Search

Objective Complete and transparent reporting is of critical importance for randomized controlled trials (RCTs). The present study aimed to determine the reporting quality and methodological quality of RCTs for interventions involving artificial intelligence (AI) and their protocols. Methods We searched MEDLINE (via PubMed), Embase, Web of Science, CBMdisc, Wanfang Data, and CNKI from January 1, 2016, to November 11, 2020, to collect RCTs involving AI. We also extracted the protocol of each included RCT if it could be obtained. CONSORT-AI (Consolidated Standards of Reporting Trials–Artificial Intelligence) statement and Cochrane Collaboration's tool for assessing risk of bias (ROB) were used to evaluate the reporting quality and methodological quality, respectively, and SPIRIT-AI (The Standard Protocol Items: Recommendations for Interventional Trials–Artificial Intelligence) statement was used to evaluate the reporting quality of the protocols. The associations of the reporting rate of CONSORT-AI with the publication year, journal's impact factor (IF), number of authors, sample size, and first author's country were analyzed univariately using Pearson's chi-squared test, or Fisher's exact test if the expected values in any of the cells were below 5. The compliance of the retrieved protocols to SPIRIT-AI was presented descriptively. Results Overall, 29 RCTs and three protocols were considered eligible. The CONSORT-AI items “title and abstract” and “interpretation of results” were reported by all RCTs, with the items with the lowest reporting rates being “funding” (0), “implementation” (3.5%), and “harms” (3.5%). The risk of bias was high in 13 (44.8%) RCTs and not clear in 15 (51.7%) RCTs. Only one RCT (3.5%) had a low risk of bias. The compliance was not significantly different in terms of the publication year, journal's IF, number of authors, sample size, or first author's country. Ten of the 35 SPIRIT-AI items (funding, participant timeline, allocation concealment mechanism, implementation, data management, auditing, declaration of interests, access to data, informed consent materials and biological specimens) were not reported by any of the three protocols. Conclusions The reporting and methodological quality of RCTs involving AI need to be improved. Because of the limited availability of protocols, their quality could not be fully judged. Following the CONSORT-AI and SPIRIT-AI statements and with appropriate guidance on the risk of bias when designing and reporting AI-related RCTs can promote standardization and transparency.

Most of the research on smoking and human health has focused on the harmful effect of smoking on health. However, some epidemiological studies have shown that smoking has a protective effect on the occurrence of some diseases, such as Parkinson's disease. This phenomenon has attracted the attention of some researchers, and many systematic reviews and meta-analyses have been carried out. However, high quality systematic reviews can provide decision basis for clinical decision makers, while low quality systematic reviews may mislead decision makers. At present, there is no research to analyses the results and quality of systematic reviews on the protective effect of smoking, as well as the protective effect of smoking on which diseases, which is still unclear.

Most of the researches on smoking and human health has focused on the harmful effect of smoking on health. However, some epidemiological studies have shown that smoking has a protective effect on the occurrence of some diseases, such as Parkinson's disease. This phenomenon has attracted the attention of some researchers, and many systematic reviews and meta-analyses have been carried out. However, high quality systematic reviews can provide decision basis for clinical decision makers, while low quality systematic reviews may mislead decision makers. At present, there is no research to analyses the results and quality of systematic reviews on the protective effect of smoking, as well as the protective effect of smoking on which diseases, which is still unclear.

