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Protocol for active safety monitoring of a cohort of patients using a dolutegravir-based antiretroviral regimen in Mozambique

Por: Mussa · M. · Gaspar · I. · Namburete · L. · Sitoie · T. V. · Couto · A. · Paulino · J. M. · Lemos · A. · Vilanculos · S. · Ogar · C. K. · Namburete · D. · Seni · E. D. · Hafner · T. · Stergachis · A.
Introduction

Dolutegravir-based antiretroviral therapy (ART) is increasingly being used as the preferred first-line regimen for the treatment of HIV in low-income and middle-income countries. The National Program for the Control of STI/HIV/AIDS in Mozambique has planned a phased introduction of the tenofovir/lamivudine/dolutegravir (TLD) regimen. In 2019, concerns about a potential safety signal identified with dolutegravir identified in the results of the Tsepamo study, conducted in Botswana, led the National Directorate of Pharmacy and the National Program for the Control of STI/HIV/AIDS to establish an active pharmacovigilance surveillance system among newly placed patients on a TLD regimen. This activity aims to establish an active pharmacovigilance system to monitor adverse events in patients on a TLD regimen to support the effectiveness of Mozambique’s public health programmes in improving the process of care and treatment outcomes for people with HIV/AIDS.

Methods and analysis

This is a prospective, non-interventional, descriptive cohort study to monitor HIV patients managed with TLD at 10 sentinel health centres in Mozambique. The cohort consists of HIV-infected patients commencing treatment with TLD, either as treatment naïve patients or switched from other ART regimens. Patients have monthly routine follow-up visits for the first 3 months after starting HIV treatment with TLD, and subsequently every 3 months for a total period of 1 year. Patients are monitored to identify possible adverse events during the follow-up period. The intended size of the cohort is 3000 patients.

Ethics and dissemination

Ethical approval was obtained from the National Commission on Bioethics in Health in Mozambique. Written informed consent is obtained from each participant who agrees to participate to have their information collected, analysed and stored. Findings will be reported to the Ministry of Health and participating health centres to inform policy and practice as well as disseminated by peer-review publications.

Impact of prehabilitation on objectively measured physical activity levels in elective surgery patients: a systematic review

Por: Wagnild · J. M. · Akowuah · E. · Maier · R. H. · Hancock · H. C. · Kasim · A.
Objective

To systematically review the impact of prehabilitation on objectively measured physical activity (PA) levels in elective surgery patients.

Data sources

Articles published in Web of Science Core Collections, PubMed, Embase (Ovid), CINAHL (EBSCOHost), PsycInfo (EBSCOHost) and CENTRAL through August 2020.

Study selection

Studies that met the following criteria: (1) written in English, (2) quantitatively described the effect(s) of a PA intervention among elective surgery patients prior to surgery and (3) used and reported objective measures of PA in the study.

Data extraction and synthesis

Participant characteristics, intervention details, PA measurement, and clinical and health-related outcomes were extracted. Risk of bias was assessed following the revised Cochrane risk of bias tool. Meta-analysis was not possible due to heterogeneity, therefore narrative synthesis was used.

Results

6533 unique articles were identified in the search; 21 articles (based on 15 trials) were included in the review. There was little evidence to suggest that prehabilitation is associated with increases in objectively measured PA, but this may be due to insufficient statistical power as most (n=8) trials included in the review were small feasibility/pilot studies. Where studies tested associations between objectively measured PA during the intervention period and health-related outcomes, significant beneficial associations were reported. Limitations in the evidence base precluded any assessment via meta-regression of the association between objectively measured PA and clinical or health-related outcomes.

Conclusions

Additional large-scale studies are needed, with clear and consistent reporting of objective measures including accelerometry variables and outcome variables, to improve our understanding of the impact of changes in PA prior to surgery on surgical and health-related outcomes.

PROSPERO registration number

CRD42019151475.

Early outcomes of a rural-oriented physician education programme against rural physician shortages in Guangxi province: a prospective cohort study

Por: Shen · Y. · Huang · X. · Li · H. · Chen · E. · Kong · Y. · Yu · J. · Liu · X. · Mobarak · S. A. · Zuo · Y.
Objectives

This study aimed to investigate early outcomes of one of the first medical undergraduate education programmes with a goal of mitigating severe rural physician shortages in China, which was developed by Guangxi Medical University (GXMU) and was called the Rural-oriented Free Tuition Medical Education (RTME)-GXMU programme.

