No

INTRODUCTION:

% =Percentage,     n= Individual type of sample,  N=Total number of sample,      AK= Amikacin (R =>22 mm),    CRO= Ceftriaxone (R=>21 mm),     CTX=Cefotaxime (R=>22 mm),    SCF= Sulzone (R= > 20 mm) (Cefapeozone+Sulbactum), MEM=Meropenam (R= >18 mm), CIP=Ciprofloxacin (R= > 21mm),     FOS=Fosfomycin (R= > 18mm ),    µgms= micro grams, S= sensitive

Introduction

The herniation of a gravid uterus through an incisional hernia site is a rare occurrence. Incisional hernia is a frequent complication of abdominal wall closure and the management of pregnancy with a large incisional hernia with gravid uterus in its sac is challenging. The following is a case report of gravid uterus through an incisional hernia of a midline incision. Case Report
 Mrs LB, 35 years, Parity 2, period of amenorrhea of 34 weeks 3 days, married for 12 years was admitted to the hospital from the outpatient department due to  the ulceration of abdominal skin as a result of herniation of gravid uterus through the midline longitudinal incision of a previous caesarean section . She was a booked case of our hospital and had been receivingantenatal care since 20 weeks of gestation. At 20 weeks  there was no herniation of the uterus through the incision line. In her subsequent visits she came with the uterus protruding through the incisional hernia. She was referred to the General Surgeon who recommended elective Caesarean section with repair of hernia. Her past obstetric history revealed that she had her first emergency caesarean section eight years before because of a breech presentation and a second caesarean section, due to thepremature rupture of membranes at term. Both the babies were living & well. On both occasions she was operated on through infra umbilical midline vertical incision. There was no history of caesarean section wound infection during the post operative period in the previous two pregnancies. On examination, she was moderately built and adequately nourished. There was mild pallor. Her pulse rate was 88 beats per minute and her blood pressure was 126/86 mm Hg. Heart and chest were normal. Abdominal examination revealed distention of the abdomen in thecentral area. The uterus was felt just underneath the skin with acomplete lack of anterior abdominal wall. (Figure I)   Figure 1- Photograph showing gravid uterus lying in the incisional hernia sac The overlying skin was necrosed with evidence of ulceration and the presence of engorged veins. The fetus was lying in the herniated gravid uterus outside the abdominal cavity. Routine investigations were within normal limits. Ultrasound examination showed the uterus herniated in the incisional hernia of the anterior abdominal wall with the live fetus in cephalic presentation without any gross congenital malformation. The placenta was located in the upper uterine segment. She was kept in the hospital for bed rest with abdominal support. Emollients & antiseptic skin ointment were applied over the skin of the anterior abdominal wall. An elective caesarean section was planned for 37 weeks but she went into labour at 36 weeks. The abdomen was opened by elliptical incision. The uterus was visualized just beneath the skin and there was no evidence of the rectus sheath in the vicinity of the incision. A uterineincision was made over the previous caesarean scar and the baby was delivered with APGAR 7/10 at 1 minute and 9/10 at 5 minutes. The uterus was repaired in layers and a bilateral tubal ligation was done. Herniorraphy was performed in double buttress fashion. She was given a course of antibiotics. Her post operative period was uneventful and she went home with a healthy baby weighing 2.25 Kg. During her follow up visits she was found to be problem free. Discussion The remote complication of a caesarean section could be an incisional hernia due to defective abdominal wound healing and herniation of gravid uterus through the abdominal wall. This is a rare complication.¹ The complications that have been reported in literature in association with this complication include strangulation, abortion, pre-term labour, accidental haemorrhage, intrauterine fetal death and rupture of the lower uterine segment.²  Excessive stretching of the skin may cause ulceration of the skin as in this present case due to friction between the hernia sac and other parts of the patient’s body. Caesarean section should be performed and herniorrhaphy can be performed during the caesarean section as in the present case.¹ Herniorrhaphy can be performed during pregnancy if there is evidence of morbid incarceration or the skin is necrosed.³  However, herniorrhaphy can be postponed until delivery, as the enlarged uterus may interfere with healing of the repair.

Introduction: The aim of the NHS Modernisation Agency’s Hospital at night project is to “Redefine how medical cover is provided in hospitals during the out of hours period.”⁽¹⁾ The project “requires a move from cover requirements defined by  professional demarcation and grade, to cover defined by competency in order to release significant amounts of medical staff time and support the compliance with WTD (Working Time Directive) while enhancing clinical practice and training.”⁽¹⁾ Chairman of the BMA’s Junior Doctors Committee and also medical advisor to the Hospital at Night Project undertook a survey of  junior doctors’ activity in the evening, night, and weekends. They noted that the evenings were very busy and the nights quieter, that general physicians work harder at night than those in other specialties or orthopaedic surgeons. In summary their survey showed that a huge amount of doctors’ time was wasted on tasks which did not require their level of skills. Such tasks included phlebotomy, searching for notes, and x-rays.⁽¹⁾  An evaluation report into the implementation and impact of the hospital at night pilot project, August 2005, identified key elements to minimize medical workload at night. These included working within a multidisciplinary, competency-based team, with extended skills ward staff to minimize reliance on the night team, reduce duplication, take away inappropriate tasks, bleep-filtering and better use of new technologies such as digital imaging and e-prescribing ⁽²⁾. Our aim was to assess the experience of a typical junior orthopaedic doctor’s experience during his on-call to assess their perspective of the implementation of hospital at nightand to establish whether the recommendations of the evaluation report were being implemented. Methods: A prospective review was conducted of the night duties of all junior doctors working or cross-covering trauma and orthopaedics across Frenchay and Southmead hospital sites of the North Bristol NHS Trust between December 2007 and January 2008.A questionnaire included nature of activity and level of experience, closed questions relating to the hand-over experience. Details of calls received and the nature of tasks undertaken during on-call period with times. Data were then stored and analysed using excel-office 2002. Results: Total of 51 questionnaires were completed by the junior orthopaedic doctors during their respective on-call duties. A total of 109 calls were received or tasks requested. The average time spent during hand-over was 14.1 minutes (range 5-20 minutes).  Discussion: Our data indicates busiest times occurred between 21:00 – 23:00 (Fig 1)  Figure 1, illustrates a distribution of the peak work-load period which occurred between 9pm-11pm and 1am-3am. This finding contradicts previous surveys done prior to the implementation of the hospital at night where it was noted that the nights were quieter and sub-specialist such as orthopaedic surgeons were not working as hard as general medics ⁽¹⁾. Figure 2, shows the overall experience of the hand-over as judged by the orthopaedic juniors. There was an eighty-five percent (43/51) attendance by the on-call orthopaedic juniors of which seventy-two percent (32/44) thought that it was a useful experience Figure 3 illustrates a distribution of the calls received. As illustrated, 37/109 calls were viewed as inappropriate The majority of the orthopaedic juniors surveyed framed hospital-at-night hand-over was useful but thirty-four percent (37/109) of the calls they received were viewed as inappropriate (Fig 2,3). The most frequent of the inappropriate ward calls were ‘requests to rewrite drug-charts’ (Fig 4,5). Figure 4 describes the frequencies of these calls. As illustrated the most frequently inappropriate ward-call was to ‘rewrite drug-charts’. There were twenty-three (23/37) inappropriate ward-calls Figure 5 shows the reasons given by the on-call doctors for the inappropriate tasks. The most frequently given reason was that ‘the request should have been done during the day’. The second most frequently given reason for inappropriate calls was the fact that ‘it was a duplicated request’ Our survey also highlighted that the most frequently given reason for inappropriate tasks was firstly that the request should have been done during the day and secondly that it was a duplicated request. These findings seem to defeat the key purpose of the hospital-at-night project for an orthopaedic SHO on-call.  Conclusion: Hospital at night cannot function in isolation. There are fewer doctors available then normally and the system has to use their time effectively. 30% of inappropriate calls to wards were to rewrite drug charts and to prescribe warfarin. This should have been identified and performed by the day staff. 10% of calls were to review X-rays.  Much of the inappropriate activity could be pre-empted if both day and night staff attended the handover and the tasks outstanding from the day identified. The doctor on the night could then perform an hourly ward round completing these tasks without interrupting at the beginning of the night.

IntroductionHospital inpatient falls have remained the subject of extensive research and intervention over the past 55 years¹. Despite risk factor identification, multiple prediction system developments and harm reducing technologies, the issue of falls remains. The incidence of falls varies between 2.2 and 14 per 1000 patient days ^2,3 and increases with age ⁴. In the UK’s National Health Service, 32% of adverse incident reports are due to falls ² . In 2007 it reported 200,000 inpatient falls to the National Patient Safety Association ⁵. Whilst most patients (96%) came to no harm or minor harm, they estimated that over 500 hip fractures and 26 deaths resulted from these falls.Inpatient falls lead to greater morbidity and mortality than equivalent fractures in the community, ⁶ and they significantly increase the length of stay in hospital⁷. Apart from physical harm, there are also psychological consequences for patients such as anxiety, loss of confidence, and fear of falling ⁴. The risk of falls leads to a conundrum in rehabilitative care. Ideally, patients’ mobility, autonomy and dignity must be encouraged and respected - yet slips, trips and falls must be pre-empted often with varying degrees of intrusion and even restraint. In order to selectively target individual patients who would benefit from closer attention, many risk stratification tools have been developed to predict potential fallers. They were developed on a background of over 400 independent risk factors identified with falls ⁸. The most prominent in the UK are STRATIFY (St Thomas's risk assessment tool in falling elderlyinpatients) and Downton with the recent addition of the Wandering Behaviour Assessment ⁸. STRATIFY ⁴ was designed to be used once per week and assesses 5 factors –falls history, patient agitation, visual impairment that limits daily function, frequent toileting, and a transfer or mobility score of 3 or 4 . Each factor scores 1 point and a score greater than 2 was found to have a 92% sensitivity and 68% specificity for a fall in the following week. In the Wandering Behaviour study the STRATIFY criteria results were not reproduced and were found to have only an 82% sensitivity and 34% specificity in their study population ⁸. Downton ⁹ also has 5 categories of assessment; falls history, medication subtypes, audio-visual-sensory deficits, mental state (using the Mini Mental State Score <24) and stability of gait. Each category scores 1 point and a score of greater than 3 is considered significant. In the Wandering Behaviour study, when applying the Downton criteria they only found an 82% sensitivity and 36% specificity ⁸. The Wandering Behaviour assessment looks for the presence of the following :checking, pottering, aimless walking, walking with inappropriate purpose, walking with appropriate purpose but inappropriate frequency, excessive activity, night-time walking, attempts to leave the hospital and being brought back to hospital. The presence of any one of these was found to have a sensitivity of 43% but specificity of 91% ⁸. Thus, both STRATIFY and Downton are limited by the multi-disciplinary assessments required, so that even when implemented, it is difficult to repeat them on a daily or weekly basis. The Wandering Score is easily repeatable on a daily basis, but lacks the sensitivity of STRATIFY and Downton ⁸. The aim of this study is to investigate whether changes in a patient’s physiology can be predictive of falls risk, and if so, can they become a useful tool for calculating risk?  The reason why we have chosen to investigate this is that many of the commonly encountered risk factors can potentially be reflected in the patient’s routine observations ¹⁰. For example, fever could indicate infection and delirium. Hypotension could result from anti-hypertensives, sedatives, or dehydration. Hypertensive states could result from stroke, stress response to infection, or even be a surrogate marker of cardiovascular disease predisposing to arrhythmias. Blood pressure variation could also be predictive since dynamic orthostatic challenges such as lying and standing blood pressure measurements are known to predict falls ¹⁰. Thus, by measuring fluctuations in the observations we hypothesised that it may be possible to make an accurate short term prediction of falls risk MethodsSubjectsWe obtained consent for this retrospective study from the hospital’s ethics committee. We based this study in the Acute Medical Unit of our hospital, as it has the largest case mix of patients recently admitted and is therefore most likely to have the largest physiological instability. We aimed to detect a mean difference of 10% in the physiological variability prior to falling with 80% power, p-value < 0.05, and a common standard deviation of  5 %. Our power calculation indicated that we needed to study 12 patients. We identified all the falls in the calendar year of 2008 by examining the records of all the incident report forms submitted by the ward. A total of 33 incident reports related to falls were logged. Two reports related to staff slips and trips and were excluded, and a third incident report failed to adequately identify either the patient’s name, date of birth or hospital number and so had to be excluded. One of the 30 patients fell twice, and this was treated as its own incident as with the STRATIFY paper. The incident report forms were also used to identify the time, nature, and outcome of the fall. Of all the case notes related to the 30 falls requested from medical records, only 13 were available for detailed review. MeasurementsHeart rate (HR), Blood Pressure (BP), Temperature and Respiratory Rates were all recorded and analysed. The PAR (Patient at Risk) Score as calculated by the nursing staff was included too. PAR Scores are validated mechanisms of identifying sick patients who may go on to develop deterioration to the point of requiring Intensive Care. Scores of >3 are associated with a high risk of deteriorating health and are calculated using the routine nursing observations set. Oxygen saturations were not included in this study, as even small deviations tend to be rapidly corrected by staff with oxygen and therefore were not thought to be a useful marker. Recordings of blood pressure and heart rate were all done with ward based equipment. It is impossible to know which machines were used on individual patients as the equipment has varied, both over the course of time, and between multiple wards. However, because the subjects were their own controls, we are confident that the same machine and cuff were used for taking all the 12 hour recordings as each individual machine is allocated to a given bay. Blood pressures were obtained using semi-automatic Dynamap equipment,   therefore the readings are in effect calculated from the Mean Arterial Pressure (MAP). We elected to study the systolic readings only, as this represents the maximum perfusion pressure to the brain and carotid sinus. Two of the thirteen patients were known to have undergone orthostatic challenges as part of their admission work up and these were included. Other parameters recorded included the time of the fall, number of medications on the drug chart, whether the fall was observed and any injuries sustained.  ControlsWe had two sets of controls. The first set was used to compare the age and gender profile of the fallers to those of the general adult admissions. We had to do this because the official hospital statistics included obstetric and paediatric admissions and comparison would have been inaccurate. We therefore took 4 random days’ of acute adult medical admissions (i.e. over the age of 18) in order to compile an age and gender profile of patients admitted with a ratio of 4:1 (n=110). In order to compare the variability in physiological parameters between fallers and non fallers we generated a second set of controls matched for age (± 5 years) and gender in a ratio of 4 to 1 from a random week’s cohort of patients in February 2009 (for practical purposes). For each matched control, recordings were made at the equivalent length of stay and the controls were not known to have previously fallen. The patients were taken from across the hospital’s medical wards (not Intensive Care or Surgical) with their diagnosis blinded from the investigators. We were able to match 47 of the 52 controls that we were aiming for. Only  BP and HR data were recorded in the controls, as we already established that temperature and respiratory rate were not sensitive markers from our faller data. StatisticsOur 13 patients allowed us to reach sufficient statistical power of 80%. Physiological parameters were tested within groups using the Students t-test (paired, two tailed) and when comparing to controls using the Students t-test (unpaired, two tailed). The null hypothesis were rejected when p<0.05. Variability in heart rate, temperature, respiratory rate and PAR (Patient At Risk Score) were calculated using the mean, range and standard deviation between maximum and minimum values. Blood pressure variability was measured by using the maximum and minimum systolic pressure and calculating the mean, range and standard deviation. We have chosen to primarily measure variability by the range as it is a simple calculation that can be done by anyone on a ward. It doesn’t require a calculator nor any detailed knowledge of mathematics. It is therefore an effective and repeatable measure which could be easily implemented as part of a scoring system. Data processing and Statistical Analyses was done in MS Excel 2002 and SPSS v.14. ResultsThe mean age of fallers was 79 years old (SD 16, n=30) and of the acute medical admission controls 67 years old (SD 20, n=110) with p=0.003. The gender distribution of males to females was 63% to 37% respectively for fallers (n=30), but 38% to 62% in general medical take controls (Fishers exact test p<0.001). 54% of fallers (n=13) were admitted from their own home with 31% from Residential Homes and 15% from Nursing Homes. 54% were known to have a preceding falls history (n=13). The timings of the falls showed that 60% of falls occurred between 08.00 and 20.00 (n=30). 77% of falls occurred within 48 hours of admission (n=13). The circumstances of the falls were consistent with the NPSA statistics with 20% falling out of bed, 17% from chair, 17% from commode / toilet, 20% when walking, 3% in the bath and 23% not documented. The significance of the falls as measured by the incident report forms (n=26, in 4 cases not recorded) was 70% under the level of 6 (i.e. low level and did not require further investigation), 13% were over the level of 6 (i.e. were serious and required further investigation) and 17% were unrecorded. Most of the injuries (n=30) were none or minor – 47%, 10% had a head injury and 43% were not recorded. 95% of the falls were not observed. 31% of the patients (n=13) were taking fewer than 4 medications, 38% were taking between 4 and 7 medications and 32% were taking over 8 medications. Comparing the demographic characteristics of our fallers to the age and gender matched controls; average age was 79 for both fallers and controls (p=0.94) and the gender distribution was 7 females : 6 males in the fallers, and 27 females: 21 males in the controls (Fisher’s Exact Test p=1.0).   The overall PAR score (n=13) was not sufficiently sensitive to predict falls risk – 77% had no change in their PAR score, 8% had a 1 point change and 15% had a 2 point change ( Table 1). Temperature variation (n=13) was minimal with 69% having less than 1 degree Celsius change and 31% having change of 1 to 1.5 degrees Celsius . Recorded respiratory rate variation was also minor (n=13) with 85% having a maximum change of up to 4 breaths per minute. Table 1. Physiological Parameter Data * denotes p<0.05

