The Community Pharmacy of the Department of Ambulatory Care and Community Medicine , University of Lausanne, developed and implemented an interdisciplinary medication adherence program. The program aims to support and reinforce medication adherence through a multifactorial and interdisciplinary intervention. Motivational interviewing is combined with medication adherence electronic monitors  and a report to patient, physician, nurse, and other pharmacists. This program has become a routine activity and was extended for use with all chronic diseases. From 2004 to 2014, there were 819 patient inclusions, and 268 patients were in follow-up in 2014. This paper aims to present the organization and program's context, statistical data, published research, and future perspectives. A widely known challenge in chronic healthcare is the percentage of patients who do not follow their medication regimen, from poor adherence to nonadherence . When paAddressing the problem of nonadherence would evidently help alleviate the burden of added costs to healthcare. To do so, healthcare systems need to change by developing interdisciplinary medication adherence intervention programs to ensure better adherence to medication, especially to chronic therapies . WorldwiIn 2004, based on previous experience with other chronic diseases, the Community Pharmacy of the Department of Ambulatory Care and Community Medicine , University of Lausanne, in collaboration with the Infectious Diseases Service of the Lausanne University Hospital , developed and implemented an interdisciplinary antiretroviral therapy (ART) adherence program for HIV patients. Since then, this program has become a routine activity and was extended for use with all chronic diseases. The program aims to support and reinforce medication adherence through a multifactorial and interdisciplinary intervention. According to the National Institute for Health and Care Excellence's (NICE) 2009 Guidelines, it is important to involve patients in decisions about prescribed medicines and adherence support . This isThis paper aims to describe the organization and program's context, statistical data, published research on medication adherence interventions, and future prospects for the medication adherence program at the PMU.The physician, pharmacist, or nurse invites the patient to take part in the program, but in practice, the physician is often the best person to invite the patient to participate in the program because of the established patient-provider relationship. The first interview between the patient and pharmacist happens on the same day or within a few days after the patient agrees to participate in the program. The following interviews are arranged with the patient and called follow-up interviews, which take place 30–45 minutes before a medical visit and last for 15–30 minutes. The medication adherence interview is conducted when medicines are given and happens in an interview room to ensure confidentiality. At the beginning of each interview, the pharmacist validates the medical prescriptions to ensure treatment is prescribed in a safe, effective, adequate, and economic way and according to evidence-based medicine. At the end of each follow-up interview and with the patient's consent, a report is sent to the physician. The patient is informed that the pharmacist, physician, and nurse exchange information to support medication adherence. Any decision to stop the program is made mutually by the physician and pharmacist in collaboration with the patient. In this case, a discontinuation visit takes place with the pharmacist see .The frequency of interviews depends first on the patient's needs and second on his or her availability . For example, an HIV patient starting a new treatment attends a medical visit at 2 and 4 weeks and at 2, 3, 4, and 6 months if no problem of toxicity appears. The pharmacist organizes the medication adherence interview according to these medical visits. The pharmacist also plans extrainterviews in between medical visits, in case of difficulties to adherence that could potentially lead to clinical consequences. Special attention is given at the beginning of follow-up.Medication adherence interviews are scheduled in the pharmacy's electronic agenda to keep track of all patients. A pharmacy technician, specialized in medication adherence, checks the agenda at least once a day and validates the daily list of scheduled patients. If the next interview date is not yet scheduled with a patient, the technician enters an electronic reminder to contact the patient 10 days before a shortage of medicines occurs. If a patient does not come to an interview, the technician contacts the patient to arrange another appointment. In the case of 3 unsuccessful calls and before a shortage of medicine, the pharmacist contacts the physician to decide on a mutual action. The physician invites the patient to return for a medical appointment and to visit the adherence clinic.All information is collected electronically at the pharmacy, which uses 2 software programs for the medication adherence program: medAmigo  or SISPhWhen a patient agrees to take part in the adherence program, the physician calls the pharmacist, who completes a document for the “medication adherence program request.” This document gathers details on the patient ; details on the physician (contact information and knowledge of the adherence program); and clinical data .failure to achieve therapeutic goals;adherence difficulties exposed by the patient and/or discussed with the physician, pharmacist, or nurse;difficult psychosocioeconomic conditions;complexity of the current treatment ;comorbidities known to affect medication adherence ;history of nonpersistence to treatment;frailty known to have an impact on medication adherence .The main reasons to include a patient in this program are the following:The interview consists of 4 parts. During the first part of the interview, the pharmacist describes the nature and direction of the program, which is completely new to most patients; sets the framework ; and assesses the patient's readiness to start or keep taking the treatment. While the pharmacist is the one who guides the interviews (semidirective intervention), the patient is invited to actively participate in the interviews, according to the principle of patient-centered care. The interviews can be attended by the patient alone or with a significant other. A 1-page leaflet with written information is provided to the patient. This document also attests that the electronic monitors (EMs) are delivered on a loan basis to the patient and must be returned at the end of the program. Otherwise, the pharmacy would claim the cost of the EM by sending an invoice to the patient. This document is then signed and dated by the patient and pharmacist.During the second part of the interview, the pharmacist gets to know the patient's personal and psychosocial conditions ; therapeutic history ; experienced barriers and facilitators to medication intake; and previous adherence support, if any . Having this information then starts the intervention.During the interview's third part, the pharmacist presents the EMs and verifies that the patient can adopt them without any major difficulties . The patient is informed that the EM records the day and the hour of each opening and that this information is made available to the patient at any time through the LCD screen on top of the monitor. To prevent a mix of monitors and their containers, each corresponding EM and its container are marked with the same color. The patient is asked to bring back EMs at each medication adherence interview, even if there is still some medicine remaining, as the pharmacist always delivers more medicine than necessary to anticipate any appointment changes.During the interview's fourth part, the pharmacist presents the monitored treatment and provides medical pamphlets. Afterward, the patient and pharmacist schedule medication intake by combining the pharmaceutical recommendation with the patient's own preferences, and they define individual, appropriate use for the patient. In case of drug continuation, the pharmacist considers the patient's current and previous organization, as well as capturing former and actual barriers and facilitators to support the patient in finding sound, individual, and appropriate use.Finally, the pharmacist invites the patient to ask questions, summarizes the interview, and eventually sets a realistic short-term goal to meet first for the next interview and fixes the next appointment.Follow-up interviews focus on the patient's adherence and medicine-related issues . The pharmacist prepares the interview and at least reviews 2 to 3 previous reports, including the inclusion document if he or she does not know the patient.Within which time interval do you take your medicine after opening the EMs? The answer is then categorized .Are EMs consistently used for each dose or did you organize pocket dosing or experience nonmonitored periods ? The pharmacist notes dates and reasons for each deviation of EM use with the greatest possible accuracy.Do you think you have missed taking some pills since the last interview? If yes, then the patient describes when, how much, and in which circumstances and reasons . This information allows the pharmacist to identify whether self-reported adherence is close or not to electronic adherence and guide the presentation of EM results by accounting for the patient's attitude.After validating the use of the EMs, the pharmacist shows, describes, and discusses the EM results with the patient. The results are displayed using patient-friendly graphs ; informs him/her according to individual, evolving needs; and/or refers the patient to the physician.Motivation in Medication Intake. The pharmacist assesses the patient's motivation; patient's own clinical and quality of life expectations; and emotions linked to the treatment  to check that emotional needs are balanced, such as by expectations and/or social or practical support that the patient receives.Behavioral Skills. The pharmacist explores the levels of integration of medication intake in the patient's daily routine; self-efficacy; capacity to self-manage treatment and side effects; and the patient's strategies to prevent missed doses .In case the physician foresees a change in treatment, the pharmacist explores the patient's opinion about this change and discusses previous change experiences, if any, and the patient's readiness for this