Development of a health technology assessment module for evaluating mobile medical applications.

OBJECTIVE: The aim of this study was to develop a module which could be used to facilitate the assessment of mobile medical applications (MMA) for regulatory and reimbursement purposes. METHODS: In-depth interviews were conducted with policymakers, healthcare practitioners, and application developers to determine possible pathways and impediments to MMA reimbursement. These findings were integrated with our previous research on MMA reimbursement and regulation to create a module that could be used with existing health technology assessment (HTA) methodological frameworks to guide the evaluation of MMAs. RESULTS: Stakeholders indicated that they trust how traditional medical devices are currently appraised for reimbursement. They were concerned that there was a lack of clarity regarding which entity in the health system was responsible for determining app quality. They were also concerned about the digital health literacy of medical practitioners and patients. Concepts emerging from our previous research were reinforced by the interview findings, including that the connectivity and cybersecurity of apps need to be considered, along with an assessment of software reliability. It is also critical that the credibility of the information presented in apps is assessed as it could potentially mislead patients and clinicians. CONCLUSION: An MMA evaluation module was created that would enable an existing HTA process to be adapted for the assessment of MMA technology. These adaptations include making provisions for an assessment of app cybersecurity, the impact on MMA clinical utility of software updates, and compatibility issues. Items to address concerns around practitioner responsibility and app misinformation were also incorporated into the module.

Evaluation of Mobile Health Applications: Is Regulatory Policy Up to the Challenge?

OBJECTIVES: The aim of this study is to determine whether the approach used in Australia to regulate mobile medical applications (MMA) is consistent with international standards and is suitable to address the unique challenges of these technologies. METHODS: The policies of members of the International Medical Device Regulator's Forum (IMDRF) were analyzed, to determine whether these regulatory bodies address IMDRF recommendations for the clinical evaluation of software as a medical device (SaMD). Case-studies of varying types of regulated MMAs in Australia and the United States were also reviewed to determine how well the guidance in the IMDRF's SaMD: Clinical Evaluation (2017) document was operationalized. RESULTS: All included jurisdictions evaluated the effectiveness of MMAs and addressed the majority of the key sub-categories recommended in the IMDRF guidance document. However, safety principles concerning information security (cybersecurity) and potential dangers of misinformation (risk-classification) were generally not addressed in either the case-studies or in the policy documents of international regulatory bodies. Australia's approach was consistent with MMA regulation conducted internationally. None of the approaches used by global regulatory bodies adequately addressed the risk of misinformation from apps and the potential for adverse clinical consequences. CONCLUSIONS: The risks posed by MMAs are mainly through the information they provide and how this is used in clinical decision-making. Policy in Australia and elsewhere should be adjusted to follow the IMDRF risk-classification criteria to address potential harms from misinformation. Australian regulatory information should also be updated so the harm posed by cybersecurity and connectivity can be comprehensively evaluated.

Have musicians' musculoskeletal symptoms been thoroughly addressed? A systematic mapping review.

The authors aimed to characterize the current evidence base regarding musicians' musculoskeletal symptoms (MSS), in order to identify gaps for future research. A systematic search was conducted to identify peer-review studies published in English in 2007-2016 that investigated musicians' MSS. Narrative reviews, case reports, protocols, and questionnaire or program development papers were excluded. Data were synthesized descriptively in order to identify gaps in the current evidence base. Five systematic reviews and 153 primary studies (133 unique) were included in this review. The majority (71%) of studies investigated professional musicians and/or university music students, with orchestral musicians being the most commonly investigated group. The majority of studies investigated the extent of the problem (68%) and/or associated factors (54%). Eight studies compared the prevalence of MSS outcomes with other populations. A range of risk factors were investigated; however, few studies used longitudinal designs. A total of 16 intervention studies were identified (3 clinical, 13 public health), with 12 investigating education or exercise programs. There is a need for research into musicians beyond classical university music students and professional orchestral musicians, and these musical sub-groups should be compared to determine the most at risk groups of musicians. Studies looking at potential risk factors should move towards longitudinal designs so that the temporal relationship of these factors and MSS could be established, where cross-sectional designs have indicated that an association exists. Intervention studies should be based upon the risk factors identified, and extend beyond education and exercise programs. Int J Occup Med Environ Health. 2019;32(3):291-331.

