Tag: statistics

J Long Term Eff Med Implants. 2024;34(3):55-63. doi: 10.1615/JLongTermEffMedImplants.2023048690.

ABSTRACT

Robotic arm-assisted total knee arthroplasty (RATKA) represents a haptic assistive robotic arm used for bone preparation. The purpose of this study was to present implant survivorship, complications and evaluate patients’ satisfaction, clinical and functional outcome of RATKA with a minimum of 1-year follow-up. The Oxford Knee Score was recorded preoperatively and at last follow-up. Patients’ satisfaction rates, as well as complications and re-operations were studied. Anatomical alignment including varus, valgus deformities and flexion, extension, pre-and postoperatively were evaluated. A total of 156 patients with mean age = 71.9 years were included in the study. The mean follow-up was 35.7 months, while one revision was performed due to infection. Statistically significant improvement of the Oxford Knee Score, as well as of the knee alignment deformities were recorded, while 99.4% of patients reported to be “very satisfied” or “satisfied” with the procedure. RATKA seems to be a safe, as well as reproductible procedure at short-and mid-term follow-up, while the accurate implant positioning may lead to favorable long-term outcomes.

PMID:38505894 | DOI:10.1615/JLongTermEffMedImplants.2023048690

J Long Term Eff Med Implants. 2024;34(3):27-36. doi: 10.1615/JLongTermEffMedImplants.2023048783.

ABSTRACT

Ramus frame dental implants were retrospectively studied in 360 adults with severely atrophic edentulous mandibles. Patient records up to 12 years post-treatment were independently reviewed after a single clinician surgically placed titanium long-arm (“Tatum”) ramus frame implants and immediately loaded them with a mandibular overdenture. A total of 11 ramus frames were removed at 19 to 109 months post-treatment, mostly due to supramucosal bar fracture (N = 6) or mobility (N = 3). Kaplan-Meier product-limit analysis revealed the post-treatment survival probability for functional ramus frame implants to be 99.3% at 2 years (266 patients), 98.9% at 3 years (223 patients), 97.9% at 4 years (198 patients), 96.9% at 5 years (160 patients), 96.9% at 6 years (123 patients), 95.0% at 7 years (86 patients), 95.0% at 8 years (67 patients), 93.3% at 9 years (43 patients), and 91.1% at 10 years (25 patients). No statistically significant differences in functional ramus frame implant survival were found relative to patient gender, smoking, presence of natural maxillary teeth, or compliance with semi-annual maintenance care. Fracture of endosseous anterior feet/posterior arms was the most frequent implant-related complication on 29 implants, which were left in place, repaired, or replaced in situ without implant removal. At 5 years, the ramus frame implant functional survival probability without any implant-related biological or mechanical complication was 88.9%. Ramus frame dental implants, immediately loaded with a fully implant-borne mandibular overdenture, exhibited a high degree of long-term functional survival and safety in severely atrophic edentulous human mandibles.

PMID:38505891 | DOI:10.1615/JLongTermEffMedImplants.2023048783

Phytother Res. 2024 Mar 19. doi: 10.1002/ptr.8189. Online ahead of print.

ABSTRACT

Turmeric has been gaining popularity as a treatment option for digestive disorders, although a rigorous synthesis of efficacy has not been conducted. This study aimed to summarize the evidence for the efficacy and safety of turmeric in the treatment of digestive disorders, including inflammatory bowel diseases (IBD), irritable bowel syndrome (IBS), dyspepsia, gastroesophageal reflux disease, and peptic ulcers. Literature searches were conducted in Medline, EMBASE, AMED, the Cochrane Central Register of Control Trials, and Dissertation Abstracts from inception to November 15, 2021. Dual independent screening of citations and full texts was conducted and studies meeting inclusion criteria were retained: randomized controlled trials (RCT) and comparative observational studies evaluating turmeric use in people of any age with one of the digestive disorders of interest. Extraction of relevant data and risk of bias assessments were performed by two reviewers independently. Meta-analysis was not conducted due to high heterogeneity. From 1136 citations screened, 26 eligible studies were retained. Most studies were assessed to have a high risk of bias, and many had methodological limitations. Descriptive summaries suggest that turmeric is safe, with possible efficacy in patients with IBD or IBS, but its effects were inconsistent for other conditions. The efficacy of turmeric in digestive disorders remains unclear due to the high risk of bias and methodological limitations of the included studies. Future studies should be designed to include larger sample sizes, use rigorous statistical methods, employ core outcome sets, and adhere to reporting guidance for RCTs of herbal interventions to facilitate more meaningful comparisons and robust conclusions.

