A new bilingual (English and French) Internet-based self-management program, Teens Taking Charge: Managing Arthritis Online, for adolescents with arthritis and their parents was developed following a needs assessment.This study explored the usability (user performance and satisfaction) of the self-management program for youth with juvenile idiopathic arthritis (JIA) and their parents to refine the health portal prototype.A qualitative study design with semi-structured, audio taped interviews and observation by a trained observer was undertaken with two iterative cycles to determine the usability  of the user interface and content areas of the intervention. A purposive sample of English-speaking  and French-speaking  adolescents with JIA and one of their respective parents/caregivers were recruited from 2 Canadian tertiary care centers. Descriptive statistics and simple content analyses were used to organize data into categories that reflected the emerging usability themes.All of the participants had access to a computer/Internet at home; however, adolescents were more comfortable using the computer/Internet than their parents. Adolescents and parents provided similar as well as differing suggestions on how the website user interface could be improved in terms of its usability . There were no major differences in usability issues between English- and French-speaking participants. Minor changes to the website user interface were made and tested in a second cycle of participants. No further usability problems were identified in the second iterative cycle of testing. Teens and parents responded positively to the appearance and theme of the website  and felt that it was easy to navigate, use, and understand. Participants felt that the content was appropriate and geared to meet the unique needs of adolescents with JIA and their parents as well as English- and French-speaking families. Many participants responded that the interactive features  made them feel supported and “not alone” in their illness.We describe the usability testing of a self-management health portal designed for English- and French-speaking youth with arthritis and their parents, which uncovered several usability issues. Usability testing is a crucial step in the development of self-management health portals to ensure that the various end users (youth and parents) have the ability to access, understand, and use health-related information and services that are delivered via the Internet and that they are delivered in an efficient, effective, satisfying, and culturally competent manner. Juvenile idiopathic arthritis (JIA) is the most common rheumatic disease in childhood . JIA canSelf-management interventions typically encompass educational strategies designed to achieve optimal patient knowledge, understanding, beliefs, and skill acquisition as well as to provide meaningful social support . HoweverWith emerging interactive and communication technologies , new media for the delivery of health interventions are now available . The IntWe developed the Teens Taking Charge: Managing Arthritis Online treatment program. This program is a multi-component, interactive Internet-based program consisting of JIA-specific education, self-management strategies, and social support (in the form of a discussion board and video clips) designed for youth with JIA and their parents that is available in English and French. This program was developed and evaluated using a sequential phased approach consisting of program development, usability testing, and outcome evaluation . In PhasUsability testing is a critical step in the development of Internet interventions and solicits end-user feedback to learn what works, what doesn't, and where gaps in information or functionality exist using iterative cycles to refine the prototype ,17. ThesAdolescent/parent dyads were recruited from 2 large rheumatology clinics in university-affiliated pediatric tertiary care centers. Dyads were eligible to participate if (1) the adolescents were 12 to 18 years of age, (2) the adolescent had been diagnosed with JIA by a rheumatologist, and (3) both adolescent and parent were able to speak and read English or French as their primary language. Adolescents were excluded if they had major cognitive impairments or comorbid medical or psychiatric illnesses that may have impacted their ability to understand and use the Internet program. Eligible patients listed on the participating hospitals’ rheumatology database registries were sent a study information letter inviting them to participate. This method was supplemented by convenience sampling of patients attending a regularly scheduled clinic visit to achieve a heterogeneous sample in terms of age and disease severity. The study was approved by research ethics boards at both sites.A qualitative usability testing approach with semistructured, audio taped interviews and observation by a trained observer was undertaken, with iterative cycles to determine the usability of the Internet intervention and to further refine the prototype ,17. ThisAfter giving informed consent, participants were asked to complete a general information questionnaire that included questions about demographic characteristics and level of comfort with computers and the Internet. A health information questionnaire was completed by a research assistant to gather additional demographic and disease-related data from the patient’s chart  . AdolescThe Internet program is a 12-module interactive multi-component treatment protocol that consists of JIA-specific education , self-management strategies , and social support . There are two modules specifically for parents to help them promote healthy teens’ behaviors. The program content was developed by a team of experts from across Canada, written at a grade 6 to7 reading level, and geared to the needs identified by adolescents and their parents . The TeeIn the website architecture, four applications are integrated together to provide the experience of a single website to the users. These applications include (1) the content application for both English and French, which is delivered by the AboutKidsHealth.ca content management system; (2) the forums application, which provides a framework for creating and managing discussion forums for the users; (3) the survey application, which provides support for creating, managing, and gathering survey questions and responses; and (4) the custom application, which provides management of interactive questions. Each of the applications has its own database model where data are managed and stored. Security and restriction of the program are based on the ASP.NET membership model and ensure that only authenticated users with the allowed permission  are able to view the allowed content and to participate in the private forums. The membership model works across several applications and accommodates a single sign-on process so users do not have to sign in to every application and thus can move across the applications seamlessly. Users get the best experience of the Teens Taking Charge: Managing Arthritis Online treatment program with Internet Explorer 6/7 and Flash player 9+ on a Windows XP/Vista platform. The given computer requirements ensure that users are able to view the animation and video streams within the site and as well view the embedded interactive forms, which are delivered via an AJAX interface that captures the responses to a database. The AJAX interface reduces the number of clicks and pages to keep the user experience intuitive. Please see The quantitative data from the questionnaires was analyzed using SAS version 9.1.3  to deterPatients meeting the study criteria who attended clinics from August 22 through October 2, 2008, were invited to participate in this study at the two sites. Of the 20 eligible English-speaking dyads, 11 (55%) agreed to participate, and of the 23 French-speaking dyads, 8 (39%) agreed to participate. The mean age of the sample of adolescents was 15.7 years (SD 1.5), and 14 (74%) were female. Of the 19 adolescents, 15 (79 %) were in high school. The mean duration of illness was 6.99 years . The most common disease onset subtype was polyarticular arthritis with 7 of the 19 adolescents (37%) having this diagnosis; the average disease severity rating was 0.92 out of 10 . Of the participating adolescents, 100% had a computer at home, and 100% were comfortable using a computer. These findings are in accordance with recent data that 88% of 15-year-old Canadian students have at least one computer at home and are comfortable using the computer/Internet . ThirteeUser performance was measured in terms of (1) ease at which the user could navigate through the site, (2) ease of learning in terms of how fast a user who has never seen the user interface before could learn it sufficiently well to accomplish basic tasks, and (3) the frequency and severity of errors. Overall the participants rated the Teens Taking Charge: Managing Arthritis Online health portal as easy to use. All of the adolescents were able to navigate through the site with little to no guidance, whereas 5 of the 19 parents (27%) required several minutes to orientate themselves to the site before confidently navigating the interface. In terms of ease of learning, all participants were able to accomplish the standardized set of basic tasks in 35 minutes or less, as was predicted.During the usability testing, three types of errors were observed: navigation errors, presentation errors, and control usage problems. Navigation errors were defined as failures to locate functions, excessive keystrokes, or failures to follow recommended