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Nevin Manimala Statistics

A neutral comparison of statistical methods for analyzing longitudinally measured ordinal outcomes in rare diseases

Biom J. 2023 Mar 8:e2200236. doi: 10.1002/bimj.202200236. Online ahead of print.

ABSTRACT

Ordinal data in a repeated measures design of a crossover study for rare diseases usually do not allow for the use of standard parametric methods, and hence, nonparametric methods should be considered instead. However, only limited simulation studies in settings with small sample sizes exist. Therefore, starting from an Epidermolysis Bullosa simplex trial with the above-mentioned design, a rank-based approach using the R package nparLD and different generalized pairwise comparisons (GPC) methods were compared impartially in a simulation study. The results revealed that there was not one single best method for this particular design, because a trade-off exists between achieving high power, accounting for period effects, and for missing data. Specifically, nparLD as well as the unmatched GPC approaches do not address crossover aspects, and the univariate GPC variants partly ignore the longitudinal information. The matched GPC approaches, on the other hand, take the crossover effect into account in the sense of incorporating the within-subject association. Overall, the prioritized unmatched GPC method achieved the highest power in the simulation scenarios, although this may be due to the specified prioritization. The rank-based approach yielded good power even at a sample size of N=6$N=6$ , whereas the matched GPC method could not control the type I error.

PMID:36890631 | DOI:10.1002/bimj.202200236

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Nevin Manimala Statistics

Pitfalls and potentials in simulation studies: Questionable research practices in comparative simulation studies allow for spurious claims of superiority of any method

Biom J. 2023 Mar 8:e2200091. doi: 10.1002/bimj.202200091. Online ahead of print.

ABSTRACT

Comparative simulation studies are workhorse tools for benchmarking statistical methods. As with other empirical studies, the success of simulation studies hinges on the quality of their design, execution, and reporting. If not conducted carefully and transparently, their conclusions may be misleading. In this paper, we discuss various questionable research practices, which may impact the validity of simulation studies, some of which cannot be detected or prevented by the current publication process in statistics journals. To illustrate our point, we invent a novel prediction method with no expected performance gain and benchmark it in a preregistered comparative simulation study. We show how easy it is to make the method appear superior over well-established competitor methods if questionable research practices are employed. Finally, we provide concrete suggestions for researchers, reviewers, and other academic stakeholders for improving the methodological quality of comparative simulation studies, such as preregistering simulation protocols, incentivizing neutral simulation studies, and code and data sharing.

PMID:36890629 | DOI:10.1002/bimj.202200091

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Nevin Manimala Statistics

Imagined Timed Up and Go test (iTUG) in people with Parkinson’s Disease: test-retest reliability and validity

Disabil Rehabil. 2023 Mar 8:1-11. doi: 10.1080/09638288.2023.2185688. Online ahead of print.

ABSTRACT

PURPOSE: To determine the test-retest reliability and validity of the Imagined Timed Up and Go Test (iTUG) as a Motor Imagery measure of temporal accuracy in people with Parkinson’s Disease (PD).

MATERIALS AND METHODS: A descriptive study was conducted following the GRRAS recommendations. Thirty-two people with idiopathic, mild to moderate PD (Hoehn and Yahr I-III), without cognitive impairment (MMSE ≥ 24), were assessed twice (7-15 days apart) with the iTUG. The absolute unadjusted difference in seconds, and the absolute adjusted difference as percentage of estimation error, between real and imagined TUG times, were calculated as outcome measures. Test-retest reliability was assessed using a two-way mixed-effects model of the ICC. Construct validity was tested with the Imagined Box and Blocks Test (iBBT) and convergent validity with clinical characteristics of PD, using the Spearman’s rank correlation coefficient.

RESULTS: The ICC for the unadjusted and adjusted measures of the iTUG was ICC = 0.61 and ICC = 0.55, respectively. Correlations between iTUG and iBBT were not statistically significant. The iTUG was partially correlated to clinical characteristics of PD.

CONCLUSIONS: Test-retest reliability of the iTUG was moderate. Construct validity between iTUG and iBBT was poor, so caution should be taken when using them concurrently to assess imagery’s temporal accuracy.

PMID:36890615 | DOI:10.1080/09638288.2023.2185688

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Nevin Manimala Statistics

Circadian aspects of mortality in hospitalized patients: A retrospective observation from a large cohort

Nurs Open. 2023 Mar 8. doi: 10.1002/nop2.1711. Online ahead of print.

