Conditions Associated With Hypertriglyceridemia in Adult Patients in a Tertiary Care Center in Basrah, Iraq.

Background Hypertriglyceridemia (HTG) is one of the major modifiable risk factors for the development of several metabolic diseases. Determining the factors associated with HTG is an important step for increasing awareness of the problem and proper planning of health programs for HTG prevention. This study aimed to determine the conditions associated with HTG in adult patients in Basrah, Iraq. Methodology This retrospective study was conducted at Faiha Specialized Diabetes Endocrine and Metabolism Center (FDEMC) in Basra, southern Iraq, in January 2024. The data were retrieved from the center database of 37,133 subjects registered from 2008 to 2023 (16,284, 43.8% males and 20,849, 56.2% females) who attended the FDEMC in Basra due to different reasons. Results The most common causes of HTG were type 2 diabetes mellitus (T2DM) (29,799, 80%), obesity (19,914, 53.63%), and smoking (7,309, 12.68%). The age group of 18-45 years displayed higher triglyceride (TG) levels (281.1 ± 210.1 mg/dL) than other age groups. Furthermore, male patients had higher TG levels than females (288.0 ± 196.3 mg/dL vs. 268.9 ± 165.9 mg/dL). Regarding body mass index, overweight and obese patients had higher mean TG levels (284.4 ± 182.1 mg/dL and 281.7 ± 184.6 mg/dL, respectively). Current and ex-smokers had higher TG levels (305.1 ± 212.2 mg/dL and 283.4 ± 161.3 mg/dL, respectively) than non-smokers (272.5 ± 175.4 mg/dL). Moderate HTG was the most common category encountered in 24,137 patients (65%), followed by mild HTG (12,705, 34.2%). Very few patients had severe (264, 7%) or very severe HTG (27, 0.07%). Male patients had more frequent severe and very severe HTG than females. Conclusions The most common conditions associated with HTG were T2DM, obesity, and smoking. Smoker males were prone to severe and very severe HTG.

Impulse Control Disorders in Southern Iraqi Patients Medicated With Cabergoline for Prolactinoma.

BACKGROUND: Among the patient population in Basrah, Iraq, prolactinoma is the most commonly found pituitary tumor. Impulse control disorders (ICDs) were reportedly associated with these patients being treated with cabergoline. This study aimed to assess the prevalence of ICDs in cabergoline-treated prolactinoma patients versus healthy, matched controls. METHODS: This cross-sectional case-control study was conducted at the Faiha Specialized Diabetes, Endocrine and Metabolism Center (FDEMC) in Basrah, southern Iraq, from January 2023 to May 2023. It included 30 cabergoline-treated prolactinoma patients and 30 healthy, matched controls. The questionnaire for ICDs in Parkinson's disease was used as a screening tool. Following this, positively screened patients were evaluated using validated criteria accordingly to diagnose impulse control disorders. RESULTS: The ICDs were diagnosed in nine (30%) cabergoline-treated prolactinoma patients versus two (6.7%) in control (p = 0.02). The most frequent ICD types were hypersexuality and binge eating, while no patient reported pathological gambling. Three patients reported multiple types of ICDs. The patients' sociodemographic characteristics, prolactinoma duration and size, and cabergoline dose did not correlate significantly with ICD diagnosis. CONCLUSIONS: Treatment with cabergoline is associated with the development of ICDs. Therefore, clinicians should be aware of this disabling side effect to ensure its early detection and treatment.

Triiodothyronine/Thyroxine Ratio as a Marker of Clinical Response to Levothyroxine Replacement in Patients With Hypothyroidism.

BACKGROUND:  Hypothyroidism is one of the most common endocrine disorders with a simple therapy, that is levothyroxine (LT4). A normal thyroid-stimulating hormone (TSH) measurement is used as a marker of optimal replacement. But, many patients still have symptoms. Triiodothyronine (T3), thyroxine (T4), and their ratio may correlate with clinical improvement. The study aims to assess the T3/T4 ratio as a marker of clinical response in patients with hypothyroidism.  Method: A cross-sectional study was conducted from June to November 2022 at Faiha Specialized Diabetes, Endocrine, and Metabolism Center, in Basrah, southern Iraq. We included 48 adult patients with primary hypothyroidism on LT4 treatment only and TSH within the target reference range for at least within the last six months. Each patient was subjected to a questionnaire that was designed to capture hypothyroidism-related complaints in the form of a five-point Likert scale. Biochemical assessments were done with the measurement of TSH, T3, and T4. RESULTS: Despite having a normal TSH level, nearly all the patients had persistent and varying severity of clinical complaints of hypothyroidism. Tiredness, hair problems, weight gain, and cold intolerance were the most severely persistent symptoms. Patients with scores of two and more for weight gain, cold intolerance, and skin problems had significantly lower T3/T4 ratios (P = 0.04, 0.002, and 0.02, respectively), while in the remaining clinical symptoms, the T3/T4 ratio did not differ significantly. CONCLUSION: A low T3/T4 ratio was significantly associated with resistant symptoms of hypothyroidism and may be used as a marker for treatment efficacy with TSH rather than TSH value alone.

