This study aimed to evaluate the analgesic efficacy of systemic acupuncturetherapy on the pain caused after orthodontic adjustments.An initial sample of 30 orthodontic patients with fixed appliances monthlyadjusted was selected; however, only 11 participants completed the study. For thisreason, final sample comprised these patients' data only. Initially, average painlevels were assessed at different periods by means of an analogue visual scale(VAS) for three months without acupuncture. In the following three months, thevolunteers were submitted to systemic acupuncture sessions on Hegu (LI4) andJiache (St6) points,before orthodontic adjustments were carried out.Results revealed statistically significant reduction in pain level indexes bothfor men (P = 0.030) and women (P = 0.028) when acupuncture therapy was performedprior to orthodontic adjustment. Patients did not present any side effects.Acupuncture is a safe and effective method in reducing orthodontic post-adjustmentpain. Pain is considered a very subjective symptom, for this reason, it is bestdefined as: "An uncomfortable sensory and emotional experience associated with real orpotential injuries or described in terms of such injuries".4The literature shows that all orthodontic procedures, such as separator placement, fixedorthodontic appliances installation and activation, and orthopedic force application,cause pain. Additionally, fixed appliances tend to cause more pain than removable orfunctional ones, and the correlation between applied forces and pain is small.There are two major forms of distress caused by fixed orthodontic appliances: traumaticulcers and pain during orthodontic movement.In case of traumatic ulcers, orthodontic appliance functions as a traumatic factor thatlesions the mucosa and causes epithelial tissue loss, thereby exposing subjacentconjunctive tissue and causing pain by local nociceptors stimulation.5 Bergius et al3 analyzed 203 orthodontic patients, and demonstrated that 91% ofthem reported pain caused by orthodontic appliance, whereas 39% reported pain in everyorthodontic appointment while adjustment was carried out. Studies show that nearly 95%of patients under orthodontic treatment present different levels ofdiscomfort,7 especially within the first 24 hours after orthodonticadjustment. Pain caused by fixed orthodontic treatment gradually increases 4 hours afterappliance adjustment, returning to normality on the seventh day.10As for orthodontic movement, there are no doubts that pain perception is part of theinflammatory reaction caused by blood flow alterations after orthodontic forces areapplied. As a result, many chemical mediators are released as follows: Substance P,histamine, encephalin, dopamine, serotonin, glycine, glutamate, gamma-aminobutyric acid(GABA), prostaglandin, leucotriene, cytokine; thereby causing localhyperalgesia.4 conducted a literaturereview and found that nearly all orthodontic patients report moderate to extremedifficulty in chewing and swallowing solid food because of pain, proving thatorthodontic pain can also interfere in patient's diet, thus raising another majorconcern for patients and professionals.Studies reveal that the first 48 hours of pain after orthodontic adjustment cause asmuch disturbance as to interfere in patient's sleep and induce the need for medication.Krishnan11 reported thatnearly 50% of their patients suffered pain within 6 hours to two days after orthodonticadjustment, which interfered in their daily activities. The authors also reported areduction in pain intensity and the number of patients with pain from the third dayon.Erdinç and Dinçer5Considering the high rate of patients complaining about pain suffered during orthodontictreatment, different methods have been tested for its control, namely: low-level laser(LEDs) application, transcutaneous electrical nerve stimulation (TENS), neuralstimulation, vibration to stimulate periodontal ligament, among others resulting in paincontrol.In addition to conventional techniques, researchers have sought new procedures for paincontrol. As a result, Dentistry is trying alternative methods to aid professionals bringmore comfort to their patients. Nevertheless, new methods do not include the developmentof new ultra-modern equipments and/or last generation drugs, only. Researches show thatancient techniques are scientifically efficient in pain control, and acupuncture isamong the most effective ones.The present study assessed the analgesic efficacy of systemic acupuncture therapy onpain caused after orthodontic adjustments. The tested hypotheses were whetheracupuncture was efficient or not in reducing pain caused by orthodontic adjustment.This research was approved by the Ethics Committee on Human Research under protocol00080375000-08. All volunteers filled an informed consent form.This research was conducted as a blind study. The researcher responsible for acupuncturewas aware of the treatment modality each patient would be submitted to. However, resultswere analyzed by a statistician unaware of the treatment to which each volunteer wassubjected to.3Patients under fixed orthodontic treatment at the Graduate Program Orthodontic Clinicparticipated in this research. First, research volunteers were selected. To be includedin the group, the patient had to be complaining of pain after orthodontic adjustment andaccept acupuncture treatment. Thirty patients volunteered, although, only 11 (7 womenand 4 man) concluded the study. Patients' mean age was of 16.2 years . The vol3VAS allowed pain to be quantified during different periods . Eachparticipant received 7 scales every month in accordance with previously describedperiods. In the following appointments, the scales were filled and collected foranalysis which measured each scale with a millimetric ruler so as to obtain numericaldata.12 Dragon® Sterile stainlesssteel needles (0.20 x 25 mm) were used.Within the first 3 months, the volunteers were instructed to fill out VAS afterorthodontic adjustment so as to obtain an average of participant's pain withoutacupuncture treatment. In the following 3 months, antisepsis of the areas of needleinsertion was done with cotton and 70% alcohol 5 minutes prior to each orthodonticadjustment. Subsequently, systemic needles were inserted at Hegu (LI4) and Jiache (St6)points on both sides. The needles remained in place for twenty minutes.New VASs were filled out during the same periods previously described. Results were usedto calculate the average pain described by each patient during the three orthodonticadjustment appointments after acupuncture therapy. Therefore, volunteers performedself-analyses.Patients were instructed not to take any other analgesic medication while the effect ofacupuncture therapy was being analyzed. Should pain be too intense so as to requireanalgesic medication, the instruction was to record the date, time, type and doses ofmedication.Analysis of results of the 11 volunteers was carried out with Sigma-Stat statisticprogram. Data was first submitted to analysis of variance (ANOVA) (P ≤ 0.05). ShouldANOVA yield significant values, Tukey test was used to identify significant differencesbetween the average pain level obtained through VAS.Since significant statistic differences were found in pain perception between male andfemale patients, results were separately assessed according to that variable.Results reveal a gradual increase in volunteers' pain level right after orthodonticadjustments and within the first 24 hours with gradual reduction during the followingperiods. Analysis of variance (ANOVA) followed by Tukey test at a 5% significance level wasconducted between male and female patients and showed a statistically significantdifference in pain level after orthodontic activation with or without previousacupuncture therapy. Results are shown in Averages obtained with or without acupuncture treatment at different studied periodssubmitted to analysis of variance (ANOVA) at 5% significance level between male andfemale patients showed that although there was a reduction in pain level during allperiods when acupuncture was performed before orthodontic adjustments, it was onlystatistically significant during the pre-orthodontic adjustment period. Results areshown in Analysis of variance (ANOVA) was performed at 5% significance level among maleparticipants during different periods with and without acupuncture and revealed astatistically significant difference in pain level 8 hours after orthodonticadjustment, only. Nevertheless, there was a visual reduction in the levels of painperception recorded during all periods. Results are shown in 4Even if analgesic and anesthetic medications are used, dental therapy, includingorthodontic treatment, is acknowledged by most people to cause pain or even a lightdistress. The literature shows that all orthodontic procedures, such as separatorplacement, bracket installation and activation, and the application and activation oforthopedic forces, cause pain. Additionally, fixed appliances cause more pain thanremovable or functional ones and the correlation among applied forces and pain felt bypatients is small. all of which may pose difficulties inmeasuring the symptom. Except for patient's age and sex, which can easily be assessed,all other factors are quite personal and can be considered as limitations of the presentstudy, since they were not considered as variants that influence pain levels and couldinterfere in the results.3Participants' motivation and expectations towards the acupuncture analgesic effect alsoseem not to influence the results. Since the average values were monthly collected,participants had no access to former analyses and could hardly compare the records in away that allowed them to forge final results. This could be considered a limitation ofthis study. Ideally, Sham acupuncture should have also been used; however, once a great number of participants quit, it wasimpossible to divide the group due to the limited number of volunteers comprising thesample. Further studies will be able to correct this fact.Among the facts that influence pain level are: former experiences, emotional state,cultural background, age and sex,5 In addition toconventional techniques to control pain, Dentistry has introduced alternative methods toaid professionals bring more comfort to their patients. Those alternative techniqueshave been acknowledged and approved by the Federal Council of Dentistry , and can be applied to reduce pain in dental patients. Acupuncture is one ofthe most effective techniques.Considering the high rate of patients complaining about pain suffered during orthodontictreatment, different methods have been tested for its control, namely: Low-power laser(LEDs) application, transcutaneous electrical nerve stimulation (TENS), neuralstimulation, vibration to stimulate periodontal ligament, among others resulting in paincontrol.The aim of the present study was to assess the analgesic efficiency of systemicacupuncture performed before orthodontic adjustment to treat orthodontic post-adjustmentpain. The research started with 30 patients gathered from an Orthodontic GraduateProgram, but only 11 participants concluded it. Some degree of desistance is expectedduring human research. No volunteers declined to participate in this study due to itsmethodology. A great number of absences during orthodontic adjustment appointments wereobserved, thereby eliminating some participants. In some cases, the orthodontistresponsible for the orthodontic adjustment was absent, which also hindered patient'sparticiation on the research. All volunteers had their pain level analyzed by VisualAnalogical Scales (VAS).13 Patients were asked to register theintensity of pain they felt on the line representing the estimate variable.13 A numerical value was assigned by theresearcher using a millimetric ruler. Consequently, precise values were notpossible.14 No volunteers haddifficulties in filling out the scales, reinforcing their easiness.VAS was chosen due to being greatly used to measure pain and having some advantagesamong verbal scales, such as the facility children have in filling it out.3 assert that pain causedby orthodontic adjustment can be immediate or delayed. Immediate pain occurs after thearchwire is attached and periodontal ligament is compressed. The latter starts a fewhours later when hyperalgesia of periodontal ligament generates allodynia through therelease of chemical active substances ,thereby causing partial depolarization of afferent fibers, neural facilitation andperipheral sensitization. When an