Psychosocial morbidity in women with abnormal cervical cytology managed by cytological surveillance or initial colposcopy: longitudinal analysis from the TOMBOLA randomised trial.

OBJECTIVE: To compare psychosocial outcomes (follow-up related worries and satisfaction with follow-up related information and support) over 30 months of two alternative management policies for women with low-grade abnormal cervical cytology. METHODS: Women aged 20-59 years with low-grade cytological abnormalities detected in the National Health Service Cervical Screening Programme were randomised to cytological surveillance or initial colposcopy. A total of 3399 women who completed psychosocial questionnaires at recruitment were invited to complete questionnaires at 12, 18, 24 and 30 months. Linear mixed models were used to investigate differences between arms in the two psychosocial outcomes. Each outcome had a maximum score of 100, and higher scores represented higher psychosocial morbidity. RESULTS: On average, over 30 months, women randomised to colposcopy scored 2.5 points (95%CI -3.6 to -1.3) lower for follow-up related worries than women randomised to cytological surveillance. Women in the colposcopy arm also scored significantly lower for follow-up related satisfaction with information and support (-2.4; -3.3 to -1.4) over 30 months. For both outcomes, the average difference between arms was greatest at 12th- and 18th-month time points. These differences remained when the analysis was stratified by post-school education. CONCLUSIONS: Women with low-grade cytology, irrespective of their management, have substantial initial psychosocial morbidity that reduces over time. Implementation of newer screening strategies, which include surveillance, such as primary HPV screening, need to consider the information and support provided to women. © 2016 The Authors. Psycho-Oncology published by John Wiley & Sons Ltd.

A normal colposcopy examination fails to provide psychological reassurance for women who have had low-grade abnormal cervical cytology.

OBJECTIVE: Worldwide, each year, large numbers of women are referred for colposcopy following low-grade abnormal cervical cytology. Many have no visible abnormality on examination. The risk of cervical intra-epithelial neoplasia grade 2/3 (CIN2/3) in these women is low. It is unknown whether, for women, a normal colposcopy resolves the anxiety which often follows the receipt of an abnormal cytology result. We investigated the prevalence of adverse psychological outcomes over 30 months following a normal colposcopy. METHODS: This cohort study was nested within the UK TOMBOLA randomized controlled trial. Women aged 20-59 years, with recent low-grade cytology, who had a satisfactory colposcopy examination and normal transformation zone, completed the Hospital Anxiety and Depression Scale (HADS) and Process Outcome Specific Measure (POSM) at recruitment and during follow-up (12, 18, 24 and 30 months post-recruitment). Outcomes included percentages reporting significant anxiety (HADS anxiety subscale score ≥11), significant depression (HADS depression subscale score ≥8) or worries about the result of the next cytology test, cervical cancer, having sex, future fertility and general health at each time point (point prevalence) and during follow-up (cumulative prevalence). RESULTS: The study included 727 women. All psychological measures (except depression) had high prevalence at recruitment, falling substantially by 12 months. During follow-up, the cumulative prevalence of significant anxiety was 27% and significant depression was 21%. The most frequently reported worry was that the next cytology test would be abnormal (cumulative prevalence of 71%; point prevalence of ≥50% at 12 and 18 months). The cumulative prevalence values of worries about cervical cancer, having sex and future fertility were 33%, 20% and 16%, respectively. CONCLUSIONS: For some women who have low-grade cytology, a normal colposcopy does not appear to provide psychological reassurance.

Management of women with low grade cytology: how reassuring is a normal colposcopy examination?