How do we assess musicians' musculoskeletal symptoms?: a review of outcomes and tools used.

Recent reviews of musicians' musculoskeletal symptoms (MSS) have reported heterogeneity in the outcomes reported and data collection tools used, making it difficult to compare and synthesise findings. The purpose of this present review was to improve the consistency of future research, by documenting the outcomes reported in recent studies of musicians' MSS and the data collection tools used. All English language, peer-reviewed studies, published 2007-2016 that reported musicians' self-reported MSS outcomes were identified. Details of the types of outcomes reported and the tools used were extracted, and synthesised descriptively. A range of MSS outcomes were reported, including MSS with a temporal relationship to activities performed, and the consequences of symptoms. Only 24% of studies used standardised questionnaires, with the Nordic Musculoskeletal Questionnaire (NMQ) being the most commonly used. To improve the homogeneity of outcomes and data collection tools when investigating musicians' MSS, we recommend using the NMQ, where appropriate. Recall periods of 12-months and 7-d are the most appropriate for prevalence, and 7-d recall periods for ratings. Importantly, outcomes and the tools used to collect data should be reported in sufficient detail to ensure that the study can be replicated, critiqued, and accurately interpreted.

SUITABILITY OF CURRENT EVALUATION FRAMEWORKS FOR USE IN THE HEALTH TECHNOLOGY ASSESSMENT OF MOBILE MEDICAL APPLICATIONS: A SYSTEMATIC REVIEW.

OBJECTIVES: To identify and appraise existing evaluation frameworks for mobile medical applications (MMA) and determine their suitability for use in health technology assessment (HTA) of these technologies. METHODS: Systematic searches were conducted of seven bibliographic databases to identify literature published between 2008 and 2016 on MMA evaluation frameworks. Frameworks were eligible if they were used to evaluate at least one of the HTA domains of effectiveness, safety, and/or cost and cost-effectiveness of an MMA. After inclusion, the frameworks were reviewed to determine the number and extent to which other elements of an HTA were addressed by the framework. RESULTS: A total of forty-five frameworks were identified that assessed MMAs. All frameworks assessed whether the app was effective. Of the thirty-four frameworks that examined safety, only seven overtly evaluated potential harms from the MMA (e.g., the impact of inaccurate information). Only one framework explicitly considered a comparator. Technology specific domains were sporadically addressed. CONCLUSION: None of the evaluation frameworks could be used, unaltered, to guide the HTA of MMAs. To use these frameworks in HTA they would need to identify relevant comparators, improve assessments of harms and consider the ongoing effect of software updates on the safety and effectiveness of MMAs. Attention should also be paid to ethical issues, such as data privacy, and technology specific characteristics. IMPLICATIONS: Existing MMA evaluation frameworks are not suitable for use in HTA. Further research is needed before an MMA evaluation framework can be developed that will adequately inform policy makers.

Community perspectives on the use of regulation and law for obesity prevention in children: A citizens' jury.

INTRODUCTION: Childhood obesity is a significant challenge for public health internationally. Regulatory and fiscal measures propagated by governments offer a potentially effective response to this issue. Fearing public criticism, governments are often reluctant to use such measures. In this study we asked a descriptively representative and informed group of Australians their views on the use of legislation and fiscal measures by governments to address childhood obesity. METHODS: A citizens' jury, held in South Australia in April 2015, was asked to consider the question: What laws, if any, should we have in Australia to address childhood obesity? RESULTS: The jury agreed that prevention of obesity was complex requiring multifaceted government intervention. Recommendations fell into the areas of health promotion and education (n=4), regulation of food marketing (n=3), taxation/subsidies (n=2) and a parliamentary enquiry. School-based nutrition education and health promotion and mandatory front-of-pack interpretive labelling of food and drink were ranked 1 and 2 with taxation of high fat, high sugar food and drink third. CONCLUSION: The recommendations were similar to findings from other citizens' juries held in Australia suggesting that the reticence of decision makers in Australia, and potentially elsewhere, to use legislative and fiscal measures to address childhood obesity is misguided. Supporting relevant informed public discussion could facilitate a politically acceptable legislative approach.

