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1.  Laparoscopic versus open gastrectomy for gastric cancer, a multicenter prospectively randomized controlled trial (LOGICA-trial) 
BMC Cancer  2015;15:556.
Background
For gastric cancer patients, surgical resection with en-bloc lymphadenectomy is the cornerstone of curative treatment. Open gastrectomy has long been the preferred surgical approach worldwide. However, this procedure is associated with considerable morbidity. Several meta-analyses have shown an advantage in short-term outcomes of laparoscopic gastrectomy compared to open procedures, with similar oncologic outcomes. However, it remains unclear whether the results of these Asian studies can be extrapolated to the Western population. In this trial from the Netherlands, patients with resectable gastric cancer will be randomized to laparoscopic or open gastrectomy.
Methods
The study is a non-blinded, multicenter, prospectively randomized controlled superiority trial. Patients (≥18 years) with histologically proven, surgically resectable (cT1-4a, N0-3b, M0) gastric adenocarcinoma and European Clinical Oncology Group performance status 0, 1 or 2 are eligible to participate in the study after obtaining informed consent. Patients (n = 210) will be included in one of the ten participating Dutch centers and are randomized to either laparoscopic or open gastrectomy. The primary outcome is postoperative hospital stay (days). Secondary outcome parameters include postoperative morbidity and mortality, oncologic outcomes, readmissions, quality of life and cost-effectiveness.
Discussion
In this randomized controlled trial laparoscopic and open gastrectomy are compared in patients with resectable gastric cancer. It is expected that laparoscopic gastrectomy will result in a faster recovery of the patient and a shorter hospital stay. Secondly, it is expected that laparoscopic gastrectomy will be associated with a lower postoperative morbidity, less readmissions, higher cost-effectiveness, better postoperative quality of life, but with similar mortality and oncologic outcomes, compared to open gastrectomy. The study started on 1 December 2014. Inclusion and follow-up will take 3 and 5 years respectively. Short-term results will be analyzed and published after discharge of the last randomized patient.
Trial registration
NCT02248519
doi:10.1186/s12885-015-1551-z
PMCID: PMC4518687  PMID: 26219670
Gastric cancer; Gastrectomy; Laparoscopy
2.  Measuring Client Experiences in Maternity Care under Change: Development of a Questionnaire Based on the WHO Responsiveness Model 
PLoS ONE  2015;10(2):e0117031.
Background
Maternity care is an integrated care process, which consists of different services, involves different professionals and covers different time windows. To measure performance of maternity care based on clients' experiences, we developed and validated a questionnaire.
Methods and Findings
We used the 8-domain WHO Responsiveness model, and previous materials to develop a self-report questionnaire. A dual study design was used for development and validation. Content validity of the ReproQ-version-0 was determined through structured interviews with 11 pregnant women (≥28 weeks), 10 women who recently had given birth (≤12 weeks), and 19 maternity care professionals. Structured interviews established the domain relevance to the women; all items were separately commented on. All Responsiveness domains were judged relevant, with Dignity and Communication ranking highest. Main missing topic was the assigned expertise of the health professional. After first adaptation, construct validity of the ReproQ-version-1 was determined through a web-based survey. Respondents were approached by maternity care organizations with different levels of integration of services of midwives and obstetricians. We sent questionnaires to 605 third trimester pregnant women (response 65%), and 810 women 6 weeks after delivery (response 55%). Construct validity was based on: response patterns; exploratory factor analysis; association of the overall score with a Visual Analogue Scale (VAS), known group comparisons. Median overall ReproQ score was 3.70 (range 1–4) showing good responsiveness. The exploratory factor analysis supported the assumed domain structure and suggested several adaptations. Correlation of the VAS rating and overall ReproQ score (antepartum, postpartum) supported validity (r = 0.56; 0.59, p<0.001 Spearman's correlation coefficient). Pre-stated group comparisons confirmed the expected difference following a good vs. adverse birth outcome. Fully integrated organizations performed slightly better (median = 3.78) than less integrated organizations (median = 3.63; p<0.001). Participation rate of women with a low educational level and/or a non-western origin was low.
