Activities to support the implementation of complex interventions as part of routine care: a review of the quality of reporting in cluster randomised controlled trials

Objective: To review a sample of cluster randomised controlled trials and explore the quality of reporting of (1) enabling or support activities provided to the staff during the trial, (2) strategies used to monitor fidelity throughout the trial and (3) the extent to which the intervention being tested was delivered as planned. Design: A descriptive review. Data sources and study selection: We searched MEDLINE for trial reports published between 2008 and 2014 with combinations of the search terms 'randomised', 'cluster', 'trial', 'study', 'intervention' and 'implement∗'. We included trials in which healthcare professionals (HCPs) implemented the intervention being tested as part of routine practice. We excluded trials (1) conducted in non-health services settings, (2) where the intervention explicitly aimed to change the behaviours of the HCPs and (3) where the trials were ongoing or for which only trial protocols were available. Data collection: We developed a data extraction form using the Template for Intervention Description and Replication (TIDieR checklist). Review authors independently extracted data from the included trials and assessed quality of reporting for individual items. Results: We included 70 publications (45 results publications, 25 related publications). 89% of trials reported using enabling or support activities. How these activities were provided (75.6%, n=34) and how much was provided (73.3%, n=33) were the most frequently reported items. Less than 20% (n=8) of the included trials reported that competency checking occurred prior to implementation and data collection. 64% (n=29) of trials reported collecting measures of implementation. 44% (n=20) of trials reported data from these measures. Conclusions: Although enabling and support activities are reported in trials, important gaps exist when assessed using an established checklist. Better reporting of the supports provided in effectiveness trials will allow for informed decisions to be made about financial and resource implications for wide scale implementation of effective interventions

An Informatics Approach to Interprofessional Management of Low Back Pain: A Feasibility Study using the Omaha System

Background: Low back pain (LBP) is a complex health care issue that often involves multiple providers across various care settings. Health information technology (HIT) holds promise to improve care delivery by providing infrastructure for communication, clinical documentation, and management of patient data. Standardized terminology is essential for interoperability and enables evaluation of clinical data generated by documentation in an electronic health record (EHR).Objective: The purpose of this study was to demonstrate the feasibility of mapping evidence-based practice for conservative management of low back pain to the Omaha System and foster inter-professional communication and collaboration among diverse practitioners and patients.Methods: Evidence-based practice (EBP) guidelines for non-invasive treatment of low back pain were mapped to the Omaha System using a clinical expert approach with attention to content feasibility, linguistic validity, and granularity of terms. Results: A clinical guideline for low back pain management was developed consisting of 13 interventions for Pain and Neuro-musculo-skeletal problems. The most common intervention categories were Case management followed by Treatments and procedures, Teaching, guidance, and counseling and Surveillance. Scope of practice overlap was identified between primary care, chiropractic, and physical therapy practice.Conclusion: Use of the guideline may facilitate clinical documentation using the Omaha System for low back pain management, and has potential to generate meaningful data to evaluate clinical effectiveness and promote quality research. The use of encoded EBP evidence within an EHR can increase use of available evidence, enable interprofessional communication, improve quality of care, and enhance usability of data across care settings

Investigating the effect of independent blinded digital image assessment on the STOP GAP trial

