Aims To identify and quantify risk factors for posterior capsule rupture or vitreous loss or both (PCR or VL or both) during cataract surgery and provide a method of composite risk assessment for individual operations. Methods The Cataract National Dataset was extracted on 55 567 operations from 12 National Health Service (NHS) Trusts using an electronic patient record (EPR) system between November 2001 and July 2006. Risk indicators for variations in the rate of 'PCR or VL or both' were identified by univariate and multivariate analyses. Adjusted odds ratios (ORs) were used to formulate a composite 'bespoke' risk for individual cases. Results Overall 'PCR or VL or both' rate was 1.92% (95% CI ¼ 1.81-2.04%). Risk indicators for this complication were increasing age, male gender, presence of glaucoma, diabetic retinopathy, brunescent/white cataract, no fundal view/vitreous opacities, pseudoexfoliation/phacodonesis, reducing pupil size, axial length X26.0 mm, the use of the ablocker doxazosin, inability to lie flat and trainee surgeons performing operations. Adjusted ORs for these variables are used to estimate overall composite risk across multiple risk indicators in the form of a predicted probability of PCR or VL or both. Predicted probability for this complication ranged from less than 0.75% to more than 75%, depending on risk profile of individual operations. Conclusions Higher-risk cases can be predicted, thus better informing the consent process and allowing surgeons to take appropriate precautions. Case-mix is a major determinant of the probability of an intraoperative complication. A simple composite risk estimation system has been developed.
The CND is fit for purpose, is able to deliver useful benefits and can be collected as part of routine clinical care via EPR systems. This survey confirms shifts in practice since the 1997-1998 UK National Survey with full conversion to phacoemulsification, better preoperative acuity, a halving of the surgical 'index' benchmark complication of posterior capsule rupture and/or vitreous loss, and improved VA outcomes.
SummaryBackgroundThe use of prophylactic radiotherapy to prevent procedure-tract metastases (PTMs) in malignant pleural mesothelioma remains controversial, and clinical practice varies worldwide. We aimed to compare prophylactic radiotherapy with deferred radiotherapy (given only when a PTM developed) in a suitably powered trial.MethodsWe did a multicentre, open-label, phase 3, randomised controlled trial in 22 UK hospitals of patients with histocytologically proven mesothelioma who had undergone large-bore pleural interventions in the 35 days prior to recruitment. Eligible patients were randomised (1:1), using a computer-generated sequence, to receive immediate radiotherapy (21 Gy in three fractions within 42 days of the pleural intervention) or deferred radiotherapy (same dose given within 35 days of PTM diagnosis). Randomisation was minimised by histological subtype, surgical versus non-surgical procedure, and pleural procedure (indwelling pleural catheter vs other). The primary outcome was the incidence of PTM within 7 cm of the site of pleural intervention within 12 months from randomisation, assessed in the intention-to-treat population. This trial is registered with ISRCTN, number ISRCTN72767336.FindingsBetween Dec 23, 2011, and Aug 4, 2014, we randomised 203 patients to receive immediate radiotherapy (n=102) or deferred radiotherapy (n=101). The patients were well matched at baseline. No significant difference was seen in PTM incidence in the immediate and deferred radiotherapy groups (nine [9%] vs 16 [16%]; odds ratio 0·51 [95% CI 0·19–1·32]; p=0·14). The only serious adverse event related to a PTM or radiotherapy was development of a painful PTM within the radiotherapy field that required hospital admission for symptom control in one patient who received immediate radiotherapy. Common adverse events of immediate radiotherapy were skin toxicity (grade 1 in 50 [54%] and grade 2 in four [4%] of 92 patients vs grade 1 in three [60%] and grade 2 in two [40%] of five patients in the deferred radiotherapy group who received radiotherapy for a PTM) and tiredness or lethargy (36 [39%] in the immediate radiotherapy group vs two [40%] in the deferred radiotherapy group) within 3 months of receiving radiotherapy.InterpretationRoutine use of prophylactic radiotherapy in all patients with mesothelioma after large-bore thoracic interventions is not justified.FundingResearch for Patient Benefit Programme from the UK National Institute for Health Research.