Conclusions
The ReproQ appears suitable for assessing quality of maternity care from the clients' perspective. Recruitment of disadvantaged groups requires additional non-digital approaches.
doi:10.1371/journal.pone.0117031
PMCID: PMC4324965  PMID: 25671310
3.  Clustering of health-related behaviors, health outcomes and demographics in Dutch adolescents: a cross-sectional study 
BMC Public Health  2013;13:1118.
Background
Recent studies show several health-related behaviors to cluster in adolescents. This has important implications for public health. Interrelated behaviors have been shown to be most effectively targeted by multimodal interventions addressing wider-ranging improvements in lifestyle instead of via separate interventions targeting individual behaviors. However, few previous studies have taken into account a broad, multi-disciplinary range of health-related behaviors and connected these behavioral patterns to health-related outcomes. This paper presents an analysis of the clustering of a broad range of health-related behaviors with relevant demographic factors and several health-related outcomes in adolescents.
Methods
Self-report questionnaire data were collected from a sample of 2,690 Dutch high school adolescents. Behavioral patterns were deducted via Principal Components Analysis. Subsequently a Two-Step Cluster Analysis was used to identify groups of adolescents with similar behavioral patterns and health-related outcomes.
Results
Four distinct behavioral patterns describe the analyzed individual behaviors: 1- risk-prone behavior, 2- bully behavior, 3- problematic screen time use, and 4- sedentary behavior. Subsequent cluster analysis identified four clusters of adolescents. Multi-problem behavior was associated with problematic physical and psychosocial health outcomes, as opposed to those exerting relatively few unhealthy behaviors. These associations were relatively independent of demographics such as ethnicity, gender and socio-economic status.
Conclusions
The results show that health-related behaviors tend to cluster, indicating that specific behavioral patterns underlie individual health behaviors. In addition, specific patterns of health-related behaviors were associated with specific health outcomes and demographic factors. In general, unhealthy behavior on account of multiple health-related behaviors was associated with both poor psychosocial and physical health. These findings have significant meaning for future public health programs, which should be more tailored with use of such knowledge on behavioral clustering via e.g. Transfer Learning.
doi:10.1186/1471-2458-13-1118
PMCID: PMC3890495  PMID: 24305509
4.  The effect of acute kidney injury on long-term health-related quality of life: a prospective follow-up study 
Critical Care  2013;17(1):R17.
Introduction
Acute kidney injury (AKI) is a serious complication in critically ill patients admitted to the Intensive Care Unit (ICU). We hypothesized that ICU survivors with AKI would have a worse health-related quality of life (HRQOL) outcome than ICU survivors without AKI.
Methods
We performed a long-term prospective observational study. Patients admitted for > 48 hours in a medical-surgical ICU were included and divided in two groups: patients who fulfilled RIFLE criteria for AKI and patients without AKI. We used the Short-Form 36 to evaluate HRQOL before admission (by proxy within 48 hours after admission of the patient), at ICU discharge, hospital discharge, 3 and 6 months following ICU discharge (all by patients). Recovery in HRQOL from ICU-admission onwards was assessed using linear mixed modelling.
Results
Between September 2000 and January 2007 all admissions were screened for study participation. We included a total of 749 patients. At six months after ICU discharge 73 patients with AKI and 325 patients without AKI could be evaluated. In survivors with and without AKI, the pre-admission HRQOL (by proxy) and at six months after ICU discharge was significantly lower compared with an age matched general population. Most SF-36 dimensions changed significantly over time from ICU discharge. Change over time of HRQOL between the different AKI Rifle classes (Risk, Injury, Failure) showed no significant differences. At ICU discharge, scores were lowest in the group with AKI compared with the group without AKI for the physical functioning, role-physical and general health dimensions. However, there were almost no differences in HRQOL between both groups at six months.
