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Identifying common core outcome domains from core outcome sets of musculoskeletal conditions: protocol for a systematic review

Syst Rev. 2022 Nov 19;11(1):248. doi: 10.1186/s13643-022-02120-1.

ABSTRACT

BACKGROUND: Core outcome sets (COSs) aim to reduce outcome heterogeneity in clinical practice and research by suggesting a minimum number of agreed-upon outcomes in clinical trials. Most COSs in the musculoskeletal field are developed for specific conditions. We propose that there are likely to be common core domains within existing musculoskeletal COSs that may be used as a starting point in the development of future COSs. We aim to identify common core domains from existing COSs and to facilitate the development of new COSs for musculoskeletal conditions. As a secondary aim, we will assess the development quality of these COSs.

METHODS: A systematic review including musculoskeletal COSs. We will search Core Outcome Measures in Effectiveness Trials (COMET) database, MEDLINE, EMBASE, Scopus, Cochrane Methodology Register and International Consortium for Health Outcome Measurement (ICHOM). Studies will be included if related to the development of a COS in adults with musculoskeletal conditions and for any type of intervention. Quality will be assessed using the Core Outcome Set-Standards for Development (COS-STAD) recommendations. Data extracted will include scope of the COS, health condition, interventions and outcome domains. Primary outcomes will be all core domains recommended within each COS. We define a common core outcome domain as one present in at least 67% of all COSs. All findings will be summarized and presented using descriptive statistics.

DISCUSSION: This systematic review of COSs will describe the core domains recommended within each musculoskeletal COS. Common domains found may be used in the initial stages of development of future musculoskeletal COSs.

SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42021239141.

PMID:36403060 | DOI:10.1186/s13643-022-02120-1

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The burden of chronic obstructive pulmonary disease and its attributable risk factors in the Middle East and North Africa region, 1990-2019

Respir Res. 2022 Nov 19;23(1):319. doi: 10.1186/s12931-022-02242-z.

ABSTRACT

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is a preventable and treatable disease that is characterised by persistent respiratory symptoms and airflow limitation. The present study reported the burden of COPD, and its attributable risk factors, in the Middle East and North Africa (MENA) region between 1990 and 2019, by age, sex and socio-demographic index (SDI).

METHODS: Data from the Global Burden of Disease (GBD) 2019 study were used to report the burden of COPD in the MENA countries. The prevalence, deaths, and disability-adjusted life-years (DALYs) were presented as counts and age-standardised rates per 100,000 population, with their associated 95% uncertainty intervals (UIs).

RESULTS: In 2019, the regional age-standardised point prevalence and rates of death due to COPD were 2333.9 (2230.1, 2443.6) and 26.1 (22.2, 29.5) per 100,000, which represent a 30.6% (28.2%, 33.0%) increase and an 18.0% (2.8%, 30.9%) decrease, respectively, since 1990. The regional age-standardised DALY rate in 2019 was 649.1 (574.6, 717.7) per 100,000, which had decreased by 11.8% (0.9%, 21.1%) since 1990. Turkey had the highest age-standardised point prevalence in 2019 [3287.1 (3187.4, 3380.3)], while Afghanistan had the highest age-standardised death [40.4 (24.2, 52.6)] and DALY [964.5 (681.8, 1203.2)] rates. The regional age-standardised point prevalence, death and DALY rates in 2019 increased with advancing age and were higher in males in almost all age groups. There was a U-shaped association between SDI and the burden of COPD over the period 1990 to 2019. Moreover, in 2019 smoking (43.7%), ambient particulate matter pollution (22.8%) and occupational particulate matter (11.4%) had the largest proportion of attributable DALYs for both sexes.

CONCLUSIONS: COPD is one of the leading causes of death and disability in the MENA region, although the age-standardised burden has decreased over the last 30 years. Nevertheless, COPD accounted for a substantial number of deaths and DALYs, especially among the elderly. Programs targeting risk factors, like smoking, should be taken into consideration.

PMID:36403049 | DOI:10.1186/s12931-022-02242-z

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Convergent validity of EQ-5D with core outcomes in dementia: a systematic review

Health Qual Life Outcomes. 2022 Nov 19;20(1):152. doi: 10.1186/s12955-022-02062-1.

ABSTRACT

OBJECTIVES: To explore through a systematic review, the convergent validity of EQ-5D (EQ-5D-3L and EQ-5D-5L (total score and dimensions)) with core outcomes in dementia and investigate how this may be impacted by rater-type; with the aim of informing researchers when choosing measures to use in dementia trials.

