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.

[Importance of complementary medicine approaches for patients with prostate cancer]. / Bedeutung komplementärmedizinischer Verfahren bei Patienten mit Prostatakarzinom.

BACKGROUND: In Germany, many prostate cancer patients use complementary medicine (CM) or have an interest in these treatment approaches; however, the information and consultation situation of cancer patients is insufficient and therefore the Competence Network Complementary Medicine in Oncology (COCON) was launched by the German Cancer Aid Society. One of the projects of the COCON examines the use of CM and the information and counseling needs regarding these topics in various groups of cancer patients. The focus of this article is on the qualitative study reporting selected results for the subgroup of prostate cancer patients. STUDY DESIGN AND STUDY METHODS: A total of 19 semi-structured qualitative interviews with prostate cancer patients were conducted regarding the use of CM as well as their information and consultation needs. RESULTS: It was found that the patients interviewed discussed various issues surrounding nutrition, particularly a healthy diet, the selective use of certain foods and the use of dietary supplements. Additional themes mentioned by interviewees were physical exercise, psychological well-being, mistletoe therapy, homeopathy and traditional Chinese medicine. Patients indicated that they wanted more information and counseling opportunities with regards to CM. They also expressed a desire for more holistic care. CONCLUSION: The results show that prostate cancer patients use a range of CM and have a need for information about CM. Prostate cancer patients are in a special situation because of a regular feedback on the prostate-specific antigen (PSA) value. This should be taken into consideration in consultation with prostate cancer patients regarding CM.

Mistletoe therapy in oncology.

BACKGROUND: Mistletoe extracts are commonly used in cancer patients. It is claimed that they improve survival and quality of life (QOL) in cancer patients. OBJECTIVES: To determine the effectiveness, tolerability and safety of mistletoe extracts given either as monotherapy or adjunct therapy for patients with cancer. SEARCH STRATEGY: Search sources included the Cochrane Central Register of Controlled Trials (CENTRAL, Issue 3, 2007) Cochrane Complementary Medicine Field Registry of randomized clinical trials (RCTs) and controlled clinical trials, MEDLINE, EMBASE, HEALTHSTAR, INT. HEALTH TECHNOLOGY ASSESSMENT, SOMED, AMED, BIOETHICSLINE, BIOSIS, CancerLit, CATLINE, CISCOM (August 2007). For the search the Standard Operating Procedures of the Information System in Health Economics at the German Institute for Medical Documentation and Information (DIMDI) were utilized. Reference lists of relevant articles and authors extensive files were searched for additional studies. Manufacturers of mistletoe preparations were contacted. SELECTION CRITERIA: We included RCTs of adults with cancer of any type. The interventions were mistletoe extracts as sole treatments or given concomitantly with chemo- or radiotherapy. The outcome measures were survival times, tumor response, QOL, psychological distress, adverse effects from antineoplastic treatment and safety of mistletoe extracts. DATA COLLECTION AND ANALYSIS: Three review authors independently assessed trials for inclusion in the review. All review authors independently took part in the extraction of data and assessment of study quality and clinical relevance. Disagreements were resolved by consensus. Study authors were contacted where information was unclear. Methodological quality was narratively described and additionally assessed with the Delphi list and the Jadad score. High methodological quality was defined if six out of nine Delphi criteria, or four out of five Jadad criteria were fulfilled. Results were presented qualitatively. MAIN RESULTS: Eighty studies were identified. Fifty-eight were excluded for various reasons, usually as there was no prospective trial design with randomised treatment allocation. Of the 21 included studies 13 provided data on survival, 7 on tumour response, 16 on measures of QOL or psychological outcomes, or prevalence of chemotherapy-related adverse effects and 12 on side effects of mistletoe treatment; overall comprising 3484 randomised cancer patients. Interventions evaluated were 5 preparations of mistletoe extracts from 5 manufacturers and one commercially not available preparation. The general reporting of RCTs was poor. Of the 13 trials investigating survival, 6 showed some evidence of a benefit, but none of them was of high methodological quality. The results of two trials in patients with melanoma and head and neck cancer gave some evidence that the used mistletoe extracts are not effective for improving survival. Of the 16 trials investigating the efficacy of mistletoe extracts for either improving QOL, psychological measures, performance index, symptom scales or the reduction of adverse effects of chemotherapy, 14 showed some evidence of a benefit, but only 2 of them including breast cancer patients during chemotherapy were of higher methodological quality. Data on side effects indicated that, depending on the dose, mistletoe extracts were usually well tolerated and had few side effects. AUTHORS' CONCLUSIONS: The evidence from RCTs to support the view that the application of mistletoe extracts has impact on survival or leads to an improved ability to fight cancer or to withstand anticancer treatments is weak. Nevertheless, there is some evidence that mistletoe extracts may offer benefits on measures of QOL during chemotherapy for breast cancer, but these results need replication. Overall, more high quality, independent clinical research is needed to truly assess the safety and effectiveness of mistletoe extracts. Patients receiving mistletoe therapy should be encouraged to take part in future trails.

