Women's Experiences of Mammography: Quantitative Evaluation (WEM-Quant)

Study will develop, validate and pilot measures to assess quality of experiences of mammography. Pilot data collection and analysis will investigate modifiable factors most important in determining quality of patient experiences of mammography.

Study Overview

• Status: Completed
• Conditions: Breast Cancer

Detailed Description

While instruments to measure experiences of breast screening and mammography have been developed in the past, there is none which (a) concentrates in depth on the experience of the examination itself, (b) includes detailed breast positioning variables, (c) has been designed based on robust and transparent qualitative evidence, and (d) has been validated in a UK breast setting. Such a tool is needed to inform the design, development and testing of interventions to improve experiences of mammography. This is an important goal because many women are deterred from future breast screening by poor mammography experiences. Furthermore, regular client satisfaction surveys are required by the UK national breast screening programmes but there is no standard, validated measure in place.

The aim of this project is to develop, and obtain evidence for the validity of, a comprehensive toolkit of measures to evaluate experiences of mammography. The measures will be capable of assessing the quality of experiences of mammography and identifying modifiable predictors thereof. The investigators will pilot the measures in a sample of women attending for NHS breast screening. The resulting data will be used as the basis for building a statistical analysis model, for further validation of the measures, and for producing preliminary findings on what they are intended to measure.

Items generated from the investigators recent qualitative study will be combined with items from existing literature and with novel image-based metrics to draft comprehensive measures of women's mammography experiences. Questionnaires will capture 1. relevant modifiable potential determinants of overall quality of experience, such as the mammographer's ability to put the client at ease, 2. key potential confounding variables (e.g. client physical characteristics such as mobility problems or breast tenderness), and 3. outcome variables representing or postulated to contribute to overall quality of experience, including pain from the mammogram. Questionnaire development will follow established methods, including testing for face and content validity with a sample of field experts and of the target population, and checking for question design errors - such as leading questions - by a member of the team experienced in questionnaire construction. The draft questionnaires will be cognitively tested for understandability and acceptability with a small sample of women eligible for breast screening, and refined before administration to a larger sample of women attending for screening mammography. The questionnaire data will be incorporated into a statistical analysis model along with additional data which the investigators will extract from participants' mammographic images as follows.

The mammographic images will be examined for variables which may affect the client experience. These will include e.g. the compression force applied to the breast tissue during mammography, and features of the breast positioning technique. Thus, the measurement toolkit will have multiple parts. The investigators expect it to be capable of rigorous routine service and performance evaluation in mammography, of identifying what nature of interventions are needed to improve mammography experiences, and of evaluating the effectiveness of such interventions in the future.

• Study Type: Observational
• Enrollment (Actual): 311

Contacts and Locations

Study Locations

• United Kingdom
  • Scotland
    • Dundee, Scotland, United Kingdom, DD1 9SY
      • Ninewells Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 47 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women eligible for population-based breast screening in the UK, i.e. aged 47+

Description

Inclusion Criteria:

• Eligible for NHS breast screening
• Able to speak and write English.

Exclusion Criteria:

• Unable to provide informed consent

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction with mammography experience	11-point NRS	Immediate

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain from mammography	11-point NRS	Immediate
Intention to re-attend for mammography screening	11-point NRS	Immediate

Collaborators and Investigators

• Sponsor: University of Dundee
• Collaborators: NHS Tayside; University of St Andrews
• Investigators: Principal Investigator: Patsy Whelehan, MSc, University of Dundee and NHS Tayside

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2016
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): June 30, 2018

Study Registration Dates

• First Submitted: July 8, 2016
• First Submitted That Met QC Criteria: July 11, 2016
• First Posted (Estimate): July 12, 2016

Study Record Updates

• Last Update Posted (Actual): July 3, 2018
• Last Update Submitted That Met QC Criteria: July 2, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: patient satisfaction; mass screening; radiography; mammography
• Other Study ID Numbers: 2016ON15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Applications considered on case by case basis.