Ida J. Korfage

Quality-of-Life Effects of Prostate-Specific Antigen Screening

BACKGROUND After 11 years of follow-up, the European Randomized Study of Screening for Prostate Cancer (ERSPC) reported a 29% reduction in prostate-cancer mortality among men who underwent screening for prostate-specific antigen (PSA) levels. However, the extent to which harms to quality of life resulting from overdiagnosis and treatment counterbalance this benefit is uncertain. METHODS On the basis of ERSPC follow-up data, we used Microsimulation Screening Analysis (MISCAN) to predict the number of prostate cancers, treatments, deaths, and quality-adjusted life-years (QALYs) gained after the introduction of PSA screening. Various screening strategies, efficacies, and quality-of-life assumptions were modeled. RESULTS Per 1000 men of all ages who were followed for their entire life span, we predicted that annual screening of men between the ages of 55 and 69 years would result in nine fewer deaths from prostate cancer (28% reduction), 14 fewer men receiving palliative therapy (35% reduction), and a total of 73 life-years gained (average, 8.4 years per prostate-cancer death avoided). The number of QALYs that were gained was 56 (range, -21 to 97), a reduction of 23% from unadjusted life-years gained. To prevent one prostate-cancer death, 98 men would need to be screened and 5 cancers would need to be detected. Screening of all men between the ages of 55 and 74 would result in more life-years gained (82) but the same number of QALYs (56). CONCLUSIONS The benefit of PSA screening was diminished by loss of QALYs owing to postdiagnosis long-term effects. Longer follow-up data from both the ERSPC and quality-of-life analyses are essential before universal recommendations regarding screening can be made. (Funded by the Netherlands Organization for Health Research and Development and others.).

Five-year follow-up of health-related quality of life after primary treatment of localized prostate cancer

Although with earlier detection of prostate cancer more men face the long‐term consequences of primary treatment, studies on the impact of treatment on long‐term health‐related quality of life (HRQoL) are scarce. We followed 314 men with newly diagnosed localized prostate cancer from 1 month before until 5 years after radical prostatectomy (n = 127) or external beam radiotherapy (n = 187; median follow‐up = 52 months). Questionnaires addressing disease‐specific (UCLA PCI) and generic (SF‐36, EQ‐5D) HRQoL were sent 1 month before and 6, 12 and 52 months after treatment. Repeated‐measures modeling was used to study HRQoL over time. Regular urinary leakage was reported by 12% of prostatectomy patients before treatment and by 31% at the 52‐month assessment. Erectile dysfunction before treatment was reported by 31% of prostatectomy patients and by 40% of radiotherapy patients; at the 52‐month assessment, these percentages were 88% and 64%, respectively. Erectile dysfunction present at 1 year posttreatment can be considered permanent. Prostatectomy patients reported better generic functioning both before and after treatment than radiotherapy patients, who were on average 5.9 years older and had more comorbid conditions. General physical functioning of prostatectomy patients slightly improved over time, but declined in radiotherapy patients. The relation between age and physical scores was found to be nonlinear. The long‐term physical decline in radiotherapy patients partly resulted from aging and its nonlinear impact on health, although treatment effects cannot be excluded. Scores of both patient groups remained above those of norm populations. Innovative graphs describing disease‐specific and generic functions after treatment can help patients and physicians in their treatment choices.

Anxiety and depression after prostate cancer diagnosis and treatment: 5-year follow-up

To document anxiety and depression from pretreatment till 5-year follow-up in 299 men with localized prostate cancer. To assess, if baseline scores were predictive for anxiety and depression at 1-year follow-up. Respondents completed four assessments (pretreatment, at 6 and 12 months, and at 5-year follow-up) on anxiety, depression and mental health. Respondents were subdivided according to therapy (prostatectomy or radiotherapy) and high vs low-anxiety. Pretreatment 28% of all patients were classified as ‘high-anxiety’; their average anxiety scores decreased significantly post-treatment, that is towards less anxiety. At all assessments, high-anxiety men treated by prostatectomy reported less depression than high-anxiety men treated by radiotherapy. Of men treated by radiotherapy, 27% reported clinical significant levels of depression while 20% is expected in a general population. The improvement in mental health at 6-months follow-up was statistically significant and clinically meaningful in all respondent groups. Sensitivity of anxiety at baseline as a screening tool was 71% for anxiety and 60% for symptoms of depression. We recommend clinicians to attempt early detection of patients at risk of high levels of anxiety and depression after prostate cancer diagnosis since prevalence is high. STAI-State can be a useful screening tool but needs further development.