Conclusions
The pre-admission HRQOL (by proxy) of AKI survivors was significantly lower in two dimensions compared with the age matched general population. Six months after ICU discharge survivors with and without AKI showed an almost similar HRQOL. However, compared with the general population with a similar age, HRQOL was poorer in both groups.
doi:10.1186/cc12491
PMCID: PMC4057105  PMID: 23356544
5.  Both cardiovascular and non-cardiovascular comorbidity are related to health status in well-controlled type 2 diabetes patients: a cross-sectional analysis 
Background
Type 2 diabetes patients have a decreased health-related quality of life compared to healthy persons, especially regarding physical functioning and well-being. Health-related quality of life is even lower in type 2 diabetes patients when other diseases co-exist. In contrast to earlier studies, we assessed the associations between the number and type of comorbidities and health status in well-controlled type 2 diabetes patients, in whom treatment goals for HbA1c, blood pressure and cholesterol had been reached. Approximately one in five type 2 diabetes patients belongs to this group.
Methods
Cross-sectional analysis was performed in 2086 well-controlled (HbA1c ≤58 mmol/mol, systolic blood pressure ≤145 mmHg, total cholesterol ≤5.2 mmol/l and not using insulin) type 2 diabetes patients in general practice. Both number and type (cardiovascular and non-cardiovascular) of comorbidities were determined for each patient. Health status was assessed with the questionnaires Short Form-36 (SF-36) and EuroQol (EQ). The SF-36 generates eight dimensions of health and a Physical and Mental Component Score (PCS and MCS), scale: 0–100. The EQ consists of two parts: EQ-5D and EQ Visual Analogue Scale. Multivariable linear regression analysis was used to assess if number and type of comorbidities were associated with health status.
Results
Well-controlled type 2 diabetes patients with comorbidities had a much lower health status, with a decrease ranging from -1.5 for the MCS to -26.3 for role limitations due to physical problems, compared to those without. Health status decreased when the number of comorbidities increased, except for mental health, role limitations due to emotional problems, MCS and both EQ measures. In patients with both cardiovascular and non-cardiovascular comorbidity, physical functioning, role limitations due to physical problems and PCS were significantly lower than in patients with only cardiovascular comorbidity. Physical functioning was also lower compared to patients with only non-cardiovascular comorbidity.
Conclusions
Even acceptable values of HbA1c, blood pressure and cholesterol in type 2 diabetes patients are not necessarily related with a good health status. We have shown that comorbidities have a large impact on health status. Physicians may take into account patient’s health status and integrate the impact of comorbidities into diabetes care.
doi:10.1186/1475-2840-11-121
PMCID: PMC3508839  PMID: 23039172
Type 2 diabetes mellitus; General practice; Health status; Comorbidity
6.  The consumer quality index (CQ-index) in an accident and emergency department: development and first evaluation 
Background
Assessment of patients’ views are essential to provide a patient-centred health service and to evaluating quality of care. As no standardized and validated system for measuring patients’ experiences in accident and emergency departments existed, we have developed the Consumer Quality index for the accident and emergency department (CQI A&E).
Methods
Qualitative research has been undertaken to determine the content validity of the CQI A&E. In order to assess psychometric characteristics an 84-item questionnaire was sent to 653 patients who had attended a large A&E in the Netherlands. Also, fifty importance questions were added to determine relevance of the questions and for future calculations of improvement scores. Exploratory factor analysis was applied to detect the domains of the questionnaire.
Results
Survey data of 304 (47%) patients were used for the analysis. The first exploratory factor analysis resulted in three domains based on 13 items: ‘Attitude of the healthcare professionals’, ‘Environment and impression of the A&E’ and ‘Respect for and explanation to the patient’. The first two had an acceptable internal consistency. The second analysis, included 24 items grouped into 5 domains: ‘Attitude of the healthcare professionals’, ‘Information and explanation’, ‘Environment of the A&E’,’Leaving the A&E’ and ‘General information and rapidity of care’. All factors were internal consistent. According to the patients, the three most important aspects in healthcare performance in the A&E were: trust in the competence of the healthcare professionals, hygiene in the A&E and patients’ health care expectations. In general, the highest improvement scores concerned patient information.
