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Background The Schedule for the Evaluation of Individual Quality of Life-Direct Weighting (SEIQoL-DW) is a prevalent face-to-face interview method for measuring quality of life by integrating respondent-generated dimensions. To apply this method in clinical trials, a paper-administered alternative would be of interest. Therefore, our study aimed to analyze the agreement between the SEIQoL-DW and a paper questionnaire version (SEIQoL-PF/G). Methods In a crossover design, both measures were completed in a random sequence. 104 patients at a heart surgery hospital in Germany were randomly assigned to receive either the SEIQoL-DW or the SEIQoL-PF/G as the first measurement in the sequence. Patients were approached on their earliest stable day after surgery. The average time between both measurements was 1 day (mean 1.3; SD 0.8). Agreement regarding the indices, ratings, and weightings of nominated life areas (cues) was explored using Bland-Altman plots with 95% limits of agreement (LoA). Agreement of the SEIQoL indices was defined as acceptable if the LoA did not exceed a threshold of 10 scale points. Data from n = 99 patients were included in the agreement analysis. Results Both measures led to similarly nominated cues. The most frequently nominated cues were “physical health” and “family”. In the Bland-Altman plot, the indices showed a mean of differences of 2 points (95% CI, − 1 to 6). The upper LoA showed a difference of 36 points (95% CI, 30 to 42), and the lower LoA showed a difference of − 31 points (95% CI, − 37 to − 26). Thus, the LoAs and confidence intervals exceeded the predefined threshold. The Bland-Altman plots for the cue levels and cue weights showed similar results. The SEIQoL-PF/G version showed a tendency for equal weighting of cues, while the weighting procedure of the SEIQoL-DW led to greater variability. Conclusions For cardiac surgery patients, use of the current version of the SEIQoL-PF/G as a substitute for the SEIQoL-DW is not recommended. The current questionnaire weighting method seems to be unable to distinguish weighting for different cues. Therefore, the further design of a weighting method without interviewer support as a paper-administered measure of individual quality of life is desirable.

Background The GRADE-CERQual (Confidence in Evidence from Reviews of Qualitative research) approach has been developed by the GRADE (Grading of Recommendations Assessment, Development and Evaluation) working group. The approach has been developed to support the use of findings from qualitative evidence syntheses in decision-making, including guideline development and policy formulation. CERQual includes four components for assessing how much confidence to place in findings from reviews of qualitative research (also referred to as qualitative evidence syntheses): (1) methodological limitations; (2) coherence; (3) adequacy of data; and (4) relevance. This paper is part of a series providing guidance on how to apply CERQual and focuses on CERQual’s adequacy of data component. Methods We developed the adequacy of data component by searching the literature for definitions, gathering feedback from relevant research communities and developing consensus through project group meetings. We tested the CERQual adequacy of data component within several qualitative evidence syntheses before agreeing on the current definition and principles for application. Results When applying CERQual, we define adequacy of data as an overall determination of the degree of richness and the quantity of data supporting a review finding. In this paper, we describe the adequacy component and its rationale and offer guidance on how to assess data adequacy in the context of a review finding as part of the CERQual approach. This guidance outlines the information required to assess data adequacy, the steps that need to be taken to assess data adequacy, and examples of adequacy assessments. Conclusions This paper provides guidance for review authors and others on undertaking an assessment of adequacy in the context of the CERQual approach. We approach assessments of data adequacy in terms of the richness and quantity of the data supporting each review finding, but do not offer fixed rules regarding what constitutes sufficiently rich data or an adequate quantity of data. Instead, we recommend that this assessment is made in relation to the nature of the finding. We expect the CERQual approach, and its individual components, to develop further as our experiences with the practical implementation of the approach increase. Electronic supplementary material The online version of this article (10.1186/s13012-017-0692-7) contains supplementary material, which is available to authorized users.

Funding: This work, including the publication charge for this article, was supported by funding from the Alliance for Health Policy and Systems Research, WHO (http://www.who.int/alliance-hpsr/en/). Additional funding was provided by the Department of Reproductive Health and Research, WHO (www.who.int/ reproductivehealth/en/); Norad (Norwegian Agency for Development Cooperation: www.norad.no), the Research Council of Norway (www.forskningsradet.no); and the Cochrane Methods Innovation Fund. SL is supported by funding from the South African Medical Research Council (www.mrc.ac.za). Background: The GRADE-CERQual (Confidence in Evidence from Reviews of Qualitative research) approach has been developed by the GRADE (Grading of Recommendations Assessment, Development and Evaluation) Working Group. The approach has been developed to support the use of findings from qualitative evidence syntheses in decision-making, including guideline development and policy formulation. CERQual includes four components for assessing how much confidence to place in findings from reviews of qualitative research (also referred to as qualitative evidence syntheses): (1) methodological limitations, (2) coherence, (3) adequacy of data and (4) relevance. This paper is part of a series providing guidance on how to apply CERQual and focuses on a probable fifth component, dissemination bias. Given its exploratory nature, we are not yet able to provide guidance on applying this potential component of the CERQual approach. Instead, we focus on how dissemination bias might be conceptualised in the context of qualitative research and the potential impact dissemination bias might have on an overall assessment of confidence in a review finding. We also set out a proposed research agenda in this area. Methods: We developed this paper by gathering feedback from relevant research communities, searching MEDLINE and Web of Science to identify and characterise the existing literature discussing or assessing dissemination bias in qualitative research and its wider implications, developing consensus through project group meetings, and conducting an online survey of the extent, awareness and perceptions of dissemination bias in qualitative research. Results: We have defined dissemination bias in qualitative research as a systematic distortion of the phenomenon of interest due to selective dissemination of studies or individual study findings. Dissemination bias is important for qualitative evidence syntheses as the selective dissemination of qualitative studies and/or study findings may distort our understanding of the phenomena that these syntheses aim to explore and thereby undermine our confidence in these findings. Dissemination bias has been extensively examined in the context of randomised controlled trials and systematic reviews of such studies. The effects of potential dissemination bias are formally considered, as publication bias, within the GRADE approach. However, the issue has received almost no attention in the context of qualitative research. Because of very limited understanding of dissemination bias and its potential impact on review findings in the context of qualitative evidence syntheses, this component is currently not included in the GRADE-CERQual approach. Conclusions: Further research is needed to establish the extent and impacts of dissemination bias in qualitative research and the extent to which dissemination bias needs to be taken into account when we assess how much confidence we have in findings from qualitative evidence syntheses. Publisher PDF

Background The GRADE-CERQual (Confidence in Evidence from Reviews of Qualitative research) approach has been developed by the GRADE (Grading of Recommendations Assessment, Development and Evaluation) Working Group. The approach has been developed to support the use of findings from qualitative evidence syntheses in decision-making, including guideline development and policy formulation. CERQual includes four components for assessing how much confidence to place in findings from reviews of qualitative research (also referred to as qualitative evidence syntheses): (1) methodological limitations, (2) coherence, (3) adequacy of data and (4) relevance. This paper is part of a series providing guidance on how to apply CERQual and focuses on CERQual’s relevance component. Methods We developed the relevance component by searching the literature for definitions, gathering feedback from relevant research communities and developing consensus through project group meetings. We tested the CERQual relevance component within several qualitative evidence syntheses before agreeing on the current definition and principles for application. Results When applying CERQual, we define relevance as the extent to which the body of data from the primary studies supporting a review finding is applicable to the context (perspective or population, phenomenon of interest, setting) specified in the review question. In this paper, we describe the relevance component and its rationale and offer guidance on how to assess relevance in the context of a review finding. This guidance outlines the information required to assess relevance, the steps that need to be taken to assess relevance and examples of relevance assessments. Conclusions This paper provides guidance for review authors and others on undertaking an assessment of relevance in the context of the CERQual approach. Assessing the relevance component requires consideration of potentially important contextual factors at an early stage in the review process. We expect the CERQual approach, and its individual components, to develop further as our experiences with the practical implementation of the approach increase. Electronic supplementary material The online version of this article (10.1186/s13012-017-0693-6) contains supplementary material, which is available to authorized users.

Background Military medicine is a research field that seeks to solve the medical problems that occur in modern war conditions based on public medicine theory. Methods We explore the main research topics of military health and medical research in the web of science™ core collection (WoSCC) from 2007 to 2016, and the goal of this work is to serve as a reference for orientation and development in military health and medicine. Based on CiteSpace III, a reference co-citation analysis is performed for 7921 papers published in the WoSCC from 2007 to 2016. In addition, a cluster analysis of research topics is performed with a comprehensive analysis of high-yield authors, outstanding research institutions and their cooperative networks. Results Currently, the research topics in military health and medicine mainly focus on the following seven aspects: mental health diagnoses and interventions, an army study to assess risk and resilience in service members (STARRS), large-scale military action, brain science, veterans, soldier parents and children of wartime, and wound infection. We also observed that the annual publication rate increased with time. Wessely S, Greenberg N, Fear NT, Smith TC, Smith B, Jones N, Ryan MAK, Boyko EJ, Hull L, and Rona RJ were the top 10 authors in military health and medicine research. The top 10 institutes were the Uniformed Services University of the Health Sciences, the United States Army, the United States Navy, Kings College London, Walter Reed National Military Medical Center, Boston University, Walter Reed Army Institute of Research, Walter Reed Army Medical Center, Naval Health Research Center, and the VA Boston Healthcare System. Conclusions We are able to perform a comprehensive analysis of studies in military health and medicine research and summarize the current research climate and the developmental trends in the WoSCC. However, further studies and collaborations are needed worldwide. Overall, our findings provide valuable information and new perspectives and shape future research directions for further research in the area of military health and medicine.

