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Method

Overview of the Research Process

The project involves a multi-phased, qualitative and quantitative research design, based on a standardised research protocol, designed by the project co-ordinators at the University of Salford in partnership with shiatsu practitioners through collaboration with members of the European Federation of Shiatsu (the ESF). Phase One will involve a two country, qualitative study of the practice and experience of shiatsu, and generate the standardised research protocol (including data collection instruments) for the cross-European study. Phase Two will comprise a cross-European cohort study of a random sample of shiatsu practitioners and up to ten consecutive 'new' users in the participating countries, and follow-up of these users for up to a three months.

Phase One - A Two Country Case Studies

Rationale

There is a need for detailed, qualitative studies of individual practitioners and receivers, to gain insight into the depth of relationship, initial and subsequent expectations and outcomes. These will be provide an important addition to knowledge in the area. In addition, they will play a critical role in clarifying the sorts of data to collect in Phase Two and the basis for the development of appropriate and feasible standardised measurement tools and general research practitioner protocol. The aim is to ensure that the resultant instruments do not smooth over the depth and subtlety implicit in a therapy user-practitioner interaction or ignore these by implication.

Objectives

  1. Gain insight into the way shiatsu is practised
  2. Identify retrospectively receivers' perceptions and expectations of shiatsu
  3. Develop and pilot the standardised measurement tools for use in Phase Two
  4. Explore possible and alternative ways to recruit clients for the main study and select the most feasible
  5. Finalise the research protocol for practitioners for use in Phase Two, including recruitment procedures (practitioners and clients), consent forms and data collection instruments (the latter, then being ready for translation into relevant European languages)

Duration

Phase One will take 10 months, with a proposed start date of 1st January 2001 and end date of 31st October 2001.

Location

This part of the study will be undertaken in two countries, the UK (for the convenience of the research team) and Germany (a setting where shiatsu is well established).

Approach

A number of case studies will be undertaken with a set of practitioners in each country or until no 'new' data, in the sense of themes or insights, emerge. The work will be taken forward in a phased manner, beginning within the UK and then moving onto the second country (Germany):

In the UK, to:

  • Undertake in-depth, focused group discussions with two carefully selected groups of practitioners to explore the way they practise, following these up with individual interviews of a sub-set
  • Supplement these with interviews of a small number of highly experienced practitioners about the way they practise
  • Collect information about a sample of practitioner-receiver interactions, from the perspective of both the practitioner and the receiver. Ideally, this would include a number of sessions for the same receiver
  • Analyse the data arising identifying key themes and issues for measurement within Phase Two of the study

It is proposed that the focus group discussions will take place in two locations - locally in the Northwest of England, and perhaps London. Practitioners will be selected according to the principle of typicality, that is, to ensure that important potential sources of variation are covered. Key contrasts include: part and full time practice; length of practice; age and gender.

In Germany, to:

  • Undertake a facilitated workshop with a carefully selected group of practitioners, presenting the results of the UK field work, with a view to explore areas of similarity and difference in the way they practise shiatsu
  • As appropriate, repeat this with another group
  • Supplement these with interviews of a small number of highly experienced practitioners about the way they practise
  • Collect information about a sample of practitioner-receiver interactions, from the perspective of both the practitioner and the receiver. Ideally, this would include a number of sessions for the same receiver [this could be in the form of a focus group discussion]
  • Analyse the data arising identifying key themes and issues for measurement within Phase Two of the study

The initial workshop would take place in Munich, with a second location to be decided with the German national association. Again, practitioners will be selected according to ensure that important potential sources of variation are covered.

The combined data will provide a base for the development of the standardised measurement tools and research protocol for use in Phase Two (the cross-European study). Once developed, the tools and protocol will be piloted with a sub-set of the participating practitioners in the two countries, and appropriate modification and refinements made.

Selection of Practitioners and Clients

A volunteer / convenience sample of shiatsu practitioners will be selected. It is proposed that the sample represents typical practitioners (to ensure that important potential sources of variation are covered) and to maximise the generalisability of the findings. Key variables include: part and full time practice; length of practice; age and gender. The participating practitioners will guide choice of clients.

