Remote Patient Monitoring Systems (RPMS) based on e-health, Nurse Navigators (NNs) and patient engagement can improve patient follow-up and have a positive impact on quality of care (by limiting adverse events) and costs (by reducing readmissions). However, the extent of this impact depends on effective implementation which is often restricted. This is partly due to the lack of attention paid to the RPMS design phase prior to implementation. The content of the RPMS can be carefully designed at this stage and various obstacles anticipated. Our aim was to report on an RPMS design case to provide insights into the methodology required in order to manage this phase.This study was carried out at Gustave Roussy, a comprehensive cancer centre, in France. A multidisciplinary team coordinated the CAPRI RPMS design process (2013–2015) that later produced positive outcomes. Data were collected during eight studies conducted according to the Medical Research Council (MRC) framework. This project was approved by the French National Data Protection Authorities.Based on the study results, the multidisciplinary team defined strategies for resolving obstacles prior to the implementation of CAPRI. Consequently, the final CAPRI design includes a web app with two interfaces  and two NNs. The NNs provide regular follow-up via telephone or email to manage patients’ symptoms and toxicity, treatment compliance and care packages. Patients contact the NNs via a secure messaging system. Eighty clinical decision support tools enable NNs to prioritise and decide on the course of action to be taken.In our experience, the RPMS design process and, more generally, that of any complex intervention programme, is an important phase that requires a sound methodological basis. This study is also consistent with the notion that an RPMS is more than a technological innovation. This is indeed an organizational innovation, and principles identified during the design phase can help in the effective use of a RPMS . The delivery of healthcare services for patients with chronic diseases requires more effective coordination between professionals and patients/relatives along the care pathway. In response, many health care organisations have implemented Remote Patient Monitoring Systems (RPMS). This type of intervention programme can improve patient follow-up and have a positive impact on the quality of care  and health-related costs  –5.According to the Chronic Care Model , 7, an Rex ante to the intervention [However, two recent literature reviews reported mixed results in terms of the effective impact of RPMS on quality of care and cost management , 18. Thirvention . Otherwirvention . A precirvention , 23.Development, Feasibility/piloting, Evaluation, and Implementation [In order to investigate the design process, an RPMS is defined as a complex intervention involving several interactions between various individuals, organisations and tools which in this case refer to the combination of stages outlined above , 24. An entation , 29. Thientation . It helpThe aim of this paper is to report on our RPMS process design experience based on the CAPRI (Cancérologie Parcours Région Ile de France) Case Study. The RPMS, recognised as such by the French public authorities, consists of 2 NNs and technological support (a telephone platform and a web application). Its added-value has been assessed through a Randomized Clinical Trial (RCT) that significantly demonstrated an increased follow-up of the medical prescription, a reduction in the effects of severe toxicity, a decrease in hospital days, and a better patient experience in the follow-up of their disease . The RPMGustave Roussy Institute , a leading European cancer centre with 449 beds and 94 day-care places, treating over 48,000 patients (year 2018).The RPMS under test, namely, CAPRI (CAncerologie Parcours Région Ile de France), was trialled at the The purpose of CAPRI was to develop a RPMS dedicated to patients receiving oral cancer medication - a treatment that has been used more extensively in recent years . The useAn expert group focused on the scientific aspects. Several disciplines were represented: oncologists, pharmacists, and health service researchers (management science and biostatistics);A functional group was set up comprising hospital management personnel from various departments: Quality, Medical Information, Information System Management, Nursing Directorate, Outpatients, Pharmacy and Finance to make administrative decisions;An operational working group including researchers from the expert group, and staff from different clinical departments to plan the daily agenda.The initial stage of the project was devoted to the design of CAPRI (mid-2013-2015), and the second stage to implementation and evaluation (2016–2019). Three groups were formed depending on the work being carried out and the individual areas:During the initial intervention design stage, the expert group met monthly, the functional group once every 3 months, and the last group on a weekly basis depending on project progression, in addition to telephone calls and emails.The Principal Investigator of the evaluation programme was the Outpatient Senior Oncologist given his interaction with other healthcare professionals (MdP followed by OM). The Scientific Lead was a senior researcher in Healthcare Management Science (EM). A Programme Coordinator was also appointed to oversee all project management issues (MF).The design process was managed by the multidisciplinary team comprising the three groups. Their role was backed by various studies carried out at Gustave Roussy. Eight studies were finally outlined, based on the three principles covered in the MRC framework during the development phase : (1) IdeThe CNIL approved each study. As a result, several stages in the design process were carried out between 2013 and 2015 , were deemed potentially appropriate to meet coordination needs identified in the specific case of CAPRI. Patient commitment, another important factor in the successful patient-professional relationship, is linked as much with IT usage as with the quality of the NNs relationship  , has allmodel process and outcomes and define the major expected outcomes and the most relevant target population for the design of CAPRI.Under the supervision of the three groups, these exploratory studies have led to a precise design, suggesting a technological tool, including a definition of these functions and a detailed description of the NNs role. The initial design could be discussed with potential users in order to The interviews carried out during study 5 Table  highlighAlongside the intervention design, one major point was to define the entire assessment system prior to the implementation process in order to outline the evaluation criteria, the data to be collected and the target population.According to the literature , 46, theIn addition, the difficulty in quantitatively measuring some of its effects and the behaviour of professionals in coordinating their actions, in particular, resulted in a longitudinal study. Collectively, and based on the analyses of articles in an attempt to RPMS evidence , a telemedicine contract had to be signed with the Agence Régionale de Santé Ile de France (ARSIF) . This step took 7 months and the contract with the ARS Ile de France was signed in October 2015. A mandatory procedure was also required with regard to the Commission Nationale de l’Informatique et des Libertés (CNIL) to authorise the pooling of personal health-related information. The CNIL procedure was initiated only after signature of the ARS Ile contract, and was obtained in May 2016. These legal issues have governed the regulatory framework in which the CAPRI system can be used.Apart from the timescales imposed by these regulatory authorities, compliance also impacted system design. For instance, the plan was to allow community professionals, and General Practitioners in particular, to document mutual patient information using the shared patient follow-up record. This option was abandoned since an agreement would have been required with each health care professional in accordance with regulatory requirements. This system was deemed to be too complex for routine use.All the issues outlined above refer to a dynamic design process. As summarised in Fig. This iterative approach allowed various obstacles to be identified  and corrected prior to implementation .The final CAPRI design includes a web/mobile app with two interfaces  and two Nurse Navigators Fig. .Fig. 3FThe organisational aspects are quite important. We have already described the different clinical decision support tools developed to assist NNs activities. The two NNs provide regular telephone follow-up to manage patients’ symptoms and toxicity issues, treatment compliance and supportive care needs. Patients have access to the app to record/track data, contact the NNs via a secure messaging system, view therapy and side effect information or store documents. The NNs are linked to health professionals involved in patient management.NNs conduct an initial assessment interview with each patient in-person or over the phone to identify his or her needs. The patient interview also includes a review of treatment, medical prescriptions and appointments. NNs then prepare the individual patient electronic medical record on the CAPRI application. Following this initial phase, NNs ensure patient follow-up  remotely, through telephone interviews and emails, from Monday to Friday, during office hours only (from 9 am to 5 pm). Patients benefit from a regular phone follow-up in addition to individual contact depending on access difficulties, needs, and resources. In addition, NNs help patients to identify and overcome obstacles, provide health and practical information as well as emotional support, help patients to organise their appointments, help them to understand their conditions and treatments and help them to be actively involved in their care. They also forge links between the patient and hospital professionals and primary care providers  who are given access to the CAPRI application with the patient’s consent. To this end, NNs ensure that consultation reports, examination and test results and new medical prescriptions are available on the CAPRI application to all authorised healthcare providers at the time of an appointment. NNs inform health care providers about patient appointments, new treatments, new symptoms or difficulties, as required. Patient monitoring is described in a specific protocol prepared and validated by the expert group. During the initial assessment, each patient is given a starter box, which includes the following: login data to gain access to the portal, instructions for use and covering letters for healthcare providers, required .The CAPRI application is available in web or mobile version and provides an interface to connect patients, hospital professionals, primary care providers and NNs.The application offers patients