screen flow. There were minimal navigation errors with 10% of adolescents and 21% of parents experiencing one. All navigation errors encountered were easily recovered from and were considered to be minor. No changes were made based on these findings. Presentation errors were defined as failures to locate and properly act upon desired information or selection errors due to labeling ambiguities. These were found to be concentrated in the medication module. Presentation errors were encountered by 58% of parents and 26% of adolescents on the homepage of the medication module, which were coded as fatal errors. Users found the labeling on the medication homepage by classification of medication type to be unclear and were unable to navigate to the information they wanted about their/their child’s particular arthritis medication(s). This page was changed by adding a list of generic medications grouped by their drug classification with direct links to each medication discussed in that section to enhance user performance  and language.The overall design aesthetics of the website were felt to be a critical factor from the perspective of the end users that helped to enhance engagement and motivation to use the site. Four subthemes were identified under the broad theme of design aesthetics including layout, navigation, visual assets, and visual appeal. Differences were found between both adolescents and parents and French and English participants. Adolescents wanted the large amounts of text “chunked up” and broken up with visual assets , while parents did not mind having large amounts of text to scroll through. Similarly, 42% of parents indicated that they would like a larger font; however, only 15% of adolescents cited this as a problem. Furthermore, 16% of both French adolescents and parents suggested adding labels to the medical diagrams, where this was not an issue with English participants. Finally, all the participants felt that the most important information on each page should be at the top of the page, otherwise teens will not scroll down to find it. See All of the participants commented positively on the content of the program including the text, images, and multimedia components. Four subthemes were identified under the broad theme of content including completeness, understandability, quality and credibility, and relevance. For the most part, participants were satisfied with the completeness of content; however, 21% of adolescents and 32% of parents suggested additional content. The most common suggestion for additional content was for videos or photos to show teens how to do the various exercises. However, due to budgetary and time constraints we were not able to add these. Additionally, 89% of adolescents and 95% of parents felt that the content was relevant, and 74% of adolescents and 79% of parents rated the content as trustworthy. The site was created with a focus on understandability and all text was developed at a grade 6 to7 reading level. Participants expressed appreciation for this consideration and generally found the information, language level, and explanation of medical terminology (in a glossary of words) to be helpful in furthering their understanding of topics that were either unclear, new to them, or both. French grammar errors were found by 20% of French adolescents and 5% of French parents. These errors were corrected following usability testing. See Functionality and features refers to the adaptive and interactive features of the website. These included a glossary of terms, relaxation audio clips, printable PDF information forms for teachers, click-through animations , videos of teens with arthritis, interactive questions (weekly knowledge quizzes), a journal for keeping track of symptoms and weekly goals, and a discussion board with an “Ask an Expert” feature where participants could send an email question to a designated health care professional. Participants unanimously felt that these adaptive and interactive features allowed for an increased level of personalization of the website content to meet the individual needs of the users and were all good features of the website. They also commented that these features would help to enhance motivation and engagement with the program.Sociability refers to the ability of the Internet program to support social interactions among participants. The site featured 2 discussion boards, one for teens and one for parents, video clips of teens talking about ways they have learned to manage their arthritis, in addition to written stories of hope submitted by teens with JIA. All of the participants commented that these features of the site would help to ease feelings of hopelessness and particularly isolation. However, while almost all teens (95%) indicated that they would like to use the discussion forum to chat with other teens; less than one-half (42%) of parents felt they would use a parent discussion forum. Many teens commented that they did not know another teen with arthritis and that the interactive features  made them feel supported and “not alone” in their illness.Overall, the program was well received, and 84% of all participants expressed a desire to use the program in the future. Most participants felt the program would have been especially helpful when they were first diagnosed with JIA. Adolescents and caregivers also liked that the site was geared toward the promotion of self-management skills to reduce symptoms, improve quality of life, and promote transition to adult health care services.This study assessed the user performance and satisfaction with a new health portal designed to help youth with arthritis learn how to better manage their chronic health condition. This health portal is unique in that it was developed for two different end-user groups (youth and their parents) and in two languages (English and French). Testing uncovered user performance errors (minor navigator and major presentation and control usage errors) as well as areas to enhance user satisfaction. Adolescents and parents provided ideas on how the website user-interface could be improved in terms of its usability . Changes were made to the health portal that corrected the errors uncovered and improved user satisfaction. Formative usability testing was a crucial step to help ensure the relevance of the content and that the website was easy to use and learn, efficient to complete, and acceptable to youth and their parents. The results of this study also provide a model for formative evaluation of other online interventions for delivery of chronic disease self-management, especially those that target different end users and are provided in multiple languages.This study also highlights the value of conducting usability testing prior to wide scale outcome assessment  and/or implementation to ensure that the end product is usable and acceptable to the end users (youth and parents), and is culturally competent when targeting different languages. While there is increased attention regarding the need for health care professionals to provide face-to-face culturally competent care, there is little research examining how to provide culturally competent health interventions delivered over the Internet. Culturally competent care is defined as the ability to effectively work within the cultural context of the client . While oFurthermore, these types of interventions have typically been developed by health care professionals  with little input from the end users during intervention development. This is particularly important given the proliferation of Internet-based interventions and the resources currently being invested in health-related websites by governments worldwide . Many ofUsability testing also uncovered some differences by end user. However, little is known about how user traits, which refer to user characteristics such as computer proficiency and demographic and disease characteristics, may affect the use of these health portals . As an eA few potential limitations of our study need to be addressed. First, the study was conducted in two tertiary pediatric care centers and the sample was relatively small, which could be considered a threat to the generalizability of the results. However, with a representative sample of end users, typically involving as few as five participants per cycle, the majority of usability problems and issues can be identified. It has been estimated that a single initial cycle of design/evaluation/redesign can lead to as much as a 10-fold reduction in usability problems ,31. SecoThis study provides strong initial support for the usability of the Teens Taking Charge: Managing Arthritis Online treatment program for youth with JIA. Findings from this study were used to refine the website prototype prior to conducting a pilot randomized controlled trial to determine the feasibility of the Internet-based self-management program for teens with JIA. If effective in improving health outcomes, this program could be used as a template for other pediatric chronic illness interventions as the psychosocial challenges facing adolescents with JIA are generalizable to all youth with chronic illnesses. Furthermore, the Internet may be critical to improving the accessibility and acceptability of self-management programs for the large population of youth with chronic health conditions that are not able to receive these treatments in their local communities. Usability testing during the formative phase of developing Internet-based treatments is a crucial step in ensuring that these interventions are effective and acceptable to youth with chronic health conditions and their parents.


