Innovative Patient Involvement During Covid-19: Keeping Patients at the Heart of HTA

The COVID-19 pandemic and lockdown measures in the United Kingdom resulted in significant challenges and created opportunities for innovation to keep patients at the heart of HTA. The introduction of the Coronavirus Act 2020 and the associated public health guidance meant that NICE's conventional HTA methods were no longer feasible. NICE introduced rapid, innovative updates to patient and public involvement (PPI), decision-making meetings, and consultations to harness the expertise of patients and the public to ensure guidance addressed the expected concerns and identified barriers which could impact access. This article describes the PPI support for NICE's rapid shift to virtual meetings and virtual engagement. We utilize the authors' experience and patient and public contributor feedback to understand the experience of participating in a virtual setting and identify four themes: accessibility; inclusivity; transparency; and intrapersonal relationships and committee dynamics. The article also considers how patient representatives participated in, and facilitated, the development of guidance for a hypothetical technology to keep patients and the public at the heart of expedited and novel HTA processes to identify and understand the expected patient concerns and potential barriers for when a technology would be introduced.

Opportunities and Barriers of Telemedicine in Rheumatology: A Participatory, Mixed-Methods Study

Despite all its promises, telemedicine is still not widely implemented in the care of rheumatic and musculoskeletal diseases (RMDs). The aim of this study is to investigate opportunities, barriers, acceptance, and preferences concerning telemedicine among RMD patients and professional stakeholders. From November 2017 to December 2019, a participatory, mixed-methods study was conducted, consisting of (1) expert interviews (n = 27) with RMD patients and professional stakeholders, (2) a national paper-based patient survey (n = 766), and (3) focus groups (n = 2) with patient representatives and rheumatologists. The qualitative findings indicate that patients equate personal contact with physical face-to-face contact, which could be reduced by implementing telemedicine, thus negatively influencing the patient–doctor relationship. Correspondingly “no personal contact with the doctor” is the main reason (64%) why 38% of the surveyed patients refuse to try telemedicine. Professional stakeholders expect telemedicine to contribute to the effective allocation of scarce resources in rheumatology care. The main barriers reported by stakeholders were the scarcity of time resources in RMD care, the absence of physical examinations, and organizational challenges associated with the implementation of telemedicine in RMD care. While the exact integration of telemedicine into routine care has yet to be found, the consequences on the patient-physician relationship must be permanently considered.

Delivery of Virtual Care in Oncology: Province-Wide Interprofessional Consensus Statements Using a Modified Delphi Process

Virtual cancer care (i.e., teleoncology) was rapidly adopted during the COVID-19 pandemic to meet the needs of patients with cancer. However, there is a paucity of guidance for clinicians regarding virtual cancer care. We sought to develop consensus-based statements to guide the optimal provision of virtual care for clinicians caring for patients with cancer, using a modified Delphi consensus process with a 29-member panel consisting of an interprofessional group of clinicians caring for patients with cancer and patient representatives. The consensus process consisted of two rounds and one synchronous final consensus meeting. At the end of the modified Delphi process, 62 of 62 statements achieved consensus. Fifty-seven statements reached consensus in the first round of the process. Concerns regarding the ability to convey difficult news virtually and maintaining similar standards as in-person care without disproportionate strain on clinicians and patients were addressed in the consensus process. We achieved interprofessional consensus on virtual cancer care practices. Further research examining the impact of virtual cancer care on person-centred and clinical outcomes are needed to inform practices during the COVID-19 pandemic and beyond.

P-O01 A patient education video to support the management of post-gastrectomy / oesophagectomy syndromes

Background Oesophagectomy and gastrectomy result in profound and life-long changes in eating behaviour and appetite, and significant post-prandial symptoms. Despite decades of research, and recent advantages in the understanding of gut physiology, medical approaches to post-resectional patient care remain limited. The mainstay of treatment is patient education. Using clinical and lab-based studies, we investigated the effects of altered gut hormone secretion in patients after surgery for oesophageal and gastric cancer. We then produced a partially animated patient information video to better equip our patients to manage their altered alimentation. Methods The scientific background to the video was previously presented at AUGIS, and published. Studies included examination of eating behaviour, post-prandial symptoms, glucose homeostasis, gut hormone profiles and intestinal transcriptomic / peptidomic changes in a cohort of patients after oesophagectomy and gastrectomy. The movie storyboard and script were written by a team of surgeons, dietitians, patient representatives, clinical scientists and communications specialists. The goal was to communicate the physiological basis of altered eating in post-operative patients and appropriate nutritional strategies. Results The video is now freely available on Vimeo at: https://vimeo.com/356892336 It is in routine use for pre- and post-operative patient education. Conclusions Multimedia patient education is a useful tool to help manage the late effects of upper GI cancer treatment.

Priorities for research in child and adolescent anxiety and depression: a priority setting partnership with youth and professionals

Background: A starting point for evaluating the effectiveness of treatments should be to identify evidence gaps. Furthermore, such evaluations should consider the perspectives of patients, clinicians and carers to ensure relevance and potentially influence future research initiatives. Methods: Our approach, inspired by the James Lind Alliance methods, involved three steps. First, we performed a document analysis by identifying interventions and outcomes in two recently published overviews of systematic reviews, which summarised the effects of interventions for anxiety and depression in children and adolescents. Second, we surveyed children and adolescents with personal experiences of depression or anxiety as well as clinicians, and asked them to suggest treatments and outcomes associated with uncertainty. Finally, we facilitated a consensus process where clinicians and youth mental health patient representatives were invited to prioritise research uncertainties in separate consensus processes. Results: The survey included 674 respondents who reported a total of 1267 uncertainties. Independent coding by four investigators revealed 134 suggestions for treatments of anxiety, 90 suggestions for treatments of depression, 84 for outcomes of interventions for anxiety and 71 suggestions for outcomes of interventions for depression. Two separate priority setting workshops with eight clinicians and ten youth resulted in four independent top ten priority lists. Conclusion: Top ten lists of treatments and outcome domains of anxiety and depression in children and adolescents was identified by youth and clinicians. The results may influence the research agenda, and ultimately benefit patients.