several modules as shown in Table Gustave Roussy professional or contact the relevant services in order to arrange hospitalisation or schedule an appointment for the patient.The CAPRI application provides NNs with a dashboard to enable them to monitor the individual electronic medical records of patients. Each time a patient is contacted, the NN can create intervention reports to record what they have done or discussed, and transmit the information to the professionals previously indicated by the patients. These professionals can log on the portal to communicate with the NNs online and access the relevant patient information. The system also generates automatic alerts which are sent to the patients or the NNs. The alerts and patients’ requests can be generated in different ways: 1) automatically, via the app, for instance while reporting follow-up measures (if the patient’s parameters are below or above predefined thresholds); 2) by the NNs during regular follow-ups; 3) by messaging/calling the patient or the professionals. The NNs assess the alert grade based on clinical decision support tools and determine the action to be taken according to navigation algorithms. Depending on the grade, the NNs can give advice, refer the patient to his or her primary care physician, or a This paper discusses the design of the CAPRI – an RPMS intended to improve the care pathway for cancer patients receiving oral medication. Two findings come to light.Firstly, it outlines the crucial role of the design phase and provides an insight into the method required to carry out the process.The way in which the system is accepted by patients and healthcare professionals as well as hospital managers is a key factor in effective implementation that starts during this design phase . One majOur experience also shows that evaluation design must be carefully analysed in advance as a process evaluation. In terms of process and outcome evaluation measures, the work on identifying the target population, outcomes and programme content was crucial to improve the design, criteria and indicators to be followed in the randomised control trial, as noted elsewhere , 54 and . The three principles of the development phase , were very helpful. In the experiments reported in the scientific literature, existing evidence in terms of intervention content, implementation strategy and process evaluation measures was sparse. Following the MCR principles, we collected evidence about the relevant target population, anticipated outcomes and the most suitable intervention. We developed the underlying theory and finally designed the intervention programme in operational terms, modelling the implementation strategy and the process and outcome evaluation measures. Indeed, the exploratory survey carried out initially and the literature review on care coordination requirements highlighted the priorities in terms of both the target population and outcomes. An intervention programme designed to address numerous requirements or several outcomes at the same time may produce confused and imprecise results. Similarly, these guidelines allowed the intervention content to be finely tuned following an iterative approach [These insights can contribute to the knowledge of development and implementation processes of healthcare intervention programmes. We based our research protocol on the MRC framework for the development and evaluation of complex interventions , 29. Theapproach . Althougapproach . Furtherapproach .Secondly, our experience shows the importance of organizational aspects in the RPMS context, precisely the coordination of care required for the organization of a remote follow-up of patients, as noticed elsewhere . From a -NNs have already proved their added-value in the patient management of different chronic diseases –16. Here-The clinical decision support tools provide a basis for defining the most appropriate answer for specific patient requirements as well as the most appropriate direction based on the clinical severity. Designing clinical decision support tools that are not only guides for evaluation, but also for orientation, whatever the organizational conditions to accomplish it, represent another recommendation.-The need to link NNs to the technological application in order to process information more efficiently and direct patients accordingly suggests that there is a need to link the three factors of the Chronic Care Model , 7: use -Finally, the selection of the feedback support, between the application allowing automated feedback and the phone, generally preferred by patients but more time-consuming for NNs, is another key point. In our design, we have integrated both options, the use of the RPMS showing the dominant use of the phone on the application afterwards , 65.This study has various limitations. This was initially a specific case of RPMS, in a specific setting, namely Gustave Roussy, with the aim of monitoring patients receiving oral medication. All of these specific features require additional research in other settings, with other objectives, to define RPMS models. Secondly, the effective use of the RPMS and the study outcomes are not presented in the paper. The experimentation gave positive outcomes , and shoDespite limitations, our investigation reveals two findings about the RPMS content and the likelihood of encountering various issues relating to the implementation process during the design phase. Firstly, the RPMS programme is not only a technological innovation, something which is often outlined, but also an organisational innovation. This means that it is important to acknowledge the use of IT in conjunction with human practices and in a specific context . Secondly, this study confirms that the design phase of RPMS and, more generally, of any organisational intervention, must not be overlooked. As regards the methodological aspects of designing complex healthcare interventions, we wish to emphasise the fact that incorporation of the local context and relevant process evaluation are crucial in order to design an appropriate intervention programme and promote acceptance by users. Research programmes must therefore include the relevant dedicated stages. These preliminary phases warrant a constant review of the intervention content in order to ensure that it is fit for purpose in the given context. This should help to increase the likelihood of implementing an intervention programme in the most appropriate manner, which is a current issue in modern healthcare delivery systems.


The aim of structured education for type 2 diabetes is to improve knowledge, skills and confidence in self-management. It is recommended in the UK for everyone who is newly diagnosed with type 2 diabetes. We developed an on-line programme called HeLP-Diabetes: Starting Out to address poor uptake of face-to-face structured education. The aim of this paper is to describe the intervention in line with the Template for Intervention Description and Replication guide, which calls for better reporting of interventions.The Template for Intervention Description and Replication guide provided the item headings for the description. These included the theoretical underpinning, materials, procedures, providers, and mode of delivery.The programme was developed to meet NICE requirements for structured education and therefore followed a structured curriculum with four sessions covering content such as what diabetes is and how it is treated, possible complications, and how lifestyle changes can improve health. Content was delivered in text, images and video, and behaviour change techniques, self-assessment and feedback were used to help people target key health behaviours. The programme was delivered entirely online, but the team were available for support via telephone. Email feedback and reminders were sent.The TIDieR checklist allowed us to provide a clear structure for the description of the intervention. However, it could not capture the full complexity of the programme, and intervention developers considering using it in the future may find that it needs to be adapted to make it more specific to their intervention. National Audit Office data suggest than only 8.3% of eligible patients attended in 2016.4The aim of structured education for Type 2 Diabetes Mellitus (T2DM) is to improve people’s knowledge, skills and confidence to take control of their condition and integrate self-management into daily life.57 Systematic reviews of online self-management support have been conducted suggesting evidence of improvements in glycaemic control and self-care behaviours.811Hence, improving uptake of structured education is a priority for the National Health Service (NHS) in England. Recommendations for improving uptake have been made, and this includes offering patients online courses.12 but it was aimed at patients at all stages of the illness journey, not just newly diagnosed patients, and hence did not follow a structure with specific aims and objectives, and a structured written curriculum, as recommended by NICE3 and required for certification by the Quality Institute for Self-Management Education & Training (QISMET).13 Such certification was required for referral to the programme to be eligible for QOF remuneration. A structured programme for people newly diagnosed with T2DM  was therefore developed in order to be NICE and QiSMET compliant. The key differences between HeLP-Diabetes and HeLP-Diabetes: Starting Out were:HeLP-Diabetes: Starting Out was aimed at people newly diagnosed with type 2 diabetes, rather than people at any stage of the illness.HeLP-Diabetes: Starting Out consisted of selected content from the HeLP-Diabetes website, and additional behaviour change techniques, relevant to people newly diagnosed with type 2 diabetes. It was therefore much smaller in size than HeLP-Diabetes.HeLP-Diabetes: Starting Out followed a structured spiral curriculum, with specific aims and learning objectives. People built on their learning as they worked through the programme. HeLP-Diabetes contained a large amount of information divided into sections, but without a curriculum or learning objectives.People worked through the modules in HeLP-Diabetes: Starting Out in a linear fashion, with access to the next module being given once the previous one had been completed. This is in contrast to HeLP-Diabetes, where people could dip in and out of different pages and sections depending on interest.A National Institute for Health Research (NIHR) programme grant funded the development of an online self-management resource called HeLP-Diabetes for people with T2DM. Randomised controlled trial (RCT) data showed this to be effective and cost-effective,14 and online self-management interventions for TDM15 have found reporting of interventions to be limited. This results in less reliable implementation and replication of interventions. The aim of this paper is to describe the HeLP-Diabetes: Starting Out programme in line with the TIDieR (Template