Background Given an observed test statistic and its degrees of freedom, one may compute the observed P value with most statistical packages. It is unknown to what extent test statistics and P values are congruent in published medical papers. Methods We checked the congruence of statistical results reported in all the papers of volumes 409–412 of Nature (2001) and a random sample of 63 results from volumes 322–323 of BMJ (2001). We also tested whether the frequencies of the last digit of a sample of 610 test statistics deviated from a uniform distribution (i.e., equally probable digits). Results 11.6% (21 of 181) and 11.1% (7 of 63) of the statistical results published in Nature and BMJ respectively during 2001 were incongruent, probably mostly due to rounding, transcription, or type-setting errors. At least one such error appeared in 38% and 25% of the papers of Nature and BMJ, respectively. In 12% of the cases, the significance level might change one or more orders of magnitude. The frequencies of the last digit of statistics deviated from the uniform distribution and suggested digit preference in rounding and reporting. Conclusions This incongruence of test statistics and P values is another example that statistical practice is generally poor, even in the most renowned scientific journals, and that quality of papers should be more controlled and valued.

Background Recruiting to primary care studies is complex. With the current drive to increase numbers of patients involved in primary care studies, we need to know more about successful recruitment approaches. There is limited evidence on recruitment to focus group studies, particularly when no natural grouping exists and where participants do not regularly meet. The aim of this paper is to reflect on recruitment to a focus group study comparing the methods used with existing evidence using a resource for research recruitment, PROSPeR (Planning Recruitment Options: Strategies for Primary Care). Methods The focus group formed part of modelling a complex intervention in primary care in the Resources for Effective Sleep Treatment (REST) study. Despite a considered approach at the design stage, there were a number of difficulties with recruitment. The recruitment strategy and subsequent revisions are detailed. Results The researchers' modifications to recruitment, justifications and evidence from the literature in support of them are presented. Contrary evidence is used to analyse why some aspects were unsuccessful and evidence is used to suggest improvements. Recruitment to focus group studies should be considered in two distinct phases; getting potential participants to contact the researcher, and converting those contacts into attendance. The difficulty of recruitment in primary care is underemphasised in the literature especially where people do not regularly come together, typified by this case study of patients with sleep problems. Conclusion We recommend training GPs and nurses to recruit patients during consultations. Multiple recruitment methods should be employed from the outset and the need to build topic related non-financial incentives into the group meeting should be considered. Recruitment should be monitored regularly with barriers addressed iteratively as a study progresses.

Background Informal medicine, entailing undocumented medical advice, has been described in diverse medical disciplines and geographical regions. We assessed the current prevalence and characteristics of informal medical consulting, the reasons physicians provide it, and their attitudes toward it. Methods We conducted a survey among family physicians in Israel, a country with a national health insurance system. A questionnaire was emailed to all primary care physicians in the two largest HMOs in southern Israel. Fifteen questions addressed the prevalence, practice and attitudes to informal medical consulting. Ten questions assessed demographics and professional experience. Results Of 143 respondents (mean age 41 years), 55% were women. Ninety-five percent of the respondents reported requesting informal medical consulting from other physicians. Fifty-four percent reported often providing informal consulting to family and friends; and an additional 27% reported doing so under exceptional circumstances. The main reasons given for informal consulting requests were availability and accessibility (81% of respondents), and not financial savings. Only 17.5% stated being in favor of informal consulting for family and friends. Only 11% expressed feeling satisfaction after providing such consultation; 49% expressed discomfort. Sixty-six percent thought a position paper on informal consulting to family and friends is needed. Conclusions Our survey of primary care physicians shows very frequent informal medical consulting, despite high dissatisfaction with such, and an interest in receiving guidelines on this practice.

Background A zero-inflated continuous outcome is characterized by occurrence of "excess" zeros that more than a single distribution can explain, with the positive observations forming a skewed distribution. Mixture models are employed for regression analysis of zero-inflated data. Moreover, for repeated measures zero-inflated data the clustering structure should also be modeled for an adequate analysis. Methods Diary of Asthma and Viral Infections Study (DAVIS) was a one year (2004) cohort study conducted at McMaster University to monitor viral infection and respiratory symptoms in children aged 5-11 years with and without asthma. Respiratory symptoms were recorded daily using either an Internet or paper-based diary. Changes in symptoms were assessed by study staff and led to collection of nasal fluid specimens for virological testing. The study objectives included investigating the response of respiratory symptoms to respiratory viral infection in children with and without asthma over a one year period. Due to sparse data daily respiratory symptom scores were aggregated into weekly average scores. More than 70% of the weekly average scores were zero, with the positive scores forming a skewed distribution. We propose a random effects probit/log-skew-normal mixture model to analyze the DAVIS data. The model parameters were estimated using a maximum marginal likelihood approach. A simulation study was conducted to assess the performance of the proposed mixture model if the underlying distribution of the positive response is different from log-skew normal. Results Viral infection status was highly significant in both probit and log-skew normal model components respectively. The probability of being symptom free was much lower for the week a child was viral positive relative to the week she/he was viral negative. The severity of the symptoms was also greater for the week a child was viral positive. The probability of being symptom free was smaller for asthmatics relative to non-asthmatics throughout the year, whereas there was no difference in the severity of the symptoms between the two groups. Conclusions A positive association was observed between viral infection status and both the probability of experiencing any respiratory symptoms, and their severity during the year. For DAVIS data the random effects probit -log skew normal model fits significantly better than the random effects probit -log normal model, endorsing our parametric choice for the model. The simulation study indicates that our proposed model seems to be robust to misspecification of the distribution of the positive skewed response.

Background Since the 2008 recession, Ireland has experienced large-scale doctor emigration. This paper seeks to ascertain whether (and how) the COVID-19 pandemic might disrupt or reinforce existing patterns of doctor emigration. Method This paper draws on qualitative interviews with 31 hospital doctors in Ireland, undertaken in June–July 2020. As the researchers were subject to a government mandated work-from-home order at that time, they utilised Twitter™ to contact potential respondents (snowball sampling); and conducted interviews via Zoom™ or telephone. Findings Two cohorts of doctors were identified; COVID Returners (N = 12) and COVID Would-be Emigrants (N = 19). COVID Returners are Irish-trained emigrant doctors who returned to Ireland in March 2020, just as global travel ground to a halt. They returned to be closer to home and in response to a pandemic-related recruitment call issued by the Irish government. COVID Would-be Emigrants are hospital doctors considering emigration. Some had experienced pandemic-related disruptions to their emigration plans as a result of travel restrictions and border closures. However, most of the drivers of emigration mentioned by respondents related to underlying problems in the Irish health system rather than to the pandemic, i.e. a culture of medical emigration, poor working conditions and the limited availability of posts in the Irish health system. Discussion/conclusion This paper illustrates how the pandemic intensified and reinforced, rather than radically altered, the dynamics of doctor emigration from Ireland. Ireland must begin to prioritise doctor retention and return by developing a coherent policy response to the underlying drivers of doctor emigration.

Whilst the issues around early termination of randomised controlled trials (RCTs) are well documented in the literature, trials can also be temporarily suspended with the real prospect that they may subsequently restart. There is little guidance in the literature as to how to manage such a temporary suspension. In this paper, we describe the temporary suspension of a trial within our clinical trials unit because of concerns over the safety of transvaginal synthetic mesh implants. We also describe the challenges, considerations, and lessons learnt during the suspension that we are now applying in the current COVID-19 pandemic which has led to activities in many RCTs across the world undergoing a temporary suspension.There were three key phases within the temporary suspension: the decision to suspend, implementation of the suspension, and restarting. Each of these phases presented individual challenges which are discussed within this paper, along with the lessons learnt. There were obvious challenges around recruitment, delivery of the intervention, and follow-up. Additional challenges included communication between stakeholders, evolving risk assessment, updates to trial protocol and associated paperwork, maintaining site engagement, data-analysis, and workload within the trial team and Sponsor organisation.Based on our experience of managing a temporary suspension, we developed an action plan and guidance (see Additional File 1) for managing a significant trial event, such as a temporary suspension. We have used this document to help us manage the suspension of activities within our portfolio of trials during the current COVID-19 pandemic.

Plain English summaryBackgroundThe Canadian Institutes of Health Research funded a program, “patient-oriented research” (POR), to change the way health research is done. POR involves patients and their families/caregivers as equal partners on research teams with researchers, healthcare providers and decision-makers. The authors of this paper work through a unit in British Columbia, Canada that functions to help research teams learn how to do patient-oriented research. We felt that we could not train people if we didn’t first understand what others had learned about what competencies (knowledge, skills and attitudes) were helpful for members of these research teams.MethodWe used a method called a scoping review to search literature on patient-involved research. Our search included papers in academic journals as well as information on websites, training manuals, conference proceedings, governmental documents and statements from health organizations.FindingsWriters reported the usefulness of many competencies for researchers and patients, with fewer competencies for healthcare providers or decision-makers. The main competencies for researchers had to do withparticipation,communicationandconflict management;for patients they had to do withresearch knowledge and skills,cultural competenceandparticipation. It was helpful that all team members want to work as part of a group for the public good.ConclusionsWe worked with an advisory group of people representing patients and their families/caregivers, researchers, healthcare providers and decision-makers to review our findings. We concluded that our competency statements are helpful for people to determine what they need to know or learn as they join research teams.AbstractBackgroundThe Canadian Institutes of Health Research (CIHR) launched an initiative called the Strategy for Patient-Oriented Research (SPOR) encouraging patient-oriented research (POR) that engages patients as equal partners in research teams alongside researchers, healthcare providers and health system decision-makers. Other countries have launched similar initiatives (POR-related work) yet there has never been full review of the competencies needed by individuals engaging in this work.Purpose and methodsOur purpose was to summarize existing knowledge on POR and POR-related competencies by conducting a scoping review of peer-reviewed and grey literature. Our objectives were to systematically explore literature, articulate competencies necessary for research team members, identify research gaps and provide recommendations for further research. Using standard health databases and search methods, a total of 2036 sources was retrieved. Data were extracted from 35 peer-reviewed papers and 38 grey literature sources. We used an iterative process to reach consensus on competency statements.Findings and conclusionsThe main competencies for researchers were in categories ofparticipation,communication and teamworkandconflict/tension management;for patients the main competencies were inresearch knowledge and skills,cultural competence/contextandparticipation. While fewer competencies were documented for the other stakeholder groups, the need forunderstanding patient involvement in researchandknowledge of the needs that research partners haveare noted as competencies for healthcare providers and decision-makers. Attitudes demonstrating inclination to conduct the work were noted for all. The competencies can be used to consider learning needs of research team members and for team members wishing to assess their own readiness to serve on a POR or POR-related research team. Incidentally, we noted the lack of a common vocabulary used to describe patient-involved research, a situation making research and literature review/retrieval quite challenging. Recommendations for future research and for achieving consistency in language are addressed.

