Jane Gunn

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.

Validation of PHQ-2 and PHQ-9 to Screen for Major Depression in the Primary Care Population

PURPOSE Although screening for unipolar depression is controversial, it is potentially an efficient way to find undetected cases and improve diagnostic acumen. Using a reference standard, we aimed to validate the 2- and 9-question Patient Health Questionnaires (PHQ-2 and PHQ-9) in primary care settings. The PHQ-2 comprises the first 2 questions of the PHQ-9. METHODS Consecutive adult patients attending Auckland family practices completed the PHQ-9, after which they completed the Composite International Diagnostic Interview (CIDI) depression reference standard. Sensitivities and specificities for PHQ-2 and PHQ-9 were analyzed. RESULTS There were 2,642 patients who completed both the PHQ-9 and the CIDI. Sensitivity and specificity of the PHQ-2 for diagnosing major depression were 86% and 78%, respectively, with a score of 2 or higher and 61% and 92% with a score 3 or higher; for the PHQ-9, they were 74% and 91%, respectively, with a score of 10 or higher. For the PHQ-2 a score of 2 or higher detected more cases of depression than a score of 3 or higher. For the PHQ-9 a score of 10 or higher detected more cases of major depression than the PHQ determination of major depression originally described by Spitzer et al in 1999. CONCLUSIONS We report the largest validation study of the PHQ-2 and PHQ-9, compared with a reference standard interview, undertaken in an exclusively primary care population. The PHQ-2 score or 2 or higher had good sensitivity but poor specificity in detecting major depression. Using a PHQ-2 threshold score of 2 or higher rather than 3 or higher resulted in more depressed patients being correctly identified. A PHQ-9 score of 10 or higher appears to detect more depressed patients than the originally described PHQ-9 scoring for major depression.

Association between depression and abuse by partners of women attending general practice: descriptive, cross sectional survey

Abstract Objective To explore the association between depression and physical, emotional, and sexual abuse by partners or ex-partners of women attending general practice. Design Descriptive, cross sectional survey. Setting 30 general practitioners in Victoria, Australia. Participants 1257 consecutive female patients. Main outcome measures Some type of abuse in an adult intimate relationship (composite abuse scale), depression (Beck depression inventory or Edinburgh postnatal depression scale), and physical health (SF-36). Results 18.0% (218/1213) of women scored as currently probably depressed and 24.1% (277/1147) had experienced some type of abuse in an adult intimate relationship. Depressed women were significantly more likely to have experienced severe combined abuse than women who were not depressed after adjusting for other significant sociodemographic variables (odds ratio 5.8, 95% confidence interval 2.8 to 12.0). These variables included not being married, having a poor education, being on a low income, being unemployed or receiving a pension, pregnancy status, or being abused as a child. Conclusion Physical, emotional, and sexual abuse are strongly associated with depression in women attending general practice. Doctors should sensitively ask depressed women about their experiences of violence and abuse in intimate relationships. Research into depression should include measures of partner abuse in longitudinal and intervention studies.

Service use for mental health problems: findings from the 2007 National Survey of Mental Health and Wellbeing

Objectives: To provide an overview of 12 month rates of service use for mental health problems and mental disorders by the general Australian adult population. Method: Data came from the 2007 National Survey of Mental Health and Wellbeing (2007 NSMHWB), a nationally representative household survey of 8841 individuals aged between 16 and 85 years. Results: Overall, 11.9% of the general Australian adult population made use of any services for mental health problems in a 12 month period. Approximately one-third of people (34.9%) meeting criteria for a mental disorder did so. Female subjects with mental disorders were more likely to use services than male subjects (40.7% vs 27.5%). People in the youngest age group made relatively less use of services than older adults. Those with affective disorders were most likely to make use of services (58.6%), followed by those with anxiety (37.8%) and substance use disorders (24.0%), respectively. Mental health hospitalizations were less common than consultations with community-based providers (2.6%), whereas 34.6% consulted a community-based provider – particularly general practitioners (24.7%) and psychologists (13.2%). There was a clear dose-response effect between severity of disorders and rates of community-based service use: 63.5% of those with severe mental disorders used community-based services, compared with 40.2% and 17.7% of those with moderate and mild mental disorders, respectively. There was also a relationship between comorbidity of mental disorders and service use. Conclusions: Rates of service use for mental health problems among those with mental disorders in Australia are less than optimal. Little international guidance is available regarding appropriate levels of treatment coverage and other comparable countries face similar difficulties. Further work is required to determine what an appropriate rate of service use is, and to set targets to reach that rate. Australia has demonstrated that concerted policy efforts can improve rates of service use. These efforts should be expanded.