Conclusions
The Consumer Quality index for the accident and emergency department measures patients’ experiences of A&E healthcare performance. Preliminary psychometric characteristics are sufficient to justify further research into reliability and validity.
doi:10.1186/1472-6963-12-284
PMCID: PMC3447703  PMID: 22929061
Factor analysis, statistical; Emergency medical services; Patient experiences; Patient satisfaction, statistics and numerical data; Questionnaires, standards; Health care surveys
7.  Validity and reliability of a structured interview for early detection and risk assessment of parenting and developmental problems in young children: a cross-sectional study 
BMC Pediatrics  2012;12:71.
Background
Preventive child health care is well suited for the early detection of parenting and developmental problems. However, as far as the younger age group is concerned, there are no validated early detection instruments which cover both the child and its environment. Therefore, we have developed a broad-scope structured interview which assesses parents’ concerns and their need for support, using both the parental perspective and the experience of the child health care nurse: the Structured Problem Analysis of Raising Kids (SPARK). This study reports the psychometric characteristics of the SPARK.
Method
A cross-sectional study of 2012 18-month-old children, living in Zeeland, a province of the Netherlands. Inter-rater reliability was assessed in 67 children. Convergent validity was assessed by comparing SPARK-domains with domains in self-report questionnaires on child development and parenting stress. Discriminative validity was assessed by comparing different outcomes of the SPARK between groups with different levels of socio-economic status and by performing an extreme-groups comparison. The user experience of both parents and nurses was assessed with the aid of an online survey.
Results
The response rate was 92.1% for the SPARK. Self-report questionnaires were returned in the case of 66.9% of the remaining 1721 children. There was selective non-reporting: 33.1% of the questionnaires were not returned, covering 65.2% of the children with a high-risk label according to the SPARK (p < 0.001). Inter-rater reliability was good to excellent with intraclass correlations between 0.85 and 1.0 for physical topics; between 0.61 and 0.8 for social-emotional topics and 0.92 for the overall risk assessment. Convergent validity was unexpectedly low (all correlations ≤0.3) although the pattern was as expected. Discriminative validity was good. Users were satisfied with the SPARK and identified some topics for improvement.
Conclusion
The SPARK discriminates between children with a high, increased and low risk of parenting and developmental problems. It does so in a reliable way, but more research is needed on aspects of validity and in other populations.
doi:10.1186/1471-2431-12-71
PMCID: PMC3465192  PMID: 22697218
8.  Attitudes of Klinefelter men and their relatives towards TESE-ICSI 
Purpose
At the start of the implementation of TESE-ICSI for Klinefelter men in the Netherlands, we aimed to evaluate their wish to father children and their attitudes towards this artificial reproduction technique.
Methods
Questionnaires were distributed to members of the Dutch Klinefelter Association (n = 365) and to Klinefelter cases known at our Department (n = 58). Questions addressed several aspects: socio-demographic characteristics, ascertainment of diagnosis, children and child wish, and TESE-ICSI. Data were characterized using descriptive statistics.
Results
A total of 260 questionnaires (corresponding to 194 cases, 46%) were returned. A possible wish to father children was reported by 90% of Klinefelter men. 70% of Klinefelter men and 74% of their partners would (probably) opt for TESE-ICSI.
Conclusion
The majority of Dutch Klinefelter men and their partners desire to have children and have a positive attitude towards TESE-ICSI. Concerns include the risk of congenital malformations/developmental delay of the child and the limited success rate of TESE-ICSI.
Electronic supplementary material
The online version of this article (doi:10.1007/s10815-011-9603-z) contains supplementary material, which is available to authorized users.
doi:10.1007/s10815-011-9603-z
PMCID: PMC3169690  PMID: 21717174
Klinefelter syndrome; Testicular sperm extraction; Intracytoplasmic sperm injection; Child wish; Questionnaire
9.  DIRECT trial. Diverticulitis recurrences or continuing symptoms: Operative versus conservative Treatment. A MULTICENTER RANDOMISED CLINICAL TRIAL 
BMC Surgery  2010;10:25.
Background
Persisting abdominal complaints are common after an episode of diverticulitis treated conservatively. Furthermore, some patients develop frequent recurrences. These two groups of patients suffer greatly from their disease, as shown by impaired health related quality of life and increased costs due to multiple specialist consultations, pain medication and productivity losses.
