Reliability and Validity of Mediterranean Colorectal Cancer Registry

Registries Clinical Trial

Official title:

Reliability and Validity of Mediterranean Colorectal Cancer Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03864640
• Other study ID #: 19920022019
• Status: Completed
• Start date: February 27, 2019
• Est. completion date: January 1, 2020

Study information

• Verified date: January 2020
• Source: Akdeniz University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study will examine the validity and reliability of the Mediterranean Colorectal Cancer Registry. Aspects of the analysis will cover parallel forms reliability, test-retest reliability, split half internal consistency and face validity of the Mediterranean Colorectal Cancer Registry.

Description:

Although central cancer registry programs have many benefits (the determination of national cancer incidences, strategic planning of health care systems etc.) data entry in such programs is often collected in restricted variables and physicians participating in the registration process may not be able to interact with each other during the management of their patients. For these reasons, a complete record in national general cancer registries can only be established retrospectively and the direct contribution to patient-specific diagnosis / treatment is limited. On the other hand, local registries have many advantages like easy integration of the data into the hospital electronic systems and multidisciplinary proactive enrollment.

Thus, characteristics of ongoing colorectal cancer registries (Swedish, South Australian, Oregon, Lublin, Ontario etc.) reported previously in the English medical literature are reviewed and an electronic form is tabulated for the Mediterranean Colorectal Cancer Registry. This study will examine the validity and reliability of this registry. Aspects of the analysis will cover construct validity, content validity, parallel forms reliability, test-retest reliability, split half internal consistency and face validity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients with colorectal cancer.

Exclusion Criteria:

• Patients reluctant to participate in the study.

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Registries

Locations

Country	Name	City	State
Turkey	Muhittin Yaprak	Antalya

Sponsors (1)

Lead Sponsor	Collaborator
Volkan Dogru

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Construct validity of Mediterranean Colorectal Cancer Registry: answering multiple-choice items	Construct validity will be based on the combination of qualitative and statistical methods in order to develop representative and structured set of multiple-choice items for colorectal cancer registry.	2 week
Primary	Content validity of Mediterranean Colorectal Cancer Registry: answering multiple-choice items	Content validity will be based on the combination of qualitative and statistical methods in order to develop shortest-possible but well-matched set of multiple-choice items reflecting the subjects being assessed in the colorectal cancer registry. .	2 week
Secondary	Parallel forms reliability of Mediterranean Colorectal Cancer Registry: answering multiple-choice items	Parallel forms reliability will be based on assessments analyzing the extent to which the items answered by different responders correlate with each other within their domain. It will be evaluated by correlation scores or positive predictive values according to the subject being assessed.	2 week
Secondary	Test-retest reliability of Mediterranean Colorectal Cancer Registry: answering multiple-choice items	Test-retest reliability will be based on the reproducibility of the answers to multiple-choice items during a specific time period of stable condition. It will be evaluated by intraclass correlation coefficient or positive predictive values according to the subject being assessed.	2 week
Secondary	Split half internal consistency of Mediterranean Colorectal Cancer Registry: answering multiple-choice items	Split half internal consistency will be based on the comparison of two sets of items inquirying the same subject. It will be evaluated by correlation scores or positive predictive values according to the subject being assessed.	2 week
Secondary	Face validity of Mediterranean Colorectal Cancer Registry: binary scoring of items	Face validity will be based on the scores of respondents indicating their overall positive or negative impression after evaluating each item for every file they registered.	2 week
Secondary	Face validity of Mediterranean Colorectal Cancer Registry: the major reason behind the negative response	For negative responses, respondents will provide further feedback whether the item was ambiguous, confusing, excessively short, excessively long or there was another reason for their negative impression.	2 week