A Randomized Controlled Trial of Betamethasone on Fatigue in Patients With Advanced Cancer.

CONTEXT: Fatigue is one of the most uncomfortable physical symptoms seen in patients with advanced cancer. Previous studies have reported on the efficacy of corticosteroids from Western countries. OBJECTIVES: To assess the effectiveness of 4mg betamethasone improving fatigue among Japanese patients with advanced cancer. METHODS: A randomized, double-blind, placebo-controlled trial enrolled eligible patients with advanced cancer expected to survive 1-2 months, with an Eastern Cooperative Oncology Group Performance Status of 2-3, and experiencing fatigue according to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-15-palliative criteria. Participants received twice-daily oral administration of 2 mg betamethasone (4 mg/d) or placebo for seven days, with fatigue assessed using EORTC QLQ-C15-PAL subscale and numerical rating scale (NRS) score (at baseline and day seven). The trial was registered under the University Hospital Medical Information Network (UMIN)000011913. RESULTS: Among the 267 screened patients, 81 were eligible, of which 70 were evaluable (betamethasone, 33; placebo, 37). The mean difference in the EORTC-QLQ-C15-PAL fatigue subscale was -8.2 (95% CIs: -22.3, 0.0; P = 0.178) and in a NRS for fatigue was -1.2 (95% CIs: -2.5, -0.01; P = 0.048), respectively. Emotional function, appetite loss, and global-health were slightly better in the betamethasone group than in the placebo group. CONCLUSION: The impact of betamethasone 4 mg/d on alleviating fatigue in patients with advanced cancer in the last weeks of life did not reach statistical significance in the EORTC-QLQ-C15-PAL as the primary endpoint, however, it was significant in the NRS, the secondary endpoint.

Sexual function using the EORTC QLQ-TC26 in testicular cancer survivors: A multi-institutional, cross-sectional study.

OBJECTIVE: To evaluate sexual function after treatment using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Testicular Cancer 26 (EORTC QLQ-TC26) questionnaire in Japanese testicular cancer (TC) survivors in a multi-institutional, cross-sectional study. METHODS: This study enrolled TC survivors who visited any of eight high-volume institutions in Japan from 2018 to 2019. After obtaining informed consent, participants completed the EORTC QLQ-TC26 questionnaires. We evaluated sexual function after treatment for TC using the EORTC QLQ-TC26 and analyzed the impact of treatment on sexual function in TC survivors. RESULTS: A total of 567 TC survivors responded to the EORTC QLQ-TC26. Median age at the time of response was 43 years (interquartile range [IQR] 35-51 years), and median follow-up period after treatment was 5.2 years (IQR 2.2-10.0 years). Sexual function, particularly ejaculatory function, was significantly lower after post-chemotherapy retroperitoneal lymph node dissection (PC-RPLND) than after Surveillance or Chemotherapy groups (p < 0.05). In the PC-RPLND group, nerve-sparing procedure preserved postoperative ejaculatory function after RPLND compared with the non-nerve-sparing and offered improved ejaculatory function with time. On multivariate analysis, RPLND was a significant predictor of post-treatment ejaculatory dysfunction, particularly without nerve-sparing (odds ratio 3.0, 95% CI 1.2-7.7, p < 0.05). In addition, TC survivors with nerve-sparing RPLND had higher sexual activity than those without. CONCLUSION: This survey of the EORTC QLQ-TC26 showed that sexual function and activity in TC survivors after RPLND was reduced in the absence of nerve-sparing techniques.

Impact of diagnosis and treatment of uterine fibroids on quality of life and labor productivity: The Japanese online survey for uterine fibroids and quality of life (JOYFUL survey).