PMID:38503513 | DOI:10.1002/ptr.8189

Heart. 2024 Mar 19:heartjnl-2023-323474. doi: 10.1136/heartjnl-2023-323474. Online ahead of print.

ABSTRACT

BACKGROUND: We assessed the prevalence and diagnostic value of ECG abnormalities for cardiomyopathy surveillance in childhood cancer survivors.

METHODS: In this cross-sectional study, 1381 survivors (≥5 years) from the Dutch Childhood Cancer Survivor Study part 2 and 272 siblings underwent a long-term follow-up ECG and echocardiography. We compared ECG abnormality prevalences using the Minnesota Code between survivors and siblings, and within biplane left ventricular ejection fraction (LVEF) categories. Among 880 survivors who received anthracycline, mitoxantrone or heart radiotherapy, logistic regression models using least absolute shrinkage and selection operator identified ECG abnormalities associated with three abnormal LVEF categories (<52% in male/<54% in female, <50% and <45%). We assessed the overall contribution of these ECG abnormalities to clinical regression models predicting abnormal LVEF, assuming an absence of systolic dysfunction with a <1% threshold probability.

RESULTS: 16% of survivors (52% female, mean age 34.7 years) and 14% of siblings had major ECG abnormalities. ECG abnormalities increased with decreasing LVEF. Integrating selected ECG data into the baseline model significantly improved prediction of sex-specific abnormal LVEF (c-statistic 0.66 vs 0.71), LVEF <50% (0.66 vs 0.76) and LVEF <45% (0.80 vs 0.86). While no survivor met the preset probability threshold in the first two models, the third model used five ECG variables to predict LVEF <45% and was applicable for ruling out (sensitivity 93%, specificity 56%, negative predictive value 99.6%). Calibration and internal validation tests performed well.

CONCLUSION: A clinical prediction model with ECG data (left bundle branch block, left atrial enlargement, left heart axis, Cornell’s criteria for left ventricular hypertrophy and heart rate) may aid in ruling out LVEF <45%.

PMID:38503487 | DOI:10.1136/heartjnl-2023-323474

Br J Ophthalmol. 2024 Mar 19:bjo-2023-324243. doi: 10.1136/bjo-2023-324243. Online ahead of print.

ABSTRACT

AIMS: To report the 1-year results of the efficacy of a defocus distributed multipoint (DDM) lens in controlling myopia progression in a multicentre, randomised controlled trial.

METHODS: Overall, 168 children aged 6-13 years were recruited and randomly assigned to wear a DDM lens (n=84) or single-vision (SV) lens (n=84) in three centres. Cycloplegic autorefraction (spherical equivalent refraction (SER)) and axial length (AL) were measured. Linear mixed model analysis was performed to compare between-group SER and AL changes. Logistic regression analysis was used to analyse the between-group difference in rapid myopia progression (SER increase≥0.75 D per year or AL growth≥0.40 mm per year).

RESULTS: After 1 year, mean changes in SER were significantly lower in the DDM group (-0.47±0.37 D) than in the SV group (-0.71±0.42 D) (p<0.001). Similarly, mean changes in AL were significantly lower in the DDM group (0.21±0.17 mm) than in the SV group (0.34±0.16 mm) (p<0.001). After adjusting for age, sex, daily wearing time and parental myopia, rapid myopia progression risk was higher in the SV group than in the DDM group (OR=3.51, 95% CI: 1.77 to 6.99), especially for children who wore a lens for >12 hours per day, boys and younger children (6-9 years) with ORs (95% CIs) of 10.82 (3.22 to 36.37), 5.34 (1.93 to 14.78) and 8.73 (2.6 to 29.33), respectively.

CONCLUSIONS: After 1 year, DDM lenses effectively retarded myopia progression in children. Longer daily wearing time of DDM lens improved the efficacy of myopia control. Future long-term studies are needed for validation.

TRIAL REGISTRATION NUMBER: NCT05340699.