OBJECTIVES: To determine the rate of cervical intraepithelial neoplasia grade 2 (CIN2+) in women with low grade cervical cytology and a normal colposcopy examination over 3 years of follow-up. DESIGN: Cohort study within a randomised controlled trial. SETTING: NHS Cervical Screening Programmes in Grampian, Tayside and Nottingham. POPULATION: Eight hundred and eighty-four women aged 20-59 years with borderline nuclear abnormalities (BNA) or mild dyskaryosis with a normal and adequate colposcopy examination. METHODS: Samples at baseline were tested for 14 high-risk (Hr) types using GP5+6+ methodology and for HPV 16 and 18 using type-specific primers. Women were followed up post-colposcopy by cervical cytology at 6-month intervals in primary care. After 3 years, women were invited for an exit colposcopy examination and underwent LLETZ if any colposcopic abnormality was identified. MAIN OUTCOME MEASURES: Absolute and relative risks of CIN2+ during follow-up and/or at exit colposcopy. RESULTS: The median age was 36 years. The absolute risk of developing CIN2+ within 3 years was 1.86 per 100 woman years and for CIN3+, 0.64 per 100 woman years. One microinvasive cancer was identified. The relative risk (RR) was highest for women with initial mild dyskaryosis who were HrHPV-positive (RR 5.86, 95% confidence interval 2.53-13.56) compared with women with BNA who were HrHPV-negative. CONCLUSION: For women with low grade cervical cytology, the risk of a high grade CIN within 3 years of a normal colposcopy examination is low. Women can be reassured that, even with a positive HPV test, the risk of developing CIN2 or worse is sufficiently low to return to the routine 3-year recall.

Psychological impact and acceptability of magnetic resonance imaging and X-ray mammography: the MARIBS Study.

BACKGROUND: As part of the Magnetic Resonance Imaging for Breast Screening (MARIBS), Study women with a family history of breast cancer were assessed psychologically to determine the relative psychological impact and acceptability of annual screening using magnetic resonance imaging (MRI) and conventional X-ray mammography (XRM). METHODS: Women were assessed psychologically at baseline (4 weeks before MRI and XRM), immediately before, and immediately after, both MRI and XRM, and at follow-up (6 weeks after the scans). RESULTS: Overall, both procedures were found to be acceptable with high levels of satisfaction (MRI, 96.3% and XRM, 97.7%; NS) and low levels of psychological morbidity throughout, particularly at 6-week follow-up. Low levels of self-reported distress were reported for both procedures (MRI, 13.5% and XRM, 7.8%), although MRI was more distressing (P=0.005). Similarly, higher anticipatory anxiety was reported before MRI than before XRM (P=0.003). Relative to XRM, MRI-related distress was more likely to persist at 6 weeks after the scans in the form of intrusive MRI-related thoughts (P=0.006) and total MRI-related distress (P=0.014). More women stated that they intended to return for XRM (96.3%) than for MRI (88%; P<0.0005). These effects were most marked for the first year of screening, although they were also statistically significant in subsequent years. CONCLUSION: Given the proven benefits of MRI in screening for breast cancer in this population, these data point to the urgent need to provide timely information and support to women undergoing MRI.

Differences in cytokine levels due to gender in colorectal cancer patients.

INTRODUCTION: Female gender is associated with longer survival after treatment for colorectal cancer (CRC). Reasons behind this phenomenon are not entirely clear. In addition, higher interleukin-6 (IL-6) and interleukin-1 (IL-1) levels have been found to be associated with poorer prognosis in CRC patients. The aim of this study was to investigate if cytokine levels were different in male and female CRC patients. METHODS: Pre- and post-operative levels of IL-1, interleukin-1 receptor antagonist (IL-1ra), IL-6 and tumour necrosis factor-alpha (TNF-alpha) were measured using standard solid phase sandwich ELISA in 104 consecutive eligible patients undergoing elective resection for CRC. RESULTS: Seventy (67.3%) participants were male and the mean age of the group was 67.6years (standard deviation 10.4years, range 39-86years). Pre-operative IL-1beta and post-operative IL-6 levels were significantly higher in males compared with females (U=486.5, p=0.03, U=424, p=0.04), values approaching statistical significance were obtained for pre-operative IL-6 (U=508.5, p=0.06) and post-operative IL-1beta (U=448, p=0.07). Differences in the levels of TNF-alpha and IL-1ra were not statistically significant. Multiple regression analysis using TNM stage as a covariate, showed that gender was an independent predictor of post-operative IL-6 levels (p=0.04). CONCLUSION: IL-1beta and IL-6 levels were significantly higher in men than in women. This provides evidence of a possible link between gender and cytokine levels in patients with colorectal cancer.

