European clinical guidelines for Tourette syndrome and other tic disorders: summary statement

In 2011 a working group of the European Society for the Study of Tourette syndrome (ESSTS) developed the first European Guidelines for Tourette syndrome (TS) published in the ECAP journal. After a decade ESSTS now presents updated guidelines, divided into four sections: Part I: assessment, Part II: psychological interventions, Part III: pharmacological treatment and Part IV: deep brain stimulation (DBS). In this paper, we summarise new developments described in the guidelines with respect to assessment and treatment of tics. Further, summary findings from a recent survey conducted amongst TS experts on these same topics are presented, as well as the first European patient representative statement on research. Finally, an updated decision tree is introduced providing a practical algorithm for the treatment of patients with TS. Interestingly, in the last decade there has been a significant shift in assessment and treatment of tics, with more emphasis on non-pharmacological treatments.

Enhancing Neurofibromatosis Clinical Trial Outcome Measures Through Patient Engagement: Lessons From REiNS

Objective:As part of an evaluation of the Response Evaluation in Neurofibromatosis and Schwannomatosis (REiNS) International Collaboration patient representative program, we surveyed REiNS members to 1) identify facilitators and barriers to involving patient representatives and 2) understand if and how involving patient representatives affected recommendations for clinical trial outcomes.Methods:We administered an anonymous, online survey to all REiNS members. Facilitators and barriers to patient representative involvement were solicited using a modified free listing technique; responses were inductively grouped into higher-order categories and ranked based on saliency score (Smith’s s). Open-ended questions assessed patient representative expectations for engagement, perceived benefits/costs of patient engagement, and patient representative contributions; responses were analyzed using conventional content analysis.Results:63/172 (37%) members responded, including 18/30 (60%) patient representatives. Providing sufficient opportunities to meaningfully engage in research tasks and cultivating a respectful, inclusive atmosphere were key facilitators to patient representatives’ satisfaction and ability to make an impact. Respondents perceived that patient representatives directly (through their input on research tasks) and indirectly (through effects on other stakeholders’ knowledge and communication style) improved the organization’s research, leading to selection of more meaningful, relevant, and feasible clinical trial outcome measures. Ongoing challenges to patient engagement include difficulty scheduling meetings and concerns about the level of scientific knowledge patient representatives needed to effectively engage.Conclusions:Involving patient representatives in REiNS improved perceived quality of neurofibromatosis clinical trial outcome measures. Negotiating sufficient opportunities to engage, fostering an inclusive atmosphere and navigating time pressures are key to effective patient engagement.

ESGO/ISUOG/IOTA/ESGE Consensus Statement on pre-operative diagnosis of ovarian tumors

The European Society of Gynaecological Oncology (ESGO), the International Society of Ultrasound in Obstetrics and Gynecology (ISUOG), the International Ovarian Tumour Analysis (IOTA) group, and the European Society for Gynaecological Endoscopy (ESGE) jointly developed clinically relevant and evidence-based statements on the pre-operative diagnosis of ovarian tumors, including imaging techniques, biomarkers, and prediction models. ESGO/ISUOG/IOTA/ESGE nominated a multidisciplinary international group, including expert practising clinicians and researchers who have demonstrated leadership and expertise in the pre-operative diagnosis of ovarian tumors and management of patients with ovarian cancer (19 experts across Europe). A patient representative was also included in the group. To ensure that the statements were evidence-based, the current literature was reviewed and critically appraised. Preliminary statements were drafted based on the review of the relevant literature. During a conference call, the whole group discussed each preliminary statement and a first round of voting was carried out. Statements were removed when a consensus among group members was not obtained. The voters had the opportunity to provide comments/suggestions with their votes. The statements were then revised accordingly. Another round of voting was carried out according to the same rules to allow the whole group to evaluate the revised version of the statements. The group achieved consensus on 18 statements. This Consensus Statement presents these ESGO/ISUOG/IOTA/ESGE statements on the pre-operative diagnosis of ovarian tumors and the assessment of carcinomatosis, together with a summary of the evidence supporting each statement.

Being a Patient Representative Is More Work Than Being a Patient Advocate—Done Right, It Is Also Likely to Be More Effective

For a patient to be effective as a “patient representative” within a health-related organization, work and more than just accepting an honorific title is required. I argue that for a patient to be most effective as a patient representative requires different types of background knowledge and commitment than being a “patient advocate”. Patients need to be cautious about how, when, and where they take on an official role of either an “advocate” or “representative”, if they truly want to be a positive influence on health outcomes.

