Reporting Conflicts of Interest and Funding in Health Care Guidelines: The RIGHT-COI&F Checklist.

BACKGROUND: Conflicts of interest (COIs) of contributors to a guideline project and the funding of that project can influence the development of the guideline. Comprehensive reporting of information on COIs and funding is essential for the transparency and credibility of guidelines. OBJECTIVE: To develop an extension of the Reporting Items for practice Guidelines in HealThcare (RIGHT) statement for the reporting of COIs and funding in policy documents of guideline organizations and in guidelines: the RIGHT-COI&F checklist. DESIGN: The recommendations of the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) network were followed. The process consisted of registration of the project and setting up working groups, generation of the initial list of items, achieving consensus on the items, and formulating and testing the final checklist. SETTING: International collaboration. PARTICIPANTS: 44 experts. MEASUREMENTS: Consensus on checklist items. RESULTS: The checklist contains 27 items: 18 about the COIs of contributors and 9 about the funding of the guideline project. Of the 27 items, 16 are labeled as policy related because they address the reporting of COI and funding policies that apply across an organization's guideline projects. These items should be described ideally in the organization's policy documents, otherwise in the specific guideline. The remaining 11 items are labeled as implementation related and they address the reporting of COIs and funding of the specific guideline. LIMITATION: The RIGHT-COI&F checklist requires testing in real-life use. CONCLUSION: The RIGHT-COI&F checklist can be used to guide the reporting of COIs and funding in guideline development and to assess the completeness of reporting in published guidelines and policy documents. PRIMARY FUNDING SOURCE: The Fundamental Research Funds for the Central Universities of China.

Evaluating tuberculosis treatment outcomes in Haiti from 2018 to 2019: A competing risk analysis.

Objectives: This study assesses tuberculosis (TB) treatment outcomes in Haiti. Methods: Data from drug-susceptible patients with TB (2018-2019) were analyzed using the Fine & Gray model with multiple imputation. Results: Of the 16,545 patients, 14.7% had concurrent HIV coinfection, with a 66.2% success rate. The median treatment duration was 5 months, with patients averaging 30 years (with an interquartile range of 22-42 years). The estimated hazard of achieving a successful treatment outcome decreased by 2.5% and 8.1% for patients aged 45 and 60 years, respectively, compared with patients aged 30 years. Male patients had a 6.5% lower estimated hazard of success than their female counterparts. In addition, patients coinfected with HIV experienced a 35.3% reduction in the estimated hazard of achieving a successful treatment outcome compared with those with a negative HIV serologic status. Conclusions: Integrated health care approaches should be implemented, incorporating innovative solutions, such as machine learning algorithms combined with geographic information systems and non-conventional data sources (including social media), to identify TB hotspots and high-burden households.

CARE-radiology statement explanation and elaboration: reporting guideline for radiological case reports.

Despite the increasing number of radiological case reports, the majority lack a standardised methodology of writing and reporting. We therefore develop a reporting guideline for radiological case reports based on the CAse REport (CARE) statement. We established a multidisciplinary group of experts, comprising 40 radiologists, methodologists, journal editors and researchers, to develop a reporting guideline for radiological case reports according to the methodology recommended by the Enhancing the QUAlity and Transparency Of health Research network. The Delphi panel was requested to evaluate the significance of a list of elements for potential inclusion in a guideline for reporting mediation analyses. By reviewing the reporting guidelines and through discussion, we initially drafted 46 potential items. Following a Delphi survey and discussion, the final CARE-radiology checklist is comprised of 38 items in 16 domains. CARE-radiology is a comprehensive reporting guideline for radiological case reports developed using a rigorous methodology. We hope that compliance with CARE-radiology will help in the future to improve the completeness and quality of case reports in radiology.

The effects of exercise on insomnia disorders: An umbrella review and network meta-analysis.