ABSTRACT

AIM: This study aimed to describe the circadian characteristics of hospitalized mortality in order to provide nursing guidance for preventing in-hospital mortality.

DESIGN: A retrospective analysis on inpatient information was implemented.

METHODS: Harmonic Analysis of Time Series was applied to quantify the periodic structure of the frequency of the occurrence of death.

RESULTS: A total of 3300 cases were included in the present study (male, 63.4% and median age 73 years), including 1540 (46.7%) ICU patients. Incidence of overall hospitalized death exhibited a circadian pattern, presenting peaks from 07:00 to 12:00 and 15:00 to 20:00 P.M., with 21.5% and 13.1% increase above the average at those peak points, respectively. Similarly, the incidence of sudden cardiac death (SCD) showed peaks between 06:00-12:00 and 15:00-20:00, with a 34.7% and 28.0% increase above the average at peak time, respectively. The distribution of death incidence revealed no statistical difference between SCD and non-SCD (p = 0.525).

PMID:36890609 | DOI:10.1002/nop2.1711

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Nevin Manimala Statistics

Free sugar intake from snacks and beverages in Canadian preschool- and toddler-aged children: a cross-sectional study

BMC Nutr. 2023 Mar 8;9(1):44. doi: 10.1186/s40795-023-00702-3.

ABSTRACT

BACKGROUND: Excess consumption of free sugar (FS) increases the risk of dental caries and unhealthy weight gain. However, the contribution of snacks and beverages to young children’s FS intake is not well understood. The purpose of this study was to determine FS intake from snacks and beverages among preschool-aged Canadian children.

METHODS: This cross-sectional study examined baseline data from 267 children 1.5 to 5 y enrolled in the Guelph Family Health Study. Dietary assessment was completed over a 24-h period using ASA24-Canada-2016 to, 1) estimate the proportion of children whose FS intake from snacks and beverages consumed exceeded 5% total energy intake (TE) and 10% TE, and 2) identify the top snack and beverage sources of FS.

RESULTS: FS contributed 10.6 ± 6.9% TE (mean ± SD). 30 and 8% of children consumed ≥ 5% TE and ≥ 10% TE from snack FS, respectively. Furthermore, 17 and 7% of children consumed ≥ 5% TE and ≥ 10% TE from beverages FS, respectively. Snacks and beverages accounted for 49 ± 30.9% of FS energy. Top snack sources of FS (% children, children’s %TE from FS) were bakery products (55%, 2.4%), candy and sweet condiments (21%, 3.0%), and sugar-containing beverages (20%, 4.1%). Top sugar-containing beverage sources of FS (48%, 5.3%) were 100% fruit juice (22%, 4.6%) and flavored milk (11%, 3.1%).

CONCLUSIONS: Snacks and beverages contributed nearly half of FS intake among a sample of young children in Canada. Thus, long-term monitoring of snacking behavior and consumption of FS is warranted. These findings may help inform nutritional strategies and public policies to improve diet quality and FS intake in preschool-aged children.

TRIAL REGISTRATION: The Clinical Trial Registry number is NCT02939261 from clinicaltrials.gov. Date of Registration: October 20, 2016.

PMID:36890595 | DOI:10.1186/s40795-023-00702-3

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Nevin Manimala Statistics

Trends in and predictors of animal source food consumption among 6-23 months age children in Tigrai, Northern Ethiopia: evidence from three consecutive ethiopian demographic and health surveys, EDHS 2005-2016

BMC Nutr. 2023 Mar 8;9(1):43. doi: 10.1186/s40795-023-00699-9.

ABSTRACT

BACKGROUND: Despite numerous interventions, child undernutrition continues as a problem of global concern. Although consumption of animal source foods has shown positive associations with child undernutrition, no much evidence exists on its trends and predictors among children in Tigrai.

OBJECTIVES: This study aimed to investigate the trends in and predictors of consumption of animal source foods among children 6-23 months of age in Tigrai.

METHODOLOGY: This study used complex data of 756 children extracted from three consecutive Ethiopian Demographic and Health Surveys. Data were analyzed using STATA 14.0 by accounting for sampling weight and cluster and strata variables. Multivariable logistic regression was used to determine the independent predictors of animal source foods consumption. Odds ratio and 95% confidence interval were used to measure strength of association at a statistical significance of p < 0.05.

