Development and psychometric evaluation of item banks for memory and attention - supplements to the EORTC CAT Core instrument.

BACKGROUND: Cancer patients may experience a decrease in cognitive functioning before, during and after cancer treatment. So far, the Quality of Life Group of the European Organisation for Research and Treatment of Cancer (EORTC QLG) developed an item bank to assess self-reported memory and attention within a single, cognitive functioning scale (CF) using computerized adaptive testing (EORTC CAT Core CF item bank). However, the distinction between different cognitive functions might be important to assess the patients' functional status appropriately and to determine treatment impact. To allow for such assessment, the aim of this study was to develop and psychometrically evaluate separate item banks for memory and attention based on the EORTC CAT Core CF item bank. METHODS: In a multistep process including an expert-based content analysis, we assigned 44 items from the EORTC CAT Core CF item bank to the memory or attention domain. Then, we conducted psychometric analyses based on a sample used within the development of the EORTC CAT Core CF item bank. The sample consisted of 1030 cancer patients from Denmark, France, Poland, and the United Kingdom. We evaluated measurement properties of the newly developed item banks using confirmatory factor analysis (CFA) and item response theory model calibration. RESULTS: Item assignment resulted in 31 memory and 13 attention items. Conducted CFAs suggested good fit to a 1-factor model for each domain and no violations of monotonicity or indications of differential item functioning. Evaluation of CATs for both memory and attention confirmed well-functioning item banks with increased power/reduced sample size requirements (for CATs ≥ 4 items and up to 40% reduction in sample size requirements in comparison to non-CAT format). CONCLUSION: Two well-functioning and psychometrically robust item banks for memory and attention were formed from the existing EORTC CAT Core CF item bank. These findings could support further research on self-reported cognitive functioning in cancer patients in clinical trials as well as for real-word-evidence. A more precise assessment of attention and memory deficits in cancer patients will strengthen the evidence on the effects of cancer treatment for different cancer entities, and therefore contribute to shared and informed clinical decision-making.

Disease modifying treatment trials in Parkinson's disease: how to balance expectations and interests of patients, physicians and industry partners?

BACKGROUND: The advent of therapeutic strategies designed to modify the disease course in Parkinson's disease has raised great expectations in the currently conducted clinical trials. However, we see ethical challenges in the cooperation of industry and clinical partners, specifically evident in the way recruitment is performed.We here discuss the different positions and challenges of all involved to set the stage for a study and recruitment culture taking into account the expectations of all: (i) patients and their caregivers, ready to take the considerable burden of clinical trials in hope for the development of disease-modifying treatments; (ii) physicians and study nurses, obligated to the patients' well-being and benefit who accompany and supervise patients closely as basis for the performance of elaborate clinical trials (iii) industrial partners, investing years of efforts and finances to develop new treatments. CONCLUSIONS: We conclude that the current competitive race for enrollment in clinical studies in PD is challenging the primary goal to ensure patients' benefit and formulate requests to the industrial partners to encounter these concerns.

Outcomes and outcome measures used in evaluation of communication training in oncology - a systematic literature review, an expert workshop, and recommendations for future research.

BACKGROUND: Communication between health care provider and patients in oncology presents challenges. Communication skills training have been frequently developed to address those. Given the complexity of communication training, the choice of outcomes and outcome measures to assess its effectiveness is important. The aim of this paper is to 1) perform a systematic review on outcomes and outcome measures used in evaluations of communication training, 2) discuss specific challenges and 3) provide recommendations for the selection of outcomes in future studies. METHODS: To identify studies and reviews reporting on the evaluation of communication training for health care professionals in oncology, we searched seven databases (Ovid MEDLINE, CENTRAL, CINAHL, EMBASE, PsychINFO, PsychARTICLES and Web of Science). We extracted outcomes assessed and the respective assessment methods. We held a two-day workshop with experts (n = 16) in communication theory, development and evaluation of generic or cancer-specific communication training and/or outcome measure development to identify and address challenges in the evaluation of communication training in oncology. After the workshop, participants contributed to the development of recommendations addressing those challenges. RESULTS: Out of 2181 references, we included 96 publications (33 RCTs, 2 RCT protocols, 4 controlled trials, 36 uncontrolled studies, 21 reviews) in the review. Most frequently used outcomes were participants' training evaluation, their communication confidence, observed communication skills and patients' overall satisfaction and anxiety. Outcomes were assessed using questionnaires for participants (57.3%), patients (36.0%) and observations of real (34.7%) and simulated (30.7%) patient encounters. Outcomes and outcome measures varied widely across studies. Experts agreed that outcomes need to be precisely defined and linked with explicit learning objectives of the training. Furthermore, outcomes should be assessed as broadly as possible on different levels (health care professional, patient and interaction level). CONCLUSIONS: Measuring the effects of training programmes aimed at improving health care professionals' communication skills presents considerable challenges. Outcomes as well as outcome measures differ widely across studies. We recommended to link outcome assessment to specific learning objectives and to assess outcomes as broadly as possible.

