Evaluation of the impact of technical physicians on improving individual patient care with technology.

BACKGROUND: The rapid introduction of technical innovations in healthcare requires that professionals are adequately prepared for correct clinical use of medical technology. In response to the technological transformation of healthcare, a new type of professional, the Technical Physician (TP), was created and is trained to improve individual patient care using technology tailored to the needs of individual patients. This study investigates the TPs' impact on patient care in terms of innovation, effectiveness, efficiency, and patient safety. METHOD: Semi-structured, in-depth interviews were conducted with 30 TPs and 17 medical specialists (MSs) working in academic or teaching hospitals in the Netherlands. The pre-structured and open-ended interview questions focused on: 1) the perceived impact on innovation, effectiveness, efficiency, and safety, and 2) opportunities and challenges in daily work. RESULTS: TPs and MSs unanimously experienced that TPs contributed to innovation. A majority indicated that effectiveness (TP 57%; MS 71%) and efficiency (TP 67%; MS 65%) of clinical practice had increased. For safety, 87% of TPs but only 47% of MSs reported an increase. The main explanation given for TPs positive impact was combining medical and technical knowledge. Mainly organizational barriers were mentioned as a potential cause for a less visible contribution of TPs. CONCLUSION AND DISCUSSION: TPs and MSs unanimously agreed that TPs contributed to innovating patient care through their integrative medical and technical competencies. Most TPs and MSs also reported increased effectiveness, efficiency, and safety of patient care due to the TPs' work. TPs and MSs expected that the TPs' impact on direct and indirect patient care will be enhanced once organizational barriers are removed.

Trends in incidence, treatment, survival and subsequent breast cancer in lobular carcinoma in situ in the Netherlands: A population-based analysis.

PURPOSE: We analysed incidence, treatment, survival, occurrence of ductal carcinoma in situ (DCIS) and invasive breast cancer (IBC) after lobular carcinoma in situ (LCIS) in the Netherlands. METHODS: All women diagnosed with classic LCIS between 1989 and 2017 were identified from the Netherlands Cancer Registry. We calculated overall (OS), relative survival (RS) and cumulative incidence functions (CIF, accounting for competing risks) of mortality, DCIS and IBC. For IBC, standardised incidence ratios (SIR) of IBC were calculated. Analyses were stratified for surgical treatment. RESULTS: We included 1890 patients. Median age was 51 years. Median follow-up was 8.5 years. In 1989-2017, LCIS incidence increased from 41 to 124, surgical treatment decreased from 100% to 41.1 % - mostly BCS. 10-year OS and 20-year RS exceeded 90 % in all subgroups. Overall, 48 (2.5 %) and 270 (14.3 %) patients were diagnosed with DCIS and IBC. IBCs were mostly early-stage. After mastectomy, 13 of 14 IBCs presented contralaterally. In the other groups, 64.8-70.9 % of IBCs presented ipsilaterally, 34.5-53.9 % of these were lobular. The SIR of ipsilateral IBC was highest after no surgery (6.9, 95%CI:4.9-9.4), lowest after mastectomy (0.2, 95%CI:0.4-0.8). CONCLUSION: LCIS incidence increased, surgical treatment decreased. The low mortality risks support consideration of active surveillance. However, the increased IBC incidence suggests careful monitoring.

[Patient participation in the development and application of eHealth]. / Patiëntparticipatie bij de ontwikkeling en toepassing van e-health: Bereidheid en voorkeuren van mensen met diabetes mellitus type 2.

Aim: The aim was to gain insight in the preferences of people with type 2 diabetes mellitus regarding the moments and methods of patient participation in the development and application of eHealth, and which factors influence this. Methods: A digital questionnaire with both closed and open questions was distributed via various online platforms and the newsletter of the Diabetes Association in the Netherlands. Information was collected on: 1) willingness to participate; 2) preferences about the method of participation; 3) influencing factors on participation, including motivation, competence, resources, social influences, and outcome expectations; 4) background characteristics. Results: 160 questionnaires were analysed. More than three quarter of the respondents intend to be involved in patient participation. Most respondents prefer solo participation methods over group participation, respectively 93% and 46%. Half of the respondents feel that they have sufficient knowledge to participate, and 40% feels that they can provide valuable input. As compensation for participation, participants prefer to use new technologies for free. Conclusion: As people with diabetes type 2 differ in their preferences for moments and methods of participation, it is recommended to offer different methods of participation and types of compensation in the process from development to application of eHealth.

