The SAKK cancer-specific geriatric assessment (C-SGA): a pilot study of a brief tool for clinical decision-making in older cancer patients

BACKGROUND Recommendations from international task forces on geriatric assessment emphasize the need for research including validation of cancer-specific geriatric assessment (C-SGA) tools in oncological settings. The objective of this study was to evaluate the feasibility of the SAKK Cancer-Specific Geriatric Assessment (C-SGA) in clinical practice. METHODS A cross sectional study of cancer patients >=65 years old (N = 51) with pathologically confirmed cancer presenting for initiation of chemotherapy treatment (07/01/2009-03/31/2011) at two oncology departments in Swiss canton hospitals: Kantonsspital Graubunden (KSGR N = 25), Kantonsspital St. Gallen (KSSG N = 26). Data was collected using three instruments, the SAKK C-SGA plus physician and patient evaluation forms. The SAKK C-SGA includes six measures covering five geriatric assessment domains (comorbidity, function, psychosocial, nutrition, cognition) using a mix of medical record abstraction (MRA) and patient interview. Five individual domains and one overall SAKK C-SGA score were calculated and dichotomized as below/above literature-based cut-offs. The SAKK C-SGA was evaluated by: patient and physician estimated time to complete, ease of completing, and difficult or unanswered questions. RESULTS Time to complete the patient questionnaire was considered acceptable by almost all (>=96%) patients and physicians. Patients reported slightly shorter times to complete the questionnaire than physicians (17.33 +/- 7.34 vs. 20.59 +/- 6.53 minutes, p = 0.02). Both groups rated the patient questionnaire as easy/fairly easy to complete (91% vs. 84% respectively, p = 0.14) with few difficult or unanswered questions. The MRA took on average 8.32 +/- 4.72 minutes to complete. Physicians (100%) considered time to complete MRA acceptable, 96% rated it as easy/fairly easy to complete. Individual study site populations differed on health-related characteristics (excellent/good physician-rated general health KSGR 71% vs. KSSG 32%, p = 0.007). The overall mean C-SGA score was 2.4 +/- 1.12. Patients at KSGR had lower C-SGA scores (2.00 +/- 1.19 vs. 2.81 +/- 0.90, p = 0.009) and a smaller proportion (28% vs.65%, p = 0.008) was above the C-SGA cut-off score compared to KSSG. CONCLUSIONS These results suggest the SAKK C-SGA is a feasible practical tool for use in clinical practice. It demonstrated discriminative ability based on objective geriatric assessment measures, but additional investigations on use for clinical decision-making are warranted. The SAKK C-SGA also provides important usable domain information for intervention to optimize outcomes in older cancer patients.

Myocardial Infarction - Stress PRevention INTervention (MI-SPRINT) to reduce the incidence of posttraumatic stress after acute myocardial infarction through trauma-focused psychological counseling: study protocol for a randomized controlled trial

