Tammy Hoffmann

Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide

Without a complete published description of interventions, clinicians and patients cannot reliably implement interventions that are shown to be useful, and other researchers cannot replicate or build on research findings. The quality of description of interventions in publications, however, is remarkably poor. To improve the completeness of reporting, and ultimately the replicability, of interventions, an international group of experts and stakeholders developed the Template for Intervention Description and Replication (TIDieR) checklist and guide. The process involved a literature review for relevant checklists and research, a Delphi survey of an international panel of experts to guide item selection, and a face to face panel meeting. The resultant 12 item TIDieR checklist (brief name, why, what (materials), what (procedure), who provided, how, where, when and how much, tailoring, modifications, how well (planned), how well (actual)) is an extension of the CONSORT 2010 statement (item 5) and the SPIRIT 2013 statement (item 11). While the emphasis of the checklist is on trials, the guidance is intended to apply across all evaluative study designs. This paper presents the TIDieR checklist and guide, with an explanation and elaboration for each item, and examples of good reporting. The TIDieR checklist and guide should improve the reporting of interventions and make it easier for authors to structure accounts of their interventions, reviewers and editors to assess the descriptions, and readers to use the information.

Poor description of non-pharmacological interventions: analysis of consecutive sample of randomised trials

Objectives To evaluate the completeness of descriptions of non-pharmacological interventions in randomised trials, identify which elements are most frequently missing, and assess whether authors can provide missing details. Design Analysis of consecutive sample of randomised trials of non-pharmacological interventions. Data sources and study selection All reports of randomised trials of non-pharmacological interventions published in 2009 in six leading general medical journals; 133 trial reports, with 137 interventions, met the inclusion criteria. Data collection Using an eight item checklist, two raters assessed the primary full trial report, plus any reference materials, appendices, or websites. Questions about missing details were emailed to corresponding authors, and relevant items were then reassessed. Results Of 137 interventions, only 53 (39%) were adequately described; this was increased to 81 (59%) by using 63 responses from 88 contacted authors. The most frequently missing item was the “intervention materials” (47% complete), but it also improved the most after author response (92% complete). Whereas some authors (27/70) provided materials or further information, other authors (21/70) could not; their reasons included copyright or intellectual property concerns, not having the materials or intervention details, or being unaware of their importance. Although 46 (34%) trial interventions had further information or materials readily available on a website, many were not mentioned in the report, were not freely accessible, or the URL was no longer functioning. Conclusions Missing essential information about interventions is a frequent, yet remediable, contributor to the worldwide waste in research funding. If trial reports do not have a sufficient description of interventions, other researchers cannot build on the findings, and clinicians and patients cannot reliably implement useful interventions. Improvement will require action by funders, researchers, and publishers, aided by long term repositories of materials linked to publications.

The Connection Between Evidence-Based Medicine and Shared Decision Making

Evidence-based medicine (EBM) and shared decision making (SDM) are both essential to quality health care, yet the interdependence between these 2 approaches is not generally appreciated. Evidence-based medicine should begin and end with the patient: after finding and appraising the evidence and integrating its inferences with their expertise, clinicians attempt a decision that reflects their patient’s values and circumstances. Incorporating patient values, preferences, and circumstances is probably the most difficult and poorly mapped step—yet it receives the least attention.1 This has led to a common criticism that EBM ignores patients’ values and preferences—explicitly not its intention.2 Shared decision making is the process of clinician and patient jointly participating in a health decision after discussing the options, the benefits and harms, and considering the patient’s values, preferences, and circumstances. It is the intersection of patient-centered communication skills and EBM, in the pinnacle of good patient care (Figure).

