Bridie Kent

Realist synthesis: illustrating the method for implementation research

BackgroundRealist synthesis is an increasingly popular approach to the review and synthesis of evidence, which focuses on understanding the mechanisms by which an intervention works (or not). There are few published examples of realist synthesis. This paper therefore fills a gap by describing, in detail, the process used for a realist review and synthesis to answer the question ‘what interventions and strategies are effective in enabling evidence-informed healthcare?’ The strengths and challenges of conducting realist review are also considered.MethodsThe realist approach involves identifying underlying causal mechanisms and exploring how they work under what conditions. The stages of this review included: defining the scope of the review (concept mining and framework formulation); searching for and scrutinising the evidence; extracting and synthesising the evidence; and developing the narrative, including hypotheses.ResultsBased on key terms and concepts related to various interventions to promote evidence-informed healthcare, we developed an outcome-focused theoretical framework. Questions were tailored for each of four theory/intervention areas within the theoretical framework and were used to guide development of a review and data extraction process. The search for literature within our first theory area, change agency, was executed and the screening procedure resulted in inclusion of 52 papers. Using the questions relevant to this theory area, data were extracted by one reviewer and validated by a second reviewer. Synthesis involved organisation of extracted data into evidence tables, theming and formulation of chains of inference, linking between the chains of inference, and hypothesis formulation. The narrative was developed around the hypotheses generated within the change agency theory area.ConclusionsRealist synthesis lends itself to the review of complex interventions because it accounts for context as well as outcomes in the process of systematically and transparently synthesising relevant literature. While realist synthesis demands flexible thinking and the ability to deal with complexity, the rewards include the potential for more pragmatic conclusions than alternative approaches to systematic reviewing. A separate publication will report the findings of the review.

Preventing excessive gestational weight gain: a systematic review of interventions

Women who gain excessive weight during pregnancy have an increased risk of post‐partum obesity, and retention of gestational weight gain (GWG) post birth is a strong predictor of maternal overweight/obesity a decade or more after the birth. The aim of the current review was to identify, and evaluate the effect of key variables designed to modify risk factors for excessive weight gain in pregnant women that have been targeted in interventions over the last decade. The 10 interventions focused primarily on behavioural changes in relation to physical activity and/or to eating. While six studies reported significantly less weight gain in the intervention women, only three showed that women in the intervention were significantly more likely to gain within recommended guidelines. GWG was reduced in only normal‐weight, low‐income, obese, or overweight women, or not at all. Only one study reported a reduction in GWG in women with body mass indexes spanning the normal, overweight and obese categories. The findings were inconsistent in relation to what factors need to be targeted in intervention programmes to reduce GWG. Consideration of psychological factors relevant to pregnancy, in addition to behavioural changes in relation to eating and physical activity, is suggested for future intervention studies.

Conflicting attitudes to corneal and organ donation: a study of nurses' attitudes to organ donation

The demand for transplantable organs and tissues is steadily increasing and action is necessary to improve the organ and tissue donation rates. Previous research has suggested that nurses have a substantial influence on the rates of donation in the clinical area. Nurses (N = 150) were asked to complete a number of measures to assess positive and negative attitudes towards cadaveric organ donation, with 112 (74.6%) responding. The findings identified conflicting attitudes particularly in relation to corneal donation; 25% of the respondents would not donate their corneas. Reasons given included fear of disfigurement, religious factors such as the need to see into the next life, and dislike of the thought of donation of eyes but without knowing why. The majority of the respondents were in favour of donation generally and many carried or had signed donor cards. Nurses are usually the professionals who have the most contact with the patient in the clinical and are therefore able to identify potential donors. It seems likely that nurses with conflicting attitudes to donation are less likely to undertake the emotional costs involved when relatives of potential donors are approached re donation, than those who have more positive attitudes.

