The effects of respiratory rate and tidal volume on pulse pressure variation in healthy lungs-a generalized additive model approach may help overcome limitations.

Pulse pressure variation (PPV) is a well-established method for predicting fluid responsiveness in mechanically ventilated patients. The predictive accuracy is, however, disputed for ventilation with low tidal volume (VT) or low heart-rate-to-respiratory-rate ratio (HR/RR). We investigated the effects of VT and RR on PPV and on PPV's ability to predict fluid responsiveness. We included patients scheduled for open abdominal surgery. Prior to a 250 ml fluid bolus, we ventilated patients with combinations of VT from 4 to 10 ml kg-1 and RR from 10 to 31 min-1. For each of 10 RR-VT combinations, PPV was derived using both a classic approach and a generalized additive model (GAM) approach. The stroke volume (SV) response to fluid was evaluated using uncalibrated pulse contour analysis. An SV increase > 10% defined fluid responsiveness. Fifty of 52 included patients received a fluid bolus. Ten were fluid responders. For all ventilator settings, fluid responsiveness prediction with PPV was inconclusive with point estimates for the area under the receiver operating characteristics curve between 0.62 and 0.82. Both PPV measures were nearly proportional to VT. Higher RR was associated with lower PPV. Classically derived PPV was affected more by RR than GAM-derived PPV. Correcting PPV for VT could improve PPV's predictive utility. Low HR/RR has limited effect on GAM-derived PPV, indicating that the low HR/RR limitation is related to how PPV is calculated. We did not demonstrate any benefit of GAM-derived PPV in predicting fluid responsiveness.Trial registration: ClinicalTrials.gov, reg. March 6, 2020, NCT04298931.

The impact of the extent of surgery on late adverse effects following cytoreductive surgery and HIPEC.

AIM: To investigate the impact of the surgical extent on late adverse effects (LAE) following cytoreductive surgery (CRS) and Hyperthermic Intraperitoneal Chemotherapy (HIPEC). METHOD: A prospective cohort study including patients undergoing CRS + HIPEC due to peritoneal metastases from gastrointestinal tumour origin. From 2006 through 2019, consecutive patients treated with CRS + HIPEC were followed at 3, 6 and 12 months, and LAEs were assessed using the symptom scales and items from the European Organization for Research and Treatment of Cancer QLQ-C30 (EORTC QLQ-C30). Surgical extent was categorized into three groups (major, intermediate, minor) based on peritonectomy procedures and colorectal resections performed as part of CRS. EORTC data were analysed using a linear mixed effects regression model adjusted for age, gender, origin of tumour and comorbidity. RESULTS: In total, 257 patients who responded to at least one questionnaire during the follow-ups were included. Only diarrhoea symptoms were positively associated with surgical extent (mean differences: major vs. minor: 8.4 (-0.5; 17.2) (p = 0.06) and major vs. intermediate: 10.9 (3.8; 18.0) (p = 0.00)). Additionally, diarrhoea symptoms persisted throughout the study period and did not change over time (mean difference 12-3 months: -3.6 (-9.1; 1.7) (p-value = 0.18)). Overall, the levels of different symptom scales (fatigue, nausea and vomiting, pain, dyspnoea, and appetite loss) significantly decreased from 3 to 12 months. CONCLUSION: Patients undergoing extensive CRS suffer from persistent impaired gastrointestinal function in terms of diarrhoea compared patients undergoing to less extensive surgery. Attention should be directed at detecting such LAE and to guide patients accordingly.

Biopsychosocial Late Effects After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy for Peritoneal Metastases from Colorectal and Appendiceal Cancer: A National Prospective Cohort Study.

