Aesthetic Outcome and Psychosexual Distress After Treatment for Vulvar High-Grade Squamous Intraepithelial Lesions.

OBJECTIVES: This study compared aesthetic outcome, psychosexual distress, and treatment satisfaction between women receiving surgical treatment or medical treatment with imiquimod for vulvar high-grade squamous intraepithelial lesion. MATERIALS AND METHODS: This is an extended analysis of the multicenter, randomized noninferiority trial "topical imiquimod versus surgery for vulvar intraepithelial neoplasia." Patients were randomized to primary topical treatment or surgery and stratified by unifocal or multifocal disease. Digital photos of vulvar appearance were subsequently assessed for aesthetic outcome by 3 investigators blinded to group allocation. Psychosexual distress and treatment satisfaction were assessed with the Cervical Dysplasia Distress Questionnaire, the Sexual Activity Questionnaire, and the Client Satisfaction Questionnaire at baseline and follow-up. RESULTS: One hundred ten patients aged between 19 and 82 years were enrolled. Per-protocol analysis showed complete clinical response in 80% (37/46) using imiquimod, compared with 79% (41/52) after one surgical intervention. Photodocumentation at baseline and 6-month follow-up was available for 84 of these patients (44 imiquimod, 40 surgery). Blinded reviewer assessments of lesion size and lesion severity showed improvement from baseline to follow-up, with no differences between treatment groups. Sexual pleasure, discomfort, and distress remained stable from baseline to follow-up in both groups. CONCLUSIONS: Good aesthetic outcome of vulvar high-grade squamous intraepithelial lesion treatment can be achieved with imiquimod and surgery, consisting of ablation or local excision. Treatment satisfaction and stable psychosexual health may not be dependent on chosen treatment modality, but rather on counseling in accordance with patients' preferences.

Minimally important differences for interpreting EORTC QLQ-C30 change scores over time: A synthesis across 21 clinical trials involving nine different cancer types.

INTRODUCTION: Early guidelines for minimally important differences (MIDs) for the EORTC QLQ-C30 proposed ≥10 points change as clinically meaningful for all scales. Increasing evidence that MIDs can vary by scale, direction of change, cancer type and estimation method has raised doubt about a single global standard. This paper identifies MID patterns for interpreting group-level change in EORTC QLQ-C30 scores across nine cancer types. METHODS: Data were obtained from 21 published EORTC Phase III trials that enroled 13,015 patients across nine cancer types (brain, colorectal, advanced breast, head/neck, lung, mesothelioma, melanoma, ovarian, and prostate). Anchor-based MIDs for within-group change and between-group differences in change over time were obtained via mean change method and linear regression, respectively. Separate MIDs were estimated for improvements and deteriorations. Distribution-based estimates were derived and compared with anchor-based MIDs. RESULTS: Anchor-based MIDs mostly ranged from 5 to 10 points. Differences in MIDs for improvement vs deterioration, for both within-group and between-group, were mostly within a 2-points range. Larger differences between within-group and between-group MIDs were observed for several scales in ovarian, lung and head/neck cancer. Most anchor-based MIDs ranged between 0.3 SD and 0.5 SD distribution-based estimates. CONCLUSIONS: Our results reinforce recent claims that no single MID can be applied to all EORTC QLQ-C30 scales and disease settings. MIDs varied by scale, improvement/deterioration, within/between comparisons and by cancer type. Researchers applying commonly used rules of thumb must be aware of the risk of dismissing changes that are clinically meaningful or underpowering analyses when smaller MIDs apply.

Vaginal laser therapy versus hyaluronic acid suppositories for women with symptoms of urogenital atrophy after treatment for breast cancer: A randomized controlled trial.