Risk Stratification of Differentiated Thyroid Cancer: A Single-Center Study in Basrah.

Background Differentiated thyroid cancer is a common endocrine cancer; most of it has an indolent course and favorable outcomes, with a subset of patients having the risk of disease recurrence, which can be assessed using the fixed American Thyroid Association (ATA) risk stratification system or the dynamic response to therapy risk stratification that can be modified during patients follow-up. Aim The aim of this article is to assess the risk stratification of patients having differentiated thyroid cancer. Methods This is a retrospective cross-sectional study in which we evaluated medical records of 75 patients having differentiated thyroid cancer to assess the baseline ATA risk of recurrence and compared it to the results of dynamic risk stratification in response to therapy at 6-12 months post-surgery and at the last visit. Thyroglobulin level, anti-thyroglobulin antibody, thyroid ultrasound, and cytopathological examination were used to determine dynamic response to therapy and divided subjects into four groups: excellent response (ER), biochemical incomplete response (BIR), structural incomplete response (SIR), and indeterminate response (IR). Results At baseline, 55 patients had low risk, 14 patients had intermediate risk, and six patients had high risk. At 6-12 months post-surgery, in the low-risk group, ER, BIR, and IR responses were observed in 56.4%, 5.5%, and 38.2% of patients, respectively, and none of them exhibited SIR. In the intermediate-risk group, ER, BIR, and IR responses were observed in 57.1%, 21.4%, and 21.4% of patients, respectively, and none exhibited SIR. Among the high-risk group, two patients had ER, two patients had BIR, one patient had IR, and one patient had SIR. At the last visit, ER, BIR, and IR were observed in 65.5%, 9.1%, and 25.5% of low-risk patients, respectively, and no patient developed SIR. In the intermediate-risk group, ER, BIR, and IR were observed in 50%, 21.4%, and 28.6% of patients, respectively, and no patients developed SIR. Among the high-risk group, three patients achieved ER, one had BIR, one had IR, and one had SIR. Conclusion Most of the differentiated thyroid cancers in this study are low-risk. Dynamic risk stratification appears to be an effective tool in the follow-up of this population of patients having differentiated thyroid cancer.

Diurnal Variation of Serum Total Testosterone in Women: A Single-Center Study From Basrah.

Background The diurnal variation of testosterone in women has received limited attention, despite its growing recognition as a crucial factor in female health and well-being. This study aims to investigate the diurnal fluctuations of total testosterone levels in apparently healthy women with regular menstrual cycles. Methodology A cross-sectional study was conducted at Faiha Specialized Diabetes Endocrine and Metabolism Center in July 2023. This study involved 46 apparently healthy women volunteers aged between 21 and 40 years. To explore diurnal variations in total testosterone, blood samples were collected from each participant at two distinct time points, i.e., 8:30 AM and 1:30 PM. These samples were collected regardless of fasting status with the exclusion of the menstruating phase. Results The mean total testosterone level at 8:30 AM was 23.4 ± 12.4 ng/dL and at 1:30 PM was 21.7 ± 12.9 ng/dL, with a p-value of 0.03. Neither age nor body mass index demonstrated a significant impact on testosterone levels. Conclusions This study showed a significant diurnal variation in serum total testosterone levels among apparently healthy women, with higher levels observed in the morning.

Cut-Off Value of Thyrotropin-Receptor Antibodies in Grave's Disease in Basrah.

