Ten reasons to conduct a randomized study in quality improvement.
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Awards and Prizes↗
Biomedical subjects
Thomas Perneger
Publications and source records attributed to Thomas Perneger.
CD4-guided scheduled treatment interruptions compared with continuous therapy for patients infected with HIV-1: results of the Staccato randomised trial.
BACKGROUND: Stopping antiretroviral therapy in patients with HIV-1 infection can reduce costs and side-effects, but carries the risk of increased immune suppression and emergence of resistance. METHODS: 430 patients with CD4-positive T-lymphocyte (CD4) counts greater than 350 cells per muL, and viral load less than 50 copies per mL were randomised to continued therapy (n=146) or scheduled treatment interruptions (n=284). Median time on randomised treatment was 21.9 months (range 16.4-25.3). Primary endpoints were proportion of patients with viral load less than 50 copies per mL at the end of the trial, and amount of drugs used. Analysis was intention-to-treat. This study is registered at ClinicalTrials.gov with the identifier NCT00113126. FINDINGS: Drug savings in the scheduled treatment interruption group, compared with continuous treatment, amounted to 61.5%. 257 of 284 (90.5%) patients in the scheduled treatment interruption group reached a viral load less than 50 copies per mL, compared with 134 of 146 (91.8%) in the continued treatment group (difference 1.3%, 95% CI-4.3 to 6.9, p=0.90). No AIDS-defining events occurred. Diarrhoea and neuropathy were more frequent with continuous treatment; candidiasis was more frequent with scheduled treatment interruption. Ten patients (2.3%) had resistance mutations, with no significant differences between groups. INTERPRETATION: Drug savings with scheduled treatment interruption were substantial, and no evidence of increased treatment resistance emerged. Treatment-related adverse events were more frequent with continuous treatment, but low CD4 counts and minor manifestations of HIV infection were more frequent with scheduled treatment interruption.
Adolescent↗
Satisfaction of patients on chronic haemodialysis and peritoneal dialysis.
BACKGROUND: In contrast to quality of life, patient satisfaction on chronic haemodialysis (HD) and peritoneal dialysis (PD) has only rarely been studied. PATIENTS AND METHODS: All chronic HD and PD patients of the 19 centres located in western Switzerland were asked to complete a specific questionnaire, assessing dialysis centre characteristics, treatment modalities, and information received before and during dialysis treatment. Comparison between satisfaction with PD and HD was carried out on the patients in the nine centres offering both treatment modalities. RESULTS: Of the 558 questionnaires distributed to chronic HD patients, 455 were returned (response rate 82%). Fifty of 64 PD patients (78%) returned the questionnaire. The two groups were similar in age, gender, and duration of dialysis treatment. Completion rates were >90% for a majority of questions, with the lowest rate for information on sexuality (49% in HD and 54% in PD respectively). The lowest scores were recorded for information received about complications and costs of dialysis, and impact of end-stage kidney disease on sexuality. Satisfaction was lower in anonymous questionnaires. Satisfaction of PD patients was significantly better in 50% of the questions, particularly session tolerance (p<0.001), information about dialysis sessions (p=0.007), and complications (p=0.006). CONCLUSIONS: PD patients were on average more satisfied with their treatment than HD patients. Satisfaction could be improved with more information about potential adverse treatment effects.
Age Factors↗
Variability in quality of care among dialysis units in western Switzerland.
