Registration of catheter-related complications in adverse events reporting systems: a major underestimation of the real complication practice.

Reporting and learning from preventable adverse events is crucial to improve patient safety. Although physicians should file and analyse adverse events by law in The Netherlands, it is unknown if these reporting systems are sufficiently used in clinical practice. This study is a substudy of the multicenter RICAT trial, a successful quality improvement project to reduce inappropriate use of intravenous and urinary catheters in medical wards in seven hospitals, in which we screened 5696 patients and documented 803 catheter-related complications. We also checked the adverse events reporting systems of these patients and found that only 13 (1.6%) of 803 catheter-related complications were registered. Of the infectious complications only five (10.9%) of 46 catheter-associated bloodstream infections and urinary tract infections were registered. We conclude that the reported complications were a major underestimation of the real complication practice in medical wards in The Netherlands. The RICAT trial is registered at Netherlands Trial Register, trial NL5438.

De-implementation strategy to reduce inappropriate use of intravenous and urinary catheters (RICAT): a multicentre, prospective, interrupted time-series and before and after study.

BACKGROUND: Catheter-associated bloodstream infections and urinary tract infections are frequently encountered health care-associated infections. We aimed to reduce inappropriate use of catheters to reduce health care-associated infections. METHODS: In this multicentre, interrupted time-series and before and after study, we introduced a de-implementation strategy with multifaceted interventions in seven hospitals in the Netherlands. Adult patients admitted to internal medicine, gastroenterology, geriatic, oncology, or pulmonology wards, and non-surgical acute admission units, and who had a (central or peripheral) venous or urinary catheter were eligible for inclusion. One of the interventions was that nurses in the participating wards attended educational meetings on appropriate catheter use. Data on catheter use were collected every 2 weeks by the primary research physician during the baseline period (7 months) and intervention period (7 months), which were separated by a 5 month transition period. The primary outcomes were percentages of short peripheral intravenous catheters and urinary catheters used inappropriately on the days of data collection. Indications for catheter use were based on international guidelines. This study is registered with Netherlands Trial Register, NL5438. FINDINGS: Between Sept 1, 2016, and April 1, 2018, we screened 6157 patients for inclusion, of whom 5696 were enrolled: 2650 patients in the baseline group, and 3046 in the intervention group. Inappropriate use of peripheral intravenous catheters occurred in 366 (22·0%, 95% CI 20·0 to 24·0) of 1665 patients in the baseline group and in 275 (14·4%, 12·8 to 16·0) of 1912 patients in the intervention group (incidence rate ratio [IRR] 0·65, 95% CI 0·56 to 0·77, p<0·0001). Time-series analyses showed an absolute reduction in inappropriate use of peripheral intravenous catheters from baseline to intervention periods of 6·65% (95% CI 2·47 to 10·82, p=0·011). Inappropriate use of urinary catheters occurred in 105 (32·4%, 95% CI 27·3 to 37·8) of 324 patients in the baseline group compared with 96 (24·1%, 20·0 to 28·6) of 398 patients in the intervention group (IRR 0·74, 95% CI 0·56 to 0·98, p=0·013). Time-series analyses showed an absolute reduction in inappropriate use of urinary catheters of 6·34% (95% CI -12·46 to 25·13, p=0·524). INTERPRETATION: Our de-implementation strategy reduced inappropriate use of short peripheral intravenous catheters in patients who were not in the intensive care unit. The reduction of inappropriate use of urinary catheters was substantial, yet not statistically significant in time-series analysis due to a small sample size. The strategy appears well suited for broad-scale implementation to reduce health care-associated infections. FUNDING: Netherlands Organisation for Health Research and Development.

Preconception use of cART by HIV-positive pregnant women increases the risk of infants being born small for gestational age.