Background Blinding is the process of keeping treatment assignment hidden and is used to minimise the possibility of bias. Trials at high risk of bias have been shown to report larger treatment effects than low risk studies. In dermatology, one popular method of blinding is to have independent outcome assessors who are unaware of treatment allocation assessing the end point using digital photographs. However, this can be complex, expensive and time-consuming. The objective of this study was to compare the effect of blinded and unblinded outcome assessment on the results of the STOP GAP trial. Methods The STOP GAP trial compared prednisolone to ciclosporin in treating pyoderma gangrenosum. Participants’ lesions were measured at baseline and 6 weeks to calculate the primary outcome, speed of healing. Independent blinded assessors obtained measurements from digital photographs using specialist software. In addition, unblinded treating clinicians estimated lesion area by measuring length and width. The primary outcome was determined using blinded measurements where available, otherwise unblinded measurements were used (method referred to as trial measurements). In this study, agreement between the trial and unblinded measurements was determined using the intraclass correlation coefficient (ICC). The STOP GAP primary analysis was repeated using unblinded measurements only. We introduced differential and non-differential error in unblinded measurements and investigated the effect on the STOP GAP primary analysis. Results 86 (80%) of the 108 patients were assessed using digital images. Agreement between trial and unblinded measurements was excellent (ICC=0.92 at baseline; 0.83 at 6 weeks). There was no evidence that the results of the trial primary analysis differed according to how the primary outcome was assessed (p-value for homogeneity = 1.00). Conclusions Blinded digital image assessment in STOP GAP did not meaningfully alter trial conclusions compared with unblinded assessment. However, as the process brought added accuracy and credibility to the trial it was considered worthwhile. These findings question the usefulness of digital image assessment in a trial with an objective outcome and where bias is not expected to be excessive. Further research should investigate if there are alternative, less complex ways of incorporating blinding in clinical trials

Hydroxymethylglutaryl-CoA reductase inhibition with simvastatin in acute lung injury to reduce pulmonary dysfunction (HARP-2) trial : study protocol for a randomized controlled trial

Acute lung injury (ALI) is a common devastating clinical syndrome characterized by life-threatening respiratory failure requiring mechanical ventilation and multiple organ failure. There are in vitro, animal studies and pre-clinical data suggesting that statins may be beneficial in ALI. The Hydroxymethylglutaryl-CoA reductase inhibition with simvastatin in Acute lung injury to Reduce Pulmonary dysfunction (HARP-2) trial is a multicenter, prospective, randomized, allocation concealed, double-blind, placebo-controlled clinical trial which aims to test the hypothesis that treatment with simvastatin will improve clinical outcomes in patients with ALI

Developing standards for reporting implementation studies of complex interventions (StaRI): a systematic review and e-Delphi

This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited

PSS Users and Harley Davidson Riders: : The importance of consumer identity in the diffusion of sustainable consumption solutions

This is the peer-reviewed version of the following article: Catulli, M., Cook, M. and Potter, S. (2016), ‘Product Service Systems Users and Harley Davidson Riders: The Importance of Consumer Identity in the Diffusion of Sustainable Consumption Solutions’, Journal of Industrial Ecology, which has been published in final form at 10.1111/jiec.12518. Under embargo. Embargo end date: 2 December 2018. This article may be used for non-commercial purposes in accordance with Wiley Terms and Conditions for Self-Archiving. © 2016 by Yale UniversityThis paper sets out an approach to researching socio-cultural aspects of Product Service Systems (PSS) consumption in consumer markets. PSS are relevant to Industrial Ecology as they may form part of the mix of innovations that move society toward more sustainable material and energy flows. The paper uses two contrasting case studies drawing on ethnographic analysis, Harley Davidson motorcycles and Zip Car Car Club. The analysis draws on Consumer Culture Theory to explicate the socio-cultural, experiential, symbolic and ideological aspects of these case studies, focusing on product ownership. The paper shows that ownership of Harley Davidson motorcycles enables riders to identify with a brand community and to define themselves. Owners appropriate their motorcycles through customization. In contrast, Zip Car users resist the company’s attempts to involve them in a brand community, see use of car sharing as a temporary fix and even fear contamination from shared use of cars. We conclude that iconic products such as Harley Davidson motorcycles create emotional attachment and can challenge PSS propositions. But we also suggest that somewhat standardized products may present similar difficulties. Knowing more about socio-cultural aspects of PSS may help designers overcome these difficulties.Peer reviewedFinal Accepted Versio

Computational medicine, present and the future: obstetrics and gynecology perspective.

