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Predicting the pulmonary effects of long-term e-cigarette use: are the clouds clearing?
No full textCommercially available since 2007, e-cigarettes are a popular electronic delivery device of ever-growing complexity. Given their increasing use by ex-smokers, smokers and never-smokers, it is important to evaluate evidence of their potential pulmonary effects and predict effects of long-term use, since there has been insufficient time to study a chronic user cohort. It is crucial to evaluate indicators of harm seen in cigarette use, and those potentially unique to e-cigarette exposure. Evaluation must also account for the vast variation in e-cigarette devices (now including at least five generations of devices) and exposure methods used and Thus far, short-term use cohort studies, combined with and models, have been used to probe for the effects of e-cigarette exposure. The effects and mechanisms identified, including dysregulated inflammation and decreased pathogen resistance, show concerning overlaps with the established effects of cigarette smoke exposure. Additionally, research has identified a signature of dysregulated lipid processing, which is unique to e-cigarette exposure.This review will evaluate the evidence of pulmonary effects of, and driving mechanisms behind, e-cigarette exposure, which have been highlighted in emerging literature, and highlight the gaps in current knowledge. Such a summary allows understanding of the ongoing debate into e-cigarette regulation, as well as prediction and potential mitigation of future problems surrounding e-cigarette use
Lactic acid gel versus metronidazole for recurrent bacterial vaginosis in women aged 16 years and over: the VITA RCT.
No full textBACKGROUND
Bacterial vaginosis is a common and distressing condition associated with serious comorbidities. Antibiotic treatment is usually clinically effective in the short term, but recurrence is common and side effects can occur.
OBJECTIVES
The objective is to assess whether or not intravaginal lactic acid gel is clinically effective and cost-effective for treating recurrent bacterial vaginosis compared with oral metronidazole (Flagyl, Sanofi).
DESIGN
This was an open-label, multicentre, parallel-arm, randomised (1 : 1) controlled trial.
SETTING
This took place in one general practice and 19 sexual health centres in the UK.
PARTICIPANTS
Women aged ≥ 16 years with bacterial vaginosis symptoms and one or more episode(s) within the past 2 years took part.
INTERVENTIONS
The interventions were 5 ml of intravaginal lactic acid gel taken once daily for 7 days (intervention) or 400-mg oral metronidazole tablets taken twice daily for 7 days (control).
MAIN OUTCOME MEASURES
The primary outcome was the resolution of bacterial vaginosis symptoms 14 days after randomisation. The secondary outcomes were time to first recurrence of symptoms; number of recurrences and treatment courses over 6 months; microbiological resolution on microscopy of vaginal smears at week 2; time to resolution of symptoms; tolerability, adherence and acceptability of the treatment; prevalence of concurrent sexually transmitted infections; quality of life; and cost-effectiveness.
RESULTS
Recruitment stopped prior to reaching the target of 1900 participants on recommendation from the Data Monitoring Committee and Trial Steering Committee after a planned review of the results indicated that the research question had been answered. Overall, 518 participants were randomised and primary outcome data were available for 409 participants (79%; 204 in the metronidazole arm, 205 in the lactic acid gel arm). Participant-reported symptom resolution at week 2 was higher with metronidazole (143/204; 70%) than with lactic acid gel (97/205; 47%) (adjusted risk difference -23.2%, 95% confidence interval -32.3% to -14.0%). Recurrence in 6 months in a subset of participants who had initial resolution and were available for follow-up was similar across arms (metronidazole arm: 51/72, 71%; lactic acid gel arm: 32/46, 70%). A higher incidence of some side effects was reported with metronidazole than with lactic acid gel (nausea 32% vs. 8%; taste changes 18% vs. 1%; diarrhoea 20% vs. 6%, respectively). At week 2, the average cost per participant with resolved symptoms was £86.94 (metronidazole), compared with £147.00 (lactic acid gel). Some participants preferred using lactic acid gel even if they perceived it to be less effective than metronidazole.
LIMITATIONS
Loss to follow-up for collection of the primary outcome data was 21% and was similar in both arms. There is a risk of bias owing to missing outcome data at 3 and 6 months post treatment.
