Increasing value and reducing waste by optimizing the development of complex interventions: Enriching the development phase of the Medical Research Council (MRC) Framework

This is the final version of the article. Available from Elsevier via the DOI in this record.Background In recent years there has been much emphasis on ‘research waste’ caused by poor question selection, insufficient attention to previous research results, and avoidable weakness in research design, conduct and analysis. Little attention has been paid to the effect of inadequate development of interventions before proceeding to a full clinical trial. Objective We therefore propose to enrich the development phase of the MRC Framework by adding crucial elements to improve the likelihood of success and enhance the fit with clinical practice Methods Based on existing intervention development guidance and synthesis, a comprehensive iterative intervention development approach is proposed. Examples from published reports are presented to illustrate the methodology that can be applied within each element to enhance the intervention design. Results A comprehensive iterative approach is presented by combining the elements of the MRC Framework development phase with essential elements from existing guidance including: problem identification, the systematic identification of evidence, identification or development of theory, determination of needs, the examination of current practice and context, modelling the process and expected outcomes leading to final element: the intervention design. All elements are drawn from existing models to provide intervention developers with a greater chance of producing an intervention that is well adopted, effective and fitted to the context. Conclusion This comprehensive approach of developing interventions will strengthen the internal and external validity, minimize research waste and add value to health care research. In complex interventions in health care research, flaws in the development process immediately impact the chances of success. Knowledge regarding the causal mechanisms and interactions within the intended clinical context is needed to develop interventions that fit daily practice and are beneficial for the end-user

Storage of lyophilized cultures of Lactobacillus bulgaricus under different relative humidities and atmospheres

The viability of lyophilized cultures of Lactobacillus bulgaricus in skim milk, during storage at different temperatures, relative humidities, and atmospheres was investigated. Survival was greatest at 11% relative humidity and at 5°C. Indirect and direct evidence is presented supporting the hypothesis that membrane damage occurs during storage. Experiments on the lipid composition of the cell membrane demonstrate that changes occur with time that are probably the result of oxidation. A study on the lipid composition of the cell membrane by gas chromatography showed that the unsaturated/saturated fatty acid index changes with time during storage

Determinants of activation for self-management in patients with COPD

YJG Korpershoek,1–3 ID Bos-Touwen,2 JM de Man-van Ginkel,2,4 J-WJ Lammers,3 MJ Schuurmans,1,2 JCA Trappenburg2 1Research Group Chronic Illnesses, Faculty of Health Care, University of Applied Sciences Utrecht, 2Department of Rehabilitation, Nursing Science & Sports, University Medical Center Utrecht, 3Department of Respiratory Medicine, Division of Heart & Lungs, University Medical Center Utrecht, 4Nursing Science, Program in Clinical Health Science, University Medical Center Utrecht, Utrecht, the Netherlands Background: COPD self-management is a complex behavior influenced by many factors. Despite scientific evidence that better disease outcomes can be achieved by enhancing self-management, many COPD patients do not respond to self-management interventions. To move toward more effective self-management interventions, knowledge of characteristics associated with activation for self-management is needed. The purpose of this study was to identify key patient and disease characteristics of activation for self-management. Methods: An explorative cross-sectional study was conducted in primary and secondary care in patients with COPD. Data were collected through questionnaires and chart reviews. The main outcome was activation for self-management, measured with the 13-item Patient Activation Measure (PAM). Independent variables were sociodemographic variables, self-reported health status, depression, anxiety, illness perception, social support, disease severity, and comorbidities. Results: A total of 290 participants (age: 67.2±10.3; forced expiratory volume in 1 second predicted: 63.6±19.2) were eligible for analysis. While poor activation for self-management (PAM-1) was observed in 23% of the participants, only 15% was activated for self-management (PAM-4). Multiple linear regression analysis revealed six explanatory determinants of activation for self-management (P<0.2): anxiety (β: -0.35; -0.6 to -0.1), illness perception (β: -0.2; -0.3 to -0.1), body mass index (BMI) (β: -0.4; -0.7 to -0.2), age (β: -0.1; -0.3 to -0.01), Global Initiative for Chronic Obstructive Lung Disease stage (2 vs 1 β: -3.2; -5.8 to -0.5; 3 vs 1 β: -3.4; -7.1 to 0.3), and comorbidities (β: 0.8; -0.2 to 1.8), explaining 17% of the variance. Conclusion: This study showed that only a minority of COPD patients is activated for self-management. Although only a limited part of the variance could be explained, anxiety, illness perception, BMI, age, disease severity, and comorbidities were identified as key determinants of activation for self-management. This knowledge enables health care professionals to identify patients at risk of inadequate self-management, which is essential to move toward targeting and tailoring of self-management interventions. Future studies are needed to understand the complex causal mechanisms toward change in self-management. Keywords: COPD, self-management, patient activation, patient and disease characteristic