Approaches to prioritising research for clinical trial networks: a scoping review.

BACKGROUND: Prioritisation of clinical trials ensures that the research conducted meets the needs of stakeholders, makes the best use of resources and avoids duplication. The aim of this review was to identify and critically appraise approaches to research prioritisation applicable to clinical trials, to inform best practice guidelines for clinical trial networks and funders. METHODS: A scoping review of English-language published literature and research organisation websites (January 2000 to January 2020) was undertaken to identify primary studies, approaches and criteria for research prioritisation. Data were extracted and tabulated, and a narrative synthesis was employed. RESULTS: Seventy-eight primary studies and 18 websites were included. The majority of research prioritisation occurred in oncology and neurology disciplines. The main reasons for prioritisation were to address a knowledge gap (51 of 78 studies [65%]) and to define patient-important topics (28 studies, [35%]). In addition, research organisations prioritised in order to support their institution's mission, invest strategically, and identify best return on investment. Fifty-seven of 78 (73%) studies used interpretative prioritisation approaches (including Delphi surveys, James Lind Alliance and consensus workshops); six studies used quantitative approaches (8%) such as prospective payback or value of information (VOI) analyses; and 14 studies used blended approaches (18%) such as nominal group technique and Child Health Nutritional Research Initiative. Main criteria for prioritisation included relevance, appropriateness, significance, feasibility and cost-effectiveness. CONCLUSION: Current research prioritisation approaches for groups conducting and funding clinical trials are largely interpretative. There is an opportunity to improve the transparency of prioritisation through the inclusion of quantitative approaches.

Annual report of the National Influenza Surveillance Scheme, 2004.

The National Influenza Surveillance Scheme includes data on influenza-like illness from sentinel general practitioner practices, laboratory reports of influenza from National Notifiable Diseases Surveillance Scheme and absenteeism data from a national employer. In 2004, 2,116 cases of laboratory-confirmed influenza-like illness were reported, which was 41 per cent lower than the previous year. Peak activity was recorded in September, a month later than in 2003. Influenza A was again predominant while influenza B had an increased activity compared to the previous season. Four hundred and fifty-four isolates were antigenically analysed: 342 were A (H3N2 strain), 4 were A(H1N1 strain) strains and 108 were influenza B viruses. Further antigenic drift was seen in the A(H3N2) subtype with approximately one third of all isolates antigenically distinguishable from the A/Fujian/411/2002 reference strain. Vaccination coverage indicated that 79 per cent of Australians aged over 65 years received the 2004 influenza vaccine.

Australia's notifiable diseases status, 2003 annual report of the National Notifiable Diseases Surveillance System.

In 2003, 58 diseases and conditions were notifiable at a national level in Australia. States and territories reported a total of 104,956 cases to the National Notifiable Diseases Surveillance System an increase of 3.2 per cent on the total number of notifications in 2002. In 2003, the most frequently notified diseases were sexually acquired infections (38,854, 37% of total notifications), gastrointestinal diseases (24,655 notifications, 24%) and bloodborne viruses (20,825 notifications, 20%). There were 11,113 notifications of vaccine preventable diseases, 6,780 notifications of vectorborne diseases, 1,826 notification of other bacterial infections and 903 notifications of zoonotic diseases.

Evaluation of Australia's National Notifiable Disease Surveillance System.

The Australian National Notifiable Diseases Surveillance System (NNDSS) is a passive surveillance system that collects information on communicable diseases. The Australian Government manages NNDSS under the auspices of the Communicable Diseases Network Australia (CDNA). Data collected by each state and territory are collated, analysed and disseminated by the Australian Government Department of Health and Ageing. We report the first evaluation of NNDSS since it was established in 1991. Three primary stakeholder groups were surveyed: (a) CDNA members, (b) the National Surveillance Committee and (c) the readership of Communicable Diseases Intelligence, the primary means of data dissemination from NNDSS. The evaluation revealed that the system was acceptable, structurally simple, and that the data collected were actively used by stakeholders. However, the lack of clearly documented aims and objectives for NNDSS, inflexibility to changing needs, lack of timeliness and complexity in processes were seen as problematic. The results of this evaluation, supported by recent federal funding to enhance national biosecurity, will provide the framework for enhancing NNDSS to meet national communicable disease surveillance requirements in Australia.