Health-Related Quality of Life in Cervical Cancer Survivors: A Population-Based Survey

PURPOSE In a population-based sample of cervical cancer survivors, health-related quality of life (HRQoL) was assessed 2-10 years postdiagnosis. METHODS AND MATERIALS All patients given a diagnosis of cervical cancer in 1995-2003 in the Eindhoven region, The Netherlands, and alive after Jan 2006 were identified through the cancer registry. Generic HRQoL (36-Item Short-Form Health Survey, EQ-5D), cervical cancer-specific HRQoL (European Organization for Research and Treatment of Cancer Quality-of-Life questionnaire cervical cancer module), and anxiety (6-item State Trait Anxiety Inventory) were assessed and compared with a reference population (n = 349). Data for tumor characteristics at diagnosis and disease progression were available. RESULTS A total of 291 women responded (69%), with a mean age of 53 +/- 13 (SD) years (range, 31-88 years). Treatment had consisted of surgery (n = 195) or a combination of therapies (n = 75); one woman had not been treated. Of all women, 85% were clinically disease free, 2% had a recurrence/metastasis, and in 13%, this was unknown. After controlling for background characteristics (age, education, job and marital status, having children, and country of birth), generic HRQoL scale scores were similar to the reference population, except for worse mental health in survivors. The most frequent symptoms were crampy pain in the abdomen or belly (17%), urinary leakage (15%), menopausal symptoms (18%), and problems with sexual activity. Compared with the 6-10-year survivors, more sexual worry and worse body image were reported by the 2-5-year survivors. Compared with surgery only, especially primary radiotherapy was associated with an increased frequency of treatment-related side effects, also after controlling for age and disease stage at diagnosis and follow-up. CONCLUSIONS Most cervical cancer survivors were coping well, although their mental health was worse than in the reference population. Even after 2-10 years, radiotherapy was associated with an increased frequency of treatment-related side effects.

Effective PSA contamination in the Rotterdam section of the European Randomized Study of Screening for Prostate Cancer

The extent of effective prostate‐specific antigen (PSA) contamination in the Rotterdam section of the ongoing European Randomized Study of Screening for Prostate Cancer (ERSPC) trial was evaluated and defined as when opportunistic PSA testing of ≥ 3.0 ng/ml was followed by biopsy, similar to the regular procedure within the trial. Records of participants aged 55–74 years at entry were linked to the regional database of the general practitioner (GP) laboratory to obtain PSA tests requested by GPs in the period 1 July 1997 to 31 May 2000 (2.9 years), and to the national pathology database to quantify the number of biopsies. All men randomized were included, only those with prostate cancer screen‐detected or clinically diagnosed before July 1997 were omitted from the analyses. 2,895 out of the 14,349 men (20.2%) in the control arm and 1,981 out of the 14,052 men (14.1%) in the screening arm were PSA‐tested, at an average annual rate of 73 and 52 per 1,000 person‐years, respectively. These rates were higher than those recorded at the national and regional levels, 33 and 38 per 1,000 person‐years, respectively. Opportunistic PSA testing in the control arm reached a peak within the first months of randomization, after which it decreased to around 70 per 1,000 person‐years. An opposite pattern was observed in the screening arm, where participants already had received the scheduled screening within the trial. The proportion of men in the control arm with PSA ≥ 3.0 ng/ml followed by biopsy and prostate cancer was 7–8% and 3%, respectively (3% and 0.4–0.6% in the screening arm), over the whole study period. Over a 4‐year rescreening interval, the average PSA and effective contamination amount were approximately 28% and 10%, respectively. PSA testing in the control arm in the Rotterdam ERSPC section is high, but was not followed by a substantial increase in prostate biopsies. Although the reasons for ordering PSA test or indicating biopsy are unknown, effective PSA contamination in the Rotterdam ERSPC section is low and not likely to jeopardize the power of the trial.

Developing core outcomes sets: methods for identifying and including patient-reported outcomes (PROs)

BackgroundSynthesis of patient-reported outcome (PRO) data is hindered by the range of available PRO measures (PROMs) composed of multiple scales and single items with differing terminology and content. The use of core outcome sets, an agreed minimum set of outcomes to be measured and reported in all trials of a specific condition, may improve this issue but methods to select core PRO domains from the many available PROMs are lacking. This study examines existing PROMs and describes methods to identify health domains to inform the development of a core outcome set, illustrated with an example.MethodsSystematic literature searches identified validated PROMs from studies evaluating radical treatment for oesophageal cancer. PROM scale/single item names were recorded verbatim and the frequency of similar names/scales documented. PROM contents (scale components/single items) were examined for conceptual meaning by an expert clinician and methodologist and categorised into health domains. A patient advocate independently checked this categorisation.ResultsSearches identified 21 generic and disease-specific PROMs containing 116 scales and 32 single items with 94 different verbatim names. Identical names for scales were repeatedly used (for example, ‘physical function’ in six different measures) and others were similar (overlapping face validity) although component items were not always comparable. Based on methodological, clinical and patient expertise, 606 individual items were categorised into 32 health domains.ConclusionThis study outlines a methodology for identifying candidate PRO domains from existing PROMs to inform a core outcome set to use in clinical trials.

