory factor analysis met the pre-specified criteria (SRMR = 0.056, CFI = 0.993, RMSEA = 0.067) indicating 'good' structural validity. The IMPRESS-C illustrated: 'good' internal consistency, with Cronbach's alpha values from 0.53 to 0.92; 'emerging' concurrent validity; 'poor' known groups validity; 'good' norms; and 'good' overall pragmatic qualities (cost, readability, length, and assessor burden)., Conclusions: The IMPRESS-C possesses strong psychometric and pragmatic qualities for assessing service executive-level perceptions of determinants influencing sustainment of public health interventions within ECEC settings. To achieve a full range of perspectives in this setting, future work should be directed to also develop and test measures of sustainability determinants at the implementer level (e.g., among individual educators and staff)., (© 2024. The Author(s).)
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- 2024
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20. Associations of childhood, adolescence, and midlife cognitive function with DNA methylation age acceleration in midlife.
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Chen J, Moubadder L, Clausing ES, Kezios KL, Conneely KN, Hüls A, Baccarelli A, Factor-Litvak P, Cirrillo P, Shelton RC, Link BG, and Suglia SF
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- Humans, Female, Male, Adolescent, Middle Aged, Child, Aging genetics, Adult, Intelligence genetics, Cognitive Aging, DNA Methylation, Cognition physiology
- Abstract
Prior studies showed increased age acceleration (AgeAccel) is associated with worse cognitive function among old adults. We examine the associations of childhood, adolescence and midlife cognition with AgeAccel based on DNA methylation (DNAm) in midlife. Data are from 359 participants who had cognition measured in childhood and adolescence in the Child Health and Development study, and had cognition, blood based DNAm measured during midlife in the Disparities study. Childhood cognition was measured by Raven's Progressive Matrices and Peabody Picture Vocabulary Test (PPVT). Adolescent cognition was measured only by PPVT. Midlife cognition included Wechsler Test of Adult Reading (WTAR), Verbal Fluency (VF), Digit Symbol (DS). AgeAccel measures including Horvath, Hannum, PhenoAge, GrimAge and DunedinPACE were calculated from DNAm. Linear regressions adjusted for potential confounders were utilized to examine the association between each cognitive measure in relation to each AgeAccel. There are no significant associations between childhood cognition and midlife AgeAccel. A 1-unit increase in adolescent PPVT, which measures crystalized intelligence, is associated with 0.048-year decrease of aging measured by GrimAge and this association is attenuated after adjustment for adult socioeconomic status. Midlife crystalized intelligence measure WTAR is negatively associated with PhenoAge and DunedinPACE, and midlife fluid intelligence measure (DS) is negatively associated with GrimAge, PhenoAge and DunedinPACE. AgeAccel is not associated with VF in midlife. In conclusion, our study showed the potential role of cognitive functions at younger ages in the process of biological aging. We also showed a potential relationship of both crystalized and fluid intelligence with aging acceleration.
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- 2024
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21. A systematic review to determine the effect of strategies to sustain chronic disease prevention interventions in clinical and community settings: study protocol.
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Riley-Gibson E, Hall A, Shoesmith A, Wolfenden L, Shelton RC, Doherty E, Pollock E, Booth D, Salloum RG, Laur C, Powell BJ, Kingsland M, Lane C, Hailemariam M, Sutherland R, and Nathan N
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- Humans, Chronic Disease prevention & control, Health Promotion methods, Health Behavior, Research Design, Systematic Reviews as Topic
- Abstract
Background: The primary purpose of this review is to synthesise the effect of strategies aiming to sustain the implementation of evidenced-based interventions (EBIs) targeting key health behaviours associated with chronic disease (i.e. physical inactivity, poor diet, harmful alcohol use, and tobacco smoking) in clinical and community settings. The field of implementation science is bereft of an evidence base of effective sustainment strategies, and as such, this review will provide important evidence to advance the field of sustainability research., Methods: This systematic review protocol is reported in accordance with the Preferred Reporting Items for Systematic review and Meta-Analysis (PRISMA) checklist. Methods will follow Cochrane gold-standard review methodology. The search will be undertaken across multiple databases, adapting filters previously developed by the research team, data screening and extraction will be performed in duplicate, strategies will be coded using an adapted sustainability-explicit taxonomy, and evidence will be synthesised using appropriate methods (i.e. meta-analytic following Cochrane or non-meta-analytic following SWiM guidelines). We will include any randomised controlled study that targets any staff or volunteers delivering interventions in clinical or community settings. Studies which report on any objective or subjective measure of the sustainment of a health prevention policy, practice, or programme within any of the eligible settings will be included. Article screening, data extraction, risk of bias, and quality assessment will be performed independently by two review authors. Risk of bias will be assessed using Version 2 of the Cochrane risk-of-bias tool for randomised trials (RoB 2). A random-effect meta-analysis will be conducted to estimate the pooled effect of sustainment strategies separately by setting (i.e. clinical and community). Sub-group analyses will be undertaken to explore possible causes of statistical heterogeneity and may include the following: time period, single or multi-strategy, type of setting, and type of intervention. Differences between sub-groups will be statistically compared., Discussion/conclusion: This will be the first systematic review to determine the effect of strategies designed to support sustainment on sustaining the implementation of EBIs in clinical and community settings. The findings of this review will directly inform the design of future sustainability-focused implementation trials. Further, these findings will inform the development of a sustainability practice guide for public health practitioners., Systematic Review Registration: PROSPERO CRD42022352333., (© 2024. The Author(s).)
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- 2024
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22. Advancing the Science and Application of Implementation Science to Promote Health Equity: Commentary on the Symposium.
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Shelton RC and Brownson RC
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- Humans, Health Promotion organization & administration, Health Promotion methods, Public Health, Health Equity organization & administration, Implementation Science
- Abstract
There has been an increasing focus on making health equity a more explicit and foundational aspect of the research being conducted in public health and implementation science. This commentary provides an overview of five reviews in this Annual Review of Public Health symposium on Implementation Science and Health Equity. These articles reflect on and advance the application of core implementation science principles and concepts, with a focus on promoting health equity across a diverse range of public health and health care settings. Taken together, the symposium articles highlight critical conceptual, methodological, and empirical advances in the study designs, frameworks, and approaches that can help address equity considerations in the use of implementation science in both domestic and global contexts. Finally, this commentary highlights how work featured in this symposium can help inform future directions for rapidly taking public health to scale, particularly among systemically marginalized populations and communities.
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- 2024
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23. Challenges and Opportunities for Paving the Road to Global Health Equity Through Implementation Science.
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Adsul P, Shelton RC, Oh A, Moise N, Iwelunmor J, and Griffith DM
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- Humans, Health Equity organization & administration, Global Health, Implementation Science
- Abstract
Implementation science focuses on enhancing the widespread uptake of evidence-based interventions into routine practice to improve population health. However, optimizing implementation science to promote health equity in domestic and global resource-limited settings requires considering historical and sociopolitical processes (e.g., colonization, structural racism) and centering in local sociocultural and indigenous cultures and values. This review weaves together principles of decolonization and antiracism to inform critical and reflexive perspectives on partnerships that incorporate a focus on implementation science, with the goal of making progress toward global health equity. From an implementation science perspective, wesynthesize examples of public health evidence-based interventions, strategies, and outcomes applied in global settings that are promising for health equity, alongside a critical examination of partnerships, context, and frameworks operationalized in these studies. We conclude with key future directions to optimize the application of implementation science with a justice orientation to promote global health equity.
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- 2024
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24. Advancing a mission of translational intervention science: Comment on premature implementation.
