Pain is a challenge for patients following hematopoietic stem cell transplantation (HCT).This study aimed to develop and test the feasibility, acceptability, and initial efficacy of a Web-based mobile pain coping skills training (mPCST) protocol designed to address the needs of HCT patients.Participants had undergone HCT and reported pain following transplant (N=68). To guide intervention development, qualitative data were collected from focus group participants (n=25) and participants who completed user testing (n=7). After their input was integrated into the mPCST intervention, a pilot randomized controlled trial  was conducted to examine the feasibility, acceptability, and initial efficacy of the intervention. Measures of acceptability, pain severity, pain disability, pain self-efficacy, fatigue, and physical disability  were collected.P=.03, d=0.61), and on the 2MWT , whereas the patients in the treatment-as-usual group did not report any such improvements. Significant changes in pain disability and fatigue were found in both groups (multiple P<.02); the magnitudes of the effect sizes were larger for the mPCST group than for the control group . There were no significant changes in pain severity in either group.Participants in the focus groups and user testing provided qualitative data that were used to iteratively refine the mPCST protocol. Focus group qualitative data included participants’ experiences with pain following transplant, perspectives on ways to cope with pain, and suggestions for pain management for other HCT patients. User testing participants provided feedback on the HCT protocol and information on the use of videoconferencing. The final version of the mPCST intervention was designed to bridge the intensive outpatient (1 in-person session) and home settings (5 videoconferencing sessions). A key component of the intervention was a website that provided personalized messages based on daily assessments of pain and activity. The website also provided intervention materials . The intervention content included pain coping advice from other transplant patients and instructions on how to apply pain coping skills while engaging in meaningful and leisure activities. In the RCT phase of this research, HCT patients (n=36) were randomized to receive the mPCST intervention or to proceed with the treatment as usual. Results revealed that the mPCST participants completed an average of 5 out of 6 sessions. The participants reported that the intervention was highly acceptable (mean 3/4), and they found the sessions to be helpful (mean 8/10) and easy to understand (mean 7/7). The mPCST participants demonstrated significant improvements in pre- to post-treatment pain, self-efficacy  Persistent pain is a major challenge for patients following hematopoietic stem cell transplantation (HCT) -5. This Psychosocial interventions that teach patients with chronic diseases skills to manage their pain can improve their abilities to cope with and reduce the pain ,10. AddrPsychosocial pain protocols are typically delivered in-person, require patients to travel to a medical center setting, and/or are not tailored to the unique challenges faced by HCT patients -21. PatiThe objective of this line of research was to develop a mobile health pain coping skills training (mPCST) protocol, designed to address the specific pain and psychosocial challenges of HCT patients. We used an iterative development model to design the protocol; methods from grounded theory were followed . First, A pilot randomized controlled trial (RCT) was conducted to examine the feasibility, acceptability, and initial efficacy of the final mPCST protocol. The first aim of the pilot RCT was to show that the mPCST protocol would be feasible  and acceptable. The second aim was to examine the initial efficacy of the mPCST protocol  on pain severity, pain disability, pain self-efficacy, fatigue, and physical disability .All participants were recruited from the adult bone marrow transplant clinic (ABMT) at a major academic medical center. Eligible patients were >21 years old, had cancer that led to transplant, and had at least one clinical post-transplant pain score of ≥3/10. Exclusion criteria included cognitive impairment  and inability to converse in English. Eligible health care providers were recruited through ABMT administrators and included nurse practitioners, physician’s assistants, and registered nurses.An initial mPCST protocol was developed that was informed by the investigators’ expertise in several areas including PCST protocol development ,23-31, mMost PCST protocols include some combination of the following content and skills training. A rationale is provided ,41 to heThe initial mPCST protocol we proposed included 6, 50-min sessions delivered over a period of 6-10 weeks. This protocol included several innovative features designed to address the unique challenges faced by HCT patients: it was brief, bridged the intensive outpatient (1 session) and home (5 sessions) settings, and used videoconferencing via an iPad for delivery in patients’ homes. The initial mPCST session was designed to occur in-person in the medical center setting before discharge home to allow facilitation of a relationship between the therapist and patient, and to establish care that bridges intensive outpatient and home care. The subsequent 5 sessions were to be delivered to the patients in their home environment through the use of videoconferencing (iPad and Skype). Videoconferencing (vs in-person and/or telephone delivery) provided the following important advantages: (1) it allowed patients who lived far from the medical center to engage in the intervention, (2) there is evidence that educational and psychosocial content is better communicated through videoconferencing than through telephone , and (3)The initial intervention included didactic and experiential components, which were summarized in handouts and on the study website. Homework on how to incorporate material from the session into daily life was also given to facilitate skill acquisition and generalization of skills use into their normal routine ,46. AdheTwo participatory design focus groups (n=10) were conducted to guide investigators in tailoring the mPCST protocol to meet the unique needs of HCT patients with pain. Focus group guides were developed based on the investigators’ experience, past work, and the larger empirical literature. Group discussions focused on the patient’s experiences and challenges of HCT pain, intervention content, and intervention characteristics .Two intervention development focus groups allowed participants (n=11) to evaluate the tailored mPCST protocol materials developed in the intervention design focus groups. These groups were conducted using both in-person examples and a visual demonstration of the iPad and Skype system; patients were asked to provide the research team with objective information on challenges in using and preferences for delivery using this modality.The final two focus groups comprised HCT patients (n=4) and providers (n=10). Providers recruited for the focus groups were clinical providers in the ABMT clinic and had no other role in this study. Using the feedback from the intervention design and development focus groups, the evaluation focus group was geared toward the final refinement of the mPCST protocol and technology. Participants were provided with a description of the intervention protocol, were asked detailed questions about specific components of the protocol , and were provided with an example of the materials that would be given to the potential participants . Providers were asked to review and provide feedback on the patient manual and session handouts, and to use the study website on the iPad.User testing of the developed mPCST protocol was conducted with 7 participants who reported HCT-related pain. Participants completed the 6-session mPCST protocol and were asked to provide feedback following each session. The information collected was used to further refine the intervention protocol.A separate group of participants (n=36) were randomized to either the mPCST or treatment-as-usual, control group. Pre- (before randomization) and postintervention assessments included measuring pain severity, pain disability, pain self-efficacy, fatigue, and physical disability . Self-report assessments were completed via the study website; the 2MWT was conducted at the medical center.Participants randomized to mPCST completed the first session following their baseline study assessment and before discharge home. The time between the baseline assessment and first session was on average 4.5 days (SD 9) and from the first session in the hospital to the first session at home was on average 10.5 days (SD 10). Participants who did not have Internet access to participate in videoconferencing and Web-based assessments from home or who desired to have study-provided hardware were loaned a tablet computer  equipped with 3G Internet access; most participants elected to use the study-provided iPad to complete the intervention. Participants randomized to treatment as usual were also loaned a tablet computer as needed to complete assessments.Pilot RCT participants completed self-reported measures of acceptability, pain severity, pain disability, pain self-efficacy, fatigue, and physical disability. Demographic and medical variables were also collected.Feasibility was assessed by examining overall accrual, attrition, and adherence.Acceptability was assessed with the client satisfaction questionnaire (CSQ), 10-item version . CSQ wasPain severity was assessed with the 4-item brief pain inventory . PatientPain disability was measured with the pain disability index . This 7-Self-efficacy for pain control was measured using the 5-item self-efficacy for pain subscale of the chronic pain self-efficacy scale measure  .Fatigue was measured with the patient-reported outcomes measurement information system adult fatigue profile short form (6 items) ,52. ThisSelf-reported physical disability was measured with the functional assessment of cancer therapy well-being scale . FACT has demonstrated good internal consistency, criterion validity, and sensitivity to change . InternaFocus groups were audio-recorded and 2 group leaders took field notes. Audio files were transcribed by a member of the research study team; a second team member performed a quality check by replaying the audio file and editing the transcript as needed. Grounded theory methods were used to evaluate the data gathered from the focus groups. Audio recordings were reviewed using open coding  and memoing by 3 members of the study team to generate repeated concepts. These results were categorized into 5 major themes through selective coding methods.t tests were used to examine within group differences from baseline to follow-up on study outcome variables . The magnitudes of the effect sizes were defined according to standard convention for Cohen d   because you can’t just stop. When you scale back, we’re trying to work it out, so I’m gradually dosing down.Always wind up with my hips hurting the most [post-transplant].Honestly I can say I went from horrendous pain and can say I’m in no pain sitting here. It felt like a huge rubber band around my chest. And it was just as tight as it could possibly be. I couldn’t lie down; I would sit up and rock, just rock and pray, until