BACKGROUND: The benefits of combination anti-retroviral therapy (cART) in HIV-positive pregnant women (improved maternal health and prevention of mother to child transmission [pMTCT]) currently outweigh the adverse effects due to cART. As the variety of cART increases, however, the question arises as to which type of cART is safest for pregnant women and women of childbearing age. We studied the effect of timing and exposure to different classes of cART on adverse birth outcomes in a large HIV cohort in the Netherlands. MATERIALS AND METHODS: We included singleton HEU infants registered in the ATHENA cohort from 1997 to 2015. Multivariate logistic regression analysis for single and multiple pregnancies was used to evaluate predictors of small for gestational age (SGA, birth weight <10th percentile for gestational age), low birth weight and preterm delivery. RESULTS: A total of 1392 children born to 1022 mothers were included. Of these, 331 (23.8%) children were SGA. Women starting cART before conception had an increased risk of having a SGA infant compared to women starting cART after conception (OR 1.35, 95% CI 1.03-1.77, p = 0.03). The risk for SGA was highest in women who started a protease inhibitor-(PI) based regimen prior to pregnancy, compared with women who initiated PI-based cART during pregnancy. While the association of preterm delivery and preconception cART was significant in univariate analysis, on multivariate analysis only a non-significant trend was observed (OR 1.39, 95% CI 0.94-1.92, p = 0.06) in women who had started cART before compared to after conception. In multivariate analysis, the risk of low birth weight (OR 1.34, 95% CI 0.94-1.92, p = 0.11) was not significantly increased in women who had started cART prior to conception compared to after conception. CONCLUSION: In our cohort of pregnant HIV-positive women, the use of cART prior to conception, most notably a PI-based regimen, was associated with intrauterine growth restriction resulting in SGA. Data showed a non-significant trend in the risk of PTD associated with preconception use of cART compared to its use after conception. More studies are needed with regard to the mechanisms taking place in the placenta during fetal growth in pregnant HIV-positive women using cART. It will only be with this knowledge that we can begin to understand the potential impact of HIV and cART on the fetus, in order to be able to determine the optimal individualised drug regimen for HIV-infected women of childbearing age.

De-implementation strategy to Reduce the Inappropriate use of urinary and intravenous CATheters: study protocol for the RICAT-study.

BACKGROUND: Urinary and (peripheral and central) intravenous catheters are widely used in hospitalized patients. However, up to 56% of the catheters do not have an appropriate indication and some serious complications with the use of these catheters can occur. The main objective of our quality improvement project is to reduce the use of catheters without an appropriate indication by 25-50%, and to evaluate the affecting factors of our de-implementation strategy. METHODS: In a multicenter, prospective interrupted time series analysis, several interventions to avoid inappropriate use of catheters will be conducted in seven hospitals in the Netherlands. Firstly, we will define a list of appropriate indications for urinary and (peripheral and central) intravenous catheters, which will restrict the use of catheters and urge catheter removal when the indication is no longer appropriate. Secondly, after the baseline measurements, the intervention will take place, which consists of a kick-off meeting, including a competitive feedback report of the baseline measurements, and education of healthcare workers and patients. Additional strategies based on the baseline data and local conditions are optional. The primary endpoint is the percentage of catheters with an inappropriate indication on the day of data collection before and after the de-implementation strategy. Secondary endpoints are catheter-related infections or other complications, catheter re-insertion rate, length of hospital (and ICU) stay and mortality. In addition, the cost-effectiveness of the de-implementation strategy will be calculated. DISCUSSION: This study aims to reduce the use of urinary and intravenous catheters with an inappropriate indication, and as a result reduce the catheter-related complications. If (cost-) effective it provides a tool for a nationwide approach to reduce catheter-related infections and other complications. TRIAL REGISTRATION: Dutch trial registry: NTR6015 . Registered 9 August 2016.

HIV infection is independently associated with frailty in middle-aged HIV type 1-infected individuals compared with similar but uninfected controls.

BACKGROUND: Frailty is an age-related syndrome of decreased physiological reserve and resistance to stressors, associated with increased morbidity and mortality in the general elderly population. An increased prevalence of frailty has been reported amongst HIV-infected individuals. METHODS: Fried frailty phenotype was systematically assessed in predominantly virologically suppressed HIV type 1 (HIV-1)-infected and otherwise comparable HIV-uninfected participants aged at least 45 at enrollment into the AGEhIV Cohort Study. Multivariable ordinal logistic regression was used to investigate associations between HIV- and antiretroviral therapy-related covariates, markers of inflammation and body composition and prefrailty/frailty. RESULTS: Data were available for 521 HIV-infected and 513 HIV-uninfected individuals. Prevalence of frailty (10.6 versus 2.7%) and prefrailty (50.7 versus 36.3%) were significantly higher in HIV-infected individuals (Ptrend < 0.001). HIV infection remained statistically significantly associated with prefrailty/frailty after adjustment for age, sex, race/ethnicity, smoking, hepatitis C infection, comorbidities and depression [adjusted odds ratio (ORadj) 2.16, P < 0.001]. A higher waist-to-hip ratio attenuated the coefficient of HIV-infected status (ORadj 1.93, P < 0.001), but not waist- or hip-circumference individually or markers of inflammation. Within the HIV-infected group, parameters related to body composition were most strongly and independently associated with prefrailty/frailty: current BMI less than 20 kg/m2 (OR 2.83, P = 0.01), nadir BMI less than 20 kg/m2 (OR 2.51, P = 0.001) and waist-to-hip ratio (OR 1.79 per 0.1 higher, P < 0.001). CONCLUSION: HIV infection was independently associated with prefrailty/frailty in middle-aged HIV-infected patients compared with HIV-uninfected controls. This partly may be mediated by the higher waist- and lower hip-circumference in the HIV-infected individuals, potentially partially caused by lipodystrophy, and in part be a consequence of historic weight loss associated with advanced HIV-disease.

