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Nevin Manimala Statistics

French validation of the e-PROSCeSS questionnaire: stakeholder perceptions of the health promoting sports club

Health Promot Int. 2022 Jan 21:daab213. doi: 10.1093/heapro/daab213. Online ahead of print.

ABSTRACT

The health promoting sports club describes the development of the settings-based approach in sports clubs. Based on this model, a questionnaire was developed to measure health promotion perceptions in sports clubs (e-PROSCeSS). The objective of this study was to assess the psychometric properties of a French version of the e-PROSCeSS measurement tool. The questionnaire includes three scales measuring stakeholder’s perceptions of club (macro), managers (meso) and coaches (micro) activities toward promoting health. Five steps were undertaken to assess perceptions. First, scales were translated into French. Second, each item’s content clarity was tested in three populations: managers, coaches, sports participants. Third, descriptive statistics were analyzed for each scale. Fourth, confirmatory factorial analysis was used to select items for each level. Predictive validity found positive relationships between health promotion perceptions and managing/coaching positions, and negative relationships with drop-out intentions. Positive relationships were found between sports participants’ perceptions of health promotion and their self-rated performance and quality of life, while negative relationships were detected with drop-out intentions. The French e-PROSCeSS subscales showed good psychometric properties in measuring health determinants at multiple levels. However, the tool did not measure health promotion as an overarching concept that questions its applicability in the sports club setting.

PMID:35060597 | DOI:10.1093/heapro/daab213

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The effect of lung-conduction exercise in chronic obstructive pulmonary disease: Randomized, assessor-blind, multicenter pilot trial

Medicine (Baltimore). 2022 Jan 21;101(3):e28629. doi: 10.1097/MD.0000000000028629.

ABSTRACT

BACKGROUND: Pulmonary rehabilitation (PR) is a management modality that improves the quality of life of patients with chronic obstructive pulmonary disease (COPD); however, PR is not readily accessible. Therefore, we developed lung-conduction exercises (LCE) that can be performed easily without any limitations. The purpose of this randomized, assessor-blind, multicenter pilot trial was to compare the effects of LCE with PR and standard care (SC) in COPD patients.

METHODS: Twenty-five participants who met the eligibility criteria were randomly allocated to the SC group (only medication, n = 9), LCE group (medication + LCE, 5 times a week, n = 8), or PR group (medication + PR, 5 times a week, n = 8). The 6-minute walk distance (6WMD), pulmonary function test, modified Medical Research Council dyspnea scale, COPD assessment test (CAT), and St. George Respiratory Questionnaire (SGRQ) survey were carried out before starting the trial and after 4 and 8 weeks to determine motor performance, lung function, and dyspnea.

RESULTS: After 8 weeks, the pulmonary function test scores were the same. The 6MWD (PR, 28.3 ± 38.5; LCE, 14.5 ± 53.1; SC, 11.5 ± 20.5; P = .984), modified Medical Research Council dyspnea scale (PR, 0.8 ± 1.0; LCE, 0.8 ± 0.8; SC, 0.3 ± 0.5; P = .772), CAT (PR, 7.3 ± 6.2; LCE, 4.2 ± 5.2; SC, 1.0 ± 2.2; P = .232), and SGRQ scores (PR, 11.5 ± 15.4; LCE, 5.5 ± 13.1; SC, 4.8 ± 5.1; P = .358 [PR vs LCE], P = .795 [PR vs SC]) had improved in order of PR, LCE, and SC group. Although there were no statistically significant differences in the outcome measures between the groups, there were clinically significant improvements in the CAT and SGRQ scores.

CONCLUSIONS: In this trial, PR showed more improvement in symptoms and quality of life than SC alone. To seek a more precise use of LCE, further full-sized studies with a long duration and additional outcome measures such as psychological assessment tools and cost-effectiveness ratio should be conducted.

TRIAL REGISTRATION: KCT0004724.

PMID:35060543 | DOI:10.1097/MD.0000000000028629

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Clinical impact of pulmonary hypertension on the outcomes of acute myocardial infarction patients with or without chronic obstructive pulmonary disease

Medicine (Baltimore). 2022 Jan 21;101(3):e28627. doi: 10.1097/MD.0000000000028627.

