Childbirth Experience Questionnaire (CEQ) in the Sri Lankan setting: translation, cultural adaptation and validation into the Sinhala language.

OBJECTIVE: To adapt the CEQ into Sri Lankan Sinhala cultural context and to determine the psychometric properties of CEQ. This would yield an opportunity to evaluate childbirth experience among Lankan population. RESULTS: Out of 390, 226 (57.9%) postnatal mothers completed the CEQ after 1 month postpartum. Face validity and content validity were demonstrated with all participants stating that CEQ was easy to understand and complete. For reliability, internal consistency was acceptable for the overall score (0.85) and for all four domains in CEQ (0.65, 0.80, 0.70, 0.83 for "own capacity", "professional support", "perceived safety" and "participation", respectively). A weighted kappa of 0.61-0.80 for all 22 items in CEQ demonstrated a good test-retest reliability. This Sri Lankan version showed fit statistics in line with standard recommendations in exploratory factor analysis. Women with spontaneous onset of labour (except for "professional support" in women with spontaneous onset of labour) and women with a normal birth showed significantly higher CEQ scores. However, oxytocin augmentation could not yield a difference in CEQ scores.

Vaginal, sexual and urinary symptoms following hysterectomy: a multi-centre randomized controlled trial.

BACKGROUND: Hysterectomy is the most common major gynaecological procedure. The aim of this study was to study vaginal, sexual and urinary symptoms following total abdominal hysterectomy (TAH), non-descent vaginal hysterectomy (NDVH) and total laparoscopic hysterectomy (TLH) in a low resource setting. METHODS: A multi-centre randomized controlled trial (RCT) was conducted in two public sector hospitals in Sri Lanka. Participants were patients requiring hysterectomy for non-malignant uterine causes. Exclusion criteria were uterus> 14 weeks, previous pelvic surgery, medical illnesses which contraindicated laparoscopic surgery, and those requiring incontinence surgery or pelvic floor surgery.Vaginal, sexual function and urinary symptoms were assessed by the validated translations of ICIQ-VS and ICIQ-FLUTS questionnaires. Post-operative improvement (pre-operative - post-operative) was assessed. RESULTS: There was an improvement (median (IQ1-IQ3) in vaginal symptoms [TAH 6(2-8) vs 4(0-8), p < 0.001; NDVH 6(4-8.5) vs 5(0-8), p < 0.001; TLH 4(2-10.5) vs 4(0-10), p < 0.001], urinary flow symptoms [TAH 2(1-4) vs 1 (0-3), p < 0.001; NDVH 3 (2-5) vs 2 (0.5-4), p < 0.001; TLH 1(1-4) vs 1(0-3), p < 0.05], urinary voiding symptoms [TAH 0(0-0) vs 0(0-0), p = 0.20; NDVH 0(0-1) vs 0(0-0.8), p < 0.05; TLH 0(0-0) vs 0(0-0), p < 0.05] and urinary incontinence symptoms [TAH 0(0-2) vs 0(0-2), p = 0.06; NDVH 0(0-3) vs 0(0-3), p < 0.001; TLH 0(0-3) vs 0(0-2), p < 0.05] at 1-year (TAH n = 47, NDVH n = 45, TLH n = 47). There was an improvement in sexual symptoms only in the TLH group [TAH 0(0-11.5) vs 0(0-14), p = 0.08); NDVH 0(0-0) vs 0(0-0), p = 0.46; TLH 0(0-0) vs 0(0-4), p < 0.05].There was no significant difference among the three different routes in terms of vaginal symptoms score [TAH 2 (0-2), NDVH 0 (0-2), TLH 0 (0-2), p = 0.33], sexual symptoms [TAH 0 (0-0), NDVH 0 (0-0), TLH 0 (0-0), p = 0.52], urinary flow symptoms [TAH 0 (0-1), NDVH 0 (0-1), TLH 0 (0-2), p = 0.56], urinary voiding symptoms [TAH 0 (0-0), NDVH 0 (0-0), TLH 0 (0-0), p = 0.64] and urinary incontinence symptoms [TAH 0 (0-0), NDVH 0 (0-1), TLH 0 (0-1), p = 0.35] at 1-year. CONCLUSIONS: There was a post-operative improvement in vaginal symptoms and urinary symptoms in all three groups. There was no significant difference in pelvic organ symptoms between the three routes; TAH, NDVH and TLH. TRIAL REGISTRATION: Sri Lanka clinical trials registry, SLCTR/2016/020 and the International Clinical Trials Registry Platform, U1111-1194-8422, on 26 July 2016. Available from: http://slctr.lk/trials/515.

