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Project nature: promoting outdoor physical activity in children via primary care

Author/s: 
Georgia M Griffin, Carolina Nieto, Kirsten Senturia, Marshall Brown, Kimberly Garrett, Elizabeth Nguyen, Danette Glassy, Emily Kroshus, Pooja Tandon

Background

Families face a range of barriers in supporting their children’s active play in nature including family circumstances, environmental constraints, and behavioral factors. Evidence-based strategies to address these barriers are needed. We aimed to develop and pilot test a primary care-based family-centered behavioral intervention to promote active outdoor play in 4–10 year-old children.

Methods

Project Nature, a provider-delivered intervention that provides informational resources and an age-appropriate toy for nature play, was initially developed for children ages 0–3. With stakeholder input, we adapted existing materials for 4–10 year-olds and conducted usability testing at an urban clinic serving families from diverse backgrounds. Subsequently, we conducted a mix-methods pilot study to evaluate intervention feasibility and acceptability. Parents of 4–10 year-olds completed pre- and post-surveys (n = 22), and a purposive subset (n = 10) completed qualitative interviews. Post-intervention, pediatric providers (n = 4) were interviewed about their implementation experiences.

Results

The majority (82%) of parents liked the information provided and the remaining (18%) were neutral. Qualitatively, parents reported that: the toy provided a tangible element to help children and parents be active, they did not use the website, and they wished the intervention emphasized strategies for physical activity during cold and wet seasons. Providers felt the materials facilitated discussion about behavior change with families. There were no statistically significant changes in PA and outdoor time pre- and post-intervention.

Conclusions

Project Nature was welcomed by providers and families and may be a practical intervention to promote outdoor active play during well-child visits. Providing an age-appropriate nature toy seemed to be a critical component of the intervention, and may be worth the additional cost, time and storage space required by clinics. Building from these results, Project Nature should be revised to better support active outdoor play during suboptimal weather and evaluated to test its efficacy in a fully-powered trial.

Keywords 
behavior therapy children children's health preschool-age children school-age children exercise nature parenting

Effect of Psychological and Medication Therapies for Insomnia on Daytime Functions: A Randomized Clinical Trial

Author/s: 
Charles M Morin, Si-Jing Chen, Hans Ivers, Simon Beaulieu-Bonneau, Andrew D Krystal, Bernard Guay, Lynda Bélanger, Ann Cartwright, Bryan Simmons, Manon Lamy, Mindy Busby, Jack D Edinger

Importance: Daytime functional impairments are the primary reasons for patients with insomnia to seek treatment, yet little is known about what the optimal treatment is for improving daytime functions and how best to proceed with treatment for patients whose insomnia has not remitted.

Objectives: To compare the efficacy of behavioral therapy (BT) and zolpidem as initial therapies for improving daytime functions among patients with insomnia and evaluate the added value of a second treatment for patients whose insomnia has not remitted.

Design, setting, and participants: In this sequential multiple-assignment randomized clinical trial conducted at institutions in Canada and the US, 211 adults with chronic insomnia disorder were enrolled between May 1, 2012, and December 31, 2015, and followed up for 12 months. Statistical analyses were performed on an intention-to-treat basis in April and October 2023.

Interventions: Participants were randomly assigned to either BT or zolpidem as first-stage therapy, and those whose insomnia had not remitted received a second-stage psychological therapy (BT or cognitive therapy) or medication therapy (zolpidem or trazodone).

Main outcomes and measures: Study outcomes were daytime symptoms of insomnia, including mood disturbances, fatigue, functional impairments of insomnia, and scores on the 36-item Short-Form Health Survey (SF-36) physical and mental health components.