BACKGROUND: Colorectal cancer with peritoneal metastases can be treated with cytoreductive surgery and hyperthermic intraperitoneal chemotherapy. Treatment may result in biopsychosocial late effects (LEs). We explored the frequency and severity of the following biopsychosocial LEs: anxiety, depression, fear of cancer recurrence (FCR), insomnia, fatigue, cognitive impairment, and pain, and evaluated their impact on quality of life (QoL). METHOD: This was a national prospective cohort study screening for LEs during the period January 2021-May 2023. Patients completed the following questionnaires: General Anxiety Disorder-7, Patient Health Questionnaire-9, FCR Inventory-Short Form, Insomnia Severity Index, Functional Assessment of Chronic Illness Therapy-Fatigue, cognitive impairment (six items from the European Organisation for Research and Treatment of Cancer Item Library), and the Rectal Cancer Pain Score. Preregistration was completed at ClinicalTrials.gov (NCT04956107). RESULT: In total, 99 patients were included. The mean age was 61 years and 57% were women. At 3 months after surgery, the frequent LEs were fatigue (72%), FCR (58%), and pain (48%), and at 12 months after surgery, the frequent LEs were FCR (65%), fatigue (40%), and insomnia (33%). More than half of the patients (54%) reported at least two LEs after 12 months. Patients with moderate-to-severe LEs reported a lower QoL than patients with no/mild LEs. Patients with no/mild LEs had a similar QoL as the Danish norm population. CONCLUSION: Biopsychosocial LEs were prevalent. The QoL of patients reporting LEs in the worst severity categories was negatively impacted. Screening and treatment for these LEs should be a focus in cancer survivor follow-up.

Quality of life and symptom burden after rectal cancer surgery: a randomised controlled trial comparing patient-led versus standard follow-up.

PURPOSE: After curatively intended rectal cancer (RC) surgery, new follow-up strategies are warranted, seeking more individualised care and targeting health-related quality of life (HRQoL) and functional outcomes. The FURCA trial aimed to investigate the effect of patient-led follow-up on HRQoL and symptom burden 3 years after surgery. METHODS: RC patients from four Danish centres were randomised 1:1 to intervention (patient-led follow-up with patient education and self-referral to a specialist nurse) or control (standard follow-up with five routine doctor visits). Patients in both groups had a computed tomography (CT) at 1 and 3 years. The primary outcome (HRQoL) was assessed by the Functional Assessment of Cancer Therapy - colorectal (FACT-C) score (Ward et al. in Qual Life Res. 8(3):181-95, 18). Secondary outcomes were functional measures, patient involvement and satisfaction and cancer recurrence at 3 years. RESULTS: From Feb 2016 to Aug 2018, 336 patients were included of whom 248 completed 3 years of follow-up. Between-group differences were found neither for the primary endpoint, nor for functional outcomes. The recurrence rate did not differ between the groups. Patient involvement and satisfaction were higher in the intervention group with statistical significance in almost half of the items. CONCLUSIONS: We found no effect on HRQoL and symptom burden from patient-led follow-up, although it may improve patient-perceived involvement and satisfaction. IMPLICATIONS FOR CANCER SURVIVORS: The findings in this study suggest that patient-led follow-up is a more tailored approach to meet cancer survivors' needs and might improve their ability to cope with survivorship. GOV IDENTIFIER: R97-A6511-14-S23.

Implementation of a standardized surgical technique in robot-assisted restorative rectal cancer resection: a single center cohort study.