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Beidas RS, Saldana L, and Shelton RC
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- Humans, Translational Research, Biomedical
- Abstract
Replies to comments made by Kenneth E. Freedland et al. (see record 2024-89430-002) on Rinad S. Beida, Lisa Saldana, and Rachel C. Shelton's original article (see record 2023-46817-001). In reading Freedland et al.'s (2024) commentary, it appears that their lens prioritizes internal validity and more explanatory and mechanistic work. While we also value these scientific goals and concur that the approaches they identify are clearly methodologically rigorous, we do not think the approaches will substantially reduce the unacceptable translation gap or address the fundamental issues of context. Our approach recognizes that there is tremendous value in cocreating solutions and interventions with patients, clinicians, and community members in the settings where we are seeking to promote health and address health inequities, and questions traditional assumptions and paradigms that scientists "know best" have effective solutions or should hold all of the power and knowledge (Brownson et al., 2022; Sanchez et al., 2023; Shelton, Adsul, & Oh, 2021; Shelton, Adsul, Oh, et al., 2021). We believe it is critical that we expand the pathways through which we advance intervention science in a meaningful and impactful way, and with more explicit attention to issues of context, equity, engagement, and external validity. (PsycInfo Database Record (c) 2024 APA, all rights reserved).
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- 2024
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25. Addressing social needs in oncology care: another research-to-practice gap.
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Haines E, Shelton RC, Foley K, Beidas RS, Dressler EV, Kittel CA, Chaiyachati KH, Fayanju OM, Birken SA, Blumenthal D, and Rendle KA
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- Humans, Medical Oncology, Social Support, Social Work organization & administration, Health Services Needs and Demand, Professional Practice Gaps, Cancer Care Facilities organization & administration, Neoplasms therapy, Needs Assessment, Social Determinants of Health
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Social determinants of health and unmet social needs are directly related to cancer outcomes, from diagnosis to survivorship. If identified, unmet social needs can be addressed in oncology care by changing care plans in collaboration with patients' preferences and accounting for clinical practice guidelines (eg, reducing the frequency of appointments, switching treatment modalities) and connecting patients to resources within healthcare organizations (eg, social work support, patient navigation) and with community organizations (eg, food banks, housing assistance programs). Screening for social needs is the first step to identifying those who need additional support and is increasingly recognized as a necessary component of high-quality cancer care delivery. Despite evidence about the relationship between social needs and cancer outcomes and the abundance of screening tools, the implementation of social needs screening remains a challenge, and little is known regarding the adoption, reach, and sustainability of social needs screening in routine clinical practice. We present data on the adoption and implementation of social needs screening at two large academic cancer centers and discuss three challenges associated with implementing evidence-based social needs screening in clinical practice: (1) identifying an optimal approach for administering social needs screening in oncology care, (2) adequately addressing identified unmet needs with resources and support, and (3) coordinating social needs screening between oncology and primary care., (© The Author(s) 2024. Published by Oxford University Press.)
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- 2024
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26. Enhancing Impact: A Call to Action for Equitable Implementation Science.
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Shelton RC and Brownson RC
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- Humans, Health Equity, Implementation Science
- Abstract
Despite investments in evidence-based interventions and Implementation Science, most evidence-based interventions are not widely or routinely adopted, delivered, or sustained in many real-world community and healthcare settings. This gap is even greater in settings and populations experiencing numerous social and structural barriers to health, with important implications for persistent patterns in health inequities. In this Viewpoint, as part of a Special Issue on Advancing the Adaptability of Chronic Disease Prevention and Management through Implementation Science, we outline seven calls to action for the field of Implementation Science, with the goal of encouraging researchers, practitioners, and funders to be more intentional and accountable in applying Implementation Science to have greater impact on promoting health equity. Calls to action include (1) enhance public health, community, and multi-sectoral partnerships to promote health equity and equitable implementation; (2) revisit and build the evidence base needed to promote health equity and impact at multiple levels; (3) prioritize focus on policy development, dissemination, and implementation; (4) be agile and responsive in application of Implementation Science frameworks, processes, and methods; (5) identify and redefine meaningful metrics for equity and impact; (6) disseminate scientific evidence and research to a diverse range of partners and potential beneficiaries; and (7) extend focus on de-implementation, mis-implementation, and sustainability which are central to enhancing health equity. Additionally, we outline why a focus on prevention and public health is essential to making progress towards health equity in Implementation Science, summarize important advancements that the field has made towards making equity more foundational, and pose important research questions to enhance equitable impact of work in this area., (© 2023. The Author(s).)
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- 2024
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27. Cumulative Stress Across the Life Course and Biological Aging in Adulthood.
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Suglia SF, Clausing ES, Shelton RC, Conneely K, Prada-Ortega D, DeVivo I, Factor-Litvak P, Cirillo P, Baccarelli AA, Cohn B, and Link BG
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- Adult, Child, Humans, Female, Middle Aged, Adolescent, Aging, DNA Methylation, Educational Status, Epigenesis, Genetic, Life Change Events, Stress, Psychological
- Abstract
Objective: Psychosocial stressors have been linked with accelerated biological aging in adults; however, few studies have examined stressors across the life course in relation to biological aging., Methods: In 359 individuals (57% White, 34% Black) from the Child Health and Development Studies Disparities study, economic (income, education, financial strain), social (parent-child relations, caretaker responsibilities) and traumatic (death of a sibling or child, violence exposure) stressors were assessed at multiple time points (birth and ages 9, 15, and 50 years). Experiences of major discrimination were assessed at age 50. Life period stress scores were then assessed as childhood (birth-age 15 years) and adulthood (age 50 years). At age 50 years, participants provided blood samples, and DNA methylation was assessed with the EPIC BeadChip. Epigenetic age was estimated using six epigenetic clocks (Horvath, Hannum, Skin and Blood age, PhenoAge, GrimAge, Dunedin Pace of Aging). Age acceleration was determined using residuals from regressing chronologic age on each of the epigenetic age metrics. Telomere length was assessed using the quantitative polymerase chain reaction-based methods., Results: In linear regression models adjusted for race and gender, total life stress, and childhood and adult stress independently predicted accelerated aging based on GrimAge and faster pace of aging based on the DunedinPace. Associations were attenuated after adjusting for smoking status. In sex-stratified analyses, greater childhood stress was associated with accelerated epigenetic aging among women but not men. No associations were noted with telomere length., Conclusions: We found that cumulative stressors across the life course were associated with accelerated epigenetic age, with differences by sex (e.g., accelerated among women). Further research of this association in large and diverse samples is needed., (Copyright © 2024 by the American Psychosomatic Society.)
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- 2024
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28. National Survey of Patient Safety Experiences in Hospital Medicine During the COVID-19 Pandemic.
