The effect on consent rates for deceased organ donation in Wales after the introduction of an opt-out system.

Organ transplantation saves and transforms lives. Failure to secure consent for organ retrieval is widely regarded as the single most important obstacle to transplantation. A soft opt-out system of consent for deceased organ donation was introduced into Wales in December 2015, whilst England maintained the existing opt-in system. Cumulative data on consent rates in Wales were compared with those in England, using a two-sided sequential procedure that was powered to detect an absolute difference in consent rates between England and Wales of 10%. Supplementary risk-adjusted logistic regression analysis examined whether any difference in consent rates between the two nations could be attributed to variations in factors known to influence UK consent rates. Between 1 January 2016 and 31 December 2018, 8192 families of eligible donors in England and 474 in Wales were approached regarding organ donation, with overall consent rates of 65% and 68%, respectively. There was a steady upward trend in the proportion of families consenting to donation after brain death in Wales as compared with England and after 33 months, this reached statistical significance. No evidence of any change in the donation after circulatory death consent rate was observed. Risk-adjusted logistic regression analysis revealed that by the end of the study period the probability of consent to organ donation in Wales was higher than in England (OR [95%CI] 2.1 [1.26-3.41]). The introduction of a soft opt-out system of consent in Wales significantly increased organ donation consent though the impact was not immediate.

Palliative care advanced practice nursing in Israel: bridging creation and implementation.

AIM: To describe Israel's development of the palliative care advanced practice registered nurse as a foundation for the development of the advanced practice registered nurse role in other specialties. BACKGROUND: Palliative care centres on alleviating physical, emotional, social and spiritual distress associated with life-limiting illness. In 2009, Israel introduced the palliative care advanced practice nurse role, that is, registered nurses with specialized training in palliative care, to address increasing palliative care needs. INTRODUCTION: While there has been investment in its development, full implementation of the advanced practice nurse has not yet been achieved. METHODS: In this qualitative descriptive study, we conducted a document analysis (n = 11) and key informant interviews (n = 11), extracted themes using qualitative content analysis and triangulated data sets. RESULTS: Documents reflected growing palliative care needs and uniform requirements for advanced practice nurse training. Interviews uncovered a perceived lack of awareness of palliative care, the need for increased role definition and practice authority for advanced practice nurses, and barriers to entry and training for this role. DISCUSSION: Findings highlight ongoing needs in palliative care and advanced practice nursing and a trajectory of growth. CONCLUSIONS: The challenges Israel faces in implementation of the palliative care advanced practice nurse role inform development of other advanced practice nursing roles in Israel and other countries. IMPLICATIONS FOR NURSING PRACTICE: Streamlining training pathways and resolving scope of practice issues will assist in implementation of advanced practice nursing roles. IMPLICATIONS FOR HEALTH POLICY: Our data offer targets for policymakers advocating the advanced practice nurse role, including training requirements and scope of practice.

Dependent censoring in piecewise exponential survival models.

There are often reasons to suppose that there is dependence between the time to event and time to censoring, or dependent censoring, for survival data, particularly when considering medical data. This is because the decision to treat or not is often made according to prognosis, usually with the most ill patients being prioritised. Due to identifiability issues, sensitivity analyses are often used to assess whether independent censoring can lead to misleading results. In this paper, a sensitivity analysis method for piecewise exponential survival models is presented. This method assesses the sensitivity of the results of standard survival models to small amounts of dependence between the time to failure and time to censoring variables. It uses the same assumption about the dependence between the time to failure and time to censoring as previous sensitivity analyses for both standard parametric survival models and the Cox model. However, the method presented in this paper allows the use of more flexible models for the marginal distributions whilst remaining computationally simple. A simulation study is used to assess the accuracy of the sensitivity analysis method and identify the situations in which it is suitable to use this method. The study found that the sensitivity analysis performs well in many situations, but not when the data have a high proportion of censoring.

Estimated risk of cancer transmission from organ donor to graft recipient in a national transplantation registry.

