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Nevin Manimala Statistics

Empirical evidence of study design biases in nutrition randomised controlled trials: a meta-epidemiological study

BMC Med. 2022 Oct 11;20(1):330. doi: 10.1186/s12916-022-02540-9.

ABSTRACT

BACKGROUND: Instruments to critically appraise randomised controlled trials (RCTs) are based on evidence from meta-epidemiological studies. We aim to conduct a meta-epidemiological study on the average bias associated with reported methodological trial characteristics such as random sequence generation, allocation concealment, blinding, incomplete outcome data, selective reporting, and compliance of RCTs in nutrition research.

METHODS: We searched the Cochrane Database of Systematic Reviews, for systematic reviews of RCTs, published between 01 January 2010 and 31 December 2019. We combined the estimates of the average bias (e.g. ratio of risk ratios [RRR] or differences in standardised mean differences) in meta-analyses using the random-effects model. Subgroup analyses were conducted to investigate the potential differences among the RCTs with low versus high/unclear risk of bias with respect to the different types of interventions (e.g. micronutrients, fatty acids, dietary approach), outcomes (e.g. mortality, pregnancy outcomes), and type of outcome (objective, subjective). Heterogeneity was assessed through I2 and τ2, and prediction intervals were calculated.

RESULTS: We included 27 Cochrane nutrition reviews with 77 meta-analyses (n = 927 RCTs). The available evidence suggests that intervention effect estimates may not be exaggerated in RCTs with high/unclear risk of bias (versus low) judgement for sequence generation (RRR 0.97, 95% CI 0.93 to 1.02; I2 = 28%; τ2 = 0.002), allocation concealment (RRR 1.00, 95% CI 0.96 to 1.04; I2 = 27%; τ2 = 0.001), blinding of participants and personnel (RRR 0.95, 95% CI 0.91 to 1.00; I2 = 23%; τ2 = 0), selective reporting (RRR 0.97, 95% CI 0.92 to 1.02; I2 = 24%; τ2 = 0), and compliance (RRR 0.95, 95% CI 0.89 to 1.02; I2 = 0%; τ2 = 0). Intervention effect estimates seemed to be exaggerated in RCTs with a high/unclear risk of bias judgement for blinding of outcome assessment (RRR 0.81, 95% CI 0.70 to 0.94; I2 = 26%; τ2 = 0.03), which was predominately driven by subjective outcomes, and incomplete outcome data (RRR 0.92, 95% CI 0.88 to 0.97; I2 = 22%; τ2 = 0.001). For continuous outcomes, no differences were observed, except for selective reporting.

CONCLUSIONS: On average, most characteristics of nutrition RCTs may not exaggerate intervention effect estimates, but the average bias appears to be greatest in trials of subjective outcomes. Replication of this study is suggested in this field to keep this conclusion updated.

PMID:36217133 | DOI:10.1186/s12916-022-02540-9

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Effects of pendulum appliance versus clear aligners in the vertical dimension during Class II malocclusion treatment: a randomized prospective clinical trial

BMC Oral Health. 2022 Oct 10;22(1):441. doi: 10.1186/s12903-022-02483-w.

ABSTRACT

BACKGROUND: The aim of the present study was to compare the effects on vertical dentoskeletal dimension produced by Pendulum appliance and Clear Aligners in patients with Class II malocclusion.

TRIAL DESIGN: This is a prospective two-arm parallel group randomized clinical trial with 1:1 allocation ratio.

METHODS: The Pendulum Group (PG) consisted of 20 patients (15F, 5 M) with a mean age of 17.2 ± 4.3 years. The Clear Aligners Group (CAG) comprised 20 patients (13F, 7 M) with a mean age of 17.2 ± 3.2 years. Distalization’s protocol in PG involved the activation of TMA wires till the achievement of Class I molar relationship. A protocol of sequential distalization was applied in the CAG. For each subject lateral cephalograms have been analyzed before treatment (T1) and at the end of the therapy (T2). Descriptive statistics and statistical between-group comparisons (PG vs CAG) were calculated for the craniofacial starting forms at T1 and for the T2-T1 changes. Statistical between-group comparisons for the T2-T1 changes were performed with independent samples t-tests (P < 0.05).