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Carter D, Rosen A, Applebaum JR, Southern WN, Crossman DJ, Shelton RC, Auerbach A, Schnipper JL, and Adelman JS
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- Humans, Pandemics, Patient Safety, Personal Protective Equipment, COVID-19, Hospital Medicine
- Abstract
Background: During the COVID-19 pandemic, hospitals were caring for increasing numbers of patients with a novel and highly contagious respiratory illness, forcing adaptations in care delivery. The objective of this study was to understand the impact of these adaptations on patient safety in hospital medicine., Methods: The authors conducted a nationwide survey to understand patient safety challenges experienced by hospital medicine clinicians during the COVID-19 pandemic. The survey was distributed to members of the Society of Hospital Medicine via an e-mail listserv. It consisted of closed- and open-ended questions to elicit respondents' experience in five domains: error reporting and communication, staffing, equipment, personal protective equipment (PPE) and isolation practices, and infrastructure. Quantitative questions were reported as counts and percentages; qualitative responses were coded and analyzed for relevant themes., Results: Of 196 total responses, 167 respondents (85.2%) were attending physicians and 85 (43.8%) practiced at teaching hospitals. Safety concerns commonly identified included nursing shortages (71.0%), limiting patient interactions to conserve PPE (61.9%), and feeling that one was practicing in a more hazardous environment (61.4%). In free-text responses, clinicians described poor outcomes and patient decompensation due to provider and equipment shortages, as well as communication lapses and diagnostic errors resulting from decreased patient contact and the need to follow isolation protocols., Conclusion: Efforts made to accommodate shortages in staff and equipment, adapt to limited PPE, and enforce isolation policies had unintended consequences that affected patient safety and created a more hazardous environment characterized by less efficient care, respiratory decompensations, diagnostic errors, and poor communication with patients., (Copyright © 2023 The Joint Commission. Published by Elsevier Inc. All rights reserved.)
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- 2024
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29. Assessing the implementation of a multi-component hypertension program in a Guatemalan under-resourced dynamic context: an application of the RE-AIM/PRISM extension for sustainability and health equity.
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Paniagua-Avila A, Shelton RC, Figueroa JC, Guzman AL, Gutierrez L, Hernandez-Galdamez DR, Ramirez JM, Rodriguez J, Irazola V, Ramirez-Zea M, and Fort MP
- Abstract
Background: The COVID-19 pandemic necessitated rapid changes in healthcare delivery in Guatemala's public primary care settings. A new hypertension program, implemented as part of a type 2 hybrid trial since 2019, exemplifies an implementation effort amidst a changing context in an under-resourced setting. We assessed the implementation of an evidence-based intervention (EBI; protocol-based hypertension treatment) and one of its main implementation strategies (team-based collaborative care), raising implications for health equity and sustainability. We present innovative application of systems thinking visuals., Methods: Conducting a convergent mixed methods analysis, we assessed implementation in response to contextual changes across five Ministry of Health (MoH) districts at the pandemic's onset. Utilizing quantitative programmatic data and qualitative interviews with stakeholders (n=18; health providers, administrators, study staff), we evaluated dimensions of "Reach, Effectiveness, Adoption, Implementation and Maintenance," RE-AIM (Reach, Implementation delivery + adaptations), and "Practical Robust Implementation and Sustainability Model," PRISM (Organizational perspective on the EBI, Fit, Implementation and sustainability infrastructure) frameworks. We assessed representativeness by comparing participants to census data. To assess implementation delivery, we built behavior-over-time (BOT) graphs with quantitative programmatic data (July 2019-July 2021). To assess adaptations and contextual changes, we performed matrix-based thematic qualitative analysis. We converged quantitative implementation delivery data + qualitative adaptations data in joint displays. Finally, we analyzed qualitative and quantitative results across RE-AIM/PRISM and health districts to identify equity and sustainability considerations., Results: Contextual factors that facilitated program delivery included the perception that the EBI was beneficial, program champions, and staff communication. Key barriers to implementation delivery included competition with other primary care activities and limited implementation infrastructure (e.g., equipment, medications). Contextual changes related to COVID-19 hindered implementation delivery, threatened sustainability, and may have exacerbated inequities. However, adaptations that were planned enhanced implementation delivery and may have supported improved equity and sustainability., Conclusions: Recognition of an EBI's benefits and program champions are important for supporting initial uptake. The ability to plan adaptations amid rapid contextual changes has potential advantages for sustainability and equitable delivery. Systems thinking tools and mixed methods approaches may shed light on the relations between context, adaptations, and equitable and sustainable implementation., Trial Registration: NCT03504124., (© 2024. The Author(s).)
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- 2024
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30. Current Practices, Perceived Barriers, and Promising Implementation Strategies for Improving Quality of Smoking Cessation Support in Accredited Cancer Programs of the American College of Surgeons.
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Ostroff JS, Reilly EM, Burris JL, Warren GW, Shelton RC, and Mullett TW
- Subjects
- Humans, United States epidemiology, Delivery of Health Care, Smoking, Smoking Cessation psychology, Neoplasms epidemiology, Neoplasms therapy, Surgeons
- Abstract
Purpose: Persistent smoking is associated with poor outcomes in cancer care. It is strongly recommended that oncology care providers provide cessation support; however, there is limited information about smoking cessation assessment and treatment patterns in routine oncology practice., Methods: Leaders of the American College of Surgeons Commission on Cancer (CoC) and National Accreditation Program for Breast Centers (National Accredited Program for Breast Cancer) elected to participate in a national quality improvement initiative (Just ASK) focused on smoking assessment/treatment in cancer care. Online baseline survey responses were received from 762 accredited programs., Results: Most programs reported regularly asking about smoking (89.9%), documenting smoking history and current use (85.8%), and advising patients to quit (71.2%). However, less than half of programs reported documenting a smoking cessation treatment plan (41.7%). Even fewer programs reported regularly assisting patients with quitting (41.3%), providing self-help information (27.2%), providing individual counseling (18.2%), and referring patients to an affiliated tobacco treatment program (26.1%) or external Quitline (28.5%). Very few programs reported regularly prescribing medications (17.6%). Principal barriers to tobacco treatment delivery were lack of staff training (68.8%), lack of designated specialists (61.9%), perceived patient resistance (58.3%), lack of available resources (53.3%), competing clinical priorities (50.9%), inadequate program funding (40.6%), insufficient staff time (42.4%), and inadequate reimbursement (31.0%)., Conclusion: Although programs reported a high rate of smoking assessment, critical gaps in advising and assisting patients with cessation were found. Improving equitable delivery of smoking assessment/treatment in cancer care will require addressing key organizational and provider barriers for implementation of best practices.
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- 2024
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31. Leveraging a Digitized Mental Wellness (DIGImw) Program to Provide Mental Health Care for Internally Displaced People.
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Mootz JJ, Chantre C, Sikkema K, Greene MC, Lovero KL, Gouveia L, Santos P, Suleman A, Comé AS, Feliciano P, Uribe-Restrepo JM, Sweetland AC, Shelton RC, Kane J, Mello M, Fumo W, Cadena-Camargo Y, Weissman M, and Wainberg ML
- Subjects
- Humans, Mental Health, Mozambique, South Africa, Mental Health Services, Disasters
- Abstract
A local insurgency has displaced many people in the northern Mozambican province of Cabo Delgado. The authors' global team (comprising members from Brazil, Mozambique, South Africa, and the United States) has been scaling up mental health services across the neighboring province of Nampula, Mozambique, now host to >200,000 displaced people. The authors describe how mental health services can be expanded by leveraging digital technology and task-shifting (i.e., having nonspecialists deliver mental health care) to address the mental health needs of displaced people. These methods can serve as a model for other researchers and clinicians aiming to address mental health needs arising from humanitarian disasters in low-resource settings., Competing Interests: The authors report no financial relationships with commercial interests.
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- 2024
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32. Community Engagement in Behavioral Medicine: A Scoping Review.
