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J. Jpn. Acad. Midwif., Vol. 26, No. 2, 179-189, 2012 原 著 授乳期の乳腺炎診断アセスメントツールの開発 信頼性と妥当性の検討 Development of an assessment tool to identify lactation mastitis Evaluation of validity and reliability Chieko OSADA 抄 録 目的 方法 ATLM2010 16 9 277554 4 2010 4 11 ATLM LATCH LATCH assessment tool 1 結果 12 3 LATCHr= 0.525 96.9 α0.820 0.859 0.803 0.818 0.490 0.852 32 98.0 87.5211 11 結論 1 キーワード : University of Shizuoka 2011 8 15 2012 9 10 179

Abstract Objectives To develop an Assessment Tool that identifies Lactational Mastitis (ATLM) for lactating mothers and to examine its reliability and validity. Methods The original "ATLM" was developed based on a descriptive study and a comprehensive review of the literature. After receiving examination on the content validity by the experts who are supporting lactating mothers, we made a preliminary study of ATLM. Based on the results, the present study was conducted, with 16 examination items. The subjects, from whom the lactating mothers with the previous history of breast disease except mastitis were excluded, were 277 pairs of mothers and child, with 554 breasts, during the III stage of lactation. The survey was conducted at 4 institutions in total such as the lactation and child-care center, etc. from April to November, 2010. The survey consisted of filling in the questionnaire for the mothers and children who visited to the survey-cooperating institutions, and measuring their body temperatures. The midwives were asked to fill in the ATLM and LATCH which are being developed. Additionally, 1 week after the survey, the mothers were asked to reply to another questionnaire inquiring of their conditions. Results Exploratory factor analysis by principal factor analysis with promax rotation was conducted. The following three factors comprised of 12 items were finally extracted: (1) "Status of milk, (2)" "Production of milk," and "(3) Drainage of milk." A confirmatory factor analysis was conducted by analyzing covariance structures and the hypothesized statistical model was found to fit the actual data. The reliability of the scale was confirmed by a Cronbach alpha's internal consistency reliability coefficient of 0.820 (0.803-0.859 for subscales) and an inter-rater reliability coefficient of 0.490-0.852. The criterion-related validity was confirmed by concurrent validity. The coefficient was r=- 0.525** and predictive validity was confirmed with a predictive value of 96.9%. The cut-off point for referral to a physician was 32 points. The sensitivity at this point was 98.0% and the specificity was 87.5%. In addition, the 1st factor scored 11 points higher than the 2nd factor. Conclusion The above findings indicate that the "ATLM" is sufficiently valid to improve the quality of identifying lactational mastitis. Keyword: mastitis, lactation, assessment tool, reliability, validity Ⅰ. はじめに 2010 2007 2002 2009 2010 180 26 2 2012

Ⅱ. 研究デザイン Ⅲ. 方法 1. 用語の定義 Riordan, 2005 9 2. 調査に用いる測定用具 1 Assessment Tool to Identify Lactational MastitisATLM 2010 6 2009 5 45 16 5 16 80 2010 2 51 1 0.1C202 LATCH LATCH assessment tool LATCH LATCH Jensen D., Wallace S., & Kelsay P 1994 5 30 1 2; 0 10 3. 協力助産師および対象者, 対象施設 1 8 2 9 3 1 1 1 1 4 4 16 505250 2005 2010 95.6 260 520 2007 181

2.2 2010 N=220N=60 70/1 N=20N=260 4. 調査手順 1 30 2 3 LATCH 4 1 5. 倫理的配慮 1 2 3 4 5 6 :09-091 6. 分析方法 AMOS SPSS17.0J for Windows 1 2009 GP r 0.2 2007 IT 2 LATCH 2 182 26 2 2012

3 Cronbach's α κ Ⅳ. 結果 1. 協力助産師と対象者の概要 1 9 1 16 23 2 277 554255 92.1 22 46 33.0214 61 28.5 16.113.9 23.6 22.618.8 6.7 6.04.3 25 9.0 3 22 191 2 38.53.8 1.5X 2 p 0.05 37.0 37.5 X 2 p 0.05 25 17 68.08 32.0 146 52.7126 45.5 9 1 114.8 2. 記述統計と項目分析 1 16 IT G 0.168M 0.168 p 0.001 3. 妥当性の検討 2 3 1 2 G M 14 1 3 1 34.62 20.8312.7 3 F 10.355 2 0.400 20.3 C D C 1 3 1 31.2842 17.93 9.2 12 3 1 H J K L 1 2A B C E I 3N O 183