for Intervention Description and Replication) guide.16 A detailed description of the HeLP-Diabetes website is given elsewhere.17Reviews of behaviour change interventionsThe TIDieR checklist was developed in response to the poor quality of descriptions of interventions in publications. The TIDieR checklist is based on a literature review of relevant checklists and research, a Delphi survey of an international panel of experts, and the 2010 Consolidated Standards for Reporting Trials (CONSORT) and 2013 Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statements. It consists of 12 items including: the name of the intervention; the rationale, theory or goal; the procedures, activities and processes used in the intervention; the intervention provider; the mode and location of delivery; the number of sessions the intervention is delivered in; if the intervention is personalised; if any modifications were made; if adherence was assessed, and the extent to which the intervention was delivered as planned see .18The TIDieR checklist was chosen for use in this paper because it provides a clear structure for describing interventions, with items covering the what, who, how, and when of an intervention and its delivery package, to permit successful implementation and replication. The items in the TIDieR checklist were particularly relevant to HeLP-Diabetes: Starting Out because it was delivered online in a number of sessions, by a multidisciplinary team. Using the checklist was therefore considered the most appropriate way to meet the aim of the paper.Little guidance is available from journals about how to report interventions.19 We have ensured that all items and relevant details are included by using items from the checklist as section headings in the results below. Subcategories reflect the description of the items given in the checklist as closely as possible. The section headings and subcategories used to describe the intervention are illustrated in This paper provides the information required by items 1–10. Items 11–12 (‘How well’) are discussed elsewhere.17 HeLP-Diabetes was followed by HeLP-Diabetes: Starting Out (HDSO), a structured education programme based on the content of the original website, but with a curriculum and learning objectives and aimed at newly diagnosed patients (Starting Out). This paper describes HeLP-Diabetes: Starting Out.The name of the intervention was HeLP-Diabetes : Starting Out. HeLP-Diabetes was a website which people at any stage of their T2DM could use flexibly (this is described briefly in the background above and in more detail elsewhere).20 This is conceptualised as consisting of three tasks: (1) medical management ; (2) emotional mangement (addressing the negative emotions associated with being diagnosed with a long-term condition); and (3) role management (coming to terms with disruption to one's sense of self).The theoretical model that was used to underpin HeLP-Diabetes was the Corbin and Strauss model of the work of managing a long term condition.21 which suggests that behaviour is influenced by personal factors like self-efficacy (confidence in one’s own capabilities). Goal-setting, action planning and reviewing goals improve self-efficacy by allowing people to monitor and review their progress. When people can see their progress it provides a sense of accomplishment which sustains motivation and skills development.2224The aim of the HDSO programme was to help people newly diagnosed with type 2 diabetes to improve their knowledge, self-efficacy and emotional wellbeing by learning about how to address a wide range of needs including lifestyle changes, taking medication, interacting with the healthcare system, managing feelings and the impact of the illness on social life, work and relationships. We used the Corbin & Strauss model again in the development of the HDSO programme, due to its relevance to the aim of the programme. We linked Corbin & Strauss’ three self-management tasks to the intended outcomes of the HDSO programme , and developed a causal model for the intervention (see Appendix 1). In order to achieve the intended behavioural outcomes, behaviour change techniques (BCTs) based on behaviour change theory were used to target key behaviours. BCTs including goal-setting; action planning; and reviewing goals can be seen in the causal model and were key features of the programme. These BCTs have their basis in social cognitive theory,25 NPT provides an empirically grounded model of the factors that promote or inhibit the routine incorporation of interventions in everyday practice.26 These factors include making sure that the programme was easy to differentiate from other programmes and had clear benefits; fit with professional priorities (such as adhering to NICE recommendations); fit into existing working practices easily; and made consultations between patients and health professionals more productive.25A theory of implementation known as the Normalization Process Theory (NPT) was also considered from the outset of the development of HeLP-Diabetes and HDSO to ensure that they were optimally “implementable” within the NHS.27The use of theory and evidence is recommended by the Medical Research Council (MRC) for health researchers developing and evaluating complex interventions. An interdisciplinary approach was taken in the development of the HDSO programme, and methods common to computer science and Human-Computer Interaction (HCI) were used in addition to methods from health. Findings from focus groups undertaken to establish user requirements for the HeLP-Diabetes website  were combined with the theoretical model described above to develop the first iteration of HeLP-Diabetes: Starting Out. We then carried out usability testing and “in the wild testing” to refine the intervention. These steps are described in more detail elsewhere, along with a detailed description of the initial design, usability testing, “in the wild testing” and revisions.28The programme was completed online, and was developed for use either on a tablet or a desktop computer. People therefore needed access to the internet and a tablet or desktop computer to use the programme. People who did not have home access to the internet or a computer, were given information about public internet access at local libraries.Information about the HDSO programme was given to people with T2DM registered at GP practices in the Clinical Commissioning Groups (CCGs) who commissioned the programme. Information included an outline of the programme and contact details for the HDSO team. People were asked to contact the HDSO team if there were interested in using the programme. The HDSO team registered people and gave them the webpage details  for the programme, and a username and password for accessing it online. The HDSO team and registration process are described further below.29 The programme therefore aimed to encourage behaviour change by increasing self-efficacy .The content of the HDSO programme was a small subset of the HeLP-Diabetes website, selected for its relevance to newly diagnosed people. In selecting content we prioritised actionable information with support for behaviour change and emotional issues, as the underlying principles of HDSO focused on empowering and enabling patients, through increasing perceived autonomy and competence (self-efficacy). Self-regulation theory states that self-efficacy has a strong impact on thought, affect, motivation, and action.25 People who registered for the HDSO programme, also had access to both the HDSO programme and the HeLP-Diabetes website via a common homepage.The criteria for selecting content were based on user needs from qualitative data and the experience of the Diabetes Specialist Nurses (DSNs) in the HDSO team who were trained in facilitating face-to-face education with newly diagnosed patients with T2DM. It was decided that all aspects of diabetes management should be included, to give people a good overview of the disease process, its complications and impact on emotions, relationships and work, and an understanding of the types of treatment that are recommended .30 A detailed description of the number and timing of the sessions of the programme is given below (‘When and how much’).Information was presented using text, images and videos, with an emphasis on the positive . Text was written for people with a reading age of 12 to correspond to with 80% of the UK population.Patients were able to register for the intervention initially by contacting the HDSO team  who then called them by telephone to register their details. The HDSO team then emailed people the webpage URL, a username and password. Following modifications to the programme (detailed below), people were able to register themselves online by visiting the self-registration page of the website.People could contact the HDSO team for support via telephone. The HDSO team provided support for problems with registration or using the website. Individualised email feedback and reminders were sent at various stages of the programme (see ‘Tailoring’).The HDSO team consisted of patients, administrators, General Practitioners, Diabetes Specialist nurses (DSNs) and health and HCI researchers. The patients we worked with had experience of living with T2DM, and the GPs had experience of managing patients with T2DM and referring to structured education. The DSNs were trained in facilitating structured education for patients with T2DM. The health and HCI researchers had experience developing and evaluating other online interventions.The patients, GPs, DSNs and researchers worked together on the initial development of the programme, and the subsequent testing and refinement. The GPs and DSNs wrote the individualised feedback and reminders. The administrators and DSNs visited practices and met with practice managers, GPs and Nurses to publicise the programme and encourage them to inform patients about the programme. It was the role of the administrators to register people and send username and password details. The administrators, GPs and DSNs provided telephone and email support to people who contacted the team with questions. Telephone support was limited to helping people with technical problems such as lost passwords. Coaching and individual clinical advice was not included.The programme was delivered online for individuals. Telephone support from an administrator was available for technical problems, such as lost passwords or problems logging on, and individualised feedback and reminders were provided by email. People could interact with other users via an online forum (part of the HeLP-Diabetes website which HDSO users had access to), where they could post messages about their progresses, tips or queries.The programme was available to adults with T2DM registered with a practice in one of the Clinical Commissioning Groups (CCGs) that commissioned the programme.The programme was delivered online, and could therefore be used wherever people had computer