Publication

Publication:

Study Note

Brief summary

Study Design

Prospective / Retrospective: Prospective: forward-looking, examples include clinical trials, cohort studies, and long-term observational studies; </br>Retrospective: backward-looking, relying on existing data, examples include case-control studies and retrospective cohort studies	Prospective Retrospective ? NI
Monocentric / Multicentric: Monocentric: conducted in one center/ hospital; </br>Multicentric: conducted in multiple centers/ hospitals	Monocentric Multicentric ? NI
Blinding: No: Open, all parties are aware of group assignments; </br>Single: one party is unaware of group assignments (generally participants); </br>Double: two parties are unaware of group assignments (generally the participants and the researchers); </br>Triple: concealing group assignment from additional parties	? No Single Double Triple NI
Is randomized:
Cross-over: Participants alternate between different treatment groups or conditions over a specified period, allowing each participant to serve as their own control
Number of arms:

Study characteristics

Inclusion criteria:
Exclusion criteria:
N randomized:
Analysis: PP: Per Protocol analysis, i.e. only participants included who adhered to the study protocol.</br>ITT: Intention-to-treat analysis, i.e. all randomized participants included regardless of any drop-outs or changes in assignment.</br>mITT: modified Intention-to-treat analysis can refer to analyses in which participants with missing outcome data are excluded or it can refer to analyses in which only participants who received at least one treatment dose are included. In this case, participants dropped out of the study prematurely for reasons unrelated to the treatment.	? PP Analysis ITT Analysis mITT Analysis NI
Specifications on analyses:
Countries of data collection:
LoE: Level of evidence
Outcome timeline: Data collection times

Characteristics of participants

Setting: Refers to cancer therapy setting.</br>- Curative therapy: aims to completely eradicate a disease and achieve a full recovery; </br>- Neo-adjuvant therapy: form of curative therapy, given before the primary treatment for cancer (usually surgery); </br>- Adjuvant therapy: form of curative therapy, given after the primary treatment for cancer (usually surgery); </br>- Palliative therapy: focuses on providing relief from symptoms and improving the quality of life for patients, without necessarily targeting the underlying disease; </br>- Active surveillance: involves close monitoring of disease progression without any intervention (typically used for prostate cancer);</br>- No therapy setting: Patients who completed therapy/are currently not in cancer treatment, cancer survivors.	? Curative Neo-adjuvant Adjuvant Palliative Active surveillance No therapy setting NI
Types of cancer: "Other Cancers" means that only a subpopulation was specified, but further unspecified cancer types were included
Cancer stage: Early Stage: generally refers to cancer that is localized to the area where it started, mostly stages I and II;</br>Advanced Stage: cancer that has spread beyond its original site, mostly stages III and IV, with stage IV indicating distant metastasis	Early Stage Advanced Stage ? NI NA
Cancer stage specification:
Comorbidity:
Current cancer therapy:
Specifications on cancer therapies:
Previous cancer therapies:
Gender:	? Male Female Mixed NI
Gender specifications:
Age groups:	? Children (0-15) Adolescents and young adults (15-39) Adults (18+) Elderly (65+) NI
Age groups specification:

Arms

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Outcomes

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Funding and Conflicts of Interest

Funding:
Conflicts of Interest:

Further points for assessing the study

Sample

Power analysis performed	Yes No NI ?
- Sample size corresponds to power analysis	Yes No NI NA ?
- Reasons for insufficient sample size based on power analysis
If no power analysis performed: at least moderate sample size (n >= 30 per arm)	Yes No NI ? NA
Ethnicity mentioned	Yes No NI ?

Alternative Explanation

Other explanations for an effect besides the investigated intervention	Yes No NI ?
- Possibility of attention effects e.g. due to lack of a placebo arm
- Possibility of placebo effects
- Other reasons

Statistics

Correct use of parametric and non-parametric tests Testing for normal distribution only necessary if parametric tests are used, NI: use of parametric tests without report of normal distribution testing	Yes No NI ?
Correction for multiple testing	Yes No NI NA ?
Measurement of compliance	Yes No NI NA ?
Consistent reporting in numbers (figures, flowchart, abstract, results)	Yes No NI ?
Comprehensive and coherent reporting	Yes No NI ?
Cross-Over study	Yes No NI ?
- Sufficient washout period	Yes No NI NA ?
- Tested for carry-over effects	Yes No NI NA ?
- Tested for sequence effects	Yes No NI NA ?

Interpretation of results

Effect sizes reported (clinical vs. statistical significance)	Yes No NI NA ?
Side effects systematically recorded	Yes No NI NA ?
Side effects considered in result interpretation	Yes No NI NA ?
Ethics votum	Yes No NI ?

Additional Notes

Summary:

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Edit RCT Study: Lintzeris, N

Contents

Publication

Study Note

Brief summary

Study Design

Study characteristics

Characteristics of participants

Arms

Outcomes

Risk of Bias Assessment: Cochrane RoB tool 2.0

Funding and Conflicts of Interest

Further points for assessing the study

Sample

Alternative Explanation

Statistics

Interpretation of results

Additional Notes