Laser therapy for onychomycosis in patients with diabetes at risk for foot ulcers: a randomized, quadruple-blind, sham-controlled trial (LASER-1).

BACKGROUND: Patients with diabetes mellitus are at high risk for onychomycosis, which is related to the development of foot ulcers. OBJECTIVE: The aim of this study was to evaluate the safety and efficacy of the treatment of onychomycosis with local laser therapy. METHODS: In a single-centre, randomized (1:1), quadruple-blind, sham-controlled trial, patients and microbiological confirmation with diabetes mellitus, at risk for developing diabetic foot ulcers (Sims classification score 1, 2) and a clinical suspicion on onychomycosis, were randomized to either four sessions neodymium-doped yttrium aluminium garnet (Nd-YAG) 1064 nm laser or sham treatment. The primary outcome was clinical and microbiological cure of onychomycosis after 1-year follow-up. RESULTS: From March 2015 to July 2016, 64 patients were randomized; 63 could be analysed. Trichophyton rubrum was the most detected pathogen. There was no difference in the primary outcome between laser and sham treatment. With the exception of a subungual haematoma in the fifth toenail occurring 2 weeks after laser treatment, the results suggested that treatment with Nd-YAG 1064 nm laser is safe. CONCLUSION: At this moment, there is no evidence of any effect of laser treatment for onychomycosis in patients with diabetes at increased risk for foot ulcers, at least not within 1 year after treatment.

Healthcare reimbursement costs of children with type 1 diabetes in the Netherlands, a observational nationwide study (Young Dudes-4).

BACKGROUND: Type 1 diabetes mellitus (T1DM) is one of the most common chronic diseases in children. Studies on costs related to T1DM are scarce and focused primarily on the costs directly related to diabetes. We aimed to investigate both the overall healthcare costs and the more specific costs related to the management of diabetes. METHODS: This is a retrospective and observational, nationwide cohort study of all Dutch children (aged 0-18 years) with T1DM. Data were collected from the national registry for healthcare reimbursement, in which all Dutch insurance companies combine their reimbursement data. In the Netherlands for all Dutch citizens health care is covered by law and all children are treated by hospital-based paediatricians. RESULTS: We analysed 6710 children distributed over 81 hospitals: 475 children in 6 university hospitals and 6235 children in 75 general hospitals. Total reimbursement for all children with T1DM over the period 2009 to 2011 was € 167,494,732 corresponding to an annual mean of € 55,831,577 of total costs and € 8326 euros per child. When comparing small (between 26 and 54 patients), medium (57-84 patients) and large (88-248 patients) general hospitals, costs per patient were highest in the hospitals with the highest number of T1DM patients. The costs for devices, secondary care and pharmaceutics had most impact on total expenditures. Over the study period, there was a slight decrease in per person costs. CONCLUSION: The overall health expenditure of a child with T1DM is more than € 8000 per patient per annum. Given the move towards more device-intensive multidisciplinary care for these patients, the costs of treating T1DM in children are likely to increase further in the coming years.

Copeptin, a surrogate marker for arginine vasopressin, is associated with declining glomerular filtration in patients with diabetes mellitus (ZODIAC-33).

AIM/HYPOTHESIS: Arginine vasopressin (AVP), the hormone important for maintaining fluid balance, has been shown to cause kidney damage in rodent models of diabetes. We investigated the potential role of AVP in the natural course of kidney function decline in diabetes in an epidemiological study. METHODS: Plasma copeptin, a surrogate for AVP, was measured in baseline samples from patients with type 2 diabetes treated in primary care and included in the Zwolle Outpatient Diabetes project Integrating Available Care (ZODIAC) cohort. RESULTS: Samples from 1,328 patients were available; 349 were analysed separately because they used renin-angiotensin-aldosterone system inhibition (RAASi), which influences albumin/creatinine ratio (ACR) and estimated (e)GFR. In the other 979 patients (46% men, age 68 years [58-75], ACR 1.8 mg/mmol [0.9-5.7], eGFR 67 ± 14 ml min(-1) 1.73 m(-2)) baseline copeptin (5.3 pmol/l [3.2-9.5]) was significantly associated with log e [ACR] and eGFR, even after adjustment for sex, age and risk factors for kidney function decline (standardised [std] ß 0.13, p < 0.001, std ß -0.20, p < 0.001 respectively). Follow-up data were available for 756 patients (6.5 years [4.1-9.6]). Baseline copeptin was associated with increase in ACR (std ß 0.09, p = 0.02), but lost significance after adjustment (std ß 0.07, p = 0.08). Copeptin was associated with a decrease in eGFR after adjustment (std ß -0.09, p = 0.03). The strength of the association of copeptin with change in eGFR was stronger than that of established risk factors for kidney function decline (e.g. BMI, HbA1c). In patients who used RAASi there was a significant association between baseline copeptin and ACR and eGFR, but not with change in ACR and eGFR. CONCLUSIONS/INTERPRETATION: In patients with diabetes not using RAASi a higher baseline copeptin concentration is significantly associated with higher baseline ACR and lower eGFR values and with a decline in eGFR during follow-up. This last association is independent of, and stronger than, most traditional risk factors for kidney function decline.

