Reliability and Validity of Mediterranean Colorectal Cancer Registry

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.

Study Overview

• Status: Completed
• Conditions: Registries

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• Turkey
  • Antalya, Turkey, 07059
    • Muhittin Yaprak

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

- Adult patients with colorectal cancer

Description

Inclusion Criteria:

• Adult patients with colorectal cancer.

Exclusion Criteria:

• Patients reluctant to participate in the study.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Colorectal cancer; Patients with colorectal cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Volkan Doğru
• Investigators: Study Director: Muhittin Yaprak, Akdeniz Universitesi Hastanesi

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2019
• Primary Completion (Actual): January 1, 2020
• Study Completion (Actual): January 1, 2020

Study Registration Dates

• First Submitted: February 27, 2019
• First Submitted That Met QC Criteria: March 4, 2019
• First Posted (Actual): March 6, 2019

Study Record Updates

• Last Update Posted (Actual): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 15, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 19920022019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No