RESULTS: The PG showed significantly greater increases in SN^GoGn° when compared with CAG (+ 2.1 and – 0.3 degrees, respectively). Clockwise rotation of the occlusal plane with significantly greater increase of SN^POccl angle was observed in PG (+ 2.8 degrees) when compared with CAG (- 4.2 degrees). The PG revealed a significant increase in the N-Me variable with a mean change of + 4.4 mm compared to the CAG with mean values of – 1.2 mm. The PG showed an increase in the ArGo^GoMe angle (+ 0.7° degrees) compared to the CAG (- 3.4° degrees). The PG showed significantly greater increases in both maxillary and mandibular first molar to palatal plane (+ 1.3 and + 2.1 mm, respectively) when compared with CAG (- 0.9 and – 0.2 mm, respectively).

CONCLUSIONS: Upper molar distalization with clear aligners represents a valid alternative to non-extraction treatment of Class II malocclusion, reducing the extrusion of maxillary first molars and improving the management of the occlusal plane and vertical dimension.

TRIAL REGISTRATION: ClinicalTrials.gov, NCT05298280. Registered 28 March 2022-Retrospectively registered, https://clinicaltrials.gov .

PMID:36217134 | DOI:10.1186/s12903-022-02483-w

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Nevin Manimala Statistics

Oximetry Indices in the Management of Sleep Apnea: From Overnight Minimum Saturation to the Novel Hypoxemia Measures

Adv Exp Med Biol. 2022;1384:219-239. doi: 10.1007/978-3-031-06413-5_13.

ABSTRACT

Obstructive sleep apnea (OSA) is a multidimensional disease often underdiagnosed due to the complexity and unavailability of its standard diagnostic method: the polysomnography. Among the alternative abbreviated tests searching for a compromise between simplicity and accurateness, oximetry is probably the most popular. The blood oxygen saturation (SpO2) signal is characterized by a near-constant profile in healthy subjects breathing normally, while marked drops (desaturations) are linked to respiratory events. Parameterization of the desaturations has led to a great number of indices of severity assessment commonly used to assist in OSA diagnosis. In this chapter, the main methodologies used to characterize the overnight oximetry profile are reviewed, from visual inspection and simple statistics to complex measures involving signal processing and pattern recognition techniques. We focus on the individual performance of each approach, but also on the complementarity among the great amount of indices existing in the state of the art, looking for the most relevant oximetric feature subset. Finally, a quick overview of SpO2-based deep learning applications for OSA management is carried out, where the raw oximetry signal is analyzed without previous parameterization. Our research allows us to conclude that all the methodologies (conventional, time, frequency, nonlinear, and hypoxemia-based) demonstrate high ability to provide relevant oximetric indices, but only a reduced set provide non-redundant complementary information leading to a significant performance increase. Finally, although oximetry is a robust tool, greater standardization and prospective validation of the measures derived from complex signal processing techniques are still needed to homogenize interpretation and increase generalizability.

PMID:36217087 | DOI:10.1007/978-3-031-06413-5_13

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Nevin Manimala Statistics

The effect of stress hyperglycemıa seen ın acute ST-segment elevatıon ın myocardıal ınfarctıon on ın-hospıtal mortalıty

Ir J Med Sci. 2022 Oct 10. doi: 10.1007/s11845-022-03182-9. Online ahead of print.

ABSTRACT

INTRODUCTION: The brief rise in blood glucose level during acute physiological stress in patients with no previous symptoms of diabetes mellitus is called stress hyperglycemia.

METHODS: This study is conducted with 1033 patients over the age of 18 who are diagnosed with STEMI and who did not meet the exclusion criteria for 1 year. Patients were divided into 2 groups as DM and non-DM and their blood glucose levels, demographic data (age, sex, cardiovascular risk factors, DM, HT presence/absence, history of smoking), vital signs, fatal arrhythmia requiring intervention (ventricular tachycardia and ventricular fibrillation), cardiac insufficiency development according to Killip score, length of hospital stay, mortality and cardiogenic shock conditions were evaluated. Statistical analysis was made using SPSS 23.0 for Windows® (IBM Inc. Chicago, IL, USA). Results were considered significant at p < 0.05, with a 95% confidence interval.