Results: Among 211 adults with insomnia (132 women [63%]; mean [SD] age, 45.6 [14.9] years), 104 were allocated to BT and 107 to zolpidem at the first stage. First-stage treatment with BT or zolpidem yielded significant and equivalent benefits for most of the daytime outcomes, including depressive symptoms (Beck Depression Inventory-II mean score change, -3.5 [95% CI, -4.7 to -2.3] vs -4.3 [95% CI, -5.7 to -2.9]), fatigue (Multidimensional Fatigue Inventory mean score change, -4.7 [95% CI, -7.3 to -2.2] vs -5.2 [95% CI, -7.9 to -2.5]), functional impairments (Work and Social Adjustment Scale mean score change, -5.0 [95% CI, -6.7 to -3.3] vs -5.1 [95% CI, -7.2 to -2.9]), and mental health (SF-36 mental health subscale mean score change, 3.5 [95% CI, 1.9-5.1] vs 2.5 [95% CI, 0.4-4.5]), while BT produced larger improvements for anxiety symptoms relative to zolpidem (State-Trait Anxiety Inventory mean score change, -4.1 [95% CI, -5.8 to -2.4] vs -1.2 [95% CI, -3.0 to 0.5]; P = .02; Cohen d = 0.55). Second-stage therapy produced additional improvements for the 2 conditions starting with zolpidem at posttreatment in fatigue (Multidimensional Fatigue Inventory mean score change: zolpidem plus BT, -3.8 [95% CI, -7.1 to -0.4]; zolpidem plus trazodone, -3.7 [95% CI, -6.3 to -1.1]), functional impairments (Work and Social Adjustment Scale mean score change: zolpidem plus BT, -3.7 [95% CI, -6.4 to -1.0]; zolpidem plus trazodone, -3.3 [95% CI, -5.9 to -0.7]) and mental health (SF-36 mental health subscale mean score change: zolpidem plus BT, 5.3 [95% CI, 2.7-7.9]; zolpidem plus trazodone, 2.0 [95% CI, 0.1-4.0]). Treatment benefits achieved at posttreatment were well maintained throughout the 12-month follow-up, and additional improvements were noted for patients receiving the BT treatment sequences.

Conclusions and relevance: In this randomized clinical trial of adults with insomnia disorder, BT and zolpidem produced improvements for various daytime symptoms of insomnia that were no different between treatments. Adding a second treatment offered an added value with further improvements of daytime functions.

Trial registration: ClinicalTrials.gov Identifier: NCT01651442.

Keywords 
Insomnia Insomnia medications sleep behavior therapy cognitive behavior therapy

Risk for Serious Infection With Low-Dose Glucocorticoids in Patients With Rheumatoid Arthritis

Author/s: 
George, Michael D., Bake, Joshua F., Winthrop, Kevin, Hsu, Jesse Y., Wu, Qufei, Chen, Lang

Abstract

Background: Low-dose glucocorticoids are frequently used for the management of rheumatoid arthritis (RA) and other chronic conditions, but the safety of long-term use remains uncertain.

Objective: To quantify the risk for hospitalized infection with long-term use of low-dose glucocorticoids in patients with RA receiving stable disease-modifying antirheumatic drug (DMARD) therapy.

Design: Retrospective cohort study.

Setting: Medicare claims data and Optum's deidentified Clinformatics Data Mart database from 2006 to 2015.

Patients: Adults with RA receiving a stable DMARD regimen for more than 6 months.

Measurements: Associations between glucocorticoid dose (none, ≤5 mg/d, >5 to 10 mg/d, and >10 mg/d) and hospitalized infection were evaluated using inverse probability-weighted analyses, with 1-year cumulative incidence predicted from weighted models.

Results: 247 297 observations were identified among 172 041 patients in Medicare and 58 279 observations among 44 118 patients in Optum. After 6 months of stable DMARD use, 47.1% of Medicare patients and 39.5% of Optum patients were receiving glucocorticoids. The 1-year cumulative incidence of hospitalized infection in Medicare patients not receiving glucocorticoids was 8.6% versus 11.0% (95% CI, 10.6% to 11.5%) for glucocorticoid dose of 5 mg or less per day, 14.4% (CI, 13.8% to 15.1%) for greater than 5 to 10 mg/d, and 17.7% (CI, 16.5% to 19.1%) for greater than 10 mg/d (all P < 0.001 vs. no glucocorticoids). The 1-year cumulative incidence of hospitalized infection in Optum patients not receiving glucocorticoids was 4.0% versus 5.2% (CI, 4.7% to 5.8%) for glucocorticoid dose of 5 mg or less per day, 8.1% (CI, 7.0% to 9.3%) for greater than 5 to 10 mg/d, and 10.6% (CI, 8.5% to 13.2%) for greater than 10 mg/d (all P < 0.001 vs. no glucocorticoids).

Limitation: Potential for residual confounding and misclassification of glucocorticoid dose.

Conclusion: In patients with RA receiving stable DMARD therapy, glucocorticoids were associated with a dose-dependent increase in the risk for serious infection, with small but significant risks even at doses of 5 mg or less per day. Clinicians should balance the benefits of low-dose glucocorticoids with this potential risk.