OBJECTIVE: To summarize the evidence of various exercise modalities on population with insomnia disorders. METHOD: PubMed, Embase, Cochrane Library, and Web of Science were searched for eligible studies published from inception to October 2022 and updated on September 2023. Systematic reviews with meta-analyses and randomized controlled trials designed to investigate the effect of various exercise modalities on population with insomnia were eligible. RESULTS: A total of 4 SRs with (very) low methodological quality and 1034 participants in 10 network meta-analyses explored the association between different types and intensity exercise modalities with insomnia disorders. Various exercise modalities could significantly improve total sleep time and sleep quality and alleviate insomnia severity. Compared to passive control, moderate aerobic exercise, moderate aerobic exercise combined with light intensity strength and mind-body exercise can improve sleep efficiency and reduce wake after sleep onset by objectively measured. Moderate intensity strength, light intensity strength and mind-body exercise can improve sleep efficiency subjectively measured; mind-body exercise can reduce sleep onset latency and wake time after sleep onset, and increase total sleep time; moderate aerobic exercise can reduce sleep onset latency. Moderate intensity strength, light intensity strength, mind body exercise and moderate aerobic exercise combined with light intensity strength can the severity of insomnia and improv sleep quality. CONCLUSION: Exercise had a positive effect on relief insomnia and improve sleep quality. Moderate aerobic exercise, mind-body exercise and moderate aerobic exercise combined with light intensity strength play an important role in improving the sleep quality in people with insomnia disorders.

The spatial spread of HIV in Malawi: An individual-based mathematical model.

Background: The prevalence of HIV varies greatly between and within countries. We aimed to build a comprehensive mathematical modelling tool capable of exploring the reasons of this heterogeneity and test its applicability by simulating the Malawian HIV epidemic. Methods: We developed a flexible individual-based mathematical model for HIV transmission that comprises a spatial representation and individual-level determinants. We tested this model by calibrating it to the HIV epidemic in Malawi and exploring whether the heterogeneity in HIV prevalence could be reproduced. We ran the model for 1975-2030 with five alternative realizations of the geographical structure and mobility: (I) no geographical structure; 28 administrative districts including (II) only permanent inter-district relocations, (III) inter-district permanent relocations and casual sexual relationships, or (IV) permanent relocations between districts and to/from abroad and inter-district casual sex; and (V) a grid of 10 × 10km2 cells, with permanent relocations and between-cell casual relationships. We assumed HIV was present in 1975 in the districts with >10 % prevalence in 2010. We calibrated the models to national and district-level prevalence estimates. Results: Reaching the national prevalence required all adults to have at least 22 casual sex acts/year until 1990. Models II, III and V reproduced the geographical heterogeneity in prevalence in 2010 to some extent if between-district relationships were excluded (Model II; 4.9 %-21.1 %). Long-distance casual partnership mixing mitigated the differences in prevalence substantially (range across districts 4.1%-18.9 % in 2010 in Model III; 4.0%-17.6 % in Model V); with international migration the differences disappeared (Model IV; range across districts 6.9%-13.3 % in 2010). National prevalence decreased to 5 % by 2030. Conclusion: Earlier introduction of HIV into the Southern part of Malawi may cause some level of heterogeneity in HIV prevalence. Other factors such as sociobehavioural characteristics are likely to have a major impact and need investigation.

Differences between persons with and without disability in HIV prevalence, testing, treatment, and care cascade in Tanzania: a cross-sectional study using population-based data.

