{"id":41325,"date":"2018-09-11T01:00:00","date_gmt":"2018-09-17T06:52:27","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/09\/17\/%e5%88%86%e4%ba%ab%e4%b8%a8%e7%9c%9f%e5%ae%9e%e4%b8%96%e7%95%8c%e7%a0%94%e7%a9%b6%e6%8c%87%e5%8d%972018%e5%b9%b4%e7%89%88%ef%bc%88%e5%85%a8%e6%96%87%ef%bc%89\/"},"modified":"2018-09-17T14:52:34","modified_gmt":"2018-09-17T06:52:34","slug":"%e5%88%86%e4%ba%ab%e4%b8%a8%e7%9c%9f%e5%ae%9e%e4%b8%96%e7%95%8c%e7%a0%94%e7%a9%b6%e6%8c%87%e5%8d%972018%e5%b9%b4%e7%89%88%ef%bc%88%e5%85%a8%e6%96%87%ef%bc%89","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/41325\/","title":{"rendered":"\u5206\u4eab\u4e28\u771f\u5b9e\u4e16\u754c\u7814\u7a76\u6307\u53572018\u5e74\u7248\uff08\u5168\u6587\uff09"},"content":{"rendered":"
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2018\u5e748\u67083\u65e5\uff0c\u7531\u5434\u9636\u5e73\u533b\u5b66\u57fa\u91d1\u4f1a\u80bf\u7624\u533b\u5b66\u90e8\u4e3b\u59d4\u5434\u4e00\u9f99\u6559\u6388\u7275\u5934\u7ec4\u7ec7\u76f8\u5173\u4e13\u5bb6\u64b0\u5199\u7684\u300a\u771f\u5b9e\u4e16\u754c\u7814\u7a76\u6307\u5357\u300b\u5728\u5e7f\u5dde\u53d1\u5e03\uff0c\u5c06\u5e2e\u52a9\u4e2d\u56fd\u7814\u7a76\u8005\u66f4\u597d\u5730\u5f00\u5c55RWS\u7814\u7a76\uff0c\u63d0\u9ad8RWS\u8d28\u91cf\u3002<\/span><\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n


<\/p>\n

\"\u5206\u4eab\u4e28\u771f\u5b9e\u4e16\u754c\u7814\u7a76\u6307\u53572018\u5e74\u7248\uff08\u5168\u6587\uff09\"<\/p>\n

\"\u5206\u4eab\u4e28\u771f\u5b9e\u4e16\u754c\u7814\u7a76\u6307\u53572018\u5e74\u7248\uff08\u5168\u6587\uff09\"
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<\/p>\n

\"\u5206\u4eab\u4e28\u771f\u5b9e\u4e16\u754c\u7814\u7a76\u6307\u53572018\u5e74\u7248\uff08\u5168\u6587\uff09\"<\/p>\n

<\/span><\/p>\n

\"\u5206\u4eab\u4e28\u771f\u5b9e\u4e16\u754c\u7814\u7a76\u6307\u53572018\u5e74\u7248\uff08\u5168\u6587\uff09\"<\/p>\n


<\/p>\n

\u4e00\uff0e\u80cc\u666f<\/span><\/strong><\/span><\/p>\n

\u8fd1\u5e74\u6765\uff0c\u56fd\u5185\u5916\u5bf9\u771f\u5b9e\u4e16\u754c\u7814\u7a76\uff08Real World Study, RWS\uff09\u7684\u5173\u6ce8\u5ea6\u65e5\u76ca\u589e\u52a0\u3002\u9996\u5148\uff0c\u4ece\u653f\u7b56\u5c42\u9762\u770b\uff0c\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08Food and Drug Administration\uff0cFDA\uff09\u4e8e 2016 \u5e747 \u6708 27 \u65e5\u53d1\u5e03\u300a\u91c7\u7528\u771f\u5b9e\u4e16\u754c\u8bc1\u636e\u652f\u6301\u533b\u7597\u5668\u68b0\u7684\u6cd5\u89c4\u51b3\u7b56\u300b\u8349\u6848\uff0c\u51e0\u7ecf\u4fee\u8ba2\u5230 2017 \u5e74 8\u6708 31 \u65e5\u53d1\u5e03\u6700\u65b0\u7248 [1] \uff0c\u8be5\u6307\u5357\u8868\u660e\u4e86 FDA \u5bf9\u771f\u5b9e\u4e16\u754c\u8bc1\u636e\u7528\u4e8e\u533b\u7597\u5668\u68b0\u6cd5\u89c4\u51b3\u7b56\u4e2d\u7684\u6001\u5ea6\u3002\u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u603b\u5c40\uff08China Food and Drug Administration, CFDA\uff09\u4e5f\u4e8e 2017 \u5e74<\/span>10 \u6708 8 \u65e5\u51fa\u53f0\u4e86\u300a\u5173\u4e8e\u6df1\u5316\u5ba1\u8bc4\u5ba1\u6279\u5236\u5ea6\u6539\u9769\u9f13\u52b1\u836f\u54c1\u533b\u7597\u5668\u68b0\u521b\u65b0\u7684\u610f\u89c1 [2] \uff0c\u63d0\u5230\u4e3a\u6ee1\u8db3\u4e34\u5e8a\u6025\u9700\u836f\u54c1\u533b\u7597\u5668\u68b0\u4f7f\u7528\u9700\u6c42\uff0c\u52a0\u5feb\u5ba1\u8bc4\u5ba1\u6279\uff0c\u5141\u8bb8\u53ef\u9644\u5e26\u6761\u4ef6\u6279\u51c6\u4e0a\u5e02\uff0c\u4e0a\u5e02\u540e\u6309\u8981\u6c42\u5f00\u5c55\u8865\u5145\u7814\u7a76\uff0c\u6b64\u7c7b\u8865\u5145\u7814\u7a76\u4e5f\u53ef\u90e8\u5206\u5f52\u5c5e\u4e8e RWS \u8303\u7574\u3002<\/span><\/p>\n

\u5176\u6b21\uff0c\u4ece\u533b\u7597\u5927\u73af\u5883\u770b\uff0c\u533b\u7597\u5927\u6570\u636e\u7684\u6784\u5efa\u7ed9 RWS \u63d0\u4f9b\u4e86\u524d\u6240\u672a\u6709\u7684\u4fbf\u5229\u3002\u5404\u7ea7\u533b\u7597\u673a\u6784\u3001\u533b\u4fdd\u90e8\u95e8\u3001\u533b\u836f\u76d1\u7ba1\u90e8\u95e8\u79ef\u7d2f\u4e86\u5927\u91cf\u7684\u533b\u7597\u6570\u636e\uff0c\u5404\u7ea7\u6570\u636e\u5e93\u7684\u7535\u5b50\u5316\uff0c\u4ee5\u53ca\u5404\u79cd\u7535\u5b50\u8bbe\u5907\u7684\u666e\u53ca\uff0c\u5404\u7ea7\u6570\u636e\u5e93\u5e73\u53f0\u7684\u5efa\u7acb\uff0c\u6781\u5927\u5730\u589e\u52a0\u4e86\u5229\u7528\u9ad8\u8d28\u91cf\u6570\u636e\u8fdb\u884c\u771f\u5b9e\u4e16\u754c\u7814\u7a76\u7684\u53ef\u80fd\u6027\u3002\u53e6\u5916\uff0c\u60a3\u8005\u3001\u533b\u751f\u3001\u533b\u7597\u4fdd\u9669\u63d0\u4f9b\u65b9\u3001\u76d1\u7ba1\u8005\u4ee5\u53ca\u653f\u7b56\u5236\u5b9a\u8005\u90fd\u5728\u52aa\u529b\u5bfb\u6c42\u5404\u79cd\u6765\u81ea\u4e8e\u7279\u5b9a\u4eba\u7fa4\u836f\u54c1\u4f7f\u7528\u7684\u51c6\u786e\u4fe1\u606f\u3002\u800c RWS \u5219\u5c06\u6210\u4e3a\u836f\u54c1\u4e34\u5e8a\u5e94\u7528\u3001\u533b\u4fdd\u5236\u5b9a\u3001\u51b3\u7b56\u5236\u5b9a\u7b49\u5404\u65b9\u53c2\u8003\u7684\u91cd\u8981\u4f9d\u636e\u3002<\/span><\/p>\n

\u867d\u7136 RWS \u8d8a\u6765\u8d8a\u591a\u53d7\u5230\u5404\u65b9\u7684\u91cd\u89c6\uff0c\u4f46\u56e0\u76ee\u524d\u5927\u591a\u533b\u7597\u6570\u636e\u5206\u5e03\u96f6\u6563\uff0c\u6ca1\u6709\u8fdb\u884c\u7cfb\u7edf\u6027\u6536<\/span>\u96c6\u548c\u7ed3\u6784\u5316\u5904\u7406\uff0cRWS \u6240\u9700\u6837\u672c\u91cf\u76f8\u5bf9\u8f83\u5927\uff0c\u6570\u636e\u5f02\u8d28\u6027\u5f3a\uff0c\u6df7\u6742\u548c\u5e72\u6270\u56e0\u7d20\u591a\uff0c\u5bf9\u7814\u8bbe<\/span>\u8ba1\u548c\u7edf\u8ba1\u65b9\u6cd5\u7684\u8981\u6c42\u6bd4\u4f20\u7edf\u7814\u7a76\u66f4\u9ad8\u3002\u66f4\u91cd\u8981\u7684\u662f\uff0c\u6211\u56fd\u76ee\u524d\u5c1a\u6ca1\u6709\u7cfb\u7edf\u6027\u7684\u6307\u5357\u5bf9 RWS \u63d0\u4f9b\u5efa\u8bae\u548c\u6307\u5bfc\uff0c\u6545\u5982\u4f55\u5e2e\u52a9\u4e2d\u56fd\u7814\u7a76\u8005\u66f4\u597d\u5730\u5f00\u5c55 RWS \u7814\u7a76\uff0c\u63d0\u9ad8 RWS \u8d28\u91cf\uff0c\u662f\u7f16\u5199\u672c\u6307\u5357\u7684\u521d\u8877\u3002\u672c\u6307\u5357\u4e3a\u56fd\u5bb6\u91cd\u70b9\u7814\u53d1\u8ba1\u5212\u9879\u76ee\uff08\u9879\u76ee\u7f16\u53f7\uff1a 2016YFC1303800\uff09\u548c\u56fd\u5bb6\u516c\u76ca\u6027\u884c\u4e1a\u4e13\u9879\uff08\u9879\u76ee\u7f16\u53f7\uff1a201402031\uff09\u3002<\/span><\/p>\n


<\/p>\n

\u4e8c\uff0e\u51e0\u4e2a\u91cd\u8981\u6982\u5ff5\u7684\u5173\u7cfb<\/span><\/strong><\/span><\/p>\n

1. \u771f\u5b9e\u4e16\u754c\u8bc1\u636e\u4e0e\u771f\u5b9e\u4e16\u754c\u6570\u636e<\/span><\/strong><\/span><\/p>\n

\u771f\u5b9e\u4e16\u754c\u6570\u636e\u4e0d\u7b49\u540c\u4e8e\u771f\u5b9e\u4e16\u754c\u8bc1\u636e\u3002\u771f\u5b9e\u4e16\u754c\u6570\u636e\u901a\u8fc7\u4e25\u683c\u7684\u6570\u636e\u6536\u96c6\u3001\u7cfb\u7edf\u7684\u5904\u7406\u3001\u6b63<\/span>\u786e\u7684\u7edf\u8ba1\u5206\u6790\u4ee5\u53ca\u591a\u7ef4\u5ea6\u7684\u7ed3\u679c\u89e3\u8bfb\uff0c\u624d\u80fd\u4ea7\u751f\u771f\u5b9e\u4e16\u754c\u8bc1\u636e\u3002\u7f8e\u56fd FDA \u5728\u8bc4\u4f30\u771f\u5b9e\u4e16\u754c\u6570\u636e\u80fd\u5426\u6210\u4e3a\u771f\u5b9e\u4e16\u754c\u8bc1\u636e\u65f6\u9700\u8981\u770b\u5176\u6570\u636e\u7684\u8d28\u91cf\uff0c\u5305\u62ec\u771f\u5b9e\u4e16\u754c\u6570\u636e\u4e0e\u5176\u7ed3\u679c\u7684\u76f8\u5173\u6027\u4ee5\u53ca\u53ef\u9760\u6027\u7b49 [1] \u3002<\/span><\/span><\/p>\n


<\/span><\/strong><\/span><\/p>\n

2. \u771f\u5b9e\u4e16\u754c\u7814\u7a76\u4e0e\u968f\u673a\u5bf9\u7167\u4e34\u5e8a\u8bd5\u9a8c<\/span><\/strong><\/span><\/p>\n

RWS \u662f\u5bf9\u4e34\u5e8a\u5e38\u89c4\u4ea7\u751f\u7684\u771f\u5b9e\u4e16\u754c\u6570\u636e\u8fdb\u884c\u7cfb\u7edf\u6027\u6536\u96c6\u5e76\u8fdb\u884c\u5206\u6790\u7684\u7814\u7a76\uff0c\u4e0e\u968f\u673a\u5bf9\u7167\u4e34\u5e8a\u8bd5\u9a8c\uff08 Randomized Controlled Trial,  RCT\uff09\u662f\u4e92\u8865\u7684\u5173\u7cfb\uff0c\u5e76\u4e0d\u5bf9\u7acb\u3002RWS \u548c RCT \u4e00\u6837\uff0c\u90fd\u9700\u8981\u79d1\u5b66\u5408\u7406\u7684\u7814\u7a76\u8bbe\u8ba1\uff0c\u7814\u7a76\u65b9\u6848\u4ee5\u53ca\u7edf\u8ba1\u8ba1\u5212\u3002\u53e6\u5916\u5224\u65ad RWS\u548c RCT\u7684\u6807\u51c6\u4e0d\u662f\u8bd5\u9a8c\u8bbe\u8ba1\u548c\u7814\u7a76\u65b9\u6cd5\uff0c\u800c\u662f\u7814\u7a76\u5b9e\u65bd\u7684\u573a\u666f [3] \u3002RWS \u6570\u636e\u6e90\u81ea\u533b\u7597\u673a\u6784\u3001\u5bb6\u5ead\u548c\u793e\u533a\u7b49\uff0c\u800c\u975e\u5b58\u5728\u8bf8\u591a\u4e25\u683c\u9650\u5236\u7684\u7406\u60f3\u73af\u5883\u3002RWS \u4e0e RCT \u76f8\u6bd4\uff0c\u5404\u5177\u7279\u70b9\uff0c\u8be6\u89c1\u8868 1\uff1a<\/span><\/p>\n

\"\u5206\u4eab\u4e28\u771f\u5b9e\u4e16\u754c\u7814\u7a76\u6307\u53572018\u5e74\u7248\uff08\u5168\u6587\uff09\"<\/p>\n


<\/p>\n

\u4e09\uff0e\u771f\u5b9e\u4e16\u754c\u7814\u7a76\u7684\u601d\u8def\u4e0e\u6d41\u7a0b<\/span><\/strong><\/span><\/p>\n

RWS \u7684\u5f00\u5c55\u987b\u4ece\u4e34\u5e8a\u95ee\u9898\u7684\u786e\u5b9a\u3001\u73b0\u6709\u6570\u636e\u60c5\u51b5\u7684\u8bc4\u4f30\u5207\u5165\uff08\u91c7\u7528\u65e2\u5f80\u56de\u987e\u6027\u6570\u636e\u6216\u662f\u524d\u77bb\u6027\u91c7\u96c6\u6570\u636e\uff0c\u8fdb\u4e00\u6b65\u5230\u7814\u7a76\u8bbe\u8ba1\u7684\u9009\u62e9\u4ee5\u53ca\u7edf\u8ba1\u5206\u6790\u65b9\u6cd5\u7684\u786e\u5b9a\u3001\u6570\u636e\u7684\u7ba1\u7406\u3001\u7edf\u8ba1\u5206\u6790\u3001\u7ed3\u679c\u89e3\u8bfb\u548c\u8bc4\u4ef7\u3001\u4ee5\u53ca\u6839\u636e\u9700\u6c42\u5224\u65ad\u662f\u5426\u52a0\u5165\u4e8b\u540e\u5206\u6790\uff08Adhoc analysis\uff09\u7b49\u6b65\u9aa4\uff08\u89c1\u56fe1\uff09\u3002\u7531\u4e8e RWS\u53ef\u80fd\u5b58\u5728\u4e00\u4e9b\u5185\u5728\u7684\u504f\u501a (Bias)\uff0c\u8fd9\u4e9b\u504f\u501a\u53ef\u80fd\u9650\u5236\u4e86\u771f\u5b9e\u4e16\u754c\u6570\u636e\u5728\u56e0\u679c\u5173\u7cfb\u4e0a\u7684\u63a8\u7406\u548c\u89e3\u8bfb\u3002\u56e0\u6b64\uff0c\u4e3a\u4e86\u51cf\u5c11\u6f5c\u5728\u7684\u504f\u501a\uff0c\u9700\u8981\u8c28\u614e\u800c\u5468\u5bc6\u7684\u7814\u7a76\u8bbe\u8ba1\uff0c\u5e76\u4e14\u5e94\u8be5\u786e\u5b9a\u7814\u7a76\u95ee\u9898\u540e\u5c3d\u65e9\u5f00\u59cb\u5236\u5b9a\u7814\u7a76\u65b9\u6848\u548c\u7edf\u8ba1\u5206\u6790\u8ba1\u5212\u3002<\/span><\/p>\n

\"\u5206\u4eab\u4e28\u771f\u5b9e\u4e16\u754c\u7814\u7a76\u6307\u53572018\u5e74\u7248\uff08\u5168\u6587\uff09\"<\/p>\n


<\/p>\n

\u56db\uff0e\u4e34\u5e8a\u95ee\u9898\u7684\u786e\u5b9a\u548c\u7814\u7a76\u8bbe\u8ba1\u5e38\u89c1\u7c7b\u578b<\/span><\/strong><\/span><\/p>\n