upcoming change.The cardinal points of the intervention are as follows:Moderators of Fisher's model—such as psychological clinical or subclinical deficit, unstable living situation, poor access to medical care, and substance abuse—are considered. According to the identified variable affecting adherence, the pharmacist, physician, or nurse takes the lead in supporting the patient. For example, in case psychosocial components affect adherence, the patient could be referred to a psychologist or psychosocial worker. In case treatment complexity is the main trigger of nonadherence, the pharmacist and the physician identify ways to simplify treatment. Finally, the pharmacist helps the patient in setting realistic goals until the next interview and summarizes the interview. Then, the pharmacist fixes the next appointment and invites the patient to call him/her in case of intercurrent medication intake problems.Objective description of the patient's adherence since the last interview and validation of EMs use .Description of medication adherence facilitators and barriers encountered by the patient, including medication side effects and symptoms.Summary of the intervention based on the IMB model and adherence subgoal(s) for the next interview.After each medical visit, the patient returns to the pharmacy to fill the EMs with the prescribed pills until the next appointment.The pharmacist finalizes the medication adherence report and sends it to the physician at a maximum of 3 days after the interview or gives the report directly to the patient if the medical visit happens on the same day. The three main goals of this electronic report are to ensure (1) continuity of care between the pharmacist, physician, and nurse and a multidirectional flow of information; (2) continuity of care at the pharmacy between interviews, with the possibility to easily notice changes in patient adherence ; and (3) quality management and activity's traceability. The report presents the EMs' adherence results and the pharmacist's comments according to 3 sections:Initiation Phase . Problems are clearly identified and a search for solutions takes place. During this phase, the patient is followed as often as possible by the same pharmacist (in collaboration with a substitute pharmacist).Consolidation Phase . The patient enters this phase if he or she achieved 4 conditions: (1) he or she achieved or came significantly closer to his or her therapeutic goals, (2) medication adherence improved and has been adequate for a minimum of 4 months, (3) identified barriers to adherence are either resolved or balanced by facilitators, and (4) at least 3 adherence interviews were conducted. During this phase, the patient consolidates the newly learned adherence behavior, and it is no longer necessary to be seen by the same pharmacist every time, as in the previous phase.Maintenance Phase . Adherence has been adequate for the last 12 months, barriers encountered are solved or self-managed by the patient, and a major clinical improvement in therapeutic goals is achieved. Patients are invited to stop the program after the pharmacist, physician, and nurse agree on it. However, some patients express their wish to continue the program. This wish can be because the EMs structure the patient's daily medication intake, and the electronic feedback given during medication interviews increases the patient's feeling of security. In this case, uploads of EMs data are scheduled 3 to 4 times a year, and interviews are short, based on electronic feedback. If new adherence issues emerge, the patient is invited to enter a new initial phase.At the end of the program or if the patient decides to quit prematurely, a closing visit is scheduled. The reason for closing is detailed in the report, especially whether treatment is pursued or not. The pharmacist informs the patient of the possibility of relapse and ways to decrease its risk, including letting the patient know that the adherence program remains available at any time.The medication adherence program is divided into 3 phases:To maximize efficiency, pharmacy technicians are in charge of logistics and technical work linked to EM management. They activate and program EMs and check their functional use before the first delivery and also upload EM data before each interview. The pharmacists prepare and fill in EMs at each prescription refill and document this activity in a dedicated form. Additionally, the pharmacist verifies the medicine stability in EMs.The medication adherence program is ISO certified. All procedures are written and made available to the team at any time.First, the new pharmacists receive basic training. They attend a 10-hour class organized into 5 modules: (1) introduction to medication adherence, (2) theoretical frameworks of medication adherence, (3) medication adherence intervention programs, (4) structure of medication adherence interviews, and (5) case studies. After these modules, pharmacists in training observe a minimum of 3 medication-adherence interviews with a trained pharmacist.Second, pharmacists are trained in motivational interviewing during four 4-hour sessions . They inThird, pharmacists in training deliver 3 to 8 medication-adherence interviews, depending on the pharmacist's experience and skills, under the supervision of a senior trainer (pharmacist) who attends the interview, gives feedback after each interview, and validates each medication adherence report.To maintain a high and standardized quality level for the medication adherence program, one interview per pharmacist is recorded every 18 months, and a debriefing with a trainer is conducted. Every 6 to 8 weeks, a 1-hour adherence internal meeting is organized for educational purposes and discussing complex case studies.Pharmacy technicians are advised on the spot by trained technicians and pharmacists. While there is no formal training for the new technicians, they participate in the adherence internal meetings.The Community Pharmacy of the Department of Ambulatory Care and Community Medicine is linked to the Research Unit of Community Pharmacy, School of Pharmaceutical Sciences, University of Geneva-University of Lausanne. The Community Pharmacy practice helps and gives ideas to the research team and in parallel, this academic setting promotes research and development .http://dx.doi.org/10.1155/2015/103546).Progressive for the time, the medication adherence program started in 1995. The Community Pharmacy introduced EMs without showing medication adherence data to patients and physicians. When results were shown for the first time to patients, pharmacists and physicians noticed patients' positive reactions –24. InteThe intervention follows the Behavior Change Technique Taxonomy by Michie et al. that was developed to provide an extensive consensually agreed structured taxonomy for behavior change techniques used in interventions  see Tab.From 2004 to 2014, 819 patients were included and pharmacists delivered 10'911 interviews for different chronic diseases from 2008 to 2014 . The amount of the monthly insurance premium is then adjusted, depending on the franchise (the higher limit of the franchise is 2500 CHF per year). When the franchise exceeds, which is often the case with chronic conditions, patients pay 10% of the care costs until they reach a maximum quota of 700 CHF per year. After this quota, all care is reimbursed to the patient, including pharmaceutical services, for example, a medication adherence support fee (20.80 CHF per week) and a polymedication check fee (48.60 CHF every 6 months) .Our first prospect for this medication adherence program is to extend the research to diseases other than HIV. Studies currently in progress concern chronic dialysis, hypertension, type 2 diabetes, multiple sclerosis, and oral oncology. Cost-effectiveness analyses are also in progress.The second prospect is to implement this program in other community pharmacies in the French-speaking part of Switzerland. The program is also in the process of being implemented for HIV patients at the Hospital of Neuchâtel (Switzerland) in collaboration with local physicians, nurses, and community pharmacies.This paper thoroughly describes the experience of a well-established adherence program in Lausanne, Switzerland. It is an intervention that includes motivational interviews, electronic pill monitors, and reports, and it has interdisciplinary collaboration between all healthcare professionals. It is used with chronic patients experiencing or at risk of experiencing medication adherence issues. The fact that it is patient-centered makes it possible for the patients to develop autonomy. The program bridges research and practice, and it encourages the implementation of such a program elsewhere in the world. More articles should describe similar successful intervention programs to promote experience exchanges, comparisons, and replications in different settings.Published research about the medication adherence program.


