Tag: pubmed

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

J Orthop Surg Res. 2022 Oct 4;17(1):439. doi: 10.1186/s13018-022-03333-9.

ABSTRACT

BACKGROUND: Posterior wall acetabular fractures remain one of the most difficult fracture injuries to treat. Accurate assessment of fracture characteristics and appropriate preoperative surgical strategies are essential for excellent reduction. This paper evaluates the feasibility and effectiveness of a one-stop computerized virtual planning system for the surgical management of posterior wall acetabular fractures.

METHODS: 52 cases of posterior wall acetabular fractures treated surgically were selected in our department between January 2015 and December 2020 for retrospective analysis. 52 cases were classified into group A (25 patients) and group B (27 patients) according to whether computerized virtual planning procedures were performed preoperatively. In group A, virtual surgical simulation was conducted using a one-stop computerized planning system preoperatively. In group B, traditional surgery was employed. Reduction quality, surgical time, blood loss, hip function, complications, and instrumentation time were compared between the two groups.

RESULTS: The actual surgery for all patients in group A was essentially the same as the virtual surgery before the operation. Compared to group B, patients in group A had markedly shorter surgical time (-43 min), shorter instrumentation time (-20 min), and less intraoperative blood loss (-130 ml). However, no significant statistical difference was observed in reduction quality and hip function. The complication rate was slightly lower in group A (4/25) than in group B (7/27), without a significant difference.

CONCLUSION: The one-stop computerized virtual planning system is a highly effective, user-friendly and educational tool for allowing the cost-efficient surgical simulation of posterior wall acetabular fractures and providing a more individualized therapeutic schedule. The one-stop computerized planning system is feasible to treat posterior wall acetabular fractures, which is an effective method than the conventional treatment of posterior wall acetabular fractures.

TRIAL REGISTRATION: retrospective registration.

PMID:36195909 | DOI:10.1186/s13018-022-03333-9

J Otolaryngol Head Neck Surg. 2022 Oct 4;51(1):38. doi: 10.1186/s40463-022-00584-8.

ABSTRACT

BACKGROUND: Squamous cell carcinoma is the most common malignancy of the oral cavity. Primary treatment involves surgical resection of the tumour with a surrounding margin. Historically, the most commonly accepted margin clearance is 5 mm. This distance is controversial, with recent publications suggesting closer margins do not impact local recurrence and survival. The objective of this study is to determine the closest surgical margin that does not impact local recurrence and overall survival.

METHODS: A retrospective review of the London Health Sciences Centre Head and Neck Multidisciplinary Clinic between 2010 and 2018 was performed. Demographic data, subsite, tumour staging, treatment modality, margins, and survival outcomes were analyzed. The primary endpoint was local recurrence free survival. Secondary endpoints included recurrence-free survival and overall survival. Descriptive statistics, as well as univariable and multivariable Cox proportional hazards regression modelling were performed for all patients.

RESULTS: Four-hundred and twelve patients were included in the study, with a median follow-up of 3.3 years. On univariable analysis, positive margins and margins < 1 mm were associated with significantly worse local recurrence-free survival, recurrence-free survival, and overall survival (p < 0.05), compared to margins > 5 mm. Patients with surgical margins > 1 mm experienced similar outcomes to those with margins > 5 mm. Multivariable analysis identified age of diagnosis, alcohol consumption, pathological tumour and nodal category as predictors of local recurrence free survival.

CONCLUSIONS: Although historical margins for head and neck surgery are 5 mm, similar outcomes were observed for margins greater than 1 mm in our cohort. These findings require validation through multi-institutional collaborative efforts.

PMID:36195903 | DOI:10.1186/s40463-022-00584-8

BMC Public Health. 2022 Oct 4;22(1):1856. doi: 10.1186/s12889-022-14260-z.

ABSTRACT

BACKGROUND: Creating an environment for emotional and social well-being is an important responsibility of Health-Promoting and Child-Friendly Schools. Thus, the present study aimed to assess cultural adaptation and validation of the Persian version of the Psycho-Social Environment (PSE) Profile. The second purpose of this study was to survey the psycho-social environment of schools among a local sample of Iranian school staff.

