Rates of adverse events of antiretroviral therapy in women living with HIV/AIDS: a systematic review and meta-analysis

Objective
There is limited information regarding the incidence of treatment-related adverse events (AE) following antiretroviral therapy (ART) in women. So, this review aimed to describe the incidence of AE of ART in women living with HIV/AIDS.

Design
Systematic review and meta-analysis.

Data sources
Medline, Embase, Cochrane Library, Epistemonikos, Lilacs and Who Index, from inception to 9 April 2023.

Eligibility criteria
We included randomised controlled trials with at least 12 weeks of follow-up and evaluated AE of ART in women at any age living with HIV/AIDS, without restrictions on status, year or language of publication. We excluded post hoc or secondary analyses and open-label extensions without comparator, and trials involving pregnant or breastfeeding women or with a focus on coinfection with tuberculosis, hepatitis B or C. The primary outcomes were the incidence rate of participants with any clinical and/or laboratory AE related or not to ART and treatment discontinuation.

Data extraction and synthesis
Two independent reviewers extracted data and assessed the risk of bias using Cochrane’s risk of bias tool 2. We used Bayesian random-effects meta-analysis to summarise event rates. Results were presented as event rates per 1000 person-years (95% credibility intervals, 95% CrI). The pooled incidence rate per 1000 person-years adjusted for duration and loss to follow-up was estimated. We assessed the certainty of the evidence using Grading of Recommendations, Assessment, Development and Evaluation.

Results
A total of 24 339 studies were identified for screening, of which 10 studies (2871 women) met the eligibility criteria, with 11 different antiretrovirals (ARVs) regimens. Seven studies included exclusively women, while in the remaining three, the proportion of women ranged from 11% to 46%. Nine studies received industry funding. The pooled analysis showed a mean incidence rate of ART-related clinical and laboratory AE of 341.60 events per 1000 person-years (95% CrI 133.60–862.70), treatment discontinuation of 20.78 events per 1000 person-years (95% CrI 5.58–57.31) and ART-related discontinuation of 4.31 per 1000 person-years (95% CrI 0.13–54.72). Summary estimates were subject to significant uncertainty due to the limited number of studies and sparse data. The certainty of the evidence was graded as very low for all outcomes assessed.

Conclusion
Existing randomised trials do not provide sufficient evidence on the incidence rates of safety outcomes from antiretroviral treatment in women living with HIV/AIDS. Large comparative studies in well-characterised populations are needed to provide a more comprehensive landscape of the safety profile of these ARV therapies in women with HIV/AIDS.

PROSPERO registration number
CRD42021251051.

Read More

Association of complete blood count parameters with the risk of incident pulmonary heart disease in pneumoconiosis: a retrospective cohort study

Background
Pneumoconiosis mostly combines pulmonary and cardiovascular diseases, among which pulmonary heart disease (PHD) is of major concern due to its significant impact on the survival of pneumoconiosis patients. White cell count (WCC), red cell distribution width (RDW) and platelet parameters are thought to affect inflammatory responses and may be predictors of various cardiovascular diseases. However, very few studies have focused on PHD.

Objectives
To examine the relationship between baseline complete blood count parameters (WCC, RDW, platelet parameters) and the risk of incident PHD in pneumoconiosis patients.

Design
A retrospective cohort study.

Setting
This was a single-centre, retrospective cohort study that used data from an Occupational Disease Hospital, Chengdu, Sichuan.

Participants
A total of 946 pneumoconiosis patients from January 2012 to November 2021 were included in the study. Female patients and patients who had PHD, coronary heart disease, hypertensive heart disease, cardiomyopathy, heart failure, oncological disease, multiple organ dysfunction, AIDS at baseline and follow-up time of less than 6 months were also excluded.

Outcome measures
We identified PHD according to the patient’s discharge diagnosis. We constructed Cox proportional hazard regression models to assess the HR of incident PHD in pneumoconiosis, as well as 95% CIs.

Results
In the multiple Cox proportional hazard regression analysis, platelet count (PLT) and plateletcrit (PCT) above the median at baseline were associated with an increased risk of PHD in pneumoconiosis with adjusted HR of 1.52 (95% CI 1.09 to 2.12) and 1.42 (95% CI 1.02 to 1.99), respectively.

Conclusion
Higher baseline PLT and PCT are associated with a higher risk of PHD in pneumoconiosis.