Challenges of Costing a Surgical Procedure in a Lower-Middle-Income Country.

BACKGROUND: It is vital to enquire into cost of health care to ensure that maximum value for money is obtained with available resources; however, there is a dearth of information on cost of health care in lower-middle-income countries (LMICs). Our aim was to develop a reproducible costing method for three routes of hysterectomy in benign uterine conditions: total abdominal (TAH), non-descent vaginal (NDVH) and total laparoscopic hysterectomy (TLH). METHODS: A societal perspective with a micro-costing approach was applied to find out direct and indirect costs. A total of 147 patients were recruited from a district general hospital (Mannar) and a tertiary care hospital (Ragama). Costs incurred from preoperative period to convalescence included direct costs of labour, equipment, investigations, medications and utilities, and indirect costs of out-of-pocket expenses, productivity losses, carer costs and travelling. Time-driven activity-based costing was used for labour, and top-down micro-costing was used for utilities. RESULTS: The total cost [(interquartile range), number] of TAH was USD 339 [(308-397), n = 24] versus USD 338 [(312-422), n = 25], NDVH was USD 315 [(316-541), n = 23] versus USD 357 [(282-739), n = 26] and TLH was USD 393 [(338-446), n = 24] versus USD 429 [(390-504), n = 25] at Mannar and Ragama, respectively. The direct cost of TAH, NDVH and TLH was similar between the two centres, whilst indirect cost was related to the setting rather than the route of hysterectomy. CONCLUSIONS: The costing method used in this study overcomes logistical difficulties in a LMIC and can serve as a guide for clinicians and policy makers in similar settings. TRIAL REGISTRATION: The study was registered in the Sri Lanka clinical trials registry (SLCTR/2016/020) and the International Clinical Trials Registry Platform (U1111-1194-8422) on 26 July 2016.

Should male doctors in Sri Lanka wear a necktie to be recognized and respected?

INTRODUCTION: European cultural norms have influenced physicians' attire in Sri Lanka. The necktie is one such item of clothing which is worn to be recognized and respected as professionals. This study was carried out to assess the perceptions of doctors and patients towards male doctors wearing neckties while providing patient care. METHODOLOGY: A descriptive cross-sectional study was carried out at the National Hospital of Sri Lanka. An interviewer-administered questionnaire was used to collect data from doctors and patients. RESULTS: The study included 105 doctors (57% males) and 333 patients (54% males). Mean ages of the doctors and patients were 37 years (95% C.I. 36-39) and 47 years (95% C.I. 45-49) respectively. Sixty-nine percent of the patients had completed secondary education or above. None of the patients were aware of the risk of spreading infections by wearing a necktie. Of the 41% of doctors who thought it was unnecessary to wear a necktie, 95% believed the necktie can spread infections. Ninety-five percent of patients believed doctors should wear neckties to be identified and respected and to maintain trustworthiness. CONCLUSIONS: None of the patients were aware of the possible risk of spreading infections by wearing a necktie, while most of the doctors who thought neckties were unnecessary also believed neckties can spread infections. Almost all patients thought that doctors should wear a necktie to be recognized and respected. Therefore, implementing a change in dress policy for doctors is a challenging task in Sri Lanka.

An atypical presentation of an ovarian lymphoma: a case report.