orthodontic force is applied to a tooth, an initialdistress and/or pain phase of 1 or two days usually occur.10 The intensity of pain generally increases within 4 to 24hours and then reduces to normal levels within a 7-day period.3 There is generally a circadian variation in painintensity, with an increase of pain between late afternoon and night, although that doesnot intensely interfere in sleep.8 Ourresults confirm the fact that pain begins after orthodontic adjustment, its apex occurswithin 8 to 24 hours and gradually reduces over time, even with previous acupuncturetreatment. However, the present work shows that intense decrease occurs when acupuncturetreatment is previously performed.Bergius et al7 also showed that generalpain intensity perception, analgesic taking, pain during feeding and distress influenceon daily life were significantly greater in women than men. Women are more sensitive toexperimental painful stimuli than men, with clinical pain of greater frequency andseverity lasting for a longer period of time and in a larger range of bodylocations.16 In the present study, we also observed greater femininepain sensitiveness, with or without previous acupuncture treatment. This fact could berelated to women's great hormonal variability, mainly in female teenagers voluntaries.For both males and females, acupuncture treatment significantly reduced pain afterorthodontic adjustments, thus proving its efficiency.Scheurer3Even when results showed a reduction in pain levels after acupuncture treatment duringall studied periods (both for men and women), it was only statistically significantduring two periods. Before orthodontic adjustment in female patients, which is justifiedby their hormonal alterations - a limitation for the study since their menstrual periodwas not assessed. For men, within 8 hours after adjustment, corresponding, according tothe literature, to the time of pain apex.17Pain reduction observed in the present study probably occurred due to acupuncture actionmechanism, activating descending pain inhibition and antinociceptive substances release,such as β-endorphin , cortisol (anti-inflammatory) and serotonin(antidepressant) in the blood flow and cephalorachidian liquid.4 Also, Erdinç and Dinçer11 reported that nearly 50% of theirpatients suffered from pain that interfered on their daily activities within 6 hours totwo days after orthodontic adjustments, which could be diminished by stimulation ofanalgesic points through acupuncture, as shown in the present study.Data obtained in the present study confirm the efficiency of acupuncture as acomplementary treatment in Orthodontics. It is important since nearly all orthodonticpatients, as described in many studies, report moderate to extreme difficulty in chewingand swallowing solid food because of pain, proving that orthodontic pain can alsointerfere on patient's diet, a major concern for patients and professionals.The literature highlights many analgesic acupoints. Microsystems of acupuncture such asear acupuncture, hand acupuncture and scalp acupuncture points are another treatmentoption, instead of systemic acupuncture. Hegu (LI4) and Jiache (St6) points were usedfor its location and professional easy access.Acknowledgment and approval of acupuncture practice as a complement to dental treatment,issued by the Federal Council of Dentistry in July 2008, will certainly bring progressin this matter, since national researches using acupuncture for dental treatment are fewand, for this reason, narrow the benefits of the method for both patients andprofessionals. Acupuncture does not produce side effects and can be safely practiced bya qualified professional. In this study, a total of 33 acupuncture sessions were done (3on each one of the 11 volunteers), and no patients presented side effects related toneedle insertion.The fact that it is not an onerous technique is important and must also be observed,particularly considering the present social-economic situation in Brazil.Within the limitations and conditions of this experiment, it is reasonable to concludethat systemic acupuncture treatment performed before orthodontic therapy can reduce painlevel in both men and women. Additionally, acupuncture proves to be a safe techniqueemployed for this purpose.


Minilaparoscopy is considered one of the minimally invasive options available for acute appendicitis treatment, although not always employed in less complexity public health services.  Report surgical outcomes of minilaparoscopy use in acute appendicitis treatment. The study included 21 patients undergoing minilaparoscopic appendectomy with instrumental of 3 mm. The following variables were analyzed: sex, age, body mass index, stage of appendicitis, surgical time, hospital stay, surgical complications, conversion rate to conventional laparoscopy or laparotomy, pain after surgery and aesthetic result. 2. The operative time ranged from 33 to 160 min and the average of hospital stay was three days. Among the 21 patients, 20 reported mild pain or no pain in the first postoperative day. The aesthetic result was considered "satisfactory" and "very satisfactory" by 95% of the patients. Twelve men and nine women underwent minilaparoscopic appendectomy. The average age was 27,8 years, the mean BMI was 24,8 kg/m The minilaparoscopy is viable technique for treating acute appendicitis with a satisfactory recovery. It combines the benefits of minimally invasive procedures with results similar to conventional techniques. In an attempt to make less and less invasive procedures resulting in shorter recovery time, shorter hospital stay and fewer complications, new techniques derived from conventional laparoscopy gained notoriety in the last two decades,In turn, in recent years it returned to gain ground in the search for procedures that could have smaller portal diameters, with less complexity and cost, when compared to other techniques considered minimally invasive as NOTES and single portNot always the minilaparoscopy has been employed in medium complexity hospitals, mainly in the Brazilian Unified Health System . The normal assistance consists in performing open appendectomy for most cases and in fewer cases conventional laparoscopy. In an attempt to improve the aesthetic result, decrease surgical hospital stay and promoting less pain in the postoperative period, minilaparoscopy as a technique for the treatment of acute appendicitis began the be used.The objective of this study was to report the results of the use of minilaparoscopic technique for the treatment of acute appendicitis.The study was approved by the Ethics Committee of the institution.Twenty-one patients diagnosed with acute appendicitis were operated from February 2013 to May 2015 at the Surgery Service of the Santa Casa de Misericórdia de Lins, Lins, SP, Brazil. The following variables were analyzed: gender, age, body mass index (BMI), stage of appendicitis, surgical time, hospital stay, surgical complications, conversion rate to conventional laparoscopy or laparotomy, pain in the postoperative period and aesthetic result. The phase or degree of appendicitis was stratified according to the laparoscopic classificationPain was recorded on the first day after surgery and used the visual analog pain scale classificating: no pain, mild pain, moderate pain and severe pain.In outpatient care, usually on the 7th and 30th days after surgery, the patients were asked about their satisfaction with the cosmetic outcome of the procedure, and asked if they were "very satisfied," "satisfied," "somewhat satisfied" or " dissatisfied".The surgical technique was minilaparoscopy with three access ports, one 10 mm and two 3 mm in all patients. Under general anesthesia, pneumoperitoneum was performed by open puncture under direct vision through the umbilicus, 10 mm incision, through which it was introduced optical 30⁰ device. After examination of the cavity and confirmation of the disease, the other two punctures were performed, both 3 mm, one at the midclavicular line in the left iliac fossa, and the other in the hypogastric midline at pubic hair .The appendix was identified and mobilized to make possible to dissect its mesentery in appendicular base, creating small transfixing orifice in mesoappendix . ThroughIn some cases, with appendix in retrocecal position, the right colon was mobilized by careful right parietocolic dissection in sufficient length to completely expose the appendix similar to the dissection for right colectomy. After ligation of the appendicular base, was proceeded dissection and cauterization of mesoappendix vessels with monopolar electrode in its terminal branches, near the appendix. When some large-caliber vessels were present, where electrocoagulation was not apropriated, dissection and ligation with cotton thread 2-0 were performed.After completion of the mesoappendix dissection, the base incision with scissor 3 mm was conducted, cauterizing its stump which has not buried or invaginated.The appendix was placed in a sterile plastic bag (adapted from sterile glove finger). Then, cleaning and irrigation of the cavity with 0.9% saline solution were done when needed, and appendix was removed from the cavity through the umbilical 10 mm incision. At the end of the procedure, intradermal suturing was done only in 10 mm incision.2, with an average value of 24.8 kg/m2. The shorter surgical time was 33 min and 160 min for the longer procedure, average 64.1 min. Regarding the hospitalization period, average was three days  were men and nine (42.9%) women with a mean age of 27.8 years. Also BMI was analyzed, ranging from 18-35 kg/mays 2-7, .As for disease staging, there was grade 2 prevalence (42.8%) and only one patient with grade 5. Pain was assessed on the first day after surgery and patients responded according to the visual analog scale pain - EVA: 11 "no pain"; 9 "slight pain", one "moderate pain" and no "intense pain". As for the aesthetic result in outpatient 95% said they were "very satisfied" or "satisfied" and there was just one "somewhat satisfied" with the patient's aesthetic appearance, due to conversion to laparotomy .Only in this case there was need for conversion to laparotomy due to retrocecal appendicitis (with 10 days of evolution), which caused necrosis of the posterior wall of the cecum and ascending colon and diffuse peritonitis, being chosen right paramedian laparotomy and partial colectomy. Of the patients, the only complication after surgery  occurred in the same case needing laparotomic conversion.,,Because the diameter variations of the materials used, there is still controversy about the concept of minilaparoscopy. Accordingly Avila et al.Similarly, with this technique, was dispensed the use of metal clips, clamps and laparoscopic staplers. Moreover minilaparoscopy material, that is reusable and has long durability, was used only low cost cotton threads for ligations.It may be questioned a possible increase in surgical time due to the need of making endosutures. Sato et al.2 underwent cholecystectomy, three by minilaparoscopic technique and a significant increase in operative time and pain were related in these patients. Mostafa et al.2, and there was no significant increase in surgical time, need for conversion, damage to material or reported complications, which can be explained, perhaps, by improving material quality using a 10 mm optics and simplified technique.Another point to be considered to perform the technique is in BMI. Noack et al.,,,As for the aesthetic result, minilaparoscopic proved to be promising. There is scientific evidence on the satisfactory cosmetic result, which is considered one of technique attractive,When using material with reduced diameter providing low friction and gripper devices, they have promoted more precise and delicate movements generating less trauma to the abdominal wall, and thus favoring the healing process. Another result that can be attributed to these factors, is less pain postoperatively due to less handling and peritoneal trauma,,Despite the difficulty of acceptance of laparoscopic techniques, especially in smaller centers, defenders refer as attractive the small size of the incisions, less surgical trauma, important aesthetic gain and possible reduction of complications related to abdominal wallThe minilaparoscopy is safe and effective option for the treatment of acute appendicitis in its various stages and in different age groups, with complication rates and conversion similar to conventional laparoscopic technique, aesthetically satisfying and less postoperative pain.


