Suzanne McKenzie

Efficacy and safety of ketotifen eye drops in the treatment of seasonal allergic conjunctivitis

Background: Ketotifen blocks histamine H1 receptors, stabilises mast cells, and prevents eosinophil accumulation. These multiple, pharmacological mechanisms provided the rationale for assessing the efficacy and safety of ketotifen 0.025% eye drops in subjects with seasonal allergic conjunctivitis (SAC) in an environmental setting. Methods: This was a double masked, randomised, multicentre trial conducted in Australia. Subjects were randomly assigned to ketotifen fumarate 0.025% ophthalmic solution, placebo (as vehicle), or levocabastine hydrochloride 0.05% ophthalmic suspension, twice daily in each eye for a 4 week period. Subjects were assessed at follow up (days 5–8) and termination (days 25–31) visits. The primary efficacy variable was the responder rate, based on the subjects’ assessment of global efficacy at the follow up visit. Results: 519 subjects were randomised to treatment. At the follow up visit, the responder rate, based on subjects’ assessment of global efficacy, was significantly greater in the ketotifen group (49.5%) than in the placebo group (33.0%) for subjects with a positive diagnostic test for pollen allergy (p = 0.02). The investigators’ assessment of responder rates also showed that ketotifen was superior to placebo (p = 0.001). Ketotifen produced a significantly better outcome than levocabastine (p<0.05) for relief of signs and symptoms of SAC, at both the follow up and the termination visit. The type and frequency of adverse events were similar across treatment groups. Conclusions: In an environmental setting, ketotifen fumarate 0.025% ophthalmic solution was well tolerated and effective in reducing the signs and symptoms of SAC, and in preventing their recurrence. Ketotifen consistently showed the best efficacy in comparison with both placebo and levocabastine. These results indicate that ketotifen eye drops are a valuable treatment option for this condition.

Predictors of primary care referrals to a vascular disease prevention lifestyle program among participants in a cluster randomised trial

BackgroundCardiovascular disease accounts for a large burden of disease, but is amenable to prevention through lifestyle modification. This paper examines patient and practice predictors of referral to a lifestyle modification program (LMP) offered as part of a cluster randomised controlled trial (RCT) of prevention of vascular disease in primary care.MethodsData from the intervention arm of a cluster RCT which recruited 36 practices through two rural and three urban primary care organisations were used. In each practice, 160 eligible high risk patients were invited to participate. Practices were randomly allocated to intervention or control groups. Intervention practice staff were trained in screening, motivational interviewing and counselling and encouraged to refer high risk patients to a LMP involving individual and group sessions. Data include patient surveys; clinical audit; practice survey on capacity for preventive care; referral records from the LMP. Predictors of referral were examined using multi-level logistic regression modelling after adjustment for confounding factors.ResultsOf 301 eligible patients, 190 (63.1%) were referred to the LMP. Independent predictors of referral were baseline BMI ≥ 25 (OR 2.87 95%CI:1.10, 7.47), physical inactivity (OR 2.90 95%CI:1.36,6.14), contemplation/preparation/action stage of change for physical activity (OR 2.75 95%CI:1.07, 7.03), rural location (OR 12.50 95%CI:1.43, 109.7) and smaller practice size (1–3 GPs) (OR 16.05 95%CI:2.74, 94.24).ConclusionsProviding a well-structured evidence-based lifestyle intervention, free of charge to patients, with coordination and support for referral processes resulted in over 60% of participating high risk patients being referred for disease prevention. Contrary to expectations, referrals were more frequent from rural and smaller practices suggesting that these practices may be more ready to engage with these programs.Trial registrationACTRN12607000423415

Factors influencing participation in a vascular disease prevention lifestyle program among participants in a cluster randomized trial

BackgroundPrevious research suggests that lifestyle intervention for the prevention of diabetes and cardiovascular disease (CVD) are effective, however little is known about factors affecting participation in such programs. This study aims to explore factors influencing levels of participation in a lifestyle modification program conducted as part of a cluster randomized controlled trial of CVD prevention in primary care.MethodsThis concurrent mixed methods study used data from the intervention arm of a cluster RCT which recruited 30 practices through two rural and three urban primary care organizations. Practices were randomly allocated to intervention (n = 16) and control (n = 14) groups. In each practice up to 160 eligible patients aged between 40 and 64 years old, were invited to participate. Intervention practice staff were trained in lifestyle assessment and counseling and referred high risk patients to a lifestyle modification program (LMP) consisting of two individual and six group sessions over a nine month period. Data included a patient survey, clinical audit, practice survey on capacity for preventive care, referral and attendance records at the LMP and qualitative interviews with Intervention Officers facilitating the LMP. Multi-level logistic regression modelling was used to examine independent predictors of attendance at the LMP, supplemented with qualitative data from interviews with Intervention Officers facilitating the program.ResultsA total of 197 individuals were referred to the LMP (63% of those eligible). Over a third of patients (36.5%) referred to the LMP did not attend any sessions, with 59.4% attending at least half of the planned sessions. The only independent predictors of attendance at the program were employment status - not working (OR: 2.39 95% CI 1.15-4.94) and having high psychological distress (OR: 2.17 95% CI: 1.10-4.30). Qualitative data revealed that physical access to the program was a barrier, while GP/practice endorsement of the program and flexibility in program delivery facilitated attendance.ConclusionBarriers to attendance at a LMP for CVD prevention related mainly to external factors including work commitments and poor physical access to the programs rather than an individuals’ health risk profile or readiness to change. Improving physical access and offering flexibility in program delivery may enhance future attendance. Finally, associations between psychological distress and attendance rates warrant further investigation.Trial registrationACTRN12607000423415