Health care in patients 1 year post-stroke in general practice: research on the utilisation of the Dutch Transmural Protocol transient ischaemic attack/cerebrovascular accident.

This study evaluates the kind of aftercare that ischaemic stroke patients receive and the extent that aftercare fulfils the criteria of the 'Dutch Transmural Protocol transient ischaemic attack/cerebrovascular accident'. Fifty-seven patients were interviewed 1 year post-stroke about secondary prevention and aftercare. Forty general practitioners (GPs) completed a questionnaire about guidance and secondary prevention (concerning medication and lifestyle advice). Most patients would like to see their GP more regularly. More aftercare was required than was planned. The use of aspirin remained the same, fewer patients used statins and more used antihypertensives. Of the 40 GPs who participated, 12% did not apply prevention. Blood pressure, glucose and cholesterol were measured in 84%, 28% and 40% of patients. All of these measures were often elevated, but treatment was not given. Lifestyle advice was offered to one-quarter of patients. Considering all of the advice given in the Dutch Protocol, several aspects can be improved in relation to secondary prevention. Too little attention is paid to giving lifestyle advice, stricter medical checkups by GPs are necessary and there is a decrease in use of preventive medication, partly because GPs monitors use of medication inadequately. The use of the Dutch Protocol in aftercare can be improved by a more detailed description of advice.

Lower estimated glomerular filtration rate and higher albuminuria are associated with all-cause and cardiovascular mortality. A collaborative meta-analysis of high-risk population cohorts.

Screening for chronic kidney disease is recommended in people at high risk, but data on the independent and combined associations of estimated glomerular filtration rate (eGFR) and albuminuria with all-cause and cardiovascular mortality are limited. To clarify this, we performed a collaborative meta-analysis of 10 cohorts with 266,975 patients selected because of increased risk for chronic kidney disease, defined as a history of hypertension, diabetes, or cardiovascular disease. Risk for all-cause mortality was not associated with eGFR between 60-105 ml/min per 1.73 m², but increased at lower levels. Hazard ratios at eGFRs of 60, 45, and 15 ml/min per 1.73 m² were 1.03, 1.38 and 3.11, respectively, compared to an eGFR of 95, after adjustment for albuminuria and cardiovascular risk factors. Log albuminuria was linearly associated with log risk for all-cause mortality without thresholds. Adjusted hazard ratios at albumin-to-creatinine ratios of 10, 30 and 300 mg/g were 1.08, 1.38, and 2.16, respectively compared to a ratio of five. Albuminuria and eGFR were multiplicatively associated with all-cause mortality, without evidence for interaction. Similar associations were observed for cardiovascular mortality. Findings in cohorts with dipstick data were generally comparable to those in cohorts measuring albumin-to-creatinine ratios. Thus, lower eGFR and higher albuminuria are risk factors for all-cause and cardiovascular mortality in high-risk populations, independent of each other and of cardiovascular risk factors.

Glycaemic control and the risk of mortality in elderly type 2 diabetic patients (ZODIAC-20).

