Validation of the Russian Version of the Prolapse Quality-of-life Questionnaire and its Application to Assess the Impact of Pelvic Organ Prolapse on Quality of Life and the Effect of Treatment in Women Undergoing Reconstructive Surgery.

INTRODUCTION AND HYPOTHESIS: The objective was to validate the translated Russian version of the prolapse quality-of-life (P-QoL) questionnaire and test its applicability to assess the impact of pelvic organ prolapse (POP) on QoL and the effect of treatment in women undergoing reconstructive surgery. METHODS: Following a forward- and back-translation of the original English P-QOL questionnaire into Russian, the translated questionnaire was reviewed by a group of patients as well as an expert panel. Women with POP who were admitted to a university hospital for reconstructive surgery were recruited. All the women completed the P-QoL questionnaire, Pelvic Floor Distress Inventory (PFDI-20) and 36-Item Short Form Survey (SF-36) questionnaires before surgery. Clinical data and POP Quantification (POP-Q) Index according to the International Continence Society were obtained. Psychometric properties of the questionnaire were assessed. RESULTS: A total of 303 women with POP were included in the study. Most patients presented with POP-Q >2. The P-QoL questionnaire demonstrated good psychometric properties. High internal consistency was shown in all domains (Cronbach's alpha coefficient from 0.65 to 0.92). The test-retest reliability confirmed a highly significant stability between the total scores for each domain. Significant correlations of the P-QoL domains with the PFDI-20 and SF-36 scales (p < 0.05) were obtained, demonstrating satisfactory convergent validity. Discriminative construct validity was proved by the differences in the mean scores for P-QoL domains across POP-Q stages (p < 0.05): general health perceptions, role limitations, physical limitations, social limitations and severity measures were significantly higher for POP-Q stages 3 and 4 than for POP-Q stage 2 (p < 0.01); general health perceptions and severity measures were higher for POP-Q stage 4 than for POP-Q stage 3 (p < 0.05); sleep/energy was higher for POP-Q stage 3 than for POP-Q stage 2 (p < 0.05). Significant improvement of QoL in the 2 months after surgery (p < 0.05) indicated that the P-QoL questionnaire is sensitive to change. CONCLUSIONS: The Russian version of the P-QoL questionnaire is characterized by appropriate psychometric properties. The P-QoL questionnaire is a useful tool for describing the QoL profile in women with POP before reconstructive surgery and evaluating treatment outcomes after the procedure.

The Reporting, Use, and Validity of Patient-Reported Outcomes in Multiple Myeloma in Clinical Trials: A Systematic Literature Review.

BACKGROUND: Patient-reported outcomes (PROs) are becoming increasingly important in supporting clinical outcomes in clinical trials. In multiple myeloma (MM), PRO measurement is useful to reveal how treatment affects physical, psychosocial, and functional behaviour as well as symptoms and treatment-related adverse events to evaluate the benefit-risk ratio of a particular drug or drug combination. We report the types of PRO instruments used in MM, the frequency in which they are utilised in randomised controlled trials (RCTs), and the consistency of their reporting. METHODS: The European Hematology Association (EHA) supports the development of guidelines for the use of PROs in adult patients with haematological malignancies. The first step is the present systematic review of the literature. MEDLINE and CENTRAL were searched for RCTs in MM between 2015 and 2020. Study design, characteristics of MM and its treatment, the primary outcomes, and the types of PRO instrument(s) were extracted using a predefined template. Additionally, in a stepwise approach, it was assessed whether the identified instruments had been validated for multiple myeloma patients, patients with haematological malignancies, or cancer patients. RESULTS: Following screening for RCTs, 283 studies were included for review from 10,707 records retrieved, and 118 of these planned the use of PRO measures. Thirty-eight PRO instruments were reported. The most frequently used instrument (92 studies) was the EORTC QLQ-30. The EORTC-MY20 MM-specific questionnaire was the second most frequently used (50 studies), together with the EQ-5D (50 studies). Only 19 PRO instruments reported were consistent with the trial registry. Furthermore, in 58 publications, the information on PRO instruments differed between the publication and the trial registry. Further, information on PRO in HTA reports was available for 26 studies, of which 18 reports were consistent with the trial registries. Out of the 38 instruments used, six had been validated for patients with multiple myeloma (the most frequently used), six for patients with haematological malignancies, and 10 for cancer patients in general. CONCLUSIONS: The findings indicate that the measurement of PROs in RCTs for MM is underutilised, underreported, and often inconsistent. Guidelines for the appropriate use of PROs in MM are needed to ensure standardisation in selection and reporting. Furthermore, not all PRO instruments identified have been validated for myeloma patients or patients with haematological malignancies. Thus, guidelines for the appropriate use and reporting of PROs are needed in MM to ensure standardisation in the selection and reporting of PROs.

