Erik Bischoff

Comprehensive self management and routine monitoring in chronic obstructive pulmonary disease patients in general practice: randomised controlled trial

Objective To assess the long term effects of two different modes of disease management (comprehensive self management and routine monitoring) on quality of life (primary objective), frequency and patients’ management of exacerbations, and self efficacy (secondary objectives) in patients with chronic obstructive pulmonary disease (COPD) in general practice. Design 24 month, multicentre, investigator blinded, three arm, pragmatic, randomised controlled trial. Setting 15 general practices in the eastern part of the Netherlands. Participants Patients with COPD confirmed by spirometry and treated in general practice. Patients with very severe COPD or treated by a respiratory physician were excluded. Interventions A comprehensive self management programme as an adjunct to usual care, consisting of four tailored sessions with ongoing telephone support by a practice nurse; routine monitoring as an adjunct to usual care, consisting of 2-4 structured consultations a year with a practice nurse; or usual care alone (contacts with the general practitioner at the patients’ own initiative). Outcome measures The primary outcome was the change in COPD specific quality of life at 24 months as measured with the chronic respiratory questionnaire total score. Secondary outcomes were chronic respiratory questionnaire domain scores, frequency and patients’ management of exacerbations measured with the Nijmegen telephonic exacerbation assessment system, and self efficacy measured with the COPD self-efficacy scale. Results 165 patients were allocated to self management (n=55), routine monitoring (n=55), or usual care alone (n=55). At 24 months, adjusted treatment differences between the three groups in mean chronic respiratory questionnaire total score were not significant. Secondary outcomes did not differ, except for exacerbation management. Compared with usual care, more exacerbations in the self management group were managed with bronchodilators (odds ratio 2.81, 95% confidence interval 1.16 to 6.82) and with prednisolone, antibiotics, or both (3.98, 1.10 to 15.58). Conclusions Comprehensive self management or routine monitoring did not show long term benefits in terms of quality of life or self efficacy over usual care alone in COPD patients in general practice. Patients in the self management group seemed to be more capable of appropriately managing exacerbations than did those in the usual care group. Trial registration Clinical trials NCT00128765.

Oral immunotherapy for the treatment of peanut allergy: systematic review of six case series studies

BACKGROUND Allergy to peanuts is associated with considerable morbidity and, in a minority of cases, mortality. Natural resolution to peanut allergy occurs in only a few cases, hence the need to find effective interventions. Peanut oral immunotherapy (OIT) is a potentially important new therapeutic development. AIMS To assess the benefits and harms of OIT for peanut allergy. METHODS Fourteen databases were searched for published reports and unpublished/in-progress studies. We included studies employing randomised controlled trial (RCT), quasi-RCT, controlled clinical trial, controlled before-and-after, interrupted time series, and case series designs. RESULTS Six studies enrolling a total of 85 participants satisfied our inclusion criteria. All studies employed a case series design and were thus judged to be at high risk of bias. Overall, this body of evidence provided suggestive evidence that it is possible for many participants to increase their threshold dose for peanut exposure whilst receiving treatment. Adverse reactions were common and, whilst most of these were relatively minor, some were potentially life-threatening. CONCLUSIONS OIT appears to be a potentially promising new therapy for the short- to medium-term management of carefully selected and monitored patients with peanut allergy. The effectiveness and cost-effectiveness of OIT - particularly over the longer term - need to be clearly established using more robust designs before its clinical use can be contemplated. Given the risk of triggering serious adverse reactions, OIT should not be administered outside clinical trial settings.

Definition of a COPD self-management intervention: International Expert Group consensus

There is an urgent need for consensus on what defines a chronic obstructive pulmonary disease (COPD) self-management intervention. We aimed to obtain consensus regarding the conceptual definition of a COPD self-management intervention by engaging an international panel of COPD self-management experts using Delphi technique features and an additional group meeting. In each consensus round the experts were asked to provide feedback on the proposed definition and to score their level of agreement (1=totally disagree; 5=totally agree). The information provided was used to modify the definition for the next consensus round. Thematic analysis was used for free text responses and descriptive statistics were used for agreement scores. In total, 28 experts participated. The consensus round response rate varied randomly over the five rounds (ranging from 48% (n=13) to 85% (n=23)), and mean definition agreement scores increased from 3.8 (round 1) to 4.8 (round 5) with an increasing percentage of experts allocating the highest score of 5 (round 1: 14% (n=3); round 5: 83% (n=19)). In this study we reached consensus regarding a conceptual definition of what should be a COPD self-management intervention, clarifying the requisites for such an intervention. Operationalisation of this conceptual definition in the near future will be an essential next step. Consensus of a conceptual definition of what should be a COPD self-management intervention with its requisites http://ow.ly/Zfr0F