CONCLUSIONS
A higher initial response was seen with metronidazole than with lactic acid gel, but subsequent treatment failure was common with both. Lactic acid gel was less cost-effective than metronidazole. In general, women disliked taking repeated courses of metronidazole and preferred lactic acid gel, even when they were aware that it was less likely to provide symptom resolution. In the absence of effective curative therapy, further evaluation of non-antibiotic treatments to control the symptoms of recurrent bacterial vaginosis is required to improve quality of life for these patients. Further microbiological analysis of vaginal samples would be useful to identify additional factors affecting response to treatment.
TRIAL REGISTRATION
Current Controlled Trials ISRCTN14161293.
FUNDING
This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 26, No. 2. See the NIHR Journals Library website for further project information
The risk of mental illness in people living with HIV in the UK: a propensity score-matched cohort study.
No full textBACKGROUND
Prevalence of mental illness is higher in people living with HIV than in the general population, but the incidence of composite mental illness and its components is unclear. We aimed to identify the risk of incident mental illness along with individual conditions of depression, anxiety, and severe mental illness in people living with HIV in the UK.
METHODS
Data for this population-based cohort were extracted from the IQVIA Medical Research Database, a nationally representative UK-based database of primary care electronic health records. We included adults (aged ≥18 years) living with HIV, matched with adults without HIV using propensity score matching (1:1 ratio). The primary outcome was composite mental illness comprising a diagnosis of depression, anxiety, or severe mental illness. Secondary outcomes were individual mental health conditions. Cox proportional hazard regression models were used to compare the risk of each outcome between people with and without HIV. Each model excluded those with the outcome at baseline. Individuals were followed up prospectively. The study period was from Jan 1, 2000, to Jan 1, 2020.
FINDINGS
Of 7167 people living with HIV without mental illness at baseline, 586 developed a mental illness (incidence rate 19·6 per 1000 person-years) compared with 418 of 7167 people without HIV (incidence rate 12·1 per 1000 person-years), resulting in an adjusted hazard ratio (HR) of 1·63 (95% CI 1·44-1·85). People living with HIV had higher incidence rates for depression (15·4 per 1000 person-years), anxiety (7·2 per 1000 person-years), and severe mental illness (1·6 per 1000 person-years) compared with people without HIV (7·9, 5·0, and 0·6 per 1000 person-years, respectively), with adjusted HRs of 1·94 (95% CI 1·68-2·24) for depression, 1·38 (1·15-1·66) for anxiety, and 2·18 (1·41-3·39) for severe mental illness.
INTERPRETATION
People living with HIV have an increased risk for developing composite mental illness, depression, anxiety, and severe mental illness compared with people without HIV. People living with HIV should be regularly screened for mental illness; however, there is a strong need to improve prevention of mental illness in people living with HIV and for more outreach programmes to ensure that no groups of people living with HIV are being underdiagnosed.
FUNDING
None
Evaluating semantic similarity methods for comparison of text-derived phenotype profiles.
No full textBACKGROUND
Semantic similarity is a valuable tool for analysis in biomedicine. When applied to phenotype profiles derived from clinical text, they have the capacity to enable and enhance 'patient-like me' analyses, automated coding, differential diagnosis, and outcome prediction. While a large body of work exists exploring the use of semantic similarity for multiple tasks, including protein interaction prediction, and rare disease differential diagnosis, there is less work exploring comparison of patient phenotype profiles for clinical tasks. Moreover, there are no experimental explorations of optimal parameters or better methods in the area.
METHODS
We develop a platform for reproducible benchmarking and comparison of experimental conditions for patient phentoype similarity. Using the platform, we evaluate the task of ranking shared primary diagnosis from uncurated phenotype profiles derived from all text narrative associated with admissions in the medical information mart for intensive care (MIMIC-III).
RESULTS
300 semantic similarity configurations were evaluated, as well as one embedding-based approach. On average, measures that did not make use of an external information content measure performed slightly better, however the best-performing configurations when measured by area under receiver operating characteristic curve and Top Ten Accuracy used term-specificity and annotation-frequency measures.
CONCLUSION
We identified and interpreted the performance of a large number of semantic similarity configurations for the task of classifying diagnosis from text-derived phenotype profiles in one setting. We also provided a basis for further research on other settings and related tasks in the area
Endovascular thrombectomy beyond 24 hours from ischemic stroke onset: a propensity score matched cohort study.
No full textBACKGROUND
The safety and functional outcome of endovascular thrombectomy (EVT) in the very late (VL; >24 hours) time window from ischemic stroke onset remains undetermined.
