Translation and cultural adaptation of the Greek integrated palliative care outcome scale (IPOS): challenges in a six-phase process.

AIM: To translate and culturally adapt IPOS to the Greek population. METHODS: A four phases- sequential study, which included verification of conceptual equivalence, double forward- backward translations and conceptual cognitive debriefing. Focus group interviews used 'think aloud' and 'verbal probing' techniques. Interviews were audio-recorded, transcribed verbatim and thematically analyzed using predefined categories. Purposely sampled from two oncology and palliative care units in Athens. RESULTS: The Integrated Palliative Care Outcome Scale was well accepted by both patients and health professionals. Overall comprehension and acceptability of the scale were good. The comprehension and judgement challenges identified in the pre-final version were successfully resolved in the cognitive interviewing phase. Five out of the seventeen translated items of the scale were modified after cognitive debriefing. Comprehension difficulties were identified with specific terms (e.g., energy/feeling depressed) and with some answer options. Severity of symptoms and not their impact was a common difficulty. A judgement challenge was reported in relation to 7-days recall and fluctuation of symptoms. Layout concerns in relation to length of questions were also stated. All questions were considered important and none as inappropriate. CONCLUSION: This study demonstrated face and content validity and acceptability of the Integrated Palliative Care Outcome Scale in the Greek context. Cognitive Interviewing proved valuable in refining concepts within the specific cultural context. CLINICAL IMPLICATIONS: The IPOS outcome measure tool is now being used routinely in a palliative care service in Athens and is currently used to evaluate service outcomes.

Attitudes of primary care providers on early palliative care, in new community settings of Attica, Greece; a qualitative analysis.

Background: Early provision of palliative care globally can be achieved by primary health professionals. In Greece, a primary care reformation is currently under development; novel community units have been introduced, with the family physician working for the first time with an interdisciplinary team. Objectives/Setting: To explore the attitudes of such providers, on early palliative care in Attica. A clear understanding of primary care workforce attitudes would facilitate the National primary care strategic development. Participants/Design: Qualitative research design, with 3 focused-groups of 23 primary health care providers, including family physicians, nurses, health visitors, administrative assistants and sociologists. All were members of the Hellenic Association of Research and Education in Primary Care. Semi-structured question guides were used. Experiences, practices, needs and barriers were evaluated. Responses were audio recorded, transcribed, grouped under various themes, listed out and analyzed, through thematic analysis. Results: Three major themes were identified and all teams were able to: 1) Identify patient and family populations with palliative care unmet needs, early at diagnosis. 2) Respond to those needs by the holistic model of care and integrate strategies of early palliative care, working as a team. 3) Recognize barriers to the best-possible approach: a) lack of education on severe pain and grief management, b) lack of collaboration with experts, and c) instability of governmental decisions. Conclusions: Teams of primary care providers in Attica, could integrate early palliative care. Issues to be addressed include further education on pain and grief management, collaboration with palliative care experts and stability.

Factors Affecting Opioid Treatment in Cancer Patients.

PURPOSE: Pain is prevalent in cancer patients, appearing to be moderate to severe in more than one third of them. Despite the fact that fentanyl is widely used with effective analgesic results, some patients do not correspond to treatment, resulting in opioid change. METHODS: This is a cohort study, performed in Greek patients with cancer. Its scope was to identify potential reasons responsible for opioid change, due to transdermal-fentanyl intolerance, resulting from inadequate analgesia (pain relief<33% in 1week) and/or unacceptable adverse-events (grade≥3 at Common Terminology Criteria-v4.0). The final sample included 289 participants. To investigate responsible reasons for transdermal-fentanyl intolerance we studied its relation with patients' history, haematology, biochemistry, body-mass-index, demographic and disease related characteristics. The Eastern Cooperative Oncology Group performance status scale, the Mini Mental State Examination questionnaire, the M.D.Anderson Symptom Inventory and the Greek Brief Pain Inventory were also used to measure performance status and quality-of-life for the same reason. RESULTS: Almost one third of the patients had to change to an alternative opioid oral-morphine in order to achieve adequate analgesia or/and avoid adverse-events. The most common adverse-events observed were nausea/vomiting and sleepiness. Statistical analysis demonstrated that younger age (OR=0.976) and obesity (OR=0.29 against underweight, OR=0.39 against normal, OR=0.48 against pre-obese) had a higher possibility to contribute to modification of the analgesic treatment. Furthermore, a higher impact of symptoms in patient's life (OR=1.184) and chemotherapy (OR=2.109) could also contribute to the need of change of the opioid analgesic medication. CONCLUSION: This study found significant variables for transdermal-fentanyl intolerance. This knowledge may help person-center care in moderate to severe cancer pain. This article is open to POST-PUBLICATION REVIEW. Registered readers (see "For Readers") may comment by clicking on ABSTRACT on the issue's contents page.

