1. Bridging the gap between qualitative and quantitative research: A randomised controlled pilot and feasibility study of the effectiveness of music therapy in improving the quality of life of palliative care patients.
Professor Joanne Reid

2. Introductions who you are, where you are from,
how comfortable are you using both qualitative and quantitative research methods (very, somewhat, not at all)?

3. Qualitative and quantitative research – key differences
The obvious difference – numerical v. textual data; numbers v. words

4. Why use both qualitative and quantitative research methods?
You have a question that has rarely been asked or has been asked with questionable results
You want the strength of multiple methods - triangulation
Some, and only some, of your variables are easily quantifiable at this stage of inquiry
To “illuminate the black box” of relationships defined only in statistical terms
To hear from those who are rarely reached effectively by typical quantitative approaches

5. How to combine qualitative and quantitative research methods
Multi-methods research
E.g. more than one qualitative method
Mixed – methods research
Both qualitative and quantitative methods of data collection and analysis
MRC guidance 2008 included a process evaluation

6. Mixed method type
Research processes
Examples
Explanatory sequential
Quantitative data are collected and analysed first, then qualitative data are collected and analysed to help explain quantitative data QUAN →  QUAL
AIM: Identify levels of stress among new graduate registered nurses (RNs) working in emergency room (ER) settings QUAN: National survey of new RNs working in ER settings measuring levels of workplace stress QUAL: Personal interviews with 15–20 new RNs working in ER settings to discuss their experiences with stressful workplace situations SYNTHESIS: Sequential QUAL data help explain QUAN data
Exploratory sequential
Qualitative data are collected and analysed first, then quantitative data are collected and used to test findings empirically QUAL →   QUAN
AIM: Identify highest sources of workplace stress for new RNs working in hospital ERs QUAL: Focus group data collected from newly registered RNs working in hospital ERs within a local area health service to discuss workplace stress QUAN: QUAL data used to create a national survey administered to all RNs working in ERs about sources of workplace stress experienced within their first year of practice SYNTHESIS: Sequential QUAL data inform collection of QUAN data, which verify QUAL data
Parallel
Qualitative and quantitative data collected and analysed concurrently QUAL + QUAN
AIM: Identify sources of stress for RNs working in ER settings, personal coping strategies used and types of programmes or support systems provided by hospitals QUAN: National survey of all RNs working in ER departments, based on the literature, to identify common sources of stress and methods of support used by employers to reduce RN stress QUAL: Focus groups and interviews with a random selection of RNs working in ERs to broaden understanding of different sources of stress and personal coping strategies used SYNTHESIS: Data integration during interpretation phase after QUAN and QUAL data analyses
Nested
Can be either QUAL or QUAN main design with the alternative paradigm embedded within the study to answer a complementary question QUAL + quan or QUAN + qual
AIM: Test an online peer support programme designed to reduce workplace stress for new RNs working in ERs QUAN: RCT to test online programme effect on stress levels and intention to remain working in the ER QUAL: Interview nested in the RCT, focused on user experiences of the online programme SYNTHESIS: QUAL analysis embedded within the main QUAN study

7. Case study: A randomised controlled pilot and feasibility study of the effectiveness of music therapy in improving the quality of life of palliative care patients:
J.Reid,1 T.McConnell,1 M.Clarke,4. L.Graham,2 M.McKeown,2 J.Regan,2 K.McGrillen,2 J.Leitch,2 N.Hughes,3 & J.Kirkwood,3 S.Porter 5
1 School of Nursing and Midwifery, Queen’s University Belfast
2 Marie Curie Hospice Belfast
3 Every Day Harmony Music Therapy
4 School of Medicine, Dentistry and Biomedical Sciences, Queen’s University Belfast.
5 Social Sciences and Social Work, Bournemouth University 7

8. What is music therapy? https://www.youtube.com/watch?v=1NF73a9lPJY

9. Music therapy
Use of music and sounds to facilitate the development of a relationship between patients and professionally trained therapists with the aim of supporting relaxation and improving both physical and emotional well-being
Used in palliative care for more than a decade
In palliative care, the music therapeutic approach used is a creative process of musical interaction where the client engages while singing or playing, listening to music
or extemporaneously creating a melody, rhythm, song or instrumental piece. In the sessions, the music therapist uses music in various formats to meet the patients’ specific
needs. In doing so, they ‘make use of the therapeutic relationship established with the patient to meet clinical goals and employ a systematic therapeutic process that includes assessment, treatment and evaluation’
[17].