BACKGROUND: Despite increasing focus on the technical performance of total mesorectal excision over recent decades, anastomotic leakage (AL) continues to be a serious complication for many patients, even in the hands of experienced surgical teams. This study describes implementation of standardized surgical technique in an effort to reduce variability, decrease the risk of anastomotic leakage, and improve associated short-term outcomes for rectal cancer patients undergoing robot-assisted restorative rectal resection (RRR). METHODS: We evaluated all rectal cancer patients undergoing robot-assisted RRR at Aarhus University Hospital between 2017 and 2020. Six standardized surgical steps directed to improve anastomotic healing were mandatory for all RRR. Additional changes were made during the period with prohibition of systemic dexamethasone and limiting the use of endoscopic stapling devices. RESULTS: The use of the full standardization, including all six surgical steps, increased from 40.3% (95% CI, 0.28-0.54) to 86.2% (95% CI, 0.68-0.95). The incidence of AL decreased from 21.0% (95% CI, 0.12-0.33) to 6.9% (95% CI, 0.01-0.23). Length of hospital stay (LOS) decreased from 6 days (range 2-50) to 5 days (range 2-26). The rate of patients readmitted within 90 days decreased from 21.0% (95% CI, 0.12-0.33), to 6.9% (95% CI, 0.01-0.23). CONCLUSION: The full standardization was effectively implemented for rectal cancer patients undergoing robot-assisted RRR. The risk of AL, LOS and readmission decreased during the study period. A team focus on high-reliability and peri-operative complications can improve patient outcomes.

Functional outcome and quality of life after transanal minimal invasive pouch surgery.

PURPOSE: To investigate functional outcomes and quality of life (QoL) after restorative proctocolectomy (RPC) using transanal minimal invasive surgery (TAMIS). METHOD: The study consists of two sub-studies. A cohort study comprised 98 consecutive patients, who underwent TAMIS RPC. These patients were the first at our department to undergo TAMIS RPC. We collected information about surgery, complications, postoperative morbidity and mortality ≤ 30 days, and pouch problems. Patients were also invited to participate in a case-control study in which the patients would respond to three different questionnaires, the Inflammatory Bowel Disease Questionnaire (IBDQ), the Short Form-36 General Health Questionnaire (SF-36), and questions from the Pouch Dysfunction Score. We compared the responding TAMIS RPC patients to a Danish national cohort (0-10 years from RPC, n = 514) of patients having RPC between 1980 and 2010. We compared functional outcomes and QoL. RESULTS: Four (4%) of the TAMIS patients had an anastomotic leak; none of these required re-operation with removal of the pouch. Anastomotic leak was treated with antibiotics and drain. Out of the four leaks, only one ended up with a permanent stoma; all others had their stoma reversed successfully. The TAMIS patients had the same number of bowel movements as the patients in the Danish national cohort study. The same was seen with regard to incontinence. We had no conversions in our series of TAMIS procedures. CONCLUSION: The TAMIS technique shows acceptable outcomes, both in regard to postoperative complications and also functional outcome and QoL.

Investigating the experiences, thoughts, and feelings underlying and influencing prehabilitation among cancer patients: a qualitative perspective on the what, when, where, who, and why.

PURPOSE: To investigate the experiences, thoughts, and feelings that underlie and influence prehabilitation among cancer patients due to undergo major abdominal surgery. MATERIALS AND METHODS: Prior to their surgery, sixteen patients with peritoneal carcinomatosis of colorectal or ovarian origin due to undergo major surgery received oral information and a leaflet with preoperative recommendations. They subsequently participated in individual, semi-structured interviews. Malterud's principles of systematic text condensation were used to analyse the interviews, and the concept of action competence inspired and framed the discussion. RESULTS: Although the patients found themselves in an unpredictable and uncontrollable situation, they nevertheless knew what was important to them. These factors were contextualised in five themes that reflected the experiences, thoughts, and feelings that underlay and influenced their actions: "Perception of preparation," "The two-sided preoperative period," "Home or facility-based prehabilitation," "Stakeholders in prehabilitation," and "Reasons for taking action". CONCLUSIONS: The patients demonstrated action competence in relation to their preoperative preparation. However, in relation to the kind of prehabilitation that required lifestyle changes, their action competence needed to be developed and supported. To do so, it is necessary to ask questions that cover the patients' perspectives of the what, when, where, who, and why of prehabilitation.IMPLICATIONS FOR REHABILITATIONPatients undergoing major, abdominal cancer surgery have very clear opinions about what are important to them during the preoperative period, and this is not only limited to prehabilitation-related actions.In order to develop patients' action competence in relation to prehabilitation, patients need more support and supervision from health professionals.Qualitative in-depth knowledge concerning the what, when, where, who, and why of prehabilitation should be taken into account in the development of future prehabilitation programmes.

