The Be Our Ally Beat Smoking (BOABS) study, a randomised controlled trial of an intensive smoking cessation intervention in a remote aboriginal Australian health care setting.

BACKGROUND: Australian Aboriginal and Torres Strait Islander peoples (Indigenous Australians) smoke at much higher rates than non-Indigenous people and smoking is an important contributor to increased disease, hospital admissions and deaths in Indigenous Australian populations. Smoking cessation programs in Australia have not had the same impact on Indigenous smokers as on non-Indigenous smokers. This paper describes the outcome of a study that aimed to test the efficacy of a locally-tailored, intensive, multidimensional smoking cessation program. METHODS: A randomised controlled trial of Aboriginal researcher delivered tailored smoking cessation counselling during face-to-face visits, aiming for weekly for the first four weeks, monthly to six months and two monthly to 12 months. The control ("usual care") group received routine care relating to smoking cessation at their local primary health care service. Data collection occurred at enrolment, six and 12 months. The primary outcome was self-reported smoking cessation with urinary cotinine confirmation at final follow-up (median 13 (interquartile range 12-15) months after enrolment). RESULTS: Participants in the intervention (n = 55) and usual care (n = 108) groups were similar in baseline characteristics, except the intervention group was slightly older. At final follow-up the smoking cessation rate for participants assigned to the intervention group (n = 6; 11%), while not statistically significant, was double that of usual care (n = 5; 5%; p = 0.131). A meta-analysis of these findings and a similarly underpowered but comparable study of pregnant Indigenous Australian women showed that Indigenous Australian participants assigned to the intervention groups were 2.4 times (95% CI, 1.01-5.5) as likely to quit as participants assigned to usual care. CONCLUSIONS: Culturally appropriate, multi-dimensional Indigenous quit smoking programs can be successfully implemented in remote primary health care. Intensive one-on-one interventions with substantial involvement from Aboriginal and Torres Strait Islander workers are likely to be effective in these settings. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ACTRN12608000604303).

Clinical trials in a remote Aboriginal setting: lessons from the BOABS smoking cessation study.

BACKGROUND: There is limited evidence regarding the best approaches to helping Indigenous Australians to stop smoking. The composite analysis of the only two smoking cessation randomised controlled trials (RCTs) investigating this suggests that one-on-one extra support delivered by and provided to Indigenous Australians in a primary health care setting appears to be more effective than usual care in encouraging smoking cessation. This paper describes the lessons learnt from one of these studies, the Be Our Ally Beat Smoking (BOABS) Study, and how to develop and implement an integrated smoking cessation program. METHODS: Qualitative study using data collected from multiple documentary sources related to the BOABS Study. As the project neared completion the research team participated in four workshops to review and conduct thematic analyses of these documents. RESULTS: Challenges we encountered during the relatively complex BOABS Study included recruiting sufficient number of participants; managing the project in two distant locations and ensuring high quality work across both sites; providing appropriate training and support to Aboriginal researchers; significant staff absences, staff shortages and high workforce turnover; determining where and how the project fitted in the clinics and consequent siloing of the Aboriginal researchers relating to the requirements of RCTs; resistance to change, and maintaining organisational commitment and priority for the project. The results of this study also demonstrated the importance of local Aboriginal ownership, commitment, participation and control. This included knowledge of local communities, the flexibility to adapt interventions to local settings and circumstances, and taking sufficient time to allow this to occur. CONCLUSIONS: The keys to the success of the BOABS Study were local development, ownership and participation, worker professional development and support, and operating within a framework of cultural safety. There were difficulties associated with the BOABS Study being an RCT, and many of these are shared with stand-alone programs. Interventions targeted at particular health problems are best integrated with usual primary health care. Research to investigate complex interventions in Indigenous health should not be limited to randomised clinical trials and funding needs to reflect the additional, but necessary, cost of providing for local control of planning and implementation.

The protocol for the Be Our Ally Beat Smoking (BOABS) study, a randomised controlled trial of an intensive smoking cessation intervention in a remote Aboriginal Australian health care setting.