BACKGROUND: Ovarian lymphoma has a varied clinical presentation and rarely presents with heavy menstrual bleeding. It may occur de novo or secondary to systemic disease and macroscopically appear as solid ovarian tumors. CASE PRESENTATION: A 32-year-old Tamil woman presented with heavy menstrual bleeding of 4 months' duration. On examination she was anemic with no lymphadenopathy. A large immobile pelvic mass and three firm nodules were found involving her vaginal walls. Ultrasonography suggested a fibroid uterus with two large pedunculated fibroids. Following preoperative optimization an endometrial sampling and biopsy of the nodules were done. Subsequently, histology revealed proliferative phase endometrium. The vaginal nodules showed lymphoid tissue. She presented a week later with an undulating fever and features of acute abdomen with clinical evidence of ascites. During an emergency laparotomy two large solid ovarian masses, gross ascites, pelvic lymph nodes, para-aortic lymph nodes, mesenteric lymph nodes, omental deposits, and a 24-week-size uterus were found. Bilateral oophorectomy was done. Laboratory investigations revealed raised lactate dehydrogenase with normal serum ß-human chorionic gonadotropin, alpha-fetoprotein, and cancer antigen-125 levels. Histology of ovarian specimens revealed a diffuse large B cell lymphoma. A bone marrow biopsy revealed more than 80% infiltration with lymphoid cells. Two weeks after the laparotomy a computed tomography of her chest, abdomen, and pelvis revealed a pelvic mass, gross ascites, omental deposits, hepatosplenomegaly, and enlarged lymph nodes above and below her diaphragm. Immunohistochemistry confirmed the diagnosis of B cell lymphoblastic lymphoma. She was classified as stage IV E non-Hodgkin's lymphoma on the Ann Arbor staging system. CONCLUSION: This is an atypical presentation of an ovarian lymphoma. The atypical presentations of ovarian lymphomas can lead to diagnostic dilemmas.

Cost evaluation, quality of life and pelvic organ function of three approaches to hysterectomy for benign uterine conditions: study protocol for a randomized controlled trial.

BACKGROUND: Hysterectomy is the commonest major gynaecological surgery. Although there are many approaches to hysterectomy, which depend on clinical criteria, certain patients may be eligible to be operated in any of the several available approaches. However, most comparative studies on hysterectomy are between two approaches. There is also a relative absence of data on long-term outcomes on quality of life and pelvic organ function. There is no single study which has considered quality of life, pelvic organ function and cost-effectiveness for the three main types of hysterectomy. Therefore, the objective of this study is to provide evidence on the optimal route of hysterectomy in terms of cost-effectiveness by way of a three-armed randomized control study between non-descent vaginal hysterectomy, total laparoscopic hysterectomy and total abdominal hysterectomy. METHODS: A multicentre three-armed randomized control trial is being conducted at the professorial gynaecology unit of the North Colombo Teaching Hospital, Ragama, Sri Lanka and gynaecology unit of the District General Hospital, Mannar, Sri Lanka. The study population is women needing hysterectomy for non-malignant uterine causes. Patients with a uterus > 14 weeks, previous pelvic surgery, those requiring incontinence surgery or pelvic floor surgery, any medical illness which caution/contraindicate laparoscopic surgery and who cannot read and write will be excluded. The main exposure variable is non-descent vaginal hysterectomy and total laparoscopic hysterectomy. The control group will be patients undergoing total abdominal hysterectomy. The primary outcome is time to recover following surgery, which is the earliest time to resume all of the usual activities done prior to surgery. In total, 147 patients (49 per arm) are needed to have 80% power at α-0.01 considering a loss to follow-up of 20% to detect a 7-day difference between the three routes; TLH versus TAH versus NDVH. The economic evaluation will take a societal perspective and will include direct costs in relation to allocation of healthcare resources and indirect costs which are borne by the patient. A micro-costing approach will be adopted to calculate direct costs from the time of presentation to the gynaecology clinic up to 6 months after surgery. Incremental cost-effectiveness ratios (ICER) will be obtained by calculating the incremental costs divided by the incremental effects (time to recover and QALYs gained) for the intervention groups (NDVH and TLH) over the standard care (TAH) group. DISCUSSION: The cost of the procedure, quality of life and pelvic organ function following the three main routes of hysterectomy are important to clinicians and healthcare providers, both in developed and developing countries. TRIAL REGISTRATION: The study was registered in the Sri Lanka clinical trials registry (SLCTR/2016/020) and the International Clinical Trials Registry Platform ( U1111-1194-8422 ) on 26 July 2016.

Validation of the International Consultation on Incontinence Questionnaire-Vaginal Symptoms (ICIQ-VS) in two south- Asian languages.