RESULTS: Although statistically not significant (p-trend = 0.28), animal source foods consumption increased from 31.3% to 2005 through 35.9% in 2011 to 41.5% in 2016. For every month increase in the age of a child, a 9% increment in the odds of animal source food consumption was observed. Muslim children showed 3.1 times higher odds of animal source food consumption than Orthodox Christians. The likelihood of animal source foods consumption were 33% lower among children born to mothers who didn’t attend formal education as compared to their counterparts. A unit increase in the number of household assets and number of livestock led to a 20% and 2% increase in the odds of animal source foods consumption, respectively.

CONCLUSION: Animal source foods consumption showed a statistically non-significant increase over the three consecutive Ethiopian Demographic and Health Surveys. This study found out that consumption of animal source foods might be increased through pro-maternal education policies, programs with household asset increasing schemes, and pro-livestock projects. Our study also highlighted the need for considering religion as one important player when planning or undertaking ASF programs.

PMID:36890578 | DOI:10.1186/s40795-023-00699-9

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Nevin Manimala Statistics

Analysis of the clinical characteristics and predisposing factors for neurological deficit with Hangman fractures

J Orthop Surg Res. 2023 Mar 9;18(1):179. doi: 10.1186/s13018-023-03650-7.

ABSTRACT

BACKGROUND: Hangman fracture is the second most common injury of the upper cervical spine, and neurological deficit with Hangman fracture is not rare. To our knowledge, few reports have statistically analyzed the predisposing factors for this injury. The objective of this study was to describe the clinical characteristics of neurological deficit associated with Hangman fracture and evaluate its risk factors.

METHODS: In this retrospective study, 97 patients with Hangman fractures were included. Data on the age, sex, injury etiology, neurological deficits, and associated injuries were obtained and evaluated. The pretreatment parameters, anterior translation and angulation of C2/3, presence of the posterior vertebral wall (PVW) fractures of C2, and presence of spinal cord signal changes were measured. Twenty-three patients with neurological deficits after Hangman fractures comprised group A, and 74 patients without neurological deficit comprised group B. Student’s t-test or a nonparametric test and the chi-square test were used to evaluate the differences between groups. Binary logistic regression analysis was used to identify the risk factors for neurological deficit.

RESULTS: Among the 23 patients in group A, 2 were American Spinal Injury Association (ASIA) scale B, 6 were C, and 15 were D, and spinal cord magnetic resonance imaging signal change was observed at the level of C2-C3 disc, C2, or both. Patients with the combination of PVW fractures and ≥ 50% significant translation or angulation of C2/3 were significantly more likely to have a neurological deficit. Both factors remained significant in binary logistic regression analysis.

CONCLUSIONS: Neurological deficit after Hangman fractures always presents clinically as a partial neurological impairment. The combination of PVW fractures with ≥ 1.8 mm of translation or ≥ 5.5° of angulation of C2/3 was the predisposing factor for neurological deficit with Hangman fractures.

PMID:36890563 | DOI:10.1186/s13018-023-03650-7

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Nevin Manimala Statistics

Do different incision techniques for implant surgery affect gingival papilla height around dental implants? A retrospective study of 115 cases

BMC Oral Health. 2023 Mar 8;23(1):128. doi: 10.1186/s12903-023-02828-z.

ABSTRACT

BACKGROUND: Surgical incision designs are considered closely correlated to gingival papilla of dental implants. This study aims to explore whether different incision techniques for implant placement and second stage surgery affect gingival papilla height.

METHODS: Cases using different incision techniques (intrasulcular incisions or papilla sparing incisions) between November 2017 and December 2020 were selected and analyzed. A digital camera was used to capture images of gingival papilla at different time points. Ratio of papilla height to crown length using different incision techniques were measured and statistically compared.

RESULTS: A total of 115 papillae (68 patients) were eligible according to the inclusion/exclusion criteria. The average age was 39.6 years. Decreased postoperative papilla height were observed after implant placement surgery in all groups without statistical difference. However, for second stage surgery, intrasulcular incisions lead to more atrophy in gingival papilla compared to papilla sparing incisions.

CONCLUSIONS: Selection of incision techniques in implant placement surgery does not significantly affect papilla height. For second stage surgery, intrasulcular incisions significantly leads to more papilla atrophy compared with papilla sparing incisions. Trial registration KQCL2017003.

