Effectiveness of a new model of primary care management on knee pain and function in patients with knee osteoarthritis: Protocol for THE PARTNER STUDY.

BACKGROUND: To increase the uptake of key clinical recommendations for non-surgical management of knee osteoarthritis (OA) and improve patient outcomes, we developed a new model of service delivery (PARTNER model) and an intervention to implement the model in the Australian primary care setting. We will evaluate the effectiveness and cost-effectiveness of this model compared to usual general practice care. METHODS: We will conduct a mixed-methods study, including a two-arm, cluster randomised controlled trial, with quantitative, qualitative and economic evaluations. We will recruit 44 general practices and 572 patients with knee OA in urban and regional practices in Victoria and New South Wales. The interventions will target both general practitioners (GPs) and their patients at the practice level. Practices will be randomised at a 1:1 ratio. Patients will be recruited if they are aged ≥45 years and have experienced knee pain ≥4/10 on a numerical rating scale for more than three months. Outcomes are self-reported, patient-level validated measures with the primary outcomes being change in pain and function at 12 months. Secondary outcomes will be assessed at 6 and 12 months. The implementation intervention will support and provide education to intervention group GPs to deliver effective management for patients with knee OA using tailored online training and electronic medical record support. Participants with knee OA will have an initial GP visit to confirm their diagnosis and receive management according to GP intervention or control group allocation. As part of the intervention group GP management, participants with knee OA will be referred to a centralised multidisciplinary service: the PARTNER Care Support Team (CST). The CST will be trained in behaviour change support and evidence-based knee OA management. They will work with patients to develop a collaborative action plan focussed on key self-management behaviours, and communicate with the patients' GPs. Patients receiving care by intervention group GPs will receive tailored OA educational materials, a leg muscle strengthening program, and access to a weight-loss program as appropriate and agreed. GPs in the control group will receive no additional training and their patients will receive usual care. DISCUSSION: This project aims to address a major evidence-to-practice gap in primary care management of OA by evaluating a new service delivery model implemented with an intervention targeting GP practice behaviours to improve the health of people with knee OA. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry: ACTRN12617001595303 , date of registration 1/12/2017.

Comparability of health service use by veterans with multisymptom illness and those with chronic diseases.

OBJECTIVE: To compare health service utilization and disability claims among military personnel with multisymptom illness (MSI) (but no chronic diseases), those with chronic disease(s) and those without MSI or chronic diseases. MSI is also known as Gulf War illness. DESIGN: Cohort study. SETTING: Australia. PARTICIPANTS: In total, 1288 participants of a Gulf War veterans' study conducted in 2000-2003 (Wave-1) were followed up in 2011-2012 (Wave-2), aged on average 40 years. About 160 had MSI, 217 had chronic disease(s) and 911 had neither chronic disease(s) nor MSI. METHODS: At Wave-2, the cohort was linked to the national Medicare and Department of Veterans' Affairs (DVA) databases to obtain health service utilization and disability claims data recorded between 2001 and 2012. RESULTS: The likelihood of visiting a general practitioner (GP) (risk ratio [RR] = 1.04, 95% confidence interval [CI] = 0.92, 1.19) or visiting a specialist medical doctor (RR = 0.83; 95% CI = 0.54, 1.28) or hospitalizations (RR = 0.89; 95% CI = 0.61, 1.29) or) in the 12 months preceding Wave-2 or successfully claiming for DVA disability compensation (RR = 1.13; 95% CI = 0.86, 1.47) was similar for personnel with MSI and those with chronic disease(s). However, GP consultations, hospitalizations, specialist doctor consultations and disability claims were significantly higher among those with MSI than those without MSI/chronic diseases. CONCLUSIONS: Health service use and disability claims by personnel with MSI were comparable to those with chronic disease(s), but were in excess of those without MSI/chronic diseases. Hence recognition of the high health service use by personnel with MSI is important to ensure adequate provision of health services.

The quality of reporting in cluster randomised crossover trials: proposal for reporting items and an assessment of reporting quality.