[Decision-making support in Intensive Care to facilitate organ donation : Position paper of the Ethics Section and the Organ Donation and Transplantation Section of the German Interdisciplinary Association of Critical Care and Emergency Medicine (DIVI) in collaboration with the Ethics Section of the German Society of Medical Intensive Care Medicine and Emergency Medicine (DGIIN)]. / Entscheidungshilfe bei erweitertem intensivmedizinischem Behandlungsbedarf auf dem Weg zur Organspende : Positionspapier der Sektion Ethik und der Sektion Organspende und -transplantation der Deutschen Interdisziplinären Vereinigung für Intensiv- und Notfallmedizin (DIVI) unter Mitarbeit der Sektion Ethik der Deutschen Gesellschaft für Internistische Intensivmedizin und Notfallmedizin (DGIIN).

BACKGROUND AND CHALLENGE: Injuries, especially traumatic brain injury, or specific illnesses and their respective sequelae can result in the demise of the patients afflicted despite all efforts of modern intensive care medicine. If in principle organ donation is an option after a patient's death, intensive therapeutic measures are regularly required in order to maintain the homeostasis of the organs. These measures, however, cannot benefit the patient afflicted anymore-which in turn might lead to an ethical conflict between dignified palliative care for him/her and expanded intensive treatment to facilitate organ donation for others, especially if the patient has opted for the limitation of life-sustaining therapies in an advance directive. METHOD: The Ethics Section and the Organ Donation and Transplantation Section of the German Interdisciplinary Association of Critical Care and Emergency Medicine (DIVI) have convened several meetings and a telephone conference and have arrived at a decision-making aid as to the extent of treatment for potential organ donors. This instrument focusses first on the assessment of five individual dimensions regarding organ donation, namely the certitude of a complete and irreversible loss of all brain function, the patient's wishes as to organ donation, his or her wishes as to limiting life-sustaining therapies, the intensity of expanded intensive treatment for organ protection and the odds of its successful attainment. Then, the combination of the individual assessments, as graphically shown in a {Netzdiagramm}, will allow for a judgement as to whether a continuation or possibly an expansion of intensive care measures is ethically justified, questionable or even inappropriate. RESULT: The aid described can help mitigate ethical conflicts as to the extent of intensive care treatment for moribund patients, when organ donation is a medically sound option. NOTE: Gerald Neitzke und Annette Rogge contributed equally to this paper and should be considered co-first authors.

[Amendment to the documentation of decisions to withhold or withdraw life-sustaining therapies in consideration of wish to donate organs : Recommendation of the Ethics Section and the Organ Donation and Transplantation Section of the German Interdisciplinary Association of Critical Care and Emergency Medicine (DIVI) in collaboration with the Ethics Section of the German Society of Medical Intensive Care Medicine and Emergency Medicine (DGIIN)]. / Ergänzung des Dokumentationsbogens "Therapiebegrenzung" unter Berücksichtigung eines möglichen Organspendewunsches : Empfehlung der Sektion Ethik sowie der Sektion Organspende und Organtransplantation der Deutschen Interdisziplinären Vereinigung für Intensiv- und Notfallmedizin (DIVI) unter Mitarbeit der Sektion Ethik der Deutschen Gesellschaft für Internistische Intensivmedizin und Notfallmedizin (DGIIN).

The Ethics Section of the German Interdisciplinary Association of Critical Care and Emergency Medicine (DIVI) recently published a documentation for decisions to withhold or withdraw life-sustaining therapies. The wish to donate organs was not considered explicitly. Therefore the Ethics Section and the Organ Donation and Transplantation Section of the DIVI together with the Ethics Section of the German Society of Medical Intensive Care Medicine and Emergency Medicine worked out a supplementary footnote for the documentation form to address the individual case of a patient's wish to donate organs.