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Persad-Clem R, Ventura LM, Lyons T, Keinath C, Graves KD, Schneider ML, Shelton RC, and Rosas LG
- Abstract
Background: Behavioral medicine has made key contributions toward improving health outcomes. Engaging community partners in research is critical to addressing persistent health inequities. The aim of this scoping review was to explore how researchers engaged community partners within the field of behavioral medicine research from 2005 to 2023., Method: Publication databases and gray literature were searched for research that engaged community partners to address questions relevant to behavioral medicine. Articles were screened by title and abstract, and then by full text. Articles meeting the inclusion criteria were coded using the framework provided by the Engagement Navigator to identify engagement approaches, methods, and tools and when they were used during the research., Results: Of 1486 articles initially identified, 58 met the inclusion criteria. Most articles used well-known approaches (e.g., community-based participatory research; 67%), methods (e.g., advisory committees; 59%), and tools (e.g., interviews; 41%), and engaged with healthcare service providers (62%) and/or patients (53%). Community partners were most often included in research planning and design (79%), and less often in dissemination (45%)., Conclusion: Community engagement has considerable potential to address health inequities. Our assessment of the approaches, methods, and tools used by behavioral medicine researchers to engage with a diverse range of community partners points toward promising strategies for enhancing the impact of community engagement. Researchers should incorporate explicit descriptions of community engagement strategies in publications, an outcome that could be facilitated by clear publishing guidelines, structured reporting tools, and clear messaging from funders about the value of community engagement in behavioral medicine research., (© 2023. International Society of Behavioral Medicine.)
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- 2023
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33. Advancing healthcare equity through dissemination and implementation science.
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Baumann AA, Shelton RC, Kumanyika S, and Haire-Joshu D
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- Humans, Delivery of Health Care, Implementation Science, Health Equity
- Abstract
Objective: To provide guiding principles and recommendations for how approaches from the field of dissemination and implementation (D&I) science can advance healthcare equity., Data Sources and Study Setting: This article, part of a special issue sponsored by the Agency for Healthcare Research and Quality (AHRQ), is based on an outline drafted to support proceedings of the 2022 AHRQ Health Equity Summit and further revised to reflect input from Summit attendees., Study Design: This is a narrative review of the current and potential applications of D&I approaches for understanding and advancing healthcare equity, followed by discussion and feedback with Summit attendees., Data Collection/extraction Methods: We identified major themes in narrative and systematic reviews related to D&I science, healthcare equity, and their intersections. Based on our expertise, and supported by synthesis of published studies, we propose recommendations for how D&I science is relevant for advancing healthcare equity. We used iterative discussions internally and at the Summit to refine preliminary findings and recommendations., Principal Findings: We identified four guiding principles and three D&I science domains with strong promise for accelerating progress toward healthcare equity. We present eight recommendations and more than 60 opportunities for action by practitioners, healthcare leaders, policy makers, and researchers., Conclusions: Promising areas for D&I science to impact healthcare equity include the following: attention to equity in the development and delivery of evidence-based interventions; the science of adaptation; de-implementation of low-value care; monitoring equity markers; organizational policies for healthcare equity; improving the economic evaluation of implementation; policy and dissemination research; and capacity building., (© 2023 The Authors. Health Services Research published by Wiley Periodicals LLC on behalf of Health Research and Educational Trust.)
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- 2023
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34. Cognitive behavioral therapy following esketamine for major depression and suicidal ideation for relapse prevention: The CBT-ENDURE randomized clinical trial study protocol.
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Kitay BM, Murphy E, Macaluso M, Corlett PR, Hershenberg R, Joormann J, Martinez-Kaigi V, Nikayin S, Rhee TG, Sanacora G, Shelton RC, Thase ME, and Wilkinson ST
- Subjects
- Humans, Suicidal Ideation, Depression therapy, Randomized Controlled Trials as Topic, Depressive Disorder, Major drug therapy, Cognitive Behavioral Therapy methods
- Abstract
In 2020, esketamine received a supplemental indication as a therapy for major depression with suicidal ideation (MDSI), based on protocols enrolling hospitalized patients. Given the high risk of suicide following hospital discharge and the high relapse rates following discontinuation of esketamine, the optimal long-term treatment approach remains unclear. Cognitive behavioral therapy (CBT) is highly effective in relapse prevention and has been shown to prevent suicide attempts in high-risk populations. Here we describe the study protocol for the CBT-ENDURE trial: Cognitive Behavioral Therapy Following Esketamine for Major Depression and SUicidal Ideation for RElapse Prevention. Patients with depression (N = 100) who are admitted to hospital or are outpatients with clinically significant suicidal ideation will be enrolled in the study. All patients will receive esketamine (twice weekly for four weeks) and will be randomly assigned (1:1 ratio) to receive a 16-week course of CBT plus treatment as usual (CBT group) or treatment as usual only (TAU only group). Patients are followed for a total of 6 months. Supported under a funding announcement from NIMH to conduct safety and feasibility trials for patients at high risk for suicide, the primary outcome of the CBT-ENDURE study is feasibility (as measured by recruitment and retention), with a key secondary outcome being relapse among those who experience substantial benefit following two weeks of esketamine., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023. Published by Elsevier B.V.)
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- 2023
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35. Protocol for a pragmatic stepped wedge cluster randomized clinical trial testing behavioral economic implementation strategies to increase supplemental breast MRI screening among patients with extremely dense breasts.
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McCarthy AM, Fernandez Perez C, Beidas RS, Bekelman JE, Blumenthal D, Mack E, Bauer AM, Ehsan S, Conant EF, Wheeler BC, Guerra CE, Nunes LW, Gabriel P, Doucette A, Wileyto EP, Buttenheim AM, Asch DA, Rendle KA, Shelton RC, Fayanju OM, Ware S, Plag M, Hyland S, Gionta T, Shulman LN, and Schnoll R
- Subjects
- Humans, Female, Breast Density, Mammography, Economics, Behavioral, Magnetic Resonance Imaging, Randomized Controlled Trials as Topic, Breast Neoplasms diagnostic imaging, Breast Neoplasms prevention & control
- Abstract
Background: Increased breast density augments breast cancer risk and reduces mammography sensitivity. Supplemental breast MRI screening can significantly increase cancer detection among women with dense breasts. However, few women undergo this exam, and screening is consistently lower among racially minoritized populations. Implementation strategies informed by behavioral economics ("nudges") can promote evidence-based practices by improving clinician decision-making under conditions of uncertainty. Nudges directed toward clinicians and patients may facilitate the implementation of supplemental breast MRI., Methods: Approximately 1600 patients identified as having extremely dense breasts after non-actionable mammograms, along with about 1100 clinicians involved with their care at 32 primary care or OB/GYN clinics across a racially diverse academically based health system, will be enrolled. A 2 × 2 randomized pragmatic trial will test nudges to patients, clinicians, both, or neither to promote supplemental breast MRI screening. Before implementation, rapid cycle approaches informed by clinician and patient experiences and behavioral economics and health equity frameworks guided nudge design. Clinicians will be clustered into clinic groups based on existing administrative departments and care patterns, and these clinic groups will be randomized to have the nudge activated at different times per a stepped wedge design. Clinicians will receive nudges integrated into the routine mammographic report or sent through electronic health record (EHR) in-basket messaging once their clinic group (i.e., wedge) is randomized to receive the intervention. Independently, patients will be randomized to receive text message nudges or not. The primary outcome will be defined as ordering or scheduling supplemental breast MRI. Secondary outcomes include MRI completion, cancer detection rates, and false-positive rates. Patient sociodemographic information and clinic-level variables will be examined as moderators of nudge effectiveness. Qualitative interviews conducted at the trial's conclusion will examine barriers and facilitators to implementation., Discussion: This study will add to the growing literature on the effectiveness of behavioral economics-informed implementation strategies to promote evidence-based interventions. The design will facilitate testing the relative effects of nudges to patients and clinicians and the effects of moderators of nudge effectiveness, including key indicators of health disparities. The results may inform the introduction of low-cost, scalable implementation strategies to promote early breast cancer detection., Trial Registration: ClinicalTrials.gov NCT05787249. Registered on March 28, 2023., (© 2023. The Author(s).)
