Controlled Trial In Australia Research Articles

Aflibercept monotherapy versus aflibercept with targeted retinal laser to peripheral retinal ischemia for diabetic macular oedema (LADAMO)

ObjectiveWe tested the hypothesis that targeted retinal laser photocoagulation (TPRP) to peripheral retinal ischaemia reduces the overall burden of aflibercept injections when treating diabetic macular oedema (DMO) over a 24-month period.MethodsProspective, double-masked, multicentre, randomised controlled trial in Australia comparing aflibercept monotherapy, following a treat-and-extend protocol, or combination therapy of aflibercept and TPRP for DMO. The aflibercept monotherapy group received placebo laser. The primary outcome measure was the mean number of intravitreal aflibercept injections for each group at 24 months. Secondary outcome included: mean change in central macular thickness (CMT) and vision at trial completion, the proportion of eyes whose DMO resolved and the mean injection treatment interval. Ocular and systemic adverse events were recorded.ResultsWe enrolled 48 eyes of 47 patients; 27 eyes were randomised to combination therapy (aflibercept and TPRP) and 21 to aflibercept monotherapy. Thirty-two eyes (67%) completed the 2-year study. The number of intravitreal treatments given were similar for combination therapy (10.5 (SD 5.8) and monotherapy (11.8 (SD5.6)) (P = 0.44). The mean visual improvement (+4.0 (−1.8, 9.8) and +7.8 (2.6, 12.9) letters, P = 0.32), mean decrease in CMT (−154 (−222,−87) µm and −152 (−218,−86) µm, P = 0.96), proportion of eyes with CMT < 300 µm (48% and 67%; P = 0.50) and safety outcomes were similar in both the combination and monotherapy treatment groups (respectively).ConclusionsLaser to areas of ischaemic peripheral retina does not reduce the burden of intravitreal aflibercept injections when treating diabetic macular oedema.

The effect of a therapeutic smartphone application on suicidal ideation in young adults: Findings from a randomized controlled trial in Australia.

BackgroundSuicidal ideation is a major risk for a suicide attempt in younger people, such that reducing severity of ideation is an important target for suicide prevention. Smartphone applications present a new opportunity for managing ideation in young adults; however, confirmatory evidence for efficacy from randomized trials is lacking. The objective of this study was to assess whether a therapeutic smartphone application (“LifeBuoy”) was superior to an attention-matched control application at reducing the severity of suicidal ideation.Methods and findingsIn this 2-arm parallel, double-blind, randomized controlled trial, 455 young adults from Australia experiencing recent suicidal ideation and aged 18 to 25 years were randomly assigned in a 2:2 ratio to use a smartphone application for 6 weeks in May 2020, with the final follow-up in October 2020. The primary outcome was change in suicidal ideation symptom severity scores from baseline (T0) to postintervention (T1) and 3-month postintervention follow-up (T2), measured using the Suicidal Ideation Attributes Scale (SIDAS). Secondary outcomes were symptom changes in depression (Patient Health Questionnaire-9, PHQ-9), generalized anxiety (Generalized Anxiety Disorder-7, GAD-7), distress (Distress Questionnaire-5, DQ5), and well-being (Short Warwick–Edinburgh Mental Well-Being Scale, SWEMWBS). This trial was conducted online, using a targeted social media recruitment strategy. The intervention groups were provided with a self-guided smartphone application based on dialectical behavior therapy (DBT; “LifeBuoy”) to improve emotion regulation and distress tolerance. The control group were provided a smartphone application that looked like LifeBuoy (“LifeBuoy-C”), but delivered general (nontherapeutic) information on a range of health and lifestyle topics. Among 228 participants randomized to LifeBuoy, 110 did not complete the final survey; among 227 participants randomized to the control condition, 91 did not complete the final survey. All randomized participants were included in the intent-to-treat analysis for the primary and secondary outcomes. There was a significant time × condition effect for suicidal ideation scores in favor of LifeBuoy at T1 (p < 0.001, d = 0.45) and T2 (p = 0.007, d = 0.34). There were no superior intervention effects for LifeBuoy on any secondary mental health outcomes from baseline to T1 or T2 [p-values: 0.069 to 0.896]. No serious adverse events (suicide attempts requiring medical care) were reported.The main limitations of the study are the lack of sample size calculations supporting the study to be powered to detect changes in secondary outcomes and a high attrition rate at T2, which may lead efficacy to be overestimated.ConclusionsLifeBuoy was associated with superior improvements in suicidal ideation severity, but not secondary mental health outcomes, compared to the control application, LifeBuoy-C. Digital therapeutics may need to be purposefully designed to target a specific health outcome to have efficacy.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12619001671156

