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Development of a measure to assess the quality of proxy decisions about research participation on behalf of adults lacking capacity to consent: the Combined Scale for Proxy Informed Consent Decisions (CONCORD scale)

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

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Effect of bioactive glass paste on efficacy and post-operative sensitivity associated with at-home bleaching using 20% carbamide peroxide: a randomized controlled clinical trial

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

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Musculoskeletal imaging authority, levels of training, attitude, competence, and utilisation among clinical physiotherapists in Nigeria: a cross-sectional survey

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

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One-stop computerized virtual planning system for the surgical management of posterior wall acetabular fractures

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

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Surgical margins of the oral cavity: is 5 mm really necessary?

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

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Status of Iranian schools’ psycho-social environment: cultural adaptation and validation of the Persian version of the W.H.O profile to create Child-Friendly Schools

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

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Person-centered maternity care during childbirth and associated factors at selected public hospitals in Addis Ababa, Ethiopia, 2021: a cross-sectional study

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

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Changes in concentrations of cervicovaginal immune mediators across the menstrual cycle: a systematic review and meta-analysis of individual patient data

BMC Med. 2022 Oct 5;20(1):353. doi: 10.1186/s12916-022-02532-9.

ABSTRACT

BACKGROUND: Hormonal changes during the menstrual cycle play a key role in shaping immunity in the cervicovaginal tract. Cervicovaginal fluid contains cytokines, chemokines, immunoglobulins, and other immune mediators. Many studies have shown that the concentrations of these immune mediators change throughout the menstrual cycle, but the studies have often shown inconsistent results. Our understanding of immunological correlates of the menstrual cycle remains limited and could be improved by meta-analysis of the available evidence.

METHODS: We performed a systematic review and meta-analysis of cervicovaginal immune mediator concentrations throughout the menstrual cycle using individual participant data. Study eligibility included strict definitions of the cycle phase (by progesterone or days since the last menstrual period) and no use of hormonal contraception or intrauterine devices. We performed random-effects meta-analyses using inverse-variance pooling to estimate concentration differences between the follicular and luteal phases. In addition, we performed a new laboratory study, measuring select immune mediators in cervicovaginal lavage samples.

RESULTS: We screened 1570 abstracts and identified 71 eligible studies. We analyzed data from 31 studies, encompassing 39,589 concentration measurements of 77 immune mediators made on 2112 samples from 871 participants. Meta-analyses were performed on 53 immune mediators. Antibodies, CC-type chemokines, MMPs, IL-6, IL-16, IL-1RA, G-CSF, GNLY, and ICAM1 were lower in the luteal phase than the follicular phase. Only IL-1α, HBD-2, and HBD-3 were elevated in the luteal phase. There was minimal change between the phases for CXCL8, 9, and 10, interferons, TNF, SLPI, elafin, lysozyme, lactoferrin, and interleukins 1β, 2, 10, 12, 13, and 17A. The GRADE strength of evidence was moderate to high for all immune mediators listed here.

CONCLUSIONS: Despite the variability of cervicovaginal immune mediator measurements, our meta-analyses show clear and consistent changes during the menstrual cycle. Many immune mediators were lower in the luteal phase, including chemokines, antibodies, matrix metalloproteinases, and several interleukins. Only interleukin-1α and beta-defensins were higher in the luteal phase. These cyclical differences may have consequences for immunity, susceptibility to infection, and fertility. Our study emphasizes the need to control for the effect of the menstrual cycle on immune mediators in future studies.

PMID:36195867 | DOI:10.1186/s12916-022-02532-9

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Management of oesophageal foreign bodies in children: a 10-year retrospective analysis from a tertiary care center

BMC Emerg Med. 2022 Oct 4;22(1):166. doi: 10.1186/s12873-022-00723-4.

ABSTRACT

OBJECTIVE: Oesophageal foreign bodies (EFBs) are a common emergency issue in paediatrics, and few studies have revealed its clinical features and treatment methods. We conducted this retrospective study to provide our 10-year clinical evidence for the diagnosis and treatment of EFB and reduce the incidence of complications.

