Amputation of the lower limb is one of the most feared diabetic complications. It is associated with loss of mobility and a poor quality of life. Amputations result in high economic burden for the healthcare system. The financial cost is also high for patients and their families, particularly in countries that lack a comprehensive health service and/or have a low income. Losing a leg frequently implies financial ruin for a whole family in these countries; therefore, a reduction in diabetes-related amputations is a major global priority. Marked geographical variation in amputation rates has been reported within specific regions of an individual country and between countries. A coordinated healthcare system with a multidisciplinary approach is essential if the number of amputations is to be reduced. This commentary discusses how studies on the variation in amputation rates can help to identify barriers in the access or delivery of care with the aim of reducing the burden of diabetic foot disease. Diabetologia Holman and co-workers describe a worrisome variation in the recorded incidence of lower extremity amputations in England [In this issue of  England . Based o England , 3.Amputations are usually preceded by a foot ulcer and the most important factors predicting a poor outcome of these ulcers are the extent of tissue loss, infection, peripheral arterial disease (PAD) and co-morbidity –4. The rr = 0.75). Amputation rate should therefore not be used as a quality indicator in diabetic foot disease, unless it can be corrected for the relevant characteristics of the patient, the leg and the foot.As reviewed in 2004 in this journal, there are many factors that determine the amputation rate and pinpointing why it varies so markedly in England and elsewhere is a challenge  could beThe management of a diabetic foot ulcer requires a multidisciplinary approach, including revascularisation and surgical procedures as well as treatment of infection, oedema, pain, metabolic disturbances, malnutrition, co-morbidities, meticulous wound care and biomechanical offloading . A coordr = 0.433), pointing to a common factor. Differences in PAD management might explain part of the observed geographical variation in both diabetic and non-diabetic patients. In an earlier study in England, there was marked variation between vascular surgeons in terms of the procedure chosen when given the choice of amputation or revascularisation in a series of clinical cases [Interestingly, Holman et al  observedal cases . A recenal cases . MoreoveAlthough amputation seems a clearly defined endpoint, there are several caveats in the study by Holman et al ; besidesDocumentation of the geographical variation in amputation rate within a healthcare system can help to identify barriers to the access and/or delivery of care that need to be removed to reduce the incidence of diabetes-related amputations. But, as discussed above, the amputation rate is not a good marker of the quality of care, and studies similar to that reported in the Holman et al paper should be used as a starting point in a process to improve the outcome of diabetic foot ulcers. There are four major decision points in the prevention of an amputation in a patient with a foot ulcer: early referral to a multidisciplinary team, aggressive  management of infection, diagnosis of PAD with the appropriate tests and revascularisation in the case of impaired tissue perfusion. As shown in the Eurodiale study, even in centres with a specific interest in the diabetic foot, the standard of care was suboptimal for many patients, resulting from a lack of clear referral guidelines, financial barriers caused by inadequate reimbursement, a lack of availability of staff and the personal beliefs of the doctors . Treatin


Spatial attention is most often investigated in the visual modality through measurement of eye movements, with primates, including humans, a widely-studied model. Its study in laboratory rodents, such as mice and rats, requires different techniques, owing to the lack of a visual fovea and the particular ethological relevance of orienting movements of the snout and the whiskers in these animals. In recent years, several reliable relationships have been observed between environmental and behavioural variables and movements of the whiskers, but the function of these responses, as well as how they integrate, remains unclear. Here, we propose a unifying abstract model of whisker movement control that has as its key variable the region of space that is the animal's current focus of attention, and demonstrate, using computer-simulated behavioral experiments, that the model is consistent with a broad range of experimental observations. A core hypothesis is that the rat explicitly decodes the location in space of whisker contacts and that this representation is used to regulate whisker drive signals. This proposition stands in contrast to earlier proposals that the modulation of whisker movement during exploration is mediated primarily by reflex loops. We go on to argue that the superior colliculus is a candidate neural substrate for the siting of a head-centred map guiding whisker movement, in analogy to current models of visual attention. The proposed model has the potential to offer a more complete understanding of whisker control as well as to highlight the potential of the rodent and its whiskers as a tool for the study of mammalian attention. The management of attention is central to animal behaviour and a central theme of study in both neuroscience and psychology. Attention is usually studied in the visual system (most often using cats or primates) owing to the ease of generating controlled visual stimuli and of measuring its expression through eye movement. In this study, we develop a model of the expression of attention in another sensory modality, that served by the tactile whiskers of small mammals (such as rats and mice). This sensory system has long been a popular model in neuroscience and is well characterised. It has become recognised in recent years that the modulations of whisker movements prevalent in the behaving animal represent “active sensing” (in the sense of moving the sensors to optimise sensing performance), yet a unified understanding of these modulations is still lacking. Our model proposes just such a unified understanding, suggesting that whisker movement modulations can be understood as an overt expression of the animal's changing focus of attention. This proposal, therefore, offers to provide both an enhanced understanding of the whisker sensory system and an insight into the management of attention in these animals. A succinct summary of contemporary models of primate visual spatial attention is that exogenous signals  from multiple sensory modalities and endogenous signals  compete and combine to produce a spatial map of salience from which a single region of immediate spatial attention is chosen Whisker movements have been most studied in animals that express ‘whisking’, a periodic protraction and retraction of the whiskers, typically occurring at several cycles per second (each cycle being termed a ‘whisk’) and in bouts lasting several seconds, with a close coupling of the oscillatory motions of the left and right whisker fields. Most data have been gathered using rats The modulation of whisker motion parameters under different conditions has been previously explained as arising from reflex responses e.g.  or from asymmetric in response to contact with the object. Whisker positioning is, of course, dependent on head position, therefore our model also addresses the issue of moving the head and body in order to reposition the whiskers on larger spatial and temporal scales The upper panel of We have previously shown that whisker motion in the horizontal plane can be well summarized by just two variables for each side of the snout To account for the observation of HTA, Towal and colleagues proposed that the whiskers search in the space into which the head will shortly be moved, perhaps partly to avoid collisions One clue to the nature of this mechanism is the observation that unilateral contact often elicits head-turning towards the contact point suggesting that CIA (Contact-Induced Asymmetry) and HTA (Head-Turning Assymetry), at least, may be related. The simplest possibility is that they are examples of the same response, to head movement or whisker-contact, expressed under different circumstances, but this is excluded by the following two cases. First, CIA is expressed regularly even where head-turning is precluded or absent, such as when the animal is following a wall  drives asymmetric whisking and also head-turning. This model, summarised in Thus, our central hypothesis is that a transformation from the attended region to whisker protraction angles is the primary driver of long-term modulations of whisker movement . The second behavioural response seen in The current model is focused on the movement of the whiskers and head, as driven by tactile and other (i.e. non-tactile) stimuli. In this section, we present an implementation  that simThe remainder of this sub-section details the operation of the components of the implementation, and its structure reflects that of Some perceptual tasks face an agent, whether biological or simulated, with solving what Treisman (1996) contact signal for each whisker is then computed through a procedure mimicking that used in physiological investigations of whisker afferent responses to whisker bending  channel is similar. At each oscillator tick, a single random location contributes to activity in the other input map ion map   mirrors et al. (1998) An inhibition map,  , is creaAt each oscillator tick, a new target for foveation The central computation of the model is a transform that generates a maximum protraction angle for each whisker, eth entry of salience map first part of the active region in the map that it would reach during a protraction  et al. Lines of best fit from both of these studies are also included in our et al.) in the behavioural analyses. Note that no obstacles are used in this experiment, and the physical model does not contain inertial terms, so no whisker deformation occurs. Therefore, the presented results are unchanged if computed using whisker base angles Measurement of HTA has been previously reported in rat during motivated whisking in free-space by Towal & Hartmann (2006) et al. (2007) et al. (2011) relative mean protraction angle on the left, CIA has been reported previously in rats interacting with vertical walls by Mitchinson et al. (2007) et al. measured electromyogram rather than whisker movement and binned results on a radial grid. The result from that study is re-analysed on a rectangular grid to match the current analysis, and presented in our et al. (2011) et al. observed interactions with corners, rather than flat walls, and over short timescales.The features of the plot of the behavioural analysis  can be set al. (2009) et al. defined. Following their analysis, we start by identifying the pre-contact, first and second contact whisks, in only these selected trials. In each time sample of each trial, we measure the angular spread as the angular separation between one caudal whisker (the rearmost) and one rostral whisker (the fifth from the rear), using et al.  with comparable strength to that reported in a behavioural study. To assess the sensitivity of these results to the ‘Reference’ parameter choices listed in per se. Adjusting the nominal protraction angles To begin with, we tried flipping the array The central variable of the model is a representation of the immediate region of space attended by the animal which rapidly modulates, through a fixed transform, the maximum protraction angles of the whiskers and drives the movement of the snout  on a longer timescale. Thus, both whisker and head movements are modelled as overt expressions of attention. In the implementation presented, the attended region is represented in the activity of a salience map driven by contact and by an endogenous stochastic signal and inhibited by an IOR mechanism, maximum whisker protraction angles are set by an MIMC-like transform driven by activity in the map, and the fovea is driven towards the location of the peak in the map. This implementation expresses HTA, CIA and SR, when challenged by experimental paradigms equivalent to those used in the behavioural laboratory. Furthermore, these results were robust to parameter variation—this is unsurprising, given the intuitive development of the underlying model presented in Attention is a prototypical example of what is generally considered to be a cognitive process. That is, compared to the simpler notion of a reflex arc, attention requires mechanisms that can implement bottom-up filtering of stimuli, working memory for recent events, competitive selection, and top-down modulation   et al. (2013) Whilst not a minimal model in terms of the computations involved, we propose that our attentional hypothesis for rodent whisking modulation is parsimonious in the sense of being explanatorily powerful. That is, the model accounts for multiple observed phenomena , and, moreover, does so in a way that is robust to parameter change . The model should also naturally reproduce phenomena described in the literature that cannot, even in principle, be explained by reflex mechanisms. Specifically, anticipatory ‘reaching’, in the form of increased whisker protraction, has now been reported in a range of experimental paradigms: Sachdev The validity of the attentional explanation of whisking modulation can be further tested in the behavioural laboratory. One key prediction is that non-attended objects will not elicit whisker modulation, as we have previously observed informally in a handful of trials but have not yet quantified Our model does not include modulation of whisk frequency, nor changes in whisker movement at very short time-scales. As a result, two notable observations not accounted for by the model are Rapid Cessation of Protraction (RCP) The model presented is abstract in form and also in substrate, however, neuroscientific evidence does point towards some likely substrates for different aspects of these attentional computations in the rat brain.Most clearly, the superior colliculus (SC) would be a very plausible location for a spatial attention map to be sited. SC has the right inputs from somatosensory centres—rapid bottom-up inputs arrive directly from trigeminal sensory complex, whilst top-down inputs from somatosensory cortex are also present et al. (2000) Aside from colliculus, other centres likely to be involved in attention management and/or whisker movement include motor cortex and the basal ganglia. Stimulation of vibrissal motor cortex (vMCx) can evoke whisking-like movements of the whiskers, and the parameters of stimulation affect the parameters of whisking The model has two interesting architectural features distinct to this system. First, whisker-centric data are mapped into a head-centric representation of space, implying dynamic routing of sensory data, in analogy to remappings of auditory and somatosensory data in other animals to an object rather than just pointed at it Second, whilst visual overt attention is primarily expressed through the azimuth and elevation angles of the eye et al. (2010) In summary, then, our findings support the general hypothesis that there exists in the rat a system somewhat homologous to the visual orienting system known from primate studies Video S1Behaving animal Click here for additional data file.Video S2Behaving animal Click here for additional data file.Video S3Behaving animal Click here for additional data file.Video S4Implementation Click here for additional data file.Video S5(Simulated) Head-Turning Asymmetry Click here for additional data file.Video S6(Simulated) Contact-Induced Asymmetry Click here for additional data file.Video S7(Simulated) Spread Reduction Click here for additional data file.


Investigators recently tested the effectiveness of a collaborative-care intervention for anxiety disorders: Coordinated Anxiety Learning and Management(CALM) ) in 17 primary care clinics around the United States. Investigators also conducted a qualitative process evaluation. Key research questions were as follows: (1) What were the facilitators/barriers to implementing CALM? (2) What were the facilitators/barriers to sustaining CALM after the study was completed?Key informant interviews were conducted with 47 clinic staff members  and 14 study-trained anxiety clinical specialists (ACSs) who coordinated the collaborative care and provided cognitive behavioral therapy. The interviews were semistructured and conducted by phone. Data were content analyzed with line-by-line analyses leading to the development and refinement of themes.Similar themes emerged across stakeholders. Important facilitators to implementation included the perception of "low burden" to implement, provider satisfaction with the intervention, and frequent provider interaction with ACSs. Barriers to implementation included variable provider interest in mental health, high rates of part-time providers in clinics, and high social stressors of lower socioeconomic-status patients interfering with adherence. Key sustainability facilitators were if a clinic had already incorporated collaborative care for another disorder and presence of onsite mental health staff. The main barrier to sustainability was funding for the ACS.The CALM intervention was relatively easy to incorporate during the effectiveness trial, and satisfaction was generally high. Numerous implementation and sustainability barriers could limit the reach and impact of widespread adoption. Findings should be interpreted with the knowledge that the ACSs in this study were provided and trained by the study. Future research should explore uptake of CALM and similar interventions without the aid of an effectiveness trial. Anxiety disorders are highly prevalent. In the United States, population surveys estimate that close to 29% have experienced an anxiety disorder in their lifetime , while aAs primary care is the most frequent care location for patients with anxiety, it is not surprising that clinical research has focused on interventions for that setting. Many of the empirically supported interventions to date can be characterized as "collaborative care," as they center around the activities of a care manager, usually a nurse or social worker, who maintains relatively frequent contact with the patient; performs a range of psychoeducational, therapeutic, and monitoring functions; and works as a liaison between the primary care provider and a consulting mental health professional, usually a psychiatrist. While most of the research and implementation work in the field thus far has concerned itself with collaborative care for depression -15, a grGiven the effectiveness of these interventions, a next generation of work will likely pursue implementation research and the development and testing of implementation interventions and strategies to support widespread adoption of collaborative care for anxiety disorders. This work will draw upon current models of implementation  ,22 and tThe purpose of this paper is to present qualitative data from a process evaluation of the Coordinated Anxiety Learning and Management (CALM) intervention, as part of a randomized controlled effectiveness trial of a collaborative-care for anxiety disorders. As noted above, results from this study have been recently published demonstrating CALM's clinical effectiveness . AlongsiIt should be noted here that the study investigated implementation of the CALM intervention during a clinical effectiveness trial-the clinics were not explicitly attempting to adopt the CALM intervention as part of their routine care. The collaborative-care interventionists were employees of the research study (though some were previously employed by these same clinics), and the providers were referring to them within the context of a research study. However, many of the challenges and successes associated with implementing research interventions within community clinics are illustrative and informative to future implementation efforts ,30. FurtA total of 1004 adult primary care patients with one of four anxiety disorders  were recruited from 17 clinics within four national sites . The clinics were purposively selected based on a number of considerations, including clinician interest, space availability, size and diversity of patient population, and insurance mix. Anxiety clinical specialists (ACSs) delivered education, self-activation in the context of promoting medication adherence, and CBT to intervention patients and monitored their symptoms using a web-based system in which they recorded anxiety and depression ratings at each contact. Intervention patients chose CBT (34%), anti-anxiety medications (9%), or both (57%) in a "stepped care" treatment that varied according to clinical need. ACSs were located on-site in each clinic and conducted face-to-face CBT with the assistance of a computerized program. ACSs interacted with an off-site study psychiatrist as needed and communicated clinical recommendations about medications between the study psychiatrist and the patients' primary care providers. Control patients received usual care from their primary care clinician. Anxiety symptoms, functioning, satisfaction with care, and healthcare utilization were assessed at six-month intervals. The salaries of the ACSs were covered by the study, and most facilities received some additional assistance/incentives, such as fees, to cover the use of space and/or small amounts of salary coverage for clinic liaisons/champions who helped facilitate the study.CALM's innovations included (1) the flexibility to treat any one of four anxiety disorders, co-occurring depression, and/or alcohol abuse; (2) using on-site clinicians (ACSs) to conduct initial assessments; (3) a computer-assisted psychotherapy delivery system; and (4) a web-based system customized for anxiety status tracking. CALM was designed for easy dissemination in a variety of primary care settings.The 17 clinics can be categorized as members of large health maintenance organizations , federally qualified community healthcare centers (n = 4), university-affiliated clinics (n = 4), or private clinics, either free-standing or part of a hospital group (n = 5). Some of the private clinics and federally qualified centers, however, had university affiliations to some extent, though they were not located on university campuses. About two-thirds of the clinics were internal medicine, with the remaining being family practice. Less than half of the clinics had an in-house mental health provider or providers, and those professionals were usually master's-trained clinicians . About three-fourths of the clinics served some uninsured patients.The total number of participants in this qualitative key-informant interview study was 61, including 14 ACSs hired and trained by the study to conduct the intervention, 18 primary care physicians (PCPs), 13 primary care nurses, and 16 primary care clinic administrators or other staff members. The ACSs came from nursing or social work backgrounds almost exclusively, and all but two were female. Eleven of the PCPs were internal medicine physicians, and the remaining seven were family practice physicians. Twelve of the physicians were female, and six were male. The clinic nurses were a relatively even mixture of registered nurses, licensed practical nurses, and licensed vocational nurses. All but two were female. The clinic administrators interviewed (n = 8) were the administrative leads for their clinics, and all but three were female. The other "clinic staff" informants were a mixture of front desk clerks, scheduling and administrative assistants, and project coordinators. All but one was female. No other personal or demographic information was collected from the participants. While a substantial majority of the participants were female, we feel that the sample generally reflects the characteristics of the work environment and the gender make-up of the majority of the professions sampled, namely, nursing, clinic administration, and social work.In terms of recruitment, all of the ACSs were asked to participate in the key informant interviews. Most of the ACSs (N = 9) were interviewed twice, at a midpoint of the intervention's implementation and at the conclusion of the study. Four ACSs were interviewed only at the midpoint (two had moved on to another position by the endpoint of the study). One was interviewed only at the conclusion. Two ACSs refused to participate. The majority of ACSs worked in one clinic at their respective sites, but several worked in more than one (part-time) across the span of the study. The PCPs, nurses, and clinic administrators/staff with moderate-to-strong involvement in the CALM study (as rated by the study coordinators and/or ACSs) were targeted and "oversampled" for participation. The rationale for this was that because the aim of the qualitative implementation study was to uncover barriers and facilitators to implementation and sustainability of the intervention, it was necessary to interview mostly those clinicians and staff with at least moderate knowledge about the implementation, firsthand, in their clinics. However, clinicians and staff less involved with the CALM intervention (approximately 20% of the sample) were also interviewed to provide balance. The implications of this sampling strategy, both positive and negative, are discussed later in the manuscript. The clinician and staff participants were all interviewed during the final year of the intervention. We did not track approaches to and refusal rates of clinicians and other staff. Some of the potential participants were approached individually, based on their level of participation with the CALM intervention, while others were collectively approached in open calls for participation in meetings or via email. We did not predefine a desired number of participants per category or site; however, we attempted to get at least two employees per clinic to participate, including at least one clinician.The study protocol, consent forms, and interview guides were reviewed and approved by the Institutional Review Boards at the University of Washington, the University of California at Los Angeles, the University of California at San Diego, and the University of Arkansas for Medical Sciences. After the study was described to potential participants, written informed consent was obtained. Data were collected via key informant interviews by phone. Interview guides were used for each provider/staff group, including ACSs. While each guide elicited some information specific to the provider/staff type, a common core of questions was included in all of the interview guides  interviewed their clinic's clinicians and staff. Interviews were recorded and transcribed verbatim. In two instances, the audio recorder malfunctioned and notes from the interviewer were used during coding.Transcripts were content analyzed through a combination of manual coding of printed transcripts and electronic coding using ATLAS.ti software . Content analysis is a common research method for the subjective interpretation of text through a systematic process of classifying text into categories or themes that represent similar meanings . In the In terms of coding, the lead author coded the ACS interviews himself, while he and another investigator co-coded the provider/staff interviews. When two coders were involved, they independently coded identical sections of text and compared coding and interpretations. Each subsample of participants' transcripts was coded as a group, in this sequence: ACSs, physicians, nurses, administrators, and staff. This method allowed the coders to focus on that data and emergent themes of one group at a time (as opposed to coding random transcripts), and the sequence allowed the coders to investigate the stakeholders most involved with the CALM intervention first (ACSs), then in descending order of overall stakeholder involvement in implementation.barriers/facilitators to implementation and barriers/facilitators to sustainability. Organizing the analyses around these top-level codes [Informed by the aims of the study and guided by previous examples of similar implementation analyses -27, the el codes  improvedWhile numerous barriers and facilitators were recognized and reported by the informants, we chose to highlight here those reported most often and those referred to by the participants as the most salient from their perspective. Additional information about the full range of barriers and facilitators is available from the authors. Below we present barriers and facilitators to implementation and sustainability, across stakeholder and clinic types, organized by the following subcategories: provider attitudes/behavior, clinic structure, intervention characteristics, and patient characteristics  feeling that the prevalence of anxiety was low in their clinic. Also, many physicians reported that enthusiasm for the intervention could wane without supportive attention from "champions" or "opinion leaders."The most often cited barrier to implementation across stakeholders was high prevalence of part-time primary care providers and space concerns for the ACS. The ACS and physician stakeholder groups especially reported concerns about part-time physicians (including residents) being harder to reach with information about CALM than full-time providers, and thus it was harder to engage with them and facilitate their involvement. University-affiliated clinics with large numbers of residents seemed most impacted by the barrier. Informants from all stakeholder groups and clinic types noted barriers associated with finding adequate space for the ACSs to do their work. If an ACS's work space was not proximal to the providers, their relationships with them suffered. Further, if an ACS had no permanent or reliable place to work, a common issue in many clinics, this also hindered communication with providers and negatively impacted referrals.Two very commonly noted barriers to implementation across stakeholder group and clinic types were ACSs who worked part-time in a clinic. Referrals are hindered when an ACS is on-site only certain days per week to receive them. Also, less "face time" in the clinic means less communication and fewer opportunities for building rapport with clinic providers and staff. Some physicians discussed communication with ACSs being unsatisfactory. Interestingly, the nature of the dissatisfaction was not uniform. In fact, some physicians wanted more frequent and extensive communication with the ACS, while others felt there was too much. A goal of the CALM intervention was to customize communications with providers to meet their requests/needs for monitoring patients, and it appears that this was not optimized during the study. In addition, some nurses reported feeling "out of the loop" between their PCPs, the ACSs, and the off-site psychiatrist, and they felt that they could not act as "champions" for the intervention when they were out of the loop. This barrier could also fall under the category of clinic structure if its genesis had more to do with pre-existing clinic culture. Some nurses also reported only hearing about the intervention from their PCP, indicating that in some clinics the nurses were not consistent targets for education and marketing about the intervention.An often cited barrier to implementation within this category was when patients drop out or "no show" for their ACS appointments, this can weaken their enthusiasm for the intervention. Perhaps related to this, a patient-related barrier noted among ACSs working in clinics with high numbers of uninsured was that the high overall disease burden and social stressors among lower socioeconomic status (SES) patients seemed to make it harder for those patients to engage in the intervention. The pressures of unstable employment, housing, and transportation appeared to negatively affect how some patients prioritized their anxiety treatment. Two ACSs who worked in clinics that saw many Hispanic patients noted that in general, Hispanic patients were reluctant to engage in the CALM intervention. They speculated that culturally bound beliefs about mental illness were contributing to males being resistant to admitting a problem and females not getting necessary support from their families to participate in the sessions.Some physicians noted that enthusiastically "bought in" to the intervention. The factor most linked to strong buy-in was a belief that mental health concerns should be a priority. This is the inverse of the buy-in barrier noted above. It is unclear to what extent education and outreach efforts of the study investigators and the ACSs influenced this priority setting. When the ACSs were asked to speculate on this point, they reported that most of the enthusiastic providers were that way "from the get go," indicating that many providers were positively predisposed to a mental health intervention. Approximately half of the providers interviewed self-identified as champions of the intervention. Some ACSs made the point that a highly "bought in" nurse could act as a champion and facilitate numerous contacts and referrals, even in the case where his/her physician was not as enthusiastic. Informants from all of the stakeholder groups noted that when positive outcomes of patients were communicated, this increased provider enthusiasm and referral activity. Additionally, when reduced somatic complaints were observed in some patients, provider enthusiasm increased. In addition, among those with a favorable view of CALM, providers did not need to see dramatic improvements in their patients to maintain a positive attitude towards the intervention. As well, most provider informants said they appreciated the additional referral source.Implementation seemed to go smoothly and referrals to the ACS were most plentiful when physicians  and nurses had pre-existing presence of a mental health provider and pre-existing presence of collaborative-care services for another disorder. If the providers were in the habit of referring patients to another mental health specialist within their clinic, or were in the habit of using a collaborative-care coordinator of some kind, those factors facilitated the use of the ACS. The large HMO clinics were the most likely to be already employing a collaborative-care coordinator for another disorder . As noted above, the in-house mental health professionals were usually master's-level clinicians. The interviews with the ACSs did not uncover much information about their relationship with these providers, though some found them to be "good referrers."Two related facilitators in this category were the CALM intervention was not overly burdensome. The physicians and nurses reported little to no increased burden in their workload, and many noted reductions in their workload as a result of reduced somatic complaints. The vast majority found the referral processes very easy and that referrals worked best when the ACSs were in the clinic full time. While it was usual for providers to leave a paper-and-pencil or electronic referral note for the ACSs to follow up on, some providers liked to have the ACS join their encounter with the patient for a face-to-face "hand-off." These face-to-face hand-offs were certainly easier when the ACSs were in the clinic full-time, but the other kinds of referrals were also more quickly acted upon when the ACS was in the clinic full-time. Further, the ACSs found that the more they had "face time" with providers to discuss CALM and establish rapport, the better the implementation went. Face time could occur in the hallways, at lunchtime, or during staff meetings. From the clinic stakeholder point of view, when ACSs were seen as warm, engaging, and visible, they received high marks. And most of the informants who commented specifically about their ACS did so very positively. Most of the providers found the distribution of flyers and information about the study in the patient rooms and/or waiting rooms to be helpful, with this resulting in many patients presenting their concerns about anxiety and asking about the intervention without needing to be screened or prompted.Perhaps the most universal facilitator across clinic stakeholders was that they prefer coming to primary care for their mental health issues. This preference seemed to be rooted in both the ease of coming there ("one-stop shopping") and that stigma was reduced by coming to primary care and seeing a mental health provider there.The main patient-level facilitator seemed to be that many expressed their preference to these informants  that paying for the ACS services and space for the ACS. Most, but not all, of the stakeholders expressed doubt that the intervention would be maintained and that the main "culprit" would be the difficulty in paying for the ACS. A payor or payors would have to decide to reimburse for the services, an external source would have to provide the service for free , or the clinic would have to pay for the employee themselves. In the latter case, the informants indicated that a strong "business case" would have to be made in favor of it and that this seemed unlikely at the present time. Further, many participants noted their difficulty in finding appropriate space for the ACS during the intervention, and they suspected that this would continue if they tried to sustain the intervention.The two main barriers expressed by the vast majority of stakeholders were a positive opinion about the CALM intervention and expressed that they would like to see CALM continue in their clinic. Many informants reported that, overall, the intervention increased their clinic's awareness of anxiety and that increased their desire to continue treating anxiety.Numerous providers and administrators reported already have a mental health provider or a collaborative-care program for another disorder felt more confident that sustaining CALM was possible or even probable in a minority of cases.The clinics that This qualitative process evaluation found, in general, that the CALM collaborative-care intervention for multiple anxiety disorders was not overly burdensome to providers and staff, and it was relatively easy to incorporate into the clinics' routine. Satisfaction with the intervention among these respondents was generally high. Primary care providers appreciated the additional referral source and the feedback they received from the ACS and psychiatrist. The majority of informants reported seeing moderate improvements in enough patients for them to find value in the intervention. A majority of informants stated, without being prompted, they would like to see the intervention continue after the clinical effectiveness study was over. We did not see much evidence of outright "resistance" to the CALM intervention, rather more a lack of motivation/buy-in from a number of providers and some not seeing it as solving key concerns of the clinics, which served more as a challenge to sustainability than uptake during the clinical trial.There were many important facilitators to implementation, perhaps the most important being positive attitudes about the intervention among providers (buy-in). Providers who held a pre-existing belief in the importance of recognizing and treating mental health problems in primary care, who found the intervention nonburdensome, who perceived the ACS as visible and well-liked, who valued the feedback from the clinical team, and who observed positive patient outcomes  were those who most enthusiastically supported the intervention. Other facilitators were a reliable and proximate location of the ACS's workspace, having the ACS work full-time in the clinic, "face time" for ACSs to interact frequently with providers, and the perception of a relatively high prevalence of anxiety among clinic patients. Those clinics with previous experience with an on-site mental health provider and/or collaborative-care interventionist appeared to more readily implement the intervention. It is also possible that clinics with pre-existing mental health providers attracted a greater number of patients with anxiety disorders, and therefore, those clinics might have recognized a greater benefit of the intervention.Numerous barriers to implementation were also found. First and foremost, it was clear that not all providers bought in to the intervention. Some were infrequent users of the intervention, and some never used it at all. For some, this relative lack of use appeared to be tied to their impression that anxiety prevalence was low in their clinics. For others, the lack of use appeared to be linked to a general lack of comfort with treating mental illness or a belief that mental health should not be treated in primary care. Further, these providers did not seem to respond to (or perhaps did not attend) traditional educational sessions by experts presenting evidence on anxiety prevalence and effectiveness of collaborative-care interventions. It is possible that additional marketing of the intervention might have improved provider buy-in. However, many of the providers' attitudes might have been relatively easily fixed. Future research should test the effect of various marketing strategies in primary care clinics.In addition, it was clear that nurses in some clinics served as key advocates and sources of referral. Yet, the study did not specifically market to clinic nurses or provide educational opportunities for them. This was an important oversight. Future studies should consider active promotion of primary care interventions with clinic nursing staff. Other key barriers to implementation were having large numbers of part-time primary care providers within a clinic, using a part-time ACS, a lack of dedicated space for ACSs, unsatisfactory communication with ACSs, and engagement challenges related to low SES and Hispanic patients. Important barriers to sustainability of the intervention were the cost of the ACS  and space concerns.There were not many dramatic differences in reaction to the intervention across stakeholder groups or clinic types, but a few differences did emerge. Clinic administrators/managers, who were usually those charged with finding ACS work space and overseeing clinic operations, reported the most initial skepticism about the intervention and reported experiencing the most burden caused by the intervention. The burden, however, was still mild to moderate, and administrators were generally quite positive about the intervention. In terms of clinic types, the federally qualified community health centers were perhaps at some disadvantage because more of their patients were low SES, and those patients seemed to struggle more with engagement. At the same time, providers in these clinics seemed to especially appreciate the additional referral source . Offering CBT was also a key draw for participation as some of the providers reported very little access to CBT, even when a patient was insured. Two clinics administered by a large, regional HMO and one university-affiliated clinic had experience with collaborative-care interventions, and providers in these clinics were more likely to think that sustainability would be feasible.Most of the barriers and facilitators found in this study are consistent with leading conceptual models of dissemination and implementation in healthcare and the empirical literatures supporting them. For example, numerous barriers and facilitators to implementation and sustainability reported by informants had to do with provider beliefs, attitudes, motivation, and norms, and these are central determinants of implementation in the models of Mendel et al. , Greenhacommunication. Many of the barriers and facilitators we found appear related to positive communication among the ACS, primary care staff, and study-provided psychiatrist, for example, satisfaction with communication with the ACS, nurses being in or out of "the loop," positive clinical outcomes being communicated to the providers, ACSs being part-time or full-time, face-to-face hand-offs of patients, and space (proximity to ACSs). These communication issues are certainly linked to rapport and trust, and together they form a necessary foundation for a working collaborative relationship. It is clear from these analyses that for a collaborative-care intervention to be successfully implemented, there need to be positive lines of communication created that foster rapport and trust. The second meta-theme relates to the lack of anxiety-specific barriers and facilitators observed. Most of the barriers and facilitators were similar to those noted for depression collaborative care and perhaps other collaborative-care interventions in other non-mental health conditions [It was apparent from the analyses that at least two "meta-themes" emerged-the first being associated with nditions ,41. The nditions . Such coThe next step in the research agenda for CALM investigators will be to develop and test an implementation strategy to facilitate adoption under more naturalistic circumstances, that is, without research funding covering the ACS salaries and other cost offsets. This research provides important data to inform the development of such an implementation strategy. The data presented here indicate that the implementation strategy should, at a minimum, include the following elements:1) A marketing plan designed to engage those who are not predisposed to identifying and treating mental health problems in primary care  and incl2) Encouragement of the clinic participants to tailor the intervention to their needs , with sp3) A process for delivering "easily digestible" outcomes data elements to providers and staff to reinforce uptake .4) Additional features to support engagement of lower SES patients Hispanic patients.5) A focus on financing. Bachman and colleagues  have outThe study has several limitations that deserve mention. As noted above, this study investigated barriers and facilitators to the implementation of the CALM intervention during a clinical effectiveness trial. The implications derived here, while contributing to accumulating findings on collaborative-care interventions, still need to be tested in future implementation trials and observational studies of real-world adoption in order to be generalizable. Further, the timings of the clinic provider and staff interventions were not uniform. They occurred during the final year of a two-year intervention. Therefore, "exposure" to the intervention and its outcomes varied considerably, and this difference could have impacted the results. Perhaps most importantly, the sampling strategy likely introduced a positive bias in that most of the participants were at least moderate users of CALM, and such users were more likely to be positively predisposed to the intervention. The investigators decided that the majority of respondents should have at least moderate experience with the intervention to be able to provide the richest feedback. To counteract this bias, we did interview providers and staff with less or no direct involvement with the CALM intervention. Also, the ACS interviews asked specific questions about provider and staff buy-in from the perspective of the clinic as a whole, which also contributed balance.The study has several strengths that also deserve mention. Very few clinical effectiveness studies devote the time and resources to an implementation-focused process evaluation. By doing so, the investigators were able to gather useful data to help them plan for future implementation efforts and reduce the time between development of research findings and adoption in routine care settings. Further, the process evaluation was large in scope, encompassing 61 key informants from multiple perspectives across 17 clinics. The use of semistructured interview guides contributed consistency and reliability to the data collection but did not limit the flow of conversation or discovery of themes. Also, "saturation" was reached, indicating that the number of interviews per stakeholder group was sufficient to fully explore the phenomena under study.This study demonstrated that the CALM intervention is implementable in community settings within a clinical research context and supported by appropriate facilitation provided by research investigators and staff. Future research will develop and test implementation interventions.The authors declare that they have no competing interests.GMC participated in the design of the study, performed data analyses, and took the lead in drafting the manuscript. GS conceived of the study with other co-authors, participated in its design and coordination, and helped to draft the manuscript. PM conceived of the study with other co-authors, participated in its design and coordination, and helped to draft the manuscript. MGC conceived of the study with other co-authors and participated in its design and coordination. MBS conceived of the study with other co-authors and participated in its design and coordination. CDS conceived of the study with other co-authors and participated in its design and coordination. AM participated in the study's design, helped coordinate the study, and performed data analyses. PRB conceived of the study with other co-authors, participated in its design and coordination, and helped to draft the manuscript. All authors read and approved the final manuscript.Major themes and exemplar quotations from informants.Click here for file


Hemorrhage is the leading direct cause of maternal death globally. While oxytocin is the drug of choice for postpartum hemorrhage prevention, its use has generally been limited to health facilities. This trial assesses the effectiveness, safety, and feasibility of expanding the use of prophylactic intramuscular oxytocin to peripheral health care providers at home births in four predominantly rural districts in central Ghana.TM injection system within one minute of delivery of the baby to women who request their presence at home at the onset of labor. The primary aim is to determine if administration of prophylactic oxytocin via Uniject™ by this cadre will reduce the risk of postpartum hemorrhage by 50 % relative to deliveries which do not receive the prophylactic intervention. Postpartum hemorrhage is examined under three sequential definitions: 1) blood loss ≥500 ml (BL); 2) treatment for bleeding (TX) and/or BL; 3) hospital referral for bleeding and/or TX and/or BL. Secondary outcomes address safety and feasibility of the intervention and include adverse maternal and fetal outcomes and logistical concerns regarding assistance at home births and the storage and handling of oxytocin, respectively.This study is designed as a community-based cluster-randomized trial in which Community Health Officers are randomized to provide (or not provide) an injection of oxytocin 10 IU via the UnijectResults from this trial will build evidence for the effectiveness of expanding the delivery of this established prophylactic intervention to peripheral settings. Complementary data on safety and logistical issues related to this intervention will assist policymakers in low-income countries in selecting both the best uterotonic and service delivery strategy for postpartum hemorrhage prevention. Results of this trial are expected in mid-2013. The trial is registered at ClinicalTrials.gov: NCT01108289. An estimated 350,000 women die each year in childbirth. Progress in reducing maternal mortality has been varied within and between regions, with the least progress in sub-Saharan Africa . The leaOxytocin is a naturally occurring hormone which promotes smooth muscle contraction. When released postpartum it stimulates both the breastmilk let-down reflex and uterine contraction to slow and stop blood loss. Its synthetic analogue is the recommended uterotonic drug of choice for AMTSL, due to its rapid onset of action, minimal side effects, and low cost .In the absence of a skilled birth attendant, WHO recommends that a uterotonic  should be given by a health worker trained in its use to prevent PPH. Oxytocin is preferred over misoprostol where its use is feasible . While mThus, research is needed to assess the safety and feasibility of expanding access to this drug. Expanding provision of oxytocin to peripheral settings raises three main concerns: (1) providers may not be skilled in giving injections, (2) heat exposure may compromise drug integrity/potency, and (3) administration prior to delivery of the baby  outside a fully qualified facility increases risk to mother and baby.TM injection system addresses the first of these concerns. The injection system  to the foil pouch containing each Uniject™ injection system Figure . This inGiven that a simple injection system is now available which facilitates safe administration of chemically potent oxytocin, a drug known to be effective at PPH prevention when administered by medical personnel in health facilities, the question remains whether this intervention is effective, safe, and feasible in the hands of a minimally trained health care provider assisting home births. This trial, conducted as part of the Oxytocin Initiative project, is designed to address this question.This study is designed as a cluster-randomized community-based trial in which Ghana Health Service (GHS) Community Health Officers (CHOs) are randomized into one of two study arms determining the care that CHOs provide to enrolled women during their home-based deliveries. For the purposes of this trial, all deliveries assisted by an individual CHO constitute a cluster. The trial is designed to determine if intramuscular administration of 10 IU of oxytocin in Uniject™ during the third stage of labor by a CHO will reduce the risk of PPH by 50 % relative to deliveries attended by a CHO who does not provide the prophylactic intervention. This is not, however, a drug efficacy trial. The trial is designed to assess the mode of service delivery.Implementation of the trial is divided into three phases. The first phase is designed as a month-long Active Preparation Phase in which all field procedures and data collection systems are activated except administration of oxytocin by CHOs. The Comparative Phase marks the initiation of enrollment into the trial and was originally planned to last nine months. The third phase of the trial is a conditional three month Universal Distribution Phase in which all women enrolled in the trial would receive prophylactic oxytocin following delivery of the baby. Implementation of the Universal Distribution Phase of the trial is conditional upon results of the Comparative Phase and feedback from the Data Safety and Monitoring Board.The trial is being conducted in four predominantly rural districts of Brong-Ahafo region in central Ghana. The study districts, which are under demographic surveillance by the Kintampo Health Research Centre (KHRC), are Kintampo North and South and Nkoranza North and South Figure , with a Field staff for this trial consist of 69 field workers, with at least senior-high school education, dedicated to this study and resident in the communities for which they are responsible, and nine field supervisors. The field workers were provided with bicycles and the supervisors were provided with motorcycles to facilitate movement within their areas of work. All field staff participated in a three-day training prior to the start of the study.Extensive consultations were required during the design phase of the study between KHRC leadership, study investigators, and GHS staff at both the district and regional levels regarding the involvement of GHS CHOs as the agents to administer the study intervention. CHOs are the centerpiece of the GHS Community-based Health Planning and Services (CHPS) Initiative, which has the goal of expanding access to basic health care for the rural population. CHO services include childhood vaccination, antenatal and postnatal care, family planning outreach, emergency deliveries, and referral for complications during pregnancy and delivery. While CHOs are permitted to administer ergometrine tablets in an emergency for treatment of postpartum hemorrhage, they are not currently permitted to administer injectable uterotonics. Following training, CHOs are posted to a CHPS compound from which their clinical and outreach work is based.The study facilitated the placement of CHOs into communities in study districts where there were no CHOs and provided resources to improve CHO compounds where these were inadequate. Prior to the start of the study, all CHOs completed a five-day training course and were required to pass a competency-based examination specific to their cluster allocation. Throughout the course of the study, CHOs are provided with some allowance to purchase credit for their mobile phones as well as basic comfort items such as solar lamps and beds. The compounds are also provided with basic hospital equipment such as examination couches and cupboards for storage of medical supplies as a contribution to the expansion of the CHPS initiative. Study-related work by the CHOs is jointly supervised by the GHS and KHRC.TM group or the Comparison group using the STATA utility “ralloc” [Among the four participating districts, 52 CHO areas were identified and categorized as either “near” ≤ 10 km) and “far” (> 10 km) from a facility with capacity for emergency obstetric care. The categorization resulted in eight strata (4 district x 2 distance), two of which contained an odd number  and six of which contained an even number of CHOs . A temporary placeholder CHO was added to each of the two strata containing an odd number of CHOs, and all units were randomly allocated to either the oxytocin in Uniject“ralloc” , stratif0 km and Figure TM injection system has been used.Oxytocin in Uniject™ injection devices with time-temperature indicators were produced by Instituto Biológico Argentino (BIOL), a pharmaceutical producer in Argentina, and imported into Ghana as clinical study supplies after obtaining a clinical sample import permit from the Ghana Food and Drug Board. They are transported to KHRC under cold chain conditions and are distributed from KHRC refrigerators on a weekly or as-needed basis to CHOs, who store them in their compounds in a cool place. Storing oxytocin out of the cold chain is being done to ensure that the intervention is being conducted under conditions as similar as possible to a scaled-up government service. To the best of our knowledge, this study constitutes the first randomized controlled trial in which the oxytocin in UnijectPrior to the start of field work, community meetings were held with GHS authorities in various communities, opinion leaders, chiefs, and community members regarding the objectives of the study. KHRC field workers then began identifying on a weekly basis all households with a pregnant woman within their allotted communities. There are no exclusion criteria for this study. As pregnant women at seven months or more gestation are identified, the study is explained to them and they are asked for initial consent to participate in the study. Initial consent indicates that a woman is interested in having a CHO present at her delivery should she be unable to travel to a health facility or should she choose to deliver at home. Field workers remain in contact with women who have initially consented, and where possible, they arrange to introduce the CHO to the pregnant woman’s family. They then wait to see if the woman calls the field worker at the onset of her labor. When field workers are contacted, they phone the CHO and both travel to the woman’s household, although the field worker will generally remain outside of the house. Final consent for full participation is obtained at this time.Once in the home and after administration of final consent, CHOs in both groups place a BRASSS-V calibrated drape designed to collect postpartum blood under the woman’s body before birth of the baby. Women are asked to remain recumbent, if possible, for one hour if bleeding ceases within one hour, or for two hours if active bleeding continues at one hour. The blood loss measure excludes fluid, urine, and feces passed during the birthing process. All blood collected in the drape is scooped into the pouch. The drape is removed from the woman and held up vertically in order to obtain the blood loss reading Figure . This meTM in the thigh within one minute after delivery of the baby. CHOs in both arms collaborate with the birth attendant to conduct their study-related responsibilities and do not directly manage the delivery.While all CHOs measure blood loss and provide treatment and referral (if necessary), CHOs randomized to the intervention arm provide one injection of 10 IU of oxytocin administered via UnijectTwo to three days following delivery, the field worker visits the house of all enrolled women for a follow-up interview with questions regarding the care they received, and in particular, the timing relative to delivery of the baby of any injections they may have received. When necessary, a family member who was present during the birth may assist in responding to these questions. In cases where traditional birth attendants managed the delivery, a similar interview is also conducted with them.The sample size estimation procedure followed a standard approach for cluster-randomized trials . First, CHOs, KHRC field workers, and supervisors collected data using paper-based forms during their contacts with pregnant women and family members. These included a Background Information form filled at the time of the preliminary consent (approximately seven months gestation); a CHO form filled at and soon after the observed delivery; and follow-up forms with the delivered woman, a family member, and, if present, the traditional birth attendant that assisted at the time of delivery. All forms filled by CHOs and field workers were checked by supervisors for completeness and consistency, and then transferred to the KHRC Computer Center for double data entry into a customized Visual FoxPro database. Consistency, validity, and referential integrity are enforced through automated post-entry checks on the database. Basic enrollment status reports are generated fortnightly.Both the interim and final analyses will begin with descriptive information regarding the extent  of enrollment, the dynamic of enrollment over the period of the trial, and variation between the clusters in terms of enrollment. Given the importance of assessing feasibility of this intervention in any scaled-up program, particular focus will be placed on describing the frequency with which women in labor contact the CHO to request her presence and the proportion of these women for whom the CHO arrives before delivery. Reasons for not contacting the CHO or for non-arrival by the CHO will be estimated and compared across the groups. Enrolled women will be defined as those for whom (1) the field worker/CHO arrived at the home prior to delivery, (2) consent to participate was reconfirmed , and (3) the CHO was present at the home of the woman at the time of delivery. Among enrolled women, a range of covariates will be compared to determine if the cluster randomization achieved balance across socio-economic, household, and maternal characteristics.The primary outcome of this trial is PPH. This outcome was selected based on (1) extended discussions with an international technical advisory group established for the study, which concluded that for policy impact, it would be insufficient to assume a health benefit from this intervention given the use of minimally trained health care providers and use of a new technology; (2) a general consensus that blood loss equal to or greater than 500 mL constitutes PPH; and (3) the availability of a validated tool for the measurement of blood loss in a home setting.PPH will be defined using three different definitions Table . The strAnalysis of each of these three definitions will follow an intent-to-treat approach; that is, enrolled women will be included in the analysis according to their cluster allocation, regardless of their specific receipt (or non-receipt) of the assigned intervention. Separately for each definition, the proportion of women in each group meeting the criteria will be estimated, and the risk of the outcome in the intervention group relative to the control group will be calculated  using a binomial regression model with log link function. Standard errors will be adjusted for the clustered allocation using the generalized estimating equation approach , and 95 TM was given prior to delivery of the (last) baby will be estimated, and a 95 % confidence interval constructed. If appropriate, this outcome will be examined separately by allocation group and compared using standard methods .Given concerns regarding the safety of the intervention and its programmatic feasibility, several secondary outcomes were selected. The predominant safety concern is administration of oxytocin for induction, or more likely, for augmentation of labor. Use of any intramuscular uterotonic drug before the birth of the infant is regarded as dangerous because it is not possible to adjust the dosage if it causes hyperstimulation and cannot be adapted to the level of uterine activity, as is possible with the monitored administration of intravenous oxytocin in health facilities . HyperstTM injection systems disposed of properly.Other safety outcomes include individual and composite estimates of the frequency of adverse maternal, fetal, and neonatal events, including maternal deaths, stillbirths, early neonatal deaths, birth asphyxia, need for newborn resuscitation, uterine rupture, and referral and/or transport to a higher-level facility. Among participating women, comparisons will be made for all deliveries across both arms of the trial and also restricted to deliveries for which oxytocin was given before delivery of the baby. For each comparison (and the composite measure), proportions will be estimated, and 95 % confidence intervals constructed. Comparisons across groups will utilize binomial regression with a log link function, will account for clustered allocation using GEE, and will adjust for imbalance as necessary. Analyses of feasibility outcomes will be descriptive in nature . These include, among others, the proportion of deliveries in which the CHO arrives late, the mean time between call and arrival of the CHO, proportion of participating pregnancies  that become participants , and the proportion of oxytocin in UnijectAn independent Data Safety and Monitoring Board (DSMB) consisting of national and regional experts was established. Stopping guidelines for efficacy were agreed upon by the DSMB members and the investigating team prior to the trial, using Lan-DeMets boundaries and nominal p-values for group sequential analyses estimated using O’Brien-Fleming spending function ,30. A siThe study protocol was approved by the KHRC and GHS Ethical Review Committees, the Institutional Review Board of the Johns Hopkins Bloomberg School of Public Health (#00002673), and the Research Ethics Committee of PATH (#547). The protocol is reviewed and reapproved on an annual basis. The trial is registered at ClinicalTrials.gov: NCT01108289.TM injection system.Programmatic responses to PPH prevention must take into account contextual issues, including health care provider skills, location, and authorizations for use of specific drugs and modes of administration. Drug effectiveness, PPH treatment options, drug and service delivery costs, and logistical constraints are all important considerations. This trial is designed to address many of these questions for prophylactic oxytocin administered via the UnijectPPH  was selected as the primary outcome of the study for reasons described above. Blood loss data and clinical signs are being used as triggers to initiate early treatment of PPH, and in the case of clinical signs, treatment is initiated without regard to blood loss. Given that PPH is extremely time-sensitive, CHOs are not skilled birth attendants, infrastructure in many areas is poor, and some study households are in remote locations, waiting to initiate treatment until blood loss reached 500 mL or more (as has been done in some health facility-based trials ,32 was nThe priority for this study design is to conduct a methodologically rigorous study that ensures the safety of all study participants and that yields valid results regarding the risks and benefits of expanding use of a known, effective lifesaving drug for prevention of PPH. Results of this trial are expected in 2013, and will inform national and international PPH prevention policy and guideline development.The authors declare that they have no competing interests.Important contributions to trial design were made by CS, LCM, SN, OA, JG and DA. The first draft of the manuscript was jointly developed by CS, LCM, SN, SK, AL, and ND. PC and SK are co-investigators and all authors provided editing, assisted in the finalization of the draft, and approved the final manuscript.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2393/12/42/prepub


However, the postvention field is still facing a number of important challenges and questions. This article aims to discuss a series of essential issues on suicide bereavement and postvention, regarding the current state of the art and future developments. Who is a suicide survivor and how many suicide survivors are there? Is suicide bereavement different from other types of bereavement? What are the needs of suicide survivors and what is postvention from a clinical perspective and from a public health perspective? Can postvention be prevention? With this last question, the article concludes with a series of recommendations in order to strengthen the potential of postvention as prevention. During the past decades public and research interest in postvention,  Two basic, but nonetheless challenging questions have to be answered before starting a discussion on the potential impact of loss by suicide, the needs of the bereaved and the prerequisites of effective postvention. The first question is: how can we define a “suicide survivor”? The second question addresses the magnitude of the problem: how many suicide survivors are there?Any discussion of suicide, a serious public health problem claiming globally approximately one million victims per year, will be incomplete without taking into consideration the perspective of the bereaved, or in other word, the suicide survivors. Their number is significantly higher than the number of suicide victims and some of the survivors have to cope with serious and long lasting psycho-social sequelae of the loss, including increased risk of suicidality. Although a wide range of support initiatives organised by survivors themselves, mental health professionals and concerned communities are available, numerous challenges lie ahead with regards to program and policy development, research and clinical practice, to ensure effective care for the bereaved by suicide, There is a lack of consensus in the literature regarding the definition of a “suicide survivor”; however, the proposed definitions share several commonalities. They focus on the fact that there existed a relationship between the deceased and the bereaved, on the closeness of this relationship and/or the impact of the loss on the bereaved. For example, McIntosh  defined guesstimate” of Shneidman [Indeed, a suicide death can affect people in various types of relationships with the deceased: from close family members to more distant relatives, friends, neighbours, and employers  and sevehneidman . The metaphor of a stone thrown into a lake reflects well the wide-reaching impact of suicide. It causes many ripples which turbulently affect the water’s surface. The big challenge for effective postvention is ensuring that every survivor, from the close family members and friends to those indirectly exposed to suicide, can receive help and support they need. Provision of timely and adequate services for the bereaved requires also a good understanding of the bereavement process and the needs of the survivors as a group as well as acknowledging the individual differences between the bereaved. There seems to be a gap between personal accounts of individual survivors, for example first person accounts written by survivors themselves, e.g.,  and narrIn an attempt to explain the differences observed in clinical practice and research studies, Jordan & McIntosh  have proi.e., the perspective of mental health professionals and services, and the public health perspective of policy development and general population strategies.Postvention can be defined as “activities developed by, with or for suicide survivors, in order to facilitate recovery after suicide and to prevent adverse outcomes including suicidal behaviour” , (p. 43)et al. [Jordan, Feigelman, McMenamy and Mitchell  noted thet al.  showed tet al.  reportedet al. ,21,22,23et al. . Such inet al.  and adulet al. . Suicide survivor support groups and psychotherapy seem to be promising forms of help addressing the wide variety of problems and needs of the survivors. The former may be helpful for suicide survivors in general, while the latter might be helpful especially for survivors who develop psychological and/or psychiatric problems . Howeveret al. [In addition, only a minority of survivors attend support groups and/or other services. A study by Provini et al.  showed tet al. . It has et al. . Besideset al. . For somSuicide comprises a serious, although sometimes underestimated, occupational hazard for  health professionals, and training and postvention for this group should be routinely available to reduce the psychological and public health cost of suicide. Mental health professionals as well as other professionals can be affected by suicide on both personal and professional levels ,35. A goAs Shneidman  has writThere remains of course the question if the social taboo relating to suicide and stigmatization of suicide survivors might not limit the effectiveness of such interventions and prevent some of the survivors in need from taking advantage of these resources. Grad  has propThe evaluation of postvention programs is another important, albeit relatively neglected, public health challenge. A recent pioneering example of such a health-economic evaluation is the study of the Australian StandBy Response Service, a community-based outreach program providing support and a coordinated response for people bereaved through suicide . The evaSuicide survivors comprise not only the target group of postvention activities; they are also an active force behind many suicide prevention initiatives, such as Suicide Prevention Action Network USA, Lifekeeper Memory Quilt in Australia and the Media Award for Responsible Portrayal of Suicide in Belgium. In the words of Paul Quinnett, “the suicide prevention movement has not been powered by rhetorical interest, but by the pain of those who have lost loved ones” . Also, given the fact that suicide survivors are a group with increased suicide risk, postvention is an integral and indispensable component of comprehensive suicide prevention programs. Just as suicidology without the involvement of survivors would be poor suicidology, suicide prevention without survivors would be poor suicide prevention. The voice of survivors should be included in public health policies related to suicide prevention as well as involved in design and implementation of postvention programs and studies, although a detailed discussion of this issue is beyond the scope of this paper . There i


Improving the coordination of cancer care is a priority area for service improvement. However, quality improvement initiatives are hindered by the lack of accurate and reliable measures of this aspect of cancer care. This study was conducted to develop a questionnaire to measures patients' experience of cancer care coordination and to assess the psychometric properties of this instrument.Questionnaire items were developed on the basis of literature review and qualitative research involving focus groups and interviews with cancer patients, carers and clinicians. The draft instrument was completed 686 patients who had been recently treated for a newly diagnosed cancer, including patients from metropolitan, regional and rural areas of New South Wales, Australia. To assess test-retest reliability, 119 patients completed the questionnaire twice. Unreliable items those with limited variability or high levels of missing data were eliminated. Exploratory factor analysis was conducted to define the underlying factor structure of the remaining items and subscales were constructed. Correlations between these and global measures of the experience of care coordination and the quality of care were assessed.Of 40 items included in the draft questionnaire, 20 were eliminated due to poor test-retest reliability (n = 4), limited response distributions (n = 8), failure to load onto a factor (n = 7) or detrimental effect on the internal consistency of the scale (n = 1). The remaining 20 items loaded onto two factors named 'Communication' and 'Navigation', which explained 91% of the common variance. Internal consistency was with high for the instrument  and each subscale . There was no apparent 'floor' or 'ceiling' effect for the total score or the Communication subscale, but evidence of a ceiling effect for the Navigation subscale with 21% of respondents achieving the highest possible score. There were moderate positive associations between the total score and global measures of care coordination (r = 0.57) and quality of care (r = 0.53).The instrument developed in this study demonstrated consistency and robust psychometric properties. It may provide a useful tool to measure patients' experience of cancer care coordination in future surveys and intervention studies. Effective coordination of care between different clinicians, services and health sectors throughout the patient journey is fundamental to the provision of high-quality care -3. In hePeople with cancer are particularly at risk of receiving poorly organized and fragmented care due to the complex nature of the disease and its management, which often involves multidisciplinary care from a large team of medical, nursing and allied health practitioners in both hospital and community settings over extended periods of time. As a result, many national strategic cancer plans have identified the improvement of cancer care coordination as a priority for service improvement ,4,6,7.Efforts to improve cancer care coordination to date have been hindered by a dearth of accurate and reliable measures by which progress can be monitored. This partly stems from the lack of an agreed theoretical framework or definition of the term 'care coordination' to underpin the development of measures. For example, a recent literature review prepared for the Agency for Healthcare Research and Quality (AHRQ) identified more than 40 different definitions for 'care coordination'. However, the authors identified a number of common elements to inform the following working definition:'Care coordination is the deliberate organization of patient care activities between two or more participants (including the patient) involved in a patient's care to facilitate the appropriate delivery of health care services. Organizing care involves the marshaling of personnel and other resources needed to carry out all required patient care activities, and is often managed by the exchange of information among participants responsible for different aspects of care [ of care .This definition provides a starting point to identify the specific aspects of the care experience that should be addressed in any measurement tool.There are a number of sources of data that could be used to assess aspects of cancer care coordination, including administrative health datasets, audits of individual patient records or measures based on the experience of patients or clinicians. Patients are ideally placed to rate the adequacy of cancer care coordination, however, as they are likely to be the only individual present at every encounter with health services. Furthermore, the move towards more patient-centred care in which services are organized around the needs and preferences of individual patients, emphasizes the primacy of measures based on patients' own experience. Therefore we conducted this study to develop a questionnaire for patients to assess their experience of cancer care coordination in the treatment phase of the cancer journey, to define the underlying factor structure of the questionnaire and to conduct initial validation by assessing construct validity, internal consistency and test-retest reliability.A literature review was undertaken to identify relevant issues and terminology as well as items and scales within existing instruments that could be used to measure aspects of cancer care coordination -13. The The results of the literature review and this qualitative work were used to identify existing items and to generate new items that addressed these eight components of cancer care coordination as well as the concepts espoused in the AHRQ definition . To geneForty items that related to concepts considered important by a broad range of stakeholders in the qualitative phase and that addressed the theoretical components of cancer care coordination were selected for inclusion in a draft questionnaire. Items were worded both in the positive and the negative with bolding of words used to highlight differences between similar statements. To investigate the most reliable format for response options, two formats were tested. Eighteen items were phrased as statements to which respondents were asked to indicate their level of agreement, using a five-point Likert scale . The remaining 22 items asked about patients' experiences of care in the previous three months, again using a five-point Likert scale . A time frame of three months was chosen on clinical grounds to provide a sufficient time window for patients to have received multidisciplinary cancer care. The items with the 'agreement' format were included in random order, followed by the items using the 'experience' format, again in random order. The response option headings were repeated at intervals down the page to break up the lines of text and tick boxes so as to improve the ease of completing the questionnaire. In addition, the questionnaire included two global assessment questions in which respondents were asked to rate firstly, the coordination of their care and secondly, the overall quality of the care they had received, on a scale from one ('Very poor') to ten ('Excellent'). The draft questionnaire was reviewed by clinicians and researchers to assess comprehensiveness of items  and clarity of wording.The draft questionnaire was then tested in two separate samples of patients.A purposive sample was recruited from six centres ) to provide patients with a range of cancer types, treatment modalities and geographical location. Eligible patients were in follow up for any cancer that had been treated between three and twelve months previously. This time-frame was considered optimal as patients would have experienced the full range of care-co-ordination through the treatment phase of their illness. Patients were considered ineligible if they had insufficient English skills or were cognitively impaired such that they could not complete the questionnaire or were receiving end of life care.Patients were asked to read and sign a consent form, complete the questionnaire and return these items to the research team in a reply paid envelope. In addition, patients completed items assessing demographic and clinical information, including age; sex; country of birth; marital, education and occupational status; cancer type, year of diagnosis and treatment modalities. To assess test-retest reliability, on receipt of their completed questionnaire, patients in the first three month period of recruitment were mailed a second, identical copy of the questionnaire to complete two weeks later.This sample comprised patients with a newly diagnosed colorectal cancer who were participating in an ongoing randomised trial. Patients treated at 22 public and private hospitals in metropolitan and regional centres in NSW were recruited at the time of initial surgical treatment and asked to complete self-administered questionnaires at baseline, one, three and six months. The data for the present study are from the 3-month assessment which included the draft questionnaire about cancer care coordination. Demographic and clinical information was collected at the time of enrolment into the trial.Characteristics of participants were summarized. For the subsample of Sample 1 who completed the questionnaire twice, test-retest reliability (repeatability) of individual items was assessed by calculating weighted Kappa statistics with 95% confidence intervals (CIs). Items with kappa values of less than 0.40, representing 'fair' or 'poor' agreement, were eliUsing the combined dataset (n = 686), frequency distributions for each item were examined. Items with more than 5% missing data and those with limited response distributions (70% or more respondents gave the same response) were eliminated .Study data were then randomly split into two equal sized sub-samples. Exploratory factor analysis using squared multiple correlations as prior communality estimates was conducted in each sub-sample separately to assess the consistency of the factor pattern. The principal factor method was used to extract the factors, followed by a promax rotation ,18. The The factors were used to develop subscales within the questionnaire. First, the scoring for items worded in the negative were reversed, so that a higher score indicated better care coordination for all items. Items that loaded onto each factor were summed to create factor-based scales. To assess whether any individual items reduced the internal consistency of the total score or individual subscales, item-total correlations were calculated. These statistics provide a measure of the correlation between an item and the sum of the remaining items in the scale, with low values (less than 0.2)  indicatiThe distribution of subscale scores and the total score were assessed with descriptive statistics and the proportions of respondents with the highest ('ceiling') and lowest ('floor') scores were calculated. Spearman's rank correlation coefficient was calculated for the total score and each of the subscales firstly with the global cancer care coordination item and secondly with the global quality of care item. All statistical analyses were undertaken using SAS statistical software .A sample of five times the number of questionnaire items is considered the minimum for factor analysis . As the The study was approved by the Sydney South West Area Health Service Ethics Review Committee (RPAH zone).Overall, 686 patients completed the questionnaire, 245 from Sample 1 and 441 from sample 2. Characteristics of patients are summarized in Table Among 119 patients in Sample 1 who completed the questionnaire twice, values of weighted Kappa for individual items ranged from 0.29 to 0.69. Four items with values less than 0.40 were eliminated from further analyses. Two of these used the 'agreement' response format and two the 'experience' response format. Using the entire dataset (n = 686), eight items demonstrated limited response distributions with 70% or more of the sample giving the same response and so were eliminated. These eight items each used the 'experience' response format.The underlying constructs represented by the remaining items were explored in factor analysis using the split sample approach. In the first sub-sample, a solution in which 21 items loaded onto two factors had a simple structure with all items having a high loading on one factor and a low loading on the other. Furthermore, each factor contained at least three items, considered the minimum for a robust subscale  and the Although the Navigation subscale demonstrated a ceiling effect with 21% of the sample achieving the highest possible score, the Communication subscale and total score were both more Normally distributed with no evidence of ceiling or floor effects Table . There wDespite increasing recognition of inadequate care coordination as a common problem experienced by patients, to date there have been few measures by which improvement or deterioration in this crucial aspect of cancer care could be measured. The aim of this study was to develop a valid and reliable self-administered questionnaire for patients to measure the adequacy of cancer care coordination for those in the treatment phase of the cancer journey. The resulting questionnaire demonstrated robust psychometric properties and consistent subscales, suggesting that this instrument could provide a useful tool to measure cancer care coordination in future patient surveys and intervention studies.The process of developing a new questionnaire is lengthy, requiring a number of iterative steps to further refine the wording and items to provide an instrument that is both acceptable and easily-understood by the target audience as well as providing a comprehensive, accurate and reliable measure of the phenomenon of interest. Furthermore, there is always a tension between the comprehensiveness of the instrument and the burden that a lengthy instrument will place on respondents. Brief instruments may achieve higher response rates, but may also limit the breadth or depth of information that can be collected. The approach to instrument development in this study was to only include items that had sound psychometric properties. Unreliable items that elicit inconsistent responses from an individual are of no value, as are items that are frequently missed out, perhaps due to lack of clarity in the wording or lack of relevance to a significant number of individuals. Furthermore, items that elicit highly skewed responses, with almost everyone giving a similar response, are of limited value for measurement. On the basis of these considerations, the draft questionnaire was reduced to 20 items that demonstrated good internal consistency and addressed two important components of cancer care coordination, namely the issues of communication and navigation of the health care system.The Communication factor was the strongest, accounting for nearly 75% of the variance and demonstrating internal consistency in the desired range of 0.7-0.9 . Compris'Care coordination' and 'continuity of care' are related but distinct concepts -23. WhilIn the non-oncology setting, McGuiness and Sibthorpe took a broad approach to measuring health care coordination, developing an instrument for older patients with chronic, complex medical conditions in the primary care setting . Others Overall, rates of item completion were high, suggesting that the questions were clear and acceptable to patients. Of note, the highest rates of missing data were for items asking about family and carer issues. The reason for this warrants further investigation as it could be that some patients do not have a carer, or do not identify their family or friends as 'carers', or are unable to answer questions relating to the experience of their carers. Assessment of the experience of cancer care coordination from the perspective of carers warrants further research.A number of limitations to this study are acknowledged. Although our sampling strategy aimed to include a broad range of patients in Sample 1, there was a preponderance of those with colorectal cancer and people from metropolitan centres. Furthermore, people with limited English skills were excluded from both samples and so the questionnaire may not be applicable to those from culturally and linguistically diverse communities. The methods used in this study were to reduce the number of questionnaire items to those with good psychometric properties and to provide a brief questionnaire. It is possible that the resulting instrument omits important aspects of cancer care coordination and the development of additional items and subscales could improve the content validity of the instrument. Furthermore, the responsiveness of this instrument to change needs to be tested in future studies.In conclusion, the questionnaire developed in this study has been shown to be a psychometrically robust patient-report measure of cancer care coordination. Further studies will help establish the usefulness of this measure in future needs assessment surveys and intervention studies.The authors declare that they have no competing interests.JY designed the study, conducted the statistical analysis of the data and drafted the manuscript. JW recruited clinicians and patients, conducted the qualitative studies to generate items, managed the data, contributed to interpretation of findings, critically reviewed the manuscript and approved the final version. PB contributed to study design and development of questionnaire items, interpretation of findings, critically reviewed the manuscript and approved the final version. MS contributed to study design and development of questionnaire items, recruited patients, contributed to interpretation of findings, critically reviewed the manuscript and approved the final version. JS contributed to factor analyses and interpretation of the data, critically reviewed the manuscript and approved the final version. All authors read and approved the final manuscript.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2407/11/298/prepubCancer Care Coordination Questionnaire for Patients. Copy of the 20-item questionnaire for patients.Click here for file