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Nevin Manimala Statistics

The relationship between family socioeconomic status and adolescent sleep and diurnal cortisol

Psychosom Med. 2022 Jun 30. doi: 10.1097/PSY.0000000000001104. Online ahead of print.

ABSTRACT

OBJECTIVE: To investigate the associations between indices of family socioeconomic status and sleep during adolescence and to examine whether measures of hypothalamic-pituitary-adrenal (HPA) axis functioning mediate the observed associations.

METHODS: A total of 350 ethnically diverse adolescents (57% female; mean agewave1 = 16.4, SD = 0.7 years) completed a three-wave longitudinal study in which sleep and cortisol data were collected at two-year time intervals. Sleep duration, latency, and variability was assessed via actigraphy over a period of eight days per study wave. Salivary cortisol was collected across three days per study wave to assess cortisol diurnal slope, area under the curve and the cortisol awakening response. Adolescents’ caregivers reported their education levels, family income, and economic hardship.

RESULTS: A greater family income-to-needs ratio was associated with longer adolescent sleep duration (b = 2.90, p = .023), whereas greater parental education was associated with shorter sleep duration (b = -3.70, p = .030), less sleep latency (b = -0.74, p = .016), and less variability across days (b = -2.06, p = .010). Diurnal cortisol slope statistically mediated the association of parental education with sleep duration (b = -0.48, 95% CI [-1.099, -0.042]), but not the association of income-to-needs ratio with sleep duration.

CONCLUSION: Findings suggest parental education and family resources may have unique impacts upon sleep and HPA axis functioning during the period of adolescence. Future research is needed to examine family and behavioral factors that may underlie SES associations with adolescent sleep and HPA axis functioning.

PMID:35797448 | DOI:10.1097/PSY.0000000000001104

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Nevin Manimala Statistics

Postural stability and flexibility responses of yoga training in women: Are improvements similar in both sexes?

Health Care Women Int. 2022 Jul 7:1-16. doi: 10.1080/07399332.2022.2061971. Online ahead of print.

ABSTRACT

The researchers’ aim is to examine the postural stability and flexibility responses of yoga training in women. The authors conducted the yoga training program 2 days a week and they assessed flexibility using the sit and reach test, trunk hyperextension test and trunk lateral flexion test. The researchers measured static and dynamic balance employing the device and database system. Then, the authors repeated all assesments were at the end of the first, the fifth and the tenth sessions. As a result of this study, the researchers revealed that the male participants had significantly poorer results in a single parameter (longitudinal sway) when compared with the female group, but the groups were statistically equivalent in this parameter after the first yoga training session. The authors also revealed that yoga was effective in improving flexibility among healthy young adults of both sexes, although the males showed greater improvement than females in the flexibility results.

PMID:35797446 | DOI:10.1080/07399332.2022.2061971

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Risk factors for breast cancer-related lymphedema in patients undergoing 3 years of prospective surveillance with intervention

Cancer. 2022 Jul 7. doi: 10.1002/cncr.34377. Online ahead of print.

ABSTRACT

BACKGROUND: To evaluate risk factors (treatment-related, comorbidities, and lifestyle) for breast cancer-related lymphedema (BCRL) within the context of a Prospective Surveillance and Early Intervention (PSEI) model of care for subclinical BCRL.

METHODS: The parent randomized clinical trial assigned patients newly diagnosed with breast cancer to PSEI with either bioimpedance spectroscopy (BIS) or tape measurement (TM). Surgical, systemic and radiation treatments, comorbidities, and lifestyle factors were recorded. Detection of subclinical BCRL (change from baseline of either BIS L-Dex ≥6.5 or tape volume ≥ 5% and < 10%) triggered an intervention with compression therapy. Volume change from baseline ≥10% indicated progression to chronic lymphedema and need for complex decongestive physiotherapy. In this secondary analysis, multinomial logistic regressions including main and interaction effects of the study group and risk factors were used to test for factor associations with outcomes (no lymphedema, subclinical lymphedema, progression to chronic lymphedema after intervention, progression to chronic lymphedema without intervention). Post hoc tests of significant interaction effects were conducted using Bonferroni-corrected alphas of .008; otherwise, an alpha of .05 was used for statistical significance.

RESULTS: The sample (n = 918; TM = 457; BIS = 461) was female with a median age of 58.4 years. Factors associated with BCRL risk included axillary lymph node dissection (ALND) (p < .001), taxane-based chemotherapy (p < .001), regional nodal irradiation (RNI) (p ≤ .001), body mass index >30 (p = .002), and rurality (p = .037). Mastectomy, age, hypertension, diabetes, seroma, smoking, and air travel were not associated with BCRL risk.

