Tag: statistics

Dent Med Probl. 2022 Jul-Sep;59(3):421-425. doi: 10.17219/dmp/133645.

ABSTRACT

BACKGROUND: Pain from dental injections is a common reason why people fear dentistry and avoid dental treatment. Thus, researchers have attempted to find methods to decrease dental injection pain.

OBJECTIVES: Considering the analgesic effect of the photobiomodulation therapy (PBMT), the aim of this study was to evaluate the effects of PBMT on the pain caused by dental anesthetic injections.

MATERIAL AND METHODS: This randomized, split-mouth, triple-blind clinical trial evaluated 60 bilateral canine teeth in 30 dental students. After the random selection of the test (laser) quadrant, the injection site was irradiated with a 940 nm diode laser. Buccal infiltration anesthesia was then administered by injecting lidocaine plus epinephrine with a short needle. The level of pain experienced during the injection was determined using a 100-millimeter visual analog scale (VAS). The same procedure was performed for the control (no laser) quadrant, with the difference being that the laser handpiece was turned on, but no radiation was administered. The 2 groups were compared using the non-parametric Wilcoxon signed-rank test.

RESULTS: The mean VAS pain scores were 21.2 ±15.7 for the laser quadrant and 27.9 ±18.9 for the control quadrant; this difference was statistically significant (p = 0.030), but did not seem to be clinically relevant.

CONCLUSIONS: The photobiomodulation therapy prior to dental anesthetic injections has no clinical advantage for reducing injection pain.

PMID:36196515 | DOI:10.17219/dmp/133645

Ren Fail. 2022 Dec;44(1):1623-1631. doi: 10.1080/0886022X.2022.2129064.

ABSTRACT

BACKGROUND: A large number of studies have shown that proton pump inhibitors (PPIs) are associated with infection events. Therefore, we retrospectively evaluated the association of PPI therapy with the occurrence of first pneumonia and peritoneal dialysis(PD)-related peritonitis events in the maintenance PD patients.

METHODS: We collected PD patients in two large hospitals from January 1, 2012 to December 31, 2016, and divided them into the PPI group and the non-PPI group. Multivariate Cox proportional hazards models were applied to evaluate the cumulative incidence and hazard ratios (HRs). Inverse probability of treatment weight (IPTW) method was used to adjust for covariate imbalance between the two groups and further confirm our findings.

RESULTS: Finally, 656 PD patients were included for data analysis, and the results showed that PPI usage was associated with an increased risk of pneumonia [HR 1.71; 95% CI 1.06-2.76; p = 0.027] and peritonitis [HR 1.73; 95% CI 1.24-2.40; p = 0.001]. IPTW-adjusted HRs for the association of PPIs with pneumonia and peritonitis were 1.58 (95% CI:1.18-2.12; p = 0.002) and 2.33 (95% CI:1.91-2.85; p < 0.001), respectively. Moreover, the competitive risk model proved that under the conditions of competition for other events(including transfer to hemodialysis therapy, kidney transplant, transfer from our research center, loss to follow-up, and death), the differences in endpoints events between the two groups were still statistically significant (p = 0.009, p < 0.001, respectively).

CONCLUSIONS: PPIs was associated with an increased risk of first pneumonia and PD-related peritonitis events in PD patients, which reminds clinicians to be cautious when prescribing acid-suppressing drugs for PD patients.

PMID:36195979 | DOI:10.1080/0886022X.2022.2129064

Phys Occup Ther Pediatr. 2022 Oct 4:1-14. doi: 10.1080/01942638.2022.2128973. Online ahead of print.

ABSTRACT

AIM: To systematically review evidence of the effectiveness of sticky mittens training to improve reaching skills and manual exploration of full-term and at-risk infants and optimal training dosage.

METHODS: The Cochrane Collaboration and Preferred Reporting Items for Systematic Reviews and Meta-Analyses guided this systematic review. The electronic search was performed from September 2017 to August 2021 on PubMed, Scopus, Science Direct, and Cochrane databases. Eligibility criteria followed PICO terms: clinical trials investigating the effects of sticky mittens training on reaching skills and manual exploration of full-term and at-risk infants. PEDro scale and GRADE assessed methodological quality and quality of evidence, respectively.

