Cascade diagrams for depicting complex interventions in randomised trials

Clarity about how trial interventions are delivered is important for researchers and those who might want to use their results. A new graphical representation aims to help make complex interventions clearer. Many medical interventions—particularly non-pharmacological ones—are complex, consisting of multiple interacting components targeted at different organisational levels. Published descriptions of complex interventions often do not contain enough detail to enable their replication. Reports of behaviour change interventions should include descriptions of setting, mode, intensity, and duration, and characteristics of the participants. Graphical methods, such as that showing the relative timing of assessments and intervention components, may improve clarity of reporting. However, these approaches do not reveal the connections between the different “actors” in a complex intervention.8 Different audiences may want different things from a description of an intervention, but visualising relationships between actors can clarify crucial features such as the fidelity with which the intervention is passed down a chain of actors and possible routes of contamination between treatment arms. Here we describe a new graphical approach—the cascade diagram—that highlights these potential problems

Obstacles to returning to work with chronic pain : in-depth interviews with people who are off work due to chronic pain and employers

Background: The global burden of chronic pain is growing with implications for both an ageing workforce and employers. Many obstacles are faced by people with chronic pain in finding employment and returning to work after a period of absence. Few studies have explored obstacles to return-to-work (RTW) from workers’ and employers’ perspectives. Here we explore views of both people in pain and employers about challenges to returning to work of people who are off work with chronic pain. Methods: We did individual semi-structured interviews with people who were off work (unemployed or off sick) with chronic pain recruited from National Health Service (NHS) pain services and employment services, and employers from small, medium, and large public or private sector organisations. We analysed data using the Framework method. Results: We interviewed 15 people off work with chronic pain and 10 employers. Obstacles to RTW for people with chronic pain spanned psychological, pain related, financial and economic, educational, and work-related domains. Employers were concerned about potential attitudinal obstacles, absence, ability of people with chronic pain to fulfil the job requirements, and the implications for workplace relationships. Views on disclosure of the pain condition were conflicting with more than half employers wanting early full disclosure and two-thirds of people with chronic pain declaring they would not disclose for fear of not getting a job or losing a job. Both employers and people with chronic pain thought that lack of confidence was an important obstacle. Changes to the job or work conditions (e.g. making reasonable adjustments, phased return, working from home or redeployment) were seen by both groups as facilitators. People with chronic pain wanted help in preparing to RTW, education for managers about pain and supportive working relationships. Conclusions: People with chronic pain and employers may think differently in terms of perceptions of obstacles to RTW. Views appeared disparate in relation to disclosure of pain and when this needs to occur. They appeared to have more in common regarding opinions about how to facilitate successful RTW. Increased understanding of both perspectives may be used to inform the development of improved RTW interventions

Research ethics oversight in Norway : structure, function, and challenges

Background While the development and evaluation of clinical ethics services in Norway has been recognized internationally, the country’s research ethics infrastructure at times may have been less well developed. In 2016, media interest in the controversial nature of some health services research and pilot studies highlighted gaps in the system with certain types of research having no clear mechanisms through which they may be given due independent consideration. It is not clear that new legislation, implemented in 2017, will address this problem. Summary We explore relevant law, committee scope, and the function of the system. We show that 1) Norwegian law provides for ethics assessment for all forms of health research; 2) regional RECs in Norway might not have always enforced this provision, considering some interventional health services research to be outside their remit; and 3) Norwegian law does not explicity provide for local/university RECs, meaning that, in practice, there may be no readily accessible mechanisms for the assessment of research that is excluded by regional RECs. This may include health services research, pilot studies, and undergraduate research. New 2017 legislation has no effect on this specifically but focuses on institutions regulating researcher activity. This may place researchers in the difficult situation of on one hand, needing to hold to recognized ethical standards, while on the other, not readily having access to independent committee scrutiny to facilitate consistent operation with these standards. Conclusion To support researchers in Norway and to protect the public, it may be necessary either to widen the regional RECs’ remit or to make legislative alterations that permit and do not discourage the existence of local RECs

The work of return to work. Challenges of returning to work when you have chronic pain : a meta-ethnography

