Jacobus Adrianus Maria van der Palen

Self management for patients with chronic obstructive pulmonary disease

BACKGROUNDnSelf management interventions help patients with chronic obstructive pulmonary disease (COPD) acquire and practise the skills they need to carry out disease-specific medical regimens, guide changes in health behaviour and provide emotional support to enable patients to control their disease. Since the first update of this review in 2007, several studies have been published. The results of the second update are reported here.nnnOBJECTIVESn1. To evaluate whether self management interventions in COPD lead to improved health outcomes.2. To evaluate whether self management interventions in COPD lead to reduced healthcare utilisation.nnnSEARCH METHODSnWe searched the Cochrane Airways Group Specialised Register of trials (current to August 2011).nnnSELECTION CRITERIAnControlled trials (randomised and non-randomised) published after 1994, assessing the efficacy of self management interventions for individuals with COPD, were included. Interventions with fewer than two contact moments between study participants and healthcare providers were excluded.nnnDATA COLLECTION AND ANALYSISnTwo review authors independently assessed trial quality and extracted data. Investigators were contacted to ask for additional information. When appropriate, study results were pooled using a random-effects model. The primary outcomes of the review were health-related quality of life (HRQoL) and number of hospital admissions.nnnMAIN RESULTSnTwenty-nine studies were included. Twenty-three studies on 3189 participants compared self management versus usual care; six studies on 499 participants compared different components of self management on a head-to-head basis. Although we included non-randomised controlled clinical trials as well as RCTs in this review, we restricted the primary analysis to RCTs only and reported these trials in the abstract.In the 23 studies with a usual care control group, follow-up time ranged from two to 24 months. The content of the interventions was diverse. A statistically relevant effect of self management on HRQoL was found (St Georges Respiratory Questionnaire (SGRQ) total score, mean difference (MD) -3.51, 95% confidence interval (CI) -5.37 to -1.65, 10 studies, 1413 participants, moderate-quality evidence). Self management also led to a lower probability of respiratory-related hospitalisation (odds ratio (OR) 0.57, 95% CI 0.43 to 0.75, nine studies, 1749 participants, moderate-quality evidence). Over one year of follow-up, eight (95% CI 5 to 14) participants with a high baseline risk of respiratory-related hospital admission needed to be treated to prevent one participant with at least one hospital admission, and 20 (95% CI 15 to 35) participants with a low baseline risk of hospitalisation needed to be treated to prevent one participant with at least one respiratory-related hospital admission.No statistically significant effect of self management on all-cause hospitalisation (OR 0.77, 95% CI 0.45 to 1.30, 6 studies, 1365 participants, low-quality evidence) or mortality (OR 0.79, 95% CI 0.58 to 1.07, 8 studies, 2134 participants, very low-quality evidence) was detected. Also, dyspnoea measured by the (modified) Medical Research Council Scale ((m)MRC) was reduced in individuals who participated in self management (MD -0.83, 95% CI -1.36 to -0.30, 3 studies, 119 participants, low-quality evidence). The difference in exercise capacity as measured by the six-minute walking test was not statistically significant (MD 33.69 m, 95% CI -9.12 to 76.50, 6 studies, 570 participants, very low-quality evidence). Subgroup analyses depending on the use of an exercise programme as part of the intervention revealed no statistically significant differences between studies with and without exercise programmes in our primary outcomes of HRQoL and respiratory-related hospital admissions.We were unable to pool head-to-head trials because of heterogeneity among interventions and controls; thus results are presented narratively within the review.nnnAUTHORS CONCLUSIONSnSelf management interventions in patients with COPD are associated with improved health-related quality of life as measured by the SGRQ, a reduction in respiratory-related hospital admissions, and improvement in dyspnoea as measured by the (m)MRC. No statistically significant differences were found in other outcome parameters. However, heterogeneity among interventions, study populations, follow-up time and outcome measures makes it difficult to formulate clear recommendations regarding the most effective form and content of self management in COPD.

Mesh-fixation method and pain and quality of life after laparoscopic ventral or incisional hernia repair: a randomized trial of three fixation techniques.