I finally fell asleep.I wonder if my chemo and the whole situation didn’t just age my whole body, and the pains that I feel now might have been pains I wouldn’t feel, 5, 6, 17 years from now but that I think I’m feeling now.I have a lot of bone pain, but I had it before the transplant because the chemo was eating away at the bones in my back, so I’ve had some surgery on my back to help with that. The pain in my back got better during the transplant because I was in so much pain everywhere else.I’ve had some trouble with neuropathy. I still feel it, but I’m not taking anything for it.I’m feeling more pain now post-transplant. After the transplant was when I really started having the pain.Foot and leg cream—it has done wonders.Walking is the best thing for me when I have pain.I find that at night, even putting socks on makes a difference [in regards to the pain].I need to sit properly; if I didn’t have support in my lower back the pain is immediate. Breathing helps, in through the nose out through the mouth.Theme 2: Activities and limitations in activitiesI was a very athletic person, and still am, I try to keep up with my kids. I had my walking stick, I had to stop and rest for a bit.I take breaks. I love baking Christmas cookies, but I can’t stand that long anymore. I’ll do a little bit; then take a break. Funny ways to do it and still get something accomplished.My husband bought me a piano for Christmas because I’ve always wanted to play it. I just forget everything. It is really a good relaxer.I love to garden, even on my worst days, I take a bucket and sit out there. Not only did I get something accomplished, but I did something I really enjoy.You’re finally home and you’re like I can do something, but you’re not allowed to.Right now I’m just getting out of seclusion so I’m not able to do much, but we’re planning to take trips.Now I have a totally different perspective on life, and it’s nice to get out and do something.Theme 3: Pain-related cognitionsI just try to deal with it.Sometimes I just live with it because I don’t want to take the pain meds.I feel better when I do anything.I made it through the first time, if I have to go it through again, I know what to expect and I can do it again.My cancer is back [in reference to thinking about the pain].How long is this [pain] going to last?It’s been 2 years, and if something strange happens [related to pain], I still worry.When you don’t really have any symptoms, it’s scary.Theme 4: Advice for other transplant patientsDon’t try to fight it [the pain]. Let the doctors know. It’s not their first rodeo.We’re not supposed to be proud at a time like this; we’re supposed to be honest.Would have been helpful to have spoken to some who had been through transplant beforehand.It does make you have to learn how to do things, such as learning how to take medication. And washing my hands, I’m good at that now.Theme 5: Feedback on the mobile pain coping skills training (mPCST) protocolI’d call my daughter for help [with the iPad]. [I] wouldn’t try if she wasn’t there, she is a real techie. It could be managed with her.I can barely turn a computer on.I’ve been wearing a pedometer for about 3 years, so I wouldn’t have a problem. I do it already.I’d be willing to give this [the iPad and videoconferencing] a try with help.Focus group participants were asked about their thoughts (negative and positive) surrounding their pain experience pre- and post-transplant. Many patients worried that their pain might indicate disease recurrence or progression. For example, participants endorsed the following cognitions: “What are they going to find at my next check-up appointment?,” “My cancer is back,” and “Something is wrong.” For others, thoughts were associated with perceptions of their pain and their abilities to reduce their pain. Negative thoughts included the following: “I want to get rid of this,” “How long will this pain last?,” “Will this ever go away?,” and “Why me?.” Overall, participants said that staying positive yet realistic was the best way for them to cope with these negative cognitions related to post-transplant pain. Positive thoughts that helped patients cope with pain and combat the aforementioned negative cognitions included the following: “This too shall pass,” “I am blessed,” and “This is my life right now.” Common negative and positive cognitions about pain provided by focus group participants were used as examples in the protocol during sessions with the therapist and in patient handouts.We asked participants what pain-related information they wish they had known before their own transplant. Group members acknowledged that it would have been helpful to receive more information on neuropathy and the different types of pain that might be experienced post-transplant. More broadly, participants expressed a desire for communication with prior transplant patients regarding the pain experience and general transplant-related information. Most of the participants agreed that having someone who had gone through a similar situation to talk to about their pain was helpful and comforting, and that such an outlet should be made available to HCT patients approaching transplant. On the basis of this consistent observation acknowledged across the focus groups, patient materials were updated to reflect advice from other transplant patients. The most common suggestion among HCT patients was to communicate any pain, discomfort, or other concerns to the medical team and caregivers rather than holding back. Group members advised future patients to be honest about their pain and about what physical and emotional help they needed. Focus group participants provided feedback on the mPCST protocol and technology. The majority of participants agreed that they would be willing to use the iPad, Skype, and website technology with adequate instruction. Many of the participants reported that it would be helpful to have a connection with their medical team and a therapist during the transition to post-transplant life, as they often missed the daily contact with their medical team once discharged from daily care. This feedback reinforced our position that the most appropriate timing of this protocol was once the patient returned home. Participants’ responses also led to the inclusion of detailed instruction in the use of the technology  for this study in the patient handouts.Just for You feedback box designated for individualized therapist feedback for participants  was designed to identify problems with the mPCST protocol and videoconferencing technology. Overall, participants reported enjoying the relationship they fostered with their therapist first in-person and then by videoconferencing. Participants noted that they looked forward to sessions and appreciated having someone to talk to about their pain and progress each week. Progressive muscle relaxation and goal-setting skills were reported to be especially helpful. Although participants acknowledged that some skills presented were new, they described that it was helpful to receive a refresher course for previously learned skills  to remind them of the importance of the skill and how the skill applied to pain management.Overall, positive feedback was common, yet 2 noteworthy criticisms were reported. One participant believed the 6-session protocol felt too condensed for the amount of information delivered. Another participant recommended we tailor the sessions to suit the individual needs of different patients, for example, spending more or less time on certain sessions depending on the patient’s specific needs and preferences. Three testers reported difficulties in using the iPad and connecting with their therapist via videoconferencing; these difficulties were resolved and all participants were able to finish the protocol. We added visual information to the directions for the protocol based on these technical difficulties. All participants reported videoconferencing to be more convenient than in-person pain coping skills training sessions. Two of the 7 user-testers indicated it would be beneficial to also include the caregiver in these sessions due to the stress experienced by caregivers of HCT patients. Along these lines, 1 patient indicated the title of the protocol could be changed to “Pain and Stress Coping Skills Training” due to the relevance of the coping skills introduced in the intervention for both pain and stress management. The pilot RCT participants  were on average 56 (SD 12) years old and 50% female (18/36). Most participants were white  and 17% were black (6/36). The majority of participants were married  and just over half  had a college and/or professional degree. Most participants received an autologous HCT ; 61% (22/36) had been diagnosed with multiple myeloma, 19% with lymphoma (7/36), and the remaining with various other hematological diseases. The average time since cancer diagnosis was 22 months (SD 30). Participants reported 1 other medical comorbidity, on average, with hypertension , osteoarthritis , diabetes , and sciatica  being the most common. There were no significant differences in medical or sociodemographic variables by the treatment group.U-test or Fisher exact test, whichever was appropriate, was used to determine if the baseline characteristics of noncompleters systematically differed from participants completing the study. There were no significant differences in the baseline sociodemographic characteristics between individuals who completed the study and those who did not. However, noncompleters reported significantly greater pain severity at baseline when compared with completers .The consort diagram for the RCT is presented in Out of all the patients accrued, 50% (18/36) were randomized to the intervention group. Patients in the intervention group completed an average of 5 of the 6 sessions offered to them. A total of 14 participants completed all 6 sessions (1 in-person and 5 via videoconferencing); on average, these participants completed the intervention in 34 days (SD 5). Following the final session, 85% of participants reported using the skills they had learned on several days of the week. Participants reported the sessions to be helpful (mean 8/10), easy to understand (mean 7/7), and highly acceptable (mean 4/4). Overall, 75% participants rated the intervention as excellent and 25% rated it as good.d=0.79 vs 0.69), pain self-efficacy (d=0.61 vs 0.10), fatigue (d=0.94 vs 0.81), and on the 2MWT (d=0.66 vs 0.41), an objective assessment of physical disability. Although differences between the outcomes are fairly subtle, the largest relative difference between the intervention and control groups appears to be for pain self-efficacy, which is a natural intermediate outcome that the intervention was designed to address directly. The magnitude of the effect sizes was greater for the control group with regard to self-reported physical disability and pain severity; however, both groups evidenced large and small-to-medium effect sizes, respectively, on these variables.At baseline, there were no significant differences in outcome variables  between randomization groups. Within-group comparisons from baseline to postintervention are presented in The goal of this study was to develop a PCST intervention that could be used to enhance the ability of HCT patients to manage their pain following transplant. HCT patients face many pain-related