Multicentre randomised controlled trial examining the cost-effectiveness of contrast-enhanced high field magnetic resonance imaging in women with primary breast cancer scheduled for wide local excision (COMICE).

OBJECTIVES: To determine whether the addition of magnetic resonance imaging (MRI) to current patient evaluation by triple assessment would aid tumour localisation within the breast and thus reduce the reoperation rate in women with primary breast tumours who are scheduled for wide local excision (WLE), and to assess whether the addition of MRI would be cost-effective for the UK NHS. DESIGN: A multicentre, randomised controlled, open, parallel group trial with equal randomisation. The main design was supplemented with a qualitative study to assess patients' experiences of the treatment process and care pathway, and involved the development of a non-scheduled standardised interview (NSSI). SETTING: The study took place at 45 hospitals throughout the UK. PARTICIPANTS: Women aged 18 years or over with biopsy-proven primary breast cancer who had undergone triple assessment, were scheduled for WLE, and were capable of providing written informed consent. INTERVENTIONS: Patients were randomised to receive MRI or no MR1. Randomisation was performed using minimisation, incorporating a random element. All MRI was performed at 1.5 T or 1.0 T with a dedicated bilateral breast coil. MAIN OUTCOME MEASURES: The primary end point of the trial was the reoperation rate. Secondary outcome measures included discrepancies between imaging and histopathology, and the effectiveness of using both procedures; change in clinical management after using MRI; the clinical significance of MRI-only-detected lesions; the rate of interventions; the ipsilateral tumour recurrence rate; patient quality of life (QoL); and cost-effectiveness. RESULTS: From a total of 1623 patients, 816 were randomised to MRI and 807 to no MRI. No differences in reoperation rates were found between the two groups of patients [MRI patients 18.75%, no MRI 19.33%, difference 0.58%, 95% confidence interval (CI) -3.24 to 4.40]. Therefore, the addition of MRI to conventional triple assessment was not found to be statistically significantly associated with a reduced reoperation rate (odds ratio = 0.96, 95% CI 0.75-1.24, p = 0.7691). The best agreement between all imaging modalities and histopathology with regard to tumour size and extent of disease was found in patients over 50 years old with ductal tumours NST and who were node negative. In the imaging arm, mastectomy was found to be pathologically avoidable for 16 (27.6%) out of 58 patients who underwent the procedure. There were no significant differences between the groups regarding the proportion of patients receiving chemotherapy, radiotherapy or additional adjuvant therapies, as well as for local recurrence-free interval rates and QoL. An acceptable NSSI was developed for use in this population of patients. Economic analysis found no difference in outcomes between the two trial arms. CONCLUSIONS: The addition of MRI to triple assessment did not result in a reduction in operation rates, and the use of MRI would thus consume extra resource with few or no benefits in terms of cost-effectiveness or HRQoL. However, MRI showed potential to improve tumour localisation, and preoperative biopsy of MRI-only-detected lesions is likely to minimise the incidence of inappropriate mastectomy. TRIAL REGISTRATION: Current Controlled Trials ISRCTN57474502.

Stress and burnout in colorectal and vascular surgical consultants working in the UK National Health Service.

