Using the Three-Step Test Interview to understand how patients perceive the St. George’s Respiratory Questionnaire for COPD patients (SGRQ-C)

Purpose The aim of this study was to assess the experiences of patients with chronic obstructive pulmonary disease (COPD) while they were completing the St. George’s Respiratory Questionnaire for COPD patients (SGRQ-C), using qualitative research methods. Methods Twenty Dutch COPD patients were recruited through pulmonary physicians [13 women; mean age = 63.3 years (SD = 11.4)]. A trained interviewer applied the Three-Step Test Interview which allowed the interviewer to follow the thought process of the patient filling out the SGRQ-C. The official Dutch translation of the SGRQ-C was used. Results Patients missed a recall period for the Symptoms subscale; were uncertain how to interpret specific words and phrases like “good days”, “games”, and “housework”; were confused by long-item stems that included a list of activities; and were frustrated by the dichotomous format used for the majority of SGRQ-C items (true/false). Conclusions Overall, patients were satisfied with the SGRQ-C. Nevertheless, making minor adjustments could further increase its quality. This includes reintroducing a recall period in the first set of items such as used in the previous version and splitting up items consisting of multiple activities. Furthermore, we recommend using the same response format (4 or 5 response categories) for all items

Necessity of amoxicillin clavulanic acid in addition to prednisolone in mild-to-moderate COPD exacerbations

Background: The effectiveness of antibiotics in chronic obstructive pulmonary disease (COPD) exacerbations is still a matter of debate, especially in outpatients with an intermediate probability of bacterial infection. Methods: In this study, 35 COPD outpatients diagnosed by their chest physician with moderately severe COPD exacerbation, but without pneumonia, were randomised in a double blind, placebo-controlled study. Patients had one or two of the following characteristics: a positive Gram's stain of the sputum, 2 or more exacerbations in the previous year, a decrease in lung function of >200 mL and >12%. Patients received amoxicillin clavulanic acid (500/125 mg three times daily) or placebo for 7 days, always combined with a course of prednisolone (30 mg/day) for 7 days. Primary outcome was duration of the exacerbation. Additionally, we measured severity of the exacerbation, health-related quality of life, sputum parameters, number of relapses within 28 days and the number of re-exacerbations within 4 months after the study. Results: There was no difference observed in time to resolution of the exacerbation between the two groups (HR=1.12; (95% CI 0.5 to 2.3; p=0.77)), nor in any other treatment parameter. Conclusions: We detected no evidence for the effectiveness of addition of antibiotics to prednisolone for COPD exacerbations of moderate severity and with intermediate probability of bacterial infection in this underpowered study. More placebo-controlled studies are needed to properly define subgroups of COPD outpatients in which antibiotics are of additional value

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

Background: Persistent, 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. Methods: A 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 2 weeks, 6 weeks and 3 months postoperatively by using a visual analogue scale (VAS). Quality of life (QoL) was evaluated by administering a standard health survey before and 3 months after surgery. Results in the three groups were compared. Results: The 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. Conclusion: In 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

The influence of type of inhalation device on adherence of COPD patients to inhaled medication

Objective: To study the influence of type of inhalation device on medication adherence of COPD patients. Methods: Adherence to inhalation medication of 795 patients was recorded from pharmacy records over 3 years. It was expressed as percentage and deemed good at ≥75–≤125%, sub-optimal ≥50–<75%, and poor <50% (underuse) or >125% (overuse). Since most patients used more than one device, 1379 medication periods were analyzed. Results: Patients using a Metered Dose Inhaler (MDI) or Diskus had a 2.3-fold and 2.2-fold increased risk, respectively, of suboptimal adherence versus good adherence, compared to Handihaler and a 2.1-fold and 2.2-fold increased risk, respectively, of underuse versus good adherence compared to Handihaler. Turbuhaler, MDI, Respimat had a 7.9-fold, 3.5-fold, and 2.0-fold increased risk, of overuse versus good adherence compared to Handihaler. Conclusions: In COPD, adherence to inhalation medication is device-related. Overuse was most pronounced for devices without a dose counter, devices with the ability to load a dosage without actual inhalation, or devices lacking feedback of correct inhalation. The design of the device seems to be related to underuse and overuse of inhaled medication. Future research might investigate whether prescribing a different device with similar medication improves therapy adherence

Differences in adherence to common inhaled medications in COPD

Objective: To study differences in adherence to common inhaled medications in COPD. Methods: Adherence of 795 patients was recorded from pharmacy records over 3 years in the COMIC cohort. It was expressed as percentage and deemed good at ≥75–≤125%, sub-optimal ≥50–<75%, and poor <50% (underuse) or >125% (overuse). Most patients used more than one medication, so we present 1379 medication periods. Results: The percentages of patients with good therapy adherence ranged from 43.2 (beclomethasone) –75.8% (tiotropium); suboptimal from 2.3 (budesonide) –23.3% (fluticasone); underuse from 4.4 (formoterol/budesonide) –18.2% (beclomethasone); and overuse from 5.1 (salmeterol) –38.6% (budesonide). Patients using fluticasone or salmeterol/fluticasone have a 2.3 and 2.0-fold increased risk of suboptimal versus good adherence compared to tiotropium. Patients using salmeterol/fluticasone or beclomethasone have a 2.3- and 4.6-fold increased risk of underuse versus good adherence compared to tiotropium. Patients using budesonide, salmeterol/fluticasone, formoterol/budesonide, ciclesonide and beclomethasone have an increased risk of overuse versus good adherence compared to tiotropium. Adherence to inhalation medication is inversely related to lung function. Conclusion: Therapy adherence to inhalation medication for the treatment of COPD is in our study related to the medication prescribed. Tiotropium showed the highest percentage of patients with good adherence, followed by ciclesonide, both dosed once daily. The idea of improving adherence by using combined preparations cannot be confirmed in this study. Further research is needed to investigate the possibilities of improving adherence by changing inhalation medication