Annual report of the National Influenza Surveillance Scheme, 2003.

Surveillance of influenza in Australia is based on laboratory isolation of influenza viruses, sentinel general-practitioner practices for influenza-like illness, and absenteeism data from a major national employer. In 2003, the peak in influenza activity was in August which was later than in 2002. In 2003, 3,604 laboratory-confirmed cases of influenza were notified to the National Notifiable Diseases Surveillance System, which was marginally lower than for the previous year. Ninety-four per cent of the circulating viruses were influenza A. This was the highest proportion in the last five years. Nine hundred and thirty-five isolates were antigenically analysed: 928 were A(H3), two were A(H1) strains and five were influenza B viruses. The majority (98%) of the A(H3) subtypes were A/Fujian/411/2002(H3N2)-like and have shown a significant antigenic drift. The 2003 Australian influenza vaccine contained A/Panama/2007/99, which induced 2-4-fold lower antibody response against the drifted strain. An A/Fujian/411/2002(H3N2)-like virus has been incorporated in the Australian influenza vaccine for 2004. In 2003, the influenza vaccine was given to 77 per cent of Australians aged over 65 years; the same up take as in 2002.

Severe acute respiratory syndrome surveillance in Australia.

In March 2003, the World Health Organization (WHO) issued a global alert recommending active worldwide surveillance for severe acute respiratory syndrome (SARS). This paper describes the epidemiological features of cases reported by Australian states and territories to the Australian Government Department of Health and Ageing between 17 March and 31 July 2003. There were 138 people investigated for SARS: 111 as suspect and 27 as probable. Five probable cases were reported to WHO after review of other possible diagnoses and Australia-specific exclusion criteria had been applied. An additional probable case identified by laboratory testing overseas, but who was not under investigation when in Australia, was also reported to WHO. The method by which surveillance for SARS was rapidly established provided an opportunity to examine Australia's planning and preparedness for future respiratory disease epidemics such as influenza.

Australia's notifiable diseases status, 2002: Annual report of the National Notifiable Diseases Surveillance System.

There were 57 infectious diseases notifiable at the national level in Australia in 2002. States and territories reported 100,278 cases of infectious diseases to the National Notifiable Diseases Surveillance System (NNDSS), a fall of 4 per cent compared to the number of notifications in 2001. In 2002, the most frequently notified diseases were, sexually transmitted infections (31,929 reports, 32% of total notifications), gastrointestinal infections (26,708 reports, 27% of total notifications) and bloodborne infections (23,741, 24%). There were 11,711 (12% of total) cases of vaccine preventable diseases, 3,052 (3% of total) cases of vectorborne diseases, 1,155 (1% of total) cases of zoonotic infections, two cases of quarantinable diseases (Vibrio cholerae O1) and 1,980 cases of other bacterial diseases, notified to NNDSS. Compared to 2001, notifications of sexually transmitted infections increased by 16 per cent and gastrointestinal infections by 2 per cent while bloodborne infections fell by 18 per cent. The number of notifications of chlamydial infection and Q fever were the highest since 1991 and 1995 respectively. By contrast, the number of notification for hepatitis A and measles were the lowest since 1991. For other notifiable diseases, the number of notifications was within the range of the five years between 1997 and 2002 (range = five-year mean plus or minus two standard deviations). This report also includes 2002 summary data on communicable diseases from other surveillance systems including the Laboratory Virology and Serology Reporting Scheme and sentinel general practitioner schemes.

Border screening for SARS in Australia: what has been learnt?

OBJECTIVE: To assess the effectiveness of the Australian border entry screening program to detect arriving travellers with symptoms of severe acute respiratory syndrome (SARS). DESIGN AND SETTING: Descriptive study of outcomes of screening at Australian airports and seaports between 5 April 2003 and 16 June 2003. To determine the number of international travellers who were symptomatic on arrival in Australia but missed by screening, data were obtained on the number of arrivals screened and the number with symptoms (from the Australian Quarantine and Inspection Service [AQIS]), as well as the number of people investigated for SARS (from the Australian SARS Case Register). RESULTS: There were 1.84 million arrivals into Australia during the study period, and 794 were referred for screening to AQIS staff. Of these, the findings in four travellers were consistent with the World Health Organization case definition for SARS, and they were referred by the Chief Quarantine Officers to designated hospitals for further investigation. None of these people was confirmed to have SARS. One person reported as a probable SARS case acknowledged being symptomatic on arrival, but had been missed by border screening. CONCLUSIONS: The low identification rate was attributed to the low prevalence of SARS, the use of exit screening by affected countries, and the subjective measures used in the screening process. With current knowledge about SARS, border screening should focus on educating incoming travellers, especially groups at high risk of transmitting the disease (the elderly and those with underlying chronic illnesses). Objective screening measures should be used during SARS outbreaks to prevent importation of the disease.