BACKGROUND: Urogenital atrophy affects >50 % of women after breast cancer (BC) and there is reluctance to use local estrogen for this group. Hormone-free therapies like intravaginal laser therapy and hyaluronic acid suppositories have been shown to produce symptom relief in women with BC and urogenital atrophy, but have not been tested against each other. The aim of this study was to compare these nonhormonal modalities in women with urogenital atrophy after BC in a randomized fashion. STUDY DESIGN: We randomly assigned 43 women (aged 49-58 years, mean age 54 years) with urogenital atrophy and a history of BC to receive intravaginal laser therapy (2 courses within 1 month) or hyaluronic acid suppositories (3 times/week continuously for three months). The primary endpoint was score on the Vaginal Health Index after 3 months. Secondary endpoints were subjective bother on a numeric rating scale for all urogenital atrophy domains, quality of life, sexual health and pelvic organ prolapse symptoms using validated questionnaires. RESULTS: Of the 43 women who participated, 22 were randomized to intravaginal laser therapy, and 21 to vaginal suppositories. At 3 months score on the Vaginal Health Index had improved significantly in both groups (p = 0.001), without a significant difference between treatment groups (p = 0.232). Significant improvement was also seen in both groups for subjective bother of urogenital atrophy, quality of life and sexual health, without significant differences between laser or hyaluronic acid therapy. CONCLUSIONS: Both intravaginal laser therapy and hyaluronic acid suppositories are effective treatment options for women after BC suffering from urogenital atrophy. No difference was found between treatment regimens. CLINICALTRIALS: gov identifier: NCT03816735, https://clinicaltrials.gov/ct2/show/NCT03816735.

Acculturation, Adaptation, and Health among Croatian Migrants in Austria and Ireland: A Cross-Sectional Study.

Since Croatia joined the European Union, majority of the studies on Croatian emigrants have predominantly addressed the reasons for migration and their future predictions. The primary purpose of this study was to investigate the relationship between the sense of coherence, health behavior, acculturation, adaptation, perceived health, and quality of life (QoL) in first-generation Croatian migrants living in Austria and Ireland. Our study is the first study that addresses the perceived health and QoL of Croatian migrants since the last emigration wave in 2013. An online survey was conducted in Austria (n = 112) and Ireland (n = 116) using standardized questionnaires. Multiple linear regression analyses were conducted for emigrated Croats to identify the predictors of perceived health and QoL. The analyses revealed that the sense of coherence and psychological adaptation were the strongest predictors of perceived health and QoL in Austria and Ireland. Furthermore, in the environmental domain of QoL, a higher education, higher net income, life in Austria rather than Ireland, better health behavior, higher sense of coherence, and better psychological and sociocultural adaptation explained 55.9% of the variance. Health policies and programs should use the salutogenic model to improve the health-related quality of life and psychological adaptation of Croatian migrants.

Maternal Resilience and Postpartum Depression at the Neonatal Intensive Care Unit.

Background: The neonatal intensive care unit causes maternal stress and postpartum depressive symptoms in preterm and term mothers. Personal resources like maternal resilience are usually not considered in counselling these women. Objective: This study aims to evaluate the resilience and differences in postpartum depression after admission of newborns at the neonatal intensive care unit. Methods: This prospective pilot study was conducted in a single teaching hospital in Austria from December 2016 until December 2018. Sixty women completed two internationally validated questionnaires, the Edinburgh Postnatal Depression Scale (EPDS) to evaluate depressive symptoms and the Resilience Scale RS-13 to measure maternal resilience during the postpartum period (3 to 10 days postpartum). Additionally, women answered two open questions about burdens and relief. Results: Twenty women (34%) showed lower resilience scores. The 39 high-resilient women (66%) showed significantly less depression (p = 0.005). Women reported social support from their partner (n = 15), health professionals and psychologists (n = 15), family and friends (n = 12), and child-specific relief, e.g., spending time with the newborn and involvement in care (n = 7) as the most helpful variable during the first postpartum period. Conclusion: The experience of having a newborn at the neonatal intensive care unit is a challenging event for women. Women have different resilience parameters. Mothers with lower resilience will benefit from social support and emotional health-promoting activities.

Microablative Erbium: YAG Laser Therapy for Vulvodynia - A Report on Efficacy, Safety, and Treatment Satisfaction.