BACKGROUND: Persons with disability may have a higher HIV prevalence and be less likely than persons without disability to know their HIV-positive status, access antiretroviral therapy (ART), and suppress their HIV viral load (HIV care cascade). However, studies examining differences between persons with and without disability in HIV prevalence and the HIV care cascade are lacking. Using the Tanzania HIV Impact Survey (THIS) data collected between October 2016 and August 2017, we assessed differences in HIV prevalence and progress towards achieving the 2020 HIV care cascade target between persons with and without disability. METHODS: Using the Washington Group Short Set (WG-SS) Questions on Disability, we defined disability as having a functional difficulty in any of the six life domains (seeing, hearing, walking/climbing, remembering/ concentrating, self-care, and communicating). We classified respondents as disabled if they responded having either "Some Difficulty", "A lot of difficulties" or "Unable to" in any of the WG-SS Questions. We presented the sample characteristics by disability status and analyzed the achievement of the cascade target by disability status, and sex. We used multivariable logistic regressions, and adjusted for age, sex, rural-urban residence, education, and wealth quintile. RESULTS: A total of 31,579 respondents aged 15 years and older had HIV test results. Of these 1,831 tested HIV-positive, corresponding to an estimated HIV prevalence of 4.9% (CI: 4.5 - 5.2%) among the adult population in Tanzania. The median age of respondents who tested HIV-positive was 32 years (with IQR of 21-45 years). HIV prevalence was higher (5.7%, 95% CI: 5.3-7.4%) among persons with disability than persons without disability (4.3%, 95% CI: 4.0 - 4.6%). Before adjustment, compared to women without disability, more women with disability were aware of their HIV-positive status (n = 101, 79.0%, 95% CI: 68.0-87.0% versus n = 703, 63.0%, 95% CI: 59.1-66.7%) and accessed ART more frequently (n = 98, 98.7%, 95% CI: 95.3-99.7% versus n = 661, 94.7%, 95% CI: 92.6-96.3%). After adjusting for socio-demographic characteristics, the odds of having HIV and of accessing ART did not differ between persons with and without disability. However, PLHIV with disability had higher odds of being aware of their HIV-positive status (aOR 1.69, 95% 1.05-2.71) than PLHIV without disability. Men living with HIV and with disability had lower odds (aOR = 0.23, 95% CI: 0.06-0.86) to suppress HIV viral loads than their counterparts without disability. CONCLUSION: We found no significant differences in the odds of having HIV and of accessing ART between persons with and without disability in Tanzania. While PLHIV and disability, were often aware of their HIV-positive status than their non-disabled counterparts, men living with HIV and with disability may have been disadvantaged in having suppressed HIV viral loads. These differences are correctable with disability-inclusive HIV programming. HIV surveys around the world should include questions on disability to measure potential differences in HIV prevalence and in attaining the 2025 HIV care cascade target between persons with and without disability.

Treatment effect of remdesivir on the mortality of hospitalised COVID-19 patients in Switzerland across different patient groups: a tree-based model analysis.

AIMS OF THE STUDY: Remdesivir has shown benefits against COVID-19. However, it remains unclear whether, to what extent, and among whom remdesivir can reduce COVID-19-related mortality. We explored whether the treatment response to remdesivir differed by patient characteristics. METHODS: We analysed data collected from a hospital surveillance study conducted in 21 referral hospitals in Switzerland between 2020 and 2022. We applied model-based recursive partitioning to group patients by the association between treatment levels and mortality. We included either treatment (levels: none, remdesivir within 7 days of symptom onset, remdesivir after 7 days, or another treatment), age and sex, or treatment only as regression variables. Candidate partitioning variables included a range of risk factors and comorbidities (and age and sex unless included in regression). We repeated the analyses using local centring to correct the results for the propensity to receive treatment. RESULTS: Overall (n = 21,790 patients), remdesivir within 7 days was associated with increased mortality (adjusted hazard ratios 1.28-1.54 versus no treatment). The CURB-65 score caused the most instability in the regression parameters of the model. When adjusted for age and sex, patients receiving remdesivir within 7 days of onset had higher mortality than those not treated in all identified eight patient groups. When age and sex were included as partitioning variables instead, the number of groups increased to 19-20; in five to six of those branches, mortality was lower among patients who received early remdesivir. Factors determining the groups where remdesivir was potentially beneficial included the presence of oncological comorbidities, male sex, and high age. CONCLUSIONS: Some subgroups of patients, such as individuals with oncological comorbidities or elderly males, may benefit from remdesivir.

Molnupiravir for the treatment of non-severe COVID-19: a systematic review and meta-analysis of 14 randomized trials with 34 570 patients.