Design

A prospective cohort study comprising a baseline investigation and follow-up research was conducted to dynamically observe the evolution of the RTME-GXMU programme that began since 2010.

Participants

380 RTME-GXMU graduates and 383 non-RTME-GXMU graduates from GXMU who completed trainings between 2015 and 2018 were recruited in the baseline investigation. Among them, 285 RTME-GXMU and 283 non-RTME-GXMU graduates responded to the follow-up research.

Main outcome measures

Graduate practice location, registered specialty, passing rate of the National Medical Licensing Examination (NMLE), specialty of residency programme and contract compliance for the RTME-GXMU graduates.

Results

By the end of 2018, 100% of the 2015 RTME-GXMU graduates enrolled in this study practised in rural township health centres and registered themselves as general practitioners (GPs). All the RTME-GXMU graduates had completed or were attending residency programmes of general practice (GP). The above data stood in stark contrast to that of the non-RTME-GXMU graduates among whom as few as 1.06% worked in rural areas, 2.13% registered as GPs and less than 3% chose GP residency programmes. No significant differences were detected on passing rates of the NMLE between the two groups. Only one RTME-GXMU graduate broke the contract and dropped off the programme.

Conclusions

The RTME-GXMU programme has achieved encouraging early outcomes. Reduced entry score and proper usage of urban primary care institutions are two key approaches contributing to these positive early results.

Longitudinal Outcomes of Gender Identity in Children (LOGIC): protocol for a prospective longitudinal cohort study of children referred to the UK gender identity development service

Por: Kennedy · E. · Spinner · L. · Lane · C. · Stynes · H. · Ranieri · V. · Carmichael · P. · Omar · R. · Vickerstaff · V. · Hunter · R. · Wright · T. · Senior · R. · Butler · G. · Baron-Cohen · S. · Young · B. · King · M.
Introduction

Gender identity development services (GIDS) worldwide have seen a significant increase in referrals in recent years. Many of these referrals consist of children and young people (CYP) who experience gender-related distress. This study aims to improve understanding of outcomes of CYP referred to the UK GIDS, specifically regarding gender identity, mental health, physical health and quality of life. The impact of factors such as co-occurring autism and early social transition on outcomes over time will be explored.

Methods and analysis

This is a prospective cohort study of CYP aged 3–14 years when referred to the UK GIDS. Eligible participants will be ≤14 years at the time their referral was accepted and will be on the waitlist for the service when baseline measures are completed. Children aged under 12 years will complete the measures in an interview format with a researcher, while young people aged 12 years and over and their parents/caregivers will complete online or paper-based questionnaires. Participants will complete follow-up measures 12 months and 24 months later. The final sample size is expected to be approximately 500. Logistic regression models will be used to explore associations between prespecified explanatory variables and gender dysphoria. Appropriate regression models will also be used to investigate explanatory variables for other outcomes. Subgroup analyses based on birth-assigned gender, age at referral and co-occurring autistic traits will be explored.

Ethics and dissemination

The study has been approved by the Health Research Authority and London – Hampstead Research Ethics Committee (reference: 19/LO/0857). The study findings will be published in peer-reviewed journals and presented at both conferences and stakeholder events. Findings will be used to inform clinical practice.

Protocol for 'virtual presence: a qualitative study of the cultural dialectic between loneliness and technology

Por: Johannessen · L. E. F. · Engebretsen · E. · Greenhalgh · T. · Hughes · G. · Köhler-Olsen · J. · Rasmussen · E. B. · Haldar · M.
Introduction

Most research on loneliness comes from the health sciences, statistically seeking to measure the health-related effects of feeling alone or isolated. There is a need to expand on this understanding and explore loneliness as a more complex social phenomenon. In this article, we present a qualitative design for studying the intersection between loneliness, technology and culture. Conceptualising this as the cultural dialectic between loneliness and technology, we aim to unpack the reciprocal ways by which understandings of loneliness shape technology, while technologies also affect society’s understandings of loneliness. In elucidating this dialectic, we aim to develop new knowledge and a novel theoretical framework for understanding loneliness and its technological solutions, which, in turn, can enable better solutions to contemporary problems of loneliness.

Methods and analysis

We will adopt a qualitative approach that combines interviews, participant observation and textual analysis to explore loneliness and its technological solutions from the perspectives of policy-makers, producers, professionals and users in Norway and the UK. The data will be analysed through an analytical framework combining insights from discourse theory and philosophical debates on presence, which will allow us to capture and rethink fundamental assumptions about loneliness and technology. Outcomes will be revised understandings of loneliness, relevant to researchers, entrepreneurs, policy-makers, clinicians, educators and the broader public.