Hcv coinfection, an important risk factor for hepatotoxicity in pregnant women starting antiretroviral therapy.

OBJECTIVES: This retrospective cohort study evaluated the risk of hepatotoxicity in HIV-1 positive pregnant and non-pregnant women starting combined ART. METHODS: Data were used from the ATHENA observational cohort. The study population consisted of HIV-1 infected, therapy naïve, pregnant and non-pregnant women, followed between January 1997 and February 2008. Demographic, treatment and pregnancy related data were collected. Risk of hepatotoxicity was determined using univariate and multivariate logistic regression. Analyses were adjusted for age, region of origin, baseline HIV-RNA levels and CD4 cell counts, cART regimen and hepatitis B and C coinfection. ALT and AST values of more than 5 times ULN were considered as hepatotoxicity. RESULTS: Four-hundred and twenty-five pregnant and 1121 non-pregnant women were included. Independent risk factors of hepatotoxicity in all women were the presence of detectable HCV RNA (OR 5.48, 95% CI 2.25-13.38, p<0.001) and NVP use (OR 2.63, 95% CI 1.54-4.55, p<0.001). Stratified for pregnancy, the adjusted risk of hepatotoxicity was significantly associated with HCV coinfection only during pregnancy (OR 23.53, 95% CI 4.69-118.01, p<0.001). NVP use is related to hepatotoxicity in pregnant (OR 5.26, 95% CI 1.61-16.67, p<0.005) as well as in non-pregnant women (OR 2.13, 95% CI 1.11-4.00, p=0.02). CONCLUSION: HCV coinfection and NVP use are associated with a higher risk of cART induced hepatotoxicity in pregnant women.

[Treatment of HIV-infected pregnant women: prevention of virus transmission and adverse effects in mother and child]. / Behandeling van hiv-geïnfecteerde zwangeren: preventie van virustransmissie en bijwerkingen bij moeder en kind.

Without intervention, the probability of HIV transmission from mother to child varies from less than 10% to over 60%, dependent on the quantity of freely circulating HIV in the plasma. The prevention of HIV transmission from mother to child is based on the perinatal administration of a combination of antiretroviral drugs (highly active antiretroviral therapy; HAART) to both mother and child. The value of elective caesarean section along with an effective treatment with HAART during the pregnancy is very limited. Exclusive breastfeeding does not lead to a higher HIV transmission than bottle-feeding, but this effect does not lead to a successful strategy. As prophylactic treatment with HAART is widely used, it can be assumed that, in general, the use of HAART during pregnancy is relatively safe. Whether the same is true for the use of specific, and often newer drugs, is frequently not known due to the scarcity of data. For pregnant women it is important to carefully monitor adverse effects such as hepatotoxicity during the first few weeks of treatment. The most important adverse effect for the pregnancy appears to be premature birth. Yet this only occurs if HAART has to be used throughout the entire pregnancy. In the neonate mitochondrial toxicity and haematological effects can occur. These appear to be clinically insignificant but longer term effects cannot be excluded. On the basis of the available long-term safety data for children, no single antiretroviral drug has proven safety.

Medical specialists' patient-centered communication and patient-reported outcomes.

BACKGROUND: Physicians' patient-centered communication in the medical consultation is generally expected to improve patient outcomes. However, empirical evidence is contradictory so far, and most studies were done in primary care. OBJECTIVE: We sought to determine the association of specialists' patient-centered communication with patient satisfaction, adherence, and health status. METHODS: Residents and specialists in internal medicine (n = 30) and their patients (n = 323) completed a questionnaire before a (videotaped) follow-up encounter. Patients' satisfaction was assessed immediately after the consultation and their self-reported treatment adherence, symptoms, and distress 2 weeks later. Specialists' patient-centered communication was assessed by coding behaviors that facilitate or rather inhibit patients to express their perspective. Patient participation was assessed by determining their relative contribution to the conversation and their active participation behavior. Outcomes were assessed using standard questionnaires. Analyses accounted for relevant patient, visit and physician characteristics. RESULTS AND CONCLUSIONS: Medical specialists' facilitating behavior was associated with greater satisfaction in patients who were less confident in communicating with their doctor. Patient-centered communication was not associated with patients' health status or adherence in general, but facilitating behavior was positively related to the adherence of patients with a foreign primary language. In general, patients appeared to be more satisfied after an encounter with a more-facilitating and a less-inhibiting physician, but these associations diminished when controlling for background characteristics. We conclude that the absence of strong associations between patient-centered communication and patient-reported outcomes may be explained by medical specialists being responsive to patients' characteristics.