Selenium for alleviating the side effects of chemotherapy, radiotherapy and surgery in cancer patients.

BACKGROUND: Selenium supplements are frequently used by cancer patients. Selenium is an essential trace element and is involved in antioxidant protection and redox-regulation in humans. Several adverse effects of radiotherapy and chemotherapy in cancer patients as well as cellular processes that maintain chronic lymphoedema have been linked to oxidative cell damage in the human body. Selenium has recently been investigated as a remedy against chemotherapy and radiotherapy-associated side effects as well as its effects on lymphoedema. OBJECTIVES: This review assessed the effects of supplementary selenium on adverse effects of conventional radiotherapy, chemotherapy, or surgery, in oncologic patients and on quality of life or performance status during and after oncologic treatment. SEARCH STRATEGY: We searched the Cochrane Pain, Palliative & Supportive Care Trials Register, the Cochrane Database of Systematic Reviews (The Cochrane Library , Issue 2, 2004), Medline (1966 - Sep 2004), Embase (1980 - 2004 week 12), SIGLE (October 2004), Cancerlit (October 2004), Clinical Contents in Medicine CCMed (October 2004), the German Register of Cancer Studies (October 2004), the NCI Clinical Trials Register (October 2004), the International Standard Randomised Controlled Trial Number Register ISRCTN (October 2004) and the Meta-Register of Controlled Trials mRCT (October 2004), reference lists and the archive of our working group. We contacted manufacturers of selenium supplements and investigators. SELECTION CRITERIA: Randomised-controlled trials of selenium mono-supplements in cancer patients undergoing tumour specific therapy such as chemotherapy, radiotherapy or surgery. DATA COLLECTION AND ANALYSIS: Two review authors independently checked trials for eligibility, extracted data and assessed trial quality. We sought additional information from investigators when required. MAIN RESULTS: Two trials have been included, a randomised controlled trial with 60 participants at the beginning of the study investigating secondary lymphoedema and an ongoing trial with preliminary results of 63 participants investigating radiotherapy induced diarrhoea as a secondary outcome. Both trials had drawbacks with regard to study quality and reporting. The trial on secondary lymphoedema reported a decreased number of recurrent erysipela infections in the selenium supplementation group compared to placebo. However, results must be interpreted with caution and cannot be generalised to other populations. The ongoing trial on radiotherapy associated diarrhoea preliminarily reported a lower incidence of diarrhoea in patients receiving selenium supplementation concomitant to pelvic radiation, however, no data were presented. Publication of final results must be awaited to discuss these findings in detail. No randomised controlled trials were found studying the effect of selenium supplementation on other therapy-associated toxicities or quality of life or performance status in cancer patients. AUTHORS' CONCLUSIONS: There is insufficient evidence at present that selenium supplementation alleviates the side effects of tumour specific chemotherapy or radiotherapy treatments. Or, that it improves the after effects of surgery, or improves quality of life in cancer patients or reduces secondary lymphoedema. To date research findings do not provide a basis for any recommendation in favour or against selenium supplementation in cancer patients. Potential hazards of supplementing a trace mineral should be kept in mind.

Use of and attitudes held towards unconventional medicine by patients in a department of internal medicine/oncology and haematology.