A realist review of interventions and strategies to promote evidence-informed healthcare: A focus on change agency

BackgroundChange agency in its various forms is one intervention aimed at improving the effectiveness of the uptake of evidence. Facilitators, knowledge brokers and opinion leaders are examples of change agency strategies used to promote knowledge utilization. This review adopts a realist approach and addresses the following question: What change agency characteristics work, for whom do they work, in what circumstances and why?MethodsThe literature reviewed spanned the period 1997-2007. Change agency was operationalized as roles that are aimed at effecting successful change in individuals and organizations. A theoretical framework, developed through stakeholder consultation formed the basis for a search for relevant literature. Team members, working in sub groups, independently themed the data and developed chains of inference to form a series of hypotheses regarding change agency and the role of change agency in knowledge use.Results24, 478 electronic references were initially returned from search strategies. Preliminary screening of the article titles reduced the list of potentially relevant papers to 196. A review of full document versions of potentially relevant papers resulted in a final list of 52 papers. The findings add to the knowledge of change agency as they raise issues pertaining to how change agents’ function, how individual change agent characteristics effect evidence-informed health care, the influence of interaction between the change agent and the setting and the overall effect of change agency on knowledge utilization. Particular issues are raised such as how accessibility of the change agent, their cultural compatibility and their attitude mediate overall effectiveness. Findings also indicate the importance of promoting reflection on practice and role modeling. The findings of this study are limited by the complexity and diversity of the change agency literature, poor indexing of literature and a lack of theory-driven approaches.ConclusionThis is the first realist review of change agency. Though effectiveness evidence is weak, change agent roles are evolving, as is the literature, which requires more detailed description of interventions, outcomes measures, the context, intensity, and levels at which interventions are implemented in order to understand how change agent interventions effect evidence-informed health care.

A conceptual model of psychosocial risk and protective factors for excessive gestational weight gain

OBJECTIVE nearly half of all women exceed the guideline recommended pregnancy weight gain for their Body Mass Index (BMI) category. Excessive gestational weight gain (GWG) is correlated positively with postpartum weight retention and is a predictor of long-term, higher BMI in mothers and their children. Psychosocial factors are generally not targeted in GWG behaviour change interventions, however, multifactorial, conceptual models that include these factors, may be useful in determining the pathways that contribute to excessive GWG. We propose a conceptual model, underpinned by health behaviour change theory, which outlines the psychosocial determinants of GWG, including the role of motivation and self-efficacy towards healthy behaviours. This model is based on a review of the existing literature in this area. ASSESSMENT AND CONCLUSION there is increasing evidence to show that psychosocial factors, such as increased depressive symptoms, anxiety, lower self-esteem and body image dissatisfaction, are associated with excessive GWG. What is less known is how these factors might lead to excessive GWG. Our conceptual model proposes a pathway of factors that affect GWG, and may be useful for understanding the mechanisms by which interventions impact on weight management during pregnancy. This involves tracking the relationships among maternal psychosocial factors, including body image concerns, motivation to adopt healthy lifestyle behaviours, confidence in adopting healthy lifestyle behaviours for the purposes of weight management, and actual behaviour changes. IMPLICATIONS FOR PRACTICE health-care providers may improve weight gain outcomes in pregnancy if they assess and address psychosocial factors in pregnancy.

Protocol for a randomized controlled trial of a specialized health coaching intervention to prevent excessive gestational weight gain and postpartum weight retention in women: the HIPP study