AIM: To investigate the impact of uterine fibroid diagnosis/treatment status on quality of life (QOL) and work productivity in women living in Japan. METHODS: Women aged 20-49 years who registered on Macromill were recruited via the opt-in method. They completed an online survey on demographic and uterine fibroid diagnosis/treatment status, 36-Item Short-Form Health Survey, Uterine Fibroid Symptom and Health-Related Quality of Life questionnaire (UFS-QOL), and World Health Organization Health and Work Performance Questionnaire. RESULTS: There were 4120 respondents: 1362 untreated, 249 with ongoing treatment, 449 with past treatment, 1030 with no uterine fibroids, and 1030 with unknown uterine fibroid status. A high proportion of women with ongoing treatment had moderate to severe uterine fibroid-like symptoms (symptom severity score of UFS-QOL ≥40 points), accompanied by reduced QOL. QOL was improved in women with past treatment. Uterine fibroids had a significant impact on physical and psychosocial aspects in the ongoing treatment group versus other groups. Using classification and regression tree analysis, anemia was identified as a plausible predictor of reduced QOL in the ongoing treatment group. Approximately 20% of women-even in groups other than the ongoing treatment group-experienced moderate to severe uterine fibroid-like symptoms. However, the diagnosis and treatment status of uterine fibroids had no clear impact on work productivity. CONCLUSIONS: Uterine fibroids, especially in association with anemia, were related to reduced QOL. Given that uterine fibroid-related reduced QOL is likely improved by appropriate treatment, women with uterine fibroid-like symptoms, such as menorrhagia, should be examined and treated.

Association between Low Forced Vital Capacity and High Pneumonia Mortality, and Impact of Muscle Power.

Impaired % predicted value forced vital capacity (% FVC) is related to higher all-cause mortality in aged adults, and strong muscle force may improve this relationship. A muscle disease, sarcopenia, causes higher mortality. We aimed to identify the unknown disease that relates impaired % FVC with higher mortality in aged adults among the three major leading causes of death, and the effect of strong leg force on this relationship. Cox proportional hazard model analyzed the longitudinal Tsurugaya cohort that registered 1048 aged Japanese for 11 years. The primary outcome was the relationship between % FVC and mortality by cancer, cardiovascular disease, or pneumonia. Exposure variables were % FVC or leg force divided by 80% or median values, respectively. The secondary outcome was the effects of leg force on the relationship. Among the diseases, % FVC < 80% was related only to higher pneumonia mortality (hazard ratio [HR], 4.09; 95% CI, 1.90-8.83) relative to the % FVC ≥ 80% group before adjustment. Adding the leg force as an explanatory variable reduced the HR to 3.34 (1.54-7.25). Weak leg force might indicate sarcopenia, and its prevention may improve higher pneumonia mortality risk related to impaired % FVC, which we may advise people in clinical settings.

Association of financial toxicity with quality of life in testicular cancer survivors.

OBJECTIVES: Most testicular cancer (TC) survivors have long-term survival. However, the association between financial toxicity (FT), which is an economic side effect of cancer treatment, and the quality of life (QOL) of TC survivors is still unclear. Thus, the impact of FT on the QOL of TC survivors was examined in a multi-institutional cross-sectional study. METHODS: We recruited TC survivors from eight high-volume institutions in Japan between January 2018 and March 2019. A total of 562 participants completed the EORTC QLQ-C30, EORTC QLQ-TC26 and the questionnaires on demographics, including annual income. Financial difficulty in the EORTC QLQ-C30 and low income were used to assess financial distress (FD) and financial burden (FB), respectively. FT was defined as FD and FB. The QOL scores were compared, and a multivariate logistic regression analysis for FT was performed. RESULTS: With severe FD, TC survivors had more treatment side effects, physical limitations, and anxiety concerning employment and future. The TC survivors who reported low income were worried about their jobs and the future. The QOL of the survivors with FT exhibited high impairment, except for sexual activity. In particular, the TC survivors with FT were physically limited and anxious concerning the future. The multivariate logistic regression analysis revealed that four or more chemotherapy cycles were substantial risk factors for FT (4 cycles, odds ratio (OR) = 4.17; ≥5 cycles, OR = 6.96). CONCLUSIONS: TC survivors who received multi-cycle chemotherapy were prone to experience FT, resulting in a decline in their health-related QOL.