A sizeable percentage of patients receiving conventional medical treatment also use unconventional medicine (UM). Surveys indicate that the prevalence of and motivation for the pursuit of the different approaches of UM is subject to individual, geographical, cultural and disease-related factors. We were interested in the concurrent use of and attitudes towards UM in patients who underwent conventional medical treatment in our oncologically orientated department of internal medicine in a regionally dominant teaching hospital. A representative sample (n = 131) of all inpatients and outpatients receiving treatment in the department or in its oncological/haematological outpatient clinic were asked to participate in a cross-sectional interview study on the use of unconventional therapies. In all, 128 patients (97.7%) agreed to participate in the study, and 65% of these patients were suffering from malignancies. Use of unconventional treatment was reported by 24% of all patients for their current medical problem, and 16% of the remaining patients had been thinking of adjunctive use. The use of UM was significantly higher among oncological patients (32%), and among oncological outpatients in particular (50%), than among patients with acute or chronic non-malignant diseases. Female patients predominated among the users of UM (71%). UM mainly took the form of various pharmacological and dietary approaches. Patients availing themselves of UM most frequently identified physicians (41%) as the source of treatment recommendation. Only 18% of the users of UM relied on these methods as a chance of cure. Use of UM was not generally motivated by dissatisfaction with conventional medical care. Only half the users informed their hospital physician of their adjunctive use of UM. Nearly 2 out of 3 of the users contended that UM had contributed to a mild or distinct improvement in their physical or psychological wellbeing. The use of UM in modern health care systems represents a widespread and intricate phenomenon, which cannot be understood by focusing exclusively on the objective assessment of clinical efficacy. Use of UM may be related more to a disease's unfavourable attribution than to its medically expected outcome. Coherence with individual illness paradigms and perceived efficacy are apparently important factors in patients' use of UM. These subjective aspects need to be recognised in caring patient-doctor communication.

Quantitative and morphological changes of the choroid vasculature in RCS rats and their congenic controls.

In Royal College of Surgeons (RCS) rats the outer retina degenerates owing to a phagocytic defect of the retinal pigmented epithelium (RPE). To analyse whether the choriocapillaris also undergoes degenerative changes, corrosion casts of choroidal vessels of ten RCS rats and 12 age-matched controls of different age groups were investigated by scanning electron microscopy. The pattern of the ciliary arteries was analysed qualitatively and the areas covered by capillaries in the different quadrants and regions of the choroid were evaluated quantitatively. In both RCS rats and their congenic controls the choroid was supplied by only three ciliary arteries. A separate artery supplying the upper quadrant in other rat strains was lacking. The quantitative evaluation revealed that in controls the capillary density decreased from the central to the peripheral regions. In addition there were slightly fewer capillaries in the upper temporal quadrant compared to other quadrants. In RCS rats older than 6 months, all parts of the choroid displayed a decrease in the number of capillaries of about 10-15% compared to the controls. Most prominent loss of capillaries was found in the upper temporal quadrant. Electron-microscopical investigation of the upper temporal quadrant showed that loss of choriocapillaris was directly correlated with degeneration of the adjacent retinal pigmented epithelium (RPE).

Characterization of Meibomian gland innervation in the cynomolgus monkey (Macaca fascicularis).