BACKGROUND: It has been suggested that dealing with cancer is associated with increased stress and burnout in health-care professionals. The aim of this study is to examine the prevalence of psychiatric morbidity and burnout in surgeons working in the National Health Service (NHS), and the putative relationship between psychiatric morbidity, burnout and the amount of cancer-related work. METHODS: All consultant colorectal and vascular surgeons identified from their professional societies were sent a booklet consisting of questions about cancer-related and specialty-specific work load, job satisfaction and socio-demographics. It also included the General Health Questionnaire (GHQ-12), the Maslach Burnout Inventory (MBI) and the Coping Questionnaire. Logistic regression analysis was used to identify independent predictors of psychiatric morbidity (GHQ), burnout (MBI) and retirement intentions. RESULTS: Five hundred and one questionnaire booklets were completed and returned (response rate 58.7%). The mean age of respondents was 47 years (range 31-65). The majority of the surgeons were male (460, 92%). One hundred and sixty-three (33%) surgeons scored in the positive range of the GHQ, and 154 (32%) had high burnout on at least one subscale of the MBI. Three hundred and eighty-three (77%) surgeons stated that they intended to retire before the statutory retirement age. Level of work satisfaction and perceived adequacy of training in communication and management skills were significantly negatively correlated with GHQ and MBI scores. Surgeons who planned to take early retirement or wished to retire as soon as they could afford to were more likely to have psychiatric morbidity and/or burnout. Surgeons who were married or cohabiting were less likely to have psychiatric morbidity, and younger surgeons were more likely to have higher levels of depersonalization (DP). Work satisfaction was negatively correlated with psychiatric morbidity and all three burnout scales. Colorectal surgeons had a greater cancer-related workload than vascular surgeons (48.6 vs 7.5%, respectively, U=2667, p<0.005). However, there were no significant differences between the two groups in psychiatric morbidity, personal accomplishment and emotional exhaustion. Vascular surgeons, however, had significantly higher levels of DP (p=0.04). CONCLUSION: Levels of psychiatric morbidity, burnout and work dissatisfaction are worryingly high in colorectal and vascular surgeons and are likely to impact adversely on patient satisfaction and service quality. The number of surgeons intending to retire early is also a cause for concern both in terms of the overall number of trained surgeons in the NHS and in the balance between senior and junior surgeons. Apart from DP, these indicators of stress, however, were unrelated to cancer workload.

Colorectal MDTs: the team's perspective.

OBJECTIVE: Multidisciplinary teams (MDTs) are an integral part of the National Cancer Plan. However, there is surprisingly little empirical research on how these are perceived by colorectal surgeons (CRSs) and colorectal clinical nurse specialists (CNSs). The purpose of this study therefore was to obtain the views of a national cohort of CRSs and CNSs regarding various important aspects of MDT functioning and role of CNS in current setting. METHOD: Two hundred and fifty-three CRSs and 177 CNSs, identified from the Association of Coloproctologists of Great Britain and Ireland, responded to an ad hoc postal questionnaire. RESULTS: 96.5% of respondents considered that MDTs improved the overall quality of care of colorectal cancer patients, and 78.6% thought MDTs were good for their morale. Eighty per cent considered that they improved training. Seventy-three per cent of surgeons and nurses thought that MDTs were cost effective, and 89% did not consider them to be a passing fad. However, more than half (50.4%) of the CRSs and 35.2% of the CNSs stated that their job plan did not contain adequate time to attend MDT meetings. Compared with CRSs, CNSs were significantly more likely to have positive views regarding the MDT (P < 0.005). CONCLUSION: CNSs and CRSs consider that colorectal MDTs have very beneficial effects on patient care, training and morale. However, many surgeons and nurse specialists consider that attendance at MDTs is not taken into account adequately in terms of their job plans, and this issue needs to be addressed.

Stress and burnout among colorectal surgeons and colorectal nurse specialists working in the National Health Service.