Clinical decision trees support systematic evaluation of multidisciplinary team recommendations.

PURPOSE: EUSOMA's recommendation that "each patient has to be fully informed about each step in the diagnostic and therapeutic pathway" could be supported by guideline-based clinical decision trees (CDTs). The Dutch breast cancer guideline has been modeled into CDTs ( www.oncoguide.nl ). Prerequisites for adequate CDT usage are availability of necessary patient data at the time of decision-making and to consider all possible treatment alternatives provided in the CDT. METHODS: This retrospective single-center study evaluated 394 randomly selected female patients with non-metastatic breast cancer between 2012 and 2015. Four pivotal CDTs were selected. Two researchers analyzed patient records to determine to which degree patient data required per CDT were available at the time of multidisciplinary team (MDT) meeting and how often multiple alternatives were actually reported. RESULTS: The four selected CDTs were indication for magnetic resonance imaging (MRI) scan, preoperative and adjuvant systemic treatment, and immediate breast reconstruction. For 70%, 13%, 97% and 13% of patients, respectively, all necessary data were available. The two most frequent underreported data-items were "clinical M-stage" (87%) and "assessable mammography" (28%). Treatment alternatives were reported by MDTs in 32% of patients regarding primary treatment and in 28% regarding breast reconstruction. CONCLUSION: Both the availability of data in patient records essential for guideline-based recommendations and the reporting of possible treatment alternatives of the investigated CDTs were low. To meet EUSOMA's requirements, information that is supposed to be implicitly known must be explicated by MDTs. Moreover, MDTs have to adhere to clear definitions of data-items in their reporting.

Quality of life among symptomatic compared to PSA-detected prostate cancer survivors - results from a UK wide patient-reported outcomes study.

BACKGROUND: Quality of life among prostate cancer survivors varies by socio-demographic factors and treatment type received; however, less in known about differences in functional outcomes by method of presentation. We investigate differences in reported urinary, bowel, sexual and hormone-related problems between symptomatic and PSA-detected prostate cancer survivors. METHODS: A UK wide cross-sectional postal survey of prostate cancer survivors conducted 18-42 months post-diagnosis. Questions were included on presentation method and treatment. Functional outcome was determined using the EPIC-26 questionnaire. Reported outcomes were compared for symptomatic and PSA-detected survivors using ANOVA and multivariable log-linear regression. RESULTS: Thirty-five thousand eight hundred twenty-three men responded (response rate: 60.8%). Of these, 31.3% reported presenting via PSA test and 59.7% symptomatically. In multivariable analysis, symptomatic men reported more difficulty with urinary incontinence (Adjusted mean ratio (AMR): 0.96, 95% CI: 0.96-0.97), urinary irritation (AMR: 0.95, 95% CI: 0.95-0.96), bowel function (AMR: 0.97, 95% CI: 0.97-0.98), sexual function (AMR: 0.90, 95% CI: 0.88-0.92), and vitality/hormonal function (AMR: 0.96, 95% CI: 0.96-0.96) than PSA-detected men. Differences were consistent across respondents of differing age, stage, Gleason score and treatment type. CONCLUSION: Prostate cancer survivors presenting symptomatically report poorer functional outcomes than PSA-detected survivors. Differences were not explained by socio-demographic or clinical factors. Clinicians should be aware that men presenting with symptoms are more likely to report functional difficulties after prostate cancer treatment and may need additional aftercare if these difficulties persist. Method of presentation should be considered as a covariate in patient-reported outcome studies of prostate cancer.

Changes in medicine prescription following a medication review in older high-risk patients with polypharmacy.