Medicine is, in its essence, decision making under uncertainty; the decisions are made about tests to be performed and treatments to be administered. Traditionally, the uncertainty in decision making was handled using expertise collected by individual providers and, more recently, systematic appraisal of research in the form of evidence-based medicine. The traditional approach has been used successfully in medicine for a very long time. However, it has substantial limitations because of the complexity of the system of the human body and healthcare. The complex systems are a network of highly coupled components intensely interacting with each other. These interactions give those systems redundancy and thus robustness to failure and, at the same time, equifinality, that is, many different causative pathways leading to the same outcome. The equifinality of the complex systems of the human body and healthcare system demand the individualization of medical care, medicine, and medical decision making. Computational models excel in modeling complex systems and, consequently, enabling individualization of medical decision making and medicine. Computational models are theory- or knowledge-based models, data-driven models, or models that combine both approaches. Data are essential, although to a different degree, for computational models to successfully represent complex systems. The individualized decision making, made possible by the computational modeling of complex systems, has the potential to revolutionize the entire spectrum of medicine from individual patient care to policymaking. This approach allows applying tests and treatments to individuals who receive a net benefit from them, for whom benefits outweigh the risk, rather than treating all individuals in a population because, on average, the population benefits. Thus, the computational modeling-enabled individualization of medical decision making has the potential to both improve health outcomes and decrease the costs of healthcare

Low-temperature specific heat and thermal conductivity of glycerol

We have measured the thermal conductivity of glassy glycerol between 1.5 K and 100 K, as well as the specific heat of both glassy and crystalline phases of glycerol between 0.5 K and 25 K. We discuss both low-temperature properties of this typical molecular glass in terms of the soft-potential model. Our finding of an excellent agreement between its predictions and experimental data for these two independent measurements constitutes a robust proof of the capabilities of the soft-potential model to account for the low-temperature properties of glasses in a wide temperature range.Comment: 4 pages, 3 figures. To be published in Phys. Rev. B (2002

Oral rehydration versus intravenous therapy for treating dehydration due to gastroenteritis in children: a meta-analysis of randomised controlled trials

BACKGROUND: Despite treatment recommendations from various organizations, oral rehydration therapy (ORT) continues to be underused, particularly by physicians in high-income countries. We conducted a systematic review of randomised controlled trials (RCTs) to compare ORT and intravenous therapy (IVT) for the treatment of dehydration secondary to acute gastroenteritis in children. METHODS: RCTs were identified through MEDLINE, EMBASE, CENTRAL, authors and references of included trials, pharmaceutical companies, and relevant organizations. Screening and inclusion were performed independently by two reviewers in order to identify randomised or quasi-randomised controlled trials comparing ORT and IVT in children with acute diarrhea and dehydration. Two reviewers independently assessed study quality using the Jadad scale and allocation concealment. Data were extracted by one reviewer and checked by a second. The primary outcome measure was failure of rehydration. We analyzed data using standard meta-analytic techniques. RESULTS: The quality of the 14 included trials ranged from 0 to 3 (Jadad score); allocation concealment was unclear in all but one study. Using a random effects model, there was no significant difference in treatment failures (risk difference [RD] 3%; 95% confidence intervals [CI]: 0, 6). The Mantel-Haenzsel fixed effects model gave a significant difference between treatment groups (RD 4%; 95% CI: 2, 5) favoring IVT. Based on the four studies that reported deaths, there were six in the IVT groups and two in ORT. There were no significant differences in total fluid intake at six and 24 hours, weight gain, duration of diarrhea, or hypo/hypernatremia. Length of stay was significantly shorter for the ORT group (weighted mean difference [WMD] -1.2 days; 95% CI: -2.4,-0.02). Phlebitis occurred significantly more often with IVT (number needed to treat [NNT] 33; 95% CI: 25,100); paralytic ileus occurred more often with ORT (NNT 33; 95% CI: 20,100). These results may not be generalizable to children with persistent vomiting. CONCLUSION: There were no clinically important differences between ORT and IVT in terms of efficacy and safety. For every 25 children (95% CI: 20, 50) treated with ORT, one would fail and require IVT. The results support existing practice guidelines recommending ORT as the first course of treatment in appropriate children with dehydration secondary to gastroenteritis