and internet access. The HDSO team were based at the Royal Free Hospital Campus of University College London. They provided support to users via telephone and email.The programme had four “sessions” which were divided into four or five parts or modules. The sessions are described in more detail below, starting with the spiral curriculum which formed the core structure of the programme.31 This model was chosen because it allows for an ‘iterative revisiting of topics, subjects or themes throughout the course’.31 The idea is that topics are not just repeated, but that knowledge and understanding should be deepened each time. The learner’s competence should increase with each visit until the overall aim is achieved.The programme followed a spiral curriculum. This means that people built on the knowledge they acquired in each session as they proceeded. The spiral model is an evidence-based model for adult education which is based on the Harden and Stamper spiral curriculum model.The curriculum was structured into four sessions, with a fifth bonus session. Each session consisted of four or five parts and took about ninety minutes to complete. The titles of each session and part in listed in Week 1 contained information about what diabetes is see , eating Week 2 Part 1 .37 The aim of the Week 1 questionnaires was to help people recognise their learning needs at the start of the programme, and to make clear the purposes and goals of the programme. Feedback at this stage helped learners to understand how they could improve by signposting them to parts of the course that would help address the gaps in their learning.At Week 1 the questionnaires were used as formative assessments. Formative practice allows learners to understand their strengths and weaknesses, in order to make progress.36 Formative assessment can be seen as helping learning to move forward, whereas summative assessment can be seen as summarizing learning that has taken place.38 The aim of the Week 4 questionnaires was to help people to reflect on the learning they had accomplished by the end of the programme. Feedback was provided to summarise the learning and achievement that had taken place.At week 4, the questionnaires were used as summative assessments. Summative assessment is a recording of the overall achievement of the student, and relates to progression in their learning.27) We linked the theoretical framework (the self-management tasks proposed by Corbin and Strauss) with the components of the intervention, to predict a range of effects. The proximal effects that were proposed were improved knowledge, increased motivation, increased self-efficacy, and decreased emotional distress. More distal effects predicted were weight loss and increased physical activity, with final outcomes being improved HbA1c and health-related quality of life. We chose to measure the proximal outcomes because it was more feasible to measure knowledge, self-efficacy and diabetes-related emotional distress ; because there were reliable and valid questionnaires available to measure these outcomes; and because improving these outcomes made it more likely (as predicted by behaviour change theory) that people would be able to change distal outcomes like weight loss and physical activity.The questionnaires that were used were the: (1) Audit of Diabetes Knowledge (AdKnowl); (2) Diabetes Management Self-efficacy Scale (DMSES); and (3) Problem Areas in Diabetes (PAID). These questionnaires were chosen based on the outcomes proposed from the causal model of the intervention  was chosen to assess knowledge. It was chosen because one of its purposes is to evaluate the success of educational interventions. There are 23 item-sets (114 items), all of which reflect the content of the HDSO programme. These are: diabetes treatment, sick days, hypoglycaemia, complication risk, physical activity, smoking, alcohol, foot care and diet. Higher scores indicate greater knowledge and the topic sub-sets allow specific knowledge deficits to be targeted.40The Diabetes Management Self-Efficacy Scale (DMSES) was used to measure self-efficacy. It has 20 items and measures individuals’ expectations for being able to engage in diabetes self-management activities which reflect activities targeted by the HDSO programme, like daily exercise, and keeping to a healthy eating plan when away from home. The questionnaire has been used in previous research, and has been found to have good internal reliability, criterion and construct validity, and acceptable test-retest reliability.42Problem Areas in Diabetes (PAID) was used to measure diabetes-related emotional distress. It has 20 items focusing on areas that cause difficulty for people living with diabetes, including social situations, food, friends and family and social support. Psychometric tests have shown that PAID has consistently high internal reliability, sound test-retest reliability, and was a statistically significant predictor of glycaemic control in a one-year study of a managed care population.43Feedback has been described above as being a necessary part of self-assessment as it can provide information on gaps in learning and instruction on how learning can be improved. Users were emailed their actual scores for knowledge, self-efficacy and distress about diabetes self-management, with total possible scores, as personalised feedback. The total possible scores provided people with reference levels for knowledge and skills. In order to help people move from their actual levels to reference levels of knowledge and skills, at Week 1 we signposted users to parts of the programme that would help them improve. This is illustrated in 44 Users who had a decrease in knowledge score were reassured that making sense of all the information would take time, and any topics of confusion could be clarified by referring to other sources, including the main HeLP-Diabetes programme, peer support groups, face-to-face group education programmes and scientific research papers. These were all described and links were given to websites with further information in Week 4 Part 5 (“Moving on: the end of the beginning”).At Week 4, feedback was provided to record achievement and progress in learning. When scores improved, users were congratulated. When these parameters stayed the same, users were reassured that their self-efficacy, distress and knowledge would improve as they learned more about diabetes self-management. When the parameters did not improve, we explained why this can occur. For example, self-efficacy can decrease and distress can increase with greater awareness of complications. Knowledge can apparently decrease because the increase in the amount of information the user is exposed to may cause confusion. This fits with theory on cognitive overloading, which suggests that performance deteriorates with excessively high cognitive load.46 Alkhaldi et al. found that studies of the effectiveness of prompts to increase of digital interventions reported borderline small-to-moderate positive effects of technological strategies, including emails, to improve use of interventions.46 As we were mindful of the need for the intervention to be scalable if it were to be rolled out across the NHS, emails were chosen as a cost and time-effective strategy, compared to telephone or face-to-face contact.Personalized emails were sent to users to promote engagement and maintain motivation. Systematic reviews of strategies to improve adherence to digital health interventions provide some evidence of effect for email reminders.Emails were sent automatically if: (i) a user completed a session or; (ii) a user did not log in to the programme for a week or more. Emails were personalised by addressing users by their names. The emails sent on completion of a session included a congratulations message to acknowledge and monitor progress, and an outline of the topic of the next part of the programme. People who did not log in to the programme for one week received an email reminder that the programme was open to them, and a brief outline of the content of the next part of the programme. This was repeated if the user did not login for two weeks, and again if they did not login for three weeks. Emails did not include coaching or individual clinical advice.47 Studies of digital health behaviour change interventions have found that interventions that use more BCTs have larger effects compared to interventions that use fewer techniques.48 In light of this evidence the BCTs identified as effective for changing the behaviours relevant to type 2 diabetes  were adopted in the HDSO programme. . This is described in more detail below.The overall programme included support for behaviour change in the areas of diet, physical activity, taking medication, smoking cessation and moderating alcohol consumption. Goal-setting, action planning and reviewing goals were behaviour change techniques (BCTs) used to tailor the intervention and promote behaviour change. BCTs are based on theories of behaviour change, which predict how behaviour change occurs.49 The rationale for asking users to choose specific achievable goals is based on theories of self-efficacy,50 and goal-setting is used in other diabetes self-management programmes.51 Goal-setting increases motivation, as it allows us to compare our performance against personal standards we have set for ourselves.22 Easier, more proximal and specific goals are easier to monitor and more likely to be achieved.52In Week 2 of the programme, users were asked to set specific, measurable, achievable, realistic, time-bound (SMART) goals.Users could enter and save their goal onto the website see , along wLater in the course there were opportunities to review goals that had been set, and rate progress from 0 to 5. People were asked questions about how they felt about their progress, and given encouragement and feedback such as making a goal more achievable, or setting new reminders.This paper has described the final intervention that resulted after an iterative process of evaluation and modification. This section describes the modifications which were undertaken in order to produce the final intervention.27 The quantitative findings from these evaluations suggested that there were problems with uptake and completion of the programme. The qualitative findings suggested that there were both patient and programme factors influencing uptake and completion. We used the qualitative findings to inform modifications that we made to the programme. These are summarised below:Reducing the number of session from eight to four. The programme was shortened due to people’s concerns that it would take too long, or that they did not have enough time to complete it. All aspects of management of type 2 diabetes were retained. Topics relating to special situations such as ‘Managing my diabetes when I’m ill’, and ‘Working with diabetes’, were moved to the fifth bonus session.39 was removed because it was significantly longer than the other