BACKGROUND: Quality indicators for dialysis care vary across countries and regions, but regional variability across centres has received little attention. We analysed variations in quality indicators among dialysis facilities in western Switzerland to identify opportunities for improving care for patients with end-stage kidney disease. METHODS: A cross-sectional study of 617 dialysis patients treated at 19 facilities examined the distribution of indicators of quality of care addressing: adequacy of dialysis (Kt/V > or =1.2 for haemodialysis, Kt/V > or =2 for peritoneal dialysis), anaemia control (haemoglobin > or =110 g/l), calcium and phosphate control (product < or =4.4 mmol2/l2), adequate nutrition (serum albumin >35 g/l), hypertension control (pre-dialysis blood pressure <140/90 mmHg) and type of vascular access. Centre quality targets were the following: achievement of quality criteria for 80% of their patients, except 85% for anaemia control and 60% for arterio-venous fistulae. RESULTS: Most centres fulfilled quality targets for dialysis adequacy, but substantial variations existed among centres (haemodialysis, 76%, range 36-100; peritoneal dialysis, 76%, range 33-100). Results were similar for anaemia (77%, range 35-100), calcium x phosphate product (69%, range 29-92), albumin (63%, range 26-95), hypertension control (33%, range 13-54) and arterio-venous fistula (61%, range 49-92). The between-centre variability was significantly greater than would be expected by chance, for all indicators. Dialysis facilities with >40 patients better fulfilled quality targets than university-based centres. Adjustment for patient characteristics did not modify these results. CONCLUSIONS: Substantial variations in quality indicators existed between dialysis centres in western Switzerland, which could not be attributed to different centre policies, or to differences in available measures of patient case mix. These findings indicate opportunities for improvement in dialysis practice which may translate into improved clinical outcomes.
Aged↗
Biphasic decline of CD4 cell count during scheduled treatment interruptions.
In 115 patients whose scheduled treatment interruptions (STI) lasted 24 weeks, the CD4 cell count declined by a median of 30 cells/ml/week during the first 4 weeks, compared with 3 cells/ml/week during the next 20 weeks. In multivariate regression, a pronounced early fall in CD4 cells correlated with a higher CD4 cell count at the start of STI, with more gain in CD4 cells during antiretroviral treatment preceding STI, and with a higher viral load at week 4.
Anti-HIV Agents↗
Knowledge of standard and isolation precautions in a large teaching hospital.
OBJECTIVE: To assess the level of knowledge regarding and attitudes toward standard and isolation precautions among healthcare workers in a hospital. METHOD: A confidential, self-administered questionnaire survey was conducted in a random sample of 1500 nurses and 500 physicians in a large teaching hospital. RESULTS: A total of 1,241 questionnaires were returned (response rate, 62%). The median age of respondents was 39 years; 71.9% were women and 21.2% had senior staff status. One-fourth had previously participated in specific training regarding transmission precautions for pathogens conducted by the infection control team. More than half (55.9%) gave correct answers to 10 or more of the 13 knowledge-type questions. The following reasons for noncompliance with guidelines were judged as "very important": lack of knowledge (47%); lack of time (42%); forgetfulness (39%); and lack of means (28%). For physicians and healthcare workers in a senior position, lack of time and lack of means were significantly less important (P < .0005). On multivariate linear regression, knowledge was independently associated with exposure to training sessions (coefficient, 0.33; 95% confidence interval, 0.08 to 0.57; P = .009) and less professional experience (coefficient per increasing professional experience, -0.024; 95% confidence interval, -0.035 to -0.012; P < .0005). CONCLUSIONS: Despite a training effort targeting opinion leaders, knowledge of transmission precautions for pathogens remained insufficient. Nevertheless, specific training proved to be the major determinant of "good knowledge".
Adult↗
Quality of life on chronic dialysis: comparison between haemodialysis and peritoneal dialysis.