ABSTRACT

Acute myocardial infarction (AMI) and chronic obstructive pulmonary disease (COPD) are leading global causes of morbidity and mortality. In patients with both of these conditions, the presence of pulmonary hypertension (PH) can further worsen their prognosis. We examined the outcomes of AMI patients with COPD (AMI+COPD) and without COPD (AMI-COPD), depending on the presence or absence of PH.A total of 318 AMI patients with COPD (AMI+COPD cohort) (n = 109) or without COPD (AMI-COPD cohort) (n = 209) were included in this study and were subdivided into 2 groups according to right ventricular systolic pressure (RVSP) level (PH group [RVSP ≥35 mm Hg] and no PH group [RVSP <35 mm Hg]).We investigated characteristics and clinical outcomes in both the AMI-COPD and AMI+COPD cohorts. When investigating in-hospital clinical outcomes, the PH group had a higher proportion of new-onset heart failure (HF) in both cohorts. In the AMI+COPD cohort, however, the PH group had a higher incidence of cardiogenic shock than the no PH group, which was consistent with the result of the post-inverse probability of treatment weighting (IPTW) analysis. When investigating 1-year clinical outcomes, the PH group had higher incidences of a major adverse cardiac event and all-cause mortality in both cohorts. This finding was mainly driven by cardiac death in the AMI-COPD cohort, whereas it was mainly driven by non-cardiac death in the AMI+COPD cohort. After IPTW adjustment, these differences were statistically attenuated such that all variables were similar between both groups.PH may be associated with the development of new-onset HF (in all patients) and cardiogenic shock (in the AMI+COPD cohort). In addition, PH may be also associated with all-cause mortality, although it was statistically attenuated after IPTW adjustment.

PMID:35060541 | DOI:10.1097/MD.0000000000028627

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The efficacy of parenteral nutrition (PN) and enteral nutrition (EN) supports in cirrhosis: A systematic review and network meta-analysis

Medicine (Baltimore). 2022 Jan 21;101(3):e28618. doi: 10.1097/MD.0000000000028618.

ABSTRACT

IMPORTANCE: Multiple nutritional therapies are currently available for patients with liver cirrhosis, yet many interventions have not been compared head-to-head within randomized clinical trials.

OBJECTIVE: To evaluate the improvement of nutritional indicators and liver function indexes of liver cirrhosis treated with different nutrition intervention.

DATA SOURCE: We searched PubMed, Embase. com and Cochrane Library database from construction to April 3, 2020. After eliminating the duplicated or overlapping reports, 6 studies were included. We performed a Bayesian network meta-analysis by Stata 12.0 and GeMTC 0.14.3 in order to compare different nutritional interventions with consistency model.

STUDY SELECTION: Randomized clinical trials comparing 2 or more therapies in patients with cirrhosis were evaluated. Six randomized clinical trials met the selection criteria.

DATA EXTRACTION AND SYNTHESIS: Two investigators independently reviewed the full manuscripts of eligible studies and extracted information into an electronic database: patients’ characteristics study design, interventions, the number of events of interest in each group.

MAIN OUTCOMES AND MEASURES: Body mass index, Child-Pugh score, model for end-stage liver disease score, total bilirubin, alanine transaminase, aspartate transaminase, total protein, Triceps skinfold, Midarm Muscle Circumference, Fischer ratio, overall survival.

RESULTS: There are 6 studies enrolling a total of 1148 patients who received different nutrition supports including parenteral nutrition (PN), enteral nutrition (EN), EN (without branched-chain amino acids), EN + intestinal probiotics, PN + EN, late evening snacks (LES), EN + LES, noLES. The direct comparisons showed that the effect of EN was better than EN (without branched-chain amino acids); EN + intestinal probiotics was better than EN and PN; PN + EN was better than them alone; EN + LES was better than LES and EN; LES was better than noLES. Although the difference of indirect comparisons between the included regimens was not statistically significant, the results showed that EN + intestinal probiotics appeared to be superior to PN + EN. While LES and EN + LES seemed to rank behind them and the difference between them was extremely small.