Although smoking is known to be powerful risk factor for other vascular diseases, such as cardiac and peripheral vascular disease, only relatively recently has evidence for the role of smoking in the development of stroke been established. The reasons for this advance lie in the acknowledgement that stroke is a heterogeneous disease, in which its subtypes are associated with different risk factors. Furthermore, improvements in the stringency of epidemiological studies and the greater use of CT scanning have enabled the role of smoking in the development of stroke to be elucidated.This is a qualitative examination of high quality epidemiological studies in which the role of smoking and passive smoking, as a risk factor for cerebral infarction, intracerebral haemorrhage and subarachnoid haemorrhage, is examined. In addition, the pathological mechanisms by which smoking or passive smoking may contribute to the development of stroke are reviewed.Smoking is a crucial independent determinant of cerebral infarction and subarachnoid haemorrhage, however its role in intracerebral haemorrhage is unclear. Although studies are limited, there is evidence that exposure to passive smoking may also increase the risk of stroke. Smoking appears to be involved in the pathogenesis of stroke via direct injury to the vasculature and also by altering haemodynamic factors within the circulation. Importantly, smoking is modifiable risk factor for stroke. Therefore, the encouragement of smoking cessation may result in a substantial reduction in the incidence of this devastating disease. Although smoking is an established and potent risk factor for other vascular diseases, such as cardiac and peripheral vascular disease ,2, the eCerebral infarction is the most common subtype of stroke, accounting for more than 70% of all strokes . Over thThe relationship between smoking and cerebral infarction has been confirmed in more recent case-control studies from the U.S., Australia, U.K., Scandinavia, and Russia Table  10-13,1,23,25,35Similar results have been obtained in cohort studies in the United States and Taiwan ,19,21,36The use of pack-years by investigators to determine the dose of lifetime exposure to cigarettes was used in some studies ,23. ThisThe difference in the definition used for exposure is an important issue. Measuring pack-years provides information on both the quantity of cigarettes smoked and the duration of this level of smoking. Thus it could be that either or both of these factors contribute to the increased stroke risk. It would be useful to determine whether one pack per day for 20 years produced a stroke risk similar to that of two packs per day for 10 years (with both equating to 20 pack-years). However, this type of information relies heavily on participant recall. Such accurate recall may be challenging, especially for individuals with cognitive deficits following stroke. Partly because of the difficulties outlined, it remains to be established whether it is the quantity or the duration of smoking that results in the increased risk of cerebral infarction.The effect of cessation of smoking on the subsequent development of cerebral infarction is important in determining a causal relationship between this disease and smoking. In men, Kurth and colleages found that past smokers had a risk of cerebral infarction comparable to that of never smokers  . KawachiSimilar results have been reported from case-control studies. In studies conducted in the U.S. ,25, ex-sSubarachnoid haemorrhage (SAH) accounts for only about 2–9% of strokes , but is In a cohort study Kawachi and colleagues found an adjusted relative risk of SAH of 4.85  among current women smokers . ImportaThe RR of SAH among former smokers is consistently less than that among current smokers ,18,19,26These studies demonstrate that smoking is a major independent risk factor for SAH. Importantly, this association is strengthened by the presence of a dose-response relationship. Of note is that ex-smokers are found to be at a higher risk of SAH than never smokers for many years after smoking cessation, but it appears that within 10 years their risk will return to that of a never smoker .In a meta-analysis of published studies of smoking and intracerebral haemorrhage (ICH), the pooled relative risk of ICH associated with smoking was 0.74  . HoweverThe most recent published data on smoking and intracerebral haemorrhage comes from the Physicians' Health Study, which included 108 cases of ICH . The invAnother study that somewhat supports the findings of Kurth and colleagues involved a prospective study of haemorrhagic stroke patients in the US . AlthougIn contrast to the previously mentioned findings, numerous investigators have found no association between smoking and ICH. In a large sample of patients with ICH (331) and using case-control methodology, Thrift and colleagues found no increased risk of intracerebral haemorrhage associated with smoking  . ImportaThe results of 13 studies, in which the contribution of smoking in the risk of ICH was investigated, were included in a recent meta-analysis . The autBeyond the damage that active smoking may cause an individual are the adverse effects that inhaling environmental tobacco smoke (ETS) from the sidestream smoke of a burning cigarette may cause others. This smoke contains high concentrations of CO, nicotine and carcinogens . In someThe first examination of the link between exposure to ETS and the development of stroke was conducted by Lee and colleagues using a hospital based case-control study . The stuThe most recent study on passive smoking and stroke was a population based case-control study conducted in New Zealand . The stuIn support of these findings, potential mechanisms whereby ETS may contribute to the pathogenesis of stroke have been identified. The Atherosclerosis Risk in Communities (ARIC) study investigators presented findings linking ETS to the development of carotid atherosclerosis . After cOverall, data from the few studies conducted on exposure to ETS and the development of stroke, together with data concerning ETS and atherosclerosis, provide some support for the notion that ETS can lead to the development of stroke. To clarify the role of ETS in the development of stroke, studies must be designed to determine whether altering the amount or duration of ETS changes the rate of stroke within a population. More evidence is needed on the role of ETS in the development of stroke. An examination of the effect of ETS by stroke subtype may better evaluate the relationship between this potentially modifiable risk factor and stroke.Smoking appears to be involved in the pathogenesis of stroke via two mechanisms. First, smoking can cause direct damage to the vasculature, altering both its architecture and function -54. SecoCerebral infarction occurs due to a disruption of the blood supply to the cerebral arteries. This can be a consequence of either occlusion of the cerebral vessels themselves or due to occlusion of the carotid arteries. There are a number of ways in which this occlusion can occur including artery occlusion by atherosclerosis and its associated plaques and thrombi or via emboli from a ruptured atherosclerotic plaque.Smoking is a major factor in the development of atherosclerosis. In the ARIC study current smokers were found to have the greatest progression of atherosclerosis over time, at a rate 50% greater than in non-smokers . FurtherSmoking is believed to induce the development of atherosclerosis by initiating endothelial injury, presumably due to either the production of oxygen radicals or via direct toxic effects of cigarette smoke constituents. Even brief exposure to cigarette smoke has been found to activate leukocytes, stimulating the release of the pro-coagulant, von Willebrand Factor (vWF) and causing endothelial damage . This inThe mechanisms by which endothelial dysfunction and a reduction in dilatory ability occur were further investigated by Fang and colleagues in the cerebral arteries of rats . They reStudies on arteries of human smokers have found similar results to Fang and colleagues. Poredôs and colleagues reported data on the intima-media thickness (IMT) of smokers compared with non-smokers, with IMT being used as a measure of atherosclerotic change . The invThe ramifications of the reduction in dilatory ability following smoking may place smoking individuals at a higher risk of cerebral ischaemic events in two ways. First, due to both a reduced ability to respond to alteration in perfusion pressure, and second, due to lack of distensibility of the arterial wall as a result of endothelial dysfunction. The notion that this lack of distensibility of the arterial wall may increase the risk of atherosclerotic plaque rupture, leading to emboli and subsequent infarction, was presented by Kool and colleagues . They foStudies conducted on the reactivity of the cerebral vessels of smokers are particularly pertinent to the role of smoking in the development of stroke. Terborg and colleagues investigated the reactivity of the cerebral circulation in smokers to