A modified Delphi consensus study to identify UK osteopathic profession research priorities

A modified Delphi consensus study to identify UK osteopathic profession research priorities

Accepted Manuscript A modified Delphi consensus study to identify UK osteopathic profession research priorities A.B. Rushton, EdD, MSc, MCSP, FMACP C...

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Accepted Manuscript A modified Delphi consensus study to identify UK osteopathic profession research priorities A.B. Rushton, EdD, MSc, MCSP, FMACP C.A. Fawkes, DO PG Cert MSc D. Carnes, BSc PhD A.P. Moore, PhD PhD FCSP FMACP Cert Ed PII:

S1356-689X(14)00078-2

DOI:

10.1016/j.math.2014.04.013

Reference:

YMATH 1560

To appear in:

Manual Therapy

Received Date: 18 December 2013 Revised Date:

24 April 2014

Accepted Date: 28 April 2014

Please cite this article as: Rushton A, Fawkes C, Carnes D, Moore A, A modified Delphi consensus study to identify UK osteopathic profession research priorities, Manual Therapy (2014), doi: 10.1016/ j.math.2014.04.013. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

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A modified Delphi consensus study to identify UK osteopathic profession research priorities Rushton AB1, Fawkes CA2, Carnes D2, Moore AP3

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1. Dr Alison Rushton EdD, MSc, MCSP, FMACP

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School of Health Professions, University of Brighton, 49, Darley Road, Eastbourne, East Sussex, BN20 7UR.

Senior Lecturer in Physiotherapy, School of Sport, Exercise and Rehabilitation Sciences University of Birmingham, Edgbaston, Birmingham, B15 2TT. 2. Miss Carol Fawkes DO PG Cert MSc

2. Dr Dawn Carnes BSc PhD

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Research Officer, National Council for Osteopathic Research, Barts and The London School of Medicine and Dentistry, Centre for Primary Care and Public Health, Yvonne Carter Building, 58 Turner Street, London E1 2AB.

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Senior Research Fellow, National Council for Osteopathic Research, Barts and The London School of Medicine and Dentistry, Centre for Primary Care and Public Health, Yvonne Carter Building, 58 Turner Street, London E1 2AB.

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3. Professor Ann P Moore PhD PhD FCSP FMACP Cert Ed Professor of Physiotherapy, School of Health Professions, University of Brighton, 49, Darley Road, Eastbourne, East Sussex, BN20 7UR.

Corresponding author Email: [email protected] Telephone: 0207 882 6131

ACCEPTED MANUSCRIPT ABSTRACT

There is an increasing emphasis to take an evidence-based approach to healthcare. To obtain evidence relevant to the osteopathic profession a clear research direction is required based on A modified Delphi consensus

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the views of stakeholders in the osteopathic profession.

approach was conducted to explore the views of osteopaths and patients regarding research priorities for osteopathy.

Osteopaths and patients were invited to complete an online

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questionnaire survey (n=145). Round 1 requested up to 10 research priority areas and the rationale for their selection. All of the themes from Round 1 were fed back verbatim, and in

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Round 2 participants were asked to rank the importance of the research priorities on a 5-point Likert scale. Finally, in Round 3 participants were asked to rank the importance of a refined list of research topics which had reached consensus. Descriptive analysis and use of Kendall’s coefficient of concordance enabled interpretation of consensus. The response rate

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for Round 1 was 87.9% and identified 610 research priority areas. Round 2 identified 69 research themes as important, and Round 3 identified 20 research priority topic areas covering four themes: effectiveness of osteopathic treatment (7 areas prioritised), role of

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osteopathy: the management of four conditions were prioritised, risks with osteopathic treatment (two areas prioritised) and outcomes of osteopathic treatment (two areas

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prioritised). The findings will be taken forward to develop the research strategy for osteopathy.

ACCEPTED MANUSCRIPT A modified Delphi consensus study to identify UK osteopathic profession research priorities

INTRODUCTION Over the past decade, there has been an increasing emphasis on the need for osteopaths to take an

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evidence-based approach to their practice. This emphasis, driven by a range of stakeholders, is set to grow in both its demands and requirements. Sackett, (1998) first advocated the need for evidence-based practice underpinned by integrating the best available research with the clinicians’ However, health

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own expertise and experience to produce effective clinical decision-making.

professions are at different stages of development and maturity, and this will affect their individual

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research capacity and capability. Moore and Petty (2001) acknowledged that different health professions have varying capacity to produce the evidence on which their practice can be based, a diversity of suitable methodological approaches, and unequal levels of access to evidence by clinicians.

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One very real practical issue faced by clinicians who work outside publicly-funded healthcare, is limited access to research funding, and limited availability of financially-supported time to undertake research activity. Osteopathy is a case in point. In the UK, osteopaths work predominantly outside of

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the National Health Service (NHS), that since its launch in 1948 has grown to become the largest

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publicly funded healthcare system in the world. Research capacity and capability within the osteopathy profession is slowly growing. Implicit to the development of research within osteopathy has been its evolution into a regulated profession in the UK since the Osteopaths’ Act (1993) was passed, the subsequent creation of the National Council for Osteopathic Research (NCOR), and the growth of scholarship which is being encouraged among staff in the Osteopathic Educational Institutions.

The NCOR has supported the osteopathic profession by disseminating evidence

relevant to practice, and encouraging practice-based data collection and audit activities. Such activities, in turn, are supporting osteopaths as they engage with new opportunities introduced by

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ACCEPTED MANUSCRIPT the recent Health and Social Care Act (2012), for example the Any Qualified Provider System that enables patients to choose from a range of approved providers for their healthcare.