Primary funding source: National Institute of Arthritis and Musculoskeletal and Skin Diseases.

Keywords 
Arthritis, Rheumatoid

Combined Pharmacotherapy and Cognitive Behavioral Therapy for Adults With Alcohol or Substance Use Disorders: A Systematic Review and Meta-analysis

Author/s: 
Ray, L.A., Meredith, L.R., Kiluk, B.D., Walthers, J., Carroll, K.M., Magill, M.

Abstract

Importance: Substance use disorders (SUDs) represent a pressing public health concern. Combined behavioral and pharmacological interventions are considered best practices for addiction. Cognitive behavioral therapy (CBT) is a first-line intervention, yet the superiority of CBT compared with other behavioral treatments when combined with pharmacotherapy remains unclear. An understanding of the effects of combined CBT and pharmacotherapy will inform best-practice guidelines for treatment of SUD.

Objective: To conduct a meta-analysis of the published literature on combined CBT and pharmacotherapy for adult alcohol use disorder (AUD) or other SUDs.

Data sources: PubMed, Cochrane Register, MEDLINE, PsychINFO, and Embase databases from January 1, 1990, through July 31, 2019, were searched. Keywords were specified in 3 categories: treatment type, outcome type, and study design. Collected data were analyzed through September 30, 2019.

Study selection: Two independent raters reviewed abstracts and full-text articles. English language articles describing randomized clinical trials examining CBT in combination with pharmacotherapy for AUD and SUD were included.

Data extraction and synthesis: Inverse-variance weighted, random-effects estimates of effect size were pooled into 3 clinically informative subgroups: (1) CBT plus pharmacotherapy compared with usual care plus pharmacotherapy, (2) CBT plus pharmacotherapy compared with another specific therapy plus pharmacotherapy, and (3) CBT added to usual care and pharmacotherapy compared with usual care and pharmacotherapy alone. Sensitivity analyses included assessment of study quality, pooled effect size heterogeneity, publication bias, and primary substance moderator effects.

Main outcomes and measures: Substance use frequency and quantity outcomes after treatment and during follow-up were examined.

Results: The sample included 62 effect sizes from 30 unique randomized clinical trials that examined CBT in combination with some form of pharmacotherapy for AUD and SUD. The primary substances targeted in the clinical trial sample were alcohol (15 [50%]), followed by cocaine (7 [23%]) and opioids (6 [20%]). The mean (SD) age of the patient sample was 39 (6) years, with a mean (SD) of 28% (12%) female participants per study. The following pharmacotherapies were used: naltrexone hydrochloride and/or acamprosate calcium (26 of 62 effect sizes [42%]), methadone hydrochloride or combined buprenorphine hydrochloride and naltrexone (11 of 62 [18%]), disulfiram (5 of 62 [8%]), and another pharmacotherapy or mixture of pharmacotherapies (20 of 62 [32%]). Random-effects pooled estimates showed a benefit associated with combined CBT and pharmacotherapy over usual care (g range, 0.18-0.28; k = 9). However, CBT did not perform better than another specific therapy, and evidence for the addition of CBT as an add-on to combined usual care and pharmacotherapy was mixed. Moderator analysis showed variability in effect direction and magnitude by primary drug target.

Conclusions and relevance: The present study supports the efficacy of combined CBT and pharmacotherapy compared with usual care and pharmacotherapy. Cognitive behavioral therapy did not perform better than another evidence-based modality (eg, motivational enhancement therapy, contingency management) in this context or as an add-on to combined usual care and pharmacotherapy. These findings suggest that best practices in addiction treatment should include pharmacotherapy plus CBT or another evidence-based therapy, rather than usual clinical management or nonspecific counseling services.

Keywords 
substance abuse treatment

Active Case Finding With Case Management: The Key to Tackling the COVID-19 Pandemic

Author/s: 
China CDC COVID-19 Emergency Response Strategy Team

Abstract

COVID-19 was declared a pandemic by WHO on March 11, 2020, the first non-influenza pandemic, affecting more than 200 countries and areas, with more than 5·9 million cases by May 31, 2020. Countries have developed strategies to deal with the COVID-19 pandemic that fit their epidemiological situations, capacities, and values. We describe China's strategies for prevention and control of COVID-19 (containment and suppression) and their application, from the perspective of the COVID-19 experience to date in China. Although China has contained severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and nearly stopped indigenous transmission, a strong suppression effort must continue to prevent re-establishment of community transmission from importation-related cases. We believe that case finding and management, with identification and quarantine of close contacts, are vitally important containment measures and are essential in China's pathway forward. We describe the next steps planned in China that follow the containment effort. We believe that sharing countries' experiences will help the global community manage the COVID-19 pandemic by identifying what works in the struggle against SARS-CoV-2.