BackgroundPregnancy is a time of significant physiological and physical change for women. In particular, it is a time at which many women are at risk of gaining excessive weight. We describe the rationale and methods of the Health in Pregnancy and Post-birth (HIPP) Study, a study which aims primarily to determine the effectiveness of a specialized health coaching (HC) intervention during pregnancy, compared to education alone, in preventing excessive gestational weight gain and postpartum weight retention 12 months post birth. A secondary aim of this study is to evaluate the mechanisms by which our HC intervention impacts on weight management both during pregnancy and post birth.Methods/DesignThe randomized controlled trial will be conducted with 220 women who have a BMI > 18.5 (American IOM cut-off for normal weight), are 18 years of age or older, English speaking, no history of disordered eating or diabetes and are less than 18 weeks gestation at recruitment. Women will be randomly allocated to either a specialized HC intervention group or an Education Alone group. Our specialized HC intervention has two components: (1) one-on-one sessions with a Health Coach, and (2) two by two hour educational group sessions led by a Health Coach. Women in the Education Alone group will receive two by two hour educational group sessions with no HC components. Body Mass Index, waist circumference, and psychological factors including motivation, readiness to change, symptoms of depression and anxiety, and body dissatisfaction will be assessed at baseline (14-16 weeks gestation), and again at follow-up: 32 weeks gestation, 6 weeks, 6 months and 12 months postpartum.DiscussionOur study responds to the urgent need to design effective interventions in pregnancy to prevent excessive gestational weight gain and postpartum weight retention. Our pregnancy HC intervention is novel and innovative and has been designed to be easily adopted by health professionals who work with pregnant women, such as obstetricians, midwives, allied health professionals and health psychologists.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12611000331932

Effects of a clinician referral and exercise program for men who have completed active treatment for prostate cancer: A multicenter cluster randomized controlled trial (ENGAGE)

BACKGROUND : The purpose of this study was to determine the efficacy of a clinician referral and exercise program in improving exercise levels and quality of life for men with prostate cancer. METHODS : This was a multicenter cluster randomized controlled trial in Melbourne, Australia comprising 15 clinicians: 8 clinicians were randomized to refer eligible participants (n = 54) to a 12-week exercise program comprising 2 supervised gym sessions and 1 home-based session per week, and 7 clinicians were randomized to follow usual care (n = 93). The primary outcome was self-reported physical activity; the secondary outcomes were quality of life, anxiety, and symptoms of depression. RESULTS : A significant intervention effect was observed for vigorous-intensity exercise (effect size: Cohens d, 0.46; 95% confidence interval [CI], 0.09-0.82; P = .010) but not for combined moderate and vigorous exercise levels (effect size: d, 0.08; 95% CI, −0.28 to 0.45; P = .48). Significant intervention effects were also observed for meeting exercise guidelines (≥150 min/wk; odds ratio, 3.9; 95% CI, 1.9-7.8; P = .002); positive intervention effects were observed in the intervention group for cognitive functioning (effect size: d, 0.34; 95% CI, −0.02 to 0.70; P = .06) and depression symptoms (effect size: d, −0.35; 95% CI, −0.71 to 0.02; P = .06). Eighty percent of participants reported that the clinicians referral influenced their decision to participate in the exercise program. CONCLUSIONS : The clinician referral and 12-week exercise program significantly improved vigorous exercise levels and had a positive impact on mental health outcomes for men living with prostate cancer. Further research is needed to determine the sustainability of the exercise program and its generalizability to other cancer populations.The purpose of this study was to determine the efficacy of a clinician referral and exercise program in improving exercise levels and quality of life for men with prostate cancer.

Interventions designed to promote exclusive breastfeeding in high-income countries: a systematic review.

BACKGROUND Worldwide, women seldom reach the recommended target of exclusive breastfeeding up to 6 months postpartum. The aim of the current study was to update a previously published review that presented a conceptual and methodological synthesis of interventions designed to promote exclusive breastfeeding up to 6 months in high-income countries. MATERIALS AND METHODS A systematic search of leading databases was conducted for scholarly, peer-reviewed, randomized controlled trials published from June 2013 to December 2016. Twelve new articles were identified as relevant; all were published in English and assessed exclusive breastfeeding with a follow-up period extending beyond 4 months postpartum. Articles were analyzed for overall quality of evidence in regard to duration of exclusive breastfeeding, using the Grading and Recommendations Assessment, Development, and Evaluation approach. RESULTS A significant increase in the duration of exclusive breastfeeding was found in 4 of the 12 studies. All four successful interventions had long-duration postpartum programs, implemented by telephone, text message, or through a website. Some of the successful interventions also included prenatal education or in-hospital breastfeeding support. CONCLUSIONS Results from this review update correspond closely with previous findings, in that all of the successful interventions had lengthy postnatal support or an education component. More studies assessed intervention fidelity than in the previous review; however, there was little discussion of maternal body-mass index. While a pattern of successful interventions is beginning to emerge, further research is needed to provide a robust evidence base to inform future interventions, particularly with overweight and obese women.