BACKGROUND: Quality of life (QOL) assessment in patients on chronic haemodialysis (HD) or peritoneal dialysis (PD) has only rarely been carried out with the generic Euroqol-5D questionnaire. METHODS: All chronic HD and PD patients in the 19 centres of western Switzerland were requested to fill in the validated Euroqol-5D generic QOL questionnaire, assessing health status in five dimensions and on a visual analogue scale, allowing computation of a predicted QOL value, to be compared with the value measured on the visual analogue scale. RESULTS: Of the 558 questionnaires distributed to chronic HD patients, 455 were returned (response rate 82%). Fifty of 64 PD patients (78%) returned the questionnaire. The two groups were similar in age, gender and duration of dialysis treatment. Mean QOL was rated at 60+/-18% for HD and 61+/-19% for PD, for a mean predicted QOL value of 62+/-30 and 58+/-32% respectively. Results of the five dimensions were similar in both groups, except for a greater restriction in usual activities for PD patients (P = 0.007). The highest scores were recorded for self-care, with 71% HD and 74% PD patients reporting no limitation, and the lowest scores for usual activities, with 14% HD and 23% PD patients reporting severe limitation. Experiencing pain/discomfort (for HD and PD) or anxiety/depression (for PD) had the highest impact on QOL. CONCLUSIONS: QOL was equally diminished in HD and PD patients. The questionnaire was well accepted and performed well. Improvement could be achievable in both groups if pain/discomfort and anxiety/depression could be more effectively treated.
Health Status Indicators↗
New editor for a quality journal.
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Humans↗
Home-based care after a shortened hospital stay versus hospital-based care postpartum: an economic evaluation.
OBJECTIVES: To compare the cost effectiveness of early postnatal discharge and home midwifery support with a traditional postnatal hospital stay. DESIGN: Cost minimisation analysis within a pragmatic randomised controlled trial. SETTING: The University Hospital of Geneva and its catchment area. POPULATION: Four hundred and fifty-nine deliveries of a single infant at term following an uncomplicated pregnancy. METHODS: Prospective economic evaluation alongside a randomised controlled trial in which women were allocated to either early postnatal discharge combined with home midwifery support (n= 228) or a traditional postnatal hospital stay (n= 231). MAIN OUTCOME MEASURES: Costs (Swiss francs, 2000 prices) to the health service, social services, patients, carers and society accrued between delivery and 28 days postpartum. RESULTS: Clinical and psychosocial outcomes were similar in the two trial arms. Early postnatal discharge combined with home midwifery support resulted in a significant reduction in postnatal hospital care costs (bootstrap mean difference 1524 francs, 95% confidence interval [CI] 675 to 2403) and a significant increase in community care costs (bootstrap mean difference 295 francs, 95% CI 245 to 343). There were no significant differences in average hospital readmission, hospital outpatient care, direct non-medical and indirect costs between the two trial groups. Overall, early postnatal discharge combined with home midwifery support resulted in a significant cost saving of 1221 francs per mother-infant dyad (bootstrap mean difference 1209 francs, 95% CI 202 to 2155). This finding remained relatively robust following variations in the values of key economic parameters performed as part of a comprehensive sensitivity analysis. CONCLUSIONS: A policy of early postnatal discharge combined with home midwifery support exhibits weak economic dominance over traditional postnatal care, that is, it significantly reduces costs without compromising the health and wellbeing of the mother and infant.
Adult↗
Infrequent transmission of HIV-1 drug-resistant variants.
Transmission of drug-resistant variants is influenced by several factors, including the prevalence of drug resistance in the population of HIV-1-infected patients, HIV-1 RNA levels and transmission by recently infected patients. In order to evaluate the impact of these factors on the transmission of drug-resistant variants, we have defined the population of potential transmitters and compared their resistance profiles to those of newly infected patients. Sequencing of pol gene was performed in 220 recently infected patients and in 373 chronically infected patients with HIV-1 RNA >1000 copies/ml. Minimal and maximal drug-resistance profiles of potential transmitters were estimated by weighting resistance profiles of chronically infected patients with estimates of the Swiss HIV-1-infected population, the prevalence of exposure to antiviral drugs and the proportion of infections attributed to primary HIV infections. The drug-resistance prevalence in recently infected patients was 10.5% (one class drug resistance: 9.1%; two classes: 1.4%; three classes: 0%). Phylogenetic analysis revealed significant clustering for 30% of recent infections. The drug-resistance prevalence in chronically infected patients was 72.4% (one class: 29%; two classes: 27.6%; three classes: 15.8%). After adjustment, the risk of transmission relative to wild-type was reduced both for one class drug resistance (minimal and maximal estimates: odds ratio: 0.39, P<0.001; and odds ratio: 0.55, P=0.011, respectively), and for two to three class drug resistance (odds ratios: 0.05 and 0.07, respectively, P<0.001). Neither sexual behaviour nor HIV-1 RNA levels explained the low transmission of drug-resistant variants. These data suggest that drug-resistant variants and in particular multidrug-resistant variants have a substantially reduced transmission capacity.