Designing effective written health education materials: Considerations for health professionals

Purpose: Written health education materials can only be effective if they can be read, understood, and remembered by patients. The purpose of this article was to review the literature about features that should be incorporated into written health education materials to maximize their effectiveness, identify where there is consensus and debate about which features should be incorporated, and develop recommendations that health professionals can use when reviewing their existing materials and designing new materials. Method: Literature review of published research and education articles. Results: There is a large number of features that need to be considered when designing written health education materials so that they are suitable for the target audience and effective. Although there is consensus about the majority of features that should be included, further research is needed to explore the contribution of certain features, such as illustrations, to the effectiveness of written materials and the effect of well-designed written materials on patient outcomes. Conclusions: Health professionals need to provide their patients with written health education materials that are patient-orientated and designed according to the best practice principles in written health education material design.

Patient Education to Prevent Falls Among Older Hospital Inpatients: A Randomized Controlled Trial

BACKGROUND Falls are a common adverse event during hospitalization of older adults, and few interventions have been shown to prevent them. METHODS This study was a 3-group randomized trial to evaluate the efficacy of 2 forms of multimedia patient education compared with usual care for the prevention of in-hospital falls. Older hospital patients (n = 1206) admitted to a mixture of acute (orthopedic, respiratory, and medical) and subacute (geriatric and neurorehabilitation) hospital wards at 2 Australian hospitals were recruited between January 2008 and April 2009. The interventions were a multimedia patient education program based on the health-belief model combined with trained health professional follow-up (complete program), multi-media patient education materials alone (materials only), and usual care (control). Falls data were collected by blinded research assistants by reviewing hospital incident reports, hand searching medical records, and conducting weekly patient interviews. RESULTS Rates of falls per 1000 patient-days did not differ significantly between groups (control, 9.27; materials only, 8.61; and complete program, 7.63). However, there was a significant interaction between the intervention and presence of cognitive impairment. Falls were less frequent among cognitively intact patients in the complete program group (4.01 per 1000 patient-days) than among cognitively intact patients in the materials-only group (8.18 per 1000 patient-days) (adjusted hazard ratio, 0.51; 95% confidence interval, 0.28-0.93]) and control group (8.72 per 1000 patient-days) (adjusted hazard ratio, 0.43; 95% confidence interval, 0.24-0.78). CONCLUSION Multimedia patient education with trained health professional follow-up reduced falls among patients with intact cognitive function admitted to a range of hospital wards. Trial Registration anzctr.org.au Identifier: ACTRN12608000015347.

Measuring falls events in acute hospitals - A comparison of three reporting methods to identify missing data in the hospital reporting system

OBJECTIVES: To compare three different methods of falls reporting and examine the characteristics of the data missing from the hospital incident reporting system.

Aphasia friendly written health information: Content and design characteristics

People with aphasia need communicatively accessible written health information. Healthcare providers require knowledge of how to develop printed education materials (PEMs) in formats that people with aphasia prefer and can read. This study aimed to explore formatting characteristics considered to be barriers and facilitators to reading PEMs. Semi-structured in-depth interviews were conducted with 40 adults with aphasia who were selected using maximum variation sampling across aphasia severity, reading ability, and time post-stroke. Participants were shown stroke and aphasia PEMs obtained from the recruiting stroke services, asked to rank them from most liked to least liked, and comment on factors that made the PEMs easier and harder to read. The majority of participants ranked the aphasia friendly stroke (56.4%, n = 22) and aphasia (87.2%, n = 34) PEMs as most liked. Forty-five facilitator and 46 barrier codes were identified using qualitative content analysis and grouped into two categories; (1) content characteristics and (2) design characteristics. Findings support many of the recommendations found within the literature for developing best practice PEMs and accessible information for other patient groups. Routine consideration of the facilitators and barriers identified will contribute to making written information more accessible to people with aphasia.