Read More

Effects of interacting with a large language model compared with a human coach on the clinical diagnostic process and outcomes among fourth-year medical students: study protocol for a prospective, randomised experiment using patient vignettes

Introduction
Versatile large language models (LLMs) have the potential to augment diagnostic decision-making by assisting diagnosticians, thanks to their ability to engage in open-ended, natural conversations and their comprehensive knowledge access. Yet the novelty of LLMs in diagnostic decision-making introduces uncertainties regarding their impact. Clinicians unfamiliar with the use of LLMs in their professional context may rely on general attitudes towards LLMs more broadly, potentially hindering thoughtful use and critical evaluation of their input, leading to either over-reliance and lack of critical thinking or an unwillingness to use LLMs as diagnostic aids. To address these concerns, this study examines the influence on the diagnostic process and outcomes of interacting with an LLM compared with a human coach, and of prior training vs no training for interacting with either of these ‘coaches’. Our findings aim to illuminate the potential benefits and risks of employing artificial intelligence (AI) in diagnostic decision-making.

Methods and analysis
We are conducting a prospective, randomised experiment with N=158 fourth-year medical students from Charité Medical School, Berlin, Germany. Participants are asked to diagnose patient vignettes after being assigned to either a human coach or ChatGPT and after either training or no training (both between-subject factors). We are specifically collecting data on the effects of using either of these ‘coaches’ and of additional training on information search, number of hypotheses entertained, diagnostic accuracy and confidence. Statistical methods will include linear mixed effects models. Exploratory analyses of the interaction patterns and attitudes towards AI will also generate more generalisable knowledge about the role of AI in medicine.

Ethics and dissemination
The Bern Cantonal Ethics Committee considered the study exempt from full ethical review (BASEC No: Req-2023-01396). All methods will be conducted in accordance with relevant guidelines and regulations. Participation is voluntary and informed consent will be obtained. Results will be published in peer-reviewed scientific medical journals. Authorship will be determined according to the International Committee of Medical Journal Editors guidelines.

Read More

Clinical experiences, current approaches, opinions and awareness of healthcare professionals regarding the audio-vestibular consequences of individuals with traumatic brain injury: a cross-sectional online survey study

Objective
To explore the experiences, current approaches, opinions and awareness of healthcare professionals (HCPs) caring for adults with traumatic brain injury (TBI) regarding the audio-vestibular consequences.

Design/setting
Cross-sectional online survey study.

Participants
HCPs with experience of caring for adults with TBI, who were not ENT (ear nose throat) specialists or audiologists.

Methods
The study was conducted from May 2022 to December 2022. The online survey consisted of 16 closed and open-text questions in English and Turkish about clinical experience, current approaches and awareness of audio-vestibular consequences following TBI. Frequencies of responses to closed questions and associations between variables were analysed using SPSS V.28. Open-text responses were summarised in Microsoft Excel.

Results
Seventy HCPs participated from 17 professions and 14 countries, with the majority from the UK (42.9%). HCPs stated that ‘some’ to ‘all’ of their patients had auditory problems such as ‘inability to understand speech-in-noise’ (66%), ‘tinnitus’ (64%), ‘hyperacusis’ (57%) and balance problems such as ‘dizziness’ (79%) and ‘vertigo’ (67%). Usually, HCPs asked about the balance status of patients at appointments and when they observed dizziness and/or balance disorder they used screening tests, most commonly finger-to-nose (53%). For auditory impairments, HCPs preferred referring patients with TBI to audiology/ENT services. However, 6% of HCPs felt that audio-vestibular conditions could be ignored on referral because patients with TBI struggled with many impairments. Additionally, 44% would suggest hearing aids to patients with TBI with hearing loss ‘if they would like to use’ rather than ‘definitely’.

Conclusions
Many audio-vestibular impairments are observed by HCPs caring for patients with TBI. The assessment and intervention opinions and awareness of HCPs for these impairments vary. However, non-expert HCPs may not be aware of negative consequences of untreated audio-vestibular impairments following TBI. Therefore, developing a simple framework for screening and indications of audio-vestibular impairments for referral may be helpful for non-audiological specialists regularly seeing these patients.

Read More

Community perspective and healthcare assessment in malaria endemic states of India: a cross-sectional study protocol

Introduction
India’s contribution to the malaria burden was highest in South-East Asia Region in 2021, accounting for 79% of the estimated malaria cases and 83% of malaria-related deaths. Intensified Malaria Control Programme supported by Global Funds to Fight against AIDS, Tuberculosis and Malaria has deployed crucial interventions to reduce the overall burden of malaria in India. Evaluation of utilisation of malaria elimination interventions by the community and assessment of the healthcare system is underway in eleven high malaria endemic states in India. Health system preparedness for malaria elimination, logistics, and supply chain management of diagnostic kits and anti-malarial drugs in addition to the knowledge, attitude and practice of the healthcare workers is also being assessed.