Candidate gene investigation of spinal degenerative osteoarthritis in Greek population.

BACKGROUND CONTEXT: Few data exist concerning the natural history of degenerative osteoarthritis (OA) of the spine and its associated gene investigation. Degenerative spinal OA demonstrates an international prevalence of 15% in the general population. PURPOSE: The aim of this Greek case-control study is to examine gene polymorphisms that have been previously shown or hypothesized to be correlated to degenerative OA. Gene polymorphisms, especially for OA, have never been previously studied in the Greek population. STUDY DESIGN/SETTING: The study was conducted from May 2009 to December 2012. Eligible subjects who agreed to take part in the study were Greek adults from all of Greece, referred for consultation to the Palliative Care and Pain Relief Unit of Aretaieion University Hospital, in Athens, Greece. PATIENT SAMPLE: A total of 601 matched pairs (cases and controls) participated in the study, 258 patients (188 women and 70 men) with clinically and radiologically confirmed degenerative OA and 243 control subjects (138 women and 105 men). OUTCOME MEASURES: All patients presented with chronic pain at the spine (cervical, thoracic or lumbar) caused by sympomatic osteophytes or disc narrowing, whereas clinical diagnosis of OA was based on the presence of both joint symptoms and evidence of structural changes seen on plain conventional X-rays. METHODS: We investigated genetic variation across candidate OA gene GDF5, CDMP1, CDMP2, Asporin, SMAD3, and chromosomal region 7q22, in a sample of 258 patients with clinically and radiologically confirmed degenerative OA, and 243 control subjects from the Greek population. All subjects (patients and controls) were subsequently matched for the epidemiologic, demographic, and clinical risk factors, to prevent selection biases. A tagging single nucleotide polymorphism (SNP) approach was pursued to cover variation across all targeted loci. Single marker tests as well as haplotypic tests of association were performed. There is no conflict of interest, and also, there are no study funding sources. RESULTS: We found significant association of spine OA with SNPs and haplotypes along the 7q22 chromosomal region and the SMAD3 gene. At 7q22, single marker association tests showed SNPs rs3801954 and rs2023685 to be associated with the disorder (p-value .0312 and .0041, respectively), but only SNP rs2023685 retained a significant p-value (.046) after performing 1,000 permutation tests. At the SMAD3 gene, SNP rs422342 was also found to be statistically associated (p-value .0282) to intervertebral disc degeneration (permutation p-value .042). CONCLUSIONS: This is the first study to investigate genetic variation in relation to spine OA in the Greek population. Our results indicate that the genetic basis of the disease may differ in the Greek population in relation to populations of Asian origin, although larger sample sizes are required to underpin the full extent of the involvement of analyzed loci.

Reliability and Validity of the Greek Version of Patient Generated-Subjective Global Assessment in Cancer Patients.

The authors sought to determine the reliability and validity of psychometric properties of the Greek Patient-Generated Subjective Global Assessment (PG-SGA) in cancer patients attending a palliative care unit. The scale was translated into Greek. The study took place in an outpatient palliative care unit and 238 cancer patients completed the nutrition assessment. For treatment effect, the index was administered to 164 patients, whereas for the test of the instrument's robustness to 100 patients. Both assessments took place 15 days after the baseline assessment. Ninety-three patients were well-nourished, 104 were moderately malnourished, and 41 were severely malnourished. Reliability was assessed by the internal consistency and test-retest of the instrument. Validity was assessed with construct validity using the PG-SGA items, treatment effect, and criterion validity. Weight loss, physical examination, activities and function, and symptoms were predictors to the classification. Mean values in male patients classified as severely malnourished had the lowest values in all objective parameters except serum albumin, whereas severely malnourished female patients had the lowest values in all objective parameters except serum albumin and arm muscle circumference (AMC). Values of serum transferrin, AMC, and body mass index were significantly lower in patients classified as severely malnourished. The Greek PG-SGA is a psychometrically sound assessment in Greek cancer patients.