Primary care physicians struggle to treat chronic noncancer pain while limiting opioid misuse, abuse, and diversion. The objective of this study was to understand how primary care physicians perceive their decisions to prescribe opioids in the context of chronic noncancer pain management. This question is important because interventions, such as decision support tools, must be designed based on a detailed understanding of how clinicians use information to make care decisions.We conducted in-depth qualitative interviews with family medicine and general internal medicine physicians until reaching saturation in emergent themes. We used a funneling approach to ask a series of questions about physicians’ general decision making challenges and use of information when considering chronic opioids. We then used an iterative, open-coding approach to identify and characterize themes in the data.We interviewed fifteen physicians with diverse clinical experiences, demographics, and practice affiliations. Physicians said that general decision making challenges in providing pain management included weighing risks and benefits of opioid therapies and time and resource constraints. Also, some physicians described their active avoidance of chronic pain treatment due to concerns about opioid risks. In their decision making, physicians described the importance of objective and consistent information, the importance of identifying “red flags” related to risks of opioids, the importance of information about physical function as an outcome, and the importance of information that engenders trust in patients.This study identified and described primary care physicians’ struggles to deliver high quality care as they seek and make decisions based on an array of incomplete, conflicting, and often untrusted patient information. Decision support systems, education, and other interventions that address these challenges may alleviate primary care physicians’ struggles and improve outcomes for patients with chronic pain and other challenging conditions. Chronic pain imposes a major clinical, social and economic burden, affecting an estimated 100 million Americans and costing $600 billion annually in health care and lost worker productivity . BecausePrior research has examined physicians’ challenges during encounters involving opioids ,4,8, patThe objective of this study was to understand how primary care physicians perceive their decisions to prescribe opioids in the context of chronic noncancer pain management. As described above, this is important because systems interventions, such as decision support tools, must be designed based on an understanding of how clinicians perceive and make decisions in the context of their daily practice. To answer this question, we conducted in-depth qualitative interviews with primary care physicians with varying experience and training in pain care. Interview techniques are commonly used in medical decision making research (cite) and are particularly appropriate for this study because it aims to inform new decision support tools that physicians will be likely to adopt and regularly use in their clinical practice.We conducted in-depth qualitative interviews in the spring of 2013 with family medicine and general internal medicine physicians practicing in the Gainesville and Jacksonville areas of north-central Florida. Participation was voluntary, and all participating physicians gave written informed consent to participate. The interviews were recorded and then transcribed. Identifying information was removed from the transcripts to preserve physicians’ confidentiality. The study was approved by the University of Florida Institutional Review Board.To obtain a diverse set of perspectives and fully understand physician decision making, we purposefully recruited from nine practices that spanned rural and urban settings and that had different racial, ethnic, and socioeconomic patient mixes. Furthermore, the practices varied in organizational structure, including private practices, United States Veteran’s Health Administration practices, academic practices located on a university campus, and academic-affiliated practices that function as independent community practices. We used emails and phone calls to invite individuals to participate. To further achieve sample diversity, we recruited physicians who varied in terms of age, gender, and experience or training in pain care.We developed a series of semi-structured interview questions that followed a funneling approach, beginning with broad questions, such as “tell me about your patients,” and then moving to increasingly specific questions, such as “tell me about how you manage patients with chronic non-cancer pain” and “tell me about the decision process you go through when you consider whether to prescribe opioids.” Each question was followed by probing questions to further clarify physicians’ use of information and use of other resources and decision strategies. We also included probing questions that asked about common challenges and information needs. To help understand how physicians’ perceived decisions align with guideline recommendations, a number of the most specific questions asked if and how physicians use strategies that are recommended by clinical practice guidelines for chronic opioid therapy, such as risk assessment and medication tapering or discontinuation .The lead author [CAH] conducted each interview one-on-one. The lead author is a non-clinician health services and health informatics researcher. He had no prior relationship with any of the participants. Each interview lasted 30-45 minutes. Interviews were conducted over approximately two months, with up to four interviews being conducted in one day. After the first two interviews, we consulted with a qualitative research methodology committee that had not been involved in developing the research objectives. The group included a mix of clinicians and non-clinicians who reviewed the interview process to ensure the quality of the questions and consistency of the process. To increase internal validity of the study, at the end of each interview day, the interviewer wrote memos to describe the interview context, document emerging themes, and to review the interview process. By writing memos, we were able to identify and protect against potential biases in and preserve consistency of the interviews. Finally, we continued recruitment and interviews until we reached saturation. Saturation was judged by the authors with feedback from the external qualitative research methodology committee [We chose an open-coding analytic approach to maximally capture physician attitudes and behaviors. Two authors [CAH and HQH] independently coded the data to identify emerging themes on an ongoing basis during the data collection. The analysts used Nvivo 9 software  to store, organize, and iteratively refine emergent themes in the data . After cOur final sample included physicians from one private, one U.S. Veteran’s Health Administration (VA), and seven academic-affiliated practices Table . The samPhysicians discussed the types of information that are important to them during clinical encounters for chronic noncancer pain and how that information affects their prescribing decisions.I also look to see if he’s got legitimate reasons for pain, ‘cause sometimes patients’ pain is way out of proportion to objective findings, like radiographic findings” (Physician 2). Along the same lines, physicians reported skepticism about the value of patient self-reported pain . Physicians expressed concern about the inconsistency of self-reported pain, observed pain behaviors, and exam findings. For example: “Somebody will say, ‘Oh, I have ten out of [ten] pain”, but they’re sitting there, comfortably. They’re walking around, totally fine, and you’re like, ‘This is not what I would consider ten out of ten pain”, (Physician 15). Similarly, another physician expressed frustration about the legitimacy of pain presentations that are inconsistent with physical exam:A lot of people come in with this chronic back pain that—it should present one way but they’re in pain all over the place. Their pain is just completely ridiculous, out of proportion to exam. You just barely touch them. ‘Ahhh!’ Jumping off the table—you know it’s like, all right, it’s probably not real (Physician 3).Physicians frequently described their desire for objective and consistent information about patients’ pain, such as imaging that shows musculoskeletal pathology. One physician said: “As a consequence of their challenges to assess pain, physicians frequently described concern about the appropriateness of prescribing opioids.I do get nervous if their pain is way out of proportion to objective findings. We do get outside records. If they saying that they have very mild degenerate disc, but there’s 10 out of 10 [pain score] and wanting opiates, that gives me red flags too. Those are the hardest ones for us because they’re subjectively in so much pain but objectively they’re not (Physician 2).Numerous physicians mentioned the importance of identifying “red flags” that might indicate a patient is medication seeking, at risk of addiction, or otherwise not a good candidate for opioids. Red flags emerge from different information, including inconsistencies between subjective and objective assessments:Generally not, scale of one to ten, I do not. That’s a red flag. Get a new patient and they walk in and, ‘Doc, my back really hurts, and it’s a nine or ten out of ten.’ [Laughter] Where did they learn that? (Physician 11).Other potential red flag information that physicians seek and can trigger concerns about opioid appropriateness included new patients, patients traveling from another county, patients who are unwilling to try non-opioid therapies, patients who request opioid dose increases, psychiatric history, drug or alcohol abuse history, suspect prescription refill history, and unsolicited patient reporting of pain scores. For example, when asked if he assesses patients using standardized pain scales, one physician said:I have this little speech I do with everyone that says, ‘The goal of this medicine is not to get rid of all your pain because if you’re looking for that, I can’t do that for you. But I can, hopefully, make you more functional.’ That’s the approach I use (Physician 8).Multiple physicians described the importance of patients’ physical function as the most important outcome. At times, physicians described their value of physical function in the same context as their devaluing of pain scores as subjective and less important outcomes. One physician explained it succinctly:Their function might be tailored to, and it probably should be directed at trying to what would motivate them to get going. Be it maybe playing with their grandkids, or walking with their wife, or, so I think the functional thing should be something. This never happened, but it should be discussed at that visit before the opioids are started. What are we trying to accomplish here? (Physician 10)Another physician went further and described the important of individualized approaches to identifying and assessing patients’ functional goals:Similarly, other physicians described how setting goals and expectations that are important to the patient can help them confidently prescribe opioids as well as taper or discontinue them if patients’ explicit goals, such as weight loss or function, are not met.I’ve known some of my patients for over 20 years. Whether it’s right or wrong, I guess I have a sense of whether they’re someone that I feel could or would appropriately use these medications” (Physician 8). These reports suggested that some physicians go beyond explicit, objective assessments and use more intuitive judgments and decisions about appropriateness of opioids. Multiple physicians’ described how their impressions of patients’ trustworthiness, based on their accumulated experience over time, increased their willingness to prescribe opioids. In contrast, some physicians described their relative unwillingness to prescribe opioids to patients for whom they did not have a long-standing relationship. One physician explained how he trades off his need for specific information to “check” on patients’ opioid-related risks based on his accumulated trust:So for people that I don’t trust, I use that outside information to evaluate whether or not this should be continued in an ongoing relationship or not. The more I trust them, based on how much I know them, the less likely I am to sort of do drug tests on them or do kind of checks on them in some way (Physician 6).Some physicians went beyond clinical findings and outcome measures when discussing the information they use. They described their reliance on harder-to-measure information, such as their history with and “sense” of their patients’ need for opioids. One physician explained “With me, because I know so many details about them and I know their kids and know what’s going on in their life. I know their day-to-day affairs, I’m not worried like they [other clinicians] are when they go into the hospital and they only see the medication list. I had a patient where that was the case here recently. So I kind of documented some of my trust and my history with that patient on the chart when they went into the hospital …. (Physician 6)The same physician described how for some of his most trusted patients who are taking chronic opioids, he formally documents his trust in their medical record, so that they won’t be judged negatively by other clinicians:Physicians described a number of other serious decision making challenges associated with prescribing opioids in the context of chronic noncancer pain.You have the patients who definitely need the medications. You have the patients who definitely don’t need the medications. Then you have the really tough management cases of the ones in between that are difficult to assess whether or not they truly do need the medication (Physician 12).Physicians reported struggles in weighing potential therapeutic benefits of opioids versus risks, such as the risks that patients are being dishonest about their pain and/or are at risk of abusing, misusing, or diverting opioids. Some physicians described risks of side effects and adverse events, but physicians more often emphasized risk of misuse, abuse, and diversion. One physician categorized his patients, saying:I would say the vast majority of people I think I get a good feel for it. But I’ve been snagged so many times [laughs]. I could have sworn this person was being straight with me [in reporting their pain]. … I would imagine you’re not 100 percent right all the time. … So sometimes you’re probably erring in … not giving somebody pain medications when they truly do need it. And you’re gonna err sometimes in giving patients medications when they don’t need it. (Physician 12)The same physician admitted that despite his confidence, he knows he has misjudged patients’:I did a couple of urine screens and things like that. I was a little uncomfortable, but she was a patient for a long time. It seemed to keep her out of the emergency room. If I didn’t give her pain medicine, she’d end up in the emergency room. Anyway, just recently I found out that she came into the hospital and she was positive for cocaine a couple of times. I was like, oh. You know, sometimes I don’t know how to manage them effectively …. (Physician 1)Another physician described a patient who received opioids and was using cocaine:I mean she's been my patient a really long time. We've kind of been through a lot of things together (Physician 1).In addition to wanting to keep the patient out of the emergency room, this physician suggested she prescribed opioids because of her long-term relationship and desire to trust the patient, saying: “There’s this sense of, you feel like you’ve been taken advantage of, and you were out there trying to help them, and instead, they’re abusing the medication. In a way, you’re either harming them or harming someone else out in the community, and so, there is that feeling of, you don’t wanna be one of those docs. … It’s kind of like, you get bit several times, and then, you’re like, ‘I’m just not gonna give pain meds to anybody.’ (Physician 15)In contrast, another physician said her struggles to judge opioid risks have led her to avoid prescribing opioids altogether:The university has increased the number of patients you are required to see ever since I’ve been here. … It’s racing from one patient to another, and sitting down and doing formal assessments is hard to work in. … but formal assessment scales and these lengthy conversations that you would think family practitioners would sit down and spend all this time, this practice isn’t set up to do that. It’s set up to move 35,000 patient visits through a year (Physician 11).Physicians also said that time and other resource constraints impede their ability to manage chronic opioids effectively. For example, one physician said:“you’re given a 30-minute appointment at the VA, and you’ve got a lot to document, and you got to see about their diabetes and their hypertension, and their lipids, and all this other stuff. Pain really never, it’s sort of a labor intensive thing treating pain, so it takes time” (Physician 10). In addition to time, some physicians perceived a need for resources such as secure urine drug screening processes and access to other specialists, saying, for example:I find that hard because our office isn’t really set up for that [urine drug screens]. I really don’t know about the security. … Occasionally, I’ll do a random one, but I know I should do them more, but I don’t. It’s just too complicated. … They’ve [patients who have gone to pain specialty clinics] described to me the process; that there’s someone monitoring their urine when they come out of the bathroom or something. That’s not true of our clinic, we’re not set up that way. Then I think, well, should I even bother? (Physician 1)Similarly, a VA physician described how managing other chronic conditions can crowd out time to effectively manage pain and opioids: Because the thing is we are—family is so broad that people can specialize in all type of stuff and still be called a family physician. It’s accordin' to what your interests lie. My interests started with chronic pain management because of my previous jobs (Physician 14).Physicians offered multiple perspectives on their preparedness to manage chronic opioid therapy and on the role of primary care in chronic pain. For example, a family and an internal medicine physician each described how, over time, they began to specialize in pain care. As one said:I felt like, ”okay, this cannot be good medicine. I’m sittin’ here writin’ 20 pills. I have got to find a better way to do this.“ At that point that’s when now all my CMEs are goin’ this way” (Physician 14). Similarly, one of the internal medicine physicians from the VA described how his volume of patients on chronic opioids led him to “specialize” in pain:It’s [pain] been, it’s become an interest of mine in the last four or five years. I did none in private practice. Then when I came back here [the VA] and inherited a practice with just, probably, I think as much as 20 percent of primary care is on opioids, so you come into this system and all of a sudden you see all these people on high dose, long acting medicines with very little risk assessment, very little monitoring, very little safety stuff that you normally have in place to make sure the drugs were being used safely. (Physician 10)She further described how an increasing volume of patients with chronic pain led her to enroll in pain-related continuing education to learn about alternatives to opioids: “I guess when you’re in primary care you can choose. It’s not like you’re specializing but some of the docs decide to go ahead and do more pain management so I guess I didn’t go that route” (Physician 5). Altogether, physicians described varying levels of interest in caring for chronic pain and willingness to prescribe chronic opioids.In contrast, other physicians described how they actively avoid patients with complex chronic pain conditions and/or on chronic opioids therapy. For example, one said: “Physicians in our U.S.-based study described a range of decision making challenges, including uncertainty in diagnosing chronic non-cancer pain conditions, discomfort assessing opioid-related risks and benefits, a lack of time and resources to provide pain care, and trouble establishing trust in patients. As a product of these challenges, our study indicates that some primary care physicians actively avoid caring for chronic noncancer pain. Given the enormous prevalence of chronic pain relative to pain specialist physicians in the U.S. , this fiOur study also provides insight into how some primary care physicians’ judgments are likely molded by perceptions of insufficient training, misinformation, conflicting information, high uncertainty, frustration, and mistrust when managing chronic opioids for pain. Others have described such clinical scenarios as “information chaos,” which may harm physician performance and patient safety . Thus, oTo complement decision support, our study also suggests the need for education and policies that support high quality primary care for chronic noncancer pain. Like prior work in an inpatient setting , our stuThis study has some limitations. First, we aimed to obtain rich information from a small, diverse sample of physicians in one U.S. state. As a consequence, our results do not allow us to make general or representative conclusions about physician populations. However, our sampling strategy was successful in recruiting physicians who varied in terms of age, gender, practice location, practice ownership, and experience and training in pain care. Yet, it is possible that our sampling did not capture some physician decision making approaches, such as those that vary across cultures or larger international boundaries. Therefore, we would be cautious in ascribing transferability of our results to international settings. Another limitation is the potential that our results reflect predispositions or other biases of the data analysts rather than purely reflecting the phenomenon being studied. To mitigate these risks, we used multiple data analysts. And, each analyst wrote reflective memos during the analysis to help verify their processes and ensure that emergent themes reflected the study data rather than internal biases. Finally, our data reflect physicians’ perceptions of how they make decisions, which may reflect their sensemaking process, social desirability, or actual decision making -43. WhilThis study contributes new insights into decision making challenges that primary care physicians face in managing the many patients with chronic noncancer pain. In particular, we identified and richly described physicians’ struggles to deliver high quality care as they seek and make decisions based on an array of incomplete, conflicting, and often untrusted information about their patients. Future work should develop and disseminate decision support and education that corrects misconceptions about chronic pain assessment and opioid management while also providing usable point-of-care information that meaningfully aids physician-patient interactions.


