Cytological results of ultrasound-guided fine-needle aspiration cytology for thyroid nodules: emphasis on correlation with sonographic findings

Purpose

To compare the cytological results of ultrasound-guided fine-needle aspiration (US-FNA) cytology of thyroid nodules to sonographic findings and determine whether US findings are helpful in the interpretation of cytological results.

Materials and Methods

Among the thyroid nodules that underwent US-FNA cytology, we included the 819 nodules which had a conclusive diagnosis. Final diagnosis was based on pathology from surgery, repeated FNA cytology or follow-up of more than one year. Cytological results were divided into five groups: benign, indeterminate (follicular or Hurthle cell neoplasm), suspicious for malignancy, malignant, and inadequate. US findings were categorized as benign or suspicious. Cytological results and US categories were analyzed.

Results

Final diagnosis was concluded upon in 819 nodules based on pathology (n=311), repeated FNA cytology (n=204) and follow-up (n=304), of which 634 were benign and 185 were malignant. There were 560 benign nodules, 141 malignant nodules, 49 nodules with inadequate results, 21 with indeterminate results, and 48 that were suspicious for malignancy. The positive and negative predictive values of the US categories were 59.1% and 97.0%, and those of the cytological results were 93.7% and 98.9%. The US categories were significantly correlated with final diagnosis in the benign (p=0.014) and suspicious for malignancy (p<0.001) cytological result groups, but not in the inadequate and indeterminate cytological results groups. The false positive and negative rates of cytological results were 1.9% and 3.2%.

Conclusion

Sonographic findings can be useful when used alongside cytological results, especially in nodules with cytological results that are benign or suspicious for malignancy.     

Focal Lymphocytic Thyroiditis Nodules Share the Features of Papillary Thyroid Cancer on Ultrasound

Purpose

It is often difficult to discriminate focal lymphocytic thyroiditis (FLT) or adenomatous hyperplasia (AH) from thyroid cancer if they both have suspicious ultrasound (US) findings. We aimed to make a predictive model of FLT from papillary thyroid cancer (PTC) in suspicious nodules with benign cytologic results.

Materials and Methods

We evaluated 214 patients who had undergone fine-needle aspiration biopsy (FNAB) and had shown thyroid nodules with suspicious US features. PTC was confirmed by surgical pathology. FLT and AH were confirmed through more than two separate FNABs. Clinical and biochemical findings, as well as US features, were evaluated.

Results

Of 214 patients, 100 patients were diagnosed with PTC, 55 patients with FLT, and 59 patients with AH. The proportion of elevated thyrotropin (TSH) levels (p=0.014) and thyroglobulin antibody (Tg-Ab) or thyroid peroxidase antibody (TPO-Ab) positivity (p<0.001) in the FLT group was significantly higher than that in the PTC group. Regarding US features, absence of calcification (p=0.006) and "diffuse thyroid disease" (DTD) pattern on US (p<0.001) were frequently seen in the FLT group. On multivariate analysis, Tg-Ab positivity, presence of a DTD pattern on US, and absence of calcification in nodules were associated with FLT with the best specificity of 99% and positive predictive value of 96%. In contrast, a taller than wide shape of nodules was the only variable significant for differentiating AH from PTC.

Conclusion

Suspicious thyroid nodules with cytologic benign results could be followed up with US rather than repeat FNAB, if patients exhibit Tg-Ab positivity, no calcifications in nodules, and a DTD pattern on US.     

Thyroid Nodules with Macrocalcification: Sonographic Findings Predictive of Malignancy

Purpose

To analyze which sonographic features of thyroid nodules with macrocalcifications were predictable of thyroid malignancy.

Materials and Methods

We reviewed sonographic findings of 854 macrocalcified thyroid nodules in patients who underwent fine needle aspiration biopsy between December 2009 and January 2011. There were 171 non-diagnostic aspirations, 34 nodules with category 3, 4, 5 based on Bethesda system, which were not confirmed by surgery, and these nodules were excluded from the analysis. Sonographic characteristics of the macrocalcifications including its thickness, interruption, and existence of soft tissue rim outside the macrocalcification were analyzed. Other sonographic characteristics of nodules such as shape, margin, composition, echo pattern, vascularity, and underlying parenchymal echogenicity were also evaluated. The correlation of sonographic features with cytopathologic results and the diagnostic performance of sonographic features for the prediction of malignancy were analyzed.