Cancer follow-up supported by patient-reported outcomes in patients undergoing intended curative complex surgery for advanced cancer.

BACKGROUND AND AIM: Patient activation (PA) and Patient Involvement (PI) are considered elements in good survivorship. We aimed to evaluate the effect of a follow-up supported by electronic patient-reported outcomes (ePRO) on PA and PI. METHOD: From February 2017 to January 2019, we conducted an explorative interventional study. We included 187 patients followed after intended curative complex surgery for advanced cancer at two different Departments at a University Hospital. Prior to each follow-up consultation, patients used the ePRO to screen themselves for clinical important symptoms, function and needs. The ePRO was graphically presented to the clinician during the follow-up, aiming to facilitate patient activation and involvement in each follow-up. PA was measured by the Patient Activation Measurement (PAM), while PI was measured by five indicator questions. PAM and PI data compared between (- ePRO) and interventional (+ ePRO) consultations. PAM data were analysed using a linear mixed effect regression model with intervention (yes/no) and time along with the interaction between them as categorical fixed effects. The analyses were further adjusted for time (days) since surgery. RESULTS: According to our data, ePRO supported consultations did not improve PA. The average mean difference in PAM score between + ePRO and - ePRO consultations were - 0.2 (95% confidence interval - 2.6; 2.2, p = 0.9). There was no statistically significant improvement in PAM scores over time in neither + ePRO nor - ePRO group (p = 0.5). Based on the five PI-indicator questions, the majority of all consultations were evaluated as "some, much or very much" involved in consultation; providing a wider scope of dialogue, encouraged patients to ask questions and share their experiences and concerns. Nevertheless, another few patients reported not to be involved at all in the consultations. CONCLUSION: We did not demonstrate evidence for ePRO supported consultations to improve patient activation, and patient activation did not improve over time. Our results generate the hypotheses that factors related to ePRO supported consultation had the potential to support PI by offering a wider scope of dialogue, and encourage patients to ask questions and share their experiences and concerns during follow-up.

Non-curative surgical oncology: postoperative needs and preferences.

OBJECTIVE: When intended curative cancer surgery is not completed, the postoperative transition to palliative care represents a prognostic landmark to patients and their families. In patients referred for highly specialised surgery for peritoneal metastases from the intestinal tract and ovaries, surgery is not performed in approximately 25%. Still, little is known of their postoperative needs and preferences. METHODS: We performed 14 qualitative research interviews with 12 patients (four men and eight women, aged 41-85 years) undergoing surgery for peritoneal metastases; five of these were together with a relative. Five of the participants had ovarian, and seven had colorectal cancer (four men and seven women). The interviews followed a semistructured interview guide, were audio recorded, transcribed verbatim and analysed using meaning condensation. RESULTS: Patients accepted the surgeon's decision of refraining from the intended surgery. During the postoperative period, when realising the prognostic consequences, their needs changed rapidly, in some cases from day to day, and gradually they developed a reoriented focus on their lives. The findings were framed by two themes dealing with 'Change in treatment strategy' and 'Physical and psychosocial aspects of not undergoing curative surgery'. CONCLUSION: When curative cancer surgery is not completed as intended, patient-centred communication is essential for patients' psychosocial reorientation and quality of life. Further, to support their well-being and action competences, patients have a need for basic supportive care and physical restitution. Finally, high-quality postoperative palliative care needs to be coordinated, which requires staff training and reorganisation of pathways.

The impact of patient involvement in research: a case study of the planning, conduct and dissemination of a clinical, controlled trial.

