A Feasibility Study of Direct Access to an Abdominal ´Yes-No´ Pathway for Primary Care Patients
A Feasibility Study of Direct Access to an Abdominal ´Yes-No´ Pathway for Primary Care Patients
Background To optimise cancer outcome in Denmark, cancer diagnostic pathways should, beside
 cancer patient pathways (CPP) for alarm symptoms, also include a pathway for patients with
 vague and non-specific symptoms. Research has demonstrated that 50% of all cancers do not
 qualify for specific CPPs, although the majority of patients initially present symptoms in
 general practice.

 Hypothesis Direct access to an abdominal 'yes-no' pathway is feasible in general practice.
 Aim The aim of this study is to assess the implementation and clinical implications of direct
 access to an abdominal 'yes-no' pathway for primary care patients with vague and non-specific
 abdominal symptoms Materials and methods The study is a feasibility study in which all
 general practitioners (GPs) in the municipality of Silkeborg in Central Denmark Region are
 offered direct access to a newly developed abdominal ´yes-no´ pathway for both men and women
 aged 30 years or above, who present vague and non-specific abdominal symptoms in primary
 care. The abdominal ´yes-no´ pathway consists of: 1) Medical and objective examination, 2)
 Selected blood samples and a Fecal Immunochemical test (FIT), and 3) Abdominal ultrasound
 (US) and transvaginal US (TVUS) (for women).

 Perspectives This study will provide important knowledge on how to improve abdominal cancer
 diagnostics in general practice.
Background Danish cancer patients have poorer cancer outcome compared to other European
 cancer patients. Earlier cancer diagnosis is a pivotal step to improve the prognosis, and
 there seems to be opportunity for improvement, as e.g. colon cancer is more often diagnosed
 at an advanced stage in Denmark than in other countries.

 In Denmark, more than 11,500 abdominal cancers are registered yearly, which corresponds to
 31% of all newly diagnosed cancers. The majority (75-85%) of cancer patients initially
 present symptoms to their GP. But only half of the patients present an alarm symptom, while
 20% present serious non-specific symptoms, and 30% present vague non-specific symptoms.
 Site-specific CPPs for alarm symptoms were implemented in Denmark in 2008/2009 to optimise
 the diagnostic route for cancer. In 2012, a new Danish CPP was implemented to target patients
 with serious non-specific symptoms and signs of cancer (NSSC-CPP). No pathway exists for
 patients with vague abdominal symptoms.

 Presenting in general practice with abdominal symptoms is very common. Most abdominal
 symptoms presented in general practice can be signs of serious disease in the abdomen and the
 pelvic region. However, in most cases, the symptoms are benign, self-limiting and harmless.
 Still, more than ten different cancer types can cause these symptoms, but clinically it is
 often difficult to distinguish between the symptoms.

 For patients presenting vague symptoms to the GP, the ideal strategy could be easy and direct
 access to relevant investigations rather than a wait-and-see approach or referral to a CPP.

 Aim The study sets out to investigate the need for an abdominal 'yes-no' pathway for primary
 care patients with vague and non-specific abdominal symptoms, how it could be clinically
 organised and integrated, and whether such pathway is feasible.

 Material and methods Prior to the current intervention, a developmental part was conducted in
 2018. It consisted of focus group meetings with 16 selected specialist, with expertise
 regarding patients with abdominal symptoms in general practice and abdominal cancers and
 other abdominal diseases.

 The investigators assembled two focus groups during autumn 2017, each comprising the
 following experts: two GPs, a physician with expertise in gastroenterology, an abdominal
 surgeon, a radiologist, a gynecologist, a microbiologist and a physician in clinical
 biochemistry. The focus groups aimed to develop and agree on an abdominal 'yes-no' pathway
 using the following criteria: 1) reduce the time to diagnosis, 2) avoid unnecessary tests, 3)
 increase patient safety and minimise missed opportunities, 4) order the specific
 investigations temporally, 5) place responsibility and develop a structure and 6) illustrate
 an optimal pathway.

 From January to September 2018, the investigators completed two meetings in each focus group,
 after which the investigators compared the results and gathered the groups in a common
 session. From the literature and the preliminary results of an yet unpublished register
 study, the investigators were able to present the clinical challenges to the participants
 during the meetings. Moreover, the possible access to investigations was presented
 (laboratory tests, imaging, endoscopies and access to specialist advice). Based on
 discussions during the meetings, the investigators developed an abdominal ´yes-no´ pathway.
 The abdominal ´yes-no´ pathway consists of three steps; 1) Medical and objective examination,
 2) Selected blood samples and a FIT, and 3) Abdominal US and TVUS. The GP continues to hold
 responsibility for follow-up, while hospital examinations are performed on an outpatient
 basis with direct access from general practice. After finished investigation, the results
 from the tests will all return electronically to the referring GP.

 The intervention is planned to initiate as a feasibility study at Silkeborg Regional Hospital
 from 1 April 2019. Agreements have been made with the hospital management, and an information
 meeting has taken place in March 2019 at the hospital. All GPs in the municipality of
 Silkeborg were invited to participate. An illustration, to hand out for involved GPs has been
 developed. Prior to investigation, all patients referred to the abdominal ´yes-no´ pathway
 will receive a consent form with information of the study. The inclusion period is 6 months
 from 1 April 2019 to 30 September 2019, after which the investigators will monitor the
 patients for up to 6 months.

 The study has been approved and is registered in the Record of Processing Activities at the
 Research Unit of General Practice in Aarhus in accordance with the provisions of the General
 Data Protection Regulation (GDPR). The Central Denmark Region Committees on Health Research
 Ethics has concluded that the study can be conducted without an approval from the Committees
 (Request 16/2019). Further, The committee on multi-practice studies under the Danish College
 of General Practitioners (DSAM) and the Organisation of General Practitioners in Denmark
 (PLO) have been asked to recommend GPs to participate in the study.

 The analyses will be descriptive with frequencies and incidence rates of use of the pathway
 corrected for practice population. An overview of all findings in the abdominal 'yes-no'
 pathway will be provided, and possible side effects will be assessed.

 Perspectives The study will provide new important knowledge of patients with vague and
 non-specific abdominal symptoms, who do not fulfil access criteria for the CPPs, but for whom
 the diagnosis of an abdominal cancer should not be missed. This may improve the diagnostics
 of abdominal cancers or other serious abdominal disease in the future, aiming to reduce time
 to diagnosis.
Inclusion Criteria:

 -  GPs in the municipality of Silkeborg can refer patients with the following criteria to
 Silkeborg Regional Hospital:

 Men and women ≥30 years old presenting with vague and non-specific abdominal symptoms for
 at least 3-4 weeks

 Exclusion Criteria:

 -  Men or women who fulfil access criteria for the CPPs.