Consistency of patient-reported outcomes after cholecystectomy and their implications on current surgical practice: a prospective multicenter cohort study.

BACKGROUND: Persistent postoperative pain (up to 41 %) and significant practice variation necessitate better patient selection for cholecystectomy. Patient-reported outcome measures (PROMs) are nowadays known to serve as a tool for better patient selection, although variability within these subjective outcomes may be a point for debate. This study determines associations of both the preoperative pain and patient characteristics with PROMs at 24 weeks after cholecystectomy. In order to evaluate variability of PROMs, we also determined consistency of these outcomes in time. METHODS: This prospective multicenter cohort study included adult patients diagnosed with uncomplicated symptomatic cholecystolithiasis. Twenty-four weeks after surgery, a questionnaire study was carried out, containing Gastrointestinal Quality of Life Index (GIQLI) and Patients' Experience of Surgery Questionnaire. Results were compared to preoperative data and results 12 weeks post-cholecystectomy. Logistic regression analyses were performed to determine associations. Additional post hoc analysis on associations between preoperative selection criteria and PROMs was done. RESULTS: A total of 360 patients (85 %) responded. Postoperative absence of pain was reported by 59.2 %. Associated characteristics were symptoms ≤1 year prior to surgery [OR 1.85 (95 % CI 1.11-3.09)] and high baseline GIQLI score [OR 1.04 (95 % CI 1.02-1.05)]. General improvement in abdominal symptoms and positive result of surgery were found in 90 %; no preoperative variables were significantly associated. PROMs showed consistency at 12 and 24 weeks postoperatively. Post hoc analysis showed no significant associations. CONCLUSION: PROM-based preoperative selection criteria need to be considered to select those patients who achieve freedom of pain after surgical treatment of uncomplicated symptomatic cholecystolithiasis. Other patients might consider cholecystectomy as successful, but are less likely to be free of pain. Usefulness of PROMs is underscored as they proved to be consistent in time in evaluating surgical outcome.

Biopsychosocial predictors of sexual function and quality of sexual life: a study among patients with colorectal cancer.

OBJECTIVE: A low sexual function (SF) has been reported in patients with colorectal cancer. However, research often focusses on clinical predictors of SF, hereby omitting patients' subjective evaluation of SF [i.e., the quality of sexual life (QoSL)] and psychosocial predictors of SF and QoSL. In addition, research incorporating a biopsychosocial approach to SF and QoSL is scarce. Therefore, this study aimed to evaluate (I) relatedness between SF and the QoSL, (II) the course of SF and QoSL, and (III) biopsychosocial predictors of SF and QoSL. METHODS: Patients completed questionnaires assessing sociodemographic factors (i.e., age, sex) and personality characteristics (i.e., neuroticism, trait anxiety) before surgery. Questionnaires assessing psychological (i.e., anxious and depressive symptoms, body image, fatigue) and social (i.e., sexual activity, SF, non-sensuality, avoidance of sexual activity, non-communication, relationship function) aspects were measured preoperative and 3, 6, and 12 months after surgery. Clinical characteristics were obtained from the Eindhoven Cancer Registry (ECR). Bivariate correlations evaluated relatedness between SF and QoSL. Linear mixed-effects models examined biopsychosocial predictors of SF and QoSL. RESULTS: SF and QoSL are related constructs (r=0.206 to 0.642). Compared to preoperative scores, SF did not change over time (P>0.05). Overall, patients' QoSL decreased postoperatively (P=0.001). A higher age (ß=-0.02, P=0.006), fatigue (ß=-0.02, P=0.034), not being sexually active (ß=-0.081, P<0.001), and having a stoma (ß=0.37, P=0.035) contributed to a lower SF. Having rectal cancer (ß=-1.64, P=0.003), depressive symptoms (ß=-0.09, P=0.001), lower SF (ß=1.05, P<0.001), and more relationship maladjustment (ß=-0.05, P=0.027) contributed to a lower QoSL (P<0.05). In addition, partners' SF (ß=0.24, P<0.001) and QoSL (ß=0.30, P<0.001) were predictive for patients' SF and QoSL, respectively. A significant interaction between time and gender was reported for both outcomes (P's=0.002). CONCLUSIONS: SF and QoSL are related but distinctive constructs. The course of SF and QoSL differed. Different biopsychosocial predictors were found for SF and QoSL. The contribution of partner-related variables to patients' outcomes suggests interdependence between patients and partners. Men and women showed different SF and QoSL trajectories. We recommend that health care professionals, when discussing sexuality, realize that SF and QoSL are no interchangeable terms and should, therefore, be discussed as two separate entities. In addition, it is favored that clinicians focus not only on biological predictors of SF and QoSL, but obtain a broader perspective in which they also pay attention to psychosocial factors that may impair SF and QoSL. More in depth research on interdependence between patients and partners, biopsychosocial predictors of partners' SF and QoSL, and gender effects is needed.