BACKGROUND: The interest in patient and public involvement (PPI) in health research is increasing. However, the experience and knowledge of PPI throughout the entire research process and especially in the analysis are limited. We explored ways to embrace the perspectives of patients in a research process, and the impact and challenges our collaboration has had on patients, researchers, and the research outcomes. METHODS: This is an explorative single case study of a Danish, clinical, controlled intervention trial and a nested intervention fidelity study included herein. Five patient representatives with metastatic melanoma were part of designing, undertaking and disseminating the trial where the effect of using patient-reported outcome (PRO)-measures as a dialogue tool in the patient-physician consultation was tested. In the fidelity study, audio-recorded consultations were analyzed after training in the Verona Coding Definitions of Emotional Sequences (VR-CoDES). Results were jointly disseminated at an international scientific conference. The outcomes, impact, and challenges were explored through a workshop. RESULTS: In the design phase, we selected PRO-measures and validated the dialogue tool. The information sheet was adjusted according to the patients' suggestions. The analysis of the fidelity study showed that patients and researchers had a high consensus on the coding of emotional cues and concerns. The patients contributed with a new vocabulary and perspective on the dialogue, and they validated the results. PPI caused considerations related to emotional (sadness/sorrow and existential thoughts), administrative (e.g. arranging meetings, balancing work and small talk) and intellectual (e.g. avoiding information harm, continuing activities despite the death of patients) investments. A limitation of the study was the lack of use of a solid evaluation tool to determine the impact of PPI. CONCLUSION: PPI throughout the process and co-creation in the analysis was feasible and beneficial. The case is unique in the degree of workable details, sustainability, and transparency. Moreover, the co-creation provides ideas of ways to operationalize PPI. An evaluation workshop revealed considerations about emotional, administrative and intellectual investments - best described as tacit, yet important 'work'. This knowledge and experience can be applied to other studies where patients are partners in the research. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT03163433, registration date: 8th May 2017.

The development of PROmunication: a training-tool for clinicians using patient-reported outcomes to promote patient-centred communication in clinical cancer settings.

BACKGROUND: The value of using real-time patient-reported outcome (PRO) measures in cancer communication has gained attention both in the clinic and in research. Despite this, no internationally accepted guidelines or training programs for clinicians on how to engage in patient-centred communication based on PROs exist. Lack of training may complicate implementation and systematic use of PROs in the clinic. We aimed to develop a short and feasible manual and training session in PRO-based dialogue rooted in patient-centred communication, coined PROmunication. METHODS: PROmunication was implemented in two studies using PROs in different clinical cancer settings. We interviewed clinicians twice during the development phase. First, adopting a clinical perspective, they provided ideas for content, length and structure of the training session and the manual. Second, they approved the draft of the manual with minor adjustments on how to document clinician-patient communication. The final version of the PROmunication tool was built on clinicians' input, theory on patient-centred communication, a literature review, and didactic considerations. RESULTS: The one-page manual gave clinicians a brief and clear overview of how to prepare for, undergo and document a PRO-based consultation. Illustrations and verbal phrases were offered to operationalize and facilitate patient-centred communication. The training session included elements like evidence-based knowledge about the rationale, benefits and challenges of using PROs and comprised theory, experimental training and instructions for the use of the manual in clinical practice. Ad hoc training and feedback in the clinic followed the training session. CONCLUSIONS: This paper presents the development of a short, theory-driven manual and training session intended to support and engage clinicians in PRO-based dialogue leading to patient-centred communication. Further testing of the tool is necessary and adjustments may be required if the PROmunication tool should be applied in other clinical settings were patients are seen regularly. An evaluation of the tool is planned to be performed in future studies. Training in PROmunication may further systematic and consistent use of PRO data in the consultation, leading to patient-centred consultations and increased patient involvement.

Patient involvement in comprehensive, complex cancer surgery: Perspectives of patients, relatives and health professionals.

