Development of Nursing Practice Scale of Cancer Pain Management and Examination of Reliability and Validity

The aims of this study were (1) to develop and validate the scale to measure evidence-based nursing practice in cancer pain management and (2) to identify associated factors. We developed potential items based on the 2014 version of Japanese Clinical Guidelines for Cancer Pain Management and administered anonymous questionnaire for 189 oncology nurses in a designated cancer center. We conducted a re-test to test reliability.167 nurses participated in the study. As a result of item analysis and exploratory factor analysis, we developed a nursing practice scale of cancer pain management and its shortened version. This scale consists of 1 domain 50 items The Cronbach’s α coefficient showing internal consistency was 0.98 (shortened version 0.88). The intra-class correlation coefficient of reliability was 0.52 (shortened version 0.77). Concurrent validity was confirmed by the correlation between the total score of the whole scale and the total score of the practice of palliative care, knowledge, difficulty, self-confidence scale. We concluded that this scale was valid and reliable. Factors related to the nursing practice of cancer pain management were years of experience in cancer nursing, opportunities of postgraduate education, and satisfaction with postgraduate education. This scale can be used for evaluation of daily clinical practice and practice evaluation after educational efforts such as cancer pain nursing training.

Functional Recovery Groups in Critically Ill COVID-19 Patients and Their Associated Factors: From ICU to Hospital Discharge.

OBJECTIVES: To analyze functional recovery groups of critically ill COVID-19 survivors during their hospital stay and to identify the associated factors. DESIGN: Prospective observational multicenter study. SETTING: Demographic, clinical, and therapeutic variables were collected, and physical and functional status were evaluated. The Barthel index was evaluated at three time points: 15 days before hospitalization, at ICU discharge, and at hospital discharge from the ward. PATIENTS: Patients with functional independence before COVID-19 diagnosis were recruited from four hospitals and followed up until hospital discharge. MEASUREMENTS AND MAIN RESULTS: Three groups of functional recovery were described for 328 patients: functional independence ( n = 144; 44%), which included patients who preserved their functional status during hospitalization; recovered functionality ( n = 109; 33.2%), which included patients who showed dependence at ICU discharge but recovered their independence by hospital discharge; and functional dependency ( n = 75; 22.8%), which included patients who were dependent at ICU discharge and had not recovered their functional status at hospital discharge. The factors associated with becoming functionally dependent at ICU discharge were time to out-of-bed patient mobilization (odds ratio [OR], 1.20; 95% CI, 1.11-1.29), age (OR, 1.02; 95% CI, 1.01-1.04), hyperglycemia (OR, 2.52; 95% CI, 1.56-4.07), and Simplified Acute Physiology Score (OR, 1.022; 95% CI, 1.01-1.04). Recovery to baseline independence during ward stays was associated with ICU length of stay (OR, 0.97; 95% CI, 0.94-0.99) and muscle strength (Medical Research Council test) at ICU discharge (OR, 1.13; 95% CI, 1.08-1.18). CONCLUSIONS: Age, hyperglycemia, and time for patient mobilization out of bed were independent factors associated with becoming physically dependent after their ICU stay. Recovery of physical function at hospital discharge was associated with muscle strength at ICU discharge and length of ICU stay.

1．The Survey of Trends on Japanese Post-marketing Study after Enforcement of Revised Good Post-marketing Study Practice （GPSP) / 薬剤疫学

In Japan, a re-examination system was introduced in the 1970s, and Post-marketing surveillance (PMS) has been conducted in many cases after the launch of new drugs or the approval of new indications for existing drugs. The revised Good Post-marketing Study Practice (r-GPSP) was enacted in 1 April 2018, and more scientific approach has been required for PMS. The survey aims to identify what kinds of change occurred in the PMS planned after r-GPSP enacted. As for the study method, after confirming the review report of each product, Risk Management Plan (RMP), and the package insert, and extracting necessary items, tabulation and analysis were performed. As a result of analysis, Drug Use Investigations (DUI) still accounted for more than 60％ of the total in PMS. Regarding the target number of DUI, Fifty-eight out of 90 had a sample size of 500 or fewer, only 3 studies exceeded 3,000. Regarding the newly introduced Post-marketing database surveillance (DB study) after r-GPSP enacted, 13 products and 18 surveillances were confirmed, although the number was not as large as the number of DUI. The most used database was Medical Data Vision Co., Ltd. (MDV), which were used in twelve DB studies, and cardiovascular disease and interstitial pneumonia were set as survey targets for safety considerations in multiple studies. There was no Drug Use Comparative Investigation. Furthermore, there were two products which were approved on the condition with re-examination period but did not required additional Pharmacovigilance activities. In terms of sample size calculation, 88 out of 135 studies mentioned rationales for setting the number of samples. Of which, 58 studies had statistical rationales. In many studies, the sample size calculation method that was commonly used in conventional PMSs, called ‘Rule of three’ was described as the statistical rational. After r-GPSP enacted, newly introduced Post-marketing surveillance, including DB surveys, and the scientific approach recommended by PMDA have been adopted in companies gradually. In the future, in order to further promote the scientific approach, it is necessary to further improve the capability of human resources of companies involved in PMS.

Effect of Lung Recruitment and Titrated Positive End-Expiratory Pressure (PEEP) vs Low PEEP on Mortality in Patients With Acute Respiratory Distress Syndrome: A Randomized Clinical Trial.

