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Efficacy of Ḥammām-i-yābis (dry bath) in metabolic syndrome: a single arm, open-labelled clinical trial

J Complement Integr Med. 2021 Jul 16. doi: 10.1515/jcim-2021-0072. Online ahead of print.

ABSTRACT

OBJECTIVES: This study intended to evaluate the efficacy of Ḥammām-i-yabis (dry bath) in metabolic syndrome as primary objective and perceived improvement and changes in quality of life as secondary objective.

METHODS: The study was designed as single arm, open-labelled, pre and post without control clinical trial comprising 30 diagnosed cases of metabolic syndrome belonging to 20-50 years of age of either sex. The enrolled patients were exposed to the dry heat of Ḥammām-i-yābis for 15 min at a temperature of 60 degree centigrade on every third day for a duration of 30 days (A total of 10 sittings). Objective parameters comprising systolic &diastolic blood pressure and waist circumference were assessed on every follow up, while other objective parameters (FBS, HDL and Serum Triglycerides) were assessed before and after the study.

RESULTS: Significant statistical difference was observed in objective parameters. Two tailed paired Student’s t-test, (for pre and post) and Repeated Measure ANOVA (for 0, 15th and 30th day) were used to find the significance of mean change in study parameters. No significant adverse change appeared in safety parameters.

CONCLUSIONS: Ḥammām-i-yābis was found effective, safer, more feasible and less expensive regimenal modality for the patients of Metabolic Syndrome.

PMID:34265883 | DOI:10.1515/jcim-2021-0072

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A Prognostic Model to Facilitate Palliative Care Referral in Oncology Outpatients

Cancer Res Treat. 2021 Jul 13. doi: 10.4143/crt.2021.483. Online ahead of print.

ABSTRACT

PURPOSE: We aimed to develop a prognostic model to assist palliative care referral at least 3 months before death in advanced cancer patients treated at an outpatient medical oncology clinic.

MATERIALS AND METHODS: In this prospective cohort study, a total of 200 patients were enrolled at a tertiary cancer center in South Korea. The major eligibility criterion was an expected survival of less than a year as estimated by their oncologists. We analyzed the influences of known prognostic factors along with chemotherapy status, mid-arm circumference, and triceps skinfold thickness on survival time.

RESULTS: The mean age of the patients was 64.5 years, 36% were female, and the median survival time was 7.6 months. In the multivariate analysis, we found 6 significant factors related to poor survival: a poor Eastern Cooperative Oncology Group (ECOG) performance status (≥2), not undergoing chemotherapy, anorexia, a low lymphocyte level (<12%), a high lactate dehydrogenase (LDH) level (≥300 IU/L), and a low mid-arm circumference (<23 cm). We developed a prognostic model (score, 0-8.0) to predict 3-month survival based on the multivariate analysis. Patients who scored ≥4.0 points had a short survival of less than 3 months (p<0.001). The discriminating ability of the prognostic model using the area under the receiver operating characteristic curve (AUC) was 0.88.

CONCLUSION: The prognostic model using ECOG performance status, chemotherapy status, anorexia, lymphocytes, LDH, and mid-arm circumference can predict 3-month survival in medical oncology outpatients. It can alert oncologists to refer patients to palliative care specialists before it is too late.

PMID:34265891 | DOI:10.4143/crt.2021.483

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Clinically significant depressive symptoms and high diabetes distress in adults with type 1 and type 2 diabetes in Appalachian Ohio

J Osteopath Med. 2021 Jul 15. doi: 10.1515/jom-2021-0091. Online ahead of print.

ABSTRACT

CONTEXT: In rural southeastern Ohio, the prevalence of diabetes is 19.9%, nearly double the national average of 10.5%. Despite the high rate of diabetes, its impact on the region is understudied; one such understudied topic is psychosocial difficulties. People with diabetes experience disproportionately higher rates of major depressive disorder (MDD), clinically significant depressive symptoms, and diabetes distress. Diabetes distress refers to the negative emotional experience of living with diabetes. It reflects an individual’s worries, concerns, and fears about living a chronic and progressive disease.

OBJECTIVES: To assess the prevalence of diabetes distress as well as comorbid, clinically significant depressive symptoms and diabetes distress among patients in southeastern Ohio; and to assess impact of depressive symptoms and diabetes distress on A1C levels, diabetes self care behaviors, and diabetes quality of life (DQOL).