Both conservative and operative management of patients with persisting abdominal complaints after an episode of diverticulitis and/or frequently recurring diverticulitis are applied. However, direct comparison by a randomised controlled trial is necessary to determine which is superior in relieving symptoms, optimising health related quality of life, minimising costs and preventing diverticulitis recurrences against acceptable morbidity and mortality associated with surgery or the occurrence of a complicated recurrence after conservative management.
We, therefore, constructed a randomised clinical trial comparing these two treatment strategies.
Methods/design
The DIRECT trial is a multicenter randomised clinical trial. Patients (18-75 years) presenting themselves with persisting abdominal complaints after an episode of diverticulitis and/or three or more recurrences within 2 years will be included and randomised. Patients randomised for conservative treatment are treated according to the current daily practice (antibiotics, analgetics and/or expectant management). Patients randomised for elective resection will undergo an elective resection of the affected colon segment. Preferably, a laparoscopic approach is used.
The primary outcome is health related quality of life measured by the Gastro-intestinal Quality of Life Index, Short-Form 36, EQ-5D and a visual analogue scale for pain quantification. Secondary endpoints are morbidity, mortality and total costs. The total follow-up will be three years.
Discussion
Considering the high incidence and the multicenter design of this study, it may be assumed that the number of patients needed for this study (n = 214), may be gathered within one and a half year.
Depending on the expertise and available equipment, we prefer to perform a laparoscopic resection on patients randomised for elective surgery. Should this be impossible, an open technique may be used as this also reflects the current situation.
Trial Registration
(Trial register number: NTR1478)
doi:10.1186/1471-2482-10-25
PMCID: PMC2928179  PMID: 20691040
10.  Weekly self-monitoring and treatment adjustment benefit patients with partly controlled and uncontrolled asthma: an analysis of the SMASHING study 
Respiratory Research  2010;11(1):74.
Background
Internet-based self-management has shown to improve asthma control and asthma related quality of life, but the improvements were only marginally clinically relevant for the group as a whole. We hypothesized that self-management guided by weekly monitoring of asthma control tailors pharmacological therapy to individual needs and improves asthma control for patients with partly controlled or uncontrolled asthma.
Methods
In a 1-year randomised controlled trial involving 200 adults (18-50 years) with mild to moderate persistent asthma we evaluated the adherence with weekly monitoring and effect on asthma control and pharmacological treatment of a self-management algorithm based on the Asthma Control Questionnaire (ACQ). Participants were assigned either to the Internet group (n = 101) that monitored asthma control weekly with the ACQ on the Internet and adjusted treatment using a self-management algorithm supervised by an asthma nurse specialist or to the usual care group (UC) (n = 99). We analysed 3 subgroups: patients with well controlled (ACQ ≤ 0.75), partly controlled (0.75>ACQ ≤ 1.5) or uncontrolled (ACQ>1.5) asthma at baseline.
Results
Overall monitoring adherence was 67% (95% CI, 60% to 74%). Improvements in ACQ score after 12 months were -0.14 (p = 0.23), -0.52 (p < 0.001) and -0.82 (p < 0.001) in the Internet group compared to usual care for patients with well, partly and uncontrolled asthma at baseline, respectively. Daily inhaled corticosteroid dose significantly increased in the Internet group compared to usual care in the first 3 months in patients with uncontrolled asthma (+278 μg, p = 0.001), but not in patients with well or partly controlled asthma. After one year there were no differences in daily inhaled corticosteroid use or long-acting β2-agonists between the Internet group and usual care.
Conclusions
Weekly self-monitoring and subsequent treatment adjustment leads to improved asthma control in patients with partly and uncontrolled asthma at baseline and tailors asthma medication to individual patients' needs.
Trial registration
Current Controlled Trials ISRCTN79864465
doi:10.1186/1465-9921-11-74
PMCID: PMC2893513  PMID: 20537124
11.  Conceptual issues specifically related to health-related quality of life in critically ill patients 
Critical Care  2009;13(1):118.