Intersectoral collaboration to implement school-based health programmes: Australian perspectives.

Understanding the processes and the factors influencing intersectoral collaboration is vital for the ongoing success of programmes that rely on effective partnerships between sectors, such as the school-based immunization programme, the school dental health programme and health promotion interventions delivered in school settings. We studied school-based health programmes delivered by partnerships between health, education and the local government sectors. We used purposive sampling to identify 19 people working in school-based health programmes and interviewed them about the barriers and enablers of successful collaboration. Data were analysed thematically. We found that collaboration between complex systems was a skilled endeavour which relied on a strong foundation of communication and interpersonal professional relationships. Understanding the core business, operational context and intersectoral point-of-view of collaborative partners was important both for establishing good intersectoral programmes and sustaining them as contexts and personnel changed. Aligning divergent sectoral agendas early in the collaborative process was essential for ensuring that all partners could meet their core business needs while also delivering the programme outcomes.

Prioritizing government funding of adolescent vaccinations: recommendations from young people on a citizens' jury.

OBJECTIVE: Adolescents' views, and preferences are often over-looked when public health policies that affect them are designed and implemented. The purpose of this study was to describe young people's views and preferences for determining government funding priorities for adolescent immunization programs. METHODS: In 2015 we conducted a youth jury in metropolitan Adelaide, South Australia to deliberate on the question "What criteria should we use to decide which vaccines for young people in Australia should receive public funding?" Fifteen youth aged 15-19 years participated in the jury. Jury members were recruited from the general community through a market research company using a stratified sampling technique. RESULTS: The jury's key priorities for determining publically funded vaccines were: Disease severity - whether the vaccine preventable disease (VPD) was life threatening and impacted on quality of life. Transmissibility - VPDs with high/fast transmission and high prevalence. Demonstration of cost-effectiveness, taking into account purchase price, program administration, economic and societal gain. The jury's recommendations for vaccine funding policy were strongly underpinned by the belief that it was critical to ensure that funding was targeted to not only population groups who would be medically at risk from vaccine preventable diseases, but also to socially and economically disadvantaged population groups. A novel recommendation proposed by the jury was that there should be a process for establishing criteria to remove vaccines from publically funded programs as a complement to the process for adding new vaccines. CONCLUSIONS: Young people have valuable contributions to make in priority setting for health programs and their views should be incorporated into the framing of health policies that directly affect them.

Ethical Challenges in School-Based Immunization Programs for Adolescents: A Qualitative Study.

OBJECTIVES: We investigated ethical issues in school-based immunization programs for adolescents and how they are addressed. METHODS: We used qualitative methods and an ethnographic approach to observe 9 secondary schools on immunization days in South Australia in 2011; concurrently, we conducted 9 focus groups with female secondary school students, 6 semistructured interviews with parents, and 10 interviews with nurses and teachers. We explored ethical challenges from the perspective of these groups. RESULTS: We identified ethical challenges for the delivery of adolescent immunization in a school-based setting in 3 main areas: informed consent, restrictions on privacy, and harm to students in the form of fear and anxiety. CONCLUSIONS: We found areas in which the design and delivery of school-based immunization programs can be improved. Information about immunization should be provided in ways that are appropriate to young people and their parents, and privacy protections should be enhanced when possible. Involving young people in the design and delivery of programs would assist with making these improvements.

Eliciting youth and adult recommendations through citizens' juries to improve school based adolescent immunisation programs.