METHODS: In this cross sectional survey study, individuals aged 18 years and older, diagnosed with type 1 (T1D) or type 2 (T2D) diabetes, who were able to read and speak English, and living in southeastern Ohio were invited to participate. Participants completed the Diabetes Distress Scale for T2D or T1D, the Patient Health Questionnaire-9, the Self Care Inventory-Revised, and the DQOL Scale as part of the study survey. Participants completed the survey via an online questionnaire service or mailed packets. Chi square tests determined the comorbidity of clinically significant depressive symptoms and high diabetes distress levels by type of diabetes. Multiple regression models examined the relationships among clinically significant depressive symptoms, diabetes distress scores, A1C levels, self care behaviors, and DQOL scores. Statistical significance was defined as a p<0.05.

RESULTS: A total of 325 adults participated (mean ± standard deviation [SD] age, 41.6 ± 19.2 years; 131 (40.7%) with T1D; 194 (59.7%) with T2D; mean ± SD A1C, 7.5 ± 1.6%; mean ± SD duration, 12.4 ± 9.6 years). Of the 325 participants, 70 (21.5%) indicated clinically significant depressive symptoms, with 29 (22.3%) T1D participants and 41 (21.0%) T2D participants reporting clinically significant depressive symptoms. A total of 92 (28.3%) participants reported high diabetes distress (39 (30.5%) T1D participants and 53 (27.5%) T2D participants). Forty-eight participants (15.0%) screened positive for both clinically significant depressive symptoms and high diabetes distress. Regression models showed that higher diabetes distress scores were associated with fewer self care behaviors (T1D, b=-0.268, p=0.030; T2D, b=-0.312, p<0.001) and lower DQOL (T1D, b=0.726, p<0.001; T2D, b=0.501, p<0.001). Further, more depressive symptoms were associated with lower DQOL in participants with T2D (b=0.363, p<0.001). Higher diabetes distress scores were not associated with higher A1C levels in participants with T1D or T2D; however, increased depressive symptoms were associated with higher A1C levels in participants with T2D (b=0.390, p<0.001).

CONCLUSIONS: Findings showed that adults in southeastern Ohio experienced high levels of diabetes distress and co-occurring clinically significant depressive symptoms that were within range of data from previous studies. These findings highlight the importance of routine screening for both clinically significant depressive symptoms and diabetes distress. Future longitudinal research is needed to confirm these findings and examine the evolution of these relationships over time.

PMID:34265882 | DOI:10.1515/jom-2021-0091

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Verification of Maximal Oxygen Uptake in Active Military Personnel During Treadmill Running

J Strength Cond Res. 2021 Jul 13. doi: 10.1519/JSC.0000000000004019. Online ahead of print.

ABSTRACT

Figueiredo, PS, Looney, DP, Pryor, JL, Doughty, EM, McClung, HL, Vangala, SV, Santee, WR, Beidleman, BA, and Potter, AW. Verification of maximal oxygen uptake in active military personnel during treadmill running. J Strength Cond Res XX(X): 000-000, 2021-It is unclear whether verification tests are required to confirm “true” maximal oxygen uptake (V[Combining Dot Above]O2max) in modern warfighter populations. Our study investigated the prevalence of V[Combining Dot Above]O2max attainment in U.S. Army soldiers performing a traditional incremental running test. In addition, we examined the utility of supramaximal verification testing as well as repeated trials for familiarization for accurate V[Combining Dot Above]O2max assessment. Sixteen U.S. Army soldiers (1 woman, 15 men; age, 21 ± 2 years; height, 1.73 ± 0.06 m; body mass, 71.6 ± 10.1 kg) completed 2 laboratory visits, each with an incremental running test (modified Astrand protocol) and a verification test (110% maximal incremental test speed) on a motorized treadmill. We evaluated V[Combining Dot Above]O2max attainment during incremental testing by testing for the definitive V[Combining Dot Above]O2 plateau using a linear least-squares regression approach. Peak oxygen uptake (V[Combining Dot Above]O2peak) was considered statistically equivalent between tests if the 90% confidence interval around the mean difference was within ±2.1 ml·kg-1·min-1. Oxygen uptake plateaus were identified in 14 of 16 volunteers for visit 1 (87.5%) and all 16 volunteers for visit 2 (100%). Peak oxygen uptake was not statistically equivalent, apparent from the mean difference in V[Combining Dot Above]O2peak measures between the incremental test and verification test on visit 1 (2.3 ml·kg-1·min-1, [1.3-3.2]) or visit 2 (1.1 ml·kg-1·min-1 [0.2-2.1]). Interestingly, V[Combining Dot Above]O2peak was equivalent, apparent from the mean difference in V[Combining Dot Above]O2peak measures between visits for the incremental tests (0.0 ml·kg-1·min-1 [-0.8 to 0.9]) but not the verification tests (-1.2 ml·kg-1·min-1 [-2.2 to -0.2]). Modern U.S. Army soldiers can attain V[Combining Dot Above]O2max by performing a modified Astrand treadmill running test. Additional familiarization and verification tests for confirming V[Combining Dot Above]O2max in healthy active military personnel may be unnecessary.