BACKGROUND Posttraumatic Stress Disorder (PTSD) may occur in patients after exposure to a life-threatening illness. About one out of six patients develop clinically relevant levels of PTSD symptoms after acute myocardial infarction (MI). Symptoms of PTSD are associated with impaired quality of life and increase the risk of recurrent cardiovascular events. The main hypothesis of the MI-SPRINT study is that trauma-focused psychological counseling is more effective than non-trauma focused counseling in preventing posttraumatic stress after acute MI. METHODS/DESIGN The study is a single-center, randomized controlled psychological trial with two active intervention arms. The sample consists of 426 patients aged 18 years or older who are at 'high risk' to develop clinically relevant posttraumatic stress symptoms. 'High risk' patients are identified with three single-item questions with a numeric rating scale (0 to 10) asking about 'pain during MI', 'fear of dying until admission' and/or 'worrying and feeling helpless when being told about having MI'. Exclusion criteria are emergency heart surgery, severe comorbidities, current severe depression, disorientation, cognitive impairment and suicidal ideation. Patients will be randomly allocated to a single 45-minute counseling session targeting either specific MI-triggered traumatic reactions (that is, the verum intervention) or the general role of psychosocial stress in coronary heart disease (that is, the control intervention). The session will take place in the coronary care unit within 48 hours, by the bedside, after patients have reached stable circulatory conditions. Each patient will additionally receive an illustrated information booklet as study material. Sociodemographic factors, psychosocial and medical data, and cardiometabolic risk factors will be assessed during hospitalization. The primary outcome is the interviewer-rated posttraumatic stress level at three-month follow-up, which is hypothesized to be at least 20% lower in the verum group than in the control group using the t-test. Secondary outcomes are posttraumatic stress levels at 12-month follow-up, and psychosocial functioning and cardiometabolic risk factors at both follow-up assessments. DISCUSSION If the verum intervention proves to be effective, the study will be the first to show that a brief trauma-focused psychological intervention delivered within a somatic health care setting can reduce the incidence of posttraumatic stress in acute MI patients. TRIAL REGISTRATION ClinicalTrials.gov: NCT01781247.

ASSIP Attempted Suicide Short Intervention Program. A Manual for Clinicans

Attempted Suicide is the main risk factor for suicide. The Attempted Suicide Short Intervention Program (ASSIP) described in this manual is an innovative brief therapy that has proven to be highly effective in reducing the risk of further attempts. ASSIP is the result of the authors' extensive practical experience in the treatment of suicidal individuals. The emphasis is on the therapeutic alliance with the suicidal patient, based on an initial video-recorded narrative interview and the development of personalized safety strategies. The three to four therapy sessions are followed by continuing contact with patients by means of regular letters.

Workshop: ASSIP - Attempted Suicide Short Intervention Program. Theory, Practice, and 24 Months Follow-up RCT.

Background: ASSIP is a manualized brief therapy based on a model of suicide as goal-directed action, aimed at establishing a therapeutic alliance in a patient-oriented, collaborative approach. The main goals of the three-session program ASSIP are for patients to understand, from an observer’s position, patterns leading to a suicidal crisis, recognize triggers and warning signs, and to establish individual safety strategies for future suicidal crises. An ongoing therapeutic support is provided with regular letters over 24 months. Method: The study was conducted in a naturalistic setting. 120 Patients were randomly assigned to an intervention group (60 participants) treated with ASSIP combined with follow-up contact through letters, and a control group (60 participants) receiving a single session of clinical assessment. Both groups had treatment as usual. Patients completed a set of psychosocial and clinical questionnaires every six months over a period of 24 months. Results: In the ASSIP group 5 patients made a total of 5 reattempts, compared to 15 patients with 41 reattempts in the control group. The survival analysis yielded a significant difference with a Wald Chi2 of .000003. The ASSIP group had significantly lower suicidal ideation and fewer days of inpatient treatment compared to the control group. Higher scores in the Penn Helping Alliance Questionnaire were associated with lower suicidal ideation during follow-up. Conclusions: ASSIP is a highly effective brief therapy for patients with recent suicide attempts. Forming a strong therapeutic alliance is considered to be a major factor for outcome. ASSIP can be used with minimal training by experienced therapists. An English version of the manual will be published in May 2015.

Baseline quality of life as a predictor of exercise intervention adherence among endometrial cancer survivors