RWS\u901a\u5e38\u4f1a\u56f4\u7ed5\u7740\u75c5\u56e0\uff0c\u8bca\u65ad\uff0c\u6cbb\u7597\uff0c\u9884\u540e\u53ca\u4e34\u5e8a\u9884\u6d4b [4] \u7b49\u76f8\u5173\u7684\u7814\u7a76\u95ee\u9898\u5c55\u5f00\u3002\u75c5\u56e0\u7814\u7a76\u4e3b\u8981\u662f\u7814\u7a76\u5371\u9669\u56e0\u7d20\u4e0e\u75be\u75c5\u4e4b\u95f4\u7684\u5173\u7cfb\uff0c\u5e76\u7814\u7a76\u5f15\u8d77\u4eba\u4f53\u53d1\u75c5\u7684\u673a\u5236\uff0c\u5982\u7814\u7a76\u5e7d\u95e8\u87ba\u6746\u83cc\u611f\u67d3\u4e0e\u5341\u4e8c\u6307\u80a0\u6e83\u75a1\u7684\u5173\u7cfb\u3002\u8bca\u65ad\u7814\u7a76\u4e3b\u8981\u662f\u7814\u7a76\u67d0\u7c7b\u65b0\u65b9\u6cd5\u5bf9\u7279\u5b9a\u75be\u75c5\u8bca\u65ad\u7684\u51c6\u786e\u5ea6\u7814\u7a76\uff0c\u4ee5\u5224\u65ad\u65b0\u8bca\u65ad\u65b9\u6cd5\u7684\u4e34\u5e8a\u4ef7\u503c\u3002\u6cbb\u7597\u6027\u7814\u7a76\u4e3b\u8981\u662f\u7814\u7a76\u67d0\u7c7b\u6cbb\u7597\u65b9\u6848\u5bf9\u7279\u5b9a\u75be\u75c5\u7684\u7597\u6548\u53ca\u526f\u4f5c\u7528\u7814\u7a76\u3002\u4e3b\u8981\u5305\u62ec\u4e24\u65b9\u9762\uff1a\u2460 \u6cbb\u7597\u65b9\u6848\u5bf9\u7279\u5b9a\u75be\u75c5\u7684\u7597\u6548\u7814\u7a76\uff1b\u2461\u6cbb\u7597\u65b9\u6848\u7684\u4e0d\u826f\u53cd\u5e94\u7814\u7a76\u3002\u9884\u540e\u7814\u7a76\u662f\u5bf9\u75be\u75c5\u53d1\u5c55\u7684\u4e0d\u540c\u7ed3\u5c40\u7684\u53ef\u80fd\u6027\u7684\u9884\u6d4b\u4ee5\u53ca\u4e0e\u5f71\u54cd\u5176\u9884\u540e\u7684\u56e0\u7d20\u7814\u7a76\uff0c\u4e3b\u8981\u5305\u542b\u4e09\u5927\u7c7b\uff1a \u2460 \u5bf9\u75be\u75c5\u7684\u9884\u540e\u72b6\u51b5\u8fdb\u884c\u5ba2\u89c2\u63cf\u8ff0\uff1b\u2461 \u5bf9\u5f71\u54cd\u9884\u540e\u7684\u56e0\u7d20\u8fdb\u884c\u7814\u7a76\uff1b \u2462 \u5bf9\u5065\u5eb7\u76f8\u5173\u751f\u6d3b\u8d28\u91cf\u7684\u7814\u7a76\u3002\u4e34\u5e8a\u9884\u6d4b\u7814\u7a76\u5219\u662f\u5bfb\u627e\u51fa\u6700\u4f73\u7684\u5bf9\u75be\u75c5\u8bca\u65ad\u6216\u75be\u75c5\u8f6c\u5f52\u7684\u9884\u6d4b\u6307\u6807\u6216\u75c7\u72b6\u7b49\uff0c\u4e3b\u8981\u5305\u62ec\u8bca\u65ad\u9884\u6d4b\u7814\u7a76\u548c\u9884\u540e\u9884\u6d4b\u7814\u7a76 \u3002\u9664\u4e0a\u8ff0\u7814\u7a76\u5916\uff0cRWS \u4e5f\u4f1a\u6d89\u53ca\u836f\u7269\u7ecf\u6d4e\u5b66\u7814\u7a76\u7b49\u5176\u5b83\u7814\u7a76\u7c7b\u578b\u3002<\/span><\/p>\n

RWS \u5305\u62ec\u89c2\u5bdf\u6027\u7814\u7a76\u548c\u8bd5\u9a8c\u6027\u7814\u7a76\u3002\u5176\u4e2d\u89c2\u5bdf\u6027\u7814\u7a76\u8fdb\u4e00\u6b65\u5206\u4e3a\u63cf\u8ff0\u6027\u7814\u7a76\uff08\u75c5\u4f8b\u4e2a\u6848\u62a5\u544a\u3001\u5355\u7eaf\u75c5\u4f8b\u3001\u6a2a\u65ad\u9762\u7814\u7a76\uff09\u548c\u5206\u6790\u6027\u7814\u7a76\u3010\uff08\u5de2\u5f0f\uff09\u75c5\u4f8b\u5bf9\u7167\u7814\u7a76\u3001\u961f\u5217\u7814\u7a76\u3011\uff0c\u8bd5\u9a8c\u6027\u7814\u7a76\u5373\u5b9e\u6548\u6027\u4e34\u5e8a\u7814\u7a76\uff08Pragmatic randomized clinical trial\uff0cPRCT\uff09\u3002\u9664\u6b64\u4ee5\u5916\uff0c\u4e00\u4e9b\u65b0\u578b\u7684\u7814\u7a76\u8bbe\u8ba1\u5982\u75c5\u4f8b\u4ea4\u53c9\u8bbe\u8ba1\u548c\u5e8f\u8d2f\u8bbe\u8ba1\u7b49\u4e5f\u88ab\u7528\u5728\u57fa\u4e8e\u73b0\u6709\u6570\u636e\u7684\u7814\u7a76\u4e2d\u3002\u4e0b\u8868\u662f\u5e38\u89c1\u7814\u7a76\u7c7b\u578b\u5bf9\u5e94\u7684\u4e34\u5e8a\u5e94\u7528\u573a\u666f\u53ca\u4f18\u52a3\u52bf\u6bd4\u8f83\uff0c\u4f9b\u53c2\u8003\u3002<\/span><\/p>\n

\"\u5206\u4eab\u4e28\u771f\u5b9e\u4e16\u754c\u7814\u7a76\u6307\u53572018\u5e74\u7248\uff08\u5168\u6587\uff09\"<\/p>\n

\"\u5206\u4eab\u4e28\u771f\u5b9e\u4e16\u754c\u7814\u7a76\u6307\u53572018\u5e74\u7248\uff08\u5168\u6587\uff09\"<\/p>\n


<\/p>\n

\u4e94\uff0e\u57fa\u4e8e\u4e0d\u540c\u6570\u636e\u6e90\u7684\u7814\u7a76\u8981\u7d20<\/span><\/strong><\/span><\/p>\n

1. \u57fa\u4e8e\u73b0\u6709\u6570\u636e<\/span><\/strong><\/span><\/p>\n

1.1 \u73b0\u6709\u6570\u636e\u5229\u7528<\/span><\/strong><\/span><\/p>\n

\u73b0\u6709\u6570\u636e\u4e3b\u8981\u5305\u542b\u7535\u5b50\u75c5\u5386\uff08electronic medical record, EMR\uff09\uff0c\u7535\u5b50\u5065\u5eb7\u6863\u6848\uff08electronic <\/span>health record, EHR\uff09\uff0c\u533b\u4fdd\u6570\u636e\uff08claims data\uff09\uff0c\u51fa\u751f\u6b7b\u4ea1\u767b\u8bb0\uff0c\u516c\u5171\u5065\u5eb7\u76d1\u6d4b\u6570\u636e\u4ee5\u53ca\u533a\u57df\u5316\u533b\u7597\u6570\u636e\u7b49\uff0c\u8fd9\u4e9b\u6570\u636e\u6570\u91cf\u975e\u5e38\u5e9e\u5927\uff0c\u4f46\u7531\u4e8e\u6570\u636e\u7684\u91c7\u96c6\u5e76\u975e\u4e3a\u67d0\u7279\u5b9a\u7814\u7a76\u76ee\u7684\u800c\u8bbe\u8ba1\uff0c\u6570\u636e\u5206\u6563\uff0c\u5f02\u8d28\u6027\u9ad8\uff0c\u6570\u636e\u7684\u5b8c\u6574\u6027\u53ca\u51c6\u786e\u6027\u4e5f\u5b58\u5728\u4e00\u4e9b\u95ee\u9898\u3002\u53e6\u5916\u533b\u4fdd\u6570\u636e\u4e00\u822c\u7531\u5404\u7ea7\u653f\u5e9c\u673a\u6784\u638c\u63e1\uff0c\u53ef\u53ca\u6027\u8f83\u5f31\u3002<\/span><\/p>\n


<\/p>\n

1.2 \u6570\u636e\u53ef\u884c\u6027\u8bc4\u4f30<\/span><\/strong><\/span><\/p>\n

\u6570\u636e\u53ef\u884c\u6027\u8bc4\u4f30\u9996\u5148\u57fa\u4e8e\u5f85\u7814\u7a76\u7684\u4e34\u5e8a\u95ee\u9898\uff0c\u786e\u5b9a\u4e3b\u8981\u7814\u7a76\u53d8\u91cf\u6bd4\u5982\u5f85\u7814\u7a76\u7684\u6cbb\u7597\u63aa\u65bd\uff0c\u5173\u952e\u57fa\u7ebf\u4fe1\u606f\uff0c\u4e3b\u8981\u7814\u7a76\u7ed3\u5c40\u5305\u62ec\u60a3\u8005\u4e3b\u8981\u4eba\u53e3\u7edf\u8ba1\u5b66\u7279\u5f81\u3001\u60a3\u75c5\u53f2\u3001\u5e76\u53d1\u75c7\u3001\u5408\u5e76\u75c7\u548c\u5b9e\u9a8c\u5ba4\u6307\u6807\u7b49\u5173\u952e\u6570\u636e\u662f\u5426\u5b58\u5728\uff1b\u5176\u6b21\u5bf9\u7f3a\u5931\u6570\u636e\u7684\u6570\u91cf\u548c\u7c7b\u578b\u7684\u5f71\u54cd\u8fdb\u884c\u5168\u9762\u8bc4\u4f30\uff0c\u5305\u62ec\u4e3b\u8981\u7814\u7a76\u53d8\u91cf\u53ca\u5176\u4ed6\u76f8\u5173\u7814\u7a76\u53d8\u91cf\uff0c\u53ef\u4ee5\u901a\u8fc7\u62bd\u6837\u6216\u5168\u6570\u636e\u96c6\u6765\u68c0\u67e5\u5173\u952e\u53d8\u91cf\u7684\u6570\u636e\u7f3a\u5931\u7a0b\u5ea6\u548c\u6a21\u5f0f\u6765\u5b9e\u73b0\u3002\u53e6\u5916\u8fd8\u9700\u8fdb\u884c\u6570\u636e\u8d28\u91cf\u8bc4\u4f30\uff1a\u5305\u542b\u6570\u636e\u7684\u51c6\u786e\u6027\uff0c\u53ef\u9760\u6027\uff0c\u5b8c\u6574\u6027\u53ca\u53ef\u6eaf\u6e90\u6027\u7b49\u8bc4\u4f30\u3002<\/span><\/p>\n


<\/p>\n

1.3 \u7814\u7a76\u8bbe\u8ba1\u7684\u8003\u91cf<\/span><\/strong><\/span><\/p>\n

    \n
  • \n

    \u7814\u7a76\u4eba\u7fa4\u548c\u5165\u6392\u6807\u51c6<\/span><\/strong><\/span><\/p>\n<\/li>\n<\/ul>\n

    \u56de\u987e\u6027\u961f\u5217\u548c\u75c5\u4f8b\u5bf9\u7167\u7814\u7a76\u4e2d\uff0c\u9996\u5148\u9700\u8981\u786e\u5b9a\u7814\u7a76\u5bf9\u8c61\u5c24\u5176\u662f\u5bf9\u7167\u7684\u9009\u62e9\u548c\u5165\u6392\u6807\u51c6\u7684\u8bbe\u5b9a\u3002\u75c5\u4f8b\u5bf9\u7167\u7814\u7a76\u4e2d\uff0c\u5bf9\u7167\u5e94\u5c3d\u91cf\u9009\u62e9\u5185\u90e8\u5bf9\u7167\uff0c\u9009\u62e9\u6ca1\u6709\u53d1\u751f\u7814\u7a76\u7ed3\u5c40\u7684\u4eba\u7fa4\uff0c\u4e14\u4e0e\u75c5\u4f8b\u6765\u81ea\u540c\u4e00\u4eba\u7fa4\uff1b\u5bf9\u7167\u7684\u9009\u62e9\u4e0d\u53d7\u66b4\u9732\u56e0\u7d20\u7684\u5f71\u54cd\uff0c\u5373\u9664\u4e86\u66b4\u9732\u56e0\u7d20\u5916\uff0c\u5bf9\u7167\u5e94\u4e0e\u75c5\u4f8b\u5728\u5176\u4ed6\u7279\u5f81\u4e0a\u76f8\u4f3c\uff1b\u75c5\u4f8b\u5bf9\u7167\u6bd4\u4f8b\u53ef\u4ee5\u4ece 1:1 \u5230 1:4 \u4e0d\u7b49\u3002\u5355\u7eaf\u75c5\u4f8b\u7814\u7a76\u8bbe\u8ba1\u5219\u65e0\u9700\u5bf9\u7167\u7ec4\u3002\u56de\u987e\u6027\u961f\u5217\u8bbe\u8ba1\u4e2d\uff0c\u987b\u6839\u636e\u7814\u7a76\u95ee\u9898\u6e05\u6670\u5b9a\u4e49\u66b4\u9732\uff0c\u6bd4\u5982\u53ef\u4ee5\u662f\u6709\/\u65e0\u67d0\u6cbb\u7597\u65b9\u6848\uff0c\u66b4\u9732\u7684\u7a0b\u5ea6\u5982\u5242\u91cf\uff0c\u6216\u8005\u66b4\u9732\u7684\u6a21\u5f0f\u5982\u987a\u5e8f\u7b49\u7b49\u3002\u975e\u66b4\u9732\u7ec4\u7684\u4eba\u7fa4\u5e94\u5728\u9664\u4e86\u66b4\u9732\u56e0\u7d20\u5916\u4e0e\u66b4\u9732\u7ec4\u5c3d\u53ef\u80fd\u76f8\u4f3c\u3002\u5728\u786e\u5b9a\u7814\u7a76\u4eba\u7fa4\u7684\u6807\u51c6\u540e\uff0c\u8981\u5728\u6570\u636e\u5e93\u4e2d\u4f7f\u7528\u4e00\u5b9a\u7684\u7b97\u6cd5\u548c\u4ee3\u7801\u6765\u8bc6\u522b\u7814\u7a76\u4eba\u7fa4\uff0c\u5982 ICD \u7f16\u7801\u548c\u836f\u54c1\u7f16\u7801\u3002\u503c\u5f97\u6ce8\u610f\u7684\u662f\uff0c\u4efb\u4f55\u4e00\u79cd\u7f16\u7801\u7531\u4e8e\u4e0d\u540c\u673a\u6784\u533b\u7597\u6c34\u5e73\u6216\u8005\u7535\u5b50\u75c5\u5386\u7cfb\u7edf\u5e73\u53f0\u4e0d\u540c\uff0c\u5bf9\u4e8e\u75be\u75c5\u8bca\u65ad\u7684\u51c6\u786e\u6027\u548c\u5b8c\u6574\u6027\u90fd\u4f1a\u6709\u6240\u4e0d\u540c\u3002\u56e0\u6b64\uff0c\u7efc\u5408\u5404\u9879\u7f16\u7801\u548c\u5b9e\u9a8c\u5ba4\u8bca\u65ad\u7b49\u8054\u5408\u7684\u8bc6\u522b\u65b9\u5f0f\uff0c\u662f\u57fa\u4e8e\u6570\u636e\u5e93\u5f00\u5c55\u7814\u7a76\u7684\u5e38\u7528\u65b9\u6cd5\u3002<\/span><\/p>\n


    <\/p>\n

      \n
    • \n

      \u66b4\u9732\u56e0\u7d20\u548c\u7814\u7a76\u7ec8\u70b9<\/span><\/strong><\/span><\/p>\n<\/li>\n<\/ul>\n

      \u66b4\u9732\u56e0\u7d20\u548c\u7814\u7a76\u7ec8\u70b9\u662f\u7814\u7a76\u4e2d\u9996\u8981\u8003\u91cf\u7684\u5173\u952e\u56e0\u7d20\u3002\u5728\u6570\u636e\u53ef\u884c\u6027\u8bc4\u4f30\u53ca\u7eb3\u5165\u548c\u6392\u9664\u7814\u7a76\u5bf9\u8c61\u7684\u9636\u6bb5\u4e4b\u540e\uff0c\u8fdb\u4e00\u6b65\u786e\u8ba4\u66b4\u9732\u72b6\u6001\u53ca\u7814\u7a76\u7ec8\u70b9\u7684\u51c6\u786e\u6027\u548c\u4ee3\u8868\u6027\uff0c\u662f\u5426\u6709\u4e0d\u540c\u6570\u636e\u4f50\u8bc1\u5173\u952e\u6570\u636e\u7684\u51c6\u786e\u6027\u3002\u5982\u679c\u7814\u7a76\u57fa\u4e8e\u5df2\u6709\u75c5\u4f8b\u6570\u636e\uff0c\u5219\u9700\u7279\u522b\u6ce8\u610f\u6536\u96c6\u6570\u636e\u7684\u5b8c\u6574\u6027\u3001\u771f\u5b9e\u6027\u548c\u53ef\u6eaf\u6e90\u6027\uff1b\u5982\u679c\u7814\u7a76\u57fa\u4e8e\u60a3\u8005\u7684\u81ea\u6211\u62a5\u544a\u6216\u8005\u7814\u7a76\u8005\u7684\u56de\u5fc6\uff0c\u5219\u987b\u5f3a\u8c03\u6570\u636e\u7684\u51c6\u786e\u6027\u548c\u771f\u5b9e\u6027\uff0c\u4ee5\u9632\u51fa\u73b0\u56de\u5fc6\u504f\u501a\u3002<\/span><\/p>\n


      <\/p>\n

        \n
      • \n

        \u6837\u672c\u91cf<\/span><\/strong><\/span><\/p>\n<\/li>\n<\/ul>\n

        RWS \u540c\u6837\u9700\u8981\u5c06\u6837\u672c\u91cf\u7684\u4f30\u8ba1\u4f5c\u4e3a\u4e0d\u53ef\u7f3a\u5c11\u7684\u8bbe\u8ba1\u8981\u7d20\u4e4b\u4e00\u3002\u5bf9\u4e8e\u5b58\u5728\u5047\u8bbe\u68c0\u9a8c\u7684\u5206\u6790\u6027\u7814\u7a76\uff08\u5982\u75c5\u4f8b\u5bf9\u7167\u8bbe\u8ba1\u3001\u961f\u5217\u8bbe\u8ba1\u7b49\uff09\uff0c\u5982\u679c\u6837\u672c\u91cf\u4e0d\u8db3\uff0c\u4f1a\u5bfc\u81f4\u6ca1\u6709\u8db3\u591f\u7684\u628a\u63e1\u5ea6\uff08power\uff09\u53bb\u68c0\u9a8c\u63d0\u51fa\u7684\u95ee\u9898\u548c\u5047\u8bf4\u3002\u57fa\u4e8e\u4e0d\u540c\u7814\u7a76\u7c7b\u578b\u9700\u8981\u4f9d\u636e\u4e0d\u540c\u7684\u7edf\u8ba1\u5206\u6790\u65b9\u6cd5\uff0c\u786e\u5b9a\u91cd\u8981\u53c2\u6570\uff0c\u5b9a\u4e49 I \u7c7b\u9519\u8bef\u548c\u628a\u63e1\u5ea6\uff0c\u5728\u4fdd\u8bc1\u7814\u7a76\u5177\u6709\u4e00\u5b9a\u53ef\u9760\u6027\u6761\u4ef6\u4e0b\uff0c\u4f30\u8ba1\u5e76\u786e\u5b9a\u6700\u5c0f\u6837\u672c\u91cf\uff0c\u786e\u4fdd\u7814\u7a76\u540c\u65f6\u5177\u5907\u79d1\u5b66\u6027\u548c\u7ecf\u6d4e\u6027\u3002\u53e6\u4e00\u65b9\u9762\uff0cRWS \u5f80\u5f80\u91c7\u7528\u8f83\u5bbd\u6cdb\u7684\u7eb3\u6392\u6807\u51c6\uff0c\u6709\u65f6\u9700\u8981\u968f\u8bbf\u8f83\u957f\u65f6\u95f4\u6765\u6765\u7814\u7a76\u957f\u671f\u4e34\u5e8a\u7ed3\u5c40\uff0c\u5145\u5206\u53cd\u6620\u5b9e\u9645\u7684\u4e34\u5e8a\u5b9e\u8df5\uff0c\u56e0\u6b64\u5e94\u5728\u786e\u5b9a\u6700\u5c0f\u6837\u672c\u91cf\u7684\u57fa\u7840\u4e0a\uff0c\u5c3d\u53ef\u80fd\u5730\u6269\u5927\u6837\u672c\u91cf\u4ee5\u4fdd\u8bc1\u5176\u80fd\u591f\u8986\u76d6\u66f4\u5e7f\u6cdb\u7684\u60a3\u8005\u7fa4\u4f53\u5e76\u8003\u8651\u5230\u8f83\u957f\u968f\u8bbf\u65f6\u95f4\u5bfc\u81f4\u7684\u5931\u8bbf\u7684\u53ef\u80fd\u6027\u3002\u5728\u5177\u6709\u5f02\u8d28\u6027\u7684\u60a3\u8005\u7fa4\u4f53\u4e2d\u53ef\u8fdb\u884c\u4e9a\u7ec4\u5206\u6790\uff0c\u4ece\u800c\u62d3\u5c55\u7814\u7a76\u7684\u610f\u4e49\u3002\u5177\u4f53\u6837\u672c\u91cf\u7684\u4f30\u7b97\u9700\u8981\u5728\u4e34\u5e8a\u533b\u751f\u3001\u7edf\u8ba1\u5e08\u548c\u6d41\u884c\u75c5\u5b66\u5bb6\u7b49\u7684\u5408\u4f5c\u4e0b\u5171\u540c\u5b8c\u6210\u3002<\/span><\/p>\n