two questionnaires anduser feedback suggested patients found it burdensome and off-putting.Reducing the number of questionnaires from three to two. The AdKnowl (knowledge) questionnaireOnline self-registration was introduced to reduce the time it took patients to access the programme. People who contacted the HDSO team were emailed the URL of the self-registration page. Telephone support was still available for those who had difficulty.The evaluation process involved usability testing and “in the wild” testing in the NHS.53 There are therefore many patients with T2DM who are not newly diagnosed but have not received structured self-management education, and are in need of it. It was therefore decided to offer it everyone with T2DM, but to compare the uptake and completion rates between patients who were newly diagnosed and those who were not.We also made the programme available to everyone with T2DM, not just those who were newly diagnosed. We based this decision not just on uptake and completion data, but also on data from the National Diabetes Audit (NDA) which shows that not all patients are offered structured education at the time of diagnosis, and of those who are offered it, in 2016–7 only 7.1% attended.19Intervention adherence and fidelity were assessed by the HDSO team in a mixed methods study of feasibility, acceptability and impact. The processes and outcomes of this study are outside the scope of this paper, and are described in detail elsewhere.55 Descriptions of content are usually brief and vague, using broad categorisations such as ‘behavioural counselling’ or ‘motivational strategies’. In some cases, studies describe mode of intervention delivery such as ‘face to face’ or ‘nurse delivered’, but don’t mention content. In the field of T2DM, reviews of online T2DM self-management interventions have highlighted problems with lack of high quality descriptions of interventions. Greenwood et al conducted a review of reviews of technology-enabled diabetes self-management education and support, and found that education was described as either generalised, customised or a combination of the two, but poorly defined in more detail.15 The authors also found that feedback was described as live or automated, but the type of feedback that was given was not described.15 A 2013 Cochrane review of computer-based diabetes self-management interventions for adults with T2DM also found that interventions were not described in sufficient detail to replicate them.8 The authors found that this limited the possibility of specifying component behaviour change techniques, or identifying the likely mechanisms of action.This paper uses the TIDieR checklist to describe the HeLP-Diabetes: Starting Out programme. Items in the checklist include the theoretical underpinning, materials, procedures, providers, mode of delivery, structure, dose, personalisation and modifications of the intervention. Descriptions of interventions are important because they allow researchers to replicate and build on existing knowledge. In the field of behaviour change research, reviews have found that reporting of interventions in published evaluations is insufficient to reliably identify content and effective ingredients.The aim of this paper was to address some of these gaps in the literature, particularly on online interventions for T2DM self-management, by providing a detailed description of the intervention. Our description is novel in that it includes screenshots and summaries of the content of each session of the programme, and the details and rationale for BCTs and personalised components. This description serves to highlight the some of the strengths of the programme, which include the scope of information and the way information is presented ; the use of BCTs with evidence for effectiveness in behaviour change interventions ; and tailoring of feedback and email reminders to help users work out their level of knowledge and skills and how to improve. Modifications were made to the intervention after data were collected from usability testing and “in the wild testing”, to help improve uptake and completion. Further modifications could be made to the intervention to improve uptake and completion, such as mobile access via a smartphone application, and more regular email reminders to programme users with an increased amount of personalisation.16 This was the case for the description of HDSO, and subcategories needed to be added to some of the items from the checklist to capture the intervention more accurately. HDSO was a structured education programme, and so additional subcategories were particular necessary when it came to describing the programme content and structure. Hence we added subcategories to the ‘What’ and ‘When and how much items’ to include ‘Information provided to participants (programme content)’, ‘Spiral curriculum’ and ‘session descriptions’. The checklist provided an appropriate overall template for the description, but intervention developers may find that it needs to be adapted to make it more specific for particular interventions.The TIDieR checklist was chosen as a template for the description of the intervention, because of the clear structure it uses and the inclusion of items relevant to an online structured education programme . The TIDieR checklist allowed us to provide a clear structure for this paper, with items from the checklist used as section headings . The developers of the TIDieR checklist have acknowledged that describing complex interventions is challenging, and a checklist cannot capture the full complexity of some interventions.With this paper we have attempted to provide a description of the HeLP-Diabetes: Starting Out online structured education programme of sufficient detail, that researchers will be able to use to replicate and build on their interventions. It is hoped that this will help improve the quality and uptake of similar interventions in the future.Click here for additional data file.Supplemental material, sj-pdf-1-dhj-10.1177_2055207620975647 for Use of the TIDieR checklist to describe an online structured education programme for type 2 diabetes by Shoba Poduval, Jamie Ross, Kingshuk Pal, Nicola Newhouse, Fiona Hamilton and Elizabeth Murray in Digital Health


To assess the availability, accessibility, appropriateness and quality of adolescent sexual and reproductive health (ASRH) services in primary health care (PHC) facilities in Plateau State, Nigeria, a cross-sectional study was conducted in 230 PHC facilities across the three senatorial zones of Plateau state. Primary data were obtained through face-to-face interviews with heads of facilities from December 2018 to May 2019. An adapted questionnaire from the World Health Organization (WHO) was used, covering five domains, to ascertain the extent that ASRH services were available and provided. Very few PHC facilities in the state had space (1.3%) and equipment (12.2%) for ASRH services. The proportion of PHC facilities offering counselling on sexuality was 11.3%, counselling on safe sex was 17%, counselling on contraception was 11.3% and management of gender-based violence was 3%. Most facilities were not operating at convenient times for adolescents. Only 2.6% PHC facilities had posters targeted at ASRH and just 7% of the PHCs had staff trained on ASRH. These findings underscore that the majority of PHC facilities surveyed in Plateau State, Nigeria, lacked dedicated space, basic equipment, and essential sexual and reproductive health care services for ASRH, which in turn negatively affect general public health and specifically, maternal health indices in Nigeria. Structural changes, including implementation of policy and adequate additional training of healthcare workers, are necessary to effectively promote ASRH. Adolescents worldwide, including in sub-Saharan Africa, are known to engage in sexual behaviours that place them at risk of adverse sexual and reproductive health outcomes, such as condomless sex and multiple sexual partners . DespiteIn addition to increased risk of infection with HIV and other STIs, condomless sex is also related to the high rates of teenage pregnancy that are reported in most sub-Saharan African countries ,7,8. A sFurthermore, teenage pregnancies that are not terminated are associated with maternal reproductive risks for the teenage mother, as they are at higher risk of pre-eclampsia and eclampsia, antepartum haemorrhage and feto-pelvic disproportion, as well as obstructed labour and its sequelae, notably genital fistulae. Teenage pregnancy also contributes significantly to maternal mortality rates . FurtherThere is thus a clear need to reduce the risk of HIV and STIs as well as teenage pregnancy among adolescents in Nigeria. The World Health Organization (WHO) notes that the availability and access to quality sexual and reproductive health (SRH) information and services for adolescents is essential to reduce STI/HIV infections and teenage pregnancies . The proTo meet the WHO recommendations, the Nigerian government introduced a policy about ten years ago to address the lack of adolescent-friendly sexual and reproductive health (ASRH) services in health facilities, especially in primary health care facilities, which are the first point of call and the nearest health facilities in communities . The aimExtending our earlier research on the sexual behaviour, SRH challenges and factors influencing the health seeking behaviour of adolescents, the objective of this study is to contribute to an assessment of the state of implementation of the national reproductive health policy for adolescents in Nigeria. Specifically, the aim was to assess the current provision of comprehensive ASRH services in primary health care facilities in Plateau State, Nigeria, and to compare if there are any differences across the senatorial zones related to the variation in the settings. Notably, the northern senatorial zone is an urban zone, the central zone is semi-urban and the southern zone is rural. To assess the ASRH services, we drew on the WHO guidelines for youth friendly health care services  that undThis study was conducted in 230 public primary health care facilities (PHC) in six Local Government Areas (LGA) in Plateau State, Nigeria. Plateau State is located in north-central Nigeria, and shares boundaries with Kaduna State (northwest), Bauchi State (northeast), Nasarawa State (southwest) and Taraba State (southeast). Plateau State has an estimated population of 3,206,531 , with a growth rate of 2.8%; 32% of the population are adolescents . There a0 = Z2pq/e2) was used to calculate the sample size of health facilities to be included in the study [0/1 + (n0 − 1)/N), the estimated required sample size was 217 facilities but eventually assessed 230 facilities.We selected health facilities in two stages: First, two LGAs were selected from each of the three senatorial zones, using a simple random sampling technique. Second, we identified and included all the PHCs that provide