Leitlinienprogramm OnkologiePsycho-oncology

2. Introduction – Psycho-oncology

Version 2.0 · May 2023 · AWMF 032-051OL
Leitlinienprogramm Onkologie · Deutsche Krebsgesellschaft · Deutsche Krebshilfe · AWMF

2.1 Scope and Purpose

2.1.1 Objective and Key Questions

This guideline provides recommendations for psycho-oncological diagnosis, counseling and the treatment of adult cancer patients (≥18 years) during the entire course of a cancer illness as well as throughout all sectors of medical care. It provides the basis for implementing of psycho-oncological care services in all sectors. In particular:

  • The guideline should demonstrate the need for comprehensive psycho-oncological baseline documentation.
  • The guideline should be aligned with the goals of the National Cancer Plan [1] for psycho-oncological care.
  • The guideline should encourage regional cross-sector networking.
  • The quality of psycho-oncological services should assessed in order to evaluate the work of service providers.

The psycho-oncological concerns of cancer patients under 18 years of age (children and adolescents) are addressed in a separate S3 Guideline for Pediatric Oncology (https://www.awmf.org/leitlinien/detail/ll/025-002.html). The recommendations for this guideline are based on study data identified through systematic literature searches. In areas where a literature search was not possible, an expert consensus was attained through a formal consensus process.

2.1.2 Target Audience

The guideline is intened for all professional groups working in psycho-oncology and oncology such as physicians, psychologists, psychotherapists, social workers and social educators. Furthermore, patients are an important target group of this guideline, whereby a special patient guideline is offered for this target group within the framework of the German Guideline Program in Oncology.

2.1.3 Validity and Update Process

The S3 Guideline is valid until the next update. The validity period is set at 5 years from the date of publication of the updated version (2.0). Regular updates are planned. Comments and advice for the update process are welcome and can be sent to the following address: psychoonkologie@leitlinienprogramm-onkologie.de

2.2 Methodology

2.2.1 Levels of Evidence (LoE) According

The assessment and classification of the studies reviewed, with the exception of studies on screening procedures, was carried out in accordance with the Oxford Centre of Evidence-Based Medicine (see Table 4) system.

Table 4: Evidence Grading Scheme (based on the Oxford Centre of Evidence-Based Medicine scheme [available in full here]).

Studies on Therapy, Prevention, Etiology

Studies on the Quality of Diagnostic Testing

1a

High-quality systematic review (SR) of randomized controlled trials (RCT) with low risk of bias.

High-quality systematic review (SR) of validation cohort studies with low risk of bias

1b

Single RCT with low risk of bias

Single validation cohort study with low risk of bias

1c

„All or None" Principle*

Absolute SpPins and SnNouts**

2a

SR of cohort studies with low risk of bias.

SR of exploratory cohort studies

2b

Single cohort study with low risk of bias

Exploratory cohort study

2c

Outcome research; ecological studies

 

3a

SR of case-control studies

SR of 3b and better studies

3b

Single case-control study

Cohort study at risk for bias (e.g., nonconsecutive or lacking consistency in reference standards used

4

Case series

Diagnostic case-control study

5

Expert opinion or based on pathophysiological models or basic experimental research or „basic principles“

* Dramatic effects, e.g., all patients died before therapy was available and some survived after therapy was introduced.

** An “Absolute SpPin” is a diagnostic finding whose specificity is so high that a positive result rules-in the diagnosis. An “Absolute SnNout” is a diagnostic finding whose sensitivity is so high that a negative result rules-out the diagnosis.

 

2.2.2 Grades of Recommendation (GoR)

The methodology of the German Guideline Program in Oncology specifies that the grading of recommendation should be assigned by the guideline authors within the framework of a formal consensus process. Accordingly, moderated, nominal group processes or structured consensus conferences were conducted by the AWMF (see AWMF Guidelines Rulebook). During these processes, the recommendations were formally consented upon by the representatives holding the right to vote. The results of the respective votes (consensus strength) are assigned to the recommendations according to the categories listed below in the Table on Consensus Strength .

In this guideline, the level of evidence (see Chapter 2.2.1) of the underlying studies is indicated for each evidence-based statement (see Chapter 2.2.3) and recommendation: in the case of recommendations, the strength is also indicated. Three grades of recommendation are distinguished in this guideline (see the following table) and are reflected in the wording of the recommendations.

Scheme of recommendation grading

Grade of Recommendation 

Description 

Expression

A

Strong recommendation 

shall

B

Recommendation 

should

0

Open recommendation

can

Consensus Strength

Percentage of Consensus

Strong consensus

> 95% of those eligible to vote

Consensus

>75 – 95% of those eligible to vote

Majority consensus

50 – 75% of those eligible to vote

Dissent

<50% of those eligible to vote

2.2.3 Statements

Statements are presentations or explanations of specific subjects or questions that do not immediately require action. They are adopted in a formal consensus process, much in the same way as the recommendations, and are based either on study data or expert opinion.

2.2.4 Expert Consensus

Recommendations for which no literature search was conducted are referred to as ‘Expert consensus (EC)’. As a rule, these recommendations address procedures of good clinical practice for which no scientific studies are necessary or can be expected. No symbols were used for the gradation of "expert consensus"; the strength of the recommendation results from the wording used (shall/should/can) according to the grading in Chapter 2.3.2.

2.2.5 Independence and Disclosure of Possible Conflicts of Interest

Funding was provided by the German Cancer Aid Foundation through the German Guideline Program in Oncology (GGPO). These funds were used for personnel costs, office supplies, license fees, and literature procurement, as well as external support for updating the Patient Guideline. The development of the guideline was editorially independent of the funding organization. There were no additional sponsors. A standardized declaration of conflicts of interest was obtained from all participants in the guideline group. These were reviewed and evaluated by members of the WG Conflicts of Interest (Prof. Dr. Joachim Weis, Dr. Markus Follmann, Dipl. Psych. Thorsten Kreikenbohm). In individual cases, a consultation took place with the respective mandate holders. The assessment of the disclosed information demonstrated a minor conflict of interest for all mandate holders. Conflicts of interest of minor relevance could be giving lectures on guideline topics on behalf of pharmaceutical companies, membership in professional associations or societies, as well as funding of research by private donors. Moderate conflicts of interest (only defined as paid consulting activities for companies in the health care industry) as well as high-level conflict of interest (defined as ownership interests) were not found in any of the persons involved, Thus, corresponding countermeasures (moderate relevance: abstention rule when voting; high relevance: abstention from deliberations and voting) were not necessary. The results from the reviewing process can be found in the Guideline Report (https://www.leitlinienprogramm-onkologie.de/leitlinien/psychoonkologie/).

We would like to take this opportunity to thank the collaborators for their exclusively voluntary work on the project.

References

[1] Bundesgesundheitsministerium, Nationaler Krebsplan: Handlungsfelder, Ziele und Umsetzungsempfehlungen, Januar 2012., https://www.bundesgesundheitsministerium.de/fileadmin/Dateien/5_Publikationen/Praevention/Broschueren/Broschuere_Nationaler_Krebsplan-Handlungsfelder_Ziele_und_Umsetzungsempfehlungen_2012.pdf