INTRODUCTION: Treatment for vulvodynia is challenging and a multidisciplinary approach is recommended. AIM: To examine the effectiveness, safety and treatment satisfaction of vulvovaginal microablative laser treatment for vulvodynia. METHODS: Case study of women who received laser treatment as part of a multidisciplinary treatment program for vulvodynia. Subjective improvement was compared to a retrospective cohort of women treated for vulvodynia without LASER therapy. LASER treatment was offered to women with vulvodynia presenting to a gynecologic pain clinic of a tertiary university hospital. LASER treatments were performed with a microablative 2,940 nm Er:YAG LASER and potentially repeated after 1 month. MAIN OUTCOME MEASURES: Change in local vulvar pain was assessed with cotton-swab tests and rated on a numeric rating scale (NRS). Treatment discomfort and short-term adverse events were recorded. The Freiburg Index of Patient Satisfaction was used to assess treatment satisfaction. Subjective symptom improvement was assessed with the Patient Global Impression of Improvement questionnaire. RESULTS: 35 women received at least 1 laser treatment, with overall mild treatment adverse effects (mean pain NRS 2.4 ± 1.9) and good treatment satisfaction (mean total score of 27.6 ±5.1; potential range 8-32). One month after last LASER treatment the pain NRS on vulvar cotton swab test improved from 6.1 ± 2.6 at baseline to 3.1 ± 2.6 (P < .001), and 74% of women (n = 26) reported symptom improvement. At 9-12 months follow-up 66% reported ongoing symptom improvement, with no significant difference to the control group of 32 women. CONCLUSION: Microablative Er:YAG vulvovaginal LASER therapy appears safe and well accepted among vulvodynia patients, but there was no significant difference in symptom improvement compared to a control group. Trutnovsky G, Bliem B, Greimel E, et al. Microablative Erbium: YAG Laser Therapy for Vulvodynia - A Report on Efficacy, Safety, and Treatment Satisfaction. Sex Med 2021;9:100432.

Psychometric validation of the European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire Sexual Health (EORTC QLQ-SH22).

BACKGROUND: The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group developed a questionnaire to assess sexual health in patients with cancer and cancer survivors. This study evaluates the psychometric properties of the questionnaire. METHODS: The 22-item EORTC sexual health questionnaire (EORTC QLQ-SH22) was administered with the EORTC QLQ-C30 to 444 patients with cancer. The hypothesised scale structure, reliability and validity were evaluated through standardised psychometric procedures. RESULTS: The cross-cultural field study showed that the majority of patients (94.7%) were able to complete the QLQ-SH22 in less than 20 min; 89% of the study participants did not need any help to fill in the questionnaire. Multi-item multi-trait scaling analysis confirmed the hypothesised scale structure with two multi-item scales (sexual satisfaction, sexual pain) and 11 single items (including five conditional items and four gender-specific items). The internal consistency yielded acceptable Cronbach's alpha coefficients (.90 for the sexual satisfaction scale, .80 for the sexual pain scale). The test-retest correlations (Pearson's r) ranged from .70 to .93 except for the scale communication with professionals (.67) and male body image (.69). The QLQ-SH22 discriminates well between subgroups of patients differing in terms of their performance and treatment status. CONCLUSION: The study supports the reliability, the content and construct validity of the QLQ-SH22. The newly developed questionnaire is clinically applicable to assess sexual health of patients with cancer at different treatment stages and during survivorship for clinical trials and for clinical practice.

Neonates in the Intensive Care Unit: Maternal Health-Related Quality of Life and Depression After Term and Preterm Births.

Background/Objective: To examine maternal physical and mental health-related quality of life (HRQoL) and depression after early and late preterm and term births in the early postpartum period. Method: In a prospective pilot study, three groups of women whose newborns had to be treated in the neonatal ward during the immediate postpartum period were established and compared with each other: 20 women with extremely to very preterm birth, 20 with moderate to late preterm birth and 20 women with term birth. All participants completed the Short Form-12 Health Survey (SF-12) to measure HRQoL, and the Edinburgh Postnatal Depression Scale (EPDS) to detect depressive symptoms combined with independently developed questions to evaluate anxiety and psychological distress. Results: Maternal psychological HRQoL was significantly worse in the very preterm birth group compared to moderate to late preterm birth (p < 0.001) and full-term birth groups (p = 0.004). There were no differences between the birth groups in depressive symptoms (p = 0.083), anxiety (p = 0.238), perceived stress (p = 0.340) and the general psychological distress values (p = 0.755). In the EPDS, the depression screening instrument 30 to 65% were beyond the cut-off-value to detect major depression. Conclusions: During the early postpartum period, an extensive medical care focussing on acute stress, HRQoL parameters and depression may be a good step to improving maternal well-being.