CONCLUSION AND RELEVANCE: Available evidence suggests that EN + intestinal probiotics appear to be the most effective strategy for patients with cirrhosis compared with other interventions.

PMID:35060537 | DOI:10.1097/MD.0000000000028618

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Hydromorphone vs sufentanil in patient-controlled analgesia for postoperative pain management: A meta-analysis

Medicine (Baltimore). 2022 Jan 21;101(3):e28615. doi: 10.1097/MD.0000000000028615.

ABSTRACT

BACKGROUND: Patient-controlled analgesia (PCA) is an effective method of postoperative pain, there have been many studies performed that have compared the efficacy of hydromorphone with continuous sufentanil. The purpose of this systematic review is to compare the efficacy and safety of hydromorphone and sufentanil.

METHODS: Seven databases were searched for controlled trials to compare the efficacy and safety of hydromorphone and sufentanil. After selecting the studies, extracting the data, and assessing study quality, the meta-analysis was performed on several of the studies with RevMan 5.3.

RESULTS: Thirteen studies comprised of 812 patients were found. The pain intensity of the hydromorphone group was significantly lower than that of the sufentanil group at 12 hours. With no statistical difference at 24 to 48 hours (MD12 = -1.52, 95% CI [-2.13, -1.97], P <.05). The sedation intensity of the hydromorphone group at 12, 24, and 48 hours were lower than those of the sufentanil group, with no statistical difference (MD12 = -0.03, 95% CI [-0.18, 0.12], P > .05; MD24 = -0.20, 95% CI [-0.42, 0.03], P > .05; MD48 = -0.03, 95% CI [-0.18, 0.11)], P > .05). The PCA requests in the hydromorphone group were less than that in the sufentanil group, and there was no significant difference (RR = -0.20, 95% CI [-1.93,1.53], P > .05). The incidence of adverse events in the hydromorphone group was less than that in the sufentanil group, and there was a statistical difference: (RR = 0.61, 95% CI [0.47,0.79], P < .05).

CONCLUSION: Compared with sufentanil, PCA with hydromorphone was more effective in relieving pain and PCA requests 12, 24, and 48 hours after operation, and significantly reduced the incidence of adverse events, but it did not have an advantage in sedation intensity.

PMID:35060534 | DOI:10.1097/MD.0000000000028615

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Moxibustion for abdominal pain in COVID-19: A protocol for systematic review and meta-analysis

Medicine (Baltimore). 2022 Jan 21;101(3):e28596. doi: 10.1097/MD.0000000000028596.

ABSTRACT

BACKGROUND: Coronavirus disease 2019 (COVID-19) is an acute respiratory infectious disease that makes breathing difficult and is often accompanied by abdominal pain and distension. Moxibustion, a special external treatment of traditional Chinese medicine, has shown beneficial effects in the treatment of abdominal pain. Currently, there is a lack of systematic reviews on moxibustion for the treatment of abdominal pain. We conduct this study to evaluate the efficacy and safety of moxibustion in the treatment of abdominal pain. This study is designed to evaluate the effectiveness and safety of moxibustion for abdominal pain in COVID-19.

METHODS: Randomized controlled trials from December 2019 to December 2021 will be included, without restrictions on language or publication date. PubMed, EMBASE, Cochrane Library, Web of Science, Chinese Biomedical Databases, China National Knowledge Infrastructure, Wanfang Database, and VIP Database were searched. Two researchers will independently select studies, extract data, and evaluate study quality. The Cochrane risk of bias tool for randomized trials will be used to assess the risk of bias in the included studies. Statistical analyses will be conducted using the RevMan 5.3 software.

RESULTS: This study aimed to prove the efficacy and safety of moxibustion for abdominal pain in patients with COVID-19. Our study provides a more accurate treatment method for abdominal pain during COVID-19. We will publish our results in a peer-reviewed journal.

CONCLUSION: This study will provide more convincing evidence for clinicians to treat these conditions and help them make appropriate decisions.

ETHICS AND DISSEMINATION: This study did not include personal information. Ethical approval was not required for this study.

INPLASY REGISTRATION NUMBER: INPLASY2021120104.

