Pancreatic Cancer PSP (Germany) Protocol

Contents

Objective of the PSP and background

The purpose of this Protocol is to establish the objectives and obligations of the PSP Pancreatic Cancer and the fundamental roles and responsibilities of the partners involved. The protocol will be reviewed by the Steering Group on a regular basis, but at least every six
months.

The James Lind Alliance (JLA) is a non-profit initiative founded in 2004. It brings together patients, family members, nurses and health care professionals in a Priority Setting Partnership (PSP). These partnerships identify and prioritize the most important
uncertainties or "unanswered questions" about treatment effects. This is to help ensure that the health care providers are aware of what is really important for patients, family members, nurses and employees of the health care system.

Pancreatic cancer is currently the fourth most frequent cause of cancer deaths in Europe and the United States, and is expected to overtake breast cancer as the third most common cause of death in 2017. The prognosis of the pancreatic cancer is still one of the worst of all cancers (the relative 5-year survival is currently 8%).

Various occupational groups are involved in the care and treatment of patients with pancreatic cancer (surgeons, oncologists, outpatient and inpatient care, psychooncologists, general practitioners, palliative physicians, etc.). The treatment and care of patients with pancreatic cancer requires a multidisciplinary, intersectoral approach, from diagnosis through acute therapy to follow-up care, palliative therapy and, where necessary, support for death. Patients, relatives, nurses, surgeons and oncologists are faced with specific challenges because they must cope with the physical, psychosocial, emotional and organizational effects of cancer diagnosis and treatment.

Purpose and Objectives of PSP Pancreatic Cancer

The aim of the PSP Pancreatic Cancer is to identify the unanswered questions about the therapy and management of pancreatic cancer from the perspective of patients, family members and employees of the health system, and then prioritize those questions that are consistently rated by all groups as the most important.

The objectives of PSP pancreatic cancer are:

  • Collaborate with patients, family members, nurses and health care staff to identify open questions / uncertainties about the therapy / treatment of pancreatic cancer therapy
  • To agree by agreement a prioritized list of therapeutic uncertainties for further research
  • publish the process and the results of the PSP transparently.
  • submit studies on the prioritized results of public funding for research applications.

The "Steering Group"

The PSP Pancreas is managed and managed by the following persons:

Patient representatives:

  • Hans Berg (patient, regional group leader "working group of the pancreatectomized")
  • Renata Welz (patient)
  • Peter Knörr (husband)
  • Babak Jacob-Qmarsi (patient)
  • Susanne Jacob (wife)
  • Stefanie Böspflug (family members)
  • Gisela Köhler (patient)
  • Mr Köhler (husband)

Employees of the health care system

  • André L. Mihaljevic (Surgeon, Department of General, Visceral and Transplant Surgery, Heidelberg)
    Christin Tjaden (General Physician, Department of General, Visceral and Transplant Surgery Heidelberg, European Pancreas Center)
  • Tobias Aurig (nurse with specialization in anesthesia, intensive care and pain therapy, clinic for general, visceral and transplant surgery Heidelberg, head of the department of pancreatic surgery)
  • Michaela Wüsten (nurse specializing in anesthesia, intensive care and pain therapy, clinic for general, visceral and transplant surgery Heidelberg, head of the department of pancreatic surgery)
  • Dominik Bruckner (internist, hematologist, oncologist and palliative physician with practice in Weinheim)
  • Susanne Frankenhauser (anesthetist in Heidelberg University Hospital, palliative doctor of the palliative ward in St. Vincentius Hospital Heidelberg)
  • Thilo Hackert (surgeon, head of the Department of Pancreatic Surgery, Department of General, Visceral and Transplant Surgery Heidelberg)

Information Specialist:

  • Colette Dörr-Harim (Clinical Center for Surgery, Center for Surgery of the German Society for Surgery SDGC)

PSP Lead:

  • Rosa Klotz (surgeon, clinic for general, visceral and transplant surgery, Heidelberg) The partnership and the prioritization process are supported by
  • Maryrose Tarpey (Adviser, James Lind Alliance) and will be a member of the steering group

The Steering Group is made up of patients, family members and employees in the health care system (doctors, nurses, etc.). The members of the Steering group oversee the individual steps of the PSP process. The JLA adviser supports and guides the Steering Group in its work.

Other partners

Partners are groups or individuals who commit themselves to assist the PSP by distributing the PSP questionnaire and helping PSP to collect questions and uncertainties with practical clinical relevance related to the therapy and management of the pancreatic carcinoma. The partners represent the following groups:

  • People who have or have had a pancreatic carcinoma
  • Caring / caring / representative of people who have or have had a pancreatic carcinoma
  • Doctors, nurses and medical professionals with clinical experience in pancreatic cancer

Further details of partners are available on the PSP website : https://www.europaeischespankreaszentrum.de/index.php?id=13.