INTRODUCTION: The multifaceted nature of pelvic floor disorders means that a systematic evaluation is required for optimal treatment outcome. It is also generally acknowledged that a valid tool is necessary to objectively assess symptoms reported by affected women. METHODS: The International Consultation on Incontinence Questionnaire-Vaginal Symptoms (ICIQ-VS) questionnaire was translated to Sinhala and Tamil and a validation study carried out among women attending gynecology clinics at North Colombo Teaching Hospital, Ragama, and the district general hospitals Mannar and Vavuniya. RESULTS: Content validity was assessed by the level of missing answers, which was < 4% and 2% for each item in Sinhala and Tamil, respectively. Construct validity was assessed by the ability of the questionnaire to differentiate between patients and controls. Both differentiated patients from controls on vaginal symptoms score (VSS) (p < 0.001), sexual symptoms score (SSS) (p < 0.01), and quality of life (QoL) (p < 0.001). There was a strong positive correlation between Pelvic Organ Prolapse Quantification (POP-Q) scores and VSS (Sinhala r s = 0.64, p < 0.001, Tamil r s = 0.65, p < 0.001), and QoL (Sinhala r s = 0.49, p < 0.001, Tamil r s = 0.60, p < 0.001). Internal consistency as assessed using Cronbach's coefficient alpha: 0.78 (0.76-0.78) and 0.83 (0.80-0.84) in Sinhala and Tamil, respectively. Test-retest reliability was assessed by weighted kappa scores (Sinhala 0.58-0.88 and Tamil 0.76-0.90). Both questionnaires were sensitive to change and showed that VSS and QoL improved following surgery (Wilcoxon matched-pairs signed-rank test p < 0.001). CONCLUSION: The validated Sinhala and Tamil translations of ICIQ-VS will be useful for assessing vaginal and sexual symptoms among women speaking Sinhala and Tamil.

Translation and validation of ICIQ-FLUTS for Tamil-speaking women.

AIMS: Research in to lower urinary tract symptoms (LUTS) in women in South Asia is hampered by lack of validated tools. Our aim was to validate the International Consultation on Incontinence Modular Questionnaire on Female Lower Urinary Tract Symptoms (ICIQ-FLUTS) from English to Tamil. METHOD: After translation to Tamil, a validation study was carried out among women attending the gynecology clinic at District General Hospital-Mannar. RESULTS: Content validity assessed by the level of missing data was <2%. Construct validity was assessed by the ability of the questionnaire to identify patients with incontinence (n = 45) from controls (n = 93) using the incontinence score [patients = 7.7 standard deviation (SD) = 4.7, controls = 1.4 SD = 2.2, p < 0.001] and those with symptomatic anterior wall prolapse (n = 16) from controls (n = 93) using voiding symptoms score (patients = 4.8 SD = 2.3, controls = 0.3 SD = 0.8, p < 0.001). Internal consistency was assessed using Cronbach's coefficient alpha score [0.80 (0.77-0.81)]. Test-retest reliability assessed by weighted kappa (κ) ranged from 0.73 to 0.87. Patients with incontinence (n = 30, pretreatment incontinence score = 7.9, SD = 4.9 versus posttreatment incontinence score = 3.3, SD = 3.1) and symptomatic anterior wall prolapse (n = 14, preoperative voiding symptoms score = 4.9 SD = 2.5 versus postoperative voiding symptoms score = 0.9 SD = 1.5) showed an improvement with treatment (Wilcoxon matched--pairs signed-rank test p < 0.001 and p < 0.01, respectively). An incontinence score ≥ 3 (sensitivity = 86.7%, specificity = 78.4%) and a voiding symptoms score ≥ 3 (sensitivity = 87.5%, specificity = 96.2%) detected any form of incontinence and symptomatic anterior wall prolapse, respectively. CONCLUSION: Tamil translation of ICIQ-FLUTS retained the psychometric properties of the original English questionnaire and will be an invaluable tool to detect LUTS among Tamil-speaking women.

Factors associated with nonresponse to ovulation induction using letrozole among women with World Health Organization group II anovulation.