Methods and analysis
The study is being undertaken in 11 malaria endemic states with a variable annual parasite incidence of malaria. In total, 47 districts (administrative unit of malaria control operations) covering 37 976 households are to be interviewed and assessed. We present here the protocol following which the study is being undertaken at the behest and approval of Ministry of Health and Family Welfare in India.

Ethics and dissemination
No patients were involved in the study. Study findings will be shared with Institutional ethics board of National Institute for Malaria Research New Delhi (NIMR) in a timely, comprehensive, accurate, unbiased, unambiguous and transparent manner and to the National Vector-borne Disease (Malaria) Control Programme officers and the Community public who participated. Important findings will be communicated through community outreach meetings which are existing in the Health system. Results will be informed to study participants via local fieldwork supervised by District Malaria Officers. Also findings will be published in reputed journals based on Indian Council of Medical Research (ICMR) publication policy.
The ICMR-NIMR ethics committee approved the study via letter No. NIMR/ECM/2023/Feb/14 dated 24 April 2023 for version 5. All standard ethical practices will be followed.

Read More

Cross-sectional analysis of pharmaceutical industry payments to authors of clinical practice guidelines for bipolar disorder and major depressive disorder in Japan

Objective
Clinical practice guidelines (CPGs) are essential for standardising patient care based on evidence-based medicine. However, the presence of financial conflicts of interest (COIs) among CPG authors can undermine their credibility. This study aimed to examine the extent and size of COIs among authors of psychiatry CPGs in Japan.

Methods
This cross-sectional analysis of disclosed payments from pharmaceutical companies assesses the prevalence and magnitude of personal payments for lecturing, consulting and writing to CPGs for bipolar disorder and major depressive disorder in Japan between 2016 and 2020.

Results
This study found that 93.3% of authors received payments over a 5-year period, with total payments exceeding US$4 million. The median payment per author was US$51 403 (IQR: US$9982–US$111 567), with a notable concentration of payments among a small number of authors, including the CPG chairperson. Despite these extensive financial relationships, only a fraction of authors disclosed their COIs in the CPGs. These large amounts of personal payments were made by pharmaceutical companies manufacturing new antidepressants and sleeping aids listed in the CPGs.

Conclusions
This study found that more than 93% of authors of CPGs for major depressive disorder and bipolar disorder in Japan received considerable amounts of personal payments from the pharmaceutical industry. The findings highlight deviations from international COI management standards and suggest a need for more stringent COI policies for psychiatry CPGs in Japan.

Read More

Unravelling clinicians shared decision-making adoption: a qualitative exploration through the lens of diffusion of innovations theory

Objectives
This study uses the diffusion of innovations (DOI) theory to comprehensively understand the adoption of shared decision-making (SDM) in clinical practice, specifically focusing on the ‘knowledge’ and ‘persuasion’ stages within DOI. We aim to understand the challenges and dynamics associated with SDM adoption, offering insights for more patient-centred decision-making in healthcare.

Design
This qualitative study employs a modified framework analysis approach, integrating ethnographic and interview data from prior research, along with additional interviews. The framework used is based on the DOI theory.

Study setting and participants
This study was conducted in the obstetrics and gynaecology department of a tertiary teaching hospital in the Eastern region of the Netherlands. It included interviews with 20 participants, including gynaecologists, obstetrics registrars and junior doctors currently practising in the department. Additionally, data from prior research conducted within the same department were incorporated, ensuring the maintenance of contextual consistency.

Results
Findings reveal a complex interplay between SDM’s benefits and challenges. Clinicians value SDM for upholding patient autonomy and enhancing medical practice, viewing it as valuable for medical decision-making. Decision aids are seen as advantageous in supporting treatment decisions. Challenges include compatibility issues between patient and clinician preferences, perceptions of SDM as time-consuming and difficult and limitations imposed by the rapid pace of healthcare and its swift decisions. Additionally, perceived complexity varies by situation, influenced by colleagues’ attitudes, with limited trialability and sparsely observed instances of SDM.

Conclusions
Clinicians’ decision to adopt or reject SDM is multifaceted, shaped by beliefs, cognitive processes and contextual challenges. Cognitive dissonance is critical as clinicians reconcile their existing practices with the adoption of SDM. Practical strategies such as practice assessments, open discussions about SDM’s utility and reflective practice through professional development initiatives empower clinicians to make the best informed decision to adopt or reject SDM.

