Christopher Dowrick

Development of a theory of implementation and integration: Normalization Process Theory

BackgroundTheories are important tools in the social and natural sciences. The methods by which they are derived are rarely described and discussed. Normalization Process Theory explains how new technologies, ways of acting, and ways of working become routinely embedded in everyday practice, and has applications in the study of implementation processes. This paper describes the process by which it was built.MethodsBetween 1998 and 2008, we developed a theory. We derived a set of empirical generalizations from analysis of data collected in qualitative studies of healthcare work and organization. We developed an applied theoretical model through analysis of empirical generalizations. Finally, we built a formal theory through a process of extension and implication analysis of the applied theoretical model.ResultsEach phase of theory development showed that the constructs of the theory did not conflict with each other, had explanatory power, and possessed sufficient robustness for formal testing. As the theory developed, its scope expanded from a set of observed regularities in data with procedural explanations, to an applied theoretical model, to a formal middle-range theory.ConclusionNormalization Process Theory has been developed through procedures that were properly sceptical and critical, and which were opened to review at each stage of development. The theory has been shown to merit formal testing.

Understanding the implementation of complex interventions in health care: The normalization process model

BackgroundThe Normalization Process Model is a theoretical model that assists in explaining the processes by which complex interventions become routinely embedded in health care practice. It offers a framework for process evaluation and also for comparative studies of complex interventions. It focuses on the factors that promote or inhibit the routine embedding of complex interventions in health care practice.MethodsA formal theory structure is used to define the model, and its internal causal relations and mechanisms. The model is broken down to show that it is consistent and adequate in generating accurate description, systematic explanation, and the production of rational knowledge claims about the workability and integration of complex interventions.ResultsThe model explains the normalization of complex interventions by reference to four factors demonstrated to promote or inhibit the operationalization and embedding of complex interventions (interactional workability, relational integration, skill-set workability, and contextual integration).ConclusionThe model is consistent and adequate. Repeated calls for theoretically sound process evaluations in randomized controlled trials of complex interventions, and policy-makers who call for a proper understanding of implementation processes, emphasize the value of conceptual tools like the Normalization Process Model.

Normalisation process theory: a framework for developing, evaluating and implementing complex interventions

BackgroundThe past decade has seen considerable interest in the development and evaluation of complex interventions to improve health. Such interventions can only have a significant impact on health and health care if they are shown to be effective when tested, are capable of being widely implemented and can be normalised into routine practice. To date, there is still a problematic gap between research and implementation. The Normalisation Process Theory (NPT) addresses the factors needed for successful implementation and integration of interventions into routine work (normalisation).DiscussionIn this paper, we suggest that the NPT can act as a sensitising tool, enabling researchers to think through issues of implementation while designing a complex intervention and its evaluation. The need to ensure trial procedures that are feasible and compatible with clinical practice is not limited to trials of complex interventions, and NPT may improve trial design by highlighting potential problems with recruitment or data collection, as well as ensuring the intervention has good implementation potential.SummaryThe NPT is a new theory which offers trialists a consistent framework that can be used to describe, assess and enhance implementation potential. We encourage trialists to consider using it in their next trial.

Negative life events, social support and gender difference in depression: a multinational community survey with data from the ODIN study

ObjectiveTo explore if differences in negative life events, vulnerability and social support may explain the gender difference in depression.MethodsCross-sectional, multinational, community survey from five European countries (n = 8,787). Depression is measured by Beck Depression Inventory, whereas negative life events and social support are measured by various questionnaires.ResultsWomen report slightly more negative life events than men do, mainly related to the social network, but more social support in general and in connection with reported life events. This trend is the same in all participating countries except Spain, where there is no gender difference in the reported support. In general, women are not more vulnerable to negative life events than men are. However, women with no social support, who are exposed to life events, are more vulnerable than men without support.ConclusionThe higher rate of depression in women is not explained by gender differences in negative life events, social support or vulnerability.