Surveillance for newly acquired hepatitis C in Australia.

BACKGROUND: The purpose of the present paper was to determine recent patterns of hepatitis C virus (HCV) transmission in Australia through a national system of enhanced surveillance of newly acquired hepatitis C. METHODS: Demographic, clinical, and risk behavior information on newly acquired hepatitis C cases from 1997 to 2000 was collected. Newly acquired hepatitis C included cases of HCV antibody sero-conversion within a 12 month period and acute clinical hepatitis C cases. RESULTS: Nine hundred and twelve cases of newly acquired hepatitis C were identified, representing 2.8% of all HCV notifications for this period. The majority of cases (72%) were diagnosed in people aged between 20 and 39 years. Injecting drug use was reported in the vast majority of cases (93%), with sexual transmission (2%) and tattooing (2%) reported in small numbers. HCV antibody sero-conversion was the mode of diagnosis in most cases (78%). CONCLUSIONS: Injecting drug use is the main route of HCV transmission in Australia. As only a small proportion of HCV infections are detected as newly acquired, enhanced surveillance procedures, including increased regular HCV testing of at-risk populations are required to more effectively monitor recent patterns of transmission.

Tuberculosis notifications in Australia, 2003.

The National Notifiable Disease Surveillance System (NNDSS) received 982 tuberculosis (TB) notifications in 2003, of which 947 were new cases, 33 were relapses and two were cases with unknown history. The incidence of TB in Australia has remained at a stable rate since 1985 and was 4.9 cases per 100,000 population in 2003. The high-incidence groups remain people born overseas and Indigenous Australians at 19.9 and 8.7 cases per 100,000 population, respectively. By contrast the incidence in non-Indigenous Australians was 0.9 per 100,000. Comparison of the 2003 TB notification data against the performance indicators set by National Tuberculosis Advisory Committee highlights that enhanced TB control measures should be considered among these high-risk groups.

Modelling hepatitis C virus incidence, prevalence and long-term sequelae in Australia, 2001.

BACKGROUND: To plan an appropriate public health response to the hepatitis C virus (HCV) epidemic requires that estimates of HCV incidence and prevalence, and projections of the long-term sequelae of infection, are as accurate as possible. In this paper, mathematical models are used to synthesize data on the epidemiology and natural history of HCV in Australia to estimate HCV incidence and prevalence in Australia to end 2001, and project future trends in the long-term sequelae of HCV infection. METHODS: Mathematical models of the HCV epidemic in Australia were developed based on estimates of the pattern of injecting drug use. Estimates of HCV infections due to injecting drug use were then adjusted to allow for HCV infections resulting from other transmission routes. Projections of the long-term sequelae of HCV infection were obtained by combining modelled HCV incidence with estimates of the progression rates to these outcomes. RESULTS: It was estimated that there were 210 000 (lower and upper limits of 157 000 and 252 000) people in Australia living with HCV antibodies at the end of 2001, with HCV incidence in 2001 estimated to be 16 000 (11 000-19 000). It was estimated that 6500 (5000-8000) people were living with HCV-related cirrhosis in 2001, that 175 (130-210) people developed HCV-associated liver failure, and that there were 50 (40-60) incident cases of HCV-related hepatocellular carcinoma (HCC). It was estimated that in 2001 22 500 quality adjusted life years were lost to chronic HCV infection, the majority (77%) in people with early (stage 0/1) liver disease. DISCUSSION: Model-based estimates were broadly consistent with other sources of information on the HCV epidemic in Australia. These models suggest that the prevalence of HCV-related cirrhosis and the incidence of HCV-related liver failure and HCC will more than triple in Australia by 2020.

Annual report of the National Influenza Surveillance Scheme, 2002.