BACKGROUND: The diagnosis of Grave's disease (GD) poses a challenge. Thyrotropin-receptor antibodies (TRAb) are the key diagnostic feature of GD, as the American and European Thyroid Associations suggested. AIM OF THE STUDY: This study aims to find a cut-off level of TRAb in GD in Basrah. METHODS: This is a retrospective study that included 617 patients with hyperthyroidism (530 GD and 87 non-Grave's disease (NGD) (thyroiditis or subclinical hyperthyroidism)). The candidates were patients presenting with hyperthyroidism who were referred for TRAb assay, while patients with thyroid carcinoma or nodular thyroid disease, pregnant ladies, and patients who were treated were excluded. RESULTS: The manufacturer cut-off value of 1.75 IU/L had a sensitivity of 88.1%, specificity of 72.4%, positive predictive value (PPV) of 95.1%, and negative predictive value (NPV) of 50.0%. Our data analysis through receiver operating characteristic (ROC) statistics revealed that the optimum cut-off point with the highest total sensitivity and specificity was determined to be 3.95 IU/L, as it had a sensitivity of 76.9%, specificity of 98.8%, PPV of 99.7%, NPV of 41.3%. CONCLUSION: For a more accurate diagnosis of GD, the findings of the present study support the implementation of a higher TRAb cut-off value (3.95 IU/L) than that predefined by the manufacturer (1.75 IU/L).

Validity of the Rapid Thyroxine Absorption Test for the Differentiation Between Levothyroxine Non-compliance and Malabsorption in Thyroid-Stimulating Hormone Refractory Hypothyroidism.

Introduction Thyroid-stimulating hormone refractory hypothyroidism is a common problem. This is due to either non-compliance or malabsorption with levothyroxine (LT4). The study aimed to assess the validity of the rapid LT4 absorption test in the differentiation between LT4 malabsorption and non-compliance. Methods A cross-sectional study was done from January to October 2022 at Faiha Specialized Diabetes, Endocrine, and Metabolism Center, in Basrah, Southern Iraq. Twenty-two patients with thyroid-stimulating hormone (TSH) refractory hypothyroidism were evaluated by rapid LT4 absorption test with measurements of TSH before 1000 µg LT4 intake, and free thyroxine (pmol/l) and total thyroxine before (nmol/l) (baseline TT4 and baseline FT4) and two hours after (2-HR TT4 and 2-HR FT4). The findings were compared with the following four-week-long supervised LT4 absorption test results. Results In the rapid LT4 absorption test, patients with (2-HR FT4 minus baseline FT4 ≤1.28 pmol/l (0.1 ng/dl) or 2-HR FT4 minus baseline FT4 1.28-6.43 pmol/l (0.1-0.5 ng/dl) plus 2-HR TT4 minus baseline TT4<72.08 nmol/l (5.6 µg/dl)), eight out of 10 patients were correctly diagnosed with malabsorption. And in those with (2-HR FT4 minus baseline FT4 ≥6.43 (0.5 ng/dl) or 2-HR FT4 minus baseline FT4 1.28-6.43 (0.1-0.5 ng/dl) plus 2-HR TT4 minus baseline TT4≥72.08 (5.6 µg/dl)), 11 out of 12 patients were correctly diagnosed as non-compliant. This criterion showed 88.8% sensitivity, 15.4% specificity, 80% positive predictive value, and 91.6% negative predictive value for diagnosing LT4 malabsorption. Conclusion The rapid LT4 absorption test showed good diagnostic accuracy in differentiating non-compliance from malabsorption when (2-HR FT4 minus baseline FT4) and (2-HR TT4 minus baseline TT4) were used as criteria.

The Clinical Implications of Anti-thyroid Peroxidase Antibodies in Graves' Disease in Basrah.

Background Graves' disease (GD) is an autoimmune disease, with thyrotropin receptor antibodies (TRAbs) being the most important cause in the pathogenesis. The aim of this study is to assess the clinical significance of anti-TPO Abs in GD. Methods A retrospective study was conducted at the Faiha specialized Diabetes, Endocrine, and Metabolism Center (FDEMC) in Basrah during the period between December 2021 and December 2022. A total of 141 patients with GD were involved in this study, and of them, 97 (68.8%) were women. They were divided into two groups: patients with positive and negative anti-TPO Abs groups. Results Positive anti-TPO Abs were seen in 83 patients (58.9%) with GD. Pretreatment-free thyroxine level (ng/dL) was higher in the anti-TPO Abs positive GD patients than in those with negative antibodies (3.7±0.2 versus 3.0±0.2 with a p=0.021). Similarly, higher TRAb titers (IU/ml) at baseline were also seen in patients with positive anti-TPO Abs (9.8±0.7 versus 6.8±0.8) with a p=0.008. Giraffe appearance on thyroid ultrasound was more common in the group with positive anti-TPO Abs as compared to patients with negative anti-TPO Abs: 20 (87.0%) versus 3 (13.0%) with a p=0.005. A higher anti-TPO Abs titer (IU/mL) was associated with a baseline TRAb level of more than 6.4 IU/mL, and giraffe appearance on thyroid ultrasound (206.5±20.0 p-value<0.0001 and 228.0±35.3 p value=0.007, respectively). Conclusion A positive anti-TPO Abs in GD is associated with a high TRAb titer and free T4 level at baseline, as well as a giraffe appearance on thyroid ultrasound.