Copyright © 2020 Elsevier Ltd. All rights reserved.

Pharmacologic and Nonpharmacologic Treatments for Urinary Incontinence in Women: A Systematic Review and Network Meta-analysis of Clinical Outcomes

Author/s: 
Balk, E.M., Rofebero, V.N., Adam, G.P., Kimmel, H.J., Trikalinos, T.A., Jeppson, P.C.

BACKGROUND:

Urinary incontinence (UI), a common malady in women, most often is classified as stress, urgency, or mixed.

PURPOSE:

To compare the effectiveness of pharmacologic and nonpharmacologic interventions to improve or cure stress, urgency, or mixed UI in nonpregnant women.

DATA SOURCES:

MEDLINE, Cochrane Central Register of Controlled Trials (Wiley), Cochrane Database of Systematic Reviews (Wiley), EMBASE (Elsevier), CINAHL (EBSCO), and PsycINFO (American Psychological Association) from inception through 10 August 2018.

STUDY SELECTION:

84 randomized trials that evaluated 14 categories of interventions and reported categorical cure or improvement outcomes.

DATA EXTRACTION:

1 researcher extracted study characteristics, results, and study-level risk of bias, with verification by another independent researcher. The research team collaborated to assess strength of evidence (SoE) across studies.

DATA SYNTHESIS:

84 studies reported cure or improvement outcomes (32 in stress UI, 16 in urgency UI, 4 in mixed UI, and 32 in any or unspecified UI type). The most commonly evaluated active intervention types included behavioral therapies, anticholinergics, and neuromodulation. Network meta-analysis showed that all interventions, except hormones and periurethral bulking agents (variable SoE), were more effective than no treatment in achieving at least 1 favorable UI outcome. Among treatments used specifically for stress UI, behavioral therapy was more effective than either α-agonists or hormones in achieving cure or improvement (moderate SoE); α-agonists were more effective than hormones in achieving improvement (moderate SoE); and neuromodulation was more effective than no treatment for cure, improvement, and satisfaction (high SoE). Among treatments used specifically for urgency UI, behavioral therapy was statistically significantly more effective than anticholinergics in achieving cure or improvement (high SoE), both neuromodulation and onabotulinum toxin A (BTX) were more effective than no treatment (high SoE), and BTX may have been more effective than neuromodulation in achieving cure (low SoE).

LIMITATION:

Scarce direct (head-to-head trial) evidence and population heterogeneity based on UI type, UI severity, and history of prior treatment.

CONCLUSION:

Most nonpharmacologic and pharmacologic interventions are more likely than no treatment to improve UI outcomes. Behavioral therapy, alone or in combination with other interventions, is generally more effective than pharmacologic therapies alone in treating both stress and urgency UI.

Keywords 
behavioral interventions incontinence

Primary care intervention to reduce alcohol misuse ranking its health impact and cost effectiveness

Author/s: 
Solberg, Leif I., Maciosek, Michael V., Edwards, Nichol M.

BACKGROUND:

The U.S. Preventive Services Task Force (USPSTF) has recommended screening and behavioral counseling interventions in primary care to reduce alcohol misuse. This study was designed to develop a standardized rating for the clinically preventable burden and cost effectiveness of complying with that recommendation that would allow comparisons across many recommended services.

METHODS:

A systematic review of the literature from 1992 through 2004 to identify relevant randomized controlled trials and cost-effectiveness studies was completed in 2005. Clinically preventable burden (CPB) was calculated as the product of effectiveness times the alcohol-attributable fraction of both mortality and morbidity (measured in quality-adjusted life years or QALYs), for all relevant conditions. Cost effectiveness from both the societal perspective and the health-system perspective was estimated. These analyses were completed in 2006.

RESULTS:

The calculated CPB was 176,000 QALYs saved over the lifetime of a birth cohort of 4,000,000, with a range in sensitivity analysis from -43% to +94% (primarily due to variation in estimates of effectiveness). Screening and brief counseling was cost-saving from the societal perspective and had a cost-effectiveness ratio of $1755/QALY saved from the health-system perspective. Sensitivity analysis indicates that from both perspectives the service is very cost effective and may be cost saving.