[Population screening: there are no certainties]. / Bevolkingsonderzoek: niets is zeker.

Massive investments are being made for research into the prevention and reduction of risks and diseases. False-positive outcomes from screening investigations result in fear in a substantial number of patients, and are expensive for society as a whole. Screening for breast cancer has little or no impact on breast-cancer mortality; rather, the negative side-effects of false-positive outcomes of breast cancer screening are a serious problem. The incidence of false-positive results of colorectal cancer screening is underestimated. The risks of overdiagnosis and overtreatment as a result of screening are substantial.

Depressive symptoms are a risk factor for all-cause mortality: results from a prospective population-based study among 3,080 cancer survivors from the PROFILES registry.

BACKGROUND: The goal of this large prospective population-based study was to examine the association between depressive symptoms and all-cause mortality among cancer survivors up to 10 years post-diagnosis. METHODS: All currently alive individuals diagnosed with endometrial or colorectal cancer (CRC) between 1998 and 2007 or with lymphoma or multiple myeloma between 1999 and 2008, as registered in the Eindhoven Cancer Registry, received a questionnaire on depressive symptoms (Hospital Anxiety and Depression Scale (HADS)) in 2008 or 2009, respectively; 69 % (n = 3,080) responded. Survival status was obtained from the Central Bureau for Genealogy. RESULTS: Clinically elevated levels of depressive symptoms (HADS cutoff value ≥8) were more prevalent in those who died compared to those who survived (38 vs. 19 %, respectively; p < 0.0001). This was also evident across different types of cancer. After adjustment for independent predictors of all-cause mortality, 1-10-year survivors with depressive symptoms had an increased risk of death (hazard ratio (HR) 2.07; 95 % confidence interval (CI) 1.56-2.74; p < 0.0001), and this was also found among 1-2-year survivors (HR, 2.20; 95 % CI, 1.41-3.43; p < 0.001). Sub-analyses among CRC survivors gave the opportunity to adjust for metastasis and showed that depressive symptoms among 1-10-year CRC survivors and 1-2-year CRC survivors increased the risk of death (HR, 1.88; 95 % CI, 1.24-2.83; p < 0.01 and HR, 2.55; 95 % CI, 1.44-4.51; p < 0.001, respectively). CONCLUSIONS: This study showed that patients with depressive symptoms had twofold risk for all-cause mortality, even after adjustment for major clinical predictors. IMPLICATIONS FOR CANCER SURVIVORS: Paying more attention to the recognition and treatment of depressive symptoms seems warranted since depressive symptoms are often underdiagnosed and undertreated in cancer patients.

Second primary cancers in subsites of colon and rectum in patients with previous colorectal cancer.