services in the selected LGAs, while excluding PHCs that no longer provide services. The Cochran formula  were scored 1, and negating responses  were scored 0. Availability of ASRH space and equipment was assessed with five items regarding the availability of a dedicated ASRH waiting area, a dedicated space for ASRH consultation, a dedicated area for ASRH counselling, a dedicated ASRH examination room and ASRH specific equipment .Availability of ASRH services was assessed with nine items regarding the provision of counselling on sexuality, prevention of pregnancy/contraception, safe sex/STI prevention and gender-based violence (GBV); as well as the management of GBV, voluntary counselling and testing (VCT) for HIV; and post-abortion care.Accessibility of ASRH services was assessed with four items regarding distance of the facility from the main road, distance from places in the locality where adolescents gather, distance from school in the locality and opening/closing hours of the PHCs.Appropriateness of ASRH services was assessed based on the availability of specific clinic hours for adolescent consultations, availability of posters and other ASRH educational materials, the availability of dedicated ASRH peer education staff, the provision of outreach services for adolescents, and the availability of ASRH services without parental consent.Quality of ASRH services was assessed with three items regarding the availability of guidelines for provision off ASRH services, whether staff were trained on ASRH and the availability of referrals to specialized services if necessary.Data were analysed using SPSS version 23  For each of the three senatorial zones, we first computed the proportion of PHC responding affirmatively to each of the items pertaining the various domains of the adapted WHO guideline for ASRH . For each domain, we also established if a PHC responded affirmatively to all items, reflecting that a PHC met all criteria for that domain. We also compared the proportions of PHCs across the three senatorial zones that responded affirmatively to specific items per domain, using chi-square tests or Fisher’s exact tests, as appropriate. Furthermore, for each of the domains we compared the observed proportions of PHC per senatorial zone that met all criteria to the target of the National Sexual and Reproductive Health Policy stipulating that at least 50% of PHC should provide comprehensive ASRH services. Ethical approval was obtained from the Jos University Teaching Hospital Human Research and Ethics Committee before the commencement of the study (reference number JUTH/DCS/ADM/127/XXVIII/1187). Permission to undertake the research was also obtained from the Ministry of Health, as well as from the chair persons of all LGAs. At each PHC facility, written informed consent was obtained from the officers who completed the questionnairesp = 0.630).The findings from this study show that the state did not met the criteria for adolescent friendly SRH service as stated in the national policy. As can be seen in With regards to the availability of dedicated space and equipment for ASRH, the results shown in As shown in With regards to the accessibility of the health facilities and services, the results in Overall, the SRH services in the state were not appropriate for adolescents see , and allThe quality of ASRH services was poor across the three senatorial zones, and no significant differences were found.One of the most critical ways of meeting the sexual and reproductive health needs of adolescents is through the provision of comprehensive, adolescent-friendly sexual and reproductive health services. Most adolescents are in need of various SRH services and studies in Nigeria and elsewhere have shown they at times self-medicate or go to unqualified providers for help, and may risk their health and lives as a result of unsafe practices ,29. The For SRH services to be adolescent friendly, several factors must be considered, according to WHO guidance: the availability of dedicated space and equipment for ASRH, the availability of specific ASRH services, the accessibility of ASRH services, the appropriateness of ASRH services and the quality of ASRH services . The resIn the present research, the majority of the PHCs across the three zones did not meet basic requirements for the provision of ASRH services. Facilities that were sampled in this study generally lacked space and equipment for ASRH. For example, many of the facilities did not have a dedicated space for consultations with adolescents, no waiting rooms to separate adult clients from adolescents and no dedicated examination rooms for adolescents. The equipment was all adult size, and they lacked sphygmomanometers with the cuff for adolescents and had no adolescent size speculum for vaginal examination. Traditionally, health facilities in Nigeria in general are designed for adults, with no consideration for adolescents. Many of the facilities lack separate spaces for adolescents, have no waiting room to separate adult clients from adolescents and have no separate examination room for adolescents ,24.The provision of essential ASRH services was below the benchmark stipulated by the national policy. Very few PHCs in the three zones offered critical ASRH services such as counselling on sexuality, contraception or safe sex/STI prevention. Although family planning services were available in most facilities, these are usually not targeted at adolescents but at married women. Counselling on gender-based violence was least likely to be provided, probably because it is not recognized as a reproductive health problem. This finding is in line with an assessment of youth-friendly health services in Nigeria, which also found that specific ASRH services, such as counselling on safe sex and provision of contraception, were either not available or of poor quality in centres designated to provide these services ,26. OnlyASRH services should be accessible to those who need it, and findings show that most of the facilities were situated close to schools and other places where adolescents gather in the localities. While this could have been a strength and opportunity to leverage on in reaching out to adolescents, that was not the case, as it was found that the opening and closing hours of the majority of the facilities were not suited to adolescents’ needs. The facilities did not operate at hours convenient for adolescents , and had no separate hours for adolescent counselling. Again, the Southern senatorial zone did best, but still less than 50% of facilities had convenient operating hours. Other studies have shown that adolescents have preferred hours for visiting health facilities, usually when adults are not around, because of privacy and confidentiality ,31. AdolHealth education is an important approach to meeting the SRH needs of adolescents, which was lacking in almost all the PHCs. There were no appropriate SRH health education materials like posters, and peer education was not provided in most of the facilities because of an absence of peer educators. The southern senatorial zone also scored best with respect to ASRH health education with respect to compared to the others. Outreach services have been identified as a promising approach to meet adolescents’ SRH service needs, bearing in mind that they value confidentiality and most will not want their parents to know they access such services ,34,35. UIt is important that health care providers are knowledgeable about ASRH, and that ASRH service delivery is support by a policy guideline to ensure the availability and quality of services. Unfortunately, policy guidelines were generally lacking in PHCs in the three senatorial zones. Furthermore, very few facilities had staff specifically trained to deliver ASRH, especially in the central zone. A lack of staff training for ASRH was also reported in studies conducted in Tanzania and Nepal, where a lack of qualified staff affected the utilization of ASRH services ,36,37,38Some limitations of the current research need to be acknowledged: The study could have been subject to a social desirability bias in healthcare workers’ responses, i.e., a desire to present the facility in a good light in order to comply with policy recommendations. However, because the data collectors insisted on viewing and inspecting the infrastructure and the equipment, we feel this bias has been avoided. Additionally, our study was limited to public primary health care facilities and did not explore the private health facilities—it could be possible that some private health facilities may have adequate ASRH services in place. It would have been more holistic to assess all categories of health facilities. However, as the public health facilities are the first go-to for the majority of adolescents, particularly in the rural areas, we felt that ASRH at these facilities should be investigated first.This study showed that most of the PHCs that were surveyed in this study lack the basic infrastructure and equipment for the provision of ASRH and also to do provide essential ASRH services. Only few PHC facilities, especially in the southern senatorial zone, had a dedicated counselling area for adolescents and also provided essential ASRH services, such as counselling on safe sex and prevention of pregnancy. While about half of the facilities were situated around schools and other places where adolescents gather, outreach activities to contact and provide SRH services for adolescents were not carried out in most of the facilities. Most of the health care providers had no training in delivering ASRH services, and thus likely lack skills and competencies in ASRH service delivery. This may explain why even basic ASRH services were generally not provided. Overall, the availability of ASRH space and equipment, specific ASRH services and appropriate ASRH service delivery were suboptimal across the three senatorial zones in Plateau State, as was the quality of ASRH services. While the health system is not the only factor affecting the sexual and reproductive health of adolescents in Nigeria, the lack of basic infrastructure and essential SRH services for adolescents will adversely affect any efforts to achieve meaningful reduction in adolescents’ sexual and reproductive health challenges, which in turn contribute to the poor maternal health indices in Nigeria. To effectively promote ASRH, the country needs to take a critical next step of going beyond policy formulation to ensuring the implementation of services to achieve the policy targets. This likely requires a restructuring to make PHCs more adolescent friendly, and additionally requires an urgent strengthening of the training of health care providers to increase skill in ASRH service delivery. These actions should be supported by standard management guidelines and procedures issued at government-level and that need to be made available in all PHCs providing ASRH services in Plateau State, and Nigeria more generally.