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- 2023
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36. Protocol to evaluate sequential electronic health record-based strategies to increase genetic testing for breast and ovarian cancer risk across diverse patient populations in gynecology practices.
- Author
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Symecko H, Schnoll R, Beidas RS, Bekelman JE, Blumenthal D, Bauer AM, Gabriel P, Boisseau L, Doucette A, Powers J, Cappadocia J, McKenna DB, Richardville R, Cuff L, Offer R, Clement EG, Buttenheim AM, Asch DA, Rendle KA, Shelton RC, Fayanju OM, Wileyto EP, Plag M, Ware S, Shulman LN, Nathanson KL, and Domchek SM
- Subjects
- Female, Humans, Male, Cohort Studies, Electronic Health Records, Genetic Testing methods, Pragmatic Clinical Trials as Topic, Adult, Gynecology, Ovarian Neoplasms
- Abstract
Background: Germline genetic testing is recommended by the National Comprehensive Cancer Network (NCCN) for individuals including, but not limited to, those with a personal history of ovarian cancer, young-onset (< 50 years) breast cancer, and a family history of ovarian cancer or male breast cancer. Genetic testing is underused overall, and rates are consistently lower among Black and Hispanic populations. Behavioral economics-informed implementation strategies, or nudges, directed towards patients and clinicians may increase the use of this evidence-based clinical practice., Methods: Patients meeting eligibility for germline genetic testing for breast and ovarian cancer will be identified using electronic phenotyping algorithms. A pragmatic cohort study will test three sequential strategies to promote genetic testing, two directed at patients and one directed at clinicians, deployed in the electronic health record (EHR) for patients in OB-GYN clinics across a diverse academic medical center. We will use rapid cycle approaches informed by relevant clinician and patient experiences, health equity, and behavioral economics to optimize and de-risk our strategies and methods before trial initiation. Step 1 will send patients messages through the health system patient portal. For non-responders, step 2 will reach out to patients via text message. For non-responders, Step 3 will contact patients' clinicians using a novel "pend and send" tool in the EHR. The primary implementation outcome is engagement with germline genetic testing for breast and ovarian cancer predisposition, defined as a scheduled genetic counseling appointment. Patient data collected through the EHR (e.g., race/ethnicity, geocoded address) will be examined as moderators of the impact of the strategies., Discussion: This study will be one of the first to sequentially examine the effects of patient- and clinician-directed strategies informed by behavioral economics on engagement with breast and ovarian cancer genetic testing. The pragmatic and sequential design will facilitate a large and diverse patient sample, allow for the assessment of incremental gains from different implementation strategies, and permit the assessment of moderators of strategy effectiveness. The findings may help determine the impact of low-cost, highly transportable implementation strategies that can be integrated into healthcare systems to improve the use of genomic medicine., Trial Registration: ClinicalTrials.gov. NCT05721326. Registered February 10, 2023. https://www., Clinicaltrials: gov/study/NCT05721326., (© 2023. The Author(s).)
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- 2023
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37. A bibliographic review of sustainability research output and investment in 10 leading public health journals across three time periods.
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Hall A, Wolfenden L, Gardner C, McEvoy B, Lane C, Shelton RC, McFadyen T, Lee DCW, Shoesmith A, Austin K, and Nathan N
- Abstract
Objectives: Long-term delivery, or sustainability, of evidence-based interventions is necessary for public health benefits to be realised. However, sustainment of effective interventions is poor. Understanding the evidence-base and identifying potential gaps is necessary to inform where future research efforts are most warranted., Study Design: We undertook a repeat cross-sectional bibliographic review of research published in 10 public health journals across three time periods (2010, 2015 and 2020/2021)., Methods: Studies were eligible if they were a data-based study or review article. Studies were assessed as to whether they focused on sustainability. The percentage of public health research studies assessing sustainability overall and by the three time periods was calculated. The association between time period and the proportion of sustainability articles was assessed using logistic regression. Descriptive statistics were used to summarise study characteristics overall and by time period., Results: 10,588 data-based articles were identified, of which 1.3 % (n = 136) focused on sustainability. There was a statistically significant association between time period and the proportion of sustainability research, with a slight increase across the three time periods: 0.3 % (95 % CI: 0.1 %, 0.7 %) in 2010, 1.4 % (95 % CI: 1.0 %, 1.9 %) in 2015 and 1.6 % (95 % CI: 1.3 %, 1.9 %) in 2020/2021. Most research was descriptive/epidemiological (n = 69, 51 %), few focused on measurement (n = 2, 1.5 %) and none on cost effectiveness. Only one intervention study assessed the effect of specific sustainability strategies., Conclusions: This bibliographic review highlights the need for more public health research on sustainability, particularly in the areas of measurement, sustainability interventions, and cost effectiveness., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2023 The Authors. Published by Elsevier Ltd on behalf of The Royal Society for Public Health.)
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- 2023
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38. Sustainability, spread, and scale in trials using audit and feedback: a theory-informed, secondary analysis of a systematic review.
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Laur C, Ladak Z, Hall A, Solbak NM, Nathan N, Buzuayne S, Curran JA, Shelton RC, and Ivers N
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- Humans, Feedback, Leadership, Health Behavior, Health Personnel, Systematic Reviews as Topic
- Abstract
Background: Audit and feedback (A&F) is a widely used implementation strategy to influence health professionals' behavior that is often tested in implementation trials. This study examines how A&F trials describe sustainability, spread, and scale., Methods: This is a theory-informed, descriptive, secondary analysis of an update of the Cochrane systematic review of A&F trials, including all trials published since 2011. Keyword searches related to sustainability, spread, and scale were conducted. Trials with at least one keyword, and those identified from a forward citation search, were extracted to examine how they described sustainability, spread, and scale. Results were qualitatively analyzed using the Integrated Sustainability Framework (ISF) and the Framework for Going to Full Scale (FGFS)., Results: From the larger review, n = 161 studies met eligibility criteria. Seventy-eight percent (n = 126) of trials included at least one keyword on sustainability, and 49% (n = 62) of those studies (39% overall) frequently mentioned sustainability based on inclusion of relevant text in multiple sections of the paper. For spread/scale, 62% (n = 100) of trials included at least one relevant keyword and 51% (n = 51) of those studies (31% overall) frequently mentioned spread/scale. A total of n = 38 studies from the forward citation search were included in the qualitative analysis. Although many studies mentioned the need to consider sustainability, there was limited detail on how this was planned, implemented, or assessed. The most frequent sustainability period duration was 12 months. Qualitative results mapped to the ISF, but not all determinants were represented. Strong alignment was found with the FGFS for phases of scale-up and support systems (infrastructure), but not for adoption mechanisms. New spread/scale themes included (1) aligning affordability and scalability; (2) balancing fidelity and scalability; and (3) balancing effect size and scalability., Conclusion: A&F trials should plan for sustainability, spread, and scale so that if the trial is effective, the benefits can continue. A deeper empirical understanding of the factors impacting A&F sustainability is needed. Scalability planning should go beyond cost and infrastructure to consider other adoption mechanisms, such as leadership, policy, and communication, that may support further scalability., Trial Registration: Registered with Prospero in May 2022. CRD42022332606., (© 2023. The Author(s).)
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- 2023
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39. Cluster Randomized Pragmatic Clinical Trial Testing Behavioral Economic Implementation Strategies to Improve Tobacco Treatment for Patients With Cancer Who Smoke.