Background Patient and public involvement (PPI) has become enshrined as an important pillar of health services empirical research, including PPI roles during stages of research development and analysis and co-design approaches. Whilst user participation has been central to qualitative evidence synthesis (QES) for decades, as seen in the Cochrane consumer network and guidelines, meta-ethnography has been slow to incorporate user participation and published examples of this occurring within meta-ethnography are sparse. In this paper, drawing upon our own experience of conducting a meta-ethnography, we focus on what it means in practice to ‘express a synthesis’ (stage 7). We suggest the methodological importance of ‘expression’ in Noblit and Hare’s seven stage process (Noblit, GW and Hare, RD. Meta-ethnography: synthesizing qualitative studies, 1988) has been overlooked, and in particular, opportunities for PPI user participation within it. Methods Meta-ethnography comprises a seven-stage process of evidence synthesis. Noblit and Hare describe the final 7th stage of the meta-ethnography process as ‘expression of synthesis’, emphasizing co-construction of findings with the audience. In a previous study we conducted a meta-ethnography exploring patient and student experience of medical education within primary care contexts. We subsequently presented and discussed initial meta-ethnography findings with PPI (students and patients) in focus groups and interviews. We transcribed patient and student PPI interpretations of synthesis findings. As a research team, we then translated these into our existing meta-ethnography findings. Results We describe, with examples, the process of involving PPI in stage 7 of meta-ethnography and discuss three methodological implications of incorporating PPI within an interpretative approach to QES: (1) we reflect on the construct hierarchy of user participants’ interpretations and consider whether incorporating these additional 1st order, 2nd level constructs implies an additional logic of 3rd order 2nd level constructs of the QES team; (2) we discuss the link between PPI user participation and what Noblit and Hare may have meant by ideas of ‘expression’ and ‘audience’ as integral to stage 7; and (3) we link PPI user participation to Noblit and Hare’s underlying theory of social explanation, i.e. how expression of the synthesis is underpinned by ideas of translation and that the synthesis must be ‘translated in the audience’s (user participants) particular language’. Conclusions The paper aims to complement recent attempts in the literature to refine and improve guidance on conducting a meta-ethnography, highlighting opportunities for PPI user participation in the processes of interpretation, translation and expression. We discuss the implications of user participation in meta-ethnography on ideas of ‘generalisability’.

Randomized controlled trials are considered the gold standard in assessing treatment regimens, and since abstracts may be the only part of a paper that a physician reads, accurate reporting of data in abstracts is essential. The CONSORT checklist for abstracts was designed to standardize data reporting; however, for papers submitted to anesthesiology journals, the level of adherence to the CONSORT checklist for abstracts is unknown. Therefore, we commend Janackovic and Puljak for their efforts in determining the adherence of reports of trials in the highest-impact anesthesiology journals between 2014 and 2016. The results of their study are extremely important; however, we believe that that study had some methodological limitations, which we discuss in this manuscript.

Background The paper opens with a brief history of two of the major intellectual components of the recent utilitarian turn in clinical research, namely ‘pragmatic trials’ and ‘implementation science’. The two schools of thought developed independently and the paper scrutinises their mutual compatibilities and incompatibilities, asking: i) what do the leading advocates of pragmatic trials assume about the transfer of research findings to real-world practice and ii) what role pragmatic trials can and should play in the evaluation of implementation science strategies. Methods The paper utilises ‘explication de texte’: i) providing a close reading of the inferential logics contained in major published expositions of the two paradigms, and ii) interrogating the conclusions of a pragmatic trial of an intervention providing guidelines on retinal screening aimed at family practitioners. Results The paper is in two parts. Part 1 unearths some significant incommensurability – the pragmatic trial literature retains an antiquated view of knowledge transfer and is overly optimistic about the wide applicability the findings of pragmatic trials to ‘real world’ conditions. Part 2 of the paper outlines an empirical strategy to better penetrate the mechanisms of knowledge transfer and to tackle the issue of the generalisabilty of research findings in implementation science. Conclusions Pragmatism, classically, is about problem solving and the melding of perspectives. The core research requirement in implementation science is a fundamental shift from the narrow shoulders of pragmatic trials to a model of explanation building based upon a multi-case, multi-method body of evidence.

Background The attendance to cervical cancer screening is low among immigrants in many high-income countries. Although several interventions have been experimentally tested,implementation remains a challenge. Several factors are an impediment, including the lack of methodological descriptions of the development and implementation of such interventions. In this paper,we present in detail the development, methodological challenges and practical implementation of a community based intervention aimed to increase the participation of immigrant women in cervical cancer screening in Norway. Methods This study was initially designed as a cluster randomized trial to be carried out in four geographical areas near Oslo between Feb-October 2017. Participants were immigrant women aged 25–69 years from Pakistan and Somalia. This paper describes the theoretical background for the development of the intervention,followed by challenges,the changes in the original design and solutions adopted related to the study design,recruitment and implementation of the intervention. The intervention was developed based on two theoretical frameworks, the Ecological and the Heron’s six categories intervention framework. An oral 20–25 min presentation in the language of participants encompassing topics of cervical cancer and screening was given according to the needs detected in focus groups conducted at the beginning of the study,followed by an opportunity to raise questions and answering a short questionnaire. Results Contrary to the initial study design, this had to be converted into a non-randomised trial due to the difficulties associated with randomization of immigrant families who are finely scattered in heavily populated towns and a high risk of contamination. We therefore adopted a pragmatic approach and recruited women in the intervention areas through a variety of channels and institutions. Neighboring areas were considered to be non-randomised controls. Female researchers with Pakistani and Somali background invited as many women as possible in the intervention areas. Among the women who were invited to participate,42% of the Pakistani and 78% of Somali attended the meetings. Conclusion Despite the careful development of a culturally adapted health intervention in collaboration with the community; randomization and recruitment of immigrants for community trials remains challenging. Nevertheless, sharing strategies to overcome specific challenges related to promoting health interventions for immigrants, can be of potential help to scale-up interventions and for building new research projects. Trial registration NCT03155581. Retrospectively registered, on 16 May 2017. Electronic supplementary material The online version of this article (10.1186/s12874-019-0795-8) contains supplementary material, which is available to authorized users.

Background With patient and public engagement in many aspects of the healthcare system becoming an imperative, the recruitment of patients and members of the public into service and research roles has emerged as a challenge. The existing literature carries few reports of the methods – successful and unsuccessful – that researchers engaged in user-centred design (UCD) projects are using to recruit participants as equal partners in co-design research. This paper uses the recruitment experiences of a specific UCD project to provide a road map for other investigators, and to make general recommendations for funding agencies interested in supporting co-design research. Methods We used a case study methodology and employed Nominal Group Technique (NGT) and Focus Group discussions to collect data. We recruited 25 family caregivers. Results Employing various strategies to recruit unpaid family caregivers in a UCD project aimed at co-designing an assistive technology for family caregivers, we found that recruitment through caregiver agencies is the most efficient (least costly) and effective mechanism. The nature of this recruitment work – the time and compromises it requires – has, we believe, implications for funding agencies who need to understand that working with caregivers agencies, requires a considerable amount of time for building relationships, aligning values, and establishing trust. Conclusions In addition to providing adaptable strategies, the paper contributes to discussions surrounding how projects seeking effective, meaningful, and ethical patient and public engagement are planned and funded. We call for more evidence to explore effective mechanisms to recruit family caregivers into qualitative research. We also call for reports of successful strategies that other researchers have employed to recruit and retain family caregivers in their research.

Background Looked after children and care leavers have an increased risk of drug and alcohol use compared to their non-LAC peers. Despite high prevalence rates within this population, looked after children are reported to show low levels of engagement in services resulting in unmet needs emerging from substance use. This paper reports on the initial formative phase of a pilot feasibility randomised controlled trial; SOLID (Supporting Looked After Children and Care Leavers In Decreasing Drugs, and Alcohol) that aimed to adapt two evidence-based psychosocial interventions, Motivational Enhancement Therapy and Social Behaviour and Network Therapy, which will aim to reduce substance misuse by looked after children. Methods We conducted qualitative semi-structured interviews and focus groups with 19 looked after children aged 12 to 20 years old, 16 carers and 14 professionals across four local authorities in the North East of England. The data gathered were analysed and then presented within co-production workshops inclusive of 13 young people and 14 professionals (drug and alcohol practitioners and social workers). Findings were used to adapt and refine the interventions prior to the trial. Results Overall findings suggested that whilst original components of both interventions were feasible to deliver and acceptable, specific process areas were highlighted including: increased emphasis upon therapeutic relationships, the benefits of using creative non-traditional methods of engagement and identification of treatment goals wider than those narrowly focused on substance misuse. Conclusion This paper provides an example of methods used to collect multiple perspectives to refine and co-develop interventions to reduce drug and alcohol use in the specific population of looked after children. Trial registration ISRCTN80786829 (first registered 06.06.2016- prospectively registered).