CONCLUSIONS: Within the context of 3 years of PSEI for subclinical lymphedema, variables of ALND, taxane-based chemotherapy, RNI, body mass index >30, and rurality increased risk.

PMID:35797441 | DOI:10.1002/cncr.34377

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Nevin Manimala Statistics

Splenic volume as a predictor of treatment response in patients with non-small cell lung cancer receiving immunotherapy

PLoS One. 2022 Jul 7;17(7):e0270950. doi: 10.1371/journal.pone.0270950. eCollection 2022.

ABSTRACT

INTRODUCTION: The spleen is a lymphoid organ and we hypothesize that clinical benefit to immunotherapy may present with an increase in splenic volume during treatment. The purpose of this study was to investigate whether changes in splenic volume could be observed in those showing clinical benefit versus those not showing clinical benefit to pembrolizumab treatment in non-small cell lung cancer (NSCLC) patients.

MATERIALS AND METHODS: In this study, 70 patients with locally advanced or metastatic NSCLC treated with pembrolizumab; and who underwent baseline CT scan within 2 weeks before treatment and follow-up CT within 3 months after commencing immunotherapy were retrospectively evaluated. The splenic volume on each CT was segmented manually by outlining the splenic contour on every image and the total volume summated. We compared the splenic volume in those achieving a clinical benefit and those not achieving clinical benefit, using non-parametric Wilcoxon signed-rank test. Clinical benefit was defined as stable disease or partial response lasting for greater than 24 weeks. A p-value of <0.05 was considered statistically significant.

RESULTS: There were 23 responders and 47 non-responders based on iRECIST criteria and 35 patients with clinical benefit and 35 without clinical benefit. There was no significant difference in the median pre-treatment volume (175 vs 187 cm3, p = 0.34), post-treatment volume (168 vs 167 cm3, p = 0.39) or change in splenic volume (-0.002 vs 0.0002 cm3, p = 0.97) between the two groups. No significant differences were also found between the splenic volume of patients with partial response, stable disease or progressive disease (p>0.017). Moreover, there was no statistically significant difference between progression-free survival and time to disease progression when the splenic volume was categorized as smaller or larger than the median pre-treatment or post-treatment volume (p>0.05).

CONCLUSION: No significant differences were observed in the splenic volume of those showing clinical benefit versus those without clinical benefit to pembrolizumab treatment in NSCLC patients. CT splenic volume cannot be used as a potentially simple biomarker of response to immunotherapy.

PMID:35797413 | DOI:10.1371/journal.pone.0270950

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The Effect of a Future-Self Avatar Mobile Health Intervention (FutureMe) on Physical Activity and Food Purchases: Randomized Controlled Trial

J Med Internet Res. 2022 Jul 7;24(7):e32487. doi: 10.2196/32487.

ABSTRACT

BACKGROUND: Insufficient physical activity and unhealthy diets are contributing to the rise in noncommunicable diseases. Preventative mobile health (mHealth) interventions may help reverse this trend, but present bias might reduce their effectiveness. Future-self avatar interventions have resulted in behavior change in related fields, yet evidence of whether such interventions can change health behavior is lacking.

OBJECTIVE: We aimed to investigate the impact of a future-self avatar mHealth intervention on physical activity and food purchasing behavior and examine the feasibility of a novel automated nutrition tracking system. We also aimed to understand how this intervention impacts related attitudinal and motivational constructs.

METHODS: We conducted a 12-week parallel randomized controlled trial (RCT), followed by semistructured interviews. German-speaking smartphone users aged ≥18 years living in Switzerland and using at least one of the two leading Swiss grocery loyalty cards, were recruited for the trial. Data were collected from November 2020 to April 2021. The intervention group received the FutureMe intervention, a physical activity and food purchase tracking mobile phone app that uses a future-self avatar as the primary interface and provides participants with personalized food basket analysis and shopping tips. The control group received a conventional text- and graphic-based primary interface intervention. We pioneered a novel system to track nutrition by leveraging digital receipts from loyalty card data and analyzing food purchases in a fully automated way. Data were consolidated in 4-week intervals, and nonparametric tests were conducted to test for within- and between-group differences.