Results

Among 649 nodules, 179 (27.6%) nodules were malignant and 470 (72.4%) nodules were benign. Among the features of the macrocalcification, interruption, irregular thickness, or the presence of soft tissue outside calcification rim were associated with malignancy (p<0.001). A high sensitivity and negative predictive values for the prediction of malignancy was found in sonographic characteristics of irregular thickness (92.2% and 91.0%, respectively) and the presence of soft tissue (88.5% and 88.8%, respectively).

Conclusion

Sonographic characteristics of macrocalcification such as interruption, irregular thickness and the presence of soft tissue rim were associated with malignancy in thyroid nodules with macrocalcifications.     

Can Ultrasound Be as a Surrogate Marker for Diagnosing a Papillary Thyroid Cancer? Comparison with BRAF Mutation Analysis

Purpose

We investigated the merit of ultrasound (US) features and BRAF^V600E mutation as an additional study of cytology and compared the diagnostic performances of cytology alone, cytology with US correlation, cytology with BRAF^V600E mutation, and a combination of cytology, US, and BRAF^V600E mutation all together.

Materials and Methods

This study included 185 patients (mean age, 48.4 years; range 20-77 years) with 191 thyroid nodules who underwent US-guided fine-needle aspiration (FNA) with an additional BRAF^V600E mutation test. Three radiologists highly experienced in thyroid imaging retrospectively reviewed US images and classified each nodule into two categories (positive for malignancy or negative for malignancy). Interobserver variability (IOV) of US assessment between the three readers was estimated using the generalized kappa statistic of Landis and Koch. We also calculated the diagnostic performances of these studies.

Results

There were 131 cases of malignancy (131/191, 68.6%) and 60 cases of benign nodules (60/191, 31.4%). In terms of IOV of US assessment, the generalized kappa value was 0.242, indicating fair agreement was reached. The combination of cytology with BRAF^V600E showed higher specificity (100%) and positive predictive value (PPV) (100%) compared to the combination of cytology, BRAF^V600E, and US (specificity 28.3%, 66.7%, 68.3%; PPV 74.6%, 86.6%, 86.8%, respectively; p<0.001). However, cytology with BRAF^V600E showed lower sensitivity (84.7%) than cytology with BRAF^V600E and US (96.2%, 98.5%, 95.4%, respectively; p<0.001).

Conclusion

Considering the diagnostic performance and low reproducibility of US, the combination of FNA with BRAF^V600E is the most reliable and objective method for diagnosing thyroid malignancy.     

Prevalence of thyroid cancer at a medical screening center: pathological features of screen-detected thyroid carcinomas

Purpose

To assess the incidence of thyroid malignancy in an adult population screened by high-resolution ultrasonography at a medical screening center and to compare the clinical and pathological features of screen-detected thyroid carcinomas to symptomatic overt thyroid carcinomas.

Materials and Methods

We calculated the prevalence of screen-detected thyroid cancer at a medical screening center using high-resolution ultrasonography and fine needle aspiration. We then compared the clinical and pathological features of screen-detected thyroid cancers (n = 46) to clinical symptomatic thyroid cancers (n = 157). We evaluated age, gender, size, perithyroidal extension, lymphovascular extension, stage, histological lymph node metastasis, and the type of cancer. We also compared the above findings of micropapillary carcinomas to papillary thyroid carcinomas that were larger than 1 cm in diameter.

Results

Screen-detected thyroid nodule patients were 2,747 (37%) of 7,491 patients. Nodules selected for fine needle aspiration were 658 and cytology confirmed malignancy were 79 (12%) nodules. When screen-detected thyroid cancers (n = 46) were compared to symptomatic overt thyroid cancers (n = 157), only statistically significant factor was size (p = 0.002). Papillary thyroid carcinomas that were larger than 1 cm had more frequent capsular invasion (p = 0.000) and a higher stage (p = 0.027), and a higher prevalence of lymph node metastases (p = 0.002).