BACKGROUND: Molnupiravir has been considered a promising candidate for COVID-19. Its efficacy and safety in non-severe COVID-19 patients and the differences between patients with different risk factors need further evaluation. METHODS: We conducted a systematic review and meta-analysis of randomized controlled trials that allocated adult patients with non-severe COVID-19 to molnupiravir or a control. We used random-effects models, and conducted subgroup analyses and meta-regression for COVID-19 patients with high-risk factors. The GRADE approach was used to rate the certainty of evidence. RESULTS: Fourteen trials with 34 570 patients were included. Moderate- to low-certainty evidence showed that molnupiravir was associated with a reduction in the risk of hospitalization (relative risk [RR] = 0.63, 95% CI: 0.47-0.85), risk of mechanical ventilation (RR = 0.37, 95% CI: 0.19-0.72) and time to symptom resolution (mean differences [MD] = -2.91 days, 95% CI: -3.66 to -2.16). However, no significant differences were found in adverse events, all-cause mortality, rate of and time to viral clearance, or duration of hospitalization. For the rate of viral clearance, subgroup effects were found between trials with low and high risk of bias (P = 0.001) and between trials with male or female majority (P < 0.001). For admission to hospital, subgroup effects were also found between trials with ≥50% and <50% of the participants being female (P = 0.04). Meta-regression showed a significant association between higher trial mean age and elevated risk of hospitalization (P = 0.011), and female majority and elevated risk of hospitalization (P = 0.011). CONCLUSIONS: Molnupiravir was found to be effective in non-severe COVID-19, but the efficacy varied with age and sex.

Historical visit attendance as predictor of treatment interruption in South African HIV patients: Extension of a validated machine learning model.

Retention of antiretroviral (ART) patients is a priority for achieving HIV epidemic control in South Africa. While machine-learning methods are being increasingly utilised to identify high risk populations for suboptimal HIV service utilisation, they are limited in terms of explaining relationships between predictors. To further understand these relationships, we implemented machine learning methods optimised for predictive power and traditional statistical methods. We used routinely collected electronic medical record (EMR) data to evaluate longitudinal predictors of lost-to-follow up (LTFU) and temporal interruptions in treatment (IIT) in the first two years of treatment for ART patients in the Gauteng and North West provinces of South Africa. Of the 191,162 ART patients and 1,833,248 visits analysed, 49% experienced at least one IIT and 85% of those returned for a subsequent clinical visit. Patients iteratively transition in and out of treatment indicating that ART retention in South Africa is likely underestimated. Historical visit attendance is shown to be predictive of IIT using machine learning, log binomial regression and survival analyses. Using a previously developed categorical boosting (CatBoost) algorithm, we demonstrate that historical visit attendance alone is able to predict almost half of next missed visits. With the addition of baseline demographic and clinical features, this model is able to predict up to 60% of next missed ART visits with a sensitivity of 61.9% (95% CI: 61.5-62.3%), specificity of 66.5% (95% CI: 66.4-66.7%), and positive predictive value of 19.7% (95% CI: 19.5-19.9%). While the full usage of this model is relevant for settings where infrastructure exists to extract EMR data and run computations in real-time, historical visits attendance alone can be used to identify those at risk of disengaging from HIV care in the absence of other behavioural or observable risk factors.

Socioeconomic inequalities in cervical precancer screening among women in Ethiopia, Malawi, Rwanda, Tanzania, Zambia and Zimbabwe: analysis of Population-Based HIV Impact Assessment surveys.