T Ferdous al-Hekma (Paradise of Wisdom) is one of the oldest medical texts in the Islamic world written in Arabic in 850 AD by Ali ibn Raban Tabari. He was a Persian physician who moved from Tabaristan (Mazandaran province of modern day Iran) to Samarra during the reign of the Abbasid Caliph al-Mutawakkil (847-861 AD). We studied the book of Ferdous al-Hekma fil-Tibb, in an attempt to comprehend its general outlook on diseases of different organs, their classifications and the associated signs and symptoms. th century AD. Tabari was mainly influenced by Hippocrates, Galen and Aristotle, as well as his contemporaries Johanna ibn Massavieh and Hunayn ibn Ishaq. The book is written in thirty chapters in a total number of 308 subtitles. In each part there is an introduction to the symptomatology, followed by organ specific diseases and therapeutic recommendations. The book is one of the earliest medical pandects of the period of translation, adaptation and expansion of knowledge in the Islamic world during the 9Symptoms and physical signs of different diseases are vividly described in Ferdous al-Hekma, and some of them are even understandable for contemporary medical students. Ferdous al-Hekma (Paradise of Wisdom) is one of the oldest medical texts in the Islamic world written in 850 AD in Arabic. The writer, Ali ibn Raban Tabari ?-882 AD), was a Persian Muslim who moved from Tabaristan (the present Mazandaran province of Iran) to Samarra during the rule of the Abbasid Caliph al-Mutawakkil 847-861 AD)  in Azerbaijan (816-837 AD), and the great achievements of Yaqub Leis Saffar (840-879 AD) in Sistan. The Saffarids recaptured major territories of Persia from the Abbasid Caliph and appointed Naser ibn Ahmad Samani as the ruler of Balkh in Transoxiana. These movements marked the revival of Persian art, culture, science and language in the following century . He was the teacher of Rhazes and may have died in 882 AD , 5.The name of Ali ibn Raban Tabari has been mentioned by Ibn al-Nadim (died 998 AD) in his book Al-Fehrest, and he has also listed some of Tabari’s writings including: Ferdous al-Hekma, Essay on Possessions, Medicines and Herbs. In his book Tabaghat Pezeshkan (Physicians and their Ranking), Ibn Abi Usaibia has attributed two other works to Tabari, including one on health, and one on the understanding the life. In the books of Tarikh-e- Tabarestan (History of Tabaristan) and Kashf al-Zonon, the two pandects Bahr al-Favaa’ed (Ocean of Advantages) and Din Va Daolat (Power and Religion) are attributed to Tabari .Ferdous al-Hekma is written in thirty chapters in a total number of 308 subtitles. The first five chapters are mainly dedicated to temperaments, humors and the general aspects of health. Then the diseases of different organs and their treatments are discussed in detail. In each part there is an introduction to symptomatology , 5. The With the recommendation and encouragement of E.G. Browne, in 1922 M.Z. Seddiqi collated and compared the three versions of Ferdous al-Hekma, including the British museum manuscript, the Berlin manuscript, and the Indian Gotha manuscript. In 1928 a complete copy based on the findings of Seddiqi was published in Arabic by Kaviani Publications in Berlin. Years later this version was translated into Persian by S.A. Madani and A.H. Broujerdi and published by Mehramin Publications in Tehran in 2008 . What foIn this work we studied the Persian translation of Ferdous al-Hekma thoroughly and tried to find the passages on symptoms, signs and physical examinations associated with different disorders. We tried to comprehend the content of those passages and compared them against modern medicine. At the same time we studied the main historical sources on early Islamic periods to get a more vivid outlook on the period.PassagesA General Outlook on Clinical MedicineIn the opening pages of his book Tabari writes about his main objectives and outlooks as a thinker and physician, and offers valuable ethical messages. “It is my wish that anyone who reads this book, thinks about it deeply and kindly corrects my flaws, and I shall be indebted to such persons… .  excretion along with coughing is a sign of lung infection; 6) discomfort in different organs; and 7) signs that can be found by asking the patient about his disease…. As Hippocrates says, “The disease by itself guides us…”   intestine is involved. If the pain is intermittent, the upper  or lower intestines are involved… .The distinction between large and small intestinal pathology is difficult and even modern textbooks on physical examination consider the abdominal surface distribution of pain as a guide to find the source of pain. For example duodenal pain often happens in subxiphoid areas. involvement of the third part of the duodenum, jejunum and also proximal ileum pain often radiate around the umbilicus .On dyspnea and asthmaRespiratory organs include the lung, larynx and a partition that exists between the chest and the abdomen and is called the diaphragm… and in pleuritis the pain radiates to the neck or the brain and disturbs consciousness…. . In the paragraph above, the anatomical considerations about the radiating pattern of pain are interesting as these symptoms are used in contemporary medicine as well. Signs of stomach disease and ulcersIf the pain appears on the interscapular areas of the back, it may have originated from the esophagus because the stomach is adjacent to the lumbar area. If we feel such pain while eating spicy food, it is a sign of stomach inlet ulcer, and if the painful area is lower, the ulcer is located inside the stomach, and if the pain originates in the duodenum, it is felt within te abdomen… In the above-mentioned passages, it is noticeable that reflux esophagitis and esophageal spasm were considered a cause of chest pain that can mimic angina. Peptic ulcer pain could radiate to the back and the upper left quadrant. Hoarseness and recurrent laryngitis could also be a sign of gastroesophageal reflux .Signs of liver diseaseThe patient is thirsty, his mouth is dry, appetite is decreased, urine is [deep yellow], and his pulse is rapid… if inflammation appears in the upper surface of the liver, the patient feels pain on the right clavicle [particularly] during respiration. Pain on the right side and coughing happens because the congestion is adjacent to the lung and the diaphragm…. If the inflammation develops on the lower part of the liver, it is less painful than congestion in the upper part... if the congestion happens on the lateral surface of the liver, it is similar to the first type… . Liver pain can be hard to identify and localize because pain from abdominal organs, such as the liver, is often experienced as a vague pain in the right hypochondrium and epigastrium, which may lead one to suspect liver abscess or cancer. Patients with liver disease may report more abdominal pain than other individuals, and the pain is worse after meals. Biliary colic and acute cholecystitis must also be considered in patients with liver disease because the prevalence of gallstones is increased in patients with cirrhosis. Pyogenic liver abscess could present with fever and upper right quadrant pain, while sub diaphragmatic abscess could present with dyspnea, chest pain and even hemoptysis.Irritation of the central part of the diaphragm radiates to the shoulder. The combination of lower chest pain and ipsilateral shoulder pain is highly suggestive of diaphragmatic pleural disease. Mediastinal pain is less severe and is located in midline and radiates to the back in the interscapular area. It is very interesting that this pattern of referral pain has been described in modern textbooks as well , 10.Signs of hemorrhage in upper and lower organsBlood that is vomited originates from the stomach, and blood that comes from the lung or pharynx is clotted. Blood from the lung is dark and is associated with pain and coughing… and is mixed with puss… and is more diluted and foamy… In the above-mentioned passages there is an interesting distinction between hematemesis and hemoptysis. The latter can be caused by a wide range of disorders, but massive hemoptysis is most frequently caused by tuberculosis, bronchiectasis, lung abscess, cancer, and Aspergilloma. These conditions were probably common in those periods , 11.Signs of pain in the large intestineIf someone has large intestine problems…, he feels the pain in his kidney. Large intestine pain happens in the lateral part of the abdomen and is expandable… but kidney pain is constant and remains confined to one area, does not spread and is [often] located above the waist… And if [the patient] lies in the prone position, he feels heaviness in the kidney area…. In patients who complain from flatulence and intestinal air entrapment, if you palpate the affected area, you can feel a lump…. If air entrapment is the cause of pain, it radiates from one part to the other part…. In constipation the patient feels severe pain, pressure and a tearing sensation … .The passage above contains some very interesting information. Flatulence and air entrapment within the intestinal loop are sometimes mistakenly diagnosed as kidney pain, a fact that has been pointed out in modern physical examination books .Pain that originates from the right colon and transverse colon pain radiate toward the sub-umbilical region, as is the case in ulcerative colitis. In partial obstruction of recto-sigmoid colon the pain is distributed in the lower left abdominal quadrant .Types of pulses in different diseases:…in pleural infection the pulse is rapid and full, although often it is not completely full, but it is rapid. If the pulse rate is increased it means that the lung is involved… sometimes the patients’ pulse converts to serrated pulse that is not regular and changes, and it is similar to the teeth of a saw… the pulse of persons with lung inflation and infection is small and rapid and moves like a wave… .Tachycardia is a sign of fever, but decreased intravascular volume, hypoxia and pain are some other causes of tachycardia in a patient with cardio-thoracic disease. It could also be an early sign of pleural effusion, pericarditis and myocardial involvements . th century. Such revolutionary thinking established that diseases are not the product of unbalanced humors, but rather originate from organs. Viennese physician Leopold Auenbrugger (1722-1809) started to use the percussion of the chest as a diagnostic tool, an innovation that was later revived by Jean Nicolas Corvisart. Physicians have always tried to examine the diseased organ by using their senses, and with those ideas Joseph Skoda (1805-1881) invented auscultation. A strong connection between physical diagnosis and autopsy later created a great achievement in physical diagnosis , the great physician of Bait-al-Hekma and physician of Caliph al-Ma’mun (813-833 AD). Another important influence on Tabari was Johanna ibn Massavieh, who was also a Persian Christian physician and Gabriel ibn Bakhtisho’s student. He was a renowned physician in the Islamic world during the 9th century and died in 857 AD in Samarra , a great Nestorian physician and translator of Galen’s works from Greek to Arabic and Syriac in the early 9 Samarra .Greco-Roman medicine was preserved and expanded in the Arabic language as it was the lingua franca of the Islamic world during the Dark Ages (500 to 1050) and early Middle Ages. In these centuries Europe entered a period of intellectual darkness while the Islamic world was a sanctuary for scientific ideas to flourish. Ferdous al-Hekma created a new arena for other great medical compendiums to appear in the Islamic world , 13. In In conclusion, Ferdous al-Hekma fil-Tibb (Paradise of Wisdom in Medicine) by Ali ibn Raban Tabari shows the strength and depth of medical knowledge in the early Islamic period. Greco-Roman medical heritage was introduced to the Islamic world and then reentered Europe during the middle Ages, and the achievements in Islamic medicine greatly influenced the modern scientific movements in the following years.