Relationship of general self-efficacy with anxiety, symptom severity and quality of life in cancer patients before and after radiotherapy treatment.

PURPOSE: Treatment-related symptoms can increase psychological and physical distress and alter the patient's quality of life. The present study evaluates prospectively treatment-related symptoms, general self-efficacy, anxiety and quality of life (QoL) in patients with different types of cancer undergoing external beam radiotherapy (RT) and the relationship of patients' general self-efficacy with the assessed measures, at the baseline and their absolute change 1 month after the end of the treatment. METHODS: The sample consisted of 90 cancer patients. General self-efficacy was assessed using the General Perceived Self-efficacy (GSE). QoL was evaluated using the Linear Analogue Scale Assessment (LASA), anxiety with the Anxiety subscale of the Hospital Anxiety and Depression (HAD) scale, whereas symptom severity and interference were assessed using the MD Anderson Symptom Inventory (MDASI). The instruments were administered first at the beginning of the RT and then 1 month after the completion of the RT. RESULTS: At post-treatment, general self-efficacy was reduced (28.86 ± 6.42), anxiety scores were elevated (9.56 ± 4.42), QoL scores were reduced (6.74 ± 1.81) and symptoms severity were deteriorated (3.24 ± 2.62). Pre-treatment and post-treatment absolute change scores revealed statistically significant negative correlations between general self-efficacy absolute scores and anxiety (p < 0.0005). Moderate negative correlations between general self-efficacy absolute scores and symptoms (MDASI symptom severity: p = 0.003, symptom interference: p = 0.002), whereas a low positive correlation was found between general self-efficacy absolute scores and LASA energy scale (p = 0.048). CONCLUSIONS: A sense of self-efficacy and its relationship with anxiety, symptom distress and quality of life are important factors for patients receiving radiotherapy. Health care professionals need to be aware of anxiety, symptom severity and patient's quality of life prior to treatment initiation.

Geriatric depression in advanced cancer patients: the effect of cognitive and physical functioning.

AIM: The aims of the current study were to evaluate geriatric depression and its risk factors in advanced cancer patients. METHODS: A cross-sectional study was carried out in a palliative care unit in Greece. Patients completed the Geriatric Depression Scale, the M. D. Anderson Symptoms Instrument (MDASI), the Activities of Daily Living and the Mini-Mental State Examination. Patients were included if they were aged >65 years, if they had cancer, were able to communicate and had agreed to sign informed consent. The final sample consisted of 92 elderly advanced cancer patients. RESULTS: The prevalence of depression was found to be 67.4%. The univariate comparison between the depressed elderly and non-depressed group showed that patients with metastases were found to be 2.2-fold more likely to suffer from geriatric depression compared with those without metastases (P = 0.074). Patients with moderate or severe cognitive impairment were found to be 3.61-fold more likely to suffer from geriatric depression in comparison with those with normal cognitive function (P = 0.019). In the multiple logistic regression analysis, elderly with cognitive impairment were 3.3-fold more likely to have geriatric depression than those without (adjusted odds ratio = 3.3 [95% CI 0.99-10.74], P = 0.052) and MDASI factor 1 was consistently a significant risk factor for depression in the elderly; when MDASI factor 1 increased by 1 unit, the odds of being classified as depressed increased by 7.6%. CONCLUSIONS: The present study found that cognitive impairment and symptoms such as enjoyment of life, walking, relationship with people, general activity, sadness and pain (MDASI F1) are strong independent predictors of depression in the elderly.

Activities of daily living in Greek cancer patients treated in a palliative care unit.