'Managing patient involvement': provider perspectives on diabetes decision-making.

Background  Most studies of shared decision‐making focus on acute treatment or screening decision‐making encounters, yet a significant proportion of primary care is concerned with managing patients with chronic disease.Background  Most studies of shared decision-making focus on acute treatment or screening decision-making encounters, yet a significant proportion of primary care is concerned with managing patients with chronic disease. Aim  To investigate provider perspectives on the role of patient involvement in chronic disease decision-making. Design  A qualitative, grounded theory study of patient involvement in diabetes care planning. Setting and participants  Interviews were conducted with 29 providers (19 general practitioners, eight allied health providers, and two endocrinologists) who participated in diabetes care planning. Results  Providers described a conflict between their responsibilities to deliver evidence-based diabetes care and to respect patients’ rights to make decisions. While all were concerned with providing best possible diabetes care, they differed in the emphasis they placed on ‘treating to target’ or practicing ‘personalized care’. Those preferring to ‘treat to target’ were more assertive, while ‘personalized care’ meant being more accepting of the patient’s priorities. Providers sought to manage patient involvement in decision-making according to their objectives. ‘Treating to target’ meant involving patients where necessary to tailor care to their needs and abilities, but limiting patient involvement in decisions about the overall agenda. ‘Personalized care’ meant involving patients to tailor care to patient preference. Discussion and conclusions  Respecting a patient’s autonomy and delivering high-quality diabetes care are important to providers. At times it may not be possible to do both, so a careful balance is required. Involving patients in decision-making may be a means to this end, rather than an end in itself.

What predicts patient-reported GP management of smoking, nutrition, alcohol, physical activity and weight?

This study aimed to describe patient-reported management of behavioural risk factors in Australian general practice. Six hundred and ninety-eight eligible patients from 30 general practices in two rural and three urban Divisions of General Practice responded to a mailed invitation to participate and completed a questionnaire. Data were analysed using univariate and multi-level multivariate methods. The prevalence of risk factors varied between 12.6% for smoking and 72.6% for at-risk diet (56.2% were overweight). Most patients were at the action or maintenance phases of their readiness to change their risky behaviours. General practitioners (GPs) provided education or advice to between one-quarter and one-third of those at risk for each risk factor; 9.2% and 9.6% of patients reported having been referred for diet or physical activity interventions. Patient body mass index was associated with increased likelihood of receiving GP advice or referral for diet and physical activity interventions. Having poor diet or physical activity levels and being more ready for change were not associated with the likelihood of GP referral. The major challenge for general practice is to ensure that effective lifestyle interventions are provided to those who will most benefit. Patient-reported GP behavioural risk factor advice and referral is less frequent than is optimal. Priority needs to be given to those most at risk and ready to change their behaviour.

Understanding the relationship between stress, distress and healthy lifestyle behaviour: a qualitative study of patients and general practitioners

BackgroundThe process of initiating and maintaining healthy lifestyle behaviours is complex, includes a number of distinct phases and is not static. Theoretical models of behaviour change consider psychological constructs such as intention and self efficacy but do not clearly consider the role of stress or psychological distress. General practice based interventions addressing lifestyle behaviours have been demonstrated to be feasible and effective however it is not clear whether general practitioners (GPs) take psychological health into consideration when discussing lifestyle behaviours. This qualitative study explores GPs’ and patients’ perspectives about the relationship between external stressors, psychological distress and maintaining healthy lifestyle behaviours.MethodsSemi-structured telephone interviews were conducted with 16 patients and 5 GPs. Transcripts from the interviews were thematically analysed and a conceptual model developed to explain the relationship between external stressors, psychological distress and healthly lifestyle behaviours.ResultsParticipants were motivated to maintain a healthy lifestyle however they described a range of external factors that impacted on behaviour in both positive and negative ways, either directly or via their impact on psychological distress. The impact of external factors was moderated by coping strategies, beliefs, habits and social support. In some cases the process of changing or maintaining healthy behaviour also caused distress. The concept of a threshold level of distress was evident in the data with patients and GPs describing a certain level of distress required before it negatively influenced behaviour.ConclusionMaintaining healthy lifestyle behaviours is complex and constantly under challenge from external stressors. Practitioners can assist patients with maintaining healthy behaviour by providing targeted support to moderate the impact of external stressors.