Historically, the focus of osteopathic research has been musculoskeletal practice in adults

et al., 2004; Williams et al., 2004; Fawkes et al., 2013).

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(MacDonald and Bell, 1990; Andersson et al., 1999; Burton et al., 2000; Williams et al., 2003; Gurry More recent research has involved

osteopaths in collaboration with physiotherapists and chiropractors delivering interventions for

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patients with low back pain (UK BEAM Trial Team, 2004a & b).

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In order to support professional development and the growth of further research in osteopathy, it is important to have a clear scope of practice. Little systematic information has been available regarding the osteopathic profession, although recent initiatives have attempted to address this. The development and piloting of a standardised data collection tool for osteopaths in 2009 has

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produced a profile of professional activity. This, in turn, has led to the development of other initiatives which will support standard setting for practice-based audit activities, and identify relevant research questions (http://www.ncor.org.uk/practitioners/patient-reported-outcomes/).

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The key to successful research development has been described as a combination of flexibility and balance in coordinating both strategic direction (top down approach) and responsive research To facilitate such development, clinician

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(bottom up approach) (Research Council UK, 2005).

engagement is important for research development in osteopathy.

Within the physiotherapy profession, work has been conducted to identify research priorities for postgraduate theses in musculoskeletal physiotherapists internationally (Rushton and Moore, 2010), and research priorities for the Chartered Society of Physiotherapy nationally (Rankin et al., 2012). Research priorities have also been identified in wound care (Serena et al., 2012), paediatric intensive care units (Ramelet and Gill, 2012), midwifery (Aguilar et al., 2013), occupational medicine 2

ACCEPTED MANUSCRIPT (Harrington, 1994), dentistry (Cramer et al., 2008), complementary therapies (Barnard et al., 1997), and nursing (Kirkwood et al., 2003). These studies all used the Delphi method to define research priorities. The Delphi method is a powerful tool to achieve consensus as it enables participation among a large group of professionals, and therefore can encompass all aspects of practice. Delphi

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has the benefit of identifying areas of practice which may be of particular concern to professionals (Rankin et al., 2012). It can also highlight areas where dissemination of research findings is most needed, and the types of methodological approach potentially required by a particular research area

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allowing approximate funding to be sought (Rushton and Moore, 2010; Rankin et al., 2012). This allows professional development to take place in a rational manner to ensure that the progress of a

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profession is strategic (Marshall, 2004).

Earlier work has also questioned the value of identifying research priorities compared to the actual research output delivered as a result of identifying such priorities (Marshall, 2004). Riegel et al

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(1993) reviewed the priorities identified by Lewandoski and Kotsisky in their 1980 research priorities study, and found that little research had been conducted in several of the identified areas. This highlights the need to maintain a focus on priorities, and identify a clear strategy for progressing

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identified research priority areas into specific research questions. It is also important to be mindful of the changing priorities for professions which are imposed from both political and social pressure.

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In view of the increasing limitations being placed on available funding, it would appear to be prudent to undertake a systematic process to identify priorities to target restricted resources.

The literature highlights the importance of the researcher and research consumer (osteopaths and patients) within the process of identifying research priorities (Rushton and Moore, 2010). The aim of this study was therefore to identify, by professional and patient consensus, key research priority areas for the osteopathic profession thereby informing the strategic research direction of the osteopathic profession in the UK. 3

ACCEPTED MANUSCRIPT METHOD

The modified Delphi consensus approach

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A modified Delphi consensus approach (Rushton and Moore, 2010; Rankin et al., 2012) was used to explore the views of osteopaths, and osteopathic patients about research priorities for the osteopathic profession in the UK. This approach has been used successfully with osteopaths in

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previous work (Carnes et al., 2010), and many of the previous research priority exercises utilised the Delphi approach. Delphi has been described as “a method for the systematic collection and

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aggregation of informed judgements from a group of experts on specific questions or issues” (Reid, 1993); and has been confirmed as providing both face (Cross, 1999) and concurrent validity (Williams and Webb, 1994) for the identified priorities.

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Osteopaths were asked to complete an online questionnaire survey through an iterative process on 3 separate occasions. The questionnaires were administered through SurveyMonkey software. Initial questions focussed on views about research priorities and priority areas (Rushton and Moore,

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2010) for the osteopathic profession. Data were summarised and fed back to respondents in two further stages to capture consensus views about priorities and to encourage prioritisation. All data

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fed back from individuals were anonymised to maintain participant confidentiality. In addition, demographic data including age, gender, location of training, years in practice, type of practice, and whether clinicians specialised in any particular area of practice, were collected. For patients, data were collected concerning their age, gender, occupation, and type of osteopathic treatment that they had received. The study was approved by the host university following ethical review.

Participant recruitment

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ACCEPTED MANUSCRIPT Osteopathic participants were invited to take part in the study by email circulation to the whole profession via the British Osteopathic Association and General Osteopathic Council email distribution lists. Advertisements were placed also on the website of these organisations and the website for the NCOR. The osteopathic participants included clinicians, researchers, and educators

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to ensure that research priorities were identified within the context of their intended use. Service users (patients) were invited to participate by information being communicated via participating osteopathic practices to potentially recruit a wide and diverse range of participants. Owing to the

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stage of development of the osteopathy profession in the UK and this being the first research

priority setting project, in contrast to previous research priority projects (Rankin et al., 2012), an

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expert panel was not established. All participants indicating an interest in taking part in the project (email or telephone), were forwarded a participant information sheet and consent form; and return of signed consent forms was requested via facsimile, post, or scanned email, depending on

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Data Collection process

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participant preference.