Conclusion

Screen-detected thyroid cancers should be managed as same as symptomatic thyroid cancers in respect to size, and an assessment should strictly be based on the ultrasound features and fine needle aspiration biopsy findings.     

Anaplastic Thyroid Cancer: Ultrasonographic Findings and the Role of Ultrasonography-Guided Fine Needle Aspiration Biopsy

Purpose

To investigate the ultrasonographic (US) features of anaplastic thyroid cancer (ATC) and the diagnostic performance of US-guided fine needle aspiration biopsy (FNAB) therein.

Materials and Methods

Eighteen cases of ATC diagnosed between January 2001 and May 2011 were included. FNAB was performed in all cases. Initial FNAB results were divided into three groups: 1) the cytological ATC group, cytological diagnosis of ATC; 2) the underestimated group, cytological diagnoses of malignancy other than ATC; and 3) the false negative group, cytological diagnoses of atypical, benign and non-diagnostic lesions. We retrospectively reviewed US findings and compared treatment modalities between each group.

Results

Among the 18 patients, there were nine in the initially cytological ATC group, four in the underestimated group and five in the false negative group. The most common US features of ATC were a solid (64.7%) and irregular shaped (88.2%) mass with lymph node involvement (76.4%). However, except for lymph node involvement (p=0.003), US findings for each group were not statistically different. The initial cytological diagnostic accuracy of ATC was 50% (9/18). Surgery was performed less in the ATC group (11%) and the false negative group (20%) than the underestimated group (75%).

Conclusion

The US features of ATC were not especially different from other types of aggressive thyroid cancer. A correct diagnosis of ATC by initial US-FNAB was made in 50% of the patients, which is significant in that therapeutic surgery can be undertaken in lower numbers if correctly diagnosed.     

Breast ultrasound diagnostic performance and outcomes for mass lesions using Breast Imaging Reporting and Data System category 0 mammogram

PURPOSE:

To evaluate the outcomes and diagnostic performance of ultrasonography after a Breast Imaging Reporting and Data System (Bi-RADS) category 0 mammogram.

MATERIAL AND METHODS:

This retrospective study reviewed 4,384 consecutive patients who underwent a screening mammography from January 2005 to July 2006; 391 of the 4,384 exams were classified as Bi-RADS category 0. After exclusions, 241 patients received subsequent sonogram. Ultrasonography was considered diagnostic when the Bi-RADS category was changed to 2, 4, or 5, and it was considered indeterminate (Bi-RADS 3) when the results indicated that the patients should return for a mammographic follow-up. The outcomes of these patients were assessed to evaluate the diagnostic performance of ultrasonography.

RESULTS:

The mean age of the patients was 53.3 years (ranging from 35 to 81). Of the 241 patients, ultrasonography was considered diagnostic in 146 (60.6%) patients and indeterminate in 95 (39.4%) patients. In the diagnostic group, 111 out of 146 patients (70.2%) had a sonogram result of Bi-RADS category 2 after a 2-year follow-up without evidence of malignancy. Furthermore, 35 out of 146 patients (29.8%) had a suspicious sonogram with a result of Bi-RADS category 4. After a tissue sampling procedure, 10 patients were confirmed to have breast cancer, and 25 had benign histopathological features without any evidence of malignancy after a 2-year follow-up. The sensitivity of ultrasonography was 100%, specificity was 89.1%, and overall accuracy was 89.6%.

CONCLUSIONS:

Based on the degree of resolution and its diagnostic performance, ultrasonography was determined to be an excellent method for the subsequent evaluation of Bi-RADS 0 mammograms.     

CT-guided biopsy of lung lesions: defining the best needle option for a specific diagnosis

OBJECTIVES:

To evaluate the performance of fine and cutting needles in computed tomography guided-biopsy of lung lesions suspicious for malignancy and to determine which technique is the best option for a specific diagnosis.