BACKGROUND: Transplanted organs carry the risk of inadvertent donor cancer transmission. Some cancers in organ donors have been classified as being associated with a high or unacceptable risk, but the evidence for such recommendations is scanty. METHODS: The risk of cancer transmission from donors characterized as high or unacceptable risk was studied by analysing transplant and cancer registry data. Donors and recipients from England (1990-2008) were identified from the UK Transplant Registry. Cancer details were obtained from cancer registries and classified using guidelines from the Council of Europe and Organ Procurement and Transplantation Network/United Network for Organ Sharing. RESULTS: Of 17,639 donors, 202 (1.1 per cent) had a history of cancer, including 61 donors with cancers classed as having an unacceptable/high risk of transmission. No cancer transmission was noted in 133 recipients of organs from these 61 donors. At 10 years after transplantation, the additional survival benefit gained by transplanting organs from donors with unacceptable/high-risk cancer was 944 (95 per cent confidence interval (c.i.) 851 to 1037) life-years, with a mean survival of 7.1 (95 per cent c.i. 6.4 to 7.8) years per recipient. CONCLUSION: Strict implementation of present guidelines is likely to result in overestimation of cancer transmission risk in some donors. Organs from some donors with cancers defined as unacceptable/high risk can be used safely.

Standardized deceased donor kidney donation rates in the UK reveal marked regional variation and highlight the potential for increasing kidney donation: a prospective cohort study†.

BACKGROUND: The UK has implemented a national strategy for organ donation that includes a centrally coordinated network of specialist nurses in organ donation embedded in all intensive care units and a national organ retrieval service for deceased organ donors. We aimed to determine whether despite the national approach to donation there is significant regional variation in deceased donor kidney donation rates. METHODS: The UK prospective audit of deaths in critical care was analysed for a cohort of patients who died in critical care between April 2010 and December 2011. Multivariate logistic regression was used to identify the factors associated with kidney donation. The logistic regression model was then used to produce risk-adjusted funnel plots describing the regional variation in donation rates. RESULTS: Of the 27 482 patients who died in a critical care setting, 1528 (5.5%) became kidney donors. Factors found to influence donation rates significantly were: type of critical care [e.g. neurointensive vs general intensive care: OR 1.53, 95% confidence interval (CI) 1.34-1.75, P<0.0001], patient ethnicity (e.g. 'Asian' vs 'white': OR 0.17, 95% CI 0.11-0.26, P<0.0001), age (e.g. age >69 vs age 18-39 yr: OR 0.2, 0.15-0.25, P<0.0001), and cause of death [e.g. 'other' (excluding 'stroke' and 'trauma') vs 'trauma': OR 0.04, 95% CI 0.03-0.05, P<0.0001]. Despite correction for these variables, kidney donation rates for the 20 UK kidney donor regions showed marked variation. The overall standardized donation rate ranged from 3.2 to 7.5%. Four regions had donation rates of >2 standard deviations (sd) from the mean (two below and two above). Regional variation was most marked for donation after circulatory death (DCD) kidney donors with 9 of the 20 regions demonstrating donation rates of >2 sd from the mean (5 below and 4 above). CONCLUSIONS: The marked regional variation in kidney donation rates observed in this cohort after adjustment for factors strongly associated with donation rates suggests that there is considerable scope for further increasing kidney donation rates in the UK, particularly DCD.

An evaluation of statistical process control techniques applied to blood component quality monitoring with particular reference to CUSUM.

BACKGROUND: Statistical process control (SPC) is used to monitor the performance of blood component collection and production processes in the UK and elsewhere. The sensitivity of the applied technique(s) needs to be matched to the clinical importance of the parameter being monitored such that significant deviations in the process mean and/or variability of critical parameters (e.g. the leucocyte content of leucodepleted components) are detected and investigated immediately. AIMS: This study assessed the sensitivity and specificity of a range of techniques for variable and attribute (proportion non-conforming) data. MATERIALS AND METHODS: Comparison was based on a range of simulated and 'live' blood component quality monitoring data including X/R, cumulative sum (CUSUM) procedures, the scan statistic and np charts. RESULTS: X/R and CUSUM could detect shifts of two standard deviations in the process mean within 5 days. Current leucocyte count data (substantially skewed even after log transformation) was found to be better suited to attribute analysis. CUSUM alone was able to detect shifts on the same day when based on 20 or more samples and achieved acceptable specificity. CONCLUSIONS: CUSUM procedures for proportion non-conforming can usefully augment existing X/R techniques for leucodepletion monitoring, provide valid control limits and the required sensitivity. The scan statistic and 'np' charts offered no obvious advantages.

Cold machine perfusion versus static cold storage of kidneys donated after cardiac death: a UK multicenter randomized controlled trial.