OBJECTIVES: We examined age, residence, education and wealth inequalities and their combinations on cervical precancer screening probabilities for women. We hypothesised that inequalities in screening favoured women who were older, lived in urban areas, were more educated and wealthier. DESIGN: Cross-sectional study using Population-Based HIV Impact Assessment data. SETTING: Ethiopia, Malawi, Rwanda, Tanzania, Zambia and Zimbabwe. Differences in screening rates were analysed using multivariable logistic regressions, controlling for age, residence, education and wealth. Inequalities in screening probability were estimated using marginal effects models. PARTICIPANTS: Women aged 25-49 years, reporting screening. OUTCOME MEASURES: Self-reported screening rates, and their inequalities in percentage points, with differences of 20%+ defined as high inequality, 5%-20% as medium, 0%-5% as low. RESULTS: The sample size of participants ranged from 5882 in Ethiopia to 9186 in Tanzania. The screening rates were low in the surveyed countries, ranging from 3.5% (95% CI 3.1% to 4.0%) in Rwanda to 17.1% (95% CI 15.8% to 18.5%) and 17.4% (95% CI 16.1% to 18.8%) in Zambia and Zimbabwe. Inequalities in screening rates were low based on covariates. Combining the inequalities led to significant inequalities in screening probabilities between women living in rural areas aged 25-34 years, with a primary education level, from the lowest wealth quintile, and women living in urban areas aged 35-49 years, with the highest education level, from the highest wealth quintile, ranging from 4.4% in Rwanda to 44.6% in Zimbabwe. CONCLUSIONS: Cervical precancer screening rates were inequitable and low. No country surveyed achieved one-third of the WHO's target of screening 70% of eligible women by 2030. Combining inequalities led to high inequalities, preventing women who were younger, lived in rural areas, were uneducated, and from the lowest wealth quintile from screening. Governments should include and monitor equity in their cervical precancer screening programmes.

Development of the Scientific, Transparent and Applicable Rankings (STAR) tool for clinical practice guidelines.

BACKGROUND: This study aimed to develop a comprehensive instrument for evaluating and ranking clinical practice guidelines, named Scientific, Transparent and Applicable Rankings tool (STAR), and test its reliability, validity, and usability. METHODS: This study set up a multidisciplinary working group including guideline methodologists, statisticians, journal editors, clinicians, and other experts. Scoping review, Delphi methods, and hierarchical analysis were used to develop the STAR tool. We evaluated the instrument's intrinsic and interrater reliability, content and criterion validity, and usability. RESULTS: STAR contained 39 items grouped into 11 domains. The mean intrinsic reliability of the domains, indicated by Cronbach's α coefficient, was 0.588 (95% confidence interval [CI]: 0.414, 0.762). Interrater reliability as assessed with Cohen's kappa coefficient was 0.774 (95% CI: 0.740, 0.807) for methodological evaluators and 0.618 (95% CI: 0.587, 0.648) for clinical evaluators. The overall content validity index was 0.905. Pearson's r correlation for criterion validity was 0.885 (95% CI: 0.804, 0.932). The mean usability score of the items was 4.6 and the median time spent to evaluate each guideline was 20 min. CONCLUSION: The instrument performed well in terms of reliability, validity, and efficiency, and can be used for comprehensively evaluating and ranking guidelines.

Reporting standards for child health research were few and poorly implemented.

OBJECTIVES: This study aims to identify existing reporting standards for child health research, assess the robustness of the standards development process, and evaluate the dissemination of these standards. STUDY DESIGN AND SETTING: We searched MEDLINE, the EQUATOR Network Library, and Google to identify reporting standards for child health research studies. We assessed the adherence of the Guidance for Developers of Health Research Reporting Guidelines (GDHRG) by the identified reporting standards. We also assessed the use of the identified reporting standards by primary research studies, and the endorsement of the included reporting standards by journals. RESULTS: We identified six reporting standards for child health research, including two under development. Among the four available standards their median adherence to the 18 main steps of the GDHRG was 58.35% (range: 27.8%-83.3%). None of these four reporting standards had been endorsed by pediatric journals indexed by the Science Citation Index. Only 26 primary research studies declared that they followed one of the reporting standards. CONCLUSION: There is a quantitative and qualitative paucity of well-developed reporting standards for child health research. The available standards are also poorly implemented. This situation demands an urgent need to develop robust standards and ensure their implementation.

Sub optimal HIV status ascertainment at antenatal clinics and the impact on HIV prevalence estimates: A cross sectional study.