Aims To report risk factors for visual acuity (VA) improvement and harm following cataract surgery using electronically collected multi-centre data conforming to the Cataract National Dataset (CND). Methods Routinely collected anonymised data were remotely extracted from the electronic patient record systems of 12 participating NHS Trusts undertaking cataract surgery. Following data checks and cleaning, analyses were performed to identify risk indicators for: (1) a good acuity outcome (VA 6/12 or better), (2) the pre-to postoperative change in VA, and (3) VA loss (doubling or worse of the visual angle). Results In all, 406 surgeons from 12 NHS Trusts submitted data on 55 567 cataract operations. Preoperative VA was known for 55 528 (99.9%) and postoperative VA outcome for 40 758 (73.3%) operations. Important adverse preoperative risk indicators found in at least 2 of the 3 analyses included older age (3), short axial length (3), any ocular comorbidity (3), age-related macular degeneration (2), diabetic retinopathy (3), amblyopia (2), corneal pathology (2), previous vitrectomy (2), and posterior capsule rupture (PCR) during surgery (3). PCR was the only potentially modifiable adverse risk indicator and was powerfully associated with VA loss (OR ¼ 5.74). Conclusion Routinely collected electronic data conforming to the CND provide sufficient detail for identification and quantification of preoperative risk indicators for VA outcomes of cataract surgery. The majority of risk indicators are intrinsic to the patient or their eye, with a notable exception being PCR during surgery.
Objectiveto develop a breast feeding assessment tool to facilitate improved targeting of optimum positioning and attachment advice and to describe the changes seen following the release of a tongue-tie.Designdevelopment and validation of the Bristol Breastfeeding Assessment Tool (BBAT) and correlation with breast feeding self-efficacy.Settingmaternity hospital in South West England.Participants218 breast feeds (160 mother–infant dyads); seven midwife assessors.Findingsthe tool has more explanation than other tools to remind those supporting breast-feeding women about the components of an efficient breast feed. There was good internal reliability for the final 4-item BBAT (Cronbach׳s alpha=0.668) and the midwives who used it showed a high correlation in the consistency of its use (ICC=0.782).Midwives were able to score a breast feed consistently using the BBAT and felt that it helped them with advice to mothers about improving positioning and attachment to make breast feeding less painful, particularly with a tongue-tied infant. The tool showed strong correlation with breast feeding self-efficacy, indicating that more efficient breast feeding technique is associated with increased confidence in breast feeding an infant.Conclusionsthe BBAT is a concise breast feeding assessment tool facilitating accurate, rapid breast feeding appraisal, and targeting breast feeding advice to mothers acquiring early breast feeding skills or for those experiencing problems with an older infant. Accurate assessment is essential to ensure enhanced breast feeding efficiency and increased maternal self-confidence.Implications for practicethe BBAT could be used both clinically and in research to target advice to improve breast feeding efficacy. Further research is needed to establish its wider usefulness.
Oral domperidone and metoclopramide increased the volume of milk produced by mothers who are expressing to feed their babies in NICU. There were small differences in milk output between the two medications and in the incidence of side effects, but the differences were non-significant.
Aims To demonstrate variations in posterior capsule rupture (PCR) rate between surgeons of the same and different grades as a by-product of routine clinical care. Method NHS departments using electronic medical record (EMR) systems to collect the Cataract National Dataset (CND) were invited to submit data. Data were remotely extracted, anonymised, assessed for conformity and completeness, and analysed for rates of PCR for individual surgeons within each of the three grades. Results Data were extracted on 55 567 cataract operations performed at 12 NHS trusts by 406 surgeons between November 2001 and July 2006. Data on the grade of 404 of the 406 surgeons who contributed to the study were available for 55 515 cases (99.9%) and were used for this analysis. Variation in PCR rate between surgeons was highest for the most junior grade of surgeon and between those surgeons contributing relatively few cases to the data set. Variation in PCR was lowest among experienced surgeons contributing large numbers of cases to the data set. Conclusions Considerable variation in PCR rate exists both between and within surgical grades. Routine electronic collection of the CND allows detailed analysis of variations in PCR rates between individual surgeons. To define acceptable limits for this benchmark complication of cataract surgery, further work is needed to adjust surgeons' outcomes for the case mix complexity.
Human embryonic stem (hES) cells are pluripotent cells isolated from early human embryos. They can be grown in vitro and made to differentiate into many different cell types. These properties have suggested that they may be useful in cell replacement therapy for many degenerative diseases. However, if hES cells could also be manufactured with mutations significant in human disease, they could provide a powerful in-vitro tool for modelling disease processes and progression in a number of different cell types, as well as providing an ideal system for studying in-vitro toxicity and efficacy of drugs and other therapeutic systems such as gene therapy. Embryos with such mutations are generated as part of routine genetic testing during preimplantation genetic diagnosis, providing the opportunity to generate cell lines with significant mutations. A human embryonic stem cell line homozygous for the most common mutation leading to cystic fibrosis in humans (delta F508) has been generated and characterized. This cell line has the same morphology and expresses proteins typical of other unaffected hES cell lines. This cell line represents an important in-vitro tool for understanding the pathophysiology of cystic fibrosis, and presents exciting opportunities to test the efficacy and toxicity of new therapies relevant to CF.
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