challenges and challenges accessing behavioral interventions post-transplant. We used both patient and provider focus groups to adapt the effective components of existing PCST protocols to meet the unique needs of patients following transplant. After developing the HCT-focused protocol, we conducted a small RCT to examine feasibility, acceptability, and initial efficacy of the developed mPCST protocol.The developed mPCST protocol included 1 in-person session at the medical center between the patient and study therapist, which led to the development of a successful working relationship and the integration of mPCST with the patient’s medical care. Then, once the patient returned home following intensive outpatient care, 5 more sessions were conducted using videoconferencing. This bridge between hospitalization and home maintained the continuity of care as patients moved away from the medical center. This mixed delivery modality fostered a strong patient-therapist relationship that likely increased the feasibility, acceptability, and efficacy of the intervention. To our knowledge, this is one of the first studies that has examined the use of videoconferencing to provide patients with PCST upon their return home from inpatient or intensive outpatient care.Patient focus groups highlighted several areas of consideration in the development of the intervention content including the importance of strategies for coping with pain that was unique to HCT patients, enjoyable activities following transplant, pain-related thoughts following HCT, and connecting with other HCT patients for support. Accordingly, we addressed many of these areas in the developed mPCST protocol. For example, we highlighted advice from other patients throughout the sessions and in patient materials. Although we were unable to include all patient suggestions  into the protocol, we will consider these suggestions in our future work.Just for You portion of the website  would the intervention group improve and, if so, how much, and also which outcomes would show the greatest improvement, and (2) how much improvement would we see in the control group? This latter question is critical for the design of the more definitive RCT. We used a small pilot RCT to examine the pattern of effects for those who received mPCST and those who did not. We found that participants who received the intervention experienced greater improvements in pain disability, pain self-efficacy, fatigue, and the 2MWT, with the largest relative difference between the intervention and control groups being for pain self-efficacy and the 2MWT. The finding that HCT patients completed the mPCST intervention at the intended pace of about 1 session per week adds support for past work suggesting that videoconferencing intervention protocols compared with in-person protocols can be completed at the pace of 1 session per week, whereas in-person protocols can take twice as long .These outcomes suggest that mPCST is particularly likely to help patients manage their pain in a way that might lead to decreases in the impact of pain on their day-to-day activities . In line with social cognitive theory, teaching and receiving feedback on pain coping skills practice in their own home  may have been particularly helpful for increasing participants’ self-efficacy for pain management. Furthermore, the finding that an objective measure of the physical ability  appears to have been positively impacted by mPCST has important implications for improving patients’ physical functioning in their daily activities. It may also be said that helping patients control their pain and other symptoms can lead to increased physical activity.Both the groups evidenced small-moderate effect sizes for pain severity. The majority of individuals participating in the RCT had been diagnosed with multiple myeloma (62%) for which autologous transplantation is most commonly recommended . CompletThe small effect sizes for pain severity ratings may indicate that it is necessary to target patients with higher baseline pain levels to find a change in pain severity. The average pain severity of patients recruited in this study was 3 on a 10-point scale; this relatively low pain level may not have been high enough to demonstrate significant change from pre- to postintervention. Another important consideration is that patients with higher pain were less likely to complete the study and may have been less likely to enroll; future work may want to consider recruitment and retention strategies to provide treatment to individuals with the highest pain levels who may need it the most. Finally, there is evidence that changes in self-efficacy for pain control and pain disability are critical for overall functioning and as such, investigators may want to consider using these variables as primary outcome variables with actual pain severity being a secondary outcome.This study has several limitations. First, this work was completed through the use of iPads, which require either a data plan or Internet connection to be able to videoconference with the therapist. The intervention itself is scalable for use on either a personal computer or mobile phone; the number of individual’s access to a personal computer, tablet, or mobile phone is greater than 50%, and future work should be designed to be inclusive of all possible technology devices. Second, the RCT was relatively small (N=36), conducted in a single medical center, and had a short follow-up period; future work should expand the study size, consider using multiple sites, and examine longer term outcomes.In summary, this study relied on past work and the expertise of the large study team to develop a mobile pain coping skills training intervention that was efficacious and could be delivered to patients following HCT. The developed intervention was also informed by patient and provider focus groups and included a 6-session, hybrid protocol . Our pilot RCT found that the developed intervention was highly feasible and acceptable to HCT patients with pain. Preliminary data suggest that the developed mPCST intervention likely improves patients’ abilities to manage their pain , decrease pain-related disability, and decrease symptoms of fatigue.


As the number of reversed shoulder arthroplasty (RSA) procedures increases, the revision rate will also increase. In case of severe bone insufficiency, instability or infection of the primary RSA, revision to another RSA is preferable but not always possible. Hemiarthroplasty (HA), spacers and resection arthroplasty (RA) have been described in this indication.Between 2004 and 2016, 20 shoulders in 19 patients were treated at Ghent University Hospital for failed revision of RSA. Nine received a megahead prosthesis, a spacer was implanted in 6, and 5 underwent RA.n = 5), infection (n = 4), dislocation (n = 1) and nerve irritation (n = 1). Improvement of range of motion was observed. Anterosuperior migration of the prosthesis was noted in 2 patients. Another 2 patients were ultimately revised to RSA. Seven permanent spacers were implanted for infection, of which 2 remain in place till today. The other 5 were revised to RSA. Of the 5 patients treated with RA, 3 were revised further on to RSA, resulting in pain relief and regain of function.Indications for implantation of a megahead prosthesis were loosening RSA (Our study shows that a megahead prosthesis has better functional results than RA, but is inferior to RSA. Due to increasing surgical experience and improving technique, 9 patients could ultimately be reconverted to another RSA. A review of current literature is presented. In HA and RA, the functional results are poor, and pain relief is uncertain. Results of spacers are variable and can be satisfactory. Arthrodesis is a last resort.In our case series study, a hemiarthroplasty can be performed in case of failure of RSA. However, the results are inferior to another RSA. In 2011, 66,485 patients underwent a shoulder arthroplasty procedure in the USA, of which 44.2% received a total shoulder arthroplasty (TSA), 32.6% a reversed shoulder arthroplasty (RSA) and 23.2% a hemiarthroplasty (HA). Since its approval by the FDA (US Food and Drug Administration) in 2004, the number of RSA procedures has increased over tenfold in 7 years, from approximately 2000 interventions in 2004 to 21,692 in 2011 [Also, the indications for the RSA have been expanded: whereas the original goal was to treat pseudoparalysis with cuff tear arthropathy, today, RSA is used in the treatment of massive rotator cuff tears, failed total shoulder arthroplasty or hemiarthroplasty, acute fractures or their sequelae, tumors and rheumatoid arthritis . This spIn some cases, a new RSA cannot be placed because of insufficient or low quality bone stock, infection or refractory instability . In thesThe purpose of this study was to retrospectively evaluate the outcome of revision RSA with megahead cuff tear arthropathy prosthesis (DePuy-Synthes), spacers or resection arthroplasty. We hypothesise that the results of these techniques offer adequate pain relief and acceptable shoulder function.This study was set up at the University Hospital of Ghent. Approval was obtained from the Ghent University Hospital (UZ Gent) ethics committee (B670201422180). A consecutive series of all patients with failed reversed total shoulder arthroplasty treated with hemiarthroplasty, spacer or resection arthroplasty between 2004 and 2016 were analysed. The senior author performed the operation in all patients. Indications for revision of failed reversed total shoulder arthroplasty included infections, glenoid loosening, instability, malpositioning and suprascapular nerve irritation. Whenever possible, the prosthetic elements were kept in place, or replaced by new ones when needed. If preservation of the reversed shoulder joint was impossible, a salvage procedure was performed: implantation of a megahead prosthesis (massive glenoid bone loss), a permanent spacer or a resection arthroplasty (infection). We grouped our patients according to their indication and for each group we described the surgical technique and the clinical outcome using the Constant score  . In case of persistent failure of the RSA 20 shoulders in 19 patients were treated with a salvage procedure: 9 were treated with a megahead prosthesis , 6 with a permanent spacer because of persistent infection (patients 10–15), and 5 with a resection arthroplasty .Mean age at implantation of the megahead was 75.2 years; 7 of the 9 patients were females. Five of the 9 patients showed clinical and radiographical signs of loosening of the original RSA  and did not improve postoperatively.In 2 patients (patients 4 and 9) the megahead prosthesis was revised and ultimately converted to another RSA . Patient 4 had a long history of infections of the shoulder prostheses: in 2003 an initial hemiprosthesis was revised to RSA because of infection with omnisensitive coagulase negative staphylococci (CNS). One year later, in 2004, the RSA was removed and converted to a megahead prosthesis because of CNS that was resistant to oxacilline, cotrimoxazol and gentamycin. This prosthesis remained functional till 2008 when another infection with CNS was detected: the megahead was removed and a hip spacer was placed. After 12 months, the spacer was finally converted to a RSA, which remains in place till current day, with improving