Background The more (inappropriate) drugs a patient uses, the higher the risk of drug related problems. To reduce these risks, medication reviews can be performed. Objective To report changes in the prescribed number of (potentially inappropriate) drugs before and after performing a medication review in high-risk polypharmacy patients. A secondary objective was to study reasons for continuing potentially inappropriate drugs (PIDs). Setting Dutch community pharmacy and general medical practice. Methods A retrospective longitudinal intervention study with a pre-test/post-test design and follow-up of 1 week and 3 months was performed. The study population consisted of 126 patients with polypharmacy and with additional risk for drug related problems that underwent a medication review in five community pharmacies. The medication review was performed by the pharmacist in close cooperation with the general practitioner of each corresponding patient. Main outcome measure Number of (potentially inappropriate) drugs, and appropriateness of prescribed medicines. Results The average number of drugs a patient used 1 day before the review was 8.7 (SD = 2.9), which decreased (p < 0.05) to 8.3 (SD = 2.7) 1 week after the review, and to 8.4 (SD = 2.6) 3 months after the review. The average number of PIDs was initially 0.6 (SD = 0.8) per patient and decreased to 0.4 (SD = 0.6, p < 0.05). Twenty-two of the 241 initial drug changes (9%) were deprescribed during follow-up. Registered reasons for continuing PIDs are clinical or patients' preferences. Conclusions Performing medication reviews in polypharmacy patients seems useful to continue at least in high-risk patients in The Netherlands. The time-consuming reviews could be limited to patients who are willing to change their medication.

Reasons for (not) discontinuing antipsychotics in dementia.

BACKGROUND: The gap between high antipsychotic prescription rates for patients with dementia and the guidelines' advice to prescribe cautiously indicates that barriers to discontinuation exist. This exploratory study used the theory of planned behaviour to give a first overview of the factors that influence physicians to discontinue antipsychotics in nursing home patients with dementia. METHODS: Forty-one physicians in the Netherlands completed an online survey based on the theory of planned behaviour. RESULTS: Half of the respondents agreed that antipsychotics have positive consequences for patients, such as calming effects. Physicians who indicated that they tend not to discontinue antipsychotics believe that antipsychotics are associated with positive consequences for nursing home staff. Physicians who tend to discontinue antipsychotics had a higher perceived behavioural control than those who indicated having a low intention. CONCLUSION: To enhance discontinuation of antipsychotics, interventions should focus on both patient-related factors and staff-related factors. Prescribing decisions are influenced by staff-related factors that need to be addressed as well.

Psychotropic Drug-Related Fall Incidents in Nursing Home Residents Living in the Eastern Part of The Netherlands.

BACKGROUND: Older people are more susceptible to falls than younger people. Therefore, as the Dutch population ages, the total number of falls and costs associated with them will rise. The use of psychotropic drugs is associated with an increased risk of falling. To create tailored fall-prevention programmes, information on the magnitude of the association between fall incidents and specific psychotropic drugs or drug classes is needed. OBJECTIVE: The goal of this study was to delineate the associations between fall incidents and specific psychotropic drugs or drug classes. METHODS: In this retrospective cohort study, electronic patient records, medication records and fall incident reports were collected for 1415 residents receiving somatic or psychogeriatric care in 22 nursing homes in the eastern part of the Netherlands from May 2012 until March 2015. Using a Cox proportional hazards model, we analysed the magnitude of the association between psychotropic drugs and the risk of falling for users and non-users of the psychotropic drugs or drug classes. RESULTS: Antipsychotics (adjusted hazard ratio [aHR] 1.49; 95% confidence interval [CI] 1.12-2.00) and hypnotics and sedatives (aHR 1.51; 95% CI 1.13-2.02) increase the risk of falling. There was no difference between the risk incurred by typical and atypical antipsychotics. However, within these groups, there were differences between the most commonly prescribed drugs: haloperidol and quetiapine were seen to have an association with falls, whereas pipamperone and risperidone were not. CONCLUSIONS: The results suggest falls may be associated with individual drugs rather than drug classes. Within the drug classes, clear differences are evident between individual drugs. Future fall-prevention programmes should highlight the differential risks involved with the use of specific psychotropic drugs, and doctors should take the fall risk into account when choosing specific drugs.

Pharmacological and non-pharmacological treatment preferences of healthcare professionals and proxies for challenging behaviors in patients with dementia.