  In fallers (n=13), the mean highest heart rate was 86 bpm (SD=13) and the mean lowest heart rate was 71 bpm (SD=16). The range was 15 bpm (SD=9.6) with p<0.001. In controls (n=47) the mean highest heart rate was 86 bpm (SD=14) and the mean lowest heart rate was 79 bpm (SD=14). The range was 7 bpm (SD=7) with p<0.001. The significance test when comparing the highest average heart rate between fallers and controls shows p=0.98 showing that they were well matched. The significance test for comparing the variation of the heart rate between fallers and controls is p<0.001. In fallers (n=13), the mean highest systolic BP was 142 mmHg (SD=22) and the mean lowest systolic BP was 116 mmHg (SD=19). The average variation was 26 mmHg (SD=12) with p<0.001. In controls (n=47) the mean highest systolic BP was 140 mmHg (SD=24) and the mean lowest systolic BP was129 mmHg (SD=24). The average variation was 11 mmHg (SD=6.5) with p<0.001. The significance test when comparing the highest average systolic BP between fallers and controls shows p=0.77 showing that they were well matched. The significance test for comparing the variation of the systolic BP between fallers and controls is p<0.001. Charts 1 and 2 show the spread of measurements in the cardiovascular parameters between fallers and controls.

Chart 1. Comparison of the heart rate variation between Fallers and Controls

Chart 2. Comparison of the systolic blood pressure variation between Fallers and Controls

 DiscussionThe average age of the fallers was significantly greater than  the average age of those admitted to the hospital in general. This is unsurprising considering both mechanical deterioration of the musculoskeletal system with advancing age and the accumulation of disease processes. It is noteworthy that despite making up the smaller percentage of admissions to the hospital, men made up the greater proportion of fallers. Other much larger studies show considerable variability in their gender proportions ^11,12, therefore this finding is unlikely to be truly significant.  Apart from age and gender, polypharmacy was also a feature of our fallers. This is consistent with other studies ^13,14,15. Additionally, our data was consistent with the overall NPSA statistics in terms of the significance and circumstances of the falls ⁵. The main and novel finding of our study was that fallers were significantly more likely to display a larger range in their cardiovascular observations than the standard hospital population. Whilst it is generally expected that subjects undergoing any routine measurement of heart rate and blood pressure will have a variation in measurements of about 10% over the course of 12 hours ^16,17, we found that our fallers had a variation in their heart rate and blood pressure of approximately 20%. This is similar to the dips experienced by the normal population over the course of the night and during orthostatic challenge. This was despite the fact that the baseline measurements of highest value were virtually the same for both populations. Furthermore, almost all the values recorded were within normal limits – and would not normally require specific remedial action to be taken. This could also explain why this risk factor has not previously been identified in other studies. Our study indicates that it is the cardiovascular lability rather than the cardiovascular measurements per se, which acts as an acute predictor of falls. In fact, the sensitivity for falls prediction with either a range of HR values > 15 beats per minute or range of BP systolic values >25 mmHg was 77%. We would therefore expect that when such patients mobilize, the superadded orthostatic challenge would be too great for cardiac output to be suitably matched and so patients are at greater risk of falling. In terms of the 12 hour prospective risk of falling this could certainly explain why a patient with known risk factors will fall during a given nursing shift.  Indeed it may also explain why a patient may fall during a hospital admission when patients were, for example, already parkinsonian and arthritic and yet had not previously fallen.  Interestingly, neither temperature, respiratory rate, nor PAR Score showed any significant lability in the lead up to the falls. This was surprising as we would have expected them to be predictive of other well known risk factors. The lack of fluctuation in temperature and respiratory rate could provide further evidence that the key short term factor responsible for falls is cardiovascular lability. More detailed analysis showed that it was more likely that these measurements were insufficiently sensitive. Only four of the fallers were admitted with infections, and those subjects showed some temperature fluctuations. However, only 2 had temperatures above 37.5 degrees Celsius, which is consistent with the blunted fever response that is well known to occur in 50% of the elderly population ^19,20 (and most fallers were elderly). The lack of value in respiratory rate recordings probably reflects the lack of due care and attention paid to this, the only manually measured parameter. It has long been recognized that respiratory rate recordings tend to be inaccurate  ²¹ . The highly limited range of measurements recorded (16-22 breaths per minute) amongst all the fallers, despite some patients having severe pneumonia, further supports this finding. Finally, the PAR score tended to be quite static. This was a result of its constituent parameters not being sensitive (temperature, respiratory rate) and the fact that most of the heart rate and blood pressure recordings were within normal limits. LimitationsDespite the fact that this study was well powered and statistically significant, ultimately it is quite limited in numbers with just 13 patients. It was disappointing that we were not able to obtain case-notes or the appropriate file in the other 17. We are also presenting calculated data from the MAP measurements, without knowing the exact algorithms being used. For this reason, we analysed the given systolic pressures as further data manipulation would have increased inaccuracies. Our data is taken from relatively acute admissions and as such may not necessarily be applicable to long stay patients, where cardiovascular lability may not play an important role.Furthermore, controls were not matched for diagnosis or for the number of medications taken. This could lead to criticism that the comparison was poor, though the baseline measurements for the two were remarkably consistent. One of our aims was to see if variability could be used to accurately model general falls risk. We therefore thought it would be more useful to study the hospital’s general physiology, in all its varying degrees of illness. ConclusionsThis study shows the value of looking closely at patients’ observations and that even ‘normal’ values have to be interpreted in context . The data supports the finding that the risk of falling at a given point in time relates not only to predisposing factors, but also to their current cardiovascular status. We therefore suggest that a one-off falls risk assessment is no longer appropriate, but should be continuously reviewed on a shift-by-shift basis by nursing staff. This has significant ramifications for modernizing current risk stratification tools so that they are able take this into account.

INTRODUCTION

Chest radiographs are done not only for diagnostic reasons to look for abnormalities in the heart, lungs, soft tissues and bones but also to check the position of various invasive lines and tubes. In the previous two editions of pictorial essay, we have discussed the normal and abnormal positions of tracheal tube, nasogastric tube and central venous catheters on chest radiographs. In this edition, we shall look into permanent pacemakers and oesophageal Doppler probe on chest radiographs. PERMANENT PACEMAKERS  A permanent pacemaker (artificial pacemaker) is a small battery powered medical device that is placed subcutaneously in the chest or abdomen to help control abnormal heart rhythms. They are inserted for different types of conduction problems (eg: sinus node disease, atrio-ventricular block, tachyarrhythmia etc). Permanent cardiac pacemakers consist of two parts:1. Pulse generator (power unit) – usually felt like a “bar of soap” beneath the skin and2. Pacing electrode leads The pulse generator consists of an energy source (battery) and all electrical circuits necessary for pacing and sensory function. The electrode is the exposed metal tip in contact with the myocardium. The electrode is connected to the pulse generator via an insulated wire (lead). Details regarding classification and functioning of a pacemaker is beyond the scope of this article and can be found in any standard cardiology text book. We shall now discuss what to look for in a chest radiograph in a patient with permanent cardiac pacemaker. Chest radiograph is one of the important diagnostic tools used in the evaluation of a patient with a pacemaker. However, it is not complete by itself and in addition to reviewing chest radiographs, it is important to take a detailed history from the patient, do a thorough examination of the patient, review all necessary case notes and analyse the ECG. If required, a cardiology opinion should be sought. Important points to note on a chest radiograph are: Fig 1 (CR 1836): Single chamber pacemaker There is a single chamber permanent pacemaker. The pacing wire passes via the left subclavian vein and tricuspid valve. Its electrode is situated in the apex of the right ventricle (labelled B) and is anchored in the trabeculae by some sort of hook 2,3. Fig 2 (CR-1840): Dual chamber pacemaker with displaced right atrial lead This chest radiograph shows a dual chamber pacemaker. There are two pacing leads – one in the right atrium and another in the apex of the right ventricle (labelled B). The right atrial lead is displaced (labelled A). Note the normal position of the right atrial lead in Fig 3 (CR 1835). Fig: 3 (CR-1835) Biventricular pacemaker This radiograph shows the presence of a permanent biventricular pacemaker and its pacing leads passing through the left subclavian vein. There are three pacemaker leads – the 1st lead is situated in the right atrium (J shaped wire- labelled A), the 2nd lead is in the apex of the right ventricle (labelled B) and the 3rd lead in the lateral wall of the left ventricle (labelled C). Pacing the apex of the right ventricle and the lateral wall of the left ventricle simultaneously improves the co-ordination of the left ventricular contraction 2. Biventricular pacemakers are used as cardiac synchronisation therapy in patients with cardiac failure.  OESOPHAGEAL DOPPLER PROBE The oesophageal Doppler is a non-invasive cardiac monitoring device useful in critically ill patients in the Intensive care unit. The probe of the oesophageal Doppler monitor is inserted into the oesophagus and the ideal position for its tip is at the level between the 5th and 6th thoracic vertebra because at this level the descending aorta is adjacent and parallel to the oesophagus 4. The probe contains a crystal which produces continuous ultrasound wave of 4 MHz. The lubricated probe is inserted down till the 40 cm mark, rotated and slowly pulled back while listening to a good audible signal. It is essential that the probe is located in the correct position to record accurate values. Fig 4 (CR 1839) shows the normal position of the oesophageal Doppler probe (labelled D). Also, note the normal position of the tracheal tube and right Internal Jugular Vein catheter [discussed in detail in the previous two editions of pictorial essay 5,6]. 

 CONCLUSION Valuable information can thus be obtained on reviewing chest radiographs. Our aim is to provide a quick overview on what to look for in pacemakers and oesophageal Doppler probe on chest radiographs. It is by no means an exhaustive description. This article is for the benefit of medical students, junior doctors in training, nurses and paramedical teams who would be involved in the care of critically ill patients.  Self Assessment Multiple Choice questions (only one option is correct):1. The wires of permanent pacemakers are usually inserted viaA. Femoral veinB. Basilic veinC. Subclavian veinD. Subclavian artery 2. A chest radiograph is not useful in one of the followingA. To detect intact pacemaker wiresB. To indicate whether a pacemaker is working optimallyC. To detect whether pacemaker wires are dislodgedD. To identify a single chamber or dual chamber pacemaker Answers:1. C2. B