ROM and a Constant score of 57. Perioperative cultures remained negative (Table Patient 9 was revised because of very poor shoulder function 1 year after implantation of the megahead and increasing pain (VAS 8/10). The preoperative Constant score was 12 and improved to 52, only 3 months after conversion to RSA.Seven spacers were implanted in 6 patients . We used the smallest size of commercially available hip spacers instead of shoulder spacers because of reimbursement reasons. Mean age at implantation of the spacer was 69.2 years. Two spacers remain in place till current day (patients 10 and 11). Patient 10 received a spherical spacer, made of gentamycin-impregnated cement, because of loosening due to persistent infection with CNS Fig. . A hip sPatient 11 was implanted with a spacer, normally used for the hip, because of infection and dislocation of the RSA Fig. . The preIn the other 4 patients (patients 12–15), the spacer was removed after an average of 7.2 months because of pain, severe loss of function or recurrent infection. All patients could be treated with a RSA. Patient 12 had received 2 spacers: his first because of abscess formation of a primary RSA. After 8 months, a revision RSA was implanted. Unfortunately, reinfection occurred 13 months after revision, necessitating another spacer implantation. A final RSA was implanted 10 months after the second spacer.Five patients  were treated with resection arthroplasty when all other options failed. Mean age was 69.4 years; 3 out of 5 were males. Patient 1 was treated for infection of the right-sided RSA, which could not be controlled, and therefore the prosthesis was originally replaced by a hip spacer. Because of persistent infection, the spacer was ultimately removed and converted to a resection arthroplasty. Constant scores did not change and remained very poor (5/100); the level of pain was reported as high.Patient 16 received an arthrodesis after two revisions of the initial RSA because of loosening and pain. Nevertheless, the pain was not relieved, and ultimately a resection arthroplasty was performed. Constant scores before and after surgery went from 7/100 to 10/100.Three patients (patients 17–19) treated with resection arthroplasty were unsatisfied with their outcome, largely because of the pain. By mutual agreement, a final attempt to implant a RSA was performed Fig. . Mean prReversed shoulder arthroplasty is a very successful treatment for a wide variety of shoulder pathologies, but along with the enormous increase in number of performed procedures, the number of complications and revisions has increased proportionally.In our study, we found that the function after implantation of a megahead prosthesis is better than resection arthroplasty. The results however are inferior to RSA.In our group of 20 shoulders in 19 patients with failing RSA who were initially treated with HA, spacer or RA because another RSA was thought to be impossible, it was ultimately possible to convert 9 to a RSA, as the surgical experience and technique of the senior author had increased, with satisfactory results concerning shoulder function and pain relief.In case a revision is necessary but the preservation of a reversed implant is impossible, due to insufficient bone stock, infection or instability, a few procedures have been described Table : hemiartn = 3) and dislocation . The patients who had an infection received a preformed antibiotic-loaded cement hemiarthroplasty. Shoulder function was reported as very poor, although pain was slight (2.42 ± 2.06).Little literature has been published about the results of hemiarthroplasty as salvage after RSA. Zumstein et al.  describen = 11) and infection (n = 3). Comparison between pre- and postoperative shoulder function revealed no significant changes in pain, average anterior elevation, external or internal rotation. However, the authors note that in 5 patients the level of pain had increased after the hemiarthroplasty.A larger series was published by Glanzmann et al. : 16 RSA Our own results show 9 cases of conversion from RSA to a hemiprosthesis (megahead), of which 2 were ultimately reconverted to RSA. The latter can be explained because of the introduction of a revision baseplate , the improvement of the surgical technique due to more surgical experience the bone stock appeared to be sufficient. In case that a stable fulcrum could be obtained we could give those patients reasonable shoulder function. This can be explained by the smooth lateral extension of the humeral head allowing gliding underneath the acromial arc. To obtain this fulcrum perioperative testing and an increased retroversion of the humeral implant together with a medialized glenoid  are desirable.Spacers are normally used in 2‑stage revisions as a temporary interposition, but in certain cases they can be a permanent solution if the patient is unable or unwilling to be subjected to another operation.Brodt et al.  reportedA larger study of 11 patients with septic shoulder arthritis treated with an antibiotic impregnated PMMA spacer in 30° retroversion was presented by Themistocleous et al. . It mustVerhelst et al.  retrospeIt is our impression that stability can be enhanced by the tensioning of the deltoid and conjoined tendon, andlateralisation of the humeral shaft. Due to the improvement of the deltoid wrapping , a cemenAlthough a drastic treatment, resection arthroplasty has been described for shoulder infections of various origin. Several authors have evaluated this option in infected arthroplasties –20 and iMost authors agree that resection arthroplasty is a valid therapeutic option in low demanding and highly painful shoulders after failed arthroplasty and that outcomes concerning function and pain not always can be predicted –20.We advise this procedure only in cases of extreme weakness of the acromion/glenoid, in case of deltoid/conjoined tendon dysfunction (due to axillary nerve lesion) or due to deltoid dehiscence problems where it can serve as a salvage procedure because it is always better than an amputation of the upper limb. In our own experience however, we saw that reconversion to RSA was often possible  we performed , it was possible to reconvert the salvage to a RSA because of improvement of technique and growing surgical experience.


Psychological pain is a relatively understudied and potentially important construct in the evaluation of suicidal risk. Psychological pain also referred to as ‘mental pain’ or ‘psychache’ can be defined as an adverse emotional reaction to a severe trauma  or may be associated with an illness such as depression. When psychological pain levels reach intolerable levels, some individuals may view suicide as the only and final means of escape. To better understand psychological pain, we previously developed and validated a brief self-rating 10-item scale, Mee-Bunney Psychological Pain Assessment Scale [MBP] in depressed patients and non-psychiatric controls. Our results showed a significant increase in psychological pain in the depressed patients compared to controls. We also observed a significant linear correlation between psychological pain and suicidality in the depressed patient cohort. The current investigation extends our study of psychological pain to a diagnostically heterogeneous population of 57 US Veterans enrolled in a suicide prevention program. In addition to the MBP, we administered the Columbia Suicide Severity Rating Scale (C-SSRS), Beck Depression Inventory (BDI-II), Beck Hopelessness Scale (BHS), and the Barratt Impulsiveness Scale (BIS-11). Suicidal patients scoring above a predetermined threshold for high psychological pain also had significantly elevated scores on all the other assessments. Among all of the evaluations, psychological pain accounted for the most shared variance for suicidality (C-SSRS). Stepwise regression analyses showed that impulsiveness (BIS) and psychological pain (MBP) contributed more to suicidality than any of the other combined assessments. We followed patients for 15 months and identified a subgroup (24/57) with serious suicide events. Within this subgroup, 29% (7/24) had a serious suicidal event , including one completed suicide. Our results build upon our earlier findings and recent literature supporting psychological pain as a potentially important construct. Systematically evaluating psychological pain along with additional measures of suicidality could improve risk assessment and more effectively guide clinical resource allocation toward prevention. Suicide is a serious public health problem and one of the leading causes of death worldwide accounting for an estimated 800,000 deaths annually according to recent statistics from the World Health Organization . In the Psychological pain is a relatively understudied and potentially important construct for the assessment of suicidal risk. Also referred to as ‘mental pain’ or ‘psychache’, psychological pain can be defined as an emotionally-based aversive feeling that at its extreme can be experienced as torment that may result from a severe emotional trauma (such as the loss of a child) or may be associated with an illness such as depression . SchneidA review of ‘mental pain’ in mood disorder patients and studies in clinically heterogeneous patient populations found a significant correlation between high levels of psychological pain and suicidality, independent of psychiatric diagnoses . It is lIn our original study, we developed and validated a brief 10-item self-rating scale, the Mee-Bunney Psychological Pain Assessment Scale [MBP] . The MBPIn the current study, we assessed psychological pain in a diagnostically heterogeneous population of suicidal VA patients enrolled in a suicide prevention program. In addition to the MBP, we evaluated depression . To explore the relationship between psychological pain and future suicidal behavior we followed patients for 15 months and recorded suicide events. Serious suicide events (SSEs) were identified using the lethality/medical damage subscale of the C-SSRS. Due in part to a potential association with high psychological pain and suicidality –8 we hypInformed Consent: This study was approved by the Veteran’s Affairs Long Beach Healthcare System. All subjects provided written signed consents.Subjects: Suicidal patients: A total of 57 psychiatric patients (23 outpatients and 34 inpatients) from the Veterans Affairs Long Beach Healthcare System (LBVAHS) meeting criteria were consecutively enrolled in the study.  administered by trained clinicians at in- or outpatient settings. Although not a fully comprehensive DSM-IV diagnostic instrument, the MINI provides reliable assessment of mood and anxiety disorders as well as substance abuse/dependence. It has demonstrated high concordance with the SCID for major depression and represents a reduced time burden for the participant .To determine the relationships between measured psychiatric constructs and suicidality, C-SSRS scores were independently regressed on each predictor in seven separate analyses. Based on the linear regression , psycholIn our previous study we used a predetermined threshold of MBP ≥ 32 representing 0.5 SD above the mean for depressed MDE patients as a cutoff for high psychological pain  have increased sensitivity for suicidality, they may not be as accurate for suicide prediction . The addS1 Table(DOCX)Click here for additional data file.