BACKGROUND: Compared with the general population, patients with a previous colorectal cancer are at higher risk for a second colorectal cancer, but detailed risk analysis by subsite is scarce. OBJECTIVE: Our goal was to investigate the risk of a second cancer in relation to subsite as a basis for planning surveillance strategies. DESIGN, SETTING, AND PATIENTS: This was a retrospective analysis of a prospectively designed, population-based cancer registry (The Netherlands Cancer Registry). Patients with a stage I, II, or III colorectal cancer diagnosed between 1989 and 2008 were included. MAIN OUTCOME MEASURES: Cumulative incidence, standardized incidence ratio, and absolute excess risk for second primary cancers in subsites of the colon and rectum were estimated for follow-up periods of 2 to 5, 6 to 10, and more than 10 years after the index cancer in patients older than 50 years and in those aged 50 years or younger. RESULTS: A total of 123,347 patients had a first invasive colorectal cancer diagnosed between 1989 and 2008. Of these, 1849 patients (1.5%) had a second colorectal lesion that was found more than 1 year after the initial cancer and diagnosed as a second primary colorectal cancer. In patients older than 50 years, the 20-year cumulative incidence for second cancers was 3.4% in the proximal colon, 1.2% in the distal colon, and 1.2% in the rectum. More than 60% of second cancers occurred within 5 years after the index cancer. The standardized incidence ratio was highest in the proximal-colon (1.9; 95% CI, 1.8-2.0), followed by the distal-colon (1.0, 95% CI, 0.9-1.1), and the rectum (0.9, 95% CI, 0.8-1.0). The corresponding absolute excess risks per 10 000 person years were 9 in the proximal colon, 0.1 in the distal colon, and 1 in the rectum. After 5 years of follow-up, elevated risk was observed only in the proximal colon. A similar risk pattern was observed in patients younger than 50 years. The absolute excess risk for a second cancer in the proximal colon increased over time. The proportion of stage III and stage IV second cancers increased from 31% during the first 5 years of follow-up to 38% after 10 years of follow-up. LIMITATIONS: Limitations of this study included lack of data regarding polypectomy rates and interval of surveillance colonoscopies. CONCLUSIONS: Compared with the general population, individuals with previous colorectal cancer have a higher risk for a second cancer in all subsites of the colon and rectum. Among long-term survivors older than 50 years, risk remains elevated only in the proximal colon. Further studies should be encouraged to develop a suitable surveillance method for aging, high-risk, long-term colorectal cancer survivors.

The preoperative sexual functioning and quality of sexual life in colorectal cancer: a study among patients and their partners.

INTRODUCTION: Even though the body of literature on sexual functioning is growing, information on the preoperative sexual functioning and the quality of sexual life after colorectal cancer is lacking. Research focusing on female patients and on partners is also rather scarce. AIM: This cross-sectional study aimed to describe the preoperative sexual functioning, quality of sexual life, and relationship functioning for male and female colorectal cancer patients and their partners. In addition, the mean scores of the patients and partners were compared with mean norm scores. METHODS: Patients diagnosed with colorectal cancer (N = 136) and their partners (N = 106) were recruited before surgical treatment in six Dutch hospitals. MAIN OUTCOME MEASURES: Men completed the International Index of Erectile Functioning, while women completed the Female Sexual Function Index. All partnered participants completed the Golombok-Rust Inventory of Sexual Satisfaction and the Maudsley Marital Questionnaire. The mean scores were compared with mean norm scores derived from the manuals of the questionnaires. RESULTS: All participants were in a heterosexual relationship. Female patients reported a lower quality of sexual life compared with male patients. Male partners reported a lower sexual functioning and a lower quality of sexual life compared with male patients. Colorectal cancer patients and partners (both sexes) reported a lower sexual functioning and a lower quality of sexual life compared with norm populations but scored similar on relationship functioning. CONCLUSION: A lower sexual functioning and a lower quality of sexual life are already reported preoperatively; however, relationship functioning was comparable with a norm population. Therefore, all the impairment seen after treatment should not be solely attributed to the effects of treatment.

Type D personality is associated with increased comorbidity burden and health care utilization among 3080 cancer survivors.