BACKGROUND: Prescribing antipsychotics to patients with neuropsychiatric symptoms is a matter of concern. Physicians have to make treatment decisions for patients with dementia together with proxies and/or nurses. However, it is unknown whether physicians, nurses, and proxies' treatment preferences are aligned; hence this study. METHODS: Sixteen treatment attributes were selected to elicit the preferences of physicians and nurses. Ten of these attributes were used for the proxies. Preferences were estimated using a case-1 Best-Worst-Scaling design; respondents are asked to select the best and worst attribute on being presented with a hypothetical patient with dementia demonstrating neuropsychiatric symptoms. The treatments offered are: antipsychotic treatment or non-pharmaceutical regimens. RESULTS: The questionnaire was filled in by 41 physicians, 81 nurses, and 59 proxies. The non-pharmacological treatment option was chosen by 52% of the proxies and 71% of the physicians and nurses. The respondents who chose antipsychotics rated the aspects "fastest result" and "most effective" as important. Physicians ranked "experience with antipsychotics" as an important aspect for prescribing antipsychotics. Only the proxies rated the aspect "having a low negative effect on the patient" as important. The nurses and elderly care physicians who chose the non-pharmaceutical treatment ranked "appropriateness" and "of little burden to the patient" as important aspects. CONCLUSIONS: While doctors and nurses prefer non-pharmacological interventions, proxies indicated a preference for pharmacological treatment because of the immediate effect. However, physicians follow treatment guidelines and nurses and proxies rely on the physician's recommendations. We suggest physicians should be sensitive to these differences.

Determinants of the nurses' and nursing assistants' request for antipsychotics for people with dementia.

BACKGROUND: Although physicians are responsible for writing the antipsychotic prescriptions for patients with dementia, the initiative is often taken by nurses or nursing assistants. To reduce antipsychotics uses, one needs to understand the reasons for nurses and nursing assistants to request them. This study gives an overview of the influencing factors for this request based on the Theory of Planned Behavior in which attitude, beliefs, and behavioral control is thought to influence the intention to request, which in turn affects the behavior to request for a prescription. METHODS: Eighty-one nurses and nursing assistants of one Dutch nursing home organization completed an online survey. RESULTS: Nurses and nursing assistants frequently agreed on items related to the positive effects of antipsychotics for the resident and for the staff. Nurses and nursing assistants with a lower job satisfaction were more likely to call for antipsychotics. Having more positive beliefs about treatment effects and feel of being more in control toward asking for antipsychotics were positively associated with intention to call. All variables explained 59% of the variance of intention. The current position (nurse/nursing assistant) was associated with actual behavior to call. The explained variance was 25%. CONCLUSIONS: Policy-makers should focus on the nurses' and nursing assistants' belief in positive effects of antipsychotics for the resident, which is not in line with available evidence. Nurses and nursing assistants should be educated about the limited effectiveness of antipsychotics.

Psychotropic drug prescriptions in Western European nursing homes.

BACKGROUND: Despite the numerous warnings of European and national drug agencies as well as clinical guidelines since the year 2004, psychotropic drugs are still frequently used in dementia. A systematic review comparing the use of psychotropic drugs in nursing homes from different European countries is lacking. OBJECTIVE: The aim of this study was to examine prescription rates of psychotropic drug use in nursing home patients between different Western European countries since the first warnings were published. METHODS: A literature review was performed and the various psychotropic prescribing rates in European nursing homes were investigated. The prescription rates of antipsychotic and antidepressants were pooled per country. Other classes of psychotropic drugs could not be pooled because of the limited number of studies found. RESULTS: Thirty-seven studies on antipsychotic drug use and 27 studies on antidepressant drug use conducted in 12 different European countries. The antipsychotic use in nursing homes ranged from 12% to 59% and antidepressant use from 19% to 68%. The highest rates of antipsychotic drug prescription were found in Austria, Ireland, and Belgium while for antidepressants in Belgium, Sweden, and France. CONCLUSIONS: Despite warnings about the side effects and recommendation to focus on non-pharmacological interventions, antipsychotics and antidepressants are commonly used drugs in nursing homes. The data suggest that Norway does best with regards having a low antipsychotic drug usage. Studies are needed to explain the differences between Norway and other European countries.

Using the analytic hierarchy process to elicit patient preferences: prioritizing multiple outcome measures of antidepressant drug treatment.