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Jenssen BP, Schnoll R, Beidas RS, Bekelman J, Bauer AM, Evers-Casey S, Fisher T, Scott C, Nicoloso J, Gabriel P, Asch DA, Buttenheim AM, Chen J, Melo J, Grant D, Horst M, Oyer R, Shulman LN, Clifton ABW, Lieberman A, Salam T, Rendle KA, Chaiyachati KH, Shelton RC, Fayanju O, Wileyto EP, Ware S, Blumenthal D, Ragusano D, and Leone FT
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- Humans, Quality of Life, Economics, Behavioral, Smoking, Physicians, Neoplasms therapy
- Abstract
Purpose: Few cancer centers systematically engage patients with evidence-based tobacco treatment despite its positive effect on quality of life and survival. Implementation strategies directed at patients, clinicians, or both may increase tobacco use treatment (TUT) within oncology., Methods: We conducted a four-arm cluster-randomized pragmatic trial across 11 clinical sites comparing the effect of strategies informed by behavioral economics on TUT engagement during oncology encounters with cancer patients. We delivered electronic health record (EHR)-based nudges promoting TUT across four nudge conditions: patient only, clinician only, patient and clinician, or usual care. Nudges were designed to counteract cognitive biases that reduce TUT engagement. The primary outcome was TUT penetration, defined as the proportion of patients with documented TUT referral or a medication prescription in the EHR. Generalized estimating equations were used to estimate the parameters of a linear model., Results: From June 2021 to July 2022, we randomly assigned 246 clinicians in 95 clusters, and collected TUT penetration data from their encounters with 2,146 eligible patients who smoke receiving oncologic care. Intent-to-treat (ITT) analysis showed that the clinician nudge led to a significant increase in TUT penetration versus usual care (35.6% v 13.5%; OR = 3.64; 95% CI, 2.52 to 5.24; P < .0001). Completer-only analysis (N = 1,795) showed similar impact (37.7% clinician nudge v 13.5% usual care; OR = 3.77; 95% CI, 2.73 to 5.19; P < .0001). Clinician type affected TUT penetration, with physicians less likely to provide TUT than advanced practice providers (ITT OR = 0.67; 95% CI, 0.51 to 0.88; P = .004)., Conclusion: EHR nudges, informed by behavioral economics and aimed at oncology clinicians, appear to substantially increase TUT penetration. Adding patient nudges to the implementation strategy did not affect TUT penetration rates.
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- 2023
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40. Integrating a focus on health equity in implementation science: Case examples from the national cancer institute's implementation science in cancer control centers (ISC 3 ) network.
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Aschbrenner KA, Oh AY, Tabak RG, Hannon PA, Angier HE, Moore WT, Likumahuwa-Ackman S, Carroll JK, Baumann AA, Beidas RS, Mazzucca-Ragan S, Waters EA, Sadasivam RS, and Shelton RC
- Abstract
Background: A Health Equity Task Force (HETF) of members from seven Centers funded by the National Cancer Institute's (NCI) Implementation Science in Cancer Control Centers (ISC
3 ) network sought to identify case examples of how Centers were applying a focus on health equity in implementation science to inform future research and capacity-building efforts., Methods: HETF members at each ISC3 collected information on how health equity was conceptualized, operationalized, and addressed in initial research and capacity-building efforts across the seven ISC3 Centers funded in 2019-2020. Each Center completed a questionnaire assessing five health equity domains central to implementation science (e.g., community engagement; implementation science theories, models, and frameworks (TMFs); and engaging underrepresented scholars). Data generated illustrative examples from these five domains., Results: Centers reported a range of approaches focusing on health equity in implementation research and capacity-building efforts, including (1) engaging diverse community partners/settings in making decisions about research priorities and projects; (2) applying health equity within a single TMF applied across projects or various TMFs used in specific projects; (3) evaluating health equity in operationalizing and measuring health and implementation outcomes; (4) building capacity for health equity-focused implementation science among trainees, early career scholars, and partnering organizations; and (5) leveraging varying levels of institutional resources and efforts to engage, include, and support underrepresented scholars., Conclusions: Examples of approaches to integrating health equity across the ISC3 network can inform other investigators and centers' efforts to build capacity and infrastructure to support growth and expansion of health equity-focused implementation science., Competing Interests: Dr. Beidas is principal at Implementation Science & Practice, LLC. She receives royalties from Oxford University Press, consulting fees from United Behavioral Health and OptumLabs, and serves on the advisory boards for Optum Behavioral Health, AIM Youth Mental Health Foundation, and the Klingenstein Third Generation Foundation outside of the submitted work. All other authors declare no relevant financial or non-financial interests., (© The Author(s) 2023.)- Published
- 2023
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41. Making the connection between health equity and sustainability.
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Shelton RC, Hailemariam M, and Iwelunmor J
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- Humans, Delivery of Health Care, Poverty, Implementation Science, Public Health, Health Equity
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Sustainability and health inequities are key challenges in public health and healthcare. Research suggests that only about half of evidence-based interventions (EBIs) are sustained over time, and settings and populations experiencing systemic and structural barriers to health (e.g., poverty, racism, stigma, and discrimination) experience even greater challenges to sustainability. In this article, we argue that an enhanced focus on sustainability in the field of implementation science is critical in order to maximize the long-term health benefits and broader societal impacts of EBIs for all populations and settings. From an equity perspective, a focus on sustainability is particularly critical to prioritize among population sub-groups that have not historically received the benefits of health-related EBIs. We discuss how a health equity framing is essential to sustaining EBIs in under-resourced communities, and requires moving away from a deficit mindset that focuses on why EBIs are challenging to sustain, to one that focuses more on identifying and nurturing existing assets within individuals and communities to increase the likelihood that EBIs are sustained. We conclude with a discussion of future directions as well as recommendations and resources (e.g., frameworks, tools) to advance and make progress toward sustainability from a health equity mindset, including: (1) Actively planning early for sustainability alongside key partners; (2) Tracking progress toward enhancing sustainability and being accountable in doing so equitably for all settings and populations; and (3) Focusing on both equity and engagement early and often throughout the research process and all implementation phases., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Shelton, Hailemariam and Iwelunmor.)
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- 2023
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42. Strong associations of telomere length and mitochondrial copy number with suicidality and abuse history in adolescent depressed individuals.
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Ochi S, Roy B, Prall K, Shelton RC, and Dwivedi Y
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- Adult, Humans, Adolescent, Child, Suicidal Ideation, DNA Copy Number Variations genetics, DNA, Mitochondrial genetics, Telomere genetics, Depressive Disorder, Major genetics, Suicide
- Abstract
Major depressive disorder (MDD) is highly prevalent in adolescents and is a major risk factor for suicidality. Recent evidence shows that accelerated cellular senescence/aging is associated with psychiatric illness, including depression, in adults. The present study examined if the relationships of telomere length (TL) and mitochondrial DNA copy number (mtDNAcn), two critical indicators of cellular senescence/aging, are altered in depressed adolescents and whether these alterations are associated with suicidality, early-life adversities, and other co-occuring factors. In genomic DNA isolated from 53 adolescents (ages 16-19, 19 MDD with suicide attempt/suicidal ideation [MDD + SI/SA], 14 MDD without SA/SI [MDD-SI/SA], and 20 healthy controls [HC]), TL and mtDNAcn were measured as the ratio between the number of telomere repeats and that of a single-copy nuclear-hemoglobin [HBG] gene or the amount of mtDNA (NADH dehydrogenase, subunit 1) relative to HBG. Our data show that TL was significantly lower, and mtDNAcn was significantly higher in the total MDD group than HC. TL was significantly lower and mtDNAcn was significantly higher in the MDD + SA/SI group than in the HC, whereas there were no differences in the MDD-SI/SA group. TL was positively correlated with mtDNAcn in both HC and MDD-SA/SI groups; however, TL was negatively correlated with mtDNAcn in MDD + SA/SI. Furthermore, TL was negatively correlated with the severity of both depression and anxiety, while mtDNAcn was positively correlated with the severity of prior emotional abuse. Our study indicates that cellular senescence is more advanced in depressed adolescents with suicidal ideation and that childhood emotional abuse may participate in such a process., (© 2023. The Author(s).)