10. Background
Anecdotal evidence strongly supports music therapy as a palliative therapy, with the primary aim of improving people’s quality of life
……..However the evidence base is weak
…….Research challenging in this area
Anecdotal info suggesting benefits of music therapy BUT we need more scientific evidence to support it.
Several challenges to conducting music therapy randomised controlled trials (RCTs) in palliative care have also been identified, including high levels of attrition, the need for flexibility in time commitment and inclusion of family members if desired, and provision of a standardised yet tailored intervention

11. Study aims
Aim – the feasibility of conducting a phase III pragmatic RCT
Primary objectives
Outcome measures
Intervention duration
Recruitment and attrition rates
Secondary objectives
Indicative outcomes related to Quality of life
Inter-familial communication (data not available until results unlocked)
The main aim of the study is to evaluate the feasibility of administering the McGill Quality of Life Questionnaire
(MQOL) [23], reported to have the best clinometric quality rating, content validity, construct validity
and internal consistency of reviewed quality of life questionnaires [24].
In terms of ‘dose’ of music therapy, previous studies in palliative care patients have shown that a short course, consisting of two or more sessions, is effective and appropriate
for this population [25, 26].
We will also assess the viability of delivering a 3-week music therapy intervention, along with using recruitment and attrition rates to determine the sample size required for a phase III randomised controlled trial. 2
The potential effectiveness of music therapy upon quality of life at week one (one to two music therapy sessions), week three (after completion of the music therapy course) and week five (two weeks after completion of music therapy)
The effect of music therapy upon inter-familial Communication. Carer interviews aim to assess whether music therapy improves inter-familial communication within a palliative
care population. In the absence of a validated tool to measure this outcome, an interview topic guide will be developed by the research team.

12. Method UK-based, single-centre, pilot RCT
Two parallel arms (randomised 1:1)
Participants (n>52) 18-bed specialist palliative care inpatient unit in Northern Ireland
Eligibility criteria - ECOG≤ 3, AMT≥ 7
McGill Quality of Life Questionnaire (MQOL), and socio-demographic data.
Baseline (before randomisation), one, three and five-week follow-up
Qualitative data collection – patients and focus groups HCPs to examine impact and context
UK-based, single-centre, pilot RCT
Two parallel arms, one receiving individual music therapy in addition to usual care, and the other receiving usual care only. Participants (n>52) recruited from the inpatient unit at an 18-bed specialist palliative care inpatient unit in Northern Ireland.
The aim is to recruit 52 patients across both treatment allocations (33% more than the minimum recommended for good practise [33] including a 30% attrition allowance as recommended for a palliative care population. The calculation of the sample size was informed both by good practise for feasibility trials.
Participants will be randomly assigned to two groups. Patients assigned to the control group will receive usual care only from the hospice multidisciplinary team. The
dose and frequency of usual care will be as deemed appropriate by the hospice practitioner in charge of their treatment. As music therapy is not part of usual care within this hospice, the control group participants will be offered two sessions of music therapy upon completion of their time in the study.
In addition to the usual care described above, patients assigned to the experimental group will receive music therapy in an individual setting, delivered by a trained music therapist. Music therapy will be conducted for up to 45 min twice a week. A total of six sessions will be offered, with the aim of completing at least four sessions.
Eligibility will be assessed by a hospice clinician during inpatient admission or day hospice attendance using the Eastern Cooperative Oncology Group (ECOG) scale and
the Abbreviated Mental Test (AMT).
The ECOG [28] scale is most frequently used by physicians for assessing palliative care patients’ level of functioning [29]. An ECOG performance status of 0, 1, 2 or 3
(0 indicating the patient is asymptomatic, 1 the patient is symptomatic but fully ambulatory, 2 the patient is symptomatic and confined to bed for less than 50% of the day and 3 the patient is symptomatic and confined to bed for more than 50% of the day) indicating they are able to engage with interactive music therapy
The Abbreviated Mental Test AMT [30] has good validity and is widely used to screen for cognitive impairment within a palliative care population [31]. A score of 7 or more on the AMT, indicating they are capable of providing meaningful informed consent and accurate responses to the study’s primary outcome measurement tool.

13. Analysis
MQoL questionnaire - evaluated at each data collection point - feedback on the questionnaire’s appropriateness and level of burden
The viability of delivering a 3-week music therapy intervention - assessed by the number of patients completing the intervention and reasons for attrition
Recruitment and attrition figures - power calculation for definitive RCT
The potential effectiveness of music therapy- change in the outcome variables from baseline
Qualitative methods, in particular interviews and focus groups, will be used to assess impact, interfamilial communication and contextual factors
The feasibility of using the MQOL questionnaire will be evaluated by the researcher at each data collection point through feedback from patients on the questionnaire’s
appropriateness and level of burden. The number of completed questionnaires will also be monitored along with reasons for non-completion.
The viability of delivering a 3-week music therapy intervention will be assessed by the number of patients completing the intervention along with reasons for attrition.
Recruitment and attrition figures will be used to conduct a power calculation. This will be conducted by the Northern Ireland Clinical Trials Unit to determine the sample size required
for a phase III randomised controlled trial.
To assess the potential effectiveness of music therapy, data will be analysed using SPSS. The change in the outcome variable from baseline to 1 week, 3 weeks and 5 weeks, will be
compared between the experimental and control group using analysis of covariance [35]. To detect differences within groups, repeated measures ANOVAs will be utilised.
The principle of intention to treat analysis will be performed blind to treatment allocation. In line with the intention-to-treat principle, patients who attend fewer sessions will not be excluded from data analysis.
Qualitative methods, in particular interviews and focus groups, will be used to assess interfamilial communication and contextual factors.

