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How to be a baby-- by me, the big sister
An all-knowing big sister gives her baby sibling lessons in being a baby.
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Jetstream Atherectomy Followed by Paclitaxel-Coated Balloons versus Balloon Angioplasty Followed by Paclitaxel-Coated Balloons: Twelve-Month Exploratory Results of the Prospective Randomized JET-RANGER Study
Background: It is unknown at this time whether Jetstream atherectomy (JET) and paclitaxel-coated balloon (PCB) provides a superior outcome to balloon angioplasty (PTA) followed by PCB in treating femoropopliteal (FP) arterial disease. Methods: The JET-RANGER study was a multicenter (eleven US centers) randomized trial, core lab-adjudicated, designed to demonstrate the superiority of JET + PCB versus PTA + PCB in treating FP arterial disease. The study intended to enroll 255 patients, but was stopped early because of poor enrollment due to COVID-19 and concerns about the association of paclitaxel with mortality. The data are thus considered exploratory. A total of 47 patients (48 lesions) with claudication (80.9%) or rest pain/ulcerations (19.2%) were randomly assigned 2:1 to JET + PCB (n=31) or PTA + PCB (n=16). The In.PACT (Medtronic) and Ranger (Boston Scientific) PCBs were used. Freedom from target-lesion revascularization (TLR) was evaluated at 1 year. Analysis was performed on intention to treat. Results: Mean lesion length was 10.8[+ or -]4.3 cm for JET + PCB and 11.2[+ or -]7.6 cm for PTA + PCB (P=0.858). There were no other differences in demographic or angiographic variables between the two groups. Procedural success was superior with JET + PCB (87.1%) vs PTA + PCB alone (52.9%; P=0.0147). Overall bailout stenting rate was 17% (0 JET + DCB versus 50% PCB, P<0.0001). There was no distal embolization requiring treatment. There was no amputation or death in either group. Using KM analysis, the primary end point of freedom from TLR (bailout stent considered a TLR) at 1 year was 100% and 43.8% (P<0.0001) for JET + PCB versus PTA + PCB, respectively. When bailout stent was not considered a TLR, freedom from TLR was 100% and 93.7%, respectively (P=0.327). Conclusion: A high rate of freedom from TLR was seen in the JET + PCB arm and the PTA + DCB arm at 1-year follow-up, with a significant reduction in bailout stenting following vessel prepping with the Jetstream. Keywords: Jetstream, atherectomy, femoropopliteal, vessel prepping, drug-coated balloons, Ranger, In.PACT, randomized trial, dissections, bailout stenting
Journal Article
“From taboo to routine”: a qualitative evaluation of a hospital-based advocacy intervention for domestic violence and abuse
Background
Health services are often the first point of professional contact for people who have experienced domestic violence and abuse. We report on the evaluation of a multi-site, hospital-based advocacy intervention for survivors of domestic violence and abuse. Independent Domestic Violence Advisors (IDVAs), who provide survivors with support around safety, criminal justice, and health and wellbeing, were located in five hospitals in England between 2012 and 2015 in emergency departments and maternity services. We present views about IDVAs’ approaches to tackling domestic violence and abuse, how the IDVA service worked in practice, and factors that hindered and facilitated engagement with survivors.
Methods
We adopted a convenience sampling approach and invited participation from all who offered to take part within the study timeframe. Sixty-four healthcare professionals, IDVAs, IDVA service managers, and commissioners at all sites were interviewed. Interviews were analysed using a thematic approach: familiarising ourselves with the data through repeated readings and noting initial ideas; generating initial codes through double coding notable features of the data across the dataset; collating codes into potential themes; and reviewing themes to ensure they captured the essence of the data.
Results
Two key themes emerged. The first was
Hospital-based IDVAs fulfil several crucial roles.
This theme highlighted that healthcare professionals thought the hospital-based IDVA service was valuable because it enhanced their skills, knowledge, and confidence in asking about domestic violence and abuse. It enabled them to immediately refer and provide support to patients who might have otherwise been lost along a referral pathway. It also reached survivors who might otherwise have remained hidden. The second theme was
Success hinges on a range of structural factors
. This theme illustrated the importance of ongoing domestic violence and abuse training for staff, the IDVA having private and dedicated space, and the service being embedded in hospital infrastructure (e.g. featuring it in hospital-wide policies and enabling IDVAs access to medical records).
Conclusion
Hospital-based IDVAs offer a unique and valued way to respond to domestic violence and abuse in a healthcare setting. Further work must now be done to explore how to implement the service sustainably.
Journal Article
Cry for health: a quantitative evaluation of a hospital-based advocacy intervention for domestic violence and abuse
Background
Domestic violence and abuse (DVA) damages the health of survivors and increases use of healthcare services. We report findings from a multi-site evaluation of hospital-based advocacy services, designed to support survivors attending emergency departments and maternity services.