RESULTS: Eight studies (313 children) were included. Five studies found statistically significant differences between experimental and control groups (62.6%). One study presented high methodological quality. Evidence synthesis showed very low and low evidence of the beneficial effects of sticky mittens training in full-term and at-risk infants, respectively.

CONCLUSIONS: Findings suggest that sticky mittens training facilitates reaching skills and manual exploration. However, results should interpretation with caution because studies targeted full-term infants. Future research should focus on infants at risk or with motor impairments since sticky mittens training seems to show positive effects and is easy to apply.

PMID:36195977 | DOI:10.1080/01942638.2022.2128973

J Health Popul Nutr. 2022 Oct 4;41(1):45. doi: 10.1186/s41043-022-00326-6.

ABSTRACT

BACKGROUND: Medically unnecessary caesarean section (CS) is now an ongoing concern worldwide including in Bangladesh. This intensifies the occurrence of adverse maternal and child health outcomes. We investigated the associations of CS with some basic health and behavioural outcomes of the mothers and their children in Bangladesh.

METHODS: We conducted a community-based case-control study from May to August 2019. A total of 600 mother-child dyads were interviewed using a structured questionnaire, 300 of them had CS, and 300 had vaginal delivery (VD) in their most recent live births. The exposure variable was the mode of delivery, classified as 1 if mothers had CS and 0 if mothers had VD. The outcome variables were a group of health and behavioural problems of the mothers and their children. Multivariate or multiple logistic regression model, separately for each health and behavioural outcome, was used to determine the effect of exposure variable on outcome variable after adjusting for possible confounders.

RESULTS: The mean age and weight of mothers were 25.1 years and 53.1 kg, respectively. Likelihoods of headache, after delivery hip pain, problem of daily activities, and breastfeeding problem were reported higher among mothers who had CS in their most recent live birth than mothers who had VD. Similarly, children who were born through the CS operation were more likely to report breathing problem, frequent illness, lower food demand and lower hours of sleeping.

CONCLUSION: The use of CS increases the risks of health and behavioural problems of the mothers and their children. Policies and programs to avoid medically unnecessary CS and increase awareness over its adverse effects are important.

PMID:36195965 | DOI:10.1186/s41043-022-00326-6

Pilot Feasibility Stud. 2022 Oct 4;8(1):225. doi: 10.1186/s40814-022-01107-y.

ABSTRACT

BACKGROUND: While international guidelines recommend medication reviews as part of the management of multimorbidity, evidence on how to implement reviews in practice in primary care is lacking. The MyComrade (MultimorbiditY Collaborative Medication Review And Decision Making) intervention is an evidence-based, theoretically informed novel intervention which aims to support the conduct of medication reviews for patients with multimorbidity in primary care.

AIM: The pilot study aimed to assess the feasibility of a definitive trial of the MyComrade intervention across two healthcare systems (Republic of Ireland (ROI) and Northern Ireland (NI)).

DESIGN: A pilot cluster-randomised controlled trial was conducted (clustered at general practice level), using specific progression criteria and a process evaluation framework.

SETTING: General practices in the ROI and NI.

PARTICIPANTS: Eligible practices were those in defined geographical areas who had GP’s and Practice Based Pharmacists (PBP’s) (in NI) willing to conduct medication reviews. Eligible patients were those aged 18 years and over, with multi morbidity and on ten or more medications.

INTERVENTION: The MyComrade intervention is an evidence-based, theoretically informed novel intervention which aims to support the conduct of medication reviews for patients with multimorbidity in primary care, using a planned collaborative approach guided by an agreed checklist, within a specified timeframe.