Ethics and dissemination

The project has been evaluated and approved by the data protection officer at Oslo Metropolitan University and by the Norwegian Social Science Data Services. Additional ethical approval for data collection in the UK has been provided by the University of Oxford Interdivisional Research Ethics Committee. Informed consent will be obtained from all participants. Findings will be disseminated through peer-reviewed publications, international conference presentations and lay media.

Mechanisms of reducing joint stiffness by blocking collagen fibrillogenesis in a rabbit model of posttraumatic arthrofibrosis

by Andrzej Steplewski, Jolanta Fertala, Ryan E. Tomlinson, Mark L. Wang, Allison Donahue, William V. Arnold, Michael Rivlin, Pedro K. Beredjiklian, Joseph A. Abboud, Surena Namdari, Andrzej Fertala

Posttraumatic fibrotic scarring is a significant medical problem that alters the proper functioning of injured tissues. Current methods to reduce posttraumatic fibrosis rely on anti-inflammatory and anti-proliferative agents with broad intracellular targets. As a result, their use is not fully effective and may cause unwanted side effects. Our group previously demonstrated that extracellular collagen fibrillogenesis is a valid and specific target to reduce collagen-rich scar buildup. Our previous studies showed that a rationally designed antibody that binds the C-terminal telopeptide of the α2(I) chain involved in the aggregation of collagen molecules limits fibril assembly in vitro and reduces scar formation in vivo. Here, we have utilized a clinically relevant arthrofibrosis model to study the broad mechanisms of the anti-scarring activity of this antibody. Moreover, we analyzed the effects of targeting collagen fibril formation on the quality of healed joint tissues, including the posterior capsule, patellar tendon, and subchondral bone. Our results show that blocking collagen fibrillogenesis not only reduces collagen content in the scar, but also accelerates the remodeling of healing tissues and changes the collagen fibrils’ cross-linking. In total, this study demonstrated that targeting collagen fibrillogenesis to limit arthrofibrosis affects neither the quality of healing of the joint tissues nor disturbs vital tissues and organs.

Treatment of early-stage breast cancer with percutaneous thermal ablation, an open-label randomised phase 2 screening trial: rationale and design of the THERMAC trial

Por: van de Voort · E. M. F. · Struik · G. M. · Koppert · L. B. · Moelker · A. · Debets · R. · Yo · G. · Macco · M. J. P. V. · Sinke · R. H. J. A. · Franckena · M. · Birnie · E. · Verhoef · C. · Klem · T. M. A. L.
Introduction

Breast cancer is the most frequently diagnosed malignancy worldwide but almost half of the patients have an excellent prognosis with a 5-year survival rate of 98%–99%. These patients could potentially be treated with thermal ablation to avoid surgical excision, reduce treatment-related morbidity and increase patients’ quality of life without jeopardising treatment effectiveness. Previous studies showed highest complete ablation rates for radiofrequency, microwave and cryoablation. However, due to heterogeneity among studies, it is unknown which of these three techniques should be selected for a phase 3 comparative study.

Methods and analysis

The aim of this phase 2 screening trial is to determine the efficacy rate of radiofrequency, microwave and cryoablation with the intention to select one treatment for further testing in a phase 3 trial. Additionally, exploratory data are obtained for the phase 3 trial. The design is a multicentre open-label randomised phase 2 screening trial. Patients with unifocal, invasive breast cancer with a maximum diameter of 2 cm without lymph node or distant metastases are included. Triple negative, Bloom-Richardson grade 3 tumours and patients with an indication for neoadjuvant chemotherapy will be excluded. Included patients will be allocated to receive one of the three thermal ablation techniques. Three months later surgical excision will be performed to determine the efficacy of thermal ablation. Treatment efficacy in terms of complete ablation rate will be assessed with CK 8/18 and H&E staining. Secondary outcomes include feasibility of the techniques in an outpatient setting, accuracy of MRI for complete ablation, patient satisfaction, adverse events, side effects, cosmetic outcome, system usability and immune response.

Ethics and dissemination

This study protocol was approved by Medical Research Ethics Committee of the Erasmus Medical Center, Rotterdam, the Netherlands. Study results will be submitted for publication in peer-reviewed journals.

Trial registration number

NL9205 (www.trialregister.nl); Pre-results.