Social and behavioral predictors of two-doses 4CMenB vaccine series among adolescents enrolled in a cluster randomized controlled trial in Australia

ABSTRACT This study aimed to determine social and behavioral predictors of completing a course of 4CMenB vaccine in adolescents in a parallel cluster randomized controlled trial enrolling secondary school students (approximately 15–18 years of age) in South Australia. Participating schools were randomized to vaccination at baseline (intervention) or 12 months (control). Students assigned to the intervention group were excluded because they have received the first dose of 4CMenB vaccine at baseline. Logistic regression models examined factors associated with non-vaccination or incomplete 4CMenB doses. The study population comprised 11391 students. Overall, 8.3% (n = 946) received no doses and 91.7% (n = 10445) at least one dose. Of 10445 students who initiated their primary dose, 1334 (12.8%) did not complete the two-dose course. The final adjusted model indicated factors associated with non-vaccination in school students were older age (adjusted odds ratio; aOR 7.83, 95% CI: 4.13–14.82), smoking cigarettes (aOR 3.24, 95% CI: 1.93–5.44), exposure to passive smoke (aOR 2.64, 95% CI: 1.48–4.71), Aboriginal or Torres Strait Islander (aOR 1.77, 95% CI: 1.23–2.55), smoking water pipes (aOR 1.94, 95% CI:1.28–2.92), low socioeconomic status (aOR 1.77, 95% CI:1.21–2.60), attending government schools (aOR 1.76, 95% CI: 1.28, 2.43) and participating in intimate kissing (aOR 1.40, 95% CI:1.10–1.79). Multivariable analysis for incomplete vaccination yielded similar findings. Social and behavioral predictors of non-vaccination or incomplete MenB doses were also known risk factors for carriage of Neisseria meningitidis. Immunization strategies to improve MenB vaccination completion need to be tailored to social behavior of adolescents.

MHealth Interventions for Lifestyle and Risk Factor Modification in Coronary Heart Disease: Randomized Controlled Trial

BackgroundSelf-management of lifestyle and cardiovascular disease risk factors is challenging in older patients with coronary heart disease (CHD). SMS text messaging could be a potential support tool for self-management and the most affordable and accessible method through a mobile phone. High-quality evidence had been lacking, and previous studies evaluated the effects of SMS text messaging on the subjective measures of short-term outcomes. Recently, a large-sized randomized controlled trial in Australia reported promising findings on the objective measures upon 6-month follow-up. However, an examination of the effectiveness of such interventions in an Asian population with unique demographic characteristics would be worthwhile.ObjectiveThis study examined the effectiveness of a 1-way SMS text messaging program to modify the lifestyle and cardiovascular disease risk factors of patients who underwent the first percutaneous coronary intervention (PCI).MethodsA parallel, single-blinded, 1:1 random allocation clinical trial was conducted with 879 patients treated through PCI. They were recruited during hospital admission from April 2017 to May 2020 at 2 university hospitals in the Republic of Korea. In addition to standard care, the intervention group received access to a supporting website and 4 SMS text messages per week for 6 months regarding a healthy diet, physical activity, smoking cessation, and cardiovascular health. Random allocation upon study enrollment and SMS text messaging after hospital discharge were performed automatically using a computer program. The coprimary outcomes were low-density-lipoprotein cholesterol (LDL-C), systolic blood pressure (SBP), and BMI. The secondary outcomes were change in lifestyle and adherence to the recommended health behaviors.ResultsOf the eligible population, 440 and 439 patients who underwent PCI were assigned to the intervention and control groups, respectively. The 1-way SMS text messaging program significantly enhanced physical activity (P=.02), healthy diet (P<.01), and medication adherence (P<.04) among patients with CHD. Hence, more people were likely to control their cardiovascular disease risk factors per the recommendations. The intervention group was more likely to control all 5 risk factors by 62% (relative risk 1.62, 95% CI 1.05-2.50) per the recommendations. On the other hand, physiological measures of the primary outcomes, including LDL-C levels, SBP, and BMI, were not significant. Most participants found the SMS text messaging program useful and helpful in motivating lifestyle changes.ConclusionsLifestyle-focused SMS text messages were effective in the self-management of a healthy diet, exercise, and medication adherence, but their influence on the physiological measures was not significant. One-way SMS text messages can be used as an affordable adjuvant method for lifestyle modification to help prevent the recurrence of cardiovascular disease.Trial RegistrationClinical Research Information Service (CRiS) KCT0005087; https://cris.nih.go.kr/cris/search/detailSearch.do/19282

Does Daylength Affect Sleep and Mental Health Symptoms during Behavioral Interventions for Insomnia?