Geriatric Choosing Wisely choice of recommendations in France: a pragmatic approach based on clinical audits

Background The international Choosing Wisely campaign seeks to improve the appropriateness of care, notably through large campaigns among physicians and users designed to raise awareness of the risks inherent in overmedication. Methods In deploying the Choosing Wisely campaign, the French Society of Geriatrics and Gerontology chose early operationalization via a tool for clinical audit over a limited area before progressive dissemination. This enabled validation of four consensual recommendations concerning the management of urinary tract infections, the prolonged use of anxiolytics, the use of neuroleptics in dementia syndromes, and the use of statins in primary prevention. The fifth recommendation concerns the importance of a dialogue on the level of care. It was written by patient representatives directly involved in the campaign. Results The first cross-regional campaign in France involved 5337 chart screenings in 43 health facilities. Analysis of the results showed an important variability in practices between institutions and significant percentage of inappropriate prescriptions, notably of psychotropic medication. Discussion The high rate of participation of target institutions shows that geriatrics professionals are interested in the evaluation and optimization of professional practices. Frequent overuse of psychotropic medication highlights the need of campaigns to raise awareness and encourage deprescribing.

Building a National Reassessment Process for Oncology Drugs: Lessons Learned by the Canadian Real-World Evidence for Value of Cancer Drugs (CanREValue) Collaboration through a Simulated Reassessment Exercise

The CanREValue Collaboration established the Reassessment & Uptake Working Group to develop a preliminary process to reassess funded cancer drugs in Canada. A simulated exercise was conducted to evaluate the proposed reassessment process using a real-world case. We invited 32 attendees including representatives from Health Canada and Health Technology Assessment (HTA) agencies, along with payers, clinicians, academics, and patient representatives. A case was developed using a real-world study on a publicly funded cancer drug. In facilitated group sessions, participants were asked to deliberate upon the evidence presented in the case to issue reassessment recommendations. Several themes were identified through the deliberation discussions. While the generalizability of real-world evidence (RWE) is perceived as a strength, trust in the RWE depends largely on the source of the real-world data. The attendees suggested several improvements to the proposed reassessment process including evidence requirement for reassessment, recommendation categories, and a priori study protocols. This exercise generated important insights on the evidence required for conducting reassessment and considerations for improvements of the proposed reassessment process. Building upon lessons from this exercise, future work would continue to refine the reassessment process as part of the overall CanREValue framework.

American Society of Hematology living guidelines on the use of anticoagulation for thromboprophylaxis in patients with COVID-19: July 2021 update on post-discharge thromboprophylaxis

Background: COVID-19 related acute illness is associated with an increased risk of venous thromboembolism (VTE). Objective: These evidence-based guidelines of the American Society of Hematology (ASH) are intended to support patients, clinicians and other health care professionals in decisions about the use of anticoagulation for thromboprophylaxis in patients with COVID-19 who do not have confirmed or suspected VTE. Methods: ASH formed a multidisciplinary guideline panel, including three patient representatives, and applied strategies to minimize potential bias from conflicts of interest. The McMaster University GRADE Centre supported the guideline development process, including performing systematic evidence reviews (up to March 2021). The panel prioritized clinical questions and outcomes according to their importance for clinicians and patients. The panel used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to assess evidence and make recommendations, which were subject to public comment. Results: The panel agreed on one additional recommendation. The panel issued a conditional recommendation against the use of outpatient anticoagulant prophylaxis in patients with COVID-19 being discharged from the hospital who do not have suspected or confirmed VTE or another indication for anticoagulation. Conclusions: This recommendation was based on very low certainty in the evidence, underscoring the need for high-quality, randomized controlled trials assessing the role of post-discharge thromboprophylaxis. Other key research priorities include better evidence on assessing risk of thrombosis and bleeding outcomes in patients with COVID-19 after hospital discharge.

2021 DORIS definition of remission in SLE: final recommendations from an international task force

ObjectiveTo achieve consensus on a definition of remission in SLE (DORIS).BackgroundRemission is the stated goal for both patient and caregiver, but consensus on a definition of remission has been lacking. Previously, an international task force consisting of patient representatives and medical specialists published a framework for such a definition, without reaching a final recommendation.MethodsSeveral systematic literature reviews were performed and specific research questions examined in suitably chosen data sets. The findings were discussed, reformulated as recommendations and voted on.ResultsBased on data from the literature and several SLE-specific data sets, a set of recommendations was endorsed. Ultimately, the DORIS Task Force recommended a single definition of remission in SLE, based on clinical systemic lupus erythematosus disease activitiy index (SLEDAI)=0, Evaluator’s Global Assessment <0.5 (0–3), prednisolone 5 mg/day or less, and stable antimalarials, immunosuppressives, and biologics.ConclusionThe 2021 DORIS definition of remission in SLE is recommended for use in clinical care, education, and research including clinical trials and observational studies.