BackgroundPersistent, activity-limiting pain after laparoscopic ventral or incisional hernia repair (LVIHR) appears to be related to fixation of the implanted mesh. A randomized study comparing commonly used fixation techniques with respect to postoperative pain and quality of life has not previously been reported.MethodsA total of 199 patients undergoing non-urgent LVIHR in our unit between August 2005 and July 2008 were randomly assigned to one of three mesh-fixation groups: absorbable sutures (AS) with tacks; double crown (DC), which involved two circles of tacks and no sutures; and nonabsorbable sutures (NS) with tacks. All operations were performed by one of two experienced surgeons, who used a standardized technique and the same type of mesh and mesh-fixation materials. The severity of the patients’ pain was assessed preoperatively and at 2xa0weeks, 6xa0weeks and 3xa0months postoperatively by using a visual analogue scale (VAS). Quality of life (QoL) was evaluated by administering a standard health survey before and 3xa0months after surgery. Results in the three groups were compared.ResultsThe AS, DC, and NS mesh-fixation groups had similar patient demographic, hernia and operative characteristics. There were no significant differences among the groups in VAS scores at any assessment time or in the change in VAS score from preoperative to postoperative evaluations. The QoL survey data showed a significant difference among groups for only two of the eight health areas analyzed.ConclusionIn this trial, the three mesh-fixation methods were associated with similar postoperative pain and QoL findings. These results suggest that none of the techniques can be considered to have a pain-reduction advantage over the others. Development of new methods for securing the mesh may be required to decrease the rate or severity of pain after LVIHR.

Emergence of Colistin Resistance in Enterobacteriaceae after the Introduction of Selective Digestive Tract Decontamination in an Intensive Care Unit

ABSTRACT Selective decontamination of the digestive tract (SDD) selectively eradicates aerobic Gram-negative bacteria (AGNB) by the enteral administration of oral nonabsorbable antimicrobial agents, i.e., colistin and tobramycin. We retrospectively investigated the impact of SDD, applied for 5 years as part of an infection control program for the control of an outbreak with extended-spectrum beta-lactamase (ESBL)-producing Klebsiella pneumoniae in an intensive care unit (ICU), on resistance among AGNB. Colistin MICs were determined on stored ESBL-producing K. pneumoniae isolates using the Etest. The occurrence of both tobramycin resistance among pathogens intrinsically resistant to colistin (CIR) and bacteremia caused by ESBL-producing K. pneumoniae and CIR were investigated. Of the 134 retested ESBL-producing K. pneumoniae isolates, 28 were isolated before SDD was started, and all had MICs of <1.5 mg/liter. For the remaining 106 isolated after starting SDD, MICs ranged between 0.5 and 24 mg/liter. Tobramycin-resistant CIR isolates were found sporadically before the introduction of SDD, but their prevalence increased immediately afterward. Segmented regression analysis showed a highly significant relationship between SDD and resistance to tobramycin. Five patients were identified with bacteremia caused by ESBL-producing K. pneumoniae before SDD and 9 patients thereafter. No bacteremia caused by CIR was found before SDD, but its occurrence increased to 26 after the introduction of SDD. In conclusion, colistin resistance among ESBL-producing K. pneumoniae isolates emerged rapidly after SDD. In addition, both the occurrence and the proportion of tobramycin resistance among CIR increased under the use of SDD. SDD should not be applied in outbreak settings when resistant bacteria are prevalent.

Circulating tumor cells, disease recurrence and survival in newly diagnosed breast cancer.