BACKGROUND: Australian Aboriginal peoples and Torres Strait Islanders (Indigenous Australians) smoke at much higher rates than non-Indigenous people and smoking is an important contributor to increased disease, hospital admissions and deaths in Indigenous Australian populations. Smoking cessation programs in Australia have not had the same impact on Indigenous smokers as on non-Indigenous smokers. This paper describes the protocol for a study that aims to test the efficacy of a locally-tailored, intensive, multidimensional smoking cessation program. METHODS/DESIGN: This study is a parallel, randomised, controlled trial. Participants are Aboriginal and Torres Strait Islander smokers aged 16 years and over, who are randomly allocated to a 'control' or 'intervention' group in a 2:1 ratio. Those assigned to the 'intervention' group receive smoking cessation counselling at face-to-face visits, weekly for the first four weeks, monthly to six months and two monthly to 12 months. They are also encouraged to attend a monthly smoking cessation support group. The 'control' group receive 'usual care' (i.e. they do not receive the smoking cessation program). Aboriginal researchers deliver the intervention, the goal of which is to help Aboriginal peoples and Torres Strait Islanders quit smoking. Data collection occurs at baseline (when they enrol) and at six and 12 months after enrolling. The primary outcome is self-reported smoking cessation with urinary cotinine confirmation at 12 months. DISCUSSION: Stopping smoking has been described as the single most important individual change Aboriginal and Torres Strait Islander smokers could make to improve their health. Smoking cessation programs are a major priority in Aboriginal and Torres Strait Islander health and evidence for effective approaches is essential for policy development and resourcing. A range of strategies have been used to encourage Aboriginal peoples and Torres Strait Islanders to quit smoking however there have been few good quality studies that show what approaches work best. More evidence of strategies that could work more widely in Indigenous primary health care settings is needed if effective policy is to be developed and implemented. Our project will make an important contribution in this area. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ACTRN12608000604303).

Factors affecting pain scores during female urethral catheterization.

OBJECTIVES: To compare pain and discomfort ratings of female patients undergoing urethral catheterization randomized to topical application of plain lubricant versus lidocaine gel prior to the procedure. METHODS: This was a prospective, randomized, double-blind study involving female patients requiring urethral catheterization at an urban university-based academic emergency department. A staff nurse blinded to the lubricant type injected 5 mL of sterile surgical lubricant or 2% lidocaine gel into the urinary meatus. After 1 minute, an 8-F (for specimen collection) or a 16-F (for continuous collection) catheter was inserted into the urethra. Each patient rated the pain of the procedure on a validated 0- to 100-mm visual analog scale. The Mann-Whitney U test was used to analyze associations between pain ratings, lubricant type, and catheter size. Logistic regression was used to identify the contribution of lubricant type, catheter size, age category, difficulty of insertion, preprocedural pain, and diagnosis of urinary tract infection to procedural pain rating. RESULTS: One hundred women were randomized to plain lubricant (n = 50) or lidocaine (n = 50). The overall mean ( +/- SD) pain score was 23.5 +/- 27.2 mm. No significant differences in pain ratings were found based on catheter size or lubricant type. Younger women, aged 18-59 years, experienced higher pain ratings than women aged 60-101 (mean pain difference 14.4 mm; 95% CI = 4.3 to 24.5; p < 0.006). Multiple logistic regression identified preprocedural pain as the only predictor of higher pain rating after catheterization (OR 1.02; 95% CI = 1.002 to 1.039, p = 0.03). CONCLUSIONS: Catheter size and lubricant type did not affect the severity of pain after urethral catheterization in women.

Sustaining remote-area programs: retinal camera use by Aboriginal health workers and nurses in a Kimberley partnership.

OBJECTIVE: To describe how a novel program of diabetic retinopathy screening was conceived, refined and sustained in a remote region over 10 years, and to evaluate its activities and outcomes. DESIGN: Program description; analysis of regional screening database; audit of electronic client registers of Aboriginal community controlled health services (ACCHSs). SETTING AND PARTICIPANTS: 1318 Aboriginal and 271 non-Aboriginal individuals who underwent retinal screening in the 5 years to September 2004 in the Kimberley region of north-west Australia; 11 758 regular local Aboriginal clients of Kimberley ACCHSs as at January 2005. MAIN OUTCOME MEASURES: Characteristics of clients and camera operators, prevalence of retinopathy, photograph quality, screening intervals and coverage. RESULTS: Among Aboriginal clients, 21% had diabetic retinopathy: 19% with non-proliferative retinopathy, 1.2% with proliferative retinopathy, and 2.8% with maculopathy. Corresponding figures for non-Aboriginal clients were 11%, 11%, 0 and 0.4%, respectively. Photograph quality was generally high, and better for non-Aboriginal clients, younger Aboriginal clients and from 2002 (when mydriatic use became universal). Quality was not related to operator qualifications, certification or experience. Of 718 regular Aboriginal clients with diabetes on local ACCHS databases, 48% had a record of retinal screening within the previous 18 months, and 65% within the previous 30 months. CONCLUSIONS: Screening for diabetic retinopathy performed locally by Aboriginal health workers and nurses with fundus cameras can be successfully sustained with regional support. Formal certification appears unnecessary. Data sharing across services, client recall and point-of-care prompts generated by electronic information systems, together with policies making primary care providers responsible for care coordination, support appropriate timely screening.