METHODS
Using data from a national stroke registry, we used propensity score matched (PSM) individual level data of patients who underwent EVT, selected with CT perfusion or non-contrast CT/CT angiography, between October 2015 and March 2020. Functional and safety outcomes were assessed in both late (6-24 hours) and VL time windows. Subgroup analysis was performed of imaging selection modality in the VL time window.
RESULTS
We included 1150 patients (late window: 1046 (208 after PSM); VL window: 104 (104 after PSM)). Compared with EVT treatment initiation between 6 and 24 hours, patients treated in the VL window had similar modified Rankin Scale (mRS) scores at discharge (ordinal shift; common OR=1.08, 95% CI 0.69 to 1.47, p=0.70). No significant differences in achieving good functional outcome (mRS ≤2 at discharge; 28.8% (VL) vs 29.3% (late), OR=0.97, 95% CI 0.58 to 1.64, p=0.93), successful reperfusion (modified Thrombolysis in Cerebral Infarction score of 2b-3) (p=0.77), or safety outcomes of symptomatic intracranial hemorrhage (p=0.43) and inhospital mortality (p=0.23) were demonstrated. In the VL window, there was no significant difference in functional outcome among patients selected with perfusion versus those selected without perfusion imaging (common OR=1.38, 95% CI 0.81 to 1.76, p=0.18).
CONCLUSION
In this real world study, EVT beyond 24 hours from stroke onset or last known well appeared to be feasible, with comparable safety and functional outcomes to EVT initiation between 6 and 24 hours. Randomized trials assessing the efficacy of EVT in the VL window are warranted, but may only be feasible with a large international collaborative approach
The move towards integrated care: Lessons learnt from managing patients with multiple morbidities in the UK.
No full textINTRODUCTION
The multi-disciplinary care offered to patients with multi-morbidities offers a powerful example of the practical challenges faced by the National Health Service's planned move to more closely integrated models of care.
PURPOSE, OBJECTIVE, AND CONTRIBUTIONS
The intention of this work was to identify the opportunities and obstacles presented by the current provision of integrated care and explore their implications for existing and future policy initiatives.
MATERIALS AND METHODS
We conducted a qualitative exploration of the experiences of senior managers, commissioners and clinicians, using a post-hoc content analysis to populate and present the results within the multi-componential Sustainable integrated chronic care model for multi-morbidity: delivery, financing, and performance (SELFIE) framework designed to understand integrated care.
RESULTS
A total of 13 senior medical directors, commissioners, and managers, and 15 clinicians from a range of care settings were interviewed. Relative factors within the six framework components were identified namely; issues around communication between settings (Service delivery), the importance of collaborative leadership (Leadership & governance); the need for high-level collaboration (Workforce), better directed financial incentives (Financing), the lack of software interoperability (Technologies and medical products) and constraints on sharing and utilising patient data (Information & Research).
CONCLUSIONS
The SELFIE framework has provided valuable insight into the challenges presented by inter-organisational and inter-professional working that will help guide the design and implementation of policies promoting integrated care. These may be mitigated by sharing the varied experiences and priorities that exist across primary and care settings, alongside improving communication and supporting collaborative leadership. There also appears a clear role for refocussing financial incentives to reward shared responsibility at all levels of service delivery
Risk factors associated with COVID-19 severity among patients on maintenance haemodialysis: a retrospective multicentre cross-sectional study in the UK.
No full textOBJECTIVES
To assess the applicability of risk factors for severe COVID-19 defined in the general population for patients on haemodialysis.
SETTING
A retrospective cross-sectional study performed across thirty four haemodialysis units in midlands of the UK.
PARTICIPANTS
All 274 patients on maintenance haemodialysis who tested positive for SARS-CoV-2 on PCR testing between March and August 2020, in participating haemodialysis centres.
EXPOSURE
The utility of obesity, diabetes status, ethnicity, Charlson Comorbidity Index (CCI) and socioeconomic deprivation scores were investigated as risk factors for severe COVID-19.
MAIN OUTCOMES AND MEASURES
Severe COVID-19, defined as requiring supplemental oxygen or respiratory support, or a C reactive protein of ≥75 mg/dL (RECOVERY trial definitions), and its association with obesity, diabetes status, ethnicity, CCI, and socioeconomic deprivation.