PMID:38503477 | DOI:10.1136/bjo-2023-324243

BMJ. 2024 Mar 19;384:e079261. doi: 10.1136/bmj-2024-079261.

NO ABSTRACT

PMID:38503446 | DOI:10.1136/bmj-2024-079261

Perfusion. 2024 Mar 19:2676591241239819. doi: 10.1177/02676591241239819. Online ahead of print.

ABSTRACT

INTRODUCTION: Over the past decade, there has been an increase in the use of recombinant Anti-Thrombin III (AT-III) administration during neonatal and pediatric short- and long-term mechanical support for the replacement of acquired deficiencies. Recombinant AT-III (Thrombate) administration is an FDA licensed drug indicated primarily for patients with hereditary deficiency to treat and prevent thromboembolism and secondarily to prevent peri-operative and peri-partum thromboembolism. Herein we propose further use of Thrombate for primary AT-III deficiency of the newborn as well as for acquired dilution and consumption secondary to cardiopulmonary bypass (CPB).

METHODOLOGY: All patients undergoing CPB obtain a preoperative AT-III level. Patients with identified deficiencies are normalized in the OR using recombinant AT-III as a patient load, in the CPB prime, or both. Patient baseline Heparin Dose Response (HDR) is assessed using the Heparin Management System (HMS) before being exposed to AT-III. If a patient load of AT-III is given, a second HDR is obtained and this AT-III Corrected HDR is used as the primary goal during CPB. Once CPB is initiated, an AT-III level is obtained with the first patient blood analysis. A subtherapeutic level results in an additional dose of AT-III. During the rewarm period, a final AT-III level is obtained and AT-III treated once again if subtherapeutic. A retrospective, matched analysis review of practice analyzing two groups, a Study Group (Repeat HDR, May 2022 onward) and Matched Group (Without Repeat HDR, July 2019 to April 2022), for age (D), weight (Kg) and operation was conducted. The focus of the study was to determine any change in heparin sensitivity identified post AT-III patient bolus load in the HDR (U/mL), Slope (U/mL/s), ACT (s), and total amount of heparin on CPB (U) and protamine (mg) used in each group.

RESULTS: No significance was seen in Baseline AT-III (%), post heparin load HDR (U/mL), first CPB ACT (s), first CPB HDR (U/mL), or total CPB heparin (u/Kg) between the two groups. Statistical significance was seen in Baseline ACT (s), Baseline HDR (U/mL), Baseline Slope (U/mL/s), Post Heparin Load ACT (s), first CPB AT-III (%), and Protamine (mg/Kg) (p < .05). No statistical significance was seen in the Study Intragroup between pre versus post AT-III patient load baseline sample in ACT (s), however significance was seen in HDR (U/mL) and Slope (U/mL/s) (p < .05).

CONCLUSION: Implementation of AT-III monitoring and therapy before and during CPB in conjunction with the HMS allows patients to maintain a steady state of anticoagulation with overall less need for excessive heparin replacement and potentially thrombin activation. The result is obtaining a steady state of anticoagulation, a reduced fluctuation in the heparin and ACT levels and a potential for lower co-morbidities associated with prolonged CPB times.

PMID:38503431 | DOI:10.1177/02676591241239819

BMJ Glob Health. 2024 Mar 18;9(3):e014739. doi: 10.1136/bmjgh-2023-014739.

ABSTRACT

INTRODUCTION: One of the ultimate goals of strengthening the health system is to achieve health equity. Vietnam is considered one of the ‘fast-track countries’ to achieve the health-related Millennium Development Goals, but research on its equity strategies remains inadequate.

METHODS: Using Vietnamese official health statistics, we investigated inequity in four dimensions including health resources, service delivery, service utilisation and residents’ health status from the perspectives of income levels, poverty rates and subnational regions. The Slope Index of Inequality, concentration curve/Concentration Index, absolute difference and Theil Index were used.

RESULTS: Four indicators showed ‘pro-poor’ inequality in health resources, including the per capita health budget, per capita health personnel, per capita health personnel at the community level and per capita hospital beds at the community level, while provincial hospital beds showed ‘pro-rich’ inequality. Two health service delivery indicators (delivery of antenatal care ≥3 times and proportion of community health service centres with medical doctors) show ‘pro-rich’ inequality, although two health status indicators, mortality and malnutrition rates for children under five, showed ‘pro-poor’ inequality. The Northern Midlands and Mountain Areas, and the Central Highlands were disadvantaged regarding service delivery and health status. Intraregional differences were the main factors contributing to the inequalities in delivery of antenatal care ≥3 times, provincial hospital beds and percentage of community health centres with medical doctors, with the Red River Delta and the South East region experiencing the greatest inequalities.