OBJECTIVES: Completion of adolescent immunisation schedules in Australia is sub-optimal despite a well-established school based delivery program. The aim of this study was to seek adolescent and adult views on how existing adolescent school based immunisation policy and program delivery could be improved to increase adolescent immunisation uptake. METHOD: Two citizens' juries held separately, one with adolescent participants and one with adult participants deliberated on recommendations for public policy. Jury members were selected using a stratified sampling technique and recruited from a standing panel of community research participants through a market research company in South Australia. Juries were conducted in Metropolitan South Australia over two days and used university facilities with all meals and refreshments provided. RESULTS: Fifteen adults and 16 adolescents participated in the adult and youth juries respectively. Similar recommendations were made by both juries including increased ensuring the accuracy of information provided to adolescents and parents; employing a variety of formats for information delivery; and greater consideration of students' physical and emotional comfort in order to improve the experience for adolescents. While the youth jury recommended that it should be compulsory for adolescents to receive vaccines through the school based immunisation program, the adult jury recommended an 'opt-out' system of consent. Both juries also recommended the use of incentives to improve immunisation uptake and immunisation course completion. CONCLUSIONS: Eliciting adolescent views and including the perspectives of adolescents in discussions and development of strategies to improve engagement in the school based immunisation program provided valuable insight from the group most impacted by these policies and practices. Specifically, incorporation of adolescent and community views using citizens' juries may lead to greater overall support from the community as their values and needs are more accurately reflected.

Prophylaxis for venous thromboembolic disease in pregnancy and the early postnatal period.

BACKGROUND: Venous thromboembolism (VTE), although rare, is a major cause of maternal mortality and morbidity, and methods of prophylaxis are therefore often used for women considered to be at risk. This may include women who have given birth by caesarean section, those with a personal or family history of VTE and women with inherited or acquired thrombophilias (conditions that predispose people to thrombosis). Many methods of prophylaxis carry risks of adverse effects, and as the risk of VTE is often low, it is possible that the benefits of thromboprophylaxis may be outweighed by harms. Guidelines for clinical practice have been based on expert opinion rather than high-quality evidence from randomised trials. OBJECTIVES: To assess the effects of thromboprophylaxis in women who are pregnant or have recently given birth and are at increased risk of VTE on the incidence of VTE and adverse effects of treatment. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (27 November 2013).  SELECTION CRITERIA: Randomised trials comparing one method of thromboprophylaxis with placebo or no treatment, and randomised trials comparing two (or more) methods of thromboprophylaxis. DATA COLLECTION AND ANALYSIS: At least two review authors assessed trial eligibility and quality and extracted the data. MAIN RESULTS: Nineteen trials, at an overall moderate risk of bias, met the inclusion criteria for the review. Only 16 trials, involving 2592 women, assessing a range of methods of thromboprophylaxis, contributed data to the review. Six trials compared methods of antenatal prophylaxis: heparin versus no treatment/placebo (two trials), and low molecular weight heparin (LMWH) versus unfractionated heparin (UFH) (four trials). Nine trials assessed prophylaxis after caesarean section: four compared heparin with placebo; three compared LMWH with UFH; one compared hydroxyethyl starch (HES) with UFH; and one compared five-day versus 10-day LMWH. One study examined prophylaxis with UFH in the postnatal period (including following vaginal births).For antenatal prophylaxis, none of the included trials reported on maternal mortality, and no differences were detected for the other primary outcomes of symptomatic thromboembolic events, symptomatic pulmonary embolism (PE) and symptomatic deep venous thrombosis (DVT) when LMWH or UFH was compared with no treatment/placebo or when LMWH was compared with UFH. The risk ratios (RR) for symptomatic thromboembolic events were: antenatal LMWH/UFH versus no heparin, RR 0.33; 95% confidence interval (CI) 0.04 to 2.99 (two trials, 56 women); and antenatal LMWH versus UFH, RR 0.47; 95% CI 0.09 to 2.49 (four trials, 404 women). No differences were shown when antenatal LMWH or UFH was compared with no treatment/placebo for any secondary outcomes. Antenatal LMWH was associated with fewer adverse effects sufficient to stop treatment (RR 0.07; 95% CI 0.01 to 0.54; two trials, 226 women), and fewer fetal losses (RR 0.47; 95% CI 0.23 to 0.95; three trials, 343 women) when compared with UFH. In two trials, antenatal LMWH compared with UFH was associated with fewer bleeding episodes (defined in one trial of 121 women as bruises > 1 inch (RR 0.18, 95% CI 0.09 to 0.36); and in one trial of 105 women as injection site haematomas of ≥ 2 cm, bleeding during delivery or other bleeding (RR 0.28; 95% CI 0.15 to 0.53)), however in a further trial of 117 women no difference between groups was shown for bleeding at delivery. The results for these secondary outcomes should be interpreted with caution, being derived from small trials that were not of high methodological quality.For post-caesarean/postnatal prophylaxis, only one trial comparing five-day versus 10-day LMWH after caesarean section reported on maternal mortality, observing no deaths. No differences were seen across any of the comparisons for the other primary outcomes (symptomatic thromboembolic events, symptomatic PE and symptomatic DVT). The RRs for symptomatic thromboembolic events were: post-caesarean LMWH/UFH versus no heparin, RR 1.30; 95% CI 0.39 to 4.27 (four trials, 840 women); post-caesarean LMWH versus UFH, RR 0.33; 95% CI 0.01 to 7.99 (three trials, 217 women); post-caesarean five-day versus 10-day LMWH, RR 0.36; 95% CI 0.01 to 8.78 (one trial, 646 women); postnatal UFH versus no heparin, RR 0.16; 95% CI 0.02 to 1.36 (one trial, 210 women). For prophylaxis after caesarean section, in one trial (of 580 women), women receiving UFH and physiotherapy were more likely to have bleeding complications ('complications hémorragiques') than women receiving physiotherapy alone (RR 5.03; 95% CI 2.49 to 10.18). In two additional trials, that compared LMWH with placebo, no difference between groups in bleeding episodes (major bleeding; major bruising; bleeding/bruising reported at discharge) were detected. No other differences in secondary outcomes were shown when LMWH was compared with UFH post-caesarean, nor when post-caesarean HES was compared with UFH, post-caesarean five-day LMWH was compared with 10-day LMWH, or when UFH was compared to no heparin postnatally. AUTHORS' CONCLUSIONS: There is insufficient evidence on which to base recommendations for thromboprophylaxis during pregnancy and the early postnatal period, with the small number of differences detected in this review being largely derived from trials that were not of high methodological quality. Large scale, high-quality randomised trials of currently used interventions are warranted.