Recently a biocompatible bone adhesive was introduced in addition to the sternal wires to expedite sternal union and improve patient recovery. In this study we aim to objectively assess the biomarker of pain in patient who received the biocompatible bone adhesive.A total of 62 patients who underwent sternotomy were prospectively randomised to receive either conventional wire closure (CWC); 32 patients or adhesive enhanced closure in addition to sternal wire (AEC); 30 patients. Patients were monitored postoperatively at certain time intervals for incisional pain, serum Interleukin-6 (IL-6) level, analgesia used and postoperative complications. All patients were followed up for 4 weeks.The post-operative pain scores with coughing were significantly higher in the CWC group at 24 hours and 48 hours. The postoperative IL 6 levels were significantly higher in the CWC group in comparison with the AEC group at 6 hours, 24 hours, and 48 hours. There were no significant differences in term of additional analgesia used. No adverse events from adhesive bone cement were observed during follow up.Adhesive-enhanced sternal closure resulted in modest reduction of pain confirmed by reduction of pain biomarker. Justification of its routine use requires larger multicentre study. Since its introduction in 1957 median sternotomy has been be the most popular incision to access the cardiac structures for open heart surgery ,3. The cThis is a single blinded prospective randomised study conducted in a single centre between July 2012 and December 2012. University Malaya Medical Centre is a large tertiary teaching hospital in Kuala Lumpur Malaysia serving a population of up to 3 million people. The cardiothoracic unit performs up to three hundred fifty adult open heart surgeries per year. The study was funded by the local university research grant. Ethical approval was obtained from the University Malaya Medical Centre Kuala Lumpur Malaysia ethics committee. The patients were randomly assigned to either closure with conventional wire closure (CWC) or adhesive enhanced closure group (AEC). All patients, caregivers and research assistant were blinded to the intervention. The patients received standard postoperative care and standard analgesia protocol. All data were collected by a research assistant and were stored in a secured site at the hospital.Emergency surgery (defined as surgery within 24 hours of diagnosis)At high risk of postoperative bleeding Previous radiotherapy to chest wallPreoperative condition which can potentially cause prolonged recovery such as significant respiratory disease, renal failure on dialysis, current used of steroid or current substances abusedConsecutive adult patients over the age of 18 who were undergoing first time elective or semi elective open heart surgery through a median sternotomy were invited for the study. Exclusion criteria were:All patients were randomly assigned to receive either closure with conventional wire closure (CWC group) or adhesive enhanced closure (AEC group). A computer-generated random numbers were used for randomization of subjects into each group. Whereas the surgeons were aware of the allocated intervention or control group, patients, outcome assessors and data analysts were kept blinded to the allocation. The anaesthesia and surgery were performed according to routine standard of care. For sternal closure, all sternums were reapproximatted with 5 figure-of-8 sternal wire size 5. The AEC group received an additional bone adhesive on top of the standard closure. The use of bone wax was prohibited. In the AEC group, the trabeculae of each hemi sternum were cleaned with the provided brush and irrigated with saline solution. The ‘Kryptonite’ bone adhesive was mixed for 5 minutes and following which 5 ml of adhesive was applied as a thin layer to each hemi sternum at the trabeculae interface. Before the adhesive became complete set which was about 8 minutes the two hemi sternum were approximated. An additional 15 minutes of operative time were utilised for the application of the biological bone adhesive. The soft tissue and skin were closed in a routine manner in both groups. Post operatively the cares were identical in both groups. All patients received a standardized postoperative oral analgesia protocol which comprised of oral Paracetamol (PCM) 1 g QID and capsule Tramadol 50 mg TDS. Standard preoperative demographic data of the patients were collected. The primary outcome for this study was post-operative pain measurement. Biochemical marker of pain was measured by monitoring the serum Interleukin-6 (IL 6). The serum IL 6 (pg/ml) was measured preoperatively and at 6 hours, 24 hours, 48 hours and 72 hours postoperatively. IL 6 was measured with a commercially available enzyme linked immunosorbent assay (ELISA). The Visual Analogue Score (VAS) based on Wong-Baker faces pain scale which utilizes of face depictions that range from happy to tearful  were collected by a research assistant at 24 hours, 48 hours, 72 hours, and day 7 at rest and at coughing postoperatively. Also recorded as secondary outcome were complications following surgery which include death, chest reopen, perioperative MI, renal failure, pneumonia and sternal wound infection. The patients were followed up until 4 weeks following surgery.Based from the previous study the ability to detect the differences in pain score measurement of 3 (range 0–5.5) between the two groups were used to calculate our sample. We estimated that the enrolment of 50 patients would provide a power of 80% to detect the anticipated difference in primary outcome at a two-sided alpha level of 0.05. To allow for drop out, a total of 62 patients were recruited during the study period.All analysis was based on intention-to-treat principle. All data were entered and statistical analysis were performed using SPSS for Windows version 15 . Categorical data were expressed as percentage and analysed using Chi-Square test. Parametric data which were normally distributed were reported as mean +/− standard deviation and analysed with One-Way-Anova using Bonferonni correction to test for significance. Non parametric data which had skewed distribution were analysed using Kruskal-Wallis Test and reported as median. Values of p less than 0.05 were considered significant.Between October 2012 and December 2012, a total of 78 patients were asses for eligibility into the study , 24 hours  and 48 hours   as pain biomarker to quantify pain. In our study, the adhesive enhanced group demonstrated significant reduction of incisional pain score during coughing postoperative at 24 and 48 hours. These findings can be explained as the adhesive takes approximately 24 hours to be fully set. In our study the pain score were not significantly higher at rest. It has been shown that after a standard method of closure with wires alone, micro movement occurred between the two hemisternum during physiological distraction such as coughing . The micIn our study the absolute value of pain reduction although significant is small ranging from 0.6 to 1.91. These values are lower than the predicted value of 3 during the planning of the study and also lower than a previous study . As painIn our study the utilisation of additional analgesia were lower in the treatment group but was not statistically significant which did not replicate the findings from Fedak et al. study where the level of overall opioid usage were statistically less in the adhesive enhanced closure group. The reason for this finding may be due to the fact that our standard post-operative analgesia protocol which include oral opioid. All the additional analgesia used in our study was opioid base infusion.In the study there were more superficial sternal wound infections in the treatment group but not statistically significant. Although occasionally superficial sternal wound infection can progress to deep sternal wound infection, none of the patients developed deep sternal wound infection. All the infections were successfully treated with intravenous antibiotics. We therefore believe that the utilisation of the bone adhesive did not contribute to the superficial wound infection. There were no other significant complications from the utilisation of the bone adhesive in our study. In the literature there has been no adverse reaction reported with the utilisation of the bone adhesive. However possible adverse reaction or limitation include allergic reaction, excessive spillage into mediastinum compressing grafts after approximation of sternum, possible arrhythmias from the slight heat generated from the adhesive whilst it set. Other limitation include the necessity of an oscillating saw should the case require a chest reopen after 24 hour when the adhesive is fully set.In our study, several limitations were identified. The small number in size could have contributed to the non-significant results at 72 hour following surgery. Inclusion of multiple types of open heart surgery procedures which involves sternotomy might have influenced some of our findings. Our follow up is only for one month with no measurement of quality of life which may have added further strength to the study. Our standard dual analgesia protocol of non-opioid and opioid could have contributed to some of non-significant results when compare to other studies. Utilisation of only non-opioid analgesia to see reduction of opioid usage would be useful in future studies.The large reduction in pain score from other studies has not been replicated in our study. The addition of biological bone adhesive to the standard method of sternal closure resulted in marginal significant reduction of pain although confirmed by the reduction of pain biomarker released. Due to the marginal improvement of pain together with similar requirement of analgesia its clinical significant maybe doubtful base on our current study. As a new product the safety of its use was shown in several studies including ours. Limitations for its use would be the additional cost it incurs and the modest improvement in pain score base from our study. Further larger multi-centre trial with longer follow-up together with cost benefits analysis to confirm its clinical benefits further is needed before this technique can widely adopted.Written informed consent was obtained from the patient for the publication of this report and any accompanying images.