Plain English summary This paper describes the methods that were used to develop a health behaviour intervention specifically for teenage and young adult cancer survivors (TYACS). The program of work, carried out in partnership with CLIC Sargent (a UK based cancer charity for children and young people) was guided by The Behaviour Change Intervention Design Process. A systematic review of existing intervention studies was carried out and TYACS were surveyed on their interest in receiving health behaviour information and their preference regarding the format, delivery and timing of such information. Health professionals were also surveyed to gather their views on how health behaviour information would be best delivered to young people with cancer. The results of these studies informed the development of a collection of health behaviour change intervention resources containing comprehensive lifestyle information and behaviour change support tools. TYACS and TYA health professionals were invited to review and provide feedback on the relevance, appeal and usability of the resources. It is hoped that by involving TYACS and TYA representatives at every stage of intervention development the problem of low uptake and adherence commonly encountered during intervention piloting will be prevented. Abstract Background Teenage and Young Adult Cancer Survivors (TYACS) are advised to adopt a healthy lifestyle in order to reduce the impact of cancer and its treatments upon their long-term health. However, at present there are no interventions available in the UK to support TYACS to lead a healthy lifestyle. To inform the development of a lifestyle intervention for TYACS a partnership was set up between academic behavioural scientists and CLIC Sargent, a cancer charity which supports children and young people. Methods A series of studies to understand patient and professionals needs and perspectives regarding health behaviour change were carried out. TYACS were surveyed to gather data on their current health behaviour status; interest in, and experience of receiving, lifestyle advice; and preference regarding the type, format, and delivery of a lifestyle intervention. Health care professionals were surveyed simultaneously to gather their views on how best to promote health behaviour change to TYACS. In this paper we summarise key findings from the development work, the resulting lifestyle intervention, and new data from a preliminary evaluation study exploring TYACS and TYA health professionals’ views on the relevance, appeal and usability of the intervention resources. Results A collection of health behaviour change intervention resources containing lifestyle information and behaviour change support tools were developed. These intervention resources were well received by TYACS and health professionals with the majority rating the information as high quality, helpful and relevant. Over 80% of TYACS reported they would find the support tools ‘very appealing’ or ‘quite appealing’. TYACS and health professionals provided feedback on how the resources could be improved including commenting that more personalized or tailored health behaviour information would be beneficial. Discussion and conclusion It is hoped that by involving TYACS and TYA representatives at every stage of intervention development,and carrying out a preliminary evaluation of the intervention resources, the problem of low uptake and adherence commonly encountered during formal intervention piloting and evaluation will be prevented. Electronic supplementary material The online version of this article (10.1186/s40900-019-0142-6) contains supplementary material, which is available to authorized users.

Involving patients and members of the public to help shape and carry out research is recommended in health research in the United Kingdom (UK). There are a number of regional networks of Patient and Public Involvement (PPI) groups, which support the collaboration between researchers, patients and public members. We are a group of researchers, patients and public members who came together via a PPI regional network in the East of England to collaborate on a research study about the extent of feedback from researchers to PPI contributors. The aim of this paper is to use the recently developed UK National Standards for Public Involvement to structure our thinking about what worked well and what did not, within our recently completed study. We believe this paper is one of the first to use the National Standards to structure a retrospective reflection on PPI within a study. Our findings showed that there are benefits of regional working, including easier access to public members and bringing together researchers, public members and those who run PPI groups for research collaboration. The main challenges included involvement of people before studies are funded and working across organisations with different payment processes. The National Standards for Public Involvement has provided a useful framework to consider how best to involve patients and members of the public in research and could be a helpful structure to reflect on successes and challenges in individual projects and also regional, national or international comparisons of PPI in research. Background Regional networks of Patient and Public Involvement (PPI) organisations, including academic institutions, health and social care services, charities, patient and public groups and individuals, can play an important part in carrying out health research. In the UK, recommendations by the National Institute of Health Research (NIHR) encourage the use of regional, collaborative networks with shared resources and training. Methods The newly developed UK National Standards for Public Involvement were used as a framework for a retrospective reflection of PPI within a recently completed research study which focused on feedback from researchers to PPI contributors. PPI contributors, those running PPI groups (PPI leads) and researchers involved in the study have contributed to this reflection by completing evaluation forms throughout the research alongside notes of meetings and co-authors’ final reflections. Results Results revealed a number of successes where the regional network was particularly useful in bringing together PPI contributors, those who lead PPI groups and researchers. The regional network helped researchers to get in touch with patients and members of the public. Challenges included involving people before funding and bureaucratic and financial barriers when working across different organisations in the region. The importance of working together in flexible, informal ways was key and on-going support for the PPI contributors was vital for continued involvement, including emotional support not just monetary. The first four National Standards of inclusive opportunities, working together, support and learning and communications were particularly useful as means of structuring our reflections. Conclusions To our knowledge, this is one of the first research studies to use the UK National Standards for Public Involvement as a framework to identify what worked well and the challenges of PPI processes. It is suggested that as more reflective papers are published and the National Standards are more widely used in the UK, many lessons can be learnt and shared on how to improve our Patient and Public Involvement within research studies. Evaluations or reflections such as these can further enhance our understanding of PPI with implications for regional, national and international comparisons.

BackgroundDisease populations, clinical practice, and healthcare systems are constantly evolving. This can result in clinical prediction models quickly becoming outdated and less accurate over time. A potential solution is to develop 'dynamic' prediction models capable of retaining accuracy by evolving over time in response to observed changes. Our aim was to review the literature in this area to understand the current state-of-the-art in dynamic prediction modelling and identify unresolved methodological challenges. MethodsMEDLINE, Embase and Web of Science were searched for papers which used or developed dynamic clinical prediction models. Information was extracted on: methods for model updating, choice of update windows and decay factors, and validation of models. We also extracted reported limitations of methods and recommendations for future research.ResultsWe identified eleven papers that discussed seven dynamic clinical prediction modelling methods which split into three categories. The first category uses frequentist methods to update models in discrete steps, the second uses Bayesian methods for continuous updating and the third, based on varying coefficients, explicitly describes the relationship between predictors and outcome variable as a function of calendar time. These methods have been applied to a limited number of healthcare problems and few empirical comparisons between them have been made.ConclusionDynamic prediction models are not well established but they overcome one of the major issues with static clinical prediction models, calibration drift. However, there are challenges in choosing decay factors and in dealing with sudden changes. The validation of dynamic prediction models is still largely unexplored terrain.

Background Efforts to improve maternal health are increasingly focused on improving the quality of care provided to women at health facilities, including the promotion of respectful care and eliminating mistreatment of women during childbirth. A WHO-led multi-country research project aims to develop and validate two tools (labor observation and community survey) to measure how women are treated during facility-based childbirth. This paper describes the development process for these measurement tools, and how they were implemented in a multi-country study (Ghana, Guinea, Myanmar and Nigeria). Methods An iterative mixed-methods approach was used to develop two measurement tools. Methodological development was conducted in four steps: (1) initial tool development; (2) validity testing, item adjustment and piloting of paper-based tools; (3) conversion to digital, tablet-based tools; and (4) data collection and analysis. These steps included systematic reviews, primary qualitative research, mapping of existing tools, item consolidation, peer review by key stakeholders and piloting. Results The development, structure, administration format, and implementation of the labor observation and community survey tools are described. For the labor observations, a total of 2016 women participated: 408 in Nigeria, 682 in Guinea, and 926 in Ghana. For the community survey, a total of 2672 women participated: 561 in Nigeria, 644 in Guinea, 836 in Ghana, and 631 in Myanmar. Of the 2016 women who participated in the labor observations, 1536 women (76.2%) also participated in the community survey and have linked data: 779 in Ghana, 425 in Guinea, and 332 in Nigeria. Conclusions An important step to improve the quality of maternity care is to understand the magnitude and burden of mistreatment across contexts. Researchers and healthcare providers in maternal health are encouraged to use and implement these tools, to inform the development of more women-centered, respectful maternity healthcare services. By measuring the prevalence of mistreatment of women during childbirth, we will be able to design and implement programs and policies to transform maternity services. Electronic supplementary material The online version of this article (10.1186/s12874-018-0603-x) contains supplementary material, which is available to authorized users.

Background Patient and Public Involvement (PPI) is seen as a prerequisite for health research. However, current Patient and public involvement literature has noted a paucity of recording of patient and public involvement within research studies. There have been calls for more recordings and reflections, specifically on impact. Renal medicine has also had similar criticisms and any reflections on patient and public involvement has usually been from the viewpoint of the researcher. Roles of patient and public involvement can vary greatly from sitting on an Advisory Group to analysing data. Different PPI roles have been described within studies; one being a co-researcher. However, the role of the co-researcher is largely undefined and appears to vary from study to study. Methods The aims of this paper are to share one first time co-researcher’s reflections on the impact of PPI within a mixed methods (non-clinical trial) renal research study. A retrospective, reflective approach was taken using data available to the co-researcher as part of the day-to-day research activity. Electronic correspondence and documents such as meeting notes, minutes, interview thematic analysis and comments on documents were re-examined. The co-researcher led on writing this paper. Results This paper offers a broad definition of the role of the co-researcher. The co-researcher reflects on undertaking and leading on the thematic analysis of interview transcripts, something she had not previously done before. The co-researcher identified a number of key themes; the differences in time and responsibility between being a co-researcher and an Advisory Group member; how the role evolved and involvement activities could match the co-researchers strengths (and the need for flexibility); the need for training and support and lastly, the time commitment. It was also noted that it is preferable that a co-researcher needs to be involved from the very beginning of the grant application. Conclusions The reflections, voices and views of those undertaking PPI has been largely under-represented in the literature. The role of co-researcher was seen to be rewarding but demanding, requiring a large time commitment. It is hoped that the learning from sharing this experience will encourage others to undertake this role, and encourage researchers to reflect on the needs of those involved.