Cohort profile: the Ontario Life After Workplace Injury Study (OLAWIS)

Por: Mustard · C. · Nadalin · V. · Carnide · N. · Tompa · E. · Smith · P.
Purpose

The substantial economic burden of work-related injury and illness, borne by workers, employers and social security programmes, is primarily attributed to the durations of work disability among workers whose recovery requires a period of absence from work, with the majority of costs arising from the minority of workers with the longest duration absences. The objective of the Ontario Life After Workplace Injury Study is to describe the long-term health and labour market outcomes of workers disabled by work injury or illness after they are no longer receiving benefits or services from the work disability insurance authority.

Participants

Workers disabled by a work-related injury or illness were recruited from a sample frame of disability benefit claimants with oversampling of claimants with longer benefit durations. Characteristics of workers, their employers and claimant benefits were obtained from baseline administrative data. Interviews completed at 18 months post injury (T1) and to be completed at 36 months (T2) measure return-to-work and work status; income; physical and mental health; case manager and healthcare provider interactions and employer accommodations supporting return-to-work and sociodemographic characteristics. Of eligible claimants, 40% (1132) participated in the T1 interview, with 96% consenting to participate in the T2 interview.

Findings to date

Preliminary descriptive analyses of T1 data have been completed. The median age was 50 years and 56% were male. At 18 months following injury, 61% were employed by their at-injury employer, 16% had changed employment and 23% were not working. Past-year prescription opioid use was prevalent (34%), as was past-year cannabis use (31%). Longer duration claimants had poorer function, recovery and health and more adverse labour market outcomes.

Future plans

Multivariate analyses to identify modifiable predictors of adverse health and labour market outcomes and a follow-up survey of 96% of participants consenting to follow-up at 36 months are planned.

Comparison between Custodiol, del Nido and modified del Nido in the myocardial protection - Cardioplegia Trial: a study protocol for a randomised, double-blind clinical trial

Por: Almeida · A. S. · Ceron · R. O. · Anschau · F. · Kopittke · L. · Lira · K. B. · Delvaux · R. S. · Rode · J. · Rey · R. A. W. · Wittke · E. I. · Rombaldi · A. R.
Introduction

Myocardial protection is essential for successful cardiac surgery, and the search for an ideal cardioplegic solution has continued since its beginning. In this context, Custodiol, del Nido and modified del Nido are single-dose cardioplegic solutions with good safety profiles and great relevance in modern surgical practice. While these solutions have all been evaluated for their impact on patient outcomes independently, limited research exists comparing them directly. Thus, the present study aims to examine the effects of these cardioplegic solutions on myocardial protection and clinical outcomes in adult patients undergoing elective cardiac surgery. The assessment of the increase in myocardial injury biomarkers in patients submitted to all treatment methods may be considered a major strength of our study.

Methods and analysis

This is a clinical trial study protocol that will compare myocardial protection and clinical outcomes among three patient groups based on which cardioplegic solution was used. Patients will be randomised to receive del Nido (n=30), modified del Nido (n=30) or Custodiol (n=30). Myocardial injury biomarkers will be measured at the baseline and 2 hours, 12 hours and 24 hours after the cardiopulmonary bypass. Clinical outcomes will be assessed during the trans operative period and the intensive care unit stay, in addition to other haematological parameters.

Ethics and dissemination

This protocol and its related documents were approved by the Research Ethics Committee of the Hospital Nossa Senhora da Conceicão, Brazil, registered under no. 4.029.545. The findings of this study will be published in a peer-reviewed journal in the related field.

Trial registration number

RBR-7g5s66.

Risk of harm in synthetic and biological intervention trials in patients with inflammatory arthritis: protocol for a metaepidemiological study focusing on contextual factors

Por: Malm · E. · Nielsen · S. M. · Berg · J. · Ioannidis · J. P. A. · Furst · D. · Smolen · J. S. · Taylor · P. C. · Kristensen · L. E. · Tarp · S. · Ellingsen · T. · Christensen · R.
Introduction

Inflammatory arthritis (IA) conditions, including rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis, are characterised by inflammatory infiltration of the joints. Biological disease-modifying antirheumatic drugs (bDMARDs) and targeted synthetic disease-modifying antirheumatic drugs (tsDMARDs), respectively, reduce the effects of proinflammatory cytokines and immune cells to ameliorate disease. However, immunosuppression can be associated with high rates of serious adverse events (SAEs), including serious infections, and maybe an increased risk of malignancies and cardiovascular events. Currently, there is no empirical evidence on the extent to which contextual factors and risk of bias (RoB) domains may modify these harm signals in randomised trials.

