Health-related quality of life in pediatric patients after allogeneic SCT: development of the PedsQL Stem Cell Transplant module and results of a pilot study.

With increased survival after pediatric allogeneic hematopoietic SCT health-related quality of life (HRQL) has emerged as an essential health outcome. The impact of transplant and chronic GVHD (cGVHD)-associated morbidity remains a major obstacle. In 2005, the National Institutes of Health (NIH) Consensus Conference on Criteria for Clinical Trials in cGVHD recommended HRQL tools as an independent measure of the impact of disease burden. The NIH recommendations did not provide a cGVHD-specific tool for HRQOL measures in children. This report focuses on the development of an SCT-specific instrument to assess HRQL in children and adolescents. For the assessment of generic HRQL we chose the PedsQL (Pediatric Quality of Life Inventory) Generic Cores Scales, which have been used in a large number of healthy, acutely ill and chronically ill children and adolescents. To capture SCT- and, specifically, cGVHD-related problems, we developed the PedsQL Stem Cell Transplant module by reviewing the literature, taking over some items/scales of other PedsQL modules, interviewing patients, parents and members of the health-care team, and applying the PedsQL measurement methods. The final PedsQL Stem Cell Transplant module consists of the HRQL domains: pain and hurt, fatigue/sleeping problems/weakness, nausea, worry/anxiety about disease/treatment, nutritional problems, neurocognitive problems, communication about disease/treatment, loneliness, physical functioning and additional somatic complaints (pruritus, skin inflammation, oral problems, eyes or breathing) including patients' and parents' assessment. It was tested in 35 pediatric patients, who were referred to our SCT Outpatient Clinic about 100 days post SCT. Both the generic PedsQL and the SCT-specific scales showed high internal consistency, with Cronbach alpha levels of ⩾0.70 in almost all scales. Most problems were detected within the HRQL domains of physical functioning and pain. The summary scores of the generic PedsQL and the PedsQL Stem Cell Transplant module showed high correlations (r=0.89 in patients' and r=0.81 in parents' assessments). Moreover, both tools discriminated between patients with and without cGVHD. The PedsQL Stem Cell Transplant module is practical for use and suitable across a broad age range (2-18 years) both in patients with and without cGVHD. However, it is still a pilot instrument and needs further development and testing in a larger patient population.

[Midshaft clavicle fractures : A systematic review of different treatment approaches]. / Klavikulaschaftfrakturen : Ein systematischer Review zu verschiedenen Therapiekonzepten.

BACKGROUND: The objective of this systematic review was to summarize the current evidence on efficacy and safety of the various treatment options for midshaft clavicle fractures, taking into account fracture type and other variables. MATERIAL AND METHODS: A search for systematic reviews and controlled studies published between 1998 and 2009 was carried out. RESULTS: There is moderate evidence that operative treatment for midshaft clavicle fractures results in a lower rate of fracture non-union and improved patient-oriented outcome compared to non-operative treatment. However, because union rates are generally high and there are complications which are unique to surgical intervention, risks have to be considered and weighed before a decision on treatment is made. The most important risk factors for non-union are major displacement and fracture comminution. Of all surgical procedures the best evidence of efficacy is presently available for plate fixation and elastic stable intramedullary nailing. CONCLUSION: This paper presents an algorithm derived from the current evidence which may be useful for therapy decision-making in the clinical routine.

[Chemonucleolysis and intradiscal electrothermal therapy: what is the current evidence?]. / Chemonukleolyse und intradiskale Elektrotherapie: was ist die gegenwärtige Evidenz?