BACKGROUND: While many countries including Kenya transitioned from sentinel surveillance to the use of routine antenatal care (ANC) data to estimate the burden of HIV, countries in Sub Saharan Africa reported several challenges of this transition, including low uptake of HIV testing and sub national / site-level differences in HIV prevalence estimates. In Kenya voluntary HIV testing is offered to all 1st ANC clients. However, some women may decline testing. We aim to predict the HIV positivity (as a proxy of prevalence) at ANC assuming 100% uptake of HIV testing and compare this to the observed positivity. METHODS: Using a cross sectional study design, we examine routine data on HIV testing among all women attending ANC in Kwale County, Kenya, for the period January 2015 to December 2019.We used a generalized estimating equation with binomial distribution to model the observed HIV prevalence as explained by HIV status ascertainment. We then used marginal standardization to predict the HIV prevalence at 100% HIV status ascertainment and make recommendations to improve the utility of ANC routine data for HIV surveillance. RESULTS: HIV testing at ANC was at 91.3%, slightly above the global target of 90%. If there was 100% HIV status ascertainment at ANC, the HIV prevalence would be 2.7% (95% CI 2.3-3.2). This was 0.3% lower than the observed prevalence. Across the yearly predictions, there was no difference between the observed and predicted values except for 2018 where the HIV prevalence was underestimated with an absolute bias of -0.2 percent. This implies missed opportunities for identifying new HIV infections in the year 2018. CONCLUSIONS: Imperfect HIV status ascertainment at ANC overestimates HIV prevalence among women attending ANC in Kwale County. However, the use of ANC routine data may underestimate the true population prevalence. There is need to address both community level and health facility level barriers to the uptake of ANC services.

Guidelines for the prevention and management of children and adolescents with COVID-19.

Children are the future of the world, but their health and future are facing great uncertainty because of the coronavirus disease 2019 (COVID-19) pandemic. In order to improve the management of children with COVID-19, an international, multidisciplinary panel of experts developed a rapid advice guideline at the beginning of the outbreak of COVID-19 in 2020. After publishing the first version of the rapid advice guideline, the panel has updated the guideline by including additional stakeholders in the panel and a comprehensive search of the latest evidence. All recommendations were supported by systematic reviews and graded using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. Expert judgment was used to develop good practice statements supplementary to the graded evidence-based recommendations. The updated guideline comprises nine recommendations and one good practice statement. It focuses on the key recommendations pertinent to the following issues: identification of prognostic factors for death or pediatric intensive care unit admission; the use of remdesivir, systemic glucocorticoids and antipyretics, intravenous immunoglobulin (IVIG) for multisystem inflammatory syndrome in children, and high-flow oxygen by nasal cannula or non-invasive ventilation for acute hypoxemic respiratory failure; breastfeeding; vaccination; and the management of pediatric mental health. CONCLUSION: This updated evidence-based guideline intends to provide clinicians, pediatricians, patients and other stakeholders with evidence-based recommendations for the prevention and management of COVID-19 in children and adolescents. Larger studies with longer follow-up to determine the effectiveness and safety of systemic glucocorticoids, IVIG, noninvasive ventilation, and the vaccines for COVID-19 in children and adolescents are encouraged. WHAT IS KNOWN: • Several clinical practice guidelines for children with COVID-19 have been developed, but only few of them have been recently updated. • We developed an evidence-based guideline at the beginning of the COVID-19 outbreak and have now updated it based on the results of a comprehensive search of the latest evidence. WHAT IS NEW: • The updated guideline provides key recommendations pertinent to the following issues: identification of prognostic factors for death or pediatric intensive care unit admission; the use of remdesivir, systemic glucocorticoids and antipyretics, intravenous immunoglobulin for multisystem inflammatory syndrome in children, and high-flow oxygen by nasal cannula or non-invasive ventilation for acute hypoxemic respiratory failure; breastfeeding; vaccination; and the management of pediatric mental health.