[Rehabilitation of prostate cancer patients : A multidisciplinary consensus]. / Rehabilitation von Patienten mit Prostatakarzinom : Ein multidisziplinärer Konsens.

BACKGROUND: Even though several specialist groups, including the German Pension Insurance (Deutsche Rentenversicherung) and health insurance funds, participate in the rehabilitation of patients with prostate carcinoma, there is no standardized rehabilitation program available for these patients. Consequently, there is no transparency regarding the services provided within the scope of rehabilitation for the referring physicians to uro-oncological rehabilitation, in particular, neither for physicians at urological acute-care clinics, nor for the patients concerned. Rehabilitation clinics are rather left to their own devices as to which services they provide in the treatment of the respective disease and in social situations, but also with regard to the consulting services offered. PROBLEM: Development of a standard for the rehabilitation of patients with prostate carcinoma, taking into account both specialist circles and self-help groups relevant to this matter. METHODS: Specialist groups, including self-help groups participating in the rehabilitation of patients with prostate cancer, have formed an expert group and developed the present standard. To this end, a thematic unsystematic literature review was carried out in advance to provide an evidence-based foundation. RESULTS: Views were given with regard to rehabilitation diagnostics, the therapy of urinary incontinence and erectile dysfunction, sport and physical exercise therapy, psycho-oncology, and social- and disease-related consulting. In this context, the focus was set on classification as well as on the consensus strength of the respective recommendations. CONCLUSION: All parties involved in the rehabilitation of prostate cancer patients, as well as the patients and the responsible cost bearers, can now use the standard as an orientation guide.

Transcranial color-coded sonography successfully visualizes all intracranial parts of the internal carotid artery using the combined transtemporal axial and coronal approach.

BACKGROUND AND PURPOSE: Visualization of the intracranial internal carotid artery (ICA) with transcranial color-coded sonography (TCCS) by using the transtemporal coronal plane has been described previously. Because this approach is limited to the vertical running ICA segments, we investigated the feasibility of using TCCS to visualize all intracranial ICA segments by adding the transtemporal axial approach to the coronal plane. MATERIALS AND METHODS: Subjects with excellent transtemporal acoustic windows were examined by TCCS by using standardized axial and coronal planes. Identification rate, flow velocities, pulsatility and resistance indices, and length (as visible in color-coded power mode) were determined. RESULTS: A total of 120 intracranial ICAs from 60 subjects were investigated. By switching between the axial and coronal insonation planes, all intracranial segments of the ICA could be investigated in 100% of subjects-with the exception of the horizontal part of the petrosal ICA, which was identified in 96.7% of subjects. CONCLUSIONS: TCCS becomes a reliable tool in investigating all parts of the intracranial ICA by adding the transtemporal axial approach to the coronal plane.

[Adjusting a surgery department to new conditions in the German health service: day surgery, short-stay surgery, vascular centers and wound centers]. / Anpassung einer chirurgischen Klinik an die Herausforderungen im GesundheitswesenDie Tageschirurgie, die Kurzzeitchirurgie, das Gefässzentrum und die Wundsprechstunde.

In April 1994, after the preconditions for ambulatory surgery came into effect, the day surgery ward was opened in the Hamburg-Harburg General Hospital. Besides ambulatory operations, this ward provides all surgical pre- and postoperative care. In addition to the surgical sections, different departments (urology, gynecology, dentistry, radiology, ophthalmology) take advantage of the ward. As preoperative diagnostics also could be completed ambulatorily, we were then able to establish a short-stay surgery department. This ward was opened in June 1996. One year later, the vascular center ("Gefässcentrum Harburg") was established by the departments for surgery, radiology, and angiology. This structure has been integrated into the day and short-stay surgery wards functionally and spatially. With the organizational structures mentioned and by setting up a wound consultation service, it is possible to optimize the capacity for admissions, operations, and beds. Government and health insurance demands for better processing can be filled and efficiency is increased.

Use of progestagen-gonadotrophin treatments in estrus synchronization of sheep.