One third of deceased donor kidneys for transplantation in the UK are donated following cardiac death (DCD). Such kidneys have a high rate of delayed graft function (DGF) following transplantation. We conducted a multicenter, randomized controlled trial to determine whether kidney preservation using cold, pulsatile machine perfusion (MP) was superior to simple cold storage (CS) for DCD kidneys. One kidney from each DCD donor was randomly allocated to CS, the other to MP. A sequential trial design was used with the primary endpoint being DGF, defined as the necessity for dialysis within the first 7 days following transplant. The trial was stopped when data were available for 45 pairs of kidneys. There was no difference in the incidence of DGF between kidneys assigned to MP or CS (58% vs. 56%, respectively), in the context of an asystolic period of 15 min and median cold ischemic times of 13.9 h for MP and 14.3 h for CS kidneys. Renal function at 3 and 12 months was similar between groups, as was graft and patient survival. For kidneys from controlled DCD donors (with mean cold ischemic times around 14 h), MP offers no advantage over CS, which is cheaper and more straightforward.

Comparison of the incidence of malignancy in recipients of different types of organ: a UK Registry audit.

An increased incidence of malignancy is an established complication of organ transplantation and the associated immunosuppression. In this study on cancer incidence in solid organ transplant recipients in Britain, we describe the incidence of de novo cancers in the allograft recipient, and compare these incidences following the transplantation of different organs. Data in the UK Transplant Registry held by NHS Blood and Transplant (NHSBT) were linked with data made available by the cancer registries in England, Scotland and Wales. Incidence rates in the transplanted population were then compared with the general population, using standardized incidence ratios matched for age, gender and time period. The 10-year incidence of de novo cancer in transplant recipients is twice that of the general population, with the incidence of nonmelanoma skin cancer being 13 times greater. Nonmelanoma skin cancer, cancer of the lip, posttransplant lymphoproliferative disease and anal cancer have the largest standardized incidence ratios, but the incidence of different types of malignancy differs according to the organ transplanted. Patterns in standardized incidence ratios over time since transplantation are different for different types of transplant recipient, as well as for different malignancies. These results have implications for a national screening program.

Variation between centres in access to renal transplantation in UK: longitudinal cohort study.

OBJECTIVE: To assess whether equity exists in access to renal transplantation in the UK after adjustment for case mix in incident patients with end stage renal disease. DESIGN: Longitudinal cohort study. SETTING: UK Renal Registry and UK Transplant Registry. PARTICIPANTS: All incident renal replacement treatment patients (n=16 202) from 65 renal centres submitting data to the UK Renal Registry between 1 January 2003 and 31 December 2005, followed until 31 December 2008 (or until transplantation or death, whichever was earliest). OUTCOME MEASURES: Proportion of incident dialysis patients at each renal centre who were registered on the national transplant list; time taken to achieve registration; and proportion of patients subsequently transplanted. RESULTS: We found that recipients' age, ethnicity, and primary renal diagnosis were associated with the likelihood of accessing the waiting list or receiving a transplant. After adjustment for case mix, significant inter-centre variability existed in access to the transplant list (change in -2LogL=89.9, df=1, P<0.001), in the time taken to register patients on the waiting list (change in -2LogL=247.4, df=64, P<0.001), in receipt of a renal transplant from a donor after brain stem death (change in -2LogL=15.1, df=1, P=0.001), and in receipt of a renal transplant from a living donor or a donor after cardiac death (change in -2LogL=46.1, df=1, P<0.001). CONCLUSIONS: Significant variation in access to renal transplantation exists between centres within the UK that cannot be explained by differences in case mix.

How safe is it to transplant organs from deceased donors with primary intracranial malignancy? An analysis of UK Registry data.

Patients dying from primary intracranial malignancy are a potential source of organs for transplantation. However, a perceived risk of tumor transfer to the organ recipient has limited their use. We evaluated the risk of tumor transmission by reviewing the incidence in patients transplanted in the UK. Information from the UK Transplant Registry was combined with that from the national cancer registries of England, Wales and Northern Ireland to identify all organ donors between 1985 and 2001 inclusive with a primary intracranial malignancy and to identify the occurrence of posttransplant malignancy in the recipients of the organs transplanted. Of 11,799 organ donors in the study period, 179 were identified as having had a primary intracranial malignancy, including 33 with high-grade malignancy (24 grade IV gliomas and 9 medulloblastomas). A total of 448 recipients of 495 organs from 177 of these donors were identified. No transmission of donor intracranial malignancy occurred. Organs from patients dying from primary intracranial malignancy, including those with high-grade tumors, should be considered for transplantation and the small risk of tumor transmission should be balanced against the likely mortality for potential recipients who remain on the transplant waiting list.

Life expectancy of adult liver allograft recipients in the UK.