Minimally important differences for interpreting European Organisation for Research and Treatment of Cancer (EORTC) Quality of life Questionnaire core 30 scores in patients with ovarian cancer.

INTRODUCTION: Minimal important differences (MIDs) are useful for interpreting changes or differences in health-related quality of life scores in terms of clinical importance. There are currently no MID guidelines for the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire core 30 (EORTC QLQ-C30) specific to ovarian cancer. This study aims to estimate MIDs for interpreting group-level change of EORTC QLQ-C30 scores in ovarian cancer. METHODS: Data were derived from four EORTC published trials. Clinical anchors for each EORTC QLQ-C30 scale were selected using correlation strength and clinical plausibility. MIDs for within-group change and between-group differences in change over time were estimated via mean change method and linear regression respectively. For each EORTC QLQ-C30 scale, MID estimates from multiple anchors were summarized via weighted-correlation. Distribution-based MIDs were also examined as supportive evidence. RESULTS: Anchor-based MIDs were determined for deterioration in 7 of the 14 EORTC QLQ-C30 scales assessed, and in 11 scales for improvement. Anchor-based MIDs for within-group change ranged from 4 to 19 (improvement) and - 9 to -4 (deterioration). Between-group MIDs ranged from 3 to 13 (improvement) and - 11 to -4 (deterioration). Generally, absolute anchor-based MIDs for most scales ranged from 4 to 10 points. CONCLUSIONS: Our findings will aid interpretation of EORTC QLQ-C30 scores in ovarian cancer and inform sample size calculations in future ovarian cancer trials with endpoints that are based on EORTC QLQ-C30 scales.

LION-PAW (lymphadenectomy in ovarian neoplasm) sexual function assessment: a prospective sub-study of the LION trial.

BACKGROUND: There is limited information about the impact of radical surgery including pelvic and para-aortic lymphadenectomy and subsequent platinum-based chemotherapy on sexuality in patients with advanced ovarian cancer. OBJECTIVE: To evaluate the impact of radical surgery including pelvic and para-aortic lymphadenectomy and subsequent platinum-based chemotherapy on sexuality in patients with advanced ovarian cancer as a sub-protocol of the prospectively randomized LION trial. METHODS: The Sexual Activity Questionnaire was applied to assess sexual function according to its sub-scales activity, pleasure, and discomfort. The 'orgasm' sub-scale from the Female Sexual Function Index was also added. The questionnaire was administered in combination with the EORTC QLQ-C30 questionnaire at baseline prior surgery, after 6, 12, and 24 months. The primary endpoint was changes in sexual function. RESULTS: Overall, 495 patients received the questionnaires. 254 (51%) responded at baseline. Of these, 55 (22%) patients were sexually active, 182 (72%) were sexually inactive, and for 17 (7%) patients' data were not available. There was a total of 55/495 (11%) patients at 6 months, 139 (28%) patients at 12 months, and 81 (16%) patients at 24 months. Median age was 60.5 years (range 21.4-75.8). At baseline, sexually active responders were significantly younger (median age 51.5 years,) than sexually inactive responders (median age 61.8 years) and tended to have a better performance status. Discomfort evaluated as dryness of the vagina and pain during sexual intercourse was significantly worse at 12 months than at baseline (p<0.001); however, the surgical variable, lymphadenectomy, did not have any impact on this. The orgasm sub-scale showed diverging results with a deterioration from baseline to 12 months in the lymphadenectomy group compared with the no-lymphadenectomy group (p=0.02). CONCLUSION: The majority of patients were sexually inactive; however, in those who were sexually active, pain during intercourse was worse at 12 months. In addition, the orgasm sub-scale demonstrated worse results in patients who underwent complete lymphadenectomy. The study suggests that surgery in the retroperitoneal space may influence sexual function.