Background: Previous research has identified a link between the loss of a significant person, grief complications, and substance abuse. People with substance use disorder (SUD) are more vulnerable to complicated grieving symptoms following loss. From sociocognitive theories, the model of coping with stress assumes that substance use is one of the responses used to cope with traumatic life events. The main objective of this study is to identify the coping strategies of people with SUD and to analyze their relationship to complicated grief (CG).Methods: A sample of 196 bereaved drug-dependent patients was assessed, after providing written consent, in sociodemographic variables, drug and bereavement related characteristics, CG symptomatology (Inventory of Complicated Grief) and coping strategies (Coping Strategies Inventory).Results: There are differences in relation to the coping strategies used among patients with CG, using more those focused on emotional expression, social withdrawal, wishful thinking, and self-criticism.Conclusion: We can conclude that, in general, CG in patients with SUD is more associated with the use of less adaptive coping strategies. This data can contribute to a better understanding of the different variables involved in the grieving process among people with SUD. It is important to point out the clinical implications of addressing what the coping strategies associated with improved grief outcomes among people with addiction problems are. The identification of risk factors and protective factors associated with substance use and concurrent problems is a substantial area of research in terms of preventive and intervention strategies in vulnerable populations, such as people with substance use disorders (SUD). Numerous studies have investigated the relationship between coping and different clinical disorders course , and havPrevious research has identified a link between the loss of a significant person, grief complications and substance abuse . In addiEstimating the incidence of CG symptoms is not easy since its study has been carried out on different samples and with different definition criteria . In geneFrom sociocognitive theories, the model of coping with stress assumes that substance use is one of the responses used to cope with traumatic life events . In geneMost people encounter a challenge in their emotional states as a component of regular day to day existence. Particularly, the majority of SUD individuals may experience overpowering feelings, regardless of whether as a consequence of the impact of drugs, withdrawal, or the everyday relation with stressors. Indeed, figuring out how to balance these emotional states is a core aspect related to SUD treatment .Sometimes, when coping strategies are deficient, bereaved people can easily develop complications in bereavement, which is associated with multiple physical and mental problems that cause social disruption and significantly reduce quality of life . PreviouAlthough there is a lot of research that has analyzed the relationship between coping and substance use , and alsThe current study is part of a larger research project that aims to investigate different variables related to CG in SUD patients . The samp = 0.02).The sample was based on a consecutive non-probabilistic convenience sample of 196 SUD patients at the Public Addiction Treatment Centre in Spain. The inclusion criteria were that they: (1) had a diagnosis according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria of alcohol, cocaine or heroin dependence; (2) had suffered the loss of a significant person at some point in their life and before the year prior to the study, and (3) abstinence during the last month. Related to the sociodemographic variables, 78.1% were men and 20.2% women. The average age was 45.6 years . 37.2% were married or had a partner. More than a half of the sample (65.3%) reported primary education and the rest had secondary or higher education. Regarding the main diagnosis, 68.9% had alcohol dependency, 18.4% heroin dependency, and 12.8% cocaine dependency. Regarding professional situation at the time of the evaluation, 63.3% reported being retired, unemployed, inactive or receiving disability aid, and 36.7% were actively working. Mean time since the death of the significant person was 11.97 years . Complicated grievers reported less time since death  than adaptive grievers . According to them, the study expires with the current regulations of the International Conference of Harmonization of the Procedure of Good Clinical Practice (CPMP/ICH/135/95) as well as the International Guidelines for the Ethical Review of Epidemiological Studies. Those who voluntarily wanted to participate and signed the informed consent were evaluated through a clinical interview with the psychologist (second author) and were administered the psychometric questionnaires included in the protocol. The duration of each of the interviews carried out was about 1.5 h.n = 67). The alcohol group and the heroin and cocaine group were formed according to the main diagnosis. We use these two groups in order to separate legal and illegal substances group. Pearson correlations were used to test associations among quantitative variables of coping and CG. The Student’s t-test was used to determine differences between groups (main substance diagnoses/CG) in coping. In order to identify the coping strategies related to the presence of CG, we conducted a multiple linear regression model. Data processing and analysis were performed using the SPSS statistical program version 21.0 for Windows .The CG group was formed by the participants scoring higher than 25 on the ICG  in the CG scores between the alcohol group  and the heroin and cocaine group . In the first group, there was 30% of the cases with CG, and in the second group was 40% of CG.In relation to the types of substance, there are no significant differences  and for cocaine and heroin consumption  is important because at the clinical level the therapeutic groups are often separated. In terms of coping, patients with a main diagnosis of alcohol dependence used more strategies, and higher than those related to wishful thinking, cognitive restructuring, and problem avoidance. The difference found in cognitive restructuring could be associated with cognitive impairments that are assumed to differ between substances . There iFinally, our work concluded that social withdrawal and expression of emotion coping strategies were predictive variables of a CG dimensional factor. On the one hand, the active avoidance of contact with other people and, on the other, the need to release emotions were two of the resources that identified the presence of CG in people with SUD. According to previous research, CG tends to be associated with emotion-centered rather than problem-centered coping  and avoiOverall, these results indicated that the co-occurrence of two serious health conditions (addiction and CG) was related to poorer management of stressful situations. Maladaptive coping, characterized by using disengagement strategies and an important lack of engagement strategies, was the main result found in this study.The current research had some limitations. One of the most important is the cross-sectional design, which was an impediment to consider and justify the directionality (cause-effect) relationship between CG and coping in the SUD sample. Future longitudinal studies are necessary in order to establish a proper sequence of the events occurred. The second limitation was the size of our sample, as well as the use of a convenience sample which limit the generalization of our results. Another important limitation was that the presence of psychiatric disorders that could be associated with CG was not evaluated in the present study. Fourth, coping assessment was relied on a self-reporting measure (CSI). Finally, in this study, multiple comparisons correction was not made. Despite these limitations, the study provided significant new data related to the specificity of the sample. Future research should analyze the impact of other sociodemographic, personality, and clinical variables related to the coping strategies among SUD population. The period since the death of the significant person is another of the variables that should be analyzed in depth. Trajectories of CG can vary between subjects and numerous risk factors can be associated.Our findings may contribute to a better understanding of the different variables involved in the grieving process among people with SUD. It is important to point out the clinical implications of addressing which coping strategies are associated with a better evolution of grief in people with addiction problems. Clinical benefits can be derived from these results. In one hand, training people to employ effective coping strategies in their lives could prevent different health and psychological problems. On the other hand, focusing therapy groups on identifying and raising awareness of less adaptive strategies used will have a very beneficial effect on the course of substance use disorder. More personalized interventions are important in the process of recovery and specific interventions should target those people with special clinical conditions. New treatment approaches for SUD individuals with CG should focus primarily on decreasing frequently occurring mechanisms, such as self-criticism, desiderative thinking, and social withdrawal, and increasing emotional and cognitive strategies linked to better management of stressful situations, such as problem solving, cognitive restructuring, and social support.The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation.The studies involving human participants were reviewed and approved by Institutional Ethics and Research Review Board of the Institut d’Assistència Sanitària (IAS). The patients/participants provided their written informed consent to participate in this study.BC and LM conceived and designed the research. LM collected field data. BC wrote the manuscript. Both authors interpreted the results and approved the final manuscript.The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.