Methods and analysis

We will search MEDLINE (via PubMed) for systematic reviews published since April 2015 and all Cochrane reviews. From these reviews, randomised trials will be eligible if they include patients with an IA condition with at least one group randomly allocated to bDMARD and/or tsDMARD treatments. A predefined form will be used for extracting data on population characteristics (eg, baseline characteristics or eligibility criteria, such as medication background) and specific harm outcome measures, such as number of withdrawals, numbers of patients discontinuing due to adverse events and number of patients having SAEs. RoB in individual trials will be assessed using a modified Cochrane RoB tool. We will estimate the potentially causal harm effects related to the experimental intervention compared with control comparator as risk ratios, and heterogeneity across randomised comparisons will be assessed statistically and evaluated as inconsistency using the I2 Index. Our metaregression analyses will designate population and trial characteristics and each RoB domain as independent variables, whereas the three harm domains will serve as dependent variables.

Ethics and dissemination

Ethics approval is not required for this study. Results will be disseminated through publication in international peer-reviewed journals.

PROSPERO registration number

CRD42020171124.

Relapse prevention group therapy via video-conferencing for substance use disorder: protocol for a multicentre randomised controlled trial in Indonesia

Por: Yamada · C. · Siste · K. · Hanafi · E. · Ophinni · Y. · Beatrice · E. · Rafelia · V. · Alison · P. · Limawan · A. · Shinozaki · T. · Matsumoto · T. · Sakamoto · R.
Background

Substance use disorder (SUD) is a leading contributor to the global burden of disease. In Indonesia, the availability of formal treatment for SUD falls short of the targeted coverage. A standardised therapeutic option for SUD with potential for widespread implementation is required, yet evidence-based data in the country are scarce. In this study, we developed a cognitive behavioural therapy (CBT)-based group telemedicine model and will investigate effectiveness and implementability in a multicentre randomised controlled trial.

Methods

A total of 220 participants will be recruited from the social networks of eight sites in Indonesia: three hospitals, two primary healthcare centres and three rehabilitation centres. The intervention arm will participate in a relapse prevention programme called the Indonesia Drug Addiction Relapse Prevention Programme (Indo-DARPP), a newly developed 12-week module based on CBT and motivational interviewing constructed in the Indonesian context. The programme will be delivered by a healthcare provider and a peer counsellor in a group therapy setting via video-conferencing, as a supplement to participants’ usual treatments. The control arm will continue treatment as usual. The primary outcome will be the percentage increase in days of abstinence from the primarily used substance in the past 28 days. Secondary outcomes will include addiction severity, quality of life, motivation to change, psychiatric symptoms, cognitive function, coping, and internalised stigma. Assessments will be performed at baseline (week 0), post-treatment (week 13), and 3 and 12 months post-treatment completion (weeks 24 and 60). Retention, participant satisfaction, and cost-effectiveness will be assessed as the implementation outcomes.

Ethics and dissemination

The study protocol was reviewed and approved by the Ethics Committees of Universitas Indonesia and Kyoto University. The results will be disseminated via academic journals and international conferences. Depending on trial outcomes, the treatment programme will be advocated for adoption as a formal healthcare-based approach for SUD.

Trial registration number

UMIN000042186.

Insight into the process of postpartum care utilisation and in-home support among vulnerable women in the Netherlands: an in-depth qualitative exploration

Por: Laureij · L. T. · van der Hulst · M. · Lagendijk · J. · Been · J. V. · Ernst-Smelt · H. E. · Franx · A. · Lugtenberg · M.
Objective

To gain insight into the process of postpartum care utilisation and in-home support among vulnerable women.

Design, method, participants and setting

A qualitative interview study was conducted among 23 pregnant and postpartum vulnerable women in the Netherlands, following a grounded theory approach. Women were determined as vulnerable by their healthcare providers. Theoretical sampling of participants was applied and was alternated by data analysis to include information-rich cases until saturation was achieved.

Results

A conceptual framework of postpartum care utilisation was generated consisting of three phases: pregnancy, early postpartum period and late postpartum period. Within these phases, information provision, parenting self-efficacy and social network were identified as overarching themes. Perceived inadequate information on content of postpartum care posed a major barrier to forming realistic expectations during pregnancy and hindered its utilisation. Low self-efficacy facilitated postpartum care utilisation. All women experienced increased self-efficacy during and after postpartum care. Support from a social network influenced expectations regarding the added value of postpartum care during pregnancy, and lowered actual utilisation during the postpartum period. The costs of postpartum care and the role of the maternity care assistant acted as general barriers or facilitators influencing the three overarching themes and therefore postpartum care utilisation indirectly.

