Una esperanza reflexiva

A qualitative study was undertaken to explore the views, experiences and acceptability of the REFORM package of care from the perspective of both service users and service providers. In particular, this

Design

A semistructured interview study was used to gather in-depth information on the trial participants’ experiences of receiving the podiatry intervention, alongside the podiatrists’experiences of delivering the intervention. The interviews were conducted either face to face or over the telephone with participants and podiatrists in the trial (at the end of the intervention period).

Sampling

A purposive sampling strategy was used to achieve a hetergeneous sample of trial participants from the intervention group to ensure maximum variation40_{according to age, sex and history of falls. Previous} studies have indicated that a sample of approximately 20–30 trial participants is sufficient to address the aforementioned aims from the point of view of the service users.

As podiatrists delivering the intervention were based in a wide variety of clinics, it was expected that their views and experiences may differ. For example, some podiatrists worked in biomechanics and others worked in routine podiatry clinics. All 28 podiatrists who delivered the REFORM intervention were invited for interviews through the PI at each site.

Recruitment and consent

All REFORM trial participants living in the Yorkshire or Lincolnshire areas who expressed an interest in undertaking other associated REFORM research studies on the consent form and who had received the intervention were eligible for participation in the qualitative study. Following sampling, study participants were approached by letter, which contained an information sheet (seeAppendix 15) and two consent forms (seeAppendix 16). The letter also informed trial participants that a qualitative researcher (authors AC and SC) would contact them via telephone to find out if they would be willing to take part and, if so, to arrange a time for the interview to take place. In accordance with ethics guidelines, informed consent was gained by the researcher before the commencement of the interview. The aim of the interview was explained to the participant, and this was followed by an opportunity for them to ask questions about the study. The anonymity and confidentiality of participants’personal information were assured by the researcher. Podiatrists were also invited to take part in the qualitative interviews. The PI at each site was sent an e-mail asking if he or she and the podiatrists who delivered the intervention would like to be interviewed. The PI was asked to forward the e-mail on to podiatrists at their site who delivered the intervention. Podiatrists were asked to contact the research team directly if they wished to take part. The recruitment e-mail included an invitation, information sheet (seeAppendix 17) and consent form (seeAppendix 18). This was followed up by a telephone call or an e-mail. Prior to the interviews, podiatrists were assured anonymity and confidentiality and were given the opportunity to ask questions. For podiatrists interviewed face to face, a similar process to that used to obtain consent for trial participants was used. For interviews conducted over the telephone, verbal consent was obtained prior to the start of the interview and a copy of the consent form was sent to the qualitative researcher either in the post or via e-mail.

Data collection

The semistructured interviews with trial participants were carried out in participants’homes or at the University of York between November 2013 and March 2016 and on average lasted 40 minutes using a topic guide (seeAppendix 19). All interviews were audio-recorded, transcribed and anonymised before data analysis. The semistructured interviews with podiatrists were carried out between July 2015 and January 2016 in a private room on premises where the podiatrist was based or over the telephone. The interviews lasted between 30 and 70 minutes and were conducted using a topic guide (seeAppendix 20).

The topic guides provided a framework for the semistructured interviews and ensured that all podiatrists and trial participants were asked the same questions, allowing comparisons to be made during the analysis. However, the wording of questions was not fixed to allow interviews to flow and to allow for probing when more detail was required.

METHODS

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Data analysis

An initial thematic analysis was carried out using the stages as outlined by Braun and Clarke:41_{(1) familiarisation,} (2) generating initial codes, (3) searching for themes, (4) reviewing themes, (5) defining and naming themes and (6) data reporting. An initial coding framework was developed based on a priori themes relating to issues included in the topic guide while allowing for emergent themes. Descriptive coding was conducted, following familiarisation with the data, by the main qualitative researcher on the project (author SC), informed by regular discussion with the qualitative team (authors JA and AC). Subsequently, initial codes were refined in order to address the aims of the qualitative study outlined above, following the analysis of the main trial. A constant comparison method42_{was used to check and compare across the data set and to} establish appropriate analytical categories. This also ensured that any additional codes were added to reflect as many of the nuances or outlier views in the data as possible, taking into consideration the participants’ wider contexts. Anonymised participant identifiers are used for the reporting of results.

To promote quality, the following strategies were used: description of the participants to provide context (credibility and transferability), transparency of the research process (transferability), evidence of consistency using multiple examples from data (dependability) and engagement of the wider research team with interim findings (confirmability). In addition, a reflexive approach was taken to data analysis. The main interviewers (authors SC and AC) were academic research fellows with no podiatry training. SC was the main REFORM trial co-ordinator and AC had no prior knowledge or experience of podiatry interventions, orthotic insoles or RCTs. The other member of the qualitative team (author JA) had an academic research background and also did not have previous knowledge or experience of podiatry care. This placed the qualitative research team in a very neutral position relating to any prior expectations relating to the study intervention.

Chapter 3

Protocol changes