INTRODUCTION

The Foundation Programme^1,2,3 is a 2-year, ubiquitous, vocational curriculum undertaken by newly qualified doctors wishing to proceed onto speciality training in the United Kingdom (UK). Since 2006, Foundation Year Trainees in the UK have been required to complete one clinical audit during their two year programme. We review the practice of audit and doctors’ attitudes to the difficulty in performing audits at a National Health Service (NHS) hospital trust comprising three hospital sites in the South East of England. The Foundation Programme demands that Foundation Year Trainees are able to consider the relevance of clinical audit and describe the audit cycle with regard to developing patient care, clinical governance and risk management. They are expected to undertake a clinical audit and recognize how it relates to the improving clinical standards and addressing clinical governance¹. Clinical audit can be defined as the processof reviewing the delivery of care to identify deficiencies sothat they may be remedied⁴. Whilst it was initially used in assessing medicalpractice against local standards, audit ‘has evolved conceptuallyas a mechanism through which evidence-based guidelines can beintroduced into routine clinical practice’⁵. Apart from fulfilling the requirements of the syllabus, reasons for audit include professional education and the opportunity to improve patient care⁶. Barriers to audit might include: disagreement amongst professionals as to what constitutes a good audit⁵;organisational impediments; and a lack of resouces⁶. This study therefore sets out to investigate the level of audit activity in a hospital trust in South East England amongst all Foundation Year Trainees. Importantly it will also assess doctors’ attitudes and views towards the audit process and perceived or actual barriers to their completion. METHOD Questionnaires were sent to all Foundation Year 1 (F1s = 63 in total) and Foundation Year 2 (F2s = 56 in total) Trainees in the trust (119 doctors). The study group involved trainees in the Foundation Programme from 31^st July 2007 to 30^th July 2008. Doctors who had been transferred out of the trust were not included in the study. There were no doctors who had transferred into the trust and were in the Foundation Programme. A study representative at each of the 3 hospital sites was tasked to distribute the questionnaires. Trainees were asked to complete the questionnaires in an informal setting and to return them directly to the site representative. The study environment was variable, and questionnaires were distributed and completed on the wards or at group teaching sessions. Participants were given the choice of completing and submitting their form immediately, or submitting it at a later date. Data collection was commenced 11 months after the trainees had commenced employment in the trust and concluded after 2 weeks. This was invoked as many trainees were clearing annual-leave requirements towards the end of their hospital posting, and the consensus that very few audits would be officially completed at that stage of training in the summer. Questions were drawn from previous studies to the barriers to audit in our Trust. In the first section of the questionnaire, participants were asked about: “the number of all audits attempted or applied for”; “the number of new audits attempted or applied for”; “the number of audits completed and presented so far”; and “the number of audits started but never completed”. The second part of the questionnaire assessed subjective opinions on barriers to completing audits. Participants were asked to rate the following 5 statements on a comparative scale of 1-5 (1 being “strongly disagree” and 5 being “strongly agree”): “The audit department is helpful in approving audits”; “senior staff are helpful in involving me in audits”; “I can complete audits within official working hours”; “most audit opportunities are in my area of interest”; “most audit opportunities are of clinical value”. Results were collated and tabulated and presented at local meetings where feedback was received. RESULTS Ninety-two out of a possible 119 (77.3%) Foundation Year Trainees completed the questionnaire (57/63 - F1s, 35/56 - F2s). There were 106 total attempts at audit for the F1 trainees and 65 total attempts for the F2s. Most trainees had attempted 1 or 2 audits in their respective year (42 F1s at 73.7% and 23 F2s at 65.7%). 5 F1s (8.8%) and 3 F2s (8.6%) had neither attempted nor applied for any audits.  Ten F1s (17.5%) and 9 F2s (25.7%) had attempted more than 2 audits (Table 1). Table 1: Number of audits attempted by trainees

 The results for the total number of completed audits (i.e. an audit that included data collection, analysis and formal presentation to the respective department) are summarized in Table 2. For F1s, 32 out of a total 106 attempted audits were completed (30.2%), this percentage rising for F2s (38/65; 58.5%). Thirty-three (57.9%) F1s and 10 F2s (28.6%) failed to complete any audit, with a number able to complete one audit presentation in the year: 18 F1s (31.6%) and 16 F2s (45.7%). Table 2: Number of audits completed by trainees

 With respect to new and original audits attempted by trainees, this was achieved by 66.7% of F1s and 74.3% of F2s (Table 3). There was no formal data on the number of audit loops being closed. Table 3: Number of new audits designed by trainees

  With regard to barriers to completion of audits (Table 4), results were notably equivocal for “helpfulness of the audit department and senior staff” (both averaging 3.1 on the comparative scale of 1-5), and “the clinical value of the audits available” (mean score 3.2). The mean score for “completing audits within official hours” was 2.1 with a similar trend observed in “the audits available in an area of interest” (mean score 2.6). Table 4: Trainees’ experiences with audit

    ¶Key:   1= strongly disagree;    2=disagree;    3 = equivocal;    4 = agree;    5 = strongly agreeNB: Some forms were incomplete, and therefore responses may not add up to 92. CONCLUSIONS Although audit is well established to be beneficial in improving clinical practice⁷, this study suggests that trainees under-perform against the curriculum of the Foundation Programme. Historically, the level of audit activity amongst doctors has been low; for example, McCarthy (1997) demonstrated that whilst doctors see the conceptual value of audit, approximately one-third only had presented their data at a pertinent audit meeting⁸. These results have been replicated in numerous other studies^9,10,11. We believe that this data-set is the first available for junior trainees who have undertaken the Foundation Programme curriculum, with a good response rate of 77.3%, and incorporates the contractual pressures invoked by a European Working Time Directive (EWTD)-compliant Rota^12,13. While the results show that the majority of respondents (>90%) had attempted an audit, most significantly the majority of audits that were started were not completed. A large percentage of F1s (57.9%) and F2s (28.6%) failed to complete an audit at all. Similar numbers have been reported, even among senior pediatric trainees at registrar level, where one study demonstrated that whilst audit activity was above 90%, only 16% had completed the audit cycle¹⁴. One possible explanation is that many trainees appear to have a sub-optimal comprehension about audit and its process. Our consensus was that some trainees attempted audits that were too large or unmanageable, or even of insufficient quality, in striving to achieve a peer publication from their work. When realized that the publication value is poor, or that the audit design is flawed, many trainees lose interest and fail to complete. Another concept highlighted by this study is confusion over the definition of a “completed audit”. For consideration of completion of an audit, a trainee has to demonstrate both the ability to collect the data and present it to among his peers in a formal meeting. This generally amounts to completion of 5 out of the 6 stages of the audit loop¹⁵. Surgical morbidity and mortality presentations had been considered audit by some trainees, as they were termed by the trust as a “surgical audit”. However, the overall clinical consensus is that they are not audit but formative educational meetings because no systemic local or national standards were employed for comparison. This poor understanding of audit has been well described previously¹⁶. Potential barriers to the completion of audit include some of the issues raised in this study. In this sample, doctors were equivocal about whether the barrier was the audit department or lack of senior support. This reflected the variability of experience as well as the lack of teaching of the purpose and methods of audit in the undergraduate curriculum. They were also equivocal about the clinical value of audits they had completed. By comparison, a study in Leeds showed that less than half of the 232 respondents were aware of subsequent change in clinical practice and 27% felt it was “a waste of time”⁷. However this study did not focus on the junior doctor in the beginnings of their postgraduate training. Trainees felt that an additional barrier to audit completion included difficulty in completing audits within their working hours. All Foundation Year Trainees in the trust were working to a EWTD-compliant Rota during the year, where trainees did not exceed 48 hours a week of on-site hospital clinical duties. Trainees also found it difficult to undertake audits in their area of clinical interest. Although part of the reason is circumstantial - the Foundation Year Programme mandates that trainees rotate around various core specialties - this may also reflect a lack of understanding of what the audit cycle actually incorporates, and how it is not formal research in itself¹⁵. Approval of audit studies was also thought to be problematic because such meetings only took place monthly with a pre-determined agenda, and consequently, this meant that approval might take several months to obtain for trainees who would actually be based in the trust for no more than 12 months in 3 different specialty departments. There were a number of limitations of the study, one being the small sample size. Secondly, in asking trainees to rate each of the six statements from 1 to 5, trainees who did not complete audits tended to score 3 (neither agree or disagree), and as the results above show, they represented a considerable proportion. A larger sample size and a semantic differential scale (rating responses between 1 and 7) might have been more discerning. The fact that some trainees may have included “audits” which on reflection did not meet the criteria for inclusion was not only interesting but may also have distorted results. Finally, audits that involved joint effort among trainees, but were presented only by one of them in the absence of the others were still regarded by some trainees to be “completed and presented” by all of them. This study has highlighted a number of issues which need to be addressed for clinical audits to be successfully completed during the Foundation Programme. The authors believe that poor completion rates are most probably the result of poor understanding of audit. Potential solutions include teaching medical students concepts of audit; giving structured teaching early in the Foundation Programme; instituting regular audit meetings; incorporating audit as part of contracted working hours; defining audit more clearly among trainees and clinical staff and encouraging more cooperation and integrative liaison with the audit department to process audit proposals quickly and efficiently. Additionally, doctors’ contractual pay-bandings should reflect any out-of-hours work undertaken on audits that improve clinical governance for their Trusts. However, in spite of all these considerations, we speculate that because trainees are only in each post for no more than 4 months during their foundation years, and with the restriction of working hours, the expectation of foundation year trainees to have undertaken and properly understood an audit cycle, implemented change and closed the audit loop is unrealistic. It would be more helpful to the trusts and trainees for audits to be part of the specialty training programme onwards, where trainees stay in a department for a longer time even as they move from one team to another. Further studies might consider in detail the difficulties in each step of the audit cycle¹⁵ and explore: Foundation Trainees’ use of the audit department; guidance from senior members of staff; and perceived benefits in clinical practice. Ultimately, audits must implement change¹⁷ and all truly successful clinical audits should aid in some way to achieving our fundamental goal in medicine; that being the best clinical practice and best quality of care.

Introduction

Good Medical Practice describes the professional behaviour expected of doctors and advocates that it should be taught as well as assessed. GMC’s Good Medical Practice specifies the standards of team working, communication skills, accessibility and trustworthiness in relation to professional behaviour¹. Ramsden² stated that: “the students will learn what they think they will be assessed on, not what is in the curriculum, or even on what has been 'covered in class'.” Hence, if the intended learning objectives are to improve professional behaviour and team working in a trainee doctor, then a tool that assesses these characteristics along with providing suggestions for improvement is critical. Multisource Feedback (MSF) is a formative assessment tool that was designed to assess professional behaviour and attitudes, with the aim of continually improving an individual’s team working. Team Assessment of Behaviour (TAB) is an assessment tool for MSF (Appendix 1), and is one of the 2 assessment tools used to assess professional behaviour of foundation doctors in training in the UK, the other being the Mini-Peer Assessment Tool (mini-PAT)³. Our aims for this article were to evaluate whether the format of TAB allowed the MSF process to occur as originally intended, along with looking at possible barriers that may have to be overcome to make it an effective tool. A literature review was carried to appraise the present evidence regarding TAB as an assessment tool and only studies which had relevance to MSF/TAB were included in the study. As TAB is a relatively new tool, there were very few papers’ exploring this is depth which was a major limitation. Hence in the barriers section, we have discussed the possible obstacles to the whole MSF process rather than just TAB. Background The concept of MSF was originally developed by industrial organisations and has been used in postgraduate medicine in USA for assessment of professional behaviour since the 1990’s^4,5. Ramsey⁶ suggested that it is feasible to obtain assessments from professional associates of practicing physicians in areas such as clinical skills, humanistic qualities, and communication skills. TAB was developed by educationalists and senior doctors at the West Midlands deanery^7,8,and has undergone extensive field testing among 171 trainees, with analysis of received feedback from 1378 assessments across four different hospitals in the West Midlands. It is currently being used in the West Midlands Deanery for the multisource feedback of foundation programme trainees.  Process of TAB The primary aim of TAB as an assessment tool is to identify trainees whose professional behaviour does not meet GMC requirements for good medical practice, so that appropriate action may be taken and also to compliment those trainees who receive good reports. For TAB, up to 10-15 multi-disciplinary colleagues of a doctor assess his/her workplace behaviour. It assesses four domains of professional behaviour: professional relationship with patients, verbal communications, team-working and accessibility. It is the initiative of the trainee to distribute at least 15 TAB forms to peers of their own choice and a minimum of 10 completed forms are required to be returned. The raters should include at least three other doctors including a consultant supervisor and at least five allied healthcare professionals. It’s the responsibility of the educational supervisor to collate and summarise these forms, identifying perceived weaknesses, offering them feedback and directed learning objectives to address any issues. Critique of TAB: 1. Validity and reliability of TAB:Validity is a demonstration that a particular instrument can in fact measure what it purports to measure⁹. TAB portrays face as well as content validity as it assesses areas identified by the GMC¹ for good professional behaviour. It is shown to be capable of identifying problem behaviour in trainees, which was the primary aim of the tool⁷. This tool appears to have good construct validity as it is testing trainee’s behaviour in real life situations. It is difficult to define the predictive validity of any tool, more so in a formative assessment tool. The developers of TAB have not tested for concurrent validity. The concurrent validity for TAB could have been tested by using another MSF tool in addition to TAB for some participants during the field-testing for reliability and validity of the tool. A reliable instrument for a piece of research will yield similar data from similar respondents over a period of time⁹. Whitehouse⁷ demonstrated in the pilot study that TAB had intra-observer reliability and inter-observer variability. For inter-observer variability, the Royal College of Psychiatrists compiled a map of assessment programmes against good medical practice domains and considered it appropriate for assessing four domains: good clinical care, working with colleagues, probity, and health¹¹. 2. RatersRamsey et al⁵ concluded that, with MSF, 10-11 responses per physician were necessary to achieve a generalisablity coefficient of 0.70. Wood et al¹¹ concluded that eight raters were sufficient for a representative score in their study on Obstetrics & Gynaecology trainees in the UK. Obviously more raters would lead to better coefficient and more generalisable results. TAB presently advocates at least ten raters to achieve reliable results. 3. Feasibility TAB has four domains and a three point rating scale which are relatively easy to understand and complete. There is no training required for raters and usually takes less than five minutes per assessment per assessor. The paper-based system demanded considerable administrative resources, and therefore a web-based TAB assessment form was successfully piloted in the West Midlands⁸. 4. Trainer & trainee’s evaluation of the processThe evaluation of TAB as an assessment tool was done by Whitehouse et al⁸ as a part of their field assessment of TAB. The assessors and trainers found the process practical, valuable and fair. 76% of the trainees who responded to the questionnaire felt that it was a useful addition to the assessment of the SHO’s. The educational supervisors had mixed views, with 77% of them finding out nothing new about the trainees. 5. Scoring systemInstead of a Likert scale, the TAB employs broad boxes which offer the rater a choice of giving specific feedback under each domain. This is more helpful to a summariser/assessor than mini-PAT, where a scoring scale is not substantiated by relevant feedback. This assessment tool does not assess clinical performance and one could argue that there could have been more than four domains in order to include other areas of performance, such as clinical skills. However having just four domains can reduce the impact of the halo effect. The halo effect¹² can be defined as a rater making an overall judgement of the trainee and scoring the whole form accordingly rather than considering each domain separately. This could be a potential advantage of TAB over mini-PAT where there is no opportunity to provide specific feedback in individual domains, but rather utilises an overall action plan, which may lead to concentrating single element deficiencies while masking other shortcomings.  6. Patient OutcomesThe MSF process in itself doesn’t bear direct consequences on patients’ management, but can help the doctor improve his professionalism, which is critical element of good medical practice¹. An improvement in a doctor’s behaviour secondary to the appraisal-feedback process can indirectly improve and contribute to patient management and satisfaction. Potential barriers:  1. Choice of rater:The trainee has the choice of raters, except for the supervising consultant, who must be involved in the process. This is a potential area of difficulty, as the trainee might pick individuals who are more sympathetic to their cause, or who cannot comment much on their interpersonal behaviour, thus leading to skewed results. Kuzmits¹³ showed that both rater and those being rated needed to be trained to make the rating and feedback process more effective, but this is not felt necessary for TAB. There is also a potential conflict between being a trainer and assessor, and this conflict might lead to clouding of judgement¹⁴, which can be addressed by having different assessors and trainers, but considering the service pressures in the NHS, this may not always be possible. 2. Feedback:The value of the MSF process can be limited by the quality of feedback provided to the trainee at the end of the process and depends on the relationship of the trainee and the supervisor¹⁵. Evidence shows that non-specific feedback does little to change performance¹⁶. Whitehouse⁸ concluded in their initial study that TAB was able to produce descriptive feedback that was more specific and helpful than existing MSF tools. Assessors completing TAB may not give specific comments or feedback although they are instructed to give some details especially if they chose the rating of “some concern” or “major concern”. Bret and Atwater¹⁷ have shown that negative feedback can discourage individuals, and they can even react in anger. Feedback about performance must be descriptive and specific if it is to be helpful to trainees¹⁸. Hence it is the responsibility of the supervisor to give feedback which is relevant and helpful, along with creating an action plan with the trainee to address any perceived deficiencies. It must also be stressed that good performers need to be complimented, and encouraged to continue to do so. 3. Training the raters and the supervisor:The raters also need to be educated in the process otherwise they may not give reliable views about the trainee^13,19. From the rater’s point of view, it would be beneficial if they were to give specific comment, in order that more relevant feedback can be provided. Most importantly, the educational supervisors who provide the feedback to the trainee can make a difference in constructing agreed learning objectives, and not demoralise the trainee with negative feedback. Kaplan²⁰ also noted that negative feedback can demotivate individuals. Giving face to face negative feedback can be a daunting task and supervisors, if not trained in giving negative feedback may dislike doing it, and so not give properly constructed feedback. The provision of training, however, has time as well as cost implications. Conclusions TAB continues to be part of the national foundation programme curriculum and, used correctly, can serve its purposes both as a screening tool and also for the trainees to use the feedback provided to improve their interpersonal behaviour when needed. Evaluation and quality assurance of this assessment tool should be an ongoing process. More field work in relation to assessment of behaviour in relation to TAB is needed. Patient feedback could be included in TAB which can make it a more reliable tool for assessing a doctor’s behaviour.Further qualitative studies to explore the views and experiences of trainees can help to understand the barriers and attempt to improve the usefulness of the process for the trainees. There are several potential barriers which can subvert the process of MSF by using TAB, and these need to be addressed to make the assessment process more effective and efficient. KEY POINTS