Conclusions

Our findings suggest that postpartum care utilisation among vulnerable women may be improved by considering the particular phase and relevant themes applying to individual women, and adapt care accordingly. We recommend to provide comprehensive, understandable information and to emphasise the gains of postpartum care in improving self-efficacy for vulnerable women. Moreover, involving a woman’s social network in postpartum care may add value to this care for this population.

Non-communicable diseases, sociodemographic vulnerability and the risk of mortality in hospitalised children and adolescents with COVID-19 in Brazil: a cross-sectional observational study

Por: Sousa · B. L. A. · Brentani · A. · Costa Ribeiro · C. C. · Dolhnikoff · M. · Grisi · S. J. F. E. · Ferrer · A. P. S. · Ferraro · A. A.
Objectives

To analyse how previous comorbidities, ethnicity, regionality and socioeconomic development are associated with COVID-19 mortality in hospitalised children and adolescents.

Design

Cross-sectional observational study using publicly available data from the Brazilian Ministry of Health.

Setting

Nationwide.

Participants

5857 patients younger than 20 years old, all of them hospitalised with laboratory-confirmed COVID-19, from 1 January 2020 to 7 December 2020.

Main outcome measure

We used multilevel mixed-effects generalised linear models to study in-hospital mortality, stratifying the analysis by age, region of the country, presence of non-communicable diseases, ethnicity and socioeconomic development.

Results

Individually, most of the included comorbidities were risk factors for mortality. Notably, asthma was a protective factor (OR 0.4, 95% CI 0.24 to 0.67). Having more than one comorbidity increased almost tenfold the odds of death (OR 9.67, 95% CI 6.89 to 13.57). Compared with white children, Indigenous, Pardo (mixed) and East Asian had significantly higher odds of mortality (OR 5.83, 95% CI 2.43 to 14.02; OR 1.93, 95% CI 1.48 to 2.51; OR 2.98, 95% CI 1.02 to 8.71, respectively). We also found a regional influence (higher mortality in the North—OR 3.4, 95% CI 2.48 to 4.65) and a socioeconomic association (lower mortality among children from more socioeconomically developed municipalities—OR 0.26, 95% CI 0.17 to 0.38)

Conclusions

Besides the association with comorbidities, we found ethnic, regional and socioeconomic factors shaping the mortality of children hospitalised with COVID-19 in Brazil. Our findings identify risk groups among children that should be prioritised for public health measures, such as vaccination.

Relationship between food insecurity and smoking status among women living with and at risk for HIV in the USA: a cohort study

Por: Sheira · L. A. · Frongillo · E. A. · Hahn · J. · Palar · K. · Riley · E. D. · Wilson · T. E. · Adedimeji · A. · Merenstein · D. · Cohen · M. · Wentz · E. L. · Adimora · A. A. · Ofotokun · I. · Metsch · L. · Turan · J. M. · Tien · P. C. · Weiser · S. D.
Objectives

People living with HIV (PLHIV) in the USA, particularly women, have a higher prevalence of food insecurity than the general population. Cigarette smoking among PLHIV is common (42%), and PLHIV are 6–13 times more likely to die from lung cancer than AIDS-related causes. This study sought to investigate the associations between food security status and smoking status and severity among a cohort of predominantly low-income women of colour living with and without HIV in the USA.

Design

Women enrolled in an ongoing longitudinal cohort study from 2013 to 2015.

Setting

Nine participating sites across the USA.

Participants

2553 participants enrolled in the Food Insecurity Sub-Study of the Women’s Interagency HIV Study, a multisite cohort study of US women living with HIV and demographically similar HIV-seronegative women.

Outcomes

Current cigarette smoking status and intensity were self-reported. We used cross-sectional and longitudinal logistic and Tobit regressions to assess associations of food security status and changes in food security status with smoking status and intensity.

Results

The median age was 48. Most respondents were African-American/black (72%) and living with HIV (71%). Over half had annual incomes ≤US$12 000 (52%). Food insecurity (44%) and cigarette smoking (42%) were prevalent. In analyses adjusting for common sociodemographic characteristics, all categories of food insecurity were associated with greater odds of current smoking compared with food-secure women. Changes in food insecurity were also associated with increased odds of smoking. Any food insecurity was associated with higher smoking intensity.