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- 2023
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43. Preliminary effectiveness of online opioid overdose and naloxone administration training and impact of naloxone possession on opioid use.
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Sisson ML, Azuero A, Chichester KR, Carpenter MJ, Businelle MS, Shelton RC, and Cropsey KL
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- Humans, Naloxone therapeutic use, Analgesics, Opioid therapeutic use, Narcotic Antagonists therapeutic use, Opiate Overdose drug therapy, Opioid-Related Disorders drug therapy, Drug Overdose drug therapy
- Abstract
Background: Despite the demonstrated value of opioid overdose education and naloxone distribution (OEND) programs, uptake and utilization remains low. Accessibility to OEND is limited and traditional programs may not reach many high-risk individuals. This study evaluated the effectiveness of online opioid overdose and naloxone administration education and the impact of naloxone possession., Methods: Individuals with self-reported illicit use of opioids were recruited via Craigslist advertisements and completed all assessments and education online via REDCap. Participants watched a 20-minute video outlining signs of opioid overdose and how to administer naloxone. They were then randomized to either receive a naloxone kit or be given instructions on where to obtain a kit. Effectiveness of training was measured with pre- and post-training knowledge questionnaires. Naloxone kit possession, overdoses, opioid use frequency, and treatment interest were self-reported on monthly follow-up assessments., Results: Mean knowledge scores significantly increased from 6.82/9.00 to 8.22 after training (t(194)=6.85, p <0.001, 95% CI[1.00, 1.81], Cohen's d=0.85). Difference in naloxone possession between randomized groups was significant with a large effect size (p <0.001, diff=0.60, 95% CI[0.47, 0.73]). A bidirectional relationship was found between naloxone possession and frequency of opioid use. Overdoses and treatment interest were similar across possession status., Conclusions: Overdose education is effective in online video format. Disparity in naloxone possession across groups indicates barriers to obtaining naloxone from pharmacies. Naloxone possession did not influence risky opioid use or treatment interest and its impact on frequency of use warrants further investigation., Trial Registration: Clinitaltrials.gov-NCT04303000., Competing Interests: Declaration of Competing Interest Dr. Carpenter has received consulting honoraria from Pfizer and Frutarom Inc. The authors declare that there is no conflict of interest., (Copyright © 2023 Elsevier B.V. All rights reserved.)
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- 2023
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44. Applying User-Centered Design and Implementation Science to the Early-Stage Development of a Telehealth-Enhanced Hybrid Cardiac Rehabilitation Program: Quality Improvement Study.
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Duran AT, Keener-DeNoia A, Stavrolakes K, Fraser A, Blanco LV, Fleisch E, Pieszchata N, Cannone D, Keys McKay C, Whittman E, Edmondson D, Shelton RC, and Moise N
- Abstract
Background: Cardiac rehabilitation (CR) is an evidence-based intervention that improves event-free survival in patients with cardiac conditions, yet <27% of all eligible patients use CR in the United States. CR is traditionally delivered in clinic-based settings where implementation barriers abound. Innovative nontraditional program designs and strategies are needed to support widespread CR uptake., Objective: This study aimed to demonstrate how user-centered design (UCD) and implementation science (IS) principles and methods can be integrated into the early-stage development of nontraditional CR interventions., Methods: As part of a NewYork-Presbyterian Hospital (NYPH) quality improvement initiative (March 2020-February 2022), we combined UCD and IS principles and methods to design a novel home- and clinic-based telehealth-enhanced hybrid CR (THCR) program. We co-designed this program with multilevel stakeholders using an iterative 3-step UCD process to identify user and contextual barriers and facilitators to CR uptake (using semistructured interviews and contextual inquiry [step 1]), design an intervention prototype that targets contextual and user factors and emulates the evidence-based practice (through design workshops and journey mapping [step 2]), and review and refine the prototype (according to real-world usability testing and feedback [step 3]). The UCD process was informed by the Theoretical Domains Framework and Consolidated Framework for Implementation Research., Results: At step 1, we conducted semistructured interviews with 9 provider- and system-level stakeholders (female: n=6, 67%) at 3 geographically diverse academic medical centers, which revealed behavioral (eg, self-efficacy and knowledge) and contextual (eg, social distancing guidelines, physical space, staffing, and reimbursement) barriers to uptake; hybrid delivery was a key facilitator. Step 2 involved conducting 20 design workshops and 3 journey-mapping sessions with multidisciplinary NYPH stakeholders (eg, digital health team, CR clinicians, and creative director) where we identified key design elements (eg, mix of clinic- and home-based CR and synchronous remote patient monitoring), yielding an initial THCR prototype that leveraged NYPH's telehealth infrastructure. At step 3, we conducted usability testing with 2 CR clinicians (both female) administering home-based sessions to 3 CR patients (female: n=1, 33%), which revealed usability themes (eg, ease of using remote patient monitoring devices or a telehealth platform, technology disruptions, and confidence in using the telehealth platform to safely monitor patients) and design solutions (eg, onboarding sessions, safety surveys, and fully supervised remote sessions) to be included in the final THCR prototype., Conclusions: Combining UCD and IS methods while engaging multidisciplinary stakeholders in an iterative process yielded a theory-informed THCR program targeting user and contextual barriers to real-world CR implementation. We provide a detailed summary of the process and guidance for incorporating UCD and IS principles and methods into the early-stage development of a nontraditional CR intervention. The feasibility, acceptability, appropriateness, and usability of the final THCR prototype is being evaluated in an ongoing study., (©Andrea T Duran, Adrianna Keener-DeNoia, Kimberly Stavrolakes, Adina Fraser, Luis V Blanco, Emily Fleisch, Nicole Pieszchata, Diane Cannone, Charles Keys McKay, Emma Whittman, Donald Edmondson, Rachel C Shelton, Nathalie Moise. Originally published in JMIR Formative Research (https://formative.jmir.org), 13.07.2023.)
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- 2023
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45. A systematic review to determine the effect of strategies to sustain chronic disease prevention interventions in clinical and community settings: study protocol.