BACKGROUND: It has been suggested that changes to the organization of the National Health Service (NHS) and clinical practices in dealing with cancer are associated with increased stress and burnout in healthcare professionals. The aim of this study, therefore, was to evaluate stress and burnout in colorectal surgeons (surgeons) and colorectal clinical nurse specialists (nurses) working in the NHS. METHOD: A list of all consultant surgeons and nurses was obtained from The Association of Coloproctology of Great Britain and Ireland. Participants were sent a questionnaire booklet consisting of standardized measures [General Health Questionnaire (GHQ), Maslach Burnout Inventory (MBI), Coping Questionnaire] and various ad hoc questions to obtain information about demographics, cancer workload and job satisfaction. Independent predictors of clinically significant distress and burnout were identified using logistic regression. RESULTS: Four hundred and fifty-five surgeons and 326 nurses were sent booklets. The response rate was 55.6% in surgeons and 54.3% in nurses. The mean age of the nurses was lower than that of surgeons (42.8 vs 47.7, P < 0.001). Psychiatric morbidity was similar in the surgeons and nurses as assessed using the GHQ (30.2% and 30.3% respectively). On the MBI, compared with nurses, surgeons had significantly higher levels of depersonalization (17.4%vs 7.4%, P = 0.003) and lower personal accomplishment (26.6%vs 14.2%, P = 0.002). Seventy-seven per cent of surgeons and 63.4% of nurses stated their intention to retire before the statutory retirement age. Coping strategies, especially those in which respondents isolated themselves from friends and family, were associated with higher psychiatric morbidity and burnout. Dissatisfaction with work, intention to retire early, intention to retire as soon as affordable and poor training in communication and management skills were also significantly associated with high GHQ scores and burnout in both groups. DISCUSSION: We found high levels of psychiatric morbidity and burnout in this national cohort of surgeons and nurses working in the NHS. However, psychiatric morbidity and burnout were unrelated to cancer workload. Nurses have lower burnout levels than surgeons and this may be related to their different working practices, responsibilities and management structure.

Patient personality predicts postoperative stay after colorectal cancer resection.

OBJECTIVE: Postoperative length of stay (LOS) is an important outcome after colorectal cancer surgery. The aim of this study was to evaluate the putative effects of personality, mood, coping and quality of life on LOS. METHOD: A consecutive series of 110 eligible patients undergoing elective resection for colorectal cancer were invited to participate in the study. A battery of psychometric questionnaires including the Hospital Anxiety and Depression Scale, the Functional Assessment of Cancer Therapy (colorectal), the Courtauld Emotional Control Scale, the Positive and Negative Affectivity Scale and the Eysenck Personality Questionnaire (EPQ) were administered 5-12 days before surgery. Nonparametric correlations were computed for psychometric scores, demographic variables and the LOS. Factors found to be significantly correlated on this analysis were entered into a multiple regression model to determine the independent predictors of LOS. RESULTS: One hundred and four patients with colorectal cancer participated. Seventy were male (67%) and the mean age was 68 years (range 39-86). The median LOS was 10 days (range 4-108). LOS was negatively correlated with pre- and postoperative albumin levels, PANAS +ve affect, Functional Assessment of Cancer Therapy questionnaire with the colorectal module functional well-being score and EPQ extroversion score. LOS was strongly positively correlated with postoperative morbidity. LOS was positively correlated with CECS anger score, age and being male. Postoperative morbidity (beta = 0.379, P = 0.007) and extroversion (beta = -0.318, P = 0.05) were independent predictors of LOS. CONCLUSION: Personality as measured by EPQ predicts postoperative LOS in patients with colorectal cancer. Extroverts have a higher pain threshold and this may be part of the explanation.

Vascular endothelial growth factor and psychosocial factors in colorectal cancer.