PMID:34265816 | DOI:10.1519/JSC.0000000000004019

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Intraductal Carcinoma of the Prostate: Extreme Nuclear Size Is Not a Diagnostic Parameter

Am J Surg Pathol. 2021 Jul 15. doi: 10.1097/PAS.0000000000001776. Online ahead of print.

ABSTRACT

High-grade prostatic adenocarcinoma involving duct/acinar structures is labeled intraductal carcinoma of the prostate (IDCP). As numerous studies have shown that IDCP is associated with high stage disease with a significant negative impact on cancer-specific survival, accurate diagnosis is crucial to ensure appropriate patient management. The definition of IDCP recommended by 2016 World Health Organization (WHO) classification suggests that cases of IDCP with micropapillary or loose cribriform architecture without comedonecrosis should have cells with ≥6× nuclear enlargement. It is unclear how this size criterion was derived and which of the parameters of nuclear size (nuclear diameter, nuclear surface area, or nuclear perimeter) it relates to. To evaluate the extent of nuclear enlargement in IDCP, we performed morphometric analyses relating to each of these parameters in 100 radical prostatectomy specimens. One hundred nuclei from foci of IDCP and 50 nuclei from foci of normal luminal epithelium were examined for each patient. Diagnosis of IDCP was based on cells with definite features of carcinoma present within duct/acinar structures. Comparing the means of each of the parameters between IDCP cells and benign luminal cells, there was a statistically significant enlargement in nuclear perimeter (P<0.0005), nuclear area (P<0.0005), and nuclear diameter (P<0.0005); however, the difference in mean nuclear size was limited to factors of 1.3×, 1.6×, and 1.3×, respectively. Three patients each had rare large nuclei (largest perimeter 45, 45, and 44 μm; maximum nuclear area 135, 136, and 136 μm2; and the largest diameter 18 µm in each). For these rare cells, the nuclear size difference, when compared with benign nuclei was; nuclear perimeter 2.0×, 2.1×, and 2.1×; nuclear area 3.6×, 3.8×, and 3.8×; and nuclear maximum diameter 3.0×, 2.5×, and 2.5×. The definition of nuclear enlargement of ≥6× was not reached in any of our cases, all of which clearly showed features of duct invasive carcinoma. In these cases, reliance on nuclear size criteria would have resulted in underdiagnosis of IDCP. This is of concern as failure to recognize IDCP, particularly in needle biopsies, could lead to delays in the timely treatment of aggressive high-grade prostate cancer, resulting in cancer progression and suboptimal patient oncological outcomes.

PMID:34265803 | DOI:10.1097/PAS.0000000000001776

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Analysis of Factors associated with Return to Work After Lumbar Surgery up to 2-years follow-up: A Michigan Spine Surgery Improvement Collaborative (MSSIC) Study

Spine (Phila Pa 1976). 2021 Jul 7. doi: 10.1097/BRS.0000000000004163. Online ahead of print.

ABSTRACT

STUDY DESIGN: Michigan Spine Surgery Improvement Collaborative (MSSIC) prospectively collects data on all patients undergoing operations for degenerative and/or deformity indications.

OBJECTIVE: We aimed to identify which factors are significantly associated with return-to-work after lumbar surgery at long-term follow-up.

SUMMARY OF BACKGROUND DATA: Prior publications have created a clinically relevant predictive model for return-to-work, wherein education, gender, race, comorbidities, and preoperative symptoms increased likelihood of return-to-work at 3 months after lumbar surgery. We sought to determine if these trends 1) persisted at 1 year and 2 years postoperatively; or 2) differed among preoperatively employed versus unemployed patients.

