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      Evaluating complex health interventions: a critical analysis of the 'outcomes' concept

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          Abstract

          Background

          The extent to which a health care intervention causes or facilitates health-related change is a key question in research. The need to quantify such change has led to the development of an increasing number of change indicators, to measure what have come to be known as 'outcomes'. In the context of medical research into the efficacy or effectiveness of an intervention the term 'outcomes' has often been interpreted to mean single endpoints with a linear cause and effect link to an external intervention.

          Discussion

          In this paper we present a critical analysis of the nature and interpretation of the 'outcomes' concept and of the assumptions that underpin it. Drawing on our own work and that of others, we analyse the problems that arise when the concept is applied to complex interventions and discuss the use of other models, such as programme theory, as a basis for alternative conceptualisations for indicators of change.

          Our analysis demonstrates that the interpretation of 'outcomes' that may be appropriate for clinical trials of pharmaceutical products, is problematic when used in evaluations of complex interventions in areas such as complementary medicine, palliative care, rehabilitation, and health promotion. The 'outcomes' concept may impose inappropriate patterns of thought and meaning. We present alternative models, such as those based on programme theory, which conceptualise health-related change as resulting from the interaction between intervention, process and context over time. In this framework both the intervention and the patient are defined as causal factors, because the result of the treatment is dependent on the resources of the patient – such as the body's ability to heal itself – and the impact of the patient's situation.

          Summary

          Evaluations based on a model such as programme theory will encompass a wide range of health-related changes that include aspects of process, such as new meanings and understanding, as well as longer term changes in health, wellbeing and health-related competences and behaviours.

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          Most cited references 59

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          Trends in prevalence, awareness, treatment, and control of hypertension in the United States, 1988-2000.

          Prior analyses of National Health and Nutrition Examination Survey (NHANES) data through 1991 have suggested that hypertension prevalence is declining, but more recent self-reported rates of hypertension suggest that the rate is increasing. To describe trends in the prevalence, awareness, treatment, and control of hypertension in the United States using NHANES data. Survey using a stratified multistage probability sample of the civilian noninstitutionalized population. The most recent NHANES survey, conducted in 1999-2000 (n = 5448), was compared with the 2 phases of NHANES III conducted in 1988-1991 (n = 9901) and 1991-1994 (n = 9717). Individuals aged 18 years or older were included in this analysis. Hypertension, defined as a measured blood pressure of 140/90 mm Hg or greater or reported use of antihypertensive medications. Hypertension awareness and treatment were assessed with standardized questions. Hypertension control was defined as treatment with antihypertensive medication and a measured blood pressure of less than 140/90 mm Hg. In 1999-2000, 28.7% of NHANES participants had hypertension, an increase of 3.7% (95% confidence interval [CI], 0%-8.3%) from 1988-1991. Hypertension prevalence was highest in non-Hispanic blacks (33.5%), increased with age (65.4% among those aged > or =60 years), and tended to be higher in women (30.1%). In a multiple regression analysis, increasing age, increasing body mass index, and non-Hispanic black race/ethnicity were independently associated with increased rates of hypertension. Overall, in 1999-2000, 68.9% were aware of their hypertension (nonsignificant decline of -0.3%; 95% CI, -4.2% to 3.6%), 58.4% were treated (increase of 6.0%; 95% CI, 1.2%-10.8%), and hypertension was controlled in 31.0% (increase of 6.4%; 95% CI, 1.6%-11.2%). Women, Mexican Americans, and those aged 60 years or older had significantly lower rates of control compared with men, younger individuals, and non-Hispanic whites. Contrary to earlier reports, hypertension prevalence is increasing in the United States. Hypertension control rates, although improving, continue to be low. Programs targeting hypertension prevention and treatment are of utmost importance.
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            The sociology of chronic illness: a review of research and prospects

             Michael Bury (1991)
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              Measuring outcomes in primary care: a patient generated measure, MYMOP, compared with the SF-36 health survey.

               Ian Paterson (1996)
              To assess the sensitivity to within person change over time of an outcome measure for practitioners in primary care that is applicable to a wide range of illness. Comparison of a new patient generated instrument, the measure yourself medical outcome profile (MYMOP), with the SF-36 health profile and a five point change score; all scales were completed during the consultation with' practitioners and repeated after four weeks. 103 patients were followed up for 16 weeks and their results charted; seven practitioners were interviewed. Established practice of the four NHS general practitioners and four of the private complementary practitioners working in one medical centre. Systematic sample of 218 patients from general practice and all 47 patients of complementary practitioners; patients had had symptoms for more than seven days. Standardised response mean and index of responsiveness; view of practitioners. The index of responsiveness, relating to the minimal clinically important difference, was high for MYMOP: 1.4 for the first symptom, 1.33 for activity, and 0.85 for the profile compared with < 0.45 for SF-36. MYMOP's validity was supported by significant correlation between the change score and the change in the MYMOP score and the ability of this instrument to detect more improvement in acute than in chronic conditions. Practitioners found that MYMOP was practical and applicable to all patients with symptoms and that its use increased their awareness of patients' priorities. MYMOP shows promise as an outcome measure for primary care and for complementary treatment. It is more sensitive to change than the SF-36 and has the added bonus of improving patient-practitioner communication.
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                Author and article information

                Journal
                BMC Complement Altern Med
                BMC Complementary and Alternative Medicine
                BioMed Central
                1472-6882
                2009
                18 June 2009
                : 9
                : 18
                Affiliations
                [1 ]Institute of Health Services Research, Peninsula Medical School, University of Exeter, Exeter, UK
                [2 ]Department of Sociology, University of Copenhagen, Øster Farimagsgade 5, POB 2099, DK-1014 Copenhagen K, Denmark
                [3 ]The National Research Center in Complementary and Alternative Medicine (NAFKAM), The Medical Faculty, University of Tromsø, 9037 Tromsø, Norway
                [4 ]The Danish Multiple Sclerosis Society, Mosedalvej 15, 2500 Valby, Denmark
                [5 ]Department of Community Health Sciences, University of Calgary, 3330 Hospital Drive NW, Calgary, T2N 4N1, Canada
                Article
                1472-6882-9-18
                10.1186/1472-6882-9-18
                2712450
                19538715
                Copyright © 2009 Paterson et al; licensee BioMed Central Ltd.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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                Complementary & Alternative medicine

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