hypercapnia using near-infrared spectroscopy and transcranial Doppler sonography . It was In addition to the atherosclerotic changes that cigarette smoking induces in the vessel wall, smoking also has detrimental effects on the coagulant/anticoagulant balance throughout the vascular system of smokers. This imbalance predisposes these individuals to thrombosis and therefore an increased risk of cerebral infarction. Hioki and colleagues investigated the effects of smoking on thrombin generation, which is important in the conversion of fibrinogen to fibrin in the coagulant cascade . It was Human studies show similar findings, with long-term smokers shown to have significantly increased levels of PAI-1 when compared to non-smokers . In addiThese investigations demonstrate that cigarette smoking induces both short-term and long-term alterations in haemodynamic variables, and can also alter arterial wall architecture resulting in atherosclerosis. In turn these alterations can result in occlusion of vessels due to stenosis within the carotid region and emboli from a ruptured atherosclerotic plaque, increasing the risk of a cerebral infarction. The reduction in the risk of cerebral infarction following smoking cessation may be due to the resolution of acute pathological changes caused by smoking such as alterations in haemodynamics, rather than a reversal of more chronic changes such as atherosclerosis. However, this is speculative as the effects of smoking cessation on these variables has not been investigated.The role of smoking in the pathogenesis of haemorrhagic stroke has been less investigated. This is surprising given the strong association found between smoking and SAH in particular ,19,26,281 antitrypsin. Smoking is known to inactivate α1 antitrypsin via peroxynitrates and •OH compounds found within cigarette smoke [1 antitrypsin activity may cause an imbalance between proteolytic enzymes and systemic inhibitory capacity; in turn there would be an increase in collagen turnover resulting in a weakening of the arterial wall [1 antitrypsin [SAH is known to be due to the rupture of an artery and in many cases the rupture of a saccular aneurysm . Importate smoke . Furtherte smoke . Tartaraial wall . This miitrypsin .The potential implications of these structural alterations in the arterial wall of smokers may also lead to an increased risk of haemorrhage due to the alteration in blood pressure caused by smoking. A sharp rise in blood pressure has been observed immediately after smoking and can last for up to three hours ,52. JuveThe data relating to acute changes due to smoking, such as blood pressure surges, teamed with data on chronic smoking related changes, such as arterial wall degradation, provide a hypothesis for the role of smoking in the development of haemorrhagic stroke. Furthermore, it is evident that the cessation of smoking may lower haemorrhagic stroke risk due to the elimination of acute effects such as blood pressure surges. However, the chronic effects of smoking such as arterial wall degradation may remain. This may explain why although the risk of haemorrhagic stroke declines with smoking cessation, it does not revert to that of an individual who has never smoked ,18,19,26Smoking is an established risk factor for both cerebral ischaemia and subarachnoid haemorrhage. However, its role in ICH is less clear. There is supporting evidence for a causal relationship between smoking and CI or SAH. This is supported by reports of a dose-response relationship between smoking levels and these two types of stroke, as well as a return to never smoking risk levels with increased time since quitting smoking. Furthermore, the biological plausibility of these findings provides further evidence for the role of smoking in these diseases.Establishing smoking as a significant risk factor for CI and SAH is important, as this is a modifiable risk factor. The evidence that among smokers who cease smoking the risk of both of these forms of stroke returns to never smoking levels over time indicates that people who cease smoking can benefit in an important way. Prevention still remains the most effective way of reducing the impact of stroke.The authors declare that they have no competing interests.


The effectiveness of provider-initiated HIV testing and counseling (PITC) for patients with sexually transmitted infection (STI) in resource-constrained settings are of particular concern for high HIV prevalence countries like South Africa. This study evaluated whether the PITC approach increased HIV testing amongst patients with a new episode of sexually transmitted infection, as compared to standard voluntary counseling and testing (VCT) at the primary care level in South Africa, a high prevalence and low resource setting.The design was a pragmatic cluster-controlled trial with seven intervention and 14 control clinics in Cape Town. Nurses in intervention clinics integrated PITC into standard HIV care with few additional resources, whilst lay counselors continued with the VCT approach in control clinics. Routine data were collected for a six-month period following the intervention in 2007, on new STI patients who were offered and who accepted HIV testing. The main outcome measure was the proportion of new STI patients tested for HIV, with secondary outcomes being the proportions who were offered and who declined the HIV test.A significantly higher proportion of new STI patients in the intervention group tested for HIV as compared to the control group with . This increase was achieved despite a significantly higher proportion intervention group declining testing when offered . Patients were more likely to be offered HIV testing in intervention clinics, where providers offered the HIV test to 76.8% of new STI patients versus 50.9% in the control group (p = 0.0029). There was significantly less variation in the main outcomes across the intervention clinics, suggesting that the intervention also facilitated more consistent performance.PITC was successful in three ways: it increased the proportion of new STI patients tested for HIV; it increased the proportion of new STI patients offered HIV testing; and it delivered more consistent performance across clinics. Recommendations are made for increasing the impact and feasibility of PITC in high HIV prevalence and resource-constrained settings. These include more flexible use of clinical and lay staff, and combining PITC with VCT and other community-based approaches to HIV testing.Controlled trial ISRCTN93692532 More than two decades into the AIDS epidemic, the majority of people living with HIV are unaware of their status. In 2005, surveys showed that in Sub-Saharan Africa, the epicentre of the epidemic, only 8% to 25% of people living with HIV knew their sero-status . Low tesProvider-initiated HIV testing and counseling (PITC), (sometimes referred to as 'routine offer of testing' or 'opt-out testing') is a streamlined model promoted by the World Health Organization (WHO) and The Joint United Nations Program on HIV/AIDS (UNAIDS) to increase the opportunities for diagnosing HIV in health facilities, especially in high prevalence countries . In the Evidence from both low- and high-income countries, mainly from antenatal and tuberculosis (TB) settings, indicates that the direct offer of HIV testing by health providers can result in significant improvements in test uptake. Effect sizes range from as low as 5%  to as hiPatients with STI, another important high-risk group, have been less well-studied, particularly in high prevalence settings, perhaps because of the relative newness of the PITC approach. Given the strong association between STIs and the risk of acquiring and transmitting HIV ,18,19, iThe evidence for PITC with STI patients is limited to a few quasi-experimental studies in the UK and the Netherlands ,21,25,26The close association between HIV and STI, the high rates of missed opportunities for testing STI patients, and limited evidence on the effectiveness of PITC for STI patients in high prevalence and resource-constrained settings are of particular concern for high prevalence countries like South Africa. In April 2006, the Cape Town health authorities undertook a trial to evaluate the impact of PITC on the testing rates of STI patients, compared to the standard VCT approach at primary care level. In order to evaluate PITC in as realistic a context as possible, the intervention was implemented by existing health managers and with few additional research or clinical resources. This study therefore addresses a key gap in evidence regarding the effectiveness of PITC for STI patients in high prevalence and resource-constrained settings.The study was performed in the public sector, primary healthcare services in Cape Town, South Africa. STI services are free of charge and are delivered mostly by trained nurse practitioners. VCT is the standard approach and is provided by trained lay health counselors. At the start of the intervention in 2006, the total new STI caseload for Cape Town was more than 5,000 patients per month, with an estimated 30% HIV testing