Project description:BackgroundRecruiting participants to clinical trials is an ongoing challenge, and relatively little is known about what recruitment strategies lead to better recruitment. Recruitment interventions can be considered complex interventions, often involving multiple components, targeting a variety of groups, and tailoring to different groups. We used the Template for Intervention Description and Replication (TIDieR) reporting checklist (which comprises 12 items recommended for reporting complex interventions) to guide the assessment of how recruitment interventions are described. We aimed to (1) examine to what extent we could identify information about each TIDieR item within recruitment intervention studies, and (2) observe additional detail for each item to describe useful variation among these studies.MethodsWe identified randomized, nested recruitment intervention studies providing recruitment or willingness to participate rates from two sources: a Cochrane review of trials evaluating strategies to improve recruitment to randomized trials, and the Online Resource for Research in Clinical triAls database. First, we assessed to what extent authors reported information about each TIDieR item. Second, we developed descriptive categorical variables for 7 TIDieR items and extracting relevant quotes for the other 5 items.ResultsWe assessed 122 recruitment intervention studies. We were able to extract information relevant to most TIDieR items (e.g., brief rationale, materials, procedure) with the exception of a few items that were only rarely reported (e.g., tailoring, modifications, planned/actual fidelity). The descriptive variables provided a useful overview of study characteristics, with most studies using various forms of informational interventions (55%) delivered at a single time point (90%), often by a member of the research team (59%) in a clinical care setting (41%).ConclusionsOur TIDieR-based variables provide a useful description of the core elements of complex trial recruitment interventions. Recruitment intervention studies report core elements of complex interventions variably; some process elements (e.g., mode of delivery, location) are almost always described, while others (e.g., duration, fidelity) are reported infrequently, with little indication of a reason for their absence. Future research should explore whether these TIDieR-based variables can form the basis of an approach to better reporting of elements of successful recruitment interventions.

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:BackgroundWhile 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.MethodsThis 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.ResultsA 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.ConclusionsMuch 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:INTRODUCTION:There is evidence that the use of some reporting guidelines, such as the Consolidated Standards for Reporting Trials, is associated with improved completeness of reporting in health research. However, the current levels of adherence to reporting guidelines are suboptimal. Over the last few years, several actions aiming to improve compliance with reporting guidelines have been taken and proposed. We will conduct a scoping review of interventions to improve adherence to reporting guidelines in health research that have been evaluated or suggested, in order to inform future interventions. METHODS AND ANALYSIS:Our review will follow the Joanna Briggs Institute scoping review methods manual. We will search for relevant studies in MEDLINE, EMBASE and Cochrane Library databases. Moreover, we will carry out lateral searches from the reference lists of the included studies, as well as from the lists of articles citing the included ones. One reviewer will screen the full list, which will be randomly split into two halves and independently screened by the other two reviewers. Two reviewers will perform data extraction independently. Discrepancies will be solved through discussion. In addition, this search strategy will be supplemented by a grey literature search. The interventions found will be classified as assessed or suggested, as well as according to different criteria, in relation to their target (journal policies, journal editors, authors, reviewers, funders, ethical boards or others) or the research stage at which they are performed (design, conducting, reporting or peer review). Descriptive statistical analysis will be performed. ETHICS AND DISSEMINATION:A paper summarising the findings from this review will be published in a peer-reviewed journal. This scoping review will contribute to a better understanding and a broader perspective on how the problem of adhering better to reporting guidelines has been tackled so far. This could be a major first step towards developing future strategies to improve compliance with reporting guidelines in health research.

Dataset Information

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

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