Grounded language acquisition is an important issue, particularly to facilitate human-robot interactions in an intelligent and effective way. The evolutionary and developmental language acquisition are two innovative and important methodologies for the grounding of language in cognitive agents or robots, the aim of which is to address current limitations in robot design. This paper concentrates on these two main modelling methods with the grounding principle for the acquisition of linguistic ability in cognitive agents or robots. This review not only presents a survey of the methodologies and relevant computational cognitive agents or robotic models, but also highlights the advantages and progress of these approaches for the language grounding issue. For the past two and a half decades, computational modelling for linguistic ability of agent or robot has focused on one of the important concerns for a symbol manipulation system to obtain the meaning of words, other than the dictionary style. This concern was pointed out by Harnad  as the sIn order to complement the theory validation necessity of the symbol grounding issue, many language models based on the grounded principle have been presented –12. SomeIf we look at the models from the late 1990s and the early 2000s, some of the early models were developed for scene description, in which phrases and sentences were generated through spatial language and visually grounded object description , 13–15. As described earlier, different aspects have been considered for grounded acquisition of language in cognitive robots or agents. Some models focused on internal motivation and active exploratory behaviour to find developmental factors that favour language acquisition . It has In some models, the symbol grounding phenomenon was inspired by Pastra's two-way  grounding view –22. AccoThis two-way grounding has been illustrated in an automatically built knowledge base, known as the PRAXICON, which consists of a semantic network of embodied concepts and pragmatic relations . There aSiskind  developeOther than the factors and approaches described above, there are two very important methodologies that are adapted to ground symbol in cognitive agents or robots, which are the developmental and evolutionary acquisition of language. These two methodologies are not only important for the grounding of symbols but also useful for advancing robot controller design. In this paper, these two approaches to language grounding in cognitive agents/robots are explained in detail.The paper is arranged as follows: in In this paradigm, cognitive agents or robots with higher-order behaviour emerge from the development and are layered on former ability. Linguistic ability is developed stepwise through direct interaction between the cognitive agents or robots and the social or physical world. The modelling approach for developmental language acquisition presented here is based on the connectionist computation as found in Cangelosi's models , 31–33. The individuality of this grounded approach is that meanings of symbols emerge as a result of the imitation or sensorimotor interaction of agents that occurred for survival purpose. In the models of this approach, the agent's control architecture consists of an artificial neural network. Therefore, meaning has distributed representation, as with hidden unit activation patterns. The neural network models of this approach are designed in this manner, in which all capabilities  of agents are integrated in one architecture and language comprehension, and language production grounds in internal representations. A prototype of neural architecture used in these models is shown in With this design approach, syntactic and semantic structures emerge from the inputted stimuli for training and no explicit rules are used . This apAlthough a number of models have been presented for acquisition of grounding language ability in agents or robots, there are only a few models presented in the developmental language acquisition research paradigm from the last decade until the present , 33, 37.This robotic model was proposed by Cangelosi and Riga . In thisIn the simulation, the teacher agent firstly shows a basic action to the imitator (learner) agent. The teacher robot is manually programmed. The learner robotic agent is equipped with an artificial neural network controller through the direct grounding method and imitation grounds the actions. The learner neural controller with fully connected architecture consists of 26 input units, 8 output units, and one hidden layer which has 8 units. The details of the learner agents' functional modules, neural controller, and the three-dimensional view of robots and environment are shown in In the BG stage, the learner agent mimics the teacher's action. Names of actions are inputted to the learner's neural controller. The learner simultaneously learns the actions with names. This mechanism grounds basic action words. The actions or words like “CLOSE_RIGHT_ARM, OPEN_RIGHT_ARM, LIFT_LEFT_ARM, CLOSE_LEFT_ARM, LIFT_RIGHT_ARM, MOVE_FORWARD, MOVE_BACKWARD and OPEN_LEFT_ARM” are taught during the BG stage.In higher-order grounding stages (HG1 and HG2), the learner receives the user's description of higher-order words and through the grounding transfer mechanism grounds inputted words indirectly, grounded in already acquired basic action words.First, the action word is inputted into the network and output is memorized.Previously memorized action word at output is mapped with higher-order word on input through training.In the next two cycles, steps 1 and 2 are repeated for the second action word.The training details are 50 epochs for the BG stage, 100 epochs for HG1, and 150 epochs for HG2. In this study, the simulation results showed that the agent successfully learned the 6 basic actions and the 3 higher-order words and its knowledge level is enhanced by following quantitative language development stages.As an example, the word “GRAB” with the user's description, “GRAB [is] CLOSE_RIGHT_ARM, CLOSE_LEFT_ARM” is learned by following training cycles:Shared communication systems provide a basis for modelling approaches of language evolution in robots. Communication through language games is widely used and becomes a successfully implemented modelling method for grounding the language in cognitive agents and robots. Language grounding through evaluation is mostly seen in Steels' robot game models –42. A laLanguage games help in solving a symbol grounding problem, as strong contexts constrain the meaning of words and allow robots to find the meaning easily. This approach offers the grounding of the meaning of symbols with contextual knowledge, as well as other aspects of language like embodiment nature and evaluation, through social interactions that could be implemented. Typically, in language games, the interaction between agents/robots is turn taking. Agents can play both roles, as a speaker and hearer. Grounding of symbols can be decomposed into three submethods: (1) sensing and preprocessing of data, (2) categorization of perceptual data, and (3) tagging. Similarly, in the language models, agents perceive the context of objects or actions through their sensors, extract feature vectors, and categorize their meaning. Later, a lexicon is created through topic selection.The sensorimotor stimulation in games could be based on a scene acquired by a camera, with activation of an infrared, sonar, or simple light sensor. Usually, the raw data is processed, in which the region of interest is extracted through an algorithm, which then creates the feature vectors.In categorizing the preprocessed perceptual data in agents or robots, different techniques are used, such as the neural network and discrimination game. Discrimination games are one of the most frequently used methods for the categorization of perceptual data , 45. TheTo summarize, a language game can be defined as follows. After perceiving the context and extracting the feature vector by speaker and hearer, robots would categorize the meaning by using a discrimination game. In the categorization step, the speaker selects one object as the topic of conversation and transforms its conceptualization into an utterance. The hearer must parse the utterance, then reconstruct its meaning, and map it into the hearer's own perceptual experience of the world. Games may fail in cases where diagnostics and repair strategies are used by the speaker and hearer to expand lexicon. Thus, by adjusting and aligning their language systems, they may be more successful in the future.Discrimination games were originally implemented using a binary tree . Other rOne of the important language games used in experiments with robots is a guessing game. In a guessing game, the speaker robot points to an object, while the hearer robot draws attention to the indicated object in the environment. The hearer robot perceives and conceptualizes the situation and tries to guess the speaker's desires. An evaluation of the hearer's guess is made by the speaker robot and corrective feedback is provided in case of a mismatch.Along with the above-described language games, there are also other games, such as the classification game, motion game, naming game, and observational game which have all been implemented in robotic models from a language grounding perspective , 48. EvoIn the next section, an important robotic experiment is discussed, which implements the language evaluation phenomenon in cognitive robots with the grounding principle for action category of words and provides a prototype example for the above-described language game methodology.The game experiment which is presented here is called action game. In action game, which is a situated embodied game, humanoid robots ask each other to perform different bodily actions. In the experiment, they used Sony QRIO humanoid robots  to have Specifically, in the beginning, the robot stood in front of the mirror and acquired the relation between its body image and mirror-based own visual body image, as shown in Since all the robots have the same body structures, they can categorize the body image of the other robots, from the reversal of perspective. In this game, the agents establish and adapt the network that links body representation, action, perception, and language. In this experiment, coordination between agents' visual and motor behaviour is achieved through language and observation in the mirror. This experiment has shown that any type of concept acquisition is possible through a language game even if it is an action word or context property.In this paper, two main approaches of symbol grounding, developmental and evolutionary language acquisition, in cognitive agents or robots are reviewed. The developmental language method adopts a stepwise enhancement of linguistic ability, whereas the evolutionary game models emphasize the acquisition of language, with joint social interactions between agents or robots. It is proven from the survey that both of these approaches provide a solution to the issues relevant to the symbol grounding problem, while advancing robotic communication systems.However, progress continues in both paradigms but at a sluggish speed particularly in the developmental language area. In particular, developmental language models were mainly focused on lexicon acquisition (basic and higher categories) in cognitive agents/robots, whereas in language game models progress could be seen from word acquisition to emergence of grammatical structures. On the contrary, methodological advancement for the robotic platform  can be seen in relevant models in both paradigms, respectively.Indeed, language is a very complex and broad phenomenon; therefore there remains much to work out for the grounding of language in cognitive agents/robotic systems with these approaches.