IntroductionThe presence of circulating tumor cells (CTC) is an independent prognostic factor for progression-free survival and breast cancer-related death (BRD) for patients with metastatic breast cancer beginning a new line of systemic therapy. The current study was undertaken to explore whether the presence of CTC at the time of diagnosis was associated with recurrence-free survival (RFS) and BRD.MethodsIn a prospective single center study, CTC were enumerated with the CellSearch system in 30 ml of peripheral blood of 602 patients before undergoing surgery for breast cancer. There were 97 patients with a benign tumor, 101 did not meet the inclusion criteria of which there were 48 patients with DCIS, leaving 404 stage I to III patients. Patients were stratified into unfavorable (CTC ≥1) and favorable (CTC = 0) prognostic groups.Results≥1 CTC in 30 ml blood was detected in 15 (15%) benign tumors, in 9 DCIS (19%), in 28 (16%) stage I, 32 (18%) stage II and in 16 (31%) patients with stage III. In stage I to III patients 76 (19%) had ≥1 CTC of whom 16 (21.1%) developed a recurrence. In 328 patients with 0 CTC 38 (11.6%) developed a recurrence. Four-year RFS was 88.4% for favorable CTC and 78.9% for unfavorable CTC (P = 0.038). A total of 25 patients died of breast cancer-related causes and 11 (44%) had ≥1 CTC. BRD was 4.3% for favorable and 14.5% for unfavorable CTC (P = 0.001). In multivariate analysis ≥1 CTC was associated with distant disease-free survival, but not for overall recurrence-free survival. CTC, progesterone receptor and N-stage were independent predictors of BRD in multivariate analysis.ConclusionsPresence of CTC in breast cancer patients before undergoing surgery with curative intent is associated with an increased risk for breast cancer-related death.

Community based physiotherapeutic exercise in COPD self-management: A randomised controlled trial

Little is known about effects of community-based physiotherapeutic exercise programmes incorporated in COPD self-management programmes. In a randomised trial, the effect of such a programme (COPE-active) on exercise capacity and various secondary outcomes including daily activity as a marker of behaviour change was evaluated. All patients attended four 2-h self-management sessions. In addition the intervention group participated in the COPE-active programme offered by physiotherapists of private practices, consisting of a 6-month compulsory period (3 sessions/week) and subsequently a 5-month optional period (2 sessions/week). Because COPE-active was intended to change behaviour with regard to exercise, one session/week in both periods consisted of unsupervised home-based exercise training. Of 153 patients, 74 intervention and 68 control patients completed the one-year follow-up. Statistically significant between-group differences in incremental shuttle walk test-distance (35.1 m; 95% CI (8.4; 61.8)) and daily activity (1190 steps/day; 95% CI (256; 2125)) were found in favour of the intervention group. Over the 12-month period a significant difference of the chronic respiratory questionnaire (CRQ) dyspnoea-score (0.33 points; 95% CI (0.01; 0.64)) and a non-significant difference of the endurance shuttle walk test (135 m (95% CI (-29; 298)) was found. No differences were found in the other CRQ-components, anxiety and depression scores and percentage of fat free mass. This study demonstrates that a community-based reactivation programme improves exercise capacity in patients with moderately to severe COPD. Even more important, the programme improves actual daily activity after one-year which indicates behaviour change with regard to daily exercise. Registered trail number: ISRCTN81447311.

Comparison of a New Multidose Powder Inhaler (Diskus©/Accuhaler©) and the Turbuhaler© Regarding Preference and Ease of Use

Many patients with asthma or chronic obstructive pulmonary disease (COPD) use their inhaler ineffectively. Several studies revealed that inhaler-specific design features contributed significantly to the failure rate, which clearly demonstrates the need for developing more foolproof inhalers. This study compared ease of use and patient preference of the Diskus/Accuhaler (DA) with the Turbuhaler (TH). Fifty patients with asthma or COPD aged 15 years and older were included in a randomized, crossover comparison of DA with TH regarding patient preference and ease of use. All had to be naïve to DA and TH, but currently had to be using inhaled medication with another device. Inhalation technique was assessed using inhaler-specific checklists and patients had to state a preference for DA or TH regarding various aspects, as well as overall preference. With DA 46 patients (92%) made no errors regarding essential inhalation maneuvers, compared to 37 patients (74%) using TH (p = 0.023). This difference is exclusively caused by not loading the TH properly. When patients were asked which inhaler they would prefer, 17 wanted the DA, 25 the TH, and 8 did not state a preference. The difference was not significant. TH was favored over DA regarding factors related to size and the number of available dosages. The counting mechanism of the DA was preferred over the TH. It seems that patients have a clear, although not statistically significant, preference for TH, but with the DA fewer patients make crucial errors.