Read More

Decision aids for female BRCA mutation carriers: a scoping review

Objectives
Women who inherit a pathogenic BRCA1 or BRCA2 mutation are at substantially higher risk of developing breast and ovarian cancer than average. Several cancer risk management strategies exist to address this increased risk. Decisions about which strategies to choose are complex, personal and multifactorial for these women. Decision aids (DAs) are tools that assist patients in making health-related decisions. The aim of this scoping review was to map evidence relating to the development and testing of patient DAs for cancer unaffected BRCA mutation carriers.

Design
Scoping review conducted according to the Joanna Briggs Institute’s (JBI’s) scoping review methodological framework.

Data sources
MEDLINE, EMBASE, CINAHL, Web of Science. No restrictions applied for language or publication date. A manual search was also performed.

Eligibility criteria for selecting studies
Studies on DAs for cancer risk management designed for or applicable to women with a pathogenic BRCA1 or BRCA2 mutation who are unaffected by breast or ovarian cancer.

Data extraction and synthesis
Data were extracted using a form based on the JBI instrument for extracting details of studies’ characteristics and results. Data extraction was performed independently by two reviewers. Extracted data were tabulated.

Results
32 evidence sources relating to development or testing of 21 DAs were included. Four DAs were developed exclusively for cancer unaffected BRCA mutation carriers. Of these, two covered all guideline recommended risk management strategies for this population though only one of these was readily available publicly in its full version. All studies investigating DA effectiveness reported a positive effect of the DA under investigation on at least one of the outcomes evaluated, however only six DAs were tested in randomised controlled trials.

Conclusion
This scoping review has mapped the landscape of the literature relating to developing and testing, DAs applicable to cancer unaffected BRCA mutation carriers.

Read More

Disease burden and risk factors of children aged 0-14 years in China: a retrospective study on data from the Global Burden of Disease Study 2019

Objectives
This study aimed to analyse the current status, trends and risk factors of disease burden from 1990 to 2019 among Chinese children.

Design and participants
It was a retrospective study on data from the Global Burden of Disease Study 2019 (GBD 2019). Data of disease burden and risk factors were extracted from the GBD 2019. Children were divided into two groups of

Read More

HIV subtypes and molecular transmission characteristics among elderly HIV-infected individuals aged 50 and above: a cross-sectional study in Huzhou City, Eastern China

Objective
To analyse the HIV-1 subtypes and molecular transmission characteristics of HIV-infected older individuals aged 50 and above in Huzhou City, and provide a scientific basis for prevention and treatment strategies for them.

Design
A cross-sectional study with clustered molecular transmission network cases was performed, and basic epidemiological information was retrieved from the Chinese Centres for Disease Prevention and Control (CDC) Information System.

Setting and participants
A molecular epidemiological study was conducted in 899 newly diagnosed HIV-infected individuals from January 2019 and March 2023 in Huzhou city, Zhejiang province, Eastern China. Out of these, HIV sequences were successfully obtained from 673 individuals, including 274 who were older individuals aged 50 and above.

Primary and secondary outcomes
Reverse transcription-polymerase chain reaction (PCR) and nested PCR were used to amplify the polymerase gene of HIV-1, and gene sequencing was performed. We used univariate and multivariate logistic regression to describe the association of clustered molecular transmission network cases.

Results
In total, 274 valid HIV sequences of older individuals were obtained, which revealed 14 subtypes. Circulating recombinant forms (CRF) 07_BC accounted for 55.8% and CRF01_AE accounted for 20.1% of the subtypes. Data of 150 older individuals were included in the molecular transmission network, and the proportion of elderly individuals in clustered cases is 52.26% (150/287). The results of multivariable logistic regression analysis showed that the older age group (60–82 years) and CRF07_BC subtype were associated with case clustering (transmission risk).

Conclusions
The key high-risk transmission network was mainly composed of the older age group (60–82 years) and CRF07_BC subtype. It is necessary to further strengthen AIDS health promotion and education for individuals aged 60 years and above, as well as for patients with the CRF07_BC subtype, to reduce HIV transmission and clustering risk.

Read More

Does living alone influence fall risk among Swiss older adults aged 60+? A pooled observational analysis of three RCTs on fall prevention

Objectives
Falling and living alone have been identified as public health challenges in an ageing society. Our study investigates whether living alone influences fall risk in community-dwelling older adults in Switzerland.

Design and methods
Secondary analysis of three randomised controlled trials investigating how different doses of vitamin D and an exercise programme may influence the risk of further falls in people 60+ at risk of falling. We used logistic regression to examine the association between living alone and the odds of becoming a faller, and negative binomial regression to examine the association between living alone and the rate of falls. We assessed both any falls and falls with injury. All analyses were adjusted for sex, body mass index, age, grip strength, comorbidities, use of walking aids, mental health, trial and treatment group. Predefined subgroups were by sex and age.