METHODS:

This retrospective study reviewed the data from 362 (71.6%) patients who underwent fine-needle aspiration biopsy and from 97 (19.7%) patients who underwent cutting-needle biopsy between January 2006 and December 2011. The data concerning demographic and lesion characteristics, procedures, biopsy sample adequacy, specific diagnoses, and complications were collected. The success and complication rates of both biopsy techniques were calculated.

RESULTS:

Cutting-needle biopsy yielded significantly higher percentages of adequate biopsy samples and specific diagnoses than did fine-needle aspiration biopsy (p<0.05). The sensitivity, specificity, and accuracy of cutting-needle biopsy were 93.8%, 97.3%, and 95.2%, respectively; those of fine-needle aspiration biopsy were 82.6%, 81.3%, and 81.8%, respectively (all p<0.05). The incidence of pneumothorax was higher for fine-needle aspiration biopsy, and that of hematoma was higher for cutting-needle biopsy (both p<0.05).

CONCLUSIONS:

Our experience using these two techniques for computed tomography-guided percutaneous biopsy showed that cutting-needle biopsy yielded better results than did fine-needle aspiration biopsy and that there was no significant increase in complication rates to indicate the best option for specific diagnoses.     

Diabetes screening after gestational diabetes in England: a quantitative retrospective cohort study

Background

The National Institute for Health and Care Excellence (NICE) recommends postpartum and annual monitoring for diabetes for females who have had a diagnosis of gestational diabetes mellitus (GDM).

Aim

To describe the current state of follow-up after GDM in primary care, in England.

Design and setting

A retrospective cohort study in 127 primary care practices. The total population analysed comprised 473 772 females, of whom 2016 had a diagnosis of GDM.

Method

Two subgroups of females were analysed using electronic general practice records. In the first group of females (n = 788) the quality of postpartum follow-up was assessed during a 6-month period. The quality of long-term annual follow-up was assessed in a second group of females (n = 718), over a 5-year period. The two outcome measures were blood glucose testing performed within 6 months postpartum (first group) and blood glucose testing performed annually (second group).

Results

Postpartum follow-up was performed in 146 (18.5%) females within 6 months of delivery. Annual rates of long-term follow-up stayed consistently around 20% a year. Publication of the Diabetes in Pregnancy NICE guidelines, in 2008, had no effect on long-term screening rates. Substantial regional differences were identified among rates of follow-up.

Conclusion

Monitoring of females after GDM is markedly suboptimal despite current recommendations.     

Can Doppler or contrast-enhanced ultrasound analysis add diagnostically important information about the nature of breast lesions?

OBJECTIVES:

Despite evidence suggesting that Doppler ultrasonography can help to differentiate between benign and malignant breast lesions, it is rarely applied in clinical practice. The aim of this study was to determine whether certain vascular features of breast masses observed by duplex Doppler and color Doppler ultrasonography (before and/or after microbubble contrast injection) add information to the gray-scale analysis and support the Breast Imaging-Reporting and Data System (BI-RADS) classification.

METHODS:

Seventy solid lesions were prospectively evaluated with gray-scale ultrasonography, color Doppler ultrasonography, and contrast-enhanced ultrasonography. The morphological analysis and lesion vascularity were correlated with the histological results.

RESULTS:

Percutaneous core biopsies revealed that 25/70 (17.5%) lesions were malignant, while 45 were benign. Hypervascular lesions with tortuous and central vessels, a resistive index (RI)≥0.73 before contrast injection, and an RI≥0.75 after contrast injection were significantly predictive of malignancy (p<0.001).

CONCLUSION:

The combination of gray-scale ultrasonography data with unenhanced or enhanced duplex Doppler and color Doppler US data can provide diagnostically useful information. These techniques can be easily implemented because Doppler devices are already present in most health centers.     

Calcium,inorganic phosphates,alkaline and acid phosphatase activities in breast cancer patients in Calabar,Nigeria

Background

Breast cancer is the commonest malignancy of women in Nigeria. Change in serum levels of some biochemical parameters could assist diagnosis and follow-up of breast cancer.