Surveillance for influenza in Australia in 2002 was based on notifications to the National Notifiable Diseases Surveillance system from all states and territories, national and state-based sentinel practice consultations for influenza-like illness and reports of influenza virus isolations from a laboratory network. The impact of influenza was assessed by absenteeism data from a major national employer. Influenza A was the dominant type, 99 per cent of which were subtype H3N2 with only a single H1 isolate, which was identified as H1N2. The H3N2 isolates were closely related to the vaccine strain A/Moscow/10/99 and the A/Panama/2007/99, with less than one per cent showing genetic variation. Influenza B made up 21 per cent of circulating influenza and the majority of B strains were of the B/Victoria lineage, but had a haemagglutinin closely related to the B/Hong Kong/330/2001 strain. This strain was associated with two outbreaks but a proportion of vaccinees with the 2002 vaccine showed protective antibody titres. The 2002 influenza vaccine was given to 77 per cent of Australians over 65 years.

Australia's notifiable diseases status, 2001: annual report of the National Notifiable Diseases Surveillance System.

In 2001 there were 104,187 notifications of communicable diseases in Australia reported to the National Notifiable Diseases Surveillance System (NNDSS). The number of notifications in 2001 was an increase of 16 per cent of those reported in 2000 (89,740) and the largest annual total since the NNDSS commenced in 1991. In 2001, nine new diseases were added to the list of diseases reported to NNDSS and four diseases were removed. The new diseases were cryptosporidiosis, laboratory-confirmed influenza, invasive pneumococcal disease, Japanese encephalitis, Kunjin virus infection, Murray Valley encephalitis virus infection, anthrax, Australian bat lyssavirus, and other lyssaviruses (not elsewhere classified). Bloodborne virus infections remained the most frequently notified disease (29,057 reports, 27.9% of total), followed by sexually transmitted infections (27,647, 26.5%), gastrointestinal diseases (26,086, 25%), vaccine preventable diseases (13,030 (12.5%), vectorborne diseases (5,294, 5.1%), other bacterial infections (1,978, 1.9%), zoonotic infections (1,091, 1%) and four cases of quarantinable diseases. In 2001 there were increases in the number of notifications of incident hepatitis C, chlamydial infections, pertussis, Barmah Forest virus infection and ornithosis. There were decreases in the number of notifications of hepatitis A, Haemophilus influenzae type b infections, measles, rubella, Ross River virus infections and brucellosis. This report also summarises data on communicable diseases from other surveillance systems including the Laboratory Virology and Serology Reporting Scheme and sentinel general practitioner schemes. In addition, this report comments on other important developments in communicable disease control in Australia in 2001.

Pneumococcal disease in Australia: current status and future challenges. A report of the workshop held at the National Centre for Immunisation Research and Surveillance, 8-9 November, 2002.

In relation to surveillance, the predominant issue discussed was universal versus sentinel enhanced surveillance of IPD. In northern Australia, it will be important for enhanced surveillance to continue and to be as complete as possible. There are a number of reasons for this. First, the high incidence and high serotype diversity of IPD in Indigenous children in these areas has prompted the recommendation for boosters with 23vPPV to increase serotype coverage. This makes high quality, comprehensive surveillance essential for national policy. It is also important internationally as such as vaccine program has not been implemented anywhere else but is potentially applicable to other comparable populations. Secondly, the small absolute numbers of cases require data to be accumulated as comprehensively as possible. In relation to vaccine issues, both 23vPPV and 7vPCV policy are important. There was strong support from the meeting for the recent recommendation from the Australian Technical Advisory Group on Immunisation that both 23vPPV (for those over 65 years) and 7vPCV (for those less than 2 years) be publicly funded as universal programs. With respect to the current programs, there were important issues for Aboriginal and Torres Strait Islander people for both 23vPPV and 7vPCV. For 23vPPV, research is required into both the utility and frequency of boosters in adults as well as any potential role for 7vPCV in adults. Improving the identification of Aboriginal and Torres Strait Islander children is important, especially in urban areas.

Tuberculosis notifications in Australia, 2002.