AIMS: Studies on macrovascular consequences of glucose control in elderly patients (>75 years) with type 2 diabetes mellitus (T2DM) are lacking. The present study aimed to investigate the relationship between HbA(1c) and mortality in this specific population. METHODS: Between 1998 and 1999, 374 primary care patients with T2DM aged older than 75 years participated in the Zwolle Outpatient Diabetes project Integrating Available Care study, a prospective observational study. Early 2009, data on mortality were collected. Updated means for annually measured HbA(1c) values were calculated after a follow-up time of 10 years. Updated mean HbA(1c) was used as a time-dependent covariate in a Cox proportional hazard model. Main outcome measures were all-cause and cardiovascular disease (CVD) mortality. Analyses were performed in strata according to diabetes duration (<5, 5-11 and ≥11 years). RESULTS: In the group with a diabetes duration <5 years, an increase of 1% in the updated mean HbA(1c) level was associated with an increase in all-cause and CVD mortality risk of 51% (95% CI 17-95%) and 72% (95% CI 19-148%), respectively. Glycaemic control was not related to mortality for patients with a diabetes duration ≥5 years. CONCLUSION: Poor glycaemic control is related to increased all-cause and CVD mortality in patients >75 years with T2DM of short duration (<5 years). DISCUSSION: Because of the observational study design, our results should be interpreted with caution. Nevertheless, they are suggestive that improving glycaemic control may be beneficial in elderly patients with T2DM, especially in those with recently diagnosed T2DM. Randomised-controlled trials are necessary to investigate whether this holds true.

Modification of diet in renal disease and Cockcroft-Gault formulas do not predict mortality (ZODIAC-6).

AIMS: An inverse relationship between estimates of renal function, with formulas such as the Modification of diet in renal disease (MDRD) study equation or the Cockcroft-Gault formula, and mortality has been suggested. These formulas both contain the variables sex, serum creatinine and age and the latter also contains body weight. We investigated whether these formulas predict mortality better than the variables they contain together in patients with Type 2 diabetes. METHODS: In 1998, 1143 primary care patients with Type 2 diabetes participated in the Zwolle Outpatient Diabetes project Integrating Available Care (ZODIAC) Study, in the Netherlands. Clinical and laboratory data were collected at baseline. Life status was assessed after 6 years. We used Cox proportional hazard modelling to investigate the association between estimates of renal function (continuous data) and the variables they contain and mortality, adjusting for confounders. Both formulas were compared with models consisting of the variables present in the formulas. Predictability was assessed using Bayesian information criterion (BIC) and Harrell's C statistics. RESULTS: At follow-up, 335 patients had died. All variables, except sex, influenced mortality. Predictive capability, indicated by lower BIC values and higher Harrell's C values, was up to 10% better for models containing the separate variables as compared with Cockcroft-Gault or MDRD. CONCLUSIONS: Using estimates of renal function to assess mortality risk decreases predictability as compared with the combination of the risk factors they contain. These formulas, therefore, could be used to estimate renal function; however, they should not be used as a tool to predict mortality risk.

Corticosteroid injections effective for trigger finger in adults in general practice: a double-blinded randomised placebo controlled trial.

OBJECTIVE: To study efficacy and safety of corticosteroid injections for trigger finger (flexor tenosynovitis) in adults in general practice. METHODS: Adult patients presenting with trigger finger were recruited by 21 participating general practitioners. In this randomised placebo controlled double-blinded trial, patients were injected locally with one or two injections of 1 ml triamcinolonacetonide (TCA) or 0.9% NaCl. Outcomes regarding immediate treatment response, severity of symptoms, functional disability, patient satisfaction and side effects were measured 1 week after intervention and during the 12 months thereafter. RESULTS: A total of 50 patients were included. Short-term outcomes for the TCA and NaCl group, respectively, were: proportion of patients with satisfactory immediate treatment response 16/25 and 5/25 (p<0.001), patients with reduction in the frequency of triggering 13/24 and 6/22 (p = 0.053), mean difference in severity of pain 4.2 and 0.9 (p<0.001), patients perceiving improvement 22/25 and 9/25 (p<0.001) and difference in Arthritis Impact Measurement Scale 2 (AIMS-2) score 4.02 and 0.06 (p = 0.001). Long-term effects could only be assessed by analysing the cohort of participants who received TCA (as allocated treatment or escape treatment), due to a high proportion of non-responders in the NaCl group. The short-term beneficial effects were maintained during the follow-up phase of 12 months. Patients were satisfied with corticosteroid injection therapy and there were only a few minor side effects. CONCLUSIONS: Local injection with TCA is effective and safe for treating trigger finger as compared to placebo injection. The effects of steroid injections last up to 12 months.

