Aspergillus Infection of Paranasal Sinuses

CLINICAL STUDY

Aspergillus Infection of Paranasal Sinuses Maroof Aziz Khan FCPS, Abid Rasheed FCPS, Muhammad Rashid Awan DLO, Azhar Hameed FCPS Department of Ear, Nose, Throat and Head and Neck Surgery-Unit 1, Mayo Hospital King Edward Medical University, Lahore, Pakistan

Abstract Objectives Aspergillus sinusitis is not an uncommon disease in our part of the world. There is still no consensus on classification of the disease and treatment methods have also not been standardized as yet. We assessed clinical characterization of the pattern of the disease in this clinical study. Methods A total of 23 consecutive patients undergoing external ethmoidectomy for suspected fungal sinusitis were selected for the study. All patients included in the study were immunocompetent. Caseous material obtained following surgery was sent for microscopy with Potassium Hydroxide (KOH) and histopathological examination to know type of the fungus and nature of the disease. Results The average age of the patients was 27.7 years (SD 40±30). They ranged in age from 10 to 70 years. There were 17 (73.91 %) male and 6 (26.09 %) female patients in this study. M: F ratio was 1:0.35. In 19 (82.61 %) of 23 patients, Aspergillus species was found on microscopy and histopathological examination. Non-invasive disease revealed in 13 (56.52 %) and invasive in 6 (26.09) patients. In 4 (17.39 %) patients, simple inflammatory polyps were seen. Conclusion For all practical purposes, Aspergillus infection of paranasal sinuses can be broadly divided into two categories, non-invasive Aspergillus sinusitis that usually presents as fungus balls or caseous material without fungal tissue invasion and invasive Aspergillus sinusitis with presence of septate hyphae in the soft tissue. The final specimen obtained during surgery should be submitted for histopathological examination to detect invasion of the tissues as this has effects on further treatment of disease. Key Words: Aspergillus, External Ethmoidectomy, Paranasal Sinuses Journal of Taibah University Medical Sciences 2010; 5(2): 60 - 65

Correspondence to: Dr. Maroof Aziz Khan Associate Professor of ENT Unit 1, Mayo Hospital  King Edward Medical University, Lahore, Pakistan +92 3218436853  +92 4239923412  [email protected]

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Introduction

Intracranial spread of the infection occurs due to close proximity of the sinuses with cranial cavity. It is a dreaded complication, as it is usually fatal if not treated promptly. Orbital involvement occurs by contiguous spread of the disease from paranasal sinuses, by expansion or bone erosion due to pressure effect of the polyps or fungal tissue invasion. It is considered to worsen the prognosis of sinonasal Aspergillosis. Moreover, the superior orbital fissure and optic canal directly open into the middle cranial fossa, and are ready pathways for further intracranial spread of the infection8.

S

ince first reported by Katzenstein and her colleagues in 1983, Aspergillus sinusitis is still poorly recognized regarding its classification, characterization and management. The combination of nasal polyps, crust formation and sinus cultures yielding the Aspergillus was first noted in 1976 by Safirstein1,2. Aspergillosis of Head and Neck region, primarily affects the nasal cavity and paranasal sinuses. Mucormycosis and Rhizopus stands far behind the Aspergillus in causing fungal sinusitis. There are more than 185 species of the Aspergillus and over 95 % of all infections are caused by Aspergillus Fumigatus, Aspergillus Flavus and Aspergillus Niger. Disease may present with nasal polyps, anterior and posterior nasal discharge, nasal obstruction, epistaxis, headache, anosmia, proptosis or snoring3. Aspergillus as a pathogen cannot actively penetrate undamaged and intact mucus membrane or skin as it lacks keratolytic enzymes. On the basis of this finding, paranasal sinus Aspergillosis is now classified into invasive (acute fulminant, chronic invasive, granulomatous invasive) and non-invasive (fungus ball and allergic fungal rhinosinusitis) forms with their own pathophysiology and clinical presentation. Any type of paranasal Aspergillosis may progress to more aggressive disease illustrating the importance of early recognition of this increasingly encountered disease4,5. Prerequisites for diagnosis are sinonasal polyps, infiltrative or non-infiltrative fungal hyphae on microscopy with Potassium Hydroxide (KOH) and histopathological examination of the resected polyps and positive fungal culture of the tissue following surgery. Successful treatment includes early diagnosis, pre and post operative steroids and antifungal therapy, surgical debridement of the polyps and caseous material with adequate drainage and ventilation along with control of the underlying disease6,7.

Materials and Methods This study was carried out in Department of Ear, Nose and Throat Unit 1, Mayo Hospital affiliated with King Edward Medical University, Lahore. It spanned over a period of 18 months from February 2007 to August 2008. A total of 23 consecutive patients undergoing external ethmoidectomy for suspected fungal sinusitis were selected for the study. All patients were evaluated with Computerized Tomography (CT) Scan after obtaining detailed history and performing clinical examination. Informed consent for the surgery was taken after being briefed about the procedure, its merits and demerits. External Ethmoidectomy with or without Cald Well Luc procedure was performed on all patients. The decision of external ethmoidectomy was based on the presence of proptosis, recurrent sinonasal polyposis, evidence of orbital invasion by sinonasal polyps on CT scan, presence of hyper dense masses in paranasal sinuses or bony erosion of the sinus walls with asymmetry of two sides. Resected polyps or cheesy material obtained following surgery was sent for microscopy with KOH and histopathological examination, to know the variety of the disease and the type of fungus. Demographic profile and relevant data was recorded in a standard Performa. Data was entered in Statistical Package for the Social Sciences (SPSS) version 11, a computer based soft ware. Mean and standard deviation were computed for

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Aspergillus infection of paranasal sinuses

qualitative variables like age. Descriptive statistics like frequency and percentage were computed for categorical variables like gender, clinical and radiological features and type of the disease. Statistical test of significance was not applicable in this study.

