Lung cancer (internet-based) Delphi (LUCiD): A modified eDelphi consensus process to establish Australasian clinical quality indicators for thoracic cancer.

BACKGROUND AND OBJECTIVE: Approximately 16,000 new cases of lung cancer are diagnosed each year in Australia and Aotearoa New Zealand, and it is the leading cause of cancer death in the region. Unwarranted variation in lung cancer care and outcomes has been described for many years, although clinical quality indicators to facilitate benchmarking across Australasia have not been established. The purpose of this study was to establish clinical quality indicators applicable to lung and other thoracic cancers across Australia and Aotearoa New Zealand. METHODS: Following a literature review, a modified three round eDelphi consensus process was completed between October 2022 and June 2023. Participants included clinicians from all relevant disciplines, patient advocates, researchers and other stakeholders, with representatives from all Australian states and territories and Aotearoa New Zealand. Consensus was set at a threshold of 70%, with the first two rounds conducted as online surveys, and the final round held as a hybrid in person and virtual consensus meeting. RESULTS: The literature review identified 422 international thoracic oncology indicators, and a total of 71 indicators were evaluated over the course of the Delphi consensus. Ultimately, 27 clinical quality indicators reached consensus, covering the continuum of thoracic oncologic care from diagnosis to first line treatment. Indicators benchmarking supportive care were poorly represented. Attendant numeric quality standards were developed to facilitate benchmarking. CONCLUSION: Twenty-seven clinical quality indicators relevant to thoracic oncology care in Australasia were developed. Real world implementation will now be explored utilizing a prospective dataset collected across Australia.

Management of psoriatic arthritis: a consensus opinion by expert rheumatologists.

Background: Psoriatic arthritis (PsA) is a chronic inflammatory musculoskeletal disease involving several articular and extra-articular structures. Despite the important progresses recently made in all of the aspects of this disease, its management is still burdened by unresolved issues. The aim of this exercise was to provide a set of statements that may be helpful for the management of PsA. Methods: A group of 38 Italian rheumatologists with recognized expertise in PsA selected and addressed the following four topics: "early PsA," "axial-PsA," "extra-articular manifestations and comorbidities," "therapeutic goals." Relevant articles from the literature (2016-2022) were selected by the experts based on a PubMed search. A number of statements for each topic were elaborated. Results: Ninety-four articles were selected and evaluated, 68 out of the 1,114 yielded by the literature search and 26 added by the Authors. Each of the four topic was subdivided in themes as follows: transition from psoriasis to PsA, imaging vs. CASPAR criteria in early diagnosis, early treatment for "early PsA"; axial-PsA vs. axialspondyloarthritis, diagnosis, clinical evaluation, treatment, standard radiography vs. magnetic resonance imaging for "axial PsA"; influence of inflammatory bowel disease on the therapeutic choice, cardiovascular comorbidity, bone damage, risk of infection for "comorbidities and extra-articular manifestations"; target and tools, treat-to-target strategy, role of imaging for "therapeutic goals." The final document consisted of 49 statements. Discussion: The final product of this exercise is a set of statements concerning the main issues of PsA management offering an expert opinion for some unmet needs of this complex disease.

Prevention and Treatment of Chemotherapy-Induced Peripheral Neuropathy (CIPN) with Non-Pharmacological Interventions: Clinical Recommendations from a Systematic Scoping Review and an Expert Consensus Process.

