Multidisciplinary management of the nocebo effect in biosimilar-treated IBD patients: Results of a workshop from the NOCE-BIO consensus group.

The high cost of biological drugs for patients with inflammatory bowel disease (IBD) considerably impacts on health-care budgets. Since the patent of biological products expired, cheaper biosimilars have entered the market. Available data coming from real-world cohorts and clinical trials indicate that the efficacy and safety of biosimilars is comparable to that of the originator drugs. Treating IBD patients with a biosimilar may be complicated by the risk of the nocebo effect, a negative effect of a pharmacological or non-pharmacological treatment, induced by patients's expectations and unrelated to the physiological action of the treatment. The nocebo effect can negatively affect treatment outcomes and hamper the cost-savings of biosimilars. Reducing the nocebo effect requires a multidisciplinary effort of all health-care providers in charge of biosimilar-treated IBD patients. The aim of the review is to reflect the key messages of an international workshop on this topic, including viewpoints from the perspective of physicians, nurses, psychologists, pharmacists and patients.

Psychological distress, anger and quality of life in polycystic ovary syndrome: associations with biochemical, phenotypical andsocio-demographic factors.

OBJECTIVE: To investigate the association between polycystic ovary syndrome (PCOS) and psychological disturbances, including anger. To analyze whether the biochemical/phenotypical features of PCOS play a role in the type and severity of psychological disorders. MATERIAL AND METHODS: This case-control study included 30 PCOS patients meeting NIH criteria and 30 non-PCOS women referring to Reproductive Medicine Unit for infertility. Complete clinical and biochemical screening and the self-reported psychological data [Symptom Check List 90-R (SCL-90-R); Short-Form Health Survey 36 (SF-36); and State-Trait Anger Expression Inventory-2 (STAXI-2)] were collected. Statistical analyses were performed with SPSS-21. RESULTS: Compared with control women, women with PCOS reported significantly higher scores on SCL-90-R scales of somatization, anxiety, hostility, psychoticism, overall psychological distress and a number of symptoms. At STAXI-2, patients with PCOS scored higher in trait-anger and in the outward expression of anger, while lower in outward anger-control; PCOS patients had significantly lower scores on SF-36 scales of physical functioning and bodily pain. Hirsutism was directly associated with anxiety. Regarding the associations between phenotypical/biochemical features and psychological distress in PCOS patients, results showed that waist-to-hip ratio is inversely related to anxiety, psychoticism, hostility and to the indexes of psychological distress; such inverse relationship was also seen between plasmatic levels of testosterone and trait-anger, and between total cholesterol and hostility. CONCLUSIONS: Results were consistent with the previous literature on the well-being of PCOS women (in particular for anxiety and quality of life [QoL]) but failed to find evidence for depression. The relationship between psychological distress and the features of the syndrome highlighted the role of hirsutism. With respect to hyperandrogenemia, our data rejected its involvement in the elevated negative mood states and affects. Adopting an interdisciplinary approach in the PCOS patients' care, anger showed to be common and deserves major consideration.

[Italian version of the Defense Mechanisms Rating Scales for Clinicians: a tool for the assessment of defense mechanisms in medical oncology]. / Versione italiana della Defence Mechanisms Rating Scales for Clinicians: uno strumento per la valutazione dei meccanismi di difesa del medico in oncologia.

INTRODUCTION: Facing distress situations arising from the interaction with the patient in oncology, eg breaking bad news, clinicians also, such as patients, protect themselves using unconscious defense mechanisms. Clinicians' psychic defenses topic is related to the clinicians training on communication with patients and to clinicians' individual characteristics issues. For clinicians the defensive functioning can be adaptive when mature defenses are activated or maladaptive if the defensive mode is immature, with implications on medical care effectiveness. It is therefore important to identify, assess and intervene on clinicians' defense mechanisms. The Defense Mechanisms Rating Scales for Clinicians (DMRS-C) is a tool developed as an addendum to the DMRS (originally created by Perry), for the assessment of clinician defenses. It is an assessment tool based on the observer, which can be applied to audio or video recordings, interviews transcripts or medical - psychotherapy sessions. This tool is currently available in French language only. AIM: The aim of this work is to translate and adapt DMRS-C in Italian. METHOD: The DMRS-C has been translated into Italian and back-translated into French in order to verify the correspondence with the original language. Psychometric properties of the scale has been investigated, in terms of face validity and reliability among judges, by calculating the intraclass coefficients Correlation, based on videotaped interviews of oncology visits from the Milan San Paolo Hospital video recordings Archive. RESULTS: The assessment tool has had positive findings for the purposes of intra-judges reliability (ICC=4.73; sd mean=80,33) and face validity. CONCLUSIONS: The consistency of the italian version with the original makes it suitable to highlight the frequency and variety of clinician defenses. This is the first study on medical oncologists defenses in real interviews. This tool will be useful to the fields of training and research on defenses in clinical care settings treating severe conditions such as oncology.