Methods
Independent Domestic Violence Advisors (IDVA) were co-located in five UK hospitals. Case-level data were collected at T1 (initial referral) and T2 (case closure) from survivors accessing hospital (T1
N
= 692; T2
N
= 476) and community IDVA services (T1
N
= 3544; T2
N
= 2780), used as a comparator. Measures included indicators of sociodemographic characteristics, experience of abuse, health service use, health and safety outcomes. Multivariate analyses tested for differences in changes in abuse, health and factors influencing safety outcomes. Health service use data in the 6 months pre-and post- intervention were compared to generate potential cost savings by hospital IDVA services.
Results
Hospital IDVAs worked with survivors less visible to community IDVA services and facilitated intervention at an earlier point. Hospital IDVAs received higher referrals from health services and enabled access to a greater number of health resources. Hospital survivors were more likely to report greater reductions in and cessation of abuse. No differences were observed in health outcomes for hospital survivors. The odds of safety increased two-fold if hospital survivors received over five contacts with an IDVA or accessed six or more resources / programmes over a longer period of time. Six months preceding IDVA intervention, hospital survivors cost on average £2463 each in use of health services; community survivors cost £533 each. The cost savings observed among hospital survivors amounted to a total of £2050 per patient per year. This offset the average cost of providing hospital IDVA services.
Conclusions
Hospital IDVAs can identify survivors not visible to other services and promote safety through intensive support and access to resources. The co-location of IDVAs within the hospital encouraged referrals to other health services and wider community agencies. Further research is required to establish the cost-effectiveness of hospital IDVA services, however our findings suggest these services could be an efficient use of health service resources.
Journal Article
Health professionals responding to men for safety (HERMES): feasibility of a general practice training intervention to improve the response to male patients who have experienced or perpetrated domestic violence and abuse
To evaluate a training intervention for general practice-based doctors and nurses in terms of the identification, documentation, and referral of male patients experiencing or perpetrating domestic violence and abuse (DVA) in four general practices in the south west of England.
Research suggests that male victims and perpetrators of DVA present to primary care clinicians to seek support for their experiences. We know that the response of primary care clinicians to women patients experiencing DVA improves from training and the establishment of referral pathways to specialist DVA services.
The intervention consisted of a 2-h practice-based training. Outcome measures included: a pre-post, self-reported survey of staff practice; disclosures of DVA as documented in medical records pre-post (six months) intervention; semi-structured interviews with clinicians; and practice-level contact data collected by DVA specialist agencies.
Results show a significant increase in clinicians' self-reported preparedness to meet the needs of male patients experiencing or perpetrating DVA. There was a small increase in male patients identified within the medical records (6 pre- to 17 post-intervention) but only five of those patients made contact with a specialist DVA agency identified within the referral pathway. The training increased clinicians' confidence in responding to male patients affected by DVA. The increase in recorded identification of DVA male patients experiencing or perpetrating DVA was small and contact of those patients with a specialist DVA support service was negligible. We need to better understand male help seeking in relation to DVA, further develop interventions to increase identification of male patients experiencing or perpetrating DVA behaviours, and facilitate access to support services.
Journal Article
Extracts of Sida cordifolia contain polysaccharides possessing immunomodulatory activity and rosmarinic acid compounds with antibacterial activity
Background
The overuse of antibiotics has led to increased antimicrobial resistance, but plant-derived biological response modifiers represent a potential alternative to these drugs. This investigation examined the immunomodulatory and antibacterial activities of
Sida cordifolia
(used in ethnomedicinal systems to treat infectious disease).
Methods
Successive extractions were performed from the roots of these plants in hexane, chloroform, methanol and water. Immunomodulatory activity was determined in a series of experiments measuring the responses of splenocytes, macrophages and an in vivo model of innate immunity (
Galleria mellonella
)
.
Antibacterial activity was assessed by determining minimum inhibitory/bactericidal concentrations (MIC/MBCs) for various Gram-positive and Gram-negative bacterial strains.
Results
Immunomodulatory activity was confined to the aqueous extract, and further fractionation and biochemical analysis yielded a highly potent polysaccharide-enriched fraction (SCAF5). SCAF5 is a complex mixture of different polysaccharides with multiple immunomodulatory effects including immune cell proliferation, antibody secretion, phagocytosis, nitric oxide production, and increased expression of pro-inflammatory cytokines. Furthermore,
Galleria mellonella
pre-treated with SCAF5 produced more haemocytes and were more resistant (
P
< 0.001) to infection with methicillin-resistant
Staphylococcus aureus
(MRSA) with a 98% reduction in bacterial load in pre-treated larvae compared to the negative control. The antibacterial activity of
Sida cordifolia
was confined to the methanolic fraction. Extensive fractionation identified two compounds, rosmarinic acid and its 4-O-β-d-glucoside derivative, which had potent activity against Gram-positive antibiotic-resistant bacteria, including MRSA.