Efficacy of a referral and physical activity program for survivors of prostate cancer [ENGAGE]: Rationale and design for a cluster randomised controlled trial

AbstractBackgroundDespite evidence that physical activity improves the health and well-being of prostate cancer survivors, many men do not engage in sufficient levels of activity. The primary aim of this study (ENGAGE) is to determine the efficacy of a referral and physical activity program among survivors of prostate cancer, in terms of increasing participation in physical activity. Secondary aims are to determine the effects of the physical activity program on psychological well-being, quality of life and objective physical functioning. The influence of individual and environmental mediators on participation in physical activity will also be determined.Methods/DesignThis study is a cluster randomised controlled trial. Clinicians of prostate cancer survivors will be randomised into either the intervention or control condition. Clinicians in the intervention condition will refer eligible patients (n = 110) to participate in an exercise program, comprising 12 weeks of supervised exercise sessions and unsupervised physical activity. Clinicians allocated to the control condition will provide usual care to eligible patients (n = 110), which does not involve the recommendation of the physical activity program. Participants will be assessed at baseline, 12 weeks, 6 months, and 12 months on physical activity, quality of life, anxiety, depression, self-efficacy, outcome expectations, goals, and socio-structural factors.DiscussionThe findings of this study have implications for clinicians and patients with different cancer types or other chronic health conditions. It will contribute to our understanding on the potential impact of clinicians promoting physical activity to patients and the long term health benefits of participating in physical activity programs.Trial registrationAustralia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12610000609055 Deakin University Human Research Ethics Approval 2011-085

Health coaching to prevent excessive gestational weight gain: A randomized-controlled trial

OBJECTIVES The objectives of this study were to evaluate the efficacy of a health coaching (HC) intervention designed to prevent excessive gestational weight gain (GWG), and promote positive psychosocial and motivational outcomes in comparison with an Education Alone (EA) group. DESIGN Randomized-controlled trial. METHODS Two hundred and sixty-one women who were <18 weeks pregnant consented to take part. Those allocated to the HC group received a tailored HC intervention delivered by a Health Coach, whilst those in the EA group attended two education sessions. Women completed measures, including motivation, psychosocial variables, sleep quality, and knowledge, beliefs and expectations concerning GWG, at 15 weeks of gestation (Time 1) and 33 weeks of gestation (Time 2). Post-birth data were also collected at 2 months post-partum (Time 3). RESULTS There was no intervention effect in relation to weight gained during pregnancy, rate of excessive GWG or birth outcomes. The only differences between HC and EA women were higher readiness (b = 0.29, 95% CIs = 0.03-0.55, p < .05) and the importance to achieve a healthy GWG (b = 0.27, 95% CIs = 0.02-0.52, p < .05), improved sleep quality (b = -0.22, 95% CIs = -0.44 to -0.03, p < .05), and increased knowledge for an appropriate amount of GWG that would be best for their babys health (b = -1.75, 95% CI = -3.26 to -0.24, p < .05) reported by the HC at Time 2. CONCLUSIONS Whilst the HC intervention was not successful in preventing excessive GWG, several implications for the design of future GWG interventions were identified, including the burden of the intervention commitment and the use of weight monitoring. STATEMENT OF CONTRIBUTION What is already known on the subject? Designing interventions to address gestational weight gain (GWG) continues to be a challenge. To date, health behaviour change factors have not been the focus of GWG interventions. What does this study add? Our health coaching (HC) intervention did not reduce GWG more so than education alone (EA). There was an intervention effect on readiness and importance to achieve healthy GWG. Yet there were no group differences regarding confidence to achieve healthy GWG post-intervention.