Patient-reported outcomes and final overall survival results from the randomized phase 3 PENELOPE trial evaluating pertuzumab in low tumor human epidermal growth factor receptor 3 (HER3) mRNA-expressing platinum-resistant ovarian cancer.

INTRODUCTION: The PENELOPE trial evaluated pertuzumab added to chemotherapy for biomarker-selected platinum-resistant ovarian cancer. As previously reported, pertuzumab did not statistically significantly improve progression-free survival (primary end point: HR 0.74, 95% CI 0.50 to 1.11), although results in the paclitaxel and gemcitabine cohorts suggested activity. Here, we report final overall survival and patient-reported outcomes. PATIENTS AND METHODS: Eligible patients had ovarian carcinoma that progressed during/within 6 months of completing ≥4 platinum cycles, low tumor human epidermal growth factor receptor 3 (HER3) mRNA expression, and ≤2 prior chemotherapy lines. Investigators selected single-agent topotecan, gemcitabine or weekly paclitaxel before patients were randomized to either placebo or pertuzumab (840→420 mg every 3 weeks), stratified by selected chemotherapy, prior anti-angiogenic therapy, and platinum-free interval. Final overall survival analysis (key secondary end point) was pre-specified after 129 deaths. Patient-reported outcomes (secondary end point) were assessed at baseline and every 9 weeks until disease progression. RESULTS: At database lock (June 9, 2016), 130 (83%) of 156 randomized patients had died. Median follow-up was 27 months in the pertuzumab arm versus 26 months in the control arm. In the intent-to-treat population there was no overall survival difference between treatment arms (stratified HR 0.90, 95% CI 0.61 to 1.32; p=0.60). Results in subgroups defined by stratification factors indicated heterogeneity similar to previous progression-free survival results. Updated safety was similar to previously published results. Compliance with patient-reported outcomes questionnaire completion was >75% for all validated patient-reported outcomes measures. Pertuzumab demonstrated neither beneficial nor detrimental effects on patient-reported outcomes compared with placebo, except for increased diarrhea symptoms. DISCUSSION: Consistent with the primary results, adding pertuzumab to chemotherapy for low tumor HER3 mRNA-expressing platinum-resistant ovarian cancer did not improve overall survival, but showed trends in some cohorts. Except for increased diarrhea symptoms, pertuzumab had no impact on patient-reported outcomes. ClinicalTrials.gov: ClinicalTrials.gov: NCT01684878.

Do different treatment strategies influence women's level of psychosexual distress? Observational cohort study of women with premalignant HPV-associated genital lesions.

OBJECTIVE: To examine the impact of different treatment strategies - surgical treatment or watchful waiting- on sexual activity, psychosocial distress, and fear of progression in women with Human Papillomavirus (HPV)-associated premalignant genital lesions. STUDY DESIGN: Observational cohort study of women diagnosed with HPV-associated premalignant lesions of the cervix, vagina or vulva. Patients were stratified into two groups depending on the severity of their premalignancy: surgical treatment or watchful waiting. Validated patient administered questionnaires, i.e. Fear of Progression questionnaire (FoP-Q), Cervical Dysplasia Distress Questionnaire (CDDQ), and Sexual Activity Questionnaire (SAQ) were completed after clinical evaluation (baseline), at 6- and 12-months follow-ups. RESULTS: 209 women treated with surgery (N = 125) were compared with women who were monitored in regular intervals (N = 82). During an observational period of 12 months there were no significant differences in fear of progression, psychosocial distress, and sexual activity (p > 0.05). The level of concerns and anxiety about the future, and fear of progression were present, mostly at baseline. While there was a small increase of tension from visit to visit in both groups, patients generally were able to cope with their clinical situation quite well. CONCLUSIONS: Fear of progression, psychosocial distress and sexual activity in women with precancerous HPV- associated premalignant genital lesions seem to be independent from type of treatment. Both treatment strategies may be applied without major psychological sequelae, as long as adequate information is provided.

Health-Related Quality of Life and Depression in Women following Intrauterine Interventions in Complicated Monochorionic Twin Pregnancies.