Fertility and reproductive technology use in testicular cancer survivors in Japan: A multi-institutional, cross-sectional study.

OBJECTIVE: To evaluate fertility and use of reproductive technology of testicular cancer survivors in a multi-institutional, cross-sectional study. METHODS: This study recruited testicular cancer survivors who were followed after treatment for testicular cancer at eight high-volume institutions between 2018 and 2019. The participants completed the questionnaires on marital status, fertility and use of reproductive technology. RESULTS: A total of 567 testicular cancer survivors, with a median age of 43 years, responded to the questionnaire. Chemotherapy was given to 398 survivors, including three cycles of cisplatin-based chemotherapy in 106 patients and four cycles in 147 patients. Among 153 survivors who attempted sperm cryopreservation, 133 (87%) could preserve sperm. Of the 28 survivors whose cryopreserved sperm was used, 17 (61%) fathered children. Of the 72 survivors who fathered children without the use of cryopreserved sperm, 59 (82%) fathered naturally. Whereas 33 (20%) of 169 survivors treated without chemotherapy fathered children without using cryopreserved sperm, 39 (10%) of 398 treated with chemotherapy fathered children (P < 0.05). Furthermore, the paternity rate was 12% and 5% in testicular cancer survivors with three and four cycles of cisplatin-based chemotherapy, respectively (P < 0.05). However, of 121 survivors who wanted to have children, 14 (12%) received counseling about infertility treatment. CONCLUSIONS: Testicular cancer survivors preserving their sperm have a higher paternity rate after chemotherapy, especially after four cycles, than those not using cryopreserved sperm. Physicians who give chemotherapy for testicular cancer need to take particular care not only with respect to recurrence of testicular cancer, but also to post-treatment fertility.

Health-Related Quality of Life in Testicular Cancer Survivors in Japan: A Multi-Institutional, Cross-Sectional Study Using the EORTC QLQ-TC26.

OBJECTIVE: To evaluate the health-related quality of life (QOL) of testicular cancer (TC) survivors using the Japanese version of the EORTC QLQ-TC26 questionnaire in a multi-institutional, cross-sectional study. METHODS: This study recruited TC survivors who were followed after treatment for TC at eight high-volume institutions between January, 2018 and March, 2019. The participants completed the EORTC QLQ-TC26 questionnaire and mailed the completed questionnaires to a central institution. The QOL scores were assessed according to therapeutic modality (watchful waiting, WW; chemotherapy, CT; and CT followed by retroperitoneal lymph node dissection, CT+RPLND) and follow-up period and compared using analysis of variance and Student's t-test. RESULTS: A total of 567 TC survivors responded to the questionnaire. The median age at response was 43 years (IQR 35-51 years), and the median follow-up was 5.2 years (IQR 2.2-10.0 years). As for treatment side effects and physical limitations, the scores of the CT+RPLND group were significantly higher than those of the WW group, especially within one year after treatment. In addition, TC survivors in the CT+RPLND group reported high impairment related to job and education problems and future perspective less than 5 years after treatment. Even TC survivors in the WW group were anxious about job and education issues within one year after treatment. CONCLUSION: TC survivors were anxious about not only cancer recurrence, but also their jobs and education. TC patients should be given appropriate information on QOL after treatment for TC to attenuate post-treatment anxiety and improve their health-related QOL.

Validation study of the Japanese version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Testicular Cancer 26 for patients with testicular cancer.