BACKGROUND: Vascular endothelial growth factor (VEGF) and psychosocial factors have both been shown to have independent prognostic value in colorectal cancer. Recently, an association between VEGF and psychosocial factors has been reported in patients with ovarian cancer. METHODS: A consecutive series of eligible patients undergoing elective resection for colorectal cancer were invited to participate. Standardized measures of various aspects of quality of life (QoL) were administered 5-12 days before surgery, and again 6-8 weeks after the operation, blood samples were obtained at the same times. Solid phase ELISA was used for VEGF-A analysis using serum samples. Correlations and multiple regression analysis were used to examine the relationship between VEGF and psychosocial factors. RESULTS: One hundred and four patients with colorectal cancer were recruited. Seventy (67%) were male and the mean age was 67.6 years.A significant positive correlation was found between preoperative VEGF level and preoperative depression (r=0.227, p=0.03). Preoperative VEGF was negatively correlated with preoperative cancer-related concerns (r=-0.273, p=0.009) and positive affectivity (r=-0.219, p=0.05). Linear regression using TNM stage as a covariate showed that cancer-related concerns were an independent predictor of preoperative VEGF levels (p=0.02). Preoperative cancer-related concerns and global QoL were negatively correlated with postoperative VEGF (r=-0.381, p=0.001, r=-0.264, p=0.005), whereas preoperative depression correlated positively with postoperative VEGF (r=0.333, p=0.003). Linear regression analysis showed that preoperative HADS depression (p=0.005) and cancer-related concerns (p=0.002) were independent predictors of postoperative VEGF levels. Postoperative VEGF was significantly correlated with postoperative anxiety (r=0.249, p=0.02), depression (r=0.289, p=0.01), and functional well-being (r=-0.242, p=0.03). Linear regression analysis showed that postoperative anxiety (p=0.048), depression (p=0.013) and functional well-being (p=0.046) independently predicted postoperative VEGF-A levels. CONCLUSION: Various psychosocial factors, particularly cancer-related concerns and depression, appear to be related to preoperative and postoperative VEGF level in patients with newly diagnosed colorectal cancer. However, the clinical significance of these findings needs to be addressed in longitudinal follow-up studies of recurrence and survival. Future prognostic studies involving VEGF and related cytokines should assess psychosocial variables at various time points and include these in a multivariate analysis of outcomes.

Psychosocial factors and quality of life in colorectal cancer.

INTRODUCTION: Colorectal cancer (CRC) is one of the most common cancers in the UK. Quality of life (QoL) is increasingly being recognised as an important endpoint in the management of CRC. METHODS: Publications describing QoL in CRC were identified using Medline (PubMed) and PsychINFO. Reference lists of these articles were used to identify other relevant publications. RESULTS: Seventy-two publications described QoL changes in CRC. These were grouped into three categories: studies of psychological and psychiatric morbidity in CRC patients, QoL and survival in CRC and effects of psychological intervention on QoL and survival. CONCLUSION: Assessment of QoL is becoming increasingly important but is not routinely performed in CRC. Standard, validated and reliable questionnaires to evaluate the impact of cancer and its treatment in patients are available. There is an increasing need to establish comprehensive biopsychosocial databases to evaluate the relationship between QoL and survival in CRC.

Predictors of early postoperative quality of life after elective resection for colorectal cancer.

INTRODUCTION: Measurement of quality of life (QoL) is assuming increasing importance in cancer care. Predictors of early postoperative QoL after colorectal cancer resection are not clear and the aim of this study was to identify these factors. METHODS: A consecutive series of eligible patients undergoing elective resection for colorectal cancer were invited to participate. Standardised, reliable and validated psychological questionnaires (HADS, PANAS, MRS, FACT-C, EQ-5D) were administered seven days prior to surgery and then six weeks after discharge. RESULTS: One hundred and four patients with colorectal cancer were recruited. There were 70 males (67.3%) and the mean age of the group was 67.6 years. Postoperative anxiety and depression were closely related to the preoperative anxiety and depression scores (p < 0.001). Other QoL scores also showed significant correlation with the respective preoperative scores. Anxiety, depression, and FACT functional wellbeing scores were also correlated with the incidence of postoperative morbidity. On multiple regression analysis postoperative morbidity, tumour node metastasis (TNM) stage, presence of stoma and preoperative QoL scores were found to independently predict postoperative QoL scores. CONCLUSION: Routine preoperative QoL measurement in cancer patients can identify patients at risk of having a poor QoL postoperatively. Suitable psychological and pharmaceutical intervention can be planned in advance for this group.