BACKGROUND: Liver transplantation is a very successful therapy for those with end stage disease. Although there are numerous data on patient and graft survival after liver transplantation, life expectancy and possible loss of life (compared with a normal matched population) in those who survive remains unknown. AIMS: To assess the life expectancy and life years lost of adult liver allograft recipients, compared with an age and sex matched UK population to provide patients with more information and to improve the use of a scarce resource. METHODS: Using the National Transplant Database held by UK Transplant, on over 3600 adult liver allograft recipients transplanted between 1985 and 2003, we analysed survival of all adults who survived more than six months after transplantation and compared survival after transplantation with national age and sex matched controls to assess life years lost. RESULTS: Estimated median survival time of the analysis cohort of 2702 adult liver allograft recipients was 22.2 years (95% confidence interval 19.3-25.6), with an estimated loss of seven life years compared with an age and sex matched population. CONCLUSIONS: Overall, female recipients have a longer life expectancy and lose fewer life years than male recipients. While younger recipients have a longer life expectancy, they also lose more life years. Those transplanted for cancer, hepatitis C virus infection, and alcoholic liver disease had the greatest loss of life years.

The UK National Potential Donor Audit.

As part of a series of measures designed to improve organ donation rates in the United Kingdom, a potential donor audit has been established by UK Transplant. The audit will identify the number of patients who could be solid organ donors and will establish the obstacles to donation. Results from the first full year of the audit indicate that the overall relative refusal rate for heart-beating solid organ donation is 41.5%. The age and gender of the potential heart-beating donor has little impact on the relative refusal rate, but relatives of ethnic minority groups are more than twice as likely to deny consent than those of white potential heart-beating donors.

Some practical issues in binary data analysis.

Three topics motivated by practical problems where the response variable is binary are described and illustrated. When a number of different explanatory variables are measured on each individual, a parsimonious model may be needed to predict the response of a future patient, or in selecting the variables that any treatment effect must be adjusted for. Some variable selection procedures used in conjunction with fitting logistic regression models are summarized and their performance investigated using a simulation study. A study to compare two devices for delivering anaesthetic gas to patients during surgery is then described, in which the response variable is the incidence of post-operative sore throat. In this study, the allocation of patient to device was non-random and a method for analysing these data that takes account of this aspect of the data is illustrated. In studies to compare different forms of contraceptive, the extent of regularity in the menstrual bleeding cycle is an important consideration for the acceptability of a contraceptive. Diary data on the menstrual bleeding pattern are therefore routinely collected. A method of summarizing the cyclic behaviour in the diary data for a particular woman is described, and extended to allow comparisons to be made between groups of women on different types of contraceptive. The approach is illustrated using a database made available by the World Health Organization.

Risk factors for early childhood malnutrition in Uganda.

OBJECTIVE: To assess the dietary and environmental factors influencing stunting and other signs of poor nutritional status of children <30 months of age in a central Ugandan community, whose main dietary staples are banana (matoki) and maize. METHODS: The study was a cross-sectional survey using stratified multistage random sampling to select households with a child <30 months of age in rural and semi-urban environments. A questionnaire was administered to mothers of 261 infants and toddlers in their home setting. Their health status was assessed by clinical examination and anthropometric measurements (mid-upper arm circumference [MUAC], weight, and supine length). RESULTS: A large minority (21.5%) of the children surveyed were found in poor health after clinical examination: 3.8% being classified as suffering from kwashiorkor and 5.7% with marasmus. A high proportion of children were stunted (23. 8%), underweight (24.1%), or had low MUAC (21.6%). Although rural living, poor health, the use of unprotected water supplies, lack of charcoal as fuel, lack of milk consumption, and lack of personal hygiene were shown as risk factors for marasmus and underweight, different factors were found to be associated with risk of stunting and low MUAC, despite these three parameters being significantly correlated. For stunting the risk factors were: age of the child, poor health, prolonged breastfeeding (from >18 months to <24 months), low socioeconomic status of the family, poor education of the mother of infants <12 months, lack of paraffin as fuel, consumption of food of low energy density (<350 kcal/100 g dry matter), presence of eye pathology, and consumption of small meals. Risk factors for low MUAC were poor health, lack of meat and cow's milk consumption, low intake of energy from fat, and less well educated and older mothers. Food taboos had no influence on any of the anthropometric measurements. Although 93.1% of the children had been immunized against tuberculosis, polio, diphtheria, and measles and showed better general health than children who were not immunized, there was a high prevalence of infection in the week preceding the survey interview, including diarrhea (23.0%), malaria (32.3%), or cough/influenza (72.8%). CONCLUSIONS: This first account of dietary and environmental risk factors involved in the etiology of early childhood malnutrition in Uganda indicates differences in risk factors for marasmus and underweight compared with stunting and low MUAC. The high prevalence of malnutrition and current infection of children in this survey suggests poor immune function as a result of inadequate nutrition.

