Alicia O'Cathain

Validating the SF-36 health survey questionnaire: new outcome measure for primary care.

OBJECTIVES--To test the acceptability, validity, and reliability of the short form 36 health survey questionnaire (SF-36) and to compare it with the Nottingham health profile. DESIGN--Postal survey using a questionnaire booklet together with a letter from the general practitioner. Non-respondents received two reminders at two week intervals. The SF-36 questionnaire was retested on a subsample of respondents two weeks after the first mailing. SETTING--Two general practices in Sheffield. PATIENTS--1980 patients aged 16-74 years randomly selected from the two practice lists. MAIN OUTCOME MEASURES--Scores for each health dimension on the SF-36 questionnaire and the Nottingham health profile. Response to questions on recent use of health services and sociodemographic characteristics. RESULTS--The response rate for the SF-36 questionnaire was high (83%) and the rate of completion for each dimension was over 95%. Considerable evidence was found for the reliability of the SF-36 (Cronbachs alpha greater than 0.85, reliability coefficient greater than 0.75 for all dimensions except social functioning) and for construct validity in terms of distinguishing between groups with expected health differences. The SF-36 was able to detect low levels of ill health in patients who had scored 0 (good health) on the Nottingham health profile. CONCLUSIONS--The SF-36 is a promising new instrument for measuring health perception in a general population. It is easy to use, acceptable to patients, and fulfils stringent criteria of reliability and validity. Its use in other contexts and with different disease groups requires further research.

Process evaluation of complex interventions: Medical Research Council guidance

Process evaluation is an essential part of designing and testing complex interventions. New MRC guidance provides a framework for conducting and reporting process evaluation studies

Three techniques for integrating data in mixed methods studies

Techniques designed to combine the results of qualitative and quantitative studies can provide researchers with more knowledge than separate analysis

The quality of mixed methods studies in health services research.

Objectives To assess the quality of mixed methods studies in health services research (HSR). Methods We identified 118 mixed methods studies funded by the Department of Health in England between 1994 and 2004, and obtained proposals and/or final reports for 75. We applied a set of quality questions to both the proposal and report of each study, addressing the success of the study, the mixed methods design, the individual qualitative and quantitative components, the integration between methods and the inferences drawn from completed studies. Results Most studies were completed successfully. Researchers mainly ignored the mixed methods design and described only the separate components of a study. There was a lack of justification for, and transparency of, the mixed methods design in both proposals and reports, and this had implications for making judgements about the quality of individual components in the context of the design used. There was also a lack of transparency of the individual methods in terms of clear exposition of data collection and analysis, and this was more a problem for the qualitative than the quantitative component: 42% (19/45) versus 18% (8/45) of proposals (p 5 0.011). Judgements about integration could rarely be made due to the absence of an attempt at integration of data and findings from different components within a study. Conclusions The HSR community could improve mixed methods studies by giving more consideration to describing and justifying the design, being transparent about the qualitative component, and attempting to integrate data and findings from the individual components.

Why, and how, mixed methods research is undertaken in health services research in England: a mixed methods study

BackgroundRecently, there has been a surge of international interest in combining qualitative and quantitative methods in a single study – often called mixed methods research. It is timely to consider why and how mixed methods research is used in health services research (HSR).MethodsDocumentary analysis of proposals and reports of 75 mixed methods studies funded by a research commissioner of HSR in England between 1994 and 2004. Face-to-face semi-structured interviews with 20 researchers sampled from these studies.Results18% (119/647) of HSR studies were classified as mixed methods research. In the documentation, comprehensiveness was the main driver for using mixed methods research, with researchers wanting to address a wider range of questions than quantitative methods alone would allow. Interviewees elaborated on this, identifying the need for qualitative research to engage with the complexity of health, health care interventions, and the environment in which studies took place. Motivations for adopting a mixed methods approach were not always based on the intrinsic value of mixed methods research for addressing the research question; they could be strategic, for example, to obtain funding. Mixed methods research was used in the context of evaluation, including randomised and non-randomised designs; survey and fieldwork exploratory studies; and instrument development. Studies drew on a limited number of methods – particularly surveys and individual interviews – but used methods in a wide range of roles.ConclusionMixed methods research is common in HSR in the UK. Its use is driven by pragmatism rather than principle, motivated by the perceived deficit of quantitative methods alone to address the complexity of research in health care, as well as other more strategic gains. Methods are combined in a range of contexts, yet the emerging methodological contributions from HSR to the field of mixed methods research are currently limited to the single context of combining qualitative methods and randomised controlled trials. Health services researchers could further contribute to the development of mixed methods research in the contexts of instrument development, survey and fieldwork, and non-randomised evaluations.