Background Randomised controlled clinical trials typically have a relatively brief in-trial follow-up period which can underestimate safety signals and fail to detect long-term hazards, which may take years to appear. Extended follow-up after the scheduled closure of the trial allows detection of both persistent or enhanced beneficial effects following cessation of study treatment (i.e. a legacy effect) and the emergence of possible adverse effects (e.g. development of cancer). Methods A systematic review was conducted following PRISMA guidelines to qualitatively compare post-trial follow-up methods used in large randomised controlled trials. Five bibliographic databases, including Medline and the Cochrane Library, and one trial registry were searched. All large randomised controlled trials (more than 1000 adult participants) published from March 2006 to April 2017 were evaluated. Two reviewers screened and extracted data attaining > 95% concordance of papers checked. Assessment of bias in the trials was evaluated using the Cochrane Risk of Bias tool. Results Fifty-seven thousand three hundred and fifty-two papers were identified and 65 trials which had post-trial follow-up (PTFU) were included in the analysis. The majority of trials used more than one type of follow-up. There was no evidence of an association between the retention rates of participants in the PTFU period and the type of follow-up used. Costs of PTFU varied widely with data linkage being the most economical. It was not possible to assess associations between risk of bias during the in-trial period and proportions lost to follow-up during the PTFU period. Discussion Data captured during the post-trial follow-up period can add scientific value to a trial. However, there are logistical and financial barriers to overcome. Where available, data linkage via electronic registries and records is a cost-effective method which can provide data on a range of endpoints. Systematic review registration Not applicable for PROSPERO registration. Electronic supplementary material The online version of this article (10.1186/s13063-018-2653-0) contains supplementary material, which is available to authorized users.

Background Patient safety in primary care is an emerging field of research with a growing evidence base in western countries but little has been explored in the Gulf Cooperation Council Countries (GCC) including the Sultanate of Oman. This study aimed to review the literature on the safety culture and patient safety measures used globally to inform the development of safety culture among health care workers in primary care with a particular focus on the Middle East. Methods A systematic review of the literature. Searches were undertaken using Medline, EMBASE, CINAHL and Scopus from the year 2000 to 2014. Terms defining safety culture were combined with terms identifying patient safety and primary care. Results The database searches identified 3072 papers that were screened for inclusion in the review. After the screening and verification, data were extracted from 28 papers that described safety culture in primary care. The global distribution of the articles is as follows: the Netherlands (7), the United States (5), Germany (4), the United Kingdom (1), Australia, Canada and Brazil (two for each country), and with one each from Turkey, Iran, Saudi Arabia and Kuwait. The characteristics of the included studies were grouped under the following themes: safety culture in primary care, incident reporting, safety climate and adverse events. The most common theme from 2011 onwards was the assessment of safety culture in primary care (13 studies, 46%). The most commonly used safety culture assessment tool is the Hospital survey on patient safety culture (HSOPSC) which has been used in developing countries in the Middle East. Conclusions This systematic review reveals that the most important first step is the assessment of safety culture in primary care which will provide a basic understanding to safety-related perceptions of health care providers. The HSOPSC has been commonly used in Kuwait, Turkey, and Iran. Electronic supplementary material The online version of this article (10.1186/s12875-018-0793-7) contains supplementary material, which is available to authorized users.

Background Evaluations of complex interventions in public health are frequently undermined by problems that can be identified before the effectiveness study stage. Exploratory studies, often termed pilot and feasibility studies, are a key step in assessing the feasibility and value of progressing to an effectiveness study. Such studies can provide vital information to support more robust evaluations, thereby reducing costs and minimising potential harms of the intervention. This systematic review forms the first phase of a wider project to address the need for stand-alone guidance for public health researchers on designing and conducting exploratory studies. The review objectives were to identify and examine existing recommendations concerning when such studies should be undertaken, questions they should answer, suitable methods, criteria for deciding whether to progress to an effectiveness study and appropriate reporting. Methods We searched for published and unpublished guidance reported between January 2000 and November 2016 via bibliographic databases, websites, citation tracking and expert recommendations. Included papers were thematically synthesized. Results The search retrieved 4095 unique records. Thirty papers were included, representing 25 unique sources of guidance/recommendations. Eight themes were identified: pre-requisites for conducting an exploratory study, nomenclature, guidance for intervention assessment, guidance surrounding any future evaluation study design, flexible versus fixed design, progression criteria to a future evaluation study, stakeholder involvement and reporting of exploratory studies. Exploratory studies were described as being concerned with the intervention content, the future evaluation design or both. However, the nomenclature and endorsed methods underpinning these aims were inconsistent across papers. There was little guidance on what should precede or follow an exploratory study and decision-making surrounding this. Conclusions Existing recommendations are inconsistent concerning the aims, designs and conduct of exploratory studies, and guidance is lacking on the evidence needed to inform when to proceed to an effectiveness study. Trial registration PROSPERO 2016, CRD42016047843 Electronic supplementary material The online version of this article (10.1186/s40814-018-0290-8) contains supplementary material, which is available to authorized users.

Background Both obesity and congenital heart disease (CHD) are risk factors for the long-term cardiovascular health of children and adolescents. The addition of smart mobile technology to conventional lifestyle counseling for weight management offers great potential to appeal to technologically literate youth and can address a large geographical area with minimal burden to participants. This pilot study seeks to examine the influence of a 1-year lifestyle intervention on nutrition and physical activity-related health outcomes in overweight or obese children and adolescents with CHD. Methods This is a pilot and feasibility study which utilizes a single-arm, prospective design with a goal to recruit 40 overweight and obese patients. The feasibility metrics will evaluate the integrity of the study protocol, data collection and questionnaires, recruitment and consent, and acceptability of the intervention protocol and primary outcome measures. The primary clinical outcome metrics are anthropometry, body composition, and cardiorespiratory exercise capacity. The secondary clinical metrics include quality of life, nutrition and physical activity behavior, lung and muscle function, and cardio-metabolic risk factors. Outcomes are assessed at baseline, 6 months, and 1 year. To date, a total of 36 children and youth (11 girls), aged 7–17 years (mean = 14.4 years), have commenced the intervention. Recruitment for the study was initiated in June 2012 and is currently ongoing. Discussion The information provided in this paper is intended to help researchers and health professionals with the development and evaluation of similar lifestyle intervention programs. Since the application of smartphones to pediatric cardiac health and obesity management is a novel approach, and continued research in this area is warranted, this paper may serve as a foundation for further exploration of this health frontier and inform the development of a broader strategy for obesity management in pediatric cardiology. Trial registration This pilot study was retrospectively registered at the www.ClinicalTrials.gov registry as NCT02980393 in November 2016, with the study commencing in May 2012. Study protocol version 15OCT2014.

Background Malaria continues to be a public health problem despite past and on-going control efforts. For sustenance of control efforts to achieve the malaria elimination goal, it is important that the most cost-effective interventions are employed. This paper reviews studies on cost-effectiveness of malaria interventions using disability-adjusted life years. Methods A review of literature was conducted through a literature search of international peer-reviewed journals as well as grey literature. Searches were conducted through Medline (PubMed), EMBASE and Google Scholar search engines. The searches included articles published in English for the period from 1996 to 2016. The inclusion criteria for the study were type of malaria intervention, year of publication and cost-effectiveness ratio in terms of cost per DALY averted. We included 40 studies which specifically used the DALY metric in cost-effectiveness analysis (CEA) of malaria interventions. Results The majority of the reviewed studies (75%) were done using data from African settings with the majority of the interventions (60.0%) targeting all age categories. Interventions included case treatment, prophylaxis, vector control, insecticide treated nets, early detection, environmental management, diagnosis and educational programmes. Sulfadoxine–pyrimethamine was the most common drug of choice in malaria prophylaxis, while artemisinin-based combination therapies were the most common drugs for case treatment. Based on guidelines for CEA, most interventions proved cost-effective in terms of cost per DALYs averted for each intervention. Conclusion The DALY metric is a useful tool for determining the cost-effectiveness of malaria interventions. This paper demonstrates the importance of CEA in informing decisions made by policy makers.

Dissociative seizures (DSs), also called psychogenic non-epileptic seizures, are a distressing and disabling problem for many patients in neurological settings with high and often unnecessary economic costs. The COgnitive behavioural therapy versus standardised medical care for adults with Dissociative non-Epileptic Seizures (CODES) trial is an evaluation of a specifically tailored psychological intervention with the aims of reducing seizure frequency and severity and improving psychological well-being in adults with DS. The aim of this paper is to report in detail the quantitative and economic analysis plan for the CODES trial, as agreed by the trial steering committee. The CODES trial is a multicentre, pragmatic, parallel group, randomised controlled trial performed to evaluate the clinical effectiveness and cost-effectiveness of 13 sessions of cognitive behavioural therapy (CBT) plus standardised medical care (SMC) compared with SMC alone for adult outpatients with DS. The objectives and design of the trial are summarised, and the aims and procedures of the planned analyses are illustrated. The proposed analysis plan addresses statistical considerations such as maintaining blinding, monitoring adherence with the protocol, describing aspects of treatment and dealing with missing data. The formal analysis approach for the primary and secondary outcomes is described, as are the descriptive statistics that will be reported. This paper provides transparency to the planned inferential analyses for the CODES trial prior to the extraction of outcome data. It also provides an update to the previously published trial protocol and guidance to those conducting similar trials. ISRCTN registry ISRCTN05681227 (registered on 5 March 2014); ClinicalTrials.gov NCT02325544 (registered on 15 December 2014).