Objective Since the beginning of the COVID‐19 epidemic, a large number of guidelines on diagnosis and treatment of COVID‐19 have been developed, but the quality of those guidelines and the consistency of recommendations are unclear. The objective of this study is to evaluate the quality of the diagnosis and treatment guidelines on COVID‐19 and analyze the consistency of the recommendations of these guidelines. Methods We searched for guidelines on diagnosis and/or treatment of COVID‐19 through PubMed, CBM, CNKI, and WanFang Data, from January 1, 2020 to August 31, 2020. In addition, we also searched official websites of the US CDC, European CDC and WHO, and some guideline collection databases. We included diagnosis and/or treatment guidelines for COVID‐19, including rapid advice guidelines and interim guidelines. Two trained researchers independently extracted data and four trained researchers evaluated the quality of the guidelines using the AGREE II instruments. We extracted information on the basic characteristics of the guidelines, guideline development process, and the recommendations. We described the consistency of the direction of recommendations for treatment and diagnosis of COVID‐19 across the included guidelines. Results A total of 37 guidelines were included. Most included guidelines were assessed as low quality, with only one of the six domains of AGREE II (clarity of presentation) having a mean score above 50%. The mean scores of three domains (stakeholder involvement, the rigor of development and applicability) were all below 30%. The recommendations on diagnosis and treatment were to some extent consistent between the included guidelines. Computed tomography (CT), X‐rays, lung ultrasound, RT‐PCR, and routine blood tests were the most commonly recommended methods for COVID‐19 diagnosis. Thirty guidelines were on the treatment of COVID‐19. The recommended forms of treatment included supportive care, antiviral therapy, glucocorticoid therapy, antibiotics, immunoglobulin, extracorporeal membrane oxygenation (ECMO), convalescent plasma, and psychotherapy. Conclusions The methodological quality of currently available diagnosis and treatment guidelines for COVID‐19 is low. The diagnosis and treatment recommendations between the included guidelines are highly consistent. The main diagnostic methods for COVID‐19 are RT‐PCR and CT, with ultrasound as a potential diagnostic tool. As there is no effective treatment against COVID‐19 yet, supportive therapy is at the moment the most important treatment option.

Background: Screening for cervical pre-cancerous lesions may be inequitable among women in sub-Saharan African countries. This study examined age, residence, education and wealth inequalities and their combinations on cervical pre-cancer screening in Ethiopia, Malawi, Rwanda, Tanzania, Zambia, and Zimbabwe. Methods: We used the Population-Based HIV Impact Assessment (PHIA) data, including cervical pre-cancer screening variables and measured the magnitude of inequality between subgroups in percentages points, considering differences of 20%+ as high inequality, 5% to 20% medium, 0 to 5% as low. We described the sample characteristics using descriptive statistics for each country and examined the associations between cervical pre-cancer screening and each inequality. We analysed the differences using multivariable logistic regressions, controlling for covariates. We estimated the inequalities in cervical pre-cancer screening probability for each inequality alone and in combinations using marginal effects models. Results: The sample size of females aged 25–49 years ranged from 5882 in Ethiopia to 9186 in Tanzania. Self-reported cervical pre-cancer screening was low in the surveyed countries ranging from 3.5% (95% Confidence Interval (CI) 3.1%–4.0%) in Rwanda to 17.1% (95% CI 15.8%–18.5%) and 17.4% (95% CI16.1%–18.8%) in Zambia and Zimbabwe. Inequalities in cervical pre-cancer screening were low based on age, residence, education, and wealth. Combining the inequalities led to significant inequalities in self-reported cervical pre-cancer screening between rural dwelling women aged 25–34 years, in the lowest wealth quintile, with a primary education level, and urban dwelling women aged 35–49 years, in the highest quintile, with the highest education level ranging from 4.4% in Rwanda to 44.6% in Zimbabwe. Conclusions: Cervical pre-cancer screening was inequitable and low. None of the countries achieved one-third of the World Health Organisation target of screening 70% of eligible women for cervical pre-cancer by 2030. Inequalities in cervical pre-cancer screening related to age, rural-urban residence, education, and wealth were low. Their combinations led to high inequalities, preventing younger, rural-dwelling, uneducated, women in the lowest wealth quintile from cervical pre-cancer screening. Governments should include and monitor equity in their cervical pre-cancer screening programmes. Research is needed to understand how to scale up equitable cervical pre-cancer screening.

Additional file 3.

Additional file 2.

Additional file 1.