Parental and societal support for adolescent immunization through school based immunization programs.

OBJECTIVES: Adolescent immunizations such as human papillomavirus vaccine have been implemented through school based immunization programs (SBIPs) in Australia. We assessed community attitudes toward immunization of adolescents though SBIPs. METHODS: A cross-sectional population survey of rural and metropolitan households in South Australia in 2011. Univariate and multiple regression analyses identified predictors of support for a SBIP. RESULTS: Participation rate was 57.3% with 1926 adults interviewed. Overall, 75.9% regarded school as the best place to offer adolescent immunizations, with 16.4% preferring the family physician. Parents of high school students were most supportive (88.4%) of a SBIP with 87.9% of their adolescents reported as having participated in the program. Adults 18-34 years (79.4%) were more likely to support a SBIP compared to older adults (68.7% of >55 years) [adjusted OR=2.39, p=0.002] and men were more supportive (80.3%) than women (71.7%) [adjusted OR=1.54, p=0.003]. Reasons for participation in the SBIP included convenience (39.9%), public funding for the service (32.4%), and confidence in immunization recommendations (21.0%). CONCLUSIONS: Public support for the SBIP was very high particularly amongst parents whose adolescent/s had participated in the program.

Understanding the school community's response to school closures during the H1N1 2009 influenza pandemic.