INTRODUCTION: The aim of this study was to explore maternal health-related quality of life (HRQoL) and depression following intrauterine interventions in complicated monochorionic twin pregnancies at the Medical University Graz. MATERIAL AND METHODS: In a cross-sectional questionnaire survey, women with at least one liveborn infant following intrauterine intervention during 2011 and 2015 were matched with uncomplicated monochorionic and dichorionic pregnancies. All completed the 12-Item Short Form Health Survey to measure HRQoL and the Patient Health Questionnaire-9 to measure depression. Results were compared with local normative values. RESULTS: There were no differences in physical and mental HRQoL as compared to those with uncomplicated pregnancy. However, the whole study population had significantly lower HRQoL scores (p < 0.001) than the normative sample. Additionally, 11% of the whole study population experienced moderate (6.2%) or moderately severe (4.6%) depression. Women following uncomplicated dichorionic pregnancy revealed more depressive symptoms compared to women with intervention. DISCUSSION: Women with at least one surviving infant following intervention in complicated monochorionic twin pregnancy do not seem to have an impaired HRQoL as compared to women following uncomplicated monochorionic or dichorionic pregnancies. However, twin pregnancy itself appears to impair HRQoL, at least in the first 4 postnatal years.

International validation of the EORTC QLQ-PRT20 module for assessment of quality of life symptoms relating to radiation proctitis: a phase IV study.

BACKGROUND: Although patients experience radiation proctitis post radiotherapy no internationally tested instruments exist to measure these symptoms. This Phase IV study tested the scale structure, reliability and validity and cross-cultural applicability of the EORTC proctitis module (QLQ-PRT23) in patients who were receiving pelvic radiotherapy. METHODS: Patients (n = 358) from six countries completed the EORTC QLQ-C30, QLQ-PRT23 and EORTC Quality of Life Group debriefing questions. Clinicians completed the EORTC Radiation Therapy Oncology Group scale. Questionnaires were completed at four time-points. The module's scale structure was examined and validated using standard psychometric analysis techniques. RESULTS: Three items were dropped from the module (QLQ-PRT23 → QLQ-PRT20). Factor analysis identified five factors in the module: bowel control; bloating and gas; emotional function/lifestyle; pain; and leakage. Inter-item correlations were within r = 0.3-0.7. Test-Retest reliability was high. All multi-item scales discriminated between patients showing symptoms and those without symptomology. The module discriminated symptoms from the clinician completed scoring and for age, gender and comorbidities. CONCLUSION: The EORTC QLQ-PRT20 is designed to be used in addition to the EORTC QLQ-C30 to measure quality of life in patients who receive pelvic radiotherapy. The EORTC QLQ-PRT20 is quick to complete, acceptable to patients, has good content validity and high reliability. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry (ANZCTR) ACTRN12609000972224 .

Assessing Patient-reported Quality of Life Outcomes in Vulva Cancer Patients: A Systematic Literature Review.

OBJECTIVES: Vulva cancer (VC) treatment carries a high risk of severe late effects that may have a negative impact on quality of life (QoL). Patient-reported outcome measures (PROMs) are increasingly used when evaluating disease- and treatment-specific effects. However, the adequacy of measures used to assess sequelae and QoL in VC remains unclear. The aims of the present study were to evaluate disease- and treatment-related effects as measured by PROMs in VC patients and to identify available VC-specific PROMs. METHODS/MATERIALS: A systematic literature search from 1990 to 2016 was performed. The inclusion criterion was report of disease- and treatment-related effects in VC patients using PROMs in the assessment. Methodological and reporting quality was in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. This systematic review was performed as part of phase 1 of the development of a European Organisation for Research and Treatment of Cancer QoL questionnaire for VC patients. RESULTS: The search revealed 2299 relevant hits, with 11 articles extracted including a total of 535 women with VC; no randomized controlled trials were identified. The selected studies exhibited great heterogeneity in terms of PROMs use. Twenty-one different instruments assessed QoL. Most of the questionnaires were generic. Different issues (sexuality, lymphedema, body image, urinary and bowel function, vulva-specific symptoms) were reported as potentially important, but the results were not systematically collected. Only one VC-specific questionnaire was identified but did not allow for assessment and reporting on a scale level. CONCLUSIONS: Vulva cancer treatment is associated with considerable morbidity deteriorating QoL. To date, there is no validated PROM available that provides adequate coverage of VC-related issues. The study confirms the need for a VC-specific QoL instrument with sensitive scales that allows for broad cross-cultural application for use in clinical trials.