Round 1: All participants were asked to identify up to 10 research priority areas while also giving the

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rationale behind their choices. Participants were encouraged to discuss the task with colleagues to inform their choices. Email reminders were sent to non-responders after 3 and 6 weeks. All research priority areas suggested by participants were collated and categorised into themes / sub-themes enabling categorisation of the research priority areas. Themes were identified independently by 3 researchers (AR, CF, DC) and then collated through a process of discussion to achieve agreement.

Round 2: All participants received feedback on Round 1, consisting of a list of research priority areas grouped as themes / sub-themes, with the supporting statements provided in the original format in 5

ACCEPTED MANUSCRIPT which they were contributed. Participants were asked to rate the importance of each research priority area using a 5-point Likert scale (Disagree strongly, Disagree, No opinion, Agree, Agree strongly), and invited to make comments about the process of rating through open questions. Email

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reminders were sent to non-responders after 3 and 6 weeks.

Round 3: Participants received feedback in the form of a list of research priority areas under revised themes reaching consensus with their unadulterated supporting statements, and descriptive data

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analysis of ratings from Round 2. Participants were asked to rate each research priority area again. Participants were invited also to make comments about the process of rating. Email reminders were

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sent to non-responders again after 3 and 6 weeks.

Data analysis

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Following assumptions regarding the equality of points on the Likert Scale, it was argued as an interval scale (Kerlinger and Lee, 2000). Descriptive statistics were used to evaluate consensus agreement for research priority areas, including mean rating, median rating, and percentage

achieved:

 

Mean rating of 3.5

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agreement. Consensus was established in Round 2 if the following pre-specified criteria were

A median rating of ≥4 Percentage agreement of ≥ 60% (lower than round 3 owing to anticipated variation in responses)



Kendall’s coefficient of concordance demonstrating significant agreement across participants (p<0.05)



Analysis of free text responses supporting quantitative analysis

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ACCEPTED MANUSCRIPT Kendall’s coefficient of concordance was used to evaluate consensus across all participants (Cross, 1999; Sim and Wright, 2000) within a theme / sub-theme. Kendall's W is a non-parametric statistic used for assessing agreement among raters and ranges from 0 (no agreement) to 1 (complete

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agreement).

Research priority areas meeting the requirements of consensus were retained and evaluated in light of the free text comments. Following data analysis, any research priority area which did not reach

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consensus in Round 2 was removed from Round 3 of voting. Descriptive statistics and a value of Kendall’s coefficient of concordance were calculated for Round 3 to inform the finalised list of

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research priority areas.

The definition of consensus for round 3 was strengthened to: Mean rating ≥ 3.5



Median ≥ 4



Percentage agreement ≥ 70%



Coefficient of Variation ≤ 20% (not applied in round 2 as variability was evident in rating of



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specific priorities)

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Kendall’s coefficient of concordance demonstrating significant agreement across



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participants (p<0.05)

Analysis of free text responses in support of quantitative analysis

A composite ranking of research priority areas gaining consensus was produced using the above definition of consensus following round 3. This produced an order of priority for research priority areas identified in order of percentage agreement. Participants’ views and opinions about the research priority areas were collected throughout the study and in this paper we include comment

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ACCEPTED MANUSCRIPT on the nature of these contributions. All data were downloaded from SurveyMonkey directly into

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SPSS statistical package. All analyses were completed using SPSS version 21.

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ACCEPTED MANUSCRIPT RESULTS

Description of participants

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A total of 165 individuals responded to the email and advertisements requesting an expression of interest in participating. A total of 145 participants contributed to Round 1. Their demographic

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profile is shown in Table 1.

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Round 1

N=145 participants contributed a total of 610 research priority areas in round 1. The response rate of participants was 87.9%. Participants provided a mean of 4.15, mode of 10, and range of 1 to 10 research priority areas. N=136 (93.8%) of participants were osteopaths, and n=9 (6.2%) were service

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users. Research priority areas were grouped into themes and sub-themes to enable feedback to participants for round 2. The themes and sub-themes of research priority areas identified from the data in round 1 are shown in Table 2. Some participants identified principles of osteopathy research

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Round 2

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practice as part of their responses, rather than research priority areas.

145 round 2 questionnaires were sent, 98 responses were received with 58 questionnaires completed across all themes / sub-themes. The response rate was n=98(59.5% of the original sample of 165 respondents). Some attrition of participants occurred in round 2; participants who did not continue stated that the length of the survey had become onerous, or that they felt unable to contribute further at this stage. The underpinning principles of osteopathy research practice identified from round 1 were developed further in response to the round 2 data analysis as shown in

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ACCEPTED MANUSCRIPT Table 3. Research priority areas reaching consensus in round 2 are detailed in Table 4. Kendall’s W was <0.05 overall and for all but one sub-theme relating to identification of outcome measures where a small number of research priority areas will have influenced the test. The themes grouping the research priority areas were revised following analysis of the round 2 data by the author panel.

Theme A: Practice of osteopathy



Theme B: Effectiveness of osteopathy



Theme C: Adverse effects

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The following themes of research priority areas were identified from the data in round 2:

The rating of research priority areas in round 2 emphasised the importance of individual clinical

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conditions and this was reflected in the wording of the themes / sub-themes taken into round 3. For round 3 the wording of the research priority areas was developed based on the rationales provided in round 1 and the free text comments in round 2 to reflect specific research priority areas. Any

Round 3

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duplication was removed based on the free text comments.