OBJECTIVE Coronavirus disease 2019 (COVID-19) has rapidly spread worldwide, but there is so far no comprehensive analysis of all known symptoms of the disease. Our study aimed to present a comprehensive picture of the clinical symptoms of COVID-19 using an evidence map. METHODS We systematically searched MEDLINE via PubMed, Web of Science, Embase, and Cochrane library from their inception to March 16, 2021. We included systematic reviews reporting the clinical manifestations of COVID-19 patients. We followed the PRISMA guidelines, and the study selection, data extraction, and quality assessment were done by two individuals independently. We assessed the methodological quality of the studies using AMSTAR. We visually presented the clinical symptoms of COVID-19 and their prevalence. RESULTS A total of 102 systematic reviews were included, of which, 68 studies (66.7%) were of high quality, 19 studies (18.6%) of medium quality, and 15 studies (14.7%) of low quality. We identified a total of 74 symptoms including 17 symptoms of the respiratory system, 21 symptoms of the neurological system, 10 symptoms of the gastrointestinal system, 16 cutaneous symptoms, and 10 ocular symptoms. The most common symptoms were fever (67 studies, ranging 16.3%-91.0%, pooled prevalence: 64.6%, 95%CI, 61.3%-67.9%), cough (68 studies, ranging 30.0%-72.2%, pooled prevalence: 53.6%, 95%CI, 52.1%-55.1%), muscle soreness (56 studies, ranging 3.0%-44.0%, pooled prevalence: 18.7%, 95%CI, 16.3%-21.3%), and fatigue (52 studies, ranging 3.3%-58.5%, pooled prevalence: 29.4%, 95%CI, 27.5%-31.3%). The prevalence estimates for COVID-19 symptoms were generally lower in neonates, children and adolescents, and pregnant women than in the general populations. CONCLUSION At least 74 different clinical manifestations are associated with COVID-19. Fever, cough, muscle soreness, and fatigue are the most common, but attention should also be paid to the rare symptoms that can help in the early diagnosis of the disease.

Background Despite the availability of individual-level data of infants accessing HIV DNA-PCR testing service, there has been little in-depth analysis of such data. Therefore, we describe trends in risk of HIV infection among Malawi’s HIV-exposed infants (HEI) with DNA-PCR HIV test result from 2013 to 2020. Methods This is an implementation study using routinely collected patient-level HIV DNA-PCR test result data extracted from the national Laboratory Management Information System database managed by the Department of HIV/AIDS between 1 January 2013 and 30 June 2020. We calculated frequencies, proportions and odds ratio (OR) with their associated 95% CI. We performed a random-effects logistic regression to determine the risk factors associated with HIV infection in infants, controlling for the spatial autocorrelation between districts and adjusting for other variables. Results We evaluated 255 229 HEI across 750 facilities in 28 districts. The HIV DNA-PCR test was performed within 2 months in 57% of the children. The overall HIV prevalence among all tested HEI between 2013 and 2020 was 7.2% (95% CI 7.1% to 7.3%). We observed a decreasing trend in the proportion of HEI that tested HIV positive from 7.0% (95% CI 6.6% to 7.4%) in 2013 to 5.7% (95% CI 5.4% to 5.9%) in 2015 followed by an increase to 9.9% (95% CI 9.6% to 10.2%) in 2017 and thereafter a decreasing trend between 2017 (i.e. 9.72% (95%CI: 9.43-10.01)) and 2020 (i.e. 3.86% (95%CI: 3.34-4.37)). The HIV prevalence increased by age of the HEI. There was spatial heterogeneity of HIV prevalence between districts of Malawi. The prevalence of HIV was higher among the HEI from the Northern region of Malawi. Conclusion The main findings of the study are that the DNA test is performed within 2 months only in 57% of the children, that the decreasing trend of HIV prevalence among HEI observed up to 2015 was followed by an increase up to 2017 and a decrease afterwards, and that the risk of HIV infection increased with age at HIV testing. We summarised spatial and temporal trends of risk of HIV infection among HEI in Malawi between 2013 and 2020. There is need to ensure that all the HEI are enrolled in HIV care by 8 weeks of age in order to further reduce the risk of HIV in this population.