Table 1: Analysis of common clinical features in patients (n=23) Clinical Features =n % age Proptosis 19 82.60 Nasal obstruction 18 78.26 Multiple nasal polyps 16 69.56 Sneezing& rhinorhhea 15 65.21 Headache 10 43.47 Epistaxis 5 21.73 Past history of TB 1 4.34

Results 23 consecutive patients undergoing external ethmoidectomy included in the study ranged in age from 10 to 70 years. The average age of the patients was 27.7 years (SD 40±30). M: F ratio was 1:0.35. There were 17 (73.91 %) male and 6 (26.09 %) female patients in this study. Proptosis, nasal obstruction and multiple nasal polyps were seen in 19 (82.60 %), 18 (78.26 %) and 16 (69.56 %) patients respectively, however sneezing or rhinorrhea, headache and epistaxis were found in 15 (65.21 %), 10 (43.47 %) and 5 (21.73 %) patients respectively. One (4.34 %) of 23 patients presented with past history of tuberculosis (Table 1). On CT scan (Figures 1 and 2), ethmoid sinus was involved in 19 (82.80 %) and sphenoid in 17 (73.91 %) patients. Similarly maxillary and frontal sinus involvement were seen in 16 (69.56 %) and 14 (60.86 %) patients respectively (Table 2). In 19 (82.61 %) of 23 patients, Aspergillus species were detected by microscopy of KOH preparation) and histopathological examination. Non-invasive disease revealed in 13 (56.52 %) and invasive in 6 (26.09) patients. In 4 (17.39 %) patients, simple inflammatory polyps were seen (Figure 3).

Table 2: Involvement of paranasal sinuses on CT scan (n=23) Sinus involved =n % age Ethmoid involvement 19 82.60 Sphenoid disease 17 73.91 Maxillary involvement 16 69.56 Frontal sinus disease 14 60.86

Figure 1: Double density sign (white arrows) of non-invasive aspergillus infection of paranasal sinuses on coronal contrast enhanced CT scan.

Discussion The role of fungi in nose and paranasal sinuses is unclear as when it present as a pathogen and when as a part of normal flora. Similarly classification, terminology, pathogenesis, and criteria for diagnosis are still the matters under debate and much remains to be learnt about its optimal management. Length and dosage of topical and oral steroids and antifungal drugs are also not clearly defined yet9-11.

Figure 2: Extensive sino-nasal polyposis (white arrow) involving all sinus cavities and nose on coronal contrast enhanced CT scan.

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Non-invasive aspergillus

invasive aspergillus

They usually present with non-caseating granuloma and proptosis. They were distinguished from chronic invasive type, which has a chronic course and seen in subtly immunocompromised patients (with diabetes mellitus and on corticosteroid treatment with dense accumulation of hyphae invading tissue)15. Extensive polyps with intracranial or intraorbital extension are better dealt and exposed by transantral and external ethmoidectomy or craniofacial resection. However intranasal ethmoidectomy or functional endoscopic sinus surgery are better options for moderate disease. We used external ethmoidectomy approach in all patients due to extensive and recurrent disease in all patients16,17. The average age of the patients was 27.7 years (SD 40±30) and they ranged in age from 10 to 70 years. According to Akhtar et al, age distribution is somewhat variable however; most of the patients fell into 2nd 3rd and 4th decade of life18. As Aspergillus infection of paranasal sinuses is not a very common condition, there were 17 males and 6 females in this study. Comparing our results with local and international researchers’, Aspergillus is most commonly seen in young immunocompetent individuals with male predominance19,20. Sinuses involved on CT scan in order of frequency were ethmoid, sphenoid, maxillary and frontal sinuses respectively. Multiple nasal polyps seen in 16 (69.56 %) patients in this study, contrary to Thahim K et al where all (100 %) patients presented with multiple polyps. 19 (82.60 %) patients presented with proptosis. This high ratio of proptosis was contrary to a local study by Rehman et al, where it was in (8)33 % patients. Headache found in 10 (43.47 %) patients contrary to a local research where it was in 10 % of the patients16,21. Incidence of Aspergillus sinusitis is apparently more than what is reported in international literature and it principally represents as allergic fungal sinusitis as seen in this study. Aspergillus species was found in 19 (82.61 %) of 23 patients. Our result was in accordance with a local researcher Khan

inflammatory polyps

Figure 3: Incidence of non-invasive, invasive and inflammatory polyps. There is uncertainty about management of invasive sino-orbital Aspergillosis. Some authors recommend orbital exenteration to achieve the surgical margins while others note that vision sparing orbital debridement is adequate for the cure especially when supplemented by antifungal drug itraconazole12,13. An intact immune system can prevent the disease in a healthy individual and there may be mechanism by which fungi effect on the sinus mucosa in susceptible individuals only. In our study all the patients were immunocompetent. Noninvasive disease typically affects immunocompetent patients and it is usually not seen in patients with immune deficiency. Here adequate sinus surgery generally cures the disease. Invasive disease usually occurs in debilitated immunocompromised patients; however evidence in immunocompetent patients has been reported in the literature review. It requires prolonged medical treatment, as clearance by surgery is not usually possible because of lack of the line of demarcation between the disease and normal soft tissues, especially of the orbits14. In the late 1990s, deShazo et al proposed a new classification for tissue invasive fungal rhinosinusitis based on the clinical condition, immune status, histopathology, and fungus infection. These were acute (fulminant) invasive, granulomatous invasive and chronic invasive types. The chronic granulomatous invasive type was mainly noticed in immunocompetent patients from Sudan, India, and Pakistan.