RESULTS: We recruited 167 participants, and 95 eligible participants were randomized into either the intervention (n=42) or control group (n=53). The median age was 44 years (IQR 19), and the gender ratio was balanced (female 52/95, 55%). Attrition was unexpectedly high with only 30 participants completing the intervention, negatively impacting the statistical power. The FutureMe intervention led to small statistically insignificant increases in physical activity (median +242 steps/day) and small insignificant improvements in the nutritional quality of food purchases (median -1.28 British Food Standards Agency Nutrient Profiling System Dietary Index points) at the end of the intervention. Intrinsic motivation significantly increased (P=.03) in the FutureMe group, but decreased in the control group. Outcome expectancy directionally increased in the FutureMe group, but decreased in the control group. Leveraging loyalty card data to track the nutritional quality of food purchases was found to be a feasible and accepted fully automated nutrition tracking system.

CONCLUSIONS: Preventative future-self avatar mHealth interventions promise to encourage improvements in physical activity and food purchasing behavior in healthy population groups. A full-powered RCT is needed to confirm this preliminary evidence and to investigate how future-self avatars might be modified to reduce attrition, overcome present bias, and promote sustainable behavior change.

TRIAL REGISTRATION: ClinicalTrials.gov NCT04505124; https://clinicaltrials.gov/ct2/show/NCT04505124.

PMID:35797104 | DOI:10.2196/32487

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Development of a Quality Management Model and Self-assessment Questionnaire for Hybrid Health Care: Concept Mapping Study

JMIR Form Res. 2022 Jul 7;6(7):e38683. doi: 10.2196/38683.

ABSTRACT

BACKGROUND: Working with eHealth requires health care organizations to make structural changes in the way they work. Organizational structure and process must be adjusted to provide high-quality care. This study is a follow-up study of a systematic literature review on optimally organizing hybrid health care (eHealth and face to face) using the Donabedian Structure-Process-Outcome (SPO) framework to translate the findings into a modus operandi for health care organizations.

OBJECTIVE: This study aimed to develop an SPO-based quality assessment model for organizing hybrid health care using an accompanying self-assessment questionnaire. Health care organizations can use this model and a questionnaire to manage and improve their hybrid health care.

METHODS: Concept mapping was used to enrich and validate evidence-based knowledge from a literature review using practice-based knowledge from experts. First, brainstorming was conducted. The participants listed all the factors that contributed to the effective organization of hybrid health care and the associated outcomes. Data from the brainstorming phase were combined with data from the literature study, and duplicates were removed. Next, the participants rated the factors on importance and measurability and grouped them into clusters. Finally, using multivariate statistical analysis (multidimensional scaling and hierarchical cluster analysis) and group interpretation, an SPO-based quality management model and an accompanying questionnaire were constructed.

RESULTS: All participants (n=39) were familiar with eHealth and were health care professionals, managers, researchers, patients, or eHealth suppliers. The brainstorming and literature review resulted in a list of 314 factors. After removing the duplicates, 78 factors remained. Using multivariate statistical analyses and group interpretations, a quality management model and questionnaire incorporating 8 clusters and 33 factors were developed. The 8 clusters included the following: Vision, strategy, and organization; Quality information technology infrastructure and systems; Quality eHealth application; Providing support to health care professionals; Skills, knowledge, and attitude of health care professionals; Attentiveness to the patient; Patient outcomes; and Learning system. The SPO categories were positioned as overarching themes to emphasize the interrelations between the clusters. Finally, a proposal was made to use the self-assessment questionnaire in practice, allowing measurement of the quality of each factor.

CONCLUSIONS: The quality of hybrid care is determined by organizational, technological, process, and personal factors. The 33 most important factors were clustered in a quality management model and self-assessment questionnaire called the Hybrid Health Care Quality Assessment. The model visualizes the interrelations between the factors. Using a questionnaire, each factor can be assessed to determine how effectively it is organized and developed over time. Health care organizations can use the Hybrid Health Care Quality Assessment to identify improvement opportunities for solid and sustainable hybrid health care.

PMID:35797097 | DOI:10.2196/38683

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Psychological Effects of Aromatherapy on Smokers With Depressive Tendencies During Smoking Cessation Treatment: Protocol for a Pre-Post Single-Arm Clinical Trial

JMIR Res Protoc. 2022 Jul 7;11(7):e38626. doi: 10.2196/38626.

ABSTRACT

BACKGROUND: Cessation of smoking can markedly reduce the incidence of cardiovascular disease, improve health economics, and benefit society. Aromatherapy has the potential to be a novel option as an adjuvant therapy for smoking cessation that may alleviate depressive symptoms. However, research on the efficacy of aromatherapy as an adjuvant therapy for smoking cessation is scarce.