Patient participation in the medical specialist encounter: does physicians' patient-centred communication matter?

OBJECTIVE: Physicians' patient-centred communication is assumed to stimulate patients' active participation, thus leading to more effective and humane exchange in the medical consultation. We investigated the relationship between physicians' patient-centred communication and patient participation in a medical specialist setting. METHODS: Participants were 30 residents and specialists in internal medicine, and 323 of their patients. Participants completed a questionnaire prior to a (videotaped) follow-up consultation. Physicians' patient-centred communication was assessed by coding behaviours that facilitate or rather inhibit patients to express their perspective. Patient participation was determined by assessing (a) their relative contribution to the conversation, and (b) their active participation behaviour. Analyses accounted for relevant background characteristics. RESULTS: Physicians' facilitating behaviour was found to be positively associated with patients' relative contribution to the conversation as well as patients' active participation behaviour. Physicians' inhibiting behaviour was not related to patients' relative contribution, and was, unexpectedly, positively associated with patients' active participation behaviour. Physicians' behaviour was particularly associated with patients' expression of concerns and cues. CONCLUSIONS: Physicians in internal specialist medicine appear to be able to facilitate patients' active participation in the visit. The findings indicate that inhibiting behaviour may not have the expected blocking effect on patient participation: patients voiced their perspectives just the same and expressed even more concerns. Showing inhibiting behaviour may, alternatively, be a physician's response to the patient's increased participation in the encounter. PRACTICE IMPLICATIONS: The results may give directions for future medical education and specialist training.

Determinants of physicians' patient-centred behaviour in the medical specialist encounter.

It has been suggested that patient-centred communication does not necessarily translate into a 'one-size fits all' approach, but rather that physicians should use a flexible style and adapt to the particular needs of their patients. This paper examines variability in physicians' patient-centred behaviour in medical specialist encounters, and determines whether patient, visit, and physician characteristics influence this variability. Participants were 30 residents and specialists in internal medicine at an academic teaching hospital in The Netherlands, and 323 patients having a (videotaped) outpatient follow-up appointment. Physicians and patients completed a questionnaire prior to the encounter. Consultations were coded using the Patient-centred Behaviour Coding Instrument (PBCI); physicians' patient-centred behaviour was determined by behaviours that facilitated rather than inhibited the patient's expression of his/her perspective. The results show that physicians differ in their communicative behaviour (i.e. inter-individual variability): some internists had a more 'patient-centred' communication style and others less so. At the same time, physicians show intra-individual variation; apparently they adjust their style according to the situation. Physicians displayed more facilitating behaviour when patients were older, reported more physical symptoms, when they rated patients' health condition as more severe and when the physician was a woman. Physicians also displayed more inhibiting behaviour when patients reported more physical symptoms and when the physician rated patients' health condition as more severe. Apparently, sicker patients were targets of both greater facilitation and greater inhibition. Variability in physicians' facilitating and inhibiting behaviour was explained by patient characteristics, i.e. patients' age and health condition, and-with the exception of physician gender-not by physician or visit characteristics. This indicates that physician patient-centred behaviour is related to the type of patient visiting, especially in relation to the seriousness of symptoms.

Nelfinavir and nevirapine side effects during pregnancy.

BACKGROUND: The risk of vertical transmission of HIV has been substantially reduced since the introduction of highly active antiretroviral therapy (HAART); however, the impact of taking HAART during pregnancy on the woman, the fetus and the infant is not yet understood. OBJECTIVE: To assess and compare tolerability, safety and efficacy of nelfinavir- or nevirapine-containing HAART in a cohort of pregnant and non-pregnant HIV-infected women in The Netherlands. DESIGN: Retrospective comparative study. METHODS: In 15 centres specializing in HIV in The Netherlands, data on patient characteristics, HAART, adverse events, viral load response, mode of delivery and HIV status of the neonate were obtained from medical records of HIV-infected pregnant women who received HAART during pregnancy between January 1997 and June 2003. These data were compared with a control group of HIV-infected non-pregnant women that was obtained from the Dutch HIV-monitoring foundation database. RESULTS: Data from 186 pregnant and 186 non-pregnant HIV-infected women using a nelfinavir- or nevirapine-containing regimen were analysed. The pregnant women were younger, used a nelfinavir containing regimen more often, had higher CD4 cell counts and lower HIV RNA levels. Nelfinavir-related gastrointestinal symptoms (P < 0.001), hyperglycaemia (P < 0.001) and nevirapine-related hepatotoxicity (P = 0.003) occurred more often during pregnancy. The risk of nevirapine-induced rash was not increased. No major adverse events occurred. CONCLUSION: Nelfinavir- or nevirapine-containing HAART regimens during pregnancy are well tolerated. Side effects of antiretroviral therapy are more frequent in pregnant than in non-pregnant women.