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Aspergillus infection of paranasal sinuses

et al where it was in 83.33 % of the patients. Contrary to this, it was in 60 % by Thahim et al and 70 % by Rehman et al. On the other hand, Aspergillus was present in only 10 % of the patients in a foreign study. It indicates decreased incidence of Aspergillus sinusitis in Europe compared to South Asia16,21-24. Non-invasive disease revealed in 13 (56.52 %) and invasive in 6 (26.09) patients. In 4 (17.39 %) patients, simple inflammatory polyps were seen. Our result differ with a local study in this regard, where noninvasive disease revealed in 24 %, invasive in 14 % and simple inflammatory polyps were found in 62 % of the patients16.

6.

7.

8.

9.

Conclusion For all practical purposes, Aspergillus infection of paranasal sinuses can be broadly divided into two categories, non-invasive Aspergillus sinusitis that usually presents as fungus balls or caseous material without fungal tissue invasion and invasive Aspergillus sinusitis with presence of septate hyphae in the soft tissue. The final specimen obtained during surgery should be submitted for histopathological examination to detect invasion of the tissues as this has effects on further management of disease.

10.

11.

12.

13.

References 1.

2.

3.

4.

5.

14.

Agarwal S, Kanga A, Sharma V, Sharma DR, Sharma M.L. Invasive aspergillosis involving multiple paranasal sinuses-a case report. Indian J Med Microbiol 2005; 23 (3): 195-197. Safirstein BH. Allergic bronchopulmonary aspergillosis with obstruction of the upper respiratory tract. Chest 1976; 70: 788-790. Barclay L, Lie D. Diagnosis of allergic fungal rhinosinusitis clarified. Arch Oto Laryngol Head Neck Surg 2006; 132: 173-178. Udaipurwala IH. Allergic fungal sinusitis: a perplexing clinical entity. Pak J Otolaryngol 2008; 24: 25-27. Jones JR. Paranasal aspergillosis-a spectrum of disease. J Laryngol Otol 1993; 108: 773-4.

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Joshul, Schlf, Ahmad MS. Chronic rhizopus invasive fungal rhinosinusitisin an immunocompetent host. Laryngoscope 2004; 114:15331550. Singh N, Bholodia NH. Allergic fungal sinusitis-earlier diagnosis and management. J Laryngol Otol 2005; 119; 875-881. Mauriello JA, Yepez N, Mostafavi R, Barofsky J, Kapila R, Baredes S et al. Invasive rhinosino-orbital aspergillosis with preeipituous visual loss. Opthalmol 2005;30: 124-130. Ferguson BJ. Definitions of fungal rhinosinusitis. Otolaryngol Clin North Am 2000; 33: 227-235. Saravan K, Panda NK, Chakarbarti A, Das A, Bapuraj RJ. Allergic fungal rhinosinusitis: an attempt to resolve the diagnostic dilemma. Arch Otolaryngol Head Neck Surg 2006; 132:173-178. Chakarbarti A, Das A, Panda NK. Controversies surrounding the categorization of fungal sinusitis. Med Mycol 2009; 47: 299-308. Adler SC, Isaacson G, Sasaki CT. Invasive aspergillosis. J Oto Laryngol 1997; 18: 230-234. Massry GG, Hornbiass A, Harrison W. Itraconazole in the treatment of orbital aspergillosis. Opthalmology 2000; 103: 1467-1470. Javaid M, Mehmudi S, Mohebbi S. Management of invasive fungal sinusitis. Pak J Otolaryngol 2008; 24:3839. Lackner A, Stammberger H, Buzina W, Freudenschuss K, Panzitt T, Schosteritsch et al. Fungi: a normal content of human nasal mucus. Am J Rhinol 2005; 19 (2): 125-129. Rehman Haq I, Qadri SH, Aqil S. Frequency of allergic fungal rhinosinusitis in patients with nasal polyps and associated risk factors. Pak J Med Health Sci 2009; 3:2-10. Ferguson BJ, Barnes L, Bernstein JM, Brown D, Clark CE, Cook PR et al. Geographic variations in allergic fungal rhinosinusitis. Otolaryngol Clin North Am 2000; 33:441-449.

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18. Akhtar MR, Ishaque M, Saadat U. Etiology of nasal polyps. Pak J Otolaryngol 2004; 29:9-11. 19. Sinha V, Bhargwag D, Jeorge A, Memon RA. Proptosis through the eye of ENT surgeon. Indian J Otol Head Neck Surg 2005; 51 (3): 34-41. 20. Cody T 2nd, Neel HB 3rd, Ferreiro JA, Roberts GD. Allergic fungal sinusitis: the Mayo clinical experience. Laryngoscope 1994; 104:1074-1079. 21. Thahim K, Jawaid MA, Marfani MS. Presentation and management of

allergic fungal sinusitis. J Col Phys Surg Pak 2007; 17(1):23-27. 22. Jerome B. Paranasal sinus fungus. Am J Surg Path 2006; 30 (6): 713-720. 23. Khan AR, Ali F, Imran N, Khan NS, Din S. Invasive sino-orbital aspergillosis in immunocompetent host. J Med Sci 2009; 17 (2): 87-91. 24. Daghistani KJ, Jamel TS, Zaheer S, Naasif OI. Allergic Aspergillus sinusitis with proptosis. J Laryngol Otol 1992; 106:799-803.