rate. Although Cape Town has amongst the lowest HIV prevalence in the country, the prevalence varies dramatically between sub-districts. In 2005, the average HIV prevalence for pregnant women was 12.7% , whilst The health authority gave permission for the evaluation, and ethical approval was obtained from the University of Cape Town Research Ethics Committee. A confidentiality agreement was signed between the health authorities and the research team to ensure additional protection of patient information.The design was a pragmatic cluster non-randomised controlled trial, in which seven clinics were selected to receive the intervention, and 14 clinics served as control clinics. The trial aimed to test the effect of the intervention under normal operational and management conditions. Randomization was not feasible because the intervention clinics were selected before the evaluation was planned. The assessment of the intervention was facilitated by the health management team, which also made it impractical to blind the implementers and the assessors.The primary outcome was the HIV testing rate amongst new STI clients. Secondary outcomes were the proportion of STI clients offered HIV testing (irrespective of whether they accepted or not) and the proportion that declined HIV testing, once offered. We also describe the sample in terms of the participant's gender, age and proportion diagnosed with HIV.A pool of 24 clinics was identified by the health services as eligible to participate, based on criteria of geographical representation , nurse-patient ratio, and a minimum STI caseload of 30 new STI patients per month. A project steering committee, in consultation with local district managers, selected one representative clinic from each district. Nine intervention sites were selected initially, but two clinics declined participation shortly before implementation, citing operational difficulties. One control clinic opted out, citing similar reasons. The remaining fourteen eligible clinics became the comparison group. There was no matching of clinics, but statistical comparison of clinics at baseline was conducted using general routine administrative data that were collected retrospectively.A sample size validation was done, given that the intervention arm would consist of seven intervention clinics. With this restriction, the study would be able to show an increase of 20% in testing rate from an estimated baseline of 30%, with 80% power, at a 5% significance level and using an intra-class correlation coefficient (ICC) of 0.08 and a cluster size of 90. In a recent review of ICCs in 188 health systems research studies, the median ICC used was 0.051 (IQR 0.011 to 0.094). The ICC of 0.08 in this study is closer to the conservative end of this range . We doubThis intervention is an adapted version of the 'ACTS' approach which includes four brief steps: assess, get consent, test, and provide supportive services . In thisBy using clinical staff to deliver the intervention as an integrated part of the STI consultation, the intervention departed significantly from the standard approach in South Africa where VCT is predominantly provided by lay counselors. The shift required a reconfiguration of roles for nurses and lay counselors, with nurses taking on some of the tasks previously performed by lay counselors. It was anticipated that more patients would be tested because the clinical care setting provided the opportunity to offer HIV testing to all patients, and the setting may also increase patient willingness to test. Because this was a demonstration project to evaluate also the feasibility and acceptability of using clinical staff for HIV screening (instead of lay workers), the intervention needed to address concerns about the possible overloading of nurses. To save nurse time, nurses were allowed to refer the patient to the clinic lay counselor for the test result and post-test counseling once they completed the STI consult and HIV testing.STI nurses from each of the intervention sites received a two-day training course on PITC and how to implement it. Lay counselors also received training to emphasize follow-up support for HIV positive clients. The implementation was standardized in terms of the main components of integrated nurse-initiated testing, but clinics were allowed to adapt their patient flow arrangements to suit their clinic. No additional nursing resources were provided to implement the intervention at clinic level, but a part-time project manager from within the health service allocated 30% of her time to oversee the implementation, supervision, and monitoring of the intervention. Intervention clinics received quarterly feedback about their performance.In control sites, the routine VCT approach continued. The VCT service is available at the same site as the STI service, and any person can access the VCT service on his or her own initiative or via medical referral. The majority of patients using the VCT service would be required to initiate testing themselves, whilst a few would be medically referred if they had HIV-related symptoms or if considered high risk. In addition to patient barriers to access such as low perceived risk and poor perception of testing services, the lengthy pre-and post-test counseling and shortages of counselors are potential barriers to VCT access in these settings -5.In the VCT service, lay counselors provided pre- and post-test counseling that lasted an average of 45 minutes . This exBaseline data for 2005, the year prior to the intervention, were collated for intervention and control clinics to determine how the two groups compared on clinic demographics and health service delivery for STI and HIV testing services. The baseline data summary Table  describeThe intervention was evaluated approximately one year after the start of implementation, using six months of routine data from January to June 2007. The routine monthly report (RMR) collated by the health services provided data on the numbers of new STI patients. HIV testing data were collated from the counseling and testing (CT) register that included the patient demographics of new STI patients offered HIV testing, whether they accepted the test, and the HIV test result. The CT register recorded the type of patients, including antenatal and TB patients, and was adapted to record STI patients as a separate category.Data from the CT register was entered into an Excel database. Data were linked to patient identifiers, and for this part of the study we recorded patient record numbers, but not patient names. Data quality checks were done in stages. This involved checking the RMR data, paper copies of the CT registers, and the electronic data set for completeness and accuracy. Problems such as incomplete and inaccurate CT registers (including missing patient identifiers and missing or inconsistent testing information) were queried and corrected by clinic staff through checking patient records. The 10% sample check at the end identified a particular clinic where there were anomalies in the data (mainly for gender and age) and this was corrected. This did not require a rechecking and re-entry of the whole data set.The proportion of patients offered testing, tested, and declined per clinic was calculated. For the variables 'HIV tested', 'not tested' and 'offered HIV testing' the denominator was the total number of new STI patients treated in these clinics. For variable 'declined HIV testing' the denominator was the total number of new STI patients who were offered HIV testing, in other words, a subgroup of the total new STI population. These proportions were utilized as clinic level outcomes and used to compare the two groups. This clinic level analysis accounts for the clustering within clinics .The statistical comparison was done using STATA 10. A two-sample t-test was used for the comparison of the study outcome and baseline data between the intervention and control group. We checked the normality assumption of the t-test. A formal test for the equality of variances in the two groups was done using the F-test. The appropriate t-test was subsequently performed based on the homogeneity status of the variances. Multinomial logistic regression analysis with adjustment for clustering was done on the composite testing outcome  to confirm the results of the clinic level analysis. Only the clinics that were operationally able to implement the protocol and provide outcome data to the trial were included in the analysis because we wanted to know the effectiveness of the PITC intervention in clinics that actually implemented the intervention. The statistical adjustment for baseline differences is not reported and this is considered in the results and in the study limitations.The flow chart in Figure Baseline data on clinic demographics and service delivery from the start of the intervention in 2005 are provided in Table Clinic level raw data and results are shown in Table Patients were also more likely to be offered HIV testing in the intervention clinics: intervention clinics offered the HIV test to 2,326 (76.8%) of new STI patients