Background: The objective of this analysis is to test whether baseline quality of life (QOL) measurements, body mass index (BMI) and prior exercise behavior are significantly associated with (1) telephone counseling adherence, and (2) activity at the final assessment, in a physical activity promoting intervention among endometrial cancer survivors.^ Methods: One hundred endometrial cancer survivors not currently meeting physical activity guidelines completed baseline QOL and anthropometric assessments to measure general physical and mental health [Medical Outcomes Survey (SF-36)], sleep patterns and sleep quality [Pittsburgh Sleep Quality Index (PSQI)], perceived stress [Perceived Stress Scale (PSS)], cancer-specific concerns of long-term survivors [Quality of Life in Adult Cancer Survivors (QLACS)], and psychological distress [Brief Symptom Inventory-18 (BSI-18)]. Survivors were counseled by telephone during the 6-month intervention and their completion rate determined their adherence. The primary variables of interest included age, baseline BMI, baseline activity level, time since diagnosis, education, treatment received, and the SF-36 physical and mental component scores.^ Results: Final activity was most closely linked with baseline activity (p<.001) and less invasive surgery, being leaner and older, and experiencing less pain and more vitality. Telephone counseling was also predicted well by baseline activity, working less and having better overall cancer-related functioning.^ Conclusion: Above and beyond the QOL measures, baseline activity was the strongest predictor of both final activity and telephone counseling adherence. While education, surgery treatment type and bodily pain were important predictors for final exercise and employment status and cancer-related quality of life were important predictors for telephone counseling adherence, considering adaptive exercise interventions that focus heavily on engaging inactive participants may be a way to produce better exercise-related outcomes in the endometrial cancer survivor population.^

The Future Direction of Delaware Law (Including a Brief Exegesis on Fee Shifting Bylaws)

Delaware sets the governance standards for most public companies. The ability to attract corporations could not be explained solely by the existence of a favorable statutory regime. Delaware was not invariably the first or the only state to implement management friendly provisions. Given the interpretive gaps in the statute and the critical importance of the common law in the governance process, courts played an outsized role in setting legal standards. The management friendly nature of the Delaware courts contributed significantly to the state’s attraction to public corporations. A current example of a management friendly trend in the case law had seen the recent decisions setting out the board’s authority to adopt bylaws under Section 109 of the Delaware General Corporation Law (DGCL), particularly those involving the shifting of fees in litigation against the corporation or its directors. The DGCL allows bylaws that address “the business of the corporation, the conduct of its affairs, and its rights or powers or the rights or powers of its stockholders, directors, officers or employees.” The broad parameters are, however, subject to limits. Bylaws cannot be inconsistent with the certificate of incorporation or “the law.” Law includes the common law. The Delaware courts have used the limitations imposed by “the law” to severely restrict the reach of shareholder inspired bylaws. The courts have not used the same principles to impose similar restraints on bylaws adopted by the board of directors. This can be seen with respect to bylaws that restrict or even eliminate the right of shareholders to bring actions against management and the corporation. In ATP Tour, Inc. v. Deutscher Tennis Bund the court approved a fee shifting bylaw that had littl relationship to the internal affairs of the corporation. The decision upheld the bylaw as facially valid.The decision ignored a number of obvious legal infirmities. Among other things, the decision did not adequately address the requirement in Section 109(b) that bylaws be consistent with “the law.” The decision obliquely acknowledged that the provisions would “by their nature, deter litigation” but otherwise made no effort to assess the impact of this deterrence on shareholders causes of action. The provision in fact had the practical effect of restricting, if not eliminating, litigation rights granted by the DGCL and the common law. Perhaps most significantly, however, the bylaws significantly limited common law rights of shareholders to bring actions against the corporation and the board. Given the high dismissal rates for these actions, fee shifting bylaws imposed a meaningful risk of liability on plaintiffs. Moreover, because judgments in derivative suits were paid to the corporation, shareholders serving as plaintiffs confronted the risk of liability without any offsetting direct benefit. By preventing suits in this area, the bylaw effectively insulated the behavior of boards from legal challenge. The ATP decision was poorly reasoned and overstepped acceptable boundaries. The management friendly decision threatened the preeminent role of Delaware in the development of corporate law. The decision raised the specter of federal intervention and the potential for meaningful competition from the states. Because the opinion examined the bylaw in the context of non-stock companies, the reasoning may remain applicable only to those entities and never make the leap to for-profit stock corporations. Nonetheless, the analysis reflects a management friendly approach that does not adequately take into account the impact of the provision on the rights of shareholders.