OBJECTIVE: The aim of this study was to examine the potential effects of aromatherapy on psychological states in smokers with depressive tendencies and to determine if it is reasonable to proceed to the next step (ie, a phase III trial).

METHODS: This is a pre-post single-arm clinical trial. Smokers with depression will be subjected to aromatherapy during smoking cessation treatment for 12 weeks. We will evaluate changes in scores on the Zung Self-Rating Depression Scale and the Profile of Mood States from pretreatment screening to 4 weeks and 12 weeks after the start of aromatherapy. Moreover, we will compare the group treated with aromatherapy with the group that received standard treatment in our previous randomized controlled trial (ie, the control group in that study). Furthermore, we will compare successful smoking cessation rates after 12 weeks. In addition, we will conduct an exploratory analysis of the efficacy of aromatherapy. The target sample size is 100, which is the number of subjects expected to be enrolled in this study during the 2-year study period.

RESULTS: This study was approved by the Kyoto Medical Center Institutional Review Board (IRB approval No. 19-016). Enrollment started on July 1, 2019. As of May 2022, 76 patients have been recruited. In the original plan, recruitment should have been finished on June 30, 2021. However, the number of subjects decreased due to the COVID-19 pandemic, and the study inclusion period was extended by 1 year (ie, until the end of June 2022) with the approval of the IRB on May 17, 2021. Analyses of the results will be completed subsequently.

CONCLUSIONS: This study has some limitations. This is not a rigorous validation study because it compares the same subjects who received standard treatment in a previous study. Moreover, the sample size and methods of statistical analysis were not fully set with prior consideration of statistical rigor. To address these limitations, we plan to conduct a phase III trial that will reflect the exploratory findings of this study. This is the first study to evaluate the psychological effects of aromatherapy during a smoking cessation program, and it may help improve the quality of treatment for smoking cessation in the future.

TRIAL REGISTRATION: UMIN Clinical Trials Registry UMIN000043102; https://tinyurl.com/tn3hvt9w.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/38626.

PMID:35797095 | DOI:10.2196/38626

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Nevin Manimala Statistics

Students’ increased time spent on social media, and their level of coronavirus anxiety during the pandemic predict increased social media addiction

Health Info Libr J. 2022 Jul 7. doi: 10.1111/hir.12448. Online ahead of print.

ABSTRACT

BACKGROUND: During the COVID-19 pandemic period, the level of anxiety and the duration of social media use increased in university students.

OBJECTIVES: This study aimed to examine the relationship between coronavirus anxiety and social media addiction in university students.

METHODS: The sample consisted of 346 university students in Turkey. The data were collected online using the Sociodemographic Data Form, the Coronavirus Anxiety Scale Short Form and the Social Network Addiction Scale. The data were analysed using one-way analysis of variance, Mann-Whitney U test, Pearson correlation analysis, chi-square analysis and multiple linear regression analysis.

RESULTS: The results showed that the mean coronavirus anxiety score was higher in men than in women. Social media addiction increased as the daily time spent by the students on social media increased. A positive correlation was found between the daily time spent on social media before the pandemic and social media usage during the pandemic. It was concluded that students use social media more during the pandemic than before it and that social media addiction increases as the students’ coronavirus anxiety increases.

CONCLUSION: It is important to plan initiatives to reduce coronavirus anxiety to prevent social media addiction in young people.

STUDY LOCATION AND SAMPLE: The research population consisted of 1st and 2nd year students who are studying in the Medical Services and Techniques Department of Vocational School of Health Services at a university located in the west of Turkey, during the Fall Term of academic year 2020-2021. Students in this department are studying in anaesthesia, dialysis, first and emergency aid, medical laboratory techniques, medical imaging technique, and medical documentation and secretarial programmes.

PMID:35797092 | DOI:10.1111/hir.12448

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ISO 9001:2015 Internal Audits for Financial and Strategic Decisions in Reducing Blood Culture Contamination

Qual Manag Health Care. 2022 Jul 6. doi: 10.1097/QMH.0000000000000381. Online ahead of print.

ABSTRACT

BACKGROUND AND OBJECTIVES: Blood cultures are vital diagnostic tests that detect harmful pathogens in a patient’s bloodstream. In this study, we implemented a process-driven quality improvement program to reduce blood culture contamination rates.