Outcomes and costs of primary care surveillance and intervention for overweight or obese children: the LEAP 2 randomised controlled trial

Objective To determine whether ascertainment of childhood obesity by surveillance followed by structured secondary prevention in primary care improved outcomes in overweight or mildly obese children. Design Randomised controlled trial nested within a baseline cross sectional survey of body mass index (BMI). Randomisation and outcomes measurement, but not participants, were blinded to group assignment. Setting 45 family practices (66 general practitioners) in Melbourne, Australia. Participants 3958 children visiting their general practitioner in May 2005-July 2006 were surveyed for BMI. Of these, 258 children aged 5 years 0 months up to their 10th birthday who were overweight or obese by International Obesity Taskforce criteria were randomised to intervention (n=139) or control (n=119) groups. Children who were very obese (UK BMI z score ≥3.0) were excluded. Intervention Four standard consultations over 12 weeks targeting change in nutrition, physical activity, and sedentary behaviour, supported by purpose designed family materials. Main outcomes measures Primary measure was BMI at 6 and 12 months after randomisation. Secondary measures were mean activity count/min by 7-day accelerometry, nutrition score from 4-day abbreviated food frequency diary, and child health related quality of life. Differences were adjusted for socioeconomic status, age, sex, and baseline BMI. Results Of 781 eligible children, 258 (33%) entered the trial; attrition was 3.1% at 6 months and 6.2% at 12 months. Adjusted mean differences (intervention − control) at 6 and 12 months were, for BMI, −0.12 (95% CI −0.40 to 0.15, P=0.4) and −0.11 (−0.45 to 0.22, P=0.5); for physical activity in counts/min, 24 (−4 to 52, P=0.09) and 11 (−26 to 49, P=0.6); and, for nutrition score, 0.2 (−0.03 to 0.4, P=0.1) and 0.1 (−0.1 to 0.4, P=0.2). There was no evidence of harm to the child. Costs to the healthcare system were significantly higher in the intervention arm. Conclusions Primary care screening followed by brief counselling did not improve BMI, physical activity, or nutrition in overweight or mildly obese 5-10 year olds, and it would be very costly if universally implemented. These findings are at odds with national policies in countries including the US, UK, and Australia. Trial registration ISRCTN 52511065 (www.isrctn.org)

Outcome data from the LEAP (Live, Eat and Play) trial: a randomized controlled trial of a primary care intervention for childhood overweight/mild obesity

Objectives:To reduce gain in body mass index (BMI) in overweight/mildly obese children in the primary care setting.Design:Randomized controlled trial (RCT) nested within a baseline cross-sectional BMI survey.Setting:Twenty nine general practices, Melbourne, Australia.Participants:(1) BMI survey: 2112 children visiting their general practitioner (GP) April–December 2002; (2) RCT: individually randomized overweight/mildly obese (BMI z-score <3.0) children aged 5 years 0 months–9 years 11 months (82 intervention, 81 control).Intervention:Four standard GP consultations over 12 weeks, targeting change in nutrition, physical activity and sedentary behaviour, supported by purpose-designed family materials.Main outcome measures:Primary: BMI at 9 and 15 months post-randomization. Secondary: Parent-reported child nutrition, physical activity and health status; child-reported health status, body satisfaction and appearance/self-worth.Results:Attrition was 10%. The adjusted mean difference (intervention–control) in BMI was −0.2 kg/m2 (95% CI: −0.6 to 0.1; P=0.25) at 9 months and −0.0 kg/m2 (95% CI: −0.5 to 0.5; P=1.00) at 15 months. There was a relative improvement in nutrition scores in the intervention arm at both 9 and 15 months. There was weak evidence of an increase in daily physical activity in the intervention arm. Health status and body image were similar in the trial arms.Conclusions:This intervention did not result in a sustained BMI reduction, despite the improvement in parent-reported nutrition. Brief individualized solution-focused approaches may not be an effective approach to childhood overweight. Alternatively, this intervention may not have been intensive enough or the GP training may have been insufficient; however, increasing either would have significant cost and resource implications at a population level.