OBJECTIVE: Cancer survivors often report comorbid diseases, but there are individual differences in risk. Type D personality is a general propensity to psychological distress that is related to poor cardiovascular outcomes. In this study, we examined whether type D was also related to comorbidity burden and health care utilization among cancer survivors. METHODS: Individuals diagnosed with endometrial cancer or colorectal cancer between 1998 and 2007, or with lymphoma or multiple myeloma between 1999 and 2008 as registered in the Eindhoven Cancer Registry, received the Self-Administered Comorbidity Questionnaire, questions on health care utilization and the Type D personality scale; 69% (n=3080) responded. RESULTS: Nineteen percent of survivors had a type D personality. Over a 12-month period, type D survivors significantly more often reported osteoarthritis, back pain, and depression than non-type D survivors. Also, type D survivors more often reported to feel bothered by high blood pressure, osteoarthritis, heart disease, depression, diabetes and lung disease during daily activities. Type D survivors more often visited their general practitioner than non-type D survivors (P<.001), also in relation to cancer (0 visits: 54% vs. 60%; 1-5: 28% vs. 22%; >5: 9% vs. 5%; P<.001), as well as their specialist (0 visits: 6% vs. 7%; 1-5 visits: 59% vs. 64%; >5 visits: 30% vs. 23%; P<.01). CONCLUSION: Type D personality is a vulnerability factor that may help to identify subgroups of cancer survivors who are at an increased risk for comorbidity burden and increased health care utilization.

Review of recent studies on interventions for cognitive deficits in patients with cancer.

Research has demonstrated that patients with cancer experience cognitive deficits, often due to aggressive anticancer treatments. In this article, we critically review the interventional studies that have been conducted to investigate beneficial effects on cognitive function in cancer patients. Pharmacological agents that have been studied include psychostimulants, such as methylphenidate and modafinil, erythropoietin, and hormonal (supplement) treatments for patients who receive hormonal suppression therapy. In addition, several cognitive rehabilitation programs have been evaluated in cancer patients. Recently, the approach of physical exercise to treat cognitive deficits has received great interest, and findings from novel studies are keenly anticipated. Although, in general, the studies reviewed were well designed, future studies may wish to include larger sample sizes and pay more attention to the accurate assessment of cognitive function.

Type D (distressed) personality is associated with poor quality of life and mental health among 3080 cancer survivors.

BACKGROUND: This study assessed the association between Type D personality (the conjoint effect of negative affectivity and social inhibition) and quality of life (QoL) and mental health of cancer survivors up to 10 years post-diagnosis. METHODS: All currently alive individuals diagnosed with endometrial or colorectal cancer between 1998 and 2007, or with lymphoma or multiple myeloma between 1999 and 2008 as registered in the Eindhoven Cancer Registry received a questionnaire on Type D personality (DS14), QoL (SF-36 or EORTC-QLQ-C30) and mental health (HADS). RESULTS: Of the 3080 survivors who responded (69%), 572 (19%) had a Type D personality. Type D survivors had clinically meaningful lower levels of general health, social functioning, role-function emotional, mental health and vitality compared to non-Type D's (SF-36: all P's<0.001). They also reported clinically meaningful worse emotional and social functioning, global health status/QoL, and more fatigue (EORTC-QLQ-C30: all P's<0.001). This was also confirmed by multivariate logistic regression analyses showing that cancer survivors with a Type D personality were more likely to experience a decreased QoL on all SF-36 and EORTC-QLQ-C30 scales (all ORs ranging between 1.88 and 5.56). The proportion of survivors reporting an impaired QoL was higher among Type D (35-64%) than non-Type D's (20-36%). Finally, Type D's were more likely to be depressed (44% vs. 13%; P<0.0001) or anxious (51% vs. 14%; P<0.0001). CONCLUSIONS: Cancer survivors with a Type D personality are at increased risk of impaired QoL and mental health problems that cannot be explained by socio-demographic or clinical characteristics.

The Patient Reported Outcomes Following Initial treatment and Long term Evaluation of Survivorship registry: scope, rationale and design of an infrastructure for the study of physical and psychosocial outcomes in cancer survivorship cohorts.

'Patient Reported Outcomes Following Initial treatment and Long term Evaluation of Survivorship (PROFILES)' is a registry for the study of the physical and psychosocial impact of cancer and its treatment from a dynamic, growing population-based cohort of both short and long-term cancer survivors. PROFILES contains a large web-based component and are linked directly to clinical data from the population-based Eindhoven cancer registry. This paper describes the rationale and design of PROFILES. The primary aims of studies that use the PROFILES registry are: (1) psychosocial risk and outcome assessment to identify patients at high risk for poor physical and mental health outcomes, (2) to analyse mediating mechanisms to better understand the biological and behavioural factors associated with cancer treatment outcomes, and (3) to evaluate physical and psychosocial care needs of cancer survivors. PROFILES is a tool that enables data collection management; from inviting patients to participation in studies, to collecting patient-reported outcomes data via web-based or mailed questionnaires and linking these data with clinical data. The availability of a control cohort of approximately 2000 persons from the general population who complete the same basic questionnaire annually will provide the opportunity to estimate the unique impact of cancer, beyond that of normal ageing and comorbidities. Raw data from the PROFILES registry will be available for non-commercial scientific research, subject to study question, privacy and confidentiality restrictions, and registration (www.profilesregistry.nl).