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CLINICAL STUDY

Obstetricians' Perception of Medico-legal Problems in Al Madinah Al Munawarah Kingdom of Saudi Arabia Fawzia A. Habib M.D Department of Obstetrics and Gynecology, College of Medicine, Taibah University, Al Madinah Al Munawarah, Kingdom of Saudi Arabia

Abstract Objectives Obstetrics is a specialty that is widely perceived to be associated with a high risk of litigation. Most of the potential problems in obstetrics usually result from the lack of competence, which may harm pregnant women and their fetus. Obstetrics litigation leads the way in being the most litigation prone medical specialty in Saudi Arabia. In an attempt to improve the defining standards of quality, this study illustrates the medico-legal obstetrics claims in Al Madinah Al Munawarah region –Kingdom of Saudi Arabia, the consequences and the psychological morbidity among obstetricians. Methods A cross-sectional survey was conducted in Al Madina Al Munawara involving 90 obstetricians regarding their views about obstetrics litigation, using a piloted and well structured questionnaire. Results The response rate was 88.8%. The majority of the surveyed obstetricians were female 62.5%. 38% were below 40 and 39.4% had 21-30 year of experience. Most of the participants agreed that birth asphyxia was the commonest cause of obstetrics litigation 62% and about 53% of were exposed to legal medical organization, while 54% were exposed to Supreme Court, resulting in either financial compensation (59%) or claim dismissal (40%). Most of the participating obstetricians suffered from depression (83%) and 90% of the female participants developed family problems and about 15% of the participants thought of changing their career. Conclusion Attention to safety issues and effective risk management system should help to reduce medico-legal claims in obstetrics. Key Words: Obstetrics, Litigation, Female, Male Journal of Taibah University Medical Sciences 2010; 5 (2): 66 - 74

Correspondence to: Dr Fawzia A. Habib Associate Professor, Department of Obstetrics and Gynecology College of Medicine, Taibah University  30001, Al Madinah Al Munawarah Kingdom of Saudi Arabia  +966 4 8460008  +966 4 8461407  [email protected]

66

Fawzia A Habib

Introduction

had the highest number of the litigation during the year 2002-20035. For the reasons above, obstetrics is a major concern for maternity service providers. Unfortunately most of the litigation affected junior personnel mainly residents and this causes fear from their specialty and refusal of many junior graduates to take obstetrics as their specialty; in addition the threat of litigation is one of the major reasons for qualified obstetricians to leave the field of obstetrics. The litigation process can cause pain, suffering and distress to the obstetrician and his/her family, as well as to the patient and her family, especially if it involves fetal death, maternal death, or a baby with cerebral palsy. In this increasingly difficult environment, it's more important than ever to investigate the burden and causes of litigation among obstetricians working in Al Madinah Al Munawarah.

O

bstetrics is a specialty that is widely perceived to be associated with a high risk of litigation1. Critical evaluation of the literature on obstetrics' ethics involves pitfalls to be avoided. These pitfalls occur when the inherent limitations in several disciplines that contribute to the normative obstetric ethics are ignored. Beneficence and autonomy require an obstetrician to provide the patient with the most accurate and reliable information2. To meet this ethical obligation, the obstetrician must distinguish general from specialized competence to perform and interpret any obstetric examination or investigation. An appropriate general level of competence imposes a rigorous and thorough standard of training and continuing education. Most of the potential problems in obstetrics usually result from the lack of competence which may result in unnecessary harm to the pregnant woman or her fetus in violation of the principles of beneficence. Second, incomplete or inaccurate reporting of results to the pregnant woman undermines the informed consent in violation of the principle of autonomy. Based on the scientific knowledge, shared clinical experience and a careful, unbiased evaluation of the patient, the obstetrician is able to identify the clinical strategies that will most likely serve the health related interests of the patient from those that won't3. Obstetrical litigation is a growing problem in Saudi Arabia nowadays, especially in the small cities where there is a lack of resources and scarcity in facilities, which play a vital role. In the analysis done by AL-Saddique AA in 20044, a total of 2223 cases of medical litigation from various parts of the Kingdom for a period of 4 years were studied. Obstetrics lead the way in being the most litigation prone medical specialty4. Another study done by Samarkandi A in 2006 5 to evaluate the magnitude and underlying factors of the status of medical liability claims in Saudi Arabia, revealed that obstetrical practice took the lead with 27%. The holy capital, Makkah Almukaramah,

Materials and Methods A cross-sectional survey was conducted during the period from April to July 2010. The study sample included ninety obstetricians working in the government and private hospitals in Al Madinah Al Munawarah region; the second holiest city in the Kingdom of Saudi Arabia and the Muslim world; with a response rate of 88.8% (n=71). The survey was approved by the Medical Research Ethical Committee. A questionnaire was constructed and answered by the obstetricians themselves. The reliability of the questionnaire was assessed. It was pre-tested on a random sample of twenty participants of both genders to ensure practicability, validity and interpretation of responses. The first part of the questionnaire gathered information regarding the socio-demographic background and professional experience, whereas the second part encompassed questions regarding exposure to legal medical organization and Supreme Court. The third part of the questionnaire was developed to collect information regarding

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obstetricians' realization of litigation risk and psychological effects of their work. Statistical evaluation of all data was done using SPSS (Statistical Package for Social Sciences version 13). Quantitative data were presented as mean ± SD. For the comparison of the male and female groups' means, independent samples student t-test and chisquare test were used. All test were two tailed and considered significant when p3 years 7 58.3(77.8) 2 20.0(22.2) Outcome: payment 8 66.7(61.5) 5 50.0(38.5) Others 4 33.3(44.4) 5 50.0(55.6) - Physicians' opinion about possible causes of obstetric litigation:  6 22.2(37.5) 10 22.7(62.5) PPH 15 55.6(34.1) 29 65.9(65.9) Birth asphyxia 7 25.9(58.3) 5 11.4(41.7) Birth injuries 9 33.3(52.9) 8 18.2(47.1) Other causes * P value significant below 0.05