compared with 3,406 (50.7%) in the control group (p = 0.0029). In Figure Another way to measure those who declined testing is as a proportion of those offered testing. This alternative calculation represents test refusal within the context of those offered the test rather than all new STI patients and is reflected by the variable 'declined HIV testing' in Figure As mentioned earlier, the adjusted baseline analysis is not used. The inverse association observed between the baseline variable of a broader population and the much narrower study population may lead to a distorted estimate of the intervention effect. The unadjusted results reported in the manuscript is a more conservative estimate of the intervention effect when compared to the adjusted estimate given in this analysis (13.8% compared to 22.2%). We feel that the unadjusted result is a more reasonable result with respect to the health system setting in which this was done.From the multinomial regression (adjusted for clustering) on the composite testing outcome  the odds ratio for being tested is 2.24 (95% CI: 1.12 to 4.46), p = 0.022 for the intervention group compared to the control group with the reference category being 'not offered'. This result confirms the outcome specific comparison reported in Figure Although not a pre-specified outcome measure, the data suggested wide variability in range for outcomes measured in the clinics, and this was compared statistically using the F test. As shown in Table There were no significant differences in the male to female ratio between the intervention and control groups on any of the outcomes examined Table . Of thosA streamlined HIV testing protocol that is integrated into STI care and delivered by nurses in busy primary healthcare clinics in Cape Town appears to be effective and feasible. PITC significantly increased the proportion of new STI patients who tested for HIV as well as the proportion of patients offered testing. There was also significantly less variation in the main outcomes across the intervention clinics, suggesting that the intervention facilitated more consistent performance.The increase in testing rate was achieved even though only 76% of all STI patients in the intervention clinics were offered testing. One area for increasing the effectiveness of the PITC intervention is in increasing the coverage of the offer of testing to 100% of new STI patients. More than one-quarter of patients offered testing in the intervention group declined to test (twice the proportion in the control group), a result that is not favourable to the intervention. The result is understandable given that patients did not self-initiate testing, as is the case for VCT. Nevertheless, reducing the proportion who decline testing represents another area where the impact of the PITC intervention could be improved substantially. This could be done by training staff to use more effective motivation strategies to encourage patients to test, provided that this does not compromise informed consent from patients. The high test refusal rate found could be considered indirect evidence that patients were able to exercise their right to decline testing and is therefore an indirect marker of the ethical implementation of the PITC approach.The absolute increase in HIV testing rate of nearly 14% is smaller than the difference of 20% anticipated prior to the study, though it is similar to increases reported in prior studies in South Africa (13% increase for TB patients)  and BotsThe findings have important operational implications beyond the testing rate itself and relating to the management of staff resources. In this study, STI nurses integrated HIV screening into their STI consultations, taking on a task previously performed by lay health workers. This is unlike the task shifting recommended by WHO, where tasks are referred down to less skilled workers to free up clinical time for treatment and care of HIV (Type III task shifting) ,36. HoweWhere nursing resources are very limited, it may be less feasible to use only clinical staff for PITC, and lay providers could be used in such settings . In neigSuccessful scaling up of this PITC intervention in high prevalence and resource-constrained settings will require adaptation to the local context, including a flexible approach to the utilisation of clinical and lay staff. Retraining of nurses and lay counselors may also be necessary so as to streamline and integrate HIV testing more effectively. HIV testing rates could be increased further through expanding PITC to other categories of clinic patients; by decreasing the test refusal rate; and possibly by reducing the requirement for written consent. It is interesting to note that two control clinics achieved higher testing rates with the VCT approach than the intervention sites. Further enquiry suggested that their success was due to the close supervision and monitoring of the VCT staff team, factors that are also likely to be important for the successful up-scaling of PITC.The findings of this study contributed to the decision to roll-out a more streamlined version of PITC to several sub-districts in Cape Town in 2008. The health authorities are now formulating policy to scale up the intervention to the provincial level.As a pragmatic trial, this intervention was implemented using existing management and clinical staff resources and some internal project management support. This situation, where the service managers initiate and run the intervention and where there is little additional resources added, is an ideal context for an effectiveness evaluation as it reflects the reality of implementation in resource-constrained settings ,39. The The lack of randomization of clinics to intervention and control groups introduces the risk of bias for the study outcomes. While the baseline comparison showed few differences between intervention and control sites, we cannot exclude other unknown sources of selection bias. Also, we were not able to obtain baseline measures for the main outcome. The one baseline testing variable  that was significantly different across intervention and control sites was inappropriate as a measure of baseline differences for the following reasons: this variable is not strictly comparable to the main outcome in this study because it refers to the proportion of general clinic patients who were tested as a proportion of those who received pre-test counseling by lay counselors in the VCT service; and it covers a different and much larger general patient target group (and not STI patients only) and refers to a different testing service (VCT), delivered by lay counselors and not clinicians. However, given the lack of baseline data on the main outcome, we felt that this 'HIV test acceptance, VCT' variable should be examined in the baseline comparison of the two groups, and that unadjusted outcome measures should be presented. In the absence of blinding, factors such as staff enthusiasm and increased monitoring could have had a modifying effect. As mentioned earlier, we cannot be certain about how the unforeseen management efforts to increase HIV testing rates, implemented in parallel to this intervention, may have affected the study results.To our knowledge, this is only the second study on the impact of the PITC approach for STI patients in a high prevalence African country (the other being in Botswana), and the first where the study design was able to isolate the effect of the PITC intervention. The study demonstrates that PITC, integrated into STI care and delivered by nurses in an urban, primary healthcare setting had three successes: it increased the coverage of HIV testing opportunities, it increased testing uptake, and it delivered more consistent performance across clinics.PITC is recommended as an effective strategy for increasing the uptake of HIV testing in medical settings in high prevalence and resource-constrained countries such as South Africa. However, this study indicates that this approach alone may not deliver the large-scale increases in testing required in high prevalence settings. A multi-faceted strategy to expanding HIV testing and care may be needed. This should combine PITC with efforts to optimise existing VCT services. Creative options for community, home-based, and self testing for HIV should also be introduced and evaluated. Finally, efforts to increase testing rates should be matched by efforts to link newly diagnosed HIV positive patients to clinical care and prevention services because this is ultimately the aim of HIV testing.The authors declare that they have no financial conflict of interest. PN was the HIV manager in the health authority overseeing the implementation of the PITC intervention. She resigned from the health department midway through the evaluation, and continued as a research team member.Conception, design and acquisition of data: NL, PN, CM, SL and CL; analysis and interpretation of data: NL, PN, and CL; drafting the manuscript: NL; critical revisions for intellectual content: NL, CM, SL, PN and CL. All authors read and approved the final manuscript.


Most people with a spinal cord injury rate neuropathic pain as one of the most difficult problems to manage and there are no medical treatments that provide satisfactory pain relief in most people. Furthermore, psychosocial factors have been considered in the maintenance and aggravation of neuropathic spinal cord injury pain. Psychological interventions to support people with spinal cord injury to deal with neuropathic pain, however, are sparse. The primary aim of the CONECSI  trial is to evaluate the effects of a multidisciplinary cognitive behavioural treatment programme on pain intensity and pain-related disability, and secondary on mood, participation in activities, and life satisfaction.CONECSI is a multicentre randomised controlled trial. A sample of 60 persons with chronic neuropathic spinal cord injury pain will be recruited from four rehabilitation centres and randomised to an intervention group or a waiting list control group. The control group will be invited for the programme six months after the intervention group. Main inclusion criteria are: having chronic (> 6 months) neuropathic spinal cord injury pain as the worst pain complaint and rating the pain intensity in the last week as 40 or more on a 0-100 scale. The intervention consists of educational, cognitive, and behavioural elements and encompasses 11 sessions over a 3-month period. Each meeting will be supervised by a local psychologist and physical therapist. Measurements will be perfomed before starting the programme/entering the control group, and at 3, 6, 9, and 12 months. Primary outcomes are pain intensity and pain-related disability (Chronic Pain Grade questionnaire). Secondary outcomes are mood , participation in activities (Utrecht Activities List), and life satisfaction (Life Satisfaction Questionnaire). Pain coping and pain cognitions will be assessed with three questionnaires .The CONECSI trial will reveal the effects of a multidisciplinary cognitive behavioural programme for people with chronic neuropathic spinal cord injury pain. This intervention is expected to contribute to the rehabilitation treatment possibilities for this population.Dutch Trial Register NTR1580. Around 65-85% of the people with spinal cord injury (SCI) experience persistent pain and around one-third of these suffer from severe pain . People Our understanding of the mechanisms underlying chronic neuropathic SCI pain (CNSCIP) is still incomplete ,6,7 and,The biopsychosocial view provides an integrated model that incorporates mechanical and physiological processes as well as psychological and social/contextual variables that may cause and perpetuate chronic pain . Strong Cognitive behavioural therapy (CBT) aimed at modifying dysfunctional pain cognitions and coping abilities, has been shown to be effective in people with low back pain  and has The primary aim of the CONECSI  trial is to evaluate the effectiveness of a multidisciplinary cognitive behavioural programme for coping with CNSCIP. The intervention is expected to result in decreased pain intensity and pain-related disability, and in higher levels of mood, participation in activities, and life satisfaction. The secondary aim is to examine post-hoc (explorative) the influence of demographic and lesion characteristics, pain coping and pain cognitions on the effect of the intervention and the relation between the change of coping and cognitions and the effectiveness of the intervention. It is expected that the intervention will be most effective in persons who show dysfunctional pain cognitions and pain coping strategies before the intervention and in persons who show a change in pain coping and pain cognitions in a positive direction. The third aim is to examine the satisfaction of the participants and trainers about the intervention and to explore which parts will be regarded as effective. This paper describes the design of the CONECSI trial and the content of the programme.A multicentre RCT will be conducted to evaluate the effects of the multidisciplinary cognitive behavioural programme for coping with CNSCIP in four Dutch rehabilitation centres. Within each participating rehabilitation centre, participants will be randomly allocated to the intervention group or to the waiting list control group. The control group will be invited for the programme after a waiting period of six months.The Medical Ethics Committee of the University Medical Centre Utrecht and the participating rehabilitation centres have approved the study protocol. Written informed consent will be obtained from each participant. The trial is registered in the Dutch Trial Register (NTR1580).The study will be conducted in four rehabilitation centres with a specialisation in SCI rehabilitation in different parts of the Netherlands: 'De Hoogstraat' in Utrecht; 'Het Roessingh' in Enschede; 'Rijndam' in Rotterdam, and 'Adelante zorggroep' in Hoensbroek.Physiatrists from the four rehabilitation centres select former patients from their centre meeting inclusion criteria 1, 2, and 3 (Table This multidisciplinary programme is developed for people with CNSCIP. The programme consists of ten sessions of three hours over a ten-week period and a comeback session three weeks after the tenth session. Each meeting will be supervised by a psychologist and physiotherapist (the trainers) from the local centre. There will be a maximum of ten participants per group. The programme comprises educational, cognitive, and behavioural elements targeted at coping with CNSCIP. At the first session, participants will receive a course book containing information on all sessions, reading texts, and homework assignments. All participants will have a buddy who will attend two sessions. The buddy is the partner, family member, or a good friend of the participant. The buddy will be asked to read the course material, to help (if necessary) with the homework assignments, and the participants can discuss the intervention with the buddy. The trainers will receive the same course book as the participants, but with an extended protocol for each session. Additional file Two theoretical models will be used in the programme: the BioPsychoSocial (BPS) model  and the According to the BPS model  biologicRational Emotive Behaviour Therapy (REBT)  proposesFurther, the trainers will be assisted by two physiatrists and a role model in three sessions (Appendix 1). A local physiatrist specialised in SCI rehabilitation will provide information about SCI, pain physiology and pain classification, pharmacological and non-pharmacological SCI pain treatments, and their limitations. A local physiatrist specialised in chronic pain rehabilitation will provide information about chronic pain and chronic pain rehabilitation for other pain diagnoses than SCI. The role model will tell his/her story of living with CNSCIP and how he/she was able to live his/her life despite the pain.Four sessions will include a workshop on relaxation exercises with attention to terms for relaxation, breathing and body sensations (Appendix 1). The exercises target on stress reduction, restore balance, attention shift and awareness of available energy. Three sessions will include sports workshops in which exercises in circuit (power) training will be performed (Appendix 1). After these workshops the participants will take a closer look at their cognitions during the workshops  with the ABC model and at their balance between capacity and load with the BPS model.Primary outcome measure will be pain intensity and pain-related disability. Secondary outcome measures will be mood, participation in activities, and life satisfaction. All outcome measures and instrumentation are presented in Table The CPG  is used The HADS is a 14-item self-report measure, which is used for scoring mood. It contains two 7-item scales: one for anxiety and one for depression, both with a score range of 0-21. It is a valid and reliable measure and responsive to change . WoolricThe UAL ,31 is a The LiSat-9  is used The Dutch version of the CSQ  is an adThe PCI consists of 33 items with a four-point Likert scale, from 1 (rarely or never) to 4 (very often). The following six scales are distinguished, divided in active pain coping dimensions: 'Pain Transformation', 'Distraction', 'Reducing Demands', and passive pain coping dimensions: 'Retreating', 'Worrying', and 'Resting', all of which are internally reliable . The intThe PCL-2003 consists of 39 items. Each item presents a specific pain cognition statement, for example, 'My thoughts are always concentrated on the pain'. Items are scored on a five-point Likert scale, from 1  to 5  . The queTwo questionnaires will be used for assessing pain coping, because they cover partly different coping styles and are additional to each other. The PCI assesses passive coping styles , while the CSQ assesses active coping styles  and other coping styles that the PCI does not assess . There is an overlap in the subscale 'Catastrophizing' between the CSQ, PCI, and PCL, but the PCL assesses people's cognitions (like 'I think fate has hit me') instead of coping .In order to conduct this trial in a uniform way in the four rehabilitation centres, a detailed course book and protocol for each session have been written and a one-day training for the trainers will be organized. One of the authors (MH) will monitor on a regular basis (attending two sessions of the intervention group and two sessions of the control group in each centre) whether the content of the intervention will be executed as intended in the four rehabilitation centres. Compliance will be assessed by recording the number of sessions attended.Neuropathic pain treatments will be registered at all measurements by using a pre-coded list including common pharmacological treatments, physical methods , surgical interventions, psychological treatment, alternative treatment , and other treatments. Participants will be allowed to continue their current pain treatments, but will be asked to refrain, if possible, from starting, stopping, or changing pain treatment during the intervention.The power analysis is based on information from a previous cross-sectional study , in whicThis trial with repeated measurements nested in each patient will be used to evaluate differences in effect between the intervention group and the waiting list control group. Differences between groups, with 95% confidence intervals, will be calculated for the outcome measures: CPG, HADS, UAL, and LiSat-9, by random coefficient (multilevel) analyses. The effectiveness of the intervention will be tested by analysing differences between the intervention group and the waiting list control group in the course of outcomes over time . Further, the long-term  impact of the intervention will be analysed in participants randomised to the intervention group. The impact of demographic and lesion characteristics, pain cognitions and pain coping on the effectiveness of the intervention will be studied explorative by merging data from the intervention group  and the waiting list group . Both the impact of differences at baseline, and changes in pain cognitions and pain coping during and after the intervention will be post-hoc analysed. Factor rehabilitation centre will be controlled for in the effectiveness analyses, but post-hoc analyses of differences between rehabilitation centres will be analysed and combined with information on compliance and patient satisfaction to identify determinants of a successful intervention. Data will be analysed according to the intention-to-treat principle. SPSS statistical program for Windows (version 16.0) and the MLwiN program of the Centre for Multilevel Modelling, Institute of Education, University of London (version 2.02) will be used for the analyses. Significance level will be set at a p-value less than .05.This multidisciplinary cognitive behavioural programme for coping with CNSCIP will be evaluated in a multicentre trial, in which 60 persons will be randomised to an intervention group or a waiting list control group in four participating rehabilitation centres. The CONECSI trial meets the need for an RCT for the evaluation of CBT for people with CNSCIP, focusing on reduction of negative pain cognitions and promoting adaptive coping. This intervention is expected to contribute to the treatment options for people with CNSCIP, a severe problem for which existing treatments are insufficiently effective.This study will have the advantage of a randomised control group over other studies like Norrbrink Budh and colleagues . Our useThe intervention consists of an eclectic and multidisciplinary treatment programme: a combination of education, relaxation and activation, and using different theoretical models that are complimentary to each other. If the intervention as a whole is effective, this will make it more difficult to point out the effective elements of the intervention. But we expect to include participants with a variety of pain cognition and pain coping behaviours  and therefore we choose to present information on different topics and in different ways. The expected advantage is that, this way, each participant will find something useful in the programme.Most people with SCI have several pain types simultaneously . TherefoIf this new intervention turns out to be effective, its chances on implementation in the rehabilitation setting in the Netherlands are good. First, the multidisciplinary design fits well in a rehabilitation setting. Second, the treatment protocol will already be applied in four rehabilitation centres at that time and their experiences with this intervention will facilitate implementation in other Dutch rehabilitation centres. Third, the availability of a written treatment protocol also contributes to applicability in other rehabilitation centres by rehabilitation professionals. Finally, it is important that application of this type of interventions as part of rehabilitation outpatient treatment is eligible for reimbursement by health insurances in the Netherlands.The authors declare that they have no competing interests.MP developed the idea and procured funding for the study. All authors contributed to the design and the protocol of the study, and content of the programme. All authors reviewed the manuscript and approved the final version.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2377/10/96/prepubAppendix 1: Main contents of the 11 sessions. A table with the 11 sessions of the programme and a summary of the main content of each session.Click here for file