        <\/p>\n

          \n
        • \n

          \u7edf\u8ba1\u65b9\u6cd5\u7684\u8003\u91cf<\/span><\/strong><\/span><\/p>\n<\/li>\n<\/ul>\n

          \u5e94\u5728\u7814\u7a76\u95ee\u9898\u786e\u5b9a\u540e\uff0c\u5c3d\u65e9\u5236\u5b9a\u7814\u7a76\u65b9\u6848\u548c\u7edf\u8ba1\u5206\u6790\u8ba1\u5212\uff0c\u5c06\u89e3\u51b3\u4e3b\u8981\u7814\u7a76\u76ee\u7684\u7edf\u8ba1\u65b9\u6cd5\u7eb3\u5165\u3002RWS \u7684\u7edf\u8ba1\u65b9\u6cd5\u548c\u7597\u6548\u6bd4\u8f83\u7814\u7a76\uff08Comparative effectiveness research, CER\uff09 [5] \u7684\u5206\u6790\u65b9\u6cd5\u6709\u7c7b\u4f3c\u4e4b\u5904\u3002\u56e0 RWS \u63a5\u8fd1\u4e34\u5e8a\u5b9e\u9645\uff0c\u7814\u7a76\u5bf9\u8c61\u7684\u7eb3\u5165\u9650\u5236\u8f83\u5c11\u3001\u4eba\u7fa4\u7684\u5f02\u8d28\u6027\u8f83\u5927\u3001\u81ea\u4e3b\u9009\u62e9\u6cbb\u7597\u63aa\u65bd\u7b49\u9020\u6210\u6f5c\u5728\u504f\u501a\u548c\u6df7\u6742\uff0c\u56e0\u6b64\u7edf\u8ba1\u65b9\u6cd5\u66f4\u591a\u662f\u5173\u6ce8\u5982\u4f55\u51cf\u5c0f\u548c\u63a7\u5236\u504f\u501a\u548c\u6df7\u6742\u3002\u5e38\u89c1\u7684\u6709\u5339\u914d\u3001\u5206\u5c42\u5206\u6790\u548c\u591a\u53d8\u91cf\u5206\u6790\u3002\u5728\u8f83\u591a\u98ce\u9669\u56e0\u7d20\u6216\u8005\u7814\u7a76\u56e0\u7d20\u7684\u60c5\u51b5\u4e0b\uff0c\u4f7f\u7528\u591a\u53d8\u91cf\u5206\u6790\u5c06\u591a\u4e2a\u56e0\u7d20\u540c\u65f6\u7eb3\u5165\u6a21\u578b\uff0c\u4f1a\u7531\u4e8e\u5171\u7ebf\u6027\u7b49\u95ee\u9898\uff0c\u4f7f\u5f97\u6a21\u578b\u65e0\u6cd5\u6b63\u5e38\u8fd0\u884c\u3002\u503e\u5411\u6027\u8bc4\u5206\u5339\u914d\uff08propensity score matching\uff09\u6216\u8005\u5206\u5c42\uff08stratification\uff09\u5219\u662f\u89e3\u51b3\u8be5\u7c7b\u95ee\u9898\u7684\u5e38\u7528\u7edf\u8ba1\u65b9\u6cd5\u3002\u6210\u672c\u6548\u76ca\u6a21\u578b\u3001\u8d1d\u53f6\u65af\u6a21\u578b\u7b49\u4e5f\u5e38\u5e94\u7528\u4e8e RWS \u7684\u7814\u7a76\u8bbe\u8ba1\u4e2d\u3002<\/span><\/p>\n

          \u53e6\u5916\uff0c\u5229\u7528\u5df2\u6709\u6570\u636e\u5e93\u5f00\u5c55\u7684\u9884\u6d4b\u7814\u7a76\u4e5f\u662f\u5e38\u89c1\u7684 RWS \u7c7b\u578b\u4e4b\u4e00\uff0c\u662f\u5bf9\u75be\u75c5\u5404\u79cd\u7ed3\u5c40\u53d1\u751f\u6982\u7387\u53ca\u5176\u5f71\u54cd\u56e0\u7d20\u7684\u7814\u7a76\u3002\u4f20\u7edf\u7684\u7edf\u8ba1\u65b9\u6cd5\u5305\u62ec Logistic \u56de\u5f52\u548c Cox \u56de\u5f52\u4ee5\u53ca\u5217\u7ebf\u56fe\uff08nomogram\uff09\uff0c\u53ef\u4ee5\u7528\u6765\u9884\u6d4b\u75be\u75c5\u8f6c\u5f52\u6216\u8005\u5e76\u53d1\u75c7\u7684\u53d1\u751f\u6982\u7387\uff1b\u53e6\u5916\uff0c\u8fd1\u5e74\u6765\u53d1\u5c55\u51fa\u7684\u57fa\u4e8e\u771f\u5b9e\u4e16\u754c\u5927\u6570\u636e\u7684\u673a\u5668\u5b66\u4e60\uff08machine learning\uff09\u7684\u65b9\u6cd5\u4e5f\u662f\u7528\u4e8e\u9884\u6d4b\u7814\u7a76\u7684\u5e38\u7528\u5de5\u5177\u3002<\/span><\/p>\n


          <\/p>\n

            \n
          • \n

            \u5904\u7406\u7f3a\u5931\u6570\u636e<\/span><\/strong><\/span><\/p>\n<\/li>\n<\/ul>\n

            \u5728 RWS \u4e2d\uff0c\u6570\u636e\u7684\u7f3a\u5931\u662f\u4e00\u4e2a\u4e0d\u53ef\u907f\u514d\u7684\u95ee\u9898\u3002\u9884\u9632\u7b56\u7565\u548c\u7edf\u8ba1\u8c03\u6574\u53ef\u4ee5\u51cf\u5c11\u7f3a\u5931\u6570\u636e\u5bf9\u7814\u7a76\u7ed3\u679c\u7684\u5f71\u54cd\uff0c\u63d0\u9ad8\u7ed3\u679c\u7684\u53ef\u9760\u6027\u3002\u5173\u6ce8\u4e0d\u540c\u7814\u7a76\u7c7b\u578b\u53ef\u80fd\u51fa\u73b0\u7684\u6570\u636e\u7f3a\u5931\u4e5f\u53ef\u5e2e\u52a9\u51cf\u5c11\u7f3a\u5931\u6570\u636e\u5bf9\u7814\u7a76\u7ed3\u679c\u5f71\u54cd\u3002<\/span><\/p>\n

            \u4f7f\u7528\u7535\u5b50 EHR\u3001EMR \u6216\u8005\u533b\u7597\u4fdd\u9669\u7b49\u6570\u636e\u6e90\u4f1a\u51fa\u73b0\u4e0d\u540c\u7684\u95ee\u9898\u3002\u7531\u4e8e\u7814\u7a76\u8005\u5f80\u5f80\u65e0\u6cd5\u91c7\u96c6\u989d\u5916\u7684\u6570\u636e\uff0c\u56e0\u6b64\u7814\u7a76\u524d\u6570\u636e\u53ef\u884c\u6027\u8bc4\u4f30\u662f\u975e\u5e38\u91cd\u8981\u7684\u73af\u8282\u3002\u4f8b\u5982\uff0c\u5bf9\u4e8e\u4e34\u8fd1\u6b7b\u4ea1\u7684\u60a3\u8005\uff0c\u75c7\u72b6\u53ef\u80fd\u8bb0\u5f55\u4e0d\u5b8c\u6574\uff0c\u800c\u8fd9\u79cd\u7f3a\u5931\u4fe1\u606f\u53ef\u80fd\u4f7f\u8fd9\u4e9b\u60a3\u8005\u7684\u76f8\u5173\u6570\u636e\u770b\u4e0a\u53bb\u6bd4\u5b9e\u9645\u72b6\u51b5\u66f4\u5065\u5eb7\u800c\u9020\u6210\u7814\u7a76\u504f\u501a\u3002\u6709\u65f6\u6570\u636e\u7684\u7f3a\u5931\u5e76\u975e\u968f\u673a\u7684\uff0c\u5982\u679c\u5ffd\u7565\u7f3a\u5931\u6570\u636e\u7684\u5185\u5728\u89c4\u5f8b\uff0c\u90a3\u4e48\u4f1a\u4e22\u6389\u91cd\u8981\u7684\u4fe1\u606f\u3002\u5bf9\u4e8e\u7f3a\u5931\u6570\u636e\uff0c\u5728\u80fd\u591f\u6eaf\u6e90\u7684\u60c5\u51b5\u4e0b\uff0c\u5219\u5c3d\u53ef\u80fd\u8865\u5168\u76f8\u5e94\u7f3a\u5931\u6570\u636e\uff1b\u5bf9\u4e8e\u65e0\u6cd5\u6eaf\u6e90\u7684\u60c5\u51b5\uff0c\u5219\u5c55\u5f00\u63a2\u7d22\u6027\u5206\u6790\uff0c\u660e\u786e\u7f3a\u5931\u503c\u5728\u5404\u4e2a\u7814\u7a76\u56e0\u7d20\u4e2d\u7684\u5206\u5e03\u60c5\u51b5\uff0c\u5224\u65ad\u5176\u5206\u5e03\u662f\u5426\u968f\u673a\uff0c\u5982\u6709\u504f\u501a\uff0c\u5219\u9700\u8003\u8651\u540e\u671f\u5206\u5c42\u5206\u6790\u3002<\/span><\/p>\n


            <\/p>\n

            1.4 \u5176\u4ed6\u5e38\u89c1\u95ee\u9898<\/span><\/strong><\/span><\/p>\n

              \n
            • \n

              \u4e0d\u540c\u6570\u636e\u5e93\u6574\u5408\u7684\u95ee\u9898<\/span><\/strong><\/span><\/p>\n<\/li>\n<\/ul>\n

              \u5bf9\u4e8e\u4e0d\u540c\u6570\u636e\u5e93\u7684\u6574\u5408\uff0c\u4e00\u822c\u5efa\u8bae\u9996\u5148\u5bf9\u5404\u81ea\u6570\u636e\u5e93\u4e2d\u6570\u636e\u8fdb\u884c\u8d28\u91cf\u8bc4\u4f30\u548c\u5206\u5c42\u5206\u7ea7\uff0c\u786e\u5b9a\u597d\u9700\u8981\u6574\u5408\u7684\u5185\u5bb9\u3002\u5728\u6574\u5408\u8fc7\u7a0b\u4e2d\uff0c\u77db\u76fe\u7684\u6570\u636e\u662f\u91cd\u4e2d\u4e4b\u91cd\uff0c\u9700\u8981\u91cd\u70b9\u5173\u6ce8\u3002\u5efa\u7acb\u7edf\u4e00\u7684\u6570\u636e\u6807\u51c6\uff0c\u5c06\u4e0d\u540c\u6570\u636e\u5e93\u7684\u6570\u636e\u7ed3\u6784\u8fdb\u884c\u6807\u51c6\u5316\u5904\u7406\u3002\u5728\u6574\u5408\u8fc7\u7a0b\u4e2d\u5bf9\u4e8e\u65e0\u6cd5\u6574\u5408\u7684\u6570\u636e\u8fdb\u884c\u5904\u7406, \u540c\u65f6\u9700\u8981\u6ce8\u610f\u56e0\u6574\u5408\u9020\u6210\u7684\u7cfb\u7edf\u8bef\u5dee\uff0c\u4ee5\u53ca\u5173\u6ce8\u6574\u5408\u540e\u7684\u4e3b\u8981\u7814\u7a76\u56e0\u7d20\uff0c\u66b4\u9732\u56e0\u7d20\u53ca\u4e3b\u8981\u6df7\u6742\u56e0\u7d20\u7684\u5f71\u54cd\u3002<\/span><\/p>\n


              <\/p>\n

                \n
              • \n

                \u5206\u5b50\u6807\u8bb0\u7269\u76f8\u5173\u7814\u7a76\u7684\u6ce8\u610f\u4e8b\u9879<\/span><\/strong><\/span><\/p>\n<\/li>\n<\/ul>\n

                \u5f00\u5c55\u5206\u5b50\u6807\u8bb0\u7269\u76f8\u5173\u7684 RWS\uff0c\u7531\u4e8e\u91c7\u96c6\u751f\u7269\u6837\u672c\u7684\u96be\u5ea6\u4ee5\u53ca\u5176\u6d4b\u91cf\u7684\u7279\u6b8a\u6027\uff0c\u7814\u7a76\u8bbe\u8ba1\u9700\u8981\u6ce8\u610f\u4ee5\u4e0b\u7684\u95ee\u9898\u3002<\/span><\/p>\n

                \u57fa\u4e8e\u5df2\u6709\u6570\u636e\u5e93\u7684\u56de\u987e\u6027\u7814\u7a76\u9700\u8981\u8003\u8651\u60a3\u8005\u7684\u57fa\u7ebf\u7279\u5f81\u548c\u4ee3\u8868\u6027\u7684\u95ee\u9898\uff0c\u7531\u4e8e\u7f3a\u5931\u7684\u751f\u7269\u6837\u672c\u800c\u5bfc\u81f4\u7684\u6570\u636e\u7f3a\u5931\uff0c\u591a\u91cd\u68c0\u9a8c\u5bfc\u81f4\u7684\u201c\u5047\u9633\u6027\u201d\u7ed3\u679c\uff0c\u6570\u636e\u5206\u6790\u548c\u7ed3\u679c\u89e3\u91ca\u4e2d\u7684\u504f\u501a\uff0c\u4ee5\u53ca\u7814\u7a76\u7ed3\u679c\u662f\u5426\u5177\u6709\u53ef\u91cd\u590d\u6027\u7b49\u3002<\/span><\/p>\n

                \u524d\u77bb\u6027\u7684\u7814\u7a76\u5219\u9700\u8003\u8651\uff0c\u53ef\u80fd\u6709\u751f\u7269\u6837\u672c\u4f46\u662f\u6ca1\u6709\u8be6\u7ec6\u7684\u60a3\u8005\u57fa\u672c\u4fe1\u606f\u7684\u60c5\u51b5\uff1b\u6837\u672c\u91cf\u5c0f, \u4e14\u60a3\u8005\u4eba\u7fa4\u7f3a\u4e4f\u4ee3\u8868\u6027\uff1b\u5b9e\u9a8c\u68c0\u6d4b\u65b9\u6cd5\u662f\u5426\u7ecf\u8fc7\u9a8c\u8bc1\uff1b\u6709\u5206\u5b50\u6807\u8bb0\u7269\u6d4b\u91cf\u7ed3\u679c\uff0c\u6ca1\u6709\u6216\u4ec5\u6709\u6709\u9650\u4e34\u5e8a\u7ed3\u5c40\u6570\u636e\uff08\u5982\u603b\u751f\u5b58\u7387\uff0c \u65e0\u8fdb\u5c55\u751f\u5b58\u671f\u7b49\uff09\u7684\u60c5\u51b5\uff1b\u4e34\u5e8a\u6570\u636e\u6216\u8005\u7814\u7a76\u7ec8\u70b9\u6570\u636e\u7684\u8d28\u91cf\u7b49\u3002<\/span><\/p>\n


                <\/p>\n

                  \n
                • \n

                  \u7528\u6570\u636e\u5e93\u5f00\u5c55\u7814\u7a76\uff0c\u77e5\u60c5\u540c\u610f\u548c\u4f26\u7406\u5ba1\u6279\u7684\u76f8\u5173\u4e8b\u5b9c<\/span><\/strong><\/span><\/p>\n<\/li>\n<\/ul>\n

                  \u771f\u5b9e\u4e16\u754c\u7814\u7a76\u7684\u6570\u636e\u6536\u96c6\uff0c\u60a3\u8005\u7684\u4fe1\u606f\u6709\u53ef\u80fd\u4f1a\u6210\u4e3a\u7814\u7a76\u8d44\u6599\uff0c\u56e0\u6b64\u60a3\u8005\u672c\u8eab\u5728\u67d0\u79cd\u7a0b\u5ea6\u4e0a\u53ef\u80fd\u4e5f\u5df2\u6210\u4e3a\u201c\u53d7\u8bd5\u8005\u201d\uff0c\u6240\u4ee5\u771f\u5b9e\u4e16\u754c\u7814\u7a76\u540c\u6837\u9700\u8981\u7b26\u5408\u4f26\u7406\u7684\u8981\u6c42\u3002\u56e0\u6b64\u67d0\u4e9b\u60c5\u51b5\u4e0b\uff0c\u771f\u5b9e\u4e16\u754c\u7814\u7a76\u4e5f\u9700\u83b7\u5f97\u4f26\u7406\u5ba1\u67e5\u59d4\u5458\u4f1a\u7684\u5907\u6848\u6216\u6279\u51c6\u3002<\/span><\/p>\n

                  \u77e5\u60c5\u540c\u610f\u662f\u4fdd\u8bc1\u7814\u7a76\u7b26\u5408\u4f26\u7406\u8981\u6c42\u7684\u4e00\u4e2a\u91cd\u8981\u73af\u8282\uff0c\u5b83\u662f\u4e00\u4e2a\u6301\u7eed\u7684\u5b8c\u6574\u8fc7\u7a0b\uff0c\u4fdd\u62a4\u53d7\u8bd5\u8005\u6743\u76ca\u3002\u56e0\u771f\u5b9e\u4e16\u754c\u7814\u7a76\u591a\u4e0d\u662f\u9884\u8bbe\u65b9\u6848\uff0c\u5c24\u5176\u662f\u56de\u987e\u6027\u7814\u7a76\uff0c\u6536\u96c6\u7684\u5927\u91cf\u4fe1\u606f\u591a\u5c5e\u4e8e\u5386\u5e74\u6570\u636e\uff0c\u4e14\u6d89\u53ca\u5230\u5bf9\u5927\u89c4\u6a21\u75c5\u4f8b\u6216\u662f\u751f\u7269\u6837\u672c\u6570\u636e\u8fdb\u884c\u7814\u7a76\uff0c\u6240\u4ee5\u83b7\u5f97\u6bcf\u4e00\u4f4d\u53d7\u8bd5\u8005\u540c\u610f\u5176\u6570\u636e\u7528\u4e8e\u4e34\u5e8a\u7684\u7814\u7a76\u6709\u5f88\u5927\u7684\u6311\u6218\u3002\u5982\u679c\u7ecf\u4f26\u7406\u5ba1\u67e5\uff0c\u8ba4\u4e3a\u8bfe\u9898\u7814\u7a76\u4e0d\u5927\u4e8e\u6700\u5c0f\u98ce\u9669\uff0c\u4e14\u7814\u7a76\u8005\u4f7f\u7528\u53d7\u8bd5\u8005\u6570\u636e\u4e0d\u4f1a\u5bf9\u60a3\u8005\u9020\u6210\u4e0d\u5229\u7684\u5f71\u54cd\u548c\u53d7\u8bd5\u8005\u91cd\u8981\u9690\u79c1\u4fe1\u606f\u7684\u6cc4\u9732\uff0c\u4e00\u822c\u53ef\u8003\u8651\u514d\u9664\u77e5\u60c5\u540c\u610f [6,7] \u3002\u77e5\u60c5\u53ca\u4f26\u7406\u7684\u76f8\u5173\u5177\u4f53\u8981\u6c42\u9700\u6839\u636e\u5404\u4f26\u7406\u59d4\u5458\u4f1a\u7684\u5b9e\u9645\u8981\u6c42\u800c\u5b9a\u3002<\/span><\/p>\n