During recent years increasing attention has been given to the quality of survival in critical care. Health-related quality of life (HRQOL) is an important issue both for patients and their families. Furthermore, admission to the intensive care unit can have adverse psychological effects in critically ill patients. Recent studies conducted in critically ill patients have measured HRQOL. However, usually absent from such reports are evaluations of conceptual issues, addressing factors such as why HRQOL should be measured in critically ill patients, how to define and standardize domains of HRQOL, whether proxies can provide useful information about HRQOL in critically ill patients, whether response shift occurs in critically ill patients, and whether post-traumatic stress disorder (PTSD) occurs in critically ill patients. Some studies reported moderate agreement between patients and their proxies, although lower levels of agreement may be reported for psychosocial or physical functioning. Response shift (adaptation and change in perception) appears to be an important phenomenon and likely to be present, but it is seldom measured when estimating HRQOL in critically ill patients. Furthermore, vigilance for symptoms of PTSD and early interventions to prevent PTSD are needed.
doi:10.1186/cc7699
PMCID: PMC2688122  PMID: 19239721
12.  Early recognition of heart failure in patients with diabetes type 2 in primary care. A prospective diagnostic efficiency study. (UHFO-DM2) 
BMC Public Health  2009;9:479.
Background
We hypothesize that the prevalence of unknown heart failure in diabetic patients aged 60 years and over is relatively high (15% or more) and that a cost-effective strategy can be developed to detect heart failure in these patients. The strategy is expected to include some signs and symptoms (such as dyspnoea, orthopnoea, pulmonary crepitations and laterally displaced apical beat), natriuretic peptide measurements (Amino-terminal B-type natriuretic peptide) and possibly electrocardiography. In a subset of patients straightforward echocardiography may show to be cost-effective. With information from our study the detection of previously unknown heart failure in diabetic patients could be improved and enable the physician to initiate beneficial morbidity and mortality reducing heart failure treatment more timely.
Primary objectives
- To assess the prevalence of (previously unrecognised) heart failure in primary care patients with diabetes type 2.
- To establish the most cost-effective diagnostic strategy to detect unrecognised heart failure in these patients.
Secondary objectives
- To assess the impact of heart failure, and the combination of a new diagnosis with accordingly treatment in patients with diabetes type 2 on health status.
Methods/Design
Design: A prospective diagnostic efficiency study.
Patient population: Patients aged 60 years and older with diabetes type 2 from primary care, enlisted with the diabetes service of the Diagnostic Center in Etten-Leur (SHL)
All participants will be investigated at the cardiology out-patient department of the regional hospital (Oosterschelde Hospital in Goes, Zeeland, the Netherlands) during a single 1.5 hour standardised diagnostic assessment, including history taking, physical examination, electrocardiography, echocardiography, blood tests, and Health status questionnaires. Patients will be asked if we can contact them afterwards for follow-up and for repeating the questionnaires after three and 12 months.
Main study parameters/endpoints: Prevalence (with exact 95% confidence intervals) of (previously unrecognised) heart failure (systolic and 'isolated' diastolic) and the diagnostic value of signs and symptoms, NT-proBNP, electrocardiography and a combination of these items. The cost-effectiveness of different diagnostic strategies. Impact of heart failure and the combination of a new diagnosis with accordingly treatment on health status.
Trial registration
CCMO register NL2271704108
doi:10.1186/1471-2458-9-479
PMCID: PMC2804618  PMID: 20025758
13.  Reliability and validity of functional health status and health-related quality of life questionnaires in children with recurrent acute otitis media 
Quality of Life Research  2007;16(8):1357-1373.