BACKGROUND: Conflicts of interest (COI) and funding may influence the development of practice guidelines, but there are no internationally endorsed guidelines specifically focusing on the reporting on issues related to COI and funding in practice guidelines. Our aim is to develop an extension of the essential Reporting Items of Practice Guidelines in Healthcare (RIGHT) for COIs and Funding in practice guidelines (i.e., RIGHT-COI&F). METHODS: We will follow the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) network’s toolkit for developing a reporting guideline in six stages: (I) identifying the need for the extension; (II) registering the project and setting up working groups; (III) collecting the initial items; (IV) reaching consensus on the items to be included; (V) revision and formulation of the final checklist; and (VI) dissemination and implementation. We intend to form a multidisciplinary international team of experts to collect and evaluate the items and plan to complete the full reporting guideline in about 2 years. DISCUSSION: The RIGHT-COI&F statement will help guideline developers improve their reporting of issues related to COIs and funding, and subsequently improve the reporting quality of their guidelines. Journals editors, guideline users and evaluators will benefit from a more complete and transparent reporting of COI. TRIAL REGISTRATION: We have registered the protocol on the EQUATOR network (https://www.equator-network.org/library/reporting-guidelines-under-development/reporting-guidelines-under-development-for-other-study-designs/#RIGHT-COI).

Additional file 1.

Examples of reporting items in systematic reviews for Acupuncture. (DOCX 278 kb)

Results of the pilot test of the PRISMA for Acupuncture checklist. (DOCX 27 kb)

© 2014 Wolters Kluwer Health | Lippincott Williams Wilkins. Objectives: Many paediatric antiretroviral therapy (ART) programmes in Southern Africa rely on CD4+ to monitor ART. We assessed the benefit of replacing CD4+ by viral load monitoring. Design: A mathematical modelling study. Methods: A simulation model of HIV progression over 5 years in children on ART parameterized by data from seven South African cohorts. We simulated treatment programmes with 6 monthly CD4+ or 6 or 12 monthly viral load monitoring. We compared mortality second line ART use immunological failure and time spent on failing ART. In further analyses we varied the rate of virological failure and assumed that the rate is higher with CD4+ than with viral load monitoring. Results: About 7 of children were predicted to die within 5 years independent of the monitoring strategy. Compared with CD4+ monitoring 12 monthly viral load monitoring reduced the 5 year risk of immunological failure from 1.6 to 1.0 and the mean time spent on failing ART from 6.6 to 3.6 months; 1 of children with CD4+ compared with 12 with viral load monitoring switched to second line ART. Differences became larger when assuming higher rates of virological failure. When assuming higher virological failure rates with CD4+ than with viral load monitoring up to 4.2 of children with CD4+ compared with 1.5 with viral load monitoring experienced immunological failure; the mean time spent on failing ART was 27.3 months with CD4+ monitoring and 6.0 months with viral load monitoring. Conclusion: Viral load monitoring did not affect 5 year mortality but reduced time on failing ART improved immunological response and increased switching to second line ART.

Objective: Treatment as prevention depends on retaining HIVinfected patients in care. We investigated the effect on HIV transmission of bringing patients lost to follow up (LTFU) back into care. Design: Mathematical model. Methods: Stochastic mathematical model of cohorts of 1000 HIVinfected patients on antiretroviral therapy based on the data from 2 clinics in Lilongwe Malawi. We calculated cohort viral load (sum of individual mean viral loads each year) and used a mathematical relationship between viral load and transmission probability to estimate the number of new HIV infections. We simulated 4 scenarios: "no LTFU" (all patients stay in care) "no tracing" (patients LTFU are not traced) "immediate tracing" (after missed clinic appointment) and "delayed tracing" (after 6 months). Results: About 440 of 1000 patients were LTFU over 5 years. Cohort viral loads (million copies/mL per 1000 patients) were 3.7 [95 prediction interval (PrI) 2.9 4.9] for no LTFU 8.6 (95 PrI 7.3 10.0) for no tracing 7.7 (95 PrI 6.2 9.1) for immediate and 8.0 (95 PrI 6.7 9.5) for delayed tracing. Comparing no LTFU with no tracing the number of new infections increased from 33 (95 PrI 29 38) to 54 (95 PrI 47 60) per 1000 patients. Immediate tracing prevented 3.6 (95 PrI 23.3 to 12.8) and delayed tracing 2.5 (95 PrI 25.8 to 11.1) new infections per 1000. Immediate tracing was more efficient than delayed tracing: to 116 and 142 tracing efforts respectively were needed prevent 1 new infection. Conclusions: Tracing of patients LTFU enhances the preventive effect of antiretroviral therapy but the number of transmissions prevented is small. © 2013 by Lippincott Williams Wilkins.