Aims To understand obstacles to returning to work, as perceived by people with chronic non-malignant pain and as perceived by employers, and to develop a conceptual model. Design Synthesis of qualitative research using meta-ethnography. Data sources Eleven bibliographic databases from inception to April 2017 supplemented by citation tracking. Review methods We used the methods of meta-ethnography. We identified concepts and conceptual categories, and developed a conceptual model and line of argument. Results We included 41 studies. We identified three core categories in the conceptual model: managing pain, managing work relationships and making workplace adjustments. All were influenced by societal expectations in relation to work, self (self-belief, self-efficacy, legitimacy, autonomy and the meaning of work for the individual), health/illness/pain representations, prereturn to work support and rehabilitation, and system factors (healthcare, workplace and social security). A mismatch of expectations between the individual with pain and the workplace contributed to a feeling of being judged and difficulties asking for help. The ability to navigate obstacles and negotiate change underpinned mastering return to work despite the pain. Where this ability was not apparent, there could be a downward spiral resulting in not working. Conclusions For people with chronic pain, and for their employers, navigating obstacles to return to work entails balancing the needs of (1) the person with chronic pain, (2) work colleagues and (3) the employing organisation. Managing pain, managing work relationships and making workplace adjustments appear to be central, but not straightforward, and require substantial effort to culminate in a successful return to work

Racionalidad y valores éticos en las ciencias y la tecnología

Not available.En este artículo se critica la concepción según la cual la tecnología está libre de valores y que en sí misma no plantea problemas éticos. Frente a ella, se defiende la concepción de acuerdo con la cual las personas y los fines que ellas persiguen intencionalmente forman parte de los sistemas técnicos mismos, al igual que los conocimientos y creencias que se ponen en juego al operar esos sistemas; y, por tanto, la tecnología ya no puede concebirse como indiferente al bien y al mal. Se analiza, además, el problema que afrontaron los científicos Mario Molina y Sherwood Rowland —Premios Nobel de Química 1995— en sus estudios sobre el agujero de la capa de ozono en la atmósfera terrestre, para ilustrar, por un lado, que es factible actuar de manera responsable en una situación en la que un sistema técnico está produciendo daños, aun cuando no exista evidencia contundente para aceptar una relación causal entre la operación del sistema y los daños en cuestión; y, por otro lado, que hay situaciones en las que los científicos y los tecnólogos tienen responsabilidades morales qua científicos y tecnólogos. El artículo concluye con una revisión de los deberes para los científicos y tecnólogos, para el Estado y las instituciones de educación e investigación, así como para los ciudadanos en general, con respecto a ciertos problemas éticos que plantea la tecnología

Preferred reporting items for studies mapping onto preference-based outcome measures: The MAPS statement

'Mapping' onto generic preference-based outcome measures is increasingly being used as a means of generating health utilities for use within health economic evaluations. Despite publication of technical guides for the conduct of mapping research, guidance for the reporting of mapping studies is currently lacking. The MAPS (MApping onto Preference-based measures reporting Standards) statement is a new checklist, which aims to promote complete and transparent reporting of mapping studies. The primary audiences for the MAPS statement are researchers reporting mapping studies, the funders of the research, and peer reviewers and editors involved in assessing mapping studies for publication. A de novo list of 29 candidate reporting items and accompanying explanations was created by a working group comprised of six health economists and one Delphi methodologist. Following a two-round, modified Delphi survey with representatives from academia, consultancy, health technology assessment agencies and the biomedical journal editorial community, a final set of 23 items deemed essential for transparent reporting, and accompanying explanations, was developed. The items are contained in a user friendly 23 item checklist. They are presented numerically and categorised within six sections, namely: (i) title and abstract; (ii) introduction; (iii) methods; (iv) results; (v) discussion; and (vi) other. The MAPS statement is best applied in conjunction with the accompanying MAPS explanation and elaboration document. It is anticipated that the MAPS statement will improve the clarity, transparency and completeness of reporting of mapping studies. To facilitate dissemination and uptake, the MAPS statement is being co-published by eight health economics and quality of life journals, and broader endorsement is encouraged. The MAPS working group plans to assess the need for an update of the reporting checklist in five years' time. This statement was published jointly in Applied Health Economics and Health Policy, Health and Quality of Life Outcomes, International Journal of Technology Assessment in Health Care, Journal of Medical Economics, Medical Decision Making, PharmacoEconomics, and Quality of Life Research

Workers no longer welcome? Europeanization of solidarity in the wake of Brexit (Discussion Forum. Brexit: understanding the socio-economic origins and consequences)

Peer reviewe

Methodological criteria for the assessment of moderators in systematic reviews of randomised controlled trials : a consensus study