The main objective of this study was to investigate the effectiveness of certain progestagen-gonadotrophin treatments on synchronization of estrus in sheep. In Experiment I, 30 Chios ewes were treated at the beginning of the breeding season with medroxyprogesterone acetate (MAP) intravaginal sponges for 12 days and a single i.m. treatment of either FSH (Group 1,10 IU, n = 8; Group 2, 5 IU, n = 8; Group 3, 2.5 IU, n = 8) or eCG (Group 4, 400 IU, n = 6) at the time of sponge removal. Ten days after sponge removal laparotomy was performed to record ovarian response. Clinical estrus was observed in more (though not at a significant level) FSH treated than eCG treated sheep (62.5% versus 33.3%). Administration of 400 IU eCG resulted in the highest mean number of CL perewe ovulating (2.8 +/- 0.2), with administration of 10 IU FSH producing the next best results (2.1 +/- 0.3). Statistically significant differences in the mean number of CL per ewe ovulating were found only between ewes in Group 3 (1.7 +/- 0.4) and Group 4 (2.8 +/- 0.2) (P < 0.05). In Experiment II, 53 Chios and 30 Berrichon ewes were treated during the mid-breeding season with MAP intravaginal sponges for 12 days and a single i.m. treatment of either 10 IU FSH (27 Chios and 16 Berrichon ewes) or 400 IU eCG (26 Chios and 14 Berrichon ewes), at the time of sponge removal. Ewes that were in estrus on Days 2-4 and 19-23 after sponge removal were mated to fertile rams. No significant differences were recorded between treatment or breed groups in the proportions of ewes observed in estrus after treatment. In the Berrichon breed, FSH administration resulted in higher lambing rates (93.8% versus 57.1%, P < 0.05) and higher mean number of lambs born per ewe exposed to rams (1.4 +/- 0.2 versus 0.8 +/- 0.2, P < 0.05) than that of eCG. After treatment with eCG, the mean number of lambs born per ewe exposed to rams was higher in the Chios than the Berrichon breed (1.4 +/- 0.2 versus 0.8 +/- 0.2, P < 0.05). After treatment with FSH, the lambing rate was higher in the Berrichon than the Chios breed (93.8% versus 63.0%, P < 0.05). In conclusion, a single FSH treatment (5 or 10 IU) at the end of progestagen treatment appears to be more effective than eCG for the induction of synchronized estrus in sheep at the beginning of the breeding season, with no cases of abnormal ovarian response observed. During the mid-breeding season FSH (10 IU) appears to be equally as effective as eCG (400 IU) in respect of lambing rate and mean number of lambs born per ewe.

The effect of autoclave resterilisation on polyester vascular grafts.

OBJECTIVES: polyester grafts are expensive, single-use items. Some manufacturers of uncoated, woven grafts include instructions for autoclave resterilisation to be performed at the surgeon's own request. Others warn against such manipulation. Theoretically, the glass transition point of polyester at 70-80 degrees C and the possible acceleration of hydrolysis suggest that autoclave resterilisation at 135 degrees C might be a problem. MATERIALS AND METHODS: a DeBakey Soft Woven Dacron Vascular Prosthesis (Bard) and a Woven Double Velour Dacron Graft (Meadox) were autoclave-resterilised 0 to 20 times, having been weighed before and after sterilisation. Tactile testing was performed. Mechanical properties were examined by probe puncture and single-filament testing, the surface was examined by scanning electron microscopy and the degree of hydrolysis by infra-red spectroscopy. RESULTS: tactile testing revealed a change of feeling with increasing cycles of resterilisation. Investigation of weight, textile strength, single-filament strength, electron microscopy of the surface and infra-red spectroscopy showed no change of the material. CONCLUSIONS: changes felt are presumably a surface phenomenon, not measurably affecting strength or chemistry of material after autoclave resterilisation. We therefore feel that it is safe to use once-autoclave-resterilised surplus uncoated polyester grafts, provided that sterility is guaranteed.

Long-term in vivo alterations of polyester vascular grafts in humans.

OBJECTIVES: To examine the influence of in vivo hydrolysis on the physical properties of polyester grafts and their correlation to the period of implantation in the human body. MATERIALS AND METHODS: Sixty-five explanted vascular grafts were obtained after 0-23 years of implantation due to suture aneurysms (18), occlusion (12), graft infection (12), failure of graft material (7) and post-mortem (16). The surface was examined by scanning electron microscopy, the molecular integrity by infra-red spectroscopy and physical strength by probe puncture. RESULTS: Scission of macromolecular chains and loss of strength were shown. It was demonstrated that hydrolytic degradation of polyester takes place with increasing time of implantation in humans. Analysis by linear regression showed that polyester grafts lose 31.4% of their bursting strength in 10 years and 100% in 25-39 years after implantation. CONCLUSIONS: Regular follow-ups of patients with aged vascular grafts and the precise documentation of implanted materials are necessary to estimate graft degradation.