OBJECTIVES In low income settings treatment failure is often identified using CD4 cell count monitoring. Consequently patients remain on a failing regimen resulting in a higher risk of transmission. We investigated the benefit of routine viral load monitoring for reducing HIV transmission. DESIGN Mathematical model. METHODS We developed a stochastic mathematical model representing the course of individual viral load immunological response and survival in a cohort of 1000 HIV infected patients receiving antiretroviral therapy (ART) in southern Africa. We calculated cohort viral load (CVL; sum of individual viral loads) and used a mathematical relationship between individual viral load values and transmission probability to estimate the number of new HIV infections. Our model was parameterized with data from the International epidemiologic Databases to Evaluate AIDS Southern African collaboration. Sensitivity analyses were performed to assess the validity of the results in a universal 'test and treat' scenario wherein patients start ART earlier after HIV infection. RESULTS If CD4 cell count alone was regularly monitored the CVL was 2.6?×?10?copies/ml and the treated patients transmitted on average 6.3 infections each year. With routine viral load monitoring both CVL and transmissions were reduced by 31 to 1.7?×?10?copies/ml and 4.3 transmissions respectively. The relative reduction of 31 between monitoring strategies remained similar for different scenarios. CONCLUSION Although routine viral load monitoring enhances the preventive effect of ART the provision of ART to everyone in need should remain the highest priority.

OBJECTIVES:: To determine magnitude and reasons of loss to programme and poor antiretroviral prophylaxis coverage in prevention of mother to child transmission (PMTCT) programmes in sub Saharan Africa. DESIGN:: Systematic review and meta analysis. METHODS:: We searched PubMed and Embase databases for PMTCT studies in sub Saharan Africa published between January 2002 and March 2012. Outcomes were the percentage of pregnant women (i) tested for HIV (ii) initiating antiretroviral prophylaxis (iii) having a CD4 cell count measured and (iv) initiating antiretroviral combination therapy (cART) if eligible. In children outcomes were (v) early infant diagnosis for HIV and (vi) cART initiation. We combined data using random effects meta analysis and identified predictors of uptake of interventions. RESULTS:: Forty four studies from 15 countries including 75172 HIV infected pregnant women were analyzed. HIV testing uptake at antenatal care services was 94 (95 confidence intervals [CI] 92 95) for opt out and 58 (95 CI 40 75) for opt in testing. Coverage with any antiretroviral prophylaxis was 70 (95 CI 64 76) and 62 (95 CI 50 73) of pregnant women eligible for cART received treatment. Sixty four percent (95 CI 48 81) of HIV exposed infants had early diagnosis performed and 55 (95 CI 36 74) were tested between 12 and 18 months. Uptake of PMTCT interventions was improved if cART was provided at the antenatal clinic and if the male partner was involved. CONCLUSIONS:: In sub Saharan Africa uptake of PMTCT interventions and early infant diagnosis is unsatisfactory. An integrated family centered approach seems to improve retention.

Appendix 1. Word document describing the sampling strategy used in the study. (DOCX 24 kb)

Appendix 1. Word document describing the sampling strategy used in the study. (DOCX 24 kb)