Background: Most individuals affected by cancer who are treated with certain chemotherapies suffer of CIPN. Therefore, there is a high patient and provider interest in complementary non-pharmacological therapies, but its evidence base has not yet been clearly pointed out in the context of CIPN. Methods: The results of a scoping review overviewing the published clinical evidence on the application of complementary therapies for improving the complex CIPN symptomatology are synthesized with the recommendations of an expert consensus process aiming to draw attention to supportive strategies for CIPN. The scoping review, registered at PROSPERO 2020 (CRD 42020165851), followed the PRISMA-ScR and JBI guidelines. Relevant studies published in Pubmed/MEDLINE, PsycINFO, PEDro, Cochrane CENTRAL, and CINAHL between 2000 and 2021 were included. CASP was used to evaluate the methodologic quality of the studies. Results: Seventy-five studies with mixed study quality met the inclusion criteria. Manipulative therapies (including massage, reflexology, therapeutic touch), rhythmical embrocations, movement and mind-body therapies, acupuncture/acupressure, and TENS/Scrambler therapy were the most frequently analyzed in research and may be effective treatment options for CIPN. The expert panel approved 17 supportive interventions, most of them were phytotherapeutic interventions including external applications and cryotherapy, hydrotherapy, and tactile stimulation. More than two-thirds of the consented interventions were rated with moderate to high perceived clinical effectiveness in therapeutic use. Conclusions: The evidence of both the review and the expert panel supports a variety of complementary procedures regarding the supportive treatment of CIPN; however, the application on patients should be individually weighed in each case. Based on this meta-synthesis, interprofessional healthcare teams may open up a dialogue with patients interested in non-pharmacological treatment options to tailor complementary counselling and treatments to their needs.

Funnel plots and choropleth maps in cancer risk communication: a Delphi study.

BACKGROUND: In the last decades, the issues related to health risk communication to stakeholders and citizens involving health care practitioners and local political authorities have been increasingly debated. The study evaluated an alternative strategy to communicate cancer risk to local communities, involving an expert panel of public health operators in comparing two different graphic tools, Funnel Plot and Choropleth map. STUDY DESIGN: A Delphi method process was implemented to achieve a unified consensus on an expert panel of public health operators with regard to weaknesses and strengths of the Funnel Plot and the Choropleth map as tools for cancer risk communication to local communities and other stakeholders. METHODS: Participants were asked to score the efficacy of the two tools using a scale. Six properties were explored through two consecutive consensus rounds. Scales were used to calculate frequencies and the content validity ratio for each domain within the consensus rounds. RESULTS: After the two consecutive rounds, participants expressed their preference in favour of the Choropleth map for its ability to define the spatial location of the risk and to locate any potential cluster, while reaching a consensus with regard to the Funnel Plot properties to identify hot spots, displaying the scope of the phenomenon under investigation, and to show the precision of estimates and communicating the significance of estimates. CONCLUSIONS: The Delphi process allowed us to conclude that Funnel Plot could be used as a complement to the current and commonly used graphical and visual formats to effectively communicate cancer epidemiological data to communities and local authorities, representing a useful tool for empowering the general population.

Identifying essential information to support patient decision-making regarding participation in cancer clinical trials: A Delphi study.

PURPOSES: This research set out to contribute to ongoing efforts to improve the quality of informed consent information provided to patients by specifically focusing on establishing consensus with regard to essential information to enhance the informed consent process. DESIGN AND METHODS: A Delphi consensus method was used to conduct three rounds of online surveys. Five groups of experts directly or indirectly involved in the informed consent process were invited to participate: patients, family members/friends, physicians, other health professionals and other key informants, including ethicists, contract research staff and pharmaceutical company staff. FINDINGS: Of 156 eligible participants, 101 participants (64.7%) completed all three rounds. In round 1, 994 information items were reported and generated into 74 statements. These were grouped under eight headings essential to the informed consent process. In rounds 2 and 3, the list was reduced to 15 statements representing consensus on essential information to be included in a summarised patient information document to support decision-making regarding trial participation. Risks and discomforts, participation requirements and trial governance were identified as important considerations. CONCLUSIONS: The 15 essential statements identified in this study could be used as components of a summarised information sheet given to potential cancer clinical trial participants, as an adjunct to the informed consent process. A robust evaluation of the impact of these statements on the quality of the informed consent process is needed.

Managing challenging interactions with family caregivers in the cancer setting: Guidelines for clinicians (TRIO Guidelines-2).

