Nevin Manimala

BMJ Open. 2021 May 13;11(5):e050105. doi: 10.1136/bmjopen-2021-050105.

ABSTRACT

INTRODUCTION: Ventilator-associated pneumonia (VAP) is the most common nosocomial infection in intensive care units (ICUs). Using short-course antibiotics to treat VAP caused by Gram-negative non-fermenting bacteria has been reported to be associated with excess pneumonia recurrences. The “REducinG Antibiotic tReatment Duration for Ventilator-Associated Pneumonia” (REGARD-VAP) trial aims to provide evidence for using a set of reproducible clinical criteria to shorten antibiotic duration for individualised treatment duration of VAP.

METHODS AND ANALYSIS: This is a randomised controlled hierarchical non-inferiority-superiority trial being conducted in ICUs across Nepal, Thailand and Singapore. The primary outcome is a composite endpoint of death and pneumonia recurrence at day 60. Secondary outcomes include ventilator-associated events, multidrug-resistant organism infection or colonisation, total duration of antibiotic exposure, mechanical ventilation and hospitalisation. Adult patients who satisfy the US Centers for Disease Control and Prevention National Healthcare Safety Network VAP diagnostic criteria are enrolled. Participants are assessed daily until fever subsides for >48 hours and have stable blood pressure, then randomised to a short duration treatment strategy or a standard-of-care duration arm. Antibiotics may be stopped as early as day 3 if respiratory cultures are negative, and day 5 if respiratory cultures are positive in the short-course arm. Participants receiving standard-of-care will receive antibiotics for at least 8 days. Study participants are followed for 60 days after enrolment. An estimated 460 patients will be required to achieve 80% power to determine non-inferiority with a margin of 12%. All outcomes are compared by absolute risk differences. The conclusion of non-inferiority, and subsequently superiority, will be based on unadjusted and adjusted analyses in both the intention-to-treat and per-protocol populations.

ETHICS AND DISSEMINATION: The study has received approvals from the Oxford Tropical Research Ethics Committee and the respective study sites. Results will be disseminated to patients, their caregivers, physicians, the funders, the critical care societies and other researchers.

TRIAL REGISTRATION NUMBER: NCT03382548.

PMID:33986070 | DOI:10.1136/bmjopen-2021-050105

BMJ Open. 2021 May 13;11(5):e049877. doi: 10.1136/bmjopen-2021-049877.

ABSTRACT

INTRODUCTION: The outbreak of novel COVID-19 caught the world off guard in the first quarter of 2020. To stem the tide of this pandemic, there was acceleration of the development, testing and prelicensure approval for emergency use of some COVID-19 vaccine candidates. This led to raised public concern about their safety and efficacy, compounding the challenges of vaccine hesitancy. The onus of managing and administering these vaccines to a sceptical populace when they do become available rests mostly on the shoulders of healthcare workers (HCWs). Therefore, the vaccine confidence levels of HCWs become critical to the success of vaccination endeavours. This proposed study aims to estimate the level of vaccine confidence and the intention to receive a COVID-19 vaccine among future HCWs and their trainers at a specific university in Cape Town, South Africa, and to identify any vaccination concerns early for targeted intervention.

METHODS AND ANALYSIS: This proposed study is a cross-sectional survey study. An online questionnaire will be distributed to all current staff and students of the Faculty of Medicine Health Sciences of Stellenbosch University in Cape Town, South Africa. No sampling strategy will be employed. The survey questionnaire will consist of demographic questions (consisting of six items) and vaccine confidence questions (comprising six items in Likert scale format). Log binomial models will be employed to identify factors associated with vaccine confidence and intention. The strength of association will be assessed using the OR and its 95% CI. Statistical significance will be defined at a p value <0.05.

ETHICS AND DISSEMINATION: Ethics approval has been obtained for the study from Stellenbosch University (Human Research Ethics Committee reference number S19/01/014 (PhD)). The results will be shared with relevant health authorities, presented at conferences and published in a peer-reviewed journal.

PMID:33986069 | DOI:10.1136/bmjopen-2021-049877

BMJ Open. 2021 May 13;11(5):e045888. doi: 10.1136/bmjopen-2020-045888.

