Tag: statistics

Wounds. 2022 Apr;34(4):E34-E36.

ABSTRACT

OBJECTIVE: This is the second of 3 planned articles reporting on a prospective, multicenter, randomized controlled trial assessing the efficacy of fish skin graft in the management of diabetic foot ulcers in comparison with the standard of care (collagen alginate dressing).

MATERIALS AND METHODS: The primary end point of this prospective randomized trial is the number of closed wounds at 12 weeks.

RESULTS: As of the time of this writing, 94 patients had completed the protocol. At 12-week follow-up, healing was achieved in 63.0% of index ulcers (29 of 46 patients) in the acellular fish skin graft group compared with 31.3% in the control group (15 of 48 patients) (P =.0036). In both groups, the mean time to healing was 7 weeks. The median number of applications of the fish skin graft to achieve healing was 6.

CONCLUSION: A clinically and statistically significant difference in healing was observed between patients treated with acellular fish skin graft and those treated with a collagen alginate dressing. The data support the completion of this prospective randomized trial.

PMID:35797557

Med Sci Sports Exerc. 2022 Jul 7. doi: 10.1249/MSS.0000000000002995. Online ahead of print.

ABSTRACT

INTRODUCTION: The influence of graft type on the restoration of quadriceps strength symmetry following ACL reconstruction (ACLR) has been widely studied. However, an important consideration when evaluating quadriceps symmetry is the fact that this measure can be influenced by numerous factors beyond graft type. This study sought to determine if graft type is predictive of quadriceps strength asymmetry during the first 12 months post ACLR taking into consideration potentially influential factors (i.e., age, sex, BMI, time post ACLR).

METHODS: We retrospectively reviewed quadriceps strength data from 434 patients (303 females and 131 males) who had previously undergone ACLR with an autograft (hamstring tendon (HT), quadriceps tendon (QT), patellar tendon (PT)) or allograft. Chi-squared Automatic Interaction Detection (CHAID) decision tree analysis was used to evaluate how graft type influenced quadriceps strength asymmetry during the first 12 months post ACLR taking into consideration age, sex, BMI, and time post ACLR.

RESULTS: The best predictor of quadriceps strength asymmetry was graft type. Specifically, 3 graft categories were identified (1) allograft and HT autograft, (2) PT autograft, and (3) QT autograft. The average quadriceps strength asymmetry for each of the 3 identified categories was 0.91, 0.87, and 0.81, respectively, and differed statistically from each other (p < 0.001). The second-best predictor of quadriceps strength asymmetry was sex, albeit only in the PT and QT groups (with females having increased asymmetry). Female patients post ACLR with a QT autograft were at highest risk for quadriceps strength asymmetry.

CONCLUSIONS: Graft type and sex are important predictors of quadriceps strength asymmetry following ACLR. Clinicians should take these factors into consideration when designing rehabilitation protocols to restore quadriceps strength symmetry during the post-operative period.

PMID:35797489 | DOI:10.1249/MSS.0000000000002995

J Patient Saf. 2022 Jul 6. doi: 10.1097/PTS.0000000000001055. Online ahead of print.

ABSTRACT

INTRODUCTION: Patients leaving against medical advice (AMA) are commonly encountered in hospital medicine. The problem is prevalent worldwide and across all fields of medicine. A retrospective study of 47,583 patients reported a 3.3% AMA rate in 2015.

OBJECTIVES: In this retrospective study, we aimed (1) to study the demographic, clinical, and laboratory parameters of infective endocarditis (IE) patients leaving AMA. We also compared (2) the various risk factors and outcomes of these patients with IE patients who completed treatment.

RESULTS: A total of 111 patients diagnosed with IE were recruited for 36 months. Of the 74 patients with available details, 32 patients (29%) left AMA during their treatment. The mean age of patients leaving AMA was 39, and among those who left AMA, 66% were females. As compared with patients completing therapy, patients leaving AMA tend to have higher comorbidities, including injection drug use (68.1% versus 31.9%), prior IE (83.3% versus 16.7%), and chronic hepatitis C (72.4% versus 27.8%). Rates of consumption of substances of abuse were higher among those who left AMA. Patients leaving AMA also had higher psychiatric comorbidities (63% versus 37.5%), history of leaving AMA (70.5% versus 29.5%), and consumption of more than 2 substances of abuse. Morbidity was higher in patients leaving AMA. There was a statistically significant association between the development of distal embolus (P < 0.001), the need for recurrent admissions (P = 0.002), recurrent bacteremia (P < 0.001), developing new embolus (P < 0.001), and overall morbidity (P = 0.002) among IE patients leaving AMA.

CONCLUSIONS: Infective endocarditis patients leaving AMA tend to be younger females. These patients have prior comorbidities of injection drug use, prior IE, multiple psychiatric comorbidities, drug use, and multiple socioeconomic issues. Patients leaving AMA tend to develop further non-Central nervous system embolic events, recurrent bacteremia, and require frequent admissions. Morbidity in these patients was higher.

PMID:35797474 | DOI:10.1097/PTS.0000000000001055

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

J Environ Qual. 2022 Jul 7. doi: 10.1002/jeq2.20387. Online ahead of print.

ABSTRACT

Swine manure management and storage have been implicated as a major source of increasing agricultural ammonia (NH₃ ) emissions resulting in increased ammonium (NH₄⁺ ) deposition in North Carolina. This study was conducted to establish how improvements in manure and animal management have affected lagoons’ nutrient loading and subsequent lagoon NH₃ emissions determined from measured lagoon chemistry and climate data. Archived lagoon chemistry analyses from 182 farm lagoons (106,000 sample analyses) were used to evaluate trends in lagoon chemical properties. Process and empirical (statistical) NH₃ volatilization models were used with the data to calculate changes in NH₃ emissions from 2001 through 2018. Lagoon nutrient trends for both finisher and sow farms showed that annual averages of nutrients had decreases ranging from 18% to 93% except for a 41% increase in copper for finisher primary lagoons. Because of reduced nitrogen and pH in the lagoons, a process model of NH₃ emissions suggested decreases from primary lagoons of 49% and 25% from both finisher and sow farm lagoons, respectively. Empirical (statistical) models predicted even larger relative NH₃ decreases (up to 54%). This article is protected by copyright. All rights reserved.

PMID:35797461 | DOI:10.1002/jeq2.20387

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

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

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

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

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