1. MSF is designed to assess professional behaviour and attitudes
2. TAB along with Mini-PAT and other tools map MSF principles
3. The supervisor assumes a key role in giving constructive feedback without demotivating the trainee
4. Relevant training while giving feedback is critical to the success of MSF
5. Patient’s involvement in the MSF process could make it more robust.

Spasticity is a common symptom seen as a consequence of an injury to the brain (stroke, trauma, hypoxia, infection, cerebral palsy and post surgery), spinal cord injury or multiple sclerosis. It is a complex problem, which can cause profound disability alone or in combination with other features of upper motor neuron syndromes (figure 1). The word “spasticity” is derived from the Greek word “spasticus”, which means “To pull or To Tug”. Spasticity is defined¹ as “Disordered sensori-motor control, resulting from an upper motor neuron lesion, presenting as intermittent or sustained involuntary activation of muscles”. Simply stated, spasticity is stiffness of muscles that occurs after injury to the spinal cord or brain. Awareness of the implications and associated symptoms can minimise development of long term secondary complications (table 1). The impact of spasticity can be devastating. If not managed early and appropriately it may result in progressive disability, resulting in secondary complications such as contractures and pressure sores. This significant impact has ensured that spasticity management is a prominent feature in the national management guidelines for long term neurological conditions, promoting coordination of care between primary, secondary and social care providers. Symptoms Spasticity can range from mild muscle stiffness to severe, painful and uncontrollable muscle spasms. It is associated with both positive and negative components of upper motor neuron syndromes. Positive components include muscle overactivity, flexor and extensor spasm, hyperreflexia, athetosis, spastic dystonia, clonus, and an extensor plantar response. Common negative symptoms comprise weakness/ paralysis, early hypotonia, fatigue and loss of dexterity. Spasticity can be distinguished from rigidity by its dependence on the speed of muscle stretch and characteristic distribution in antigravity muscle groups. Spasticity does not always cause harm and can occasionally assist in the rehabilitation process by enabling a patient to stand when their limb weakness would not otherwise allow it Table 1 Clinical and functional problems associated with severe Spasticity

 Figure 1 Vicious cycle of spasticity   Assessment of spasticity Before any intervention is undertaken to modulate hypertonicity, it is important to attempt to assess the severity of spasticity. Many grading scales are used to quantify spasticity. These address the degree of muscle tone, the frequency of spontaneous spasms and the extent of hyperreflexia. Goniometry, Ashworth scale, Tardieu Scales, Goal attainment scale are only a few of these scales. One of the most widely used scales is the modified Ashworth scale². Table 2 Modified Ashworth scale

  It is also important to remember that not every “tight” muscle is spastic. The clinically detectable increase in muscle tone may be due to spasticity, rigidity or a fixed muscle contracture. Management  The key to successful spasticity management is education of the patient and carers with both verbal and written information. This allows them to understand, appreciate and be fully involved in the management plan. All patients with spasticity should be followed up by a coordinated multidisciplinary team, which allows more timely intervention and close monitor of the progress. Liaison between health and social services in both primary and secondary care is essential in long term management. This helps to deliver a more consistent approach to the individual over time (figure 2). Table 3 Aims of spasticity management.

 The first step in the management of spasticity is to identify the key aims and realistic goals of therapy. Understanding the underlying pathology and possible prognosis is helpful in planning these goals (table 3). Other key points to consider are: ·          Identification and management of any trigger or aggravating factors-Initial assessment should exclude any co morbidity that may worsen spasticity such as pressure sores, chronic pain, infection (commonly urinary tract infection), constipation or in-growing toe nails.·          Instigation of an effective and realistic physical programme including attention to posture and positioning Figure 2
Approach to spasticity assessmentComprehensive assessment of spasticityRecognition of underlying provocative factorsImpact on the individualMeasurement of spasticityPotential goals- individualised and person focussed 
Initial approachEducation to patient/ and their family /carersMultidisciplinary team assessmentIdentification of clear treatment goalsEstablish mechanism for monitoring and review  Management Manage triggering factorsBalance between positioning and movementPosture and seatingPhysical therapy and active exercise programmeSplinting and use of orthoticsPharmacotherapy A)      Physical modalities·          Stretching- this intervention has the benefit of being benign and non-invasive. Maintaining muscle length through passive or active exerciseand stretching regimens including standing or splinting canbe key to managing spasticity both in the short and the longterm.·          Cooling of muscles- this inhibits mono synaptic stretch reflex and lowers the receptor’s sensitivity, different techniques such as quick icing and evaporating spray like ethyl chloride are occasionally used.·          Heat-heat may increase the elasticity of the muscles. Techniques used include ultrasound, fluidotherapy, paraffin, superficial heat and whirlpools. These techniques should be combined with stretching and exercise.·          Orthosis/equipment/ aids – an orthosis or splint is an external device designed to apply, distribute or remove forces to or from the body in a controlled manner to control body motions and /or alter the shape of body tissues. E.g. ankle foot orthosis, insoles, ankle supports, wrist/ hand/ elbow splints, knee splints, spinal brace, hip brace, neck collar. Some equipment can also aid positioning e.g. T roles, wedges, cushions and foot straps.These are usually used in combination with other modalities like botox therapy. Attention to posture and positioning, whichmay include the provision and regular review of seating systems,is paramount in managing severe spasticity·          Massage– althoughvarious techniques are in use there is no evidence to support this·          Dynamic physiotherapy technique- many schools of physiotherapy claim that particular technique has antispastic and functional benefits, particularly for the more mobile person. E.g. Bobath technique, proprioceptive neuromuscular facilitation, Brunnstrom technique. B) Electrical therapy·          Functional Electrical stimulation –Thisis an adjunct to physiotherapythat can be of benefit to selected individuals who are predominantlyaffected by upper motor neuron pathologies resulting in a foot drop. Randomised controlled trial by Burridge et al in patients following stroke found that the use of functional electrical stimulation in combination with physiotherapy was statistically superior to physiotherapy alone³·          Transcutaneous electrical nerve stimulation – this has been found to reduce spasticitythrough its nociceptive action and reduction of pain. C) PharmacologicalMedicationshould always be used as adjunct to good general management and education. Identification of treatment goals will help optimise drug therapy not only in terms of choice of agent, but also in timing and dose. Aims of medication should be to improve function or relieve troublesome symptoms rather than to simply reduce the degree of spasticity. Table 4 Useful things to remember to optimise medication effects

 Table 5 Different methods of delivery of medication

 The oral agentsAlthough different categories of drugs are available, those most commonly used to treat spasticity are baclofen,tizanidine, benzodiazepines, dantrolene, and gabapentin^{4, 5, 6}. Different agents act through different mechanisms (table 6 and 7) for e.g. GABA-like (baclofen, benzodiazepine), central alpha 2 agonists (tizanidine, clonidine) and peripheral anti-spastics (dantrolene). Antispastic drugs act in the CNS either by suppression of excitation (glutamate), enhancement of inhibition (GABA, glycine) or a combination of the two. Table 6 Mechanism of action of commonly used oral antispasticity medication

  Baclofen remains the most commonly used anti-spastic agent. The preferential indication is spasticity caused by spinal cord disease especially in multiple sclerosis. Many studies including the pilot study by Scheinberg et al ⁷ demonstrated that oral baclofen has an effect beyond placebo in improving goal-oriented tasks (such as transfers), in children with spastic quadriplegic cerebral palsy. In open-label studies of oral baclofen, the drug improved spasticity in 70-87 per cent of patients; additionally improvement in spasms was reported in 75-96 per cent of patients. In double-blind, crossover, placebo-controlled trials, baclofen was reported to be effective, producing statistically significant improvements in spasticity⁸. The main adverse effects of oral baclofen include sedation or somnolence, excessive weakness, vertigo and psychological disturbances. The incidence of adverse effects is reported to range from 10 to 75 per cent. The majority of adverse effects are not severe; most are dose related, transient and/or reversible. The main risks of oral baclofen administration are related to withdrawal; seizures, psychic symptoms and hyperthermia. These symptoms improve after the reintroduction of baclofen, usually without sequelae. When not related to withdrawal, these symptoms mainly present in patients with brain damage and in the elderly. The limited data on baclofen toxicity in patients with renal disease suggest that administration of the drug in these persons may carry an unnecessarily high risk. Tizanidine is an efficient and well tolerated antispastic. It is predominantlyan alpha 2 agonist and thus decreases presynaptic activity of theexcitatory interneurones. There is a large body of evidence for the effective use of tizanidine monotherapy in the management of spasticity ¹⁵. Tizanidine is the antispasticity drug that has been most widely compared with oral baclofen. Studies have generally found the two drugs to have equivalent efficacy, although tizanidine has better tolerability; in particular weakness was reported to occur less frequently with tizanidine than with baclofen.Dantrolene has a peripheral mechanism of action and acts primarily on muscle through inhibitingcalcium release from the sarcoplasmic reticulum. It decreasesthe excitation–coupling reaction involved in muscle contraction and can be prescribed in the different forms of spasticity. The efficacy of benzodiazepines (diazepam, tetrazepam, clonazepam) is comparable with baclofen. Although there is no evidence to suggest any difference in effectiveness between them, diazepam and dantrolene are associated with more side effects than baclofen and tizanidine. There are other compounds with anti-spastic properties (gabapentine, cyproheptadine, piracetam). Their advantage is

Table 7

rather limited when used alone. Generally, they are administrated in combination with usual anti-spastic drugs. A few short term trials have trialed gabapentin with good results ¹⁹ .Pregabalin may be of value as a systemic agent in the treatment of spasticity, although properly controlled studies with clearly defined outcome measures are required to confirm this finding ²². The Sativex Spasticity in MS Study Group²³ concluded that oromucosal whole plant cannabis-based medicine (CBM) containing delta-9 tetrahydrocannabinol (THC) and cannabidiol (CBD) may represent a useful new agent for treatment of the symptomatic relief of spasticity in MS. 
Intrathecal pump·          Baclofen- If oral drug treatment is inadequate in controlling lower limb spasticity or is not tolerated, intrathecal delivery of baclofen should be considered. This has been found to be a cost-effective strategy when compared to conventional medical management alone by Bensmail et al ²⁰ .The benefits of continuous intrathecal baclofen infusion have been demonstrated in more than 80 percent and over 65 percent of patients report an improvement in tone and spasms respectively. The main risks of intrathecal baclofen infusion are symptoms related to overdose or withdrawal. These are mostly related to catheter disruption, failure to refill the pump reservoir or failure of the pump's power source. Abrupt disruption of intrathecal baclofen can be a serious scenario with continuous spasms, tremors, temperature elevation, seizure and death having been reported.·          Phenol- As phenol is a destructive agent which indiscriminately damagesmotor and sensory nerves, it is reserved for those individualswho do not have any functional movement in the legs, who havelost bladder and bowel function and who have impaired leg sensation. Intrathecal phenol can be an effective treatmentwhich, though it requires expert administration, does not havethe long term maintenance or cost issues that are associated with intrathecalbaclofen treatment. The effect of a single injection often lastsmany months and can be repeated if necessary ²⁴. D) Nerve blockPeripheral nerve blockade/ Regional blocks/ Neurolytic blockade²⁵ are another therapeutic possibility in the treatment of spasticity. This can be done with the help of fluoroscopy or nerve stimulation. Chemical neurolysis by phenol/ alcohol is irreversible and can be used at several sites. Blocks are applied most often to 4 peripheral sites: the pectoral nerve loop, median, obturator, and tibial nerves. The main indication is debilitating or painful spasticity. Peripheral blocks with local anaesthetics are used as tests to mimic the effects of motor blocks and determine their potential adverse effects. Peripheral neurolytic blocks are easy to perform, effective, and inexpensive³⁰. E) Botulinum toxin injectionBotulinum toxin is the most widely used treatment for focal spasticity^27,28,29. The effect of the toxin is to inhibit the release of acetylcholine at the neuromuscular junction. The clinical effect of injecting botulinum toxin is reversible due to nerve sprouting and muscle reinnervation, leading to functional recovery of the muscle in a few months. It is essential that botulinum toxin injections are given in conjunction with physiotherapy in order to obtain the maximum benefit. The toxin is injected directly into the targeted muscle and an effect can be noticed from as early as 2-3 days with a maximum effect seen by about 3 weeks, lasting at least 3 months. As it is not a permanent treatment it may have to be repeated after a few months.Many randomisedcontrolled trials show that botulinum toxin is effectivein reducing muscle tone in various conditions ^{28, 29}. Brashear and colleaguesdemonstrated a reduction in spasticity in the wrist andfingers of patients following stroke with the use of botulinum toxin, together with an improvementin their disability assessment scale²⁹.E) Surgical techniqueMost surgical procedures are irreversible. This means that realistic goal setting between the health care provider, family and patient is critical. Neurosurgical techniques have been proven useful in conditions like cerebral palsy ^{32, 33}.·          Neurosurgical techniques- Anterior and posterior rhizotomy, peripheral neurotomy ³¹, Drezotomy, percutaneous radiofrequency rhizotomy, spinal cord and deep cerebellar stimulation of the superior cerebellar peduncle ³², functional neurosurgery ³³·          Orthopaedic procedures- directly act on muscles and tendons e.g. lengthening operation, tenotomy, neurectomies, and transfer of tendons. 