Risk factors for neurological deficiency one year after blunt-induced traumatic cervical fracture.

BACKGROUND/AIMS: Little is known about the risk factors of neurological deficiency after blunt cervical fracture. This study was performed to identify factors predicting neurological deficiency after blunt cervical fracture. METHODS: Within our Level I Trauma Center, we performed a retrospective case-control study. Patients with a cervical fracture after blunt trauma between January 2000 and December 2005 were identified. In total, 76 patients sustained a cervical fracture and survived 1 year after trauma. All patient files were reviewed. Patient and trauma characteristics were registered in an electronic database. RESULTS: 26 patients were referred to the Neurology Department. Of these, 14 patients had complaints of sensory or motor loss and 12 patients were seen for sensory and motor loss. Involvement of the seventh cervical vertebrae (p = 0.030) and spinal cord compression were found to be independent significant risk factors for sensory or motor loss. The injury severity score (p = 0.001) and involvement of the vertebral body (p = 0.042) were significantly associated with sensory and motor loss. CONCLUSION: During patient evaluation, the identified variables should be taken into account. If one understands the risk factors, then it is possible to explain the expected outcome after the spine fracture.

Risk factors predicting mortality after blunt traumatic cervical fracture.

OBJECTIVE: Risk factors for mortality after blunt cervical trauma have received little attention within the literature. Therefore, we performed a study, to determine which factors are associated with mortality in patients with blunt cervical trauma. STUDY DESIGN: A retrospective study of 88 trauma patients, with cervical fractures, who were admitted to the emergency department of the St. Elisabeth hospital, Tilburg, The Netherlands. SUMMARY OF BACKGROUND DATA: A retrospective cohort study was performed within the trauma department of the St. Elisabeth Hospital, in Tilburg, The Netherlands. From January 2000 to December 2005, all patients with cervical fractures after blunt trauma were included (N=88). All patient records were reviewed. Patient and trauma characteristics were registered within a standardised electronic database. Our follow-up period was 1 year. RESULTS: In total, 12 (13.6%) patients died after a traumatic cervical fracture. Age (p=0.005), gender (p=0.005), involvement of the third cervical vertebrae (p=0.003), involvement of three cervical vertebrae (p=0.010) and involvement of the spinous process (p=0.032) were associated with mortality. The multivariate analysis showed that age and the involvement of the third cervical vertebrae (both p=0.016) are both independently associated with mortality. CONCLUSION: Age and involvement of the third cervical vertebrae were both independent predictors of mortality. Age has been previously described as a risk factor for adverse prognosis in different diseases and trauma's. However, involvement of the third cervical vertebrae has not yet been described as a significant risk factor. Before implementation within trauma support further research is needed to evaluate the role of the third cervical vertebra regarding adverse prognosis and mortality in trauma patients.

The patient's perspective of the quality of breast cancer care. The development of an instrument to measure quality of care through focus groups and concept mapping with breast cancer patients.

Quality of care is often described by professionals. However, in this study breast cancer patients participated in developing an instrument that reflects quality of care from the patient's perspective. Through focus groups and concept mapping patients' ideas on determinants of good quality of care were generated and categorised according to similarity and importance. Information from eight focus group interviews with a total of 72 participants yielded 221 quality of care aspects. Following reduction, 81 aspects were used for categorisation during six concept mapping sessions with 67 participants. After analysis, 55 aspects remained grouped into six clusters. This study was conducted with a large number of breast cancer patients, undergoing the full range of treatment modalities, in different hospitals, in different areas in the Netherlands. Therefore, this set of quality of care indicators can be considered valid and suitable for the evaluation of breast cancer care as experienced by patients.