Ethics and Data Management

Ethical issues have been considered carefully, as per the principles outlined in the Declaration of Helsinki (Declaration of Helsinki, 1964). Key ethical principles were taken into consideration, such as protecting anonymity, confidentiality, privacy, obtaining informed consent, avoiding deceptive practices, the protection of participants, briefing, the patient’s right to withdraw from the study at any time and the declaration of any conflict of interests.

The University of Salford and the JUH granted an ethical approval to the researcher (Appendix J and K). All data are anonymous. The researcher kept hard copy data (papers such as the questionnaire, consent form and demographic data sheet, and medical record data sheet) in a locked filing cabinet. In order to improve handling of the information, the researcher assigned a code to each participant. Moreover, the researcher saved soft copy data (such as Microsoft Word or Excel spreadsheet files) on a password-protected computer, which only the researcher could access.

According to the University of Salford’s requirements, the researcher and supervisory team performed a risk assessment prior to conducting the research. The researcher recognised three possible hazards: psychological distress for the involved patients, breaches of data confidentiality, and the possibility that using a driver could risk patients’ confidentiality about revealing potentially sensitive topics or issues.

To reduce the participants’ risk of psychological distress in the study, the researcher informed the participants that their participation was voluntary and approved by JUH, and that they could withdraw from the study at any point. In addition, the researcher considered the following precautions:

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 CCU nurses initially contacted potential participants

 The researcher provided the PIS to all patients who were eligible and expressed an interest in study participation.

 The researcher invited the patients to complete the questionnaire after their transfer from the CCU to MCU. At this point, they were medically stable, such as being clear site of cardiac catheterisation, chest pain-free for more than eight hours, and haemodynamically stable.

In order to reduce risks related to data confidentiality, the researcher followed the precautions listed below:

 The researcher kept hard copy data anonymously in a locked and separate filing cabinet

 Each participant was assigned a code in the study which was kept securely in locked filing cabinet that could only be accessed by the researcher

 The researcher kept software data on an encrypted computer, and only the researcher had the password.

In order to reduce the possibility of breaching the patients’ confidentiality through using a driver to collect the questionnaires and activPAL3™ monitors, the researcher considered the following steps:

 The researcher gave the driver used to collect the PA monitors the patients’ names and addresses only.

 The researcher gave an empty envelope to each participant to return the completed questionnaire.

 The agreed time to collect the questionnaire and activPAL3™ was a maximum of two hours, beginning from when the researcher called the driver, up until reaching the participant’s home, and a maximum of two hours from when the driver had left the participant’s home and returned to the researcher.

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4.3.7.2 Data Management

The following sections explain the procedures for the management of data collected for both questionnaires and ActivPAL3™ data during this study, including the accuracy of input, activPAL3™ data quality assessment protocol, missing data, activPAL3™ monitor data outcome measure and data analysis.

The researcher checked and stored the completed questionnaires and the participants’ consent forms in a separate, locked file cabinet. Then, the researcher entered questionnaire data into an SPSS IBM 22 file, which was stored on a password-protected computer for the researcher’s use only.

The researcher downloaded activPAL3™ data from each monitor using the activPAL3™ software package. These were stored in coded folders. In addition, the stored files did not include the participants’ names on the computer, thus ensuring the anonymity of all participants. Then, the researcher saved activPAL3™ data in Microsoft Excel 2010 spreadsheet software.

The researcher inspected the graphical activity profile over seven days for every participant and identified all grossly abnormal periods of activity that were out of character for the participants. In addition, the researcher inspected of the raw acceleration signals from abnormal periods in detail. If the acceleration signal remained constant throughout, this meant that the participants attached the monitor incorrectly and the researcher therefore excluded these data from the analysis. Examples of these abnormal periods included protracted periods of standing during the night and prolonged sedentary spells during the daytime in a participant who on other days changed position regularly.

The researcher saved numerical data for each of the seven days in Microsoft Excel 2010 spreadsheet software. The recorded data showed participants’ activity for 24 hours from 0100 to 2400 for seven consecutive days. Every hour recorded consisted of upright time and/or sedentary time. The researcher extracted the summary data for each hour and implemented summation of stepping and standing times to provide upright time. The participants were considered to be sedentary when the activPAL3™ signal registered sitting/lying. An event refers to each period of continuous upright or sedentary posture. All collected data from questionnaires and activPAL3™ were

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entered and kept together in an SPSS IBM 22 file, then checked for accuracy prior to analysis.