CONTEXT: Letrozole, a third generation aromatase inhibitor is gaining importance in ovulation induction. Some prefer to use it as a second line agent in women who fail to respond to clomifene citrate. However, our knowledge about the predictors of response to letrozole is limited. AIMS: The study was aimed at identifying the factors associated with letrozole resistance among women with World Health Organization (WHO) group II anovulation. SUBJECTS AND METHODS: Study was conducted at the infertility clinic at a tertiary care hospital in Sri Lanka. A case-control study design was used and included 50 subjects with WHO group II anovulation (25 clomifene responsive and 25 clomifene resistant). After a treatment cycle of letrozole, the factors were compared between the subjects who responded and those who failed to respond to treatment. RESULTS: Ovulation was achieved in 76% (n = 19) of subjects who had responded to clomifene previously and in 24% (n = 6) with clomifene resistance. The factors associated with letrozole resistance included the presence of hirsutism (odds ratio [OR]: 3.89; 95% confidence interval [CI]: 1.2-12.3) and clomifene resistance (OR: 10.03; 95% CI: 2.81-35.7). The early follicular phase mean (standard deviation) luteinizing hormone level was significantly higher among the nonresponders (9.75 [4.78] - 7.28 [2.3]; P = 0.02). Nonresponders showed significantly lower levels of oestradiol on the 5(th) and 9(th) days (28.50 [3.39] pg/mL vs. 7.49 [3.62] pg/mL; P = 0.0007 and 142.04 [76.22] pg/mL vs. 28.10 [12.8] pg/mL; P = 0.0001) of the menstrual cycle, respectively. CONCLUSIONS: The features associated with resistance to Letrozole at a dose of 2.5 mg show some overlap with those associated with clomifene resistance. However, some features do not show similar association. The effectiveness of letrozole at a dose of 2.5 mg in induction of ovulation among women with clomifene resistance is low and it does not seem to be a suitable treatment at a dose of 2.5 mg for this indication.

Efficacy of two sperm preparation techniques in reducing non-specific bacterial species from human semen.

CONTEXT: Artificial reproductive techniques using seminal preparations with bacteria may cause pelvic inflammatory disease and its sequalae. AIMS: To assess efficacy of two sperm preparation techniques to clear bacteria and the effect of bacteriospermia on sperm recovery rates. SETTINGS AND DESIGN: A descriptive cross-sectional study was carried out among males of subfertile couples. SUBJECTS AND METHODS: Semen samples were randomly allocated into swim-up method (group S, n = 68) and density gradient method (group D, n = 50) for sperm preparation. Seminal fluid analysis and bacterial cultures were performed in each sample before and after sperm preparation. STATISTICAL ANALYSIS: McNemar's chi-squared test and independent samples t-test in SPSS version 16.0 were used. RESULTS: Organisms were found in 86 (72.88%) out of 118 samples, before sperm preparation; Streptococcus species (n = 40, 46.51% of which 14 were Group D Streptococcus species), Coagulase negative Staphylococcus species (n = 17, 19.76%), Staphylococcus aureus (n = 13, 15.11%), Coliform species (n = 11, 12.79% of which 09 were Escherichia coli) and Corynebacterium species (n = 5, 5.81%). There was a statistically significant reduction of culture positive samples in raw vs. processed samples; in group S, 49 (72.05%) vs. 16 (23.52%) and in group D, 37 (74%) vs. 18 (36%). In group S and D, mean (SD) recovery rates of culture positive vs. culture negative samples were 39.44% (SD-14.02) vs. 44.22% (SD-22.38), P = 0.39 and 52.50% (SD-37.16) vs. 49.58% (SD-40.32), P = 0.82 respectively. CONCLUSIONS: Both sperm preparation methods significantly reduced bacteria in semen, but total clearance was not achieved. Sperm recovery rate was not affected by bacteriospermia.

Xanthogranulomatous salpingitis and oophoritis associated with endometriosis and uterine leiomyoma presenting as intestinal obstruction.

Xanthogranulomatous inflammation is a rare form of chronic granulomatous inflammation. Bacterial infections, immunosuppression, chronic inflammatory conditions, luminal obstruction, endometriosis, leiomyoma, abnormal lipid metabolism, ineffective antibiotic therapy, ineffective clearance of bacteria by phagocytes and chronic irritation of the urachal remnant have been implicated in the pathogenesis. There are very few reported cases of xanthogranulomatous salpingitis and oophoritis. We present such a case in a 34-year-old female, with primary subfertility for eight years, endometriosis, uterine leiomyoma, type II diabetes mellitus and a history of surgery for endometriosis and fibroids and surgical wound infection, who presented with symptoms of intestinal obstruction. The patient underwent emergency laparotomy followed by total abdominal hysterectomy and bilateral salpingo-oophorectomy. Histology revealed xanthogranulomatous salpingitis and oophoritis. Chronic inflammation due to inadequate treatment of bacterial infection, coupled with pelvic endometriosis and uterine leiomyoma may have led to xanthogranulomatous salpingitis and oophoritis.