We investigated the perspectives of patients, relatives and health professionals on the drivers and barriers to patient involvement (PI) in the treatment of peritoneal carcinomatosis with cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC). During 2016-2017, individual and focus group interviews were conducted with purposively selected participants during CRS and HIPEC, supplemented by field observations. This material was analysed using meaning condensation (Kvale). Fifteen patients, eight relatives and nine health professionals participated in 31 individual and two focus group interviews, supplemented by 37 observations. The findings were structured into themes concerning treatment decisions, organisation of pathways, knowledge of the patient and life during treatment. Deciding to treat was determined not only by preoperative biomedical information, personal preferences but also findings during surgery. This circumstance put the patients under mental pressure and affected their ability to process the offered information. They furthermore perceived the pathway as complex and occasionally unclear, leading them to attempt to coordinate transitions themselves. The study has highlighted barriers to, rather than drivers of, PI. To promote PI during comprehensive complex cancer surgery, we suggest that patients and relatives are offered patient-centred care, such as support in posing questions, overview of their treatment pathway and coherent transitions.

Differences in baseline characteristics and 1-year psychological factors between participants and non-participants in the randomized, controlled trial regarding patient-led follow-up after rectal cancer (FURCA).

Background: The ongoing multi-center randomized FURCA-trial investigates the effect of patient-led follow-up after rectal cancer, aiming at improving management of late effects and survivorship care. The purpose of this present sub-study was to identify potential systematic differences between participants and non-participants in the FURCA-trial, in regard to demographic and clinical factors at baseline, and in quality of life (QoL) and fear of cancer recurrence (FCR) after one year. Material and methods: The population comprised patients invited to the FURCA-trial during the first 13 months' recruitment. Clinical and demographic data was obtained at baseline and differences were significance tested. Non-participants were requested to fill in a short survey one year after primary surgery, while participants received the questionnaires as part of more comprehensive one-year follow-up. Results: In the first 13 months of the trial, 113 out of the 262 patients invited, declined to participate. The main reason reported for this was lack of energy surplus. Participants were younger than non-participants (p < .01), and nonparticipation was particularly evident among patients ≥ 80 years. More than half of the invited females declined to participate. Good WHO Performance status was associated with participation (p = .01), yet there were no statistically significant differences in Charlson Comorbidity Index, type of surgery, oncological treatment or UICC stages between participants and non-participants. By one year after surgery, there was no difference in FCR-level (p = .92) and QoL (p = .25) between the non-participants and control group participants. Conclusion: The sub-study found that participants and non-participants differed at baseline in regard to age, gender and performance status, which is supported by results from other studies. No between-group differences were found in psychological factors after one year. These findings are important for the generalisability of the upcoming results from the trial.

Initial validation of the Danish version of the Fear of Cancer Recurrence Inventory (FCRI) in colorectal cancer patients.

PURPOSE: The Fear of Cancer Recurrence Inventory (FCRI) is a multidimensional measure for fear of cancer recurrence (FCR). The aim of this study was to assess the psychometric properties of the translated Danish version of the FCRI in a population of colorectal cancer patients. METHODS: The English version of the FCRI was forward-backward translated into Danish and pilot tested in a gynaecological cancer population. The psychometric properties of the FCRI were assessed in terms of responsiveness, test-retest reliability and discriminative and convergent validity in a population of colorectal cancer patients by asking them to complete questionnaires at three time points during follow-up. Clinical FCR was defined as ≥ 16 at the FCRI short form. RESULTS: The participation rate was 57%. A low association was found between higher scores on the FCRI and younger age (r = - 0.29, p = 0.02). A moderate correlation was found between the FCRI score and a measure for worry traits (r = 0.49, p < 0.001). Mean difference in total FCRI score was statistically significant between 'pre-scan' and 'postscan' (p < 0.001), thus indicating that the FCRI was responsive to change. The FCRI score showed good test-retest reliability (intraclass correlation = 0.84). CONCLUSION: The Danish version of the FCRI is a reliable and responsive measure for FCR in colorectal cancer patients and shows acceptable discriminative and convergent validity. IMPLICATIONS FOR CANCER SURVIVORS: A valid measure for FCR is crucial in order to identify patients with a need for special attention or interventions for high levels of FCR and to improve future research into FCR among cancer survivors.