Total N=71

%

P-value

32

45.1(100.0)

0.164

22

31.0(100.0)

0.060

1.59±0.85

0.000*

4 9 9 13 9

18.2(100.0) 40.9(100.0) 40.9(100.0) 59.1(100.0) 40.9(100.0)

16 44 12 17

22.5(100.0) 62.0(100.0) 16.9(100.0) 23.9(100.0)

0.040* 0.225 0.429

0.711

Others include: - Postponing, no obvious responsibility, innocence, concession etc. Physicians choose more than one cause

Other causes include: CTG misinterpretation, CS, Instrumental delivery, Antepartum hage. The most common cause of medico-legal claims as stated by 62% of the participating obstetricians was birth asphyxia. Table 3 illustrates that 83% of depressed obstetricians and 90% of those with family

problems were females; with a significant gender difference (p=0.031 and 0.032 respectively). Meanwhile the most prevalent psychiatric complaint was anxiety (65%) with an insignificant gender difference.

Table 3: Frequency of morbid conditions among surveyed physicians Males Females Total N=27 % N=44 % N=71 % Depression 3 11.1(16.7) 15 34.1(83.3) 18 25.4(100.0) Anxiety 9 33.3(31.0) 20 45.5(69.0) 29 65.9(100.0) Insomnia 3 11.1(21.4) 11 25.0(78.6) 14 19.7(100.0) Family problems 1 3.7(9.1) 10 22.7(90.9) 11 15.5(100.0) Somatic problems 4 14.8(36.4) 7 15.9(63.6) 11 15.5(100.0) * P value significant below 0.05 Regarding the difference between Saudi and non Saudi graduated obstetricians (Table 4), 40% of non Saudi physicians had between 21-30 years of professional experience, 36% were consultant compared to 58% of Saudis, and 40% were exposed to legal medical organization compared to 54% of Saudis.

P-value 0.031* 0.313 0.153 0.032* 0.902

There was a significant difference between the mean number of exposure (p=0.000) among Saudi and non Saudi graduated obstetricians; 2.17±0.98 and 1.38 ±0.72 respectively.

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Fawzia A Habib

Table 4: Comparison between Saudi and non-Saudi physicians Saudi N=24 % - Professional Experience in years: 5-10 11-20 21-30 31-40 - Type of clinical practice: Resident Specialist Consultant - Exposure to legal medical organization - Exposure to supreme court

Total

N=47

%

N=71

%

P-value

8 7 9 0

33.3(47.1) 29.2(31.8) 37.5(32.1) 0.0(0.0)

9 15 19 4

19.1(52.9) 31.9(68.2) 40.4(67.9) 8.5(100.0)

17 22 28 4

23.9(100.0) 31.0(100.0) 39.4(100.0) 8.5(100.0)

0.327

8 2 14

33.3(33.3) 8.3(12.5) 58.3(45.2)

16 14 17

34.0(66.7) 29.8(87.5) 36.2(54.8)

24 16 31

33.8(100.0) 22.5(100.0) 43.7(100.0)

0.081

13

54.2(40.6)

19

40.4(59.4)

32

45.1(100.0)

0.271

6

25.0(27.3)

16

34.0(72.7)

22

31.0(100.0)

0.436

Mean number of exposure ±SD Duration: one year 2-3 years >3 years Outcome: money pay Other - Morbid conditions: Depression Anxiety Insomnia Family problems Somatic problems * P value significant below 0.05

Non-Saudi

2.17±0.98

1.38±0.72

1.59±0.85

0.000*

1 4 1 4 3

16.7(25.0) 66.7(44.4) 16.7(11.1) 66.7(28.6) 50.0(37.5)

3 5 8 10 5

18.8(75.0) 31.3(55.6) 50.0(88.9) 62.5(71.4) 31.3(62.5)

4 9 9 14 8

18.2(100.0) 40.9(100.0) 40.9(100.0) 63.6(100.0) 36.4(100.0)

0.282

10 15 6 7 5

41.7(55.6) 62.5(51.7) 25.0(42.9) 29.2(63.6) 20.8(45.5)

8 14 8 4 6

17.0(44.4) 29.8(48.3) 17.0(57.1) 8.5(36.4) 12.8(54.5)

18 29 14 11 11

25.4(100.0) 40.8(100.0) 19.7(100.0) 15.5(100.0) 15.5(100.0)

0.024* 0.008* 0.424 0.023* 0.374

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0.856 0.132


Concerning the psychiatric complaints, there was a significant difference between both groups regarding depression, anxiety and family problems (p=0.024, 0.008 and 0.023 respectively) and all these complaints were more prevalent among the Saudi participating obstetricians (55%, 51% and 63% respectively).

As stated by 74% of the surveyed obstetricians, inadequate communication is a factor in most complaints, while 71% stated that patients were not likely to sue if informed of any unintended malpractices. Only 15% of the surveyed obstetricians thought about changing their career (Figure 1).