PMID:35060526 | DOI:10.1097/MD.0000000000028596

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The effects on pain and quality of life of traditional Chinese manual therapy for knee osteoarthritis: A protocol for systematic review and meta-analysis

Medicine (Baltimore). 2022 Jan 21;101(3):e28595. doi: 10.1097/MD.0000000000028595.

ABSTRACT

BACKGROUND: Knee osteoarthritis (KOA) is a common disease with the high occurrence in the world. The symptoms of pain and dysfunction decrease quality of life in KOA patients. Several studies reported traditional Chinese manual therapy showed beneficial effects in improving pain and dysfunction of patient with KOA, but most previous reviews did not focus on the effects on quality life of traditional Chinese manual therapy for KOA. However, better quality of life is important for patients suffering KOA. Therefore, the current review and meta-analysis will be conducted to assess the effects on clinical symptoms and quality of life of traditional Chinese manual therapy for KOA.

METHODS: Eight electronic databases including PubMed, Embase, the Cochrane Library, Web of Science, Cochrane Central Register of Controlled Trials, China National Knowledge Infrastructure, Wanfang Data, and Chinese Scientific Journal Database will be searched from the beginning to December 2021. Two reviewers will independently select included studies and extract data. Heterogeneity will be evaluated by I2 statistic before the data synthesis. Subgroup analysis will be performed by duration of KOA, different types of traditional Chinese manual therapy, different outcomes, and different intervention time. The primary outcome is quality of life in KOA patients, and the secondary outcomes include pain and dysfunction due to KOA. Rev Man 5.3 software will be used for meta-analysis.

RESULTS: The results of this review will be reported in a peer-reviewed journal.

CONCLUSION: The results of this review will provide reliable evidence for the effects on quality of life and clinical symptoms of traditional Chinese manual therapy for KOA.

INPLASY REGISTRATION NUMBER: INPLASY2021120043.

PMID:35060525 | DOI:10.1097/MD.0000000000028595

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Characteristics and survival outcomes of primary splenic cancers: A SEER population-based study

Medicine (Baltimore). 2022 Jan 21;101(3):e28539. doi: 10.1097/MD.0000000000028539.

ABSTRACT

Primary splenic cancers represent a small number of cancer cases and studies on its clinicopathological features and outcomes are limited. Splenic lymphomas and primary splenic angiosarcoma (PSA) are the 2 most common histological types of splenic cancers. This population-based study aimed to investigate the clinical characteristics and survival outcomes of patients with splenic lymphomas or PSA.Patients diagnosed with splenic lymphomas or PSA between 2000 and 2015 were identified from the Surveillance Epidemiology and End Results database of the National Cancer Institutes. Overall survival (OS) and cancer-specific survival (CSS) rates were calculated using the Kaplan-Meier method. A Cox proportional hazard models were used to identify independent predictors of cancer-specific mortality.A total of 700 patients with splenic lymphoma and 48 patients with PSA were included in this study. The median age of patients with splenic lymphoma was 65 years and 57 years for patients with PSA. For patients with splenic lymphoma, the most prevalent histological subtypes were splenic marginal zone lymphoma and diffuse large B-cell lymphoma. A total of 52.6% of the cases had stage IV disease based on the Ann Arbor staging system. Five-year OS and CSS were 76.9% and 83.4%, respectively. Multivariate analysis revealed that independent predictors of splenic lymphoma CSS included race, stage, chemotherapy, and histological subtype. However, a much shorter OS time was seen in the PSA cohort which had a 5-year OS of 11.8%, a median OS of 10.0 months and the 5-year CSS of 12.4%. Chemotherapy was correlated with better outcomes in patients with PSA. However, the survival benefits of surgery for splenic cancer were not statistically significant in our study.The current study is the largest cohort of primary splenic cancer presented in literature based on the Surveillance Epidemiology and End Results database and our large series describe the characteristics and survival outcomes of such rare diseases which may provide reliable information for further studies and clinicians.

PMID:35060511 | DOI:10.1097/MD.0000000000028539

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Effectiveness and safety assessment of orthopedic device (LSM-01) for low back pain: A randomized, single-blinded, sham-controlled, parallel-group, pilot clinical trial

Medicine (Baltimore). 2022 Jan 21;101(3):e28527. doi: 10.1097/MD.0000000000028527.