CONCLUSION: The overall level of health equity in Vietnam has increased over the past decade, although inequality in health service delivery has hindered progress towards health equity based on income, poverty and subnational regions. Targeted policies need to be introduced to reduce inequities relating to the health workforce and service delivery capacity.

PMID:38503427 | DOI:10.1136/bmjgh-2023-014739

BMJ Open. 2024 Mar 18;14(3):e082761. doi: 10.1136/bmjopen-2023-082761.

ABSTRACT

INTRODUCTION: Children with cerebral palsy (CP) are prescribed home exercise programmes (HEPs) to increase the frequency of movement practice, yet adherence to HEPs can be low. This paper outlines the protocol for a single-case experimental design (SCED) with alternating treatments, using a new home therapy exercise application, Bootle Boot Camp (BBCamp), offered with and without movement tracking feedback. This study will explore the impact of feedback on engagement, movement quality, lower limb function and family experiences to help understand how technology-supported HEPs should be translated and the added value, if any, of movement tracking technology.

METHODS AND ANALYSIS: In this explanatory sequential mixed-methods study using a SCED, 16 children with CP (aged 6-12 years, Gross Motor Function Classification System levels I-II) will set lower limb goals and be prescribed an individualised HEP by their physiotherapist to complete using BBCamp on their home television equipped with a three-dimensional camera-computer system. Children will complete four weekly exercise sessions over 6 weeks. Children will be randomised to 1 of 16 alternating treatment schedules where BBCamp will provide or withhold feedback during the first 4 weeks. The version of BBCamp that results in the most therapeutic benefit will be continued for 2 final weeks. Goals will be re-evaluated and families interviewed. The primary outcome is adherence (proportion of prescribed exercise repetitions attempted) as a measure of behavioural engagement. Secondary outcomes are affective and cognitive engagement (smiley face ratings), exercise fidelity, lower limb function, goal achievement and participant experiences. SCED data will be analysed using visual and statistical methods. Quantitative and qualitative data will be integrated using joint displays.

ETHICS AND DISSEMINATION: Ethical approval was obtained from the Research Ethics Boards at Bloorview Research Institute and the University of Toronto. Results will be distributed through peer-reviewed journals and scientific conferences.

TRIAL REGISTRATION NUMBER: NCT05998239; pre-results.

PMID:38503423 | DOI:10.1136/bmjopen-2023-082761

BMJ Open. 2024 Mar 18;14(3):e078878. doi: 10.1136/bmjopen-2023-078878.

ABSTRACT

INTRODUCTION: Ulcerative colitis (UC) is a global chronic inflammatory bowel disease, and the poor efficacy of currently available pharmacological regimens makes the management of UC a great challenge. Moxibustion has shown great potential in the management of UC. However, its effectiveness and safety are still controversial. The purpose of this study is to synthesise the latest evidence regarding the clinical efficacy and safety of moxibustion for UC.

METHODS AND ANALYSIS: The Cochrane Library, PubMed, EMBASE, CNKI, Wanfang, VIP and SinoMed databases will be searched from inception to July 2023, to identify all randomised controlled trials with moxibustion for UC. The primary outcome will be clinical efficacy, as measured by validated scales. The serum inflammatory factor, colonoscopy results, quality of life, recurrence rate and adverse events will be the secondary outcomes. The Cochrane Risk of Bias 2.0 tool will be used to assess the methodological quality of each included trial. All data extraction will be carried out independently by two investigators. RevMan V.5.4 software will be used for data analysis and Cochran’s Q statistic and I² test will be used to assess heterogeneity between studies. In addition, we will perform subgroup analyses, sensitivity analyses and publication bias if the available data are sufficient. The strength of evidence will be graded using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system.

ETHICS AND DISSEMINATION: Ethics approval is not required for this review. Our findings will be published in a peer-reviewed journal.

PROSPERO REGISTRATION NUMBER: CRD42023425481.

PMID:38503422 | DOI:10.1136/bmjopen-2023-078878