In 2002, there were 1,028 cases of tuberculosis (TB) reported to the National Notifiable Disease Surveillance System, of which 997 were new cases, 30 were relapses and 1 unknown. The incidence rate of TB in Australia in 2002 was 5.2 cases per 100,000 population. The highest incidence of TB was reported in people born overseas (20.2 cases per 100,000 population), followed by Indigenous Australians (8.5 cases per 100,000 population). By contrast, the incidence rate of TB in the nonIndigenous Australian-born population was 1.1 cases per 100,000 population. This pattern of TB incidence rates amongst the sub-populations of Australia has been observed for over 10 years. The rates were evaluated against the performance indicators set by the National Tuberculosis Advisory Committee to ensure that Australia's record of TB control is maintained and improved.

Review of antenatal testing policies and practice for HIV and hepatitis C infection.

OBJECTIVE: To investigate antenatal HIV and HCV testing policy and practice in Australia. METHODS: A survey of private obstetricians and general practitioners (GPs) affiliated with the Royal Australian and New Zealand College of Obstetricians and Gynaecologists and directors of obstetric units in public hospitals was undertaken. Surveys were mailed to 40% and 20% random samples of private obstetricians and GPs, respectively, and all public hospital obstetric units. The questionnaires included information on type of antenatal policy, proportion of women tested for HIV and HCV, and number of HIV and HCV-positive women receiving antenatal care. RESULTS: Of the 995 surveys distributed, 847 (85%) were returned. Of these 847, 277 (33%) were returned from practitioners or hospitals no longer involved in antenatal care. The response rates from the remaining practitioners (n=570) included 87% from private obstetricians, 78% from GPs, and 71% from public hospitals. The proportion of private obstetricians, GPs and public hospitals with an antenatal testing policy for HIV was 62%, 42% and 44%, and for HCV 65%, 41% and 39%, respectively. Universal offer of antenatal testing among private obstetricians, GPs and public hospitals was 47%, 62% and 23% for HIV and 54%, 46% and 23% for HCV, respectively. During 1999, an estimated 33% of pregnant women were tested for HIV and 37% for HCV. Based on reported numbers of women in antenatal care, prevalence rates were estimated at 0.23 per 1,000 and 13 per 1,000, for HIV and HCV, respectively. CONCLUSIONS: Antenatal testing policy and practice varies widely in Australia. The lack of uniformity may reflect differing policies among clinical and public health bodies.

The Laboratory Virology and Serology Reporting Scheme, 1991 to 2000.

Between 1991 and 2000, the Laboratory Virology and Serology Surveillance Scheme (LabVISE) received 340,730 laboratory reports of viral and non-viral pathogen identifications. In this report, data on 136 viruses and 31 non-viral pathogens is analysed. The age and sex distribution and seasonal fluctuations in infections are described. The major clinical diseases associated with LabVISE pathogens are reviewed together with a survey of recent activity reported in Australia. The contribution of LabVISE over the 10-year period to surveillance of poliomyelitis in Australia, up to and beyond the eradication goal, is described. The contribution of LabVISE to influenza surveillance and control in Australia is also described. Prospects for the continued role of LabVISE in the surveillance and control of viral meningitis, viral gastroenteritis and viral respiratory diseases are reviewed.

Australia's notifiable diseases status, 2000. Annual report of the National Notifiable Diseases Surveillance System.

In 2000, there were 89,740 notifications of communicable diseases in Australia collected by the National Notifiable Diseases Surveillance System (NNDSS). The number of notifications in 2000 was an increase of 5.9 per cent over those reported in 1999 (84,743) and the largest reporting year since the NNDSS commenced in 1991. Notifications in 2000 consisted of 28,341 bloodborne infections (32% of total), 24,319 sexually transmitted infections (27%), 21,303 gastrointestinal infections (24%), 6,617 vaccine preventable infections (7%), 6,069 vectorborne infections (7%), 2,121 other bacterial infections (legionellosis, meningococcal infection, leprosy and tuberculosis) (2%), 969 zoonotic infections (1%) and only one case of a quarantinable infection. Steep declines in some childhood vaccine preventable diseases such as Haemophilus influenzae type b, measles, mumps and rubella, continued in 2000. In contrast, notifications of pertussis and legionellosis increased sharply in the year. Notifications of bloodborne viral diseases (particularly hepatitis B and hepatitis C) and some sexually transmitted infections such as chlamydia, continue to increase in Australia. This report also summarises data on communicable diseases from other surveillance systems including the Laboratory Virology and Serology Surveillance Scheme (LabVISE) and sentinel general practitioner schemes. In addition this report comments on other important developments in communicable disease control in Australia in 2000.