Randomized trial of two physiotherapy interventions for primary care neck and back pain patients: 'McKenzie' vs brief physiotherapy pain management.

OBJECTIVES: Interventions that take psychosocial factors into account are recommended for patients with persistent back or neck pain. We compared the effectiveness of a brief physiotherapy pain management approach using cognitive-behavioural principles (Solution-Finding Approach-SFA) with a commonly used method of physical therapy (McKenzie Approach-McK). METHODS: Eligible patients referred by GPs to physiotherapy departments with neck or back pain lasting at least 2 weeks were randomized to McK (n= 161) or to SFA (n= 154). They were further randomized to receive an educational booklet or not. The primary outcome was the Tampa Scale of Kinesiophobia (TSK) (Activity-Avoidance scale used as a proxy for coping) at 6 weeks, and 6 and 12 months. RESULTS: Of 649 patients assessed for eligibility, 315 were recruited (219 with back pain, 96 with neck pain). There were no statistically significant differences in outcomes between the groups, except that at any time point SFA patients supported by a booklet reported less reliance on health professionals (Multidimensional Health Locus of Control Powerful Others Scale), while at 6 months McK patients showed slightly more improvement on activity-avoidance (TSK). At 6 weeks, patient satisfaction was greater for McK (median 90% compared with 70% for SFA). Both interventions resulted in modest but clinically important improvements over time on the Roland Disability Questionnaire Scores and Northwick Park Neck Pain Scores. CONCLUSIONS: The McK approach resulted in higher patient satisfaction overall but the SFA could be more cost-effective, as fewer (three vs four) sessions were needed.

Cost-effectiveness of screening with contrast enhanced magnetic resonance imaging vs X-ray mammography of women at a high familial risk of breast cancer.

Contrast enhanced magnetic resonance imaging (CE MRI) is the most sensitive tool for screening women who are at high familial risk of breast cancer. Our aim in this study was to assess the cost-effectiveness of X-ray mammography (XRM), CE MRI or both strategies combined. In total, 649 women were enrolled in the MARIBS study and screened with both CE MRI and mammography resulting in 1881 screens and 1-7 individual annual screening events. Women aged 35-49 years at high risk of breast cancer, either because they have a strong family history of breast cancer or are tested carriers of a BRCA1, BRCA2 or TP53 mutation or are at a 50% risk of having inherited such a mutation, were recruited from 22 centres and offered annual MRI and XRM for between 2 and 7 years. Information on the number and type of further investigations was collected and specifically calculated unit costs were used to calculate the incremental cost per cancer detected. The numbers of cancer detected was 13 for mammography, 27 for CE MRI and 33 for mammography and CE MRI combined. In the subgroup of BRCA1 (BRCA2) mutation carriers or of women having a first degree relative with a mutation in BRCA1 (BRCA2) corresponding numbers were 3 (6), 12 (7) and 12 (11), respectively. For all women, the incremental cost per cancer detected with CE MRI and mammography combined was pound28 284 compared to mammography. When only BRCA1 or the BRCA2 groups were considered, this cost would be reduced to pound11 731 (CE MRI vs mammography) and pound15 302 (CE MRI and mammography vs mammography). Results were most sensitive to the unit cost estimate for a CE MRI screening test. Contrast-enhanced MRI might be a cost-effective screening modality for women at high risk, particularly for the BRCA1 and BRCA2 subgroups. Further work is needed to assess the impact of screening on mortality and health-related quality of life.

Psychological effects of a low-grade abnormal cervical smear test result: anxiety and associated factors.