METHODS: To identify articles relevant to the convergent validity of EQ-5D with core dementia outcomes, three databases were electronically searched to September 2022. Studies were considered eligible for inclusion within the review if they included individual level data from people with dementia of any type, collected self and/or proxy reported EQ-5D and collected at least one core dementia outcome measure. Relevant data such as study sample size, stage of dementia and administration of EQ-5D was extracted, and a narrative synthesis was adopted.

RESULTS: The search strategy retrieved 271 unique records, of which 30 met the inclusion criteria for the review. Twelve different core outcome measures were used to capture dementia outcomes: cognition, function, and behaviour/mood across the studies. Most studies used EQ-5D-3L (n = 27). Evidence related to the relationship between EQ-5D and measures of function and behaviour/mood was the most robust, with unanimous directions of associations, and more statistically significant findings. EQ-5D dimensions exhibited associations with corresponding clinical outcomes, whereby relationships were stronger with proxy-EQ-5D (than self-report).

CONCLUSION: Measuring health-rated quality of life in dementia populations is a complex issue, particularly when considering balancing the challenges associated with both self and proxy report. Published evidence indicates that EQ-5D shows evidence of convergent validity with the key dementia outcomes, therefore capturing these relevant dementia outcomes. The degree of associations with clinical measures was stronger when considering proxy-reported EQ-5D and differed by EQ-5D dimension type. This review has revealed that, despite the limited targeted psychometric evidence pool and reliance on clinical and observational studies, EQ-5D exhibits convergent validity with other dementia outcome measures.

PMID:36403046 | DOI:10.1186/s12955-022-02062-1

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The effect of family integrated care on the prognosis of premature infants

BMC Pediatr. 2022 Nov 19;22(1):668. doi: 10.1186/s12887-022-03733-0.

ABSTRACT

BACKGROUND: The purpose of this study was to investigate the effect of family integrated care (FICare) on the prognosis of children hospitalized with preterm infants.

METHODS: Two hundred thirty preterm infants admitted to our hospital from January 2019 to April 2021 were enrolled in a prospective randomized study and divided into 115 cases in the intervention group and 115 cases in the control group according to the random number table method, and given the FICare and the conventional care, respectively. The duration of nasogastric tube retention, time to achieve total enteral nutrition, rate of weight gain, exclusive breastfeeding rate, length of hospital stay, growth and development, readmission rate, parental self-efficacy, family functioning and complications related to prematurity were compared between the two groups.

RESULTS: Compared with the control group, the intervention group had shorter nasogastric tube retention time, shorter time to achieve total enteral nutrition, higher exclusive breastfeeding rate, shorter time of hospital stay and better growth rate. Before the intervention, there was no difference in parental self-efficacy and family functioning between the two groups; after the intervention, the intervention group had higher parental self-efficacy and higher ratings of family functioning, and the difference was statistically significant. Compared with the control group, the intervention group had a lower readmission rate and significantly lower incidence of infection and choking.

CONCLUSION: The FICare can shorten the time of nasogastric tube retention, shorten time to achieve total enteral nutrition and hospital stay, increase the rate of exclusive breastfeeding and the rate of weight gain, finally improve the prognosis of preterm infants and have a positive effect on parents.

PMID:36403036 | DOI:10.1186/s12887-022-03733-0

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Identification and validation of methylated PENK gene for early detection of bladder cancer using urine DNA

BMC Cancer. 2022 Nov 19;22(1):1195. doi: 10.1186/s12885-022-10275-2.

ABSTRACT

BACKGROUND: Early detection of bladder cancer (BCa) offers patients a favorable outcome and avoids the need for cystectomy. Development of an accurate and sensitive noninvasive BCa diagnostic test is imperative. DNA methylation is an early epigenetic event in the development of BCa. Certain specific aberrant methylations could serve as useful biomarkers. The aim of this study was to identify methylation biomarkers for early detection of BCa.

METHODS: CpG methylation microarray analysis was conducted on primary tumors with varying stages (T1-T4) and paired nontumor tissues from nine BCa patients. Bisulfite-pyrosequencing was performed to confirm the methylation status of candidate genes in tissues and urine sediments (n = 51). Among them, PENK was selected as a potential candidate and validated using an independent set of 169 urine sediments (55 BCa, 25 benign urologic diseases, 8 other urologic cancers, and 81 healthy controls) with a quantitative methylation-specific real time PCR (mePENK-qMSP). All statistical analyses were performed using MedCalc software version 9.3.2.0.