OUTCOME MEASURES: Feasibility outcomes, using pre-determined progression criteria, assessed practice and patient recruitment and retention and intervention acceptability and fidelity. Anonymised patient-related quantitative data, from practice medical records and patient questionnaires were collected at baseline, 4 and 8 months, to inform potential outcome measures for a definitive trial. These included (i) practice outcomes-completion of medication reviews; (ii) patient outcomes-treatment burden and quality of life; (iii) prescribing outcomes-number and changes of prescribed medications and incidents of potentially inappropriate prescribing; and (iv) economic cost analysis. The framework Decision-making after Pilot and feasibility Trials (ADePT) in conjunction with a priori progression criteria and process evaluation was used to guide the collection and analysis of quantitative and qualitative data.

RESULTS: The recruitment of practices (n = 15) and patients (n = 121, mean age 73 years and 51% female), representing 94% and 38% of a priori targets respectively, was more complex and took longer than anticipated; impacted by the global COVID-19 pandemic. Retention rates of 100% of practices and 85% of patients were achieved. Both practice staff and patients found the intervention acceptable and reported strong fidelity to the My Comrade intervention components. Some practice staff highlighted concerns such as poor communication of the reviews to patients, dissatisfaction regarding incentivisation and in ROI the sustainability of two GPs collaboratively conducting the medication reviews. Assessing outcomes from the collected data was found feasible and appropriate for a definitive trial. Two progression criteria met the ‘Go’ criterion (practice and patient retention), two met the ‘Amend’ criterion (practice recruitment and intervention implementation) and one indicated a ‘Stop – unless changes possible’ (patient recruitment).

CONCLUSION: The MyComrade intervention was found to be feasible to conduct within two different healthcare systems. Recruitment of participants requires significant time and effort given the nature of this population and the pairing of GP and pharmacist may be more sustainable to implement in routine practice.

TRIAL REGISTRATION: Registry: ISRCTN, ISRCTN80017020 ; date of confirmation 4/11/2019; retrospectively registered.

PMID:36195963 | DOI:10.1186/s40814-022-01107-y

Trials. 2022 Oct 4;23(1):846. doi: 10.1186/s13063-022-06668-0.

ABSTRACT

BACKGROUND: Enteral feeding intolerance, energy-protein malnutrition, and muscle wasting are common conditions in the critical care setting. The primary aim of this study was to investigate the effect of synbiotic supplementation on enteral feed volume, energy and protein homeostasis, and muscle mass maintenance in critically ill adult patients.

METHODS: A consecutive of 42 patients admitted to the Edalatian Medical ICU, requiring enteral nutrition (EN), were prospectively randomized to receive the synbiotic capsule (containing a combination of Lactobacillus, Bifidobacterium, Streptococcus, and fructooligosaccharides) or placebo (21 patients in each group) for a maximum of 14 days. Enteral intolerance and energy homeostasis were evaluated on a daily basis. Nitrogen balance and 24-h urine creatinine excretion were recorded on days 1 and 14. Mid-arm circumference was recorded every 3 days.

RESULTS: Mean EN volume, energy, and protein intake per day were 962.5 ± 533.82 ml, 770 ± 427.05 kcal, and 38.5 ± 21.35 g (fourth day) vs. 590 ± 321.1 ml, 472 ± 256.81 kcal, and 23.6 ± 12.84 g (first day) in the synbiotic group (p < 0.05). Changes in the placebo group were not statistically significant. On day 1, nitrogen balance (NB) was – 19.84 ± 8.03 in the synbiotic vs. – 10.99 ± 9.12 in the placebo group (p = 0.003). On day 14, NB was – 14.18 ± 13.05 in the synbiotic and – 9.59 ± 7.71 in the placebo group (p = 0.41). Mid-arm circumference (MAC), 24-h urine creatinine, and creatinine-height index were almost steady in the synbiotic group, while they decreased in the placebo group.

CONCLUSION: Overall, it can be concluded that enteral nutrition supplemented with synbiotics has no statistically significant effect on energy and protein homeostasis and muscle mass maintenance of critically ill patients on day 14, but it can increase enteral feed volume and energy and protein intake during the first 4 days of ICU admission.

