Project description:BackgroundPlacebo or sham controls are the standard against which the benefits and harms of many active interventions are measured. Whilst the components and the method of their delivery have been shown to affect study outcomes, placebo and sham controls are rarely reported and often not matched to those of the active comparator. This can influence how beneficial or harmful the active intervention appears to be. Without adequate descriptions of placebo or sham controls, it is difficult to interpret results about the benefits and harms of active interventions within placebo-controlled trials. To overcome this problem, we developed a checklist and guide for reporting placebo or sham interventions.Methods and findingsWe developed an initial list of items for the checklist by surveying experts in placebo research (n = 14). Because of the diverse contexts in which placebo or sham treatments are used in clinical research, we consulted experts in trials of drugs, surgery, physiotherapy, acupuncture, and psychological interventions. We then used a multistage online Delphi process with 53 participants to determine which items were deemed to be essential. We next convened a group of experts and stakeholders (n = 16). Our main output was a modification of the existing Template for Intervention Description and Replication (TIDieR) checklist; this allows the key features of both active interventions and placebo or sham controls to be concisely summarised by researchers. The main differences between TIDieR-Placebo and the original TIDieR are the explicit requirement to describe the setting (i.e., features of the physical environment that go beyond geographic location), the need to report whether blinding was successful (when this was measured), and the need to present the description of placebo components alongside those of the active comparator.ConclusionsWe encourage TIDieR-Placebo to be used alongside TIDieR to assist the reporting of placebo or sham components and the trials in which they are used.

Project description:BACKGROUND:While known efficacious preventive health interventions exist, the current capacity to scale up these interventions is limited. In recent years, much attention has focussed on developing frameworks and methods for scale-up yet, in practice, the pathway for scale-up is seldom linear and may be highly dependent on contextual circumstances. Few studies have examined the process of scaling up from decision to implementation nor examined the sustainability of scaled-up interventions. This study explores decision-makers' perceptions from real-world scaled-up case studies to examine how scale-up decisions were made and describe enablers of successful scale-up and sustainability. METHODS:This qualitative study included 29 interviews conducted with purposively sampled key Australian policy-makers, practitioners and researchers experienced in scale-up. Semi-structured interview questions obtained information regarding case studies of scaled-up interventions. The Framework Analysis method was used as the primary method of analysis of the interview data to inductively generate common and divergent themes within qualitative data across cases. RESULTS:A total of 31 case studies of public health interventions were described by interview respondents based on their experiences. According to the interviewees' perceptions, decisions to scale up commonly occurred either opportunistically, when funding became available, or when a deliberate decision was made and funding allocated. The latter scenario was more common when the intervention aligned with specific political or strategic goals. Decisions to scale up were driven by a variety of key actors such as politicians, senior policy-makers and practitioners in the health system. Drivers of a successful scale-up process included good governance, clear leadership, and adequate resourcing and expertise. Establishing accountability structures and appropriate engagement mechanisms to encourage the uptake of interventions were also key enablers. Sustainability was influenced by evidence of impact as well as good acceptability among the general or target population. CONCLUSIONS:Much like Kingdon's Multiple Streams Theory of 'policy windows', there is a conceptually similar 'window for scale-up', driven by a complex interplay of factors such as political need, strategic context, funding and key actors. Researchers and policy-makers need to consider scalability from the outset and prepare for when the window for scale-up opens. Decision-makers need to provide longer term funding for scale-up to facilitate longer term sustainability and build on the resources already invested for the scale-up process.

Project description:BackgroundThe Guidelines International Network (G-I-N) aims to promote high quality clinical guideline development and implementation. Guideline-based performance measures are a key implementation tool and are widely used internationally for quality improvement, quality assurance, and pay for performance in health care. There is, however, no international consensus on best methods for guideline-based performance measures. In order to address this issue, the G-I-N Performance Measures Working Group aimed to develop a set of consensus-based reporting standards for guideline-based performance measure development and re-evaluation.MethodsMethodology publications on guideline-based performance measures were identified from a systematic literature review and analyzed. Core criteria for the development and evaluation process of guideline-based performance measures were determined and refined into draft standards with an associated rationale and description of the evidence base. In a two-round Delphi-process, the group members appraised and approved the draft standards. After the first round, the group met to discuss comments and revised the drafts accordingly.ResultsTwenty-one methodology publications were reviewed. The group reached strong consensus on nine reporting standards concerning: (1) selection of clinical guidelines, (2) extraction of clinical guideline recommendations, (3) description of the measure development process, (4) measure appraisal, (5) measure specification, (6) description of the intended use of the measure, (7) measure testing/validating, (8) measure review/re-evaluation, and (9) composition of the measure development panel.ConclusionsThese proposed international reporting standards address core components of guideline-based performance measure development and re-evaluation. They are intended to contribute to international reporting harmonization and improvement of methods for performance measures. Further research is required regarding validity, acceptability, and practicality.