Objective

To determine serum levels of calcium, inorganic phosphates, alkaline phosphatase (ALP) and acid phosphatase (ACP) activities in patients with breast cancer, and change in the serum levels over time.

Methods

Total serum calcium and inorganic phosphates, and serum ALP and ACP activities were determined in 25 women with breast cancer and 25 age-matched controls using colorimetric and enzymatic methods, over 6 months with bimonthly analysis.

Results

The serum calcium level, ALP and ACP activities were significantly higher (p<0.05) in the study group than in the control group. No significant difference was seen in the inorganic phosphate levels of both groups. There were significant increases in serum calcium levels, ALP and ACP activities in the study group with time (p<0.05), whereas no significant increase was observed in the control group.

Conclusion

Breast cancer patients have higher calcium levels and higher ALP and ACP activities. The increase in the levelsof these parameters with time shows that they could be of importance in monitoring treatment and disease progress in a resource-poor setting.Key words: Breast cancer, serum calcium, inorganic phosphate, alkaline phosphatase, acid phosphatase, tumor markers     

Robotic Mechanical Localization of Prostate Cancer Correlates with Magnetic Resonance Imaging Scans

Purpose

To evaluate the concordance of cancer location of the tissue mapping from a mechanical pressure transducer with magnetic resonance imaging (MRI) scans.

Materials and Methods

A total of 60 indentations were performed on 5 prostate specimens obtained after radical prostatectomy utilizing a robotic indentation system. The mechanical elastic moduli of suspected malignant lesions were calculated and mapped, and their locations were compared with suspicious areas of malignancy on MRI scans.

Results

The concordance rate between the location mapping from the robotic indentation system and MRI scans results was 90.0% (54/60). The sensitivity and specificity of the robotic indentation system were 87.9% (29/33) and 92.6% (25/27), respectively. The positive predictive value and negative predictive value were 93.5% (29/31) and 93.1% (27/29), respectively.

Conclusion

The locations of malignant lesions derived from our robotic indentation system correlated strongly with the locations of suspected areas of malignancy on MRI scans. Our robotic system may provide a more targeted biopsy of the prostate than conventional non-targeted systemic biopsy, possibly improving the diagnostic accuracy of prostatic biopsies for cancer.     

Surgical Resection of Lung Metastases: Results from 529 Patients

OBJECTIVE:

The aim of this study is to determine clinical, pathological, and treatment-relevant variables associated with long-term (90-month) overall survival in patients with lung metastases undergoing pulmonary metastasectomy.

METHODS:

A retrospective review was performed of patients who were admitted with lung metastases, and who underwent thoracotomy for resection, after treatment of a primary tumor. Data were collected regarding demographics, tumor features, treatment, and outcome.

RESULTS:

Patients (n = 529) were submitted to a total of 776 thoracotomies. Median follow-up time across all patients was 21.6 months (range: 0–192 months). The postoperative complication rate was 9.3%, and the 30-day mortality rate was 0.2%. The ninety-month overall survival rate for all patients was 30.4%. Multivariate analysis identified the number of pulmonary nodules detected on preoperative CT-scan, the number of malignant nodules resected, and complete resection as the independent prognostic factors for overall survival.

CONCLUSION:

These results confirm that lung metastasectomy is a safe and potentially curative procedure for patients with treated primary tumors. A select group of patients can achieve long-term survival after resection.     

Outcome of knee injuries in general practice: 1-year follow-up

Background

Knee injuries may lead to pain and to functional limitations in the activities of daily living. Patients with knee injuries are frequently seen in general practice; however, the outcome and management in these patients is not known.

Aim

To assess the outcome and management of knee injuries at 12 months'' follow-up in general practice.

Design of study

A prospective observational cohort study with a 1-year follow-up.

Setting

Primary health care.

Method

Adult patients consulting their GP after knee injury (n = 134) participated in the cohort. A magnetic resonance imaging scan was carried out and patients were diagnosed as either no lesion or an isolated meniscal tear, an isolated collateral or cruciate ligament lesion, or a combination. Follow-up questionnaires were filled in up to 12 months'' follow-up.