Is there a need for a GP consultant at a university hospital?

BACKGROUND: Patients in hospital can develop complaints unrelated to the condition they are admitted for. The treating specialist will then call upon a co-specialist who is specialized in the clinical picture associated with the new complaint. For such a complaint, the GP is usually the first contact, when the patient is not in hospital. Normally specialists only encounter patients GPs have selected for referral. The risk of the specialist overestimating the predictive value of 'unselected' complaints and symptoms of a serious condition is high. This may lead to an overuse of diagnostic treatments. Such treatments weigh more heavily on the patient, cause inadequate use of hospital facilities and, as a consequence, generate higher costs. Because of these considerations, we wished to investigate if there is a need for the GP as a consultant for new complaints during hospital admittance. METHOD: The files of a random sample of patients who had an interdisciplinary consultation during their stay in hospital were judged by an expertpanel whether the consultation fitted the expertise of a GP. RESULTS: In 28 out of 84 files the consultation fitted the expertise of a GP; most cases concerned a specific condition that is not part of the specialist's expertise, most frequently dermatological problems. In a minority of cases the specialist is confronted with a clinical problem with symptoms of which the cause is not clear, for example fever. CONCLUSION: Generally, the consultations concern serious, often very complex conditions, i.e. cases that should be assessed by a specialist. Nevertheless, the expert panel's judgment of the interdisciplinary consultations shows that in more than half of the dermatological cases and in a limited number of consultations by a specialist of internal medicine and geriatrics the problems fit the GP's expertise. Given the morbidity in academic hospitals we suppose that the results of a similar study in a peripheral hospital might even show more perspective for a GP consultant. These results offer sufficient arguments to start a pilotstudy into the role of a GP consultant in hospital.

Late effects in adult survivors of childhood cancer: the need for life-long follow-up.

BACKGROUND: To assess health status and health-related quality of life (HRQoL) in childhood cancer survivors who were not involved in regular long-term follow-up. PATIENTS AND METHODS: One hundred and twenty-three long-term survivors, median age 33 (19-50) years, follow-up 27 (9-38) years, were recalled to the long-term follow-up clinic. Most of them were treated in the period 1970-1990. Late effects were graded using the Common Terminology Criteria for Adverse Events, version 3 (CTCAEv3). HRQoL was assessed by RAND-36. Socio-economic factors were compared with data from Statistics Netherlands (CBS). RESULTS: Grade 1-2 late effects were found in 54% of the survivors, grade 3-4 in 39%, two or more late effects in 70% and grade 2-4 previously unknown late effects in 33%. Survivors had significantly lower scores on RAND-36 compared with controls. CONCLUSIONS: As nearly 40% of these long-term childhood cancer survivors suffer from moderate to severe late effects and 33% had previously unknown late effects it is worthwhile recalling these patients to follow-up. Where and by whom this follow-up can best be done is still a question that needs to be answered.

Health-related quality of life and adverse late effects in adult (very) long-term childhood cancer survivors.

METHOD: The RAND-36 was used to assess HRQoL in all adult (> or =18 years) survivors who had attended the long-term follow-up clinic since 1995. The survivors were divided into two groups based on the length of follow-up: Group LF (long term follow-up, follow-up > or =20 years, n=129) and Group VLF (very long-term follow-up, follow-up >20 years, n=184). Data on diagnosis, treatment and complications were obtained from medical records. Late effects were graded using the CTCAEv3. RESULTS: The RAND-36 was completed by 313 (86.2%) out of 363 eligible patients. Except for higher scores on the subscale Bodily pain, LF patients did not differ significantly on the RAND-36 subscales from the population sample; VLF patients had significant lower scores on the subscales Physical functioning (P=0.003), Social functioning, Vitality and General health perception (P<0.001). Significantly more VLF patients (P<0.001) had severe (grade 3 and 4) late effects (47.8%) compared to LF patients (27.9%). Female gender and especially psycho-social late effects were inversely related to HRQoL. CONCLUSION: Childhood cancer survivors who were diagnosed more than 20 years ago have lower scores on the RAND 36, and have significantly more severe late effects than those diagnosed more recently. Patients with longer follow-up are more likely to become lost to follow-up. Time has come to establish new models of care for adult childhood cancer survivors, which are more flexible and appropriate to the needs of adult childhood cancer survivors.