RESULTS: CpG methylation microarray analysis and stepwise validation by bisulfite-pyrosequencing for tissues and urine sediments supported aberrant methylation sites of the PENK gene as potential biomarkers for early detection of BCa. Clinical validation of the mePENK-qMSP test using urine sediment-DNA showed a sensitivity of 86.5% (95% CI: 71.2 – 95.5%), a specificity of 92.5% (95% CI: 85.7 – 96.7%), and an area under ROC of 0.920 (95% CI: 0.863 – 0.959) in detecting Ta high-grade and advanced tumor stages (T1-T4) of BCa patients. Sensitivities for Ta low-grade, Ta high-grade, T1 and T2-T4 were 55.6, 83.3, 88.5, and 100%, respectively. Methylation status of PENK was not correlated with sex, age or stage, while it was associated with the tumor grade of BCa.

CONCLUSIONS: In this study, we analyzed the comprehensive patterns of DNA methylation identified that PENK methylation possesses a high potential as a biomarker for urine-based early detection of BCa. Validation of PENK methylation confirms that it could significantly improve the noninvasive detection of BCa.

PMID:36403035 | DOI:10.1186/s12885-022-10275-2

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The association between video or telephone telemedicine visit type and orders in primary care

BMC Med Inform Decis Mak. 2022 Nov 19;22(1):302. doi: 10.1186/s12911-022-02040-z.

ABSTRACT

INTRODUCTION: Telemedicine is increasingly relied upon for care delivery in primary care, but the impact of visit type on clinical ordering behavior is uncertain.

METHODS: Within Kaiser Permanente Northern California, we identified patients who self-scheduled and completed telemedicine encounters with their personal primary care provider or another available primary care provider in the same medical group, between April 1st, 2020, and October 31st, 2020, while physical distancing restrictions for COVID-19 were in place. We collected patient sociodemographic and clinical characteristics, measures of technology access, and categorized the most common primary encounter diagnoses. We measured proportions of patient-scheduled video versus telephone visits for each of eight diagnosis groups (Skin & Soft Tissue, Musculoskeletal Pain, Back Pain, General Gastrointestinal, Hypertension & Diabetes, Mental Health, Upper Respiratory, and Abdominal Pain), and compared physician orders for medications, antibiotics, lab and imaging studies by visit type within each diagnosis group.

RESULTS: There were 273,301 included encounters, with 86,676 (41.5%) video visits and 122,051 (58.5%) telephone visits. Of the diagnosis groups, Skin & Soft Tissue conditions had the highest proportion of video visits (59.7%), while Mental Health conditions had the highest proportion of telephone visits (71.1%). After adjusting for covariates, the overall rates of medication orders (46.6% vs. 44.5%), imaging orders (17.3% vs. 14.9%), lab orders (19.5% vs. 17.2%), and antibiotic orders (7.5% vs. 5.2%) were higher during video visits as compared to telephone visits (p < 0.05). The largest difference within diagnosis groups was for Skin & Soft Tissue conditions, where the rate of medication orders was 9.1% higher than during video visits than telephone visits (45.5% vs. 36.5%, p < 0.05).

CONCLUSIONS: We observed statistically significant differences in clinician orders by visit type during telemedicine encounters for common primary care conditions. Our findings suggest that, for certain conditions, visual information conveyed during video visits may promote clinical work-up and treatment.

PMID:36403030 | DOI:10.1186/s12911-022-02040-z

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Prescribing and sales of intramammary antimicrobials in Ireland in 2019 and 2020: the role of milk purchasers

Ir Vet J. 2022 Nov 19;75(1):20. doi: 10.1186/s13620-022-00227-4.

ABSTRACT

BACKGROUND: In Ireland between 2008 and 2022, intramammary antimicrobial (AM) products could be prescribed by a veterinary practitioner under what was known as Schedule 8 (or remote) prescribing. Under this prescribing route, an annual herd visit was not required when criteria were met as outlined in Animal Remedies Regulation 2007 to 2017 (statutory instruments No. 786/2007 and 558/2017). Under this prescribing route, the responsibilities of the milk purchaser, the farmer and the veterinary practitioner were each outlined, and a written mastitis control programme (MCP) was required. Milk purchasers implemented MCPs on participating farms (so-called MCP herds) with support from veterinary practitioner(s) who undertook Schedule 8 prescribing of intramammary AM tubes. This study seeks a clearer understanding of the role of milk purchasers in the prescribing and sale of intramammary AM products in Ireland during 2019 and 2020, whilst this Regulation was in force. Specifically, the study sought insights into the role of milk purchasers in the prescribing and sale of intramammary AM products in the Irish dairy industry during 2019 and 2020, using anonymised and highly aggregated milk purchaser data. The study also provided insights into milk quality among supplying herds during this period.