In this study the reliability and validity of generic and disease-specific questionnaires has been assessed focusing on responsiveness. This is part of a study on the effects of recurrent acute otitis media (rAOM) on functional health status (FHS) and health-related quality of life (HRQoL) in 383 children with rAOM participating in a randomized clinical trial. The following generic questionnaires were studied: 1. RAND general health rating index, 2. Functional Status Questionnaire (FSQ Generic and FSQ Specific), 3. TNO-AZL Infant Quality of Life (TAIQOL), and the following disease-specific questionnaires: 1. Otitis Media-6 (OM-6), 2. Numerical rating scales (NRS) for child and caregiver (NRS Child and NRS Caregiver), and 3. a new Family Functioning Questionnaire (FFQ). Reliability was good to excellent (Cronbach’s α range 0.80–0.90, intraclass correlation coefficient range 0.76–0.93). Moderate to strong correlations were found between the questionnaires as well as between questionnaires and relevant clinical indicators (r = 0.29–0.49), demonstrating construct validity. Discriminant validity for children with few versus frequent episodes of acute otitis media per year was good for most questionnaires (P < 0.004) but poor for the otitis media-related subscales of the TAIQOL (P = 0.10–0.97) and both NRS (P = 0.22 and 0.48). Except for the TAIQOL subscales, change scores were significant (P < 0.003) for generic and disease-specific questionnaires. Effect sizes were somewhat higher for disease-specific compared to generic questionnaires (0.55–0.95 versus 0.32–0.60) except for the TAIQOL subscales, which showed very poor sensitivity to change. Anchor-based methods resulted in a somewhat larger range of estimates of MCID than distribution-based methods. Combining distribution-based and anchor-based methods resulted in similar ranges for the minimally clinical important differences for generic and disease-specific questionnaires: 2–15 points on a 0–100 scale. Apart from the generic TAIQOL subscales, both generic and disease-specific questionnaires used in this study showed good psychometric qualities and responsiveness for use in clinical studies on children with rAOM.
doi:10.1007/s11136-007-9242-0
PMCID: PMC2039822  PMID: 17668290
Childhood infection; Acute otitis media; Functional health status; Quality of life; Reliability; Validity; Responsiveness
14.  Quality of life before intensive care unit admission is a predictor of survival 
Critical Care  2007;11(4):R78.
Introduction
Predicting whether a critically ill patient will survive intensive care treatment remains difficult. The advantages of a validated strategy to identify those patients who will not benefit from intensive care unit (ICU) treatment are evident. Providing critical care treatment to patients who will ultimately die in the ICU is accompanied by an enormous emotional and physical burden for both patients and their relatives. The purpose of the present study was to examine whether health-related quality of life (HRQOL) before admission to the ICU can be used as a predictor of mortality.
Methods
We conducted a prospective cohort study in a university-affiliated teaching hospital. Patients admitted to the ICU for longer than 48 hours were included. Close relatives completed the Short-form 36 (SF-36) within the first 48 hours of admission to assess pre-admission HRQOL of the patient. Mortality was evaluated from ICU admittance until 6 months after ICU discharge. Logistic regression and receiver operating characteristic analyses were used to assess the predictive value for mortality using five models: the first question of the SF-36 on general health (model A); HRQOL measured using the physical component score (PCS) and mental component score (MCS) of the SF-36 (model B); the Acute Physiology and Chronic Health Evaluation (APACHE) II score (an accepted mortality prediction model in ICU patients; model C); general health and APACHE II score (model D); and PCS, MCS and APACHE II score (model E). Classification tables were used to assess the sensitivity, specificity, positive and negative predictive values, and likelihood ratios.
Results
A total of 451 patients were included within 48 hours of admission to the ICU. At 6 months of follow up, 159 patients had died and 40 patients were lost to follow up. When the general health item was used as an estimate of HRQOL, area under the curve for model A (0.719) was comparable to that of model C (0.721) and slightly better than that of model D (0.760). When PCS and MCS were used, the area under the curve for model B (0.736) was comparable to that of model C (0.721) and slightly better than that of model E (0.768). When using the general health item, the sensitivity and specificity in model D (sensitivity 0.52 and specificity 0.81) were similar to those in model A (0.45 and 0.80). Similar results were found when using the MCS and PCS.
Conclusion
This study shows that the pre-admission HRQOL measured with either the one-item general health question or the complete SF-36 is as good at predicting survival/mortality in ICU patients as the APACHE II score. The value of these measures in clinical practice is limited, although it seems sensible to incorporate assessment of HRQOL into the many variables considered when deciding whether a patient should be admitted to the ICU.
doi:10.1186/cc5970
PMCID: PMC2206516  PMID: 17629906
15.  Aerobic exercise in adolescents with obesity: preliminary evaluation of a modular training program and the modified shuttle test 
BMC Pediatrics  2007;7:19.