TRIAL REGISTRATION: The trial protocol has been approved in Iranian Registry of Clinical Trials on March 17, 2019. The registration reference is IRCT20190227042857N1.

PMID:36195945 | DOI:10.1186/s13063-022-06668-0

Cancer Imaging. 2022 Oct 4;22(1):55. doi: 10.1186/s40644-022-00497-9.

ABSTRACT

OBJECTIVES: To compare the diagnostic performance of international hepatocellular carcinoma (HCC) guidelines with gadoxetic acid-enhanced MRI (EOB-MRI) and contrast-enhanced Computed tomography (CECT) and their impact on liver transplant (LT) allocation in cirrhotic patients with explant histopathology correlation.

METHODS: In this prospective single-centre ethics-approved study, 101 cirrhotic patients were consecutively enrolled with informed consent from the pre-LT clinic. They underwent CECT and EOB-MRI alternately at three monthly intervals until LT or removal from LT list. Two abdominal radiologists, blinded to explant histopathology, independently recorded liver lesions visible on CECT and EOB-MRI. Imaging-based HCC scores were assigned to non-treated liver lesions utilizing Liver Imaging Reporting and Data System (LI-RADS), European Association for the Study of the Liver (EASL), Asian-Pacific Association for the Study of the Liver (APASL) and Korean Liver Cancer Association-National Cancer Center (KLCA) guidelines. Liver explant histopathology was the reference standard. Simulated LT eligibility was assessed as per Milan criteria (MC) in reference to explant histopathology.

RESULTS: One hundred and three non-treated HCC and 12 non-HCC malignancy were identified at explant histopathology in 34 patients (29 men, 5 women, age 55-73 years). Higher HCC sensitivities of statistical significance were observed with EOB-MRI for LI-RADS 4 + 5, APASL and KLCA compared to LI-RADS 5 and EASL with greatest sensitivity obtained for LIRADS 4 + 5 lesions. HCC sensitivities by all guidelines with both EOB-MRI and CECT were significantly lower if all histopathology-detected HCCs were included in the analysis, compared to imaging-visible lesions only. A significantly greater variation in HCC sensitivity was noted across the guidelines with EOB-MRI compared to CECT. No significant differences in simulated LT eligibility based on MC were observed across the HCC scoring guidelines with EOB-MRI or CECT.

CONCLUSION: HCC sensitivities are variable depending on scoring guideline, lesion size and imaging modality utilised. Prior studies that included only lesions visible on pre-operative imaging overestimate the diagnostic performance of HCC scoring guidelines. Per-lesion differences in HCC diagnosis across these guidelines did not impact patient-level LT eligibility based on MC.

PMID:36195953 | DOI:10.1186/s40644-022-00497-9

Trials. 2022 Oct 4;23(1):843. doi: 10.1186/s13063-022-06787-8.

ABSTRACT

BACKGROUND: Recruitment of adults lacking the capacity to consent to trials requires the involvement of an alternative ‘proxy’ decision-maker, usually a family member. This can be challenging for family members, with some experiencing emotional and decisional burdens. Interventions to support proxy consent decisions in non-emergency settings are being developed. However, the ability to evaluate interventions is limited due to a lack of measures that capture outcomes of known importance, as identified through a core outcome set (COS).

METHODS: Using established measure development principles, a four-stage process was used to develop and refine items for a new measure of proxy decision quality: (1) findings from a recent scoping review and consensus study were reviewed to identify items for inclusion in the scale and any existing outcome measures, (2) assessment of content coverage by existing measures and identification of insufficiency, (3) construction of a novel scale, and (4) cognitive testing to explore comprehension of the scale and test its content adequacy through interviews with family members of people with impaired capacity.

RESULTS: A range of outcome measures associated with healthcare decision-making and informed consent decisions, such as the Decisional Conflict Scale, were identified in the scoping review. These measures were mapped against the key constructs identified in the COS to assess content coverage. Insufficient coverage of areas such as proxy-specific satisfaction and knowledge sufficiency by existing instruments indicated that a novel measure was needed. An initial version of a combined measure (the CONCORD scale) was drafted and tested during cognitive interviews with eleven family members. The interviews established comprehension, acceptability, feasibility, and content adequacy of the scale. Participants suggested re-phrasing and re-ordering some questions, leading to the creation of a revised version.