Several authors have suggested that burned out patients do not form a homogeneous group and that subgroups should be considered. The identification of these subgroups may contribute to a better understanding of the burnout construct and lead to more specific therapeutic interventions. Subgroup analysis may also help clarify whether burnout is a distinct entity and whether subgroups of burnout overlap with other disorders such as depression and chronic fatigue syndrome. In a group of 113 clinically diagnosed burned out patients, levels of fatigue, depression, and anxiety were assessed. In order to identify possible subgroups, we performed a two-step cluster analysis. The analysis revealed two clusters that differed from one another in terms of symptom severity on the three aforementioned measures. Depression appeared to be the strongest predictor of group membership. These results are considered in the light of the scientific debate on whether burnout can be distinguished from depression and whether burnout subtyping is useful. Finally, implications for clinical practice and future research are discussed. Burnout is a stress-related syndrome characterized by exhaustion, cynicism, and reduced perceived job competence PJC; . BurnoutThis criticism on the classification of major depression among other disorders is part of a larger discussion in psychiatry. An increasing number of authors argue that our current way of classification of psychiatric diseases is not sufficient . AlthougThese phenomena may also apply for syndromes like depression, CFS, and burnout. Several studies showed high comorbidity rates for depression, CFS, and burnout ,b. StresSeveral authors have suggested that burnout patients also do not form a homogeneous group and that there are subtypes , or thatFor this study, data of burnout patients who participated in studies on cognitive performance and appraisal of fatigue in burnout were used . ApprovaN = 113) were recruited from mental health centers in the Netherlands, where they asked for treatment for their symptoms. The mean age was 44.4 (SD = 9.0) years old, 60 (53.1 %) were men, 10 (9%) had a low level of education, 51 (45%) a middle level and 52 (46%) had a high level of education. We provided therapists of various mental health organizations with brochures about the research projects and asked them to give these to their patients. When patients wanted to participate, they signed an informed consent form and sent it to the researcher. Subsequently, the patient was invited for a semi-structured interview. For inclusion, patients had to meet: (1) the validated cut-off points  thef points  criteriaf points ; and (4)f points  criteriaf points . In DSM-f points .Unspecified somatoform disorder was established with the Dutch translation  of the MSeverity of burnout symptoms was assessed with the Dutch version of the MBI General Survey , referreThe level of fatigue was assessed with the Dutch version  of the CLevel of depressive symptoms was measured with the 16-item depression subscale of the Dutch adaptation  of the SThe level of anxiety was measured with the anxiety subscale of the Dutch adaptation  of the STable In order to explore relations between burnout, fatigue, depression, and anxiety, basic correlations and correlations corrected for attenuation , betweenThe correlations revealed many signific ant relations between the study variables. Especially depression and anxiety appeared to be strongly related, exhaustion appeared to be related to general fatigue, cynicism, and depression. General level of fatigue was related to depression and anxiety, the CIS subscales were closely related to each other. PJC was negatively related to exhaustion, cynicism, depression, and general level of fatigue.A two-step cluster analysis was conducted with fatigue (CIS), depression (Scl-90), and anxiety (Scl-90) as variables. In the two-step cluster analysis, the number of clusters were not determined in advance, but determined automatically by SPSS on basis of the best fit. Model fit indicated by the average silhouette of cohesion and separation was 0.5, which is considered as good . The anaF = 41.7, p < 0.001, level of depression F = 140.9, p < 0.001, and level of anxiety F = 92.1, p < 0.001, but did not differ from each other regarding, gender, age, and level of education. The most important predictor for group membership appeared to be depression (1.0), followed by anxiety (0.75) and fatigue as least important (0.41). Compared to healthy norm groups, level of fatigue was high in both groups  for the main variables (see Table 2). The effect sizes for all variables were moderate to large  and were distributed normally in the two subgroups . Anxiety and exhaustion are not distributed normally in the initial dataset  as well as in the subgroups . Cynicism and PJC are distributed normally in the initial dataset  as well as in the subgroups .In order to analyze whether the split in the data is done in terms of the distributional properties of the data we performed Shapiro–Wilk’s statistics for the main variables in both the original dataset and in the subgroups. We expected that the main variables would be distributed normally in the subgroups but not in the initial dataset. The analysis revealed that in the initial dataset depression and fatigue were not distributed normally . Depression and anxiety are correlated in both the subgroups  and in the initial sample . Exhaustion and fatigue are correlated in both the subgroups  and in the initial sample . In the initial sample but not in both subgroups a correlation between depression and fatigue  and a correlation between depression and exhaustion  was found.In order to test whether the structure of the subgroups differed from each other and from the initial dataset we calculated correlations between the main variables in the subgroups and compared them with each other and the correlations in the initial dataset . The finding that depression and fatigue were not normally distributed over the initial dataset and were distributed normally in the two subgroups supports the hypothesis that burnout patients do not form a homogeneous group and comprises two subgroups. The large effect sizes for subgroup differences between depression and anxiety suggest that these differences are clinically relevant. The relations between the study-variables were comparable in both subgroups which indicate that the subgroups only differed from each other regarding symptom severity and not regarding structure. Correlations between depression and exhaustion and depression and fatigue were present in the initial sample but not in the subgroups. This finding suggests that in the subgroups, fatigue and depression are not just two related aspects of the burnout syndrome. In the subgroups, level of fatigue is not dependent of level of depression and vice versa. A high level of depression seems to be an additional condition in the severe burnout group.The mild symptom group seems to be a subclinical group  with fatThe differentiation between mild and severe burnout is not new in the literature on burnout. For more than three decades authors have argued that a distinction should be made between a mild form of work stress related psychological h that does not prevent an employee from working and a serious clinically relevant pattern of personal distress and diminished performance which is the end stage of the burnout process. These two types of burnout are mostly referred to as clinical and non-clinical burnout . The cliIn the current study, however, all patients were diagnosed with burnout by a clinician and all patients fulfilled the criteria of clinical burnout as proposed in literature . HoweverIn order to reduce these problems, attempts to improve definitions and categorisations of burnout  should bThe finding that depression is the most important predictor for group membership suggests that the onset of depressive symptoms may be an important factor in exacerbation of symptoms in burnout. This is in line with studies that show that burnout may evolve to depression . HoweverThe very large effect size of the difference between the subgroups on depression (the largest effect size compared to the other measures), underlines the importance of depression for subgroup membership. The differences between the subgroups on the burnout measures were moderate to large, which is much smaller than the differences found in depression, anxiety and fatigue between the two subgroups.As suggested by Besides the relation between burnout and depression, this study also showed a strong relation between depression and anxiety. This finding is in line with many studies  that shoSeveral limitations of the present study need to be addressed. First, although the criteria used in the current study to diagnose burnout have been broadly used in Dutch mental healthcare, they are not recognized in the main international disease classifications (DSM-5 and ICD-10) and therefore remain non-consensual. The generalizability and comparability of our results may therefore be limited to the+ Dutch context. Second, because there are no control groups in this study we do not know whether the subgroups we found are burnout-specific. The absence of well controls has probably led to smaller correlation coefficients between the study-variables. Third, the operationalization of anxiety and depression with the SCL-90 subscales may have affected the comparability of this study with other correlational studies in which specific depression inventories like the BDI-II are used. Although the SCL-90 depression subscale is highly correlated with the BDI-II  it cannoThe results of this study showed that even in a group of burnout patients who are carefully diagnosed by clinicians, subgroups could be distinguished. This suggests that the diagnostic criteria for clinical burnout are problematic. The current way of diagnosing burnout includes patients with mild symptoms and a group with severe symptoms. The mild symptom group seems to be a subclinical group with fatigue as most prominent symptom. The group with severe symptoms is comparable with the psychiatric population with regard to fatigue, depression, and anxiety.AvD was responsible for the data collection, the studydesign, analysis and interpretation of the results.The author declares that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.


Due to low-birth-weight, preterm birth, HIV and/or AIDS and poverty-related factors, South Africa presents with an increased prevalence of infants at risk of language delay. A Kangaroo Mother Care (KMC) unit offers unique opportunities for training.The aim of the present study was to determine if formal, neonatal communication-intervention training had an effect on mothers’ knowledge and communication interaction with their high-risk infants.Three groups of mothers participated: Group 1 was trained whilst practicing KMC; Group 2 was not trained but practiced KMC; and Group 3 was also not trained but practiced sporadic KMC. Ten mothers per group were matched for age, education level and birth order of their infants. The individual training was based on graded sensory stimulation and responsive mother-infant communication interaction, which emphasised talking and singing by the mother.Significant differences were found in mother-infant communication interaction between all three groups, which indicated a positive effect on Group 1 with training. Group 2, KMC without training, also had a positive effect on interaction. However, Group 1 mothers with training demonstrated better knowledge of their infants and were more responsive during interaction than the other two groups.The present study suggests that neonatal communication-intervention training adds value to a KMC programme. In KMC, a neonate is securely carried in an upright position, skin-to-skin, between the mother's breasts. This evolutionary, reclaimed care pattern offers benefits to the infant, the parents and family, healthcare systems, and to speech-language therapy practice.Kangaroo mother care (KMC) has a strong impact and focus on mother-infant communication interaction.1 improves behavioural and state of alertness regulation and may enhance brain organisation and neuromaturation in preterm infants, as sleep patterns are better organised and cyclical.3 Cyclical sleep during the foetal period, and when interrupted by preterm birth, is important for early sensory development.5 The benefits of KMC to the mother include: increased oxytocin levels in herself and her infant, resulting in enhanced lactation and bonding to her new-born infant; and reduced stress, anxiety and postnatal depression.1 Family members, especially fathers and grandmothers, can also participate