Receipt of an abnormal cervical smear result often generates fear and confusion and can have a negative impact on a woman's well-being. Most previous studies have focussed on high-grade abnormal smears. This study describes the psychological and psychosocial effects, on women, of having received a low-grade abnormal smear result. Over 3500 women recruited to TOMBOLA (Trial Of Management of Borderline and Other Low-grade Abnormal smears) participated in this study. Anxiety was assessed using the Hospital Anxiety and Depression Scale (HADS) at recruitment. Socio-demographic and lifestyle factors, locus of control and factors associated with the psychosocial impact of the abnormal smear result were also assessed. Women reported anxiety levels consistent with those found in previous studies of women with high-grade smear results. Women at highest risk of anxiety were younger, had children, were current smokers, or had the highest levels of physical activity. Interventions that focus particularly on women's understanding of smear results and pre-cancer, and/or directly address their fears about cancer, treatment and fertility might provide the greatest opportunity to reduce the adverse psychosocial impact of receiving a low-grade abnormal cervical smear result.

Effects of bilateral breast reduction on anxiety and depression: results of a prospective randomised trial.

We assessed the effects of bilateral breast reduction on anxiety and depression in women with mammary hypertrophy (macromastia). Seventy-three consecutive women referred for consideration for breast reduction were recruited. They were randomised to have either early operation (within six weeks of initial assessment) or delayed operation (within six months of recruitment). The Hospital Anxiety and Depression Score was given before randomisation and four months later. All 73 patients completed the study. The mean (SD) age was 39 (12) years. The groups were matched for age, smoking, social class, and educational achievement. There were highly significant improvements (p<0.001) in symptoms of anxiety and depression. Reduction mammaplasty significantly improved symptoms of clinical depression in women with macromastia.

Randomized clinical trial examining psychosocial and quality of life benefits of bilateral breast reduction surgery.

BACKGROUND: The aim was to determine the effects of bilateral reduction mammaplasty on quality of life and psychosocial functioning in women with mammary hypertrophy. METHODS: Seventy-three women who were referred to either the Hull Breast Unit or Hull Plastic and Reconstructive Surgery Unit were randomized to early or delayed surgery. Both groups had quality of life and psychosocial assessment. Each group underwent two sets of tests. Women who had early bilateral breast reduction were tested before and at 4 months after surgery, whereas those in the control group were tested at the time of randomization and 4 months later, before undergoing surgery. RESULTS: All 73 women completed the study. Mean age was 39 years, and the two groups were well matched for age, body mass index and breast dimension. There were highly significant differences between groups in scores measured on the Functional Assessment of Non-Life Threatening Conditions version 4, EuroQoL, and both mental and physical scales of Short Form 36 (P < 0.001). The Eysenck Personality Questionnaire-Revised demonstrated a statistically significant increase in extroversion and emotional stability in the early treatment group. CONCLUSION: Reduction mammaplasty significantly improved quality of life, and increased extroversion and emotional stability.

Developing a questionnaire to measure the psychosocial impact of an abnormal cervical smear result and its subsequent management: the TOMBOLA (Trial of Management of Borderline and Other Low-grade Abnormal Smears) trial.

This paper describes the process of developing and testing a new questionnaire, Process Outcome Specific Measure (POSM), including an assessment of its content validity and reliability. The questionnaire was developed within the context of Trial Of Management of Borderline and Other Low-grade Abnormal smears (TOMBOLA) to assess the psychosocial impact of a low-grade abnormal cervical smear result and the subsequent management. A literature search, focus groups and thorough pre-testing involving experts and patients resulted in a short (15-item), easily completed and understood questionnaire. Questions address issues including cancer, health, fertility and sexual concerns. Repeatability was assessed in 110 TOMBOLA recruits using weighted k; all but one of the questions showed levels of reliability near to, or above, 0.5. Cronbach's standardised alpha was 0.73, indicating acceptable internal consistency. Each POSM item was correlated with the anxiety and depression sub-scales of the Hospital Anxiety Depression Scale (HADS). All except one of the questions correlated more highly with the total POSM score than with the HADS sub-scales thus indicating discriminant validity. The POSM will enable comparison of the alternative management policies for low-grade cervical smears in terms of the benefits (or otherwise) perceived by the women managed by these policies.