Results

At 12 months'' follow-up, 34 patients reported full recovery and 67 patients reported major improvement. At baseline, 37 patients (28%) were referred to physical therapy and 17 patients (13%) were referred to secondary care. During 1 year of follow-up, another 21 referrals to physical therapy and 11 referrals to secondary care took place. The pain severity decreased the most, and the Lysholm knee score increased in the majority of patients during the first 3 months after injury. In total, 18 arthroscopies were performed in 15 patients. One patient underwent an anterior cruciate ligament reconstruction.

Conclusion

The vast majority of patients report clinically relevant recovery. There is no clear difference in outcomes between patients with meniscal tears or ligament lesions and patients without these diagnoses.     

Effectiveness of diclofenac versus paracetamol in knee osteoarthritis: a randomised controlled trial in primary care

Background

The effectiveness of diclofenac versus paracetamol in primary care patients with pain caused by knee osteoarthritis is unclear.

Aim

To assess the effectiveness of diclofenac compared with paracetamol over a period of 2, 4, and 12 weeks in patients with knee osteoarthritis.

Design and setting

Randomised controlled trial in general practice.

Method

There were 104 patients included in the study, they were aged ≥45 years consulting their GP with knee pain caused by knee osteoarthritis. Patients were randomly allocated to diclofenac (n = 52) or paracetamol (n = 52) for at least 2 weeks. Primary outcomes were daily knee pain severity, and knee pain and function measured with the Knee Injury and Osteoarthritis Outcome Score (KOOS).

Results

Over a period of 2- and 4-weeks follow-up, no significant difference in daily knee pain was found between the patient groups: estimated differences of 0.5 (95% CI = −0.2 to 1.3) and −0.2 (95% CI = −1.0 to 0.7), respectively. Over the 12-weeks follow-up, no significant differences were found between both groups for KOOS pain: estimated difference of −2.8 (95% CI = −10.7 to 5.1) and KOOS function of −2.7 (−10.6 to 5.0).

Conclusion

Over a period of 2- and 4-weeks follow-up no significant difference in daily measured knee pain severity was found between primary care patients with knee osteoarthritis taking paracetamol or diclofenac. Also, over a period of 12-weeks follow-up no significant differences were found regarding KOOS pain and KOOS function between both groups. Patients more frequently reported minor adverse events after taking diclofenac (64%) than paracetamol (46%).     

Association between primary care organisation population size and quality of commissioning in England: an observational study

Background

The ideal population size of healthcare commissioning organisations is not known.

Aim

To investigate whether there is a relationship between the size of commissioning organisations and how well they perform on a range of performance measures.

Design and setting

Cross-sectional, observational study of performance in all 152 primary care trusts (PCTs) in England.

Method

Comparison of PCT size against 36 indicators of commissioning performance, including measures of clinical and preventative effectiveness, patient centredness, access, cost, financial ability, and engagement.

Results

Fourteen of the 36 indicators have an unadjusted relationship (P<0.05) with size of the PCT. With 10 indicators, there was increasing quality with larger size. However, when population factors including deprivation, ethnicity, rurality, and age were included in the analysis, there was no relationship between size and performance for any measure.

Conclusion

There is no evidence to suggest that there is an optimum size for PCT performance. Observed variations in PCT performance with size were explained by the characteristics of the populations they served. These findings suggest that configuration of clinical commissioning groups should be geared towards producing organisations that can function effectively across their key responsibilities, rather than being based on the size of their population alone.     

Pathologic Spectrum of Lymphocytic Infiltration and Recurrence of Papillary Thyroid Carcinoma

Purpose

The aim of this study was to investigate the prognosis of papillary thyroid carcinoma (PTC) patients according to different pathologic grades of lymphocytic thyroiditis (LT).

Materials and Methods

This study included 144 PTC patients who underwent total thyroidectomy with radioactive iodine remnant ablation therapy. Pathologic grades of LT were separated at two points, chronic lymphocytic thyroiditis (CLT) and Hashimoto thyroiditis (HT). Patients were divided into two groupings according to the presence of the diseases (Grouping 1; patients with CLT or HT and without CLT or HT, Grouping 2; patients with HT and without HT). The groupings were compared according to recurrence, clinicopathologic and ultrasound (US) characteristics, and disease free survival.