ABSTRACT

OBJECTIVES: The benefits of minimally invasive surgery (MIS) for endometrial carcinoma (EC) are well established although the financial impact of robotic-assisted hysterectomy (RH) compared with laparoscopic hysterectomy (LH) is disputed.

DESIGN: Retrospective cohort study.

SETTING: English National Health Service hospitals 2011-2017/2018.

PARTICIPANTS: 35 304 women having a hysterectomy for EC identified from Hospital Episode Statistics.

PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was the association between route of surgery on cost at intervention, 30, 90 and 365 days for women undergoing an open hysterectomy (OH) or MIS (LH/RH) for EC in England. The average marginal effect was calculated to compare RH versus OH and RH versus LH which adjusted for any differences in the characteristics of the surgical approaches. Secondary outcomes were to analyse costing data for each surgical approach by age, Charlson Comorbidity Index (CCI) and hospital MIS rate classification.

RESULTS: A total of 35 304 procedures were performed, 20 405 (57.8%) were MIS (LH: 18 604 and RH: 1801), 14 291 (40.5%) OH. Mean cost for LH was significantly less than RH, whereas RH was significantly less than OH at intervention, 30, 90 and 365 days (p<0.001). Over time, patients who underwent RH had increasing CCI scores and by the 2015/2016 year had a higher average CCI than LH. Comparing the cost of LH and RH against CCI score identified that the costs closely reflected the patients’ CCI. Increasing disparity was also seen between the MIS and OH costs with rising age. When exploring the association between provider volume, MIS rate and surgical costs, there was an association with the higher the MIS rate the lower the average cost.

CONCLUSIONS: Further research is needed to investigate costs in matched patient cohorts to determine the optimum surgical modality in different populations.

PMID:33986058 | DOI:10.1136/bmjopen-2020-045888

BMJ Open. 2021 May 13;11(5):e043313. doi: 10.1136/bmjopen-2020-043313.

ABSTRACT

INTRODUCTION: The 2015 Sustainable Development Goals include the objective of reducing premature mortality from major non-communicable diseases (NCDs) by one-third by 2030. Accomplishing this objective has demographic implications with relevance for countries’ health systems and costs. However, evidence on the system-wide implications of NCD targets is limited.

METHODS: We developed a cohort-component model to estimate demographic change based on user-defined disease-specific mortality trajectories. The model accounts for ageing over 101 annual age cohorts, disaggregated by sex and projects changes in the size and structure of the population. We applied this model to the context of Bangladesh, using the model to simulate demographic outlooks for Bangladesh for 2015-2030 using three mortality scenarios. The ‘status quo’ scenario entails that the disease-specific mortality profile observed in 2015 applies throughout 2015-2030. The ‘trend’ scenario adopts age-specific, sex-specific and disease-specific mortality rate trajectories projected by WHO for the region. The ‘target’ scenario entails a one-third reduction in the mortality rates of cardiovascular disease, cancer, diabetes and chronic respiratory diseases between age 30 and 70 by 2030.

RESULTS: The status quo, trend and target scenarios projected 178.9, 179.7 and 180.2 million population in 2030, respectively. The cumulative number of deaths during 2015-2030 was estimated at 17.4, 16.2 and 15.6 million for each scenario, respectively. During 2015-2030, the target scenario would avert a cumulative 1.73 million and 584 000 all-cause deaths compared with the status quo and trend scenarios, respectively. Male life expectancy was estimated to increase from 71.10 to 73.47 years in the trend scenario and to 74.38 years in the target scenario; female life expectancy was estimated to increase from 73.68 to 75.34 years and 76.39 years in the trend and target scenarios, respectively.

CONCLUSION: The model describes the demographic implications of NCD prevention and control targets, estimating the potential increase in life expectancy associated with achieving key NCD reduction targets. The results can be used to inform future health system needs and to support planning for increased healthcare coverage in countries.

PMID:33986047 | DOI:10.1136/bmjopen-2020-043313

BMJ Open. 2021 May 13;11(5):e042911. doi: 10.1136/bmjopen-2020-042911.