Conclusions

Food insecurity over time was associated with smoking in this cohort of predominantly low-income women of colour living with or at risk of HIV. Integrating alleviation of food insecurity into smoking cessation programmes may be an effective method to reduce the smoking prevalence and disproportionate lung cancer mortality rate particularly among PLHIV.

Deprescribing intervention activities mapped to guiding principles for use in general practice: a scoping review

Por: Coe · A. · Kaylor-Hughes · C. · Fletcher · S. · Murray · E. · Gunn · J.
Objective

To identify and characterise activities for deprescribing used in general practice and to map the identified activities to pioneering principles of deprescribing.

Setting

Primary care.

Data sources

Medline, EMBASE (Ovid), CINAHL, Australian New Zealand Clinical Trials Registry (ANZCTR), Clinicaltrials.gov, ISRCTN registry, OpenGrey, Annals of Family Medicine, BMC Family Practice, Family Practice and British Journal of General Practice (BJGP) from inception to the end of June 2021.

Study selection

Included studies were original research (randomised controlled trial, quasi-experimental, cohort study, qualitative and case studies), protocol papers and protocol registrations.

Data extraction

Screening and data extraction was completed by one reviewer; 10% of the studies were independently reviewed by a second reviewer. Coding of full-text articles in NVivo was conducted and mapped to five deprescribing principles.

Results

Fifty studies were included. The most frequently used activities were identification of appropriate patients for deprescribing (76%), patient education (50%), general practitioners (GP) education (48%), and development and use of a tapering schedule (38%). Six activities did not align with the five deprescribing principles. As such, two principles (engage practice staff in education and appropriate identification of patients, and provide feedback to staff about deprescribing occurrences within the practice) were added.

Conclusion

Activities and guiding principles for deprescribing should be paired together to provide an accessible and comprehensive guide to deprescribing by GPs. The addition of two principles suggests that practice staff and practice management teams may play an instrumental role in sustaining deprescribing processes within clinical practice. Future research is required to determine the most of effective activities to use within each principle and by whom.

Impact of early life nutrition on gut health in children: a prospective clinical study

Por: Ley · D. · Beghin · L. · Morcel · J. · Flamein · F. · Garabedian · C. · Accart · B. · Drumez · E. · Labreuche · J. · Gottrand · F. · Hermann · E.
Introduction

The first 1000 days of life could contribute to individual susceptibility to the later development of chronic non-communicable diseases. Nutrition in early life appears to be an important determinant factor for a sustainable child’s health. In this study, we propose to investigate the impact of exclusive breast feeding on gut health in children.

Methods and analysis

A prospective cohort of newborns (n=350) will be recruited at birth and followed up to 4 years of age. The main objective is to evaluate the link between exclusive breast feeding for at least 3 months and the gut health of the child at 4 years. The primary endpoint of assessment of gut health will be based on the non-invasive measurement of faecal secretory IgA (sIgA) as a sensitive biomarker of the intestinal ecosystem. The presence of gastrointestinal disorders will be defined according to the clinical criteria of Rome IV. Information on parent’s nutritional habits and life style, breastfeeding duration and child’s complementary feeding will be collected along the follow-up. Cord blood cells and plasma at birth will be purified for further analysis. The meconium and stools collected at birth, 6 months, 2 years and 4 years of age will allow sIgA analysis.

Ethics and dissemination

This clinical study has obtained the approval from the national ethical committee. We plan to publish the results of the study in peer-review journals and by means of national and international conference.

Trial registration number

NCT04195425.

Call for emergency action to limit global temperature increases, restore biodiversity and protect health

Por: Atwoli · L. · H Baqui · A. · Benfield · T. · Bosurgi · R. · Godlee · F. · Hancocks · S. · Horton · R. · Laybourn-Langton · L. · Monteiro · C. A. · Norman · I. · Patrick · K. · Praities · N. · Rikkert · M. G. O. · Rubin · E. J. · Sahni · P. · Smith · R. · Talley · N. J. · Turale · S. · Vazq

Wealthy nations must do much more, much faster.

The United Nations General Assembly in September 2021 will bring countries together at a critical time for marshalling collective action to tackle the global environmental crisis. They will meet again at the biodiversity summit in Kunming, China, and the climate conference (Conference of the Parties (COP)26) in Glasgow, UK. Ahead of these pivotal meetings, we—the editors of health journals worldwide—call for urgent action to keep average global temperature increases below 1.5°C, halt the destruction of nature and protect health.