Screening and counselling in the primary care setting for women who have experienced intimate partner violence (WEAVE): a cluster randomised controlled trial

BACKGROUND Evidence for a benefit of interventions to help women who screen positive for intimate partner violence (IPV) in health-care settings is limited. We assessed whether brief counselling from family doctors trained to respond to women identified through IPV screening would increase womens quality of life, safety planning and behaviour, and mental health. METHODS In this cluster randomised controlled trial, we enrolled family doctors from clinics in Victoria, Australia, and their female patients (aged 16-50 years) who screened positive for fear of a partner in past 12 months in a health and lifestyle survey. The study intervention consisted of the following: training of doctors, notification to doctors of women screening positive for fear of a partner, and invitation to women for one-to-six sessions of counselling for relationship and emotional issues. We used a computer-generated randomisation sequence to allocate doctors to control (standard care) or intervention, stratified by location of each doctors practice (urban vs rural), with random permuted block sizes of two and four within each stratum. Data were collected by postal survey at baseline and at 6 months and 12 months post-invitation (2008-11). Researchers were masked to treatment allocation, but women and doctors enrolled into the trial were not. Primary outcomes were quality of life (WHO Quality of Life-BREF), safety planning and behaviour, mental health (SF-12) at 12 months. Secondary outcomes included depression and anxiety (Hospital Anxiety and Depression Scale; cut-off ≥8); womens report of an inquiry from their doctor about the safety of them and their children; and comfort to discuss fear with their doctor (five-point Likert scale). Analyses were by intention to treat, accounting for missing data, and estimates reported were adjusted for doctor location and outcome scores at baseline. This trial is registered with the Australian New Zealand Clinical Trial Registry, number ACTRN12608000032358. FINDINGS We randomly allocated 52 doctors (and 272 women who were eligible for inclusion and returned their baseline survey) to either intervention (25 doctors, 137 women) or control (27 doctors, 135 women). 96 (70%) of 137 women in the intervention group (seeing 23 doctors) and 100 (74%) of 135 women in the control group (seeing 26 doctors) completed 12 month follow-up. We detected no difference in quality of life, safety planning and behaviour, or mental health SF-12 at 12 months. For secondary outcomes, we detected no between-group difference in anxiety at 12 months or comfort to discuss fear at 6 months, but depressiveness caseness at 12 months was improved in the intervention group compared with the control group (odds ratio 0·3, 0·1-0·7; p=0·005), as was doctor enquiry at 6 months about womens safety (5·1, 1·9-14·0; p=0·002) and childrens safety (5·5, 1·6-19·0; p=0·008). We recorded no adverse events. INTERPRETATION Our findings can inform further research on brief counselling for women disclosing intimate partner violence in primary care settings, but do not lend support to the use of postal screening in the identification of those patients. However, we suggest that family doctors should be trained to ask about the safety of women and children, and to provide supportive counselling for women experiencing abuse, because our findings suggest that, although we detected no improvement in quality of life, counselling can reduce depressive symptoms. FUNDING Australian National Health and Medical Research Council.

Chlamydia trachomatis Incidence and Re-Infection among Young Women – Behavioural and Microbiological Characteristics