PMID:36890532 | DOI:10.1186/s12903-023-02828-z

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Nevin Manimala Statistics

Does intra-articular injection of tenoxicam after arthrocentesis heal outcomes of temporomandibular joint osteoarthritis? A randomized clinical trial

BMC Oral Health. 2023 Mar 8;23(1):131. doi: 10.1186/s12903-023-02852-z.

ABSTRACT

BACKGROUND: Temporomandibular joint osteoarthritis (TMJ-OA) is a degenerative disease and manifests itself with pain and limitation of movement in the jaws. Arthrocentesis alone or in combination with intraarticular injections is one of the most commonly used treatment methods in these patients. The aim of the study is to examine the effectiveness of arthrocentesis plus tenoxicam injection and to compare it with arthrocentesis alone in patients with TMJ-OA.

METHODS: Thirty patients with TMJ-OA who were treated randomly with either arthrocentesis plus tenoxicam injection (TX group) or arthrocentesis alone (control group) were examined. Maximum mouth opening (MMO), visual analog scale (VAS) pain values, and joint sounds were the outcome variables, which were evaluated at pre-treatment and at 1, 4, 12, and 24 weeks after treatment. Statistical significance was set at p < 0.05.

RESULTS: The gender distribution and mean age were not significantly different between the two groups. Pain values (p < 0.001), MMO (p < 0.001), and joint sounds (p < 0.001) improved significantly in both groups. However, there was no significant difference between the groups in terms of outcome variables [pain (p = 0.085), MMO (p = 0.174), joint sounds (p = 0.131)].

CONCLUSIONS: Arthrocentesis plus tenoxicam injection showed no better outcomes in terms of MMO, pain, and joint sounds compared with arthrocentesis alone in patients with TMJ-OA.

TRIAL REGISTRATION: Injection of Tenoxicam Versus Arthrocentesis Alone in the Treatment of Temporomandibular Joint Osteoarthritis, NCT05497570. Registered 11 May 2022. Retrospectively registered, https://register.

CLINICALTRIALS: gov/prs/app/action/SelectProtocol?sid=S000CD7A&selectaction=Edit&uid=U0006FC4&ts=6&cx=f3anuq.

PMID:36890529 | DOI:10.1186/s12903-023-02852-z

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Nevin Manimala Statistics

Implementation of offering choice of pulmonary rehabilitation location to people with COPD: a protocol for the process evaluation of a cluster randomised controlled trial

Trials. 2023 Mar 8;24(1):173. doi: 10.1186/s13063-023-07179-2.

ABSTRACT

BACKGROUND: Pulmonary rehabilitation (PR) is a core component of management people with chronic obstructive pulmonary disease (COPD); yet, people with COPD face significant barriers to attending centre-based PR programs. The emergence of new models of PR, remotely delivered directly into people’s homes, has the potential to improve rehabilitation access and completion by providing patients with a choice of rehabilitation location (centre or home). However, offering patients a choice of rehabilitation model is not usual practice. We are undertaking a 14-site cluster randomised controlled trial to determine whether offering choice of PR location improves rehabilitation completion rates resulting in reduced all-cause unplanned hospitalisation over 12 months. The aim of this paper is to describe the protocol for the process evaluation of the HomeBase2 trial.

METHODS: A mixed methods process evaluation, to be undertaken in real time, has been developed in accordance with UK Medical Research Council (MRC) recommendations on process evaluation of complex interventions. This protocol describes the intended use of two theoretical frameworks (RE-AIM framework (Reach; Effectiveness; Adoption; Implementation; Maintenance) and Theoretical Domains Framework (TDF)) to synthesise findings and interpret data from a combination of qualitative (semi-structured interviews) and quantitative (questionnaires, clinical outcome data, intervention fidelity) methodologies. Data will be collected at an intervention, patient and clinician level. Qualitative and quantitative data will be used to derive context-specific potential and actual barriers and facilitators to offering patients choice of rehabilitation location. Acceptability and sustainability of the intervention will be evaluated for future scale-up.

DISCUSSION: The process evaluation described here will appraise the clinical implementation of offering a choice of rehabilitation program location for people with COPD. It will identify and evaluate key factors for future scale-up and sustainability and scale-up of offering choice of pulmonary rehabilitation program model for people.

TRIAL REGISTRATION: ClinicalTrials.gov NCT04217330 Registration date: January 3 2020.

PMID:36890526 | DOI:10.1186/s13063-023-07179-2