The EU’s comprehensive approach towards security: the Lisbon Treaty and “smart power”. EU Centre Singpore Policy Brief No. 6, May 2013

The European Union (EU) has increasingly become a comprehensive security actor. With the development of the Common Foreign and Security Policy (CFSP), including the Common Security and Defence Policy (CSDP) as a reaction to the failure of the EU to act during the wars in Yugoslavia/Western Balkans in the 1990s, the EU has a wide range of instruments for crisis prevention, crisis management as well as post-crisis intervention at its disposal. Observers typically agree that “hard power” is no longer sufficient to address the complex security challenges of today’s world while the EU, often criticised for only utilising “soft power”, is now able to exercise “smart power”. Through a comprehensive approach, facilitated by the Lisbon Treaty, the EU can now use the various instruments at its disposal, such as diplomacy, development aid, humanitarian assistance, trade, sanctions, international cooperation and crisis management capabilities in a joined-up manner. This mix of tools and instruments is helping the EU to achieve the aim set out in its European Security Strategy: “a secure Europe in a better world”.

The Sahel Crisis: Where do European and African Perspectives Meet? IES Policy Brief Issue 2013/02/March 2013

Summary. The crisis in Mali has brought the Sahel to the centre of international attention. This fragile region not only suffers from longstanding development challenges, but also from an acute security vacuum that has triggered military intervention. Many questions have arisen as a consequence of the crisis. Has the European Union the ability to cope with such a complex and dynamically evolving security environment? How have divergent views on the political roadmap to be adopted, and the lack of resources at the African level, impacted the crisis response? Can the different players involved agree on what are the most pertinent needs and challenges to be addressed? Are they ready for long-term engagement? Can regional organisations effectively collaborate and are they able to successfully integrate different agendas? Following a conference organised by the Institute for European Studies, the Egmont Institute and the Observatoire de l’Afrique on these questions this Policy Brief builds on the findings of the conference and provides an analytical overview of the regional crisis by focusing on the main challenges facing the Sahel, the local and regional dynamics at play and the military and security response.

The European Union and global security: is the EU becoming the indispensable partner? EU Centre Singapore Background Brief No. 11, April 2014

The European Union has developed new capacity as a security actor in third countries, in particular in the area of crisis management. Over the past two decades the EU has deployed numerous missions, both of a civilian and military nature. Moreover the EU has defined its ability to intervene all along the ‘crisis cycle’, (from prevention to mediation, from peace-keeping to post-conflict reconstruction) and using all tools at its disposal (taking a ‘comprehensive approach’). However the EU is still not perceived as a major security provider globally and interventions remain limited to some geographic areas, mostly in its neighbourhood and Africa, with just a few examples further afield. The EU also tends to avoid taking direct action and seems to prefer partnership arrangements with other players. How can we explain the growing activism and number of EU’s intervention with the low impact and lack of visibility? Can we expect the EU to become more active in the future, taking on more responsibility and leading roles in addressing conflict situations? This paper will argue that the main reason for the EU’s hesitant role in crisis management is to be found in the weak decision-making provisions for EU’s security interventions, as one of the few policy areas still subject to consensus amongst 28 European Union Member States. Lack of a clearer delegation of competence or stronger coordination structures is closely linked to low legitimacy for the EU to take more robust action as a security actor. In order to overcome this legitimacy problem, and in order to facilitate consensus amongst Member States, the EU thus privileges partnership arrangements with other actors who can provide legitimacy and know-how, such as the UN or the African Union. As there is no political desire in the EU for tighter decision-making in this area, we can expect that the EU will continue to play a supporting rather than leading role in crisis management, becoming the partner of choice as it deepens its experience. However this does not mean that the EU is playing just a secondary role in the wider area of security, in particular when looking at nontraditional security. Looking at the role of the EU in Asia, where the EU has deployed just two missions, this paper will offer a broader assessment of the EU as a partner in the area of security taking into account different types of actions. The paper will argue that in order to strengthen cooperation with Asian partners in the area of crisis management, the EU will need to define better what it is able to offer, present its actions as part of an overall strategy rather than ad-hoc and piecemeal, and enter into partnership arrangements with different players in the region.