                  <\/p>\n

                  2. \u57fa\u4e8e\u524d\u77bb\u6027\u6570\u636e<\/span><\/strong><\/span><\/p>\n

                  2.1 \u524d\u77bb\u6027\u6570\u636e<\/span><\/strong><\/span><\/p>\n

                  \u524d\u77bb\u6027\u6570\u636e\u4e3b\u8981\u5305\u62ec\u5982\u4e34\u5e8a\u8bd5\u9a8c\u7684\u8865\u5145\u6570\u636e\uff0cPRCT\uff0c\u6ce8\u518c\u767b\u8bb0\u7814\u7a76\uff08Registry\uff09\uff0c\u5065\u5eb7\u8c03\u67e5\uff0c\u516c\u5171\u5065\u5eb7\u76d1\u6d4b\u7b49\uff0c\u8be5\u7c7b\u6570\u636e\u5728\u6536\u96c6\u4e4b\u524d\u5df2\u786e\u5b9a\u5177\u4f53\u7684\u7814\u7a76\u76ee\u7684\uff0c\u9700\u8981\u6536\u96c6\u7684\u6570\u636e\u4e5f\u5f88\u660e\u786e\uff0c\u6545\u6570\u636e\u6bd4\u8f83\u89c4\u8303\u6bd4\u8f83\u6807\u51c6\uff0c\u5b8c\u6574\u6027\u51c6\u786e\u6027\u6bd4\u8f83\u597d\u3002<\/span><\/p>\n


                  <\/p>\n

                  2.2 \u7814\u7a76\u8bbe\u8ba1\u7684\u8003\u91cf<\/span><\/strong><\/span><\/p>\n

                  \u57fa\u4e8e\u524d\u77bb\u6027\u6570\u636e\u7684 RWS \u4e00\u822c\u91c7\u7528\u961f\u5217\u7814\u7a76\u7684\u8bbe\u8ba1\uff0c\u961f\u5217\u7814\u7a76\u7684\u5c55\u5f00\u9996\u5148\u8d77\u59cb\u4e8e\u8981\u7814\u7a76\u7684\u95ee\u9898\uff0c\u57fa\u4e8e\u5065\u5eb7\u7ed3\u679c\u7684\u75c5\u56e0\u6216\u8005\u98ce\u9669\u56e0\u7d20\u7684\u5047\u8bf4\uff0c\u901a\u8fc7\u5bf9\u7814\u7a76\u5bf9\u8c61\u7684\u8ffd\u8e2a\uff0c\u89c2\u5bdf\u4e0d\u540c\u7fa4\u7ec4\u5065\u5eb7\u7ed3\u5c40\u7684\u53d1\u751f\u60c5\u51b5\uff0c\u8fdb\u800c\u5efa\u7acb\u66b4\u9732\u56e0\u7d20\u548c\u5065\u5eb7\u7ed3\u5c40\u7684\u8054\u7cfb\u3002<\/span><\/p>\n

                  \u4e34\u5e8a\u7814\u7a76\u4e2d\uff0c\u5f80\u5f80\u6709\u8ba1\u5212\u5730\u62db\u52df\u60a3\u8005\u53c2\u52a0\uff0c\u8fdb\u800c\u968f\u8bbf\u60a3\u8005\u75be\u75c5\u7684\u590d\u53d1\u3001\u597d\u8f6c\u3001\u75ca\u6108\u3001\u6b7b\u4ea1\u7b49\uff0c\u7814\u7a76\u4e0d\u540c\u7684\u6cbb\u7597\u6216\u8005\u67d0\u4e9b\u75be\u75c5\u7279\u70b9\u662f\u5426\u548c\u4e0d\u540c\u75be\u75c5\u7ed3\u5c40\u7684\u76f8\u5173\u5173\u7cfb\u3002\u524d\u77bb\u6027\u961f\u5217\u7814\u7a76\u7684\u6837\u672c\u91cf\u548c\u968f\u8bbf\u65f6\u95f4\u540c\u6837\u91cd\u8981\uff0c\u7814\u7a76\u7684\u6837\u672c\u91cf\u8d8a\u5927\uff0c\u968f\u8bbf\u7684\u65f6\u95f4\u8d8a\u957f\uff0c\u89c2\u5bdf\u5230\u7684\u5065\u5eb7\u7ed3\u5c40\u6570\u91cf\u8d8a\u591a\u3002\u5f00\u5c55\u524d\u77bb\u6027\u961f\u5217\u7814\u7a76\u7684\u4e3b\u8981\u8003\u8651\u56e0\u7d20\u6709\u4ee5\u4e0b\u51e0\u70b9\uff1a<\/span><\/p>\n


                  <\/p>\n

                    \n
                  • \n

                    \u7814\u7a76\u4eba\u7fa4\u7684\u9009\u53d6<\/span><\/strong><\/span><\/p>\n<\/li>\n<\/ul>\n

                    \u75be\u75c5\u6ce8\u518c\u6216\u60a3\u8005\u6ce8\u518c\u767b\u8bb0\u5c31\u662f\u7cfb\u7edf\u6027\u5730\u6536\u96c6\u67d0\u4e9b\u7279\u70b9\u7684\u60a3\u8005\uff0c\u6bd4\u5982\u67d0\u4e9b\u8bca\u65ad\u3001\u6cbb\u7597\u6216\u75be\u75c5\u75c7\u72b6\u7b49\uff0c\u8fd9\u6837\u7684\u767b\u8bb0\u7814\u7a76\u53ef\u80fd\u4f7f\u7528\u60a3\u8005\u7684\u75c5\u5386\u8bb0\u5f55\u548c\u76f8\u5173\u4fe1\u606f\uff0c\u800c\u4e0d\u662f\u6240\u6709\u7684\u53ef\u4ee5\u83b7\u5f97\u7684\u5e9e\u5927\u7684\u6570\u636e\u3002\u4e0d\u540c\u7684\u75be\u75c5\u6ce8\u518c\u767b\u8bb0\u7684\u6837\u672c\u91cf\u6216\u8005\u6536\u96c6\u4fe1\u606f\u7684\u6df1\u5ea6\u548c\u5e7f\u5ea6\u53ef\u80fd\u662f\u4e0d\u4e00\u6837\u7684\uff0c\u53ef\u80fd\u662f\u4e00\u4e2a\u5355\u4e2d\u5fc3\u6216\u591a\u4e2d\u5fc3\u7684\u7814\u7a76\u3002\u8003\u8651\u5230\u4e0d\u540c\u7684\u7814\u7a76\u76ee\u7684\u548c\u6267\u884c\u7684\u53ef\u80fd\uff0c\u8fd9\u6837\u7684\u7814\u7a76\u4e5f\u53ef\u4ee5\u8bbe\u5b9a\u4e00\u4e9b\u5165\u6392\u6807\u51c6\u3002\u4e00\u822c\u6765\u8bf4\uff0c\u4e25\u683c\u7684\u5165\u6392\u6807\u51c6\uff0c\u662f\u4e3a\u4e86\u52a0\u5f3a\u7814\u7a76\u672c\u8eab\u7684\u5185\u90e8\u6709\u6548\u6027\uff08internal validity\uff09\uff0c\u5bbd\u6cdb\u7684\u5165\u6392\u6807\u51c6\uff0c\u4f1a\u63d0\u9ad8\u7814\u7a76\u7ed3\u679c\u7684\u5e7f\u6cdb\u4ee3\u8868\u6027\u6216\u5916\u63a8\u6027\uff08external generalizability\uff09\u3002\u53ef\u80fd\u5f88\u96be\u505a\u5230\u7814\u7a76\u7ed3\u679c\u7684\u5185\u90e8\u6709\u6548\u6027\u548c\u5916\u63a8\u6027\u4e24\u5168\u5176\u7f8e\uff0c\u5728\u8bbe\u8ba1\u9636\u6bb5\uff0c\u5982\u4f55\u5165\u9009\u60a3\u8005\u9700\u8981\u5728\u4e34\u5e8a\u533b\u751f\u548c\u6d41\u884c\u75c5\u5b66\u5bb6\u7b49\u5408\u4f5c\u4e0b\u5171\u540c\u5b8c\u6210\u8bc4\u4f30\u8d44\u6e90\u548c\u64cd\u4f5c\u7684\u53ef\u80fd\u6027\uff0c\u5e73\u8861\u7814\u7a76\u7684\u5185\u90e8\u6709\u6548\u6027\u548c\u5916\u90e8\u53ef\u63a8\u6027\u3002<\/span><\/p>\n


                    <\/p>\n

                      \n
                    • \n

                      \u57fa\u7ebf\u8c03\u67e5\u7684\u7814\u7a76\u5185\u5bb9\u7684\u5c3d\u91cf\u4e30\u5bcc\u5b8c\u6574<\/span><\/strong><\/span><\/p>\n<\/li>\n<\/ul>\n

                      \u524d\u77bb\u6027\u961f\u5217\u7814\u7a76\u7684\u57fa\u7ebf\u7814\u7a76\uff0c\u672c\u8eab\u4e5f\u662f\u4e00\u4e2a\u6a2a\u65ad\u9762\u7684\u7814\u7a76\u3002\u5728\u8ba1\u5212\u548c\u5c55\u5f00\u7814\u7a76\u65e9\u671f\u9636\u6bb5\uff0c\u53ef\u4ee5\u8003\u8651\u662f\u5426\u8981\u5229\u7528\u6a2a\u65ad\u9762\u4fe1\u606f\uff0c\u4e00\u65b9\u9762\u56de\u7b54\u5177\u4f53\u7684\u79d1\u5b66\u95ee\u9898\uff0c\u63d0\u793a\u672a\u6765\u7ee7\u7eed\u7814\u7a76\u7684\u57fa\u7840\uff1b\u53e6\u4e00\u65b9\u9762\uff0c\u4e5f\u662f\u5bf9\u6570\u636e\u7684\u53ef\u884c\u6027\u548c\u90e8\u5206\u6570\u636e\u8d28\u91cf\u7684\u68c0\u9a8c\u3002\u5728\u8fd9\u4e00\u5206\u6790\u8fc7\u7a0b\u4e2d\uff0c\u5e94\u8be5\u7279\u522b\u5173\u6ce8\u5bf9\u4e3b\u8981\u66b4\u9732\u56e0\u7d20\uff0c\u751a\u81f3\u66b4\u9732\u6c34\u5e73\u7684\u6d4b\u91cf\u548c\u8bc4\u4f30\u3002\u4f8b\u5982\u4e3b\u8981\u66b4\u9732\u56e0\u7d20\u6548\u5ea6\u7684\u7814\u7a76\uff08validation study\uff09\uff0c\u4e3a\u672a\u6765\u7684\u4e3b\u8981\u7814\u7a76\u76ee\u7684\u7684\u5206\u6790\u5960\u5b9a\u8d28\u91cf\u57fa\u7840\u3002\u53e6\u5916\uff0c\u5728\u8003\u8651\u6536\u96c6\u4e3b\u8981\u7814\u7a76\u66b4\u9732\u56e0\u7d20\u548c\u76f8\u5173\u57fa\u7ebf\u6570\u636e\u4e4b\u5916\uff0c\u5e94\u8be5\u8003\u8651\u672a\u6765\u7814\u7a76\u62d3\u5c55\u7684\u6f5c\u5728\u53ef\u80fd\u6027\uff0c\u5c3d\u53ef\u80fd\u6536\u96c6\u4e30\u5bcc\u5b8c\u6574\u7684\u6570\u636e\u3002\u8fd9\u6837\u7684\u57fa\u7ebf\u6570\u636e\u4f1a\u5b9a\u4e49\u60a3\u8005\u5728\u7814\u7a76\u57fa\u7ebf\u65f6\u95f4\u70b9\u66f4\u591a\u7684\u66b4\u9732\u56e0\u7d20\u548c\u66b4\u9732\u6c34\u5e73\uff0c\u4f7f\u9a8c\u8bc1\u7814\u7a76\u5047\u8bf4\u6216\u7814\u7a76\u5176\u4ed6\u95ee\u9898\u6210\u4e3a\u53ef\u80fd\u3002\u6700\u540e\uff0c\u57fa\u7ebf\u4fe1\u606f\u7684\u5b8c\u6574\u91c7\u96c6\uff0c\u5bf9\u4e8e\u5728\u540e\u7eed\u5206\u6790\u9636\u6bb5\u63a7\u5236\u504f\u501a\u548c\u6df7\u6742\u6709\u91cd\u8981\u7684\u4f5c\u7528\u3002<\/span><\/p>\n


                      <\/p>\n

                        \n
                      • \n

                        \u6837\u672c\u91cf\u548c\u7814\u7a76\u6df1\u5ea6\u7684\u5e73\u8861<\/span><\/strong><\/span><\/p>\n<\/li>\n<\/ul>\n

                        \u6709\u4e9b\u60c5\u51b5\u4e0b\uff0c\u524d\u77bb\u6027\u961f\u5217\u7814\u7a76\u9650\u4e8e\u7814\u7a76\u6761\u4ef6\uff0c\u7814\u7a76\u67d0\u4e9b\u79d1\u5b66\u95ee\u9898\u53d7\u9650\u4e8e\u6837\u672c\u91cf\u5c0f\uff0c\u6ca1\u6709\u8db3\u591f\u7684\u628a\u63e1\u5ea6\u6765\u9a8c\u8bc1\u5047\u8bf4\uff0c\u5728\u8fd9\u79cd\u60c5\u51b5\u4e0b\uff0c\u9f13\u52b1\u591a\u4e2a\u7fa4\u7ec4\u7814\u7a76\u7684\u5171\u540c\u7814\u7a76(cohort consortium)\uff0c\u6765\u6269\u5927\u6837\u672c\u91cf\uff0c\u4fc3\u8fdb\u79d1\u7814\u5408\u4f5c\u3002\u540c\u65f6\uff0c\u7814\u7a76\u7684\u5927\u6837\u672c\u4e5f\u76f8\u5e94\u5730\u51cf\u5c11\u4e86\u62bd\u6837\u8bef\u5dee\u3002\u5728\u5c0f\u6837\u672c\u91cf\u7814\u7a76\u7684\u60c5\u51b5\u4e0b\uff0c\u5c3d\u53ef\u80fd\u5728\u6570\u636e\u91c7\u96c6\u7684\u6df1\u5ea6\u4e0a\u52aa\u529b\uff0c\u5728\u521b\u65b0\u6027\u65b9\u9762\u505a\u51fa\u63a2\u7d22\u3002\u5177\u4f53\u6837\u672c\u91cf\u8ba1\u7b97\u53ef\u6839\u636e\u7814\u7a76\u5b9e\u9645\u60c5\u51b5\u5728\u4e34\u5e8a\u533b\u751f\u3001\u6d41\u884c\u75c5\u5b66\u5bb6\u548c\u7edf\u8ba1\u5e08\u7684\u5408\u4f5c\u4e0b\u5171\u540c\u5b8c\u6210\u3002<\/span><\/p>\n


                        <\/p>\n

                          \n
                        • \n

                          \u63d0\u9ad8\u60a3\u8005\u4f9d\u4ece\u6027\uff0c\u957f\u671f\u968f\u8bbf\u60a3\u8005<\/span><\/strong><\/span><\/p>\n<\/li>\n<\/ul>\n

                          \u524d\u77bb\u6027\u961f\u5217\u7814\u7a76\u53ef\u80fd\u4f1a\u968f\u8bbf\u6570\u5341\u5e74\uff0c\u672a\u6765\u7814\u7a76\u7684\u5065\u5eb7\u7ed3\u5c40\u4e0d\u4ec5\u53ef\u80fd\u5305\u62ec\u7535\u5b50\u75c5\u5386\u3001\u6b7b\u4ea1\u8bb0\u5f55\u3001\u4fdd\u9669\u767b\u8bb0\u7b49\u7535\u5b50\u5316\u5e73\u53f0\u63d0\u4f9b\u7684\u4fe1\u606f\uff0c\u4e5f\u5e94\u8be5\u5305\u62ec\u672a\u6765\u53ef\u80fd\u968f\u8bbf\u7b49\u83b7\u5f97\u7684\u4fe1\u606f\u3002\u6709\u4e9b\u7814\u7a76\u65f6\u95f4\u53ef\u80fd\u4f1a\u8d85\u8fc7\u7814\u7a76\u8005\u6700\u521d\u8ba1\u5212\u7684\u8ddf\u8e2a\u65f6\u95f4\uff0c\u6240\u4ee5\u63d0\u9ad8\u60a3\u8005\u4f9d\u4ece\u6027\uff0c\u907f\u514d\u5931\u8bbf\u81f3\u5173\u91cd\u8981\uff1a<\/span><\/p>\n

                            \n
                          1. \n

                            \u5145\u5206\u77e5\u60c5\uff1a\u60a3\u8005\u8131\u843d\u6216\u5931\u8bbf\u7684\u4e24\u4e2a\u5e38\u89c1\u539f\u56e0\u5206\u522b\u662f\u4e0d\u826f\u53cd\u5e94\u6216\u9891\u7e41\u68c0\u67e5\uff0c \u8ba9\u60a3\u8005\u5145\u5206\u4e86\u89e3\u7814\u7a76\u6d41\u7a0b\uff0c\u63d0\u524d\u544a\u77e5\u53ef\u80fd\u4e0d\u826f\u53cd\u5e94\u5e76\u8fdb\u884c\u76f8\u5e94\u9884\u9632\u63aa\u65bd\u53ef\u6709\u6548\u63d0\u9ad8\u60a3\u8005\u4f9d\u4ece\u6027\u3002<\/span><\/p>\n<\/li>\n

                          2. \n

                            \u4eba\u6587\u5173\u6000\uff1a\u7814\u7a76\u8fc7\u7a0b\u4e2d\u7684\u533b\u60a3\u4e92\u52a8\uff0c\u53ef\u4ee5\u53d1\u653e\u5065\u5eb7\u4fe1\u606f\uff0c\u66f4\u65b0\u7814\u7a76\u7ed3\u679c\u7b49\uff0c\u4e89\u53d6\u60a3\u8005\u7684\u914d\u5408\uff1b\u53ef\u5e2e\u52a9\u60a3\u8005\u53ca\u65f6\u89e3\u51b3\u7814\u7a76\u4e2d\u78b0\u5230\u7684\u76f8\u5173\u95ee\u9898\uff0c\u589e\u5f3a\u533b\u60a3\u95f4\u7684\u76f8\u4e92\u4e86\u89e3\uff0c\u63d0\u9ad8\u60a3\u8005\u4f9d\u4ece<\/span>\u6027\u3002<\/span><\/span><\/p>\n<\/li>\n

                          3. \n

                            \u5b9a\u671f\u63d0\u9192\uff1a\u5b9a\u671f\u7cfb\u7edf\u6216\u4eba\u5de5\u63d0\u9192\u53ef\u63d0\u9ad8\u60a3\u8005\u7528\u836f\u53ca\u8bbf\u89c6\u7684\u4f9d\u4ece\u6027\u3002<\/span><\/p>\n<\/li>\n

                          4. \n

                            \u591a\u79cd\u6c9f\u901a\u65b9\u5f0f\uff1a\u4fdd\u7559\u60a3\u8005\u53ca\u5bb6\u5c5e\u591a\u4e2a\u957f\u671f\u7684\u8054\u7cfb\u65b9\u5f0f\uff0c\u5305\u62ec\u4f4f\u5740\uff0c\u624b\u673a\uff0c\u5fae\u4fe1\uff0c\u7535\u5b50\u90ae\u7bb1\uff0c\u7ebf\u4e0a\u7b49\uff0c\u5e76\u53ca\u65f6\u66f4\u65b0\uff0c\u53ef\u6709\u6548\u907f\u514d\u60a3\u8005\u6362\u53f7\u540e\u5bfc\u81f4\u7684\u5931\u8bbf\u3002\u5bf9\u4e8e\u5931\u8bbf\u7684\u60a3\u8005\uff0c\u4e5f\u5e94\u5728\u4e0d\u540c\u65f6\u95f4\u6bb5\u7535\u8bdd\u6216\u8005\u901a\u8fc7\u5176\u5b83\u8054\u7cfb\u65b9\u5f0f\u4e89\u53d6\uff0c\u51cf\u5c11\u5931\u8bbf\u3002<\/span><\/p>\n<\/li>\n<\/ol>\n