No

Change career

Inadequate communication as a factor in most complaints Patients were not likely to Sue if told of mistakes

Yes

15.50% 84.50%

74.60% 25.40%

28.20% 71.80%

Figure 1: Physicians' realization of litigation risk. pregnancy outcome. However, all obstetrics patients undergoing any intervention should be given appropriate information on the nature and purpose of those interventions, the benefits and risks and the consent process must comply with the hospital's consent policy7. The socio-demographic results demonstrate a high ratio of female obstetricians (62%) in comparison to male counterparts (38%). This could be explained by female preference of this specialty in Saudi Arabia in the last few years6. More than half of the participating female obstetricians (52%) graduated from the Kingdom of Saudi Arabia, 47% of them were residents with about 10 years of experience. All the participating obstetricians had insurance coverage, which is mandatory for obtaining a license from the Saudi Commission for Health Specialties. Lawsuits have been more

Discussion Most obstetricians would, at some point in their career, have to address a complaint filed by a patient about their clinical performance, which may be followed by litigation. According to the annual report of the legal medical organization in the Kingdom of Saudi Arabia in 1429H (2008), there are 3210 obstetricians and gynecologists working in the Kingdom, and nearly 121 of them (38%) were exposed to medico-legal litigations and sued. All of participants either had settled claims or tried claims, and faced financial compensations that varied between 50,000 to 1,000,000 Saudi riyals6. Obstetrics patients are mostly healthy young women with high expectations for a good

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Fawzia A Habib

prevalent in the United States. A pilot survey study reported that 80-90% of obstetricians had experienced complaints or lawsuits among those approximately one third settled without payment; one third agreed to pay settlements; and the remaining one third proceeded to trial8,9. In this study, 45% of the participating obstetricians (mostly specialists) were exposed to a legal medical organization and 31% to the Supreme Court. Between 2001 and 2007, the National Health Service Litigation Authority in England received 569 obstetric claims and the total amount paid was 1592 million pounds10. Nearly 59% of the obstetricians in this study experienced a financial claim and compensation to the patients, while 40% experienced settlement without pay either because the claims were dropped, dismissed or withdrawn. The liability concerns have a negative impact on both job satisfaction and recruitment to the specialty11,12. In this study, 15% of the obstetricians thought of changing their career as fear of litigation has become an increasingly common issue. This is serious concern in this modern era of economical crisis and escalating level of competition in the medical field. There is a stress in the answers regarding interaction with 77% of participating obstetricians, believing that inadequate communication was a substantial factor in the majority of complaints, yet 71% believed that patients were more likely to sue in case of disclosure of negligence or malpractice issues. The common cause of claims in obstetrics is birth asphyxia as agreed by most of the participating obstetricians, and a common source of this claim is the failure to diagnose or misinterpretation of Cardiotocography (CTG). Accordingly, these late diagnoses led to late cesarean section and avoidable birth trauma or birth injuries in most cases13,14. Psychological morbidity in female obstetricians was significantly higher than in male obstetricians. This may be in part due to the increased number of female participants, and partly due to sentimental and emotional encounter of women with such work in this specialty. In reviewing published literature, Charles et al. showed

that 39% of sued physicians in Chicago had symptoms suggestive of major depression; 20% of them had a symptom cluster thought to be suggestive of an adjustment disorder, this included anger, frustration, insomnia, irritability and headache15,16. There was a significant difference in this study between Saudi and non Saudi physicians, regarding the morbid conditions, where Saudis were more exposed to depression, insomnia and family problems, and this may be in part due to the increased number of female participants with a considerable difference in the cultural background and fear of society and fear of litigation. Finally, this study has some limitations, and the results should be interpreted with appropriate caution. First the study sample is small as it involves only obstetricians from Al Madinah province, and this gives us only one aspect of the problem, further research involving the kingdom of Saudi Arabia is needed. Second the study did not include any analysis for litigation difference between public and private sectors as the number of participants were small.

Conclusions The swift transition from a low-risk to a high-risk situation is a common scenario in obstetrics. Medico-legal claims in obstetrics are greater than any other specialty. Attention to safety issues and effective risk management system should help to reduce medico legal claims in obstetrics. Communication plays an important role in improving patient satisfaction, preventing medical disputes and increasing treatment effectiveness. To keep obstetrics practice variation at a minimum level and to reduce medical uncertainty, the best practice guidelines can be the first step to develop support and security for obstetricians in their decision making, to avoid further increase in malpractice fear.

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References 1.

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10. NHS Litigation Authority. NHSLA risk management standards for Acute Trust, Primary care trust and independent sector providers of NHS care 2009/10. London: NHSLA, February 2009. 11. Ogburn T, Espey E, Autry A, Leeman L, Bachofer S. Why obstetrics/gynecology, and what if it were not an option?: a survey of residents applicants, Am J Obstet Gynecol 2007;197:538-539. 12. Savage W and Francome C. British consultants' attitude to caesareans, J Obstet Gynecol 2007;27:354-359. 13. Yudkin PL, Johnson A, Clover LM and Murphy KW. Assessing the contribution of birth asphyxia to cerebral palsy in term singletons. Pediatr Perinatol Epidemiol 1995; 9: 156. 14. Fuglenes D ,Oian P, Kristiansen IS. Obstetricians'' choice of cesarean delivery in ambiguous cases: is it influenced by risk attitude or fear of complaints and litigation? Am J Obstet Gnecol 2009;200:48.e 1-48.e8 15. Charles SC,Wilbert JR and Kennedy EC. Physician's self reports to reactions to malpractice litigation. Am J Psychiat 1984;141:563-565 . 16. Charles SC, Warnecke RB, Nelson A, Pyskoty CE. Appraisal of the events as a factor in coping with malpractice litigation. Behav Med 1988;14:148-155.