Project description:BACKGROUND:Studies have persistently shown deficiencies in medical reporting by the mainstream media. We have been monitoring the accuracy and comprehensiveness of medical news reporting in Australia since mid 2004. This analysis of more than 1200 stories in the Australian media compares different types of media outlets and examines reporting trends over time. METHODS AND FINDINGS:Between March 2004 and June 2008 1230 news stories were rated on a national medical news monitoring web site, Media Doctor Australia. These covered a variety of health interventions ranging from drugs, diagnostic tests and surgery to dietary and complementary therapies. Each story was independently assessed by two reviewers using ten criteria. Scores were expressed as percentages of total assessable items deemed satisfactory according to a coding guide. Analysis of variance was used to compare mean scores and Fishers exact test to compare proportions. Trends over time were analysed using un-weighted linear regression analysis. Broadsheet newspapers had the highest average satisfactory scores: 58% (95% CI 56-60%), compared with tabloid newspapers and online news outlets, 48% (95% CI 44-52) and 48% (95% CI 46-50) respectively. The lowest scores were assigned to stories broadcast by human interest/current affairs television programmes (average score 33% (95% CI 28-38)). While there was a non- significant increase in average scores for all outlets, a significant improvement was seen in the online news media: a rise of 5.1% (95%CI 1.32, 8.97; P 0.009). Statistically significant improvements were seen in coverage of the potential harms of interventions, the availability of treatment or diagnostic options, and accurate quantification of benefits. CONCLUSION:Although the overall quality of medical reporting in the general media remains poor, this study showed modest improvements in some areas. However, the most striking finding was the continuing very poor coverage of health news by commercial current affairs television programs.

Project description:BackgroundThe use of health policy and systems research (HPSR) to inform health policy-making is an international challenge. Incorporating HPSR into decision-making primarily involves two groups, namely researchers (knowledge producers) and policy-makers (knowledge users). The purpose of this study was to compare the perceptions of Israeli health systems and policy researchers and health services policy-makers regarding the role of HPSR, factors influencing its uses and potential facilitators and barriers to HPSR, and implementation of knowledge transfer and exchange (KTE) activities.MethodsA cross-sectional survey was administered to researchers and policy-makers in Israel. The survey consisted of seven closed questions. Descriptive analyses were carried out for closed-ended questions and comparative analysis were conducted between groups using the ?2 test.ResultsA total of 37 researchers and 32 policy-makers responded to the survey. While some views were in alignment, others showed differences. More policy-makers than researchers perceived that the use of HPSR in policy was hindered by practical implementation constraints, whereas more researchers felt that its use was hindered by a lack of coordination between knowledge producers and users. A larger percentage of policy-makers, as compared to researchers, reported that facilitators to the KTE process are in place and a larger percentage of researchers perceived barriers within the KTE environment. A larger percentage of policy-makers perceived KTE activities were in place as compared to researchers. Results also showed large differences in the perceptions of the two groups regarding policy formulation and which organisations they perceived as exerting strong influence on policy-making.ConclusionsThis research demonstrated that there are differences in the perceptions of knowledge producers and users about the process of KTE. Future work should focus on minimising the challenges highlighted here and implementing new KTE activities. These activities could include making the researchers aware of the most effective manner in which to package their results, providing training to policy-makers and assuring that policy-makers have technical access to appropriate databases to search for HPSR. These results underscore the need for the groups to communicate and clarify to each other what they can offer and what they require.

Project description:BackgroundLegislation is one of the most powerful weapons for improving population health and is often used by policy and decision makers. Little research exists to guide them as to whether legislation is feasible and/or will succeed. We aimed to produce a coherent and transferable evidence based framework of threats to legislative interventions to assist the decision making process and to test this through the 'case study' of legislation to ban smoking in cars carrying children.MethodsWe conceptualised legislative interventions as a complex social interventions and so used the realist synthesis method to systematically review the literature for evidence. 99 articles were found through searches on five electronic databases (MEDLINE, HMIC, EMBASE, PsychINFO, Social Policy and Practice) and iterative purposive searching. Our initial searches sought any studies that contained information on smoking in vehicles carrying children. Throughout the review we continued where needed to search for additional studies of any type that would conceptually contribute to helping build and/or test our framework.ResultsOur framework identified a series of transferable threats to public health legislation. When applied to smoking bans in vehicles; problem misidentification; public support; opposition; and enforcement issues were particularly prominent threats. Our framework enabled us to understand and explain the nature of each threat and to infer the most likely outcome if such legislation were to be proposed in a jurisdiction where no such ban existed. Specifically, the micro-environment of a vehicle can contain highly hazardous levels of second hand smoke. Public support for such legislation is high amongst smokers and non-smokers and their underlying motivations were very similar - wanting to practice the Millian principle of protecting children from harm. Evidence indicated that the tobacco industry was not likely to oppose legislation and arguments that such a law would be 'unenforceable' were unfounded.ConclusionIt is possible to develop a coherent and transferable evidence based framework of the ideas and assumptions behind the threats to legislative intervention that may assist policy and decision makers to analyse and judge if legislation is feasible and/or likely to succeed.

Dataset Information

TIDieR-PHP: a reporting guideline for population health and policy interventions.

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