Management Outcomes in Males With Hypogonadotropic Hypogonadism Treated With Gonadotropins.

Background Hypogonadotropic hypogonadism is an important cause of male infertility and loss of secondary sexual characteristics. Gonadotropin replacement is mandatory for sexual function, bone health, and normal psychological status. This study is to compare the effectiveness of different gonadotropin therapy modalities in the management of male hypogonadism. Methods A randomized open-label prospective study of 51 patients attended the Faiha Specialized Diabetes, Endocrine and Metabolism Center (FDEMC) with hypogonadotropic hypogonadism, divided randomly into three groups. The first group was treated with human chorionic gonadotropin (hCG) alone, the second group was treated with a combination of both hCG and human menopausal gonadotropin (HMG), while the third group started with hCG alone then followed by combination therapy after six months. Results All modalities of therapy result in a significant increase in mean testicular volume although no clinically significant difference between the groups, but the combination group had the highest increment. The increment in serum testosterone level was statistically significant among the different groups of treatment (p-value < 0.0001). When comparing groups, a higher mean maximum testosterone level (710.4±102.7 ng/dL) was obtained with the combination group followed by the sequential group, with mean maximum testosterone levels (636.0±68.6 ng/dL) (p-value = 0.031). Factors negatively affecting testosterone level include BMI > 30 kg/m2, initial testicular volume < 5 mL, and duration of therapy < 13 months. Conclusions Induction of puberty using recombinant hCG alone is sufficient to induce secondary sexual characteristics, while for fertility issues combination from the start or sequential therapy has better for spermatogenesis. There was no effect of prior exogenous testosterone treatment on final spermatogenesis.

Prevalence of High Aldosterone-Renin Ratio in Patients With Hypertension in Basrah.

BACKGROUND AND AIM: Aldosterone-renin ratio (ARR) is an important screening tool for the assessment of primary aldosteronism as a cause of secondary hypertension. This study aimed to measure the prevalence of patients with elevated ARR among samples of Iraqi patients with hypertension. METHODS: A retrospective study was conducted at Faiha Specialized Diabetes, Endocrine and Metabolism Center (FDEMC) in Basrah during the period of February 2020 to November 2021. We evaluated the records of patients with hypertension whom were screened for endocrine cause, and an ARR cut-off equal or more than 5.7 was considered elevated. RESULTS: Of the total 150 patients enrolled, 39 (26%) of them had an elevated ARR. No statistically significant association for the elevated ARR with age, gender, BMI, duration of hypertension, systolic and diastolic blood pressure, pulse rate, and presence or absence of diabetes mellitus or lipid profile. CONCLUSION: High frequency of elevated ARR was seen in 26% of patients with hypertension. More studies need to be conducted in the future taking larger samples.

Fasting Versus Non-Fasting Total Testosterone Levels in Women During the Childbearing Period.

Background Total testosterone in men should be measured in the fasting state early in the morning with at least two samples according to guidelines. For women, no such a recommendation is available despite the importance of testosterone in this demographic. The aim of this study is to evaluate the effect of fasting versus non-fasting state on the total testosterone levels in women during the reproductive period. Methods This study was conducted at Faiha Specialized Diabetes, Endocrine and Metabolism Center in Basrah, (Southern Iraq) between January 2022 to November 2022. The total enrolled women were 109; their age was 18-45 years. The presentation was for different complaints; 56 presented for medical consultation with 45 apparently healthy women accompanying the patients as well as eight volunteering female doctors. Testosterone levels were measured by electrochemiluminescence immunoassays using the Roche Cobas e411 platform (Roche Holding, Basel, Switzerland). Two samples were collected from each woman; one was fasting and another was non-fasting the following day, and all samples were taken before 10 am. Results  For all of the participants, the mean ± SD fasting was significantly higher as compared to the non-fasting testosterone (27.39±18.8 ng/dL and 24.47±18.6 ng/dL respectively, p-value 0.01). The mean fasting testosterone level was also significantly higher in the apparently healthy group, (p-value 0.01). In women who presented with hirsutism, menstrual irregularities and or hair fall, no difference was seen in the testosterone levels between fasting and non-fasting states (p-value 0.4).  Conclusion In the apparently healthy women of childbearing age, serum testosterone levels were higher in the fasting versus the non-fasting states. In women who presented with complaints of hirsutism, menstrual irregularities, and or hair fall, the serum testosterone levels were not affected by the fasting states.