We evaluated the efficacy and safety of chemonucleolysis and intradiscal electrothermal therapy (IDET) on the basis of the data presented in recently published papers with respect to pain relief, function, and complication rates. Detailed searches for English and German articles published between 2003 and 2008 were performed in a number of electronic databases. Further publications were identified by manual search. For summarizing the evidence, we considered only systematic reviews and controlled studies. The internal validity of reviews and studies was judged by two authors independently. Data extraction was performed by one author, and the extracted data was checked for completeness and correctness by a second author. The evidence of the efficacy of chemonucleolysis using chymopapain or collagenase is summarized in two recent, high-quality systematic reviews. We found 5 controlled studies evaluating nucleolysis using an oxygen-ozone mixture (O (2)O (3)-nucleolysis). Some of those studies were of limited methodological quality, but all showed the efficacy of O (2)O (3)-nucleolysis in comparison to microdiscectomy or the use of alternative substances. There is hardly any data regarding O (2)O (3)-nucleolysis complications. Regarding IDET, the authors of the 6 identified systematic reviews come to different conclusions about the efficacy of the procedure. The results of the 3 included controlled IDET studies, of which 2 are of high methodological quality, are also conflicting. The complication rates range from 0 to 15 %. In summary, the evidence of efficacy is presently more compelling for chemonucleolysis than for IDET. This may also be because indications for chemonucleolysis are more firmly established. However, safety aspects should be better evaluated and presented in the literature.

[Kyphoplasty and vertebroplasty for the management of osteoporotic vertebral compression fractures: a systematic review]. / Kyphoplastie und Vertebroplastie bei osteoporotischen Wirbelkörperkompressionsfrakturen: Systematischer Review.

BACKGROUND: We evaluated the efficacy and safety of kyphoplasty and vertebroplasty using the data presented in recently published papers with respect to pain relief, function, complication rate, and incidence of new vertebral fractures. METHODS: Detailed searches for English-language and German-language articles published between 2002 and 2009 were performed in a number of electronic databases. Because of the large number of case series, we considered only systematic reviews and controlled studies. The internal validity of reviews and studies was judged by two authors independently. Data extraction was performed by one author, and extracted data were checked for completeness and correctness by a second author. RESULTS: A total of eight systematic reviews, primarily summarizing results from case series, and 11 controlled studies, two of which were randomized controlled trials (RCTs), were included. Both kyphoplasty and vertebroplasty significantly reduce pain in the majority of patients and can lead to short-term and possibly long-term improvement of function. Kyphoplasty induces fewer clinically relevant complications than vertebroplasty does, and there is presently stronger evidence for its efficacy compared with vertebroplasty. There is inconclusive evidence about the risk of new fractures after kyphoplasty and vertebroplasty. CONCLUSION: Both procedures seem to be equally effective, but kyphoplasty is safer than vertebroplasty. New results, specifically from RCTs comparing the two procedures, are needed to provide more definitive data.

[Endovascular deployment of stent graft in the ascending aorta. A systematic review]. / Stentgraftimplantation bei Erkrankungen der Aorta ascendens. Systematische Ubersichtsarbeit zu Wirksamkeit und Sicherheit.

The endovascular deployment of stent graft in the ascending aorta was proposed for inclusion in the benefit catalogue of the Austrian Federal Ministry of Health. The efficacy and safety of this intervention was unclear, and therefore a systematic review was performed to support evidence-based decision making. Detailed searches for English- or German-language articles published between 2002 and 2008 were performed in a number of electronic databases. Internal validity of studies was judged by two authors independently. A total of 11 case reports but no prospective studies were identified through literature search. The case reports showed the technical feasibility of this intervention but allow no conclusions about its efficacy and safety. Therefore the endovascular deployment of stent graft in the ascending aorta must be considered as experimental and its inclusion in the benefit catalogue cannot be recommended.

Trocar-site hernia as a typical postoperative complication of minimally invasive surgery among preschool children.