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N=61 participants responded to the round 3 questionnaire from a sample of 165 original respondents, contributing to an overall response rate through to round 3 of 37%. Round 3 definitive

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research priority areas are identified in Table 5. Kendall’s W was 0.627 for theme C perhaps due to the low number of research priority areas in this theme, but 0.000 across all other themes / subthemes.

DISCUSSION

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ACCEPTED MANUSCRIPT This Delphi study looked at the views of UK osteopaths and patients concerning their research priorities for the osteopathic profession. A response rate was achieved of 37% overall which is comparable to previous research, as characteristically the response rate for a Delphi reduces as rounds progress (Reid, 1993). In round 1 the number of research priority areas suggested was large

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(610 ideas) but could be categorised into 11 themes (with sub-themes) to group the research priority areas for participants to review all of the 610 research priority areas in round 2. The response rate in round 2 was affected by the need for participants to rate each research priority area suggested in

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round 1 which took considerable time. The top 20 research priority areas identified from round 3 covered the themes of clinical effectiveness research, risk of treatment, role and scope of

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osteopathic practice, and outcomes of care as a result of osteopathic treatment. A cut off point of the top 20 research priority areas was agreed following consultation with opinion leaders and other stakeholders for the profession, based on the view that research priority areas that reached a mean greater than 3.5; a median of 4, a CV less than 30, and a percentage agreement greater than 70,

percentage agreement.

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demonstrated consensus. The top 20 research priority areas were then ranked according to the

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There are few surprises in these findings since the research priority areas represent issues of genuine concern for all clinicians. The necessity to refer to evidence for clinical effectiveness is an When obtaining consent from patients, it is

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increasing part of evidence-informed practice.

imperative to be able to draw on studies providing information on both risk and benefit, and good quality evidence is required concerning the most efficient and meaningful way to communicate with patients particularly with respect to risk and benefit to ensure that consent is truly informed. However, the tenet of dissemination has been highlighted as an outcome of this project. Considerable work has been undertaken by the osteopathic profession concerning the risk associated with manual therapy treatment (Carnes et al., 2010a; Carnes et al., 2010b; Leach et al., 2011a; Leach et al., 2011b; Vogel et al., 2013. While these studies are available to osteopaths via the 11

ACCEPTED MANUSCRIPT funder’s website, the NCOR website, and peer-reviewed publications, it is often the lack of translation to practice in a meaningful way that makes research seem less relevant and informative than it actually is. This has been remedied in the interim by the creation of a series of clinicianfocussed and patient-focussed resources which have been designed to support practice (NCOR

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practitioner information, 2014). The scope of practice has been shown to be important to many healthcare professions, and a range of initiatives have been developed, for example, standardised data collection, to facilitate this issue

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(Walker et al., 2008; Moore et al., 2012; Fawkes et al., 2013).

The final main theme concerning outcomes of care highlights increased attention on the use of

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Patient Reported Outcome Measures (PROMs) across different areas of clinical practice in UK healthcare (NHS England, 2013; NCOR, 2014).

This development is mirrored also by work

internationally especially in Sweden and the USA. The importance of looking at PROMs as a method of reflecting on practice is being advocated by NCOR, and a body of work is now being devoted to

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this initiative. Over time, the collection of PROM data will provide some evidence of effectiveness of treatment and will signpost areas for future areas of research. Increasingly, it will also give patients access to the type of prognostic information they expect from clinicians when considering their

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everyday practice.

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treatment options, and it will make clearer the range of body sites osteopaths treat as part of their

Issues and implications for the profession

In 2009 and 2012 physiotherapists undertook two similar studies to identify research priorities for postgraduate/Masters dissertations, and for the physiotherapy profession revised research priorities for the UK as a whole. In contrast to the findings of previous studies, this Delphi consensus study highlighted in many instances the lack of awareness osteopaths have about existing evidence and research from their own profession and wider healthcare. For example, participants requesting more 12

ACCEPTED MANUSCRIPT evidence of effectiveness for manual therapy treatments for persistent low back pain when the evidence has been reviewed quite comprehensively for inclusion in the United Kingdom National Institute for Health and Social Care (NICE) guidelines on the treatment of persistent non-specific low back pain (Savigny et al, 2009). In addition, participants in Round 1 suggested priorities of work

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already undertaken by the profession about the risk and nature of adverse events that were funded by the profession’s regulator (Carnes et al, 2005; Leach et al, 2011a; Leach et al, 2011b; Vogel et al, 2012). This may indicate either poor dissemination of information within the profession, lack of

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interest in research information, lack of understanding of information disseminated due to its presentation, and/or knowledge to interpret research data. As a result of this consensus study a

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need for adequate, appropriate and applicable dissemination of research has been highlighted for the profession and this should perhaps become a priority on its own.

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Strengths

This is the first time members of the osteopathic profession have been consulted about research A logical and systematic approach was used to organise and collate the views of

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priorities.

participants to demonstrate a range of research priority areas on which to focus and provide

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research direction. The inclusion of a wide cross-section of the profession is an important aspect to this study. Too frequently there is a divide between academic researchers and clinicians at the “coal face” of practice. The unfortunate result can be that clinicians fail to be engaged by research findings and do not apply them to their practice for the benefit of patients. This has been demonstrated among many professions, and involving clinicians in the research process, and acknowledging their views is an important step forward in trying to address this cultural divide (Dockery, 1996; Grol and Grimshaw, 1999; Moore and Petty, 20010.