Characteristics of effective self-management interventions in patients with COPD: individual patient data meta-analysis

It is unknown whether heterogeneity in effects of self-management interventions in patients with chronic obstructive pulmonary disease (COPD) can be explained by differences in programme characteristics. This study aimed to identify which characteristics of COPD self-management interventions are most effective. Systematic search in electronic databases identified randomised trials on self-management interventions conducted between 1985 and 2013. Individual patient data were requested for meta-analysis by generalised mixed effects models. 14 randomised trials were included (67% of eligible), representing 3282 patients (75% of eligible). Univariable analyses showed favourable effects on some outcomes for more planned contacts and longer duration of interventions, interventions with peer contact, without log keeping, without problem solving, and without support allocation. After adjusting for other programme characteristics in multivariable analyses, only the effects of duration on all-cause hospitalisation remained. Each month increase in intervention duration reduced risk of all-cause hospitalisation (time to event hazard ratios 0.98, 95% CI 0.97–0.99; risk ratio (RR) after 6 months follow-up 0.96, 95% CI 0.92–0.99; RR after 12 months follow-up 0.98, 95% CI 0.96–1.00). Our results showed that longer duration of self-management interventions conferred a reduction in all-cause hospitalisations in COPD patients. Other characteristics are not consistently associated with differential effects of self-management interventions across clinically relevant outcomes. Increasing duration of self-management interventions reduces risk of all-cause hospitalisations in patients with COPD http://ow.ly/YVw9E

Do self-management interventions in COPD patients work and which patients benefit most? An individual patient data meta-analysis

Background Self-management interventions are considered effective in patients with COPD, but trials have shown inconsistent results and it is unknown which patients benefit most. This study aimed to summarize the evidence on effectiveness of self-management interventions and identify subgroups of COPD patients who benefit most. Methods Randomized trials of self-management interventions between 1985 and 2013 were identified through a systematic literature search. Individual patient data of selected studies were requested from principal investigators and analyzed in an individual patient data meta-analysis using generalized mixed effects models. Results Fourteen trials representing 3,282 patients were included. Self-management interventions improved health-related quality of life at 12 months (standardized mean difference 0.08, 95% confidence interval [CI] 0.00–0.16) and time to first respiratory-related hospitalization (hazard ratio 0.79, 95% CI 0.66–0.94) and all-cause hospitalization (hazard ratio 0.80, 95% CI 0.69–0.90), but had no effect on mortality. Prespecified subgroup analyses showed that interventions were more effective in males (6-month COPD-related hospitalization: interaction P=0.006), patients with severe lung function (6-month all-cause hospitalization: interaction P=0.016), moderate self-efficacy (12-month COPD-related hospitalization: interaction P=0.036), and high body mass index (6-month COPD-related hospitalization: interaction P=0.028 and 6-month mortality: interaction P=0.026). In none of these subgroups, a consistent effect was shown on all relevant outcomes. Conclusion Self-management interventions exert positive effects in patients with COPD on respiratory-related and all-cause hospitalizations and modest effects on 12-month health-related quality of life, supporting the implementation of self-management strategies in clinical practice. Benefits seem similar across the subgroups studied and limiting self-management interventions to specific patient subgroups cannot be recommended.