Predictors of Perioperative Vasoactive Drug Requirement During Retroperitoneal Adrenalectomy for Pheochromocytoma: A Retrospective Exploratory Study.

The aim of the present study was to test a hypothesis that baseline systemic vascular resistance index (SVRI) assessed by method of transpulmonary thermodilution predicts perioperative requirement for vasoactive drugs. The primary outcomes were: (1) peak vasoactive-inotropic score (VIS) and (2) peak dose of hypotensive drugs at any stage of surgery. The main exposure variable was baseline SVRI. Hemodynamics were retrospectively assessed by transpulmonary thermodilution in 50 adults who had undergone posterior retroperitoneal surgery for pheochromocytoma. Univariate linear regression analysis showed predictive value of SVRI on VIS [regression coefficient, 95% CI; 0.024 (0.005, 0.4), p=0.015]. Other significant factors were the history of peak diastolic pressure, baseline MAP, baseline betablocker therapy, and history of coronary artery disease (CAD). After adjustment of SVRI for the history of CAD, its prognostic value became non-significant [0.018 (0.008, 0.03), p=0.063 and 29.6 (19, 40.2), p=0.007 for SVRI and history of CAD, respectively]. Requirements of vasodilators were predicted by baseline adrenergic activity [0.37 (0.005, 0.74), p=0.047]. In conclusion, baseline SVRI is associated with perioperative requirement of vasopressor drugs, but history of CAD is a stronger prognostic factor for vasopressor support. Perioperative requirement in vasodilators is associated with baseline adrenergic activity.

Impact of malnutrition on survival in adult patients after elective cardiac surgery: Long-term follow up data.

The data article refers to the paper titles "Impact of malnutrition on long-term survival in adult patients after elective cardiac surgery" [1]. The data refer to the analysis of the relationship between baseline malnutrition and long-term mortality after cardiac surgery. Baseline demographic, nutritional, and medical history data were collected for each enrolled patient. Baseline serum albumin and C-reactive (CRP) protein levels were also obtained. Surgical risk was assessed in accordance with the logistic EuroSCORE. Intraoperative data including cardiopulmonary bypass (CPB) time and postoperative characteristics, such as postoperative complications, number of days in the ICU, and hospitalization duration, were also collected. Data on nutritional status were collected using four nutritional screening tools: (1) malnutrition universal screening tool (MUST), (2) short nutritional assessment questionnaire (SNAQ), (3) mini-nutritional assessment (MNA), and (4) nutritional risk screening 2002 (NRS-2002). Both electronic medical records and phone interviews were used for survival data collection. ROC analysis was performed to analyze prognostic value of baseline and perioperative variables on long-term mortality. Univariate and multivariate logistic regression analysis of predictors of 3- and 8-year mortality were performed. Kaplan-Meyer curves, describing the impact of baseline and perioperative characteristics on 3- and 8-year survival were also performed.

Effects of malnutrition on long-term survival in adult patients after elective cardiac surgery.

OBJECTIVES: The aim of this study was to investigate the relationship between malnutrition and long-term survival in patients who underwent cardiopulmonary bypass (CPB). METHODS: This study analyzed the long-term survival data of a mixed cohort of 1187 cardiac patients previously enrolled in a prospective observational study of nutritional screening in cardiac surgery. Nutritional status was assessed using the Malnutrition Universal Screening Tool (MUST). The mean age of patients was 58.86 ± 10.07 y (95% confidence interval [CI], 58.2-59.4). The median time of follow-up was 73.4 mo (25th-75th percentiles, 18.3-101.3). RESULTS: In all, 449 patients (37.8%) were lost to follow-up after hospitalization. For the remaining participants, the overall 8-y survival was 68% (95% CI, 59-76) and 77% (95% CI, 73-80; log-rank, P = 0.12) in patients with and without malnutrition risk, respectively. Statistically significant differences in survival were found during the 3-y follow-up of patients with heart valve disease: 83% (95% CI, 74-92) with malnutrition versus 93% (95% CI, 90-96) without malnutrition (log-rank, P = 0.03). The final multivariate Cox regression model revealed logistic EuroSCORE (hazard ratio (HR), 1.337; 95% CI, 1.110-1.612), cardiopulmonary bypass time <110.5 min (HR 0.463, 95% CI 0.255-0.842), preoperative albumin (HR 0.799, 95% CI 0.691-0.924), and C-reactive protein (HR, 1.106; 95% CI, 1.018-1.202) as independent predictors of 3-y survival. CONCLUSION: Preoperative malnutrition is not associated with 8-y mortality in a mixed cardiac surgery cohort. However, it may be associated with worse 3-y outcomes in patients with heart valve disease.