OBJECTIVE: To validate the Japanese version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Testicular Cancer 26 in Japanese-speaking testicular cancer survivors. METHODS: A total of 200 testicular cancer survivors were recruited at eight high-volume institutions in Japan. The participants completed the Japanese version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Testicular Cancer 26, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 and the International Index of Erectile Function 15 questionnaires. A total of 40 participants completed a retest of the questionnaires 2 weeks after the first response. The psychometric properties of the Japanese version including test-retest reliability, internal consistency and concurrent validity were evaluated. RESULTS: The mean age at response was 43 years (range 22-74 years), and the mean period after treatment was 77 months (range 0-416 months). The response rate for each item, except sexual function, was high, and the percentage of missing values was less than 3.5%. For test-retest reliability, seven of 12 scales met the criteria (intraclass correlation 0.70-0.86). For internal consistency, four of seven scales met the criteria (Cronbach's alpha 0.62-0.91). For concurrent validity, treatment side effects of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Testicular Cancer 26 were related to some domains of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30. The sex-related subscales of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Testicular Cancer 26 were moderately correlated with some International Index of Erectile Function 15 domains. CONCLUSIONS: The psychometric properties of the Japanese version are equivalent to the properties of the original European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Testicular Cancer 26. The Japanese version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Testicular Cancer 26 questionnaire is a useful tool to assess the health-related quality of life of testicular cancer patients.

Response Shift-Adjusted Treatment Effect on Health-Related Quality of Life in a Randomized Controlled Trial of Taxane Versus S-1 for Metastatic Breast Cancer: Structural Equation Modeling.

OBJECTIVE: We investigated the quantification of the response shift-adjusted treatment effect on quality-of-life (QOL) data in a randomized controlled trial of taxane versus S-1 for patients with metastatic breast cancer (SELECT-BC). METHODS: This study was a secondary data analysis of a previously published trial. The response shift-adjusted treatment effect on health-related QOL (HRQOL) data measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) was estimated using structural equation modeling techniques in addition to quantifying the "true" treatment effect. Measurement invariances in the values of the common factor loadings, intercepts, and residual variances between before treatment and at the 3-, 6-, and 12-month visits were considered the response shift effects. RESULTS: In the taxane group, we observed positive recalibration effects for role functioning and positive reprioritization and negative recalibration effects for emotional functioning. The observed change of -4.56 for role functioning comprised +2.26 response shifts and -6.82 "true" change. The observed change of +9.41 for emotional functioning comprised +12.43 response shifts and -1.17 "true" change. In the S-1 group, we observed positive reprioritization and negative recalibration effects for emotional functioning and positive reprioritization effects for social functioning. The observed change of +10.54 for emotional functioning comprised +10.07 response shifts and +0.47 "true" change. The observed change of +2.43 for social functioning comprised +3.50 response shifts and -1.07 "true" change. CONCLUSION: Detailed analysis of the response shift effects will improve the evaluation reliability of observed HRQOL data during clinical trials.

Patient-reported vision-related quality of life after laser in situ keratomileusis, surface ablation, and phakic intraocular lens: The 5.5-year follow-up study.

To evaluate the long-term efficacy of refractive surgery of all cases in a single center via the use of a patient-reported outcome (PRO) refractive status questionnaire using descriptive statistics. This study was prospective, single-center, cohort study that involved 1422 patients who underwent refractive surgery (laser in situ keratomileusis, surface ablation, and phakic intraocular lens) at Baptist Eye Institute, Kyoto, Japan. The patients were asked to answer the Refractive Status and Vision Profile (RSVP) questionnaire before the surgery after 6 months (n = 1133 patients) and after 5.5 years (n = 232 patients). During the same period, examination by slit-lamp biomicroscopy and visual acuity tests were performed. Moreover, the patients were asked to rate their satisfaction with the surgery 6 months and 5.5 years after it. We examined overall RSVP scale (S), 8 RSVP subscales, rate of satisfaction with surgical outcome, slit-lamp biomicroscopy findings, and refractive error. The mean preoperative S was 36, yet that score significantly improved to 19 at 6 postoperative months postoperatively (P < .01), and basically remained the same (i.e., 20) throughout the 5.5-year postoperative period. During the 5-year follow-up period, mean refractive error became slightly myopic (0.3 D). No change in the rate of satisfaction was observed at both 6 months and 5.5 years postoperative period. The findings of this study help to clarify long-term PRO quality of vision (QOV) postrefractive surgery in a single center, and show that minor change in refractive error during 5 years postoperative period had no influence on the mean RSVP scores among outpatients. Nearly all patients reported short-term improvement of QOV, which continued throughout the long-term follow-up period.