RESULTS: In non-DM group, BG has been found to be significantly higher in mortal cases compared to surviving cases (289.25 ± 106.35 mg/dL for mortal cases; whereas 156.99 ± 58.60 mg/dL for surviving cases; p < 0.001). Likewise, in DM group BG has been found to be higher in mortal cases compared to surviving cases. (328.38 ± 77.13 mg/dL for mortal cases while 237.16 ± 95.00 mg/dL for surviving cases; p < 0.001).

CONCLUSIONS: For patients who are admitted to the hospital with STEMI, stress hyperglycemia in the non-DM group and hyperglycemia in the DM group are associated with both mortality and adverse conditions; thereby, glucose levels of those patients must be evaluated.

PMID:36217074 | DOI:10.1007/s11845-022-03182-9

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Colorectal cancer screening utilization among breast, cervical, prostate, skin, and lung cancer survivors

J Cancer Surviv. 2022 Oct 10. doi: 10.1007/s11764-022-01258-0. Online ahead of print.

ABSTRACT

PURPOSE: To examine whether sociodemographic characteristics, access to care, risk behavior factors, and chronic health conditions were associated with colorectal cancer (CRC) screening utilization among breast, cervical, prostate, skin, and lung cancer survivors.

METHODS: We analyzed the 2020 Behavioral Risk Factor Surveillance System (BRFSS) data on 9780 eligible cancer survivors. Descriptive statistics and multivariable logistic regression models were applied to assess the association between guideline-concordant CRC screening and the mentioned characteristics.

RESULTS: Overall, 81.9%, 65%, 88%,78.1%, and 80.1% of breast, cervical, prostate, skin, and lung cancer survivors received CRC screening, respectively (p-value < 0.001). In multivariable analysis, breast, cervical, and skin cancer survivors aged 60 years or older were associated with higher odds of receiving CRC screening. Respondents that had their recency of routine checkup two or more years before had lower odds of having CRC screening among cervical (OR = 0.06; 95% CI, 0.02-0.22), prostate (OR = 0.26; 95% CI, 0.14-0.49), and skin cancer (OR = 0.50; 95% CI, 0.36-0.70) survivors. The presence of chronic diseases was also associated with guideline-concordant CRC screening among breast, prostate, and skin cancer survivors.

CONCLUSIONS: Our findings provide important evidence on potential factors that are associated with guideline-concordant CRC screening utilization across different cancer survivors, which include older age, recency of routine checkup, and multiple chronic diseases. Moreover, variation in CRC screening utilization across cancer survivors may highlight missed opportunities for secondary cancer prevention.

IMPLICATIONS FOR CANCER SURVIVORS: Establishing clear CRC screening guidelines and including patient-provider communication on recommendation in cancer survivorship care may increase adherence to CRC screening.

PMID:36217067 | DOI:10.1007/s11764-022-01258-0

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Nevin Manimala Statistics

Development and Implementation of a Curriculum for Pediatric Trainees on Caring for Children Who Are Deaf and Hard of Hearing: A Pilot Study

Matern Child Health J. 2022 Oct 10. doi: 10.1007/s10995-022-03514-2. Online ahead of print.

ABSTRACT

INTRODUCTION: Children who are deaf or hard of hearing (DHH) are at risk for poor developmental outcomes related to incomplete language access. Evidence based interventions are available to improve early access to language. With a better understanding of caring for DHH children, pediatricians will be more prepared to work with families in improving outcomes for this population. To date, there are no formal curricula on educating pediatric trainees on childhood hearing differences.