A significant number of patients who undergo a standard inguinal hernia repair or a Pfannenstiel incision develop chronic (> 3 months) post-surgical inguinal pain (PSIP) due to nerve entrapment. If medication or peripheral nerve blocks fail, surgery including neurectomies may offer relief. However, some patients do not respond to any of the currently available remedial treatment modalities.Targeted spinal cord stimulation (SCS) of the dorsal root ganglion (DRG) is a relatively new type of therapy that has a potential to significantly reduce chronic PSIP. The Axium® SCS System  has been shown to be safe and successful in small cohorts of PSIP patients.Aim of this study is to evaluate targeted spinal cord stimulation therapy in patients with PSIP.A prospective, multicentre, randomized controlled trial with optional one-way crossover will assess the efficacy of the Axium® SCS system for the treatment of PSIP. Seventy-eight patients with intractable PSIP following open hernia repair or Pfannenstiel incision who did not respond favorably to previous pain treatment regimens including a neurectomy will be randomized to either an Axium® SCS arm or a control arm receiving only conventional medical management (CMM).Primary outcome is the difference in percentage of subjects with ≥50% pain relief after 6 months using a Numerical Pain Rating Scale (NPRS). Data are collected using a daily pain/sleep diary and a number needed to treat (NNT) analysis is performed. Various secondary outcomes will be collected.Targeted SCS stimulation of the DRG using the Axium® SCS system will possibly offer significant pain reduction in patients with PSIP who are refractory to other treatment modalities.http://clinicaltrials.gov, ClinicalTrials.gov identifier: NCT02349659) on January 29, 2015.The study protocol is registered at the NIH Clinical Trials Registry ( Herniorrhaphies are performed 800.000 times a year in the U.S. A male person in the industrialized world faces an up to 27% lifetime risk of requiring surgery for his inguinal hernia . Some 10Recently, a consensus was proposed concerning the management of chronic postherniorrhapy inguinal pain . If non-Currently, few therapeutic options are available for patients demonstrating limited (or no) success after neurectomy. A promising new treatment tool is spinal cord stimulation (SCS) of the dorsal root ganglion. This novel variant of traditional SCS is claimed to effectively target the groin and has proved to be a safe and efficaous therapy in small, heterogeneous case series of patients with PSIP , 12. In clinicaltrial.gov, ClinicalTrials.gov identifier: NCT02349659).The SMASHING  trial is a randomized, cross-over, multicenter study. The protocol is approved by the Regional Ethics Committee of the Máxima Medical Center, Veldhoven, The Netherlands (no. 1435). The objective is to evaluate the efficacy of SCS of the DRG with an Axium® SCS System of Spinal Modulation Inc. in patients with post-surgical pain after a hernia repair or pfannenstiel incision who did not favorably respond to a neurectomy. Clinical results of the Axium arm are compared with those in a CMM arm. Patient enrolment has started in February, 2015. The study protocol is registered at the NIH Clinical Trials Registry (http://Adults (18 years or older) of either gender suffering from persistent inguinal pain (minimum duration of 6 months) following either open or laparoscopic inguinal hernia repair surgery or a Pfannenstiel incision who have subsequently undergone and failed to respond to a neurectomy procedure will be considered for inclusion. Failure to benefit from additional treatment options such as peripheral nerve blocks, physical therapy, minimally invasive interventional pain procedures and medical regimens with at least a tricyclic antidepressant or similar neuropathic pain agents is required. Patients should have a minimum daily average baseline pain rating of 5 out of 10 in the inguinal area on an 11-point NPRS. Patients should be able to operate the device. Inclusion criteria as set out by the Dutch Neuromodulation Society should be met. A psychologist will screen patients and assess for suitability within a multidisciplinary team including an anesthesiologist or pain specialist and a surgeon-herniologist. [Patients are excluded if there are contra-indications for device implantation such as pregnancy, ongoing infection, coagulation disorders, previous spinal surgery at or between vertebral levels T10-L2, the presence of other active implantable devices or a condition which will require MRI investigations. Patients are not allowed to undergo injection therapy or radiofrequency treatment at the target neural structure in the 3 months prior to inclusion. An escalating or changing pain condition and a diagnosis of cancer in the past 2 years are also considered as exclusion criteria.Patients are considered for the trial if all criteria are satisfied. After suitability within is confirmed by the multidisciplinary team, informed consent is signed after patient is adequately informed and has agreed upon participation. Patients will be randomized in a 1:1 ratio to either arm. An independent statistician will generate and hold the allocation sequence, concealed from those involved in assessing eligibility and recruiting subjects.The SCS group  radiofrequency, epidural or peripheral injection or infusion therapy with analgesic agents or any other form of neurostimulation  are performed, these treatments are considered as a protocol violation. After 6 months, patients will be offered to cross-over to the Axium ® Group. They will then receive treatment and follow-up as previously described.Patients of both groups will undergo a follow-up visit after 2 weeks, 1 month, 3 months, 6 months and 12 months postrandomisation. Standardized questionnaires investigating quality of life, physical impairment, health resources utilization, subject satisfaction and adverse events will be completed. Validated questionnaires such as the EQ-5D, BPI, NPSI (Neuropathic Pain Symptoms Inventory) and a 7 point Likert Scale will be used. Pain and sleep will be evaluated using a pain-sleep interference diary containing an NPRS and DSIS over a 7-day period. Measures of average, worst and least pain during the previous 24 h are obtained using this diary. Primary analysis is conducted on average pain intensity scores. Physical examination will be performed in order to assess changes in neuropathic pain symptoms.The primary outcome is percentage of subjects experiencing a minimal 50% reduction in average daily pain intensity as measured using the average NPRS as noted in pain diaries in the Axium® group as compared to the CMM group. Group differences in the change in pain intensity scores (NPRS) at the 6-month FU visit are also calculated. The analysis will be done following an Intention to Treat (ITT) principle.Secondary outcomes are an ‘as treated’ analysis of the percentage of subjects experiencing a minimal 50% reduction in average daily pain intensity (NPRS) at 6 months and the mean difference in the change in pain intensity scores (NPRS) between the successfully trialed subjects with the Axium® arm as opposed to the CMM arm. This ‘as treated’ analysis is important as it reflects clinical convention i.e. utilization of a therapy trial (TNS) to improve changes of a successful outcome with the fully implantable system. A number needed to treat (NNT) analysis at the 6-months time point for ≥30% and ≥50% pain relief is also performed. However, reduction in pain intensity is not the only clinically relevant outcome in chronic pain patients. Changes in disability, pain interference, neuropathic pain symptoms, sleeping disorders and health resources utilization are also investigated using validated questionnaires at baseline and each follow-up visit. Fig. .Fig. 2SPTotal study duration is anticipated to be 2 years.Sample size estimation is based on a ‘responder’ analysis as recommended by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) group recommendations . The estThe primary analysis is a comparison of the proportion of responders (≥ 50% pain relief) in the Axium® versus CMM group at the 6-months time point. The mean difference between proportions and 95% confidence intervals are calculated. A risk difference is obtained using generalized linear modeling with a binomial distribution and an identity link. Difference between groups in the change in pain score (6-months minus baseline), adjusted for any chance imbalance between groups at baseline (ANCOVA model) are also calculated. The mean treatment effect (Axium® minus CMM) together with its 95% confidence interval is obtained. NNT will also be calculated as the reciprocal of the difference in proportions of responders (Axium® minus CMM) and presented with its 95% confidence interval. All analyses are conducted both ‘as randomized’ (intention to treat principle) and ‘as treated’ (secondary).The results of the presently proposed ´SMASHING´ trial may shed light on a possible viable alternative treatment option once other treatments have failed in therapy resistant patients with PSIP. A very recent consensus protocol does not address this group . Based oIt must be appreciated that the validation of various outcomes is of utmost importance in pain treatment studies. Pain reduction scores are subjective whereas the clinical relevance of a 30% or 50% pain reduction is debatable. The presently proposed outcome measurements are linked to improved patient satisfaction, diminished medication usage, daily functioning and sleeping quality and a positive expert’s opinion regarding patient’s improvement –19. We wPer 17-Jan-2017, sponsorship of the study has been transferred from St. Jude / Abbott to the Maxima Medical Center and primary investigator due to a slow inclusion rate. Analysis of the preliminary results of 18 patients enrolled from March 2015 to November 2016 is currently performed using repeated measures ANOVA on the primary outcome . The original protocol did not describe regulations for interim analysis, but the authors will adhere to Bayesian approach as described in Li and Gates, 2013 [