Management of Type 2 Diabetes With Insulin Glargine-100 in Iraq in a Real-Life Observation.

Introduction: Type 2 diabetes mellitus (T2DM) management is challenging in conflict zones, such as Iraq, and insulin might not be readily prescribed or available to patients who need it. This study describes the profile of Iraqi T2DM patients treated with insulin glargine-100 (Glar-100) and their response to the treatment. Research design and methods: This observational, multicenter registry collected data over six months on demographic and medical history, insulin regimen, changes in glycemic parameters, and vital signs in patients with T2DM in Iraq. Results: Patients (N = 245) were 55.2 ± 10.2 years old, with 58.4% females. They had had diabetes for 10 years, with baseline glycated hemoglobin (HbA1c) levels of 10.3% ± 1.6% (89 mmol/mol), diabetes complications, and co-morbidities. Almost all were on oral anti-diabetics before treatment intensification with Glar-100. Over 50% of patients with prior insulin exposure were receiving basal plus or bolus regimens at baseline, versus 6% of insulin-naïve patients, though some required treatment intensification. Most were asked to self-titrate according to fasting plasma glucose (FPG), but self-titration proved challenging. Upon Glar-100 treatment, HbA1c and FPG levels significantly decreased (P < 0.001), and 20% of patients (mostly insulin-naïve) achieved HbA1c < 7% (53 mmol/mol). Vital signs improved, while weight changes were modest. Most safety events were mild, and only two patients discontinued Glar-100. Conclusion. Glar-100 safely and effectively decreased FPG and HbA1c levels, achieving HbA1c control in some patients. Glar-100 is a promising T2DM therapeutic option in Iraq.

Serum Glucose Measurement after Five to Six Hours is Comparable to Eight Hours Fasting in Ramadan.

Objectives: This study aimed to evaluate whether a shorter fasting duration of five to six hours can be used as an alternative to the usually recommended eight hours for fasting glucose measurement. Methods: This one-month observational, cross-sectional study was conducted during Ramadan (May to June) 2019. It included those attending Faiha Specialized Diabetes, Endocrine and Metabolism Center, Basrah, Iraq; all individuals ate a pre-dawn meal (suhoor) followed by a complete fast for many hours. Two fasting serum glucose (FSG) venous samples were taken; the first was taken five to six hours and the second eight hours after the pre-dawn meal. Participants were divided into two groups: individuals with type 2 diabetes mellitus (T2DM) and those with a normal glucose level. T2DM patients were further subdivided into three groups: those without treatment, those on oral antidiabetic drugs (OAD) and those using insulin and OAD. Results: A total of 200 individuals participated in this study. There was no significant difference found between the mean FSG levels in the first and second samples for those without T2DM (104.5 ± 21.4 mg/dL versus 104.8 ± 12.6 mg/dL; P = 0.80) as well as those with T2DM (235.0 ± 107.0 mg/dL versus 230.0 ± 105.0 mg/dL; P = 0.20). Untreated T2DM patients had non-significant FSG readings for the two samples (194.0 ± 151.5 mg/dL versus 193.9 ± 128.9 mg/dL; P = 0.90). Patients on insulin and OAD showed a similar pattern of FSG (268.0 ± 111.0 mg/dL versus 269.0 ± 114.0 mg/dL). However, the two FSG samples were found to be significantly different among patients on OAD (220.0 ± 78.0 mg/dL versus 207.0 ± 77.0 mg/dL; P = 0.01). Conclusion: The fasting duration of five to six hours can give a comparable measurement of FSG as that obtained after eight hours.

Correlation Between Clinical and Biochemical Markers in Patients With Acromegaly on Different Modalities of Treatment.