Effects of occupational status on social adjustment after laryngectomy in patients with laryngeal and hypopharyngeal cancer.

PURPOSE: This study was performed to examine the relationship of social adjustment with occupation and life changes in patients with laryngeal and hypopharyngeal cancer, from before laryngectomy to 1 year after hospital discharge. METHODS: The subjects were 27 patients with laryngeal and hypopharyngeal cancer who were admitted to hospital for laryngectomy and provided informed consent for participation in the study. The patients answered questionnaire surveys before surgery, and 3, 6, and 12 months after hospital discharge. Regarding social adjustment, social functioning (SF) and mental health (MH) in SF-36V2 were used as dependent variables, and time, occupation status, age, family structure, and sex as independent variables. Repeated measures analysis of variance was used to examine the main effect, and second- and third-order interactions were also examined. RESULTS: The age of the subjects was 62.9 ± 6.4 years and about 30% had an occupation. Loss of voice was the reason for 30% leaving work. In an examination of the main effects of the four variables, only age was significant regarding SF, and SF was favorable in subjects aged ≥ 64 years old. Regarding MH, age and family structure were significant, and MH was higher in older subjects who lived alone. The interaction between time and the other 3 variables was not significant. Only time/age/occupation was significant for MH. Regarding SF, a weak interaction was suggested, but it was not significant. CONCLUSION: Older subjects showed better social adjustment, and those who lived alone had better MH. These findings may have been due to a reduced environmental influence. MH of subjects with an occupation decreased more at 3 months or later after hospital discharge, compared to those without an occupation. Especially for younger patients, development of new approaches is required to allow families and colleagues of patients to understand the difficulties of patients with laryngeal and hypopharyngeal cancer.

Background factors influencing postgastrectomy syndromes after various types of gastrectomy.

BACKGROUND: Postgastrectomy syndromes (PGS) after curative gastrectomy for gastric cancer are influenced by not only gastrectomy type but also by background factors. Recently, a nationwide PGS study was performed using the Postgastrectomy Syndrome Assessment Scale-45 (PGSAS-45) questionnaire. AIM: To determine the influence of each background factor on PGS for each gastrectomy type using PGS assessment study (PGSAS) data as an additional analysis. METHODS: The data of 2368 patients were obtained from the PGSAS. This included patients undergoing distal gastrectomy (DG) with Billroth I reconstruction, DG with Roux-en-Y reconstruction, total gastrectomy with Roux-en-Y, proximal gastrectomy, pylorus-preserving gastrectomy (PPG), and local resection. Multiple regression analysis was performed to explore the independent effects of each background factor on the main outcome measures (MOMs) of PGSAS-45 for each gastrectomy type. The background factors included postoperative period, age, sex, surgical approach (laparoscopic or open), and the status of the celiac branch of the vagal nerve. RESULTS: The MOMs of DG and PPG were highly affected by background factors, whereas those of total gastrectomy with Roux-en-Y, proximal gastrectomy, and local resection were not. Worse PGS were found in females, whereas a longer postoperative period alleviated some of the MOMs. For DG and PPG, a laparoscopic approach and preservation of the celiac branch improved several MOMs. CONCLUSION: Various background factors affected PGS, and their influence varied with the type of gastrectomy performed. Laparoscopic surgery and celiac branch preservation can improve PGS in patients undergoing DG and PPG.

[LINGUISTIC VALIDATION OF JAPANESE VERSION OF EUROPEAN ORGANIZATION FOR RESEARCH AND TREATMENT OF CANCER QUALITY OF LIFE QUESTIONNAIRE-TESTICULAR CANCER 26 (EORTC QLQ-TC26)].