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Riley-Gibson E, Hall A, Shoesmith A, Wolfenden L, Shelton RC, Doherty E, Pollock E, Booth D, Salloum RG, Laur C, Powell BJ, Kingsland M, Lane C, Hailemariam M, Sutherland R, and Nathan N
- Abstract
Background: The primary purpose of this review is to synthesise the effect of strategies aiming to sustain the implementation of evidenced based interventions (EBIs) targeting key health behaviours associated with chronic disease (i.e., physical inactivity, poor diet, harmful alcohol use and tobacco smoking) in clinical and community settings. The field of implementation science is bereft of an evidence base of effective sustainment strategies, and as such this review will provide important evidence to advance the field of sustainability research., Methods: This systematic review protocol is reported in accordance with the Preferred Reporting Items for Systematic review and Meta-Analysis Protocol (PRISMA-P) checklist (Additional file 1). Methods will follow Cochrane gold-standard review methodology. The search will be undertaken across multiple databases, adapting filters previously developed by the research team; data screening and extraction will be performed in duplicate; strategies will be coded using an adapted sustainability-explicit taxonomy; evidence will be synthesised using appropriate methods (i.e. meta-analytic following Cochrane or non-meta-analytic following SWiM guidelines). We will include any randomised controlled study that targets any staff or volunteers delivering interventions in clinical or community settings. Studies which report on any objective or subjective measure of the sustainment of a health prevention policy, practice, or program within any of the eligible settings will be included. Article screening, data extraction, risk of bias and quality assessment will be performed independently by two review authors. Risk of bias will be assessed using Version 2 of the Cochrane risk-of-bias tool for randomised trials (RoB 2). A random effect meta-analysis will be conducted to estimate the pooled effect of sustainment strategies separately by setting (i.e. clinical and community). Sub-group analyses will be undertaken to explore possible causes of statistical heterogeneity and may include: time period, single or multi strategy, type of setting and type of intervention. Differences between sub-groups will be statistically compared., Discussion/conclusion: This will be the first systematic review to determine the effect of strategies designed to support sustainment on sustaining the implementation of EBIs in clinical and community settings. The findings of this review will directly inform the design of future sustainability-focused implementation trials. Further, these findings will inform the development of a sustainability practice guide for public health practitioners., Registration: This review was prospectively registered with PROSPERO (registration ID: CRD42022352333)., Competing Interests: Competing interests The authors declare that they have no competing interests.
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- 2023
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46. Application of The Consolidated Framework for Implementation Research to inform understanding of barriers and facilitators to the implementation of opioid and naloxone training on college campuses.
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Shelton RC, Goodwin K, McNeil M, Bernitz M, Alexander SP, Parish C, Brotzman L, Lee M, Li WB, Makam S, Ganek N, Foskett D, Warren C, and Metsch LR
- Abstract
Background: The opioid epidemic in the US continues to worsen. Opioid-only and polysubstance-involved opioid overdose deaths are increasing among adolescents and young adults, who have limited knowledge of opioid overdose prevention, including recognition and response. College campuses have infrastructure to support national-level implementation of evidence-based public health strategies for providing opioid overdose prevention and naloxone training programs among this priority population. However, college campuses are an underutilized, understudied setting for this programming. To address this gap, we conducted research assessing barriers and facilitators to planning and implementing this programming on college campuses., Methods: We held 9 focus groups among purposively selected campus stakeholders whose perceptions were important to understand in planning for the dissemination and implementation of opioid overdose prevention and naloxone training. Focus group scripts were informed by The Consolidated Framework for Implementation Research (CFIR) to query about perceptions of opioid and other substance use, opioid and other substance use-related resources, and naloxone administration training. We used a deductive-inductive, iterative approach to thematic analysis., Results: Themes about implementation barriers included (1) the perception that problematic use of other (non-opioid) substances was more prevalent than opioid use on campus and focus on those substances would be a greater priority on college campuses; (2) student schedules were overwhelmed with academic commitments and extracurricular activities, making delivery of additional training challenging; (3) barriers related to the perceived complexity and decentralization of communication on campus, preventing students from knowing how to access substance use-related resources. Themes about implementation facilitators included (1) framing naloxone training as important in becoming a responsible leader on campus and in the broader community and (2) leveraging existing infrastructure, champions within existing campus groups, and tailored messaging to facilitate participation in naloxone training., Conclusions: This is the first study to provide in-depth insights into potential barriers and facilitators to widespread, routine implementation of naloxone/opioid education on undergraduate college campuses. The study captured diverse stakeholder perspectives and was theoretically grounded in CFIR, contributing to the growing literature on the application and refinement of CFIR across diverse community and school contexts., (© 2023. The Author(s).)
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- 2023
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47. Breaking the quality-equity cycle when implementing prevention programmes.
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McHugh S, Riordan F, and Shelton RC
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- Humans, Primary Prevention, Quality of Health Care
- Abstract
Competing Interests: Competing interests: None declared.
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- 2023
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48. Integrating dissemination and implementation sciences within Clinical and Translational Science Award programs to advance translational research: Recommendations to national and local leaders - ADDENDUM.
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Mehta TG, Mahoney J, Leppin AL, Stevens KR, Yousefi-Nooraie R, Pollock BH, Shelton RC, Dolor R, Pincus H, Patel S, and Moore JB
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- 2023
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49. Feasibility and acceptability of online opioid overdose education and naloxone distribution: Study protocol and preliminary results from a randomized pilot clinical trial.
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Sisson ML, Azuero A, Chichester KR, Carpenter MJ, Businelle MS, Shelton RC, and Cropsey KL
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Drug overdose is the leading cause of accidental death in the United States, with over 70% of drug related fatalities resulting from the use of opioids. Federal agencies have responded to this crisis with various recommendations including enhancing harm reduction approaches such as training laypersons to administer naloxone through Opioid Overdose Education and Naloxone Distribution (OEND) programs. Several studies have demonstrated that OEND programs effectively reduce opioid overdose mortality and are both safe and cost-effective, however, they are typically implemented in urban areas as part of large medical center research programs, needle exchanges, or drug treatment programs. Individuals living in areas without these programs or services lack access to critical and life-saving OEND. The current study examined the acceptability and feasibility of online recruitment, online opioid overdose education, and remote distribution of naloxone kits. Persons who illicitly use opioids and are at risk for overdose were recruited through online media and completed an opioid use questionnaire. If interested in receiving opioid overdose and naloxone administration training, participants completed pre- and post-intervention knowledge questionnaires, engaged in audiovisual training, and were randomized to either receive a naloxone kit or be given information on where they could obtain one. Preliminary results indicate feasibility and acceptability as evidenced by strong recruitment and retention, as well as high participant satisfaction ratings. Successful implementation of remote OEND through this project supports future employment of similar remote programs to expand this critical harm reduction strategy to high-risk individuals in areas lacking traditional OEND programs., Trial Registration #: Clinitaltrials.gov- NCT04303000., Competing Interests: Dr. Carpenter has received consulting honoraria from Pfizer and Frutarom Inc. The authors declare that there is no conflict of interest.
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- 2023
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50. Testing psychosocial interventions in the contexts they are meant to be delivered.
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Beidas RS, Saldana L, and Shelton RC
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- Humans, Psychosocial Intervention
- Abstract
This article discusses psychosocial interventions in the contexts they are meant to be delivered. Prevention and intervention science often follow the linear pathway of preclinical or pre-intervention research-efficacy trials, effectiveness trials, and implementation studies-with the assessment of translation into public and population health impact occurring at the end. This linear translational pathway follows stages developed for ascertaining safe, efficacious, and effective dosages for biological compounds. This approach has created limitations in the need to rapidly deploy complex, multi-component, multilevel approaches to change behavior and improve health into widespread practice for diverse clinical and public health settings. While it is important to use efficacy trials when safety is yet to be established, when the risks are identified to be low, as is often the case for psychosocial interventions, we can go faster to achieve equitable population health impact. The authors recommend that clinical trialists engaged in intervention development incorporate two considerations in the next generation of prevention and intervention research. First, consider moving right to effectiveness or pragmatic trials, as the most valid test of an intervention is the est of that intervention in the context(s) in which it is intended. Second, when designing effectiveness studies, consider investigating questions related to both effectiveness (i.e., does the intervention improve clinical outcomes) and implementation (i.e., what supports are needed to deploy the intervention routinely in that context) to accelerate impact. As a matter of both ethics and equity, there is a need to expedite the research-to-practice pipeline at a pace faster than is made available through current approaches. (PsycInfo Database Record (c) 2023 APA, all rights reserved).
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- 2023
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