Problem solving treatment and group psychoeducation for depression: multicentre randomised controlled trial

Abstract Objectives: To determine the acceptability of two psychological interventions for depressed adults in the community and their effect on caseness, symptoms, and subjective function. Design: A pragmatic multicentre randomised controlled trial, stratified by centre. Setting: Nine urban and rural communities in Finland, Republic of Ireland, Norway, Spain, and the United Kingdom. Participants: 452 participants aged 18 to 65, identified through a community survey with depressive or adjustment disorders according to the international classification of diseases, 10th revision or Diagnostic and Statistical Manual of Mental Disorders, fourth edition. Interventions: Six individual sessions of problem solving treatment (n=128), eight group sessions of the course on prevention of depression (n=108), and controls (n=189). Main outcome measures: Completion rates for each intervention, diagnosis of depression, and depressive symptoms and subjective function. Results: 63% of participants assigned to problem solving and 44% assigned to prevention of depression completed their intervention. The proportion of problem solving participants depressed at six months was 17% less than that for controls, giving a number needed to treat of 6; the mean difference in Beck depression inventory score was −2.63 (95% confidence interval −4.95 to −0.32), and there were significant improvements in SF-36 scores. For depression prevention, the difference in proportions of depressed participants was 14% (number needed to treat of 7); the mean difference in Beck depression inventory score was −1.50 (−4.16 to 1.17), and there were significant improvements in SF-36 scores. Such differences were not observed at 12 months. Neither specific diagnosis nor treatment with antidepressants affected outcome. Conclusions: When offered to adults with depressive disorders in the community, problem solving treatment was more acceptable than the course on prevention of depression. Both interventions reduced caseness and improved subjective function.

Twelve month outcome of depression in general practice: does detection or disclosure make a difference?

Abstract Objectives : To assess the extent to which the outcome of depression among primary care attenders may be affected by medical diagnosis or by feedback of questionnaire results in unrecognised cases. Design : Prospective 12 month study including a randomised controlled trial of the effects of disclosure, with data on depression status and clinical management collected by questionnaire and interview. Setting : Two group practices in north Liverpool. Subjects : 1099/1444 (76%) consecutive adult attenders completed the Beck depression inventory, of whom 179 with scores of at least 14 were followed up. Interventions : Disclosure of a random 45% (52/116) of depression scores to general practitioners for subjects whose depression was undetected. Main outcome measures : Depression status estimated by depression score at start of study and at six and 12 months, with subsample validation against ICD−10 criteria. Results : Questionnaire response rates were 76% (136/179) at six months and 68% (122/179) at 12 months and were higher for women than men. The median depression score was 19 (interquartile range 15 to 22) initially, decreasing to 16 (11 to 23) at 12 months. The median depression score decreased significantly (two sided test, P=0.019) in subjects whose depression was unrecognised at the index consultation but increased in those whose depression had been detected by their general practitioners. Disclosure of cases of unrecognised depression to general practitioners had no effect on outcome. Intention to treat was associated with a worse prognosis, although only a minority of subjects received adequate treatment. Conclusions : Disclosure of undetected depression did not improve prognosis. A diagnosis of depression in general practice should be considered simply as a marker of its severity.

Management of depression in UK general practice in relation to scores on depression severity questionnaires: analysis of medical record data.

Objective To determine if general practitioner rates of antidepressant drug prescribing and referrals to specialist services for depression vary in line with patients’ scores on depression severity questionnaires. Design Analysis of anonymised medical record data. Setting 38 general practices in three sites—Southampton, Liverpool, and Norfolk. Data reviewed Records for 2294 patients assessed with severity questionnaires for depression between April 2006 and March 2007 inclusive. Main outcome measures Rates of prescribing of antidepressants and referrals to specialist mental health or social services. Results 1658 patients were assessed with the 9 item patient health questionnaire (PHQ-9), 584 with the depression subscale of the hospital anxiety and depression scale (HADS), and 52 with the Beck depression inventory, 2nd edition (BDI-II). Overall, 79.1% of patients assessed with either PHQ-9 or HADS received a prescription for an antidepressant, and 22.8% were referred to specialist services. Prescriptions and referrals were significantly associated with higher severity scores. However, overall rates of treatment and referral were similar for patients assessed with either measure despite the fact that, with PHQ-9, 83.5% of patients were classified as moderately to severely depressed and in need of treatment, whereas only 55.6% of patients were so classified with HADS. Rates of treatment were lower for older patients and for patients with comorbid physical illness (including coronary heart disease and diabetes) despite the fact that screening for depression among such patients is encouraged in the quality and outcomes framework. Conclusions General practitioners do not decide on drug treatment or referral for depression on the basis of questionnaire scores alone, but also take account of other factors such as age and physical illness. The two most widely used severity questionnaires perform inconsistently in practice, suggesting that changing the recommended threshold scores for intervention might make the measures more valid, more consistent with practitioners’ clinical judgment, and more acceptable to practitioners as a way of classifying patients.