(Purpose) To translate the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Testicular Cancer 26 (EORTC QLQ-TC26) into Japanese and evaluate the linguistic validation of the translated EORTC QLQ-TC26. (Methods) Developing the EORTC QLQ-TC26 Japanese was performed strictly according to the EORTC Quality of Life (QOL) Group Translation Procedure. The translation process consisted of 3 steps: forward translation by 2 urologists and reconciliation (single forward translation), backward translation by 2 native English speakers and comparison with source questionnaire (intermediate version), and pilot testing of the intermediate version in 10 patients with testicular cancer and reconciliation with EORTC QOL Group. (Results) After forward translation by 2 experienced Japanese urologists, any disagreements were resolved via a reconciliation process, resulting in a single provisional forward translation. This translation was back-translated by two independent backward-translators (fluent in both, Japanese and English) in order to ensure that the provisional forward translation was an adequate representation of the English original. Based on the discussion with EORTC QOL group, the intermediate version was developed. Each translated item was pilot-tested on 10 patients diagnosed with testicular cancer. Most patients experienced no difficulties in completing the questionnaire. On the basis of the interview and reconciliation with EORTC QOL Group, two items of the provisional translation required adaptation. (Conclusions) The EORTC QLQ-TC26 Japanese was developed in a linguistically valid manner. This can be used for cross-cultural assessment of health related QOL in men with testicular cancer.

Social support and substitute voice acquisition on psychological adjustment among patients after laryngectomy.

The objective is to clarify whether social support and acquisition of alternative voice enhance the psychological adjustment of laryngectomized patients and which part of the psychological adjustment structure would be influenced by social support. We contacted 1445 patients enrolled in a patient association using mail surveys and 679 patients agreed to participate in the study. The survey items included age, sex, occupation, post-surgery duration, communication method, psychological adjustment (by the Nottingham Adjustment Scale Japanese Laryngectomy Version: NAS-J-L), and the formal support (by Hospital Patient Satisfaction Questionnaire-25: HPSQ-25). Social support and communication methods were added to the three-tier structural model of psychological adjustment shown in our previous study, and a covariance structure analysis was conducted. Formal/informal supports and acquisition of alternative voice influence only the "recognition of oneself as voluntary agent", the first tier of the three-tier structure of psychological adjustment. The results suggest that social support and acquisition of alternative voice may enhance the recognition of oneself as voluntary agent and promote the psychological adjustment.

Factors affecting the quality of life of patients after gastrectomy as assessed using the newly developed PGSAS-45 scale: A nationwide multi-institutional study.

AIM: To identify certain clinical factors other than the type of gastrectomy which affect the postoperative quality of life (QOL) of patients after gastrectomy. METHODS: The postgastrectomy syndrome assessment scale (PGSAS)-45 was designed to assess the severity of symptoms, the living status and the QOL of gastrectomized patients. It consists of 45 items, of which 22 are original items while 23 were retrieved from the SF-8 and Gastrointestinal Symptoms Rating Scale questionnaires with permission. A nationwide surveillance study to validate PGSAS was conducted and 2368 gastric cancer patients who underwent various types of gastrectomy at 52 medical institutions were enrolled. Of these, 1777 patients who underwent total gastrectomy (TG) reconstructed with Roux-Y (n = 393), distal gastrectomy (DG) reconstructed with Billroth-I (n = 909), or DG reconstructed with Roux-Y (n = 475) were evaluated in the current study. The influence of the type of gastrectomy and other clinical factors such as age, sex, duration after surgery, the symptom severity, the degree of weight loss, dietary intake, and the ability for working on the postoperative QOL (i.e., dissatisfaction for daily life subscale, physical component summary and mental component summary of the SF-8) were examined by multiple regression analysis (MRA). In addition, importance of various symptoms such as esophageal reflux, abdominal pain, meal-related distress, indigestion, diarrhea, constipation and dumping on the postoperative living status and QOL were also appraised by MRA. RESULTS: The postoperative QOL were significantly deteriorated in patients who underwent TG compared to those after DG. However, the extent of gastrectomy was not an influential factor on patients' QOL when adjusted by the MRA. Among various clinical factors, the symptom severity, ability for working, and necessity for additional meals were the most influential factors to the postoperative QOL. As for the individual symptoms, meal-related distress, dumping, abdominal pain, and esophageal reflux significantly affected the postoperative QOL in that order, while the influence of indigestion, diarrhea and constipation was insignificant. CONCLUSION: Several clinical factors such as the symptom severity (especially in meal-related distress and dumping), ability for working and necessity for additional meals were the main factors which affected the patients' well-being after gastrectomy.