ABSTRACT Background Approximately 11–33% of Australian adults experience Insomnia Disorder, which is associated with higher rates of psychiatric comorbidities, and lower quality of life. Non-pharmacological interventions are the front-line treatments for insomnia. Despite the known impact of light on the sleep/wake cycle via the circadian system, it is not yet known whether seasonal variations in environmental light levels (i.e., daylength) influence treatment outcome. We aimed to determine whether seasonal differences in daylength influenced baseline symptoms of Insomnia Disorder or treatment outcome. Participants One hundred treatment-seeking individuals with Insomnia Disorder (age: 49.3 ± 14.4y, range: 18–82 years; 58 F) enrolled in a Randomized Control Trial in Australia over a 29-month period. Methods Clients completed a seven-session behavioral intervention for insomnia over a maximum of 12 weeks. Individuals completed questionnaires assessing insomnia symptoms, diurnal preference, depression and anxiety symptoms, and daily sleep diaries. Objective rest/activity patterns were monitored using wrist actigraphy for the duration of the treatment period. Results Baseline daylength, sunset and sunrise times, and change in daylength over treatment, were not related to baseline insomnia severity or mental health symptoms. However, longer daylength at baseline predicted greater improvements in insomnia symptoms and anxiety, but not depression, symptoms. These improvements were also associated with later sunset and/or earlier sunrise at baseline. Conclusions Our results show, greater treatment-related improvements in subjective sleep and mental health symptoms during spring and summer months. This suggests that daylength could have a role to play in the outcomes of a behavioral insomnia treatment. Future research is needed to provide recommendations.

The longer-term effects of access to HIV self-tests on HIV testing frequency in high-risk gay and bisexual men: follow-up data from a randomised controlled trial.

BackgroundA wait-list randomised controlled trial in Australia (FORTH) in high-risk gay and bisexual men (GBM) showed access to free HIV self-tests (HIVSTs) doubled the frequency of HIV testing in year 1 to reach guideline recommended levels of 4 tests per year, compared to two tests per year in the standard-care arm (facility-based testing). In year 2, men in both arms had access to HIVSTs. We assessed if the effect was maintained for a further 12 months.MethodsParticipants included GBM reporting condomless anal intercourse or > 5 male partners in the past 3 months. We included men who had completed at least one survey in both year 1 and 2 and calculated the mean tests per person, based on the validated self-report and clinic records. We used Poisson regression and random effects Poisson regression models to compare the overall testing frequency by study arm, year and testing modality (HIVST/facility-based test).FindingsOverall, 362 men completed at least one survey in year 1 and 343 in year 2. Among men in the intervention arm (access to HIVSTs in both years), the mean number of HIV tests in year 2 (3⋅7 overall, 2⋅3 facility-based tests, 1⋅4 HIVSTs) was lower compared to year 1 (4⋅1 overall, 1⋅7 facility-based tests, 2⋅4 HIVSTs) (RR:0⋅84, 95% CI:0⋅75-0⋅95, p=0⋅002), but higher than the standard-care arm in year 1 (2⋅0 overall, RR:1⋅71, 95% CI:1⋅48-1.97, p<0⋅001). Findings were not different when stratified by sociodemographic characteristics or recent high risk sexual history.InterpretationIn year 2, fewer HIVSTs were used on average compared to year 1, but access to free HIVSTs enabled more men to maintain higher HIV testing frequency, compared with facility-based testing only. HIV self-testing should be a key component of HIV testing and prevention strategies.FundingThis work was supported by grant 568971 from the National Health and Medical Research Council of Australia.

Informing Women About Overdetection in Breast Cancer Screening: Two-Year Outcomes From a Randomized Trial.