14. Intervention Format Delivery Content
Individual, inpatient unit setting
2 x › 45 minute sessions, for 3 consecutive weeks, in addition to care as usual
Family may be present
Delivery
Delivered by an HCPC certified music therapist
Involving live and recorded music
‘Receptive’ and ‘recreative’
Participants will be randomly assigned to two groups.
Patients assigned to the control group will receive usual care only from the hospice multidisciplinary team. The dose and frequency of usual care will be as deemed appropriate
by the hospice practitioner in charge of their treatment. As music therapy is not part of usual care within this hospice, the control group participants will be offered two sessions of music therapy upon completion of their time in the study.
In addition to the usual care described above, patients assigned to the experimental group will receive music therapy in an individual setting, delivered by a trained music therapist. Music therapy will be conducted for up to 45 min twice a week. A total of six sessions will be offered, with the aim of completing at least four sessions.
Patient’s needs will be identified by the music therapist during the first session, guided by preliminary discussions with the hospice clinical team and by the patient’s own assessment of what needs are most important to them. The musical equipment used will include accessible instruments provided by the music therapist.
As recommended by our PPI (Patient and Public Involvement) collaborators on this protocol, patients can choose to have their carer present during the intervention as time together is precious. Patient’s written informed consent to have their carer present will be obtained by the hospice clinician during recruitment. Carers will only be observing the music therapy sessions and will not be directly involved.
In terms of ‘dose’ of music therapy, previous studies in
palliative care patients have shown that a short course,
consisting of two or more sessions, is effective and appropriate
for this population [25, 26]. While the content
of the sessions will be influenced by each patient’s needs,
interests, preferences and energy level and adapted accordingly
in the moment, the music therapist will
complete an intervention manual [27] at the end of each
session, which will include the details on who chose the
music and what strategy was used (i.e. music listening,
active music-making, improvising, legacy work), along
with strategies to enhance treatment fidelity (how the
intervention was monitored for consistency). This will
aid transparent reporting, along with guiding the development
of a standardised protocol for use across sites in
the main trial.
As with the control group, the dose and frequency of
usual care will be as deemed appropriate by the hospice
professional in charge of their treatment.
Content
A standardised yet tailored intervention
May include song composition, life review, active music making, listening to familiar music, creating legacy recordings

15. Quantitative results Recruited our target sample
Determined the viability of the intervention delivery period
Ascertained the acceptability of the QoL measure (content and level of burden)
Clarified the primary end point for data collection
Potential effectiveness - most notably, improvement in psychological and existential well-being sub-measures of MQoL
Existential well-being refers to a person’s present state of subjective well-being across existential domains, such as meaning, purpose, and satisfaction in life, and feelings of comfort regarding death and suffering

16. Practitioner perspective
One of our patients, he never would have spoken about feelings and stuff, and he composed a whole song for his wife and literally handed her the CD and was like “Listen to that on the way home”, and she was just like “That’s the nicest thing you’ve ever done for me”, and it was all about her, so it was lovely. (AHP 5)
Focus groups with HCPs aim to examine contextual factors and subgroup response to the intervention and acceptability. A semi-structured interview guide will be utilised with the focus groups moderated by an experienced qualitative researcher. The focus group topic guide will be based on realistic evaluation principles to advance theoretical understanding of what components of music therapy work best, for whom and in what circumstances
Using a purposeful sampling approach, HCPs with a direct patient role will be recruited from the hospice, approximately 2 months after trial initiation. Data will be analysed
by two researchers using a thematic content analysis based on Newell and Burnard’s framework [37] and informed by a realist approach as outlined by Porter [38] to
enhance both rigour and the ‘confidence criterion’ (the level of confidence practitioners have that the findings presented accurately portray and explain the issues being
addressed and will inform their practise

17. Family perspective
Was a bright spark in a dark environment. A wonderful experience. Great comfort to see XX having fun. (Husband)
Helped to see mum happy and having good time. (Daughter and son)
Open question at the end of the mcgill QoL tool

18. Patient perspective Music therapy helped
Joy to have lovely girl come in and we bonded through the music
Was amazing - the relationship, got on so well
Something to look forward to
I chose the music – uplifting
Overwhelming how this girl was sent to us
It was a wonderful experience. Never would’ve dreamt it could be so wonderful

19. Group work
What are the challenges and advantages of combining qualitative and quantitative research methods?
Example
Challenges
Need to have expertise in both qualitative and quantitative research
Advantages
Can explore aspects of the topic quantitative tool can’t get to
Example
Challenges
Need to have expertise in both qualitative and quantitative research
Getting the paper to fit the word count for journals
Advantages
Can explore aspects of the topic quant tool can’t get to
More meaningful research

20.
Webpage – MusiQual