BACKGROUND AND OBJECTIVE: In health technology assessment, the evidence obtained from clinical trials regarding multiple clinical outcomes is used to support reimbursement claims. At present, the relevance of these outcome measures for patients is, however, not systematically assessed, and judgments on their relevance may differ among patients and healthcare professionals. The analytic hierarchy process (AHP) is a technique for multi-criteria decision analysis that can be used for preference elicitation. In the present study, we explored the value of using the AHP to prioritize the relevance of outcome measures for major depression by patients, psychiatrists and psychotherapists, and to elicit preferences for alternative healthcare interventions regarding this weighted set of outcome measures. METHODS: Supported by the pairwise comparison technique of the AHP, a patient group and an expert group of psychiatrists and psychotherapists discussed and estimated the priorities of the clinical outcome measures of antidepressant treatment. These outcome measures included remission of depression, response to drug treatment, no relapse, (serious) adverse events, social function, no anxiety, no pain, and cognitive function. Clinical evidence on the outcomes of three antidepressants regarding these outcome measures was derived from a previous benefit assessment by the Institute for Quality and Efficiency in Health Care (IQWiG; Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen). RESULTS: The most important outcome measures according to the patients were, in order of decreasing importance: response to drug treatment, cognitive function, social function, no anxiety, remission, and no relapse. The patients and the experts showed some remarkable differences regarding the relative importance of response (weight patients = 0.37; weight experts = 0.05) and remission (weight patients = 0.09; weight experts = 0.40); however, both experts and patients agreed upon the list of the six most important measures, with experts only adding one additional outcome measure. CONCLUSIONS: The AHP can easily be used to elicit patient preferences and the study has demonstrated differences between patients and experts. The AHP is useful for policy makers in combining multiple clinical outcomes of healthcare interventions grounded in randomized controlled trials in an overall health economic evaluation. This may be particularly relevant in cases where different outcome measures lead to conflicting results about the best alternative to reimburse. Alternatively, AHP may also support researchers in selecting (primary) outcome measures with the highest relevance.

Integrating patients' views into health technology assessment: Analytic hierarchy process (AHP) as a method to elicit patient preferences.

BACKGROUND: Patient involvement is widely acknowledged to be a valuable component in health technology assessment (HTA) and healthcare decision making. However, quantitative approaches to ascertain patients' preferences for treatment endpoints are not yet established. The objective of this study is to introduce the analytic hierarchy process (AHP) as a preference elicitation method in HTA. Based on a systematic literature review on the use of AHP in health care in 2009, the German Institute for Quality and Efficiency in Health Care (IQWiG) initiated an AHP study related to its HTA work in 2010. METHODS: The AHP study included two AHP workshops, one with twelve patients and one with seven healthcare professionals. In these workshops, both patients and professionals rated their preferences with respect to the importance of different endpoints of antidepressant treatment by a pairwise comparison of individual endpoints. These comparisons were performed and evaluated by the AHP method and relative weights were generated for each endpoint. RESULTS: The AHP study indicates that AHP is a well-structured technique whose cognitive demands were well handled by patients and professionals. The two groups rated some of the included endpoints of antidepressant treatment differently. For both groups, however, the same six of the eleven endpoints analyzed accounted for more than 80 percent of the total weight. CONCLUSIONS: AHP can be used in HTA to give a quantitative dimension to patients' preferences for treatment endpoints. Preference elicitation could provide important information at various stages of HTA and challenge opinions on the importance of endpoints.

Early cardiopulmonary resuscitation and use of Automated External Defibrillators by laypersons in out-of-hospital cardiac arrest using an SMS alert service.

AIM: To evaluate an SMS service (SMS=short message service=text message) with which laypersons are alerted to go to patients with suspected out-of-hospital cardiac arrest and perform early cardiopulmonary resuscitation (CPR) and use an Automated External Defibrillator (AED). This study is the first to report on a program in which an emergency medical service (EMS) is able to alert citizens by sending them SMS messages on their mobile phone. METHODS: Web-based questionnaires were completed by laypersons who were sent an alert by the AED-Alert system between February 1, 2010 and April 30, 2010. Questions concerned the process of training, receiving alerts, actions taken and follow-up care. RESULTS: AED-Alert was activated for 52 patients suspected of cardiac arrest, sending 3227 alerts to 2287 laypersons. Out of 2168 eligible laypersons 1679 (77%) completed 2098 questionnaires, one for each alert. Action was taken in only 579 alerts. Laypersons were not in the patient's vicinity (41%), noticed alerts too late (35%), or other reasons (24%). In 298 alerts laypersons faced problems with retrieving AEDs (51%), finding addresses (29%), traffic (5%), or other (15%). Aid was provided in 75 alerts, involving 47 patients. Laypersons started early CPR and defibrillation (49%), assisted EMS personnel (52%), or took care of family (39%). Laypersons arrived before EMS personnel in 21 patients, started CPR and defibrillation in 18, and assisted EMS personnel in 9 patients. CONCLUSION: Improvements of the SMS alert service by laypersons, the EMS, and through technical adjustments, could increase the number of laypersons who provide early aid.