METHODS: The authors designed a novel pilot curriculum to educate pediatric trainees on caring for DHH children, including screening, diagnosis, signed languages, and hearing technologies. The curriculum was delivered to pediatric interns in a 1-hour seminar. Pre-lecture, immediate post-lecture, and 6-month post-lecture surveys were developed and conducted to evaluate the effectiveness of the curriculum. Descriptive statistics were used to determine differences in understanding concepts before and after the curricular intervention.

RESULTS: A total of 55 residents participated in the curriculum over a 14-month study period from 2018 to 2019. There were significant differences in responses between the pre- and post- surveys related to residents’ understanding of childhood deafness and their confidence in their ability to care for DHH children.

CONCLUSION: Pediatric trainees gained an understanding of the challenges faced by DHH children and of the interventions that aim to provide them with access to language during the critical period of development. As a result, trainees will be in a better position to care for patients and their families after a new diagnosis of a hearing difference and guide them through early language-based interventions.

PMID:36217055 | DOI:10.1007/s10995-022-03514-2

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The Malaysian Muslim Community’s Understanding of So-Called Prophetic Health and Cosmetic Products

J Relig Health. 2022 Oct 10. doi: 10.1007/s10943-022-01677-4. Online ahead of print.

ABSTRACT

The present work aimed to identify and describe the Malaysian Muslim community’s understanding of health and cosmetic products related to the sunnah of Prophet Muhammad which are available in the Malaysian market. The demographics of this understanding are examined with respect to gender, age, marital and working status, highest level of education, and monthly income earned. A survey was conducted in 2017. A structured questionnaire pertaining to such products was used to capture the relevant data. This survey implemented a multistage design stratified by state, proportionate to the size of the state population, and was representative of the Malaysian population. Data analysis of the results was carried out using frequency and Chi-square analysis with the help of Statistical Packages for Social Science (SPSS) version 22.0. The paper concluded that the community’s understanding of the term ‘prophetic products’ is that it refers to various products that Prophet Muhammad used and/or spoke of approvingly such as dates, raisins, pomegranates, honey, and others. It was observed that these ingredients were strongly identified in public perception as prophetic health and cosmetic products and that there is consequently great demand for these among Malaysians. This factor was identified through various elements. First, the combination of things recognized as prophetic items such as dates, raisins, pomegranates, honey, and others within the product. Second, the labeling of merchandise as prophetic products. Prophetic health merchandise was more popular among Malaysians than were cosmetic products.

PMID:36217041 | DOI:10.1007/s10943-022-01677-4

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Effect of osteopathic techniques on human resting muscle tone in healthy subjects using myotonometry: a factorial randomized trial

Sci Rep. 2022 Oct 10;12(1):16953. doi: 10.1038/s41598-022-20452-9.

ABSTRACT

Musculoskeletal disorders (MSDs) are highly prevalent, burdensome, and putatively associated with an altered human resting muscle tone (HRMT). Osteopathic manipulative treatment (OMT) is commonly and effectively applied to treat MSDs and reputedly influences the HRMT. Arguably, OMT may modulate alterations in HRMT underlying MSDs. However, there is sparse evidence even for the effect of OMT on HRMT in healthy subjects. A 3 × 3 factorial randomised trial was performed to investigate the effect of myofascial release (MRT), muscle energy (MET), and soft tissue techniques (STT) on the HRMT of the corrugator supercilii (CS), superficial masseter (SM), and upper trapezius muscles (UT) in healthy subjects in Hamburg, Germany. Participants were randomised into three groups (1:1:1 allocation ratio) receiving treatment, according to different muscle-technique pairings, over the course of three sessions with one-week washout periods. We assessed the effect of osteopathic techniques on muscle tone (F), biomechanical (S, D), and viscoelastic properties (R, C) from baseline to follow-up (primary objective) and tested if specific muscle-technique pairs modulate the effect pre- to post-intervention (secondary objective) using the MyotonPRO (at rest). Ancillary, we investigate if these putative effects may differ between the sexes. Data were analysed using descriptive (mean, standard deviation, and quantiles) and inductive statistics (Bayesian ANOVA). 59 healthy participants were randomised into three groups and two subjects dropped out from one group (n = 20; n = 20; n = 19-2). The CS produced frequent measurement errors and was excluded from analysis. OMT significantly changed F (-0.163 [0.060]; p = 0.008), S (-3.060 [1.563]; p = 0.048), R (0.594 [0.141]; p < 0.001), and C (0.038 [0.017]; p = 0.028) but not D (0.011 [0.017]; p = 0.527). The effect was not significantly modulated by muscle-technique pairings (p > 0.05). Subgroup analysis revealed a significant sex-specific difference for F from baseline to follow-up. No adverse events were reported. OMT modified the HRMT in healthy subjects which may inform future research on MSDs. In detail, MRT, MET, and STT reduced the muscle tone (F), decreased biomechanical (S not D), and increased viscoelastic properties (R and C) of the SM and UT (CS was not measurable). However, the effect on HRMT was not modulated by muscle-technique interaction and showed sex-specific differences only for F.Trial registration German Clinical Trial Register (DRKS00020393).