OBJECTIVE: Family caregivers can, at times, add complexity to clinical encounters. Difficult family caregivers and dynamics may: derail consultation communication, reduce patient autonomy, and compromise effective clinical care. A paucity of practical strategies guiding effective clinician-family communication exists. This study aimed to develop and evaluate the first comprehensive, evidence-based guidelines (the TRIO guidelines) for oncology physicians and nurses to better manage several complex/challenging situations involving family members. METHODS: TRIO Guidelines were based on a comprehensive review of literature, relevant guidelines, and feedback from an expert advisory group (n = 10). Draft guidelines underwent two rounds of evaluation via an online Delphi consensus process involving international experts (n = 35). RESULTS: Guidelines incorporate topic areas, strategies, and sub-strategies on managing challenging family involvement (7 topics). Example wording, behaviours and level of evidence are provided. CONCLUSION: Challenging triadic interactions require skillful navigation, and the TRIO Guidelines provide clear, specific, and evidence-based strategies for clinicians to utilise in these potentially stressful encounters. Training based on these guidelines may improve both patient care and clinician confidence. PRACTICE IMPLICATIONS: Implementation of these guidelines into medical/nursing curricula and as a component of continuing professional development programs will likely be highly beneficial.

Facilitating collaborative and effective family involvement in the cancer setting: Guidelines for clinicians (TRIO Guidelines-1).

OBJECTIVE: Family caregivers regularly attend medical consultations and are often involved in decision-making; however, there are few practical strategies to guide effective communication for the clinician-patient-family trio. We aimed to develop and evaluate the first comprehensive guidelines for oncology physicians and nurses, on how to positively and effectively involve family caregivers of adult patients in consultations and patient care (TRIO Guidelines-1) and how to manage challenging interactions with family caregivers (TRIO Guidelines-2). METHODS: The TRIO Guidelines were based on a comprehensive literature review and input from an expert advisory group (n = 10). They underwent two rounds of formal evaluation via an online Delphi consensus process involving international experts (n = 35), and a subset were piloted with 24 breast cancer clinicians in a workshop format. RESULTS: TRIO Guidelines-1 incorporate strategies and sub-strategies on facilitating collaborative and effective family involvement (6 topics). Example wording, behaviours, and level of evidence are provided throughout. All 24 clinicians rated the guidelines as helpful after the pilot workshop. CONCLUSION: These guidelines will be a useful educational tool for clinicians and medical/nursing students. PRACTICE IMPLICATIONS: By equipping clinicians with strategies to facilitate effective and collaborative family engagement, the TRIO Guidelines have the potential to transform communication in clinical practice.

Developing treatment guidelines for myasthenia gravis.

A task force of the Myasthenia Gravis Foundation of America recently published a formal consensus statement intended to be a treatment guide for clinicians caring for myasthenia gravis (MG) patients worldwide. Its development was stimulated by the fact that there is generally no accepted standard of care for MG, and no one treatment is best for all MG patients. Also, there are few randomized trials of treatments in current use, and the generalizability of the few trials that have been successful may be difficult. Fifteen international experts in MG participated in the consensus process, which used a simple consensus to develop preliminary definitions and the RAND/UCLA Appropriateness Method to quantify agreement on treatment guidance statements for seven topics: symptomatic and immunosuppressive treatment, intravenous immunoglobulin and plasma exchange, impending and manifest myasthenic crisis, thymectomy, juvenile MG, MG with muscle-specific tyrosine kinase antibodies, and MG in pregnancy. The executive summary of the guidance statement was published with open access to facilitate access by patients and healthcare professionals, and the full statement, with extensive background information, is available online. The guidance statement is a living document that will require updates as new treatments and new information on current treatments become available.

A core outcome set for localised prostate cancer effectiveness trials.

OBJECTIVE: To develop a core outcome set (COS) applicable for effectiveness trials of all interventions for localised prostate cancer. Many treatments exist for localised prostate cancer, although it is unclear which offers the optimal therapeutic ratio; which is confounded by inconsistencies in the selection, definition, measurement and reporting of outcomes in clinical trials. PATIENTS, SUBJECTS AND METHODS: A list of 79 outcomes was derived from a systematic review of published localised prostate cancer effectiveness studies and semi-structured interviews with 15 patients with prostate cancer patients. A two-stage consensus process involving 118 patients and 56 international healthcare professionals (HCPs; cancer specialist nurses, urological surgeons and oncologists) was undertaken, consisting of a three-round Delphi survey followed by a face-to-face consensus panel meeting of 13 HCPs and eight patients. RESULTS: The final COS included 19 outcomes. In all, 12 apply to all interventions: death from prostate cancer, death from any cause, local disease recurrence, distant disease recurrence/metastases, disease progression, need for salvage therapy, overall quality of life, stress urinary incontinence, urinary function, bowel function, faecal incontinence, and sexual function. Seven were intervention-specific: perioperative deaths (surgery), positive surgical margin (surgery), thromboembolic disease (surgery), bothersome or symptomatic urethral or anastomotic stricture (surgery), need for curative treatment (active surveillance), treatment failure (ablative therapy), and side-effects of hormonal therapy (hormone therapy). The UK-centric participants may limit the generalisability to other countries, but trialists should reason why the COS would not be applicable. The default position should not be that a COS developed in one country will automatically not be applicable elsewhere. CONCLUSION: We have established a COS for trials of effectiveness in localised prostate cancer, applicable across all interventions that should be measured in all localised prostate cancer effectiveness trials.