ABSTRACT

INTRODUCTION: Older Canadians living with frailty are high users of healthcare services; however, the healthcare system is not well designed to meet the complex needs of many older adults. Older persons look to their primary care practitioners to assess their needs and coordinate their care. They may need care from a variety of providers and services, but often this care is not well coordinated. Older adults and their family caregivers are the experts in their own needs and preferences, but often do not have a chance to participate fully in treatment decisions or care planning. As a result, older adults may have health problems that are not properly assessed, managed or treated, resulting in poorer health outcomes and higher economic and social costs. We will be implementing enhanced primary healthcare approaches for older patients, including risk screening, patient engagement and shared decision making and care coordination. These interventions will be tailored to the needs and circumstances of the primary care study sites. In this article, we describe our study protocol for implementing and testing these approaches.

METHODS AND ANALYSIS: Nine primary care sites in three Canadian provinces will participate in a multi-phase mixed methods study. In phase 1, baseline information will be collected through questionnaires and interviews with patients and healthcare providers (HCPs). In phase 2, HCPs and patients will be consulted to tailor the evidence-based interventions to site-specific needs and circumstances. In phase 3, sites will implement the tailored care model. Evaluation of the care model will include measures of patient and provider experience, a quality of life measure, qualitative interviews and economic evaluation.

ETHICS AND DISSEMINATION: This study has received ethics clearance from the host academic institutions: University of Calgary (REB17-0617), University of Waterloo (ORE#22446) and Université Laval (#MP-13-2019-1500 and 2017-2018-12-MP). Results will be disseminated through traditional means, including peer-reviewed publications and conferences and through an extensive network of knowledge user partners.

TRIAL REGISTRATION NUMBER: NCT03442426;Pre-results.

PMID:33986044 | DOI:10.1136/bmjopen-2020-042911

Eur Respir J. 2021 May 13:2100944. doi: 10.1183/13993003.00944-2021. Online ahead of print.

NO ABSTRACT

PMID:33986032 | DOI:10.1183/13993003.00944-2021

Eur Respir J. 2021 May 13:2004594. doi: 10.1183/13993003.04594-2020. Online ahead of print.

ABSTRACT

BACKGROUND: While air pollution has been linked to the development of chronic obstructive pulmonary disease (COPD), evidence on the role of environmental noise is just emerging. We examined the associations of long-term exposure to air pollution and road traffic noise with COPD incidence.

METHODS: We defined COPD incidence for 24 538 female nurses from the Danish Nurse Cohort (age>44 years) as the first hospital contact between baseline (1993 or 1999) and 2015. We estimated residential annual mean concentrations of particulate matter with diameter<2.5 µm (PM_2.5) since 1990 and nitrogen dioxide (NO₂) since 1970 by the Danish DEHM/UBM/AirGIS modeling system, and road traffic noise (L_den) since 1970 by the Nord2000 model. Time-varying Cox regression models were applied to assess the associations of air pollution and road traffic noise with COPD incidence.

RESULTS: 977 nurses developed COPD during 18.6 years’ mean follow-up. We observed associations with COPD for all three exposures with hazard ratios (HRs) and 95% confidence intervals (CIs) of 1.19 (1.01, 1.41) per 6.26 µg·m^-3 for PM_2.5, 1.13 (1.05, 1.20) per 8.19 µg·m^-3 for NO₂, and 1.15 (1.06, 1.25) per 10 dB for L_den. Associations with NO₂ and L_den attenuated slightly after mutual adjustment, but were robust to adjustment for PM_2.5. Associations with PM_2.5 were attenuated to null after adjustment for either NO₂ or L_den. No potential interaction effect was observed between air pollutants and noise.

CONCLUSIONS: Long-term exposure to air pollution, especially traffic-related NO₂, and road traffic noise were independently associated with COPD.

PMID:33986028 | DOI:10.1183/13993003.04594-2020

BMJ Glob Health. 2021 May;6(5):e005672. doi: 10.1136/bmjgh-2021-005672.

ABSTRACT

INTRODUCTION: Diverse gender and geographical representation matters in research. We aimed to review medical and global health journals’ sex/gender reporting, and the gender and geography of authorship.

METHODS: 542 research and non-research articles from 14 selected journals were reviewed using a retrospective survey design. Paper screening and systematic data extraction was conducted with descriptive statistics and regression analyses calculated from the coded data. Outcome measures were journal characteristics, the extent to which published articles met sex/gender reporting guidelines, plus author gender and location of their affiliated institution.