Importance: The effects of recruitment maneuvers and positive end-expiratory pressure (PEEP) titration on clinical outcomes in patients with acute respiratory distress syndrome (ARDS) remain uncertain. Objective: To determine if lung recruitment associated with PEEP titration according to the best respiratory-system compliance decreases 28-day mortality of patients with moderate to severe ARDS compared with a conventional low-PEEP strategy. Design, Setting, and Participants: Multicenter, randomized trial conducted at 120 intensive care units (ICUs) from 9 countries from November 17, 2011, through April 25, 2017, enrolling adults with moderate to severe ARDS. Interventions: An experimental strategy with a lung recruitment maneuver and PEEP titration according to the best respiratory-system compliance (n = 501; experimental group) or a control strategy of low PEEP (n = 509). All patients received volume-assist control mode until weaning. Main Outcomes and Measures: The primary outcome was all-cause mortality until 28 days. Secondary outcomes were length of ICU and hospital stay; ventilator-free days through day 28; pneumothorax requiring drainage within 7 days; barotrauma within 7 days; and ICU, in-hospital, and 6-month mortality. Results: A total of 1010 patients (37.5% female; mean [SD] age, 50.9 [17.4] years) were enrolled and followed up. At 28 days, 277 of 501 patients (55.3%) in the experimental group and 251 of 509 patients (49.3%) in the control group had died (hazard ratio [HR], 1.20; 95% CI, 1.01 to 1.42; P = .041). Compared with the control group, the experimental group strategy increased 6-month mortality (65.3% vs 59.9%; HR, 1.18; 95% CI, 1.01 to 1.38; P = .04), decreased the number of mean ventilator-free days (5.3 vs 6.4; difference, -1.1; 95% CI, -2.1 to -0.1; P = .03), increased the risk of pneumothorax requiring drainage (3.2% vs 1.2%; difference, 2.0%; 95% CI, 0.0% to 4.0%; P = .03), and the risk of barotrauma (5.6% vs 1.6%; difference, 4.0%; 95% CI, 1.5% to 6.5%; P = .001). There were no significant differences in the length of ICU stay, length of hospital stay, ICU mortality, and in-hospital mortality. Conclusions and Relevance: In patients with moderate to severe ARDS, a strategy with lung recruitment and titrated PEEP compared with low PEEP increased 28-day all-cause mortality. These findings do not support the routine use of lung recruitment maneuver and PEEP titration in these patients. Trial Registration: clinicaltrials.gov Identifier: NCT01374022.

THE PHYSICAL ACTIVITY AND NUTRITIONAL INTAKE IN COMMUNITY-DWELLING ELDERLY:THE NAKANOJO STUDY / 体力科学

Purpose : This study was undertaken to examine the relationship between pedometer counts and food intake in Japanese elderly people.Methods : One-hundred-eighty healthy, community-dwelling elderly people were divided into three groups according to age. The number of steps taken by each subject was recorded with a pedometer over a 30-day period in August. The dietary and nutritional intakes were estimated using a food frequency questionnaire.Results : There was no significant difference in the pedometer counts between men and women. The number of steps significantly decreased with age (p<0.01). The intake of energy, protein and carbohydrate were significantly higher in men than in women (p<0.05), and they were nearly the same among the three aged groups. The calcium and vitamin C intakes after adjusting for sex and age increased with the number of daily steps, except for the intakes of energy, protein and carbohydrates.Conclusion : A higher number of daily steps was found to be associated with the calcium and vitamin C intakes.

EFFECT OF DIETARY HEME-IRON INTAKES ON THE PREVENTION OF IRON-DEFICIENCY ANEMIA / 体力科学

Purpose : This study was undertaken to clarify the effect of heme-iron supplementation on the prevention of iron-deficiency anemia in male collegiate distance runners.Methods : Forty-one male collegiate runners were divided into three groups, consisting of a heme-iron group (HI), a citrate-iron group (CI), and a non-iron group (NI). Iron tablets (heme-iron or citrate-iron) were administered at a dose of 7 mg per day for two months. The blood components and nutritional intakes were estimated before and after the intervention.Results : The nutritional intakes did not differ among the three groups. The red blood cell, hemoglobin, hematocrit, ferritin, Glutamic-Pyruvate Transferase and <i>γ</i>-Glutamyl Transpeptidase levels were unchanged throughout the experimental periods. After the intervention, the serum iron levels significantly decreased in the NI group but not in the iron-supplemented groups, while the reticulocytes counts increased among the three groups.Conclusion : The small amount of heme-iron supplementation was thus found to have a preventive effect on iron deficiency anemia without causing any negative side affects.

DIETARY INTERVENTION MIGHT ENHANCE THE RBC CELL METABOLISM / 体力科学

Purpose : Rhythmic gymnasts sometimes develop severe iron-deficiency anemia. Preventing such anemia could thus enhance both their performance and health. We compared the relationship between a dietary intervention and RBC metabolism.Methods : Ten female rhythmic gymnasts were recruited for this study. Changes in the RBC delta-aminolevulinate dehydratase (δ-ALAD) activity were used as an index of biosynthesis, and changes in the haptoglobin (hp) were used to assess degradation.Results : During the one month intervention period, the athletes consumed traditional Japanese foods which provide 1500 kcal energy, 2 g/kg body weight protein, 200 g carbohydrate and 15 mg iron. No main effect of this intervention on the hematological indexes was observed. The δ-ALAD activity was significantly greater in August than in July or September. Hp concentration was significantly lower in August in comparison to the other periods.Conclusion : Dietary intervention might enhance the RBC turnover by increasing the capacity for erythrocyte biosynthesis and degradation.