Introduction

         

Case report

We describe a case of a 32 year old primigravida with type III Klippel-Feil Syndrome for an elective Caesarean section. A preanaesthetic assessment at 32^nd week of pregnancy revealed a history of mild asthma for which the patient was on regular salbutamol inhaler. She had no history of cardiovascular or respiratory insufficiency. There was no significant family history. Anaesthetic history included a repair of encephalomyelocele immediately after birth and a squint correction surgery at the age of 6 years under general anaesthesia which was uneventful.

 Examination revealed a woman of small stature, 137 cm in height and weighing 52 kg. Airway examination revealed Mallampati III with a normal mouth opening, a reduced thyromental distance (3 cm) and inability to flex or extend the neck (Figure ¹). She had thoraco-lumbar kyphoscoliosis and examination of the respiratory and cardiovascular system was unremarkable. Electrocardiogram was within normal limits as were haemoglobin, urea and electrolyte estimation. Radiography revealed fusion of atlanto-axial joint (flexion and extension views, Figure ² ) and also fusion of lumbar vertebrae with associated scoliosis (Figure ³Cobb’s angle 25 degree) and Cobb’s angle 25 degree Figure ¹. A 32 year old parturient with Klippel-Feil syndrome with a short webbed neck and severely restricted neck movements  Figure ². Radiograph of a Lateral view of cervical spine showing fusion of atlanto - occipital joint and cervical vertebrae Figure ³. Antero - posterior view of dorsal spine showing deviation of trachea and marked kyphoscoliosis of thoracic spine She was scheduled to have an elective Caesarean section. The anaesthetic management options in this case included either a general anaesthetic with an anticipated difficult endotracheal intubation or a regional anaesthetic. After discussion with the patient, we planned a general anaesthetic technique with awake intubation using a fibreoptic bronchoscope (FOB) as we considered this safe. For FOB through oral route was preferred due to narrow anterior nares. Oral Ranitidine 150 mg was administered as a premedication the night before and on the morning of the planned section. After institution of standard monitoring and securing two peripheral intravenous cannulae (18G & 16 gauges), the upper airway was anaesthetised with nebulisation of 4% Lignocaine (5 ml) and 10% Lignocaine spray to the posterior pharynx. The FOB was passed through the Berman airway by using a ‘spray as you go” technique to anaesthetise the larynx and upper trachea using 4% Lignocaine and keeping well below the toxic dose (3 mg/kg). A 6.5 mm ID endotracheal tube was rail roaded over the FOB prior to its insertion and the airway was successfully secured. Once position of the endotracheal tube was confirmed, anaesthesia was then induced using intravenous Thiopentone 200 mg, Alfentanil 0.5 mg followed by Rocuronium 25 mg. Anaesthesia was maintained using oxygen with nitrous oxide (1:1 ratio) and Sevoflurane (1 MAC). Patient was ventilated with intermittent positive pressure ventilation to maintain normocapnia. The surgery lasted for 45 min and was uneventful. Using a nerve stimulator for assessing neuromuscular blockade she was reversed with Neostigmine 2.5 mg and Glycopyrrolate 0.5 mg towards the end of surgery. The patient was extubated in supine, head-low position when fully awake and in presence of protective airway reflexes. Discussion Klippel-Feil syndrome is an inherited autosomal dominant condition. In 1912, Klippel and Feil ¹ first reported on a patient with a short neck, a low posterior hairline, and severe restriction of neck movements due to complete fusion of the cervical spine. These features now constitute the classic clinical triad which is the hallmark of Klippel-Feil syndrome. A great number of other anomalies associated with Klippel-Feil syndrome may pose a threat to the patient than the obvious deformity of neck. The spinal deformities may cause difficulties with both tracheal intubation and regional anaesthetic techniques. Anaesthetic management may therefore be challenging in these patients. In our case we opted for a general anaesthetic technique rather than a regional technique because of the following reasons: firstly, the patient was not keen to have regional anaesthesia, secondly, it would entail difficulty for regional anaesthesia keeping in view the spinal fusion and scoliosis and thirdly, the dose of a single bolus of spinal anaesthetic would be difficult to judge in this patient and epidural anaesthesia ² might prove technically difficult and is associated with an increased risk of inadvertent dural puncture and poor spread within the epidural space. This patient’s abnormalities posed problems for all the commonly used anaesthetic techniques for Caesarean section. General anaesthesia could be complicated by difficult intubation. While greater use of regional anaesthesia may have reduced the number of deaths due to failed intubation in obstetric practice, several complications of epidural and spinal anaesthesia may still require intubation as part of their management. Some of these include total or high spinal anaesthesia, inadvertent intravascular injection, overdose of local anaesthetic, anaphylaxis and failure. For these reasons, the choice of regional anaesthesia for a patient with known difficult airway does not necessarily bypass the problem of unanticipated intubation. The most commonly associated anomaly in a series of 50 patients from Delaware, USA ³ was scoliosis (60% of cases), renal abnormalities (35%), Sprengel deformity (30%), deafness (30%), synkinesia (20%) and congenital heart disease (14%). The most common heart disease variant was ventricular septal defect. Less commonly associated were ptosis, lateral rectus palsy, facial nerve palsy and upper extremity anomalies. There are 3 variants of Klippel-Feil Syndrome. ⁴ Type I is an extensive abnormality where elements of several cervical and upper thoracic vertebrae are incorporated into a single block. In Type II variant, failure of complete segmentation occurs at one or two cervical interspaces. Type III variant includes Type I or II deformities with coexisting segmentation errors in the lower thoracic or lumbar spine. The incidence of Type II abnormalities was found to be 0.71% of Black and Caucasian skeletons that were between the ages of 17 and 102 years in a study from St Louis, Missouri, USA ⁵ and it is considered to be the most common form. C₂-₃ and C₅-₆ are the interspaces usually involved. It often remains unrecognised since the neck may appear normal and the patients are asymptomatic until later in life, when they present due to their increased susceptibility to cervical osteo-arthritis. Patients with Type I abnormalities are 50 times less common than Type II but are reported more frequently. This is probably because they exhibit the classic triad and thus have bizarre appearances. ⁶ These patients are frequently disabled by birth injuries, or have major anomalies in other organ systems. A planned elective section at term was considered as the best option for delivery of the baby by the obstetricians due to severe cephalo-pelvic disproportion and also due to anaesthetic issues regarding management. The case was managed successfully with a favourable outcome both for the mother and the baby.

Introduction

The incidence of caesarean section is rising¹ and there is evidence that women who have a caesarean section may be at increased risk of complications in a subsequent pregnancy². Compared with vaginal delivery in the first pregnancy, caesarean section has been found to be associated with significantly increased rates of: uterine rupture in labour;³ placenta previa and placental abruption;⁴ placenta previa leading to peri-partum hysterectomy;⁵ stillbirth;⁶ and perinatal death⁷. Sometimes some unusual complication develops with which, we are not familiar. Here an uncommon complication following caesarean section in a post caesarean pregnancy has been reported.

Case report

A 25 years old lady P ₁₊₄ presented at the emergency department of NRS Medical College & Hospital, Kolkata as an unbooked sixth gravida with the complaint of leaking per vagina for last 4 hours and the period of amenorrhoea was 38weeks. Her past obstetric history revealed that she had caesarean section 4 years earlier (indication of caesarean section was not known to the patient) and 4 successive M.T.Ps, the last being done 1 year back. The baby was alive. The couple wanted ligation operation.

On examination, she was mildly anaemic. Pulse was 88/min and BP was 126/80 mm Hg. She was free of any medical or surgical complications like morbid obesity, COPD and umbilical hernia. Per abdominal finding revealed a term size uterus with cephalic presentation and average liquor. FHS was 144/min and regular. Her previous caesarean section scar was low transverse and there was no scar tenderness.

Per speculum examination showed dribbling of clear liquor. Vaginal examination revealed cervix was 1.5 cm dilated, tubular, station was high up (-3) and membranes were absent.

An emergency L.S.C.S. was performed under spinal anesthesia. The skin incision was Pfannenstiel with excision of the previous scar. On opening the abdomen, uterus was found to be adherent with anterior abdominal wall from which uterus was separated for delivery of the baby (a living male baby of 2.75 Kg) and bilateral tubectomy operation. Bladder was also pulled high up which was dissected and pushed down before opening the uterus. Parietal peritoneum was not closed and rectus sheath was repaired with no 1 chromic catgut. Duration of operation was one hour which was longer than usual operation time of 35 minutes.

First two post operative days were uneventful. On the 3^rd day there was a small amount of serosanguinous discharge from the umbilicus. The caesarean section wound, which was located much below the umbilicus, was healthy. Methylene blue dye was introduced into the bladder to rule out any communication with umbilicus, through which no dye came out. On 4^th post operative day a mass was seen protruding through the umbilicus and on gentle prodding it seemed to be omentum like structure (Fig-I) A provisional diagnosis of omental hernia through umbilicus was made.

Figure I showing omentum like structure protruding through umbilicus


Figure II showing omental tag held during herniorrhaphy operation

On the 5^th post operative day, she underwent herniorrhaphy operation under general anesthesia. A tag of omentum was seen to herniate through anterior rectus sheath and skin (Fig-II). The protruding tag of omentum (sent for histopathological examination and confirmed) was excised and a double breasting of rectus sheath was done, keeping a drain which was removed after 48 hours. Her subsequent recovery was uneventful. She came for check up after 6 weeks, when no abnormality was detected.

Discussion

A review of literature has failed to demonstrate the type of complication mentioned above . Intra operative complication like dense intra abdominal adhesion resulting in injury to the bladder and the bowel is not uncommon⁸. Probably this case report presents an unusual complication for the first time. Probable explanation is that during too much dissection of anterior rectus sheath (to get access to the fallopian tubes) which was firmly adherent with uterus, there was inadvertent injury to the anterior rectus sheath and skin through which omentum had protruded.

References

1. Arjun G Caesarean section: evaluation, guidelines and recommendations Indian Journal of Medical Ethics available at www.ijme.in/163co117.html accessed on 29/09/2008
2. Taylor MK, Simpson JM, Roberts CL,Olive EC, Handerson- Smart D J Risk of complications in a second pregnancy following caesarean section in the first pregnancy: a population-based study MJA 2005; 183 (10): 515-519
3. Gregory KD, Korst LM, Cane P, et al. Vaginal birth after cesarean and uterine rupture rates in California. Obstet Gynecol 1999; 94: 985-989.
4. Lydon-Rochelle M, Holt VL, Easterling TR, Martin D. First-birth cesarean and placental abruption or previa at second birth. Obstet Gynecol 2001; 97: 765-769.
5. Crane JM, Van den Hof MC, Dodds L, et al. Maternal complications with placenta previa. Am J Perinatol 2000; 17: 101-105.
6. Smith GCS, Pell JP, Dobbie R. Caesarean section and risk of unexplained stillbirth in subsequent pregnancy. Lancet 2003; 362: 1779-1784.
7. Smith GCS, Pell JP, Cameron AD, Dobbie R. Risk of perinatal death associated with labour after previous cesarean delivery in uncomplicated term pregnancies. JAMA 2002; 287: 2684-2690
8. Sobande A, Eskander M. Multiple Repeat Caesarean Sections: Complications and Outcomes. J Obstet Gynaecol Can 2006;28(3):193–197

The acquired immunodeficiency syndrome (AIDS) was first recognized among homosexual men in the United States in 1981^1,2. While initially limited, infection with the human immunodeficiency virus (HIV) has immensely increased over the past two decades to become the biggest epidemic of the twentieth century. However, we have witnessed dramatic improvement in prevention of disease progression and long-term survival in the era of Highly Active Anti Retroviral Therapy (HAART).

Apart from biological factors associated with the virus and host which play a role in the transmission and progression of HIV infection, several demographic and social variables have been studied and described in different studies worldwide. Understanding the variety of non-biological factors and behavioral patterns which can affect care and prognosis of HIV patients gives us the opportunity to design non-pharmacological interventions and where possible, to facilitate better care for our HIV positive population.

BACKGROUND:

J.E. Wood clinic of Pennsylvania Hospital in Philadelphia is a teaching outpatient care facility where Internal Medicine residents of Pennsylvania Hospital acquire their ambulatory care experience under supervision of teaching attendings. We have once a week clinic sessions dedicated to the care and follow-up of HIV/AIDS patients under close supervision of Infectious Disease specialists. Our patients have diverse socio-economic, educational and stages of HIV infection.

OBJECTIVE:

We aimed at finding out basic understanding of HIV infection, degree of awareness regarding the ongoing treatment and reasons behind irregular follow-up visits of our HIV patients who attend J.E. Wood outpatient clinic of Pennsylvania Hospital, Philadelphia for treatment of HIV/AIDS.

PARTICIPANTS AND METHODS:

In order to collect relevant information from our patients, a two paged, anonymous, study questionnaire was given to all patients who attended the clinic during January 2007 to December 2007. The questionnaire looked into three different areas of patient related factors which can influence the disease outcome: demographic and social information (Age, Sex, level of education), patients’ knowledge about their HIV disease (source of the infection, duration of HAART, individual recent CD4 count, names of current medications, duration of therapy, medication side-effects) and their behavior (sexual precautions, reasons for medication and follow-up non-compliance). Out of the 75 patients who were given the questionnaire, 7 questionnaires were rejected from the study because of the information received was incomplete, illegible or not related to the questions. 68 completed questionnaires were evaluated and comparative data was tallied using Microsoft excel sheet. We also reviewed relevant literature in pubmed to understand our findings in the light of previous studies related to demographic, socio-economic and psychological aspects of HIV treatment.

