Modelo de Propagación

In this section the different types of outcome measures are briefly discussed and evaluated for their suitability to assess CST. Examples of leading types of measures are provided. At a macro level measures can be defined as generic, utility, specific or individualised (Garratt et al., 2002).

1.3.1 Generic measures

Generic measures are used for a broad range of health problems and due to their broad scope can be used to make comparisons across therapies and can be sub- defined as profile measures e.g. the Short Form - 36 (Ware & Sherbourne, 1992; Hadorn et al., 1995). The term profile is used for a “multidimensional construct that

consists of different dimensions for which a score is presented for each dimension”

(de Vet et al., 2011, p.51). The disadvantages of generic measures are the inability to detect specific details in a specific context e.g. CST as an intervention (unless the outcome measure was designed specifically for measuring CST) or disease specific symptoms.

1.3.2 Utility measures

Utility measures have been developed from economic and decision theory to identify the health states in a population as well as individual patients at a specific point in time (Fitzpatrick et al, cite Drummond, (1993) and Bakker and Van der Linden (1995). The EuroQol EQ-5D (Euroqol Group, 1990), is the most common utility measure of disease burden in the UK and has been validated in many different patient populations worldwide. It is used to calculate the quality of

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adjusted life year (QALY) which has an important role to play in guiding policy and practice. Utility measures may be relevant for health economic assessment of CST against other therapies in due course, but are unsuitable for effectiveness research as important health consequences are excluded.

1.3.3 Specific measures

Specific measures can include: conditions or disease measures such as the Disease Activity Score (DAS) for rheumatoid arthritis (van der Heijde, 1990); site specific measures e.g. the Oxford Knee Score (OKS) Dawson et al., (1998); domain specific measures for example: fatigue; population specific measures e.g. children; or intervention-specific measures, for example the Oxford Hip Score (Dawson et al., 1996) for hip replacement surgery. Disease and site-specific measures are inappropriate for the evaluation of a holistic therapy like CST; as adopting them would contradict the CAM philosophy of working holistically and not with simply one part of a person.

1.3.4 Individualised measures

Patient-centred measures of health aim to be more sensitive to the individual’s needs, demands and change in status e.g. the Patient Generated Index (PGI) (Ruta et al., 1994) offers a patient centred approach to the evaluation of disease specific health related quality of life. The Schedule for Evaluation of Individual Quality of Life (SEIQoL) (O'Boyle, 1993) allows the respondents to nominate the 'top five' domains relevant to their quality of life. The Measure Your Medical Outcome Profile (MYMOPv2) (Paterson, 1996) was developed using a CAM population and is discussed in more depth in the literature review section (pg. 57). The individualised nature of these measures means there can be a lack of comparable evidence.

1.3.5 Patient reported outcomes

This section defines Patient Reported Outcomes (PROs) and demonstrates how they are applied in a clinical setting as part of the NHS Outcomes Framework (DOH, 2010).

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PROs are a means of collecting information as perceived by patients themselves. The Food and Drug Administration (FDA) define patient-reported outcome as "a measurement based on a report that comes directly from the patient about the status of a patient's health condition without amendment or interpretation of the patient's response by a clinician or anyone else. A PRO can be measured by self- report or by interview provided that the interviewer records only the patient's response." (2009, pg.32)

PROs aim to provide an objective measure of a subjective construct: that is, an individual's experiences and concerns in relation to their health, health care and quality of life (Fitzpatrick et al., 1998, Ganz, 2002, cited in Haywood, 2006, pg. 189) they are questionnaires which contain numerous questions or items to measure outcome variables.

Patient-reported outcome measures (PROMS) as they are known in the UK, are applied in a clinical setting as part of the NHS Outcomes Framework in England (DOH, 2010). PROMS data can be used to assess the clinical quality of providers; research what works; evaluate the effectiveness and cost-effectiveness of different technical approaches to care; assess the relative health status of patients before operations; and support the reduction of health inequalities (HSCIC, 2013).

1.3.6 Chapter summary

This section provided the background to this thesis. It introduced and defined CAM. It introduced CST and outcomes of importance to CST users. It presented the way in which health is conceptualised in both the bio-medical model and CAM models of health and introduced conceptual frameworks for such models. The concepts of health-related quality of Life (HRQoL) and spiritual wellbeing were introduced and the relationship between HRQoL and wellbeing were discussed. Health outcome measurement was introduced, the typologies of measures were presented and PRO was defined.

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2

Literature Review

This section describes a series of literature reviews designed to establish if the intended research had already been undertaken; to identify and appraise PROs that are currently being used to evaluate CST; and to identify and appraise PROs that had been developed for use in CAM to establish whether any of these are suitable for use in CST. It presents the criteria that a CST PRO needs to fulfil. The search strategies, inclusion and exclusion criteria for each review are shown. The results of the searches are reported and eligible studies are reviewed. The section concludes by reporting on the methodological challenges associated with literature searching for PROs developed for CST/CAM and a summary of the results of the review.