BACKGROUND: During the 2009 H1N1 influenza pandemic, Australian public health officials closed schools as a strategy to mitigate the spread of the infection. This article examines school communities' understanding of, and participation in, school closures and the beliefs and values which underpinned school responses to the closures. METHODS: We interviewed four school principals, 25 staff, 14 parents and 13 students in five schools in one Australian city which were either fully or partially closed during the 2009 H1N1 pandemic. RESULTS: Drawing on Thompson et al's ethical framework for pandemic planning, we show that considerable variation existed between and within schools in their attention to ethical processes and values. In all schools, health officials and school leaders were strongly committed to providing high quality care for members of the school community. There was variation in the extent to which information was shared openly and transparently, the degree to which school community members considered themselves participants in decision-making, and the responsiveness of decision-makers to the changing situation. Reservations were expressed about the need for closures and quarantine and there was a lack of understanding of the rationale for the closures. All schools displayed a strong duty of care toward those in need, although school communities had a broader view of care than that of the public health officials. Similarly, there was a clear understanding of and commitment to protect the public from harm and to demonstrate responsible stewardship. CONCLUSIONS: We conclude that school closures during an influenza pandemic represent both a challenge for public health officials and a litmus test for the level of trust in public officials, government and the school as institution. In our study, trust was the foundation upon which effective responses to the school closure were built. Trust relations within the school were the basis on which different values and beliefs were used to develop and justify the practices and strategies in response to the pandemic.

Community knowledge, behaviours and attitudes about the 2009 H1N1 Influenza pandemic: a systematic review.

BACKGROUND: Effectiveness of pandemic plans and community compliance was extensively researched following the H1N1 pandemic. This systematic review examined community response studies to determine whether behavioural responses to the pandemic were related to level of knowledge about the pandemic, perceived severity of the pandemic and level of concern about the pandemic. METHODS: Literature databases were searched from March 2009 to August 2011 and included cross-sectional or repeated population surveys undertaken during or following the H1N1 pandemic which reported on community response to the pandemic. Studies using population subgroups and other respiratory diseases were excluded, as were mathematical modelling and qualitative studies. RESULTS: Nineteen unique studies were included. Fourteen reported pandemic knowledge, 14 reported levels of concern and risk perception and 18 reported pandemic behaviours. Awareness of the pandemic was high, and knowledge was moderate. Levels of concern and risk were low moderate and precautionary behavioural actions lower than intentions. The most commonly reported factors influencing adopting recommended behaviours were increased risk perception and older age, increased pandemic knowledge and being female. CONCLUSIONS: Important implications for future pandemic planning were identified. A remarkable lack of intercountry variability in responses existed; however, differences between populations within a single country suggest one-size-fits-all plans may be ineffective. Secondly, differences between reported precautionary intentions and preventive behaviours undertaken may be related to people's perceived risk of infection.

Factors associated with HPV vaccine uptake in teenage girls: a systematic review.

BACKGROUND: Since 2006 Human papillomavirus (HPV) vaccination has become available to adolescent girls and women in an increasing number of countries, to protect against the virus causing cervical cancer. The vaccine series is offered in three doses over 6 months, and this study aimed to identify factors associated with initiation and/or completion of the 3 dose series in (pre-) adolescent girls. Previous studies have considered intention to vaccinate rather than actual vaccination uptake. METHODS: A systematic search of Medline, Medline in process, Embase and CINAHL, from 2006 to March 2011 for articles related to HPV-vaccine uptake among adolescent girls and factors potentially associated with uptake yielded 25 studies. RESULTS: The majority of studies were surveys or retrospective reviews of data, only 5 studies reported data on program completion. Most were conducted in the United States (20/25). Higher vaccine uptake was associated with having health insurance, of older age, receipt of childhood vaccines, a higher vaccine related knowledge, more healthcare utilization, having a healthcare provider as a source of information and positive vaccine attitudes. In US settings, African American girls were less likely to have either initiated or completed the three dose vaccination series. CONCLUSIONS: HPV vaccination programs should focus on narrowing disparities in vaccine receipt in ethnic and racial groups and on providing correct information by a reliable source, e.g. healthcare providers. School-based vaccination programs have a high vaccine uptake. More studies are required to determine actual vaccine course completion and factors related to high uptake and completion, and information from a broader range of developed and developing settings is needed.