BACKGROUND: Minimally invasive surgery (MIS) in preschool children (<5 years of age) is not common yet, and few reports evaluating typical complications are available. Trocar site hernias are well described in adult patients but also have been reported for preschool children. The goal of our study was to determine incidence and relevance of trocar site hernias as complications of minimally invasive surgery in preschool children. METHODS: Retrospective analysis of all pediatric patients who underwent minimally invasive surgery at a single institution. Review of the literature. RESULTS: Trocar site hernias are significantly more frequent in preschool children than in older ones (p = 0.006). Complication rates at all are not significantly different. Trocar site hernias in infants are mainly of type 3 (omental protrusion) and occur within the first postoperative week. CONCLUSION: Meticulous suturing of all layers (particularly the peritoneum) even in small incisions (2 mm) is recommended to prevent omental protrusion at trocar site in children up to 5 years of age.

Health-related quality of life of pediatric patients receiving allogeneic stem cell or bone marrow transplantation: results of a longitudinal, multi-center study.

The results of a 5-year longitudinal prospective study about the health-related quality of life (HRQL) of pediatric patients receiving allogeneic bone marrow or stem cell transplantation (BMT) are described. The patients' HRQL was assessed twice before, and five times after BMT, the end point being 1 year after BMT. For the measurement of HRQL, standardized questionnaires were completed by patients, parents and physicians. The final sample consisted of 68 patients aged 4-18 years, of which 19 were lost in the course of the study owing to relapse, transplant rejection and/or death. The worst HRQL was seen shortly after transplant and HRQL thereafter improved steadily, although the improvement was not always linear and not all patients drew benefit from this average positive evolution. Compromised emotional functioning, a high level of worry and reduced communication during the acute phase of treatment had a negative impact on HRQL 1 year after BMT. Nausea and pain during the acute phase of treatment did not have an effect on later HRQL. The interobserver agreement of HRQL reports between parents and their children was moderate to good, and generally better than child-physician and parent-physician agreement.

[Evidence-based radiology: a new approach to evaluate the clinical practice of radiology]. / Evidenzbasierte Radiologie: Ein neuer Ansatz zur Bewertung von klinisch angewandter radiologischer Diagnostik und Therapie.

Over the last several years, the concept and methodology of Evidence-Based Medicine (EBM) have received significant attention in the scientific community. However, compared to therapeutic medical disciplines, EBM-based radiological publications are still underrepresented. This article summarizes the principles of EBM and discusses the possibilities of their application in radiology. The presented topics include the critical appraisal of studies on the basis on EBM principles, the explanation of EBM-relevant statistical outcome parameters (e. g., "likelihood ratio" for diagnostic and "number needed to treat" for interventional procedures), as well as the problems facing evidence-based radiology. Evidence-based evaluation of radiological procedures does not only address aspects of cost-effectiveness, but is also particularly helpful in identifying patient-specific usefulness. Therefore it should become an integral part of radiologist training.

Validation of the German version of the Pediatric Quality of Life Inventory (PedsQL) in childhood cancer patients off treatment and children with epilepsy.

The Pediatric Quality of Life Inventory (PedsQL) is a relatively new instrument developed in the US to assess health-related quality of life (HRQL) in healthy and ill children and adolescents. It is quick and easy to use, suitable for assessment by children and parents and based on a modular approach with a generic measure addressing all general domains of HRQL and disease-specific modules. We report here the results of translating the original US generic core instrument and the cancer module into German and testing the German PedsQL in samples of paediatric patients who have been treated for cancer or epilepsy. Like in studies with the original instrument, score distributions tended to be skewed toward higher HRQL, but a full response range was demonstrated for each item. The German PedsQL is reliable in terms of internal consistency with the majority of scales exceeding a Cronbach's alpha of 0.70. Clinical validity was confirmed by differences between the cancer and epilepsy groups in the expected direction and by the ability of the PedsQL to discriminate between subjects with different degrees of medical and psychosocial sequelae. Comparing our findings to US results, the German PedsQL seems to be equivalent to the original version. Future methodologic research should evaluate construct validity, sensitivity and responsiveness, and test the usefulness of the instrument in other clinical populations and healthy children.

German cross-cultural adaptation of the Health Utilities Index and its application to a sample of childhood cancer survivors.