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ACCEPTED MANUSCRIPT The research priority areas reflect the current UK healthcare services that are undergoing reorganisation as a result of the Health and Social Care Act (2012). The delivery of primary care services under contract awarded by Clinical Commissioning Groups (CCGs) as opposed to standard National Health Service general practice is increasing with the advent of, for example, the

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commissioning of neck and back pain services. Any commissioned healthcare service provider is normally required, as a minimum, to illustrate the need or burden of the condition to justify the service, the evidence of effectiveness of treatment offered, the feasibility of delivery of the service

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and treatment, provide evidence of risk surrounding the service, and identify the potential outcomes for patients (AQP guidance: https://www.supply2health.nhs.uk/). The importance of highlighting

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the existence and availability of this type of information for the osteopathic profession has been emphasised. While a body of evidence supporting the benefits of osteopathic approaches e.g. spinal manipulation does exist, there is an increasing emphasis to collect ongoing clinical practice data (Savigny et al., 2009). The importance of doing this to support provision of effective services has

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been demonstrated by some published studies (Gurry et al., 2004; Gurden et al.,2012) which have involved the UK NHS. However, a cultural shift is starting to take place to support clinicians in private practice who do not have access to the same type of infrastructure, but who wish to engage

Limitations

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in routine PROM data collection. This is being tackled in a range of ways including education,

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There are 4,854 registered osteopaths in the UK (General Osteopathic Council, 2013). 137 osteopaths participated in this study, representing 3% of the profession. As this was the first time any such exercise had been undertaken with osteopaths, participation was limited to UK registered osteopaths only. In contrast to other research priority exercises in different professions, there was no use of an expert consensus panel to review research priority areas. An expert consensus panel, whose members may have been more aware of published research about the profession, and the wider development and demands of the healthcare arena might have contributed different findings, but the priority for this first priority setting exercise was for involvement of the breadth of the 14

ACCEPTED MANUSCRIPT profession, even though this may be considered a limitation of the current study. Future priority setting exercises may include non-osteopaths such as commissioners, insurers, academic researchers and other manual therapists. In addition, a future study would include a larger number of patient representatives to ensure that evolving research priorities reflect areas of research that

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are important to patients.

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Future activities

The validity of the research priorities identified, and where they sit within the context of available

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evidence have been expanded in the discussion. In order to make this type of study meaningful it is important to identify a strategy for action and then put it into practice. Since this study was begun, a number of initiatives have taken place to try and enhance wider dissemination and accessibility of research findings. Historically, the National Council for Osteopathic Research has used printed

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media to highlight both existing and new research to the profession. This type of medium lacks longevity when the need arises for new information. The development of a new website for NCOR (www.ncor.org.uk) has focussed on making more resources widely and continually available to

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osteopaths. The acquisition by the General Osteopathic Council of access to a larger number of journals from Elsevier has also given osteopaths the ability to read research from a wider range of

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professional groups, encompassing a broader range of topics. This Delphi study has identified a number of practical issues which can be addressed across the profession in terms of making research more accessible, but also more comprehensible to osteopaths who began their training some years ago where research education was not part of the curriculum delivered.

The focus of the

osteopathic profession’s activity based on the Delphi findings will be on three priority areas including: 1] reviewing strategies for disseminating research findings to the osteopathic profession, and to undergraduates in training where significant research already exists in areas identified as a priority; 2] the identification of suitable research priority areas to be formed into research questions 15

ACCEPTED MANUSCRIPT for Masters-level students; and 3] identifying funding streams for the remaining research priority areas and being responsive to these as they are announced.

Further consultation will be required and the osteopathic profession will need to consider whether

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the research priority areas identified address a significant need or gap in evidence. This particular issue was faced also by the physiotherapy profession in 2012. In addition, the potential impact of

should be considered (Rushton and Moore, 2012)

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CONCLUSIONS

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the research to patients, osteopathic practice, researchers, commissioners and government policy

As a result of this study a range of research priorities have been identified for the osteopathic profession. This will ensure the most relevant use of limited funds, and encourage the profession to

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build research collaborations in priority areas with expert researchers outside of the profession. The profession is now in a position to steer members of the osteopathic educational institutions to select research questions for their undergraduate and postgraduate research based on the findings of this

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Delphi Consensus exercise.

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Kerlinger FN, Lee HB. Foundations of behavioural research. 4th ed. Fort Worth, Harcourt College Publishers; 2000.

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Kirkwood M, Wales A, Wilson A. A Delphi study to determine nursing research priorities in the North Glasgow University Hospitals NHS Trust and the corresponding evidence base. Health Information Library Journal. 2003;20(Suppl 1): 53-58. Leach J, Fiske A, Mullinger B, Ives R, Mandy A. Complaints and claims against osteopaths: a baseline study of the frequency of complaints 2004–2008 and a qualitative exploration of patients’ complaints. 2011a.Available at: http://www.ncor.org.uk/wpcontent/uploads/2012/10/complaints_and_claims_against_osteopaths_2004-2008_public.pdf. (Accessed 27-11-2013).

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Leach J, Mandy A, Hankins M, Ives R, Cross V, Cage M, Lucas K. Communicating risks of treatment and informed consent in osteopathic practice: A literature review and pilot focus groups. 2011b. Available at: http://www.ncor.org.uk/wp-content/uploads/2012/10/communicating-risk.pdf. (Accessed 27-11-2013).

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Lewandowski LA, Kositsky AM. Research priorities for critical care nursing: a study by the American Association of Critical-Care Nurses. Heart and Lung 1983; 12(1):35-44.