CONCLUSIONS: The CONCORD scale provides a brief measure to evaluate the quality of decisions made on behalf of an adult who lacks the capacity to consent in non-emergency settings, enabling the evaluation of interventions to improve proxy decision quality. Initial evaluation indicates it has content adequacy and is feasible to use. Further statistical validation work is being undertaken.

PMID:36195929 | DOI:10.1186/s13063-022-06787-8

Eur J Med Res. 2022 Oct 4;27(1):194. doi: 10.1186/s40001-022-00826-5.

ABSTRACT

BACKGROUND: The aim of this study was to evaluate the effect of bioactive glass (BAG) 45S5 paste on colour change and tooth sensitivity (TS) when used in combination with 20% carbamide peroxide (CP) during at-home vital tooth bleaching.

METHODS: Twenty-four patients were selected and assigned into two experimental groups (n = 12) in a double-blind study design. Each patient received 20% CP followed by the application of either BAG paste or non-active placebo paste. The shade evaluation was performed using a digital spectrophotometer based on the CIE L*a*b* colour space system at different time points and the overall colour changes ΔE were calculated. TS was evaluated using visual analogue scale (VAS). The values of ΔE and TS were statistically analysed using paired t-test. The level of statistical significance was established at p = 0.05.

RESULTS: The overall colour changes (ΔE) between baseline and each time point showed no significant differences between BAG and placebo groups (p > 0.05). The use of BAG paste significantly decreased TS reported by the participants.

CONCLUSIONS: The association of BAG paste with at-home bleaching treatment presents a promising method as it decreased TS and did not deteriorate bleaching efficacy. Trial registration This study was approved and registered in the Australian New Zealand Clinical Trials Registry (ANZCTR) under Registration number: ACTRN12621001334897.

PMID:36195927 | DOI:10.1186/s40001-022-00826-5

BMC Med Educ. 2022 Oct 4;22(1):701. doi: 10.1186/s12909-022-03769-x.

ABSTRACT

BACKGROUND: Direct-access physiotherapy practice has led to a global review of the use of differential-diagnostic modalities such as musculoskeletal imaging (MI) in physiotherapy.

OBJECTIVE: To explore the MI authority, levels of training, attitude, utilisation, and competence among clinical physiotherapists in Nigeria.

METHODS: This national cross-sectional study analysed a voluntary response sample of 400 Nigerian physiotherapists that completed the online version of the Physiotherapist’s Musculoskeletal Imaging Profiling Questionnaire (PMIPQ), using descriptive statistics, Spearman’s correlation, Mann-Whitney U, Kruskal-Wallis, and Friedman’s ANOVA tests.

RESULTS: Of the 400 participants, 93.2% believed that physiotherapists should use MI in clinical practice. However, only 79.8% reported having MI authority in their practice settings. The participants’ median (interquartile range) levels of training =10 (24) and competence =16 (24) were moderate. Nonetheless, levels of training (χ2 [15] = 1285.899, p = 0.001), and competence (χ2 [15] = 1310.769, p < 0.001) differed across MI procedures. The level of training and competence in x-ray referral and utilisation was significantly higher than magnetic resonance imaging, computed tomography scan, ultrasonography, scintigraphy, and dual-energy x-ray absorptiometry, in that order (p < 0.05). There was a significant positive correlation between the levels of training and competence (rho =0.61, p < 0.001). The participants had a positive attitude =32 (32) and occasionally used MI in clinical practice =21 (28).

CONCLUSION: Majority of the respondents believed they had MI authority although there was no explicit affirmation of MI authority in the Nigerian Physiotherapy Practice Act. Participants had a positive attitude towards MI. However, levels of MI training, competence, and utilisation were moderate. Our findings have legislative and curriculum implications.

PMID:36195923 | DOI:10.1186/s12909-022-03769-x