Satisfaction with the outpatient encounter: a comparison of patients' and physicians' views.

OBJECTIVE: To compare patients' and physicians' visit-specific satisfaction in an internal medicine outpatient setting, and to explain their respective views. DESIGN: Patients' and physicians' background characteristics were assessed prior to outpatient encounters. Immediately after the encounter, both patients and physicians completed a questionnaire assessing satisfaction with the visit. SETTING: The outpatient division of an academic teaching hospital. PARTICIPANTS: Thirty residents and specialists in general internal medicine, rheumatology, and gastroenterology, and 330 patients having a follow-up appointment with one of these physicians. MEASUREMENTS AND MAIN RESULTS: Patients' and physicians' visit-specific satisfaction was assessed using 5 Visual Analogue Scales (0 to 100). Patients' overall satisfaction was higher than physicians' satisfaction (mean 81 vs. 66), and correlation of patients' and physicians' overall satisfaction with the specific visit was medium sized (r= .28, P < .001). Patients' satisfaction ratings were associated with their previsit self-efficacy in communicating with their physician (P < .001) and with visiting a female physician (P < .01). Physicians' satisfaction was associated with patients' higher educational level (P < .05), primary language being Dutch (P < .001), better mental health (P < .05), and preference for receiving less than full information (P < .05). CONCLUSIONS: In an outpatient setting, patients' visit-specific satisfaction ratings were substantially higher than, and only moderately associated with, physicians' ratings of the same visit. The dissimilar predictors explaining patients' and physicians' satisfaction suggest that patients and physicians form their opinion about a consultation in different ways. Hence, when evaluating outpatient encounters, physicians' satisfaction has additional value to patients' satisfaction in establishing quality of care.

Nelfinavir plasma concentrations are low during pregnancy.

Plasma nelfinavir concentration ratios (CRs) were calculated for all pregnant (n=27) and nonpregnant (n=48) human immunodeficiency virus type 1-infected women receiving the drug who visited our outpatient clinic. In pregnant women, mean and median nelfinavir CRs were significantly lower (P=.02 and P=.04, respectively), and 51% of the CRs were below the clinically relevant threshold of 0.90, compared with 35% of the CRs in nonpregnant women. After we adjusted for confounders, we found that the mean nelfinavir CR was 34% lower in pregnant women (P=.02). With targeted interventions, subsequent CRs in pregnant women showed a significant increase (median increase, 0.31; P=.01).

Frequency of spontaneous fist clenching during routine blood pressure measurements and its effect on measurement accuracy.

BACKGROUND: Guidelines for office blood pressure reading techniques do not warn us about the possibility that patients may clench their fist during cuff-inflation. It is unknown how often patients do this, and what effect it has on measured blood pressure readings. DESIGN AND METHODS: We registered double blood pressure readings in 150 outpatient clinic subjects, who were not given specific instructions as to how to hold their hand during the procedure. If they clenched their fist during the first reading, they were asked to relax their hand during the second reading, and vice versa. Double readings with a relaxed hand on both occasions were registered in 100 matched control patients as well. RESULTS: Twenty-two of 150 patients (15%) spontaneously made a fist during the first reading. No systematic effect (lower or higher blood pressure) from making a fist was observed, but individual effects were often marked, as evidenced by the median absolute differences (regardless of '+' or '-' sign) between the duplicate readings: 5 (range 0-31) versus 3 (0-18) mmHg for systolic blood pressure, and 4 (0-22) versus 2 (0-16) mmHg for diastolic blood pressure in the study group versus the control group, respectively (P < or = 0.05). A different hypertension classification occurred twice as often when a fist was made during one of the two blood pressure readings than with two fistless readings (23 versus 12%, P = 0.04). CONCLUSION: About one out of every seven patients makes a fist during blood pressure taking. This can seriously affect measurement accuracy, and doubles the risk of misclassification of hypertension.