METHODS: This study was conducted in two phases, including cultural adaptation and validation of a culturally adapted scale. The cultural adaptation process followed the procedure suggested by Beaton et al. Then, the culturally adapted scale was administered to a local sample of Iranian school staff including managers (21.9%), teachers (57.4%), support staff (4%), and other school staff (16.7%) in a cross-sectional study. The participants’ mean age was 39.98 ± 8.11 years and they were mostly female (62.8%). The psychometric properties of the culturally adapted version of the questionnaire were tested using a confirmatory factor analysis (n = 265), and a test of internal consistency. Finally, the status of schools’ psycho-social environment was assessed using descriptive and analytical statistics.

RESULTS: Confirmatory factor analysis indicated an overall good fit for the 7-factor profile (χ2/df: 1.906, PNFI: 0.62, TLI: 0.78, CFI: 0.79, RMSE: 0.059). The test of internal consistency showed an acceptable reliability (α = 0. 98).

CONCLUSIONS: The Persian version of the PSE profile was culturally adapted for use in Iranian schools. Certainly, this culturally adapted version of PSE profile could be useful to determine the school psycho-social environment and to make any changes that can promote a friendly school climate for all participants, and to enhance learning and development.

PMID:36195900 | DOI:10.1186/s12889-022-14260-z

Reprod Health. 2022 Oct 4;19(1):199. doi: 10.1186/s12978-022-01503-w.

ABSTRACT

BACKGROUND: Person-centered maternity care is respectful and responsive care to individual women’s preferences, needs, and values and ensuring that their values guide all clinical decisions during childbirth. It is recognized as a key dimension of the quality of maternity care that increases client satisfaction and institutional delivery. However, little research has been conducted about person-centered maternity care in Ethiopia.

OBJECTIVE: The aim of this study was to assess the status of person-centered maternity care and associated factors among mothers who gave birth at selected public hospitals in Addis Ababa city, Addis Ababa, Ethiopia, 2021.

METHOD: A facility-based cross-sectional study was conducted at selected public hospitals in Addis Ababa city. A structured questionnaire was used to collect data from post-natal mothers selected by systematic random sampling. Data were collected using face-to-face interview technique. The data was coded and entered using Epi-data version 4.6 and analyzed using SPSS version 25. Bivariate and multivariable linear regression analysis was used to identify factors associated with person-centered maternity care. The strength of association between independent and dependent variables was reported by using unstandardized β at 95% CI and p-value < 0.05 were considered statistically significant.

RESULTS: In this study 384 mothers were participated with a response rate of 99.2%. The overall prevalence of person-centered maternity care was 65.8% and the percentage mean Person Centered Maternity Care (PCMC) score of the respondents was 65.8% with percentage standard deviation of 17.06. Respondents who had no ANC follow-up (β = -5.39, 95% CI: -10.52, -0.26), < 4 Antenatal Care (ANC) follow up (β = -3.99, 95% CI: -6.63, -1.36), night time delivery (β = -3.95, 95% CI: -5.91, -1.98) and complications during delivery (β = -3.18, 95% CI: -6.01, -0.35) were factors significantly associated with person-centered maternity care.

CONCLUSION AND RECOMMENDATIONS: The finding of this study showed that the proportion of person-centered maternity care among mothers who gave birth in public hospitals of Addis Ababa was high as compared to previous studies. The factors affecting person-centered maternity care are manageable to interventions. Therefore, Policymakers should develop and implement guidelines about person-centered maternity care. Training should be given to health care providers on the importance of person-centered maternity care and patient and provider rights. Hospital managers should increase the number of staffs who got PCMC training, especially during nighttime to improve the provision of person-centered maternity care. Health care providers should implement person-centered maternity care for all mothers who gave birth in the health care facility.

PMID:36195884 | DOI:10.1186/s12978-022-01503-w