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Marshall A. Research priorities for Australian critical care nurses: do we need them? Australian Critical Care 2004;17(4): 142-144. MacDonald RS, Bell CM. An open controlled assessment of osteopathic manipulation in nonspecific low-back pain. Spine 1990;15(5): 364-370. Moore A, Petty N. Evidence-based practice – getting a grip and finding a balance. Manual Therapy 2001;6(4):195–6. Moore AP, Bryant EC, Olivier GW. Development and use of standardised data collection tools to support and inform musculoskeletal practice. Manual Therapy. 2012 Dec;17(6):489-96. National Council for Osteopathic Research (NCOR). http://www.ncor.org.uk. (Accessed 28-08-2013). National Council for Osteopathic Research (NCOR). http://www.ncor.org.uk/practitioners/patientreported-outcomes/patient-reported-outcome-measures-in-osteopathy/. (Accessed 17.02.2014). 18

ACCEPTED MANUSCRIPT National Council for Osteopathic Research practitioner information, 2014. http://www.ncor.org.uk/practitioners/practitioner-information-communicating-benefit-and-risk-inosteopathy/(Accessed 17.02.2014). NHS England. http://www.england.nhs.uk/statistics/statistical-work-areas/proms/ (Accessed 17.02.2014)

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Osteopaths Act (1993). http://www.legislation.gov.uk/ukpga/1993/21/contents. (Accessed 28-082013). Ramelet AS, Gill F. A Delphi study on National PICU nursing research priorities in Australia and New Zealand. Australian Critical Care. 2012;25(1): 41-57.

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Rankin G, Rushton A, Olver P, Moore A. Chartered Society of Physiotherapy's identification of national research priorities for physiotherapy using a modified Delphi technique. Physiotherapy. 2012;98(3): 260-272.

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Reid N. Health care research by degrees. Oxford, Blackwell Scientific Publications, 1993. Research Councils UK, (http://www.rcuk.ac.uk/media/news/2005news/Pages/050526.aspx). Accessed 28.08.2013. Riegel B, Banasik J, Bamsteiner J, Beecroft P, Kern L, Lindquist R et al. Reviews and summaries of research related to AACN 1980 research priorities: clinical topics. American Journal of Critical Care 1993;2(5):413-25.

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Rushton A, Moore AP. International identification of research priorities for postgraduate theses in musculoskeletal physiotherapy using a modified Delphi technique. Manual Therapy. 2010;15(2): 142-148. Sackett DL. Evidence based medicine. Spine 1998;23(10): 1085-1086.

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Savigny P, Kuntze S, Watson P, Underwood M, Ritchie G, Cotterell M, et al. Low back pain: early management of persistent non-specific low back pain. London: National Collaborating Centre for Primary Care and Royal College of General Practitioners, 2009. http://guidance.nice.org.uk/CG88/Guidance/pdf/English. Serena T, Bates-Jensen B, Carter MJ, Codrey R, Driver V, Fife CE, Haser PB, Krasner D, Nusgart M, Sim J, Wright C. Research in health care. Cheltenham: Stanley Thornes Publishers Ltd; 2000. Smith APS, Snyder RJ. Consensus principles for wound care research obtained using a Delphi process. Wound Repair and Regeneration. 2012;20(3): 284-293. UK BEAM trial team. United Kingdom Back Pain, Exercise and Manipulation (UK BEAM) randomised trial: effectiveness of physical treatments for back pain in primary care. British Medical Journal 2004;329(7479):1377.

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ACCEPTED MANUSCRIPT UK BEAM trial team. United Kingdom Back Pain, Exercise and Manipulation (UK BEAM) randomised trial: cost effectiveness of physical treatments for back pain in primary care. British Medical Journal 2004;329(7479):1381. Vogel S, Mars T, Keeping S, Barton T, Marlin N, Froud R, Eldridge S, Underwood M, Pincus T. Clinical Risk Osteopathy and Management Scientific Report: The CROaM Study. Available at http://www.osteopathy.org.uk/uploads/croam_full_report_0313.pdf. (Accessed 27-11-2013).

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Walker DS, Visger JM, Levi A. Midwifery data collection: options and opportunities. Journal of Midwifery and Women’s Health. 2008;53(5):421-9. Williams P, Webb C. The Delphi technique: a methodological discussion. Journal of Advanced Nursing, 1994;19:180–186.

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Williams NH, Wilkinson C, Russell I, Edwards RT, Hibbs R, Linck P, Muntz R. Randomized osteopathic manipulation study (ROMANS): pragmatic trial for spinal pain in primary care. Family Practice 2003;20(6):662-9.

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Williams NH, Edwards RT, Linck P, Muntz R, Hibbs R, Wilkinson C, Russell I, Russell D, Hounsome B. Cost-utility analysis of osteopathy in primary care: results from a pragmatic randomized controlled trial. Family Practice. 2004;21(6): 643-650.

20

ACCEPTED MANUSCRIPT Acknowledgements

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We would like to thank the patients and osteopaths who participated in this study, and contributed their thoughts on research priorities for the profession.