Evidence from clinical practice and the extant literature suggests that post-operative pain assessment and treatment is often suboptimal. Poor pain management is likely to persist until pain management practices become consistent with guidelines developed from the best available scientific evidence. This work will address the priority in healthcare of improving the quality of pain management by standardising evidence-based care processes through the incorporation of an algorithm derived from best evidence into clinical practice. In this paper, the methodology for the creation and implementation of such an algorithm that will focus, in the first instance, on patients who have undergone total hip or knee replacement is described.In partnership with clinicians, and based on best available evidence, the aim of the Management Algorithm for Post-operative Pain (MAPP) project is to develop, implement, and evaluate an algorithm designed to support pain management decision-making for patients after orthopaedic surgery. The algorithm will provide guidance for the prescription and administration of multimodal analgesics in the post-operative period, and the treatment of breakthrough pain. The MAPP project is a multisite study with one coordinating hospital and two supporting (rollout) hospitals. The design of this project is a pre-implementation-post-implementation evaluation and will be conducted over three phases. The Promoting Action on Research Implementation in Health Services (PARiHS) framework will be used to guide implementation. Outcome measurements will be taken 10 weeks post-implementation of the MAPP. The primary outcomes are: proportion of patients prescribed multimodal analgesics in accordance with the MAPP; and proportion of patients with moderate to severe pain intensity at rest. These data will be compared to the pre-implementation analgesic prescribing practices and pain outcome measures. A secondary outcome, the efficacy of the MAPP, will be measured by comparing pain intensity scores of patients where the MAPP guidelines were or were not followed.The outcomes of this study have relevance for nursing and medical professionals as well as informing health service evaluation. In establishing a framework for the sustainable implementation and evaluation of a standardised approach to post-operative pain management, the findings have implications for clinicians and patients within multiple surgical contexts. A major focus of the worldwide drive to improve the quality and safety of healthcare is the flexible standardisation of care processes to ensure patients receive care based on best available evidence and do not experience unnecessary variations in quality of care. Pain management after surgery is known to be a care process where the quality of care is highly variable. Prevalence studies worldwide identify that over 80% of hospitalised patients experience pain -4]. Pai. Pai4]. Poor use of analgesics has been identified as a prime reason why patients experience unnecessary pain. Robust findings indicate that patients receive 50% or less of the analgesics prescribed ,14],,, and expCrossing the Quality Chasm highlighted the imperative for patients to `…receive care based on the best available scientific knowledge,’ and that `…care should not vary illogically from clinician to clinician or from place to place’ . Th. Th29]. pro re nata, as required rather than on a fixed schedule)  wit witpro rchedule) ,15],,,, an, ane.g.,nsplants ) and conder pain , spinal der pain ). None oAlthough post-operative pain is poorly managed generally, the study will be focused in orthopaedic surgery because this surgery is common and is associated with high levels of pain that, if not well managed, interferes with rehabilitation, recovery, and long term benefits of surgery. Prolonged moderate to severe pain can lead to chronic pain in a proportion of patients -43]. Th. Th43]. Develop a post-operative, pharmacological pain management algorithm based on best available evidence in collaboration with a multidisciplinary panel to effectively manage pain in the post-operative orthopaedic environment (phase one);Implement the pain management algorithm using an evidence-based, multidimensional framework for the successful implementation of change in practice (phase two);Evaluate the impact of the algorithm on patients’ pain experience and pharmacological pain management practices across multiple sites using a pre- and post-implementation designed study (phase three).The project will be conducted in three incremental phases to achieve the aims of the project:Examine and calculate the proportion of post-operative analgesic prescriptions that comply with the MAPP;Determine the proportion of patients who experience moderate to severe pain after TKR and THR, pre- and post-implementation of the MAPP;Explore the efficacy of MAPP prescribing and administration by comparing the pain intensity ratings of patients whose analgesic prescriptions comply with MAPP recommendations with the ratings of patients whose prescriptions do not comply;Examine medical records for documented rationale explaining variation to MAPP prescribing recommendations.More specifically the objectives are to:There are two fundamental components of this research: the systematic development of the management algorithm for post-operative pain (MAPP) that is ecologically valid and based on best available evidence (phase one), and implementation of the MAPP into clinical practice in a way that ensures uptake and integration (phase two), and establishes a framework for measuring sustainability. Improving pain management is a multidisciplinary endeavour and is dependent on strong collaborative relationships between disciplines, administrators and patients themselves. There is potential for widespread uptake of the pain management algorithm however it is necessary, in the first instance to quantify the benefits in terms of quality improvement and develop a model for widespread implementation. The three-phase approach to this project will enable consultation and cooperation between disciplines and with patients (phase one), and identify barriers and enablers for successful implementation (phase two).The design of phase three is a pre- and post-implementation study to evaluate the uptake and outcomes of the MAPP in three sites.Phases one and two will be conducted in the orthopaedic units of a large private hospital in Melbourne, Australia (coordinating site) and will be rolled-out (phase three) in two additional orthopaedic sites in Melbourne, one private hospital, and one public hospital to test transferability and uptake. Three hospitals will participate in phase three, two private sector and one public sector. More than one-half of all hip replacement surgeries are performed in the private sector (59.3% in 2011) and more than two thirds of all knee replacement procedures are performed in private hospitals (69.4% in 2011) .The purpose of phase one is to develop the MAPP, determine the implementation strategy in the coordinating site, and plan the roll out to the two other participating sites. The first step is to identify the local context issues related to pain management and determine the scope of the guidelines. This will be achieved through a series of point prevalence surveys in the orthopaedic units to determine peri-operative, analgesic prescribing practices of anaesthetists and surgeons, and post-operative pain outcomes of patients. The second step is to convene an expert multidisciplinary panel and reach a consensus on the MAPP analgesic guidelines that is both context and procedure  specific.It is envisaged that the evidence from the point prevalence surveys conducted will assist participating anaesthetists and surgeons to reach consensus about standardising analgesic prescriptions for peri-operative orthopaedic patients within the local context.Sequential point prevalence surveys will provide essential baseline and outcome data throughout the three phases of this project. The point prevalence surveys will be conducted on the orthopaedic wards of participating hospitals. Data will be collected by research personnel who are also nurses and therefore familiar with pain assessment and analgesic prescribing.The study participants are all anaesthetists and surgeons who prescribe perioperative analgesics for patients undergoing THR and TKR surgery, nurses employed on the orthopaedic units who administer analgesics, and post-operative patients present on the wards at the time of the point prevalence surveys.Aged 18 years and over.i.e., are Day 0 - 7 post-surgery).Have undergone a total hip or total knee replacement in the previous 7 days .Data collection for the surveys will include patient interviews and medical record audit. Prevalence of pain, pain intensity, and the impact of pain on activities of daily living will be collected via brief interviews with patients (approximately five minutes) about their pain experience during the previous 24 hours. In order to capture the prescribing practices of all anaesthetists and surgeons, and the pain outcomes of patients across the recovery trajectory (Day 0 - 7), five prevalence surveys will be conducted over five weeks. In week one, the surveys will be conducted on Monday, in week two on Tuesday, and so on. In the coordinating centre, there are expected to be approximately 60 eligible patients available per day.patients’ demographic characteristics and relevant medical history.Pain intensity rating of current pain (pain at rest) and worst and average pain in the previous 24 hours will be measured on an 11-point numerical rating scale (NRS) where 0 denotes no pain and 10 denotes worst pain possible) .Interference with activities of daily living and patient satisfaction will be measured using sections of the revised American Pain Society Patient Outcomes Questionnaire (APS-POQ-R) ,50], a , a 50], This survey, used previously by the investigators, elicits patient information relating to height, weight and body mass index, current surgery and sequelae, as well as the type and quantity of analgesics prescribed prior to admission, the type of anaesthetic techniques used intra-operatively and the type and quantity of analgesic and symptom management medications prescribed and administered in the 24-hour period prior to the patient interview.The purpose of the point prevalence survey in phase one is to inform the development of the MAPP by providing rich descriptive data of current analgesic prescribing and administration practices to allow comparisons with guidelines based on best available evidence. patients’ pain outcomes will provide evidence for the need to change existing practices and identify where the main gaps in practice are, for example whether the gaps relate to prescribing of analgesics or treatment of breakthrough pain. In addition, the survey data will be the pre-implementation data for evaluating the success of the implementation of MAPP in phase two.Pain Management Index will be calculated for each patient. Scores are calculated based on the relationship between worse pain intensity