                            <\/p>\n

                              \n
                            • \n

                              \u5931\u8bbf\u53ca\u7f3a\u5931\u6570\u636e\u8003\u91cf<\/span><\/strong><\/span><\/p>\n<\/li>\n<\/ul>\n

                              \u7814\u7a76\u8005\u9700\u8981\u5728\u7814\u7a76\u5f00\u59cb\u65f6\u9488\u5bf9\u7f3a\u5931\u6570\u636e\u5236\u5b9a\u8ba1\u5212\uff0c\u5c3d\u53ef\u80fd\u9632\u6b62\u6570\u636e\u7f3a\u5931\uff0c\u540c\u65f6\u4e3a\u5904\u7406\u91cd\u8981\u53d8\u91cf\u7684\u7f3a\u5931\u6570\u636e\u5236\u5b9a\u8ba1\u5212\u3002<\/span><\/p>\n

                              \u5931\u8bbf\u662f\u524d\u77bb\u6027\u961f\u5217\u7814\u7a76\u7684\u4e00\u4e2a\u91cd\u8981\u95ee\u9898\u3002\u5728\u7814\u7a76\u968f\u8bbf\u671f\u95f4\uff0c\u67d0\u4e9b\u7814\u7a76\u5bf9\u8c61\u7531\u4e8e\u5404\u79cd\u539f\u56e0\u4e0d\u80fd\u6216\u4e0d\u613f\u610f\uff0c\u6216\u8005\u6b7b\u4ea1\u7b49\u539f\u56e0\u4e0d\u80fd\u7ee7\u7eed\u53c2\u4e0e\u7814\u7a76\u3002\u5728\u9700\u8981\u957f\u671f\u968f\u8bbf\u7684\u7814\u7a76\u4e2d\uff0c\u5931\u8bbf\u53d1\u751f\u7684\u53ef\u80fd\u6027\u66f4\u9ad8\uff0c\u9700\u8981\u66f4\u52a0\u91cd\u89c6\u3002\u4e00\u822c\u6765\u8bf4\uff0c\u5931\u8bbf\u4f4e\u4e8e 5%\u7684\u65f6\u5019\uff0c\u5f15\u8d77\u7684\u504f\u501a\u6bd4\u8f83\u5c0f\uff0c\u4f46\u662f\u5931\u8bbf\u8d85\u8fc7 20%\u7684\u65f6\u5019\uff0c\u5c31\u5fc5\u987b\u52a0\u4ee5\u91cd\u89c6\u548c\u5206\u6790\u3002\u5982\u679c\u5931\u8bbf\u7684\u539f\u56e0\u4e0e\u66b4\u9732\u56e0\u7d20\u548c\u7814\u7a76\u7ed3\u5c40\u6709\u5173\u8054\uff0c\u5373\u4fbf\u662f<20%\u7684\u5931\u8bbf\u4e5f\u53ef\u80fd\u4f1a\u5f15\u8d77\u504f\u501a [8] \u3002\u5982\u679c\u5931\u8bbf\u7684\u539f\u56e0\u662f\u5b8c\u5168\u968f\u673a\u7684\uff0c\u548c\u66b4\u9732\u56e0\u7d20\u4ee5\u53ca\u7814\u7a76\u7ed3\u679c\u6ca1\u6709\u8054\u7cfb\uff0c\u5931\u8bbf\u4f4e\u4e8e 60%\u4e00\u822c\u662f\u53ef\u4ee5\u63a5\u53d7\u7684\u3002\u5982\u679c\u5931\u8bbf\u5728\u67d0\u4e9b\u660e\u786e\u56e0\u7d20\u7684\u6761\u4ef6\u4e0b\u662f\u968f\u673a\u7684\uff0c\u800c\u4e14\u4f4e\u4e8e 60%\uff0c\u5728\u5206\u6790\u9636\u6bb5\uff0c\u901a\u8fc7\u5bf9\u8fd9\u4e9b\u786e\u5b9a\u56e0\u7d20\u7684\u5206\u5c42\u5206\u6790\uff0c\u53ef\u4ee5\u63a7\u5236\u5931\u8bbf\u5e26\u6765\u7684\u504f\u501a\u3002\u6b64\u5916\uff0c\u5373\u4fbf\u5931\u8bbf\u4e0d\u4e00\u5b9a\u4f1a\u5e26\u6765\u504f\u501a\uff0c\u4ecd\u4f1a\u5f71\u54cd\u7814\u7a76\u7684\u51c6\u786e\u6027\uff0c\u6216\u8005\u8bf4\u5bfc\u81f4\u7814\u7a76\u53ef\u4fe1\u533a\u95f4\u53d8\u5bbd\u3002\u56e0\u6b64\uff0c\u5b58\u5728\u5931\u8bbf\u7684\u60c5\u51b5\u4e0b\uff0c\u5e94\u8be5\u8fdb\u4e00\u6b65\u5206\u6790\u66b4\u9732\u7ec4\u548c\u975e\u66b4\u9732\u7ec4\u5931\u8bbf\u6bd4\u4f8b\u662f\u5426\u6709\u663e\u8457\u6027\u4e0d\u540c\uff0c\u5931\u8bbf\u662f\u5426\u4f1a\u548c\u4e00\u4e9b\u5173\u952e\u6307\u6807\u5b58\u5728\u5173\u8054\uff0c\u8fdb\u800c\u5224\u65ad\u5931\u8bbf\u6761\u4ef6\u4e0b\u5f97\u5230\u7684\u7814\u7a76\u7ed3\u679c\u662f\u5426\u4f4e\u4f30\u6216\u8005\u9ad8\u4f30\u4e86\u5b9e\u9645\u60c5\u51b5\u3002<\/span><\/p>\n


                              <\/p>\n

                              2.3 \u5176\u4ed6\u884d\u751f\u7814\u7a76\u7c7b\u578b<\/span><\/strong><\/span><\/p>\n

                                \n
                              • \n

                                \u961f\u5217\u7814\u7a76\u4e2d\u7684\u5de2\u5f0f\u75c5\u4f8b\u5bf9\u7167\u7814\u7a76<\/span><\/strong><\/span><\/p>\n<\/li>\n<\/ul>\n

                                \u5de2\u5f0f\u75c5\u4f8b\u5bf9\u7167\u7814\u7a76\u662f\u5728\u73b0\u5b58\u961f\u5217\u7814\u7a76\u57fa\u7840\u4e0a\u7684\u75c5\u4f8b\u5bf9\u7167\u7814\u7a76\u3002\u5728\u968f\u8bbf\u7814\u7a76\u4eba\u7fa4\u540e\uff0c\u9009\u62e9\u65b0\u53d1\u60a3\u8005\u4f5c\u4e3a\u75c5\u4f8b\uff0c\u7136\u540e\u901a\u8fc7\u5e74\u9f84\u548c\u6027\u522b\u7b49\u56e0\u7d20\u914d\u6bd4\uff0c\u9009\u62e9\u5bf9\u7167\u7ec4\uff0c\u8fdb\u800c\u6bd4\u8f83\u75c5\u4f8b\u548c\u5bf9\u7167\u7684\u66b4\u9732\u56e0\u7d20\u662f\u5426\u4e0d\u540c\uff0c\u6765\u7814\u7a76\u75be\u75c5\u548c\u66b4\u9732\u7684\u5173\u7cfb\u3002\u4e00\u822c\u6765\u8bf4\u5728\u66b4\u9732\u56e0\u7d20\u7684\u6d4b\u91cf\u96be\u5ea6\u5927\u3001\u8d39\u7528\u6bd4\u8f83\u9ad8\u6216\u8005\u75c5\u4f8b\u6bd4\u8f83\u7f55\u89c1\u7684\u60c5\u51b5\u4e0b\uff0c\u9002\u7528\u9009\u62e9\u5de2\u5f0f\u75c5\u4f8b\u5bf9\u7167\u7814\u7a76\u3002<\/span><\/p>\n


                                <\/p>\n

                                  \n
                                • \n

                                  \u5b9e\u6548\u6027\u4e34\u5e8a\u7814\u7a76<\/span><\/strong><\/span><\/p>\n<\/li>\n<\/ul>\n

                                  \u5c3d\u7ba1\u5b9e\u6548\u6027\u4e34\u5e8a\u7814\u7a76\uff08PRCT\uff09\u5728 RWS \u4e2d\u5212\u5206\u5728\u8bd5\u9a8c\u6027\u7814\u7a76\uff0c\u7136\u800c\u5176\u7814\u7a76\u8bbe\u8ba1\u548c\u524d\u77bb\u6027\u961f\u5217\u7814\u7a76\u6709\u76f8\u4f3c\u4e4b\u5904\u3002\u5176\u4e3b\u8981\u7528\u4e8e\u5e38\u89c4\u4e34\u5e8a\u5b9e\u8df5\u4e2d\u7597\u6548\u5bf9\u6bd4\u7814\u7a76\uff0c\u53e6\u5916\uff0c\u6210\u672c\u6548\u679c\u5206\u6790\uff08cost-<\/span>effectivenss analysis\uff0c CEA\uff09\u4e5f\u662f PRCT \u7684\u5173\u952e\u7ec4\u6210\u90e8\u5206\u3002\u968f\u673a\u5316\u5206\u7ec4\u662f PRCT \u7684\u5173\u952e\uff0c\u7528\u6765\u63d0\u9ad8\u7ec4\u95f4\u53ef\u6bd4\u6027\uff0c\u51cf\u5c11\u9009\u62e9\u504f\u501a\u3002\u901a\u5e38\u9009\u62e9\u4e24\u79cd\u5f85\u6bd4\u8f83\u7684\u4e34\u5e8a\u5e72\u9884\u63aa\u65bd\u6216\u65b9\u6848\uff0c\u91c7\u7528\u76f8\u5bf9\u5bbd\u6cdb\u7684\u5165\u9009\u6807\u51c6\uff0c\u5141\u8bb8\u4e0d\u540c\u7814\u7a76\u5bf9\u8c61\u95f4\u5b58\u5728\u4e34\u5e8a\u5f02\u8d28\u6027\uff0c\u4ee5\u4fdd\u8bc1\u8bd5\u9a8c\u7ed3\u8bba\u80fd\u6700\u5927\u7a0b\u5ea6\u5730\u5916\u63a8\u3002\u7814\u7a76\u4e2d\u5e72\u9884\u65b9\u6848\u7684\u4f4e\u6807\u51c6\u5316\u662f PRCT \u91cd\u8981\u7279\u5f81\u4e4b\u4e00\uff0c\u5373\u7814\u7a76\u5728\u5b9e\u9645\u4e34\u5e8a\u60c5\u51b5\u6216\u5e38\u89c4\u4e34\u5e8a\u5b9e\u8df5\u4e0b\u8fdb\u884c\uff0c\u5e76\u5c3d\u53ef\u80fd\u51cf\u5c11\u5bf9\u5e38\u89c4\u6cbb\u7597\u7684\u5e72\u9884\u3002 PRCT \u5bf9\u7167\u7ec4\u5f88\u5c11\u9009\u7528\u5b89\u6170\u5242\uff0c\u901a\u5e38\u9009\u7528\u5e38\u89c4\u6216\u76ee\u524d\u516c\u8ba4\u6700\u4f73\u7684\u4e34\u5e8a\u6cbb\u7597\u65b9\u6cd5 [9] \u30021954 \u5e74\u7f8e\u56fd\u75c5\u6bd2\u5b66\u5bb6 J. Salk \u4e3b\u6301\u5b9e\u65bd\u7684\u4e34\u5e8a\u7814\u7a76\u201c\u7d22\u5c14\u514b\u810a\u9ad3\u7070\u8d28\u708e\u75ab\u82d7\u8bd5\u9a8c\u201d\uff08Salk field trial of the polio vaccine\uff09\uff0c\u4ee5\u53ca 2015 \u5e74\u7531 National Patient-Centered Clinical Research Network \u4e3b\u5bfc\u7684\u201c\u963f\u53f8\u5339\u6797\u5fc3\u8840\u7ba1\u83b7\u76ca\u7814\u7a76\u201d \uff08Aspirin Study, ADAPTABLE\uff09, \u90fd\u5c5e\u4e8e PRCT [10]<\/span><\/p>\n


                                  <\/p>\n

                                  \u516d\uff0e\u6570\u636e\u7ba1\u7406\u6d41\u7a0b\u53ca\u6570\u636e\u8d28\u91cf\u63a7\u5236<\/span><\/strong><\/span><\/p>\n

                                  1.\u6570\u636e\u7ba1\u7406\u6d41\u7a0b<\/span><\/strong><\/span><\/p>\n

                                  RWS \u7814\u7a76\u6d41\u7a0b\u7ba1\u7406\u7684\u6838\u5fc3\u6574\u4f53\u6765\u8bf4\u8fd8\u662f\u52a0\u5f3a\u6570\u636e\u8d28\u91cf\uff0c\u63d0\u9ad8\u7814\u7a76\u6548\u7387\uff0c\u63a7\u5236\u7814\u7a76\u6210\u672c\u3002\u7814\u7a76\u8005\u53ef\u5145\u5206\u53d1\u6325\u8f6f\u4ef6\uff0c\u79fb\u52a8\u7aef\u548c\u4eba\u5de5\u667a\u80fd\u7ed3\u6784\u5316\u7b49\u65b0\u6280\u672f\u529f\u80fd\u3002\u52a0\u5f3a\u7535\u5b50\u6570\u636e\u91c7\u96c6\u7cfb\u7edf\uff08EDC\uff09\u5b9a\u5236\uff0c\u589e\u5f3a\u7cfb\u7edf\u903b\u8f91\u6838\u67e5\u529f\u80fd\uff0c\u8ba9\u7cfb\u7edf\u81ea\u52a8\u8fdb\u884c\u6570\u636e\u6838\u67e5\uff0c\u65f6\u65f6\u4fdd\u969c\u6570\u636e\u8d28\u91cf\uff1b\u4ece\u7814\u7a76\u8bbe\u8ba1\u5c42\u9762\u5e94\u8be5\u51cf\u5c11\u4e0d\u5fc5\u8981\u7684\u968f\u8bbf\u548c\u68c0\u6d4b\uff0c\u5c24\u5176\u662f\u6765\u9662\u968f\u8bbf\u3002\u5145\u5206\u5229\u7528\u5728\u7ebf\u968f\u8bbf\u529f\u80fd\uff0c\u5373\u5145\u5206\u8ba9\u60a3\u8005\u53c2\u4e0e\uff0c\u8ba9\u60a3\u8005\u62a5\u544a\u7ed3\u5c40\uff0c\u81ea\u52a8\u8fdb\u884c\u60a3\u8005\u968f\u8bbf\u63d0\u9192\u3001\u95ee\u5377\u91cf\u8868\u63a8\u9001\uff0c\u60a3\u8005\u7aef\u6570\u636e\u91c7\u96c6\u53ca\u533b\u60a3\u6c9f\u901a\uff0c\u63d0\u9ad8\u968f\u8bbf\u6548\u7387\u548c\u8d28\u91cf\uff1b\u6570\u636e\u70b9\u5206\u7ea7\u7ba1\u7406\uff0c\u5f3a\u5236\u6027\u4fdd\u8bc1\u5173\u952e\u6570\u636e\u7684\u6536\u96c6\u7684\u51c6\u786e\u771f\u5b9e\u6027\u3002\u4ece\u7814\u7a76\u76d1\u67e5\u4e0e\u6280\u672f\u5c42\u9762\u8fdb\u884c\u6280\u672f\u521b\u65b0\uff1a\u4f7f\u7528\u79fb\u52a8 APP \u8fdb\u884c\u6570\u636e\u6e90\u6536\u96c6\uff0c\u7ebf\u4e0a\u4e2d\u5fc3\u5316\u5f55\u5165\u914d\u5408\u6587\u672c\u8bc6\u522b\uff08OCR\uff09\u548c\u667a\u80fd\u7ed3\u6784\u5316\u529f\u80fd\u4ee5\u8282\u7ea6\u5f55\u5165\u6210\u672c\u3002\u540c\u65f6\u8fdc\u7a0b\u76d1\u67e5\u4ee5\u51cf\u5c11\u5dee\u65c5\u6210\u672c\u3002<\/span><\/p>\n


                                  <\/p>\n

                                  2. \u6570\u636e\u8d28\u91cf\u63a7\u5236<\/span><\/strong><\/span><\/p>\n

                                  \u6570\u636e\u8d28\u91cf\u63a7\u5236\u662f\u786e\u4fdd\u7814\u7a76\u6570\u636e\u771f\u5b9e\u3001\u51c6\u786e\u3001\u53ef\u9760\u7684\u5173\u952e\u3002\u7814\u7a76\u5404\u4e2a\u9636\u6bb5\u90fd\u9700\u8981\u5bf9\u53ef\u80fd\u5f71\u54cd\u6570\u636e\u8d28\u91cf\u7684\u5404\u4e2a\u56e0\u7d20\u548c\u73af\u8282\u8fdb\u884c\u63a7\u5236\uff0c\u6d89\u53ca\u4ece\u6570\u636e\u6536\u96c6\u3001\u5904\u7406\u3001\u5230\u7edf\u8ba1\u5206\u6790\u62a5\u544a\u7684\u5168\u8fc7\u7a0b\u3002\u53c2\u7167\u6570\u636e\u8d28\u91cf\u8bc4\u4ef7 ALCOA+\u539f\u5219 [11-13] \uff0c\u6570\u636e\u7684\u53ef\u6eaf\u6e90\u6027\u3001\u5b8c\u6574\u6027\u3001\u4e00\u81f4\u6027\u3001\u53ca\u51c6\u786e\u6027\u7b49\u6307\u6807\u5728\u5728 RWS \u5c24\u4e3a\u91cd\u8981\uff0c\u9700\u8981\u91cd\u70b9\u5173\u6ce8\u3002\u6570\u636e\u8d28\u63a7\u5219\u9700\u8981\u5efa\u7acb\u5b8c\u5584\u7684 RWS \u6570\u636e\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u3001\u5b8c\u5584\u7684\u6807\u51c6\u64cd\u4f5c\u6d41\u7a0b\uff08SOP\uff09\u4ee5\u53ca\u4eba\u5458\u5b9a\u671f\u7684\u57f9\u8bad\u3002\u4e3b\u8981\u5305\u62ec\uff1a<\/span><\/p>\n

                                    \n
                                  1. \n

                                    \u4fdd\u8bc1\u6570\u636e\u6e90\u8d28\u91cf\uff0c\u786e\u4fdd\u6570\u636e\u6e90\u4fe1\u606f\u7684\u5b8c\u6574\u6027\u548c\u51c6\u786e\u6027\uff0c\u51cf\u5c11\u6570\u636e\u6e90\u672c\u8eab\u7684\u7f3a\u5931\u548c\u504f\u5dee\u3002\u4e34\u5e8a\u75c5\u5386\u4f5c\u4e3a\u5173\u952e\u6570\u636e\u6e90\uff0c\u5176\u4e0d\u4ec5\u8981\u7b26\u5408\u75c5\u5386\u4e66\u5199\u89c4\u8303\u3001\u533b\u9662\u4e09\u7ea7\u8d28\u63a7\u8981\u6c42\u7b49\uff0c\u8fd8\u5e94\u63d0\u9ad8\u75c5\u5386\u8d28\u63a7\u6807\u51c6\u4ee5\u6ee1\u8db3\u79d1\u7814\u9700\u8981\u3002<\/span><\/p>\n<\/li>\n

                                  2. \n

                                    \u5728\u91c7\u96c6\u6570\u636e\u524d\uff0c\u5236\u5b9a\u8be6\u7ec6\u7684\u7814\u7a76\u8bbe\u8ba1\u65b9\u6848\u548c\u5206\u6790\u8ba1\u5212\u3002\u8bc4\u4f30\u786e\u7acb\u91c7\u96c6\u5b57\u6bb5\uff0c\u786e\u8ba4\u5173\u952e\u5b57\u6bb5\u5df2\u88ab\u6536\u96c6\uff0c\u5236\u5b9a\u76f8\u5e94\u7684 CRF \u548c\u6570\u636e\u5e93\u67b6\u6784\uff1b<\/span><\/p>\n<\/li>\n