Is the inverse relation between blood pressure and mortality normalized in 'low-risk' dialysis patients?

BACKGROUND: SBP is a potent predictor of mortality. However, in hemodialysis populations, the relation between SBP and mortality is a matter of debate. In hemodialysis patients, low SBP rather than high SBP has been related to mortality. It has been suggested that this inverse relationship is 'normalized' in dialysis patients with a low mortality risk and that short-term and long-term effects of SBP might differ. DESIGN: We analyzed the relationship of mortality and SBP in 1111 incident hemodialysis patients participating in the Netherlands Cooperative Study on the Adequacy of Dialysis (NECOSAD) cohort. Long-term and short-term effects were studied in patients with (n = 452) and without (n = 659) cardiovascular comorbidity. RESULTS: Maximal follow-up was 7.5 years; 477 patients died. Two-year mortality rate was 44 and 20% in the groups with and without cardiovascular comorbidity, respectively. Both in the whole group and in both subpopulations, low SBP was associated with an increased mortality. The increased mortality risk associated with low SBP was especially observed as a short-term effect (6 months). In neither group did we observe a significant long-term effect between SBP and mortality. CONCLUSION: Our data do not support the hypothesis that the inverse relation between SBP and mortality is 'normalized' in a dialysis population with a low absolute mortality risk. Neither do our data support the hypothesis that elevated SBP increases mortality risk in the long-term.

Subjective global assessment of nutritional status is strongly associated with mortality in chronic dialysis patients.

BACKGROUND: The subjective global assessment of nutritional status (SGA) is used to assess the nutritional status of chronic dialysis patients, but longitudinal data in relation to mortality risk are lacking. OBJECTIVE: Our objective was to study the long-term and time-dependent associations of the SGA with mortality risk in chronic dialysis patients. DESIGN: In a prospective, longitudinal, observational, multicenter study of incident dialysis patients, the 7-point SGA [7 = normal nutritional status; 1 = severe protein-energy wasting (PEW)] was assessed 3 and 6 mo after the start of dialysis and subsequently every 6 mo during 7 y of follow-up. With Cox regression analysis, we calculated hazard ratios (HRs) of the baseline and time-dependent SGA measurements, adjusted for age, sex, treatment modality, primary kidney diseases, and comorbidity. RESULTS: In total, 1601 patients were included [mean (+/-SD) age: 59 +/- 15 y; 61% men; 23% with moderate PEW (SGA(4-5)), and 5% with severe PEW (SGA(1-3))]. There was a dose-dependent trend of the 7-point SGA with mortality. Compared with a normal nutritional status at baseline, SGA(4-5) (HR: 1.6; 95% CI: 1.3, 1.9) and SGA(1-3) (HR: 2.1; 95% CI: 1.5, 2.8) were associated with an increase in 7-y mortality. Time-dependently, these associations were stronger: SGA(4-5) (HR: 2.1; 95% CI: 1.7, 2.5) and SGA(1-3) (HR: 5.0; 95% CI: 3.8, 6.5). CONCLUSIONS: In dialysis patients, PEW at baseline assessed with SGA was associated with a 2-fold increased mortality risk in 7 y of follow-up. Time-dependently, this association was even stronger, which indicated that PEW was associated with a remarkably high risk of short-term mortality. These data imply that the 7-point SGA may validly distinguish different degrees of PEW associated with increasing risks of mortality.

High plasma phosphate as a risk factor for decline in renal function and mortality in pre-dialysis patients.