BackgroundSupporting well-informed decisions about breast cancer screening requires communicating that inconsequential disease may be detected, leading to overdiagnosis and overtreatment. Having previously shown that telling women about overdetection improved informed choice, we investigated effects on screening knowledge and participation over 2 years.MethodsWe conducted a community-based, parallel-group, randomized controlled trial in Australia. Participants were women aged 48-50 years, without personal or strong family history of breast cancer, who had not undergone mammography in the past 2 years. We randomly assigned 879 women to receive the intervention decision aid (evidence-based information on overdetection, breast cancer mortality reduction, and false-positives) or control decision aid (identical but without overdetection information). We interviewed 838 women postintervention and recontacted them for follow-up at 6 months and 1 and 2 years. Main outcomes for this report are screening knowledge and participation.ResultsWe interviewed 790, 746, and 712 participants at 6 months, 1, and 2 years, respectively. The intervention group demonstrated superior knowledge throughout follow-up. After 2 years, conceptual knowledge was adequate in 123 (34.4%) of 358 women in the intervention group compared with 71 (20.1%) of 354 control participants(odds ratio = 2.04, 95% confidence interval = 1.46 to 2.85). Groups were similar in total screening participation (200 [55.1%] vs 204 [56.0%]; = 0.97, 95% confidence interval = 0.73 to 1.29).ConclusionsA brief decision aid produced lasting improvement in women’s understanding of potential consequences of screening, including overdetection, without changing participation rates. These findings support the use of decision aids for breast cancer screening.

A Pilot Trial of Confident Body, Confident Child in the United States

Confident Body, Confident Child (CBCC) is a parenting program designed to enhance knowledge of ways to promote body appreciation and sustainable health habits in 2- to 6-year-old children. Following a randomized controlled trial in Australia, the current study explores the international applicability of CBCC with the first pilot trial in the United States. Using an uncontrolled pretest–posttest design, this study examines (a) parental knowledge, (b) weight bias internalization, and (c) body appreciation among parents before and after program participation. A total of 13 CBCC programs were conducted for parents ( n = 92 baseline; n = 40 pretest–posttest). Findings support CBCC as a means to increase parents’ levels of knowledge around body image across countries and across cultures and are discussed for practice implications and future research with diverse populations.

Effects of health literacy, screening, and participant choice on action plans for reducing unhealthy snacking in Australia: A randomised controlled trial.

Low health literacy is associated with poorer health outcomes. A key strategy to address health literacy is a universal precautions approach, which recommends using health-literate design for all health interventions, not just those targeting people with low health literacy. This approach has advantages: Health literacy assessment and tailoring are not required. However, action plans may be more effective when tailored by health literacy. This study evaluated the impact of health literacy and action plan type on unhealthy snacking for people who have high BMI or type 2 diabetes (Aim 1) and the most effective method of action plan allocation (Aim 2). We performed a 2-stage randomised controlled trial in Australia between 14 February and 6 June 2019. In total, 1,769 participants (mean age: 49.8 years [SD = 11.7]; 56.1% female [n = 992]; mean BMI: 32.9 kg/m2 [SD = 8.7]; 29.6% self-reported type 2 diabetes [n = 523]) were randomised to 1 of 3 allocation methods (random, health literacy screening, or participant selection) and 1 of 2 action plans to reduce unhealthy snacking (standard versus literacy-sensitive). Regression analysis evaluated the impact of health literacy (Newest Vital Sign [NVS]), allocation method, and action plan on reduction in self-reported serves of unhealthy snacks (primary outcome) at 4-week follow-up. Secondary outcomes were perceived extent of unhealthy snacking, difficulty using the plans, habit strength, and action control. Analyses controlled for age, level of education, language spoken at home, diabetes status, baseline habit strength, and baseline self-reported serves of unhealthy snacks. Average NVS score was 3.6 out of 6 (SD = 2.0). Participants reported consuming 25.0 serves of snacks on average per week at baseline (SD = 28.0). Regarding Aim 1, 398 participants in the random allocation arm completed follow-up (67.7%). On average, people scoring 1 SD below the mean for health literacy consumed 10.0 fewer serves per week using the literacy-sensitive action plan compared to the standard action plan (95% CI: 0.05 to 19.5; p = 0.039), whereas those scoring 1 SD above the mean consumed 3.0 fewer serves using the standard action plan compared to the literacy-sensitive action plan (95% CI: -6.3 to 12.2; p = 0.529), although this difference did not reach statistical significance. In addition, we observed a non-significant action plan × health literacy (NVS) interaction (b = -3.25; 95% CI: -6.55 to 0.05; p = 0.054). Regarding Aim 2, 1,177 participants across the 3 allocation method arms completed follow-up (66.5%). There was no effect of allocation method on reduction of unhealthy snacking, including no effect of health literacy screening compared to participant selection (b = 1.79; 95% CI: -0.16 to 3.73; p = 0.067). Key limitations include low-moderate retention, use of a single-occasion self-reported primary outcome, and reporting of a number of extreme, yet plausible, snacking scores, which rendered interpretation more challenging. Adverse events were not assessed. In our study we observed nominal improvements in effectiveness of action plans tailored to health literacy; however, these improvements did not reach statistical significance, and the costs associated with such strategies compared with universal precautions need further investigation. This study highlights the importance of considering differential effects of health literacy on intervention effectiveness. Australia and New Zealand Clinical Trial Registry ACTRN12618001409268.