RESULTS:

We analyzed the information which was obtained from 68 patients by means of the questionnaire. Our patients consisted of 35 male, 33 female (Table 1). We had a wide range of patients regarding distribution of their age as shown in Table 2 below. Significant numbers of our patients (36%) were diagnosed with HIV for >10 years ago and more than 60% had the diagnosis at least for 5 years (Table 3)

Table 1: Socio-demographic characteristics of patients (n=68)

Table 2: Age distribution of patients (n=68)

Table 3: Duration of diagnosis (in years)

Half of our patients (n= 68) completed high school education or equivalent. About 34% quit education before attaining high school diploma. Roughly, 10% of our patients went to college for further education and 6% acquired some vocational training after high school.

We tried to establish the level of our patients’ participation in their treatment by gathering information through the questionnaire whether they could recall the names of their HIV medicines and the last CD4 count. We found that 74% of our patients, who are on HIV medicines, could recall the names of their medicines but only about 45% of our patients remembered their last CD4 count. Our patients who had completed high school education or equivalent were 2.5 times more likely to remember the names of their HIV medications(95 % confidence interval CI=1.42 to 4.98) and 1.75 times more likely to remember their last CD4 count(95 % confidence interval CI=1.12 to 4.38).

We asked our patients whether they knew that HIV medications need to be taken life long and we also enquired about their knowledge about their safe sexual practices. Only 48% patients of our study group knew that HIV medicines are for life. About 50% of all our patients mentioned that they ensure use of condom during sexual activity and another 40% claimed they practice sexual abstinence. Women patients in our practice were 2.0 times more likely to practice use protective measures during sexual activity (95 % confidence interval CI=1.22 to 4.67).

In our study, only 32 patients (47%) attempted to answer the question where we asked about reason behind not turning up for their follow up appointments as scheduled. Eight patients could not specify a cause, 7 mentioned transport related problems and 2 had insurance issues. Five patients thought their appointments were too often whereas 3 just forget to keep the appointment. Although we did not specifically ask questions on psychological state of our patients, 7 out of the 32 patients mentioned significant psychological problems in their daily life as the reason for non-adherence to medication or follow-up appointments. The responses included responses like “still dealing with the diagnosis mentally”, “feel lack of energy in life”, “life seems to have too many problems”, “been drinking heavy lately” etc.

DISCUSSION:

Interestingly, our small patient cohort roughly reflects the sex ratio of HIV patients globally in 2007 as published by World Health Organization (WHO). In our study the ratio was Male : Female = 51.5% : 48.5% and in the WHO worldwide survey it was 50% : 50%; At the end of 2007, estimated total global HIV positive adults = 33 million (30million – 36 million) ³.

Rates of progression of HIV disease appear to be similar by sex and race category if adjusted for the quality of care ^{4, 5}. Multiple studies on chronic disease management showed that patients’ level of education and health literacy has direct influence on the treatment compliance. Moreover, limited health literacy is thought to be a strong contributing factor to racial disparities in health care. A study was published in 2007 which examined the mediating effect of limited health literacy on the relationship between race and HIV-medication adherence. For the study, a total of 204 patients infected with HIV were recruited and structured in-person interviews were conducted to obtain information. In an adjusted analysis that excluded literacy, African Americans were 2.40 times more likely to be non-adherent to their HIV-medication regimen than whites (95% confidence interval [CI]=1.14-5.08). When literacy was included in the final model, the effect estimates of race diminished from 25% to insignificant level. Therefore, health care providers need to consider the potential utility of responding to literacy and communication barriers in health care as part of interventions to reduce racial disparities ⁶. In our study, we found that patients who had completed high school education or equivalent were more conscientious regarding their HIV care as demonstrated by the fact that they were more likely to remember their last CD4 count and current HIV medications.

Multiple studies have demonstrated that increasing age at the time of HIV infection is associated with more rapid progression to AIDS in the absence of antiretroviral therapy. In one series, for example, the median time from seroconversion to AIDS without therapy was 15 years for patients aged 16 to 24 years at seroconversion, compared to 6 years for those 35 years or older at seroconversion ⁷. In our study, it is notable that 36% of patients were diagnosed with HIV >10 years ago and more than 60% had the diagnosis at least for 5 years. The reason behind the high survival rate is clearly attributable to HAART. Fifty-four patients out of the 68 are currently on HAART and 25 of them are on it for more than last 5 years.

Patients' knowledge of their HIV condition and its treatment has been recognized as a factor that influences adherence to antiretroviral therapy. Patients’ knowledge & perception of the disease and participation in the treatment can be improved through targeted educational programs and support groups. One study done in Nigeria found that individuals living with HIV/AIDS who belonged to a support group and had availed themselves of relevant literature were more knowledgeable and positive about their illness than those who did not belong to support groups. The study concluded that HIV/AIDS support group membership is an important component of psycho-social care in HIV/AIDS patients ⁸. Another study done in France showed that an educational intervention improves adherence to antiretroviral regimens and health status and suggests that it should be initiated early in therapy ⁹. Communicating with patients about adherence issues is important issue, although this may not have an immediate impact on patients' behaviors. Health care professionals should play a pro-active role in this regard. The use of multi-disciplinary adherence teams to ensure that each HIV-positive patient receives the optimal amount of information and support for adherence is a practical approach. Health literacy should be provided in the context of different ethnicity, culturally sensitivity and individual needs associated with HIV, like any other chronic diseases. Epidemiological researches have shown that injection drug abusers and younger patients tend to have worse compliance, as well as subjects with depression and lack of self-perceived social support ¹⁰. Therefore, special care should be taken by health care providers to ensure treatment compliance and health literacy in these patients. In our J.E. Wood clinic, we have dedicated psychologist and social worker to for care of our HIV patients.

Psychological impact associated with treatment of any chronic illness is often neglected in clinical practice but indeed carries a huge significance in terms of long-term treatment compliance and outcome. We identified 7 of our patients who clearly expressed psychological issues related to their HIV infection and it was evident enough that those psychological problems were adversely affecting their treatment compliance. Formal and regular counseling sessions should be arranged for HIV/AIDS patients to promptly identify and manage any psychological or psychiatric disturbance that HIV patients might suffer from. We know that presence of a preexisting psychiatric disorder can increase the risk of HIV acquisition and can also complicate HIV treatment. Moreover, HIV infection can produce a number of psychiatric conditions and exacerbate many others; there is an intense co-morbidity and linkage between HIV and various types of psychiatric conditions. Personality disorders are more prevalent among HIV-infected (19 to 36 percent) and HIV at-risk (15 to 20 percent) individuals ^{11, 12} than the general population (10 percent). Antisocial personality disorder (ASPD) is the most common personality disorder among HIV infected individuals, and has been shown to significantly increase risk of HIV infection ¹³. Successful treatment can be achieved with even the most difficult patients by applying a comprehensive diagnostic formulation that includes psychiatric disease syndromes such as major depression, personality vulnerabilities, behavioral disorders such as addiction, and problems of life experiences such as trauma. With regards to anti-retroviral treatment of HIV positive or AIDS patients, nearly perfect compliance seems to be indispensable to obtain the maximum benefit from HAART. There is a clear relation between high adherence levels and virologic success. We reviewed relevant published literatures to understand the adverse effects and possible interventions of psychological problems in HIV patients. A prospective, randomized, two-arm controlled study was published in 2000 which included 116 patients starting their first-or second-line HAART who were randomized to receive psychoeducative intervention to implement adherence (experimental group [EG]) or a usual medical follow-up (control group [CG]). The study showed that specific and maintained psychoeducative interventions based on excellence on clinical practice are useful to keep high levels of adherence and therefore, high levels of viral suppression ¹⁴.

CONCLUSION:

Human Immunodeficiency Virus infection is one of the most serious disease entities in our modern time. We have witnessed dramatic improvement of long-term survival rate of HIV positive patients due to use of HAART in clinical practice. By identifying the demographic, socio-economic, behavioral and psychological variables which significantly influence patients’ adherence to treatment and understanding of the disease process, we can further improve treatment compliance and the long term prognosis of our HIV patients. These factors may not have very significant role individually, but collectively can dictate the course of success of HAART treatment in patients. Increasing awareness of these factors by practitioners caring for HIV-infected persons, recognizing and potentially treating some of them, should indirectly improve the effectiveness of antiretroviral therapy.

References

1. Pneumocystis pneumonia--Los Angeles. MMWR Morb Mortal Wkly Rep 1981; 30:250.
2. Kaposi's sarcoma and Pneumocystis pneumonia among homosexual men--New York City and California. MMWR Morb Mortal Wkly Rep 1981; 30:305.
3. Status of the global HIV epidemic. http://data.unaids.org/pub/GlobalReport/2008/jc1510_2008_global_report_pp29_62_en.pdf. Accessed January 31, 2009.
4. Collaborative Group on AIDS Incubation and HIV Survival including the CASCADE EU Concerted Action. Time from HIV-1 seroconversion to AIDS and death before widespread use of highly-active antiretroviral therapy: a collaborative re-analysis. Lancet. 2000 Apr 1; 355(9210):1131-7.
5. Altisent, C, Montoro, JB, Ruiz, I, Lorenzo, JI. Long-term survivors and progression of human immunodeficiency virus infection. N Engl J Med 1996; 334:1065.
6. Osborn CY, Paasche-Orlow MK, Davis TC, Wolf MS. Health literacy: an overlooked factor in understanding HIV health disparities. Am J Prev Med. 2007 Nov; 33(5):374-8.
7. Mariotto, AB, Mariotti, S, Pezzotti, P, et al. Estimation of the acquired immunodeficiency syndrome incubation period in intravenous drug users. Am J Epidemiol 1992; 135():428.
8. Olley BO. The role of support group and duration of infection in HIV/AIDS patients' knowledge and attitudes to their illness. Afr J Med Med Sci. 2007 Mar; 36(1):11-6.
9. Goujard C, Bernard N, Sohier N, Peyramond D, Lançon F, Chwalow J, Arnould B, Delfraissy JF. Impact of a patient education program on adherence to HIV medication: a randomized clinical trial. J Acquir Immune Defic Syndr. 2003 Oct 1; 34(2):191-4.
10. Gordillo V, del Amo J, Soriano V, González-Lahoz J. Sociodemographic and psychological variables influencing adherence to antiretroviral therapy. AIDS. 1999 Sep 10; 13(13):1763-9.
11. Sher, KJ, Trull, TJ. Substance use disorder and personality disorder. Curr Psychiatry Rep 2002; 4:25.
12. Jacobsberg, L, Frances, A, Perry, S. Axis II diagnoses among volunteers for HIV testing and counseling. Am J Psychiatry. 1995; 152:1222.
13. Perkins, DO, Davidson, EJ, Leserman, J, et al. Personality disorder in patients infected with HIV: a controlled study with implications for clinical care. Am J Psychiatry. 1993; 150:309.
14. Tuldrà A, Fumaz CR, Ferrer MJ, Bayés R, Arnó A, Balagué M, Bonjoch A, Jou A, Negredo E, Paredes R, Ruiz L, Romeu J, Sirera G, Tural C, Burger D, Clotet B. Prospective randomized two-Arm controlled study to determine the efficacy of a specific intervention to improve long-term adherence to highly active antiretroviral therapy. J Acquired Immune Deficiency Syndrome. 2000; 25(3):221-8.

Hepatitis B is one of the world’s major health problems ¹. By recent estimates, worldwide more than 2 billion people have been infected with hepatitis B virus (HBV) globally and more than 350 million have chronic (long term) liver infections². The infection is supposed to be causally related to 1 to 2 million deaths per year worldwide ³. Hepatitis B is a blood borne infection that is transmitted 1) by an infected mother to the newborn, 2) by contact with infected blood through unsafe injection, transfusion, open wounds, and sharing toothbrush or razors, and 3) by unprotected sex. Approximately 90% of newborns infected with HBV develop chronic infection, whereas 30-50% of children under age 5 years, 10% of adolescents aged 15 years, and 2-5% of older individuals develop chronic infection ^4,5.

In Pakistan, it is Hepatitis (B & C) not Human immuno deficiency virus (HIV) that is the most common serious viral infection. Number of hepatitis B carriers in Pakistan is estimated at around seven million⁴ that is about 5% of the world wide 350 million carriers of hepatitis B ⁵. Unlike HIV, there was no large-scale national awareness campaign to educate the public and healthcare professionals in Pakistan about these infections before 2006, but now a comprehensive national strategy that will lead to the elimination and control of hepatitis B is becoming a top public health priority in Pakistan after inclusion of HBV immunization in government’s expanded Program for Immunization (EPI). The World Health Organization (WHO) Assembly endorsed the recommendation of its Global Advisory Group that all countries should implement a hepatitis B immunization program⁶. The threat of HBV to the health of the nation is frequently under-recognized by epidemiologists, policy makers and the public because unlike the influenza virus, it is often not the acute infection that makes people sick, but the consequences of chronic HBV infection that occurs after 20-30 years. Fortunately, hepatitis B is a vaccine preventable disease, global eradication is therefore possible if everyone worldwide receives the HBV vaccine before they become infected. Despite advances in antiviral therapy, only a minority of patients with chronic hepatitis B will have a sustained response. Thus, primary prevention by vaccination to increase herd immunity remains the main thrust in the control of HBV infection.

The development of hepatitis B vaccine is considered to be one of the major achievements of modern medicine. Three different classes of hepatitis B vaccine are available based upon how they are derived (from plasma, yeast, or mammalian cells).The first generation HBV vaccine was prepared by concentrating and purifying plasma from Hepatitis B surface antigen (HbsAg) carriers to produce 22 nm sub viral particles, which contain HBsAg alone. Derivation from plasma has left lingering concerns regarding the potential to transmit blood-borne infections, although this vaccine has excellent efficacy and safety ⁷. Yeast-derived recombinant HBV vaccines were first introduced in the mid 1980s. They are produced by cloning of the HBV-S gene in yeast cells. These vaccines contain non-glycosylated HBV small S protein as the envelope antigen which must be released from the yeast during the manufacturing process ⁸. These vaccines do not contain antigens of the pre-S regions. The third class of HBV vaccine is the mammalian cell-derived recombinant vaccine. Three vaccines of this class have been developed. In addition to the S antigen, one of these contain antigen from the pre-S2 region while the other two contain antigens from both the pre-S1 and pre-S2 regions ⁹

The efficacy of universal immunization has been shown in different countries, with striking reductions of the prevalence of HBV carriage in children, most importantly; the HBV vaccine can be considered the first successful anti-cancer vaccine, as 20 years of mass vaccination has clearly reduced the incidence of hepatocellular carcinoma in children, at least in Taiwan ¹⁰. Currently available hepatitis B vaccine in Pakistan’s market are genetically engineered DNA recombinant vaccines and the recommended series of three intramuscular doses of hepatitis B vaccines induces a protective antibody response (anti-HBs > =10 milli-international units {mIU/ml}) in > 90% of healthy adults and in >95% of infants, children and adolescents ^{7, 11}.