Barber HR. Malpractice crises in obstetrics and gynecology: is there a solution. Acad Med 1991; 67 (2): 162172. Mavroforou A, Koumantakis E, Michalodimitrakis E. Physicians' liability in obstetrics and gynecology practice. Med Law 2005; 24 (1): 1-9 Capstick B , and Edwards P. Trends in obstetric malpractice. Lancet 1990; 336: 931-932. AL-Saddique AA. Medical liability. The dilemma of Litigation. Saudi Med J 2004; 25(7):901-906. Samarkandi A. Status of medical liability claims in Saudi Arabia. Ann Saudi Med 2006; 26(2):87-91 Legal Medical Organization Committee Annual Report at Kingdom of Saudi Arabia 1429: 31-47. Chandraharan E, Arulkumaran S. Medico legal problems in obstetrics .Curr Obstet Gynecol 2006; 16: (4) 206210. Chauhan SP, Chauhan VB, Cowan BD, Hendrix NW, Lagann EF, Morrison JC. Professional liability claims and central association of obstetricians and gynecologists members: myths versus reality. Am J Obstet Gynecol 2005;192:1820-1826. Chervenak J. Overview of professional liability. Clin Perinatol 2007; 34:227-232.

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CLINICAL STUDY

Evaluation of the Relative Efficacy of an Allograft used alone and that in Combination with Simvastatin in the Treatment of Human Periodontal Infrabony Defects – A Clinical and Radiological Study Kinra P.1 MDS, Gupta H.1 MDS, Khan S.2 MDS, Mohammad Sami Ahmad3 Ph. D Department of Periodontics Punjab Government Dental College and Hospital Amritsar1, Department of Periodontics and Community Dentistry Aligarh Muslim University Aligarh 2 India, College of Dentistry Taibah University Al Madinah Al Munawarah3 Kingdom of Saudi Arabia

Abstract Objectives Simvastatin has been found to cause increased bone formation in vitro and in animal studies. However, its effect on periodontal reconstruction in humans is yet to be determined. With this study an attempt was made to evaluate the effects of a combination of simvastatin drug with Demineralised Freeze-Dried Bone Allograft (DFDBA) and also to compare the efficacy of this combination with that of DFDBA alone in the treatment of human periodontal defects. Methods Fifteen patients with almost identical bilateral 2-walled or 3-walled infrabony defects were selected. Defects on the right side (Group A) were treated with the placement of DFDBA alone while those on the left side (Group B) were treated using a combination of DFDBA and a 10-8 M solution of the drug simvastatin. Two clinical parameters, namely probing pocket depth and clinical attachment level and one radiographic parameter, namely infrabony defect depth were measured preoperatively and 12 and 24 weeks postoperatively. Results DFDBA alone as well as the combination of DFDBA and simvastatin resulted in a highly significant mean reduction in probing depth, gain in clinical attachment level, and linear defect fill. The values of mean changes in parameters were significantly greater with the drug-graft combination in comparison with the graft alone. Conclusions Combination of DFDBA with a solution of simvastatin leads to significantly greater reduction in probing depth, gain in clinical attachment level, and linear defect fill than when the graft is used alone in the treatment of human periodontal infrabony defects. Keywords: Infrabony defects, Simvastatin, DFDBA, Clinical attachment, graft Journal of Taibah University Medical Sciences 2010; 5(2): 75 - 88

Correspondence to: Dr Mohammad Sami Ahmad Associate Professor in Dental Public Health Division of Preventive Dental Science  College of Dentistry P.O. Box 2898, Taibah University, Al Madinah Al Munawwarah, Kingdom of Saudi Arabia  +966 4 8460008  +966 4 8461407  [email protected] 75 J T U Med Sc 2010; 5(2)

Mohammad Sami Ahmad et al

Introduction

experimentally induced periodontal breakdown in rats have resulted in lesser bone loss and attachment loss than controls13. Simvastatin has also been observed to have direct effects on human periodontal ligament cells in vitro. It has been shown to enhance the proliferation and metabolism of these cells in addition to promoting their activity of the enzyme alkaline phosphatase. These actions occur in a dose dependent manner and are seen to peak at a concentration of 10-8 M concentration of simvastatin14-15. Moreover, the systemic use of statins is associated with a reduced risk of tooth loss in individuals suffering from chronic periodontitis16. In the present study, an attempt has been made to evaluate clinically and radiographically the relative efficacy of an allograft (DFDBA) used alone and that in combination with a 10-8 M simvastatin in the treatment of human periodontal infrabony defects.

P

rogressive destruction of the periodontal ligament and alveolar bone with pocket formation, recession, or both are the results of periodontitis. The ultimate goal of periodontal therapy is to regenerate lost periodontal tissue, which is directed towards a more coronal attachment of the periodontal fibres resulting in decreased probing depth, and improved bone support as evidenced radiographically. Now a day surgical procedures involving bone grafting are the most common forms of regenerative periodontal therapy and leads to predictable regeneration of bone, cementum, and functionally oriented new periodontal ligaments coronal to the base of a previous osseous defect1. One of the most commonly used grafts at present is Demineralized Freeze-Dried Bone Allograft (DFDBA). It is known to stimulate bone formation by the processes of osteoinduction2 as well as osteoconduction3. Implantation of defects with DFDBA usually results in a decrease in probing depth, gain in clinical attachment and reconstruction of hard tissue as represented by the formation of new bone and cementum4-6. The need to achieve greater regeneration an agent is used, which would not only inhibit resorption of the alveolar bone but also stimulate new bone formation. Simvastatin is a pharmacologic compound, which is widely used for the treatment of hypercholesterolaemia. It belongs to a family of drugs called the statins and is an inhibitor of the enzyme HMG-CoA reductase, an important rate limiting enzyme of the mevalonate pathway7. It has been shown to markedly increase new bone formation and osteoblast numbers in vitro and also after systemic administration in animal models by activating the gene expression of BMP-28-9. A number of studies have concentrated on the effects of locally administered simvastatin on bone formation10. It has been seen that osteogenesis is enhanced by the local application of simvastatin in the calvaria of rats 11. Injectable simvastatin is seen to increase the thickness of edentulous buccal ridges and also result in new cementum formation in relation to experimentally created infrabony defects in beagle dogs12. Furthermore, subperiosteal injections of simvastatin in the region of

Aim To compare DFDBA alone to DFDBA in combination with Simvastatin in the treatment of infrabony periodontal pockets.