ABSTRACT

BACKGROUND: More than 80% of the population suffer from low back pain at some time during their lives. An orthopedic device (LSM-01) will be used to alleviate back pain caused by muscle tension. LSM-01, which has a rotating roller, stimulates meridian-muscles around the governor vessel, bladder meridian, and gall bladder meridian.

METHODS: This study will be a randomized, single-blinded, sham-controlled, parallel-group, pilot clinical trial. Subjects will be randomly allocated to the treatment group (LSM-01) or the control group (sham device). The duration of the clinical trial will be 2 weeks. The primary outcomes will be measured using the visual analog scale; the secondary outcomes will include pressure pain threshold, Oswestry Disability Index, and Patient Global Impression of Change. Statistical analysis will be performed for the full study population. Analysis of covariance will be conducted to identify differences in pain before and after the application of the device.

DISCUSSION: This clinical trial will evaluate the safety and efficacy of the LSM-01 device. As a pilot study, this investigation includes a limited number of subjects. The results of this pilot trial will form a basis for a large-scale clinical trial, which will be conducted in the future.

CLINICAL TRIAL REGISTRATION: This study protocol is registered with the Clinical Research Information Service (CRIS) of Korea. Clinical trial registration number: CRIS-KCT0006425. Registered: October 5, 2021; https://cris.nih.go.kr/cris/search/detailSearch.do?search_lang=E&search_page=L&pageSize=10&page=undefined&seq=20056&status=5&seq_group=20056.

PMID:35060507 | DOI:10.1097/MD.0000000000028527

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Clinical efficacy of arthroscopic treatment in ischial tuberosity cyst: A retrospective comparison study

Medicine (Baltimore). 2022 Jan 21;101(3):e28128. doi: 10.1097/MD.0000000000028128.

ABSTRACT

Ischial tuberosity cyst is a common disease, and the conventional incision procedure is associated with several disadvantages, leading to unsatisfactory therapeutic outcomes. The aim of the study was to evaluate the clinical outcomes of arthroscopic treatment for ischial tuberosity cyst and compared it with conventional incision surgery.The clinical data of 57 patients with ischial tuberosity cyst from May 2016 to September 2018 were retrospectively analyzed. According to the inclusion and exclusion criteria, a total of 49 patients were included. Of these patients, 24 patients received arthroscopic procedure (N = 24) and 25 patients received conventional incision procedure (N = 25). The operation time, intraoperative blood loss, postoperative drainage, postoperative hospital stay, and postoperative complications were compared between the 2 groups. Visual analogue scale scores was used to evaluate pain at 1 day, 1 week, and 1 month after the surgery.All 49 patients were followed up for (11.3 ± 3.3) months. All patients in the arthroscopy group achieved phase I healing while 3 patients in conventional incision group developed complications. The operation time, intraoperative blood loss, postoperative drainage, and hospital stay in the arthroscopy group were (54.7 ± 7.7) minutes, (20.8 ± 3.5) mL, (20.3 ± 5.6) mL, and (2.8 ± 0.6) days, and were significantly better than those of (71.8 ± 8.8) minutes, (67.3 ± 12.0) mL, (103.6 ± 20.3) mL, and (7.8 ± 2.9) days in the conventional incision group, respectively. In the arthroscopy group, the visual analogue scale scores at 1 day, 1 week, and 1 month after the surgery [(2.6 ± 0.7), (0.5 ± 0.6), (0.3 ± 0.5) points] were significantly lower than those in the conventional incision group [(6.0 ± 0.7), (3.0 ± 1.0), and (1.1 ± 1.0) points], and the differences were statistically significant (P < .05). Finally, no significant difference was observed in the incidence of postoperative complications between the 2 groups (P > .05).In the treatment of ischial tuberosity cysts, arthroscopy has advantages of minimal invasion, less blood loss during perioperative period, milder postoperative pain, and rapid recovery when compared with conventional incision surgery.

PMID:35060495 | DOI:10.1097/MD.0000000000028128