Drug treatment of adults with nausea and vomiting in primary care

A usually healthy 25 year old man presents to you as his general practitioner at 9 am. He has had fluctuating nausea with four vomits and one loose stool overnight, associated with colicky central abdominal pain. No blood was present in the vomit or stool, and he reports that his girlfriend was recently diagnosed as having “viral gastro.” He is afebrile, intermittently uncomfortable, but otherwise well, with mild epigastric tenderness but no guarding or rebound. Clinically, you believe viral gastroenteritis is the most likely cause of his symptoms, and you consider his request for treatment that will help to stop his vomiting so that he can get to his evening shift at a factory. Nausea and vomiting are a common reason for patients to seek treatment in primary care, which we take here to include general practice and the emergency department. Identification and management of underlying problems are important, if these are apparent on clinical grounds. This article will focus on common causes in primary care such as gastroenteritis (usually viral), adverse drug reactions, pregnancy, vestibular disorders, and motion sickness. Other causes of nausea and vomiting such as postoperative, chemotherapy and radiotherapy associated, and specific conditions such as migraines are briefly discussed but are beyond the scope of this article. Although still incompletely understood, nausea and vomiting are thought to follow activation of a medullary “vomiting centre,” by either afferent input from the gastrointestinal tract due to presence of local irritants or stimulation of the central chemoreceptor trigger zone by circulating emetogenic substances; however, other pathways exist. Dopamine and serotonin seem to be key transmitters both centrally and in the gastrointestinal tract. Surveys of emergency physicians in Australia and the United States identified the most commonly prescribed agents as metoclopramide, prochlorperazine, promethazine, droperidol, and ondansetron.1 2 Anecdotally, cyclizine and …

Socio-demographic factors, behaviour and personality: associations with psychological distress

Background: Anxiety, psychological distress and personality may not be independent risk factors for cardiovascular disease; however they may contribute via their relationship with unhealthy lifestyle behaviours. This study aimed to examine the association between psychological distress, risk behaviours and patient demographic characteristics in a sample of general practice patients aged 40–65 years with at least one risk factor for cardiovascular disease. Design: Cross-sectional analytic study. Methods: Patients, randomly selected from general practice records, completed a questionnaire about their behavioural risk factors and psychological health as part of a cluster randomized controlled trial of a general practice based intervention to prevent chronic vascular disease. The Kessler Psychological Distress Score (K10) was the main outcome measure for the multilevel, multivariate analysis. Results: Single-level bi-variate analysis demonstrated a significant association between higher K10 and middle age (p = 0.001), high neuroticism (p = 0), current smoking (p = 0), physical inactivity (p = 0.003) and low fruit and vegetable consumption (p = 0.008). Socioeconomic (SES) indicators of deprivation (employment and accommodation status) were also significantly associated with higher K10 (p = 0). No individual behavioural risk factor was associated with K10 on multilevel multivariate analysis; however indicators of low SES remained significant (p < 0.001). Conclusions: When all factors were considered, psychological distress was not associated with behavioural risk factors for cardiovascular disease. Other underlying factors, such as personality type and socioeconomic status, may be associated with both the behaviours and the distress.

Study protocol for a randomized controlled trial: the feasibility and impact of cardiovascular absolute risk assessment in Australian general practice

BACKGROUND Although cardiovascular absolute risk (CVAR) assessment has been recommended for use in Australian general practice for a number of years, there is continuing uncertainty about its implementation and impact. Our previous work has developed a multifaceted implementation model. This study aims to investigate both the feasibility of using this model and the impact of CVAR assessment and management on general practice clinical processes and patient care. STUDY DESIGN This cluster randomized controlled trial will be conducted in general practices in Sydney, involving general practitioners (GPs), other practice staff, and patients aged 45 to 69 years without existing cardiovascular disease. METHODS A total of 32 practices (40 GPs) and 1,320 patients will be recruited. Randomization will be conducted at the practice level. The intervention group of GPs will be trained to use a CVAR implementation model, whereas the control group of GPs will continue usual care. Study outcomes include clinical processes, patient risk, use of lifestyle intervention, and prescription of antihypertensive and lipid-lowering medications. Data will be collected and analyzed using mixed methods. Study outcomes before and after the intervention will be compared, and the 2 groups will also be compared after adjusting for baseline difference and clustering factors. DISCUSSION This trial will be the first study in Australian general practice and one of few international studies to evaluate the impact of implementing CVAR assessment and management. Results of this study will help improve the primary prevention of cardiovascular disease and inform guidelines for clinical practice and the implementation of other health initiatives.

Rural general practice placements: alignment with the Australian Curriculum Framework for Junior Doctors

Objectives: To review the available literature regarding skills and competencies gained by junior doctors in rural and regional general practice placements and their alignment with the Australian Curriculum Framework for Junior Doctors (ACFJD).