Background Acromegaly is a disabling disease caused by growth hormone (GH) over-secretion, associated with increased morbidity and mortality through different metabolic and somatic consequences involving soft tissue, acral overgrowth, and skin thickening, which will lead to different clinical manifestations. The study aimed to assess the correlation between biochemical markers of acromegaly with different clinical findings and biochemical control with the clinical findings. Methods A cross-sectional study was done on 56 patients with acromegaly attending a tertiary center for diabetes, endocrine, and metabolism in Southern Iraq Basrah. They were 32 (57.1%) males. Fatigue, headache, excessive sweating, joint pain, backache, soft tissue swelling, numbness, snoring, and visual problems were assessed on a four-point Likert scale. In addition, biochemical dynamic GH testing was done using a five-point random GH curve and/or standard GH suppression under the oral glucose tolerance test (OGTT). Results No significant correlation was found between symptoms severity and five-point GH parameters in respect of mean, peak, and nadir. Only backache showed a significant correlation with GH under OGTT suppression parameters in respect to mean, peak, and nadir (P-values < 0.01, < 0.01, and < 0.01), respectively. No particular biochemical control cut-off value in the 9 am random GH, mean five-point GH curve, or nadir GH under OGTT was correlated with the degree of severity for any of the clinical symptoms, as there was no difference between the biochemically controlled and uncontrolled groups in respect to any of the clinical symptom's severity scale. Conclusion Only backache correlated with the biochemical tests of disease activity in the form of GH under OGTT. It appears in this study that the severity of the clinical symptoms does not correlate with biochemical control so that thorough evaluation and treatment of clinical complaints besides biochemical control is an essential part of the management plan in patients with acromegaly.

Barriers of Doctors and Patients in Starting Insulin for Type 2 Diabetes Mellitus.

Background Management of patients with type 2 diabetes mellitus (T2DM) may involve insulin therapy. However, this treatment may be avoided or delayed by physicians or patients due to the presence of certain barriers. This study aimed to evaluate the barriers to initiating insulin therapy for both physicians and patients with T2DM.  Method This was a cross-sectional, questionnaire-based study. Data related to the physicians' personal and professional experience were collected, and 15 barriers to initiating insulin therapy were scored by each physician on a four-point Likert scale. Also, the patients' general data were collected, including previous insulin experience, discontinuation reason, and willingness to start insulin therapy if indicated. Twenty-one other barriers were examined with yes/no questions as well. Results For physicians, the patient's treatment compliance, motive, dependence on others for insulin therapy, hypoglycemia, socioeconomic status, occupation, and lack of follow-up were the most highly ranked barriers to initiating insulin therapy. A history of insulin use was reported in 42 (20.7%) patients, 31 of whom had decided to discontinue insulin therapy themselves (73.8%). The three most common reasons for discontinuing insulin therapy among patients were deterioration of T2DM and causing complications, hypoglycemia, and needle injections. Based on the findings, 99 (48.8%) patients were willing to start insulin therapy, if indicated. The family history of insulin therapy was positively correlated with the patient's willingness to start insulin. On the other hand, it was negatively correlated with a low educational level and some barriers to insulin therapy, such as fear of death, dependence on others, the difficulty of carrying insulin while traveling, follow-up challenges, the difficulty of dosing accuracy, the difficulty of keeping insulin, inconveniences in daily life, considering insulin as the last resort, the deterioration of T2DM with insulin, and social stigma. Conclusion The physicians believed that the barriers to initiating insulin therapy were mainly related to the patient's attitudes and thoughts about this therapy. While hypoglycemia and weight gain are well-known side effects of insulin therapy, the most important patient-related barriers to insulin therapy were related to its impact on the patient's social life and misperceptions about the side effects of insulin.

Development of the First Health-Related Quality of Life Questionnaires in Arabic for Women With Polycystic Ovary Syndrome (Part II): Dual-Center Validation of PCOSQoL-47 and PCOSQoL-42 Questionnaires.