Incisional hernia and its impact on health-related quality of life after cytoreductive surgery and hyperthermic intraperitoneal chemotherapy: a national prospective cohort study.

BACKGROUND: To evaluate the incidence of incisional hernia (IH) after cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS + HIPEC) and its impact on health-related quality of life (HRQoL). METHOD: From June 2006 until June 2016, 152 patients were followed after CRS + HIPEC at Aarhus University Hospital, a single national center. Patients were seen postoperatively in an outpatient clinic at 3, 6, 12, 18, 24, 36 48, and 60 months. Clinical examinations at these follow-up visits were used to evaluate IH events prospectively. The incidence of IH was estimated using competing risk analysis and is presented as the cumulative incidence proportion (CIP). We expected the incidence to be 15% at 12 months. HRQoL was assessed at 12 months by the Short Form (SF-36) questionnaire, which we used to compare patients with an IH to patients without an IH. RESULTS: The median follow-up time was 16.6 months [range 0.9-62.0]. During this period, 14/152 (9.2%) patients developed an IH. The 1-year CIP was 5.9% [95% CI 2.9; 10.4] (n = 8), and the 2-year CIP was 9.2% [95% CI 5.3; 14.5] (n = 14). Patients with an IH were significantly older (67 years [range 48-72]) compared to patients without IH (60 years [range 24-75], p ≤ 0.01). The rate of postoperative complications between patients with and without IH was comparable, except that a greater proportion of patients with IH had a fascial dehiscence (21.4%) compared to patients without an IH (3.6%). Reponses to the SF-36 show that patients with an IH report lower HRQoL with regard to Role-physical (mean difference - 32.9 [95% CI - 60.6; - 5.3]) and Role-emotional (mean difference - 20.2 [95% CI - 43.4; 3.1]), meaning a reduction in work and daily activities due to their physical and psychological health. We found no general decrease in HRQoL. CONCLUSION: CRS + HIPEC do not increase the risk of IH as measured within 12 months postoperatively, contrary to expectations. However, patients with an IH report a limitation in daily activities, which can best be explained by changes in physical and psychological health. A larger cohort from multiple centres is necessary to verify our findings.

Validation of the Danish version of the disease specific instrument EORTC QLQ-CR38 to assess health-related quality of life in patients with colorectal cancer.

BACKGROUND: The European Organisation for Research and Treatment of Cancer (EORTC) quality of life colorectal questionnaire module (QLQ-CR38) was developed in 1999, and an update, the QLQ CR29 was published recently. To date the Danish version of the questionnaire has not been validated. The aim of this study was to examine the psychometric properties of the Danish version of EORTC QLQ-CR38. METHODS: EORTC QLQ-CR38 was administered to 190 patients with colorectal cancer in two Danish hospitals, one month after their operation. A psychometric evaluation of the questionnaire's structure, reliability, convergent, divergent and known-groups validity was performed. RESULTS: Data from 164 (86.3%) patients were available for analysis. The Danish version of EORTC QLQ-CR38 showed satisfactory psychometric properties for the scales: body image, sexual functioning, male sexual problems and defecations problems. Suboptimal psychometric performances were found for the scales: micturition problems, symptoms of the gastrointestinal tract and weight loss. Evaluation of the psychometric properties of the scale chemotherapy side effects was limited by the low number of patients receiving chemotherapy. It was not possible to assess the psychometric properties of the scale female sexual problems and the single item sexual enjoyment due to a high number of missing values. The homogeneity of the study population made the evaluation of known-group validity difficult. CONCLUSIONS: The results of this study suggest that the validity of the Danish version of EORTC QLQ-CR38 is acceptable. Furthermore, the results support the appropriateness of the updated version, the EORTC QLQ-CR29.