表 1 項目分析の結果 N=554 項目項目間相関 I T 分析 M±SD A.006.606 **.535 ** 1.53.981 B.013.606 **.603 ** 1.73 1.110 C.010.952 **.648 ** 1.41.985 D.023.952 **.667 ** 1.43 1.003 E.077.549 **.642 ** 2.05 1.279 F.142.542 **.628 ** 1.44.866 G.010.241 **.168 ** 1.01.165 H.085*.695 **.662 ** 1.61.992 I.026.549 **.707 ** 2.19 1.335 J.006.822 **.492 ** 2.12 1.411 K.037.822 **.576 ** 1.55.866 L.021.626 **.424 ** 1.29.697 M.013.300 **.168 ** 1.07.340 N.016.587 **.450 ** 1.22.731 O.013.681 **.619 ** 1.61.995 P.068.681 **.505 ** 1.53.836 削除項目 ( 削除を決定した分析方法 ) IT IT ** p 0.05 表 2 因子分析と信頼性分析の結果 項目 α=.820 14 α.859 K J H L 2 5 α.803 A B E I C 33 α.818 O P N 因子負荷量 第 1 因子第 2 因子第 3 因子.943.896.747.680.083.090.096.133.010.010.063.011.012.110.155.019.832.796.575.566.537.047.015.051.033.000.028.048.172.029.036.163.131.832.819.720 2.977 2.901 2.624 表 3 因子間の相関因子 第 1 因子 第 2 因子 第 3 因子 第 1 因子 1.000.239.241 第 2 因子.239 1.000.474 第 3 因子.241.474 1.000 184 26 2 2012

P 312 CFI=0.939 RMSEA=0.099 AIC=405.844 RMSEA 0.05 0.1 CFI 0.9 表 4 ツール合計得点からみた ROC 曲線の領域積 a b 漸近 95% 信頼区間面積標準誤差漸近有意確率下限上限.946.011.000.924.968 表 5 ツール合計得点と感度 特異度 ツール合計得点 感度 (%) 特異度 (%) 平均 31 100.0 85.4 92.7 32 98.0 87.5 92.7 33 94.0 89.0 91.5 0.0002009"moderate" "almost perfect" B 0.514E 0.490 2 5 LATCH LATCH L 0.006 LATCH 0.525 p 0.001 2 96.9Hosmer Lemeshow 1.000 4. 信頼性の検討 2 1 α Cronbach's α 0.820 α 1 0.859 2 0.803 3 0.818 2 κa B A C0.490 0.852 p 5. カットオフポイントの設定 4 5 ROC 31.5100 86.432.596.088.5 31100 85.43298.087.5 32 6. 実測値からみたツールの検討 6-1 2 3 32100.087.5 66 66 25 20 10 185

表 6-1 カットオフポイント32で医療介入しなかったケース主訴人数 25 20 10 1 4 1 1 2 2 66 表 6-2 カットオフポイントと実測値 32100.087.5 医療介入ありなし 計 32 25 66 91 31 0 460 460 25 526 551 表 6-3 カットオフポイント32で医療介入しなかったケースの因子別の平均値 平 均 値 第 1 因子 ( 範囲 :4-20) 第 2 因子 ( 範囲 :5-25) 第 3 因子 ( 範囲 :3-15) ツール合計 ( 範囲 :12-60) N=25 9.3 15.8 5.2 36.8 N=20 12.7 13.4 5.7 39.6 N= 3 14.7 12.3 3.0 35.7 N=22 15.7 13.3 6.1 42.7 N=10 4.9 19.7 8.0 39.8 66 12 1 2 1 2 32 1 11 94.094.3 1288.0 96.4 11 7 Ⅴ. 考察 1. 妥当性と信頼性の検討 1 2008 12 3 186 26 2 2012

表 7 授乳期の乳腺炎診断アセスメントツールの概要測定する特性乳汁生成 Ⅲ 期の母子における医療介入を必要とする乳腺炎の鑑別, 9 1, 1212-60 32 98.087.5 11 2003 WHO, 20103 LATCH 0.525 LATCH 5 LATCH 96.9 Hosmer Lemeshow H 0.986 2009 H 0.000 1 38.5 X 2 38.537.5 37.0 2011 2 Cronbach's α 2009 Cronbach's α 187

Cronbach's α =0.820 1 =0.859 2 =0.803 3 =0.818 2009Cronbach's 0.7 0.8 0.7 2 κ0.490 0.852 1H J K L 0.661 0.781 2009 substantial 2 2. 臨床的有用性の検討 2005 2005 2007X 2517 8 2009 3. 研究の限界と今後の課題 LATCH 2 3 9 Ⅵ. 結論 ATLM 554 188 26 2 2012

1. H J K L 1 A B C E I 2 N O P 3 12 3 2. α0.803 0.859 κ0.490 0.852 3. LATCH r= 0.525 96.9 p 0.05 CFI=0.892 4. 98.087.5 32 2 1 1 11 謝辞 2010 2010 引用文献 200544-66. Jensen D, Wallace S. & Kelsay P. (1994). LATCH: a breastfeeding charting system and documentation tool. Journal of Obstetric, Gynecologic, and Neonatal Nursing: JOGNN / NAACOG, 23 (1), 27-32. 2007. 2007 95(5) 522-528. 200995-111. http://www.mhlw.go.jp/houdou/2006/06/dl/ h0629-1b.pdf [2010-02-11] 2005100 70-71. 2009 23(2) 182-195. 2010 14(3) p59. 2010 24(2) 184-195. 2002 84 933-936. 2011p6-30. 2009 63(7) 558-562. 2009 SPSS195-214. Riordan J (2005). Breastfeeding and human lactation (3rd ed.). p73, Boston;Jones and Bratlett Publishers. 2007 SPSS 33-84 158-170. 189