Multidisciplinary team intervention to reduce the nocebo effect when switching from the originator infliximab to a biosimilar

ObjectivesTo evaluate an intervention to reduce the nocebo effect (NE) when switching from the originator infliximab (OI) to the infliximab biosimilar SB2 in chronic inflammatory rheumatic disease (CIRD).MethodsAn intervention was built with healthcare professionals (HPs) and a patient representative, based on a systematic review of interventions reducing the NE in musculoskeletal diseases and semi-directed questioning of five patients. Our strategy consisted of training HPs, switch information given by the nurses, a consistent vocabulary. All CIRD patients switched from OI to SB2 were included for the intervention. The primary outcome was the SB2 retention rate (RR) at 34 weeks. Secondary outcomes were the SB2 RR at 12 months, discontinuation rates due to a possible NE and comparison with a historical cohort of CIRD patients receiving the OI and 6 published European cohorts.Results45 patients were included from March 2018 (rheumatoid arthritis, n=17, spondylarthritis, n=28). After 34 weeks, the SB2 RR was 91.2%, similar to the historical cohort RR (p=0.41) but higher than the 3 European cohort RRs (p<0.05). At 12 months, the SB2 RR was 84.5% vs 88.4% for the historical cohort (p=0.52). SB2 discontinuation due to a possible NE was 6.6% after 12 months.ConclusionsA tailored communication with a prominent role of nurses reduced the NE in non-medical switches from the OI to SB2 as compared to published results. The RR was similar to the historical cohort RR. The methodology used to construct this intervention may help improve the outcomes of switches with upcoming biosimilars.

Necessity under construction – societal weighing rationality in the appraisal of health care technologies

Health care coverage decisions may employ many different considerations, which are brought together across two phases. The assessment phase examines the available scientific evidence, such as the cost-effectiveness, of the technology. The appraisal then contextualises this evidence to arrive at an (advised) coverage decision, but little is known about how this is done. In the Netherlands, the appraisal is set up to achieve a societal weighing and is the primary place where need- and solidarity-related (‘necessity’) argumentations are used. To elucidate how the Dutch appraisal committee ‘constructs necessity’, we analysed observations and recordings of two appraisal committee meetings at the National Health Care Institute, the corresponding documents (five), and interviews with committee members and policy makers (13 interviewees in 12 interviews), with attention to specific necessity argumentations. The Dutch appraisal committee constructs necessity in four phases: (1) allowing explicit criteria to steer the process; (2) allowing patient (representative) contributions to challenge the process; (3) bringing new argumentations in from outside and weaving them together; and (4) formulating recommendations to societal stakeholders. We argue that in these ways, the appraisal committee achieves societal weighing rationality, as the committee actively uses argumentations from society and embeds the decision outcome in society.

Human spermbots for patient-representative 3D ovarian cancer cell treatment

Human-sperm driven micromotors are attractive for locally delivering high concentrations of drug in hard-to-reach disease sites such as cervical cancer and early ovarian cancer lesions by non-invasive means.

AM I FRAIL, LOVE? YES, I SUPPOSE I AM: WHAT 10 OLDER PEOPLE CAN TELL US ABOUT LIVING WITH FRAILTY

We sought to explore what matters in later life with frailty from an older persons perspective. Between March and May 2018, we recruited ten people, purposively sampled from the CARE75+ ageing cohort study. Interviews took place at the participant’s own home in two sittings, each 45 minutes long. Interviews were semi-structured, used narrative techniques based on a topic guide developed with a patient representative. We used systematic analysis of the narrative experience to identify meaning in the context of an individual’s time, space and history. Participants had a mean age of 84 years (range 77 to 93), half were women, and three were interviewed with their care-givers. All had moderate or severe frailty: mean frailty index 0.36 (range 0.25 to 0.47); mean Fried score 4 (range 3 -5). Half knew hunger as children; most grew up in large families and left school early; two survived TB in early life; all lived through or were affected by war. The term frailty was: never voluntarily used; described negatively and in value laden terms; seen better in others than themselves. Decision making was best delegated to doctors who knew you and your family over time. Narratives focused on health events of a spouse; symptoms featured more than diagnoses. Survivorship, reciprocity and community were sustaining values. To engage elders in shared decision making we learnt to consider influences of cohort, of people closest to them; and to describe rather than declare someone to be frail, in terms that are real to them.

The deteriorating patient representative on a palliative care quality committee: Ethical and practical considerations

This case study describes the involvement of a patient representative on a palliative care committee and outlines some of the issues that arose as her health deteriorated. A summary of the increasing involvement of patient representation within health care governance is provided, and some of the challenges raised by the case, many of which may be relatively unique to palliative care, are discussed. It is hoped that presentation of this fairly novel scenario provides other palliative care providers with the opportunity to consider their own processes and practices around managing a similar situation should it occur in their healthcare setting.