Health is already being harmed by global temperature increases and the destruction of the natural world, a state of affairs health professionals have been bringing attention to for decades.1 The science is unequivocal; a global increase of 1.5°C above the preindustrial average and the continued loss of biodiversity risk catastrophic harm to health that will be impossible to reverse.

Cross-sectional association between long working hours and endoscopic gastritis: the Kangbuk Samsung Health Study

Por: Mun · E. · Lee · Y. · Lee · W. · Park · S.
Objectives

This study aimed to determine the cross-sectional association between long working hours and gastritis diagnosed by endoscopy.

Design

Cross-sectional study.

Setting

Large university hospitals in Seoul and Suwon, South Korea.

Participants

Workers in formal employment who underwent a comprehensive health examination at the Kangbuk Samsung Hospital Total Healthcare Centre clinics in Seoul and Suwon, South Korea, between January 2011 and December 2018. Of the 386 488 participants, 168 391 full-time day workers met the inclusion criteria and were included in the analysis.

Primary outcome measure

Endoscopic gastritis.

Results

The participants were predominantly college graduates or above (88.9%), male (71.2%) and in their 30s (51.1%), and the median age was 36 (IQR 31–42). Approximately 93.2% of participants had positive endoscopic gastritis, and there was a significant association between working hours and positive findings of endoscopic gastritis. The multivariate fully adjusted prevalence ratio (PR) of endoscopic gastritis for participants working >55 hours per week compared with 35–40 hours per week was 1.011 (95% CI 1.007 to 1.015). Furthermore, endoscopic findings were classified into nine subtypes of gastritis, including superficial gastritis, erosive gastritis, atrophic gastritis, intestinal metaplasia and haemorrhagic gastritis increased with longer working hours (p for trends 55 hours per week compared with 35–40 hours per week were 1.019 (95% CI 1.012 to 1.026), 1.025 (95% CI 1.011 to 1.040), 1.017 (95% CI 1.008 to 1.027), 1.066 (95% CI 1.028 to 1.105) and 1.177 (95% CI 1.007 to 1.375), respectively.

Conclusions

Working over 55 hours per week was cross-sectionally associated with positive findings of endoscopic gastritis. The study findings indicated potentially increased risks of superficial gastritis, erosive gastritis, atrophic gastritis, intestinal metaplasia and haemorrhagic gastritis among workers with long working hours (>55 hours per week), supporting the need for further exploration via longitudinal studies.

Measuring differential attainment: a longitudinal analysis of assessment results for 1512 medical students at four Scottish medical schools

Por: Hope · D. · Dewar · A. · Hothersall · E. J. · Leach · J. P. · Cameron · I. · Jaap · A.
Objective

To measure Differential Attainment (DA) among Scottish medical students and to explore whether attainment gaps increase or decrease during medical school.

Design

A retrospective analysis of undergraduate medical student performance on written assessment, measured at the start and end of medical school.

Setting

Four Scottish medical schools (universities of Aberdeen, Dundee, Edinburgh and Glasgow).

Participants

1512 medical students who attempted (but did not necessarily pass) final written assessment.

Main outcome measures

The study modelled the change in attainment gap during medical school for four student demographical categories (white/non-white, international/Scottish domiciled, male/female and with/without a known disability) to test whether the attainment gap grew, shrank or remained stable during medical school. Separately, the study modelled the expected versus actual frequency of different demographical groups in the top and bottom decile of the cohort.

Results

The attainment gap grew significantly for white versus non-white students (t(449.39)=7.37, p=0.001, d=0.49 and 95% CI 0.34 to 0.58), for internationally domiciled versus Scottish-domiciled students (t(205.8) = –7, p=0.01, d=0.61 and 95% CI –0.75 to –0.42) and for male versus female students (t(1336.68)=3.54, p=0.01, d=0.19 and 95% CI 0.08 to 0.27). International, non-white and male students received higher marks than their comparison group at the start of medical school but lower marks by final assessment. No significant differences were observed for disability status. Students with a known disability, Scottish students and non-white students were over-represented in the bottom decile and under-represented in the top decile.

Conclusions

The tendency for attainment gaps to grow during undergraduate medical education suggests that educational factors at medical schools may—however inadvertently—contribute to DA. It is of critical importance that medical schools investigate attainment gaps within their cohorts and explore potential underlying causes.

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