Background This study aimed to estimate rates of chlamydia incidence and re-infection and to investigate the dynamics of chlamydia organism load in prevalent, incident and re-infections among young Australian women. Methods 1,116 women aged 16 to 25 years were recruited from primary care clinics in Australia. Vaginal swabs were collected at 3 to 6 month intervals for chlamydia testing. Chlamydia organism load was measured by quantitative PCR. Results There were 47 incident cases of chlamydia diagnosed and 1,056.34 person years of follow up with a rate of 4.4 per 100 person years (95% CI: 3.3, 5.9). Incident infection was associated with being aged 16 to 20 years [RR = 3.7 (95%CI: 1.9, 7.1)], being employed [RR = 2.4 (95%CI: 1.1, 4.9)] and having two or more new sex partners [RR = 5.5 (95%CI: 2.6, 11.7)]. Recent antibiotic use was associated with a reduced incidence [RR:0.1 (95%CI: 0.0, 0.5)]. There were 14 re-infections with a rate of 22.3 per 100 person years (95%CI: 13.2, 37.6). The median time to re-infection was 4.6 months. Organism load was higher for prevalent than incident infections (p<0.01) and for prevalent than re-infections (p<0.01). Conclusions Chlamydia is common among young women and a high proportion of women are re-infected within a short period of time, highlighting the need for effective partner treatment and repeat testing. The difference in organism load between prevalent and incident infections suggests prevalent infection may be more important for ongoing transmission of chlamydia.

Implementing chlamydia screening: what do women think? A systematic review of the literature

BackgroundChlamydia trachomatis is a common sexually transmitted infection that can have serious consequences. It is universally agreed that screening for chlamydia infection should be offered to sexually active young women. We undertook a literature review to document the views, attitudes and opinions of women about being screened, tested and diagnosed with Chlamydia trachomatis.MethodsOnline databases (MEDLINE, Meditext, PsycINFO, Web of Science) and reference lists searched up to August 2005. Search terms: chlamydia, attitude, attitude to health, interview, qualitative, women. Eligibility criteria: about chlamydia, included women, involved interviews/surveys/focus groups, looked at womens views/opinions/attitudes, published in English. Thematic analysis identified the main and recurrent themes emerging from the literature. We compared our thematic analysis with the Theory of Planned Behaviour to provide a model that could assist in planning chlamydia screening programs.ResultsFrom 561 identified articles, 25 fulfilled inclusion criteria and were reviewed. 22: USA, UK; 3: Holland, Sweden, Australia. Major themes identified: need for knowledge and information, choice and support; concerns about confidentiality, cost, fear, anxiety and stigma. Women are more likely to find chlamydia screening/testing acceptable if they think chlamydia is a serious, common condition which can cause infertility and if they understand that chlamydia infection can be asymptomatic. Women want a range of options for chlamydia testing including urine tests, self-administered swabs, pelvic exams and clinician-collected swabs, home-testing and community-based testing. Tests should be free, easy and quick. Women want support for dealing with the implications of a chlamydia diagnosis, they feel chlamydia diagnoses need to be normalised and destigmatised and they want assistance with partner notification. Women need to know that their confidentiality will be maintained.ConclusionOur review found that women from various countries and ethnic backgrounds share similar views regarding chlamydia screening, testing and diagnosis. The acknowledged importance of womens views in planning an effective chlamydia screening program is expanded in this review which details the nature and complexity of such views and considers their likely impact.

Observational studies of depression in primary care: what do we know?

BackgroundWe undertook a systematic review of observational studies of depression in primary care to determine 1) the nature and scope of the published studies 2) the methodological quality of the studies; 3) the identified recovery and risk factors for persistent depression and 3) the treatment and health service use patterns among patients.MethodsSearches were conducted in MEDLINE, CINAHL and PsycINFO using combinations of topic and keywords, and Medical Subject Headings in MEDLINE, Headings in CINAHL and descriptors in PsycINFO. Searches were limited to adult populations and articles published in English during 1985–2006.Results40 articles from 17 observational cohort studies were identified, most were undertaken in the US or Europe. Studies varied widely in aims and methods making it difficult to meaningfully compare the results. Methodological limitations were common including: selection bias of patients and physicians; small sample sizes (range 35–108 patients at baseline and 20–59 patients at follow-up); and short follow-up times limiting the extent to which these studies can be used to inform our understanding of recovery and relapse among primary care patients with depression. Risk factors for the persistence of depression identified in this review were: severity and chronicity of the depressive episode, the presence of suicidal thoughts, antidepressant use, poorer self-reported quality of life, lower self-reported social support, experiencing key life events, lower education level and unemployment.ConclusionDespite the growing interest in depression being managed as a chronic illness, this review identified only 17 observational studies of depression in primary care, most of which have included small sample sizes and been relatively short-term. Future research should be large enough to investigate risk factors for chronicity and relapse, and should be conducted over a longer time frame.