RESULTS: Five of the fourteen journals explicitly encourage sex/gender analysis in their author instructions, but this did not lead to increased sex/gender reporting beyond the gender of study participants (OR=3.69; p=0.000 (CI 1.79 to 7.60)). Just over half of research articles presented some level of sex/gender analysis, while 40% mentioned sex/gender in their discussion. Articles with women first and last authors were 2.4 times more likely to discuss sex/gender than articles with men in those positions (p=0.035 (CI 1.062 to 5.348)). First and last authors from high-income countries (HICs) were 19 times as prevalent as authors from low-income countries; and women from low-income and middle-income countries were at a disadvantage in terms of the impact factor of the journals they published in.

CONCLUSION: Global health and medical research fails to consistently apply a sex/gender lens and remains largely the preserve of authors in HIC. Collaborative partnerships and funding support are needed to promote gender-sensitive research and dismantle historical power dynamics in authorship.

PMID:33986001 | DOI:10.1136/bmjgh-2021-005672

Int J Spine Surg. 2021 May 13:8082. doi: 10.14444/8082. Online ahead of print.

ABSTRACT

BACKGROUND: Accidental dural tears (DTs) are familiar complications of spinal surgery. Their reported incidence varies widely, and several risk factors have been proposed in the literature. The aim of this study was to conduct a systematic review and meta-analysis to determine the rate of DTs and assess their associated risk factors.

METHODS: A systematic literature search was conducted using specific MeSH and Text terms. Only articles with prospective data reporting the incidence and risk factors were selected and reviewed based on specific inclusion and exclusion criteria.

RESULTS: Twenty-three studies were included. The reported incidence rate ranged from 0.4% to 15.8%, giving an overall pooled incidence rate of 5.8% (95% confidence interval [CI] 4.4-7.3). The incidence rate varied in relation to the part of the spine and the type of surgery. Three factors were associated with a high rate of DTs: age (overall mean difference of 3.04, 95% CI 2.49-3.60), revision surgery (overall odds ratio of 2.28, 95% CI 1.84-2.83), and lumbar stenosis (overall odds ratio of 2.03, 95% CI 1.50-2.75). Diabetes was weakly associated with DTs, with an odds ratio of 1.40 (95% CI 1.01-1.93). The overall effects of sex and obesity were not statistically significant.

CONCLUSION: Advancing age, revision surgery, and lumbar stenosis were significantly associated with increased risk of DTs. These factors should be taken into consideration during the consenting process for spinal surgery.

CLINICAL RELEVANCE: Risk of dural tear during spine surgery.

PMID:33986000 | DOI:10.14444/8082

Int J Spine Surg. 2021 May 13:8064. doi: 10.14444/8064. Online ahead of print.

ABSTRACT

BACKGROUND: Incidental durotomies (IDs) are frequent complications of spinal surgeries which are mostly posterior or lateral. Anterior IDs are rare; however, they may lead to severe complications. We compared the transthecal approach with the conservative approach for primary closure after durotomy in anterior lumbar dural tear to assess the efficacy of these approaches to decrease postsurgical complications and clinical outcomes.

METHODS: A total of 21 patients undergoing L2-S1 laminectomy with anterior ID were randomly divided into a transthecal group (n = 9) and a conservative group (n = 12) based on the surgical dural closure technique. Postoperative pseudomeningocele, wound infection, rootlet herniation, pneumocephalus, cerebrospinal fluid (CSF) leakage, headache, meningitis, in addition to surgery duration and length of hospitalization were examined and compared in both groups.

RESULTS: The frequency of pseudomeningocele and CSF leakage in patients undergoing the transthecal approach was significantly lower than those undergoing the conservative approach (P = .045 and .008, respectively). Furthermore, although the differences in the frequency of meningitis, pneumocephalus, headache, and wound infection were not statistically significant between the 2 groups, the effect sizes of the comparison were obtained as 49.4, 19.8, 7.1, and 2.6, respectively. This indicated that the differences were clinically significant between the 2 groups.

CONCLUSIONS: We found that the transthecal approach was significantly more successful in managing CSF leakage as well as its complications and clinical outcomes. However, further clinical trials with bigger sample sizes are needed to substantiate this claim.

PMID:33985999 | DOI:10.14444/8064