CONCLUSIONS:

These results make alcohol screening and counseling one of the highest-ranking preventive services among the 25 effective services evaluated using standardized methods. Since current levels of delivery are the lowest of comparably ranked services, this service deserves special attention by clinicians and care delivery systems.

Keywords 
alcohol alcohol abuse

Nonsurgical Treatments for Urinary Incontinence in Women: A Systematic Review Update

Author/s: 
Balk, Ethan, Adam, Gaelen P., Kimmel, Hannah, Rofeberg, Valerie, Saeed, Iman, Jeppson, Peter, Trikalinos, Thomas

Introduction. About 17 percent of adult women have had urinary incontinence (UI), classified as stress, urgency, or mixed. Stress UI is associated with an inability to retain urine with activities that increase intraabdominal pressure. Urgency UI is associated with the sudden, compelling urge to void. Mixed UI occurs when both are present.

Methods. We updated the Agency for Healthcare Research and Quality's 2012 systematic review with new literature searches in MEDLINE®, the Cochrane Central Trials Registry, the Cochrane Database of Systematic Reviews, and Embase® from 2011 through December 4, 2017. We included UI outcomes (cure, improvement, satisfaction), quality of life, and adverse events. For UI outcomes, we conducted network meta-analyses, combining direct and indirect comparisons across studies. Quality of life and adverse event outcomes are narratively described.

Results. We identified 233 eligible studies, of which 140 reported on UI outcomes, 96 on quality of life, and 127 on adverse events. Studies evaluated 16 categories of interventions with 53 specific interventions. Fourteen intervention categories have been evaluated for UI outcomes; all except hormones and periurethral bulking agents were more effective to achieve at least one favorable UI outcome than no treatment (variable strength of evidence [SoE]). Among 1st or 2nd line interventions for stress UI, behavioral therapy (BT, alone and in combination with hormones) was more effective than either alpha agonists or hormones to achieve cure or improvement (moderate SoE); alpha agonists were more effective than hormones to achieve improvement (moderate SoE). Among treatments used as 1st or 2nd line interventions for urgency UI, BT was significantly more effective than anticholinergics to achieve cure or improvement (high SoE). Among 3rd line interventions for stress UI, intravesical pressure release, but not periurethral bulking agents, was more effective than no treatment (variable SoE). Neuromodulation, which is commonly used for treatment of urgency UI, is more effective than no treatment of stress UI for cure, improvement, and satisfaction (high SoE). Among studies of women with only stress UI, indirect evidence suggests that intravesical pressure release is more effective to achieve improvement than combination BT and neuromodulation, and triple combination neuromodulation, hormones, and BT may be more effective than either periurethral bulking or combination neuromodulation and BT (all low SoE). Among treatments used as 3rd line interventions for urgency UI, both neuromodulation and onabotulinum toxin A (BTX) are more effective than no treatment (high SoE), and BTX may be more effective than neuromodulation to achieve cure (low SoE). BT, neuromodulation, and anticholinergics resulted in better quality of life than no treatment (low SoE). Urinary tract infections (UTIs) were reported in 11 percent of women receiving transcutaneous electrical nerve stimulation and erosion in 1.6 percent of women with the periurethral bulking agent macroplastique (low SoE). Dry mouth was the most commonly reported adverse event for the anticholinergic oxybutynin (36%) and the alpha agonist duloxetine (13%) (high SoE). BTX was associated with UTIs (36%) and urinary retention (10% to 20%) (moderate SoE). Constitutional adverse events (e.g., nausea, insomnia, fatigue) were common with duloxetine (moderate SoE).

Conclusions. Network meta-analyses demonstrated that most nonpharmacological and pharmacological interventions are more likely than no treatment to improve UI outcomes and quality of life. BT, alone or in combination with other interventions, is generally more effective than 2nd line (pharmacological) therapies alone for both stress and urgency UI. Common adverse events with pharmacological treatments include dry mouth, nausea, and fatigue. BTX is associated with urinary infections and retention. Periurethral bulking agents are associated with erosion and need for surgical removal. Large gaps remain in the literature regarding head-to-head comparisons of individual interventions.

Keywords 
urinary tract infections behavior therapy urinary incontinence
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