GOALS OF WORK: To assess the psychometric properties of the Activities of Daily Living (ADL) scale on a Greek sample of advanced cancer patients. PATIENTS AND METHODS: The scale was translated with the forward-backward procedure to Greek. The ADL scale was administered to 136 advanced cancer patients. It was administered twice, with a 3-day interval, to 40 (of the 136) eligible patients with advanced cancer to assess the scale's stability. For the assessment of treatment effect, the index was administered to 90 (of the 136) patients 15 days later. Together with the ADL scale, the patients also completed the Instrumental Activities of Daily Living (IADL) scale. Confirmatory factor analysis was carried out using the AMOS 7.0 analysis. The reliability was assessed by the internal consistency (Cronbach's alpha co-efficients), and test/retest (Spearman's r value) of the instrument. Validity was assessed with construct validity using the IADL scale, treatment-effect, known groups, and convergent validity. MAIN RESULTS: The homogeneity of the scale proved to be satisfactory (cronbach alpha = 0.88). Overall test-retest reliability was satisfactory. Construct validity has shown satisfactory correlations with IADL p < 0.0005. Convergent validity and treatment effect were satisfactory at p < 0.0005 and p < 0.05, respectively. Known groups validity detected differences according to patient's performance status (p < 0.0005). CONCLUSIONS: The results suggest that the Greek version of ADL administered in cancer patients treated in a palliative care unit is a reliable and valid clinical instrument.

Evaluation of instrumental activities of daily living in Greek patients with advanced cancer.

Translation of the instrumental activities of daily living (IADL) was carried out and its psychometric properties were assessed in a Greek sample of patients with advanced cancer. The scale was translated with the forward-backward procedure into the Greek language. It was initially administered to 136 advanced cancer patients. To assess reliability, it was administered to 45 patients 3 days later. To assess the effect of treatment, 75 patients were studied. The patients also completed the Eastern Cooperative Oncology Group (ECOG) performance status and the linear analogue scale assessment (LASA) quality of life (QoL) scale. Confirmatory factor analysis of the IADL was carried out. Reliability was assessed in terms of internal consistency (Cronbach's α) and test-retest correlation (Pearson and ICC) of the IADL scale. Construct validity was assessed through correlation of IADL with ECOG and LASA QoL scores. Confirmatory factor analysis yielded a single-factor model. The homogeneity of the instrument proved to be satisfactory (α was 0.88 for men and 0.83 for women). Test-retest reliability was also satisfactory (P<0.0005). High correlation with ECOG (men, r=-0.87; women, r=-0.85) and LASA QoL (men, r=0.55; women, r=0.53) was observed. The Greek version of the IADL in cancer patients treated in a palliative care unit is a reliable and valid clinical instrument.

Non-analgesic effects of opioids: opioids' effects on sleep (including sleep apnea).

The exact effect of opioid analgesics on sleep is to be determined. Although literature data are sporadically reported, the aim of this review is to summarize the already known effects of such medications on sleep. A variety of effects, both positive and negative, has been suggested, when opioids are used for pain treatment, but in the absence of pain as well. Although often thought to promote restful sleep, the reality is much more complicated. Sleep disturbances and alterations of sleep quantity and quality have been reported. In addition, their sedative effects have been relatively well established and opioids can cause respiration to slow and become irregular, leading to hypercapnia and hypoxia. As a result, their usage has been linked to irregular or ataxic breathing (Biot's breathing) and their use has been associated with both central and obstructive sleep apnea. One could estimate that central apnea is a common complication of such chronic therapy, affecting between 30% and 90% of patients. Thus, sleep disturbances can be induced or deteriorated. On the other hand, extended release opioid formulations have been suggested to improve sleep due to no analgesic gaps and less walking because of breakthrough pain. Furthermore, several reports have shown significantly improved sleep quantity and adequacy, with reduced sleep disturbances. Still, as no prospective trials on the effect of opioid therapy on sleep are available and evidence is scarce, definitive conclusions cannot be drawn. Future studies with their effect on sleep as primary end-point are needed to draw permanent conclusions.

Risk factors for the development of persistent type II endoleaks after endovascular repair of infrarenal abdominal aortic aneurysms.