A vaccine consists of many parts, only one of which is the antigen by which it is known. Other components of the presentation may include, for instance, an adjuvant, a preservative or other ingredient. There may be components not stated on the information sheet that are classified as proprietary and therefore the manufacturers are not obliged to declare them. Thus, the effect the vaccine has, on an individual may be influenced in various ways by each and all of these components. Preservatives are just one of a number of additives to vaccines that are carefully regulated and which come under special scrutiny from time to time ¹². Several case reports raised concerns that hepatitis B (HB) immunization might be linked to new cases or reactivation of multiple sclerosis, could shift the immune system toward an auto-immune direction, or may cause central nervous system (CNS) demyelinating diseases etc ^{13, 14, 15, 16}. The present study sought to compare the safety of four hepatitis B vaccine regimens available in Pakistan’s market, in apparently healthy young females, and to determine the sero-response (i.e. reactogenicity and immunogenicity) to these vaccine in the same group of volunteers.

MATERIALS AND METHODS:
Study Duration: Jan 2003 to Jan 2006
Study Design: Prevention, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study.
Subject: A total of 243 apparently young healthy female students of two Universities of the city were included in this study.
Informed Consent: Prior to immunization, all volunteers were requested to give written informed consent to participate in this study. The volunteers were also advised that they are free to withdraw from the study at any time without any obligation to disclose her reason (s) for so doing.
Criteria For Inclusion In The Study: All volunteers after submitting their signed consents were subjected to selection criteria on the basis of health checkups by a medical doctor to record the various factors including:
a) Age: 18 – 30 years, b) History of Jaundice, blood transfusion, exposure to syringe, surgical and dental,
c) Weight: > 45 Kg, d) Body Temperature: 96 – 98°F, e) Hemoglobin: > 10 g/ dl, f) Blood Pressure: Systolic 100 – 180 mm of Hg, Diastolic: 60 – 100 mm of Hg, g) Pulse rate: > 65/min.

After qualifying for inclusion in this study, volunteers were asked to give 10 cc of blood sample for different hematological (CP i.e. complete blood picture and Hb% i.e. hemoglobin percentage by Sysmex blood analyzer & ESR i.e. erythrocyte sedimentation rate by Westergreen method ), and Biochemical analysis (Direct Bilirubin, Indirect Bilirubin, ALT, AST and, Alkaline phosphatase by MicroLab- Merck chemistry analyzer), this data was used to keep the record of health status of participants and its comparison with adverse effects if appeared. Screening for HBs antigen, anti HBs antibodies and HBc IgM antibodies by Immunochromatography (ICT, Australia and Abbott, USA) and confirmation by enzyme linked immunosorbent assay (IMX ELISA - Abbott, USA) was also done before first dose of immunization.
Test Vaccines: Fourrecombinant yeast derived HB vaccine were used as test regimens i.e. Euvax-B (LG Chemicals Ltd., Korea), Heptis-B (Boryang, Korea), Amvax-B (Amson, Pakistan) and Engerix-B (GS & K, Belgium). To avoid complications related to multi dose vials, it was strictly followed that the vaccination dose for each subject should be company packed, individually in a sealed container and, formulated for intra muscular injection. The dosage vial should contain same amount i.e. 20 μgm/ ml of HBs Ag absorbed on to approximately 0.5 μgm / ml adjuvant (aluminum hydroxide) and 100 μgm / ml preservative (Thiomersal/ Thimerosol) in a final volume of 1.1 ml (1 dose/ vial). Storage temperature should maintain as 2ºC to 8ºC to ensure integrity. Participants were injected with the vaccine of their own choice. Information broachers of the four vaccines were distributed among participants to help them make a choice. Out of total 729 doses administered to 243 individuals during this study, 195 were of Engerix-B, 420 were Heptis-B, 75 were Amvax-B, and 39 doses were of Euvax-B.
Categories for Determining Severity of an Adverse Effect:

• Local Symptoms: Soreness, indurations, swelling and redness.
• General Symptoms: Fever, headache and dizziness.
• Mild: Adverse events easily tolerated
• Moderate: Adverse event of sufficient discomfort to interfere with daily activity or requiring simple treatment (e.g. Paracetamol, Generic name: Paracip).
• Severe: Adverse event incapacitating and preventing usual activity or which may be life threatening, requiring hospitalization or completed treatment.

The course of an adverse event was described as:

• Spontaneous recovery without discontinuation of vaccination
• Recovery after discontinuation of vaccination
• Continuation of recovery after symptomatic treatment

Eight samples of Peripheral blood (2-3 ml) were taken from all vaccinees before administration of each dose, and at different intervals after completion of immunization as per schedule given below; the sera were collected and stored at - 20°C.

Table 1: Visits Were Scheduled As Follows:

Antibody Estimation and Statistics:

Anti-HBs were detected by ELISA using IMX- Abbott and quantitated using appropriate dilution of a positive sample with a known concentration of anti-HBs expressed as IU/L, provided by the manufacturer. The assay determined IgG type of anti- HBs antibody and the protective level of antibody was considered >10 IU/L. P values of less than 0.05 were considered significant. On the whole Hepatitis B antibodies titer was determined in participants using five standards i.e. <10 IU/ml, Between 10 – 100IU/ml, Between 100 – 1000 IU/ml, >1000 IU/ml, and no response or no antibody titer for the period of 36 months starting Jan’2003 till Jan’ 2006.

RESULTS:

Percentage of Geometric mean titer (GMT) of antibodiesbelow 10 IU/ml was in between 0.0% to 0.22% in case of Engerix-B, 0.0% to 0.20% in case of Euvax B, 0.0% to 0.30% in case of Amvax-B and 0.0% to 0.25% in case of Heptis-B. Percentage of GMT of antibodies between 10 – 100 IU/ml was in between 0.0% to 10% in case of Engerix-B, 0.0% to 9% in case of Euvax B, 0.0% to 8.9% in case of Amvax-B and 0.0% to 9.3% in case of Heptis-B. Percentage of GMT of antibodies between 100 – 1000 IU/ml was in between 0.0% to 35% in case of Engerix-B, 0.0% to 30.1% in case of Euvax B, 0.0% to 39.3% in case of Amvax-B and 0.0% to 40% in case of Heptis-B. While, Percentage of GMT of antibodies above 1000 IU/ml was in between 0.0% to 23% in case of Engerix-B, 0.0% to 25% in case of Euvax B, 0.0% to 26% in case of Amvax-B and 0.0% to 23.7% in case of Heptis-B. When Percentage of GMT of negative response was calculated we found that on the whole Engerix-B showed no response after 6 months of 3^rd dose in 0.9% recipients leading towards no response in 31.78% of recipients after 30 months of 3^rd dose. Euvax-B showed no response after 6 months of 3^rd dose in 7.9% recipients leading towards no response in 35.68% of recipients after 30 months of 3^rd dose. Amvax-B showed no response after 6 months of 3^rd dose in 11.6% recipients leading towards no response in 25.5% of recipients after 30 months of 3^rd dose. While, Heptis-B showed no response after 6 months of 3^rd dose in 9.88% recipients leading towards no response in 26.75% of recipients after 30 months of 3^rd dose. Period after 6 months of 3^rd dose and before 15^th month of 3^rd dose was the period when highest Percentage of GMT of anti- HBs was observed .

Local and generalized adverse effects observed during and after the immunization of volunteers were recorded separately for each vaccine (Table 2, 3, 4 & 5).

Table 2 Incidence of Local and/or Generalized Symptoms on Vaccination With Engerix-B

Table 3 Incidence of Local and/or Generalized Symptoms on Vaccination With Euvax-B

Table 4 Incidence of Local and/or Generalized Symptoms on Vaccination With Heptis-B

Table 5 Incidence of Local and/or Generalized Symptoms on Vaccination With Amvax-B

As Shown in Table 6 that one month after the first dose, 180/243 subjects (74.45%) had seroprotection with respect to anti-HBs. One month after the second dose, 189/243 subjects (77.92%) showed seroprotection, four months after second dose, at month 6, 224/243 subjects (92.43%) were seroprotective. After 15 months of 3^rd dose 231/243 subjects (95.27%) showed maximum seroprotection level in the immunized women. Later on seroprotection level was determined after 19, 22 and 30 months of 3^rd dose. 170/243 subjects (70.08%) subjects were seroprotected even after 30 months of 3^rd dose without having any booster dose.

Table 6: Over All Seroprotection Levels and Geometric Mean Titers (GMT) of Anti- HBs Antibodies

Comparative results of serum protection analysis of 04 candidate vaccines determined after 15 months of third dose without giving any booster dose, were found effective in healthy young female volunteers, demonstrating induction of very good immunogenicity. No significant differences were observed in seroprotection level of test vaccines (Table7). Overall serum protection rate achieved in case of Engerix-B was 95.9%, in case of Euvax-B, it was 95.2%, in case of Heptis-B was 95.0% , and in case of Amvax-B it was 95.1%. Calculated P values for all four test vaccines were lesser than 0.05 indicating significance of the used vaccines.

Table 7: Comparative Serum Protection analysis of 04 different Hepatitis-B Vaccines(n= 243; mean age= 21.5+3.7 Years)

10μgm x 3

95%

Confidence Level

P Value

Engerix-B (n=65)95.9%94.5% - 100%<0.05Euvax-B (n=13)95.2%94.3% - 100%<0.05Heptis-B (n= 140)95.0%92% - 99.4%<0.05Amvax-B (n= 25)95.1%92% - 98%<0.05

DISCUSSION:

As yet no such immunogenicity trials have been conducted in Pakistan or risk factors indigenous to the region assessed for any of the vaccine being utilized at the population level for such long period. Our study, is one of the longest study, conducted between Jan’2003 and Jan’ 2006, which includes total 243 healthy women subjects of child bearing age group. In this study we have demonstrated that there is no significant difference in reactogenicity and serum protection level among all four candidate vaccines we tested here, excellent immunogenicity of vaccines in volunteers recommends their usage for immunization purpose among different communities without having any doubts related to reactogenicity and side effects.

Recombinant hepatitis B vaccines have long been used for protection in the serum of and three doses have been shown to produce Anti HBs in the serum of approximately 95% of people who have not encountered the virus. The antibody response declines with increasing age. Patientsolder than 30 years have an increased risk of no response toHBV vaccine, as compared with younger persons ¹⁷. Thus, immunizationduring childhood or adolescence offers the greatest potentialfor protection ¹⁷ and provides lifelong immunity. Ninety percent of healthy adults and 95 percent of infants, children, and adolescents have protective serum anti-HBs antibody concentrations after the vaccine series has been completed ¹⁸.

Two kinds of recombinant vaccine are used for active immunization against hepatitis B; one of them contains the PreS1 and PreS2 antigenic domains while the other kind contains S and PreS polypeptide. No important differences between the effectiveness of these two types of vaccine have been detected ¹⁹. In a series of studies it has been demonstrated that 90-99% of healthy neonates, children, adolescents and adults develop protective levels of anti-HBs antibody following a standard vaccination course with hepatitis B vaccine ^{20, 21, 22, 23, 24, 25}.

Efficacy of vaccines in the field have been measured long after the vaccine have been introduced at large scale population levels and only selected countries have record keeping such as the Centers for Disease Control in USA and the National Health Services in UK. Most developing countries do not have infra structure to support these activities and therefore the efficacy and risk indigenous to the population remains unknown.

Procurement and delivery of high-quality vaccine has national and international public health and ‘public good’ implications far beyond the scope of most products. People immunized with vaccines of inadequate quality can become ill and die from the disease that the vaccine should have prevented. Even more lives are placed at risk if vaccination coverage declines as a result of reduced public confidence in immunization programs. If we look at the outcome of immunization programs in different countries then we will have a good idea that how mass vaccination helped in reduction of disease burden?²⁶

Importance of dose size, number of doses and dose response is another important issue related to immunization programs. Published studies regarding the dose-response relationship in terms of immunogenicity and sero-protection are highly varied. Chiaramonte et al ²⁷reported that the sero-protection reached a level of 99.6% within one month after primary immunisation with the recombinant hepatitis B vaccine. The findings of Assateerawatt et al²⁸ and Just et al ²⁹ also were the same. Baldy JLS et al carried out a comparative study with three recombinant hepatitis B vaccines, one Brazilian (Butang, Instituto Butantan) and two Korean vaccines (Euvax-B, LG Life Sciences Ltd. and Hepavax-Gene, Green cross Vaccine Corp.), administered intramuscularly to students aged 17to19 years in three doses (corresponding to half the amount of antigen routinely used for adult vaccination) at intervals of one month between the first and second dose, and of four months between the second and third dose. The GMT of anti-HBs induced by the Euvax-Band Engerix-B vaccines were higher than those obtained with the Butangvaccine (p < 0.05); this difference was not significant when comparing the other vaccines two-by-two. No spontaneous adverse effects attributable to the application of any dose of the three vaccines were reported ³⁰.

Vaccine efficacy is defined as the reduction in the incidence of a disease among people who have received a vaccine compared to the incidence in unvaccinated people. The efficacy of a vaccine is measured in clinical trials by giving one group of people a vaccine and comparing the incidence of disease in that group to another group of people who do not receive the vaccine. In our study overall efficacy of the vaccines used was satisfactory, without producing sever adverse effects, also there is no report of incidence of disease till now, in those who were vaccinated during this study(Table 2, 3, 4, 5).

Maximum protection level in terms of immunogenicity was observed in Euvax-B, which showed GMAT of 35.68% in test population. Engerix-B showed GMAT of 31.78%, Heptis-B showed GMAT of 26.75% and, Amvax-B showed GMAT of 25.5% after 30 months of 3^rd dose of immunization While highest serum protection level was achieved in case of Engerix -B i.e. 95.9%. On the whole, r-hepatitis B vaccines showed high immunogenicity and good safety profile in the test population.

The inclusion of Hepatitis B in the list of compulsory and Extended Program for Immunization (EPI) in Pakistan since 2005 will result in mass vaccination of pediatric population. However, a big chunk of the adult population, especially healthcare workers, also needs to be immunized against Hepatitis B infection. We believe that all of the above mentioned HB vaccines, which are easily available in Pakistan’s market can be used for these mass vaccination programs without having any doubts related to Reactogenecity and Immunogenicity.

CONCLUSION:

In conclusion, this prospective study reinforces that the four different recombinant hepatitis B vaccines licensed in Pakistan have a good tolerability and are highly immunogenic among young women. It is also recommended that government should ensure the serosurvey of HBsAg and vaccine coverage at country level in order to reduce the disease burden on country’s economy.

References

1.Kane MA, and Clements J. Hepatitis B. D. T. Jamison, W. H. Mosley, A. R. Meashan, and J. Bobadilla , editors. Disease control priorities in developing countries. New York: Oxford University Press N.Y; 1993:321–330.

2.World Health Organization, Revised fact sheet, August 2008.