[Patient-reported Outcomes after Laser In Situ Keratomileusis Surgery].

PURPOSE: To evaluate patient-reported quality of vision before and after laser in situ keratomileusis (LASIK) surgery. SUBJECTS AND METHODS: This study involved 140 patients who underwent LASIK surgery at Baptist Eye Clinic, Kyoto, Japan. Each patient was asked to respond to the Refractive Status and Vision Profile (RSVP) questionnaire prior to surgery and at 6-months and 5.5-years postoperative. In each patient, we defined the eye with better uncorrected visual acuity (VA) or with less refractive error as the better eye, and the other eye as the worse eye. RESULTS: Even in the worse eyes, the percentage of eyes with an uncorrected VA of decimal 0.5 or greater was 93.5% at 6-months and 88.6% at 5.5-ears postoperative. The mean preoperative total RSVP score was 37.1, yet that score significantly improved at 6-months postoperative (p< 0 .001) and remained the same throughout the 5.5-year follow-up period. CCONCLUSION The patient-reported quality of vi-ion post LASIK surgery was improved and remained improved throughout the 5.5-year follow-up period.

The Effectiveness of Specific Exercise Approach or Modifiable Heel Lift in the Treatment of Functional Leg Length Discrepancy in Early Post-surgery Inpatients after Total Hip Arthroplasty: A Randomized Controlled Trial with a PROBE design.

OBJECTIVE: This study investigated the effectiveness of a specific exercise approach (SEA) or modifiable heel lift (MHL) to improve functional leg length discrepancy (LLD) after total hip arthroplasty (THA). METHODS: The study was a randomized controlled trial with a PROBE (prospective, randomized, open, blinded-endpoint) design trial. Patients (n=33) with both functional and perceived LLDs, 1 week after THA, were randomized to the SEA, MHL, or control groups. Patients in the SEA group performed 2 weeks of exercises to improve hip contracture and lumbar scoliosis. Patients in the MHL group used an insole-type heel lift to correct functional LLD. The control group received normal postoperative care, comprising standard rehabilitation after THA. The primary outcomes were functional LLD, measured by a block test, and patient-perceived LLD at 3 weeks after the surgery. Secondary outcomes included the visual analog scale (VAS) for pain, the Timed Up and Go (TUG) test, and the Western Ontario and McMaster Universities Osteoarthritis index (WOMAC) at 3 weeks after the surgery. RESULTS: The functional LLDs (mean ± SD) for the SEA (3.3 ± 3.1 mm) and MHL (2.2 ± 2.1 mm) groups were significantly smaller than for the control group (6.4 ± 4.0 mm). The degree of patient-perceived LLD differed significantly between the SEA and the control groups (p=.005). CONCLUSIONS: SEA and MHL use, during early post-operative recovery, can produce relevant changes in functional LLD after THA.

Color of intra-ocular lens and cataract type are prognostic determinants of health indices after visual and photoreceptive restoration by surgery.