The registry is focused on collecting research data on various laser treatments for skin disorders.While laser technology has expanded the armamentarium of treatment for various skin diseases during the past years, heterogeneity in study outcomes hampers comparability and appropriate evidence synthesis. Part of these issues can be addressed by developing a generic outcome set. Using the Delphi method, this study aims to seek consensus between key stakeholders on relevant generic outcomes . The study is registered with the Cochrane Skin Core OUtcome Set INitiative) and the Core Outcome Measures in Effectiveness Trials initiative. Procedures will be conducted according to the Declaration of Helsinki. The findings will be disseminated through peer-reviewed publications and conference presentations. This protocol outlines the first international consensus effort to develop a generic outcome set for use in the international Laser trEAtments in Dermatology registry.what to measure) to patients and health professionals is crucial.With advances in laser technology, considering outcomes of importance .6Another issue hampering evidence synthesis is heterogeneity of outcome definition, measurement and reporting in laser research. Patient-reported outcomes, such as ‘patient experience of laser treatments’ and ‘health-related quality of life’, are often not reported and together with selective outcome reporting in laser research, it is all a serious threat to comparative effectiveness research as it limits the ability to compare, contrast and combine individual studies.9 10To overcome this issue in the field of laser dermatology, the development of the International Laser Treatment (Laser trEAtments in Dermatology (LEAD)) Registry has been proposed to initiate collaborative data pooling of a wide range of skin disorders. The development of a registry may be the key to the lack of solid evidence for LEAD; however, well-defined standardised and generic outcomes are required for its establishment.what to measure) for the purpose of the LEAD registry. The GOS is intended to be applied for the assessment of various, unrelated skin diseases that are treated with different types of lasers.To address the variations in outcome reporting, organisations such as the Core Outcome Measures in Effectiveness Trials Initiative (COMET) bring together researchers interested in developing a standardised set of core outcomes in various health-related fields.In summary, there is an urgency of using the same generic outcomes in laser therapy. Hence, establishing consensus on the relevant outcomes for the LEAD registry will promote clinical researchers to use outcomes chosen by consensus that are relevant to patients and clinicians. The use of generic outcomes support data synthesis for many diseases in dermatology. The protocol outlines the context, scope and methods for the development of a GOS to be implemented in the LEAD registry.The aim of this study is to reach consensus between various stakeholders on generic outcomes relevant for the LEAD registry.Our study objectives are:To identify outcomes that have previously been used and reported in RCTs, cohort studies, case-control studies and case series from a literature review and classify these outcomes into domains according to the COMET taxonomy.To reach consensus between stakeholders on the outcomes of a GOS to be implemented in the LEAD registry.The registry is envisioned to suit all types of laser interventions for skin disorders in dermatology including vascular, pigmented or inflammatory lesions, benign tumours, scars and hair follicle-related skin conditions treated with lasers. The GOS is intended for use in the LEAD registry, with the focus on prospectively recording the effectiveness and safety of cutaneous non-cosmetic laser interventions. Therefore, we excluded laser-assisted drug delivery, low laser level therapy, body contouring, skin tightening, hair removal, rejuvenation and antiageing procedures. Furthermore, because of the distinctive mode of action and use in daily clinical practice, laser-assisted drug delivery, low laser level therapy and laser procedures for (leg) veins were excluded.The steering committee  provide input at critical points of the study such as protocol development, stakeholder recruitment, consensus process and the consensus meeting. Three members of the steering committee  coordinate the overall project, ensure methodological quality of the project and make key decisions. All members of the steering committee will participate in the Delphi procedure as well as in the final consensus meeting. The steering committee has representatives from The Netherlands, Denmark, Egypt, France, Germany, Israel, Italy, Japan, Spain, Switzerland, Thailand and USA, with extensive expertise in various laser treatments, outcomes research and clinical research. A list of all members of the steering committee is given in 10.1136/bmjopen-2020-038145.supp1Supplementary dataPhase 1: identification of potential outcomes important in laser treatments by means of aA systematic review to form the preliminary list of outcomes for the Delphi survey.Classification of outcomes into domains according to the COMET taxonomy.Phase 2: A consensus process involving key stakeholders who are able to suggest additional outcomes during the first round and who will rate the importance of outcome for reaching consensus on the GOS by means of aThree-round Delphi survey.Expert consensus meeting. Attended by representatives of all stakeholder groups.This study is registered with the CS-COUSIN and COMET initiative.17The first phase of the study is to identify which outcomes should be measured and reported in a registry on laser treatments for skin disorders  of the steering committee. The preliminary list of outcomes classified to domains will be included in the consensus process.For investigating crucial outcomes in context of the LEAD registry, a Delphi study will be conducted. The Delphi is based on a structured process for gathering and condensing knowledge from key stakeholder groups by means of three rounds with a series of questionnaires The involvement of a variety of stakeholders is a key part for the identification of outcomes and strongly recommended by methodologists.21The following representatives from four international key stakeholder groups are involved in the process of reaching consensus on outcomes:Patients of age 18 with vascular, pigmented, inflammatory, metabolic or infectious lesions, benign tumours and hair follicle-related skin conditions treated by lasers.Patient representatives involved in patient associations that raise awareness on the impact of vascular, pigmented, inflammatory, metabolic or infectious lesions, benign tumours and hair follicle-related skin conditions.Healthcare professionals: laser experts who treat patients with vascular, pigmented or inflammatory, metabolic or infectious lesions, benign tumours, hair follicle-related skin conditions and who are involved in research on laser treatments.Healthcare professionals: general physicians who treat patients with dermatological indications.There is no robust guidance for calculating the number of participants needed for a Delphi study and expectations are based on COMET Initiative guidelines and previous literature.10.1136/bmjopen-2020-038145.supp4Supplementary dataParticipants will be divided into a group of patient and a group of health professional, leading to separate scoring of outcomes. All participants will be asked to rate the importance of each of the outcomes using the Grading of Recommendations Assessment, Development and Evaluations approach. The scale will range from 1 to 9 and will be categorised as follows: 1–3 ‘not important’; 4–6 ‘important but not critical’; and 7–9 ‘critical’.During the first round of the Delphi survey, baseline characteristics  will be obtained from all participants. Patients will be asked for their medical indication and type of laser treatment, and whether any complications have occurred during treatment. Health professionals will be asked their specialty , workplace  and years in practice. Next, participants will be asked to score listed outcomes and will have the option to suggest any additional outcomes that are not yet presented in the preliminary list.In the second and third Delphi rounds, all participants will receive feedback on the scores of the previous round in both the patient and the health professional group. The outcomes from the previous rounds will be presented with the median scores from each stakeholder group combined with a histogram showing the scoring distribution. Subsequently, participants will be asked to score all outcomes for which consensus has not been reached, in the same manner as in the first Delphi round. Outcomes for which there was only consensus within a single stakeholder group will also be shown to the other stakeholder group to evaluate whether consensus can be achieved in both stakeholder groups.The definition of consensus is presented in In case complete consensus is reached in the Delphi procedure on the outcomes of the GOS, no formal consensus meeting will be organised. However, the results of the Delphi will be discussed with three members of the steering committee  to check misconceptions in the Delphi method and to safeguard a well-defined GOS. For outcomes for which consensus definition during the Delphi has not been reached, we invite 15 participants from across all stakeholder groups to participate in an online expert consensus meeting within 2 months after the close of round 3. The primary goal of the meeting is discussing the ‘no consensus’ outcomes. Consensus results from the Delphi can be reversed in this meeting if reasons are very strong and clear.Patient and public were not involved in the development of this study protocol. However, patients will be involved and included within the Delphi procedure as expert group. Consensus methodology will ensure that the opinions and preferences of patients will be given the same weighting as those of the laser experts and health professionals. Furthermore, patients will participate in the final consensus meeting. We disseminate the main results to study participants and patients by email which will include a copy of the final outcomes of the GOS. In addition, where approval has been given, participants (including members of the public) will be named as contributors in the acknowledgements section.By the end of this study, we hope to reach consensus on a GOS that could be implemented in an international registry with a research focus, that collects data of rare skin diseases treated by lasers. Analysis of registry data provides insight into effectiveness and safety of different laser treatments across many skin diseases, laser centres and countries.There are several strengths using the Delphi method for this study. First, the Delphi method allows to recruit a large number of laser experts, physicians and patients from diverse regions globally. The diversity in the experts’ backgrounds and expertise ensures maximum impact of the results. Second, the Delphi method is the accurate tool in consensus processes in various stakeholder groups as individuals are able to express their own opinions and feedback can be provided in a controlled anonymous way. This means that there is room for individual disagreement but also consideration of the answers given by other individuals and stakeholder groups as a whole. However, there are also limitations of the Delphi method. Results are dependent on the composition of the participants. There is a risk of relative uneven representations among patients, but also health professionals. Especially, when focusing on a specific group of rare skin diseases, selection bias could result in insufficient representation of other skin disorders. We request health professionals of the steering committee to recruit patients with three different skin disorders. Through this method, we hope to ensure that all subgroups including vascular, pigmented, metabolic, inflammatory lesions, benign tumours and hair follicle-related skin conditions will be adequately involved. For patients, it might be a barrier to imagine what is important to be included in a registry for a broad range of diseases, rather than one disease that is important to themselves. We will stress the importance of agreeing on a GOS for all diseases in each round of the Delphi survey and consensus meetings. Photographs will be included to illustrate the variety of skin disorders that are involved. To provide the highest possible input, we will extend our invitation to take part in the Delphi survey to patients and health professionals in Africa, Asia, South-America, Australia, in addition to Europe and North-America. With support from all panel members, we hope to ensure that the LEAD registry will be internationally relevant, accepted and ready to use.The identification of generic outcomes for registry use is ongoing and in the initial phase. A systematic review has been performed to explore current outcomes used and reported in laser dermatology. We are currently preparing to recruit participants for the Delphi study. The generic outcomes are expected to be implemented in the laser registry in 2020.The medical research ethics committee of the Academic Medical Center Amsterdam confirmed that the Dutch Medical Research Involving Human Subjects Act does not apply to this study (W19_290 # 18.336) and that complete approval of this study by the committee is not necessary. All participants involved in the Delphi study will be asked for their consent before taking part. All procedures will be conducted according to the Declaration of Helsinki. All results from the consensus study will be reported in peer-reviewed indexed journals. The data will be presented at conferences chosen to reach a wide range of knowledge users.