62 research outputs found

    Evaluation of the Retinopathy of Prematurity Activity Scale (ROP-ActS) in a randomised controlled trial aiming for prevention of severe ROP: A substudy of the Mega Donna Mega trial

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    Objective The current grading of retinopathy of prematurity (ROP) does not sufficiently discriminate disease severity for evaluation of trial interventions. The published ROP Activity Scales (original: ROP-ActS and modified: mROP-ActS), describing increasing severity of ROP, versus the categorical variables severe ROP, stage, zone and plus disease were evaluated as discriminators of the effect of an ROP preventive treatment. Methods and analysis The Mega Donna Mega trial investigated ROP in infants born <28-week gestational age (GA), randomised to arachidonic acid (AA) and docosahexaenoic acid (DHA) supplementation or no supplementation. Of 207 infants, 86% with finalised ROP screening were included in this substudy. ROP-ActS versus standard variables were evaluated using Fisher\u27s non-parametric permutation test, multivariable logistic and linear regression and marginal fractional response models. Results The AA:DHA group (n=84) and the control group (n=93) were well balanced. The maximum ROP-ActS measurement was numerically but not significantly lower in the AA:DHA group (mean: 4.0 (95% CI 2.9 to 5.0)) versus the control group (mean: 5.3 (95% CI 4.1 to 6.4)), p=0.11. In infants with any ROP, the corresponding scale measurements were 6.8 (95% CI 5.4 to 8.2) and 8.7 (95% CI 7.5 to 10.0), p=0.039. Longitudinal profiles of the scale were visually distinguished for the categories of sex and GA for the intervention versus control. Conclusions The preventive effect of AA:DHA supplementation versus no supplementation was better discriminated by the trial\u27s primary outcome, severe ROP, than by ROP-ActS. The sensitivity and the linear qualities of ROP-ActS require further validations on large data sets and perhaps modifications. Trial registration number NCT03201588

    How to achieve the desired outcomes of advance care planning in nursing homes: a theory of change

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    Background: Advance care planning (ACP) has been identified as particularly relevant for nursing home residents, but it remains unclear how or under what circumstances ACP works and can best be implemented in such settings. We aimed to develop a theory that outlines the hypothetical causal pathway of ACP in nursing homes, i.e. what changes are expected, by means of which processes and under what circumstances. Methods: The Theory of Change approach is a participatory method of programme design and evaluation whose underlying intention is to improve understanding of how and why a programme works. It results in a Theory of Change map that visually represents how, why and under what circumstances ACP is expected to work in nursing home settings in Belgium. Using this approach, we integrated the results of two workshops with stakeholders (n = 27) with the results of a contextual analysis and a systematic literature review. Results: We identified two long-term outcomes that ACP can achieve: to improve the correspondence between residents’ wishes and the care/treatment they receive and to make sure residents and their family feel involved in planning their future care and are confident their care will be according to their wishes. Besides willingness on the part of nursing home management to implement ACP and act accordingly, other necessary preconditions are identified and put in chronological order. These preconditions serve as precursors to, or requirements for, accomplishing successful ACP. Nine original key intervention components with specific rationales are identified at several levels (resident/family, staff or nursing home) to target the preconditions: selection of a trainer, ensuring engagement by management, training ACP reference persons, in-service education for healthcare staff, information for staff, general practitioners, residents and their family, ACP conversations and documentation, regular reflection sessions, multidisciplinary meetings, and formal monitoring. Conclusions: The Theory of Change map presented here illustrates a theory of how ACP is expected to work in order to achieve its desired long-term outcomes while highlighting organisational factors that potentially facilitate the implementation and sustainability of ACP. We provide the first comprehensive rationale of how ACP is expected to work in nursing homes, something that has been called for repeatedly

    Development and validation of a new clinical decision support tool to optimize screening for retinopathy of prematurity

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    Background/Aims Prematurely born infants undergo costly, stressful eye examinations to uncover the small fraction with retinopathy of prematurity (ROP) that needs treatment to prevent blindness. The aim was to develop a prediction tool (DIGIROP-Screen) with 100% sensitivity and high specificity to safely reduce screening of those infants not needing treatment. DIGIROP-Screen was compared with four other ROP models based on longitudinal weights. Methods Data, including infants born at 24–30 weeks of gestational age (GA), for DIGIROP-Screen development (DevGroup, N=6991) originate from the Swedish National Registry for ROP. Three international cohorts comprised the external validation groups (ValGroups, N=1241). Multivariable logistic regressions, over postnatal ages (PNAs) 6–14 weeks, were validated. Predictors were birth characteristics, status and age at first diagnosed ROP and essential interactions. Results ROP treatment was required in 287 (4.1%)/6991 infants in DevGroup and 49 (3.9%)/1241 in ValGroups. To allow 100% sensitivity in DevGroup, specificity at birth was 53.1% and cumulatively 60.5% at PNA 8 weeks. Applying the same cut-offs in ValGroups, specificities were similar (46.3% and 53.5%). One infant with severe malformations in ValGroups was incorrectly classified as not needing screening. For all other infants, at PNA 6–14 weeks, sensitivity was 100%. In other published models, sensitivity ranged from 88.5% to 100% and specificity ranged from 9.6% to 45.2%. Conclusions DIGIROP-Screen, a clinical decision support tool using readily available birth and ROP screening data for infants born GA 24–30 weeks, in the European and North American populations tested can safely identify infants not needing ROP screening. DIGIROP-Screen had equal or higher sensitivity and specificity compared with other models. DIGIROP-Screen should be tested in any new cohort for validation and if not validated it can be modified using the same statistical approaches applied to a specific clinical setting