Validity of an automated telephonic system to assess COPD exacerbation rates

Current tools for recording chronic obstructive pulmonary disease (COPD) exacerbations are limited and often lack validity testing. We assessed the validity of an automated telephonic exacerbation assessment system (TEXAS) and compared its outcomes with existing tools. Over 12 months, 86 COPD patients (22.1% females; mean age 66.5 yrs; mean post-bronchodilator forced expiratory volume in 1 s 53.4% predicted) were called once every 2 weeks by TEXAS to record changes in respiratory symptoms, unscheduled healthcare utilisation and use of respiratory medication. The responses to TEXAS were validated against exacerbation-related information collected by observations made by trained research assistants during home visits. No care assistance was provided in any way. Diagnostic test characteristics were estimated using commonly used definitions of exacerbation. Detection rates, compliance and patient preference were assessed, and compared with paper diary cards and medical record review. A total of 1,824 successful calls were recorded, of which 292 were verified by home visits (median four calls per patient, interquartile range three to five calls per patient). Independent of the exacerbation definition used, validity was high, with sensitivities and specificities between 66% and 98%. Detection rates and compliance differed extensively between the different tools, but were highest with TEXAS. Patient preference did not differ. TEXAS is a valid tool to assess COPD exacerbation rates in prospective clinical studies. Using different tools to record exacerbations strongly affects exacerbation occurrence rates.

Dynamic hyperinflation after metronome-paced hyperventilation in COPD– A 2 year follow-up

UNLABELLED In contrast to the decline in FEV(1), the behavior of dynamic hyperinflation (DH) over time is unknown in patients with COPD. Metronome-paced hyperventilation (MPH) is a simple applicable surrogate for exercise to detect DH. OBJECTIVE To evaluate changes in MPH-induced DH during two years follow-up in mild-to-severe COPD patients. Additionally, influence of smoking status on DH and the relation between DH and other lung function parameters were assessed. METHODS Patients were recruited from a randomized controlled trial conducted in general practice. Measurements of lung function and DH were performed at baseline and after 12 and 24 months. DH was assessed by MPH with breathing frequency set at twice the baseline rate. Change in inspiratory capacity after MPH was used to reflect change in end-expiratory lung volume and therefore DH, presuming constant total lung capacity. RESULTS During follow-up, 68 patients completed all measurements. DH increased by 0.23±0.06L (p≤0.001). No significant changes in FEV(1) %pred were seen. Smokers had lower FEV(1) and a more rapid decline than non-smokers. DH in smokers increased more over time compared to non-smokers. The amount of DH correlated positively with resting inspiratory capacity. CONCLUSION After two years, a significant increase in MPH-induced DH in COPD patients was demonstrated, which was not accompanied by a decline in FEV(1). It might be that DH is a sensitive measure to track consequences of changes in airflow obstruction.

De NCSI-methode: maatwerk voor COPD-zorg

SamenvattingSamenvattingBischoff EWMA, Vercoulen J, Elbers L, Behr RA, Schermer TRJ. De NCSI-methode: maatwerk voor COPD-zorg. Huisarts Wet 2016;59(6):242-7.AchtergrondDe integrale gezondheidstoestand (‘ziektelast’) vervangt de FEV1 als voornaamste criterium voor de ernst van COPD en bepaalt de zorg die de patiënt zou moeten ontvangen. In ziekenhuizen wordt al enige jaren de NCSI-methode (Nijmegen Clinical Screening Instrument) gebruikt om de integrale gezondheidstoestand uitgebreid in kaart te brengen, maar in de huisartsenpraktijk is deze methode nog niet bekend. Wij onderzochten of de NCSI-methode ook bruikbaar is in de eerstelijns COPD-ketenzorg.Methode In vijf huisartsenpraktijken trainden wij praktijkondersteuners en implementeerden wij de NCSI-methode. Wij bepaalden de integrale gezondheidstoestand van de deelnemende COPD-patiënten met behulp van het NCSI, een internetvragenlijst. Ook gingen we na, op basis van logboeken en digitale registratie, of de methode uitvoerbaar was binnen de kaders van de COPD-ketenzorg. Tot slot onderzochten we in focusgroepinterviews hoe de deelnemen de patiënten en praktijkondersteuners de NCSI-methode waardeerden.Resultaten In de vijf praktijken namen bij elkaar 180 patiënten deel aan het COPD-ketenzorgprogramma. Van hen vulden er 134 (74%) het NCSI in, overwegend thuis op de computer. Naar het oordeel van de praktijkondersteuners had 81% van de deelnemers een lichte ziektelast. Gemeten met het NCSI ondervond echter ruim de helft ernstige problemen in drie of meer domeinen van de integrale gezondheid. Onze interventie bleek goed inpasbaar in de COPD-ketenzorg en zowel patiënten als praktijkondersteuners vonden de methode waardevol voor het bieden van zorg op maat. Alle geïnterviewden wilden de methode na afloop van het onderzoek blijven gebruiken.ConclusieCOPD-patiënten in de eerste lijn hebben vaker ernstige gezondheidsproblemen dan men zou verwachten op grond van louter FEV1-metingen. Er is behoefte aan gedetailleerdere inkaarting van de gezondheidstoestand van deze patiënten; het NCSI biedt een goed toepasbare mogelijkheid.AbstractAbstractBischoff EWMA, Vercoulen J, Elbers L, Behr RA, Schermer TRJ. The NCSI-method: COPDmanagement made to measure. Huisarts Wet 2016;59(6):242-7.BackgroundIntegral health status is replacing forced expiratory volume in 1 second (FEV1) as main indicator of the severity of chronic obstructive pulmonary disease (COPD). A method using the Nijmegen Clinical Screening Instrument (NCSI), an Internet questionnaire, has long been used in hospitals to obtain detailed information about the integral health status of patients, but it has not yet been used in primary care. The aim of this study was to assess whether the NCSI method can also be used in general practice.Method The practice nurses of five general practices were trained in the use of the NCSI method, which was then implemented to evaluate the integral health status of patients with COPD. Instrument feasibility was evaluated by means of logbooks and digital registration; focus group meetings were held to assess the experiences of patients and practice nurses.Results Of the 180 patients who received COPD care, 134 (74%) completed the NCSI, mostly by computer at home. According to the practice nurses, 81% of the patients had only mild impairment, whereas the NCSI scores indicated that more than half of the patients had severe problems in three or more of the eight NCSI subdomains. Use of the NCSI was feasible within the structure of the COPD care programme, and both patients and practice nurses found the instrument valuable. All participants would like to continue using the NCSI.Conclusions Patients seen in primary care often have more serious health problems than can be expected on the basis of FEV1 measurements. There is a need for detailed information about the health status of these patients, and the NCSI would seem to be an appropriate instrument for obtaining this information.