                                  3. \n

                                    \u5efa\u7acb\u6570\u636e\u91c7\u96c6\u548c\u5f55\u5165\u7684\u6807\u51c6\u6307\u5357\uff0c\u786e\u4fdd\u5f55\u5165\u6570\u636e\u4e0e\u6570\u636e\u6e90\u7684\u4e00\u81f4\u6027\u3002\u5bf9\u4e8e\u5f55\u5165\u8fc7\u7a0b\u4e2d\u7684\u4efb\u4f55\u4fee\u6539\uff0c\u9700\u8981\u63d0\u4f9b\u4fee\u6539\u539f\u56e0\u5e76\u7559\u4e0b\u5b8c\u6574\u7684\u7a3d\u67e5\u8f68\u8ff9\u3002<\/span><\/p>\n<\/li>\n

                                  4. \n

                                    \u5236\u5b9a\u5b8c\u5584\u7684\u6570\u636e\u8d28\u91cf\u7ba1\u7406\u8ba1\u5212\uff0c\u786e\u7acb\u5173\u952e\u5b57\u6bb5\uff1b\u5236\u5b9a\u7cfb\u7edf\u8d28\u63a7\u548c\u4eba\u5de5\u8d28\u63a7\u8ba1\u5212\uff0c\u786e\u4fdd\u6570\u636e\u7684\u771f\u5b9e\u6027\u3001\u51c6\u786e\u6027\u548c\u5b8c\u6574\u6027\u3002\u6570\u636e\u6e90\u6838\u67e5\u786e\u8ba4\u662f\u4fdd\u8bc1\u7814\u7a76\u6570\u636e\u771f\u5b9e\u5b8c\u6574\u7684\u5fc5\u8981\u63aa\u65bd\u4e4b\u4e00\uff0cRWS \u6d89\u53ca\u5230\u5927\u89c4\u6a21\u7684\u6570\u636e\uff0c\u53ef\u5145\u5206\u5229\u7528\u7cfb\u7edf\u5b9e\u65f6\u81ea\u52a8\u903b\u8f91\u6838\u67e5\u6765\u52a0\u5f3a\u8d28\u63a7\uff0c\u964d\u4f4e\u4eba\u5de5\u8d28\u63a7\u6210\u672c\uff1b\u5bf9\u4e8e\u5173\u952e\u5b57\u6bb5\uff0c\u53ef\u8fdb\u884c 100%\u539f\u59cb\u6570\u636e\u6838\u67e5 \uff08SDV\uff09\uff0c\u5176\u4ed6\u5b57\u6bb5\u53ef\u6839\u636e\u5b9e\u9645\u60c5\u51b5\u964d\u4f4e\u6838\u67e5\u7387\u3002<\/span><\/p>\n<\/li>\n

                                  5. \n

                                    \u6570\u636e\u6807\u51c6\u5316\uff0c\u5efa\u8bae\u4f7f\u7528\u6807\u51c6\u5316\u5b57\u5178\u3002RWS\u4fe1\u606f\u6765\u6e90\u590d\u6742\uff0c\u6570\u636e\u7684\u6807\u51c6\u5316\u662f\u4fdd\u969c\u6570\u636e\u8d28\u91cf\u7684\u57fa\u7840\u548c\u5173\u952e\u73af\u8282\u3002<\/span><\/p>\n<\/li>\n<\/ol>\n


                                    <\/p>\n

                                    \u4e3a\u4fdd\u969c RWS \u7684\u53d1\u5c55\uff0c\u4fdd\u8bc1\u6570\u636e\u7684\u53ef\u6eaf\u6e90\u6027\u548c\u4e00\u81f4\u6027\uff0c\u53ef\u8fd0\u7528\u65b0\u6280\u672f\uff0c\u5145\u5206\u5229\u7528\u7535\u5b50\u5316\u7cfb\u7edf\uff0c\u589e\u5f3a\u7cfb\u7edf\u903b\u8f91\u6838\u67e5\u529f\u80fd\u7b49\uff0c\u52a0\u5f3a RWS \u7684\u6570\u636e\u8d28\u91cf\u3002<\/span><\/p>\n


                                    <\/p>\n

                                    \u4e03\uff0e\u504f\u501a\u548c\u6df7\u6742\u7684\u63a7\u5236<\/span><\/strong><\/span><\/p>\n

                                    \u4e34\u5e8a\u7814\u7a76\u4e2d\u8bef\u5dee\u7684\u6765\u6e90\u53ef\u4ee5\u5206\u4e3a\u4e24\u7c7b\uff1a\u4e00\u7c7b\u662f\u968f\u673a\u8bef\u5dee\uff08random error\uff09\uff1b\u4e00\u7c7b\u662f\u7cfb\u7edf\u8bef\u5dee<\/span>\uff08systematic error\uff09\uff0c\u5373\u6211\u4eec\u7ecf\u5e38\u63d0\u5230\u7684\u504f\u501a\u3002\u5728 RWS \u7684\u8bbe\u8ba1\u548c\u5b9e\u65bd\u4e2d\uff0c\u504f\u501a\u662f\u4e00\u4e2a\u9700\u8981\u7279\u522b\u5ba1\u89c6\u7684\u95ee\u9898\u3002<\/span><\/span><\/p>\n


                                    <\/p>\n

                                    1. \u9009\u62e9\u504f\u501a\uff08selection bias\uff09\u7684\u63a7\u5236<\/span><\/strong><\/span><\/p>\n

                                    \u9009\u62e9\u504f\u501a\u662f\u5728 RWS \u4e2d\u6bd4\u8f83\u5e38\u89c1\u7684\u504f\u501a\u3002\u5927\u591a\u6570\u60c5\u51b5\u4e0b\u53ef\u4ee5\u901a\u8fc7\u79d1\u7814\u8bbe\u8ba1\u6765\u51cf\u5c11\u6216\u8005\u6d88\u9664\uff0c\u5982\u91c7\u7528\u5339\u914d\u6216\u8005\u968f\u673a\u7684\u65b9\u6cd5\u3002\u6bd4\u5982\u4e34\u5e8a\u79d1\u7814\u5e38\u89c1\u7684\u4e00\u4e2a\u5b9e\u4f8b\uff0c\u67d0\u7814\u7a76\u6570\u636e\u5e93\u91cc\u6709 3000 \u4f8b\u60a3\u8005\u7684\u6570\u636e\uff0c\u7ecf\u8fc7\u4e00\u7cfb\u5217\u5165\u6392\u4e4b\u540e\u4ec5\u6709 500 \u4eba\u53ef\u7528\u4e8e\u5206\u6790\uff0c\u5982\u679c\u5176\u4e2d\u4e00\u90e8\u5206\u4eba\u56e0\u4e3a\u6570\u636e\u7f3a\u5931\u88ab\u6392\u9664\u7814\u7a76\uff0c\u90a3\u4e48\u5c31\u8981\u8003\u8651\u662f\u5426\u5b58\u5728\u9009\u62e9\u504f\u501a\u7684\u95ee\u9898\uff0c\u5373\u6570\u636e\u5168\u9762\u5b8c\u6574\u7684\u60a3\u8005\u548c\u56e0\u6570\u636e\u7f3a\u5931\u800c\u6392\u9664\u7684\u60a3\u8005\u4e4b\u95f4\u662f\u5426\u53ef\u6bd4\uff0c\u8fd9\u662f\u4e00\u4e2a\u9700\u8981\u8003\u8651\u548c\u8bc4\u4f30\u7684\u8981\u70b9\u3002\u5982\u679c\u4fe1\u606f\u7f3a\u5931\u7684\u60a3\u8005\u56e0\u4e3a\u67d0\u79cd\u6cbb\u7597\u7597\u6548\u4e0d\u4f73\u9000\u51fa\uff0c\u751a\u81f3\u6b7b\u4ea1\u800c\u5bfc\u81f4\u5931\u8bbf\uff0c\u90a3\u4e48\u6392\u9664\u540e\u7684\u6570\u636e\u800c\u4ea7\u751f\u7684\u7ed3\u679c\u4f1a\u4e25\u91cd\u5f71\u54cd\u7814\u7a76\u7ed3\u679c\u7684\u51c6\u786e\u6027\u3001\u53ef\u9760\u6027\u4ee5\u53ca\u5916\u63a8\u6027\u3002<\/span><\/p>\n

                                    \u5bf9\u4e8e\u9009\u62e9\u504f\u501a\u9700\u91c7\u53d6\u7684\u63a7\u5236\u65b9\u6cd5\uff1a<\/span><\/strong><\/span><\/p>\n

                                    1\uff09 <\/span>\u4e25\u683c\u638c\u63e1\u7814\u7a76\u5bf9\u8c61\u7684\u7eb3\u5165\u6216\u6392\u9664\u6807\u51c6\u3002\u7b2c\u4e00\uff0c\u4e0d\u60a3\u4e0e\u7814\u7a76\u56e0\u7d20\u6709\u5173\u7684\u5176\u5b83\u75be\u75c5\u3002\u4f8b\u5982\u7814\u7a76\u5438\u70df\u548c\u80ba\u764c\u7684\u5173\u7cfb\uff0c\u90a3\u4e48\u5c31\u8981\u5c06\u6162\u6027\u963b\u585e\u6027\u80ba\u75c5\uff08COPD\uff09\u6392\u9664\u51fa\u7814\u7a76\u4eba\u7fa4\u3002\u7b2c\u4e8c\uff0c\u5728\u67d0\u4e9b\u65b9\u9762\u4e0e\u75c5\u4f8b\u7ec4\u53ef\u6bd4\u3002\u5982\u5bf9\u7167\u7ec4\u548c\u75c5\u4f8b\u7ec4\u5728\u57fa\u7ebf\u4fe1\u606f\u4e0a\u5c3d\u91cf\u53ef\u6bd4\uff0c\u5982\u5e74\u9f84\uff0c\u6027\u522b\uff0c\u75c5\u60c5\u4e25\u91cd\u7a0b\u5ea6\uff0c\u7ecf\u6d4e\u72b6\u51b5\u7b49\u3002<\/span><\/p>\n

                                    2\uff09\u5c3d\u91cf\u63d0\u9ad8\u5e94\u7b54\u7387\uff0c\u51cf\u5c11\u5931\u8bbf\u7387\uff0c\u5e76\u5bf9\u5931\u8bbf\u7684\u60a3\u8005\u8fdb\u884c\u8bc4\u4ef7\u3002<\/span><\/p>\n

                                    3\uff09\u5c3d\u53ef\u80fd\u91c7\u7528\u591a\u79cd\u5bf9\u7167\u3002\u7406\u60f3\u7684\u662f\u4ee5\u4eba\u7fa4\u4e2d\u5168\u4f53\u75c5\u4f8b\u548c\u975e\u75c5\u4f8b(\u6216\u5176\u6709\u4ee3\u8868\u6027\u7684\u6837\u672c)\u4f5c\u4e3a\u7814\u7a76\u5bf9\u8c61\u3002\u5982\u4ee5\u533b\u9662\u75c5\u4f8b\u4e3a\u7814\u7a76\u5bf9\u8c61\uff0c\u5b9c\u5728\u591a\u4e2a\u533b\u9662\u9009\u62e9\u5bf9\u8c61\uff0c\u4e14\u6700\u597d\u6709 2 \u4e2a\u5bf9\u7167\u7ec4\uff0c\u5176\u4e2d\u4e00\u4e2a\u5bf9\u7167\u7ec4\u6765\u81ea\u793e\u533a\u4e00\u822c\u4eba\u7fa4\uff1b\u5728\u961f\u5217\u7814\u7a76\u4e2d\uff0c\u6700\u597d\u4e5f\u5e94\u8bbe\u591a\u79cd\u5bf9\u7167\uff0c\u4ee5\u51cf\u5c11\u9009\u62e9\u504f\u501a\u5bf9\u7ed3\u679c\u7684\u5f71\u54cd\u3002<\/span><\/p>\n


                                    <\/p>\n

                                    PRCT \u7684\u8bbe\u8ba1\u4e5f\u53ef\u4ee5\u89c6\u4e3a\u63a7\u5236\u9009\u62e9\u504f\u501a\u7684\u4e00\u79cd\u624b\u6bb5\u3002\u901a\u8fc7\u968f\u673a\u5206\u7ec4\u5e73\u8861\u7ec4\u95f4\u5df2\u77e5\u548c\u672a\u77e5\u7684\u9884\u540e\u56e0\u7d20\uff0c\u6700\u5927\u7a0b\u5ea6\u63d0\u9ad8\u7ec4\u95f4\u7684\u53ef\u6bd4\u6027\uff0c\u5c06\u504f\u501a\u6700\u5c0f\u5316\uff0c\u4ece\u800c\u589e\u5f3a\u8bba\u8bc1\u5f3a\u5ea6\u3002\u540e\u7eed\u7684\u968f\u8bbf\u8fc7\u7a0b\u9075\u4ece\u89c2\u5bdf\u6027\u7814\u7a76\u7684\u539f\u5219\uff0c\u5373\u7814\u7a76\u5728\u5e38\u89c4\u4e34\u5e8a\u5b9e\u8df5\u4e0b\u8fdb\u884c\uff0c\u5c3d\u53ef\u80fd\u51cf\u5c11\u5bf9\u5e38\u89c4\u6cbb\u7597\u7684\u5e72\u9884\uff0c\u53cd\u6620\u771f\u5b9e\u4e34\u5e8a\u5b9e\u8df5\u4e2d\u7684\u60c5\u51b5\u3002<\/span><\/p>\n


                                    <\/p>\n

                                    2. \u4fe1\u606f\u504f\u501a\uff08information bias\uff09\u7684\u63a7\u5236<\/span><\/strong><\/span><\/span><\/p>\n

                                    \u4fe1\u606f\u504f\u501a\u4e3b\u8981\u6765\u81ea\u8d44\u6599\u6536\u96c6\u548c\u89e3\u91ca\u8fc7\u7a0b\u4e2d\u7684\u9519\u8bef\u4fe1\u606f\uff0c\u6bd4\u5982\u95ee\u5377\u7684\u95ee\u9898\uff0c\u751f\u7269\u6807\u672c\u7684\u95ee\u9898\uff0c\u6570\u636e\u7ba1\u7406\u7684\u95ee\u9898\uff0c\u8bbe\u8ba1\u4e0e\u5206\u6790\u7684\u95ee\u9898\u3002\u800c\u4ea7\u751f\u8fd9\u4e9b\u4e0d\u6b63\u786e\u4fe1\u606f\u7684\u539f\u56e0\u53ef\u4ee5\u662f\u7814\u7a76\u5bf9\u8c61\u672c\u8eab\u7684\u8bb0\u5fc6\u8bef\u5dee\uff0c\u4e5f\u53ef\u4ee5\u7531\u7814\u7a76\u8005\u7684\u6001\u5ea6\u6216\u65b9\u6cd5\u4e0d\u5f53\u6240\u81f4\uff0c\u66f4\u91cd\u8981\u7684\u662f\u5728\u7814\u7a76\u8bbe\u8ba1\u8fc7\u7a0b\u4e2d\u5bf9\u8c03\u67e5\u8868\u8bbe\u8ba1\uff0c\u6307\u6807\u8bbe\u7acb\u548c\u68c0\u6d4b\u65b9\u6cd5\u7684\u9009\u62e9\u7f3a\u4e4f\u79d1\u5b66\u6027\u548c\u5408\u7406\u6027\uff0c\u56e0\u6b64\u8981\u5728\u7814\u7a76\u7684\u4e0d\u540c\u9636\u6bb5\u63a7\u5236\u548c\u6d88\u9664\u5f71\u54cd\u4fe1\u606f\u51c6\u786e\u6027\u7684\u5404\u79cd\u56e0\u7d20\u3002<\/span><\/p>\n

                                    \u5bf9\u4e8e\u4fe1\u606f\u504f\u501a\u9700\u91c7\u53d6\u7684\u63a7\u5236\u65b9\u6cd5\uff1a<\/span><\/strong><\/span><\/p>\n

                                    \u2022  \u7814\u7a76\u8bbe\u8ba1\u9636\u6bb5\uff1a<\/span><\/strong><\/span><\/p>\n

                                    \u5728\u7814\u7a76\u8bbe\u8ba1\u4e2d\u5bf9\u66b4\u9732\u56e0\u7d20\u5fc5\u987b\u6709\u4e25\u683c\uff0c\u5ba2\u89c2\u7684\u5b9a\u4e49\uff0c\u5e76\u529b\u6c42\u6307\u6807\u5b9a\u91cf\u5316\u3002\u8981\u6709\u7edf\u4e00\u3001\u660e\u786e\u7684\u75be\u75c5\u8bca\u65ad\u6807\u51c6\uff0c\u8c03\u67e5\u8868\u7684\u95ee\u9898\u5e94\u6613\u4e8e\u7406\u89e3\u548c\u56de\u7b54\uff0c\u4f8b\u5982\uff1a\u5f53\u8be2\u95ee\u5bf9\u8c61\u662f\u5426\u5438\u70df\u65f6\uff0c\u9996\u5148\u8981\u660e\u786e\u5bf9\u5e94\u4e8e\u672c\u6b21\u7814\u7a76\u7684\u5438\u70df\u7684\u5b9a\u4e49\uff0c\u5982\uff1a”\u6bcf\u65e5\u5438\u70df\u4e00\u652f\u4ee5\u4e0a\u8fde\u7eed\u4e00\u5e74\u4ee5\u4e0a\u3002”\u8c03\u67e5\u524d\u5e94\u5f00\u5c55\u9884\u8c03\u67e5\uff0c\u5145\u5206\u4f30\u8ba1\u8c03\u67e5\u5b9e\u65bd\u8fc7\u7a0b\u4e2d\u53ef\u80fd\u9047\u5230\u7684\u95ee\u9898\u4ee5\u53ca\u5404\u8c03\u67e5\u9879\u76ee\u7684\u53ef\u884c\u6027\u3002<\/span><\/p>\n

                                    \u7814\u7a76\u5bf9\u8c61\u5e94\u6e05\u695a\u5730\u4e86\u89e3\u672c\u6b21\u7814\u7a76\u7684\u76ee\u7684\u3001\u610f\u4e49\u548c\u8981\u6c42\uff0c\u4ee5\u83b7\u53d6\u5176\u914d\u5408\u548c\u652f\u6301\u3002\u5bf9\u4e8e\u6d89\u53ca\u751f\u6d3b\u65b9\u5f0f\u548c\u9690\u79c1\u7684\u95ee\u5377\uff0c\u5e94\u4e8b\u5148\u544a\u77e5\u5bf9\u8c61\u6240\u6709\u5e94\u7b54\u5747\u83b7\u4fdd\u5bc6\u5e76\u5c06\u5f97\u5230\u59a5\u5584\u4fdd\u7ba1\uff0c\u5fc5\u8981\u65f6\u53ef\u91c7\u7528\u533f\u540d\u95ee\u5377\u3002\u8c03\u67e5\u5458\u9700\u7ecf\u8fc7\u4e25\u683c\u57f9\u8bad\uff0c\u80fd\u6b63\u786e\u7406\u89e3\u8c03\u67e5\u7684\u610f\u4e49\u3001\u65b9\u6cd5\u548c\u5185\u5bb9\uff0c\u80fd\u4e25\u8c28\u5ba2\u89c2\u5730\u4ece\u4e8b\u8d44\u6599\u6536\u96c6\u5de5\u4f5c\u3002\u7814\u7a76\u8005\u5e94\u5b9a\u671f\u68c0\u67e5\u8d44\u6599\u7684\u8d28\u91cf\uff0c\u5e76\u8bbe\u7acb\u8d28\u91cf\u63a7\u5236\u7a0b\u5e8f\u3002<\/span><\/p>\n


                                    <\/p>\n

                                    \u2022  \u8d44\u6599\u6536\u96c6\u9636\u6bb5\uff1a<\/span><\/strong><\/span><\/p>\n