scores and potency of analgesic administered. Evidence of the validity of this index has been demonstrated by Ward et al. in the cancer pain management context  wil wil55] wAccording to the PARiHS framework -55], ev, ev55], , according to the PARiHS framework, is made up of three factors: culture, leadership, and evaluation. Brown and McCormack [ContextcCormack  contend e.g., active participation in workshops, small-group discussion, problem-based learning), educational outreach visits , and other reminders . Research personnel in the project team will oversee the education component and develop an on-line education module for the multi-site roll out.Facilitation refers to the process of enabling or making easier the implementation of change and is achieved by individuals carrying out specific roles within organisations to facilitate change . We willTo evaluate the uptake and efficacy of the algorithm, another survey of pain management practices and pain outcomes will be performed 10 weeks after the implementation of the MAPP in the orthopaedic units. The results will be compared to the pre-implementation survey. The same procedure will be used to collect these data.The extent to which clinicians have adopted the pain management algorithm in terms of prescribing and multimodal medication administration, will be determined through the medical record audit. This method will be evaluated and an ongoing evaluation strategy for continuing quality assurance and sustainability will be established.The primary outcome measures to determine successful implementation are the proportion of patients who have multimodal analgesic prescriptions in accordance with the MAPP, 10 weeks after implementation, to determine the extent to which clinicians have adopted the prescribing guidelines, and the proportion of patients with moderate to severe pain intensity scores to determine whether the treatment of breakthrough pain is in accordance with the MAPP.et al. The minimum sample size required to detect a 20% reduction in the proportion of THR patients with moderate to severe pain intensity  at rest is 78 and for TKR patients  is 109. This number of participants would provide the power to show an advantage for the post-intervention group with 85% power at the 5% significance level. Therefore a minimum of 187 patients will be recruited in phase one and 187 in phase two .The sample size calculations are based on pilot data of pain prevalence and pain management practices conducted by Botti ©.Data gained from the post-implementation surveys will be compared to the pre-implementation survey data in order to determine the effectiveness of the implementation strategies for introducing the MAPP into practice. T-tests and chi-square tests will be used to compare baseline characteristics between the pre- and post-implementation patient groups. Non-parametric statistical analyses will be used to detect significant differences in the proportions of patients with analgesic prescriptions in accordance with the MAPP, and patients with moderate to severe pain. Tests will be two-tailed with statistical significance set at an alpha level of 0.05. The analyses will be undertaken using STATAThe aim of phase three is to implement and evaluate the transferability and uptake of the MAPP and establish a framework for measuring sustainability of the MAPP in multiple sites beyond the development site. This will be an important aspect of ensuring that the MAPP fits the different contexts of public and private healthcare and is transferable with modifications for the local contexts.There will be a 10-week, pre-implementation stage and a 10-week, post-implementation stage at each of the two rollout sites . Point prevalence surveys and multidisciplinary panel methodologies used in phase one and the implementation and evaluation methodologies applied in phase two will be repeated at each rollout site.The point prevalence surveys will be used to determine the quality of pain management practices at each site pre-implementation, in order to identify any site specific issues to be considered, allow modification of the implementation framework, and provide data for the pre- and post-implementation comparisons. Data collection methods including patient eligibility, survey and medical record audit will be the same as those described in phases one and two.A site specific multidisciplinary panel will be convened after the pre-intervention point prevalence surveys have been completed for the purpose of reviewing the findings and assessing analgesic prescribing and administration practices to determine whether there are local contextual factors that require the MAPP to be modified. The panel will oversee and advise on the contextual modification of the algorithm based on the best scientific evidence. In doing so the panel will also consider the clinical supports required to facilitate safe uptake of the intervention in each site. The CNC at the coordinating site will also work closely with the Clinical Nurse Specialists on the orthopaedic wards of the two rollout sites to facilitate implementation and evaluation of the MAPP.The implementation, revision and evaluation methodologies described in phase two in the coordinating site will be used in the rollout sites.The primary outcome measures identified in phase two will be applied again in phase 3 to establish the uptake of the MAPP by examining the proportion of patients whose analgesic prescriptions comply with the MAPP and the proportion of patients with moderate to severe pain at rest.The secondary outcome measure will be the efficacy of MAPP prescribing and administration by comparing the pain intensity ratings  of patients whose analgesic prescriptions comply with MAPP recommendations with the ratings of patients whose prescriptions do not comply.In addition, process evaluation will include an examination of all medical records for any documented rationale by clinicians explaining a variation to MAPP prescribing recommendations such as allergies or contraindications.The number and nature of site-specific changes made in order to implement the MAPP at each site will be recorded and analysed in order to inform the transferability of the MAPP across health services.The phase three study is powered to detect changes in point prevalence surveys before and after MAPP implementation for the two primary outcomes. A type I error of 0.05, power of 0.85 and intra-cluster correlation effect of 0.2 to account for hospital clustering effect have been considered. Based on these assumptions and a prevalence of moderate to severe pain at rest of 33.8% for THR patients and 53.1% for TKR patients, 94 THR patients and 131 TKR patients in each prevalence survey is needed to detect a 20% reduction in the proportion of patients with moderate to severe pain at rest (Rest pain >3/10). With a total 450 patients and an estimated 15.5% compliance with multimodal analgesic prescribing (according to pilot data at the coordinating site), there is 0.85 power to detect a minimum of 13% improvement in prescribing adherence.Again pre- and post-implementation data will be compared to determine the uptake of the MAPP by doctors and nurses. T-tests and chi-square tests will be used to compare baseline characteristics between the pre- and post-implementation patient groups. Non-parametric statistical analyses will be used to detect significant differences in the proportions of patients with analgesic prescriptions in accordance with the MAPP, and patients with moderate to severe pain. Due to intra correlation of hospitals adjusting for clustering effects is necessary. Appropriate generalised linear mixed models (GLMMs) for binary outcomes with logistic link will be used to evaluate the relationships between the main outcomes and the MAPP while adjusting for any important risk factors or covariates. Tests will be two-tailed with statistical significance set at an alpha level of 0.05. The analyses will be undertaken using STATA©.A secondary outcome to be analysed is the efficacy of the MAPP in reducing pain intensity ratings by comparing pain intensity ratings of patients where the MAPP guidelines are followed with those where the guidelines are not followed. Given that we are expecting to improve prescribing adherence from 15.5% to at least 28% (but it is likely to be much higher) we estimate we would have at least 70 in the compliance group and 180 in the noncompliance group. The minimum sample size required to measure a difference in mean pain intensity prior to and following implementation is 86. Data from previous research by Botti et al. were used to calculate power to show an advantage of at least 15 units (1.5 on VAS) for the post-intervention group with 80% power at the 5% significance level. Change differences of two points in cancer populations  and 3 poAll phases of this study have been approved by the Human Research and Ethics Committees at the coordinating hospital and two supporting hospitals. The project has also been reviewed and approved by the Deakin University Human Research Ethics Committee.One of the key priority goals of research in the area of preventative healthcare is to reduce the risk of adverse outcomes. Ineffective pain management has significant moral, clinical, and financial implications for health. The impact of poor pain management is substantial in both human and economic terms. The use of medicines is the most common method of healthcare treatment . There iThe drive for quality improvement through evidence-based healthcare is a dominant theme in practice, management and education in health services worldwide. There is recognition of the need for system change to support the delivery of safe, high-quality care. The algorithm will be developed according to previously described recommendations for post-operative pain management for patients undergoing total hip or total knee replacement surgery. It is not enough, however, to introduce tools and strategies with which to improve quality of care without acknowledging the complexities of change processes, the need to engage staff, and the imperative to make any practice changes sustainable in the long term . TraditiThe proposed intervention directly addresses the need for evidence-based interventions that reduce the incidence of adverse events and improves the quality of care delivery. Specifically, this project addresses the high prevalence of moderate and severe pain experienced by post-surgery orthopaedic patients. Developing improved processes for the effective prescription and administration of post-operative analgesics applies not only to orthopaedic surgery but to many other surgical contexts and thus will impact on a large number of patients in Australia and internationally.MB conceived the study, validated the methods and was involved in drafting and approving the manuscript. BK, TB, MJJ, and MD contributed to the design of phase two. JC and BR contributed to the development of the MAPP and will oversee the development of the education modules for nurses. RdS is the convener of the multi-disciplinary expert panel and MH is the coordinator of the panel. SH and EC are overseeing the prevalence surveys and analyses. All authors have read and approved the final manuscript.Alfred Deakin Professor Mari BottiChair in Nursing, Epworth-Deakin Centre for Clinical Nursing ResearchDeakin UniversityProfessor Bridie KentPlymouth UniversityProfessor Tracey BucknallProfessor of Nursing Deakin University, Foundational Chair in Nursing, Alfred HealthProfessor Megan-Jane JohnstoneProfessor of Nursing, School of Nursing and Midwifery, Deakin UniversityProfessor Maxine DukeHead, School of Nursing and Midwifery, Deakin UniversityProfessor Julie ConsidineChair in Nursing Eastern Health-Deakin University Nursing and Midwifery Research CentreAssociate Professor Bernice RedleySenior Research Fellow, Epworth-Deakin Centre for Clinical Nursing ResearchProfessor Richard de Steiger,Epworth Victor Smorgon Chair of Surgery, The University of MelbourneMs Marlene HolcombeRegistered Nurse, Special Projects OfficerMs Susan HunterPhD Candidate, School of Nursing and Midwifery, Deakin UniversityDr Emma CohenResearch Fellow, Epworth-Deakin Centre for Clinical Nursing Research