Awareness, anxiety, compliance: community perceptions and response to the threat and reality of an influenza pandemic.

This study compared community response prior to and during the H1N1 2009 influenza pandemic using a cross-sectional phone survey of rural and metropolitan South Australia, conducted in 2007 and 2009. Awareness of pandemic influenza was significantly higher and anxiety lower in 2009 than in 2007. Reported seasonal influenza vaccine uptake increased from 51.7% in 2007 to 61.4% in 2009, but there was more interest in receiving pandemic vaccine in 2007 (87.5%) than in 2009 (57%).

FORM: an Australian method for formulating and grading recommendations in evidence-based clinical guidelines.

BACKGROUND: Clinical practice guidelines are an important element of evidence-based practice. Considering an often complicated body of evidence can be problematic for guideline developers, who in the past may have resorted to using levels of evidence of individual studies as a quasi-indicator for the strength of a recommendation. This paper reports on the production and trial of a methodology and associated processes to assist Australian guideline developers in considering a body of evidence and grading the resulting guideline recommendations. METHODS: In recognition of the complexities of clinical guidelines and the multiple factors that influence choice in health care, a working group of experienced guideline consultants was formed under the auspices of the Australian National Health and Medical Research Council (NHMRC) to produce and pilot a framework to formulate and grade guideline recommendations. Consultation with national and international experts and extensive piloting informed the process. RESULTS: The FORM framework consists of five components (evidence base, consistency, clinical impact, generalisability and applicability) which are used by guideline developers to structure their decisions on how to convey the strength of a recommendation through wording and grading via a considered judgement form. In parallel (but separate from the grading process) guideline developers are asked to consider implementation implications for each recommendation. CONCLUSIONS: The framework has now been widely adopted by Australian guideline developers who find it to be a logical and intuitive way to formulate and grade recommendations in clinical practice guidelines.

Prophylaxis for venous thromboembolic disease in pregnancy and the early postnatal period.

BACKGROUND: Venous thromboembolic disease (TED), although rare, is a major cause of maternal mortality and morbidity, hence methods of prophylaxis are often used for women at risk. This may include women delivered by caesarean section, those with a personal or family history of TED and women with inherited or acquired thrombophilias (conditions that predispose people to thrombosis). Many methods of prophylaxis carry a risk of side effects, and as the risk of TED is low, it is possible that the benefits of thromboprophylaxis may be outweighed by harm. Current guidelines for clinical practice are based on expert opinion only, rather than high quality evidence from randomised trials. OBJECTIVES: To determine the effects of thromboprophylaxis in women who are pregnant or have recently delivered and are at increased risk of TED on the incidence of venous TED and side effects of treatment. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (May 2009). SELECTION CRITERIA: Randomised trials comparing one method of thromboprophylaxis with placebo or no treatment, and randomised trials comparing two (or more) methods of thromboprophylaxis. DATA COLLECTION AND ANALYSIS: Two review authors extracted data independently and resolved any discrepancies by discussion. MAIN RESULTS: Sixteen trials met the inclusion criteria but only 13 trials, involving 1774 women, examining a range of methods of thromboprophylaxis, contributed data for the outcomes of interest. Four of them compared methods of antenatal prophylaxis: low molecular weight heparin (LMWH) versus unfractionated heparin (UFH) (two studies), and heparin versus no treatment (two studies). Eight studies assessed postnatal prophylaxis after caesarean section; one compared hydroxyethyl starch with unfractionated heparin; four compared heparin with placebo; and the other three compared UFH with LMWH. One study examined prophylaxis in the postnatal period.The small number of statistically significant findings in this review are largely derived from trials which are not of high methodological quality. It was not possible to assess the effects of any of these interventions on most outcomes, and especially on rare outcomes such as death, TED and osteoporosis, because of small sample sizes and the small number of trials making the same comparisons.There was some evidence of side effects associated with thromboprophylaxis. AUTHORS' CONCLUSIONS: There is insufficient evidence on which to base recommendations for thromboprophylaxis during pregnancy and the early postnatal period. Large scale randomised trials of currently-used interventions should be conducted.