    Changes in HbA(1c) and frequency of measuring HbA(1c) and adjusting glucose-lowering medications in the 10 years following diagnosis of type 2 diabetes: a population-based study in the UK

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    Aim/hypothesis The aim of this work was to study levels of HbA(1c) and patterns of adjusting glucose-lowering drugs in patients with impaired glycaemic control over 10 years after diagnosis of type 2 diabetes. Methods We studied 4,529 individuals in The Health Improvement Network Database newly diagnosed with type 2 diabetes in the year 2000. Results From 6 months to 10 years after diagnosis, the HbA(1c) increased from 7.04% (53.4 mmol/mol) to 7.49% (58.3 mmol/mol) (average annual change: 0.047% [0.51 mmol/mol]). The greatest annual change occurred between 6 months and 2 years (0.21% [2.30 mmol/mol] increase per year, p < 0.001), followed by the 2-5 year time period (0.033% [0.36 mmol/mol] increase per year, p < 0.001). No significant increase in HbA(1c) occurred between 5 and 10 years (p = 0.20). In multivariable analyses, patients who were younger (p < 0.001), with higher BMI (p = 0.033) and who were current insulin users (p = 0.024) at diagnosis had greater increases in HbA(1c) between 6 months and 2 years. For individuals with HbA(1c) above 7.0% (53 mmol/mol) the mean time to next measurement of HbA(1c) was 0.53 years and increase in doses or changes to other glucose-lowering medications were performed in 26% of cases. Conclusions/interpretation HbA(1c) increases by approximately 0.5% (5 mmol/mol) over 10 years after diagnosis of type 2 diabetes, with the main increase appearing in the first years after diagnosis. More frequent monitoring of HbA(1c) and adjustments of glucose-lowering drugs may be essential to prevent the decline

    Zorg aan het levenseinde in het Vlaamse Gewest in de periode 2005-2014

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    &lt;p&gt;Rapport ten behoeve van het Agentschap Zorg en Gezondheid&lt;/p&gt;</p

    Hospitalisations at the end of life in four European countries: a cross-national population-based mortality followback study.

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    Background: Most people would prefer to be cared for and to die at home. On the other hand, hospital admissions towards the end of life have been related to aggressive care, higher cost than community care, and they may indicate a low quality of dying. Population-based cross-national data on hospital use at the end of life are scarce, although they are needed to develop effective public health policies on end-of-life care. We described and compared the frequency, length and timing of hospital admissions in the last three months of life in Belgium, the Netherlands, Italy and Spain. Methods: Cross-national population-based mortality followback study with data collection through nationwide representative epidemiological surveillance networks of general practitioners (GPs). Using a standardised form, GPs recorded the care in the last three months of life of every deceased adult (>18 years) patient of their practice (01/01/2009-31/12/2011). Nursing home deaths from the Netherlands (6%) were excluded as they are not attended by GPs. Results: We studied 7209 deaths of which the GPs described 66% as non-sudden. In Belgium, the Netherlands, Italy and Spain, 53%, 47%, 51% and 52% of patients, respectively (p < .001, adjusted for differences in age, sex, cause of death), were hospitalised at least once in the last three months of life, for median 14 days (inter-quartile range (IQR) 6 to 25) in Belgium and median 10 days in the other countries (IQR 3 to 20 in the Netherlands; IQR 5 to 20 in Italy and Spain). At thirty days before death Belgium revealed nearly twice the proportion of patients in hospital (13%) than did the Netherlands (7%), Italy and Spain (both 6%), but this difference decreased towards the day of death. All countries revealed an increase in the percentage of hospitalised patients over the last 10 days of life (21% to 37% in Belgium, 15% to 29% in the Netherlands, 16% to 37% in Italy, 14% to 31% in Spain). Conclusions: Across countries, and particularly in Belgium, hospital care in the last three months of life is highly prevalent and increases considerably over the final days of life, potentially counteracting patients’ preferences. Differences between countries may reflect differences in healthcare policy and end- of-life care practice. Key messages In Belgium, the Netherlands, Italy and Spain 53%, 47%, 51% and 52% of patients, respectively, are hospitalised at least once in the final three months of life. Thirty days before death Belgium had the highest percentage of patients in hospital, but in all four countries this percentage increased considerably over the final 10 days of life
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