Cross-sectional Study

The cross-sectional study required conducting an analysis of the baseline data gathered within the EEICC project’s longitudinal evaluation design, together with additional data on leadership again gathered at baseline.

As the wider project had an action research design, where teams participated in joint inquiry, evaluation and service development activities, each member of participating teams was individually consented into the study. It was felt that without consent of all individual team members, there was a danger that participants: -

a) could potentially be coerced into participating by team managers; b) may not be committed fully to participating in the inquiry, evaluation and service development activities required in the study.

The letter of invitation gave detailed information about the activities required for participation in the longitudinal study. The letter and consent form were also accompanied by an information sheet, which gave a more detailed summary of activities and the time commitment required for participation in each. Invitation letters and information sheets were also distributed at least one week prior to all IMT intervention events reminding participants about the event and what would happen. Each of these informed participants of their right to withdraw from the study at any time and not attend project events.

Staff were also given individual prepaid mail envelopes to return the Workforce Dynamics and Multifactor Leadership questionnaires. This gave them the option of individually deciding not to return the anonymised questionnaire forms.

There was also a small risk that staff who did not want to participate in the study may have been required to complete the client record pack.

Perhaps the main ethical issue arising within this study was the approach in which patients were automatically 'opted in' to the research, and had to actively withdraw their consent if they did not want to participate. However, because there was no direct intervention to the patient and the data was fully anonymised, this approach complied with the PIAG guidelines.

To further ensure that patients’ rights were not infringed in the study, service users were consulted about the proposed methods used in the research project. These service users did not identify any further ethical implications than those outlined above. Table 4.17 summarises the ethical arrangements for the study.

Table 4.17 - Summary of ethical arrangements for data gathering Activity/Data

Gathering Method

Brief Description Ethical Arrangements

Service Proforma

The Service Proforma was developed from a systematic review as part of a larger SDO workforce study (Nancarrow, 2004). It elicits data on variables that can impact on service delivery outcomes including, the setting of care, host organization, and the case mix of patients.

A letter of invitation to participate in the study, information sheet, consent form and prepaid mail envelope was sent to every team member. Staff could opt out of the study, or particular activities at any stage.

Workforce Dynamics Questionnaire (WDQ)

The WDQ is a validated, 58 item, Likert scale questionnaire That is self completed by participating team members. It explores 11 workforce domains. It was developed and validated in a study of older people’s services (Nancarrow et al., 2008).

As above. Staff can elect not to return the questionnaire, or return it incomplete if they do not wish to participate.

Multifactor Leadership Questionnaire (MLQ) form 5x peer rater data

The MLQ short form is a validated,45 item, Likert scale questionnaire which explores nine leadership dimensions and three additional variables measuring the impact of leadership behaviours on staff outcomes (Avolio and Bass, 2004). It was completed by all staff members of participating teams, asking them to assess the level of leadership they receive.

As above. Staff can elect not to return the questionnaire, or return it incomplete if they do not wish to participate.

Therapy Outcome Measures

The TOMS scale is a therapist- rated rehabilitation outcome measure. It contains four dimensions: Impairment (degree of severity of disorder); Activity (degree of limitation); Social participation; and Wellbeing (effect on

emotion/level of distress), with each dimension scored on an 11-point ordinal scale (0 to 5, including half-points). Lower scores indicate higher levels of impairment (Enderby et al., 2006).

Patients not required to be consented in, in accordance with PIAG guidelines.

Patients receive information sheet on discharge and can elect to opt out of the study.

EQ-5D

The EQ-5D, formerly know as the EuroQol, is a generic measure used primarily by economists to calculate quality adjusted life years (QALYs). It uses a single question to assess each of five health domains; mobility, self- care, usual activities, pain/discomfort and

anxiety/depression. The EQ-5D has a complex scoring system, which ranges from 1 which indicates full health, through to - 0.59 (EuroQol-Group, 2009).

Patients not required to be consented in, in accordance with PIAG guidelines.

Patients receive information sheet on discharge and can elect to opt out of the study.

Qualitative Interviews Fifteen semi-structured interviews took place with 15 staff members and team leaders of participating team.

All team members were mailed a letter of invitation to take part in the interviews, an information sheet, consent form and an invitation schedule and prepaid mailing envelope.

Participation was voluntary. Staff returned consent forms and made appointment for their interview.