The politics of the “EMU governance”. European Policy Brief No. 7, February 2012

On 6 February 2012, Yves Bertoncini participated in a conference on European economic governance organized by Egmont – Royal Institute for International Relations. This Policy Brief is based on his intervention at the conference. The author pleads for a more encompassing form of EMU governance, which should be accompanied by a clarification of its democratic dimension.

The European and Southeast Asian Single Aviation Markets. EU Centre, Background Brief No. 15, July 2015

Civil aviation in Europe is one major area where landmark changes have taken place since the late 1980s – the liberalization and deregulation of the sector by member states in three “packages” in the 1980s has transformed an economic sector historically characterized by heavy protectionism, collusion and strong state intervention. Today, the European Union’s (EU) aviation sector contributes to 2.4% of European GDP and supports 5.1 million jobs. The Association of Southeast Asian Nations (ASEAN) has also eagerly taken steps to integrate its aviation markets as part of the ASEAN Economic Community (AEC) in 2015. This background brief chronicles the changes made in the aviation sector in Europe through regional integration and examines how these changes have affected policymaking in member states, the airline industry and consumers. The brief also examines ASEAN’s own effort in the integration of its own aviation sector and, taking into account the EU’s strong interest in cooperating with ASEAN on transport and civil aviation policy, whether the changes in the EU are applicable in the ASEAN context.

Screening for physical activity in family practice - Evaluation of two brief assessment tools

Background: Physical activity (PA) is relevant to the prevention and management of many health conditions in family practice. There is a need for an efficient, reliable, and valid assessment tool to identify patients in need of PA interventions. Methods: Twenty-eight family physicians in three Australian cities assessed the PA of their adult patients during 2004 using either a two- (2Q) or three-question (3Q) assessment. This was administered again approximately 3 days later to evaluate test-retest reliability. Concurrent validity was evaluated by measuring agreement with the Active Australia Questionnaire, and criterion validity by comparison with 7-day Computer Science Applications, Inc. (CSA) accelerometer counts. Results: A total of 509 patients participated, with 428 (84%) completing a repeat assessment, and 415 (82%) accelerometer monitoring. The brief assessments had moderate test-retest reliability (2Q k = 58.0%, 95% confidence interval [CI] = 47.2-68.8%; 3Q k = 55.6%, 95% CI = 43.8-67.4%); fair to moderate concurrent validity (2Q k = 46.7%, 95% CI = 35.657.9%; 3Q k = 38.7%, 95% CI = 26.4-51.1%); and poor to fair criterion validity (2Q k = 18.2%, 95% CI = 3.9-32.6%; 3Q k = 24.3%, 95% CI = 11.6-36.9%) for identifying patients as sufficiently active. A four-level scale of PA derived from the PA assessments was significantly correlated with accelerometer minutes (2Q rho = 0.39, 95% CI = 0.28-0.49; 3Q rho = 0.31, 95% CI = 0.18-0.43). Physicians reported that the assessments took I to 2 minutes to complete. Conclusions: Both PA assessments were feasible to use in family practice, and were suitable for identifying the least active patients. The 2Q assessment was preferred by clinicians and may be most appropriate for dissemination.