RESULTS
63.5% (174/274 patients) developed severe disease. Socioeconomic deprivation associated with severity, being most pronounced between the most and least deprived quartiles (OR 2.81, 95% CI 1.22 to 6.47, p=0.015), after adjusting for age, sex and ethnicity. There was no association between obesity, diabetes status, ethnicity or CCI with COVID-19 severity. We found no evidence of temporal evolution of cases (p=0.209) or clustering that would impact our findings.
CONCLUSION
The incidence of severe COVID-19 is high among patients on haemodialysis; this cohort should be considered high risk. There was strong evidence of an association between socioeconomic deprivation and COVID-19 severity. Other risk factors that apply to the general population may not apply to this cohort
VATS surgical anatomical resection of bronchopulmonary sequestration presenting as chest sepsis.
No full textBACKGROUND
Bronchopulmonary sequestration (BPS) is a malformation of the lungs resulting in lung tissue lacking direct communication to the tracheobronchial tree. Most cases demonstrate systemic arterial blood supply from the descending thoracic aorta, the abdominal aorta, celiac axis or splenic artery and venous drainage via the pulmonary veins with occasional drainage into azygos vein. BPS is considered a childhood disease and accounts for 0.15-6.40% of congenital pulmonary malformations. BPS is divided into intralobar sequestrations (ILS) and extralobar sequestrations (ELS) with ILS accounting for 75% of all cases.
METHODS
Here we present our 11-year experience of dealing with BPS; all cases presented with recurrent chest sepsis in young-late adulthood regardless of the type of pathological sequestration. The surgical technique employed was a minimally invasive video-assisted thoracoscopic anterior approach (VATS).
RESULTS
Between May 2010 and September 2021, we have operated on nine adult patients with bronchopulmonary sequestration who presented late with symptoms of recurrent chest sepsis. Most patients in the cohort had lower lobe pathology, with a roughly even split between right and left sided pathology. Moreover, the majority were life-long never smokers and an equal preponderance in males and females. The majority were extralobar sequestrations (56%) with pathological features in keeping with extensive bronchopneumonia and bronchiectasis. There were no major intra-operative or indeed post-operative complications. Median length of stay was 3 days.
CONCLUSIONS
Dissection and division of the systemic feeding vessel was readily achievable through a successful anterior VATS approach, regardless of the type of sequestration and without the use of pre-operative coiling of embolization techniques. This approach gave excellent access to the hilar structures yet in this pathology, judicious and perhaps a lower threshold for open approach should be considered
Cost-efficient snare-assisted peroral endoscopic myotomy in comparison of conventional endoscopic knife for treatment of achalasia: results of a randomized controlled trial.
No full textBACKGROUND
To date, the ideal endoscopic knife for peroral endoscopic myotomy (POEM) with good performance and cost-effectiveness is still under investigation. The present study was aimed to evaluate the efficacy, safety, and cost-effectiveness of snare-assisted POEM, compared with the conventional endoscopic knife approach.
METHODS
From May 2017 to December 2018, patients with achalasia presenting for POEM without previous endoscopic or surgical therapy were prospectively recruited in this randomized controlled trial. Patients were randomly allocated to receive POEM using either the snare (snare group) or HookKnife (conventional group). The primary outcome was clinical success (Eckardt score ≤ 3) at 12-month follow-up, powered for noninferiority with a margin of -15%. The secondary outcomes included adverse events (AEs), procedure-related parameters, clinical outcomes, and cost-effectiveness.
RESULTS
A total of 75 patients with similar baseline characteristics between the snare (N = 37) and conventional (N = 38) groups were included. Clinical success at 12-month follow-up was achieved in 94.6% of patients in the snare group and 92.1% of patients in the conventional group (difference, 2.5% [95% CI, -8.7% to 13.7%]; P < 0.001 for noninferiority). No severe AEs occurred in both groups. The use of snare is associated with comparable procedure time (40.6 minutes vs. 42.5 minutes, P = 0.337), a lower frequency of hemostatic forceps use (27.0% vs. 68.4%, P < 0.001), and lower hospital costs (5327.3, P < 0.001). The cost-effectiveness plane revealed that 96.9% of snare-assisted POEM procedures offered more cost-savings and health utility benefits.
CONCLUSIONS
The snare-assisted POEM was noninferior to the conventional endoscopic knife approach in terms of clinical efficacy, with comparable safety outcomes and cost-effective benefits