Introduction Validation assesses the acceptability, responsiveness, interpretability, and quality of any questionnaire in any specific population. This is done by correlation matrix evaluation of the proposed test tool with a previously well-validated assessment tool. The study objective is the dual-center assessment of the construct validity of the first health-related quality of life questionnaires for married and unmarried women with polycystic ovary syndrome (PCOS), i.e., PCOSQoL-47 and PCOSQoL-42, respectively. Materials and methods At two centers in Iraq, we enrolled 406 married women and 362 unmarried women with PCOS to test for the construct validity of PCOSQoL-47 and PCOSQoL-42, respectively, from August 2019-August 2020 (after obtaining full results of reliability testing in our previous work). We used the comparable domains from the multiculturally validated questionnaire (World Health Organization Quality of Life [WHOQOL-BREF]) as a comparator to assess the construct validity of the domains of the final highly reliable questionnaire drafts of PCOSQoL-47 and PCOSQoL-42 which were obtained from our previous work. The enrolled women will respond to WHOQOL-BREF and either PCOSQoL-47 or PCOSQoL-42, according to their marital status. Pearson's parametric correlational coefficient compared the total scores of the matched domains in one of our questionnaires and WHOQOL-BREF at p≤0.05. Values more than 0.3 denoted an important correlation between our test questionnaires and the well-validated WHOQOL-BREF questionnaire. The inter-rater reliability between our questionnaires and the comparator was calculated by Cronbach's alpha level, inter-item, and intra-class correlations coefficients matrix. Results We obtained a good respondent-to-item ratio of approximately 9:1 for both questionnaires. We had a good response for the domains of our questionnaires and WHOQOL-BREF. The coping domain at PCOSQoL-42 showed the highest Pearson's coefficient value of (0.708), which indicates a strong and significant correlation between the two constructs at (p<0.001). Other domains of the PCOSQoL-42 showed moderate significant correlation coefficient values. The psychological and emotional status domain of PCOSQoL-47 showed a weak yet significant correlation with its corresponding domain of the WHOHRQOL-BREF. The other domains of the PCOSQoL-47 showed moderate significant correlation coefficient values >0.5. The PCOSQoL-42 and PCOSQoL-47 showed high inter-rater reliability levels in measuring the requested construct or concept when we used Cronbach's alpha and inter-item correlation matrix assessment. Conclusion The individualized PCOSQoL-47 and PCOSQoL-42 for married and unmarried women with PCOS, respectively, represent the first reliable and valid HRQoL assessment tools for assessing the health-related quality of life (HRQoL) in those women with PCOS who use Arabic as a first or native language and address the sexual function as a separate domain.

Patterns of Bodyweight Changes in Patients With Hypothyroidism, a Retrospective Study From Basrah, Southern Iraq.

Background Weight gain is one of the most important hypothyroidism-related concerns in patients with hypothyroidism. However, unexpectedly, levothyroxine replacement does not necessarily result in body weight (BWT) reduction among those patients. The study aimed to assess the patterns of BWT changes through time in patients with hypothyroidism. Method In a retrospective database study from Faiha Specialized Diabetes, Endocrine, and Metabolism Center, a total of 346 adult patients with hypothyroidism (192 newly diagnosed and 154 known hypothyroidism patients) who had one visit every three months, five visits in one year were included. Of these, 116 new and 69 known hypothyroidism patients had completed nine visits in two years. Each visit involved thyroid-stimulating hormone (TSH) and BWT measurements. Patients with chronic liver or renal disease, diabetes mellitus, thyroid cancer, or other malignancies, pregnancy, and steroid or hormonal therapies were excluded. The patients were further subdivided based on average TSH levels into controlled (TSH ≤ 4.2 µIU/ml) and uncontrolled (TSH > 4.2 µIU/ml). Repeated measures analysis of variance (ANOVA) with a Greenhouse-Geisser correction and post hoc tests using the Bonferroni correction were used to evaluate TSH and BWT changes through the study. Results Both in newly diagnosed and known hypothyroidism patients with an average TSH > 4.2 µIU/mL, BWT increased significantly through visits over one and two years. For newly diagnosed patients assessed over one year (F(2.41, 321.60) = 3.28, p = 0.03), the mean BWT increase was 1.4 ± 0.38 kg from 3rd to 12th month visits (p = 0.004). For newly diagnosed patients assessed over two years (F(3.10, 263.89) = 9.08, P < 0.0005), the mean BWT increase was 3.02 ± 0.77 kg from 3rd to 24th month visits (p = 0.007). For patients with known hypothyroidism assessed over one year (F(2.56, 187.47) = 7.11, p = 0.0003), the mean BWT increase was 1.97 ± 0.64 kg at 12th month visit, and over two years (F(2.35, 77.56) = 4.67, P = 0.009), the mean BWT increase was 3.78 ± 1.26 kg at 24th month visit. While in all other patients with an average TSH ≤ 4.2 µIU/mL, the BWT changed non-significantly through the visits for newly diagnosed patients over one year and two years (p = 0.10, 0.34, respectively), and known patients over one year and two years (p = 0.47, 0.34, respectively). Conclusion Contrary to what is believed, adequate treatment with levothyroxine does not associate with weight reduction. Instead, either the patient kept on the same weight or continued to gain more weight.