Inpatient Treatment of Children and Adolescents With Severe Obesity in the Netherlands: A Randomized Clinical Trial

IMPORTANCEnSevere childhood obesity has become a major health problem, and effective, evidence-based interventions are needed. The relative effectiveness of inpatient compared with ambulatory treatment remains unknown.nnnOBJECTIVEnTo determine whether an inpatient treatment program is more effective than an ambulatory treatment program at achieving a sustained weight loss in children and adolescents with severe obesity.nnnDESIGN, SETTING, AND PARTICIPANTSnWe conducted a randomized clinical trial with a 2-year follow-up at a tertiary referral center for pediatric obesity in the Netherlands. We recruited 90 children and adolescents aged 8 to 18 years with severe obesity (body mass index [BMI] z score, ≥3.0 or >2.3 with obesity-related health problems).nnnINTERVENTIONSnPatients were randomly assigned to an inpatient (6 months of hospitalization on working days) or an ambulatory (12 days of hospital visits at increasing intervals during a 6-month period) treatment program. Both treatment programs involved an intensive, family-based, lifestyle intervention, including exercise, nutritional education, and behavior modification for the patients and their caregiver(s).nnnMAIN OUTCOMES AND MEASURESnChange in BMI z score. Secondary outcomes included fasting insulin, fasting plasma glucose, 2-hour plasma glucose, and lipid levels, insulin sensitivity, liver function test results, waist circumference, blood pressure, body composition, and aerobic fitness (peak oxygen consumption, Vo₂). Outcomes were analyzed by intention to treat.nnnRESULTSnImmediately after treatment, reductions in the BMI z score were significantly larger for the inpatient than the ambulatory groups (mean [SE] difference, -0.26 [0.12; 95% CI, -0.59 to -0.01]; Pu2009=u2009.04). Change from baseline for the BMI z score in the inpatient group was -18.0% (Pu2009=u2009.001) immediately after treatment, -8.5% (Pu2009=u2009.008) at 18 months, and -6.3% (Pu2009=u2009.38) at 30 months; in the ambulatory group, changes from baseline were -10.5% (Pu2009=u2009.001), -6.2% (Pu2009=u2009.39), and -1.5% (Pu2009>u2009.99), respectively. The favorable outcomes of the inpatient group could not be sustained at 12 and 24 months after treatment. In addition, significant differences in favor of the inpatient group immediately after treatment were found for levels of fasting insulin (-6.37 IU/L; Pu2009=u2009.02), total cholesterol (-19.51 mg/dL; Pu2009=u2009.01), low-density lipoprotein cholesterol (-13.48 mg/dL; Pu2009=u2009.03), and triglycerides (-25.39 mg/dL; Pu2009=u2009.01), and insulin sensitivity (-1.37; Pu2009=u2009.02), fat mass (-3.31%; Pu2009=u2009.03), and peak Vo₂ (378.2 mL/min; Pu2009=u2009.01).nnnCONCLUSIONS AND RELEVANCEnIn severely obese children and adolescents, inpatient treatment was superior to ambulatory treatment immediately after treatment, but effects were not sustained at long-term follow-up. These findings stress the need to further study maintenance strategies for sustainable weight loss.nnnTRIAL REGISTRATIONntrialregister.nl Identifier: NTR1172.

Diurnal rhythms in seizures detected by intracranial electrocorticographic monitoring: an observational study.