Sensing an improvement: an experimental study to evaluate the use of aromatherapy, massage and periods of rest in an intensive care unit.

There is widespread belief that the use of aromatherapy and massage in an intensive care environment offers a means of increasing the quality of sensory input that patients receive, as well as reducing levels of stress and anxiety. Despite a wealth of anecdotal evidence in support of these claims, there have been few objective studies to evaluate the effects of these therapies. In this experimental study 122 patients admitted to a general intensive care unit were randomly allocated to receive either massage, aromatherapy using essential oil of lavender, or a period of rest. Both pre- and post-therapy assessments included physiological stress indicators and patients' evaluation of their anxiety levels, mood and ability to cope with their intensive care experience. Ninety-three patients (77%) were able to complete subjective assessments. There were no statistically significant differences in the physiological stress indicators or observed or reported behaviour of patients' ability to cope following any of the three interventions. However, those patients who received aromatherapy reported significantly greater improvement in their mood and perceived levels of anxiety. They also felt less anxious and more positive immediately following the therapy, although this effect was not sustained or cumulative.

A modelling approach to the analysis of menstrual diary data.

In clinical trials to compare contraceptives, women are usually asked to record whether or not each day is a bleeding day over the duration of the trial. In this paper we describe how parametric models, which include terms corresponding to covariates recorded for each woman, can be used to analyse data on the occurrence of certain adverse events identified from the diary record. Linear logistic models are used to analyse the probability of prolonged bleeding or amenorrhoea, and log-linear models are used to analyse the lengths of bleeding episodes. In both cases variation between women is allowed for by including a random effect in the model. The application of our methods is illustrated using a data base made available by the World Health Organization.

Modelling the effect of intervention on the transmission of malaria in East Malaysia.

To assess the public health importance of malaria on Banggi Island, Sabah, baseline epidemiological and entomological data were obtained in a study of three villages. These data were used to model the transmission of malaria using a non-seasonal version of the deterministic model of Dietz, Molineaux and Thomas. The model provided a satisfactory description of prevalence rates of Plasmodium falciparum parasitaemia. Modifications to the basic model enable the effects of mass chemotherapy with various combinations of schizonticidal and gametocidal drugs to be simulated. In this way, the relative merits of different procedures of mass drug administration can be compared. The fitted model is also used to examine the relationship between the overall prevalence of infection and the vectorial capacity, and to predict the consequences of a reduction in the size of the vector population.

Hepatitis B markers in non-icteric medical patients in Malaysia.

Sera were obtained from 494 non-icteric patients admitted with illnesses other than overt hepatitis into the medical wards of the rural and urban hospitals in Malaysia. They were tested for HBsAg, HBeAg, and anti-HBs by enzyme immunoassay. The overall HBsAg carrier rate was 18.0% ranging from 9.6% in children, (10 years and under), to a maximum of 23.5% in the adolescents (11 to 20 years), the rates decreasing subsequently to 16.5% and 20.8% in the adult and middle-age groups, respectively. The Chinese (18.6%) and Malays (19.9%) had similar HBsAg carrier rates but the rate in the Indians (9.0%) was distinctly lower. Similar rates were observed in the males (16.5%) and the females (19.8%). The carrier rate was 17.1% in rural patients compared with 21.4% in the urban ones. The 'e' antigen was found in 14 of the 89 HBsAg carriers (15.7%). The overall prevalence was 14/494 (2.8%) rising sharply from childhood (2.9%) to adolescence (5.3%), subsequently declining with advancing age. The Chinese had the highest rate (6.2%) followed by the Indians (1.5%) and the Malays (1.1%). Males had a rate of 3.3% compared to the females with 2.3%. Anti-HBs was found in 33.8% of the patients, increasing steadily from childhood (18.3%) to middle-age (46.4%). The Chinese had a higher prevalence rate (41.6%) than the Indians (32.8%) and the Malays (29.3%). The rates were similar for the males (35.6%) and the females (31.5%). Rural patients (46.1%) had a higher rate than urban patients (35.7%). Both areas showed rising prevalence with increasing age.(ABSTRACT TRUNCATED AT 250 WORDS)