ACCEPTED MANUSCRIPT Table 1. Demographic profile of study participants at round 1

Number of years since completion of training

Type of practice/work (multi-response question)

AC C

EP

Type of specialist practice (multi-response question)

% 100%

81 64 136 9

56% 44% 94% 6%

22 64 16 14 4 7 5 4 37 19 21 21 22 16 124 14 32 15 3 37

16% 47% 12% 10% 3% 6% 4% 3% 28% 14% 15% 15% 16% 12% 91% 10% 23% 11% 2% 28%

91 8

67% 6%

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Training establishment for participating osteopaths

Number 21-80 years

SC

Professional or nonprofessional membership

M AN U

Sex

Findings (n=145 participants) Range (the mean age is not available as data were collected as age bands and not individual ages) Male Female Osteopaths Other service users (management, research, health care professional, support, IT) British College of Osteopathic Medicine British School of Osteopathy College of Osteopaths European School of Osteopathy London College of Osteopathic London School of Osteopathy Oxford Brookes University Surrey Institute of Osteopathic Medicine 1-5 6-10 11-15 16-20 21-25 >25 Private practice NHS Education Research Other Yes (includes general medical practice, acupuncture, sports medicine, and paediatrics) No Other

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Participant data Age

ACCEPTED MANUSCRIPT Table 2. Research priority themes from Round 1. Theme A. Profession of osteopathy

Subtheme Scope of osteopathy Context of practice in osteopathy Awareness of osteopathy Non-neuro-musculoskeletal problems Neuro-musculoskeletal problems Low back problems Headache Effectiveness Underlying principles Pathology in children Manipulation Provision of information Events

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B. Clinical problems

C. Cranial osteopathy

SC

D. Adverse events

Patient reported outcomes Physiological outcome measurement Identification and appropriate application of outcome measures Management of low back pain Management of neck pain Techniques Other

M AN U

E. Clinical diagnoses F. Outcome measurement

G. Effectiveness and cost-effectiveness

AC C

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H. Education and continuing professional development I. Visceral osteopathy J. Sports injury and rehabilitation K. Effects of osteopathic technique Musculoskeletal outcomes Physiological

ACCEPTED MANUSCRIPT Table 3 Development of underpinning principles of osteopathy research practice identified from Round 1.

Underpinning principle from Round 1

Further development in Round 2 High quality research Translational research to inform practice The most appropriate outcome measures for osteopathy need to be defined Patient satisfaction central to evaluating outcome Patient satisfaction as an essential outcome measure Pain as an essential outcome measure Evaluation of long term outcomes Development of treatment protocols Targeted treatment Osteopathic care versus other professions Osteopathic care versus standard NHS care

M AN U

SC

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Underpinning principles

AC C

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Valuable methodologies

Student dissertations

Phase III randomised controlled trials o Cost effectiveness included in trials o Appropriately powered studies o Double blinding where possible o Risk to benefit ratios for all osteopathic treatment modalities but especially HVLAT Longitudinal studies Large audits Mixed methodology research Single case study research Qualitative research to evaluate patient experience Case histories Use of the student resource to collect data Publication of student dissertations

ACCEPTED MANUSCRIPT

Research priority areas

Med ian

SD

≥ 60% agreement

3.77 3.89 3.69

4 4 4

1.24 1.29 1.33

62.22 71.43 65.31

4

1.56

61.04

4

1.54

61.64

3.69 4.01 3.83

4 4 4

1.27 1.15 1.10

64.79 70.42 69.01

3.66

4

1.26

64.79

3.80

4

1.06

64.79

3.61

4

1.30

63.38

3.87 3.74 3.76 3.76

4 4 4 4

1.09 1.27 1.23 1.20

67.61 66.67 66.67 63.64

3.73

4

1.31

61.90

3.98 3.98 3.81

4 4 4

1.22 1.26 1.34

71.43 73.02 66.67

4.00 3.89

4 4

1.31 1.31

76.19 69.84

3.71

3.63

AC C

EP

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Theme A: Profession of osteopathy Aa1 Osteopathic scope of practice Aa6 Evidence of range of 'conditions treated' Aa16 Primary physiological research to investigate the osteopathic concept of health and the contribution of somatic dysfunction to disease Ac4 Perception of osteopathic treatment by GPs and doctors Theme B: Clinical problems Bb22 Treatment of specific disease processes, e.g. glue ear, vertigo, tinnitus, reflux, high blood pressure, infant colic, migraine etc, already known to respond well to osteopathic treatment Bc17 Neck pain-UOP Bc18 Treatment of Whiplash injuries Bc21 Osteopathic approach to treating chronic pain patients Bc22 To explore conditions that benefit most from osteopathic treatment Bc26 Effectiveness and safety of osteopathic treatment for the musculoskeletal problems associated with pregnancy Bb34 Quantitative and qualitative research into chronic pain and 'medically unexplained symptoms' Bc42 Osteopathic care for the elderly Bd1 Low back pain Bd8 Chronic low back pain and osteopathic intervention Bd10 Does Osteopathic regular maintenance treatment decreases incidence/frequency of lower back pain episodes ? Be1 Headaches / migraines - they are a common presentation and yet the aetiology is not well understood or treated Be2 Effectiveness of treating headaches and migraine Be3 Osteopathic treatment for headaches Be4 Clinical effectiveness of osteopathy in chronic headaches Theme D: Adverse effects Da1 Dangers and safety of cervical spine manipulation Da 2 Incidence of vascular accidents following osteopathic

Mean

RI PT

Research priority number

Round 2 consensus agreement topics

SC

Table 4.