To characterize the innervation of the cynomolgus monkey (Macaca fascicularis) Meibomian (tarsal) glands, upper lids of six cynomolgus monkeys were investigated with electronmicroscopical and double-labeling immunocytochemical methods. Antibodies against calcitonin gene-related peptide (CGRP), dopamine-beta-hydroxylase (DBH), neuropeptide Y (NPY), nitric oxide synthase (NOS), protein gene product 9.5 (PGP 9.5), substance P (SP), tyrosine hydroxylase (TH), and vasoactive intestinal peptide (VIP) were used. In addition, sections were processed for NADPH-diaphorase (NADPH-d) histochemistry. Staining for PGP 9.5 and electron microscopy showed that Meibomian gland acini were surrounded by a network of unmyelinated nerves and terminal varicose axons. The terminals contained small agranular (30-60 nm) and large granular vesicles (65-110 nm), and were observed in close contact with the basal lamina of the acini, but never internally to the basal lamina. Meibomian axons showed like-immunoreactivity (LI) for the neuropeptides SP, CGRP, NPY, and VIP. In addition, the axons stained for TH, DBH, NOS, and NADPH-d. VIP-LI, NOS- and NADPH-d-positive axons appeared to be more numerous, TH- and DBH-positive axons more rare than others. Most SP-LI axons were double-labelled for CGRP-LI, some for VIP-LI or NPY-LI. In addition, some VIP-LI axons were double-labeled for NPY-LI. NPY/VIP-LI and NPY/SP-LI axons were only observed close to the Meibomian acini. Conversely, NPY-LI colocalized with TH-IR or DBH-IR predominated in perivascular nerves of Meibomian gland vasculature. The close association of varicose axons with the acini of Meibomian glands indicates that nervous signals modulate meibomian secretion. Meibomian gland nerve fibers in the cynomolgus monkey appear to utilize various neuropeptides, catecholamines and nitric oxide as transmitter substances, and seem to derive from the pterygopalatine, superior cervical and trigeminal ganglion respectively.

Alterations in anterior segment dimensions in eyes with retinitis pigmentosa.

BACKGROUND: In visually deprived primate eyes there is a correlation between alterations in growth parameters and changes in retinal neurotransmitters. Progressive retinal degeneration also leads to alterations in retinal neurotransmitters. In this study we wanted to investigate whether alterations in the dimensions of the anterior eye segment are also present in human donor eyes of patients with hereditary retinal degeneration. METHODS: Sagittal sections through anterior segments of 47 eyes from donors with different types of retinitis pigmentosa (RP) and of 59 eyes from normal donors were investigated morphometrically using a PC-based morphometric system. RESULTS: In the RP eyes there was a significant shortening of the distance between the peripheral end of Descemet's membrane and the posterior end of Schlemm's canal and of the length of the pars plana of the ciliary body. These changes varied markedly among the different types of RP. The most pronounced shortenings were found in eyes of men with X-linked recessive RP, which had the most severe retinal changes. RP eyes showed, in contrast to normal eyes, significant age-related elongation of the ciliary body and the chamber angle. A significant increase of the axial diameter with age was also found in RP eyes. CONCLUSION: Our study reveals for the first time that there are changes in the anterior segment dimensions in human eyes with hereditary retinal degeneration. Measurements of anterior eye segment parameters might provide additional indices for the severity of RP and for the diagnosis of RP subtypes.

Anterior chamber-associated immune deviation elicited via primate eyes.

PURPOSE: To determine whether injection of a soluble antigen, ovalbumin (OVA), into the anterior chamber of cynomolgus monkey eyes would impair the ability of these animals to subsequently develop delayed hypersensitivity when confronted by this antigen in immunogenic form. METHODS: OVA or phosphate-buffered saline was injected into the anterior chamber of adult cynomolgus monkeys that were subsequently immunized with OVA in adjuvant and then skin challenged for delayed hypersensitivity with OVA. RESULTS: Recipients of intracameral OVA proved unable to acquire antigen-specific delayed hypersensitivity when they received an immunogenic regimen of OVA in adjuvant. Since the flow of aqueous humor through the uveoscleral pathway of primate eyes can be promoted by topical treatment with PGF2 alpha isopropylester, a preliminary experiment is described in which induction of anterior chamber-associated immune deviation by OVA was prevented when the antigen was first introduced into monkey eyes treated with PGF2 alpha isopropylester. CONCLUSIONS: Monkeys resemble rodents in displaying anterior chamber associated immune deviation (impaired ability to acquire antigen-specific delayed hypersensitivity) when they first encounter an antigen via the anterior chamber. The findings suggest that the cellular and molecular mechanisms of immune privilege, recently described in rodents, may apply to immune responses to intraocular antigens and pathogens in primates, including humans. Primate eyes offer an opportunity to explore the mechanisms of anterior chamber-associated immune deviation using pharmacologic agents that modify the aqueous outflow tracts.