METHODS: MSSIC was queried for all patients undergoing lumbar operations (2014-2019). All patients intended to return-to-work postoperatively. Patients were followed for up to 2 years postoperatively. Measures of association were calculated with multivariable generalized estimating equations (GEE).

RESULTS: Return-to-work increased from 63% (3542/5591) at 90 days postoperatively to 75% (3143/4147) at 1 year and 74% (2133/2866) at 2 years postoperatively. Following GEE, neither clinical nor surgical variables predicted return-to-work at all three time intervals: 90 days, 1 year, and 2 years postoperatively. Only socioeconomic factors reached statistical significance at all follow-up points. Preoperative employment followed by insurance status had the greatest associations with return-to-work. In a sub-analysis of patients who were preoperatively employed, insurance was the only factor with significant associations with return-to-work at all three follow-up intervals. The return-to-work rates among unemployed patients at baseline increased from 29% (455/1100) at 90 days, 44% (495/608) at 1 year, and 46% (366/426) at 2 years postoperatively. The only two significant factors associated with return-to-work at all three follow-up intervals were Medicaid, as compared to private insurance, and male gender.

CONCLUSION: In patients inquiring about long-term return-to-work after lumbar surgery, insurance status represents the important determinant of employment status.Level of Evidence: 2.

PMID:34265812 | DOI:10.1097/BRS.0000000000004163

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Matched-pair Analysis for Survival Endpoints Between Women With Early-stage Uterine Carcinosarcoma and Uterine Serous Carcinoma

Am J Clin Oncol. 2021 Jul 16. doi: 10.1097/COC.0000000000000851. Online ahead of print.

ABSTRACT

OBJECTIVE: The objective of this study was to compare survival endpoints between women with uterine carcinosarcoma and those with uterine serous carcinoma utilizing matching analysis.

METHODS: Patients with stages I to II who underwent hysterectomy at our institution were included in this analysis. Patients with carcinosarcoma were then matched to patients with serous carcinoma based on stage, and adjuvant management received (observation, radiation treatment alone, chemotherapy alone, or combined modality with radiotherapy and chemotherapy. Recurrence-free survival, disease-specific survival, and overall survival were calculated for the 2 groups.

RESULTS: A total of 134 women were included (67 women with carcinosarcoma and 67 with serous carcinoma, matched 1:1). There was no statistically significant difference between the 2 groups regarding 5-year recurrence-free survival (59% vs. 62%), disease-specific survival (66% vs. 67%), or overall survival (53% vs. 57%), respectively. The only independent predictor of shorter recurrence-free survival for the entire cohort was the lack of adjuvant combined modality therapy, while lower uterine segment involvement was the only independent predictor for shorter disease-specific survival. Lack of lymph node dissection and lack of adjuvant combined modality therapy were independent predictors of shorter overall survival.

DISCUSSION: When matched based on stage and adjuvant treatment, our study suggests that there is no statistically significant difference in survival endpoints between women with early-stage carcinosarcoma and serous carcinoma. Adjuvant combined modality treatment is an independent predictor of longer recurrence-free survival and overall survival.

PMID:34265785 | DOI:10.1097/COC.0000000000000851

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A Randomized Controlled Trial Evaluating the Analgesic Effect of the Combination of Methadone with Morphine for Cancer Related Pain

Clin J Pain. 2021 Jul 9. doi: 10.1097/AJP.0000000000000959. Online ahead of print.

ABSTRACT

CONTEXT AND OBJECTIVES: Although opioids play an indispensable role in the management of cancer-related pain, inadequate pain relief still occurs. The primary objective of this study was to evaluate whether the combination of a low dose of methadone with morphine promotes a reduction in opioid consumption; the secondary objectives were if the association promotes lower pain intensity, and adverse effects.

METHODS: There were studied 41 patients with cancer-related pain in palliative setting. They were starting the third step of the analgesic ladder, and one group achieve methadone (2.5▒mg/12▒h) in combination with morphine (MM), and another group received morphine (M) alone. Both groups could use morphine (5▒mg) as needed to maintain pain intensity <4, and adjuvant in stable dose. The following outcomes were evaluated: total morphine dose, pain intensity, and adverse effects.