Background Sustainability of evidence-based health promotion interventions has received increased research attention in recent years. This paper reports sustainability data from Project HEAL (Health through Early Awareness and Learning) a cancer communication implementation trial about early detection, based in African American churches. In this paper, we used a framework by Scheirer and Dearing (Am J Publ Health 101:2059-2067, 2011) to evaluate multiple dimensions of sustainability from Project HEAL. Methods We examined the following dimensions of sustainability: (a) continued benefits for intervention recipients, (b) continuation of intervention activities, c) maintaining community partnerships, (d) changes in organizational policies or structures, (e) sustained attention to the underlying issues, (f) diffusion to additional sites, or even (g) unplanned consequences of the intervention. Project HEAL provided a three-workshop cancer educational series delivered by trained lay peer community health advisors (CHAs) in their churches. Multiple sources of sustainability were collected at 12 and 24 months after the intervention that reflect several levels of analysis: participant surveys; interviews with CHAs; records from the project’s management database; and open-ended comments from CHAs, staff, and community partners. Results Outcomes differ for each dimension of sustainability. For continued benefit, 39 and 37% of the initial 375 church members attended the 12- and 24-month follow-up workshops, respectively. Most participants reported sharing the information from Project HEAL with family or friends (92% at 12 months; 87% at 24 months). For continuation of intervention activities, some CHAs reported that the churches held at least one additional cancer educational workshop (33% at 12 months; 24% at 24 months), but many more CHAs reported subsequent health activities in their churches (71% at 12 months; 52% at 24 months). No church replicated the original series of three workshops. Additional data confirm the maintenance of community partnerships, some changes in church health policies, and continued attention to health issues by churches and CHAs. Conclusions The multiple dimensions of sustainability require different data sources and levels of analysis and show varied sustainability outcomes in this project. The findings reinforce the dynamic nature of evidence-based health interventions in community contexts. Electronic supplementary material The online version of this article (doi:10.1186/s13012-017-0576-x) contains supplementary material, which is available to authorized users.

Background Paramedics make important and increasingly complex decisions at scene about patient care. Patient safety implications of influences on decision making in the pre-hospital setting were previously under-researched. Cutting edge perspectives advocate exploring the whole system rather than individual influences on patient safety. Ethnography (the study of people and cultures) has been acknowledged as a suitable method for identifying health care issues as they occur within the natural context. In this paper we compare multiple methods used in a multi-site, qualitative study that aimed to identify system influences on decision making. Methods The study was conducted in three NHS Ambulance Trusts in England and involved researchers from each Trust working alongside academic researchers. Exploratory interviews with key informants e.g. managers (n = 16) and document review provided contextual information. Between October 2012 and July 2013 researchers observed 34 paramedic shifts and ten paramedics provided additional accounts via audio-recorded ‘digital diaries’ (155 events). Three staff focus groups (total n = 21) and three service user focus groups (total n = 23) explored a range of experiences and perceptions. Data collection and analysis was carried out by academic and ambulance service researchers as well as service users. Workshops were held at each site to elicit feedback on the findings and facilitate prioritisation of issues identified. Results The use of a multi-method qualitative approach allowed cross-validation of important issues for ambulance service staff and service users. A key factor in successful implementation of the study was establishing good working relationships with academic and ambulance service teams. Enrolling at least one research lead at each site facilitated the recruitment process as well as study progress. Active involvement with the study allowed ambulance service researchers and service users to gain a better understanding of the research process. Feedback workshops allowed stakeholders to discuss and prioritise findings as well as identify new research areas. Conclusion Combining multiple qualitative methods with a collaborative research approach can facilitate exploration of system influences on patient safety in under-researched settings. The paper highlights empirical issues, strengths and limitations for this approach. Feedback workshops were effective for verifying findings and prioritising areas for future intervention and research.

Background A variety of different approaches to the synthesis of qualitative data are advocated in the literature. The aim of this paper is to describe the application of a pragmatic method of qualitative evidence synthesis and the lessons learned from adopting this "best fit" framework synthesis approach. Methods An evaluation of framework synthesis as an approach to the qualitative systematic review of evidence exploring the views of adults to the taking of potential agents within the context of the primary prevention of colorectal cancer. Results Twenty papers from North America, Australia, the UK and Europe met the criteria for inclusion. Fourteen themes were identified a priori from a related, existing conceptual model identified in the literature, which were then used to code the extracted data. Further analysis resulted in the generation of a more sophisticated model with additional themes. The synthesis required a combination of secondary framework and thematic analysis approaches and was conducted within a health technology assessment timeframe. Conclusion The novel and pragmatic "best fit" approach to framework synthesis developed and described here was found to be fit for purpose. Future research should seek to test further this approach to qualitative data synthesis.

Background While health outcomes of HIV/AIDS treatments in terms of increased longevity has been the subject of much research, there appears to be very limited research on the improved health related quality of life (HRQL) that can be applied in cost-utility analyses in Africa south of the Sahara (SSA). Most of the literature that does exist present HRQL measured by disease specific instruments, but such data is of little use as input to economic evaluations. Methods A systematic review of the literature on HRQL weights for people living with HIV/AIDS in Africa was performed, and the findings are presented and interpreted. We also use focus group discussions in panels of clinical AIDS experts to test the preference based on a generic descriptive system EQ-5D. We contrast quality of life with and without antiretroviral treatment (ART), and with and without treatment failure. Results In only four papers were the HRQL weights for HIV/AIDS in sub-Saharan Africa estimated with generic preference based methodologies that can be directly applied in economic evaluation. A total of eight studies were based on generic health profiles. While such 'health profiles' are not preference based, the scores could potentially be transformed into health state utilities. Most of the available literature (20 papers) utilized disease specific instrument, which are not applicable for economic evaluation. The focus group discussions revealed that HRQL weights are strongly correlated to disease stage. Furthermore, clinical experts consistently report that ART has a strong positive impact on the HRQL of patients, although this effect appears to rebound in cases of drug resistance. Conclusions EQ-5D appears to be an appropriate tool for measuring and valuing HRQL of HIV/AIDS in Africa. More empirical research is needed on various methodological aspects in order to obtain valid and reliable HRQL weights in economic evaluations of HIV/AIDS prevention and treatment interventions.

Background To derive micronutrient recommendations in a scientifically sound way, it is important to obtain and analyse all published information on the association between micronutrient intake and biochemical proxies for micronutrient status using a systematic approach. Therefore, it is important to incorporate information from randomized controlled trials as well as observational studies as both of these provide information on the association. However, original research papers present their data in various ways. Methods This paper presents a methodology to obtain an estimate of the dose–response curve, assuming a bivariate normal linear model on the logarithmic scale, incorporating a range of transformations of the original reported data. Results The simulation study, conducted to validate the methodology, shows that there is no bias in the transformations. Furthermore, it is shown that when the original studies report the mean and standard deviation or the geometric mean and confidence interval the results are less variable compared to when the median with IQR or range is reported in the original study. Conclusions The presented methodology with transformations for various reported data provides a valid way to estimate the dose–response curve for micronutrient intake and status using both randomized controlled trials and observational studies.

Background Dementia is increasing in prevalence as the population ages. An earlier rather than later diagnosis allows persons with dementia and their families to plan ahead and access appropriate management. However, most diagnoses are made by general practitioners (GPs) later in the course of the disease and are associated with management that is poorly adherent to recommended guidelines. This trial examines the effectiveness of a peer led dementia educational intervention for GPs. Methods The study is a cluster randomised trial, conducted across three states and five sites. All GPs will complete an audit of their consenting patients aged 75 years or more at three time points - baseline, 12 and 24 months. GPs allocated to the intervention group will receive two educational sessions from a peer GP or nurse, and will administer the GPCOG to consenting patients at baseline and 12 months. The first education session will provide information about dementia and the second will provide individualised feedback on audit results. GPs in the waitlist group will receive the RACGP Guidelines by post following the 12 month audit Outcomes: Primary outcomes are carer and consumer quality of life and depression. Secondary outcomes include: rates of GP identification of dementia compared to a more detailed gold standard assessment conducted in the patient's home; GP identification of differential diagnoses including reversible causes of cognitive impairment; and GP referral to specialists, Alzheimers' Australia and support services. A "case finding" and a "screening" group will be compared and the psychometrics of the GPCOG will be examined. Sample size: Approximately 2,000 subjects aged 75 years and over will be recruited through approximately 160 GPs, to yield approximately 200 subjects with dementia (reducing to 168 by 24 months). Discussion The trial outlined in this paper has been peer reviewed and supported by the Australian National Health and Medical Research Council. At the time of submission of this paper 2,034 subjects have been recruited and the intervention delivered to 114 GPs. Trial registration Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12607000117415.