PURPOSE: To determine, based on preoperative imaging findings, which patients treated with endovascular abdominal aneurysm repair are at high risk for the development of persistent type II endoleaks. MATERIALS AND METHODS: Preoperative computed tomography (CT) angiographies of 136 patients, treated endovascularly, were retrospectively examined for possible anatomic predictors of type II endoleak development. Specifically, the number of patent aortic branches and thrombus load parameters (i.e., thickness, perimeter, area, and localization) were recorded. Thrombus load parameters were evaluated at the level of maximum aneurysm diameter, at the level of sac lumbar arteries' ostia, and at the level of inferior mesenteric artery ostium. Follow-up CT angiographies were also studied for the presence of persistent type II endoleaks (present at six-month follow-up examination). The association of these anatomic features with the development of persistent type II endoleaks was assessed using logistic regression analysis. RESULTS: Aortic branch patency increased the risk for persistent type II endoleak development, while thrombus load parameters decreased this risk. In multiple logistic regression analysis, the total number of patent aortic branches (odds ratio = 4.23, 95% confidence interval = 1.72-10.42, P = 0.002 for each additional branch), and the percentage of aortic perimeter covered by a thrombus at the level of the sac lumbar arteries' ostia (odds ratio = 0.16, 95% confidence interval = 0.06-0.44, P < 0.001 for a 15% increase) were independent predictors. CONCLUSION: Anatomic characteristics of a preoperative aorta can be used to predict patients with higher risk for persistent type II endoleak development.

A test of the psychometric properties of the cancer locus of control scale in Greek patients with advanced cancer.

OBJECTIVE: The study aimed to assess the psychometric properties of the Cancer Locus of Control (CLOC) scale on a Greek sample of advanced cancer patients. METHODS: The scale was translated with the forward-backward procedure to Greek. The CLOC scale was administered to 140 advanced cancer patients. It was administered twice, with a 3-day interval, to 100 (of the 140) eligible patients with advanced cancer. Together with the CLOC scale, the patients also completed the Greek Mental Adjustment to Cancer (G-MAC) scale. Confirmatory factor analysis was carried out using the AMOS 7.0 analysis. The reliability was assessed by the internal consistency (Cronbach's α coefficients), test-retest (Spearman's r value) of the instrument, and inter-item correlations. Construct validity was assessed using the G-MAC scale, interscale correlations, item-scale correlations, and scales-total correlations. RESULTS: The homogeneity of the subscales proved to be satisfactory (α coefficient ranged from 0.713 to 0.786). Overall test-retest reliability was satisfactory at p < 0.0005. Construct validity has shown moderate correlations with G-MAC p < 0.0005. Interscale and inter-item correlations were satisfactory at p < 0.05. CONCLUSIONS: The results suggest that the Greek version of CLOC administered in cancer patients treated in a palliative care unit is a reliable and valid clinical instrument.

Well-differentiated hand liposarcoma with bone metastases treated successfully with zoledronic Acid.

BACKGROUND: Well-differentiated liposarcomas of the upper extremities, such as the hand or forearm, are extremely rare and are commonly misdiagnosed and considered benign. They are frequently reported as having low metastatic potential. CASE REPORT: We report the case of a 58-year-old man with well-differentiated hand liposarcoma and diffuse bone metastases. The patient initially presented with a tumor of the thenar eminence and was treated with marginal surgical excision and external beam irradiation. 4 months after this treatment, soft tissue local recurrence and skeletal metastases were detected. Zoledronic acid treatment (4 mg per month) was initiated, and both the tumor and the metastases regressed. The patient remains cancer-free 3.5 years after diagnosis of the metastatic disease. CONCLUSION: Significant metastatic disease can develop in patients with well-differentiated liposarcomas. The beneficial effect of zoledronic acid observed in this case may be related to its anticancer properties, as described in phase III trials in various tumor types.

Fentanyl nasal spray for the treatment of cancer pain.

INTRODUCTION: Breakthrough pain, a transitory flare of pain in patients with otherwise controlled chronic pain, has been well characterized in cancer patients but despite medical awareness, sometimes remains underdiagnosed and therefore undertreated. AREAS COVERED: Oral transmucosal fentanyl citrate (OTFC) and fentanyl buccal tablets are the first medications developed specifically for the treatment of breakthrough pain in opioid-tolerant patients. Since oral administration of fentanyl is not an option for many cancer patients, the development of intranasal fentanyl spray (INFS) emerged as a more effective method of administration. Intranasal administration of fentanyl has several advantages over the oral/gastrointestinal route and clinical trials have shown that it is superior to OTFC while being well tolerated and more acceptable by the majority of patients. EXPERT OPINION: The aim of this review is to summarize the pharmacological characteristics and data obtained from clinical studies of INFS in the past few years, and present Fentanyl Pectin Nasal Spray (PecFent), which uses an innovative delivery system and is now approved in the EU. Finally, we discuss the impact that it may have in the future management of breakthrough pain in cancer patients, because an accurate diagnosis followed by the best treatment is crucial for effective pain alleviation.