RESULTS: There was no difference in the number of adjuvants, and the dose of morphine used. Pain intensity was lower in the MM group after 2 weeks, with no statistically significant difference at other time points. There was no difference in the adverse effects.

CONCLUSIONS: Low dose of methadone in combination with morphine provided faster pain control as compared to morphine alone, and although this study was not powered to show differences in adverse effects, we did not notice a difference.

PMID:34265791 | DOI:10.1097/AJP.0000000000000959

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Evaluation of the ventilatory effects on human subjects in prolonged hip-flexed/head-down restraint position

Am J Emerg Med. 2021 Jul 2;50:1-4. doi: 10.1016/j.ajem.2021.06.068. Online ahead of print.

ABSTRACT

BACKGROUND: The restraint chair is a tool used by law enforcement and correction personnel to control aggressive, agitated individuals. When initiating its use, subjects are often placed in a hip-flexed/head-down (HFHD) position to remove handcuffs. Usually, this period of time is less than two minutes but can become more prolonged in particularly agitated patients. Some have proposed this positioning limits ventilation and can result in asphyxia. The aim of this study is to evaluate if a prolonged HFHD restraint position causes significant ventilatory compromise.

METHODS: Subjects exercised on a stationary bicycle until they reached 85% of their predicted maximal heart rate. They were then handcuffed with their hands behind their back and placed into a HFHD seated position for five minutes. The primary outcome measurement was maximal voluntary ventilation (MVV). This was measured at baseline, after initial placement into the HFHD position, and after five minutes of being in the position while still maintaining the HFHD position. Baseline measurements were compared with final measurements for statistically significant differences.

RESULTS: We analyzed data for 15 subjects. Subjects had a mean MVV of 165.3 L/min at baseline, 157.8 L/min after initially being placed into the HFHD position, and a mean of 138.7 L/min after 5 min in the position. The mean baseline % predicted MVV was 115%; after 5 min in the HFHD position the mean was 96%. This 19% absolute difference was statistically significant (p = 0.001).

CONCLUSIONS: In healthy seated male subjects with recent exertion, up to five minutes in a HFHD position results in a small decrease in MVV compared with baseline MVV levels. Even with this decrease, mean MVV levels were still 96% of predicted after five minutes. Though a measurable decrease was found, there was no clinically significant change that would support that this positioning would lead to asphyxia over a five-minute time period.

PMID:34265730 | DOI:10.1016/j.ajem.2021.06.068

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Deformable image registration to assist clinical decision for radiotherapy treatment adaptation for head and neck cancer patients

Biomed Phys Eng Express. 2021 Jul 15. doi: 10.1088/2057-1976/ac14d1. Online ahead of print.

ABSTRACT

Head and neck (H&N) cancer patients often present anatomical and geometrical changes in tumors and organs at risk (OARs) during radiotherapy treatment. These changes may result in the need to adapt the existing treatment planning, using an expert’s subjective opinion, for offline adaptive radiotherapy and a new treatment planning before each treatment, for online adaptive radiotherapy. In the present study, a fast methodology is proposed to assist in planning adaptation clinical decision using tumor and parotid glands percentage volume changes during treatment. The proposed approach was applied to 40 Η&Ν cases, with one planning Computed Tomography (pCT) image and CBCT scans for 6 weeks of treatment per case. Deformable registration was used for each patient’s pCT image alignment to its weekly CBCT. The calculated transformations were used to align each patient’s anatomical structures to the weekly anatomy. Clinical target volume (CTV) and parotid gland volume percentage changes were calculated in each case. The accuracy of the achieved image alignment was validated qualitatively and quantitatively. Furthermore, statistical analysis was performed to test if there is a statistically significant correlation between CTV and parotid glands volume percentage changes. Average MDA for CTV and parotid glands between corresponding structures defined by an expert in CBCTs and automatically calculated through registration was 1.4±0.1 mm and 1.5±0.1 mm, respectively. The mean registration time of the first CBCT image registration for 40 cases was lower than 3.4 min. Five patients show more than 20% tumor volume change. Six patients show more than 30% parotid glands volume change. Ten out of 40 patients proposed for planning adaptation. All the statistical tests performed showed no correlation between CTV/parotid glands percentage volume changes. The aim to assist in clinical decision making on a fast and automatic way was achieved using the proposed methodology, thereby reducing workload in clinical practice.

PMID:34265756 | DOI:10.1088/2057-1976/ac14d1