in kangaroo care.1 Since the neonate is discharged earlier from hospital than with conventional incubator care,6 and the mother is already skilled in caring for the very small baby at home, the family rather than the hospital is central to the infant's caregiving. Research indicates that mothers and families from different cultures worldwide respond spontaneously and favourably to KMC when trained to apply the procedure.7 Although the physical implementation of KMC is only applicable during the first weeks or months of an infant's life, the benefits of the intervention are far reaching.Kangaroo mother care stabilises a neonate's physiological functions,8 As described by ASHA,9 KMC endorses some of the most important principles of early communication-intervention. Similar to early-intervention principles, KMC: is family centred, culturally responsive and developmentally supportive; represents a natural environment of care and prolonged breastfeeding; is team based; starts as early as possible in a child's life; and is supported by high-quality evidence.All the benefits of KMC converge at a point where the ideal opportunity arises for speech-language therapists to intervene early and ameliorate threats to typical language development in high-risk infants. Recent studies have clearly shown that those children born preterm, even those born late preterm, are at risk of language and academic difficulties.6 the unit offers a short period of unique access to mothers and their high-risk neonates. The availability of mothers, who already have an increased interest in their infants as they have been primed by KMC, provides a valuable opportunity for speech-language therapists to start an interdisciplinary communication-intervention programme in a KMC unit  where the intervention procedure is promoted. When mothers and their high-risk neonates are discharged from a KMC unit they disperse to areas where follow-up early intervention services may not be accessible to them. Since the average lodging of a mother and infant in the KMC unit, where the research was conducted, is 13 days,unit see . Nurses tion see . Whilst 4 the period from 25 weeks gestation to 5–6 months postnatal age is most sensitive to the neurosensory development of the auditory system. The developing auditory system requires stimulation by the human voice, language and music during the last 10–12 weeks of foetal life so that the hair cells of the cochlea, the axons of the auditory nerve and the neurons of the auditory cortex are tuned to receive specific frequencies and intensities – a function that can only develop when ambient noise is not louder than 60 dB.4 The foetus appears to receive an ideal signal-to-noise ratio of auditory input in the womb. The effects of noise exposure on preterm infants were demonstrated by evidence of delayed auditory cortex organisation found in mouse pups when reared in the continuous presence of white noise.13 Considering the unique potential of the early human auditory system to make language acquisition possible, there appears to be a balance between stimulation provided by the ambient noise of the maternal heartbeat and blood circulation, other internal and external noises, and the consistency of a single maternal voice heard in utero. The ideal stimulation of the foetal auditory system during the third trimester of pregnancy, provided by the consistency of the mother's voice against vastly different and diffuse background noises, is interrupted by preterm birth. Logic follows that an appropriate ratio of signal-to-noise auditory compensation must be provided in the caregiving environment during the infant's unplanned perinatal period.The importance of appropriate auditory system stimulation in preterm infants is recognised in the literature. According to Graven and Browne,14 it is clear that complex auditory processing starts before birth and that antenatal auditory system stimulation is required. It is hypothesised that the exclusive maternal-caregiving environment created by continuous KMC provides some form of compensatory auditory system stimulation and possibly an appropriate early language-learning environment for preterm infants , University of Pretoria and the Provincial Department of Health gave permission to conduct the study. A research assistant informed prospective participants, in English or Setswana, about the aims and procedures of the study. Participant information brochures were available in English and Setswana, the home language of most of the participants. All participants gave written informed consent to participate in the study and to be video recorded. The infants were in stable conditions when their mothers handled them, and when they were video recorded. The researcher handled none of the infants. After the study, a copy of the video recording was given as an incentive to each participant.A total of 30 participants, forming three groups of ten mothers in each group, were utilised in the study. The two hospitals were tertiary-level public facilities that received patients from surrounding townships, the inner city or rural towns. The participants of Groups 1 and 2 lodged with their infants in the KMC unit of the first hospital, whilst the participants of Group 3 did not stay in the hospital and had to come in from home to visit their infants in the neonatal unit.The three groups were matched according to mothers’ ages, level of education (either primary or secondary school education), and birth order of their infants. The groups were very similar in composition of factors that could relate to experience of motherhood. Prior experience in motherhood, as measured by the number of children of a participant, was an important variable to equalise between the groups, as parental experience could have given participants an unfair advantage over those with no previous parenting experience.As further indicated in Participants were purposely selected to participate in the study. Criteria for selection included that participants had to be mothers of preterm (born before 37 weeks gestation) and low-birth-weight infants (birth weight < 2 500 g), either in a KMC programme (Groups 1 and 2) or in a neonatal unit (Group 3). Mothers of infants who received oxygen at the time of data collection, infants with congenital disorders, and twins were excluded from the study since these variables were considered to be stressors that could have influenced the mother-infant interaction negatively.A participant language proficiency and confidence rating scale was designed to rate the participants’ language proficiency and perceived confidence, respectively. This was done in order to ensure that the participants were not unfairly judged on their English language skills or intimidated by the researcher. The aim was to recruit participants who scored higher than two points on the rating scale. The 4-point rating scale was used by the research assistant and researcher whilst recruiting the participants, and is presented in 16 no state hospital in the area could be found that did not practice KMC at all. The hospital where Group 3 was recruited did not have a KMC unit at the time of data collection, but encouraged mothers to practice KMC when they visited their infants in the neonatal unit. Some mothers in Group 3, therefore, practiced sporadic KMC but did not lodge with their infants in the hospital.Group 1 was selected first. Ten participants received three individual training sessions over 14 days whilst they were practicing KMC. A short interview was conducted with them, before and after their training see . Group 2How do you know?If the response was yes, the following question was asked:When do you think your baby will be able to hear?If no, the following question was asked:Do you think your baby can hear?How do you know?If the response was yes, the following question was asked:When do you think your baby will be able to see?If no, the following question was asked:Do you think your baby can see?How do you know?If yes, the following question was asked:Do you know when your baby is tired/needs a break?How do you know?If yes, the following question was asked:Do you know when your baby is happy?What else can your baby do?Three sets of instruments were used to collect data. The first instrument was a self-designed checklist to record the demographic and biological characteristics of the participants and their infants from the medical files. The second was a self-designed interview schedule to determine participants’ knowledge of their infants’ communication abilities and development. Five main questions with follow-up questions were posed to the participants during the individual interviews:17 was used to rate the participants’ communication interaction with their infants  and vestibular stimulation occurs naturally when the mother is moving.The practice of KMC, as explained by Van Rooyen et al.,The researcher, a speech-language therapist, taught the following two components:18 is to be provided by the mother according to the three developmental stages of preterm infants: turning in, coming out and reciprocity stages.12, 2. When the infant is in the turning in and coming out stages, visual stimuli (attempts to make eye contact with the infant) are kept to a minimum. During these stages, the infant may meet attempts at eye contact with gaze aversion. Auditory stimulation is provided by the mother's own voice when she talks and sings softly to the infant during all three developmental stages. During the reciprocity stage, the visual stimulus of eye contact between mother and infant is gradually added. Singing and talking are maintained, provided that the infant is not over stimulated. As indicated by Graven and Browne,4, the importance of the mother's voice when she talks and sings to the infant is vital.Graded sensory stimulation19 is taught. The mother is trained to: identify stress signs in her infant; reduce the infant's stress by decreasing sensory stimuli, such as noise; hold the infant in the KMC position; only initiate interaction once the infant is regulated and calm. The mother is taught to respond to the infant's subtle cues for readiness to communicate and not to provide intrusive stimulation, as cautioned by Klein and Briggs.17 When the infant is in the reciprocal stage, face-to-face interaction is possible. When stress cues, such as gaze aversion, hiccupping, sneezing, couching, stretching arms and pushing feet are identified, stimulation is reduced and the infant is placed back in the KMC position.Responsive interaction between mother and infantThe material also included the neonatal communication-intervention programme. The interdisciplinary parent-training programme is based on three components:A pilot study was conducted with three mothers to test the instruments and procedures, determine the participants’ level of understanding English and openness to exchange information with the researcher, who did not share the same culture. The pilot participants were found to be very willing to explain their infants’ progress in KMC and wanted new information. The main study proceeded as indicated in The individual communication-interaction training was conducted at each participant's bed by discussing and demonstrating desired behaviours. The researcher identified the infant's developmental stage according to the gestational age and chronological age, and explained it to the mother. Whilst interacting with the infant, the researcher pointed out the infant's hearing responses, eye contact and stress signs to the mother. The mother was gently guided to interact responsively with her infant, whilst encouraging her appropriate behaviours with verbal comments. The training started with the mother's focus of attention, which was usually her infant. The language barriers were managed by adapting vocabulary, following a flexible approach, keeping the conversation interactive, using minimal prompts to encourage the participants and asking open questions instead of questions requiring yes or no answers. With Group 1, after three training sessions over a period of approximately two weeks, a post-training video was recorded. The communication-intervention programme was given to each participant in the form of a handout. Participants of Group 2 and 3 were not trained, but received the handout after their video recordings were made.P-values were calculated by means of the Kruskall-Wallis one-way analysis of variance test or Fischer's exact test in order to determine if differences between the groups were statistically significant. The interviews were transcribed from the video recordings and the ‘yes’, ‘no’ and ‘I don't know’ responses were calculated out of ten. The most representative answer to open questions 