Conclusions
Sida cordifolia
counters bacterial infections through a dual mechanism, and immunomodulatory polysaccharides from this plant should be isolated and characterised to realise their potential as anti-infective agents. Such properties could be developed as an antibiotic alternative (1) in the clinic and (2) alternative growth promoter for the agri-food industry.
Journal Article
Loss-of-function mutations in the gene encoding filaggrin cause ichthyosis vulgaris
Ichthyosis vulgaris (OMIM 146700) is the most common inherited disorder of keratinization and one of the most frequent single-gene disorders in humans. The most widely cited incidence figure is 1 in 250 based on a survey of 6,051 healthy English schoolchildren
1
. We have identified homozygous or compound heterozygous mutations R501X and 2282del4 in the gene encoding filaggrin (
FLG
) as the cause of moderate or severe ichthyosis vulgaris in 15 kindreds. In addition, these mutations are semidominant; heterozygotes show a very mild phenotype with incomplete penetrance. The mutations show a combined allele frequency of ∼4% in populations of European ancestry, explaining the high incidence of ichthyosis vulgaris. Profilaggrin is the major protein of keratohyalin granules in the epidermis. During terminal differentiation, it is cleaved into multiple filaggrin peptides that aggregate keratin filaments. The resultant matrix is cross-linked to form a major component of the cornified cell envelope. We find that loss or reduction of this major structural protein leads to varying degrees of impaired keratinization.
Journal Article
Data consistency in the English Hospital Episodes Statistics database
BackgroundTo gain maximum insight from large administrative healthcare datasets it is important to understand their data quality. Although a gold standard against which to assess criterion validity rarely exists for such datasets, internal consistency can be evaluated. We aimed to identify inconsistencies in the recording of mandatory International Statistical Classification of Diseases and Related Health Problems, tenth revision (ICD-10) codes within the Hospital Episodes Statistics dataset in England.MethodsThree exemplar medical conditions where recording is mandatory once diagnosed were chosen: autism, type II diabetes mellitus and Parkinson’s disease dementia. We identified the first occurrence of the condition ICD-10 code for a patient during the period April 2013 to March 2021 and in subsequent hospital spells. We designed and trained random forest classifiers to identify variables strongly associated with recording inconsistencies.ResultsFor autism, diabetes and Parkinson’s disease dementia respectively, 43.7%, 8.6% and 31.2% of subsequent spells had inconsistencies. Coding inconsistencies were highly correlated with non-coding of an underlying condition, a change in hospital trust and greater time between the spell with the first coded diagnosis and the subsequent spell. For patients with diabetes or Parkinson’s disease dementia, the code recording for spells without an overnight stay were found to have a higher rate of inconsistencies.ConclusionsData inconsistencies are relatively common for the three conditions considered. Where these mandatory diagnoses are not recorded in administrative datasets, and where clinical decisions are made based on such data, there is potential for this to impact patient care.
Journal Article
Jetstream Atherectomy with Paclitaxel-Coated Balloons: Two-Year Outcome of the Prospective Randomized JET-RANGER Study
The JET-RANGER study (NCT03206762) was a multicenter (11 US centers) randomized trial, core lab adjudicated, designed to demonstrate the superiority of Jetstream + Paclitaxel coated balloon (JET+PCB) versus angioplasty (PTA) + PCB in treating femoropopliteal (FP) arterial disease. The one-year primary endpoint of JET-RANGER has been recently published. The 2-year outcome data are presented in this report.
There were 43 patients who completed the 1-year follow-up. Two were lost to follow-up and one died prior to the 2-year follow-up, resulting in 40 patients. Fifteen patients were randomized to PTA+PCB and 25 patients to JET +PCB. Kaplan Meier Survival analysis was performed to estimate the freedom from TLR. Bailout stenting was not considered a TLR in this analysis. Statistical significance was determined by a p-value < 0.05.
Freedom from TLR was similar between the 2 groups at 2 years. There was also no significant difference in the change of ABI between the PTA + PCB and JET + PCB from baseline at 6-months, (p-value = 0.7890), 1-year (p-value = 0.4070), and 2-year (p-value=0.7410). There was also no statistical difference between the JET + PCB and PTA + PCB arms for RCC improvement by one or more category, (p-value= 1.000). There were no minor or major amputations for either arm throughout the 2-year follow up. One JET + PCB patient died before the 2-year specified window.
JET + PCB had similar freedom from TLR and improvement in ABI and RCC at 2-year follow-up when compared to PTA + PCB with no difference in amputation or mortality between the 2 arms.
NCT03206762.
Journal Article