A high level of comorbidity at dialysis initiation is associated with an increased risk of death. However, contemporary assessments of the validity and prognostic value of comorbidity indices are lacking.To assess the validity of two comorbidity indices and to determine if a high degree of comorbidity is associated with mortality among dialysis patients.Cohort study.QEII Health Sciences Centre .Incident, chronic dialysis patients between 01 Jan 2006 and 01 Jul 2013.Exposure: The Charlson Comorbidity Index (CCI) and End-Stage Renal Disease Comorbidity Index (ESRD-CI) were used to classify individual comorbid conditions into an overall score. Comorbidities were classified using patient charts and electronic records.Outcome: All-cause mortality.Confounders: Patient demographics, dialysis access, cause of ESRD and baseline laboratory data.Regression coefficients were estimated on the CCI and ESRD-CI. Discrimination for death was assessed using Harrell’s c-index. Adjusted Cox proportional hazard models were used to calculate relative hazards and 95 % confidence intervals for each category of the CCI and ESRD-CI.c-index, for the prediction of death, was 0.61 for the CCI and 0.63 for the ESRD-CI. ESRD-CI scores of 4, 5 and ≥6 were associated with a similar mortality risk . There was a small increased mortality risk for CCI scores of 4, 5 and ≥6 .The cohort consisted of 771 ESRD patients from 01 Jan 2006 to 01 Jul 2013. Most were male (62 %) and Caucasian (91 %). The cohort had a high proportion of diabetes (48 %), history of previous myocardial infarction (31 %) and heart failure (22 %). Regression coefficients on the CCI and ESRD-CI were 0.55 and 0.52, respectively. The Classification of comorbidities for each patient was determined by clinical impression.The CCI and ESRD-CI have a limited ability to discriminate mortality risk for incident dialysis patients. Acknowledging the frequency with which they are used, this study emphasizes the need to re-examine the usefulness of previously derived comorbidity indices in contemporary dialysis cohorts. The Charlson Comorbidity Index (CCI) and End-Stage Renal Disease Comorbidity Index (ESRD-CI) are commonly used in studies of dialysis patients, but assessments of their validity are lacking.Both indices had a limited ability to discriminate mortality risk in this study emphasizing that they may not be the best method of risk adjustment in contemporary dialysis cohorts.In patients with end-stage renal disease (ESRD), the presence of comorbid conditions has been shown to have a negative impact on survival –3. A comThere have been a number of additional comorbidity indices that have been created for ESRD patients , 14–16, While both the CCI and ESRD-CI are frequently used for risk adjustment in studies of dialysis patients –22, onlyTherefore, the purpose of this study was to assess the validity of the CCI and ESRD-CI in a contemporary cohort of ESRD patients, and to determine if a high degree of comorbidity was independently associated with mortality. We hypothesized that both indices would have a reduced level of discrimination compared to the derivation studies, but that increased comorbidity burden would be associated with a higher risk of death for dialysis patients.We conducted a cohort study of incident, adult (≥18 years) chronic dialysis patients in a large tertiary care institute between 1 Jan 2006 and 01 Jul 2013. Follow-up for patients began at the initial start date for their dialysis.Comorbidity data was collected at the start of dialysis in all patients in a prospective manner, using documentation in patient charts (dating back to the first nephrology visit) and electronic records by the patients’ primary nephrologist. Comorbidities were subsequently verified in all patients by two nephrologists (K.T. and B.K.) and one nephrology trainee (T.A.). All 19 individual comorbid conditions in the CCI were collected at the time of dialysis initiation and scored according to the CCI derivation study. ESRD-CI scores were retrospectively calculated by re-scoring the comorbidities comprising the ESRD-CI based on the derivation paper. ESRD-CI scores were analyzed as ordinal variables and after categorization into six groups to be consistent with the derivation paper  . The CCIIn addition to the CCI and ESRD-CI scores, demographic data , dialysis access  type of dialysis modality , cause of ESRD  and baseline laboratory data  were collected on all patients at the start of dialysis using a combination of electronic records and paper chart review.The primary outcome was all cause mortality after dialysis initiation. Administrative censoring was imposed on 01 Jan 2014. Patient survival was censored at the date of transplantation.Descriptive statistics for baseline characteristics of the study cohort were reported as counts with proportions, mean with standard deviation and median with interquartile range for categorical, normally distributed continuous and non-normally distributed continuous variables, respectively.et al. based on availability of data in the original derivation studies [Regression coefficients were estimated on the CCI and ESRD-CI (defined as the precise CCI and precise ESRD-CI).Regression coefficients were also estimated on the categorical CCI  and ESRD-CI  as a secondary analysis .c-index. Harrell’s c-index assesses the fraction of all possible pairings of patients in which the predictions and outcomes are concordant [c-index of 0.683 [Discrimination (defined as the level of concordance between the risk predicted by a model and the rate of events experienced ) was assncordant . Scores of 0.683 .Kaplan-Meier Survival curves were plotted for each category of CCI/ESRD-CI and discrimination was also visually assessed according to the ordering and separation of the curves.External validation of the CCI and ESRD-CI followed the methods previously described by Royston  studies :RegressiCox proportional hazard models were used to calculated relative hazards and 95 % confidence intervals for each category of the CCI and ESRD-CI. Proportionality of hazards was assessed using Schoenfeld Residuals. Multivariable models included variables based on clinical judgment and those derived from the literature as being associated with mortality in studies of dialysis patients including age , gender The cohort consisted of 771 ESRD patients from 01 Jan 2006 to 01 Jul 2013. Baseline characteristics of the cohort are noted in Table c-index was 0.61 (SE 0.02) for both the precise and categorical CCI, and 0.63 (SE 0.02) and 0.62 (SE 0.02) for the precise and categorical ESRD-CI (Table + versus 0/1 or 2). However, discordance was observed for patients with an intermediate score. A similar finding was noted for the CCI, however, there was slightly more separation between the curves in an incremental fashion based on score  and 0.52 (SE 0.07), respectively  and limited utility of comorbidity indices in general.Limited generalizability may explain the observation of only partial validity. The CCI and ESRD-CI used a relatively small population from a single geographical area and validation in this study occurred in a separate single geographical area. Differences in the determinants of health in two communities may contribute to the different outcomes of two dialysis patients with similar comorbidities. Social determinants of health, in particular, have been shown to impact mortality rates in patients with ESRD –39. MoreThere were notable characteristic differences comparing patients in our dataset and the dataset of the original studies, which may explain the reduced discrimination. Our cohort was in a more recent era (2006–2013), and the relative impact of some comorbid conditions may have changed –45. The The derivation of the CCI or ESRD-CI may have also impacted its validation. The linear predictor from a Cox model is ideal for developing a prognostic index. The linear predictor is described as the weighted sum of the variables in the model, where the regression coefficients are the weights . In the While there are limitations with the comorbidity indices, it is important to acknowledge that both indices did have some validity. It is not unexpected that a higher level of comorbidity would be associated with a higher risk of death among dialysis patients, however most evaluations of comorbidity scores look at short term mortality or use validation techniques that do not incorporate survival time , 23, 24.It is important to note that there are limitations of comorbidity indices in general that warrant consideration. Most indices do not fully take into account the stage of progression, severity or proximity of the comorbid condition in relation to dialysis initiation , 14–16. This study utilized a substantial Canadian cohort and a long follow up time while leveraging electronic medical records to ensure a high quality and robust dataset. Additionally validation of the index was performed utilizing stringent methodology . ExaminiThere are, however, limitations to this study. The classification of comorbidities for each patient was determined by clinical impression (based on documentation in paper chart and electronic records). This introduces the possibility for misclassification bias. The derivation cohort(s) would have also been affected by misclassification bias, potentially compounding the observed differences in disease prevalence and prognostic utility. Our ability to completely validate either index was limited by the level of information provided in the original studies. In particular, an assessment of calibration (the ability of the index to assign the correct event probability at any relevant follow-up time and every level of predicted risk ) could nThe CCI and ESRD-CI had a limited ability to discriminate risk of death for incident dialysis patients in a contemporary Canadian cohort. Although a higher comorbidity burden was associated with mortality, incremental increases in index scores did not considerably change the risk of death.