UNLABELLED: Steady progress in developing effective treatments for childhood cancer and other severe pediatric diseases has established the need to consider the nature and frequency of late physical and psychological effects. The Health Utilities Index Mark 2 and Mark 3 (HUI2/3) systems were developed by Feeny, Furlong, Torrance et al. in Canada. These systems are generic multi-attribute measures of a person's health status and health-related quality of life. The first German version of the Canadian HUI2/3 questionnaire was created in our clinic, following recommended guidelines for cross-cultural adaptation of health-related quality of life measures. The usefulness of the resultant version was investigated using a sample of 142 patients who presented to our oncological outpatients' department for a routine health care visit after completion of treatment. The 15 items of the HUI2/3-questionnaire were answered independently by three groups of assessors--nurses, physicians, and parents or patients. Two additional questions covered ratings of the severity of treatment effects and the specification of these effects. The questionnaire was both easy to use and acceptable to the assessors. Percentage agreement between observers about levels for individual attributes ranged from 56% to 100%, with the lowest agreement on the subjective attributes of emotion, pain and cognition. These results are in accordance with previous studies using the original instrument. HUI2 global utility scores were significantly related to ratings of treatment sequelae, giving support to the discriminant validity of the measure. CONCLUSION: The German version of HUI2/3 is a useful instrument with generally high inter-observer agreement and good suitability for outcome measurement in childhood cancer patients. Further research is needed to assess the usefulness of the instrument in other clinical populations and its sensitivity in longitudinal studies.

Psychosocial adjustment of pediatric patients after allogeneic stem cell transplantation.

The purpose of this study was to assess the psychosocial adjustment of patients who had been treated with allogeneic stem cell transplantation (SCT) in our clinic. Selection criteria for patients were to be aged 14-30 years at the time of the follow-up, to be at least 2 years post-SCT and to have a very good knowledge of German. Among 31 eligible patients, 26 participated (84% response rate). The patients were between 15 and 27 years old and were on average 7 years (range 2-13) post-SCT. Research instruments consisted of a demographic questionnaire and various subscales of established psychological measures for which data from a sample of bone cancer survivors and population norms were available. About 35% of patients showed high levels of anxiety, 62% appeared to be extremely sensitive and vulnerable, and 35% showed strong, unfulfilled needs in their love lives. In the other domains tested (self-esteem, family and peer relationships, school/vocational performance, etc), no noticeable differences were found between the subjects and comparable populations. There was no significant association between psychosocial outcome and demographic features or clinical data. Our results suggest that patients who underwent SCT in their childhood or adolescence are at risk of developing long-term emotional or social problems. Due to the retrospective design of our study and the small sample size, no predictive factors for psychosocial distress could be identified.

Quality of life and psychosocial adjustment of young patients after treatment of bone cancer.

BACKGROUND: The aim of this study was to collect information about the psychosocial situation of young patients after multimodality therapy for bone cancer. METHODS: Selection criteria for patients were ages 15-30 years, tumor localization at the extremities, and an interval of at least 1 year since the end of treatment. Of 110 patients, 60 were willing to participate. Evaluation of psychosocial quality of life included assessment of psychosocial adjustment and age-appropriate achievements as well as identification of problems typical for this patient group. RESULTS: Approximately 80% of patients revealed, at the very most, only minor psychosocial problems. They were able to adapt well to their new living conditions, although strong efforts were necessary for them to deal with problems such as restricted mobility, catching up with school, or changing jobs or job orientation. Differences between patients and control subjects emerged in the areas of marital status, independent living, and parenthood. The most recently determined levels of education and income were similar. Neither clinical data nor physical or functional sequelae affected psychosocial adjustment, with one exception: patients diagnosed in adolescence had significantly more problems, especially in the area of social well-being, than patients diagnosed in childhood or early adulthood. CONCLUSIONS: Given the limitations of this study, the findings suggest that survivors of bone cancer are not necessarily at risk of developing long term emotional or social problems and are not precluded from leading active and independent lives.