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Data Collection and Ethics

COST2CARE Home

A retrospective chart review and patient and nurse surveys will be used to collect the data for this research project. 

Retrospective Chart Review

A retrospective chart review will be conducted to validate the rates of 4 nursing-sensitive adverse events (NSAEs) recorded in the administrative (HIPE) data. These adverse events are pneumonia, delirium, urinary tract infections and pressure injuries. The chart review will take place in one Model 4 hospital. Charts of inpatients who are aged over 65 years old, and have been admitted to general adult wards in that hospital for at least 72 hours will be included in the review. Admissions from the year 2022 will be the focus of the research and the charts will be randomly selected. The review will be carried out in a two-stage process consisting of both a primary and a secondary review stage. In the primary review stage, all randomly selected chart will be screened for the presence of one or more of the predefined NSAEs (pneumonia, delirium, UTI, pressure ulcer).  Only admissions indicating at least one potential NSAE will be sent forward to secondary review. In the secondary review stage, each potential NSAE will be assessed separately. Furthermore, the reviewers will document additional information, such as the severity of each adverse event identified. 

The rates of NSAEs available within the HIPE data will then be quantified. Finally, to verify the rates of adverse events, the data collected throughout the retrospective chart review will be compared to the data available within the HIPE data, therefore allowing the true rates of NSAEs will be uncovered. 

Process for withdrawal from the Chart Review

If for some reason a current patient or member of the public expresses a wish that their hospital chart/notes would not be included in this study there is a clear process to be followed.

For patients in the participating hospital:
Members of the public and patients will be advised through posters placed in the hospital and through this website that if they do not want their charts to be included in the review, they can make that request to the hospital. The COST2CARE hospital link person can be contacted through a phone number or email address contained on the posters. When a patient or member of the public makes contact with the hospital regarding exclusion from the study, they will be asked for personal details in order to identify their chart so that the Study Team can ensure that that particular chart is excluded from the chart review.

For members of the wider public:
If a person believes they meet the criteria for inclusion in the COST2CARE study, and does not want to be included in the study, but is unsure if the hospital where they were an inpatient is part of the study, they should contact the DCU team by emailing marcia.kirwan@dcu.ie. If they are confirmed to be eligible, the DCU team will direct them to the hospital COST2CARE link person as above.

The COST2CARE team at the hospital will collect certain personal details from the person in order to identify the chart. This might include Name, Address, Date of Birth, Date of Admission in 2022 and Date of Discharge. If the Medical Record Number(MRN) is known this should also be collected. If MRN is unknown the other details will enable identification of MRN. The COST2CARE team will notify the hospital HIPE manager of the request.

The HIPE manager will check if that person’s chart has been included in the file of randomly selected charts identified for the review. If the person’s chart has been randomly selected, but not yet extracted by the Review Team, the relevant MRN will be removed by the HIPE manager from those selected for review.

If on the other hand the chart review has already taken place when the member of the public requests removal through the COST2CARE team at the hospital as above, the HIPE manager can accommodate the request for withdrawal without the MRN being revealed to the DCU team. Such a query would result in the DCU team being advised that a particular record identified by the encrypted MRN should be removed from the analysis.

It is important to note that withdrawal from the study is possible at any point up to completion of data analysis. However, this can only be carried out through the process described above, as the DCU team will not be able to identify individuals in the anonymised datafile. Once final analysis is completed, and reports written, the research team will no longer be in a position to delete data from the final datafile.

The full process for withdrawal from the study is available here.  

NOTE:

The DCU team will ensure that no identifiable patient data will be included in the research datafile that will leave the hospital site. This process will be protected through the highest standards of data protection processes including a confidentiality agreement between the hospital and the data extraction team. No patient will be identifiable in the dataset or in any reports of this study.

 

Nurse and Patient Reported Surveys

Patient and nurse surveys will be conducted to explore missed nursing care from the perspectives of both patients and nurses. Through these surveys primary data on both patients’ and nurses’ experiences of missed care will be collected. The surveys will take place in the same Irish model 4 hospital as the retrospective chart review. 

The MISSCARE survey instrument developed by Dr. Beatrice Kalisch at the University of Michigan will be used to measure nurse reported missed nursing care. A survey will be distributed to interested nurses and they will be asked to indicate how frequently necessary nursing work is missed in their experience and to estimate the potential reasons for that care being missed. 

Missed nursing care impacts on overall quality and safety in an organisation, but ultimately it is experienced by the patient, therefore a patient reported survey will also be conducted. The MISSCARE Survey – Patient, also developed by Dr. Beatrice Kalisch, is specifically designed to elicit patient reports of the extent to which nursing care was provided. This instrument will be used to measure patient reported missed nursing care. The survey will be distributed to interested patients and using Likert scales, three core areas found to be important to patients – communication, timeliness, and the provision of basic nursing care will be measured. 

Prior to participating in the survey, all participants will be provided with a plain language statement detailing all relevant information relation to the study. As no personal data will be collected through the surveys, consent forms will not be required and participation in the survey or submission of a completed survey will imply that the participant has given their consent to be involved in the research project. After survey data has been collected, participants will not be able to change their minds and withdraw from the study because their responses will not be identifiable as no personal identifiers will have been collected.

NOTE:

All survey data will be entirely anonymous, no nurse or patient will be identifiable in the dataset or in any reports of this study.

Data Protection & Ethical Considerations


Ethical approval has been granted from the DCU Research Ethics Committee for this study. Ethical approval has also been granted from the relevant Hospital Research Ethics Committee.   

A consent declaration has been granted by the Health Research Consent Declaration Committee (HRCDC) to allow the researchers to conduct the chart review without explicit consent from each patient to review their chart. The HRCDC have determined that the public interest in this research outweighs the need for consent and a consent declaration has been granted. The declaration was granted under several conditions which have been met by the researchers. 

All three applications listed above were submitted following extensive consultation with the Data Protection Unit at DCU and the Data Protection Office at the hospital site. Both are satisfied that every data protection consideration has been addressed and that all participant data is protected. All datasets associated with this research are anonymous, and no participant will be identifiable in the datasets or in any research reports. Although the Chart Review Team will have access to the personal data of patients during the chart review process, they will not be retaining any identifiable personal data. No patient will be identifiable in the final datafile. A confidentiality agreement is in place between the Chart Review Team and the Study Hospital to further protect this process.