BACKGROUND: Hyperphosphataemia is associated with increased mortality in patients with chronic kidney disease (CKD) stage IV or on dialysis. Furthermore, in animal studies, elevated plasma phosphate has been shown to be associated with an accelerated decline in renal function. The aim of this study was to determine the association of plasma phosphate with renal function loss and mortality in CKD stage IV-V pre-dialysis patients with GFR <20 ml/min/1.73 m(2). METHODS: Incident pre-dialysis patients were included between 1999 and 2001 in the multi-centre PREPARE study, and followed until 2003 or death. Rate of decline in renal function for each patient was calculated by linear regression using the Modification of Diet in Renal Disease (MDRD) formula to estimate GFR (eGFR). RESULTS: A total of 448 patients were included [mean (SD) age 60 (15) years, eGFR 13 (5.4) ml/min/1.73 m(2), decline in renal function 0.38 (0.95) ml/min/month]. Phosphate concentration at baseline was 4.71 (1.16) mg/dl, calcium 9.25 (0.77) mg/dl and calcium-phosphate product 43.5 (10.9) mg(2)/dl(2). For each mg/dl higher phosphate concentration, the mean (95% CI) decline in renal function increased with 0.154 (0.071-0.237) ml/min/month. After adjustment, this association remained [beta 0.178 (0.082-0.275)]. Seven percent of the patients died. Crude mortality risk was 1.25 (0.85-1.84) per mg/dl increase in phosphate, which increased to 1.62 (1.02-2.59) after adjustment. CONCLUSIONS: High plasma phosphate is an independent risk factor for a more rapid decline in renal function and a higher mortality during the pre-dialysis phase. Plasma phosphate within the normal range is likely of vital importance in pre-dialysis patients.

Confounding effect of comorbidity in survival studies in patients on renal replacement therapy.

BACKGROUND: After taking other confounding factors into account, the impact of comorbidity on mortality was investigated when comparing mortality between five European countries, dialysis modalities and renal disease groups. METHODS: The study included 15 571 incident patients on renal replacement therapy (RRT) from five national or regional registries participating in the European Renal Association-European Dialysis and Transplant Association Registry that collect comorbidity data. The presence of diabetes mellitus, ischaemic heart disease, peripheral vascular disease, cerebrovascular disease and malignancy was recorded at the start of RRT. RESULTS: The comorbidities were each independently associated with mortality, with hazard ratios (HRs) ranging from 1.40 (95% CI: 1.30-1.51) for peripheral vascular disease to 1.65 (95% CI: 1.48-1.83) for diabetes. Age, gender, primary renal disease, modality and country together explained 14.4% of the variance in mortality; the comorbidities explained an additional 1.9%. In the comparison of renal vascular disease with glomerulonephritis, the crude HR of 2.40 (95% CI: 2.12-2.72) changed to 1.24 (95% CI: 1.09-1.41) after adjustment for age, gender, primary renal disease, treatment modality and country and to 1.06 (95% CI: 0.93-1.22) after further adjustment for the comorbidities. For the comparison between countries and other patient groups, the change in the survival estimate after adjustment for comorbidity was less. CONCLUSION: Comorbidity is an important predictor for mortality. However, after adjustment for age, gender, primary renal disease, treatment modality and country, when comparing outcomes between patient groups the influence of comorbidity may be less important than expected.

Serum troponin T concentration as a predictor of mortality in hemodialysis and peritoneal dialysis patients.

BACKGROUND: Troponin T is a good predictor of all-cause and cardiovascular mortality in cardiac patients. Although it is known that troponin T is an independent risk factor in dialysis patients as well, its prognostic value when measured routinely in clinical practice, particularly in addition to other risk indicators, is unclear. METHODS: A cohort of 847 patients who started dialysis therapy between 1997 and 2001 and participated in a multicenter follow-up study was examined. Clinical data were determined 3 months after the start of dialysis therapy. Patients were followed up until date of death or censoring in November 2003. RESULTS: For patients with troponin T values of 0.05 to 0.10 microg/L, hazard ratio for all-cause mortality was 2.2 (95% confidence interval [CI], 1.7 to 2.8) compared with patients with values less than 0.05 microg/L. For patients with values greater than 0.10 microg/L (11%), hazard ratio was 3.3 (95% CI, 2.5 to 4.5). A survival model with clinical and laboratory risk indicators yielded an area under the curve of 0.81, which did not increase when troponin T level was added to the model. The area under the curve for troponin T level alone was 0.67. No important differences were found between patients on hemodialysis or peritoneal dialysis therapy and between patients with high and low residual renal function. CONCLUSION: Although troponin T level is an independent risk factor for mortality in dialysis patients, it has limited added predictive power as a routine screening test over other clinical risk factors in dialysis patients.