BACKGROUND: This study compared post-operative quality of life and sleep according to the type of cataract opacity and color of the implanted intra-ocular lens (IOL). METHODS: This is a cohort study and participants were 206 patients (average age 74.1 years) undergoing cataract surgery with the implantation of a clear ultra-violet (UV)-blocking IOL (C) or a yellow blue-light-blocking IOL (Y). Participants were evaluated using the National Eye Institute Visual Function Questionnaire (VFQ-25) and Pittsburgh Sleep Quality Index (PSQI) before surgery and 2 and 7 months after surgery. Changes in sub-scale scores of VFQ-25 and PSQI were compared. RESULTS: Sub-scale analyses for improvement after surgery revealed significant differences in ocular pain scores on the VFQ-25 (Y>C; the higher the score, the better the outcome). Furthermore, there were significant differences between the two IOLs in terms of the sleep latency score (C>Y) and sleep disturbances score (C>Y). A posterior sub-capsular cataract was significantly correlated with improvements in ocular pain and sleep latency scores. These effects were successfully represented by the change in scores rather than absolute post-operative scores because individual standard of response may often change after intervention, recognized as a response shift phenomenon in patient-reported outcome study. Regarding seasonal differences, patients who had surgery in summer exhibited relatively better sleep quality than those who had surgery in winter. CONCLUSIONS: Analysis of sub-scales of health indices demonstrated characteristic prognoses for each IOL and cataract type. Cataract surgery may potentially contribute to systemic health in older adults.

Characteristics and clinical relevance of postgastrectomy syndrome assessment scale (PGSAS)-45: newly developed integrated questionnaires for assessment of living status and quality of life in postgastrectomy patients.

BACKGROUND: Lack of a suitable instrument to comprehensively assess symptoms, living status, and quality of life in postgastrectomy patients prompted the authors to develop postgastrectomy syndrome assessment scale (PGSAS)-45. METHODS: PGSAS-45 consists of 45 items in total: 8 items from SF-8, 15 items from GSRS, and an additional 22 items selected by 47 gastric surgeons. Using the PGSAS-45, a multi-institutional survey was conducted to determine the prevalence of postgastrectomy syndrome and its impact on everyday life among patients who underwent various types of gastrectomy. Eligible data were obtained from 2,368 patients operated and followed at 52 institutions in Japan. Of these, data from 1,777 patients were used in the current study in which symptom subscales of the PGSAS-45 were determined. We also considered the characteristics of the postgastrectomy syndrome and to what extent these symptoms influence patients' living status and quality of life (QOL). RESULTS: By factor analysis, 23 symptom-related items of PGSAS-45 were successfully clustered into seven symptom subscales that represent esophageal reflux, abdominal pain, meal-related distress, indigestion, diarrhea, constipation, and dumping. These seven symptom subscales and two other subscales measuring quality of ingestion and dissatisfaction for daily life, respectively, had good internal consistency in terms of Cronbach's α (0.65-0.88). CONCLUSION: PGSAS-45 provides a valid and reliable integrated index for evaluation of symptoms, living status, and QOL in gastrectomized patients.

Verification of the psychometric properties of the Japanese version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 15 palliative (EORTCQLQ-C15-PAL).

PURPOSE: We compared Japanese versions of the EORTC QLQ-C15-PAL and QLQ-C30 to assess the utility of the former survey for terminal-phase cancer patients. METHODS: We used QLQ-C30 scores from the survey prior to each patient's death and extracted QLQ-C15-PAL data. We determined intraclass correlation coefficients (ICCs) of the five QLQ-C15-PAL subscales: physical functioning, emotional functioning, fatigue, nausea and vomiting, and global health status/quality of life (QOL) and assessed equivalent-form reliability. Regression analysis was used to determine the extent to which QLQ-C15-PAL items explained the QLQ-C30 score. RESULTS: Our study included 32 of 91 cancer patients receiving palliative care who could self-administer the questionnaire. The ICC between the QLQ-C15-PAL and QLQ-C30 scores was 0.93 or higher. The proportion of variance (R-squared) for each subscale was 0.87 or higher. CONCLUSION: We examined the validity and reliability of the Japanese version of the QLQ-C15-PAL. We found an 87% or higher chance that the QLQ-C15-PAL could explain the original QLQ-C30 score. Therefore, QLQ-C15-PAL appears to be useful for assessing the QOL of terminal-phase cancer patients.