Moving rehabilitation research forward: Developing consensus statements for rehabilitation and recovery research

Stroke recovery is the next frontier in stroke medicine. While growth in rehabilitation and recovery research is exponential, a number of barriers hamper our ability to rapidly progress the field. Standardized terminology is absent in both animal and human research, methods are poorly described, recovery biomarkers are not well defined, and we lack consistent timeframes or measures to examine outcomes. Agreed methods and conventions for developing, monitoring, evaluating and reporting interventions directed at improving recovery are lacking, and current approaches are often not underpinned by biology. We urgently need to better understand the biology of recovery and its time course in both animals and humans to translate evidence from basic science into clinical trials. A new international partnership of stroke recovery and rehabilitation experts has committed to advancing the research agenda. In May 2016, the first Stroke Recovery and Rehabilitation Roundtable will be held, with the aim of achieving an agreed approach to the development, conduct and reporting of research. A range of methods will be used to achieve consensus in four priority areas: pre-clinical recovery research; biomarkers of recovery; intervention development, monitoring and reporting; and measurement in clinical trials. We hope to foster a global network of researchers committed to advancing this exciting field. Recovery from stroke is challenging for many survivors. They deserve effective treatments underpinned by our evolving understanding of brain recovery and human behaviour. Working together, we can develop game-changing interventions to improve recovery and quality of life in those living with stroke.

A systematic review of the public's knowledge and beliefs about antibiotic resistance.

OBJECTIVES The objective of this study was to systematically review quantitative and qualitative studies on the publics knowledge and beliefs about antibiotic resistance. METHODS We searched four databases to July 2014, with no language or study design restrictions. Two reviewers independently extracted data. We calculated the median (IQR) of the proportion of participants who agreed with each statement and synthesized qualitative data by identifying emergent themes. RESULTS Of 3537 articles screened, 54 studies (41 quantitative, 3 mixed methods and 10 qualitative) were included (55 225 participants). Most studied adults (50; 93% studies) and were conducted in Europe (23; 43%), Asia (14; 26%) or North America (12; 22%). Some participants [median 70% (IQR 50%-84%); n = 8 studies] had heard of antibiotic resistance, but most [median 88% (IQR 86%-89%); n = 2 studies] believed it referred to changes in the human body. Many believed excessive antibiotic use [median 70% (IQR 59%-77%); n = 11 studies] and not completing antibiotic courses [median 62% (IQR 47%-77%); n = 8 studies] caused resistance. Most participants nominated reducing antibiotic use [median 74% (IQR 72%-85%); n = 4 studies] and discussing antibiotic resistance with their clinician (84%, n = 1 study) as strategies to reduce resistance. Qualitative data supported these findings and additionally identified that: participants believed they were at low risk from antibiotic resistance participants; largely attributed its development to the actions of others; and strategies to minimize resistance should be primarily aimed at clinicians. CONCLUSIONS The public have an incomplete understanding of antibiotic resistance and misperceptions about it and its causes and do not believe they contribute to its development. These data can be used to inform interventions to change the publics beliefs about how they can contribute to tackling this global issue.

Evaluation of the Sustained Effect of Inpatient Falls Prevention Education and Predictors of Falls After Hospital Discharge—Follow-up to a Randomized Controlled Trial

BACKGROUND This study aimed to determine (i) risk factors for postdischarge falls and (ii) the effect of inpatient falls prevention education on rates of falls after discharge. METHODS Participants (n = 343) were a prospective cohort nested within a randomized controlled trial (n = 1,206) of falls prevention patient education in hospital compared with usual care. Participants were followed up for 6 months after discharge and falls recorded via a falls diary and monthly telephone calls. Potential falls risk factors were assessed at point of discharge and at 6 months postdischarge using a telephone survey. RESULTS There were 276 falls among 138 (40.2%) participants in the 6 months following discharge (4.52/1,000 person days) of which 150 were injurious falls (2.46/1,000 person days). Pairwise comparisons found no significant differences between groups in rates of falls after adjustment for confounding variables. Independent risk factors for all falls outcomes were male gender, history of falls prior to hospital admission, fall during hospital admission, depressed mood at discharge, using a walking aid at discharge, and receiving assistance with activities of daily living at 6 months following discharge. Receiving assistance with activities of daily living significantly reduced the risk of falls and injurious falls for high risk patients. CONCLUSIONS Older patients are at increased risk of falls and falls injuries following discharge. Education that effectively reduced inpatient falls appears to have no ongoing protective effect after discharge. Independent risk factors for falls in this population differ from both hospital and general community settings.