Moving beyond a limited follow-up in cost-effectiveness analyses of behavioral interventions

Background Cost-effectiveness analyses of behavioral interventions typically use a dichotomous outcome criterion. However, achieving behavioral change is a complex process involving several steps towards a change in behavior. Delayed effects may occur after an intervention period ends, which can lead to underestimation of these interventions. To account for such delayed effects, intermediate outcomes of behavioral change may be used in cost-effectiveness analyses. The aim of this study is to model cognitive parameters of behavioral change into a cost-effectiveness model of a behavioral intervention. Methods The cost-effectiveness analysis (CEA) of an existing dataset from an RCT in which an high-intensity smoking cessation intervention was compared with a medium-intensity intervention, was re-analyzed by modeling the stages of change of the Transtheoretical Model of behavioral change. Probabilities were obtained from the dataset and literature and a sensitivity analysis was performed. Results In the original CEA over the first 12 months, the high-intensity intervention dominated in approximately 58% of the cases. After modeling the cognitive parameters to a future 2nd year of follow-up, this was the case in approximately 79%. Conclusion This study showed that modeling of future behavioral change in CEA of a behavioral intervention further strengthened the results of the standard CEA. Ultimately, modeling future behavioral change could have important consequences for health policy development in general and the adoption of behavioral interventions in particular

Stability in eosinophil categorisation during subsequent severe exacerbations of COPD

BACKGROUND: The blood eosinophil count has been shown to be a promising biomarker for establishing personalised treatment strategies to reduce corticosteroid use, either inhaled or systemic, in chronic obstructive pulmonary disease (COPD). Eosinophil levels seem relatively stable over time in stable state, but little is known whether this is also true in subsequent severe acute exacerbations of COPD (AECOPD). AIMS AND OBJECTIVES: To determine the stability in eosinophil categorisation between two subsequent severe AECOPDs employing frequently used cut-off levels. METHODS: During two subsequent severe AECOPDs, blood eosinophil counts were determined at admission to the hospital in 237 patients in the Cohort of Mortality and Inflammation in COPD Study. The following four cut-off levels were analysed: absolute counts of eosinophils ≥0.2×10⁹/L (200 cells/µL) and ≥0.3×10⁹/L (300 cells/µL) and relative eosinophil percentage of ≥2% and ≥3% of total leucocyte count. Categorisations were considered stable if during the second AECOPD their blood eosinophil status led to the same classification: eosinophilic or not. RESULTS: Depending on the used cut-off, the overall stability in eosinophil categorisation varied between 70% and 85% during two subsequent AECOPDs. From patients who were eosinophilic at the first AECOPD, 34%–45% remained eosinophilic at the subsequent AECOPD, while 9%–21% of patients being non-eosinophilic at the first AECOPD became eosinophilic at the subsequent AECOPD. CONCLUSIONS: The eosinophil variability leads to category changes in subsequent AECOPDs, which limits the eosinophil categorisation stability. Therefore, measurement of eosinophils at each new exacerbation seems warranted

Psychological Indices as Predictors for Phantom Shocks in Implantable Cardioverter Defibrillator Recipients

Background\ud A phantom shock—the sensation of an implantable cardioverter defibrillator (ICD) discharge in the absence of an actual discharge—is a phenomenon that can occur in ICD patients. Little is known about the influence of psychological factors on the incidence of phantom shocks. We evaluated psychological correlates of phantom shocks 2 years post-ICD implant in a cohort of Dutch ICD recipients.\ud \ud Methods\ud Consecutive patients (N = 300; 87.5% men; mean age = 62.3) willing to participate in a prospective study (Twente ICD Cohort Study) on psychological factors in ICD recipients received an ICD between September 2007 and February 2010. At baseline, patients complete the 36-item Short Form Health Survey, Hospital Anxiety and Depression Scale, and the Type D Scale. Lifetime presence of anxiety and depression was assessed with the MINI structural interview.\ud \ud Results\ud During a follow-up of 24 months, 16 patients (5.4%) experienced a phantom shock. Median time to (first) phantom shock was 13 weeks (range 0–48 weeks). In univariable analysis, no significant relationships were found between clinical or psychological indices and the occurrence of phantom shocks, nor was there an association between phantom shocks and type D personality, symptoms of anxiety, or a history of anxiety and depression.\ud \ud Conclusions\ud Neither symptoms of anxiety and depression nor psychiatric history were associated with the occurrence of phantom shocks. Further studies using more explorative, qualitative research techniques are warranted to examine the correlates of phantom shocks

Pattern of Ipsilateral Breast Tumor Recurrence After Breast-Conserving Therapy

The rate of ipsilateral breast tumor recurrence (IBTR) in breast cancer after breast-conserving therapy was analyzed. We demonstrate that after 12 years' follow-up, there is an especially high recurrence rate for women ≤40 years old. For women ≤40 years old, the absence of adjuvant systemic therapy and the presence of lymph vascular space invasion (LVSI) are associated with a higher rate of IBTR. For women >40 years old, the presence of LVSI and lobular carcinoma in situ are prognostic factors for IBTR