[Difficult conversations in nephrology: assessment of a formative experience]. / Le conversazioni difficili in nefrologia.

INTRODUCTION: Nephrologists often have to discuss difficult news with patients such as discussing treatment and prognosis, forgoing dialysis or end-of-life. Despite this, there are few educational interventions in this field. The aim of this study is to assess the efficacy of a workshop on difficult conversations in dialysis. METHOD: Within the Program to Enhance Relational and Communication Skills (PERCS) we developed a 4-hour workshop focused on communication in dialysis (PERCS-dialysis) at San Paolo Hospital,Milan. The workshop is geared around the enactment and debriefing of a case scenario. The scenario involves three conversations with a patient and a family member on dialysis and transplant. Before and after the workshop, participants are asked to complete a questionnaire on: sense of preparation, communication skills, relational skills, confidence and anxiety. The post-questionnaire also included some open-ended questions on the learning experience. RESULTS: 81 clinicians participated to 8 workshops. After the workshop, participants reported better preparation (p=.000) and confidence (p=.000). Perceived communication skills (p=.060), relational skills (p=.438) and anxiety (p=.441) improved but not significantly. All participants (100%) would recommend the workshop. In the open-ended questions participants reflected on the learning, appreciated the interactive methodology and offered suggestions. CONCLUSIONS: Consistently with the educational objectives, clinicians improved their preparedness and confidence in holding difficult conversations. Clinicians perception of their communication and relational abilities did not change. To affect these skills a longer and more intensive training is probably needed.

Satisfaction for quality of life: a comparison of patient and occupational therapist perspectives.

OBJECTIVE: To verify whether the patient's satisfaction with quality of life (QoL) is similar to or different from the occupational therapist's perception of the patient's satisfaction. MATERIALS AND METHODS: Each patient enrolled was given the Satisfaction Profile (SAT-P) questionnaire to be filled out personally; the same questionnaire, the SAT-P, was given to the respective occupational therapist who was asked to fill it out by evaluating the patient's satisfaction as perceived by the therapist. A descriptive statistic was applied for socio-demographic data to describe the cohort. Differences between patient and therapist answers to the SAT-P were evaluated using a t-test. RESULTS: 12 occupational therapists and 69 patients participated in the study. A significant difference between occupational therapist and patient was found for Factor II (physical functioning) (p = 0.048) and for Factor V (social functioning) (p = 0.011). The comparison of patient and therapist mean scores showed that therapists had a tendency to underestimate patient satisfaction levels for all factors except Factor IV. DISCUSSION: The results showed similarities between the therapist and the patient's view of the patient's satisfaction with QoL, confirming occupational therapy as a client-centred discipline. However, as far as physical functioning is concerned, it is possible that the professional makes an "a priori" judgement, considering the objective clinical data regardless of the patient's subjective experience of his/her illness.

Assumptions and blind spots in patient-centredness: action research between American and Italian health care professionals.

OBJECTIVE: To examine how patient-centredness is understood and enacted in an American (US) and an Italian group of health care professionals. METHODS: An action research methodology was used. Two interprofessional groups of US (n = 4) and Italian (n = 5) health care professionals independently wrote a patient-centred dialogue between a doctor and a patient based on the same scenario. The dialogues were then translated and exchanged. Both groups independently commented on the patient-centred aspects of the other's dialogue by completing a written questionnaire. Their respective comments were then shared by international videoconference. The transcript of the videoconference was analysed via content analysis. The participants' opinions about the study were then evaluated. RESULTS: Exploring the patient's illness experience and handling the patient's emotions were identified as core components of patient-centred care by both the US and Italian groups, but were expressed differently in their respective dialogues. Respecting the patient's autonomy was recognised as a component of patient-centred care only by the US group. The Italian group demonstrated a more implicitly paternalistic approach. Participants highlighted the usefulness of one another's feedback to uncover cultural assumptions of patient-centred care and increase self-awareness. CONCLUSIONS: Results suggest that the concept and practice of patient-centred care is variable and may be influenced by culture. The study methodology improved participants' self-awareness of cultural values, and has potential as a cost-effective, experiential educational approach.