METHODS: For this study, we had access to anonymised, highly aggregated data from all milk purchasers that operated a MCP on at least some of their supplying herds during 2019 or 2020. Data collection was undertaken by the Department of Agriculture, Food and Marine. Data analysis was primarily descriptive.

RESULTS: Data were available on 11 milk purchasers (64.7% of all) and 13,251 supplying herds. Of these, 52% were MCP herds. The quality of milk from supplying herds varied significantly by month, year and milk purchaser. During 2019 and 2020, there was a single Schedule 8 prescriber (a private veterinary practitioner prescribing intramammary AMs as part of a MCP), on average, for 549.3 herds. The sale of intramammary AM products through milk purchasers represented 15.2% and 26.9% of national sales in in-lactation and dry cow tubes, respectively. There was an overall 2% increase in sales through milk purchasers between 2019 and 2020. Few European Medicines Agency (EMA) category B (‘Restrict’) intramammary AM products were sold by milk purchasers. For both in-lactation and dry cow tubes, there was a statistically significant association between EMA classification and route of sale (through milk purchasers or otherwise).

CONCLUSIONS: The study findings provide important insights into mastitis control and intramammary AM stewardship in the Irish dairy industry. Significant differences between milk purchasers were observed in the quality of milk, as measured through somatic cell count (SCC) values, from supplying herds. This warrants further research. In the context of intramammary AM prescribing, veterinary oversight under the Animal Remedies Regulation 2007 to 2017 was very limited during 2019 and 2020. There were also significant associations between EMA classification and route of sale during 2019 and 2020, reinforcing the need for Irish veterinary practitioners to move away from EMA category B intramammary AMs. Higher quality data are needed to address important industry questions. Specifically it is recommended that national bulk tank SCC data are made available for public good research. Past experiences with Schedule 8 prescribing (no longer permitted from 28 January 2022) may influence current efforts towards improved intramammary AM stewardship.

PMID:36403021 | DOI:10.1186/s13620-022-00227-4

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Treatment barriers among young adults living with a substance use disorder in Tshwane, South Africa

Subst Abuse Treat Prev Policy. 2022 Nov 19;17(1):75. doi: 10.1186/s13011-022-00501-2.

ABSTRACT

BACKGROUND: Despite increasing substance use globally, substance use treatment utilisation remains low. This study sought to explore and measure substance use treatment barriers among young adults in South Africa.

METHODS: The study was done in collaboration with the Community-Oriented Substance Use Programme run in Tshwane, South Africa. A mixed methods approach employing focus group discussions with key informants (n = 15), a survey with a random sample of people using substances and receiving treatment (n = 206), and individual semi-structured interviews (n = 15) was used. Descriptive statistics and thematic analysis were used to analyse data.

RESULTS: Contextual barriers seemed more prominent than attitudinal barriers in the South African context. Fragmented services, stigma-related factors, an information gap and lack of resources and support (contextual factors), perceived lack of treatment efficacy, privacy concerns, and denial and unreadiness to give up (attitudinal factors) were treatment barriers that emerged as themes in both quantitative and qualitative data. Culture and religion/spirituality emerged as an important barrier/facilitator theme in the qualitative data.

CONCLUSION: Interventions need to embrace contextual factors such as culture, and more resources should be channelled towards substance use treatment. Multi-level stakeholder engagement is needed to minimise stigmatising behaviours from the community and to raise awareness of available treatment services. There is a need for strategies to integrate cultural factors, such as religion/spirituality and traditional healing, into treatment processes so that they complementarily work together with pharmacological treatments to improve health outcomes.

PMID:36403019 | DOI:10.1186/s13011-022-00501-2

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Development and validation of a risk prediction model for overall survival in patients with nasopharyngeal carcinoma: a prospective cohort study in China

Cancer Cell Int. 2022 Nov 19;22(1):360. doi: 10.1186/s12935-022-02776-8.

ABSTRACT

OBJECTIVE: Nasopharyngeal carcinoma (NPC) is prevailing in Southern China, characterized by distinct geographical distribution. Aimed to predict the overall survival (OS) of patients with nasopharyngeal carcinoma, this study developed and validated nomograms considering demographic variables, hematological biomarkers, and oncogenic pathogens in China.