A randomised controlled trial of a CBT intervention for anxiety in children with Asperger syndrome

Background: The aim of the study was to evaluate the effectiveness of a brief CBT intervention for anxiety with children diagnosed with Asperger syndrome (AS). A second interest was to evaluate whether more intensive parent involvement would increase the child's ability to manage anxiety outside of the clinic setting. Methods: Seventy-one children aged ten to twelve years were recruited to participate in the anxiety programme. All children were diagnosed with AS and the presence of anxiety symptoms was accepted on parent report via brief interview. Children were randomly assigned to one of three conditions: intervention for child only, intervention for child and parent, wait-list control. Results: The two intervention groups demonstrated significant decreases in parent-reported anxiety symptoms at follow-up and a significant increase in the child's ability to generate positive strategies in an anxiety-provoking situation. There were a number of significant differences between the two interventions to suggest parent involvement as beneficial. Conclusions: The sample of children with AS in this study presented with a profile of anxiety similar to a sample of clinically diagnosed anxious children. The intervention was endorsed by parents as a useful programme for children diagnosed with Asperger syndrome and exhibiting anxiety symptoms, and active parent involvement enhanced the usefulness of the programme. Limitations of the study and future research are discussed.

A metacognitive contextual intervention to enhance error awareness and functional outcome following traumatic brain injury: A single-case experimental design

Very few empirically validated interventions for improving metacognitive skills (i.e., self-awareness and self-regulation) and functional outcomes have been reported. This single-case experimental study presents JM, a 36-year-old man with a very severe traumatic brain injury (TBI) who demonstrated long-term awareness deficits. Treatment at four years post-injury involved a metacognitive contextual intervention based on a conceptualization of neuro-cognitive, psychological, and socio-environmental factors contributing to his awareness deficits. The 16-week intervention targeted error awareness and self-correction in two real life settings: (a) cooking at home: and (b) volunteer work. Outcome measures included behavioral observation of error behavior and standardized awareness measures. Relative to baseline performance in the cooking setting, JM demonstrated a 44% reduction in error frequency and increased self-correction. Although no spontaneous generalization was evident in the volunteer work setting, specific training in this environment led to a 39% decrease in errors. JM later gained paid employment and received brief metacognitive training in his work environment. JM's global self-knowledge of deficits assessed by self-report was unchanged after the program. Overall, the study provides preliminary support for a metacognitive contextual approach to improve error awareness and functional Outcome in real life settings.

Evaluation of a mentored self -help intervention for the management of psychotic symptoms

Cognitive behavioral therapy has been shown to be promising for the treatment of individuals experiencing psychotic symptoms, who are often diagnosed with schizophrenia. Using a non-random non-equivalent comparison group design (n = 26), this study explores whether an individually mentored self-help and self-paced intervention based upon cognitive behavioral approaches to auditory hallucinations or "hearing voices" makes a significant positive difference for individuals with major mental disorder diagnoses and psychotic symptoms who are residing in the community and receiving community mental health services. The mentored self-help intervention uses a workbook (Coleman & Smith, 1997) that stemmed from the British psychiatric survivor and "voice hearers"' movements and from cognitive behavioral approaches to treating psychotic symptoms. Thirty individuals entered the study. Pre- and post-intervention assessments of 15 participants in the intervention group and 11 participants in the comparison group were carried out using standardized instruments, including the Rosenberg Self-Esteem Scale, the Brief Psychiatric Rating Scale, and the Hoosier Assurance Plan Inventory - Adult. Four specific research questions address whether levels of self-esteem, overall psychotic symptoms, depression-anxiety, and disruption in life improved in the intervention group, relative to the comparison group. Pre- and post-assessment scores were analyzed using repeated measures analysis of variance. Results showed no significant difference on any measure, with the exception of the Brief Psychiatric Rating subscale for Anxious Depression, which showed a statistically significant pre-post difference with a strong effect size. A conservative interpretation of this single positive result is that it is due to chance. An alternative interpretation is that the mentored self-help intervention made an actual improvement in the level of depression-anxiety experienced by participants. If so, this is particularly important given high levels of depression and suicide among individuals diagnosed with schizophrenia. This alternative interpretation supports further research on the intervention utilized in this study. ^