1 – 4 was selected and reported in What else can your baby do?) were presented in the results.Standard deviations (s.d.) were calculated to indicate how far the values deviated from the mean. Evidence of the trustworthiness of the study, expressed as confirmability and internal validity, is as follows: each video recording was analysed three times by the researcher, and 33% of the recordings were analysed by a second rater, for whom the groups were concealed. The average of the ratings was calculated. Data were collected consecutively after Group 1 had been discharged, so that Groups 1 and 2 could not contaminate each other, as participants were selected from the same KMC unit. The objective was dependability, or a refined understanding of the setting. Language and cultural differences were recognised, strategies were applied to be culturally sensitive, to communicate effectively, and to allow trust and spontaneity to develop between the researcher and participants.The first result describes the participants’ language proficiency and confidence, after which the differences in knowledge, mother-infant communication interaction and behaviour types with and without training will be presented.p-values indicate no statistical differences between the three groups, for the variables of age, educational level and the number of children , demonstrated an understanding of neonatal listening and visual abilities, and knew about stress signs in their infants, as opposed to before the training.According to Group 2 gave similar accounts of their infants to Group 1 without training, as both groups were conducting KMC without additional training at that stage. Without training, both groups were mostly sure that their infants could hear, were ambivalent about their infants’ vision and stress cues, and were mostly certain when their infants were content. Groups 1 and 2 practiced continuous KMC and gave better answers during the interview than Group 3. Participants in Group 3, who practiced sporadic KMC, could hardly describe their infants’ sensory abilities, cues and behaviours. The difference in knowledge of the infants between the two groups practicing continuous KMC, and the third group conducting KMC only sporadically, may indicate the positive effect of KMC on the first two groups with regards to understanding their infants’ behaviour. The fact that Groups 1 and 3 knew their infants longer than Group 2 , displaying pleasure (Items 2 and 5), and responding contingently to the infant . The participants in Group 1 almost always positioned themselves so that the infant was able to make eye contact, talked ‘motherese’ to the infant by varying the pitch and tone of their voices, and encouraged conversation with the infant. Again, Group 1 and 2 showed better scores than Group 3. The age difference in the infants and the longer time spent with their infants in KMC could have advantaged Group 1 ; looks at infant; smiles at infant; kisses infant; wipes infant's mouth; changes nappy; feeds infant; talks to infant; strokes infant; covers infant with blanket; caresses infant; tickles infant; picks fluff from infant's blanket; adjusts blanket; adjusts infant's nasogastric tube; opens infant's blanket; pats infant gently.20 although it was not explicitly taught to them. One of the mothers in Group 1 softly sang a praise song, a traditional chant of ancestral names, to her infant.As can be seen from these observations, the participants demonstrated a wide range of natural and spontaneous behaviours with their infants whilst the videos were recorded. It appeared that the participants were not inhibited by the unnatural communication-interaction context created by a video recording. The participants who talked to their infants demonstrated the typical features of ‘motherese’, as described by Gleitman, Newport and Gleitman,On three different measures , Group 1 (who practiced continuous KMC and received training in communication interaction with their infants) showed consistently better results with training. On average, the participants in Group 1 showed a high prevalence of communication-facilitating behaviours whilst interacting with their infants. It appears that, despite language and cultural differences between participants and trainer, the training had a direct, positive effect on the participants.21The significant differences on all measures between Group 2 and 3 (who did not receive training) may indicate that KMC without any explicit communication-interaction training may also have a positive effect on the participants’ knowledge, mother-infant communication interaction and types of behaviours. The finding is supported by numerous studies indicating the positive effect of KMC on mother-infant communication interaction during the neonatal period and beyond.22 and experienced by mothers.It appears that the formal neonatal communication-intervention training made a difference to the participants’ knowledge of their infants. The lack of knowledge amongst all participants  points to a crisis of information about their children's development, as stated by GuralnickThe results are interpreted with caution, since a small sample of 30 participants was utilised. It was also not possible to randomly allocate the participants to different groups, as trainee participants could not be removed from those who were untrained. The 20-bed KMC unit where the research was conducted is in the form of a dormitory, with mothers continuously in close contact with one another. Therefore, the participants who were untrained would have observed the training and could have copied behaviours seen in the trained participants. The results indicate only the short-term effects of the interdisciplinary neonatal communication-intervention programme on the mothers and not their infants’ development, and no long-term outcomes can be deduced.Confounding factors could include that the groups were not matched for the infants’ ages, or the number of days in KMC or in the neonatal unit. The participants in Group 1 knew the researcher well due to the three training sessions, and the familiarity with the context could have given this group an unfair advantage over the other groups who only met the researcher once. The results could have been more robust if a fourth group of participants had been included in the hospital that did not routinely practice KMC. The fourth group should have received training without conducting KMC, thereby isolating the impact of the training programme. As only mothers who could communicate well in English were selected for the study, the transferability of the results is limited.The positive results of Group 1 with training may indicate that the neonatal communication-interaction programme adds value to the evidence-based practice of KMC in the hospital where the training was conducted, and should become part of the routine KMC programme. The challenge ahead is to implement the training programme on a sustainable basis. Further research should determine the long-term effects of the training programme and determine the effects on both the mother-infant communication interaction and infant auditory, speech and language development.


Dysmenorrhea is a common menstrual complaint among adolescent girls and women of reproductive age. The treatment of dysmenorrhea is typically selected from multidisciplinary options, including complementary and alternative medicine such as acupuncture and moxibustion. However, there are few published randomized controlled trials concerning moxibustion treatment for dysmenorrhea. This trial aims to investigate the efficacy and safety of moxibustion for primary dysmenorrhea, and to identify the optimal time of moxibustion treatment for primary dysmenorrhea.Sanyinjiao (SP6) and Guanyuan (CV4), while the waiting list group will not receive moxibustion treatment until the completion of the study. The trial period will consist of three baseline menstrual cycles, three menstrual cycles of treatment, and three menstrual cycles in the follow-up period. The primary outcome will be measured by changes in the Cox Menstrual Symptom Scale and the secondary outcomes will be measured using the Visual Analogue Scale, Cox Retrospective Symptom Scale, diary entries, the Self-rating Depression Scale, and the Self-rating Anxiety Scale. The safety of moxibustion will be assessed at every visit.This protocol is for a randomized controlled trial in which the assessor and statistician will be blinded. A total of 222 eligible patients with dysmenorrhea will be randomly assigned to three groups in a 1:1:1 ratio as treatment group A (treated before menstruation onset), treatment group B (treated at the onset of menstruation), or control group C (waiting list group). The participants assigned to the treatment groups will receive suspended moxibustion treatment at This trial aims to assess the effectiveness and safety of moxibustion for primary dysmenorrhea, as well as to determine whether the optimal time of treatment for primary dysmenorrhea in clinical practice is before or after the onset of menstrual pain.ChiCTR-TRC-14004627, registered on 9 May 2014.Chinese Clinical Trial Register:  Dysmenorrhea is a common menstrual complaint among adolescent girls and women of reproductive age . It usuaDysmenorrhea has a significant impact on women’s lives and represents a substantial public health burden -6. SeverArtemisia vulgaris) near acupuncture points to cause a warm and painless sensation [Qi circulation in the uterus. The pathological factors are mostly dampness, blood stasis, and Qi obstructions. Moxibustion as a therapy features on the effect of heat and Artemisia argyi, and thus can improve blood circulation in the uterus and its surrounding veins, and also help to absorb local pathological discharges in patients with PD. It is considered effective in resolving blood stagnation, Qi stagnation, and discomposing cold-damp coagulation, leading to an improved health state [Moxibustion is widely used in Asian countries as a part of Traditional Chinese Medicine (TCM). It is a thermal treatment that involves placing ignited material  that aims to assess the efficacy and safety of moxibustion, and to determine whether the optimal time of treatment for PD is preventively or after menstrual pain begins.This RCT will be conducted in a single center, with the assessor and statistician blinded to treatment allocation. A total of 222 patients diagnosed with PD in accordance with the Clinical Guidelines of Primary Dysmenorrhea by the Society of Obstetricians and Gynecologists of Canada will be enrolled in this trial . The whoThere will be three strategies for PD patient recruitment. First, participants will be recruited from the outpatient and inpatient department of the Third Teaching Hospital of Chengdu University of TCM. Second, printed recruitment posters will be distributed in public clinics and nearby communities. Third, advertisements will be published in the campuses of Chengdu University of TCM, Sichuan University, Southwest University of Nationalities and Southwest Universities of Finance and Economics, and Sichuan Vocational and Technical College of Communications.Aged from 18 to 30 years without history of delivery,Normal menstrual cycle (28 ± seven days) during the last three months,Diagnosed with PD according to the Primary Dysmenorrhea Consensus Guidelines ,Qi and blood, or retention of cold-damp coagulation ,Agree to keep a dysmenorrhea diary during the study period, andAgree with all procedures in this trial by signing a written informed consent form.Participants meeting the following criteria will be included:Secondary dysmenorrhea caused by endometriosis, uterine myoma, endometrial polyps, pelvic inflammatory disease, or other gynecological problems confirmed by a gynecological abdominal ultrasound B examination;Serious contraindications ;Any other condition that the investigator judges as likely to make the patient unable to complete, comply, or unsuitable for the study;Uncontrolled diagnosed psychiatric disorders;Intent to have a baby during any period of the trial;Having taken antidepressants, anti-serotonin, barbiturates, or psychotropic drugs in the previous two weeks; orCurrently receiving or having received any other treatment for PD in the previous three months.Participants meeting one or more of the following criteria will be excluded:A previous study found that the mean on the Cox Menstrual Symptom Scale (CMSS) of PD patients after moxibustion was 1.62 . The aveThis study protocol was reviewed and approved by the Institutional Review Board of the Teaching Hospital of Chengdu University of Traditional Chinese Medicine in February 2014 . The present study was financially supported by the National Natural Science