Effects of Systematic Screening and Detection of Child Abuse in Emergency Departments

OBJECTIVE: Although systematic screening for child abuse of children presenting at emergency departments might increase the detection rate, studies to support this are scarce. This study investigates whether introducing screening, and training of emergency department nurses, increases the detection rate of child abuse. METHODS: In an intervention cohort study, children aged 0 to 18 years visiting the emergency departments of 7 hospitals between February 2008 and December 2009 were enrolled. We developed a screening checklist for child abuse (the “Escape Form”) and training sessions for nurses; these were implemented by using an interrupted time-series design. Cases of suspected child abuse were determined by an expert panel using predefined criteria. The effect of the interventions on the screening rate for child abuse was calculated by interrupted time-series analyses and by the odds ratios for detection of child abuse in screened children. RESULTS: A total of 104 028 children aged 18 years or younger were included. The screening rate increased from 20% in February 2008 to 67% in December 2009. Significant trend changes were observed after training the nurses and after the legal requirement of screening by the Dutch Health Care Inspectorate in 2009. The detection rate in children screened for child abuse was 5 times higher than that in children not screened (0.5% vs 0.1%, P < .001). CONCLUSIONS: These results indicate that systematic screening for child abuse in emergency departments is effective in increasing the detection of suspected child abuse. Both a legal requirement and staff training are recommended to significantly increase the extent of screening.

Screening for child abuse at emergency departments: a systematic review.

Introduction Child abuse is a serious problem worldwide and can be difficult to detect. Although children who experience the consequences of abuse will probably be treated at an emergency department, detection rates of child abuse at emergency departments remain low. Objective To identify effective interventions applied at emergency departments that significantly increase the detection rate of confirmed cases of child abuse. Design This review was carried out according to the Cochrane Handbook. Two reviewers individually searched PubMed, the Cochrane Library, EMBASE, Web of Science and CINAHL for papers that met the inclusion criteria. Results Fifteen papers describing interventions were selected and reviewed; four of these were finally included and assessed for quality. In these studies the intervention consisted of a checklist of indicators of risk for child abuse. After implementation, the rate of detected cases of suspected child abuse increased by 180% (weighted mean in three studies). The number of confirmed cases of child abuse, reported in two out of four studies, showed no significant increase. Conclusions Interventions at emergency departments to increase the detection rate of cases of confirmed child abuse are scarce in the literature. Past study numbers and methodology have been inadequate to show conclusive evidence on effectiveness.

Detection of child abuse in emergency departments: a multi-centre study

Objective This study examines the detection rates of suspected child abuse in the emergency departments of seven Dutch hospitals complying and not complying with screening guidelines for child abuse. Design Data on demographics, diagnosis and suspected child abuse were collected for all children aged ≤18 years who visited the emergency departments over a 6-month period. The completion of a checklist of warning signs of child abuse in at least 10% of the emergency department visits was considered to be compliance with screening guidelines. Results A total of 24 472 visits were analysed, 54% of which took place in an emergency department complying with screening guidelines. Child abuse was suspected in 52 children (0.2%). In 40 (77%) of these 52 cases, a checklist of warning signs had been completed compared with a completion rate of 19% in the total sample. In hospitals complying with screening guidelines for child abuse, the detection rate was higher (0.3%) than in those not complying (0.1%, p<0.001). Conclusion During a 6-month period, emergency department staff suspected child abuse in 0.2% of all children visiting the emergency department of seven Dutch hospitals. The numbers of suspected abuse cases detected were low, but an increase is likely if uniform screening guidelines are widely implemented.

Bowel, Urinary, and Sexual Problems Among Long-Term Prostate Cancer Survivors: A Population-Based Study

PURPOSE To obtain insight into the long-term (5- to 10-year) effects of prostate cancer and treatment on bowel, urinary, and sexual function, we performed a population-based study. Prostate-specific function was compared with an age-matched normative population without prostate cancer. METHODS AND MATERIALS Through the population-based Eindhoven Cancer Registry, we selected all men diagnosed with prostate cancer between 1994 and 1998 in the southern Netherlands. In total, 964 patients, alive in November 2004, received questionnaire; 780 (81%) responded. RESULTS Urinary problems were most common after a prostatectomy; bowel problems were most common after radiotherapy. Compared with an age-matched normative population both urinary and bowel functioning and bother were significantly worse among survivors. Urinary incontinence was reported by 23-48% of survivors compared with 4% of the normative population. Bowel leakage occurred in 5-14% of patients compared with 2% of norms. Erection problems occurred in 40-74% of patients compared with 18% of norms. CONCLUSIONS These results form an important contribution to the limited information available on prostate-specific problems in the growing group of long-term prostate cancer survivors. Bowel, urinary, and sexual problems occur more often among long-term survivors compared with a reference group and cannot be explained merely by age. Because these problems persist for many years, urologists should provide patients with adequate information before treatment. After treatment, there should be an appropriate focus on these problems.