Orthostatic hypotension does not predict recurrent falling in a nursing home population.

OBJECTIVE: Most studies regard orthostatic hypotension (OH) as a causal factor for falls. However, the evidence is lacking for this assumption. We aimed to investigate the relationship between orthostatic hypotension and fall incidents in nursing home residents. METHODS: A total of 249 patients was included in a prospective observational cohort study of nursing home residents. Falls were prospectively registered. Cox proportional hazard modelling and the conditional frailty model were used to analyse the relationship between OH and (recurrent) falling. RESULTS: Among the 249 patients, 450 falls were recorded during follow-up and OH was present in 93 out of 249 patients. No significant associations were found between OH and the first fall incident (Hazard Ratio (HR) 1.01 (95% Confidence Interval (CI) 0.60-1.69) and recurrent falling (HR 1.21 (95%CI 0.65-2.24)). CONCLUSIONS: Although falling and OH were both highly prevalent in nursing home residents, no relationship between OH and falling was found.

Effects of intraperitoneal insulin versus subcutaneous insulin administration on sex hormone-binding globulin concentrations in patients with type 1 diabetes mellitus.

AIMS: Elevated sex hormone-binding globulin (SHBG) concentrations have been described in patients with type 1 diabetes mellitus (T1DM), probably due to low portal insulin concentrations. We aimed to investigate whether the route of insulin administration, continuous intraperitoneal insulin infusion (CIPII), or subcutaneous (SC), influences SHBG concentrations among T1DM patients. METHODS: Post hoc analysis of SHBG in samples derived from a randomized, open-labeled crossover trial was carried out in 20 T1DM patients: 50% males, mean age 43 (±13) years, diabetes duration 23 (±11) years, and hemoglobin A1c (HbA1c) 8.7 (±1.1) (72 (±12) mmol/mol). As secondary outcomes, testosterone, 17-ß-estradiol, luteinizing hormone (LH), and follicle-stimulating hormone (FSH) were analyzed. RESULTS: Estimated mean change in SHBG was -10.3nmol/L (95% CI: -17.4, -3.2) during CIPII and 3.7nmol/L (95% CI: -12.0, 4.6) during SC insulin treatment. Taking the effect of treatment order into account, the difference in SHBG between therapies was -6.6nmol/L (95% CI: -17.5, 4.3); -12.7nmol/L (95% CI: -25.1, -0.4) for males and -1.7nmol/L (95% CI: -24.6, 21.1) for females, respectively. Among males, SHBG and testosterone concentrations changed significantly during CIPII; -15.8nmol/L (95% CI: -24.2, -7.5) and -8.3nmol/L (95% CI: -14.4, -2.2), respectively. The difference between CIPII and SC insulin treatment was also significant for change in FSH 1.2U/L (95% CI: 0.1, 2.2) among males. CONCLUSIONS: SHBG concentrations decreased significantly during CIPII treatment. Moreover, the difference in change between CIPII and SC insulin therapy was significant for SHBG and FSH among males. These findings support the hypothesis that portal insulin administration influences circulating SHBG and sex steroids.

Health-related quality of life, rehabilitation and mortality in a nursing home population.

BACKGROUND: Health-related quality of life (HRQOL) in nursing home residents is generally low. The purpose of this study was to investigate the associations between HRQOL and two clinically relevant outcome measures, all-cause mortality and successful rehabilitation, in a nursing home population. METHODS: In an observational prospective cohort study in a nursing home population, HRQOL was assessed with the RAND-36. A total of 184 patients were included, 159 (86%) completed the RAND-36 and were included in the study. A Cox proportional hazard model was used to investigate the independent association between HRQOL, rehabilitation and mortality with adjustment for confounders. Risk prediction capabilities were assessed with Harrell's C statistics and the proportion of explained variance (R2). RESULTS: The median age (interquartile range) was 79 (75-85) years. The health dimensions vitality (HR 0.88 (95% CI 0.77-0.99)) and mental health (HR 0.86 (95% CI 0.75-0.98)) were inversely associated and role functioningphysical (HR 1.08 (95%CI 1.02-1.15)) was positively associated with mortality. The Harrell's C value and the R2 were ≤ 0.02 and ≤ 0.03 higher in the adjusted models with the dimensions role functioning- physical, mental health or vitality compared with the models without these dimensions. None of the health dimensions or summary scales were related to successful rehabilitation. CONCLUSION: HRQOL was significantly associated with mortality for three dimensions, but partly in opposite directions. Additional value of HRQOL in mortality prediction is very limited. There were no independent associations between HRQOL and successful rehabilitation. Although HRQOL is an important outcome, this study did not provide evidence for an association between HRQOL and successful rehabilitation.