3.Park K. Textbook of prevention and social medicine, 15th edition, Jabalpur, India: Banarsidas Bhanot Publishers;1997:159

4.Wasim J, Nadim J, Yakoob K , Muhammad I, Tirmizi SFA, et al. Hepatitis B and C: prevalence and risk factors associated with seropositivity among children in Karachi, Pakistan. BMC Infectious Disease. 2006;6:101

5.Zaman AS. 2003. Daily Dawn Internet Edition. 23 January.

6.WHO, 45th World Health Assembly, expanded programme on immunization and vaccine quality—progress report by the Director General, A45/8. World Health Organization, Geneva, Switzerland. 1992.

7.Szmuness W, Stevens CE et al. Hepatitis B vaccine: demonstration of efficacy in a controlled clinical trial in a high-risk population in the United States. N Engl J Med. 1980; 9;303(15):833-41.

8.Stephenne J. Development and production aspects of a recombinant yeast-derived hepatitis B vaccine. Vaccine. 1990;8 Suppl:S69-73; discussion S79-80.

9.Young MD, Schneider DL et al. Adult hepatitis B vaccination using a novel triple antigen recombinant vaccine. Hepatology. 2001;34(2):372-6.

10.Kao JH, Chen DS. Global control of Hepatitis B infection. Lancet Infect Dis. 2002;2(7):395-403.

11. Zajac BA, West DJ, McAleer WJ, Scolnick E M. Overview of clinical studies with hepatitis B vaccine made by recombinant DNA. J. Inf. 1986; Suppl A0:39–45.

12.Clements CJ. Vaccine preservatives: what is the big deal?. Indian J Med Res. 2006;124:5–8.

13.Duclos P. Safety of immunisation and adverse events following vaccination against hepatitis B. Expert Opin Drug Saf. 2003;2:225-31.

14.Hall A, Kane M, Roure C, Meheus A. Multiple sclerosis and hepatitis B vaccine? Vaccine. 1999;17:2473-2475.

15.DeStefano F, Verstraeten T, Jackson LA et al. Vaccinations and risk of central nervous system demyelinating diseases in adults. Arch Neurol. 2003;60:504-509.

16.Ascherio A, Zhang SM, Hernán MA et al. Hepatitis B vaccination and the risk of multiple sclerosis. N Engl J Med. 2001;344:327-332.

17.Fisman DN, Agrawal D, Leder K. The effect of age on immunologic response to recombinant hepatitis B vaccine: a meta-analysis. Clin Infect Dis. 2002;35:1368-1375.

18.Mast E, Mahoney F, Kane M, Margolis H. Hepatitis B vaccine. Plotkin SA, Orenstein WA, editors. Vaccines. Philadelphia: Saunders. 2004:299-337.

19.Bertino JS Jr, Tirrell P, Greenberg RN et al. A comparative trial of standard or high-dose S subunit recombinant hepatitis B vaccine versus a vaccine containing S subunit, pre-S1, and pre-S2 particles for revaccination of healthy adult nonresponders. J Infect Dis. 1997;175:678-681.

20.Zannolli R, Morgese G. Hepatitis B vaccine: current issues. Ann Pharmacother. 1997;31(9):1059-1067.

21.West DJ, Calandra GB. Vaccine induced immunologic memory for hepatitis B surface antigen: implications for policy on booster vaccination. Vaccine. 1996;14(11):1019-1027.

22.Jafarzadeh A, Shokri F. The antibody response to HBs antigen is regulated by coordinated Th1 and Th2 cytokine production in healthy neonates. Clin Exp Immunol. 2003;131(3):451-456.

23.Shokri F, Jafarzadeh A. High seroprotection rate induced by low doses of a recombinant hepatitis B vaccine in healthy Iranian neonates. Vaccine. 2001;19(31):4544-4548.

24.Jafarzadeh A, Kardar GA, Khoshnoodi J, Shokri F. Downregulation of IL-12 production in healthy nonresponder neonates to recombinant hepatitis B vaccine. Iran Biomed J. 2004;8:41-45.

25.Jafarzadeh A, Shokrgozar MA, Khoshnoodi J, Shokri F. Unresponsiveness to recombinant hepatitis B vaccine in healthy Iranian neonates: association with HLA antigens. Irn J Med Sci. 2002;27:51-55.

26.Proceedings of Who’s third expert working group meeting on hepatitis B. Tokyo, Japan 6-7 March 2007.

27.Chiaramonte M, Majori S, Ngatchu T et al. Two different dosages of yeast derived recombinant hepatitis B vaccines: A comparison of immunogenicity. Vaccine. 1996;14:135-7.

28.Assateerawatt A, Tanphaichitr VS, Suvatte V, Yodthong S. Immunogenicity and efficacy of a recombinant DNA hepatitis B vaccine, Gen Hevac B Pasteur in high risk neonates, school children and healthy adults. Asian Pac J Allergy Immunol. 1993;11:85-91.

29.Just M, Berger R, Just V. Reactogenicity and immunogenicity of a recombinant hepatitis B vaccine compared with a plasma derived vaccine in young adults. Postgrad Med J. 1987;63 (Suppl 2):121-3.

30.Baldy JLS, Lima GZ, Morimoto HK et al. Immunogenicity of three recombinant hepatitis B vaccines administered to students in three doses containing half the antigen amount routinely used for adult vaccination. Rev Inst Med Trop S Paulo. 2004;46(2):103-7.

“Racism at work - a crime in anyone’s language” ¹

The Civil Rights Act 1964 remains of the greatest achievements in United States (US) history. It had implications internationally, making racial discrimination illegal, but its effectiveness in the employment domain remains contestable ². The worldwide existence of workplace racism has attracted controversy and this is drawn out by psychiatry’s attempt to understand the nature of the problem ³. Discrimination at work, based on a person’s race, comes in different guises and can have negative consequences on both individuals and organisations ¹. Despite legislation to protect individuals substantial progress needs to be made to eradicate the problem.

What is racism?

The concepts of “race”, “ethnicity” and “racism” are explained in figure 1.

Racism is a social process associated with “overt and covert forceful establishment and maintenance of power by one social group over another” ³.

Racism can be seen as a misuse of power and, even today, power relations are signified by subtle cultural rules that perpetuate racial inequality ⁶.

What are the origins of racism?

That some races are superior to others has origins from the 19^th century ⁵. The history of racism has stimulated considerable debate in understanding racism.

Racism may have origins in experiences derived from, what is known in analytical psychology as, the collective and personal unconscious. The personal unconscious arises from the lifetime experiences of the individual. This is distinct from the “collective unconscious” which psychiatrist Carl Jung described to represent a form of the unconscious common to mankind as a whole and originating in the inherited structure of the brain ⁷. This contains inherited primitive cultural and racial elements. Both the personal and collective unconscious, made from our individual and ancestral experiences respectively, may account for the manifestation of racism in society today.

In recent times the experience of overt racial bigotry and prejudice is seldom seen ⁸. Nevertheless discrimination against members of a social group may persist because it is so deeply entrenched within society, by the personal and collective unconscious, that it becomes the automatic response even when no conscious intent is present ⁹. “Everyday discrimination” is the discreet, pervasive discriminatory acts experienced by stigmatised groups on a daily basis ¹⁰, and highlights the modern perspective that racism is subtle.

The subtlety of racism

“Like a virus that has mutated, racism has evolved into a new form that is difficult to recognise and harder to combat” ⁸

As blatant forms of racism become extinguished, particularly in the current climate of political correctness, unconscious racial biases in subtle forms, known as ambivalent or modern racism ¹⁰, are appearing. This has been referred to as aversive racism occurring in people who possess strong egalitarian values, and who believe they are not prejudiced, but have negative racial feelings and beliefs that they are unaware of ⁸. These feelings and beliefs are rooted in the normal psychological processes of social categorisation, satisfaction of basic needs for power and control, and socio-cultural influences ⁸. The ambivalence involving positive and negative feelings creates a psychological tension that leads to an inconsistent pattern in their behaviour ⁸.

The cumulative effects of unpredictable and seemingly trivial behaviour such as avoidance of ethnic minorities, closed and unfriendly verbal and non verbal communication, and failure to provide assistance, is more damaging ¹⁰. Apparently harmless interactions, including racist assumptions and questioning about where somebody is from, also convey messages about marginality and not belonging ¹¹. This subtle racism may contribute to the racism perceived by minority groups in higher status professions and organisations.

Does racism exist in healthcare organisations?

“American Medical Association apologizes for racism in medicine” (10^th July 2008) ¹².

This admission by the American Medical Association, of racial discriminatory practices against African-American physicians, reflects the recognition of racism in other western countries.

In the United Kingdom (UK) racism has been revealed in public institutions such as the metropolitan police ¹³ and widely reported in the nursing profession ^14,15 within the National Health Service (NHS). Trevor Phillips, chairman of the Equality and Human Rights Commission, referred to the “snowy peaks of the NHS” ¹⁶ with a large number of ethnic minorities at the base. Less than 10% of senior managers and 1% of chief executives are from ethnic minority background ¹⁷. There is a “glass ceiling” ¹⁸ preventing promotion and black and minority ethnic (BME) managers feel they have to work twice as hard and have twice as many qualifications to succeed ¹⁹.

Since 2000, after a survey commissioned by Department of Health (DOH) reported that half of front-line NHS BME staff had been victims of racial harassment in the previous 12 months ²⁰, reports of racism in healthcare have increased. In 2001 a Kings Fund report, “Racism in Medicine” ²¹, generated powerful debate after finding that bullying and discrimination were a daily fact of life for black and Asian doctors. Then in 2003 a British Medical Association (BMA) survey revealed that in ethnic minority doctors, who form nearly one third of the NHS workforce ²², more than 80 per cent believed that their ethnicity had a negative effect on their career advancement ²³. In 2004 the Royal College of Psychiatrists accepted that racism existed in the NHS and in their own institution ²⁴.

How does racism manifest itself in medicine?

“Discrimination can appear to be hidden when it is institutionalised, although it is not usually hidden from the person who is subjected to it” ³

Institutional racism is “the collective failure of an organisation to provide an appropriate and professional service to people because of their colour, culture and ethnic origin” ¹³. Health disparities among patients have been widely linked to racially biased discriminatory health practices ^{25, 26, 27} but how do structures, processes, and values within an organisation discriminate against those working in the medical profession?

There is considerable evidence to indicate that discriminatory practices against doctors evolved from medical school. For instance racial discrimination has operated at the time when students applied to study medicine ^{19, 28}, through short-listing based on whether applications had Asian or English names ^{29, 30}, and with downgrading of non-English names by computer ³¹. Discrimination has also been reported during medical school in the US and Canada ¹¹. UK ethnic minority medical students also perform poorly in examinations compared to white students ^{32, 33} although the lack of evidence of explicit discrimination may suggest the involvement of more subtle communication styles and cultural differences ³³.

If the problems at medical school are accountable by racial organisational processes it is not surprising that discriminatory practices persist after qualification (figure 2)

What are the consequences of racism in healthcare?

“Racial discrimination damages both those discriminated against and those doing the discriminating” ³⁷

The cost of workplace racism is that it acts as a chronic and acute stressor on the individual with a range of consequences (figure 3):

“Racial fatigue” characterises the potential emotional and psychological sequelae of feeling isolated in a work environment in which race regularly influences behaviour but is consistently ignored and nobody wants to discuss it (“racial silence”) ⁴⁰. Racism may be underreported for the same reasons seen with workplace bullying: fear of making matters worse, belief that nothing will be done, concerns regarding confidentiality, fear of victimisation, and concern about being labelled as a troublemaker ⁴¹. In addition the individual may fear being regarded as having a “chip on one’s shoulder”.

Organisations may also suffer with disharmony at work, high sickness levels, and resignation ¹. In medicine this results in the “double loss” of a speciality losing highly motivated people and gaining those where enthusiasm may be low ¹⁹. In addition victims of racial discrimination in healthcare may pursue legal action. In 2003 a surgeon won over £600,000 ⁴² after being denied entry to the specialist registrar. Another surgeon successfully sued the BMA for more than £800,000 for racial discrimination after it failed to support his own claim against the DOH ⁴³. In another case a UK trust paid £2.5m, including legal costs, for wrongful dismissal of a consultant obstetrician who was investigating discrimination ⁴⁴.

What can be done if you are experiencing racism at work?

In the UK there is protection by legislation. It is unlawful to discriminate against anyone on racial grounds. The Race Relation Act 1976 defined three types of discrimination (direct, indirect, and victimisation) ^{1, 45,}. Following this was the setting up of the Commission for Racial Equality (CRE) in the UK to tackle racism and promote racial equality ⁴⁵. The Race Relations Act 1976 has now been superseded by the Race Relations (amendment) Act 2000 ⁴⁶ that requires public bodies to eliminate discrimination, promote equal opportunities, and ensure good race relations. However legal processes are stressful and there are some steps you can take before pursuing this route (figure 4).

Recommendations and Conclusion

“The law may be just but its implementation is another matter” ⁴⁷

Despite legislation and procedures, to address racism at work, healthcare organisations are slow in introducing and supporting the policies for race equality ¹⁸. Suits come to legal action, not for a lack of policy, but because of not being enforced ⁴⁸. Practice is not synonymous with policy ¹⁹. Reinforcement of policies depends on the degree to which upper management understands discrimination and harassment ⁴⁸. Although implementation of policies could be successful in combating overt racism this is not so for the covert form.

The covert form of racism, as in institutional racism where organisational processes are “unwittingly” enacted ¹³, suggests that racism is inevitable. Even people with strong motivations to avoid it are subject to automatic cognitive activation of stereotypes, which can unconsciously influence behaviour, making diversity training courses and non-discrimination policies relatively ineffective ¹⁰. Attending to, and encouraging the reporting of, the “softer” aspects of racism may be the key to establishing a true “positively diverse climate” ¹⁰. New forms of racism require new approaches (Figure 5):

The most important part of the solution is education. Teaching on racism should be incorporated into the undergraduate and postgraduate curriculum ¹⁹. However of greater significance is recognising our own personal prejudices, at an early stage, so that prejudices we all harbour are challenged within ourselves.

“The hardest attitude to change is the one you don’t know you have” ⁸

Useful UK online resources

• http://www.oneworkplace.co.uk - “One Workplace Equal Rights” aims to tackle racism and promote equal opportunities in the workplace.
• http://homepage.ntlworld.com/rajen/RacialEquality - Race Equality Ltd provides phone advice about racism in the medical establishment.
• http://www.bidaonline.org.uk - The British International Doctors Association protects and promotes the interests of Ethnic Minority Doctors and Dentists working in the UK.
• http://www.equalityhumanrights.com - A new commission working to eliminate discrimination, reduce inequality, protect human rights and build good relations.

References

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