Phase 1-3 of the cross-cultural development of an EORTC questionnaire for the assessment of sexual health in cancer patients: the EORTC SHQ-22.

To develop and pretest an European Organization for the Research and Treatment of Cancer Sexual Health Questionnaire (EORTC SHQ-22) for the assessment of physical, psychological, and social aspects of sexual health (SH) in male and female cancer patients and survivors. Questionnaire construction started with creating a list of relevant SH issues based on a comprehensive literature review. Issues were subsequently evaluated for relevance and prioritization by 78 healthcare professionals (HCP) and 107 patients from 12 countries during in-depth interviews (phase 1). Extracted issues were operationalized into items (phase 2). Phase 3 focused on pretesting the preliminary questionnaire in a cross-cultural patient sample (n = 171) using debriefing interviews. Psychometric properties were preliminary determined using a principal component analysis and Cronbach's alpha. We derived 53 relevant SH issues from the literature. Based on HCP and patient interviews, 22 of these 53 issues were selected and operationalized into items. Testing the preliminary 22-item short questionnaire resulted in a change of wording in five items and two communication-related items; no items were removed. Preliminary psychometric analysis revealed a two-factor solution and 11 single items; both scales showed good reliability indicated by a Cronbach's alpha of 0.87 (sexual satisfaction) and 0.82 (sexual pain). Cross-cultural pretesting of the preliminary EORTC SH questionnaire has indicated excellent applicability, patient acceptance, and comprehensiveness as well as good psychometric properties. The final development phase, that is psychometric validation (phase four) including large-scale, cross-cultural field testing of the EORTC SHQ-22, has commenced.

Psychometric properties and validation of two global impression questionnaires (PGI-S, PGI-I) for stress incontinence in a German-speaking female population.

AIMS: The Patient Global Index of Severity (PGI-S) and the Patient Global Index of Improvement (PGI-I) are global impression questionnaires developed in English and validated in women with stress urinary incontinence (SUI). This validation study tested the psychometric properties of German-language versions of the two questionnaires in German-speaking women with SUI. METHODS: The German-language PGI-S and PGI-I were psychometrically tested and validated using the SF-12 questionnaire, the Kinǵs Health Questionnaire (KHQ), clinical parameters, incontinence episode frequency and pad use in 311 patients before and 3 months after receiving a TVT-O or TVT tape for SUI. RESULTS: At baseline and 3 months postoperatively there was a positive correlation between PGI-S response categories and clinical parameters, IEF and pad use, and nearly all KHQ subscales. There were no correlations between response categories of PGI-S at baseline and PGI-I at 3 months and the SF-12 scales PCS-12 and MCS-12. CONCLUSION: Our results demonstrated good psychometric properties of the German-language PGI-S and PGI in German-speaking women with SUI.

Patients' view of routine follow-up after breast cancer treatment.

BACKGROUND: To assess emotional distress, anxiety and stress reactions in breast cancer (BC) patients before the follow-up visits. STUDY DESIGN: Between September 2009 and December 2011 a total of 284 patients completed the BC-psychosocial assessment screening scale (PASS) and a questionnaire about their views of follow-up after treatment for BC. RESULTS: Of the patients 64% reported low level of distress on the BC-PASS. The mean scores on the physical well-being scale was 5.3, the satisfaction/sense of coherence scale 7.4, and the emotional distress scale 8.1. Women rated mammography as the most important component (71%), followed by breast ultrasound (63%) and the consultation with the physician (60%). Of the patients 94% were satisfied with the current follow-up regimen. CONCLUSIONS: In this series BC patients were satisfied with their aftercare. Mammography was thought to be the most important component of aftercare. Patient-reported outcomes should be taken into account when planning follow-up.