Materials and Methods The study was clinical trial with split mouth design. In this study fifteen patients (8 males and 7 females) showing evidence of almost identical bilateral two or three-walled infrabony defects, as determined by clinical and radiographic evaluation, were selected amongst those reporting to the Department of Periodontics, Punjab Government Dental College and Hospital, Amritsar, India. The patients selected were non-smokers, nonalcoholics, and had no history of allergies or any systemic debilitating disease. All patients meeting the selection criteria were consecutively enrolled from February, 2008 to January, 2009. Prior to surgery, oral prophylaxis, occlusal equilibration, and routine laboratory investigations were performed. Their oral hygiene status was monitored and reviewed until it was achieved to a satisfactory level. The clinical parameters assessed were probing depth and attachment level. A customised acrylic stent was used for the clinical

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Evaluation of the Relative Efficacy of an Allograft

measurements Figure 1, Figure 217. Radiographically, the infrabony defect depth was ascertained using a standardised radiographic technique and by measuring from a fixed reference point (the cementoenamel junction of the involved tooth) to the most apical point at the base of the defect.

Figure 4: The designated site of Group A with the exposed infrabony defect A grid with 1 mm X 1 mm calibrations and a Vernier calliper were used to make the measurements to an accuracy of one-tenths of a millimetre Figure 3. In this way, preoperative assessment of the above mentioned parameters was done. The infrabony defect on the right side of the patient’s mouth was designated as Group A while that on the left side was designated as Group B. Group A defects were treated by placement of DFDBA and Group B defects were treated by placement of DFDBA in combination with a 10-8 M solution of simvastatin. The surgical procedures were performed by a single operator and both pre and post results were measured by another operator who was unaware of which side received DFDBA alone or in combination with simvastatin. The patients selected were living nearby hospital so they should visit on appointment date. The full addresses as well as mobile numbers were also recorded to inform if they did not turn on appointment given.

Figure 1: Measurement of probing depth with a William’s calibrated periodontal probe after placing a customized acrylic stent.

Figure 2: Measurement clinical attachment level with a William’s calibrated periodontal probe after placing a customized acrylic stent.

Preparation of the drug solution The molecular weight of simvastatin is 418.57. To prepare a 10-8 M solution of simvastatin, 4.18 X 10-3 mg of pure simvastatin in 1 litre of water is required. To obtain this concentration, 4.18 mg of pure simvastatin in powder form was thoroughly mixed with 1000 ml of water. 0.2 ml of this solution was taken and water was added to it to achieve a total volume of 200 ml. This solution was incorporated into the DFDBA material prior to placement in Group B defects. The patients were premedicated using diazepam (10 mg/2 ml injection intramuscularly) and glycopyrrolate (0.3 mg/3 ml injection intramuscularly) 45 minutes before the

Figure 3: Radiographic grid being used for the measurement of infrabony defect depth.

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Mohammad Sami Ahmad et al

procedure. A Kirkland flap was reflected following the administration of a local anaesthetic solution (lignocaine hydrochloride 2% with adrenaline 1:200,000). The exposed defect was debrided so that it was prepared prior to the placement of graft alone in case of Group A or the graft in combination with simvastatin in case of group B Figure 4, Figure 7. A suture needle was then passed through the buccal and lingual flaps. After the placement of the designated material in the defect Figure 5, Figure 8 the flap was approximated by tying a knot so as to complete the interrupted interdental suture Figure 6, Figure 9. Antibiotic therapy (amoxicillin 250 mg + cloxacillin 250 mg + 60 million lactobacillus spores- Capsule Numox-LB, Jenburkt) three times a day for 1 week and an anti-inflammatory agent (Ibuprofen 400 mg- Tablet Brufen, Knoll) thrice daily for 3 days were prescribed postoperatively.

week after surgery and postoperative assessment of the clinical and radiographic parameters was done at 12 and 14 week.

Figure 7: The designated site of Group B with the exposed infrabony defect

Figure 8: The Group B infrabony defect after placement of the combination of DFDBA and simvastatin solution Figure 5: The Group A infrabony defect after placement of DFDBA

Figure 9: The operated site after suturing

Results

Figure 6: The operated site after suturing

It was observed that both DFDBA and simvastatin possessed excellent handling characteristics. It was easy to manipulate, and well tolerated by all patients, with no clinically observed adverse tissue reaction, infection, signs of delayed healing or rejection during the course of the study. Postoperative assessments for the

The patients were advised to follow dietary instructions strictly and perform adequate plaque control by rinsing with 15 ml of a 0.12% chlorhexidine gluconate mouthwash (Periogard, Colgate) twice daily for two weeks postoperatively. Sutures were removed one 78

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Evaluation of the Relative Efficacy of an Allograft

parameters were done at 12 weeks and 24 weeks respectively. The mean values of probing pocket depth Table 1, clinical attachment level Table 2, and infrabony defect depth Table 3 at the three points in time were evaluated. The data were subjected to analyze statistically by student’s ttest and ANOVA approach. To evaluate the relative efficacy of the two materials used, Student’s t-test (for paired samples) was applied since the observations at the two points in time were expected to be closely related to each other. On analyzing the clinical parameter of probing pocket depth in the two groups it was seen that a highly significant reduction in probing pocket depth took place with both materials at 12 weeks, 24 weeks as well as between 12 and 24 weeks postoperatively (p< 0.01) as shown in Table 4 Similarly both groups showed a statistically highly significant gain in clinical attachment level and radiographically observed linear defect fill (p