Methods of the PSP

Step 1: Identify and invite potential partners

Potential partner organizations have been identified by way of acquaintance and contact and via the networks of Steering Group members and invited to participate in an initial stakeholder meeting.

Step 2: Initial Stakeholder Meeting / Awareness Formation

The initial stakeholder meeting had the following main goals:

  • Welcoming and presenting the potential members of the PSP Pancreatic Cancer
  • present the intended plan for the PSP
  • Encourage discussion, answer questions and address concerns
  • Identify the potential partner organizations that commit themselves to the PSP and the persons who represent these organizations and serve as the principal contact partner for the PSP
  • Establish principles on the basis of which an open and transparent mechanism can be built
    that contributes to the work and progress of the PSP.

Step 3: Identification of treatment uncertainties

Each partner determines a method for acquiring questions and uncertainties with clinical relevance from the members of the Board regarding the therapy and management of the pancreatic carcinoma. To complete this task, up to three months are available.

The methods can be designed according to the circumstances and the affiliation of each organization, but must be as transparent, open and representative as possible. The methods can include member meetings, e-mail advice, questionnaire mail, web-based, Internet forums, and focus group work.

The Pancreatic Cancer PSP website provided a link to the first survey (July – October 2017) https://www.europaeisches-pankreaszentrum.de/extrainfo/psp-pankreaskarzinom/pspumfrage/

Existing sources of information regarding treatment uncertainties are searched for patients and clinicians. This can include a "question-answer service" for patients, nurses and clinicians, as well as research recommendations in systematic reviews and clinical
guidelines, protocols of planned systematic reviews, and records of ongoing research.

The starting point to identify sources of ambiguities and research recommendations is the CENTRAL library (http://www.cochranelibrary.com) and the MEDLINE database (for example, via PubMed, www.ncbi.nlm.nih.gov/pubmed).

Step 4: Further development of the questionnaire

The survey process will provide "raw" unanswered questions about treatment effects. These"raw" questions will be compiled by  Colette Dörr-Harim, Rosa Klotz and André L. Mihaljevic, categorized and further developed into "compiled indicative questions" which
are clear, researchable and understandable to all. Similar or duplicate questions are combined if necessary.

Systematic reviews and guidelines are identified and reviewed by Colette Dörr-Harim, Rosa Klotz and André L. Mihaljevic to see to what extent these advanced questions have been answered or not answered by previous research. Sometimes there are uncertainties that can be answered by the existing research paradigm, that is, "unknown knowledge" and not uncertainties. If a question about treatment effects can be answered with existing information but is not known, it suggests that the information is not communicated effectively enough to those who need it. Accordingly, the JLA urges that PSPs make a record of these questions to be answered and deal with them separately from the "true ambiguities" examined during the PSP process.

Uncertainties, which were not adequately addressed by previous research, are collected by Colette Dörr-Harim, Rosa Klotz and André L. Mihaljevic and recorded in a template. This will document the inspection carried out, which ensures that the uncertainties have not yet been answered. This is the responsibility of the Steering Group, which must determine the personnel and the resources to provide this responsibility. The data will be sent to the JLA for publication on the website when the PSP is completed, so that the results of the PSP are publicly available. This should take into account changes made during the final workshop.

The JLA will participate as a member of the steering group and adviser in this process to ensure accountability and transparency.

Step 5: Prioritization - Interim and final phase

The goal of the final phase of the priority setting process is to prioritize the identified uncertainties for the therapy or the management of the pancreatic carcinoma via a consensus. This is done by the members of the Steering Group and the wider partnership that represents patients and clinicians.

The interim priority setting stage, selects from a "longlist" of the submitted uncertainties to a "shortlist" which will be discussed in the final workshop (eg, up to 30 questions). The final step – final workshop – will then agree ten top questions of uncertainties, through small group discussions and plenary sessions.

The methods for this prioritization process are determined in consultation with the partner organizations and with the advice of the JLA consultant. The JLA adviser (Maryrose Tarpey) will support this process and ensure transparency, accountability and fairness. Participants are expected to announce potential conflicts of interest in advance.

Dissemination of results and research

Results and research

The results of the Priority Setting Partnership Pankreaskarzinom/ Pancreatic Cancer PSP are expected to be reported to funding and research organizations such as the German Research Foundation (DGF), the Federal Ministry of Education and Research (BMBF) and the Federal Ministry of Health (BMG).

Public relations

In addition to the information to sponsors, partners and members of the Steering Group will publish the results of the PSP pancreatic cancer using internal and external communication channels.

(English version of German PSP Prototol – text translated using google translate with
additional edits by Maryrose Tarpey Adviser James Lind Alliance)