The mediation effect of anxiety between post-traumatic stress symptoms and preparatory grief in advanced cancer patients.

CONTEXT: The relationship between anxiety and preparatory grief is complex and poorly understood. OBJECTIVES: To investigate the relationship between anxiety, post-traumatic stress symptoms, and preparatory grief in a sample of patients with advanced cancer. METHODS: Ninety-four patients with advanced cancer completed the Greek version of the Impact of Events Scale-Revised (IES-R-Gr), the Anxiety subscale of the Greek Hospital Anxiety and Depression Scale, and the Preparatory Grief in Advanced Cancer Patients (PGAC) scale. RESULTS: Statistically significant associations were found between IES-R-Gr subscales, anxiety (P<0.0005), and PGAC (P<0.0005). CONCLUSION: Some of the effect of post-traumatic stress symptoms on preparatory grief is mediated by anxiety.

Self-efficacy, depression, and physical distress in males and females with cancer.

AIMS: to examine the relationship between self-efficacy with depression and physical distressing symptoms in males and females with cancer. METHODS: a total of 41 males and 49 females with cancer completed the General Perceived Self-Efficacy Scale (GSE), depression scale, from the Hospital Anxiety and Depression Scale (HAD-D), and the MD Anderson Symptom Inventory (MDASI). RESULTS: correlations were found between depression and self-efficacy in males (r = -.501, P = .001) and females (r = -.588, P < .0005). The multivariate regression analysis revealed that education and depression could influence self-efficacy in male population. Urogenital versus breast cancer as well as depression seemed to influence females' self-efficacy. CONCLUSIONS: patients who had higher self-efficacy had lower depressive symptoms. Men with depressive symptoms and women with breast cancer and depression are more likely to have low self-efficacy than patients with other cancer types.

Intranasal fentanyl: from pharmacokinetics and bioavailability to current treatment applications.

Fentanyl, a short-acting synthetic pure opiate, offers an excellent option for the treatment of cancer and chronic pain. While oral administration is not an option, its high potency and lipophilicity have made intranasal administration feasible. Intranasal fentanyl has a bioavailability of 89%, with a short onset of action ( approximately 7 min) and duration times ( approximately 1 h). It bypasses the oral/gastrointestinal route, delivers the analgesic dose in a volume of 150 microl that can be adequately absorbed and, with a pH of 6.4, avoids local irritation. Intranasal fentanyl has been investigated to assess its potential as a well-tolerated acute postoperative breakthrough pain relief medication. It has been shown to be superior to oral transmucosal fentanyl for the treatment of cancer breakthrough pain. Similar analgesic effects to fentanyl or morphine intravenously and orally, with a similar safety profile, have been reported for postoperative or acute pain treatment of children and adults in the prehospital and hospital settings.

Attitudes of health care professionals, relatives of advanced cancer patients and public towards euthanasia and physician assisted suicide.

OBJECTIVES: Nowadays, euthanasia has the meaning of the direct administration of a lethal agent to the patient by another party with a merciful intent after patients' request. Physician assisted suicide refers to the patient intentionally and wilfully ending his or her own life with the assistance of a physician. The objectives of the manuscript were to investigate the opinions of Greek physicians, nurses, lay people and relatives of advanced cancer patients on euthanasia and physician assisted suicide. METHODS: The final sample consisted of 215 physicians, 250 nurses, 218 relatives and 246 lay people. A survey questionnaire was used concerning issues such as euthanasia and physician assisted suicide. The survey instrument included 13 questions and described issues such as religious and spiritual beliefs, euthanasia, physician assisted suicide and decision-making situations. RESULTS: 43.3% physicians and 41.3% relatives would agree in advance that in case of heart and/or respiratory arrest there would not be an effort to revive a terminally ill cancer patient. 20.5% physicians had a request for euthanasia. Significant associations were found between physicians (9.3%), relatives (1.8%, p=0.001) and lay people (3.7%, p=0.020) on their opinions regarding withdrawing treatment. CONCLUSIONS: The majority of the participants were opposed to euthanasia and physician assisted suicide. However many would agree to the legalization of an advanced cancer patient's hastened death.