An intervention to optimise coach-created motivational climates and reduce athlete willingness to dope (CoachMADE): a three-country cluster randomised controlled trial

ObjectivesCoach-centred antidoping education is scarce. We tested the efficacy of a motivationally informed antidoping intervention for coaches, with their athletes’ willingness to dope as the primary outcome.MethodsWe delivered a cluster...

Improved Quality of Death and Dying in Care Homes: A Palliative Care Stepped Wedge Randomized Control Trial in Australia.

Mortality in care homes is high, but care of dying residents is often suboptimal, and many services do not have easy access to specialist palliative care. This study examined the impact of providing specialist palliative care on residents' quality of death and dying. Using a stepped wedge randomized control trial, care homes were randomly assigned to crossover from control to intervention using a random number generator. Analysis used a generalized linear and latent mixed model. The trial was registered with ANZCTR: ACTRN12617000080325. Twelve Australian care homes in Canberra, Australia. A total of 1700 non-respite residents were reviewed from the 12 participating care homes. Of these residents, 537 died and 471 had complete data for analysis. The trial ran between February 2017 and June 2018. Palliative Care Needs Rounds (hereafter Needs Rounds) are monthly hour-long staff-only triage meetings to discuss residents at risk of dying without a plan in place. They are chaired by a specialist palliative care clinician and attended by care home staff. A checklist is followed to guide discussions and outcomes, focused on anticipatory planning. This article reports secondary outcomes of staff perceptions of residents' quality of death and dying, care home staff confidence, and completion of advance care planning documentation. We assessed (1) quality of death and dying, and (2) staff capability of adopting a palliative approach, completion of advance care plans, and medical power of attorney. Needs Rounds are associated with staff perceptions that residents had a better quality of death and dying (P < .01; 95% confidence interval [CI] = 1.83-12.21), particularly in the 10 facilities that complied with the intervention protocol (P < .01; 95% CI = 6.37-13.32). Staff self-reported perceptions of capability increased (P < .01; 95% CI = 2.73-6.72). The data offer evidence for monthly triage meetings to transform the lives, deaths, and care of older people residing in care homes. J Am Geriatr Soc 68:305-312, 2020.

Improving eye care in residential aged care facilities using the Residential Ocular Care (ROC) model: study protocol for a multicentered, prospective, customized, and cluster randomized controlled trial in Australia

BackgroundOlder adults in residential aged care facilities have unnecessarily high levels of vision impairment (VI) which are largely treatable or correctable. However, no current comprehensive eye health service model exists in this setting in Australia. We aimed to determine the clinical, person-centered, and economic effectiveness of a novel eye care model, the Residential Ocular Care (ROC).Methods/designThis protocol describes a multicentered, prospective, randomized controlled trial. A total of 395 participants with distance vision < 6/12 (0.30 LogMAR) and/or near vision N8 (1.00 M) or worse will be recruited from 38 urban and rural aged care facilities across Victoria, Australia. Aged care facilities will be randomized (1:1) to one of two parallel groups. Participants in the ROC group will receive a comprehensive and tailored eye care pathway that includes, as necessary, refraction and spectacle provision, cataract surgery, low vision rehabilitation, and/or a referral to an ophthalmologist for funded treatment. Usual care participants will be referred for an evaluation to the eye care service associated with the facility or an eye care provider of their choice. The primary outcome will be presenting near and distance vision assessed at the two- and six-month follow-up visits, post baseline. Secondary outcomes will include vision-specific quality of life, mobility, falls, depression, and eye care utilization at two and six months. An incremental cost-effectiveness analysis will also be undertaken.DiscussionThe ROC study is the first multicentered, prospective, customized, and cluster randomized controlled trial in Australia to determine the effectiveness of a comprehensive and tailored eye care model for people residing in aged care facilities. Results from this trial will assist health and social care planners in implementing similar innovative models of care for this growing segment of the population in Australia and elsewhere.Trial registrationAustralian and New Zealand Clinical Trials Registry, ACTRN12615000587505. Registered on 4 June 2015 – retrospectively registered.