Development of the First Health-Related Quality of Life Questionnaires in Arabic for Women with Polycystic Ovary Syndrome (Part I): The Creation and Reliability Analysis of PCOSQoL-47 and PCOSQoL-42 Questionnaires.

Background and objective We lack a reliable and validated health-related quality of life (HRQoL) questionnaire to measure the negative impact of polycystic ovary syndrome (PCOS) on the various aspects of the lives of Arabic women, which addresses sexuality in married women only. Hence, we aimed to develop two separate, simple, reliable, validated, and easily interpretable HRQoL questionnaires in Arabic for married and unmarried women with PCOS for effective QoL evaluation. Materials and methods The development and reliability analysis of the Polycystic Ovary Syndrome Quality of Life (PCOSQoL)-47 and PCOSQoL-42 involved two quantitative and qualitative phases. Phase 1 included retrieval of 158 items from 584 PubMed articles, item reduction, Arabic translation, content and face validity testing, creation of a five-domain draft (53 items for married and 45 items for unmarried women), with no sexuality domain for unmarried women. Phase 2 involved test-retest reliability, which involved using the Spearman's correlation, Wilcoxon nonparametric signed-rank, and internal consistency using Cronbach's-alpha, inter-item, and intraclass correlation (ICC) coefficients, as well as creating a second draft (47 items for married and 42 items for unmarried women). Results The content validity indices testing by 26 healthcare experts decreased the item pool to 57 items for married and 45 items for unmarried women. Face validity by another 30 experts and 30 women from each group resulted in a further reduction to 53 items for married and 45 items for unmarried women, to be tested in a pilot study, which included another 30 women from each group. Test-retest reliability analysis by 195 married and 173 unmarried women revealed significantly excellent redundancy, reliability, and stability of items (highly significant Cronbach's alpha and ICC by internal consistency testing), and reduced the item pool to 47 items for married and 42 items for unmarried women. Conclusions Both questionnaires were found to be highly reliable for the HRQoL evaluation among both married and unmarried Arabic women with different phenotypes of PCOS.

Vitamin D Metabolic Profiles in Premenopausal Women Wearing Niqab and Hijab in Sunny Basrah.

Background Conservative clothing like niqab and hijab may affect the wearer's vitamin D metabolic parameters even in predominantly sunny areas of the world (i.e., areas with adequate sunlight exposure throughout the year). Our objective was to evaluate the effect of wearing the niqab or hijab on different vitamin D3 metabolic parameters in a sample of premenopausal women from Basrah. Methodology This was a cross-sectional observational study on premenopausal women who wore a niqab (n = 64), with a comparable age-matched group of women who wore the hijab (n = 60). Biochemical evaluation of the vitamin D3 metabolic profile involved 25-hydroxycholecalciferol (25-OH)-vitamin D, corrected serum calcium, parathyroid hormone (PTH), phosphorus, and alkaline phosphatase estimation. Statistical comparison of these parameters was made using the independent sample t-test and Mann-Whitney-U test. Results The two groups of women were age- and weight-matched, with a median age of 39 and median body mass index (BMI) of 31.8 kg/m2. Overall, age, marital status, and BMI of women in both groups had no significant relationship with the vitamin D3 metabolic parameters (low 25-OH-vitamin D, low corrected calcium, and high PTH). The subgroup analysis for women wearing the niqab showed the same results. Conclusions Wearing niqab or hijab in premenopausal women was not associated with any significant statistical relationship or difference in vitamin D3 metabolic parameters. Conservative dress styles like niqab and hijab are practical barriers to sun exposure and contribute to suboptimal vitamin D levels, affecting subsequent metabolic pathways. Healthcare professionals should advise women who wear niqab or hijab to increase their vitamin D3 levels through culturally appropriate alternative mechanisms.

Insulin as a Tool in Factitious Dysglycemia.

Factitious dysglycemia is a type of self-inflicted harm that includes deliberate attempts to induce hypo- or hyperglycemia as a sickness to gain empathy. We report the cases of three Iraqi women with different motives to induce factitious dysglycemia. Two of them had used insulin to induce hypoglycemia to have their family affection centered on them again. The third woman with type 1 diabetes mellitus intentionally missed her insulin doses to induce diabetic ketoacidosis and gain familial empathy through recurrent hospital admission, with underlying suicidal ideation. The problems with all women were discovered by a thorough history, physical examination, and with family help. They were referred to have psychiatric management. This is the first case series regarding factitious dysglycemia from Iraq.