METHODS: We retrospectively reviewed all paediatric cases diagnosed with EFB from January 2012 to December 2021 at Shenzhen Children’s Hospital. The age and sex of the patients, types of foreign bodies (FBs), preoperative examination, location and duration of FB impaction, clinical symptoms, surgical methods, therapeutic effects and complications were analysed.

RESULTS: Among the 1355 cases, 759 were boys and 596 were girls, with a median age of 2.9 years (4 months to 16 years). The shortest FB lodged time was 1 hour, while the longest time was 3 months. The types of foreign bodies included coins and blunt objects (812,59.9%), bones and sharp objects (278,20.5%), button batteries (86,6.3%), food impactions (84,6.2%), toys (51,3.8%) and plastic objects (44,3.2%). A total of 720 of 812 cases impacted by coins and blunt subjects were successfully treated with a Foley catheter without any complications. A total of 558 patients underwent rigid oesophageal endoscopy under general anaesthesia, and foreign bodies were successfully removed in 525 cases. No FB was found in 33 cases, and FBs pushed into the lower digestive tract during operation in 5 cases. Oesophageal injury was found in 130 cases (23.3%). Our study showed that the age of the patient, time of foreign body incarceration, type of foreign body, location of the lodged foreign body, and fever or cough were risk factors leading to oesophageal foreign body complications, and the differences were statistically significant (P < 0.05).

CONCLUSION: Children with EFB have a risk of complications, especially if the FB is a button battery. The appropriate surgical method should be selected through the analysis of the clinical characteristics of the foreign body in the oesophagus and the risk factors for complications to reduce the incidence of complications. Health education and effective care are the keys to the prevention of EFB.

PMID:36195854 | DOI:10.1186/s12873-022-00723-4

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Violence against women from partners and other household members during COVID-19 in Burkina Faso and Kenya

BMC Public Health. 2022 Oct 5;22(1):1857. doi: 10.1186/s12889-022-14197-3.

ABSTRACT

BACKGROUND: Global evidence indicates increases in gender-based violence (GBV) during the COVID-19 pandemic following mitigation measures, such as stay at home orders. Indirect effects of the pandemic, including income loss, strained social support, and closed or inaccessible violence response services, may further exacerbate GBV and undermine help-seeking. In Kenya and Burkina Faso, as in many settings, GBV was prevalent prior to the COVID-19 pandemic. Studies specific to COVID-impact on GBV in Kenya indicate mixed results and there remains a lack of evidence from Burkina Faso. Our study takes a comprehensive lens by addressing both intimate partner violence (IPV) and non-partner household abuse through the COVID-19 pandemic in two priority settings.

METHODS: Annual, national cross-sections of women ages 15-49 completed survey data collection in November-December 2020 and December 2020-March 2021; the GBV module was limited to one woman per household [Kenya n = 6715; Burkina n = 4065]. Descriptive statistics, Venn diagrams, and logistic and multinomial regression characterized prevalence of IPV and other household abuse, frequency relative to the COVID-19 pandemic, help-seeking behaviors, and predictors of IPV and household abuse across the socioecological framework.

RESULTS: In both settings, past-year IPV prevalence exceeded non-partner household abuse (Kenya: 23.5%IPV, 11.0%household; Burkina Faso: 25.7%IPV, 16.2%household). Over half of those affected in each setting did not seek help; those that did turned first to family. Among those with past-year experiences, increased frequency since COVID-19 was noted for IPV (16.0%Burkina Faso; 33.6%Kenya) and household violence (14.3%Burkina Faso; 26.2%Kenya). Both context-specific (i.e., financial autonomy in Burkina Faso) and universal (i.e., COVID-related income loss) risk factors emerged.

CONCLUSION: Past-year IPV and household violence against women in Kenya and Burkina Faso were prevalent, and in some cases, intensified during the COVID-19 pandemic. Across settings, help-seeking from formal services was notably low, likely reflecting shame, blame, and stigmatization identified as barriers in pre-COVID literature. Both primary prevention and survivor-centered support services, including those related to economic empowerment, should be integrated within COVID-recovery efforts, and extended into the post-pandemic period to fully meet women’s safety needs.

PMID:36195851 | DOI:10.1186/s12889-022-14197-3