Results
Among 494 participants (63% women; mean age was 74.7±7.5 years) 643 falls were recorded over 936.5 person-years, including 402 injurious falls. Living alone was associated with a 1.76-fold higher odds of becoming a faller (OR (95% CI)=1.76 (1.11 to 2.79)). While the odds did not differ by sex, older age above the median age of 74.6 years increased the odds to 2.19-fold (OR (95% CI)=2.19 (1.11 to 4.32)). The rate of total or injurious falls did not differ by living status.

Conclusions
Community-dwelling older adults living alone have a higher odds of becoming a faller. The increased odds is similar for men and women but accentuated with higher age.

Trial registration numbers
ZDPT: NCT01017354, NFP53: NCT00133640, OA: NCT00599807.

Read More

Effect of HIV and substance use disorder comorbidity on the placenta, fetal and maternal health outcomes: systematic review and meta-analysis protocol

Background
Substance use disorders and HIV infection have a bidirectional relationship. People who use illicit drugs are at increased risk of contracting HIV/AIDS, and people living with HIV/AIDS are at increased risk of using substances due to disease-related complications like depression and HIV-associated dementia. There is no adequate evidence on the effect of HIV/AIDS and substance use disorder comorbidity-related effects on placental, fetal, maternal and neonatal outcomes globally.

Methods and analysis
We will search articles written in the English language until 30 January 2024, from PubMed/Medline, Cochrane Library, Embase, Scopus, Web of Sciences, SUMsearch2, Turning Research Into Practice database and Google Scholar. A systematic search strategy involving AND/OR Boolean Operators will retrieve information from these databases and search engines. Qualitative and quantitative analysis methods will be used to report the effect of HIV/AIDS and substance use disorders on placental, fetal and maternal composite outcomes. Descriptive statistics like pooled prevalence mean and SD will be used for qualitative analysis. However, quantitative analysis outcomes will be done by using Comprehensive Meta-Analysis Software for studies that are combinable. The individual study effects and the weighted mean difference will be reported in a forest plot. In addition to this, the presence of multiple morbidities like diabetes, chronic kidney disease and maternal haemoglobin level could affect placental growth, fetal growth and development, abortion, stillbirth, HIV transmission and composite maternal outcomes. Therefore, subgroup analysis will be done for pregnant women with multiple morbidities.

Ethics and dissemination
Since systematic review and meta-analysis will be conducted by using published literature, ethical approval is not required. The results will be presented in conferences and published in peer-reviewed journals.

PROSPERO registration number
CRD42023478360.

Read More

Challenges and support experienced by family caregivers seeking antiretroviral therapy services for children living with HIV/AIDS: a phenomenological study in Ghana

Background
Family caregivers of children living with HIV/AIDS in most cases are found to be overwhelmed and under-resourced, yet they are believed to be the primary source of support for children living with HIV/AIDS. Family caregivers experience different challenges that affect their children’s antiretroviral therapy (ART) adherence.

Aim
This study explored the lived experiences of family caregivers of children living with HIV/AIDS who sought ART services for these children at the St Joseph’s Hospital of Jirapa, Ghana.

Method
Using a qualitative phenomenology design and a semistructured in-depth interview guide and using purposive sampling, data were gathered from 13 family caregivers of children living with HIV/AIDS receiving ART treatment at St Joseph’s Hospital, Jirapa following ethical approval. All interviews were audio-taped and transcribed verbatim. Reflexive thematic analysis was used to analyse the transcribed data.

Findings
Six themes were generated: five challenges and one support. Family caregivers of children living with HIV/AIDS experienced: (1) Financial challenges, (2) Human-related challenges, (3) Challenges at HIV testing and counselling (HTC) centres, (4) Challenges with transportation, (5) Challenges in disclosing children’s HIV status to them and (6) Support received from HTC and their family members.

Conclusion and recommendation
Family caregivers of children living with HIV/AIDS experience daunting challenges in their quest to care for their children. Governmental and non-governmental HIV/AIDS programme support should include small business skills training and acquisition including capital to help set up small-scale businesses for such caregivers to reduce their financial challenges. Access to ART at clinics closer to caregivers is also key to promoting adherence. Family and community support has been recognised as key to enhancing ART adherence. Education of caregivers on policy regarding disclosure of the HIV/AIDS status of children, the need to work to reduce the time spent by caregivers at HTC, and ensuring privacy by limiting access to HTCs to only caregivers and their children, are important to enhancing adherence.

Read More