METHODS: St Joseph Health (SJH) utilized the ISO 9001:2015 Internal Audit tool, failure mode effect analyses, and the Centers for Disease Control and Prevention’s Hierarchy of Controls to identify opportunities for improvement and design effective corrective and preventive action plans. These actions included reeducation and ongoing coaching of staff on the blood culture collection process, reorganizing blood culture supplies on the nursing units, and adding multiple layers of supervision.

RESULTS: A statistically significant relationship was identified between 2 variables (“contamination rate” and “cumulative cost difference”). The 2 variables had a negative association, demonstrating that as the contamination rate decreased, the cumulative cost difference increased, indicating potential cost savings.

CONCLUSION: The estimated value added to the institution through this initiative was approximately $215 743 to $228 543 in potential cost savings. SJH significantly reduced the number of blood culture contaminations in the critical care division, evidenced by a controlled 6-month mean below 1%. Review of the 6-month mean as a reference point demonstrated the sustainability of the implemented corrective and preventive measures.

PMID:35797057 | DOI:10.1097/QMH.0000000000000381

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Effect of Electroacupuncture on Insomnia in Patients With Depression: A Randomized Clinical Trial

JAMA Netw Open. 2022 Jul 1;5(7):e2220563. doi: 10.1001/jamanetworkopen.2022.20563.

ABSTRACT

IMPORTANCE: Electroacupuncture (EA) is a widely recognized therapy for depression and sleep disorders in clinical practice, but its efficacy in the treatment of comorbid insomnia and depression remains uncertain.

OBJECTIVE: To assess the efficacy and safety of EA as an alternative therapy in improving sleep quality and mental state for patients with insomnia and depression.

DESIGN, SETTING, AND PARTICIPANTS: A 32-week patient- and assessor-blinded, randomized, sham-controlled clinical trial (8-week intervention plus 24-week observational follow-up) was conducted from September 1, 2016, to July 30, 2019, at 3 tertiary hospitals in Shanghai, China. Patients were randomized to receive EA treatment and standard care, sham acupuncture (SA) treatment and standard care, or standard care only as control. Patients were 18 to 70 years of age, had insomnia, and met the criteria for depression as classified in the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition). Data were analyzed from May 4 to September 13, 2020.

INTERVENTIONS: All patients in the 3 groups were provided with standard care guided by psychiatrists. Patients in the EA and SA groups received real or sham acupuncture treatment, 3 sessions per week for 8 weeks, for a total of 24 sessions.

MAIN OUTCOMES AND MEASURES: The primary outcome was change in Pittsburgh Sleep Quality Index (PSQI) from baseline to week 8. Secondary outcomes included PSQI at 12, 20, and 32 weeks of follow-up; sleep parameters recorded in actigraphy; Insomnia Severity Index; 17-item Hamilton Depression Rating Scale score; and Self-rating Anxiety Scale score.

RESULTS: Among the 270 patients (194 women [71.9%] and 76 men [28.1%]; mean [SD] age, 50.3 [14.2] years) included in the intention-to-treat analysis, 247 (91.5%) completed all outcome measurements at week 32, and 23 (8.5%) dropped out of the trial. The mean difference in PSQI from baseline to week 8 within the EA group was -6.2 (95% CI, -6.9 to -5.6). At week 8, the difference in PSQI score was -3.6 (95% CI, -4.4 to -2.8; P < .001) between the EA and SA groups and -5.1 (95% CI, -6.0 to -4.2; P < .001) between the EA and control groups. The efficacy of EA in treating insomnia was sustained during the 24-week postintervention follow-up. Significant improvement in the 17-item Hamilton Depression Rating Scale (-10.7 [95% CI, -11.8 to -9.7]), Insomnia Severity Index (-7.6 [95% CI, -8.5 to -6.7]), and Self-rating Anxiety Scale (-2.9 [95% CI, -4.1 to -1.7]) scores and the total sleep time recorded in the actigraphy (29.1 [95% CI, 21.5-36.7] minutes) was observed in the EA group during the 8-week intervention period (P < .001 for all). No between-group differences were found in the frequency of sleep awakenings. No serious adverse events were reported.

CONCLUSIONS AND RELEVANCE: In this randomized clinical trial of EA treatment for insomnia in patients with depression, quality of sleep improved significantly in the EA group compared with the SA or control group at week 8 and was sustained at week 32.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03122080.

PMID:35797047 | DOI:10.1001/jamanetworkopen.2022.20563