The use of linked administrative data in Australian randomised controlled trials: A scoping review.

BACKGROUND/AIMS: The demand for simplified data collection within trials to increase efficiency and reduce costs has led to broader interest in repurposing routinely collected administrative data for use in clinical trials research. The aim of this scoping review is to describe how and why administrative data have been used in Australian randomised controlled trial conduct and analyses, specifically the advantages and limitations of their use as well as barriers and enablers to accessing administrative data for use alongside randomised controlled trials. METHODS: Databases were searched to November 2022. Randomised controlled trials were included if they accessed one or more Australian administrative data sets, where some or all trial participants were enrolled in Australia, and where the article was published between January 2000 and November 2022. Titles and abstracts were independently screened by two reviewers, and the full texts of selected studies were assessed against the eligibility criteria by two independent reviewers. Data were extracted from included articles by two reviewers using a data extraction tool. RESULTS: Forty-one articles from 36 randomised controlled trials were included. Trial characteristics, including the sample size, disease area, population, and intervention, were varied; however, randomised controlled trials most commonly linked to government reimbursed claims data sets, hospital admissions data sets and birth/death registries, and the most common reason for linkage was to ascertain disease outcomes or survival status, and to track health service use. The majority of randomised controlled trials were able to achieve linkage in over 90% of trial participants; however, consent and participant withdrawals were common limitations to participant linkage. Reported advantages were the reliability and accuracy of the data, the ease of long term follow-up, and the use of established data linkage units. Common reported limitations were locating participants who had moved outside the jurisdictional area, missing data where consent was not provided, and unavailability of certain healthcare data. CONCLUSIONS: As linked administrative data are not intended for research purposes, detailed knowledge of the data sets is required by researchers, and the time delay in receiving the data is viewed as a barrier to its use. The lack of access to primary care data sets is viewed as a barrier to administrative data use; however, work to expand the number of healthcare data sets that can be linked has made it easier for researchers to access and use these data, which may have implications on how randomised controlled trials will be run in future.

Musculoskeletal injuries.

In 2007-2009, BEACH (Bettering the Evaluation and Care of Health) recorded 979 encounters at which a possible sports related injury was managed in a patient aged 5-24 years. Although there is no way of determining the cause of an injury through BEACH data, we selected musculoskeletal injuries which could be caused by a sporting activity, excluding problems that were said to be work related, and limited the sample by the age of patient.

NESB patients.

General practitioner consultations with patients of non-English speaking background (NESB) account for one in 10 encounters recorded in the BEACH (Bettering the Evaluation and Care of Health) program (NESB is defined as patients who reported that their primary language spoken at home is not English). We present a descriptive comparison of consultations with NESB and English speaking patients recorded between April 2007 and March 2009. Indigenous persons were excluded from the analysis to give a clearer picture of NESB patients of non- Australian origin. Only statistically significant differences with nonoverlapping 95% confidence intervals are reported.

COPD.

The BEACH data confirmed that patients managed for COPD were significantly more likely than average to be male. Male patients were managed for COPD at a rate of 10 per 1000 encounters, significantly higher than the rate for females (7 per 1000). They were also more likely to be older than the average general practice patient; three-quarters of COPD patients were aged 65 years or more. Chronic obstructive pulmonary disease was managed at a rate of 21 per 1000 encounters with patients in that age group.

Croup.

In this analysis we used BEACH (Bettering the Evaluation and Care of Health) encounters with children aged 0-14 years from January 2008 to December 2009. Croup was managed 276 times during that period (at 1.2% of 23 016 encounters with children in this age group). This suggests that croup is managed in general practice about 154,000 times per year nationally.

Perianal problems.

Between January 2008 and December 2009 in the BEACH (Bettering the Evaluation and Care of Health) program, perianal problems were managed in general practice at a rate of 0.7 per 100 encounters, about 800 000 times per year nationally. Here we present an overview of perianal problems and discuss haemorrhoids in particular.

Management of HIV/AIDS.

Male patients accounted for 96.4% of all encounters where HIV/AIDS was managed. Patients in the 25-44 years age group and 45-64 years age group had the highest management rates of HIV/AIDS (54.6% and 40.6% respectively). Just over half the patients who had HIV/AIDS managed, held a Commonwealth Government concession card, which is 10% more than the total patients sampled in BEACH. Patients were more likely to live in a major city than the total BEACH sample. Most of the patients had been diagnosed previously, with only 2.7% of them indicated as newly diagnosed, and patients were more likely to have their problem managed at the same practice, with 98% of patients having been seen previously at the practice, compared with 92% of the total BEACH sample.