To investigate the association between postoperative pain control and oncologic outcomes in resected pancreatic ductal adenocarcinoma (PDAC).From January 2009 to December 2014, 221 patients were diagnosed with PDAC and underwent resection with curative intent. Retrospective review of the patients was performed based on electronic medical records system. One patient without records of numerical rating scale (NRS) pain intensity scores was excluded and eight patients who underwent total pancreatectomy were also excluded. NRS scores during 7 postoperative days following resection of PDAC were reviewed along with clinicopathologic characteristics. Patients were stratified into a good pain control group and a poor pain control group according to the difference in average pain intensity between the early  and late  postoperative periods. Cox-proportional hazards multivariate analysis was performed to determine association between postoperative pain control and oncologic outcomes.n = 162) and poor pain control group (n = 66). Median follow-up period was 17 mo. A negative impact of poor postoperative pain control on overall survival (OS) was observed in the group of patients receiving distal pancreatectomy . Poor postoperative pain control was also associated with poor disease-free survival (DFS) in the DP group . Patients undergoing pancreaticoduodenectomy or pylorus-preserving pancreaticoduodenectomy (PD group) did not show associations between postoperative pain control and oncologic outcomes. Poor patients’ perceived pain control was revealed as an independent risk factor of both DFS  and OS  in resected left-sided pancreatic cancer.A total of 212 patients were dichotomized into good pain control group (Adequate postoperative pain relief during the early postoperative period has important clinical implications for oncologic outcomes after resection of left-sided pancreatic cancer. Core tip: This is a retrospective review to evaluate the association between postoperative pain control and oncologic outcomes in resected pancreatic ductal adenocarcinoma. In multivariate analysis, poor patients’ perceived pain control was an independent risk factor for both disease-free survival  and overall survival  in resected left-sided pancreatic cancer. Adequate postoperative pain control to reduce patients’ perceived pain during immediate postoperative period may be as important as adjuvant therapy in resected left-sided pancreatic cancer.Pancreas cancer is one of the most fatal malignancies in the world and is currently the fourth leading cause of cancer death in the United States. Surgicade novo or from pre-existing micrometastasis.Recently, the importance of the perioperative period on oncologic outcome after cancer surgery has been emphasized in several review studies-10. ThesEven when surgeons achieve R0 resection, various factors of this disproportionally pivotal perioperative period can facilitate growth of potential residual cancer beyond a critical immunological threshold, leading to cancer recurrence. Suggested perioperative risk factors that modulate surgery-induced immunosuppression include anesthetic technique, analgesic agents, blood transfusion, hypothermia, and pain-10.Among these factors, acute pain is known to suppress NK cell activity, and itsIn spite of its potential role as an immunomodulator promoting tumor growth and metastasis, there has been no study to evaluate the oncologic significance of postoperative pain following resection of pancreas cancer. In this study, we investigated the association between postoperative pain control and oncologic outcomes in resected pancreatic ductal adenocarcinoma (PDAC).From January 2009 to December 2014, 221 patients with PDAC underwent pancreatectomy with curative intent in our center. We retrospectively reviewed clinicopathologic characteristics and numerical rating scale (NRS) pain intensity score recorded in the nursing records system. One patient was excluded because of missing NRS data for an unknown reason and eight patients who required total pancreatectomy were also excluded  staging system, reflecting greater surgical stress. Increased surgical extent has been shown to be associated with higher rates of tumor metastasis[Interestingly, the negative oncologic impact of postoperative pain control was not observed following PD. This may have been influenced by wider surgical extent involved with PD and the impact of postoperative pain control during the postoperative 7 days may be rendered ineffective. The operation time, intraoperative blood loss, and rate of intraoperative transfusion were all higher after PD compared to DP [448.3 min etastasis and delaetastasis. Also, ietastasis,43. ThesOur study has several limitations. It is a retrospective study, and the number of patients in the poor pain control group after DP was small, making it difficult to reach sound conclusions. We grouped patients into good and poor pain control groups according to differences in NRS pain intensity between early  and late  periods, because inflammation and immunosuppression peak on around POD 3. However, this time frame might not fit all cases and may vary according to surgical extent or approach. Future studies are needed to test various analytic approaches targeting the critical time point when postoperative pain most significantly mediates immunomodulation.In addition, our definition of pain control groups may not fully represent pain control state. There have been reports of using satisfaction score along with pain score in fully assessing adequate pain control,45. In dLastly, for pain control, patients received intravenous patient-controlled analgesia (PCA) or epidural PCA (both based on fentanyl) or opiates on demand. However, disconnect timing of PCA, as well as the type and amount of analgesics used after clamping, were not investigated in this study. Opioids are believed to exert an immunosuppressive effect when they are used in the absence of pain. Also, cThis study suggests that a change in patients’ perceived pain intensity in the postoperative period could influence survival outcome in resected left-sided pancreatic cancer. Unlike other prognostic factors, such as tumor size, lymph node metastasis, differentiation, lymphovascular invasion, and perineural invasion, postoperative pain is a controllable factor. Surgeons play a leading role in controlling pain during the postoperative period. In spite of compelling evidence supporting the immunologic and oncologic importance of the perioperative period, its application to the clinical field is still in its infancy. More research on underutilized modulators of this period - not only postoperative pain, but also intraoperative hypothermia, transfusion, nutritional support, and psychological intervention - is needed for the development of patient-oriented perioperative therapy against pancreatic cancer.In conclusion, adequate postoperative pain relief during the early postoperative period has important clinical implications for oncologic outcomes after resection of left-sided pancreatic cancer.Acute pain is known to suppress natural killer (NK) cell cytotoxicity and promote tumor growth and metastasis in preclinical models. Therefore, postoperative pain has been suggested as one of the risk factors for cancer metastasis and recurrence after oncologic surgery. Surgery-induced immunosuppression and inflammation are known to peak around postoperative day (POD) 3, and suppression of NK cell cytotoxicity lasts from approximately POD 7 to 9. The clinical significance of postoperative pain control during this critical period in patients undergoing pancreatectomy for pancreatic ductal adenocarcinoma (PDAC) has yet to be investigated.This study contributes in discovering associations between postoperative pain control and oncologic outcomes in resected pancreatic cancer.In this study, patients undergoing distal pancreatectomy for left-sided pancreatic cancer were found to have poor oncologic outcomes under poor postoperative pain control. Adequate postoperative pain relief during the early postoperative period has important clinical implications for oncologic outcomes after resection of left-sided pancreatic cancer.Surgeons play a leading role in controlling pain during the postoperative period. Patients’ perceived postoperative pain should be actively relieved after distal pancreatectomy for pancreatic cancer to improve oncologic outcomes.PD group: Patients underwent pancreaticoduodenectomy or pylorus-preserving pancreaticoduodenectomy. DP group: Patients underwent distal pancreatectomy. Good pain control group: Patients whose late pain intensity was lower than that of early pain intensity. Poor pain control group: Patients whose late pain intensity was the same or higher than the early pain intensity. Early pain intensity: Mean of all pain scores reported on POD 1, 2, and 3. Late pain intensity: Mean of pain scores reported on POD 5 and 7. Pain scores: Measurement of numerical rating scale (NRS) pain intensity score. 11-point NRS with the score ranging from 0 to 10 was used to evaluate pain intensity whenever the patients reported pain. Patients were instructed to rate 0 as “no pain at all” and 10 as “the worst possible pain”.The study evaluated the association between postoperative pain control and oncologic outcomes in resected PDAC. The results showed that poor pain control was an independent risk factor for both DFS and OS in resected left-sided pancreatic cancer, but not in patients received PD. This is very interesting.


With the development of prosthetic mesh and tension free techniques, the recurrence rate following inguinal hernia repair has been reduced, and hernia outcomes research should focus on post-operative quality of life and potential complications.A novel hernia quality of life assessment instrument, HERQL, was developed. The HERQL questionnaire comprises a 4-item summative pain score measuring pain and discomfort resulting from various strenuous activities. Symptomatic and functional domains, as well as post-operative satisfaction are evaluated as well.A total of 386 HERQL surveys were completed by 183 patients with inguinal hernias. Internal consistency reliability of the summative pain score was satisfactory, with a Cronbach’s alpha of 0.85. Criterion validity was examined by concomitant assessment of the pain/discomfort and health impact subscales of the EQ-5D questionnaire, with substantial to moderate correlations. Pre-operative patients reported more severe hernia protrusion, more pain during mild to heavy exercise, and worse activity restriction and health impairment than the follow-up patients, indicating clinical validity. The conceptual structure of the HERQL demostrated the causal relationship between the formative symptomatic subscales and the reflective functional status indicators. Repeated measurement of the summative pain scores revealed an estimated time effect of -1.63, which was the rate of change in the summative pain score across the pre-operative, immediately post-operative, and follow-up 3-month periods suggesting the clinical responsiveness of the HERQL.This study will facilitate inguinal hernia outcomes research and enhance the quality of care for this common disease by providing a validated HERQL instrument with enhanced sensitivity. Hernia repair is one of the most common procedures performed by surgeons worldwide. With the advancements in prosthetic mesh and improvements in tension free repair, the recurrence rate following hernia repair has been reduced dramatically, and hernia outcomes research should focus on post-operative quality of life and potential complications such as chronic non-disabling pain –7.Quality of life research in hernia patients usually utilizes generic instruments, which reduces the measurement sensitivity and limits the clinical applications. Indeed, Jensen et al.  have notSome hernia-specific outcomes research instruments have been published. The Carolinas Comfort Scale (CCS) was developed for patients undergoing mesh repairs and was validated in abdominal wall/groin hernias with both laparoscopic and open repairs , and a pThe aim of the study was to provide a validated quality of life assessment tool, HERQL, to facilitate hernia outcomes research. In Taiwan, the National Health Insurance (NHI), which is the only health care system, enrolls 97% of all of the country’s medical providers and about 99% of the population . All ingThe study has been reviewed and approved by the Institute Review Board of Cathay General Hospital under the access number CGH-P102069. The purpose and procedures of the study were explained by the primary investigator (CSH), and written informed consent was obtained from all participants.Initially a quality of life measuring instrument for both inguinal and abdominal wall hernia was proposed, encompassing symptomatic and functional domains experienced by patients with diverse hernia types. Due to the limited cases of abdominal wall hernia and the concern of anatomical discrepancy, only inguinal hernia was addressed in the current study. Here we presented the