Background: Current methodological guidelines provide advice about the assessment of sub-group analysis within RCTs, but do not specify explicit criteria for assessment. Our objective was to provide researchers with a set of criteria that will facilitate the grading of evidence for moderators, in systematic reviews. Method: We developed a set of criteria from methodological manuscripts (n = 18) using snowballing technique, and electronic database searches. Criteria were reviewed by an international Delphi panel (n = 21), comprising authors who have published methodological papers in this area, and researchers who have been active in the study of sub-group analysis in RCTs. We used the Research ANd Development/University of California Los Angeles appropriateness method to assess consensus on the quantitative data. Free responses were coded for consensus and disagreement. In a subsequent round additional criteria were extracted from the Cochrane Reviewers’ Handbook, and the process was repeated. Results: The recommendations are that meta-analysts report both confirmatory and exploratory findings for subgroups analysis. Confirmatory findings must only come from studies in which a specific theory/evidence based apriori statement is made. Exploratory findings may be used to inform future/subsequent trials. However, for inclusion in the meta-analysis of moderators, the following additional criteria should be applied to each study: Baseline factors should be measured prior to randomisation, measurement of baseline factors should be of adequate reliability and validity, and a specific test of the interaction between baseline factors and interventions must be presented. Conclusions: There is consensus from a group of 21 international experts that methodological criteria to assess moderators within systematic reviews of RCTs is both timely and necessary. The consensus from the experts resulted in five criteria divided into two groups when synthesising evidence: confirmatory findings to support hypotheses about moderators and exploratory findings to inform future research. These recommendations are discussed in reference to previous recommendations for evaluating and reporting moderator studies

Relative performance of machine learning and linear regression in predicting quality of life and academic performance of school children in Norway : data analysis of a quasi-experimental study

Background: Machine learning (ML) approaches are increasingly being used in health research. It is not clear how useful these approaches are for modelling continuous health outcomes. Child quality of life (QoL) is associated with parental socioeconomic status and child activity levels, and may be associated with aerobic fitness and strength. It is not clear whether diet, or academic performance (AP) is associated with QoL. Objective: To compare predictive performances of ML approaches with linear regression for modelling QoL and AP using parental education and lifestyle data. Methods: We modelled data from children attending nine schools in a quasi-experimental study (NCT02495714). We split data randomly into training and validation sets, and simulated curvilinear, non-linear, and heteroscedastic variables. We examined relative performance of ML approaches using R2, making comparisons to mixed and fixed models, and regression with splines, with and without imputation. We also examined the effect of training set size on overfitting. Results: We had 1,711 cases. Using real data, our regression models explained 24% of AP variance in the complete-case validation set, and up to 15% of QoL variance. While ML models explained high proportions of variance in training sets, in validation sets these explained ~0% of AP and between 3% and 8% of QoL. Following imputation, ML models improved up to 15% for AP. ML models outperformed regression for modelling simulated non-linear and heteroscedastic variables only. A smaller training set did not lead to increased overfitting. The best predictors of QoL were 7-point self-reported activity (P<.001; ß=1.09 (95% CI 0.53 to 1.66)) and TV/computer use (P=.002; ß=-0.95 (-1.55 to -0.36)). For AP, these were mother having master’s-level education (P<.001; ß=1.98 (0.25 to 3.71)) and dichotomised self-reported activity (P=.001; ß=2.47 (1.08 to 3.87)). Adjusted academic performance was associated with QoL (P=.02; ß=0.12 (0.02 to 0.22)). Conclusions: Exercising to cause sweat once per week and 2 hours per day of TV or computer use are associated with small-to-medium increases and decreases in child QoL, respectively. An increase in AP of 20 units is associated with a small increase in QoL. A mother having higher and master’s-level education, 2 hours per day of TV or computer use, and taking at least 2 hours of exercise, are each associated with small-to-medium increases in AP. Differences between effects of computer/TV use for work/leisure needs further investigation. Linear regression is less prone to overfitting and performs better than ML in predicting continuous health outcomes in a dataset containing missing data. Imputation improves ML performance but not enough to outperform regression. ML outperformed regression with non-linear and heteroscedastic data and may be of use when such relationships exist, and where imputation is sensible or there are no missing data. Clinical Trial: The data are from a quasi-experimental design and not an RCT but nevertheless the study from which the data are from does have a registration: NCT0249571