Rethinking pragmatic randomised controlled trials: introducing the “cohort multiple randomised controlled trial” design

Pragmatic trials are important for informing routine clinical practice, but current designs have shortcomings. Clare Relton and colleagues outline the new “cohort multiple randomised controlled trial” design, which could help address the problems associated with existing approaches

Process evaluation in complex public health intervention studies: the need for guidance

Public health interventions aim to improve the health of populations or at-risk subgroups. Problems targeted by such interventions, such as diet and smoking, involve complex multifactorial aetiology. Interventions will often aim to address more than one cause simultaneously, targeting factors at multiple levels (eg, individual, interpersonal, organisational), and comprising several components which interact to affect more than one outcome.1 They will often be delivered in systems which respond in unpredictable ways to the new intervention.2 Recognition is growing that evaluations need to understand this complexity if they are to inform future intervention development, or efforts to apply the same intervention in another setting or population.1 Achieving this will require evaluators to move beyond a ‘does it work?’ focus, towards combining outcomes and process evaluation. There is no such thing as a typical process evaluation, with the term applied to studies which range from a few simple quantitative items on satisfaction, to complex mixed-method studies exploring issues such as the process of implementation, or contextual influences on implementation and outcomes. As recognised within MRC guidance for evaluating complex interventions, process evaluation may be used to ‘assess fidelity and quality of implementation , clarify causal mechanisms and identify contextual factors associated with variation in outcomes’.1 This paper briefly discusses each of these core aims for process evaluation, before describing current Medical Research Council (MRC) Population Health Sciences Research Network (PHSRN) funded work to develop guidance for process evaluations of complex public health interventions. ### Intervention implementation An important role for process evaluations is to examine the quantity and quality of what was actually implemented in practice, and why. This may inform implementation of similar interventions elsewhere, and facilitate interpretation of intervention outcomes. While notions of standardisation are central to implementation assessment, the nature of …

Knowledge, technology and nursing: The case of NHS Direct

NHS Direct is a relatively new, nurse-based, 24-hour health advice line run as part of the UK’s National Health Service (NHS). The service delivers health advice remotely via the telephone. A central aspect of the service is the attempt to provide a standard level of health advice regardless of time, space or the background of the nurse. At the heart of this attempt is an innovative health software called CLINICAL ASSESSMENT SYSTEM (CAS). Using a number of qualitative methods, this article highlights how the interaction between the nursing staff and this technology is key to the service. The technology is based on management’s attempt to standardize and control the caller-nurse relationship. Thus the software can be seen as part of an abstract rationality, whereas how it is deployed by nurses is based on a practical rationality that places practice and experience first and sees the technology and protocols as tools.

The acceptability of computerised cognitive behavioural therapy for the treatment of depression in people with chronic physical disease: a qualitative study of people with multiple sclerosis.

Background: People with chronic physical conditions are at elevated risk of depression. Due to a shortage of Cognitive Behavioural Therapy (CBT) practitioners, computerised CBT (CCBT) is recommended for people with mild to moderate depression. We assessed the applicability of CCBT for the treatment of depression in people with multiple sclerosis (MS). Methods: Depth interviews with 17 people with MS and mild to moderate depression who used one of the two CCBT packages for either eight (Beating the Blues; n = 8) or five (MoodGym; n = 9) weekly sessions were analysed using ‘Framework’. Results: Participants found CCBT-use burdensome due to their physical symptoms. In addition to perpetuating social isolation, the lack of human input meant some participants were unable to define problems, set goals or distinguish between events, thoughts and beliefs as required. CCBT did not legitimise their grief over losses concomitant with their MS. They characterised depression symptom inventories as contaminated by somatic symptoms of their MS. One CCBT package (MoodGym) was perceived as using inappropriate case material for people with the symptoms of MS. Conclusions: It is likely that generic CCBT packages for the treatment of depression will need to be adapted for people with chronic physical conditions to maximise their potential for health benefit.

Editorial: Mixed Methods Research in the Health Sciences: A Quiet Revolution:

Mixed methods research is undertaken in a wide range of fields, such as education, psychology, social sciences, and health sciences. The acceptance of this approach, levels of understanding, and ways in which methods are combined, may differ by research field. This makes it important to reflect on the state of methodological development within specific research fields as well as at a more macro mixed methods level. There may also be methodological developments in one field, which can benefit researchers in other fields. Health sciences is an interesting field to consider because mixed methods research is commonly used (O’Cathain, Murphy, & Nicholl, 2007) and has been the focus of discussions for many years (Baum, 1995; Morse, 1991). Here I consider how mixed methods research has developed in the health sciences, and the contribution this field has made to the wider mixed methods research endeavor. The health sciences field can encompass a wide range of research communities—public health, nursing, health promotion, health informatics, health services research, medical research, professions allied to medicine, and more. Each of these communities has a different history, value set, and preference for addressing different types of research questions, making it a challenge to consider the state of mixed methods research within the whole of ‘‘health sciences.’’ It is also the case that research communities develop in different ways depending on the country in which they are based. Although mixed methods research in health sciences has been discussed generally (Forthofer, 2003), here I draw lessons from the research community I know best—health services research within the United Kingdom. Health services researchers focus on health care provision rather than on causes of diseases. Research questions address access to care and the effectiveness and costeffectiveness of both established and new interventions. Historically, health services researchers in the United Kingdom have used quantitative methodology, with an emphasis on the use of randomized controlled trials to address the effectiveness of interventions. Qualitative methods have been used within the field for many years, but in the past have been dismissed as ‘‘poor science.’’ This changed 13 years ago when we experienced what might be termed a quiet revolution. Two researchers made a stand for the acceptance of qualitative methodology as a way of addressing questions that tended to remain unanswered in our quantitative dominant approach, such as why do some new health care interventions work and others do not (Pope & Mays, 1995). The revolution brought medical sociologists and anthropologists—who had always worked within health research—more centrally into the discipline mix of our field. The revolution was not a replacement of quantitative research with qualitative research, nor a separate qualitative research endeavor, but rather the combined use of qualitative and quantitative methods within single studies. That is, mixed methods research gained repute and momentum, with the proportion Journal of Mixed Methods Research Volume 3 Number 1 January 2009 3-6