validation of the HERQL for inguinal hernia in Taiwan, and the applicability of the HERQL for abdominal wall hernia with possible modifications will be evaluated separately.The content and dimensions of the HERQL were conceptualized from literature reviews and through panel discussions of the Taiwan Hernia Society (THS). Published hernia-specific instruments including the Activities Assessment Scale (AAS), CCS, COMI-hernia, Brief Pain Inventory (BPI), and Inguinal Pain Questionnaire (IPQ) were consulted , 13–15. These candidate items were evaluated in the pilot study with 30 pre-operative inguinal hernia patients, with interviews to assess what is important to these patients among these questions, using a five-point rating scale . Three operation-related items and eventration were discarded since these items were recognized as irrelevant by hernia patients . MutuallSuccessive explorative factor analyses were performed for the preliminary HERQL to identify any underlying higher-order construct (factor). The Principal component analysis showed that two components explained 57.5% of the variance of the HERQL response and a common factor analysis with the oblique PROMAX rotation further augmented the existence of the two common factors with wide separations of symptomatic and functional variables . It was Inclusion criteria were patients who planned to or had undergone inguinal hernia repairs at Cathay General Hospital, a tertiary referral institute in Metropolitan Taipei. Both pre-operative and post-operative hernia patients were enrolled. Exclusion criteria were concurrent participation in another human subject study, mental problems with difficulties understanding and completing the questionnaire, and refusal. Demographic characteristics, operation details, and follow-up events were retrieved from chart reviews.The HERQL was validated in a large-scale field study with the target sample size of 350 completed questionnaires. Enrolled subjects were asked to fill out the EQ-5D-5L, a brief and generic quality of life instrument, concurrently for the purpose of criterion validation  . The unconditional linear growth model was used to adjust for clustering of repeated measures on the same individual (Supplementary Methods). Fluctuations of quality of life scores in coherence with distinct clinical scenarios of hernia, such as active treatment (pre-operative), immediately post-operative, and post-operative three-month follow-up, suggested adequate responsiveness of the HERQL.In addition to the original multi-item and single-item subscales, higher-order constructs designed to capture the correlations between latent factors for the HERQL were elaborated with the aid of structural equation modeling (SEM) and more statistic details could be found in the Supplementary Methods .A total of 386 successful HERQL assessments  were performed in 183 inguinal hernia patients, each with 1 to 3 assessments during the study period between Aug 1, 2014 and Sep 30, 2015. Among these patients, 130 had both the pre-operative and post-operative surveys, including 69 with the immediately post-operative surveys (within one week), 56 with the immediately post-operative and post-operative 3-month surveys. The demographic and clinical features of the surveyed population are detailed in ™ Plug and Perfix™ Light Plug ; PROLENE™ Polypropylene Hernia System and ULTRAPRO™ Hernia System ; KUGEL™ Hernia Patch, and Modified KUGEL™ Hernia Patch . For laparoscopic repairs, 3DMAX™ and COMPOSIX™ L/P were used with the Sorbafix™ Absorbable Fixation System  for mesh fixation.During the enrollment period, most hernias were repaired with the open approach, except for 17 laparoscopic totally extraperitoneal (TEP) and 5 laparoscopic transabdominal preperitoneal (TAPP) for 7 unilateral/15 bilateral inguinal hernia repairs. The mesh devices incorporated included PerfixThe revised HERQL questionnaire from the pilot study includes a 4-item summative pain score  measuring pain and/or discomfort resulting from rest, mild, moderate, or heavy activities . The summative pain score was the additive sum of these four items (range: 0~40). Activity restriction due to hernia-induced pain or discomfort was evaluated with another 0–10 point Likert-type scale (Q09). Items categorized into the symptomatic and functional domains measured with 5-point Likert-type scales, included hernia protrusion (Q02), analgesic use for hernia (Q08), hernia’s impact on health (Q11), economic burden (Q12), and subjective quality of life/global health perception (Q13), with higher values indicating more compromised functional status or worse symptom burden. Three questionnaire items were designed with checkboxes displaying multiple selections. They were discomfort in the last week (Q10), conditions most affected by hernia (Q06), and restricted activities due to hernia (Q07).Six auxiliary items were used for the post-operative module (post-operarative patient satisfactory domain), including one with multiple selections for potential complications following hernia repairs (Q16) and five items measuring mesh foreign body sensation (Q15), severity of complications (Q17), overall satisfaction for hernia repair (Q18), confidence that hernia will not recur (Q19), and quality-of-life improvement by hernia repair (Q20). All except Q16 were arranged as 5-point Likert-type scales, with higher values representing more compromised functionality or worse symptoms. The complete HERQL instrument is displayed in the Supporting Information.For the four items measuring the summative pain score , the standardized Cronbach’s alpha coefficient was 0.85, indicating a satisfactory internal consistency reliability. The criterion validity was evidenced from the significant correlations  between the HERQL items assessing pain severity and the pain scores reported by the EQ-5D-5L. The correlation coefficients with the EQ-5D-5L pain score were 0.43, 0.58, 0.6, and 0.52 for Q01, Q03, Q04, and Q05, respectively. Items measuring hernia’s health impact (Q11) and activity restriction (Q09) were positively correlated with the corresponding EQ-5D-5L scores as well (0.42 for Q11 and 0.31 for Q09).Clinical validity was examined by comparing the pre-operative surveys (n = 140) with the follow-up surveys . Significant differences were observed  in Q03  as well as for TAPP, TEP, and modified Lichtenstein groin hernia repairs [™  and Progrip™  mesh in open groin hernia repairs [During the development of the HERQL, extensive literature reviews were performed to identify studies dealing with hernia repair outcomes , 13–15.  repairs –20. In o repairs . The majThe inguinal hernia-specific instrument, COMI-hernia, was designed with a single item each for the domains of pain, function, symptom-specific well-being, general quality of life, and social and work disability pertaining to global treatment outcome, satisfaction, and patient-rated complications . CompletThe internal consistency reliability of the summative pain score and the clinical validity of the HERQL comparing patients under active treatment and those at the post-operative three-month follow-up was ascertained. With 4 items measuring severity of pain under various strenuous activities, and considering that pain is a deterministic element in hernia disease, a single latent pain factor (summative pain score) was constructed to be independent of other symptomatic measures. Other symptomatic domain items were formative and were postulated to have a causal effect upon the latent quality of life factor. All functional domain items were reflective of the underlying latent quality of life factor, and the post-operative module items were reflective of the underlying patient satisfaction factor.Initial efforts to use SEM for quality of life measurement can be traced back to Fayers et al. , who aimThe clinical responsiveness of the HERQL was demonstrated by repeated measures of the summative pain scores across the pre-operative, immediately post-operative, and post-operative three-month surveys. It is understood that quality of life is a function of time, and the fluctuations of subjective quality of life scores corresponding to clinical scenarios supported the conclusion that HERQL was responsive to changes over time with adequate sensitivity. Since enrolled patients were assessed with an unequal number of repeated measurements, we used an unconditional growth (mixed) model to overcome the problem of missing values, to prevent list-wise deletion of all measures from patients with at least one missing value among successive surveys. Within subject correlations (repeated measures of the same participant) were considered as well. Our results showed that progressively less pain was reported when patients underwent hernia repairs and were stable at follow-up, as compared with the initial untreated disease, demonstrating that patients reported less and less pain and discomfort over time following hernia repair .Our previous studies have ascertained the efficacy of tension-free hernia repair, which has a low recurrence rate and provides early ambulation –27. Low There are some limitations of the current study. First, our modest sample size may have resulted in compromised statistical power. Second, we invited all inguinal hernia patients who had visited our clinics during the study period. Although best efforts had been tried, not every pre-operative participant could complete all the successive surveys. Our experience shows that loss of follow-up becomes a major problem for patients who had hernia repaired more than 3 months ago, and further quality of life surveys become illusive. To assess long-term results of hernia surgery, mailed questionnaires or mobile app to enhance the responsiveness may be conducted in future studies. Third, four questionnaire items (including one in the post-operative module) containing multiple-selection checkboxes were actually not addressed in the current study. Multiple-selection checkbox design did provide an efficient way to gather the maximum amount of information with limited questionnaire length. Future studies could take advantage of these assessments regarding recent co-morbidity , conditions most affected by hernia (Q06), restricted activities due to hernia (Q07), and hernia repair complications (Q16).We believe that our study developed a validated quality of life assessment tool to facilitate outcomes research for inguinal hernia and enhance the health care quality of hernia patients. The quantitative data gathered from the HERQL will provide invaluable evidence to reinforce resource allocations, preventive medicine, and even tailored approaches for personalized hernia repairs.S1 Table(DOCX)Click here for additional data file.S2 Table(DOCX)Click here for additional data file.S3 TableFit statistics: -2 restricted log likelihood score (-2RLL), Akaike information criterion (AIC), finite-population corrected Akaike information criterion (AICC), Bayesian information criterion (BIC); smaller is better for AIC, AICC, and BIC.(DOCX)Click here for additional data file.S1 FigQ01: pain at rest, Q02: hernia protrusion, Q03: pain from mild activity, Q04: pain from moderate activity, Q05: pain from heavy activity, Q08: analgesic usage, Q09: activity restriction, Q11: hernia’s impact on health, Q12: economic burden, Q13: quality of life/global health.(TIF)Click here for additional data file.S1 File(DOCX)Click here for additional data file.S2 File(DOCX)Click here for additional data file.S3 File(PDF)Click here for additional data file.S4 File(XLS)Click here for additional data file.S5 File(SAS7BDAT)Click here for additional data file.