Contains fulltext : 96371.pdf (Publisher’s version ) (Open Access) BACKGROUND: Given the rising number of asthma cases and the increasing costs of health care, prevention may be the best cure. Decisions regarding the implementation of prevention programmes in general and choosing between unifaceted and multifaceted strategies in particular are urgently needed. Existing trials on the primary prevention of asthma are, however, insufficient on their own to inform the decision of stakeholders regarding the cost-effectiveness of such prevention strategies. Decision analytic modelling synthesises available data for the cost-effectiveness evaluation of strategies in an explicit manner. Published reports on model development should provide the detail and transparency required to increase the acceptability of cost-effectiveness modelling. But, detail on the explicit steps and the involvement of experts in structuring a model is often unevenly reported. In this paper, we describe a procedure to structure and validate a model for the primary prevention of asthma in children. METHODS: An expert panel was convened for round-table discussions to frame the cost-effectiveness research question and to select and structure a model. The model's structural validity, which indicates how well a model reflects the reality, was determined through descriptive and parallel validation. Descriptive validation was performed with the experts. Parallel validation qualitatively compared similarity between other published models with different decision problems. RESULTS: The multidisciplinary input of experts helped to develop a decision-tree structure which compares the current situation with screening and prevention. The prevention was further divided between multifaceted and unifaceted approaches to analyse the differences. The clinical outcome was diagnosis of asthma. No similar model was found in the literature discussing the same decision problem. Structural validity in terms of descriptive validity was achieved with the experts and was supported by parallel validation. CONCLUSIONS: A decision-tree model developed with experts in round-table discussions benefits from a systematic and transparent approach and the multidisciplinary contributions of the experts. Parallel validation provides a feasible alternative to validating novel models. The process of structuring and validating a model presented in this paper could be a useful guide to increase transparency, credibility, and acceptability of (future, novel) models when experts are involved.

Background Several papers have discussed which effect measures are appropriate to capture the contrast between exposure groups in cross-sectional studies, and which related multivariate models are suitable. Although some have favored the Prevalence Ratio over the Prevalence Odds Ratio -- thus suggesting the use of log-binomial or robust Poisson instead of the logistic regression models -- this debate is still far from settled and requires close scrutiny. Discussion In order to evaluate how accurately true causal parameters such as Incidence Density Ratio (IDR) or the Cumulative Incidence Ratio (CIR) are effectively estimated, this paper presents a series of scenarios in which a researcher happens to find a preset ratio of prevalences in a given cross-sectional study. Results show that, provided essential and non-waivable conditions for causal inference are met, the CIR is most often inestimable whether through the Prevalence Ratio or the Prevalence Odds Ratio, and that the latter is the measure that consistently yields an appropriate measure of the Incidence Density Ratio. Summary Multivariate regression models should be avoided when assumptions for causal inference from cross-sectional data do not hold. Nevertheless, if these assumptions are met, it is the logistic regression model that is best suited for this task as it provides a suitable estimate of the Incidence Density Ratio.

An amendment to this paper has been published and can be accessed via the original article.

Background Implementation strategies are necessary to ensure that evidence-based practices are successfully incorporated into routine clinical practice. Such strategies, however, are frequently modified to fit local populations, settings, and contexts. While such modifications can be crucial to implementation success, the literature on documenting and evaluating them is virtually nonexistent. In this paper, we therefore describe the development of a new framework for documenting modifications to implementation strategies. Discussion We employed a multifaceted approach to developing the Framework for Reporting Adaptations and Modifications to Evidence-based Implementation Strategies (FRAME-IS), incorporating multiple stakeholder perspectives. Development steps included presentations of initial versions of the FRAME-IS to solicit structured feedback from individual implementation scientists (“think-aloud” exercises) and larger, international groups of researchers. The FRAME-IS includes core and supplementary modules to document modifications to implementation strategies: what is modified, the nature of the modification (including the relationship to core elements or functions), the primary goal and rationale for the modification, timing of the modification, participants in the modification decision-making process, and how widespread the modification is. We provide an example of application of the FRAME-IS to an implementation project and provide guidance on how it may be used in future work. Conclusion Increasing attention is being given to modifications to evidence-based practices, but little work has investigated modifications to the implementation strategies used to implement such practices. To fill this gap, the FRAME-IS is meant to be a flexible, practical tool for documenting modifications to implementation strategies. Its use may help illuminate the pivotal processes and mechanisms by which implementation strategies exert their effects.

Background Poor Maternal and Child Health (MCH) outcomes pose challenges to India’s ability to attain Goal-3 of the Sustainable Development Goals (SDGs). The government of India strengthened the existing network of frontline health workers (FHWs), under its National Rural Health Mission in 2005 and subsequent National Urban Health Mission in 2013 as a strategy to mitigate the shortage of skilled health workers and to provide affordable healthcare services. However, there is a lack of robust national-level empirical analysis on the role of maternal engagement with FHWs in influencing the level of maternal and child health care utilisation and child health outcomes in India. Methods Using data from the nationally representative Indian National Family Health Survey (NFHS) 2015–2016, this paper aims to investigate the intensity of engagement of FHWs with married women of child-bearing age (15–49 years), its influence on utilisation of maternal and child healthcare services, and child health outcomes. Our empirical analyses use multivariate regression analyses, focusing on five maternal and child health indicators: antenatal care visits (ANC) (4 or > 4 times), institutional delivery, full-immunisation of children, postnatal care (PNC) (within 2 days of delivery), and child survival. Results Our analysis finds that maternal engagement with FHWs is statistically significant and a positive predictor of maternal and child health care utilisation, and child survival. Further, the level of engagement with FHWs is particularly important for women from economically poor households. Our robustness checks across sub-samples of women who delivered only in public health institutions and those from rural areas provides an additional confidence in our main results. Conclusions From a policy perspective, our findings highlight that strengthening the network of FHWs in the areas where they are in shortage which can help in further improving the utilisation of maternal and child healthcare services, and health outcomes. Also, the role of FHWs in the government health system needs to be enhanced by improving skills, working environment, and greater financial incentives.

During the past few years, the pharmacy profession has expanded significantly in terms of professional services delivery and now has been recognized as an important profession in the multidisciplinary provision of health care. In contrast to the situation in developed countries, pharmacists in developing countries are still underutilized and their role as health care professionals is not deemed important by either the community or other health care providers. The aim of this paper is to highlight the role of pharmacists in developing countries, particularly in Pakistan. The paper draws on the literature related to the socioeconomic and health status of Pakistan's population, along with background on the pharmacy profession in the country in the context of the current directions of health care. The paper highlights the current scenario and portrays the pharmacy profession in Pakistan. It concludes that although the pharmacy profession in Pakistan is continuously evolving, the health care system of Pakistan has yet to recognize the pharmacist's role. This lack of recognition is due to the limited interaction of pharmacists with the public. Pharmacists in Pakistan are concerned about their present professional role in the health care system. The main problem they are facing is the shortage of pharmacists in pharmacies. Moreover, their services are focused towards management more than towards customers. For these reasons, the pharmacist's role as a health care professional is not familiar to the public.

Background Rural township health centres and urban community health centres play a crucial role in the delivery of primary health care in China. Over the past two-and-a-half decades, these health institutions have not been as well developed as high-level hospitals. The limited availability and low qualifications of human resources in health are among the main challenges facing lower-level health facilities. This paper aims to analyse the mobility of health workers in township and community health centres. Methods Data used in this paper come from a nationwide survey of health facilities in 2006. Ten provinces in different locations and of varying levels of economic development were selected. From these provinces, 119 rural township health centres and 89 urban community health centres were selected to participate in a questionnaire survey. Thirty key informants were selected from these health facilities to be interviewed. Results In 2005, 8.1% and 8.9% of health workers left township and community health centres, respectively. The health workers in rural township health centres had three to 13 years of work experience and typically had received a formal medical education. The majority of the mobile health workers moved to higher-level health facilities; very few moved to other rural township health centres. The rates of workers leaving township and community health centres increased between 2000 and 2005, with the main reasons for leaving being low salaries, limited opportunities for professional development and poor living conditions. Conclusion In China, primary health workers in township health centres and community health centres move to higher-level facilities due to low salaries, limited opportunities for promotion and poor living conditions. The government already has policies in place to counteract this migration, but it must step up enforcement if rural township health centres and urban community centres are to retain health professionals and recruit qualified health workers.

Background Pay and pay systems are a critical element in any health sector human resource strategy. Changing a pay system can be one strategy to achieve or sustain organizational change. This paper reports on the design and implementation of a completely new pay system in the National Health Service (NHS) in England. 'Agenda for Change' constituted the largest-ever attempt to introduce a new pay system in the UK public services, covering more than one million staff. Its objectives were to improve the delivery of patient care as well as enhance staff recruitment, retention and motivation, and to facilitate new ways of working. Methods This study was the first independent assessment of the impact of Agenda for Change at a local and national level. The methods used in the research were a literature review; review of 'grey' unpublished documentation provided by key stakeholders in the process; analysis of available data; interviews with key national informants (representing government, employers and trade unions), and case studies conducted with senior human resource managers in ten NHS hospitals in England Results Most of the NHS trust managers interviewed were in favour of Agenda for Change, believing it would assist in delivering improvements in patient care and staff experience. The main benefits highlighted were: 'fairness', moving different staff groups on to harmonized conditions; equal pay claim 'protection'; and scope to introduce new roles and working practices. Conclusion Agenda for Change took several years to design, and has only recently been implemented. Its very scale and central importance to NHS costs and delivery of care argues for a full assessment at an early stage so that lessons can be learned and any necessary changes made. This paper highlights weaknesses in evaluation and limitations in progress. The absence of systematically derived and applied impact indicators makes it difficult to assess impact and impact variations. Similarly, the lack of any full and systematic evaluation constrained the overall potential for Agenda for Change to deliver improvements to the NHS.