As is indicated below in the section, Ethical Issues, the researchers are acutely aware of the need to be unobtrusive and of the potential effect that they could have on the client-practitioner interaction. It is proposed that the practitioner gives a potential study recruit an information leaflet on the study, and asks them to contact the research team. Different ways to do this will form a key area of examination in this part of the study, with a view to identify the best way to recruit shiatsu receivers in Phase Two.

In Phase One, interest lies in access to typical users, in order to gain insight into their expectations, experience and effects of shiatsu. Their typicality is critical in order to ensure that the data arising form a sound basis for the design of the measuring instruments in Phase Two. The aim is to ensure coverage of the range of practice, as far as is feasible within the time limits of this study phase. Key contrasts include: clients with a specific, 'one-off' problem, long-standing clients, gender and age.

Areas for Data Collection

Key areas for exploration include:

The practitioner:

  • The way they practice, the way they build up a relationship with the client
  • The way they follow up to see how things have worked out for the receiver and the need for further treatment sessions
  • Type of clients seen, nature and duration of contact (long standing and 'one-off' specific set of treatment sessions)
  • The information collected on the client, the way in which it is recorded, stored and updated (including expectations, goals set and treatment given, the way the treatment is progressing)
  • Insight into who is seen, for what and for how many treatment sessions
  • Comments on the perceived effects of shiatsu

The receiver:

  • Reasons for seeking shiatsu
  • Expectations of shiatsu
  • Previous / other use of complementary and alternative medicine, and use of conventional medicine for the presenting condition / issue
  • Perspectives on the short and longer term effects of shiatsu
  • Satisfaction with shiatsu (practitioner and its practice)

Output/Key Deliverables

  • Report on practise of shiatsu in two countries, from the perspective of practitioners and receivers
  • Piloted data collection instruments and recruitment methods
  • Research protocol for Phase Two (cross-European study), covering inter alia recruitment of practitioners (number and methods), clients (numbers, time scale and methods) and consent forms

Phase Two - The Cross-European Study

This phase of the study will extend the research to all the participating countries in Europe. It will take the form of a cohort study, with a three-month follow-up of receivers.

Objectives

  1. Translate develop instruments and research protocol into appropriate European languages
  2. Recruit a cross-European representative sample of practitioners within participating countries
  3. Recruit a sample of up to ten consecutive 'new' users of shiatsu and follow these receivers up for a period of three months after either 3/4 months from the beginning of the treatment sessions or the end of this course of treatment (whichever is sooner)
  4. Collect systematic data on the expectations, experience and effects of shiatsu
  5. Analyse and write up the study results for internal and external dissemination
  6. Disseminate the findings arising

Duration

The expected duration of this phase is estimated at 18 months. This time scale will be finalised based on the findings from Phase One. Assuming continuity in the funding, Phase Two would be scheduled to begin in November 2001 with an end date of 30th April 2003.

Translation

The research protocol and standardised measurement tools will be translated for use in participating European countries. Considerable care will be given to ensure the appropriateness of the language used, together with its cultural and linguistic equivalence in different European countries, and to reduce the potential for disrupting the dynamic interaction between the giver and receiver of shiatsu. Notional translation costs have been indicated in the attached costings, to be finalised. Translation will be into Flemish, German, Italian and Swedish.

Sample Design

The primary sampling unit will be the receiver of shiatsu. A multi-staged sample will be employed:

  1. A representative sample of shiatsu practitioners will be drawn from the register of members of the participating national shiatsu associations. According to ESF data, there are over 2,500 practitioners in national practice, varying from 30-50 in Austria, Belgium, Ireland, Spain and Sweden (Group One) to 200 or more in Germany, Italy, Switzerland and the UK (Group Two). The sample will be drawn to be representative of the age and gender distribution of practitioners.
  2. Proposed inclusion criteria are:
  • Experienced practitioners (to be operationalised within Phase One), covering 'regular working' (in the form of the number of clients seen per week - for example, part-time practitioner within the range 5-12, and full-time12-25 or more) and experience (qualifications and length of practice as part- or full-time)
  • Written agreement to adhere to the research protocol
  1. The sample will be drawn proportional to the size of the practitioner population. It is proposed that all practitioners within Group One countries will be selected. A sample of around 50 practitioners will be drawn randomly within Group Two countries, stratifying the sample to reflect regional variations. Prospective participating national associations are from the following 8 countries: Austria, Belgium, Germany, Ireland, Italy, Sweden, Switzerland and the United Kingdom.
  2. Each participating practitioner will select up to 10 consecutive new users. The users will be recruited sequentially to avoid bias over who is included and who is not. This approach is modelled on that used by Senstad et al (1997) in a study of the frequency and nature of side effects of spinal manipulative therapy.
  3. It is proposed that recruitment of new users is limited to new users at the practice over a three-month period. This limitation is proposed on the grounds of feasibility in relation to continued enthusiastic participation of the practitioner and the limited length of research study.
  4. Each new user will be followed for three months from either 3-4 months (to be finalised in Phase One) from their first treatment session or the end of the course of treatment, whichever comes sooner. Three months is recognised to be a short time frame to see definitive and long lasting effects, but is necessitated by resource constraints. It should be noted that the total follow-up time is estimated to be at least 6 months (from initial treatment session).

This sample approach is aimed at producing both a representative national and European-wide sample of practitioners and new users (across possible reasons for treatment and number of treatment sessions). A focus on a sequential sample of new users should also enable the selection of a representative and heterogeneous sample of users of shiatsu. The study findings should be thus be generalised across Europe, providing a unique insight into the use, effects and experience of shiatsu.

To check on the representativeness of the sample of shiatsu practitioners, national associations will compare the characteristics of the recruited sample (those agreeing to take part and those who refused) and non-participating practitioners. Data will be extracted from association records.

Data Collection

The set of standardised measurement tools developed in Phase One will be used. It is expected that these will cover the following areas:

  • Reason for seeking shiatsu treatment: motivation; choice of practitioner; previous visit to conventional medical practitioner; expectations of treatment; combination with other treatments
  • User characteristics: age, gender, level of education, work status and nature of work, ethnic group, place of residence
  • Treatment details: number of sessions; duration of individual session; treatment goals; total time period for treatment; payment details
  • Effects as perceived and/or experienced by the receiver and practitioner: what, when and how long for; expected effects; realised effects during treatment; realised effects at the end of the set of treatments; and a measure of holistic practice (Long et al, 2000)
  • Practitioner characteristics: age, gender, level of education; shiatsu and other complementary medicine experience; working situation; shiatsu as main profession or what
  • Impact on wider society and health care system: use of other treatments (what, with whom, number) at beginning, during and at the end of the set of treatments; changes in working status

Each recruited receiver will be followed up for a period of three months after the end of course of treatment (see Table 1).

Table I: Overview of the Data Collection Process

Time Scale

Key Data Collection Items

At first session

Presenting problem

User characteristics

Practitioner characteristics

Either at end of course of treatment or 3/4 months after first treatment session

Treatment details

Health status and quality of life effects

Wider effects for the health system

Three months after end of course of treatment

Longer term health status and quality of life effects

Data Management and Analysis

The exact way that the data collection will be administered within each country will be developed in collaboration with the national association. This will be co-ordinated by the research team at the University of Salford together with Seamus Connolly on behalf of the EF. The research team will also provide ongoing advice and support. Careful monitoring of the practitioner's adherence to the protocol will be undertaken, building on the (signed) agreement of participating practitioners to that protocol.

Completed questionnaires will be analysed by the research team, using SPSS-X for Windows and thematic analysis for open ended questions.

Output/Key Deliverables

  • Report use, effects and experience of shiatsu in the cross-European study, from the perspective of practitioners and receivers
  • Workshop and academic papers
  • Basis for a database on effects for development and maintenance by the ESF