Cancer screening in general practice.

Cancer screening promoted through government policies includes screening for breast cancer, cervical cancer, bowel cancer, and skin cancer. These cancers, plus prostate cancer, are investigated in terms of general practitioner procedural work and pathology test ordering rates that aim to detect cancer.

Presentations of rash.

The gender distribution of patients presenting with rash were similar to all BEACH encounters. However, younger patients were more likely to present with rash, with one-quarter (24.5%) of patients being under the age of 15 years compared with 11.8% of all encounters.

Men and mental health.

Psychological problems were managed at a rate of 11.1 per 100 encounters with male patients in 2006-2008, compared with 12.6 per 100 female encounters. Two-thirds of these encounters were with males aged 45-64 years (34.5%) and 25-44 years (32.9%). Age specific rates show that psychological problems were managed most often among males aged 25-44 years (18.1 per 100 encounters with males in this age group) significantly higher than the equivalent group of females (Figure 1).

Carpal tunnel syndrome.

Between April 2000 and March 2009, carpal tunnel syndrome was managed 1700 times among 885,400 encounters in the BEACH program (Bettering the Evaluation and Care of Health) at a rate of two contacts per 1000 encounters. This extrapolates to about 195,000 contacts annually across Australia.

Glaucoma.

Between April 2007 and March 2009, glaucoma was managed by general practitioners at a rate of 1.8 contacts per 1000 encounters in the BEACH (Bettering the Evaluation and Care of Health) program, extrapolating to about 200 000 times per year nationally. This was marginally higher than in April 2000 to March 2002 (1.4 per 1000). We compared results from the two data periods to establish what changes had occurred.

Bites and stings.

Of the 426 bite or sting problems managed, 312 (73%) were caused by insects. There were 114 other types of bites recorded, the most common being dog and spider bites. There were five cases of toxicity from aquatic animal stings or adverse reactions to bee stings (Table 1).

Allergic rhinitis.

The BEACH program (Bettering the Evaluation and Care of Health) shows that allergic rhinitis was managed six times per 1000 encounters between October 2002 to September 2007. This suggests that general practitioners manage allergic rhinitis about 619 000 times nationally each year.

Urinary incontinence in the older patient.

Over a 7 year period from April 2000 to March 2007 urinary incontinence was managed 802 times for patients aged 45 years and over. Women made up 85% of these encounters. Women had a significantly higher rate of incontinence management than males in all age groups. However, the management rate for men rose significantly among those aged 75 years and over, compared with aged 45-74 years.

Upper abdominal pain.

Female patients were significantly more likely to present (8 per 1000 encounters) at upper abdominal encounters than were males (6 per 1000). Female patients were over represented (64.5%) compared with total BEACH (56.8%), as were patients of non-English speaking background and patients aged 25-64 years. Aboriginal and Torres Strait Islander patients were seen marginally more often than average at these encounters. Very young and elderly patients were under represented.

Referrals to A&E.

There were 900 encounters at which patients were referred to A&E over the 5 year period. There was no difference between male and female referral rates (0.2 per 100 encounters). Children aged < 15 years were referred at the higher rate of 0.3 per 100 encounters; the lowest rate was among patients aged 65-74 years (0.1 per 100). Patients of non-English speaking backgrounds were seen at average rates at these encounters, but Commonwealth concession card holders were seen significantly more often (48.2 per 100 A&E referred encounters compared with an average of 41.9). Aboriginal and Torres Strait Islander patients were over represented at 3.3 per 100 compared with the BEACH average of 1.1. Patients new to the practice were seen at A&E encounters at twice the average rate (20.5 per 100 compared with 9.0 in total BEACH).

Vertiginous syndrome.

The 652 occurrences of vertiginous syndrome recorded over the 2 year period can be divided into benign positional vertigo (38.7%), labyrinthitis (31.9%), Meniere disease (17.4%) and vestibular disorders (12.1%).

Indigenous patients.

In the BEACH program (Bettering the Evaluation and Care of Health) between 2000 and 2008, Aboriginal people and/or Torres Strait Islanders accounted for approximately 1.1% of total BEACH encounters. We compare these encounters with all BEACH encounters.

Somatisation.

Somatisation is when physical symptoms develop through stress or emotional problems. Each year in the BEACH program (Bettering the Evaluation and Care of Health), somatisation disorder is managed about 30 times in 100,000 encounters. Although it is rare for general practitioners to identify the problem managed as somatisation, over the 10 years of BEACH we now have 298 encounters where this occurred, and details of these encounters are shown below.