Adolescent↗
A controlled trial of granulocyte macrophage-colony stimulating factor during interruption of HAART.
OBJECTIVES: To explore the effect of granulocyte macrophage colony stimulating factor (GM-CSF) on viral load and CD4 cell count during interruption of highly active antiretroviral therapy (HAART). METHODS: Patients on effective HAART (CD4 cell count > 400 x 10(6)/l; viral load < 50 HIV RNA copies/ml) were randomized to one of two groups: 12 weeks' treatment interruption plus, during the first 4 weeks, 300 microg GM-CSF (Leucomax-Novartis) by subcutaneous injection three times weekly (GM-CSF group); 12 weeks' scheduled treatment interruption (STI-only group). Viral load, CD4 cell count, clinical events and side effects of treatment were monitored. RESULTS: Thirty-three patients, 15 in the GM-CSF group and 18 in the STI-only group, were evaluated according to the intention-to-treat principle. The two groups were well matched with regard to pre-HAART viral loads and CD4 cell counts. During STI, viraemia was approximately two to three times lower in the group receiving GM-CSF (max 4.97 versus 5.45 in STI-only group; P = 0.03). Fifteen out of 17 patients in the STI-only group showed a decrease in their CD4 cell count between weeks 0 and 4 (median decrease 231 x 10(6) cells/l; P < 0.001); there was no such tendency in the GM-CSF group (P = non-significant when comparing CD4 cell counts at weeks 0 and 4). The median CD4 cell AUC (area under the curve) from week 0 to week 12 was higher in the GM-CSF group (9166 cells.week) than in patients without GM-CSF (7257), P = 0.02. GM-CSF produced local reactions in 88% of patients, and generalized symptoms such as fever, back pain or headache in 82% of patients. Seventy-six percent of patients completed the planned course of 12 injections. CONCLUSIONS: The administration of GM-CSF blunted the viral rebound following interruption of HAART, and largely prevented a decrease of CD4 cell counts during a 12-weeks-treatment interruption. A better understanding of the underlying mechanism(s) may help to identify synergistic treatment targets and improved administration protocols to enhance control of chronic HIV infection.
Acquired Immunodeficiency Syndrome↗
Women's perception of the benefits of mammography screening: population-based survey in four countries.
BACKGROUND: Screening programmes are often actively promoted to achieve high coverage, which may result in unrealistic expectations. We examined women's understanding of the likely benefits of mammography screening. METHODS: Telephone survey of random samples of the female population aged > or =15 years in the US, UK, Italy, and Switzerland using three closed questions on the expected benefits of mammography screening. RESULTS: A total of 5964 women were contacted and 4140 women (69%) participated. Misconceptions were widespread: a majority of women believed that screening prevents or reduces the risk of contracting breast cancer (68%), that screening at least halves breast cancer mortality (62%), and that 10 years of regular screening will prevent 10 or more breast cancer deaths per 1000 women (75%). In multivariate analysis higher number of correct answers was positively associated with higher educational status (odds ratio [OR] = 1.44, 95% CI: 1.25, 1.66) and negatively with having had a mammography in the last 2 years (OR = 0.86, 95% CI: 0.73, 1.01). Compared with US women (reference group) and Swiss women (OR = 0.98, 95% CI: 0.82, 1.18) respondents in Italy (OR = 0.61, 95% CI: 0.50, 0.74) and the UK (OR = 0.73, 95% CI: 0.60, 0.88) gave fewer correct answers. CONCLUSION: In the US and three European countries a high proportion of women overestimated the benefits that can be expected from screening mammography. This finding raises doubts on informed consent procedures within breast cancer screening programmes.