Chemical sensitivity in symptomatic Cambodia veterans.

Following their participation in a United Nations peacekeeping operation in Cambodia (1992-1993), Dutch veterans complained of symptoms similar to those reported by Gulf War veterans. The authors conducted a matched case-control study to evaluate 76 symptomatic and 32 matched asymptomatic Cambodia veterans on the basis of data collected by postal questionnaire. The number of symptomatic veterans who reported having used insect repellants that contained N,N,-diethyl-meta-toluamide (DEET) during the mission in Cambodia was significantly higher, compared with asymptomatic veterans. The percentage of veterans who reported feeling ill following brief exposures to chemicals such as paint or pesticides was equal in both groups, but the percentage was low compared with the results of other studies of Multiple Chemical Sensitivity Syndrome. The current study was limited by self-report and time delay (potential recall bias) between deployment to Cambodia and the time of survey. Nevertheless, the study results did not support the hypothesis that symptoms in the total group of Cambodia veterans could be related to Multiple Chemical Sensitivity Syndrome.

Primary care cohort study in the sequence of diagnosing chronic respiratory diseases and prescribing inhaled corticosteroids

To prevent unnecessary use of inhaled corticosteroids (ICS), ICS treatment should only be started when the diagnostic process of asthma and COPD is completed. Little is known about the chronological order between these diagnoses and the start of ICS. We performed a retrospective cohort study, based on electronic medical records of 178 Dutch general practices, to explore the temporal relations between starting continuous use of ICS and receiving a diagnosis of asthma and/or COPD. The database included information of patients who were registered with a diagnosis of asthma and/or COPD in one of the practices during January 1, 2012 and December 31, 2013. Two or more successive prescriptions of ICS within 6 months were considered as continuous ICS treatment. The chronological order of events based on available dates were analysed using descriptive analyses. For 8507 patients with asthma, 4024 patients with COPD, and 801 patients with asthma–COPD overlap (ACO), the order of events could be analysed. In total, 1857 (14.4%) patients started ICS prior to their diagnosis, 11.5, 20.8, and 10.0% of patients with asthma, COPD, and ACO, respectively. In 53.4% of the patients, the first prescription of ICS was a combination inhaler with a long-acting bronchodilator. In this real-life primary care cohort, one in seven patients started ICS treatment prior to their diagnosis and approximately half of the patients started with a combination inhaler. Our findings suggest that there is relevant room for improvement in the pharmaceutical management of patients with these chronic respiratory diseases.