In Primary Sjögren’s Syndrome (PSS), there is an apparent lack of data concerning the perspectives of patients, their needs, preferences and difficulties of daily life. This qualitative study was conducted to explore perspectives and needs of patients with PSS that influence health related quality of life (HRQL).We recruited 20 PSS patients fulfilling the American-European consensus classification criteria out of the PSS cohort of the Medical University Graz, Austria. In total, 6 focus group sessions (with three to four patients per group) were performed. A modified meaning condensation procedure was used to analyse the data.The interview analysis resulted in 484 meaning units, 254 subconcepts and 86 concepts. The identified concepts were grouped into three dimensions: physical dimension, psychological & emotional challenges and social life & daily living. A dependency between the three categories was identified.The concepts most commonly reported by patients were related to the physical dimension: pain and dryness as well as complaints associated with/provoked by these symptoms. Patients also reported shortness of breath, fatigue und constipation.This qualitative study underpins that HRQL in PSS patients is affected by several factors. The problems are not limited to dryness, pain and fatigue while the complaints secondary to these symptoms are important to patients with PSS significantly affecting physical, psychological and social life components of HRQL. A disease-specific patient related outcome measures for clinical practice and trials should be developed considering the different aspects of HRQL in PSS. Primary Sjögren’s Syndrome (PSS) is one of the most common systemic autoimmune disorders affecting 0.3–5% of the general population –4. PSS pInflammation of lacrimal and salivary glands results in decreased production of tears and saliva causing dryness of eyes, mouth, gastrointestinal and genital tract as well as skin. A high proportion of patients also experience extraglandular manifestations including fatigue, musculoskeletal, gastrointestinal and/or neurological symptoms . FurtherPrevious studies reported that health related quality of life (HRQL) is impaired in PSS patients compared to the general population ,16. To oImpaired HRQL may be understood as the overall burden caused by the disease and it’s treatment to patients’ daily individual and social life . The mosThe purpose of this study was to explore the perspectives and aspects of HRQL in patients with PSS in a qualitative manner.We conducted a qualitative study, guided by a phenomenological approach with focus group interviews to investigate the aspects of HRQoL important to PSS patients. Focus groups were preferred over individual interviews because we expected that the exploration of views and opinions through group discussion would provide more information and concepts than individual questioning .PSS patients treated at the rheumatology outpatient clinic of the Medical University of Graz were invited by phone to participate in this study. For patient sampling/selection, we followed the “maximum-variation strategy” considering disease duration and age in order to ensure that patients either with new-onset disease as well as with long-standing disease experience were included. Data saAll focus groups were chaired by the same moderator (AL) aided by one assistant (AF) responsible for observing the group, taking field notes and recording the data. The moderator and assistant did not have any pre-existing relationship with the participants, and they were employed as study coordinator and resident physician, respectively at the department of Rheumatology of the Medical University Graz. The moderator was well trained in qualitative research techniques, and she introduced herself at the beginning of the interviews. Interviews were in German language, and they were conducted in a quiet room at the rheumatology outpatient clinic of the Medical University of Graz.For each focus group, a discussion guide was developed with an opening question  and four main open-ended questions based on the three  dimensions of HRQL (21) and a further literature review  finally agreed to participate. The reasons for declining study participation were lack of interest and/or time. Six focus group sessions with three (4 focus groups) or four (2 focus groups) participants each were conducted. Small focus groups of four to six participants were planned  but due Overall, we retrieved 484 meaning units. These were reduced to 254 sub-concepts and subsequently grouped into 86 concepts . The conMost commonly reported concepts were related to the physical dimension : pain, dryness and complaints secondary to dryness such as painfully dry mucosae, recurrent inflammation of the eyes and ears, sleeping disturbances and the inability to eat and chew. Patients also frequently reported joint pain, shortness of breath, fatigue und constipation.Complaints related to dryness were not limited to the physical dimension. Patients reported for example, that dryness of the oral mucosa resulted in a burning sensation in the mouth, loss of senses of smell and taste, loss of weight, inability to eat and chew food as well as speaking difficulties. These complaints subsequently led to psychological & emotional challenges because of a perceived lack of understanding by relatives as well as difficulties at work, limitation of nutrition and impaired social life. Furthermore, patients’ perceived dryness of eyes caused photophobia, inflammation of the eyes, inability to cry, gritty eye sensation, impaired sight, impossibility to drive a car or work on the computer and financial burden due to expensive eye drops.The three categories and examples for their influence are discussed below, including supporting quotes .The physical dimension revealed the most concepts (n = 38). Among them, five major subcategories were identified: pain, dryness, drug-side effects, dryness-related complications and additional complaints.Patients reported pain of joints, wandering muscle pain and pain due to dryness, as expressed by the following statements:G4, I4: ‘Every week I have pain somewhere else. I mean, the whole spine, feet, the knee. Sometimes I think I’m going crazy. Every week it hurts somewhere else. And I don’t know why.’G4, I3: ‘Yes, when it doesn’t hurt in the morning, I’m thinking that I’m not alive.’G4, I2: ‘Every week it hurts somewhere else and you think that can’t be real. The limbs, everything hurts.’As stated above, dryness caused several secondary complaints. One female patient expressed problems with eating as follows :‘The whole time I have a bottle of water with me. But, I can’t eat some dry food. You can’t swallow it. You have the feeling that you are suffocating.’The dryness of mouth also caused sleeping disturbances :‘Sleeping was just possible, when I was sitting in bed. As soon as I turned around, I had a feeling of suffocation. So I was sleeping in a sitting position for one and a half year.’The most commonly reported drug side-effect was excessive sweating after intake of pilocarpine, which was the main reason why patients stopped taking this drug.As an example of additional physical complaints, patients experienced sensitiveness to coldness, loss of muscle power, constipation, fatigue and prostration.Many patients reported about their experiences in the initial phase of the disease, when the diagnosis was not yet established. For most patients, it took several years before they were finally referred to a rheumatologist. They reported that (mainly family) physicians frequently suspected them as having a mental/psychiatric disorder or simply ignored their complaints.One patient described her experience :‘I had problems with my stomach and digestion, felt pain in my joints. The physician did not find a reason for that. After a while, I also had dry eyes with burning and pain. I went to my general practitioner but he did not take me seriously. Then I recognised that my mouth became dry. I was afraid to go to a doctor because they looked at me, as being crazy myself. They wanted to send me to a psychologist. Then, after 5 years of symptoms and unsatisfying visits at different doctors, one doctor was on the right way and I finally got the diagnosis of Sjögren’s’s. I really felt relieved.’One patient reported how the inability to cry emotionally challenged her :‘I’m starting to cry tears, which I don’t have. In former times, when I had problems, I was able to cry and the problems were easier to handle. Now, I want to cry, because I have this disease and pain but I don’t have tears, and the feeling of crying is going by. I just want to cry.’The feeling of being an encumbrance for family, excessive demand due to complaints and worries about the future were important aspects in this dimension. Most patients recognised that their complaints worsened when they suffered additional stress with family and/or job.PSS patients felt a dependency on relatives in daily life, e.g. most patients were not able to drive a car because of dry eyes or they could not handle the household without help because of pain. Dryness caused difficulties at work particularly in case of a computer work and patients felt that long conversations with customers were challenging. They worked despite feeling sick and were afraid of losing their job.Fatigue was a common reason for impairment of social life as expressed by the following statements: ‘Yes I can say that I’m often really tired, when friends are calling me; they want to go out after work. But I don’t have enough energy. I don’t want. Then I’m done. Honestly, I’m just happy when I can lay down. I do not have any energy anymore.’ ‘My husband has adjusted to this situation. But when you are never able to do anything together and you are not fit enough (…) You have to take care. You have to take care because otherwise you will be alone. And the others are living their lives. It is like that. And in the family (…) that hurts.’ ‘ (…) But now everything is so painful. I can’t go out in the evening. I miss that. I mean, my life is really impaired. Really impaired. And the others can’t understand that. They go riding a bike and you can’t go with them. Yes, then you are alone.’The most frequently mentioned concepts related to therapy within this dimension included the relevance, efficacy and costs of complementary medicine, conventional drugs, physical therapy and aids for symptoms of dryness. It was particularly emphasized by patients that these therapies caused a significant financial burden.To our knowledge, this project with focus-group interviews is the first qualitative study to explore the experiences and perspectives concerning HRQL in patients with PSS.Pain, dryness and the consequences of dryness  were the concepts most commonly raised by patients . AlthougMost of the identified concepts belonged to the physical dimension—that was also found in other rheumatic conditions , Systemic Lupus Erythematodes (SLE) and Hand Osteoarthritis) . HRQL ofThe concept of “inability to cry” was previously reported by another study suggesting that PSS patients, due to the loss of tears, may use other ways of expressing emotions .Another important emotional burden for PSS patients was the long lag from symptom to diagnosis as well as the experience of not being taken seriously by family practitioners and other physicians in the pre-diagnostic phase . Even ifThe reliable assessment of patients’ outcomes and particularly HRQL in clinical practice as well as treatment studies is an unmet need in PSS. A few patient-derived outcome measures have been developed for the assessment of dryness, fatigue and pain in PSS ,37; howeAn important limitation of our study is that the sample included only patients from one region in Austria, although patients were from different age groups and professional backgrounds. We only included female patients because none of our (few) male patients wanted to participate in this study . A limitIn summary, pain, dryness and complaints secondary to these symptoms are important to patients with PSS significantly affecting physical, psychological and social life components of HRQL. A tool for the systematic assessments of HRQL in PSS patients is needed for clinical practice and trials, and the results of this study might be used for the development of such a tool.