City-based action to reduce harmful alcohol use: review of reviews.

Background: The World Health Organization global strategy on alcohol called for municipal policies to reduce the harmful use of alcohol. Yet, there is limited evidence that documents the impact of city-level alcohol policies. Methods: Review of reviews for all years to July 2017. Searches on OVID Medline, Healthstar, Embase, PsycINFO, AMED, Social Work Abstracts, CAB Abstracts, Mental Measurements Yearbook, Health and Psychosocial Instruments, International Pharmaceutical Abstracts, International Political Science Abstracts, NASW Clinical Register, and Epub Ahead of Print databases. All reviews that address adults, without language or date restrictions resulting from combining the terms ("review" or "literature review" or "review literature" or "data pooling" or "comparative study" or "systematic review" or "meta-analysis" or "pooled analysis"), and "alcohol", and "intervention" and ("municipal" or "city" or "community"). Results: Five relevant reviews were identified. Studies in the reviews were all from high income countries and focussed on the acute consequences of drinking, usually with one target intervention, commonly bars, media, or drink-driving. No studies in the reviews reported the impact of comprehensive city-based action. One community cluster randomized controlled trial in Australia, published after the reviews, failed to find convincing evidence of an impact of community-based interventions in reducing adult harmful use of alcohol. Conclusions: To date, with one exception, the impact of adult-oriented comprehensive community and municipal action to reduce the harmful use of alcohol has not been studied. The one exception failed to find a convincing effect. We conclude with recommendations for closing this evidence gap.

City-based action to reduce harmful alcohol use: review of reviews

Background: The World Health Organization global strategy on alcohol called for municipal policies to reduce the harmful use of alcohol. Yet, there is limited evidence that documents the impact of city-level alcohol policies. Methods: Review of reviews for all years to July 2017. Searches on OVID Medline, Healthstar, Embase, PsycINFO, AMED, Social Work s, CAB s, Mental Measurements Yearbook, Health and Psychosocial Instruments, International Pharmaceutical s, International Political Science s, NASW Clinical Register, and Epub Ahead of Print databases. All reviews that address adults, without language or date restrictions resulting from combining the terms (“review” or “literature review” or “review literature” or “data pooling” or “comparative study” or “systematic review” or “meta-analysis” or “pooled analysis”), and “alcohol”, and “intervention” and (“municipal” or “city” or “community”). Results: Five relevant reviews were identified. Studies in the reviews were all from high income countries and focussed on the acute consequences of drinking, usually with one target intervention, commonly bars, media, or drink-driving. No studies in the reviews reported the impact of comprehensive city-based action. One community cluster randomized controlled trial in Australia, published after the reviews, failed to find convincing evidence of an impact of community-based interventions in reducing adult harmful use of alcohol. Conclusions: To date, with one exception, the impact of adult-oriented comprehensive community and municipal action to reduce the harmful use of alcohol has not been studied. The one exception failed to find a convincing effect. We conclude with recommendations for closing this evidence gap.

City-based action to reduce harmful alcohol use: review of reviews

Background: The World Health Organization global strategy on alcohol called for municipal policies to reduce the harmful use of alcohol. Yet, there is limited evidence that documents the impact of city-level alcohol policies. Methods: Review of reviews for all years to July 2017. Searches on OVID Medline, Healthstar, Embase, PsycINFO, AMED, Social Work Abstracts, CAB Abstracts, Mental Measurements Yearbook, Health and Psychosocial Instruments, International Pharmaceutical Abstracts, International Political Science Abstracts, NASW Clinical Register, and Epub Ahead of Print databases. All reviews that address adults, without language or date restrictions resulting from combining the terms ("review" or "literature review" or "review literature" or "data pooling" or "comparative study" or "systematic review" or "meta-analysis" or "pooled analysis"), and "alcohol", and "intervention" and ("municipal" or "city" or "community"). Results: Five relevant reviews were identified. Studies in the reviews were all from high income countries and focussed on the acute consequences of drinking, usually with one target intervention, commonly bars, media, or drink-driving. No studies in the reviews reported the impact of comprehensive city-based action. One community cluster randomized controlled trial in Australia, published after the reviews, failed to find convincing evidence of an impact of community-based interventions in reducing adult harmful use of alcohol. Conclusions: To date, with one exception, the impact of adult-oriented comprehensive community and municipal action to reduce the harmful use of alcohol has not been studied. The one exception failed to find a convincing effect. We conclude with recommendations for closing this evidence gap.

