Development of the Surgeon Satisfaction Self-Assessment Questionnaire for Shoulder Arthroscopy

August 10, 2024 updated by: İnci Hazal Ayas, Gazi University
This observational study aims to develop and validate the "Surgeon Satisfaction Self-Assessment Questionnaire for Shoulder Arthroscopy." The study involves conducting in-depth interviews with surgeons who perform shoulder arthroscopy to identify key factors influencing their surgical satisfaction, including individual, patient-related, and surgical equipment-related factors. Based on the insights gained from these interviews, a comprehensive questionnaire will be developed. The questionnaire will then undergo validation processes, including assessments of content, construct, criterion, and reliability, to ensure it accurately and consistently measures surgeon satisfaction. The final validated tool is intended to provide a reliable method for surgeons to self-assess their satisfaction with shoulder arthroscopy procedures, contributing to improved surgical practices and outcomes.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The "Surgeon Satisfaction Self-Assessment Questionnaire for Shoulder Arthroscopy" is being developed to address the need for a standardized tool to evaluate surgeon satisfaction in the context of shoulder arthroscopy. This study is structured into two primary phases: survey development and validation.

Phase 1: Survey Development In the initial phase, semi-structured interviews will be conducted with a diverse group of surgeons who specialize in shoulder arthroscopy. These interviews will explore various dimensions of surgical satisfaction, including technical factors, patient outcomes, surgical equipment performance, and team dynamics. The qualitative data obtained from these interviews will be analyzed to identify recurring themes and factors that are crucial to surgeon satisfaction. Based on these findings, a draft questionnaire will be developed, ensuring that it comprehensively covers all relevant aspects of the surgical experience.

Phase 2: Validation Process Once the questionnaire is drafted, it will undergo a rigorous validation process. Content validity will be established by consulting with a panel of experts in orthopedic surgery and psychometrics to ensure that the questionnaire items are both relevant and exhaustive. Construct validity will be tested using factor analysis to determine the underlying structure of the questionnaire and to ensure it accurately measures the intended constructs of satisfaction. Criterion validity will be assessed by comparing the questionnaire outcomes with established benchmarks or other validated tools. Additionally, the questionnaire's reliability will be evaluated through test-retest and internal consistency measures Cronbach's alpha.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
      • Ankara, Turkey, 06500
        • Gazi University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study population consists of orthopedic surgeons who specialize in shoulder arthroscopy and are actively engaged in performing these procedures. Participants will be recruited from a variety of clinical settings, including academic medical centers, private practices, and specialized orthopedic clinics. The surgeons included in the study will have diverse levels of experience, ranging from early-career surgeons with low practice to highly experienced surgeons with decades of experience in the field.

Description

Inclusion Criteria:

  • Orthopedic Surgeons:Must be a licensed orthopedic surgeon actively performing shoulder arthroscopy procedures.
  • Participants must be willing to provide informed consent and participate in both the questionnaire development (including interviews) and the validation phases of the study.
  • Participants must be proficient in the language in which the questionnaire is administered to ensure accurate and meaningful responses.

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Surgeons Performing Shoulder Arthroscopy
This is the main group of interest and includes surgeons who regularly perform shoulder arthroscopy. They will be the primary respondents to the survey and will provide insights into the factors affecting their surgical satisfaction.
Other: Surgeon Satisfaction Self-Assessment Questionnaire for Shoulder Arthroscopy
The intervention in this study involves the administration of the "Surgeon Satisfaction Self-Assessment Questionnaire for Shoulder Arthroscopy," a newly developed tool designed to measure various aspects of surgeon satisfaction related to shoulder arthroscopy procedures.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Validation of the Surgeon Satisfaction Self-Assessment Questionnaire for Shoulder Arthroscopy
Time Frame: 6 months
The primary outcome measure is the successful development and psychometric validation of the Surgeon Satisfaction Self-Assessment Questionnaire for Shoulder Arthroscopy.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gazi University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Ulunay Kanatlı, Professor, Gazi University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 10, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 14, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Iayas11

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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