Few studies have evaluated human seizure occurrence over the 24-hour day, and only one group has employed intracranial electrocorticography monitoring to record seizures. Circadian patterns in seizures may have important implications in diagnosis and therapy and provide opportunities in research. We have analyzed spontaneous seizures in 33 consecutive patients with long-term intracranial EEG and video monitoring. Several aspects of seizures were noted, including time of day, origin, type, and behavioral state (sleeping/awake). We recorded 450 seizures that showed an uneven distribution over the day, depending on lobe of origin: temporal lobe seizures occurred preferentially between 1100 and 1700 hours, frontal seizures between 2300 and 0500 hours, and parietal seizures between 1700 and 2300 hours. In the awake state, larger proportions of clinical seizures were seen from 0500 to 1100 hours and from 1700 to 2300 hours. During sleep, larger proportions occurred from 1100 to 1700 hours and from 2300 to 0500 hours. Our results suggest that seizures from different brain regions have a strong tendency to occur in different diurnal patterns.

Preference, satisfaction and errors with two dry powder inhalers in patients with COPD

Objective: To assess preference, satisfaction and critical errors with a novel, breath-actuated, multi-dose dry powder inhaler (DPI; Genuair®/Pressair™), versus a widely used, single-dose DPI (HandiHaler®) in patients with moderate-to-severe chronic obstructive pulmonary disease. Methods: In this randomised, open-label, multicentre, cross-over study, patients (aged ≥ 40 years) inhaled placebo once daily through both inhalers for 2 weeks in addition to current medication. The primary end point was percentage of patients who preferred Genuair to HandiHaler. Overall patient satisfaction (5-point scale: 1 = very dissatisfied; 5 = very satisfied), critical errors and willingness to continue using each inhaler (0 = not willing; 100 = definitely willing) were assessed. Results: Of 130 patients randomised, 105 were included in the intent-to-treat population (71.4% male; mean age 65.7 years). After 2 weeks, significantly more patients preferred Genuair than HandiHaler (79.1 vs 20.9%; p < 0.0001). Overall satisfaction scores (4.6 vs 3.8; p < 0.0001) and willingness to continue use scores (84.0 vs 62.5; p < 0.0001) were significantly higher with Genuair versus HandiHaler. Significantly fewer patients made ≥ 1 critical error with Genuair only compared with HandiHaler only (2.9 vs 19.0%; p < 0.0001). Conclusion: After 2 weeks practice, patients preferred and were more willing to continue using Genuair than HandiHaler. Genuair was associated with higher patient satisfaction and fewer critical errors than HandiHaler.

Proton-pump inhibitors are associated with a reduced risk for bleeding and perforated gastroduodenal ulcers attributable to non-steroidal anti-inflammatory drugs: a nested case-control study

Treatment with non-steroidal anti-inflammatory drugs (NSAIDs) is hampered by gastrointestinal ulcer complications, such as ulcer bleeding and perforation. The efficacy of proton-pump inhibitors in the primary prevention of ulcer complications arising from the use of NSAIDs remains unproven. Selective cyclooxygenase-2 (COX-2) inhibitors reduce the risk for ulcer complications, but not completely in high-risk patients. This study determines which patients are especially at risk for NSAID ulcer complications and investigates the effectiveness of different preventive strategies in daily clinical practice. With the use of a nested case-control design, a large cohort of NSAID users was followed for 26 months. Cases were patients with NSAID ulcer complications necessitating hospitalisation; matched controls were selected from the remaining cohort of NSAID users who did not have NSAID ulcer complications. During the observational period, 104 incident cases were identified from a cohort of 51,903 NSAID users with 10,402 patient years of NSAID exposure (incidence 1% per year of NSAID use, age at diagnosis 70.4 ± 16.7 years (mean ± SD), 55.8% women), and 284 matched controls. Cases were characterised by serious, especially cardiovascular, co-morbidity. In-hospital mortality associated with NSAID ulcer complications was 10.6% (incidence 21.2 per 100,000 NSAID users). Concomitant proton-pump inhibitors (but not selective COX-2 inhibitors) were associated with a reduced risk for NSAID ulcer complications (the adjusted odds ratio 0.33; 95% confidence interval 0.17 to 0.67; p = 0.002). Especially at risk for NSAID ulcer complications are elderly patients with cardiovascular co-morbidity. Proton-pump inhibitors are associated with a reduced risk for NSAID ulcer complications.