Implementing Kanyini GAP, a pragmatic randomised controlled trial in Australia: findings from a qualitative study

BackgroundPragmatic randomised controlled trials (PRCTs) aim to assess intervention effectiveness by accounting for ‘real life’ implementation challenges in routine practice. The methodological challenges of PRCT implementation, particularly in primary care, are not well understood. The Kanyini Guidelines Adherence to Polypill study (Kanyini GAP) was a recent primary care PRCT involving multiple private general practices, Indigenous community controlled health services and private community pharmacies. Through the experiences of Kanyini GAP participants, and using data from study materials, this paper identifies the critical enablers and barriers to implementing a PRCT across diverse practice settings and makes recommendations for future PRCT implementation.MethodsQualitative data from 94 semi-structured interviews (47 healthcare providers (pharmacists, general practitioners, Aboriginal health workers; 47 patients) conducted for the process evaluation of Kanyini GAP was used. Data coded to ‘trial impact’, ‘research motivation’ and ‘real world’ were explored and triangulated with data extracted from study materials (e.g. Emails, memoranda of understanding and financial statements).ResultsPRCT implementation was facilitated by an extensive process of relationship building at the trial outset including building on existing relationships between core investigators and service providers. Health providers’ and participants’ altruism, increased professional satisfaction, collaboration, research capacity and opportunities for improved patient care enabled implementation. Inadequate research infrastructure, excessive administrative demands, insufficient numbers of adequately trained staff and the potential financial impact on private practice were considered implementation barriers. These were largely related to this being the first experience of trial involvement for many sites. The significant costs of addressing these barriers drew study resources from the task of achieving recruitment targets.ConclusionsConducting PRCTs is crucial to generating credible evidence of intervention effectiveness in routine practice. PRCT implementation needs to account for the particular challenges of implementing collaborative research across diverse stakeholder organisations. Reliance on goodwill to participate is crucial at the outset. However, participation costs, particularly for organisations with little or no research experience, can be substantial and should be factored into PRCT funding models. Investment in a pool to fund infrastructure in the form of primary health research networks will offset some of these costs, enabling future studies to be implemented more cost-effectively.Trial registrationACTRN126080005833347Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-015-0956-y) contains supplementary material, which is available to authorized users.

Women's experiences of continuity of midwifery care in a randomised controlled trial in Australia

Objective: to compare the experiences of women who received a new model of continuity of midwifery care with those who received standard hospital care during pregnancy, labour, birth and the postnatal period. Design: a randomised controlled trial was conducted. One thousand and eighty-nine women were randomly allocated to either the new model of care, the St George Outreach Maternity Project (STOMP), or standard care. Women completed a postal questionnaire eight to ten weeks after the birth. Participants: women in the trial were of mixed obstetric risk status and more than half the sample were born in a non-English speaking country. Findings: questionnaires were returned from 69% of consenting women. STOMP women were significantly more likely to have talked with their midwives and doctors about their personal preferences for childbirth and more likely to report that they knew enough about aspects of labour and birth, particularly induction of labour, pain relief and caesarean section. Almost 80% of women in the STOMP group experienced continuity of care, that is, one of their team midwives was present, during labour and birth. STOMP women reported a significantly higher ‘sense of control during labour and birth’. Sixty-three per cent of STOMP women reported that they ‘knew’ the midwife who cared for them during labour compared with 21% of control women. In a secondary analysis, women who had a midwife during labour who they felt that they knew, had a significantly higher sense of ‘control’ and a more positive birth experience compared with women who reported an unknown midwife. Postnatal care elicited the greatest number of negative comments from women in both the STOMP and the control group. Conclusion: The reorganisation of maternity services to enable women to receive continuity of care has benefits for women. The benefits of a known labour midwife needs further research.