ACCEPTED MANUSCRIPT 4 4 4

1.33 1.41 1.38

71.43 60.32 69.84

3.76

4

1.30

61.90

3.86 3.71 3.73 3.68 3.76 3.75

4 4 4 4 4 4

1.27 1.35 1.35 1.23 1.29 1.38

63.49 60.32 63.49 60.32 61.90 63.49

4 4

1.41 1.16

60.32 66.67

3.67

4

1.17

60.66

3.67 3.56

4 4

1.17 1.25

63.93 62.30

3.64

4

1.24

65.57

3.88

4

1.13

67.24

3.62

4

1.27

62.07

3.69

4

1.29

65.52

3.59

4

1.30

62.07

SC

RI PT

3.95 3.68 3.84

3.67 3.94

AC C

EP

TE D

M AN U

manipulation Da 3 HVT safety and risks in practice Da 4 VAI and manipulations Da 5 What exactly is the risk of serious damage caused by cervical manipulation? Da 6 Risk to benefit ratios for all osteopathic treatment modalities but especially HVLAT Db1 Safety of Osteopathic treatment Db2 Assess risks of osteopathic treatment Db3 Contraindications of cervical spine thrust techniques Dc2 The risks associated with osteopathic treatment Dc3 Identify prevalence of adverse events Dc4 Comparison of risk of osteopathic treatment with pharmaceutical intervention Dc6 How safe is Osteopathy Dc8 Development of an reporting system for serious adverse reactions Theme F: Outcome measures Fa1 Patient Reported Outcome Measure standardising this for osteopathy - validating a tool Fa3 Patient satisfaction with treatment outcome Fa4 Is there a significant reduction in pain after a course of osteopathic treatment? Fa5 Patient recorded outcome statistics Theme G: Effectiveness and cost-effectiveness Gb3 Effectiveness of osteopathy in the treatment of whiplash injuries Gc1 Is osteopathy effective for non-specific pain in shoulder / knee/ hip? Gc5 Tension headaches - the efficacy of osteopathic treatment Theme K: Effects of osteopathy techniques Ka2 Understanding of the underlying science behind osteopathy's effectiveness

Table 5. Research priorities with ≥ 70% agreement in round 3.

ACCEPTED MANUSCRIPT SD

CV

4.41

Media n 5

0.84

19.05

% agree 93.10

Effectiveness of osteopathy Effectiveness of osteopathy

4.26

4.5

0.98

23.00

86.21

Effectiveness of osteopathy

4.29

4.5

0.88

20.51

84.48

Effectiveness of osteopathy

4.21

4

Effectiveness of osteopathy

4.17

4

Effectiveness of osteopathy

4.09

EP

AC C

RI PT

Mean

0.95

22.57

82.76

0.96

23.02

81.03

0.98

23.96

81.03

SC

Theme

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4

Adverse effects

4.12

4

1.05

25.49

77.19

Effectiveness of osteopathy

4.09

4

0.92

22.49

75.86

Practice of osteopathy

3.97

4

1.04

26.20

75.86

Practice of osteopathy Practice of osteopathy

3.97

4

1.00

25.19

72.13

4.00

4

1.21

30.25

72.13

Effectiveness of osteopathy Effectiveness of osteopathy

4.02

4

0.95

23.63

72.41

3.93

4

0.86

21.88

72.41

Effectiveness of osteopathy

3.95

4

0.96

24.30

72.41

Effectiveness of osteopathy Effectiveness of osteopathy Effectiveness of

4.03

4

1.12

27.79

70.69

4.12

4.5

1.09

26.46

74.14

3.97

4

1.09

27.46

74.14

TE D

Research priority (rated as ≥ 70% agreement most important, then mean) 1. What is the effectiveness of osteopathy for neck pain? 2. What is the effectiveness of osteopathy for chronic low back pain? 3. What is the effectiveness of osteopathy for whiplash injuries? 4. What is the effectiveness of osteopathy for radicular symptoms? 5. What is the effectiveness of osteopathy for cervicogenic headache (headache of cervical origin)? 6. What is the effectiveness of osteopathy for tension-type headache (primary and / or secondary headache related to muscle tension, stress, psychogenic causes)? 7. What are the risks of osteopathic intervention compared to pharmaceutical intervention? 8. What is the effectiveness of osteopathy management of age related complaints in the elderly? 9. What approaches do osteopaths take in managing patients with widespread chronic pain? 10. What are the neurological effects of osteopathy interventions? 11. Development of an osteopathic specific patient reported outcome measure and evaluation of its measurement properties. 12. What is the effectiveness of osteopathy for migraine? 13. What is the effectiveness and safety of osteopathy management of musculoskeletal problems in patients who are pregnant? 14. What is the effectiveness of osteopathy for spinal pain arising from injury / accident? 15. What is the effectiveness of osteopathy for acute low back pain? 16. What is the effectiveness of osteopathy for sciatica? 17. What is the effectiveness of ongoing

Table 5. Research priorities with ≥ 70% agreement in round 3.

ACCEPTED MANUSCRIPT osteopathy 3.91

4

1.08

27.62

72.41

Adverse effects

4.04

4

1.21

29.95

73.68

Adverse effects

4.05

4

1.11

27.41

72.41

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Effectiveness of osteopathy

AC C

EP

TE D

M AN U

SC

regular osteopathy treatment in reducing incidence / frequency of episodes of LBP? 18. What is the effectiveness of nonmanipulative osteopathy management of low back pain? 19. What are the risks of osteopathic cervical manipulation? 20. What is the rate and nature of reported adverse events?

ACCEPTED MANUSCRIPT Table 6 Summary of priority areas

Risk of osteopathic treatment:

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Outcomes of osteopathic treatment:

• • • •

Neck pain Whiplash Headaches Radicular pain (including sciatica) Reducing episodes of low back pain (LBP) Acute LBP Chronic LBP Chronic widespread pain Musculoskeletal pain in pregnancy Elderly Spinal pain resulting from accident and or injury Compared to pharmacological therapy In cervical spine manipulation Patient reported outcomes Effect on the neurological system

RI PT

Role of osteopathy in the management of:

• • • • • • • • • • •

SC

Effectiveness of osteopathic treatment for: