Currently, 10-15% of women giving birth suffer from symptoms of postpartum depression. Due to a lack of knowledge of this condition and the stigma associated with it, as well as few treatment options, a large proportion of postpartum women with depression remain untreated. Internet-based interventions have been found effective in treating depression, anxiety, phobias, and addictions. Hence, we developed such program (“Mamma Mia”) with the aim of reducing the risk for postpartum depression and enhance subjective well-being. Mamma Mia is based on positive psychology, metacognitive therapy, and couples therapy. It starts in gestational week 22, and lasts until 6 months after birth. During pregnancy, Mamma Mia is delivered weekly (every Monday). After birth, Mamma Mia is delivered three times per week for six weeks. The remaining weeks, the program is delivered more sporadically. In total, Mamma Mia consists of 44 sessions. The program is individualized, interactive, and tunneled .The purpose of the present study was to pilot test the intervention in order to assess the feasibility and acceptance among program users.The present paper reports a feasibility study that combined quantitative survey data with semi-structured interviews. Participants (N=103) were recruited via hospitals, well-baby clinics, and Facebook. Due to time constraint in completing the current study, our results were based on participation in one of the two phases: pregnancy or maternity. Participants in the pregnancy phase were surveyed 4 and 8 weeks after intervention enrollment, and participants in the postnatal phase were surveyed 2 and 4 weeks after intervention enrollment. The survey assessed perceived usefulness, ease-of-use, credibility, and unobtrusiveness. All measures were filled in by participants at both measurement occasions. Data were analyzed by running descriptives and frequencies with corresponding percentages. Binomial tests were carried out to investigate whether demographics differed significantly from a 50/50 distribution. Paired sample t tests were used to examine differences between time 1 and 2. Four participants were interviewed in the qualitative follow-up study, where they were given the opportunity to address and elaborate on similar aspects as assessed in the survey.More than two-thirds of users found Mamma Mia to be of high quality and would recommend Mamma Mia to others. By far, most also found the amount of information and frequency of the intervention schedule to be appropriate. Mamma Mia was perceived as a user-friendly and credible intervention.Overall, the user acceptance of Mamma Mia was good and our findings add to the feasibility of the program. The effect of Mamma Mia on depression and subjective well-being will be evaluated in a large randomized controlled trial, and if found to be effective, Mamma Mia could serve as a low-threshold prevention program. The postpartum period represents a vulnerable time, where the woman is at increased risk for mental disorders . StudiesFactors that put women at elevated risk for PPD include a personal history of depression, family history of depression, negative life events, partner conflicts or low relationship satisfaction, low levels of social support, and certain baby characteristics ,7. The mAccording to the National Institute for Health and Clinical Excellence (NICE) guidelines , effectiMany Web-based interventions have been designed and documented to be effective in treating various mental problems including depression , anxietyMamma Mia is an automated/unguided Web-based self-help intervention. The aim of Mamma Mia is threefold: (1) to prevent PPD, (2) to treat pregnant women/new mothers with mild-to-moderate symptoms of depression, and (3) enhance subjective well-being. Overall, Mamma Mia consists of 3 phases see . The preThe key components in Mamma Mia are (1) assessment of depressive symptoms, (2) metacognitive therapy, (3) positive psychology, (4) couples therapy, (5) breastfeeding, and (6) psychoeducation. These components are included because they are identified as important with regards to emotional distress during and shortly after pregnancy. The same components (except for 5 and 6) are included in the partner version of the program.The most common screening-tool for PPD is the Edinburgh Postnatal Depression Scale (EPDS), which assesses depressive symptoms during the last 7 days . The proMetacognitive therapy  is a recPositive psychology revolves around all that is good in life, and aspects that give meaning and enhance life satisfaction. Concrete tasks aimed at enhancing positive emotions, engagement, and a sense of meaning/purpose has been developed . The basThe gratitude component involves assignments such as counting one’s blessings, writing down 3 good things that happened during the day, writing a letter of gratitude, and saying “thank you” more often than usual. In order to increase socialization and thus strengthen the social network, which in turn facilitates social support, one is encouraged to initiate social interaction with friends and relatives. Assignments include calling a friend and inviting him/her out and mapping one’s social network. One is also advised on how to get new friends, and strengthening existing relationships . In terms of acts of kindness, one is encouraged to do acts of kindness to others, keeping track of such acts, and plan them ahead of time. Examples of kind acts are provided, while one is also encouraged to figure out such acts for oneself. The “best possible self” exercise is intended to increase optimism ,46. HereA recent study suggests relationship dissatisfaction to be the strongest predictor of maternal emotional distress during pregnancy ,49. HencResearch suggests a relation between breastfeeding and depressive symptoms -55. FormEvery session in the program includes information regarding topics such as emotional lability in pregnancy, changes and challenges in the partner relationship, the importance of social support, the fetus and the infant’s development, birth etc. Short video clips are available to demonstrate and explain the infant’s state regulation system (sleep-wake cycles), and this information is integrated with issues related to the infant’s capacity to sleep and rest, soothability, interaction/communication etc. The intention is that the program will provide the woman with relevant information adjusted to her own progress through pregnancy and after the child is born.Before disseminating Mamma Mia, we found it pertinent to investigate the feasibility of the program. Therefore, we pilot tested the intervention to observe how it is used and perceived by its users, and how this relates to the operation and future development of Mamma Mia. Consequently, the objectives with the present study were to (1) examine user acceptance of Mamma Mia, (2) examine how it was perceived among end-users, and (3) identify potential issues with use, acceptance, and program-specific needs that might provide added value to Mamma Mia and its operation and future development.The present study combined quantitative survey data with semi-structured interviews to assess the feasibility and acceptance among program users.Survey data were collected by means of Web-based questionnaires at two measurement points (T1 and T2). Due to time constraint in completing the current study, our results were based on participation in one of the two phases: pregnancy or maternity. Participants in the pregnancy phase were surveyed 4 and 8 weeks after intervention enrollment, and participants in the postnatal phase were surveyed 2 and 4 weeks after intervention enrollment. Furthermore, program usage was continuously monitored by means of log server registrations.Six items were rated on a scale from 1-7 in order to assess a person’s belief that using Mamma Mia is useful and helps increasing well-being .Four items were rated on a scale from 1-7 to measure a person’s belief that using Mamma Mia is free of effort .Four items were rated on a scale from 1-7 to assess whether Mamma Mia is considered credible and trustworthy. User Satisfaction is measured in terms of how users rate the overall quality and satisfaction of the program, and whether they would recommend it to others. Four items were rated on a 1-7 scale .Four items were rated on a 1-7 scale to assess whether users have the opportunity to use Mamma Mia seamlessly as part of their daily routines. Estimated means of all the measures were reported in Technical problems were measured using a single yes/no option . Participants that responded “yes”, were provided an additional open-ended question, “Please describe the technological problems you have been experiencing?”Improvements were assessed using a single open-ended question, “If you could improve anything in Mamma Mia, what would that be?”Participants were recruited at 5 health care clinics and 2 hospitals. Here, midwives/public health nurses handed out a brochure and offered to try Mamma Mia. We recruited primarily women, and their partners through the women. The reason why we did it this way is because women often go to the follow-ups at the well-baby clinics and hospitals by themselves. Potential participants had to take home the brochure and send an email to the administrator of the program to register for participation. Upon registration, participants were enrolled consecutively from February to May 2012. Participants were also recruited on Facebook . In order to be included in the study, one had to be in gestational week 22 or 2-3 weeks after birth, or one had to be the partner of a women in gestational week 22 or who had given birth within the last two weeks. The two inclusion criteria we applied were that all participants had to be 18 years or older, and they had to be able to read and understand Norwegian.t54=-1.1, P=.28). Furthermore, binomial tests of 50/50 proportions  confirm that most participants were ethnically Norwegian, had 4-5 years of college or university education, currently employed, and had no previous children (P≤.02). Most participants who were recruited were in their pregnancy and multinomial tests of equal categories show further that most participants were currently in a relationship (P≤.01). For more information on participant characteristics, please see A total of 103 users were recruited from February to May in 2012. By far, most participants were female (82%) and the mean age was 31.4 years . Female participants were on average slightly younger  than male participants . However, this difference in age between female and male participants was non-significant  agreed to do the in-depth, semi-structured, tape-recorded interview. The participants were interviewed in turn, and it was decided that it was not necessary to interview additional participants after the 4 interviews had been completed as the analyses reached a satisfactory saturation point . An interview schedule was developed with open-ended questions with prompts and follow-up questions employed to elicit a breadth and depth in responses . The intAll four (P1-P4) participants had higher education and were married/cohabitant. Three participants had previous children. Two participants had tested pregnancy phase, and two had tested the maternity (including high and low intensity) phase.In total, 78.6% (81/103) participants were engaged with Mamma Mia, while 21.4% (22/103) participants did not initiate the use of Mamma Mia. In the pregnancy phase, the average number of completed program days was 7.4 (SD 6.9). Median number of completed program days was 6. In the maternity phase, the average number of completed program days was 11.5 (SD 11.8). The median number of completed program days was 5. The program lasted for 11 months. Due to time constraint in completing the current study, however, we chose to study adherence within a limited time frame. Consequently, users have not been given the chance to complete the program. Thus, usage data may not accurately reflect adherence.The response rates varied from 25% (6/24)-58.6% (44/75)  of responders rated Mamma Mia to be of high quality. Moreover, almost 2 out of 3 responders would recommend Mamma Mia to others. A total of 43% (44/103) reported that the information presented in Mamma Mia was relevant to them. In terms of the quantity of information in each session , users reported that the amount of information was appropriate. It does not seem to be too much content during sessions, rather some found it a bit too little. In the pregnancy phase of Mamma Mia, 78% (58/75) reported that one session per week was appropriate, while the rest found one session per week to be too rare. In the maternity phase, 67% (16/24) found three sessions per week to be appropriate, while 33% (8/24) found it a bit too much.t tests were performed to compare ratings across time (T1 and T2), and results suggested that the ratings were stable over time. Therefore, A total of 47 improvements were suggested by the participants. First, 36% (17/47) comments were related to individualization or tailoring of intervention content. Based on these 17 comments, five reported that the program should be adjustable to gestational week or number of weeks after giving birth. Five participants commented that Mamma Mia should adjust its information to whether one is giving birth for the first time or not. Finally, 6 participants also noted that Mamma Mia should adjust the couples’ therapy so that (1) users without partners can skip the couple’s therapy and (2) that the couples’ therapy can be repeated so partners more easily can manage to follow it together. Regarding (1), one participant actually reported feeling “down” when faced with the couples’ therapy as it merely acted as a reminder about a recent sensitive event . Although such cases may not occur very frequently, they pose a real threat to the well-being of the individual and act counterproductive to the objective of Mamma Mia. Regarding (2), it is not exactly clear, based on participants’ comments, what actions can be taken to help couples follow the couples’ therapy together. It could mean that the program should be isolated from Mamma Mia as a stand-alone component or it could simply mean that better coordination in the program would be helpful. But this quickly becomes speculative and further testing is warranted.Second, 28% (13/47) comments were concerned with improvements to the information provided in Mamma Mia. It seems that users have a two-fold opinion. On the one hand, some users request more information, especially about the baby in utero and about mothers’ emotional and physical development during pregnancy. On the other hand, some information seems redundant or familiar, especially for women who already have children. The latter may be an important cue for increasing adherence. In a recent study by Tonkin-Crine and colleagues , they inThe third emergent category is related to technological development. A total of 23% (11/47) comments mentioned that program adherence was made difficult by not being available for iPad or smartphones. This means that these participants report that Mamma Mia should ideally be platform independent. Platform independence ensures the accessibility and ubiquity of Mamma Mia as participants can take the program on-the-go or wherever they are. In conclusion, we have identified three main categories of suggested improvements which account for 87% of the variation in participants’ responses. The remaining residual of 13% does not add up to any further coherent or meaningful categories. Typically, the residual consists of individual responses such as “discovered typos” or “option for chatting with health personnel”.The first lesson from the present study is that not all participants seem to read information about Mamma Mia very carefully during recruitment. It is estimated that roughly 10% of the participants that were recruited, had passed the gestational week 22 or were more than 2-3 weeks passed giving birth. Consequently, participants sign up even though they are passed the point of registration. This results in “confusion”, “misunderstandings”, and questions about “where can I adjust the program to my gestational week?” At least two participants also had to be re-registered from the prenatal phase to the postnatal phase of Mamma Mia, because they signed up late in their final trimester.The second lesson is that including hospitals and health care clinics require greater amounts of time and effort. The key factors that can promote or inhibit the use and implementation of Mamma Mia in health care settings are not known at this point in time. However, the overall impression during recruitment was that hospitals and health care clinics experienced difficulties recruiting the numbers expected and needed. Only 61.2% (63/103) participants were recruited at hospitals and health care clinics despite the fact that 925 brochures were handed out and 9 meetings were held about Mamma Mia, at the very same hospitals and health care clinics. Consequently, RBUP  started recruiting participants online after the recruitment had started at hospitals and health care clinics, and with less time and less effort they managed to recruit 35% (36/103) participants. Also, due to the slow recruitment, the question “Where were you recruited for the user survey of Mamma Mia?” was included late into the recruitment period. Out of 7 responses, only 1 reported being recruited at a health care clinic. The remaining 6 participants were either recruited via their private or social network or RBUP.We were interested in the women’s qualitative experience of Mamma Mia, and in the issues they themselves raised in relation to it. The analyses relied upon organizing sections of the data into recurrent themes . In accoThe accessibility of the program was largely mentioned as one of the strengths of the program. The opportunity to complete the sessions at home or at work, depending on when one had the time was greatly appreciated. This is in line with previous research .Participants appreciated that the information was concise and brief, and it was easy to understand. Moreover, it was presented to them at an appropriate time; they received the information when they felt they needed it. The women enjoyed that the program was organized according to a tunneled sequence; that is, they were guided through the program and had to complete one module before proceeding to the next. As one participant said “to me, the program felt like a safe guidance that contained the information I needed when I needed it” (P1). The frequency of the sessions was found to be appropriate, although it was suggested that the preparation phase of the program could ideally have had more frequent sessions.The interviewees expressed enthusiasm with regards to the information and exercises that targeted the relationship with partner and sensitivity with regards to the infant’s signals. As one participant said: “With Mamma Mia, you get the knowledge you won’t get anywhere else” (P2). Moreover, they enjoyed how the program was not a mere channel for information that provides general advice, but it “raised” questions that stimulated to self-reflection and it provided helpful exercises in an interactive manner. These aspects made learning fun, and stimulated to change.Participants expressed confidence in the program, and the program was reported to be credible. Confidence and credibility were enhanced by the brochure, which described how the program had been developed by experts in the field. It was emphasized in two of the interviews how it was of great importance that health personnel whom they trusted were the ones who conveyed information regarding the program. One participant (P1) expressed how she felt “that the program was developed and provided as part of the public health care system”, and thus she felt that the program was a good thing for her.The major reason for high fidelity was the participants’ curiosity in terms of what was to come in the program. Another reason why participants completed the program was that completing the sessions proved to be break and a “time-out” for multiparous women in a hectic everyday life. As one woman said “the program provided an opportunity to take the time to connect with the baby in my tummy” (P3). Ordinarily they would not have taken the time to focus inward on the fetus, and so the program facilitated contact and attachment with the unborn baby. A final reason for completing the program was the desire to be confirmed; confirmed that she was “doing the right thing” for her baby (P1).A major limitation had to do with a lack of flexibility. As one participant said, “my main complaint is the inflexibility in terms of when you can start with the program, you should be able to start up regardless of where you are in your pregnancy” (P2). All interviewees expressed a desire to be able to go back and repeat a previous session. The inability to use the program on tablets and smart phones was also mentioned as a major limitation. Finally, because of its emphasis on the relationship with the partner, the program was viewed as targeting the nuclear family, and other family constellations (such as single mothers) would likely not find the program to be adjusted to their needs. As one participant said, “a friend of mine, who is about to become a single mom…she sort of chose to have this baby on her own. She went to Denmark and had a donor. I thought many of the themes in the program would be good for her, but then I thought, no, no, it wouldn’t work, cause the program is really custom-made for the “standard person” for the nuclear family” (P1).Although the information provided throughout the program was largely emphasized as one of the strengths in the program, it was mentioned that the follow-up phase (10 weeks postpartum and onward) could have contained more information regarding the baby’s development and attachment etc.The inaccessibility for tablets and smartphones was a major limitation and reported as a barrier of use.The interviewees were encouraged to describe how the program could be further improved, and expectations emerged as a common topic. Specifically, they wanted the program to focus more on expectations with regards to breastfeeding. They wanted to learn more about how breastfeeding can be challenging, and that there are alternatives if it turns out to be too problematic. Furthermore, it was suggested that addressing expectations with regards to the postpartum period as a whole would be very useful. Many new mothers plan to do too many things after having a baby, and Mamma Mia could therefore serve as a useful reminder that having a baby is both unpredictable and inherently hectic in and of itself.The purpose of the present study was to assess the feasibility and acceptance among program users with regards to the Web-based intervention Mamma Mia, as well as to identify potential issues that could be improved. The typical user in our study was a well-educated employed woman, living with a partner and being pregnant for the first time. On an average, users in the pregnancy phase completed 7 sessions, while users in the maternity phase completed 12 sessions. The user-survey and interviews identified critical internal and external success factors for initiation and continued use of Mamma Mia  . InternaThe main internal strengths were the quality and relevance of the information provided in the program. More than two-thirds of users found Mamma Mia to be of high quality and would recommend Mamma Mia to others. By far, most also found the amount of information and frequency of the intervention schedule to be appropriate. Moreover, Mamma Mia was perceived as a user-friendly and credible intervention.In terms of internal weaknesses, it was mentioned that the program sessions could be more frequent during the pregnancy phase, and in the maternity phase there could be more information regarding the baby’s development and attachment.Mamma Mia is operated on a stable platform and there were few reports of technical problems. In line with previous research , the accAs many failed to understand that the intervention starts in gestational week 22 one has to take great care to communicate clearly when the intervention starts when releasing Mamma Mia among potential end-user. Communication and marketing plans have to ensure that users are registered at the right time according to gestational week, and one has to carefully plan how to implement Mamma Mia during point of care in health care settings.Findings suggest a need for improvements in mainly three domains: (1) making Mamma Mia available for iPads and smartphones to increase accessibility, (2) provide more information, and (3) individualization to gestational week, couples versus singles, first-time parents versus second-time parents.tablets and smartphones. In turn, improvements were made such that the final version of Mamma Mia is available for iPads and smartphones.The most common barrier of use was the inaccessibility for information regarding breastfeeding, sleep, child development, and attachment were requested, and all of these requests were taken into account and incorporated in the final revision of the program. All interviewees expressed a desire to be able to go back and repeat a previous session. Thus, the final version of Mamma Mia includes a “personal” home page, which gives an overview of all the sessions one has completed, and all the sessions that are to come. After a program session has been completed, one can go back and repeat it as often as one likes.More frequent program sessions during the pregnancy phase as well as more individualization, there is a definite long-term goal to adjust Mamma Mia to the needs of single parents, parents who have premature infants, parents with previous children, as well as non-Norwegian speakers. Participants in the present study also requested an improved flexibility in terms of program initiation. Participants wanted the program to be adjusted to their respective gestational week. This request has not been accommodated, however. Mamma Mia starts in mid-pregnancy because it is considered optimal to promote relationship satisfaction and prenatal attachment early (but not too early when the risk of miscarriage is still high) when the goals are to prevent depression and enhance well-being. In consequence, the program initiation continues to be limited to gestational week 22.In terms of The main concern with the present user study has to do with generalizability. Due to the use of a convenience sample the findings may not be representative for all mothers . There was a substantial dropout from the treatment program in this study. However, treatment dropout is common to most Internet-based programs . ParticuAs in all qualitative research, a potential confounding variable in this study is the influence of the interviewer on the respondents. As the interviewees were aware that the interviewer had a professional interest in Mamma Mia, it may have influenced the responses in different ways. For instance, the participants may have wished to come across in a socially desirable manner, and hence were likely to give positive feedback. On the other hand, they may have felt that the interview was the perfect opportunity to communicate directly what could be improved to the developers of the program. As the interviewees all gave nuanced feedback, it is likely that they felt comfortable being honest in the interview setting. It is important to note that while additional nuances would probably be captured with a larger sample; the main themes described herein would remain . MoreoveIt is of essence that participants are invited to use Mamma Mia when they are in gestational week 22, which is why follow-ups in hospitals and well-baby clinics are thought to be the best settings to recruit women. That way midwives and doctors can inform women of the program when they are close to gestational week 22. In the present study, the primary setting for recruitment was the hospital and well-baby clinics, and yet only 60% (62/103) of participants were recruited there. Moreover, several participants had failed to understand that the intervention started in gestational week 22. It is not clear what inhibited successful/efficient promotion of Mamma Mia in hospitals and well-baby clinics; nevertheless, it is clear that one has to find an efficient way to organize and deliver Mamma Mia which is unobtrusive to health care personnel. A more comprehensive monitoring of the recruitment process may have revealed the sticking points and thus been informative for further evaluation studies as well as real world implementation of Mamma Mia.We were able to deliver a substantial number of sessions, and the high scores on measures of usefulness, ease-of-use, credibility, unobtrusiveness, and user satisfaction suggest a high level of acceptance. Findings from the user survey and interviews were consistent, which add to the reliability of the results. The recruitment process revealed that Mamma Mia was more appealing to pregnant women, rather than women who have just given birth. This is advantageous and not surprising as the program is designed to follow women through both the pregnancy and postpartum months. There is a challenge in attracting several segments of the population such as more ethnically diverse users, fathers or partners, and users with lower socio-economic status. In order to further increase user acceptance of this and similar programs, making such programs more adaptable to individual needs and preferences seems to be a key factor. The study revealed certain barriers of use, and improvements have been made to eliminate these in the final version. Overall, the user acceptance of Mamma Mia was fairly good and our findings add to the feasibility of the program. We find it appropriate to proceed to the next step of evaluation: a randomized controlled trial to test the effect of Mamma Mia on well-being and postpartum depressive symptoms.


Lymph node metastasis from cutaneous squamous cell carcinoma is uncommon. The popliteal fossa is rarely involved with metastasis. Popliteal lymph node dissection is uncommonly performed and not frequently discussed in the literature. We present a case of squamous cell carcinoma of the heel with popliteal and inguinal metastasis. This is followed by a description of the relevant anatomy of the popliteal fossa and the technique of popliteal lymphadenectomy. Regional lymph node (LN) metastasis is an important prognostic factor for skin cancers like melanomas and squamous cell carcinomas (SCC) . The usuSkin cancers of the lower limb below the knee mainly metastasise to the groin. Metastasis to the popliteal LN is much less common. In melanoma, the incidence of popliteal metastasis ranges from 0.3% to 7% -4. For SIn 2008, a 41-year-old lady developed an ulcer on her left heel. This was excised by a general surgeon at another hospital. Pathological examination revealed a 3.8 cm, moderately differentiated SCC; the margins were involved. No further treatment was offered to the patient. A year later, in June 2009, the tumor recurred and was excised again; the margins were negative this time.Two months later she was referred to our center for further management. On examination she had a small non-healing ulcer on the left heel. There were palpable LN in the popliteal and inguinal regions of the same limb. An MRI was done for the popliteal and inguinal regions Figure . It showA wide local excision of the tumor as well as popliteal and groin dissections were performed. The ulcer was excised with a wide margin including part of the calcaneus. The resulting defect was covered with a flap. The patient underwent popliteal dissection in the prone position. The popliteal mass and LN were removed together with the adherent segment of the popliteal artery Figure . A reconThe popliteal fossa is a diamond-shaped area bound superiorly by the heads of both the Biceps Femoris and Semimembranosus muscles and inferiorly by the 2 heads of Gastrocnemius muscle Figure . This spIn general there are 2 steps to popliteal LN dissection. The first step is adequate exposure of the diamond shaped fossa. This should include careful identification and preservation of the neurovascular structures. Once that is done, dissection of the fat pad should be performed thoroughly.The patient is positioned prone with the knees slightly flexed on a pillow. The posterior approach offers the best exposure for this procedure . The skiSubsequently, the popliteal fossa is entered by opening the popliteal fascia vertically in the midline. The first structure to appear is the Tibial nerve, which crosses vertically and disappears between the 2 heads of Gastrocnemius. Lateral to it is the Peroneal nerve, which courses laterally along the biceps femoris tendon and then turns obliquely towards the fibula. Both nerves should be retracted laterally with vessel loops to allow adequate and safe exposure of the vessels and the LNs. Dissection deep to the Tibial nerve will reveal the popliteal vein. The popliteal artery passes deep and slightly medial to the vein. It is the deepest structure in the popliteal fossa and lies on the femur and capsule of the knee joint. The LNs are contained within the fatty tissue that is found superficial, alongside and deep to the popliteal vessels. LN dissection should include, therefore, all the fatty tissue in the popliteal fossa till reaching the posterior aspect of the knee joint. It should be noted that the popliteal fossa is wider in the deeper part than in the superficial part. Adequate retraction of the Gastrocnemius muscle heads, therefore, is essential to ensure adequate exposure and dissection of all the LNs.After securing hemostasis, the fascia is approximated and the wound is closed over a negative suction drain. A knee splint or back slab is preferably applied at this stage and left in for the first few postoperative days. Postoperative Lymphoedema is expected in some patients . The incWe describe an unusual case. The incidence of LN metastasis from SCC is relatively uncommon. It ranges from 0.5% to 16% , with moAlthough SLN biopsy is mainly indicated for melanomas, it is gaining wider application in the management of other skin tumors, like SCC . Still, The procedure of popliteal lymphadenectomy was first described by Karakousis in 1980. Most later descriptions are based on it. Knowledge of the relevant anatomy and the surgical technique of popliteal LN dissection is important to avoid injury to important structures and to allow adequate LN dissection.Popliteal metastasis from skin SCC is quite uncommon. It usually occurs in patients with advanced or recurrent tumors. Appropriate management is not clear, but surgical dissection, in the absence of distant metastasis, is indicated since there is no known effective adjuvant treatment for skin SCC.Written informed consent was obtained from the patient for publication of this Case report and any accompanying images. A copy of the written consent is available for review by the Editor-in-Chief of this journal.The authors declare that they have no competing interests.FA has reviewed and written part of the case report. SH arranged and provided the artwork and picture. BM conceived of the study and wrote the majority of the paper. All were involved in the design and review of the paper and all read and approved the final manuscript.


Self-management education programs seek to help patients realize that they are their own principal caregivers and that health care professionals are consultants who support them in this role. The aim of this study was to evaluate a diabetes self-management education program implemented as part of a district-wide approach in South Auckland, New Zealand, which has some of the highest prevalence rates for diabetes and is one of the most ethnically diverse and deprived regions of New Zealand.Self-management attitudes and behaviors were monitored with the use of questionnaires before and after program implementation. Clinical outcomes such as hemoglobin A1c, body mass index, and blood pressure were also tracked before the program began and 3 months after the program ended. Participant focus groups and facilitator interviews were conducted to explore perceptions of the program.Participants showed improvement in attitudes toward their own ability to manage their diabetes; in diet, physical activity, and foot care; and in hemoglobin A1c levels 3 months after the end of participation. Participants also reduced their sense of isolation when dealing with their diabetes. However, catering to the needs of a multiethnic community is extremely resource-intensive because of the need to provide adequate language and cultural interpretation.Self-management education can work in multiethnic, high-needs communities in New Zealand. Programs must ensure they enable the appropriate mechanisms and have appropriate resources to support the community's needs. In New Zealand, the diabetes epidemic has captured public health officials' attention. The prevalence of diabetes is significantly higher in the South Auckland region compared with the rest of the country ,2, and tGroup-based training for self-management strategies for people with diabetes can be effective in improving fasting blood glucose, hemoglobin A1c (HbA1c), and diabetes knowledge . FurtherCMDHB commissioned an independent evaluation of the SME program, and this article presents the primary findings. The primary objective of the evaluation was to determine whether a 6-week group SME program would produce measurable results in participants' physical indicators, attitudes, and knowledge about diabetes management. We also sought to describe lessons learned from the implementation process and to learn whether the program met the diverse needs of a multicultural population.The SME program was adapted from a similar program implemented in a neighboring district health board in 2006 to improve the uptake of best practices after a patient is diagnosed with diabetes. CMDHB worked through 5 of the 8 primary health organizations (PHOs) in Counties Manukau, which have direct patient care responsibilities, to recruit newly diagnosed diabetes patients. Each PHO recruited and employed a facilitator to lead 4 to 6 group patient education sessions of 2 hours each. The facilitator recruitment process varied among PHOs, as did area of expertise among recruits. Sessions were usually held in the evening, although a few morning groups were conducted for participants who had evening commitments. In addition, CMDHB hired a Maori facilitator and a Pacific facilitator who could speak Samoan and Tongan to provide added support for these populations. These facilitators acted as cultural interpreters and developed culturally appropriate variations of the SME program. For example, they incorporated singing and dancing in the Pacific program and used storytelling for the Maori program. The Maori SME sessions were held in a traditional Maori community house, called a marae. Other translators of several Pacific languages were also available to standard SME groups. PHOs agreed to collaborate across agencies throughout this program. One PHO hired a nutritionist as part of the facilitator team and collaborated with other PHOs to extend this expertise to other groups.General practitioners (GPs) or practice nurses in the PHO networks referred patients to the SME program. The program was intended for newly diagnosed patients, but because this was a new program, GPs referred any patient with diabetes who had been unable to develop good self-management skills and needed additional assistance. With the referral form, facilitators received baseline clinical data including measures of HbA1c, body mass index (BMI), and blood pressure. The SME facilitator contacted each patient to present the available and upcoming sessions and to help the patient solve logistical issues such as transportation. If the available program times suited the referred patient and the patient agreed to attend, the referred patient became an SME participant. SME programs ran continually from January 2007 until January 2008, and referrals were received throughout the study period.All activities related to this evaluation were granted full ethical approval by the Ministry of Health's ethics committee. This evaluation used a mixed-methods approach. The study used 2 questionnaires to collect quantitative program data: a health attitude questionnaire and a health behavior questionnaire. The evaluation team in conjunction with other primary stakeholders developed and adjusted the questionnaires. The health attitude questionnaire consisted of a 1-page tool with items to be rated on a 5-point scale.The study team adapted the tool presented by Toobert and colleagues  into a 1During the first session of each SME program, facilitators took 15 minutes at the beginning of the session to allow participants to respond to baseline questionnaires (pre). Participants then followed the SME program for 4 or 6 weekly sessions, and at the end of the last session completed the follow-up questionnaires (post). To obtain the 3-month follow-up information, facilitators organized a reunion at which participants completed the same 2 questionnaires for a third and last time. Both questionnaires were self-administered; therefore, facilitators did not assist participants unless they requested help because of a language or other limitation. For follow-up clinical data, participants' GPs provided HbA1c, BMI, and blood pressure measures with the patients' consent.In addition, the evaluation team conducted 8 focus groups with program participants at the end of the last session of SME, ranging in duration from 45 to 80 minutes. The focus group facilitator invited all participants in attendance during the last session of SME to participate in the voluntary focus group. The objective of these focus groups was to obtain information about barriers and enablers to program development, implementation, and behavior change that could not be captured through the questionnaires. The evaluation team also conducted 12 interviews with SME facilitators and PHO managers, focusing on their perceptions of support and resources during program implementation and recommendations for further program development.t tests were conducted to compare data from the health attitude and health behavior questionnaires through time; significance was set at P < .05. The analysis compared 1) participants' health attitudes and health behaviors pre-SME and post-SME (a 4- or 6-week difference between measures) < .05. The analysis compared 1) participants' health attitudes and health behaviors pre-SME and post-SME (a 4- or 6-week difference between measures) and 2) participants' health attitudes, health behaviors, and clinical outcome measures pre-SME and 3 months after program completion. The evaluation team conducted thematic analysis of the qualitative data by using NVivo version 8 .Quantitative data were analyzed by using SPSS version 15 . Paired A total of 193 people participated in an SME program during the study period. Participants' age ranged from 21 to 87 years; the mean (standard deviation) age was 57.6 (12.6) years. Two-thirds of the participants were women, and the 2 most commonly represented ethnicities were Pacific and Maori  .Five of the 7 indicators of attitude improved significantly . At 3-moComparisons between the pre- and post-SME behavioral score show that there was a significant increase in the number of days participants reported eating at least 3 meals a day, eating breakfast, eating the recommended servings of fruits and vegetables, doing at least 30 minutes of moderate physical activity each day, and checking their feet . The numHowever, when comparing the pre-SME scores with the 3-month follow-up behavioral scores , the onlThe focus group findings indicate that participants benefitted from the program. They reported feeling less isolated in their health condition and enjoying the social interaction that the group provided.Coming to this course and listening to other people who have got the same situation, I've realized that it's not something that you have to suffer by yourself. [You can] talk to people that aren't obviously dying or anything and you just feel a bit more comfortable about the situation.Language was highlighted as one of the main concerns for participants. Many preferred receiving information in their own language (mostly Pacific languages) and said that many community members would avoid participating in SME because of language concerns. Throughout the program, translators were made available when participants had language limitations that could not be addressed through facilitators. Despite this barrier, many participants indicated that they wanted to act as a bridge to close the gap between their communities and health services.In our culture it's very hard for some of our people to acknowledge that they have these types of things [like diabetes]. So I want to be able to help the elders in my family as well to learn about it, to manage it, and to maintain a better health regime.Participants revealed that facilitators were a highly motivated and committed group, who were familiar with the population and the local cultural context and were able to communicate well with their audience.Well actually we've had nobody else like [facilitator]. He talked our language. We get other professionals coming in and using all these big words and we've got to go, "Hang on a minute." You know? But with [facilitator], we never ever said that because he spoke our language.Facilitators reported several challenges to program implementation. Facilitators struggled to varying degrees to obtain data and had to negotiate with participants' GPs to gain access to some clinical information. Getting this information was often difficult, and together with post-program attrition explains the reduced sample size for statistical analyses. Participant recruitment also presented a challenge, particularly at the beginning of the program. Work schedules, transportation, and family commitments, as well as people's levels of readiness to engage in a health promotion program, affected levels of participation. Facilitators frequently said the target population was difficult to reach and named this a major barrier to change. Facilitators recognized stressful life circumstances and economic and family pressures as important determinants of participants' ability to change. Social and cultural environments were also identified as a barrier to participant learning, increasing the difficulty of implementing lifestyle changes that SME encourages.These people are hard to reach . . . and they've got so many other stressors in their lives that for them to be ready to change and actually take control and be a good self-carer. . . . They've just [got] so much else on . . . whether they can pay the bills and have somewhere to live and feed the family and have a job.Facilitators also reported that their organizations did not understand their role. Without exception, the SME facilitators were the first staff members to fulfill such a role in their organizations and therefore were mostly developing their role and establishing needs as the program was implemented. Facilitators reported that their managers often underestimated the amount of time required to prepare for SME sessions, leaving them feeling overworked. Lastly, for facilitators who were not implementing a culturally specific SME program, figuring out how to cater to participants' different language and cultural needs was a major challenge. Facilitators did not necessarily believe that segregating the groups by ethnicities was a good solution, pointing out that they live in a multiethnic community. Yet mastering the nutritional intricacies of several cultural groups and having language support added to the perception that this SME model was extremely resource-intensive.Overall, the Let's Beat Diabetes program demonstrated significant changes in participant attitudes, some behavioral changes, and a small but statistically and clinically significant reduction in HbA1c levels. In addition to the measured achievements, valuable lessons were learned from the evaluation of the implementation process. From the beginning of program development, CMDHB and PHOs were willing to pool both human and organizational resources to support the implementation of SME. This type of interagency collaboration was unprecedented in this region and constitutes a success in itself. The program was developed assuming that an initiative built in the context of the community and facilitated by local providers would have a higher probability of success and sustainability because of the high level of cultural competency, which the focus group data confirmed.Despite this success and the program's efforts to provide support and resources in many Pacific languages, language was perceived as a substantial barrier for many of the participants attending the SME programs that were not culturally specific. This perception highlights the importance of the language domain in SME. Attempting to engage with participants about psychosocial issues pertaining to health beliefs and behavior is a complex task that is further complicated by language barriers.As with any program, organizational process can enable or hinder program process. SME facilitators experienced some challenges in the implementation of the program. Appropriate resources are necessary to success for any program; working with multiethnic groups is resource-intensive, and therefore ensuring the appropriate level of support for the facilitators' roles is imperative.This project adopted program evaluation methods and was not a randomized clinical trial. This approach, combined with difficulties in obtaining follow-up clinical and questionnaire data, affected the overall sample size. Consequently, in-depth inferential statistical analysis was not feasible, which limited the study. Comparing the degree of success between the different cultural models of SME was also impossible because of lack of data.Despite the lack of generalizability of study findings, this article presents data from the first coordinated effort at a community-based SME program in New Zealand dealing with a high-needs, multiethnic population. It provides an example of the degree of change that can be expected of interventions coordinated at a primary care level in these populations.


To determine the incidence of congenital toxoplasmosis in Colombian newborns from 19 hospital or maternal child health services from seven different cities of five natural geographic regions .Toxoplasma. The results in blood cord samples were confirmed either by western blot and repeated ELISA IgM assay. In a sub-sample of 1,613 children that were negative by the anti-Toxoplasma IgM assay, the frequency of specific anti-Toxoplasma IgA by the ISAGA assay was determined. All children with positive samples by IgM, IgA, clinical diagnosis or treatment during pregnancy were recalled for confirmatory tests after day 10 of life.We collected 15,333 samples from umbilical cord blood between the period of March 2009 to May 2010 in 19 different hospitals and maternal-child health services from seven different cities. We applied an IgM ELISA assay  to determine the frequency of IgM anti 61 positive samples for specific IgM (0.39%) and 9 positives for IgA (0.5%) were found. 143 questionnaires were positive for a clinical diagnosis or treatment for toxoplasmosis during pregnancy. 109 out of the 218 children that had some of the criteria for postnatal confirmatory tests were followed. Congenital toxoplasmosis infection was confirmed in 15 children: 7 were symptomatic, and three of them died before the first month of life . A significant correlation was found between a high incidence of markers for congenital toxoplasmosis and higher mean annual rainfall for the city.Incidence for congenital toxoplasmosis is significantly different between hospitals or maternal child health services from different cities in Colombia. Mean annual rainfall was correlated with incidence of congenital toxoplasmosis. Congenital toxoplasmosis can result in permanent sequel as blindness or neurological damage in children and it seems to be more severe in South America than in other continents. There is a lack of information about this frequency in Colombia, where no control program is established, although it is a recognized cause of potentially preventable congenital blindness. We propose the first Colombian multicentric study to determine the frequency and impact of congenital toxoplasmosis. More than 15,000 newborns in seven cities were studied. Newborns were tested at birth by doing a cord blood test for toxoplasmosis. Additionally, children from mothers with history of toxoplasmosis acquired during pregnancy were recalled for a follow-up. The program identified fifteen children otherwise undiagnosed; three of these children died as consequence of congenital toxoplasmosis. The frequency of the congenital infection varied significantly between cities, being higher in Armenia and Florencia, intermediate in Bogota, Bucaramanga and Barranquilla and very low in western cities such as Cucuta and Riohacha. For the first time a significant correlation was found between mean rainfall at the city and the incidence of this congenital infection. Toxoplasma gondii in Brazil Congenital toxoplasmosis is generally the result of a primary infection during pregnancy. The clinical manifestation of the infant will depend of the gestational week when the mother acquired the infection and is characterized by a broad spectrum of symptoms at birth, including varying degrees of neurologic, ophthalmologic and systemic involvement Toxoplasma IgG in general population, indicating a high exposure to the parasite There is a lack of epidemiological information about the frequency and clinical characteristics of the congenital infection in Colombia. In a literature survey only one study concerning pregnant women was found in a Pubmed search Toxoplasma IgM antibodies in the newborn. Although this detection has been used for definitive diagnosis Toxoplasma IgG antibodies beyond 1 year of age Toxoplasma IgA in the first 6 months of life The neonatal detection of congenital toxoplasmosis was first evaluated in the region of New England in the United States Toxoplasma IgG antibodies beyond 1 year of age or the presence of specific anti-Toxoplasma IgM or IgA after the 10th day of life. In addition, clinical and laboratory findings for the identified infants are described.Considering the lack of information regarding the incidence of congenital toxoplasmosis in Colombia, we proposed a multicentric national study. The aim of this work was to determine the incidence of congenital toxoplasmosis in Colombian newborns from hospital and maternal child health services from seven different cities in five natural geographic regions . The confirmatory criteria used were the persistence of anti-Informed written consent, according to the regulation 008430 of 1993 of the Ministry of Health of Colombia, was obtained from all people that accepted to participate in the study. The University of Quindio Institutional Review Board  approved the study. Considerations in performing this study were that obtaining umbilical cord blood samples was a non-risk procedure, the study provided an additional use for a sample that would otherwise be discarded, and that identifying infection would benefit the infected child.In Colombia, according to 2003–2008 UNICEF statistics and DANE  official reports, 92% of births occur in health institutions Toxoplasma test or treatment for toxoplasmosis during pregnancy and SISBEN level. In Colombia, socioeconomic level of the population is determined according to the SISBEN classification, a socio-economic index A questionnaire was required for all mothers, interrogating about age, positive IgM anti-If mother accepted to participate in the study, blood samples from umbilical cord were collected at the moment of delivery. The personnel at the hospital's laboratory centrifuged and stored for a maximum period of 8 days at 4°C in tubes and sent to the regional laboratory.Toxoplasma IgM by a commercially available, enzyme immunocapture assay  according to the manufacturer's instructions. The absorbancies were measured in a microplate reader at 450 nm, with reference filter at 630 nm. Cutoff was calculated from western blot anti-Toxoplasma IgM negative and anti-Toxoplasma IgG negative samples. A receptor operating curve with 12 serums from confirmed cases (including symptomatic and asymptomatic cases) and 93 negative confirmed cases, indicated that a cutoff of index 8 detected all anti-Toxoplasma IgM positive cases in umbilical cord blood samples. To control for run-to-run variations, results were expressed as index, calculated by using the formula based on optical density (OD) of samples and controls: OD sample/mean OD of negative controls. The personnel at the regional laboratories received the same training to perform the technique under the same parameters. All positive samples were retested at the national reference laboratory  again by the same ELISA assay (Vircell), a Labsystems anti-Toxoplasma IgM assay  and a western blot anti-Toxoplasma IgM test .Serum from the umbilical cord blood was analyzed for anti-Toxoplasma IgM at birth Toxoplasma IgA antibodies and that this immunoglobulin can be found in absence of specific IgM Toxoplasma IgM. As an ELISA IgA was not commercially available in Colombia, we decided to use a more expensive test, the immunosorbent agglutination assay or ISAGA , a reference immunocapture test that use a formolized entire Toxoplasma antigen. Due to cost reasons, we perform the assay for anti-Toxoplasma IgA in a subsample of 1,613 cord blood samples that were negative in the ELISA anti-Toxoplasma IgM assay. Monthly, 10% of the first consecutive negative samples, from each regional laboratory, were referred to Quindio for an ISAGA IgA test. The ISAGA anti-Toxoplasma IgA was performed following recommendations of the manufacturer and a result ≥5 points was considered positive.Up to 20% of infants with congenital toxoplasmosis may have negative anti-Neither obligation nor official recommendation exists in Colombia to perform serological screening for toxoplasmosis during pregnancy, but some gynecologists request the mothers do this. Particularly, in Quindio region some health insurance companies and the health bureau of the city pay for the cost for serological diagnosis of this infection in pregnant women from patients of the lowest socioeconomic levels . For this reason, another criterion for postnatal follow up of the children was the mother's history of diagnosis or treatment during pregnancy for toxoplasmosis. This information was collected in the questionnaire used for this study at the moment of delivery at the hospital or maternal-child health service. Parents of these children were also invited to have their child followed clinically and serologically for congenital toxoplasmosis. Also, pediatricians participating in the study referred for confirmation, at the national reference laboratory, serum samples from cases with umbilical cord blood sample negative but that they considered presented compatible signs .Toxoplasma IgM or IgA or past history of treatment of toxoplasmosis during pregnancy or compatible signs were invited for diagnostic confirmation. Written, informed consent for additional assessment and follow-up was obtained from the guardians responsible for those children who tested positive. In each city there was a research assistant for the project that recalled mothers and children with criteria for follow up. Each child was examined by a neonatologist in each city, and if ophthalmological symptoms were present the child was referred to ophthalmologist. Additionally, a cerebral tomography was also indicated if physical examination was abnormal. If physical examination was normal, the children were recalled to obtain additional blood samples each month. Peripheral blood was collected from the mothers and their infants for confirmatory serological tests. During follow up mother and child were tested first for specific anti-Toxoplasma IgG, IgM, IgA and western blot and then only the child's sample was tested for IgG, IgM and IgA. Sera obtained from the child and mother was tested using an enzyme immune- assay for the quantitative detection of anti-Toxoplasma IgM by two different commercial test  and for IgA antibodies by ISAGA  according to the manufacturer's instructions. Samples showing optical densities higher than the cut-off provided by the manufacturer were considered positive for ELISA assays and if ≥5 points for ISAGA IgA test. Maternal and infant serum samples were also submitted to western blot to compare immunological profiles of anti-Toxoplasma IgG and IgM. Consequent to any alteration identified during the initial clinical assessment, the children were tested for complete blood count, cerebrospinal fluid analysis and ophthalmologic assessment. All samples from mother and child were referred to the “Centro de Investigaciones Biomédicas” at the University of Quindio.Children who had confirmed positive results on neonatal screening for anti-Toxoplasma IgG and IgM positive test in mother and of anti-Toxoplasma IgG antibodies in child serum Toxoplasma IgG negative in absence of treatment were considered to be non-infected. Treatment was provided based on current recommendations All infants identified by neonatal screening were followed up until their infection status had been established. A diagnosis of congenital toxoplasmosis was confirmed, as described by the european network on congenital toxoplasmosis 3. This data were obtained from the 2008 annual report of the IDEAM  We analyzed the differences in incidence of markers for congenital toxoplasmosis between cities by comparing geographical factors such as the altitude (meters above sea), mean annual temperature of the localities in Celsius degrees and the mean annual rainfall in mmhttp://www.cdc.gov/epiinfo/]). Values below p<0.05 were considered statistically significant.Calculations were performed using the Epi-Info 6 , EpiDat 3.1  and SPSS versión 14  statistical programs. Results are expressed as the mean and standard deviation for continuous variables and N (%) for categorical variables. Correlation analyses were done by Pearson's test. Chi square test was applied to evaluate the differences in the percent of markers for congenital toxoplasmosis between cities. Epi-Info was used to perform stratified- analysis  accounts for 2.7% of the 553,912 live newborns delivered in 2009 in Colombia and for the 9.1% of births in the seven cities included in this study, N: 167,566 . The sizToxoplasma IgM ELISA assay, but then only 61 (51.7%) were confirmed by the western blot and retesting at the reference laboratory. Consequently the prevalence for confirmed specific IgM was of 0.39%. Nine samples of 1,613 tested were positives for ISAGA IgA assay (0.5%). Results by hospital or maternal child health care center and city are shown in Toxoplasma IgM test in cord blood samples by grouping hospitals and centers by city was: Bogota 0.2% ; Bucaramanga 0.23% and Cucuta 0% (Eastern region), Barranquilla 0.06% and Riohacha 0% (Caribbean region); Armenia 2.0% (Andean region) and Florencia 1.8% (Amazonia). For specific IgA anti-Toxoplasma we found: Bogotá 0.39%; Bucaramanga 0.78%; Barranquilla 1.2%, Armenia 0%, Cucuta 0%, Florencia 0% and Riohacha 0%.In the regional laboratories 118 umbilical cord blood samples were positive for anti-Toxoplasma IgM test positive in umbilical cord blood, however in the follow up both children become negative.A history of diagnosis for toxoplasmosis during pregnancy was found in 143 questionnaires and from these mothers, 82 received antibiotics . From these mothers only two children whose mothers were treated (one with pyrimethamine-sulfadoxine during two months and one with spiramycin during three months) had anti-Five samples of serum from children who were negative at the umbilical cord blood tests (four from Bogota and one from Barranquilla) were referred because the newborn presented clinical signs compatible with congenital toxoplasmosis . In these cases mothers did not have history of toxoplasmosis during pregnancy and they did not received treatment during pregnancy.We found and followed 109 of the 218 children that had some of the criteria for postnatal confirmatory tests . We confIn newborns of mothers with history of diagnosis or treatment for toxoplasmosis during pregnancy, 56 children could be followed and five were confirmed as congenitally infected (8.9%). During pregnancy, two mothers of the confirmed congenitally infected children were treated with spiramycin and one with pyrimethamine- sulfadoxine combination, and children were asymptomatic. The other two children did not received prenatal treatment, one of them died during the first week of life and another had splenomegaly.Toxoplasma IgA test positive in peripheral blood five months after birth, that confirmed congenital toxoplasmosis. The child was not treated prenatally and had choriorretinitis.One child who was referred because he was presenting compatible signs for congenital toxoplasmosis, had specific anti-Toxoplasma IgM positive test and six children had a specific anti-Toxoplasma IgA positive test. Between the seven children with specific IgM positive, four of them also had specific IgA. Two children with specific IgA positive test did not have specific IgM.In the postnatal confirmatory samples, seven children had a specific anti-Toxoplasma IgG and IgM. In the three cases there was no suspicion of toxoplasmosis by pediatricians that attended the cases. Cerebral tomography of one of the cases in Florencia is shown on Toxoplasma tachyzoites, confirmed by direct immunofluorescence assay. In contrast, three prenatally treated children were asymptomatic. The lethality rate in 12 prenatally untreated children for this newborn congenital toxoplasmosis screening program was of 25%.Three of 15 children (20%) with confirmed congenital toxoplasmosis died during the first month of life: one in Barranquilla and other two in Florencia. The mothers of these three children had positive tests for anti-Toxoplasma IgM in umbilical blood cord (p = .000) and of the percent of mothers with history of toxoplasmosis during pregnancy (p: 0.000), were significantly different between cities, but not the incidence of specific IgA (p: 0.22). As the study involved different type of institutions, we analyzed the influence of socioeconomics classification, referral level and geographical factors on the incidence of markers at birth for congenital toxoplasmosis: incidence of anti-Toxoplasma IgM or IgA in umbilical cord or frequency of history of toxoplasmosis during pregnancy  in hospitals and centers from different level of referral in five of seven cities participating at the study. This program identified nine children otherwise undiagnosed . For the first time a significant correlation was identified between mean rainfall at the city and the incidence of markers for congenital infection. In Colombia, each city or region should define the necessity of newborn screening for congenital toxoplasmosis according to local studies.Figure S1Cerebral tomography of one confirmed case of congenital toxoplasmosis at the city of Florencia (Amazonian region).(DOCX)Click here for additional data file.Table S1Mean age ± standard deviation (SD) and percent for each level of SISBEN socioeconomic classification in population from hospitals and maternal- child health centers participating in the study.(DOCX)Click here for additional data file.


This paper describes an innovative protocol for a type-II hybrid effectiveness-implementation trial that is evaluating a smoking cessation telephone care coordination program for Veterans Health Administration (VA) mental-health clinic patients. As a hybrid trial, the protocol combines implementation science and clinical trial methods and outcomes that can inform future cessation studies and the implementation of tobacco cessation programs into routine care. The primary objectives of the trial are (1) to evaluate the process of adapting, implementing, and sustaining a smoking cessation telephone care coordination program in VA mental health clinics, (2) to determine the effectiveness of the program in promoting long-term abstinence from smoking among mental health patients, and (3) to compare the effectiveness of telephone counseling delivered by VA staff with that delivered by state quitlines.The care coordination program is being implemented at six VA facilities. VA mental health providers refer patients to the program via an electronic medical record consult. Program staff call referred patients to offer enrollment. All patients who enroll receive a self-help booklet, mailed smoking cessation medications, and proactive multi-call telephone counseling. Participants are randomized to receive this counseling from VA staff or their state’s quitline. Four primary implementation strategies are being used to optimize program implementation and sustainability: blended facilitation, provider training, informatics support, and provider feedback. A three-phase formative evaluation is being conducted to identify barriers to, and facilitators for, program implementation and sustainability. A mixed-methods approach is being used to collect quantitative clinical effectiveness data  and both quantitative and qualitative implementation data . Summative data will be analyzed using the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework.This paper describes the rationale and methods of a trial designed to simultaneously study the clinical effectiveness and implementation of a telephone smoking cessation program for smokers using VA mental health clinics. Such hybrid designs are an important methodological design that can shorten the time between the development of an intervention and its translation into routine clinical care.NCT00724308ClinicalTrials.gov  Smoking is responsible for 435,000 deaths per year . PersonsEvery US state, as well as Washington DC, has a telephone “quitline,” which residents can call to receive self-help materials, counseling, and, in some states, free or discounted medications. Unfortunately, telephone counseling has been underutilized among smokers with mental health diagnoses, and there are no published studies examining its effectiveness specifically in a mental health sample despite evidence that persons with a mental illness accept, participate in, and benefit from telephone counseling programs for other purposes -16. A siWe are conducting a hybrid effectiveness-implementation trial  to simulFigure Table All smokers who see a VA mental health provider at participating sites during our intervention period can be referred to TeleQuitMH. The decision to refer a patient is based on the provider’s assessment of the appropriateness of referral to a telephone program and the patient’s agreement to the referral. Eligibility criteria for study participation include referral from a VA mental health provider, access to a telephone, and access to a mailing address (a post-office box is acceptable). An estimated 19,500 smokers use VA mental health services annually at our six sites. Based on a prior study testing a similar smoking care coordination program in VA primary care , we antiThe TeleQuitMH care coordination program consists of the following sequential elements. The program begins with a provider-level intervention that enables the referral of patients to tobacco cessation treatment. After the referral, patient-level treatment intervention begins.Simple EMR referral—The care coordination program takes advantage of VA usual care that requires providers to screen patients for tobacco use and either provide them with counseling or refer them to treatment during routine visits. We are not attempting to standardize the screening process or counseling given by mental health providers. Our study introduces a new treatment referral option for providers—that of referring patients to TeleQuitMH via a new electronic consult in the EMR. Providers have the option to confirm the patient’s contact information and enter free-text information about their patient in the consult screen, but these responses are not required. Providers can access the consult either through the consult menu or through the tobacco use clinical reminder screens.1. Proactive outreach—Once our program receives a referral, we mail the patient a welcome packet that includes information about the TeleQuitMH program and study and a brochure containing all elements of informed consult. One week following this mailing, program staff call the patient using the phone number in his or her medical record. Staff make five attempts over two weeks to reach referred patients by phone to discuss the smoking cessation program, offer enrollment, and complete the verbal informed-consent process. Patients who enroll in treatment are provided with the next four elements of the program described below. Patients not interested in treatment have the opportunity to enroll in the follow-up surveys only.2. Medication coordination—All enrolled patients can receive mailed smoking cessation medications unless they decline or have contraindications noted by their referring provider. The method with which the TeleQuitMH program provides medications varies by site and is determined by a site Clinical Advisory Committee formed before site implementation. This committee consists of key stakeholders from the departments of Psychiatry, Social Work, Psychology, Pharmacy, and Smoking Cessation. There are three prescribing methods from which the Clinical Advisory Committee can choose:3. a. The site can designate one or two prescribers who will complete all prescriptions for participants at their site. Based on the success of the primary care-based projects that used a designated provider, we recommend this method to all sites.b. Referring prescribers prescribe for their patients at the time of referral to TeleQuitMH. If a patient was referred by a nonprescriber , or a referring prescriber did not prescribe at the time of referral, a TeleQuitMH research assistant contacts the patient’s regular psychiatrist or primary care provider to request medications.c. A combination of methods 1 and 2 is used. Referring prescribers can prescribe for their patients at the time of referral. If a patient was referred by a nonprescriber or the referring prescriber did not prescribe at the time of referral, a TeleQuitMH assistant will contact a site-designated prescriber to request medications.Self-help materials—All enrolled patients receive a mailed self-help booklet developed jointly by the University of Colorado School of Medicine and Colorado Department of Public Health and Environment. The two-page booklet provides brief advice on preparing to quit smoking, setting a quit date, and preventing relapse. The booklet also provides corrective information on five common myths about smoking among persons with a mental health diagnosis. We tailored this booklet for a VA mental health population by including brief advice on linking smoking cessation treatment with regular mental health care and changing the booklet’s imagery to include pictures of persons in the military.4. Smoking cessation counseling—All enrolled patients have the opportunity to receive multi-call telephone counseling. To meet study Aim 3 described above, we randomize participants to receive this counseling from a VA counselor or from their state quitline.5. VA counseling: For patients randomized to receive counseling from a VA counselor, they are assigned a VA counselor trained to work with smokers who have a mental health diagnosis. The counselor provides structured counseling using a protocol that we created specifically for this study. The protocol includes proactive counseling and relapse-sensitive scheduling. The content is based on motivational interviewing (MI) and problem solving therapy and addresses both behavioral and cognitive issues, including motivation, self-efficacy, difficult situations, comorbid mental health symptoms, coping strategies, medication usage, and relapse prevention. The counseling includes planning (pre-quit) and follow-up (post-quit) sessions.Planning sessions: The planning sessions last approximately 30–60 minutes and help patients develop an individualized quit plan. Content areas include smoking and quitting history, motivation, environmental factors, planning, proper use of quitting aids, and setting a quit date. Patients receive one to six planning sessions.Follow-up sessions: Patients receive follow-up calls at 0, 1, 3, 7, 14, 21, and 30 days after their quit date. The calls are intended to prevent relapse and to help those who relapse or slip resume quitting. Follow-up calls, which last 10–15 minutes, also use a manual for consistency and fidelity monitoring. Participants are able to call the program staff in between scheduled calls if desired.State quitline counseling: For patients assigned to state quitline counseling, a research assistant initiates a “warm transfer” of the patient to their quitline via a three-way call to start the counseling process. After the initial three-way call, study personnel are not involved in any aspect of the quitline counseling. The quitlines follow their regular service protocols, which are described in Table Follow-up—All patients enrolled in the study receive a call from a research assistant at two and six months. Patients who are abstinent from smoking are congratulated, but these assessment calls do not provide counseling. Patients who have relapsed at six months are asked if they want to go through the program again.6. State quitlines have standardized protocols and well-trained counselors providing counseling. For the VA counseling arm, the telephone counselors undergo an initial training consisting of two-to-four hours of MI training with a clinical psychologist and 20 hours of training on the study’s clinical protocols. This training includes role-plays with each other and with the study’s project director. After the project director has determined that a counselor has met the role-play training objectives, the counselor advances to complete a series of standardized patient (SP) encounters. The SP encounters involve calling an actor trained to portray a smoker enrolled in the study and completing planning and follow-up counseling sessions per study protocol. The SP encounters are audiotaped and reviewed by a clinical psychologist and the study’s project director for adherence to protocols and counseling techniques. To ensure TeleQuitMH counseling standardization and fidelity after study implementation, the counselors complete clinical documentation using a template that allows them to indicate which protocol objectives were covered during each call and the timing of each call. The study’s project director completes regular audits of the counselor call documentation to ensure adherence to the protocol. The counselors also attend weekly group supervision meetings with a clinical psychologist, during which time the counselors’ active cases are discussed.evidence supporting the program, the implementation context, and the process of implementation facilitation[predispose, enable, and reinforce behavior change [We are using a series of implementation strategies at each site to improve the implementation process and increase the uptake and sustainability of the TeleQuitMH program. We used the Promoting Action on Research Implementation in Health Services (PARiHS)  and the ilitation. The PREr change . Based oBased on the PARiHS model, we use a combination of external and internal facilitation to implement the TeleQuitMH program. External facilitation is conducted by the study’s principal investigator (PI) and project director, who meet with local stakeholders at each site to recommend methods for successfully implementing the care coordination program based on the methods found to be successful in the primary care-based projects. Internal facilitation is accomplished by each site’s PI, who is responsible for serving as a local champion for the project or identifying someone at their site who would be appropriate to serve as a local champion. In addition, as described in the medication coordination section above, we form a Clinical Advisory Committee at each site to guide local implementation of the TeleQuitMH program. The committees include local representatives from the Departments of Psychology, Psychiatry, Social Work, Smoking Cessation, and Pharmacy. In addition to the committees’ responsibilities in deciding the medication coordination structure for their site, the committees provide guidance on how to inform local providers of TeleQuitMH, provide input on any foreseeable barriers to implementation and provider adoption, and decide how the TeleQuitMH program should work with or complement any existing smoking cessation programs. The committees meet regularly before site TeleQuitMH implementation and as-needed after implementation.Based on the PRECEDE model, to predispose providers to utilize the TeleQuitMH program, study PIs present the program to mental health providers at each site during regular staff meetings and via email newsletters. The presentations focus on presenting the evidence behind the program, including its effectiveness in VA primary care . The presentations also include a discussion on how the TeleQuitMH program functions within the context of each site’s existing mental health structure and smoking cessation programs.The PRECEDE model posits that enabling interventions simplify the implementation of a recommended practice for providers. To enable the use of TeleQuitMH, we create a local electronic consult for the program that allows providers to refer patients with three-to-four extra clicks as they complete a regular clinical progress note in the EMR system. The consult is also attached to the tobacco clinical reminder and mental health assessment templates in the EMR system, with which providers are already familiar. For providers who do not have clinical privileges to send consults, the study’s project director also accepts referrals via secure email.To reinforce use of the TeleQuitMH program, we use two strategies. First, we document all patient outreach and counseling sessions with a clinical progress note that mental health providers can read in the EMR system. We also add referring providers as “additional signers” to key TeleQuitMH progress notes, such as notes documenting their patients’ enrollment in the program, their patients’ quit plans, and their patients’ completion of counseling. This allows providers to see their patients’ progress toward quitting smoking and to view the TeleQuitMH program as a regular source of care at their VA facility. Second, we send a regular TeleQuitMH electronic newsletter from a local opinion leader to all mental health providers at each site. The newsletters include instructions for referral and detail site-specific progress with the intervention.Table The study includes a formative evaluation to help us modify the care coordination program and implementation strategies during our study period, to enhance the interpretation of summative data, and to better inform future implementation efforts. Table Developmental phase—Based on our experience with the primary care-based projects, we anticipate that it will take six months to implement the TeleQuitMH program at a site. This time includes identifying a local champion, obtaining Institutional Review Board approval, implementing the TeleQuitMH program’s main components, and informing providers. During this time we will conduct mental health provider surveys and interviews with site stakeholders to measure 1) the level of organizational readiness of the participating clinics both in general and specific to the intervention, 2) perceptions of the evidence supporting smoking cessation telephone counseling and smoking cessation medications, 3) perceptions regarding the feasibility and utility of the planned intervention, and 4) perceptions of anticipated barriers or facilitators to the successful implementation of the intervention. We will also assess the extent to which each site’s local champion and Clinical Advisory Committee are interested in, and actually perform, their project responsibilities, assess the structure and processes of the site’s state quitline operations , and assess the type and intensity of local smoking cessation services already available to mental health patients. We will formulate modifications to the TeleQuitMH program structure and our provider outreach/marketing efforts to address findings from these activities.1. Implementation/progress-focused phase—For the purpose of our evaluation, we will combine Stetler et al.’s implementation and progress-focused phases. After implementing the TeleQuitMH program at a site, we assess several patient and provider variables on a regular basis, including the number of patient referrals, the percentage and types of providers who are referring patients, the percent of patients enrolling and engaging in treatment, and patient satisfaction with the program. We also conduct a second provider survey during this phase evaluating reasons for a provider’s referring or not referring patients to the program, provider satisfaction with various aspects of the program, and what, if any, recommendations providers have for changes to the program that they feel would improve its effectiveness. We also assess referral trends in relation to our provider outreach activities in order to modify or target future outreach efforts. Last, we continue to assess the impact of each site’s TeleQuitMH components  on implementation fidelity, referral rates and patient uptake, treatment fidelity by the VA counselors, and the presence and quality of facilitation provided by the local champions and Clinical Advisory Committees.2. Interpretation/sustainability-focused phase—Following the intervention period at each site, we collect two additional measures: an organizational survey of mental health programs, which assesses each site’s mental Health clinic structure, size, staffing, environment, and resources [3. esources ; and menesources . We use Reach—the proportion of patients reached by the intervention; Effectiveness—the effectiveness of the program at meeting clinical goals; Adoption—the proportion of providers and patients that used the intervention; Implementation—the extent the intervention was implemented; and Maintenance—whether the intervention was maintained over time.We are using the RE-AIM framework to guide summative data analyses . The RE-Reach will be calculated as the number of smokers exposed to TeleQuitMH divided by the total number of smokers with a mental health clinic visit.To assess the reach of the intervention, we will determine the proportion of mental health patients who were exposed to the TeleQuitMH program. To do this, we will first use the EMR system to identify all smokers at participating facilities who had a mental health visit during the intervention period. This group—all smokers with a mental health visit—will be our denominator. If the TeleQuitMH-adapted tobacco use clinical reminder appeared for the patient’s mental health care provider, we will consider that patient to have been exposed to TeleQuitMH. Determine the effectiveness of telephone counseling in promoting long-term abstinence from smoking among mental health patients) there will be no control group, as these data will only be collected on patients who enroll in TeleQuitMH. We will calculate the percentage of participants with 30-day point prevalence abstinence at two and six months. We will also examine which baseline characteristics  are associated with abstinence, and we will use multivariable logistic regression to determine those characteristics that are independently associated with abstinence. For Aim 3 (Compare the effectiveness of telephone counseling delivered by VA staff with that delivered by state quitlines) we will calculate the 30-day point prevalence abstinence rates at two and six months separately for the two treatment arms and compare these rates using logistic regression, adjusting for covariables.Study Aims 2 and 3 examine the clinical outcomes of the TeleQuitMH program. For Aim 2  will be used to ensure the best possible implementation given site circumstances.Referral rates, treatment uptake and exposure at the patient level, and responses to TeleQuitMH at the provider level , will be continuously monitored to track program progress and identify sites that may need additional activities and efforts focused on facilitating implementation. Information on the structure of the implementation as it unfolds will be reviewed at regular staff meetings and linked with initial patient  and provider process data  to determine next steps for implementation including directed outreach/marketing; changes in structure, etc.interpretation/sustainability phase of our formative evaluation to interpret primary outcomes, using qualitative pattern-matching approaches to explore how the implementation activities and structure of the implementation (including treatment fidelity) may help explain variations in outcomes at the site level. Similarly, data on the implementation context will be analyzed to determine variation across sites and whether that variation is associated with both the nature of the implementation and the outcomes achieved. Formative evaluation data will be analyzed longitudinally to determine if changes in implementation are associated with changes in process variables . In terms of sustainability, analyses will focus on identifying the site and implementation features and characteristics that facilitated and hampered effectiveness. Finally, descriptions of the degree to which core elements of TeleQuitMH were integrated into systems of care at each site will be used to characterize the sustainability of TeleQuitMH and to identify the local conditions which facilitate replication and dissemination.After the intervention period has ended at each site, we will use the It is not within the scope of this project to conduct a cost-effectiveness analysis. For this project, we will assess the costs involved with the TeleQuitMH program, including staff costs , cost of smoking cessation medications, and VA overhead. We will use data from the VA’s Decision Support System for the costs of provider time and smoking cessation medications. We will calculate the cost associated with counseling delivery using study administrative records for the VA counseling arm and quitline program estimates for the quitline arm. We will use VA rental space agreements at our primary site to estimate the cost of VA overhead associated with the program.It can take 17 years for new clinical interventions to make their way through the efficacy-effectiveness-implementation research pipeline and become usual clinical care that improves patient outcomes in routine practice settings . Hybrid The study will have several limitations. First, we will rely on self-reported abstience, which may produce over-estimates of short- and long-term quit rates among participants. Second, there is considerable variability in services provided by the quitlines, and we will not have sufficient power to conduct Aim 3 analyses separately for each state. Third, we randomize at the patient-level and will not be able to determine the effectiveness of our implementation strategies. However, researchers can use the qualitative and nonrandomized implementation outcomes data collected during the trial to design future group-randomized studies evaluating the effectiveness of different stratagies for implementing tobacco cessation treatment programs in mental health clinics. Lastly, we will not have data on the number or duration of counseling sessions provided to participants connected to the quitlines for counseling, so we will be unable to account for treatment intensity in our Aim 3 analyses.The authors declare that they have no competing interests.SES, DS, and ER conceptualized the study and obtained funding. ER is leading the team in implementing the study. ER, SF, and DK designed and implemented the telephone counseling protocols for the VA counseling arm. HJH and CG designed the formative evaluation, and CG is implementing the formative evaluation and will conduct all formative evaluation analyses. BE designed and will perform cost-related analyses. All authors contributed significantly to the design and implementation of methods for collecting and analyzing clinical effectivness data. All authors contributed to the preparation of the manuscript.