BACKGROUND: The cluster randomised crossover (CRXO) design is gaining popularity in trial settings where individual randomisation or parallel group cluster randomisation is not feasible or practical. Our aim is to stimulate discussion on the content of a reporting guideline for CRXO trials and to assess the reporting quality of published CRXO trials. METHODS: We undertook a systematic review of CRXO trials. Searches of MEDLINE, EMBASE, and CINAHL Plus as well as citation searches of CRXO methodological articles were conducted to December 2014. Reporting quality was assessed against both modified items from 2010 CONSORT and 2012 cluster trials extension and other proposed quality measures. RESULTS: Of the 3425 records identified through database searching, 83 trials met the inclusion criteria. Trials were infrequently identified as "cluster randomis(z)ed crossover" in title (n = 7, 8%) or abstract (n = 21, 25%), and a rationale for the design was infrequently provided (n = 20, 24%). Design parameters such as the number of clusters and number of periods were well reported. Discussion of carryover took place in only 17 trials (20%). Sample size methods were only reported in 58% (n = 48) of trials. A range of approaches were used to report baseline characteristics. The analysis method was not adequately reported in 23% (n = 19) of trials. The observed within-cluster within-period intracluster correlation and within-cluster between-period intracluster correlation for the primary outcome data were not reported in any trial. The potential for selection, performance, and detection bias could be evaluated in 30%, 81%, and 70% of trials, respectively. CONCLUSIONS: There is a clear need to improve the quality of reporting in CRXO trials. Given the unique features of a CRXO trial, it is important to develop a CONSORT extension. Consensus amongst trialists on the content of such a guideline is essential.

A Telephone Support Program to Reduce Costs and Hospital Admissions for Patients at Risk of Readmissions: Lessons from an Evaluation of a Complex Health Intervention.

This study aimed to evaluate the effectiveness of a telephone health coaching and support service provided to members of an Australian private health insurance fund-Telephonic Complex Care Program (TCCP)-on hospital use and associated costs. A case-control pre-post study design was employed using propensity score matching. Private health insurance members (n=273) who participated in TCCP between April and December 2012 (cases) were matched (1:1) to members who had not previously been enrolled in the program or any other disease management programs offered by the insurer (n=232). Eligible members were community dwelling, aged ≥65 years, and had 2 or more hospital admissions in the 12 months prior to program enrollment. Preprogram variables that estimated the propensity score included: participant demographics, diagnoses, and hospital use in the 12 months prior to program enrollment. TCCP participants received one-to-one telephone support, personalized care plan, and referral to community-based services. Control participants continued to access usual health care services. Primary outcomes were number of hospital admission claims and total benefits paid for all health care utilizations in the 12 months following program enrollment. Secondary outcomes included change in total benefits paid, hospital benefits paid, ancillary benefits paid, and total hospital bed days over the 12 months post enrollment. Compared with matched controls, TCCP did not appear to reduce health care utilization or benefits paid in the 12 months following program enrollment. However, program characteristics and implementation may have impacted its effectiveness. In addition, challenges related to evaluating complex health interventions such as TCCP are discussed. (Population Health Management 2016;19:187-195).

Temporal mood changes associated with different levels of adolescent drinking: using mobile phones and experience sampling methods to explore motivations for adolescent alcohol use.

INTRODUCTION AND AIMS: Alcohol use during adolescence is associated with the onset of alcohol use disorders, mental health disorders, substance abuse as well as socially and physically damaging behaviours, the effects of which last well into adulthood. Nevertheless, alcohol use remains prevalent in this population. Understanding motivations behind adolescent alcohol consumption may help in developing more appropriate and effective interventions. This study aims to increase this understanding by exploring the temporal relationship between mood and different levels of alcohol intake in a sample of young people. DESIGN AND METHODS: Forty-one secondary school students used a purpose-designed mobile phone application to monitor their daily mood and alcohol use for 20 random days within a 31 day period. Generalised estimating equations were used to examine the relationship between differing levels of alcohol consumption (light, intermediate and heavy) and positive and negative mood three days before and after drinking episodes. RESULTS: While there was no relationship between light and heavy drinking and positive mood, there was an increase in positive mood before and after the drinking event for those that drank intermediate amounts. No statistically significant relationships were found between negative mood and any of the three drinking categories. DISCUSSION AND CONCLUSION: Adolescents who drank in intermediate amounts on a single drinking occasion experienced an increase in positive mood over the three days leading up to and three days following a drinking event. These findings contribute to an understanding of the motivations that underpin adolescent alcohol use, which may help inform future interventions.

Comparing the responsiveness of functional outcome assessment measures for trauma registries.