Adolescent↗
Safety of low-dose spironolactone administration in chronic haemodialysis patients.
BACKGROUND: Prevention of cardiovascular diseases is essential in chronic haemodialysis patients. Recently, low-dose spironolactone has been shown to decrease cardiovascular mortality in patients with severe heart failure. However, since haemodialysis patients are prone to hyperkalaemia, a known side effect of spironolactone, this treatment is not used in this population. We performed a study to assess whether low-dose spironolactone (3 x 25 mg/week) could be administered without inducing hyperkalaemia in haemodialysis patients. METHODS: The study design included a 2-week baseline period, followed by a 4-week treatment period in which doses of spironolactone were started at 12.5 mg three times/week for 2 weeks, then increased to 25 mg three times/week, and followed by a 2-week wash-out period. Fourteen patients receiving low-dose spironolactone after each dialysis were compared with 21 haemodialysis patients (control group). RESULTS: Low-dose spironolactone did not change mean serum potassium (4.9 +/- 0.7 vs 4.9 +/- 0.3 mmol/l: control). The mean plasma canrenone level induced by administration of spironolactone 25 mg three times/week in the 14 treated patients was 13 +/- 5.3 ng/ml. Serum aldosterone was not significantly modified by the administration of spironolactone in these patients [before, median 0.35; interquartile range (IQR) 0.11-2.83 nmol/l vs after, median 0.22; IQR 0.12-0.60 nmol/l, NS]. Dietary potassium intake and the use of ion-exchange resin, angiotensin-converting enzyme inhibitors and beta-blockers were similar for the two groups throughout the study. CONCLUSION: This non-randomized and non-blinded study shows that administration of 25 mg spironolactone thrice weekly is not associated with an increased frequency of hyperkalaemia in haemodialysis patients when they are carefully monitored. More studies are required, however, before concluding that spironolactone administration is safe in the chronic haemodialysis population.
Adult↗
A risk score to predict arrhythmias in patients with unexplained syncope.
OBJECTIVES: To develop and validate a risk score predicting arrhythmias for patients with syncope remaining unexplained after emergency department (ED) noninvasive evaluation. METHODS: One cohort of 175 patients with unexplained syncope (Geneva, Switzerland) was used to develop and cross-validate the risk score; a second cohort of 269 similar patients (Pittsburgh, PA) was used to validate the system. Arrhythmias as a cause of syncope were diagnosed by cardiac monitoring or electrophysiologic testing. Data from the patient's history and 12-lead emergency electrocardiography (ECG) were used to identify predictors of arrhythmias. Logistic regression was used to identify predictors for the risk-score system. Risk-score performance was measured by comparing the proportions of patients with arrhythmias at various levels of the score and receiver operating characteristic (ROC) curves. RESULTS: The prevalence of arrhythmic syncope was 17% in the derivation cohort and 18% in the validation cohort. Predictors of arrhythmias were abnormal ECG (odds ratio [OR]: 8.1, 95% confidence interval [CI]=3.0 to 22.7), a history of congestive heart failure (OR: 5.3, 95% CI=1.9 to 15.0), and age older than 65 (OR: 5.4, 95% CI=1.1 to 26.0). In the derivation cohort, the risk of arrhythmias ranged from 0% (95% CI=0 to 6) in patients with no risk factors to 6% (95% CI=1 to 15) for patients with one risk factor, 41% (95% CI=26 to 57) for patients with two risk factors, and 60% (95% CI = 32 to 84) for those with three risk factors. In the validation cohort, these proportions varied from 2% (95% CI=0 to 7) with no risk factors to 17% (95% CI=10 to 27) with one risk factor, 35% (95% CI=24 to 46) with two risk factors, and 27% (95% CI=6 to 61) with three risk factors. Areas under the ROC curves ranged from 0.88 (95% CI=0.84 to 0.91) for the derivation cohort to 0.84 (95% CI=0.77 to 0.91) after cross-validation within the same cohort and 0.75 (95% CI=0.68 to 0.81) for the external validation cohort. CONCLUSIONS: In patients with unexplained syncope, a risk score based on clinical and ECG factors available in the ED identifies patients at risk for arrhythmias.