Results

Of 144 patients, 41 had CLT and 19 had HT. There were 10 patients (6.9%) with tumor recurrence. In both groupings, the presence of calcification was more frequently associated with patients with LT (p=0.041 and 0.047, respectively). In Grouping 2, the mean age at diagnosis was older in patients without HT compared to patients with HT (p=0.032). On multivariate analysis, the presence of LT was not an independent predictor of recurrence in both groupings. For both groupings, pathologic tumor size and taller than wide shape on US were independent predictors of recurrence. The presence of LT in PTC patients did not affect recurrence.

Conclusion

There was no relationship between PTC prognosis and different grades of LT. Pathologic tumor size and taller than wide shape on ultrasound were independent predictors of PTC recurrence regardless of concurrent LT.     

Decreased levels of circulating sex hormones as a biomarker of lung cancer in male patients with solitary pulmonary nodules

Background

An early differentiation of malignant from benign solitary pulmonary nodules (SPNs) is essential for management and prognosis of lung cancer.

Objectives

Here we investigated whether measurement of circulating sex hormones could be useful for an early detection of malignancy among patients with SPNs.

Methods

We recruited 47 patients with malignant SPNs 45 patients with benign SPNs, and 32 healthy persons. Testosterone, estradiol, and progesterone were measured. Carcinoembryonic antigen (CEA) as well as TNF-α, IL-1 and IL-6 were also measured.

Results

We found that sex hormones were decreased significantly in patients with malignant SPNs, as compared to patients with benign SPNs and healthy controls (P<0.05). Sex hormones levels showed a trend to decline in patients with benign SPNs as compared to normal controls, but the difference was not statistically significant (P>0.05). CEA levels were only abnormally elevated in eight patients with lung adenocarcinoma. The inflammatory cytokines were remarkably higher in both patients than in normal controls. However, there was no statistical difference in these cytokines among patients.

Conclusions

The reduced sex hormones levels seemed to be uniquely associated with lung cancer. Therefore, measurement of sex hormones may have clinical potential in the diagnosis of malignancy in patients with SPNs.     

Simplified sleep restriction for insomnia in general practice: a randomised controlled trial

Background

Insomnia is common in primary care. Cognitive behavioural therapy for insomnia (CBT-I) is effective but requires more time than is available in the general practice consultation. Sleep restriction is one behavioural component of CBT-I.

Aim

To assess whether simplified sleep restriction (SSR) can be effective in improving sleep in primary insomnia.

Design and setting

Randomised controlled trial of patients in urban general practice settings in Auckland, New Zealand.

Method

Adults with persistent primary insomnia and no mental health or significant comorbidity were eligible. Intervention patients received SSR instructions and sleep hygiene advice. Control patients received sleep hygiene advice alone. Primary outcomes included change in sleep quality at 6 months measured by the Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), and sleep efficiency (SE%). The proportion of participants reaching a predefined ‘insomnia remission’ treatment response was calculated.

Results

Ninety-seven patients were randomised and 94 (97%) completed the study. At 6-month follow-up, SSR participants had improved PSQI scores (6.2 versus 8.4, P<0.001), ISI scores (8.6 versus 11.1, P = 0.001), actigraphy-assessed SE% (difference 2.2%, P = 0.006), and reduced fatigue (difference −2.3 units, P = 0.04), compared with controls. SSR produced higher rates of treatment response (67% [28 out of 42] versus 41% [20 out of 49]); number needed to treat = 4 (95% CI = 2.0 to 19.0). Controlling for age, sex, and severity of insomnia, the adjusted odds ratio for insomnia remission was 2.7 (95% CI = 1.1 to 6.5). There were no significant differences in other outcomes or adverse effects.

Conclusion

SSR is an effective brief intervention in adults with primary insomnia and no comorbidities, suitable for use in general practice.