Euthanasia and physician-assisted suicide: A white paper from the European Association for Palliative Care.

BACKGROUND: In recognition of the ongoing discussion on euthanasia and physician-assisted suicide, the Board of Directors of the European Association for Palliative Care commissioned this white paper from the palliative care perspective. AIM: This white paper aims to provide an ethical framework for palliative care professionals on euthanasia and physician-assisted suicide. It also aims to provide an overview on the available evidence as well as a discourse of ethical principles related to these issues. DESIGN: Starting from a 2003 European Association for Palliative Care position paper, 21 statements were drafted and submitted to a five-round Delphi process PARTICIPANTS: A panel with 17 experts commented on the paper in round 1. Board members of national palliative care or hospice associations that are collective members of European Association for Palliative Care were invited to an online survey in rounds 2 and 3. The expert panel and the European Association for Palliative Care board members participated in rounds 4 and 5. This final version was adopted as an official position paper of the European Association for Palliative Care in April 2015. RESULTS: Main topics of the white paper are concepts and definitions of palliative care, its values and philosophy, euthanasia and physician-assisted suicide, key issues on the patient and the organizational level. The consensus process confirmed the 2003 European Association for Palliative Care white paper and its position on the relationship between palliative care and euthanasia and physician-assisted suicide. CONCLUSION: The European Association for Palliative Care feels that it is important to contribute to informed public debates on these issues. Complete consensus seems to be unachievable due to incompatible normative frameworks that clash.

Optimal systemic therapy for early breast cancer in women: a clinical practice guideline.

The Breast Cancer Disease Site Group of Cancer Care Ontario identified the need for new guidelines for the adjuvant systemic therapy of early-stage breast cancer. The specific question to be addressed was "What is the optimal adjuvant systemic therapy for female patients with early-stage operable breast cancer, when patient and disease factors are considered?" A systematic review was prepared based on literature searches conducted using the medline and embase databases for the period January 2008 to March 5, 2012, and updated to May 12, 2014. Guidelines were located from that search, from the Standards and Guidelines Evidence directory of cancer guidelines, and from the Web sites of major guideline organizations. The literature located was subdivided into the broad categories of chemotherapy, hormonal therapy, and therapy targeted to her2 (human epidermal growth factor receptor 2). Although several of the systemic therapies discussed in this guideline can be considered in the neoadjuvant setting, the review focused on trials with rates of disease-free and overall survival as endpoints and thus excluded several trials that used pathologic complete response as a primary endpoint. Based on the systematic review, the working group drafted recommendations on the use of chemotherapy, hormonal therapy, and targeted therapy; based on their professional experience, they also drafted recommendations on patient and disease characteristics and recurrence risk. The literature review and draft recommendations were circulated to a consensus panel of medical oncologists who had expertise in breast cancer and who represented the regions of Ontario. Items without initial consensus were discussed at an in-person consensus meeting held in Toronto, November 23, 2012. The final recommendations are those for which consensus was reached before or at the meeting. Some of the key evidence was revised after the updated literature search. Evidence reviews for systemic chemotherapy, endocrine therapy, and targeted therapy for her2-positive disease are reported in separate articles in this supplement. The full three-part 1-21 evidence-based series, including complete details of the development and consensus processes, can be found on the Cancer Care Ontario Web site at https://www.cancercare.on.ca/toolbox/qualityguidelines/diseasesite/breast-ebs.