Aged↗
Fondaparinux: a new synthetic pentasaccharide for thrombosis prevention.
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Arthroplasty, Replacement, Hip↗
Comparison of two clinical prediction rules and implicit assessment among patients with suspected pulmonary embolism.
PURPOSE: Two prediction rules for pulmonary embolism have been described recently: the Wells' rule, which was derived from both outpatients and inpatients, and which includes a subjective element; and the Geneva rule, which is entirely standardized and is suitable only for emergency department patients. We compared the predictive accuracy and the concordance of the two methods, as well as the Geneva score overridden by implicit clinical judgment. SUBJECTS AND METHODS: We studied 277 consecutive patients admitted to the emergency departments of three teaching hospitals. Clinical probability was assessed prospectively with the Geneva score and the Geneva score overridden by implicit clinical judgment in case of a disagreement. The Wells' score was calculated retrospectively. RESULTS: The three methods classified similar proportions of patients as having a low (53% to 58% of patients), intermediate (37% to 41% of patients), or high (4% to 10% of patients) probability of pulmonary embolism. The actual frequencies of pulmonary embolism in each category were also similar (5% to 13% in the low, 38% to 40% in the intermediate, and 67% to 91% in the high clinical probability categories). Receiver operating characteristic curve analysis showed no difference between the two prediction rules, but the Geneva score overridden by implicit evaluation had a marginally higher accuracy. Concordance between the two prediction rules was fair (kappa coefficient = 0.43). Clinicians disagreed with the Geneva score in 21% of patients (n = 57). CONCLUSIONS: The two prediction rules had a similar predictive accuracy for pulmonary embolism among emergency department patients. The Geneva rule appears to be more accurate when combined with clinical judgment, although it does not apply to inpatients.
Adult↗
ACE inhibitors or angiotensin II receptor blockers in dialysed patients and erythropoietin resistance.
BACKGROUND: To examine whether angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin II receptor blockers (ARBs) are associated with a state of recombinant human erythropoietin (rHuEPO) resistance in hemodialyzed patients. METHODS: Cross-sectional study involving all dialysis facilities in French-speaking Switzerland. All patients treated with rHuEPO in March 2001 were included. Demographic, clinical and laboratory data were collected in 515 patients treated with chronic hemodialysis (HD) and rHuEPO. Patients were classified into five groups according to their antihypertensive treatment. The main outcomes of the study were the mean rHuEPO dosage and the prevalence of erythropoietin EPO resistance among the groups. Erythropoietin resistance was defined as a weekly rHuEPO dosage >300 units/kg/wk. RESULTS: The mean rHuEPO dosage and the prevalence of EPO resistance were similar in patients treated with ACEIs (n = 138, mean EPO dosage 109 units/kg/wk, EPO resistance 12%), ARBs (n = 59, mean EPO dosage 120 units/kg/wk, EPO resistance 7%), both (n = 10, mean EPO dosage 109 units/kg/wk, EPO resistance 10%), other drugs (n = 137, mean EPO dosage 110 units/kg/wk, EPO resistance 10%) and no antihypertensive treatment (n = 171, mean EPO dosage 90 units/kg/wk, EPO resistance 9%). Differences were not statistically significant. Patients with rHuEPO resistance were characterized by a higher frequency of hospitalization and a more pronounced inflammatory state. There was no difference in the use of ACEIs and ARBs between patients with and without EPO resistance (37 vs. 41%, ns). CONCLUSIONS: Neither the use of ACEIs nor ARBs is associated with a state of rHuEPO resistance among hemodialyzed patients.
Aged↗