Patients’ and doctors’ views on depression severity questionnaires incentivised in UK quality and outcomes framework: qualitative study

Objective To gain understanding of general practitioners’ and patients’ opinions of the routine introduction of standardised measures of severity of depression through the UK general practice quality and outcomes framework. Design Semistructured qualitative interview study, with purposive sampling and constant comparative analysis. Participants 34 general practitioners and 24 patients. Setting 38 general practices in three sites in England: Southampton, Liverpool, and Norfolk. Results Patients generally favoured the measures of severity for depression, whereas general practitioners were generally cautious about the validity and utility of such measures and sceptical about the motives behind their introduction. Both general practitioners and patients considered that assessments of severity should be seen as one aspect of holistic care. General practitioners considered their practical wisdom and clinical judgment (“phronesis”) to be more important than objective assessments and were concerned that the assessments reduced the human element of the consultation. Patients were more positive about the questionnaires, seeing them as an efficient and structured supplement to medical judgment and as evidence that general practitioners were taking their problems seriously through a full assessment. General practitioners and patients were aware of the potential for manipulation of indicators: for economic reasons for doctors and for patients to avoid stigma or achieve desired outcomes. Conclusions Despite general practitioners’ caution about measures of severity for depression, these may benefit primary care consultations by increasing patients’ confidence that general practitioners are correct in their diagnosis and are making systematic efforts to assess and manage their mental health problems. Further education of primary care staff may optimise the use and interpretation of depression questionnaires.

What Do Patients Choose to Tell Their Doctors? Qualitative Analysis of Potential Barriers to Reattributing Medically Unexplained Symptoms

BACKGROUNDDespite both parties often expressing dissatisfaction with consultations, patients with medically unexplained symptoms (MUS) prefer to consult their general practitioners (GPs) rather than any other health professional. Training GPs to explain how symptoms can relate to psychosocial problems (reattribution) improves the quality of doctor–patient communication, though not necessarily patient health.OBJECTIVETo examine patient experiences of GPs’ attempts to reattribute MUS in order to identify potential barriers to primary care management of MUS and improvement in outcome.DESIGNQualitative study.PARTICIPANTSPatients consulting with MUS whose GPs had been trained in reattribution. A secondary sample of patients of control GPs was also interviewed to ascertain if barriers identified were specific to reattribution or common to consultations about MUS in general.APPROACHThematic analysis of in-depth interviews.RESULTSPotential barriers include the complexity of patients’ problems and patients’ judgements about how to manage their presentation of this complexity. Many did not trust doctors with discussion of emotional aspects of their problems and chose not to present them. The same barriers were seen amongst patients whose GPs were not trained, suggesting the barriers are not particular to reattribution.CONCLUSIONSImproving GP explanation of unexplained symptoms is insufficient to reduce patients’ concerns. GPs need to (1) help patients to make sense of the complex nature of their presenting problems, (2) communicate that attention to psychosocial factors will not preclude vigilance to physical disease and (3) ensure a quality of doctor–patient relationship in which patients can perceive psychosocial enquiry as appropriate.

Process evaluation for complex interventions in primary care: understanding trials using the normalization process model.

BackgroundThe Normalization Process Model is a conceptual tool intended to assist in understanding the factors that affect implementation processes in clinical trials and other evaluations of complex interventions. It focuses on the ways that the implementation of complex interventions is shaped by problems of workability and integration.MethodIn this paper the model is applied to two different complex trials: (i) the delivery of problem solving therapies for psychosocial distress, and (ii) the delivery of nurse-led clinics for heart failure treatment in primary care.ResultsApplication of the model shows how process evaluations need to focus on more than the immediate contexts in which trial outcomes are generated. Problems relating to intervention workability and integration also need to be understood. The model may be used effectively to explain the implementation process in trials of complex interventions.ConclusionThe model invites evaluators to attend equally to considering how a complex intervention interacts with existing patterns of service organization, professional practice, and professional-patient interaction. The justification for this may be found in the abundance of reports of clinical effectiveness for interventions that have little hope of being implemented in real healthcare settings.