                                    \u4fe1\u606f\u504f\u501a\u4e0e\u8c03\u67e5\u5bf9\u8c61\u7684\u8bb0\u5fc6\u7a0b\u5ea6\u6709\u5173\uff0c\u5728\u7814\u7a76\u4e2d\u53ef\u5bf9\u540c\u4e00\u5185\u5bb9\u4ee5\u4e0d\u540c\u7684\u5f62\u5f0f\u91cd\u590d\u8be2\u95ee\uff0c\u4ee5\u5e2e\u52a9\u8c03\u67e5\u5bf9\u8c61\u56de\u5fc6\u5e76\u68c0\u9a8c\u5176\u5e94\u7b54\u7684\u53ef\u4fe1\u6027\u3002\u5982\u8be2\u95ee\u5438\u70df\u66b4\u9732\u5e74\u6570\u65f6\u53ef\u95ee:”\u4f60\u4e00\u751f\u4e2d\u5171\u5438\u8fc7\u51e0\u5e74\u70df “\u548c”\u4f60\u4e00\u751f\u4e2d\u54ea\u51e0\u5e74\u5438\u70df, \u54ea\u51e0\u5e74\u4e0d\u5438\u70df “\u3002\u4e3a\u4e86\u4fbf\u4e8e\u5bf9\u8c61\u7406\u89e3\u5e76\u51c6\u786e\u5730\u5b9a\u91cf\uff0c\u53ef\u5728\u8be2\u95ee\u4e2d\u4f7f\u7528\u5b9e\u7269\u5982\u676f\u5b50\uff0c\u91cf\u5319\u7b49\u6765\u4e3a\u67d0\u4e9b\u66b4\u9732\u56e0\u7d20\u5982\u6bcf\u65e5\u996e\u9152\u91cf\u3001\u76d0\u6444\u5165\u91cf\u7b49\u5b9a\u91cf\u3002\u5411\u7814\u7a76\u5bf9\u8c61\u63d0\u4f9b\u6709\u5173\u56e0\u7d20\u7684\u5b9e\u7269\u7167\u7247\u4e5f\u53ef\u4ee5\u5e2e\u52a9\u5bf9\u8c61\u76f4\u89c2\u5730\u56de\u7b54\u3002<\/span><\/p>\n

                                    \u4e3a\u4e86\u907f\u514d\u4e3b\u89c2\u8bf1\u5bfc\u5bf9\u8c61\u3001\u9664\u4e86\u4e25\u683c\u57f9\u8bad\u8c03\u67e5\u5458\u5916\uff0c\u5728\u4e34\u5e8a\u8bd5\u9a8c\u548c\u67d0\u4e9b\u73b0\u573a\u7814\u7a76\u4e2d\uff0c\u5e94\u5c3d\u53ef\u80fd\u91c7\u7528”\u76f2\u6cd5”\u4ee5\u6d88\u9664\u4e3b\u89c2\u56e0\u7d20\u5bf9\u7814\u7a76\u7ed3\u679c\u7684\u5f71\u54cd\u3002\u4f46\u5728\u91c7\u7528”\u76f2\u6cd5”\u7684\u540c\u65f6\u9700\u8003\u8651\u5176\u4f26\u7406\u5b66\u53ef\u884c\u6027\u3002<\/span><\/p>\n

                                    \u7814\u7a76\u4e2d\u7684\u5404\u79cd\u6d4b\u91cf\u4eea\u5668\u3001\u8bd5\u5242\u548c\u65b9\u6cd5\u90fd\u5e94\u6807\u51c6\u5316\u3002\u5e94\u4f7f\u7528\u540c\u4e00\u578b\u53f7\u7684\u4eea\u5668\u5e76\u5b9a\u671f\u6821\u9a8c\uff0c\u8bd5\u5242\u5fc5\u987b\u662f\u540c\u4e00\u54c1\u724c\uff0c\u540c\u4e00\u6765\u6e90\u5e76\u529b\u6c42\u540c\u4e00\u6279\u53f7\uff0c\u68c0\u6d4b\u65b9\u6cd5\u8981\u7edf\u4e00\uff0c\u7531\u4e13\u4eba\u6d4b\u5b9a\u3002<\/span><\/p>\n

                                    \u5bf9\u4e8e\u4fe1\u606f\u504f\u501a\uff0c\u9664\u4e86\u5728\u65b9\u6cd5\u5b66\u4e0a\u675c\u7edd\u5176\u6765\u6e90\u5916\uff0c\u5bf9\u5176\u6240\u81f4\u7684\u9519\u8bef\u7684\u5206\u7c7b\u7ed3\u679c\uff0c\u53ef\u8fdb\u4e00\u6b65\u5728\u8d44\u6599\u5206\u6790\u8fc7\u7a0b\u4e2d\u52a0\u4ee5\u6d4b\u91cf\u3001\u6821\u6b63\uff0c\u5e76\u8fdb\u884c\u76f8\u5e94\u7684\u7075\u654f\u5ea6\u5206\u6790\u3002<\/span><\/p>\n


                                    <\/p>\n

                                    3. \u6df7\u6742 \uff08confounding\uff09 \u7684\u63a7\u5236<\/span><\/strong><\/span><\/p>\n

                                    \u6df7\u6742\u662f\u4e00\u7c7b\u5728 RWS \u4e2d\u503c\u5f97\u5168\u7a0b\u5173\u6ce8\u5374\u53c8\u65e0\u6cd5\u5b8c\u5168\u907f\u514d\u548c\u63a7\u5236\u7684\u56e0\u7d20\uff0c\u53ea\u80fd\u5c3d\u53ef\u80fd\u7684\u8bc6\u522b\u548c\u63a7\u5236\u4ee5\u51cf\u5c0f\u6df7\u6742\u5bf9\u7ed3\u679c\u7684\u5f71\u54cd\u3002\u8bc6\u522b\u548c\u9009\u62e9\u6df7\u6742\u56e0\u7d20\uff0c\u901a\u5e38\u662f\u7ed3\u5408\u4e34\u5e8a\u548c\u6d41\u884c\u75c5\u5b66\u4e13\u4e1a\u77e5\u8bc6\u8fdb\u884c\u9009\u62e9\u3002<\/span><\/p>\n

                                    \u5bf9\u4e8e\u8f83\u6210\u719f\u7684\u9886\u57df\uff0c\u4efb\u4f55\u5df2\u6709\u8bc1\u636e\u63d0\u793a\u4e3a\u6df7\u6742\u7684\u53d8\u91cf\u90fd\u5e94\u8be5\u8003\u8651\uff1b\u53ef\u4ee5\u57fa\u4e8e\u6587\u732e\u56de\u987e\u4ee5\u53ca\u7814\u7a76\u4eba\u5458\u4e13\u4e1a\u9886\u57df\u7684\u77e5\u8bc6\u548c\u7406\u89e3\u3002\u5bf9\u4e8e\u5d2d\u65b0\u7684\u9886\u57df\uff0c\u8003\u8651\u90a3\u4e9b\u4e0e\u75be\u75c5\u6709\u5173\u4e5f\u53ef\u80fd\u4e0e\u66b4\u9732\u6709\u5173\u7684\u56e0\u7d20\u3002\u5982\u679c\u96be\u4ee5\u786e\u5b9a\uff0c\u53ef\u4ee5\u5728\u8d44\u6e90\u5141\u8bb8\u7684\u6761\u4ef6\u4e0b\uff0c\u8003\u8651\u5bf9\u6240\u6709\u4e0e\u75be\u75c5\u6709\u5173\u7684\u56e0\u7d20\u90fd\u8fdb\u884c\u6d4b\u91cf\uff0c\u5c3d\u53ef\u80fd\u7684\u6536\u96c6\u66f4\u591a\u7684\u6570\u636e\u70b9\u3002<\/span><\/p>\n

                                    \u5bf9\u4e8e\u6df7\u6742\u7684\u5e38\u7528\u7684\u63a7\u5236\u65b9\u6cd5\u5982\u4e0b\uff1a<\/span><\/strong><\/span><\/p>\n

                                    \u2022  \u9650\u5236\uff1a<\/span><\/strong>\u7814\u7a76\u8bbe\u8ba1\u5f00\u59cb\u9636\u6bb5\uff0c\u9488\u5bf9\u67d0\u4e9b\u53ef\u80fd\u7684\u6df7\u6742\u56e0\u7d20\uff0c\u5bf9\u7814\u7a76\u5bf9\u8c61\u7684\u5165\u6392\u6807\u51c6\u52a0\u4ee5\u9650\u5236\u662f\u5e38\u7528\u7684\u63a7\u5236\u6df7\u6742\u7684\u65b9\u6cd5\uff0c\u7136\u800c\u8fd9\u6837\u4f1a\u4f7f\u5f97\u7814\u7a76\u5bf9\u8c61\u51cf\u5c11\u3002\u4f18\u70b9\u5728\u4e8e\u7b5b\u68c0\u5927\u91cf\u4e2a\u4f53\uff0c\u53ea\u5165\u9009\u5176\u4e2d\u4e00\u90e8\u5206\uff0c\u589e\u52a0\u4e86\u7814\u7a76\u5bf9\u8c61\u7684\u540c\u8d28\u6027\uff08homogeneity\uff09\uff0c\u63d0\u9ad8\u4e86\u7814\u7a76\u7684\u5185\u90e8\u6709\u6548\u6027\uff0c\u4f46\u662f\u7f3a\u70b9\u662f\u964d\u4f4e\u4e86\u7814\u7a76\u6548\u7387\uff0c\u53ef\u80fd\u4f1a\u5f71\u54cd\u7ed3\u679c\u7684\u5916\u63a8\u3002\u800c\u9650\u5236\u8303\u56f4\u5982\u679c\u592a\u5bbd\u6216\u4e0d\u5f53\uff0c\u53c8\u53ef\u80fd\u6709\u6b8b\u4f59\u6df7\u6742 \u3002<\/span><\/span><\/p>\n

                                    \u2022  \u5339\u914d\uff1a<\/span><\/strong>\u961f\u5217\u7814\u7a76\u4e2d\uff0c\u5339\u914d\u662f\u66b4\u9732\u8005\u4e0e\u975e\u66b4\u9732\u8005\u5728\u67d0\u56e0\u7d20\u4e0a\u7684\u5339\u914d\uff0c\u4e00\u65e6\u5339\u914d\uff0c\u539f\u5219\u4e0a\u5373\u53ef\u5b8c\u5168\u63a7\u5236\u5339\u914d\u56e0\u7d20\u5f15\u8d77\u7684\u6df7\u6742\uff0c\u4e0d\u5fc5\u5728\u7edf\u8ba1\u5206\u6790\u9636\u6bb5\u8fdb\u4e00\u6b65\u63a7\u5236\u3002\u800c\u75c5\u4f8b\u5bf9\u7167\u7814\u7a76\u4e2d\uff0c\u5339\u914d\u540e\u8fd8\u9700\u8981\u6309\u7167\u5339\u914d\u56e0\u7d20\u8fdb\u884c\u5206\u5c42\u5206\u6790\uff0c\u8fd9\u662f\u63a7\u5236\u6df7\u6742\u7684\u5fc5\u8981\u6761\u4ef6\uff0c\u5e76\u4e14\uff0c\u5339\u914d\u5e76\u975e\u76f4\u63a5\u63a7\u5236\u6df7\u6742\uff0c\u800c\u662f\u63d0\u9ad8\u4e86\u63a7\u5236\u6df7\u6742\u7684\u6548\u7387\u3002\u503c\u5f97\u7684\u6ce8\u610f\u7684\u662f\u8981\u9632\u6b62\u5339\u914d\u8fc7\u5ea6\u3002<\/span><\/span><\/p>\n

                                    \u2022  \u5206\u5c42\u5206\u6790\uff1a<\/span><\/strong>\u76ee\u7684\u5728\u4e8e\u4f30\u8ba1\u548c\u63a7\u5236\u6df7\u6742\u7684\u5f71\u54cd\uff0c\u8bc4\u4f30\u548c\u63cf\u8ff0\u6548\u5e94\u4fee\u6b63\u56e0\u5b50\uff08modifier\uff09\u4e0d\u540c\u6c34\u5e73\u5206\u5c42\u4e2d\u7684\u7814\u7a76\u7ed3\u679c\u3002\u65b9\u6cd5\u662f\u5c06\u7814\u7a76\u8d44\u6599\u6309\u7167\u6df7\u6742\u56e0\u7d20\u6765\u8fdb\u884c\u5206\u5c42\u3002\u5206\u5c42\u5206\u6790\u7f3a\u70b9\u5728\u4e8e\uff1a\u4e00\u6b21\u53ea\u80fd\u5206\u6790\u4e00\u79cd\u66b4\u9732-\u75be\u75c5\u5173\u8054\uff1b\u8fde\u7eed\u6027\u53d8\u91cf\u8f6c\u53d8\u4e3a\u79bb\u6563\u6027\u53d8\u91cf\uff0c\u4e22\u5931\u4e86\u4e00\u5b9a\u7a0b\u5ea6\u7684\u4fe1\u606f\uff0c\u53ef\u80fd\u9020\u6210\u6b8b\u4f59\u6df7\u6742\uff1b\u9700\u8981\u63a7\u5236\u7684\u6df7\u6742\u8f83\u591a\u65f6\uff0c\u5206\u5c42\u5219\u4e0d\u662f\u6700\u660e\u667a\u7684\u9009\u62e9\u3002<\/span><\/span><\/p>\n

                                    \u2022  \u591a\u56e0\u7d20\u5206\u6790\uff1a<\/span><\/strong>\u5c06\u591a\u4e2a\u53ef\u80fd\u7684\u6df7\u6742\u56e0\u7d20\u53d8\u91cf\u5f15\u5165\u5206\u6790\u6a21\u578b\uff0c\u53ef\u4ee5\u662f\u591a\u5143\u7ebf\u6027\u6a21\u578b\uff0clogistic \u56de<\/span>\u5f52\uff0c\u6bd4\u4f8b\u98ce\u9669\u6a21\u578b\uff0c\u56e0\u5b50\u5206\u6790\u7b49\u3002\u8981\u70b9\u5728\u4e8e\u5728\u8bbe\u8ba1\u9636\u6bb5\u548c\u6570\u636e\u91c7\u96c6\u9636\u6bb5\u5c06\u53ef\u80fd\u7684\u6df7\u6742\u56e0\u7d20\u6536\u96c6\uff0c\u4ee5\u4fbf\u540e\u7eed\u7eb3\u5165\u5206\u6790\uff0c\u6709\u6548\u5730\u63a7\u5236\u6df7\u6742\u3002<\/span><\/span><\/p>\n

                                    \u2022  \u503e\u5411\u6027\u8bc4\u5206\uff1a<\/span><\/strong>\u5728\u6bd4\u8f83\u4e0d\u540c\u7684\u6cbb\u7597\u65b9\u6cd5\u5bf9\u75be\u75c5\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u8bc4\u4ef7\u7684\u7814\u7a76\u4e2d\uff0c\u4e0d\u540c\u7ec4\u522b\u7684\u60a3\u8005\u5f80\u5f80\u6ca1\u6709\u53ef\u6bd4\u6027\uff0c\u6bd4\u5982\u91c7\u53d6\u624b\u672f\u6cbb\u7597\u7684\u60a3\u8005\u548c\u4fdd\u5b88\u6cbb\u7597\u7684\u60a3\u8005\u5728\u75be\u75c5\u7814\u7a76\u7a0b\u5ea6\u3001\u5e74\u9f84\u548c\u7ecf\u6d4e\u8d1f\u62c5\u80fd\u529b\u7b49\u65b9\u9762\u4f1a\u6709\u8f83\u5927\u7684\u4e0d\u540c\uff0c\u8fd9\u4e9b\u56e0\u7d20\u90fd\u662f\u8bc4\u4ef7\u624b\u672f\u6216\u4fdd\u5b88\u6cbb\u7597\u6548\u679c\u7684\u91cd\u8981\u7684\u6df7\u6742\u56e0\u7d20\uff0c\u5982\u679c\u4e0d\u80fd\u5f97\u5230\u63a7\u5236\u548c\u8c03\u6574\uff0c\u5f97\u5230\u7684\u7ed3\u679c\u5f80\u5f80\u662f\u4e0d\u51c6\u786e\u7684\u6216\u8005\u662f\u9519\u8bef\u7684\u3002\u4e3a\u4e86\u540c\u65f6\u63a7\u5236\u591a\u79cd\u4e0d\u540c\u6df7\u6742\u56e0\u7d20\u5728\u4e24\u7ec4\u4eba\u7fa4\u5206\u5e03\u7684\u4e0d\u5e73\u8861\uff0c\u53ef\u4ee5\u91c7\u7528\u4f7f\u7528\u503e\u5411\u6027\u8bc4\u5206\u7684\u65b9\u6cd5\u3002\u503e\u5411\u6027\u8bc4\u5206\u662f\u6307\u5728\u4e00\u5b9a\u534f\u53d8\u91cf\u6761\u4ef6\u4e0b\uff0c\u4e00\u4e2a\u89c2\u5bdf\u5bf9\u8c61\u53ef\u80fd\u63a5\u53d7\u67d0\u79cd\u5904\u7406\uff08\u6216\u66b4\u9732\uff09\u56e0\u7d20\u7684\u53ef\u80fd\u6027\u3002\u5f53\u7814\u7a76\u6d89\u53ca\u5230\u7684\u6df7\u6742\u56e0\u7d20\u8fc7\u591a\u65f6\uff0c\u5982 20\uff0d30 \u4e2a\uff0c\u8fdb\u884c\u5339\u914d\u5219\u53d8\u5f97\u4e0d\u73b0\u5b9e\uff0c\u4e25\u91cd\u5f71\u54cd\u4e86\u6837\u672c\u91cf\uff0c\u800c\u5168\u90e8\u8fdb\u5165\u7edf\u8ba1\u6a21\u578b\u4f1a\u56e0\u5171\u7ebf\u6027\u7b49\u95ee\u9898\uff0c\u4f7f\u5f97\u7edf\u8ba1\u6a21\u578b\u65e0\u6cd5\u6b63\u5e38\u4f30\u8ba1\u6548\u5e94\u3002\u5728\u89c2\u5bdf\u6027\u7814\u7a76\u4e2d\uff0c\u901a\u8fc7\u5bf9\u503e\u5411\u6027\u8bc4\u5206\u7684\u5206\u5c42\u5206\u6790\u3001\u5339\u914d\u3001\u56de\u5f52\u5206\u6790\uff0c\u6743\u91cd\u7b49\u65b9\u6cd5\uff0c\u4ee5\u671f\u8fbe\u5230\u63a7\u5236\u6df7\u6742\u7684\u76ee\u7684[14] \u3002<\/span><\/span><\/p>\n


                                    <\/p>\n

                                    \u516b\uff0e\u8bc1\u636e\u7b49\u7ea7\u8bc4\u4ef7<\/span><\/strong><\/span><\/p>\n

                                    1.\u6b63\u786e\u8ba4\u8bc6 RWS \u8bc1\u636e\u7b49\u7ea7<\/span><\/strong><\/span><\/p>\n