Background The within-subject coefficient of variation and intra-class correlation coefficient are commonly used to assess the reliability or reproducibility of interval-scale measurements. Comparison of reproducibility or reliability of measurement devices or methods on the same set of subjects comes down to comparison of dependent reliability or reproducibility parameters. Methods In this paper, we develop several procedures for testing the equality of two dependent within-subject coefficients of variation computed from the same sample of subjects, which is, to the best of our knowledge, has not yet been dealt with in the statistical literature. The Wald test, the likelihood ratio, and the score tests are developed. A simple regression procedure based on results due to Pitman and Morgan is constructed. Furthermore we evaluate the statistical properties of these methods via extensive Monte Carlo simulations. The methodologies are illustrated on two data sets; the first are the microarray gene expressions measured by two plat- forms; the Affymetrix and the Amersham. Because microarray experiments produce expressions for a large number of genes, one would expect that the statistical tests to be asymptotically equivalent. To explore the behaviour of the tests in small or moderate sample sizes, we illustrated the methodologies on data from computer-aided tomographic scans of 50 patients. Results It is shown that the relatively simple Wald's test (WT) is as powerful as the likelihood ratio test (LRT) and that both have consistently greater power than the score test. The regression test holds its empirical levels, and in some occasions is as powerful as the WT and the LRT. Conclusion A comparison between the reproducibility of two measuring instruments using the same set of subjects leads naturally to a comparison of two correlated indices. The presented methodology overcomes the difficulty noted by data analysts that dependence between datasets would confound any inferences one could make about the differences in measures of reliability and reproducibility. The statistical tests presented in this paper have good properties in terms of statistical power.

Background The CONSORT Statement provides recommendations for reporting randomized controlled trials. We assessed the extent to which leading medical journals that publish reports of randomized trials incorporate the CONSORT recommendations into their journal and editorial processes. Methods This article reports on two observational studies. Study 1: We examined the online version of 'Instructions to Authors' for 165 high impact factor medical journals and extracted all text mentioning the CONSORT Statement or CONSORT extension papers. Any mention of the International Committee of Medical Journal Editors (ICMJE) or clinical trial registration were also sought and extracted. Study 2: We surveyed the editor-in-chief, or editorial office, for each of the 165 journals about their journal's endorsement of CONSORT recommendations and its incorporation into their editorial and peer-review processes. Results Study 1: Thirty-eight percent (62/165) of journals mentioned the CONSORT Statement in their online 'Instructions to Authors'; of these 37% (23/62) stated this was a requirement, 63% (39/62) were less clear in their recommendations. Very few journals mentioned the CONSORT extension papers. Journals that referred to CONSORT were more likely to refer to ICMJE guidelines (RR 2.16; 95% CI 1.51 to 3.08) and clinical trial registration (RR 3.67; 95% CI 2.36 to 5.71) than those journals which did not. Study 2: Thirty-nine percent (64/165) of journals responded to the on-line survey, the majority were journal editors. Eighty-eight percent (50/57) of journals recommended authors comply with the CONSORT Statement; 62% (35/56) said they would require this. Forty-one percent (22/53) reported incorporating CONSORT into their peer-review process and 47% (25/53) into their editorial process. Eighty-one percent (47/58) reported including CONSORT in their 'Instructions to Authors' although there was some inconsistency when cross checking information on the journal's website. Sixty-nine percent (31/45) of journals recommended authors comply with the CONSORT extension for cluster trials, 60% (27/45) for harms and 42% (19/45) for non-inferiority and equivalence trials. Few journals mentioned these extensions in their 'Instructions to Authors'. Conclusion Journals should be more explicit in their recommendations and expectations of authors regarding the CONSORT Statement and related CONSORT extensions papers.

Background Randomized trials of complex interventions are increasingly including qualitative components to further understand factors that contribute to their success. In this paper, we explore the experiences of health care practitioners in a province wide smoking cessation program (the Smoking Treatment for Ontario Patients program) who participated in the COMBAT trial. This trial examined if the addition of an electronic prompt embedded in a Clinical Decision Support System (CDSS)—designed to prompt practitioners to Screen, provide a Brief intervention and Referral to Treatment (SBIRT) to patients who drank alcohol above the amounts recommended by the Canadian Cancer Society guidelines—influenced the proportion of practitioners delivering a brief intervention to their eligible patients. We wanted to understand the factors influencing implementation and acceptability of delivering a brief alcohol intervention for treatment-seeking smokers for health care providers who had access to the CDSS (intervention arm) and those who did not (control arm). Methods Twenty-three health care practitioners were selected for a qualitative interview using stratified purposeful sampling (12 from the control arm and 11 from the intervention arm). Interviews were 45 to 90 min in length and conducted by phone using an interview guide that was informed by the National Implementation Research Network’s Hexagon tool. Interview recordings were transcribed and coded iteratively between three researchers to achieve consensus on emerging themes. The preliminary coding structure was developed using the National Implementation Research Network’s Hexagon Tool framework and data was analyzed using the framework analysis approach. Results Seventy eight percent (18/23) of the health care practitioners interviewed recognized the need to simultaneously address alcohol and tobacco use. Seventy four percent (17/23), were knowledgeable about the evidence of health risks associated with dual alcohol and tobacco use but 57% (13/23) expressed concerns with using the Canadian Cancer Society guidelines to screen for alcohol use. Practitioners acknowledged the value of adding a validated screening tool to the STOP program’s baseline questionnaire (19/23); however, following through with a brief intervention and referral to treatment proved challenging due to lack of training, limited time, and fear of stigmatizing patients. Practitioners in the intervention arm (5/11; 45%) might not follow the recommendations from CDSS if these recommendations are not perceived as beneficial to the patients. Conclusions The results of the study show that practitioners’ beliefs were reflective of the current social norms around alcohol use and this influenced their decision to offer a brief alcohol intervention. Future interventions need to emphasize both organizational and sociocultural factors as part of the design. The results of this study point to the need to change social norms regarding alcohol in order to effectively implement interventions that target both alcohol and tobacco use in primary care clinics. Trial registration ClinicalTrials.gov NCT03108144. Retrospectively registered 11 April 2017, https://www.clinicaltrials.gov/ct2/show/NCT03108144

Over recent years, mesenchymal stem/stromal cells (MSCs) and their potential biomedical applications have received much attention from the global scientific community in an increasing manner. Firstly, MSCs were successfully isolated from human bone marrow (BM), but in the next steps, they were also extracted from other sources, mostly from the umbilical cord (UC) and adipose tissue (AT). The International Society for Cellular Therapy (ISCT) has suggested minimum criteria to identify and characterize MSCs as follows: plastic adherence, surface expression of CD73, D90, CD105 in the lack of expression of CD14, CD34, CD45, and human leucocyte antigen-DR (HLA-DR), and also the capability to differentiate to multiple cell types including adipocyte, chondrocyte, or osteoblast in vitro depends on culture conditions. However, these distinct properties, including self-renewability, multipotency, and easy accessibility are just one side of the coin; another side is their huge secretome which is comprised of hundreds of mediators, cytokines, and signaling molecules and can effectively modulate the inflammatory responses and control the infiltration process that finally leads to a regulated tissue repair/healing or regeneration process. MSC-mediated immunomodulation is a direct result of a harmonic synergy of MSC-released signaling molecules (i.e., mediators, cytokines, and chemokines), the reaction of immune cells and other target cells to those molecules, and also feedback in the MSC-molecule-target cell axis. These features make MSCs a respectable and eligible therapeutic candidate to be evaluated in immune-mediated disorders, such as graft versus host diseases (GVHD), multiple sclerosis (MS), Crohn’s disease (CD), and osteoarthritis (OA), and even in immune-dysregulating infectious diseases such as the novel coronavirus disease 2019 (COVID-19). This paper discussed the therapeutic applications of MSC secretome and its biomedical aspects related to immune-mediated conditions. Sources for MSC extraction, their migration and homing properties, therapeutic molecules released by MSCs, and the pathways and molecular mechanisms possibly involved in the exceptional immunoregulatory competence of MSCs were discussed. Besides, the novel discoveries and recent findings on immunomodulatory plasticity of MSCs, clinical applications, and the methods required for their use as an effective therapeutic option in patients with immune-mediated/immune-dysregulating diseases were highlighted.

Background Communicating risks of medication harm and obtaining informed consent is difficult due to structural barriers, language and cultural practices, bias and a lack of resources appropriately tailored for the health literacy of most patients. A decision support tool was proposed to alert prescribers of risk and provide tailored information for patients to facilitate informed decision-making with patients and their whānau (family) around medication use. Patient and prescriber co-design was used to ensure the tool was designed to best meet the needs of end-users and avoid increasing health inequity. This paper describes the first stage of the co-design process. Method Normalisation Process Theory (NPT) was used to prospectively evaluate the tool. Semi-structured interviews were held with fifteen patients (five Māori, five Pasifika and five NZ European) and nine general practitioners (two Māori and seven European). Results Three themes were identified, which related to the three NPT concepts most relevant to developing the tool. Theme 1 (coherence: meaning and sense making by participants) explored participants’ understanding of prescribing safety, medication harm and risk, which is based on experience. Patients want as much information as possible about their medications and risk, but doctors find it difficult to communicate that information. Theme 2 related to the NPT concept of cognitive participation (commitment and engagement by participants) explored what participants thought about a prescribing decision support tool. Participants were cautiously optimistic, but worried about potential harm arising from its use. They also identified requirements for the tool and features to avoid. Theme 3 describes the collective action required for successful implementation of the tool; namely, culturally safe and trustworthy doctor-patient relationships. Conclusion Patients and general practitioners provided different perspectives when prospectively evaluating the proposed risk assessment and communication tool. This co-design research identified important pre-requisites for the tool and features to avoid and novel ideas for the proposed tool. Overall participants supported the development of the proposed risk assessment and communication tool, but identified the important role that doctor-patient relationships would play to ensure successful implementation. The use of Māori and Pacific languages in the proposed tool may enhance engagement and understanding.

An amendment to this paper has been published and can be accessed via the original article.