Pretreatment serum squamous cell carcinoma antigen: a newly identified prognostic factor in early-stage cervical carcinoma.

PURPOSE: To investigate the prognostic value of pretreatment serum squamous cell carcinoma antigen (SCC-ag) levels in patients with cervical squamous cell carcinoma in relation to well-established conventional risk factors. PATIENTS AND METHODS: Sera from 653 women treated for squamous cervical cancer between 1978 and 1994 were analyzed for the presence of SCC-ag and related to clinicopathologic characteristics and patient outcome using univariate and multivariate analyses. RESULTS: Increased pretreatment SCC-ag levels correlated strongly with unfavorable clinicopathologic characteristics (International Federation of Gynecology and Obstetrics [FIGO] stages IB to IV [P < or = .00005]; stages IB and IIA: tumor size [P = .0236], deep stromal infiltration [P = .00009], and lymph node metastasis [P = .0001]). After multivariate analysis, elevated pretreatment serum SCC-ag levels (P = .001), lesion size (P = .043), and vascular invasion by tumor cells (P = .001) were independent predictors for the presence of lymph node metastases. In Cox regression analysis, controlling for SCC-ag, lesion size, grade, vascular invasion, depth of stromal infiltration, and lymph node status only the initial SCC-ag level had a significant independent effect on survival (P = .0152). Even in node-negative patients, the risk of recurrence was three times higher if the SCC-ag level was elevated before therapy. CONCLUSION: The determination of pretreatment serum SCC-ag level provides a new prognostic factor in early-stage disease, particularly in patients with small tumor size. In future trials to assess the value of new treatment strategies, pretreatment serum SCC-ag levels can be used to help identify patients with a poor prognosis.

Cross-sectional relationship between glycaemic control, hyperglycaemic symptoms and quality of life in type 2 diabetes (ZODIAC-2).

BACKGROUND: To describe the relationship between glycaemic control, hyperglycaemic symptoms and quality of life (HRQOL) in type 2 diabetic patients. METHODS: In a shared-care diabetes project HRQOL was assessed. A total of 1664 patients with type 2 diabetes were identified in 32 primary healthcare practices. Of these patients, 1149 were included. HRQOL was measured using a generic questionnaire (Rand-36), completed by 1006 of the 1149 participants. RESULTS: The number of hyperglycaemic symptoms was higher in women (1.88) compared with men (1.64), without differences in mean haemoglobin A1c (HbA1c) (7.5%)-Univariate analyses showed negative relationships between all dimensions of the Rand-36 and hyperglycaemic symptoms (p<0.001), but between only one dimension and HbA1c (p=0.005). Multivariate analyses showed no association between any of the dimensions of the Rand-36 and HbA1c, but the relationship between hyperglycaemic symptoms persisted in all dimensions (p<0.001). Notwithstanding these results, the presence of hyperglycaemic symptoms was related to higher HbA1c. CONCLUSION: In type 2 diabetic patients, as assessed by a generic questionnaire, there is an evident relationship between hyperglycaemic symptoms and HRQOL and not between HbA1c and HRQOL. Subjective hyperglycaemic symptoms are, independent of HbA1c, important for HRQOL in type 2 diabetic patients, and should therefore not be neglected in the management of diabetes.

Shared care with task delegation to nurses for type 2 diabetes: prospective observational study.