PMID:36217012 | DOI:10.1038/s41598-022-20452-9

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Flexible neural control of motor units

Nat Neurosci. 2022 Oct 10. doi: 10.1038/s41593-022-01165-8. Online ahead of print.

ABSTRACT

Voluntary movement requires communication from cortex to the spinal cord, where a dedicated pool of motor units (MUs) activates each muscle. The canonical description of MU function rests upon two foundational tenets. First, cortex cannot control MUs independently but supplies each pool with a common drive. Second, MUs are recruited in a rigid fashion that largely accords with Henneman’s size principle. Although this paradigm has considerable empirical support, a direct test requires simultaneous observations of many MUs across diverse force profiles. In this study, we developed an isometric task that allowed stable MU recordings, in a rhesus macaque, even during rapidly changing forces. Patterns of MU activity were surprisingly behavior-dependent and could be accurately described only by assuming multiple drives. Consistent with flexible descending control, microstimulation of neighboring cortical sites recruited different MUs. Furthermore, the cortical population response displayed sufficient degrees of freedom to potentially exert fine-grained control. Thus, MU activity is flexibly controlled to meet task demands, and cortex may contribute to this ability.

PMID:36216998 | DOI:10.1038/s41593-022-01165-8

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Donor lymphocyte infusions after haploidentical stem cell transplantation with PTCY: A study on behalf of the EBMT cellular therapy & immunobiology working party

Bone Marrow Transplant. 2022 Oct 10. doi: 10.1038/s41409-022-01839-8. Online ahead of print.

ABSTRACT

Donor lymphocyte infusion (DLI) is a treatment option to prevent or treat relapse after allogeneic hematopoietic cell transplantation (HCT). We here report data for 173 patients who received one or multiple DLIs after haploidentical-HCT with post-transplant cyclophosphamide (PTCY) at 47 EBMT centers from 2009 to 2018. Indication for DLI was: prophylactic for 59(34.3%), preemptive for 20(11.6%), and therapeutic for 93(54.1%). For the prophylactic group, the median number of DLIs was 1 (IQR:1-2.5) with a median first dose of 0.1 × 106 CD3+ T cell/kg, for the preemptive 2 (IQR:1-3) with 0.5 × 106 CD3+ T cell/kg, for the therapeutic 1 (IQR:1-3) with 1 × 106CD3+ Tcell/kg, respectively. OS after first DLI was 61% (46-75%) for prophylactic, 40% (19-61%) for preemptive, and 22% (13-31%) for therapeutic. CI of II-IV aGVHD and cGVHD was 17%(7-27%) and 53% (40-67%) for the prophylactic, 20% (2-38%) and 21% (3-39%) for the preemptive, 17% (9-24%) and 24% (15-33%) for the therapeutic group, respectively. Our data show great variability in the indications and modalities of DLI across responding EBMT centers. Survival rates remain relatively low in patients with active disease. While the cumulative incidence of aGVHD appears acceptable, we showed a high incidence proportion of cGVHD in the prophylactic group, compared with preemptive and therapeutic DLI. These data should be investigated further in prospective clinical trials.

PMID:36216975 | DOI:10.1038/s41409-022-01839-8