BACKGROUND: Measuring long-term disability and functional outcomes after major trauma is not standardized across trauma registries. An ideal measure would be responsive to change but not have significant ceiling effects. The aim of this study was to compare the responsiveness of the Glasgow Outcome Scale (GOS), GOS-Extended (GOSE), Functional Independence Measure (FIM), and modified FIM in major trauma patients, with and without significant head injuries. METHODS: Patients admitted to two adult Level I trauma centers in Victoria, Australia, who survived to discharge from hospital, were aged 15 years to 80 years with a blunt mechanism of injury, and had an estimated Injury Severity Score >15 on admission, were recruited for this prospective study. The instruments were administered at baseline (hospital discharge) and by telephone interview 6 months after injury. Measures of responsiveness, including effect sizes, were calculated. Bootstrapping techniques, and floor and ceiling effects, were used to compare the measures. RESULTS: Two hundred forty-three patients participated, of which 234 patients (96%) completed the study. The GOSE and GOS were the most responsive instruments in this major trauma population with effect sizes of 5.3 and 4.4, respectively. The GOSE had the lowest ceiling effect (17%). CONCLUSIONS: The GOSE was the instrument with greatest responsiveness and the lowest ceiling effect in a major trauma population with and without significant head injuries and is recommended for use by trauma registries for monitoring functional outcomes and benchmarking care. The results of this study do not support the use of the modified FIM for this purpose.

The spatial distribution of esophageal and gastric cancer in Caspian region of Iran: an ecological analysis of diet and socio-economic influences.

Recent studies have suggested a systematic geographic pattern of esophageal cancer (EC) and gastric cancer (GC) incidence in the Caspian region of Iran. The aims of this study were to investigate the association between these cancers and the region's dietary and socioeconomic risk factors and to map EC and GC after adjustment for the risk factors and the removal of random and geographic variations from area specific age standardised incidence ratios (SIRs). We obtained cancer data from the Babol cancer registry from 2001 to 2005, socioeconomic indices from the Statistical Centre of Iran, and dietary patterns from the control group in a case control study conducted in the study region. Regression models were fitted to identify significant covariates, and clusters of elevated rates were identified. We found evidence of systematic clustering for EC and GC in men and women and both sexes combined. EC and GC SIRs were lower in urban areas, and were also lower in areas of high income. EC SIRs were lower in areas with higher proportions of people having unrestricted food choice and higher in areas with higher proportions of people with restricted food choice. EC and GC were associated with aggregated risk factors, including income, urbanisation, and dietary patterns. These variables represent the influence of improved lifestyle which has coincided with a decrease in upper gastrointestinal cancer frequency over recent decades but which has not necessarily been uniform throughout the region.

Comparison of the risk difference, risk ratio and odds ratio scales for quantifying the unadjusted intervention effect in cluster randomized trials.

This paper evaluates methods for unadjusted analyses of binary outcomes in cluster randomized trials (CRTs). Under the generalized estimating equations (GEE) method the identity, log and logit link functions may be specified to make inferences on the risk difference, risk ratio and odds ratio scales, respectively. An alternative, 'cluster-level', method applies the t-test to summary statistics calculated for each cluster, using proportions, log proportions and log odds, to make inferences on the respective scales. Simulation was used to estimate the bias of the unadjusted intervention effect estimates and confidence interval coverage, generating data sets with different combinations of number of clusters, number of participants per cluster, intra-cluster correlation coefficient rho and intervention effect. When the identity link was specified, GEE had little bias and good coverage, performing slightly better than the log and logit link functions. The cluster-level method provided unbiased point estimates when proportions were used to summarize the clusters. When the log proportion and log odds were used, however, the method often had markedly large bias for two reasons: (i) bias in the modified summary statistic used for cluster-level estimation when a cluster has zero cases with the outcome of interest (arising when the number of participants sampled per cluster is small and the outcome prevalence is low) and (ii) asymptotically, the method estimates the ratio of geometric means of the cluster proportions or odds, respectively, between the trial arms rather than the ratio of arithmetic means.

Implementing a research governance framework for clinical and public health research.

Research conduct in Australia and worldwide is mostly unaudited. The purpose of good research governance is to ensure integrity in research through accountability, transparency and responsibility. Institutional responsibility for research governance has been adopted by Monash University's Department of Epidemiology and Preventive Medicine, providing clear lines of accountability for researchers as well as support and guidance. A research audit tool has been developed, identifying areas where practice could be improved especially among less experienced researchers; the most common adverse findings concerned research protocols and procedure manuals. The need for participant confidentiality, privacy and data security was found to be understood, and adhered to widely by all researchers. An evaluation of the effect of audit on researchers found that the process was well accepted.