Extending an evidence hierarchy to include topics other than treatment: revising the Australian 'levels of evidence'.

BACKGROUND: In 1999 a four-level hierarchy of evidence was promoted by the National Health and Medical Research Council in Australia. The primary purpose of this hierarchy was to assist with clinical practice guideline development, although it was co-opted for use in systematic literature reviews and health technology assessments. In this hierarchy interventional study designs were ranked according to the likelihood that bias had been eliminated and thus it was not ideal to assess studies that addressed other types of clinical questions. This paper reports on the revision and extension of this evidence hierarchy to enable broader use within existing evidence assessment systems. METHODS: A working party identified and assessed empirical evidence, and used a commissioned review of existing evidence assessment schema, to support decision-making regarding revision of the hierarchy. The aim was to retain the existing evidence levels I-IV but increase their relevance for assessing the quality of individual diagnostic accuracy, prognostic, aetiologic and screening studies. Comprehensive public consultation was undertaken and the revised hierarchy was piloted by individual health technology assessment agencies and clinical practice guideline developers. After two and a half years, the hierarchy was again revised and commenced a further 18 month pilot period. RESULTS: A suitable framework was identified upon which to model the revision. Consistency was maintained in the hierarchy of "levels of evidence" across all types of clinical questions; empirical evidence was used to support the relationship between study design and ranking in the hierarchy wherever possible; and systematic reviews of lower level studies were themselves ascribed a ranking. The impact of ethics on the hierarchy of study designs was acknowledged in the framework, along with a consideration of how harms should be assessed. CONCLUSION: The revised evidence hierarchy is now widely used and provides a common standard against which to initially judge the likelihood of bias in individual studies evaluating interventional, diagnostic accuracy, prognostic, aetiologic or screening topics. Detailed quality appraisal of these individual studies, as well as grading of the body of evidence to answer each clinical, research or policy question, can then be undertaken as required.

A thematic analysis of factors influencing recruitment to maternal and perinatal trials.

BACKGROUND: Recruitment of eligible participants remains one of the biggest challenges to successful completion of randomised controlled trials (RCTs). Only one third of trials recruit on time, often requiring a lengthy extension to the recruitment period. We identified factors influencing recruitment success and potentially effective recruitment strategies. METHODS: We searched MEDLINE and EMBASE from 1966 to December Week 2, 2006, the Cochrane Library Methodology Register in December 2006, and hand searched reference lists for studies of any design which focused on recruitment to maternal/perinatal trials, or if no studies of maternal or perinatal research could be identified, other areas of healthcare. Studies of nurses' and midwives' attitudes to research were included as none specifically about trials were located. We synthesised the data narratively, using a basic thematic analysis, with themes derived from the literature and after discussion between the authors. RESULTS: Around half of the included papers (29/53) were specific to maternal and perinatal healthcare. Only one study was identified which focused on factors for maternal and perinatal clinicians and only seven studies considered recruitment strategies specific to perinatal research. Themes included: participant assessment of risk; recruitment process; participant understanding of research; patient characteristics; clinician attitudes to research and trials; protocol issues; and institutional or organisational issues. While no reliable evidence base for strategies to enhance recruitment was identified in any of the review studies, four maternal/perinatal primary studies suggest that specialised recruitment staff, mass mailings, physician referrals and strategies targeting minority women may increase recruitment. However these findings may only be applicable to the particular trials and settings studied. CONCLUSION: Although factors reported by both participants and clinicians which influence recruitment were quite consistent across the included studies, studies comparing different recruitment strategies were largely missing. Trials of different recruitment strategies could be embedded in large multicentre RCTs, with strategies tailored to the factors specific to the trial and institution.