Background
Increasing activity levels in adolescents with obesity requires the development of exercise programs that are both attractive to adolescents and easily reproducible. The aim of this study was to develop a modular aerobic training program for adolescents with severe obesity, with a focus on variety, individual targets and acquiring physical skills. We report here the effects on aerobic fitness from a pilot study. Furthermore, we examined the feasibility of the modified shuttle test (MST) as an outcome parameter for aerobic fitness in adolescents with severe obesity.
Methods
Fifteen adolescents from an inpatient body weight management program participated in the aerobic training study (age 14.7 ± 2.1 yrs, body mass index 37.4 ± 3.5). The subjects trained three days per week for 12 weeks, with each session lasting 30–60 minutes. The modular training program consisted of indoor, outdoor and swimming activities. Feasibility of the MST was studied by assessing construct validity, test-retest reliability and sensitivity to change.
Results
Comparing pretraining and end of training period showed large clinically relevant and significant improvements for all aerobic indices: e.g. VO2 peak 17.5%, effect size (ES) 2.4; Wmax 8%, ES 0.8. In addition, a significant improvement was found for the efficiency of the cardiovascular system as assessed by the oxygen pulse (15.8%, ES 1.6).
Construct validity, test-retest reliability and sensitivity to change of the MST were very good. MST was significantly correlated with VO2 peak (r = 0.79) and Wmax (r = 0.84) but not with anthropometric measures. The MST walking distance improved significantly by 32.5%, ES 2.5. The attendance rate at the exercise sessions was excellent.
Conclusion
This modular, varied aerobic training program has clinically relevant effects on aerobic performance in adolescents with severe obesity. The added value of our aerobic training program for body weight management programs for adolescents with severe obesity should be studied with a randomized trial. This study further demonstrated that the MST is a reliable, sensitive and easy to administer outcome measure for aerobic fitness in adolescent body weight management trials.
doi:10.1186/1471-2431-7-19
PMCID: PMC1866229  PMID: 17445257
16.  Comparison of the SF-6D and the EQ-5D in patients with coronary heart disease 
Background
The SF-6D was derived from the SF-36. A single summary score is obtained allegedly preserving the descriptive richness and sensitivity to change of the SF-36 into utility measurement. We compared the SF-6D and EQ-5D on domain content, scoring distribution, pre-treatment and change scores.
Methods
The SF-6D and the EQ-5D were completed prior to intervention and 1, 3, 6 and 12 months post-intervention in a study enrolling 561 patients with symptomatic coronary stenosis. Patients were randomized to off-pump coronary artery bypass surgery (CABG), standard on-pump CABG, or percutaneous transluminal coronary angioplasty (PTCA). Baseline and change over time scores were compared using parametric and non-parametric tests.
Results
The relative contribution of similar domains measuring daily functioning to the utility scores differed substantially. SF-6D focused more on social functioning, while EQ-5D gave more weight to physical functioning. Pain and mental health had similar contributions. The scoring range of the EQ-5D was twice the range of the SF-6D. Before treatment, EQ-5D and SF-6D mean scores appeared similar (0.64 versus 0.63, p = 0.09). Median scores, however, differed substantially (0.69 versus 0.60), a difference exceeding the minimal important difference of both instruments. Agreement was low, with an intra-class correlation of 0.45.
Finally, we found large differences in measuring change over time. The SF-6D recorded greater intra-subject change in the PTCA-group. Only the EQ-5D recorded significant change in the CABG-groups. In the latter groups changes in SF-6D domains cancelled each other out.
Conclusion
Although both instruments appear to measure similar constructs, the EQ-5D and SF-6D are quite different. The low agreement and the differences in median values, scoring range and sensitivity to change after intervention show that the EQ-5D and SF-6D yield incomparable scores in patients with coronary heart disease.
doi:10.1186/1477-7525-4-20
PMCID: PMC1475841  PMID: 16563170

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