Foundation of China and the trial was registered in Chinese Clinical Trials Registry with the identifier number ChiCTR-TRC-14004627. Prior to undertaking any study-related procedures, all participants will provide written informed consent.An independent assessor will initially assess each potential participant according to the inclusion and exclusion criteria. After completing a screening test, participants will enter a baseline period of three months  without moxibustion treatment, during which they will be asked to record menstrual pain and use of acute medication in a dysmenorrhea diary.After participants have completed a baseline evaluation, eligible subjects will be randomly classified into three groups: treatment group A (treated before menstruation), treatment group B (treated as the onset of menstruation), and control group C (waiting list group). A computer-generated, blocked random allocation sequence will be generated with SAS software . Another research coordinator who is not involved with data collection will provide the random number and group assignment immediately to the independent assessor in opaque, sealed envelopes. This procedure guarantees that randomization concealment is adequate, and not influenced by the acupuncturists or participants. Random allocation will be performed after the first visit to participants who provide informed consent and meet the inclusion criteria. If a participant is eligible to be included in the study, the researcher will open the corresponding envelope in front of the participant. The envelopes will be opened only after the enrolled participants have completed all baseline assessments.Figure Double blinding of the clinician and patient is unfeasible owing to the unique nature of moxibustion operations. However, to ensure the integrity of the trial, the researchers will not assess the efficacy of treatment to avoid misleading the patients and inducing potential impacts on the compliance and outcome measurements. The therapist, the assessors of therapeutic effect, the data manager, and the statistician will be separated. Moreover, according to the principle of blinding, only patients allocated to the waiting list group will be told to wait for free treatments at the end of the study; allocation information will be strictly withheld from patients in the other two groups.Acupuncturists must receive a license from the Ministry of Health of the People’s Republic of China and take an educational course to ensure their strict adherence to and familiarity with the study before they become eligible to treat patients in this study. Those participants allocated to a treatment group will be requested to attend (with their partner or support person if available) a training course and demonstration session by their tutors. The training course involves advice, demonstration of moxibustion, and instructions on how to do moxibustion safely at home. The woman or her partner or support person will be trained to light the moxibustion sticks and to hold an individual stick 2.5 to 3 cm above the two acupoints (SP6 and CV4). The participants will be told not to make the acupoints uncomfortable during treatment. They will be requested to perform this treatment for five to 10 minutes on each acupoint once a day for five to seven consecutive days, and will be supplied with sufficient moxibustion sticks to do so in each treatment period.Sanyinjiao (SP6) and Guanyuan (CV4) are the most common acupoints used in PD treatment. SP6 is the convergent point of the spleen, liver, and kidney meridians according to TCM, and is closely related to the lower abdomen and uterus [Qi, and can exert a regulatory effect on the uterus because of its role of providing power to vital movement. Moxibustion at CV4 can treat dysmenorrhea because of its function of warming the conception vessel meridian, tonifying vital Qi, and promoting blood circulation to remove blood stasis.The moxibustion treatment protocol to be used is consistent with the principles of traditional moxibustion theories. These principles state that the most common causes of dysmenorrhea in TCM are blood stagnation and cold-damp coagulation in the uterus. According to previous surveys and expert consultations, d uterus . This maArtemisia vulgaris, Z32021062, Oriental Moxa Co., Suzhou, China) at acupoints SP6 and CV4 to patients in a supine position. The moxa roll is prepared by wrapping mugwort wool  with a piece of a paper. It is cylindrical, 1.5 cm in diameter, and 20 cm in length. A lighted moxa roll will be held 2.5 to 3 cm above the acupoint and moved upwards and downwards, to the left and right, or around. The patient should feel warmth but not scorching heat. Each point will be treated with moxibustion for five to 10 minutes.Group A will be treated five days before expected menstrual onset and treatment will continue until menstruation begins. However, the subjects’ menstrual cycles may change and so the actual period of treatment will be five to seven days. The treatment will be the application of a moxa stick  is a measurement of menstrual symptoms that has been shown to have high reliability, validity, and sensitivity . It giveThe women will be provided with dysmenorrhea diaries to record the specific time of menstrual pain attacks, the duration of dysmenorrhea, the associated phenomena, and any medication used. This information will be recorded daily during every menstrual cycle of the three study periods. All patients will be carefully instructed on how to use this diary to rate their symptoms. The dysmenorrhea diary will be used during baseline measurements and during the first, second, third, fourth, fifth, and sixth menstrual cycle after inclusion.The Self-rating Depression Scale (SDS) is a 20-item self-reporting questionnaire on the symptoms of depression. Subjects rate each item according to how they felt during the preceding seven days. Item responses are ranked from one to four. The sum of the 20 items produces a score between 20 and 80, with a score of greater than 40 suggesting clinically relevant depression . The SDSThe Self-rating Anxiety Scale (SAS) has been widely used in research and in clinical practice for the detection of anxiety . It alsoThe follow-up assessment is designed to evaluate the long-term effects of moxibustion. Upon completion of treatment, follow-up assessments will be conducted at the fourth, fifth, and sixth menstrual cycle after inclusion, lasting three menstrual cycles. In addition, patients will keep the daily dysmenorrhea diary and complete the CMSS and VAS measurements during every menstrual cycle in the follow-up period. Patients will send the relevant information to researchers immediately via email or short message service. To encourage participant compliance, we will show special solicitude for every participant and closely monitor the evolution of their illness.No record can be missed or omitted in the original data source. Any corrections should be explained in the appended notes signed and dated by the physicians participating in the clinical trial; primary entries are not allowed to be changed. After the observation of a clinical case, case report form (CRF) files will be submitted to the project directors for verification and signing by supervisors.Data input will be done separately by two data collectors with computers and locked once the checking work is done. The data manager will clarify any questions regarding the CRF with the researchers through clinical supervisors. Researchers should answer any questions as soon as possible so that the data manager can conduct the modification, validation, and entry of the data.P <0.05. Considering that the efficacy might be affected by factors such as age, age of menarche, and course of disease, all factors will be considered as co-variants for covariance analysis or logistic regression analysis when comparisons among groups are made. Missing data will be replaced according to the principle of multiple imputations.A statistician blinded to the whole trial process will perform the statistical analysis using the SAS statistical software package  in the Computer Integrated Manufacturing System. For the evaluation of curative effect in this trial, the per protocol set (PPS) will be used. The full analysis set (FAS) is determined according to an intention-to-treat population; all patients who are randomized and receive at least one treatment session will be included in the analysis set. The PPS is defined as the patients who complete the study and do not have major protocol violations. Demographic data and other basic indicators will be analyzed to test the balance of the three groups at baseline. The main indicators and global indicators will be analyzed within the FAS and PPS. The results will be described with the mean, standard deviation, median, P25 (Percentile 25), P75 (Percentile75), maximum, and minimum values of the differences between the treatment period and the baseline period. Between-group differences will be tested using repeated measure analyses of variance. The accepted level of significance for all analyses was Possible adverse events (AEs) due to moxibustion include blisters, redness, itching, burns, and respiratory symptoms. All unexpected and unintended responses will be reported as AEs by the researcher at every visit, even if they are not necessarily related to moxibustion intervention. The AEs will be carefully recorded in the CRF by the corresponding research staff.This proposed trial is a randomized, controlled clinical trial with separation of the practitioner, assessor, and statistician. The aims of this trial are to evaluate the efficacy and safety of moxibustion for treating PD, and to identify the optimal interventional time of moxibustion for PD treatment.DeQi appears. Selection of optimal acupoints for PD plays an important role in moxibustion treatment effectiveness. In practice, the treatment effect of moxibustion is affected by many other influential factors, including the intensity of heat stimulation, the ingredients of the moxa pillar, and the moxibustion sensations experienced. The most important factor contributing to the effectiveness of moxibustion is thought to be the selection of proper interventional time. However, in existing studies, interventional timing of moxibustion was not included as a key variant to be assessed.The form of moxibustion used in this trial will be suspended moxibustion treatment. When suspended moxibustion is applied to acupoints, the patient will have non-local or non-superficial heat sensation, such as penetrating heat, expanding heat, and transmitting heat, as In another undergoing study, we mainly focused on the effectiveness of moxibustion for pain relief in PD, which can be referred to the published protocol . As to tIn addition, our study may also have the following strengths which will be potential points of discussion in the final reports. The dysmenorrhea diaries will be used to record the symptoms and management of menstrual pain in every menstrual cycle; these diaries are important for quality monitoring of the recurrence of new PD episodes. Besides the evident physical concerns, PD may be particularly disruptive to adolescent girls and women who experience mood fluctuations, such as depression or anxiety. There is increasing evidence that psychological disorders coexist with dysmenorrhea, and these conditions may synchronize with menstrual pain. The question remains whether anxiety and depression make women prone to suffering from dysmenorrhea, or whether dysmenorrhea causes anxiety and depression. We believe that women with mood changes tend to have lowered pain thresholds compared with mentally healthy women. Anxiety and depression disrupt patients’ experiences, expressions, behaviors, and pain-coping responses. Therefore, a better understanding of the relationship between psychological characteristics and PD is crucial to the assessment of the effectiveness of moxibustion as a treatment for PD. Hence, we will apply the SAS and the SDS to examine the link between PD and psychological symptoms of depression and anxiety among dysmenorrhea sufferers.On the other hand, there are also limitations to this study. Concealment is the most critical factor in the allocation process, with a high risk of bias possibly generated by unconcealed allocation . One limIt is believed that this trial will provide good evidence to demonstrate the efficacy and safety of moxibustion for patients with PD. Moreover, it will be of great significance for clinical practice to identify an optimal moxibustion treatment time for PD.The trial is currently in the recruitment phase. Participant recruitment started in June 2014, and is expected to end in September 2015.