METHODS: The clinicopathological and follow-up data of the nasopharyngeal carcinoma patients obtained from a prospective longitudinal cohort study in the Chongqing University Cancer Hospital between Jan 1, 2017 and Dec 31, 2019 ([Formula: see text]). Cox regression model was used to tested the significance of all available variables as prognostic factors of OS. And independent prognostic factors were identified based on multivariable analysis to model nomogram. Concordance index (C-index), area under the receiver operating characteristic (AUC), calibration curve, and decision curve analysis (DCA) were measured to assess the model performance of nomogram.

RESULTS: Data was randomly divided into a training cohort (1227 observers, about 70% of data) and a validation group (408 observers, about 30% of data). At multivariable analysis, the following were independent predictors of OS in NPC patients and entered into the nomogram: age (hazard ratio [HR]: 1.03), stage (stage IV vs. stage I-II, HR: 4.54), radiotherapy (Yes vs. No, HR: 0.43), EBV ([Formula: see text] vs.[Formula: see text], HR: 1.92), LAR ([Formula: see text] vs.[Formula: see text], HR: 2.05), NLR ([Formula: see text] vs. [Formula: see text] HR: 1.54), and PLR ([Formula: see text] vs.[Formula: see text], HR: 1.79). The C-indexes for training cohort at 1-, 3- and 5-year were 0.73, 0.83, 0.80, respectively, in the validation cohort, the C-indexes were 0.74 (95% CI 0.63-0.86), 0.80 (95% CI 0.73-0.87), and 0.77 (95% CI 0.67-0.86), respectively. The calibration curve demonstrated that favorable agreement between the predictions of the nomograms and the actual observations in the training and validation cohorts. In addition, the decision curve analysis proved that the nomogram model had the highest overall net benefit.

CONCLUSION: A new prognostic model to predict OS of patients with NPC was developed. This can offer clinicians treatment making and patient counseling. Furthermore, the nomogram was deployed into a website server for use.

PMID:36403013 | DOI:10.1186/s12935-022-02776-8

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Level and comfort of caregiver-young adolescent communication on sexual and reproductive health: a cross-sectional survey in south-western Uganda

BMC Public Health. 2022 Nov 19;22(1):2129. doi: 10.1186/s12889-022-14561-3.

ABSTRACT

BACKGROUND: Communication on sexual and reproductive health (SRH) between caregivers and their young adolescent children plays a significant role in shaping attitudes and behaviours that are critical to laying the foundations for positive and safe SRH behaviours in later adolescence. Nevertheless, this communication is often limited, particularly in countries where adolescent sexuality is taboo. This study assessed the topics discussed (‘level’) and the comfort of caregivers with communicating with young adolescents on SRH, and their correlates. METHODS: A cross-sectional survey was conducted among 218 caregivers of young adolescents (10-14 years) in Mbarara district of south-western Uganda in January and February 2020. Participants were selected through consecutive sampling. A structured, pre-tested questionnaire administered by interviewers was used for data collection. The surveys were computer-assisted using Kobo Collect software. Data was exported to STATA 14 for analysis. Level of SRH communication was measured based on 10 SRH communication topics, while comfort was based on 9 SRH discussion topics. Bivariate and multivariate linear regression analyses were conducted to determine correlates of level of, and comfort with, SRH communication P-value < 0.05 was considered for statistical significance.

RESULTS: The mean number of topics that caregivers discussed was 3.9 (SD = 2.7) out of the 10 SRH topics explored. None of the respondents discussed all the topics; 2% reported ever discussing nine topics with their young adolescent, while 3.5% reported never discussing any of the topics. General health and bodily hygiene (89.9%) and HIV/AIDS and other sexually transmitted infections (STIs) (77.5%) were the most commonly discussed, while night emissions in boys (4.3%) and condoms (8.3%) were least discussed. The majority of caregivers (62%) reported a high level of comfort with discussing SRH. The mean comfort score was 21.9 (SD = 3.8). In general, the level of SRH communication increased with an increase in comfort with SRH communication β = 0.22 (0.04); 95% CI = (0.15, 0.30). The level of comfort with SRH communication decreased with an increase in the number of YAs in a household β = -0.92 (0.38); 95%CI = (-1.66,-0.18).

CONCLUSION: Overall, the level of SRH communication is low and varies according to the number of SRH topics. Caregivers’ comfort with SRH communication with YAs was a significant correlate of SRH communication. This justifies the need for interventions that aim to improve caregivers’ comfort with communicating with young adolescents about SRH.

PMID:36403003 | DOI:10.1186/s12889-022-14561-3