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Publication[edit]

Publication:

Study Note[edit]

Brief summary[edit]

Study Design[edit]

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
Monocentric / Multicentric: Monocentric: conducted in one center/ hospital; </br>Multicentric: conducted in multiple centers/ hospitals
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
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[edit]

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.
Specifications on analyses:
Countries of data collection:
LoE: Level of evidence
Outcome timeline: Data collection times

Characteristics of participants[edit]

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.
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
Cancer stage specification:
Comorbidity:
Current cancer therapy:
Specifications on cancer therapies:
Previous cancer therapies:
Gender:
Gender specifications:
Age groups:
Age groups specification:


Arms[edit]

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Outcomes[edit]

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Funding and Conflicts of Interest[edit]

Funding:
Conflicts of Interest:

Further points for assessing the study[edit]

Sample[edit]

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

Alternative Explanation[edit]

Other explanations for an effect besides the investigated intervention
- Possibility of attention effects e.g. due to lack of a placebo arm
- Possibility of placebo effects
- Other reasons

Statistics[edit]

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
Correction for multiple testing
Measurement of compliance
Consistent reporting in numbers (figures, flowchart, abstract, results)
Comprehensive and coherent reporting
Cross-Over study
- Sufficient washout period
- Tested for carry-over effects
- Tested for sequence effects

Interpretation of results[edit]

Effect sizes reported (clinical vs. statistical significance)
Side effects systematically recorded
Side effects considered in result interpretation
Ethics votum

Additional Notes[edit]




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