                                    \u5faa\u8bc1\u533b\u5b66\u91d1\u5b57\u5854\u8bc1\u636e\u5206\u7ea7\uff08hierarchy of evidence\uff09\u65b9\u6cd5[15] \u6700\u65e9\u8bde\u751f\u4e8e\u6cbb\u7597\u7814\u7a76\u9886\u57df\uff0c\u8bc1\u636e\u5206\u7ea7\u7684\u6982\u5ff5\u63d0\u51fa\u6765\u4e4b\u521d\uff0c\u5c06\u6240\u6709 RCT \u7684\u8bc1\u636e\u7ea7\u522b\u7f6e\u4e8e\u5176\u4ed6\u7814\u7a76\u4e4b\u4e0a\uff0c\u7531\u6b64\u5bfc\u81f4\u666e\u904d\u7684\u89c2\u5ff5\u8ba4\u4e3a RWS\u7684\u8bc1\u636e\u7b49\u7ea7\u6216\u53ef\u4fe1\u5ea6\u4f4e\u4e8e RCT \u7814\u7a76\u4ea7\u751f\u7684\u8bc1\u636e\u3002\u7136\u800c\uff0c\u4e0d\u540c\u7684\u7814\u7a76\u95ee\u9898\u9700\u8981\u9009\u62e9\u4e0d\u540c\u7c7b\u578b\u7684\u7814\u7a76\u8bc1\u636e\uff0c\u56e0\u4e3a\u6709\u4e9b\u4e34\u5e8a\u95ee\u9898\u96be\u4ee5\u7528 RCT \u8bbe\u8ba1\u53bb\u56de\u7b54\u3002\u4f8b\u5982\uff0c\u9488\u5bf9\u7cd6\u5c3f\u75c5\u5e76\u53d1\u6162\u6027\u80be\u708e\u7684\u60a3\u8005 10 \u5e74\u7684\u5fc3\u8840\u7ba1\u6b7b\u4ea1\u7387\u8bc4\u4f30\u8fd9\u4e00\u95ee\u9898\uff0c\u6700\u4f18\u7684\u8bc1\u636e\u6765\u6e90\u4e0d\u662f RCT\uff0c\u800c\u662f\u9ad8\u8d28\u91cf\u7684\u961f\u5217\u7814\u7a76\u3002\u7f8e\u56fd FDA \u4e8e2016 \u5e74 12 \u6708\u5728\u300a\u65b0\u82f1\u683c\u5170\u533b\u5b66\u6742\u5fd7\u300b\u4e0a\u53d1\u6587\u6307\u51fa [3] \uff0cRWS \u4e0e\u5176\u4ed6\u8bc1\u636e\u7684\u672c\u8d28\u533a\u522b\u4e0d\u5728\u4e8e\u7814\u7a76\u65b9\u6cd5\u548c\u8bd5\u9a8c\u8bbe\u8ba1\uff0c\u800c\u5728\u4e8e\u83b7\u53d6\u6570\u636e\u7684\u73af\u5883\u30022017 \u5e74 8 \u6708\u7f8e\u56fd FDA \u53d1\u5e03\u300a\u4f7f\u7528\u771f\u5b9e\u4e16\u754c\u8bc1\u636e\u652f\u6301\u533b\u7597\u5668\u68b0\u6ce8\u518c\u5ba1\u6279\u6307\u5357\u300b\u63d0\u51fa\u968f\u7740\u771f\u5b9e\u4e16\u754c\u4e34\u5e8a\u7814\u7a76\u7684\u589e\u591a\uff0c\u53ef\u4ee5\u5229\u7528\u8fd9\u4e9b\u8bc1\u636e\u7528\u6765\u652f\u6301\u533b\u7597\u5668\u68b0\u7684\u76d1\u7ba1\u51b3\u7b56 [2] \u3002\u53ef\u89c1 RWE \u751a\u81f3\u53ef\u4ee5\u4f5c\u4e3a\u836f\u68b0\u5ba1\u6279\u7684\u652f\u6301\u6027\u8bc1\u636e\u5185\u5bb9\uff0c\u662f\u5faa\u8bc1\u533b\u5b66\u4f53\u7cfb\u4e2d\u7684\u6709\u6548\u8865\u5145\u3002\u56e0\u6b64\uff0c\u628a RWS \u7684\u8bc1\u636e\u7ea7\u522b\u7b80\u5355\u5212\u5206\u5728\u91d1\u5b57\u5854\u8bc1\u636e\u5206\u7ea7\u6cd5\u4e2d\u7684\u67d0\u4e2a\u6216\u67d0\u51e0\u4e2a\u7ea7\u522b\u5e76\u4e0d\u9002\u5408\uff0c\u4e5f\u4e0d\u610f\u5473\u7740\u901a\u8fc7 RWS \u6240\u4ea7\u751f\u7684\u8bc1\u636e\u7b49\u7ea7\u4e00\u5b9a\u4f4e\u4e8e RCT \u8bc1\u636e\uff0c\u4e24\u8005\u5f80\u5f80\u662f\u4e3a\u4e86\u56de\u7b54\u4e0d\u540c\u4e34\u5e8a\u95ee\u9898\u800c\u4ea7\u751f\u7684\u4e0d\u540c\u7814\u7a76\u8bbe\u8ba1\uff0c\u5728\u8bc1\u636e\u7ea7\u522b\u4e0a\u4e0d\u5177\u5907\u7b80\u5355\u7684\u53ef\u6bd4\u6027\u3002<\/span><\/p>\n


                                    <\/p>\n

                                    2.RWE\u8bc4\u4ef7\u65b9\u6cd5<\/span><\/strong><\/span><\/p>\n

                                    \u968f\u7740\u533b\u5b66\u7814\u7a76\u9886\u57df\u7684\u53d1\u5c55\uff0c\u8bc1\u636e\u8bc4\u4ef7\u4f53\u7cfb\u4e5f\u9700\u8981\u76f8\u5e94\u62d3\u5c55\u4ee5\u9002\u5e94\u65b0\u7684\u9700\u6c42\u3002\u5bf9 RWS \u7684\u8bc1\u636e\u7b49\u7ea7\u8bc4\u4ef7\u5e94\u8be5\u4f9d\u636e\u9009\u53d6\u7684\u7814\u7a76\u8bbe\u8ba1\u4e0e\u7814\u7a76\u95ee\u9898\u4e4b\u95f4\u7684\u76f8\u5173\u6027\u3001\u7814\u7a76\u8d28\u91cf\u63a7\u5236\u7a0b\u5ea6\uff0c\u4ee5\u53ca\u9009\u53d6\u7684\u7814\u7a76\u6570\u636e\u7684\u53ef\u9760\u6027\u8fdb\u884c\u8bc4\u4ef7\u3002\u672c\u6587\u501f\u9274\u5faa\u8bc1\u533b\u5b66\u91d1\u5b57\u5854\u8bc1\u636e\u5206\u7ea7\u65b9\u6cd5 [16] \uff0c\u5c06\u5e38\u89c1\u7684 RWS \u7c7b\u578b\u6309\u7167\u8bc1\u636e\u7b49\u7ea7\u7684\u9ad8\u4f4e\u8fdb\u884c\u6392\u5e8f\uff08\u56fe 2\uff09\uff0c\u540c\u65f6\u5efa\u8bae\u7814\u7a76\u8005\u53c2\u7167\u4e00\u7cfb\u5217\u5f71\u54cd\u8bc1\u636e\u7b49\u7ea7\u7684\u5173\u952e\u56e0\u7d20\u6765\u5ba2\u89c2\u8bc4\u4f30\u771f\u5b9e\u4e16\u754c\u8bc1\u636e\u7684\u8bc1\u636e\u7ea7\u522b\uff0c\u4f8b\u5982\uff0c\u4ee5\u4e0b\u8868\u683c\uff08\u8868 4\uff09\u4e2d\u7684\u5173\u952e\u70b9\u5747\u662f\u63d0\u9ad8\u771f\u5b9e\u4e16\u754c\u8bc1\u636e\u7b49\u7ea7\u7684\u5e38\u89c1\u5173\u952e\u56e0\u7d20 [17] \uff0c\u53cd\u4e4b\uff0c\u5219\u964d\u4f4e\u7814\u7a76\u7684\u8bc1\u636e\u7ea7\u522b\u3002<\/span><\/p>\n

                                    \"\u5206\u4eab\u4e28\u771f\u5b9e\u4e16\u754c\u7814\u7a76\u6307\u53572018\u5e74\u7248\uff08\u5168\u6587\uff09\"<\/p>\n


                                    <\/p>\n

                                    \u4e5d\uff0e\u6848\u4f8b\u5206\u6790<\/span><\/strong><\/span><\/span><\/p>\n

                                    \u201c\u4ee5\u4eba\u7fa4\u4e3a\u57fa\u7840\u7684\u7532\u72b6\u817a\u764c\u60a3\u8005\u6b7b\u4ea1\u6982\u7387\u7684\u9884\u6d4b\u548c\u8bc4\u4ef7\u7814\u7a76\u201d\uff0c\u662f 2013 \u5e74\u53d1\u8868\u5728 Journal of <\/span>Clinical Oncology \u7684\u4e00\u7bc7\u57fa\u4e8e\u5df2\u6709\u6570\u636e\u5e93\u7684 RWS \u6587\u7ae0[18]\u3002\u6211\u4eec\u53c2\u8003STROBE \u8d28\u91cf\u8bc4\u4f30\u6807\u51c6\u548c\u6307\u5357\u6d41\u7a0b\u4e2d\u6d89\u53ca\u7684\u76f8\u5173\u8981\u7d20[17] \uff0c\u5bf9\u8be5\u7814\u7a76\u8fdb\u884c\u4e86\u5982\u4e0b\u5206\u6790\u3002<\/span><\/span><\/p>\n

                                    \"\u5206\u4eab\u4e28\u771f\u5b9e\u4e16\u754c\u7814\u7a76\u6307\u53572018\u5e74\u7248\uff08\u5168\u6587\uff09\"<\/p>\n

                                    \"\u5206\u4eab\u4e28\u771f\u5b9e\u4e16\u754c\u7814\u7a76\u6307\u53572018\u5e74\u7248\uff08\u5168\u6587\uff09\"<\/p>\n


                                    <\/p>\n

                                    \u5341\uff0e\u65b0\u6280\u672f\u65b9\u6848\u53ca\u672a\u6765\u5c55\u671b<\/span><\/strong><\/span><\/span><\/p>\n

                                    21 \u4e16\u7eaa\u662f\u6570\u636e\u5f15\u5bfc\u51b3\u7b56\u7684\u65f6\u4ee3\u3002\u8ba1\u7b97\u673a\u6280\u672f\u652f\u6301\u7684\u4e34\u5e8a\u5b9e\u8df5\u6240\u4ea7\u751f\u7684\u5927\u91cf\u4e34\u5e8a\u6570\u636e\u4e3a\u8fdb\u884c\u79d1\u5b66\u7814\u7a76\u5960\u5b9a\u4e86\u57fa\u7840\u3002\u5728\u6d77\u91cf\u6570\u636e\u80cc\u666f\u4e0b, \u53ef\u57fa\u4e8e\u73b0\u6709\u6570\u636e\u5e93\u4e2d\u7684\u6570\u636e\u8fdb\u884c\u5206\u6790, \u6765\u652f\u6301\u4e0d\u540c\u79cd\u7c7b\u7684\u4e1a\u52a1\u3002\u968f\u7740\u673a\u5668\u5b66\u4e60\u7684\u53d1\u5c55\uff0c\u56fe\u50cf\u8bc6\u522b\uff0c\u6587\u672c\u8bc6\u522b\uff0c\u58f0\u97f3\u8bc6\u522b\u7b49\u65b0\u6280\u672f\u53ef\u4ee5\u5feb\u901f\u5e2e\u52a9\u4e34\u5e8a\u6570\u636e\u7ed3\u6784\u5316\uff0c\u5927\u6570\u636e\u5206\u6790\u65b9\u6cd5\uff0c\u4e91\u50a8\u5b58\u53ca\u4e91\u8ba1\u7b97\u7b49\u6280\u672f\u7684\u9010\u6e10\u6210\u719f\u4ee5\u53ca\u533a\u57df\u94fe\u6280\u672f\uff08blockchain\uff09\u7684\u63d0\u51fa\u548c\u5e94\u7528\uff0c\u4f7f\u591a\u7ef4\u5ea6\u6570\u636e\u6574\u5408\u53ca\u4e00\u4f53\u5316\u7ba1\u7406\u6210\u4e3a\u53ef\u80fd\u3002\u8fd9\u4e9b\u90fd\u7ed9 RWS \u5e26\u6765\u4e86\u524d\u6240\u672a\u6709\u7684\u4fbf\u5229\uff0c\u4e3aRWS \u7684\u5f00\u5c55\u548c\u957f\u671f\u5e94\u7528\u5960\u5b9a\u4e86\u57fa\u7840\u3002<\/span><\/p>\n

                                    \u771f\u5b9e\u4e16\u754c\u8bc1\u636e\u4f5c\u4e3a\u4e00\u4e2a\u8f83\u65b0\u7684\u6982\u5ff5\uff0c\u8fd8\u5b58\u5728\u7740\u4e00\u4e9b\u6709\u4e89\u8bae\u7684\u5185\u5bb9\uff0c\u5176\u76f8\u5173\u6280\u672f\u65b9\u6cd5\u4e5f\u8fd8\u6709\u5f85\u5b8c\u5584\uff0c\u76ee\u524d\u4ec5\u4f5c\u4e3a\u836f\u54c1\u548c\u533b\u7597\u5668\u68b0\u5ba1\u6279\u51b3\u7b56\u7684\u8865\u5145\u8bc1\u636e\u3002\u7136\u800c\uff0c\u771f\u5b9e\u4e16\u754c\u8bc1\u636e\u5bf9\u4e8e\u672a\u6765\u5065\u5eb7\u548c\u533b\u7597\u7684\u63a8\u52a8\u4e0d\u53ef\u4f4e\u4f30\u3002\u672c\u6307\u5357\u4ec5\u9488\u5bf9 RWS \u63d0\u51fa\u5efa\u8bae\u6027\u601d\u8003\uff0c\u5728\u5177\u4f53\u4e34\u5e8a\u79d1\u7814\u5b9e\u8df5\u4e2d\uff0c\u7814\u7a76\u4eba\u5458\u53ef\u6839\u636e\u5177\u4f53\u60c5\u51b5\u7075\u6d3b\u53c2\u8003\u548c\u4f7f\u7528\u8be5\u6307\u5357\u3002\u5e0c\u671b\u8be5\u6307\u5357\u80fd\u591f\u5e2e\u52a9\u7814\u7a76\u4eba\u5458\u5feb\u901f\u5165\u95e8\u5e76\u89e3\u51b3\u4e34\u5e8a\u5b9e\u9645\u95ee\u9898\u3002\u9274\u4e8e\u8be5\u6307\u5357\u4e3a\u521d\u7248\uff0c\u8fd8\u6709\u975e\u5e38\u591a\u4e0d\u8db3\u548c\u9700\u8981\u4f18\u5316\u7684\u7a7a\u95f4\uff0c\u975e\u5e38\u671f\u5f85\u5927\u5bb6\u7684\u5b9d\u8d35\u610f\u89c1\u548c\u53cd\u9988\uff0c\u5728\u6b64\u57fa\u7840\u4e0a\u6211\u4eec\u5c06\u9010\u6b65\u5b8c\u5584\uff0c\u5728\u672a\u6765\u7684 3 \u5230 5 \u5e74\u65f6\u95f4\u91cc\uff0c\u5efa\u7acb\u8d77\u5b8c\u5168\u7b26\u5408\u4e2d\u56fd\u5b9e\u9645\u9700\u6c42\u7684 RWS \u6307\u5357\u4f53\u7cfb\u3002<\/span><\/p>\n


                                    <\/p>\n

                                    \u9644\u5f55 I \u56fd\u5916\u6307\u5357\u53c2\u8003<\/span><\/strong><\/span><\/p>\n

                                    \u8fd1\u5e74\u6765\u56fd\u9645\u4e0a\u591a\u4e2a\u4e34\u5e8a\u7814\u7a76\u7ec4\u7ec7\u548c\u76d1\u7ba1\u673a\u6784\u5148\u540e\u9881\u5e03\u4e86\u5173\u4e8e RWS \u7684\u6307\u5357\u6216\u5de5\u4f5c\u6307\u5bfc\u610f\u89c1\uff0c\u4f8b\u5982\u6709Good Pharmacoepidemiology Practice (GPP)\uff0c ISPOR RWD \u6307\u5357\uff0c US FDA Device RWD<\/span>\u6307\u5357\u7b49\uff0c\u672c\u6587\u4ee5\u8868\u683c\u7684\u5f62\u5f0f\u7b80\u8981\u603b\u7ed3\u51e0\u4e2a\u91cd\u8981\u56fd\u5916\u6307\u5357\u7684\u8981\u70b9\u3002<\/span><\/span><\/p>\n

                                    \"\u5206\u4eab\u4e28\u771f\u5b9e\u4e16\u754c\u7814\u7a76\u6307\u53572018\u5e74\u7248\uff08\u5168\u6587\uff09\"<\/p>\n


                                    <\/p>\n

                                    \u9644\u5f55 II \u53c2\u8003\u6587\u732e<\/span><\/strong><\/span><\/p>\n


                                    <\/p>\n

                                    \"\u5206\u4eab\u4e28\u771f\u5b9e\u4e16\u754c\u7814\u7a76\u6307\u53572018\u5e74\u7248\uff08\u5168\u6587\uff09\"<\/p>\n

                                    \"\u5206\u4eab\u4e28\u771f\u5b9e\u4e16\u754c\u7814\u7a76\u6307\u53572018\u5e74\u7248\uff08\u5168\u6587\uff09\"<\/p>\n

                                    \u3010\u8f6c\u81ea\uff1a\u9a6d\u65f6\u4e34\u5e8a\u8bd5\u9a8c\u4fe1\u606f\u3011<\/strong><\/p>\n

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                                    \"\u5206\u4eab\u4e28\u771f\u5b9e\u4e16\u754c\u7814\u7a76\u6307\u53572018\u5e74\u7248\uff08\u5168\u6587\uff09\"<\/p>\n

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                                    \u514d\u8d23\u58f0\u660e\uff1a<\/span><\/p>\n

                                    \u672c\u6587\u4fe1\u606f\u90e8\u5206\u5185\u5bb9\u6765\u81ea\u7f51\u7edc\u6587\u7ae0\uff0c\u4e0d\u4fdd\u8bc1\u6240\u6709\u4fe1\u606f\u3001\u6587\u672c\u3001\u56fe\u5f62\u3001\u94fe\u63a5\u53ca\u5176\u4ed6\u9879\u76ee\u7684\u7edd\u5bf9\u51c6\u786e\u6027\u548c\u5b8c\u6574\u6027\uff0c\u6545\u4ec5\u4f9b\u8bbf\u95ee\u8005\u53c2\u7167\u9002\u7528\u3002\u5982\u60a8\uff08\u5355\u4f4d\u6216\u4e2a\u4eba\uff09\u8ba4\u4e3a\u672c\u6587\u67d0\u90e8\u5206\u5185\u5bb9\u6709\u4fb5\u6743\u5acc\u7591\uff0c\u656c\u8bf7\u7acb\u5373\u901a\u77e5\u6211\u4eec\uff0c\u6211\u4eec\u5c06\u5728\u7b2c\u4e00\u65f6\u95f4\u4e88\u4ee5\u66f4\u6b63\u6216\u5220\u9664\u3002\u4ee5\u4e0a\u58f0\u660e\u4e4b\u89e3\u91ca\u6743\u5f52\u672c\u516c\u4f17\u53f7\u6240\u6709\u3002\u6cd5\u5f8b\u4e0a\u6709\u76f8\u5173\u89e3\u91ca\u7684\uff0c\u4ee5\u4e2d\u56fd\u6cd5\u5f8b\u4e4b\u89e3\u91ca\u4e3a\u57fa\u51c6\u3002\u5982\u6709\u4e89\u8bae\u9650\u5728\u6211\u65b9\u6240\u5728\u5730\u53f8\u6cd5\u90e8\u95e8\u89e3\u51b3\u3002\u8c22\u8c22\u3002<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n


                                    <\/p>\n<\/p><\/div>\n","protected":false},"excerpt":{"rendered":"

                                    2018\u5e748\u67083\u65e5\uff0c\u7531\u5434\u9636\u5e73\u533b\u5b66\u57fa\u91d1\u4f1a\u80bf\u7624\u533b\u5b66\u90e8\u4e3b\u59d4\u5434\u4e00\u9f99\u6559\u6388\u7275\u5934\u7ec4\u7ec7\u76f8\u5173\u4e13\u5bb6\u64b0\u5199\u7684\u300a\u771f\u5b9e\u4e16\u754c\u7814\u7a76\u6307\u5357\u300b\u5728\u5e7f\u5dde […]<\/p>\n","protected":false},"author":1,"featured_media":41326,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[2],"tags":[],"_links":{"self":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/41325"}],"collection":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/comments?post=41325"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/41325\/revisions"}],"predecessor-version":[{"id":41343,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/41325\/revisions\/41343"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/41326"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=41325"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=41325"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=41325"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}