BACKGROUND: To study the effects of two different structured shared care interventions, tailored to local needs and resources, in an unselected patient population with type 2 diabetes mellitus. METHODS: A three-year prospective observational study of two interventions and standard care. The interventions involved extensive (A) or limited (B) task delegation from general practitioners to hospital-liaised nurses specialised in diabetes and included a diabetes register, structured recall, facilitated generalist-specialist communication, audit and feedback, patient-specific reminders, and emphasised patient education. The target population consisted of 2660 patients with type 2 diabetes treated in the primary care setting. Patients who were terminally ill or who had been diagnosed with dementia were excluded from the study. RESULTS: The participation rates were high (90%) for patients, and none of the 64 GPs discontinued their participation in the study. Longitudinal analyses showed significant improvements in quality indicators for both intervention groups (process parameters and achieved target values on the individual patient level); in standard care, performance remained stable or deteriorated. Both patients and caregivers appeared satisfied with the project. CONCLUSION: This study shows that structured shared care with task delegation to nurses, targeted at a large unselected general practice population, is feasible and can positively affect the quality of care for patients with type 2 diabetes.

The association between orthostatic hypotension, falling and successful rehabilitation in a nursing home population.

PURPOSE OF THE STUDY: Our objectives were to identify the prevalence of orthostatic hypotension (OH) in frail, elderly nursing home residents, and assess its possible association with falling and chances of successful rehabilitation. MATERIALS AND METHODS: A prospective observational cohort study. A total of 290 patients participated in this study, of which 128 were admitted to the rehabilitation department. OH was defined as a drop in systolic blood pressure of >20mmHg and diastolic blood pressure of >10mmHg after postural change within 3min. The analyses regarding falling and successful rehabilitation were only performed in the rehabilitation group. Multivariate binary logistic regression analyses were used to describe risk factors related with falling. Cox proportional hazard modeling was used to investigate the relation between OH and the time to successful rehabilitation. RESULTS: The prevalence of OH in the studied nursing home population was 36.6% (95% CI (confidence interval): 31.1-42.1%). The prevalence varied from 28.6% (95% CI: 16.8-40.4%) in somatic patients, 36.7% (95% CI: 28.4-45.1%) in rehabilitation patients, to 40.6% (95% CI: 31.3-50.0%) in psychogeriatric patients. The association between orthostatic hypotension and previous falling was not significant; Odds ratio 0.66 (95% CI: 0.30-1.48). The Hazard ratio of the relationship between OH and successful rehabilitation was 2.88 (95% CI:1.77-4.69). CONCLUSIONS: OH is highly prevalent in nursing home residents. Surprisingly, patients with OH were found to have a higher chance of successful rehabilitation compared to patients without OH. If confirmed in other studies, these results may change our view of the implications of OH.

Intraperitoneal versus subcutaneous insulin therapy in the treatment of type 1 diabetes mellitus.

BACKGROUND: Continuous intraperitoneal insulin infusion (CIPII), a last-resort type 1 diabetes mellitus (T1DM) treatment, has only been investigated in small or controlled studies. We aimed to investigate glycaemia and quality of life (QoL) with CIPII versus subcutaneous (SC) insulin therapy during usual T1DM care. METHODS: A prospective, observational case-control study. CIPII-treated cases were matched to SC controls. The primary endpoint was a non-inferiority assessment (pre-defined margin of -5.5 mmol÷mol) of the baseline adjusted difference in HbA1c between groups during a 26-week follow-up. Secondary outcomes included QoL, clinical and biochemical measurements. RESULTS: In total, 183 patients were analysed (CIPII n = 39 and SC n = 144). The HbA1c difference between treatment groups was -3.0 mmol÷mol (95% CI -5.0, -1.0), being lower in the SC group. Patients using SC insulin therapy spent less percentage of time in hyperglycaemia (-9.3% (95% CI -15.8, -2.8)) and more in euglycaemia (6.9% (95% CI 1.2, 12.5) as compared with CIPII-treated patients. Besides a 3.6 U÷l (95% CI 1.2, 6.0) lower concentration of alanine aminotransferase with CIPII, no biochemical and clinical differences were present. Most QoL scores were lower at baseline among CIPII-treated patients. However, besides lower health status, there were no differences in the baseline-adjusted general and diabetes-specific QoL and treatment satisfaction. CONCLUSION: Although patients using CIPII had a higher glycaemic profile compared with patients using SC insulin therapy, the HbA1c difference was non-inferior. Overall, health status was lower among CIPII-treated patients, although diabetes-specific QoL and treatment satisfaction was similar to subcutaneously treated patients.