Publication Information

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Mascha', 'raw_affiliation_strings': ['Accepted for publication August 10, 2015.', 'From the Departments of Quantitative Health Sciences and Outcomes Research, Cleveland Clinic, Cleveland, Ohio.', 'Funding: Anesthesia Institute.', 'Reprints will not be available from the author.', 'The author declares no conflicts of interest.'], 'affiliations': [{'raw_affiliation_string': 'Accepted for publication August 10, 2015.', 'institution_ids': []}, {'raw_affiliation_string': 'From the Departments of Quantitative Health Sciences and Outcomes Research, Cleveland Clinic, Cleveland, Ohio.', 'institution_ids': ['https://openalex.org/I1316902750']}, {'raw_affiliation_string': 'Funding: Anesthesia Institute.', 'institution_ids': []}, {'raw_affiliation_string': 'The author declares no conflicts of interest.', 'institution_ids': []}, {'raw_affiliation_string': 'Reprints will not be available from the author.', 'institution_ids': []}]}], 'institution_assertions': [], 'countries_distinct_count': 1, 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1583, 1715], 'conclusion!': [333], 'Common': [334], 'methods': [335, 369, 391, 1832, 1982], 'Bonferroni': [342], 'correction': [343], 'comparisons': [346], 'α': [349, 450, 1252], 'level': [350, 465, 878, 1316, 2284], 'enough': [354], '(e.g.,': [355, 824], 'some': [356, 446, 1812, 2375, 2381], 'journals/editors': [357], 'recommend': [358], '<0.01': [360], 'smaller': [362, 486], 'observational': [364], 'studies)': [365], 'group': [367, 429, 534, 602, 753, 1238, 1247, 1291, 1306, 1324, 1342, 1352, 1374, 1386, 1423, 1509, 1518, 1603, 1676, 1911, 2292], 'sequential': [368, 535, 586, 603, 754, 1912, 2028, 2293], 'clinical': [371, 418, 659, 1198, 2298], 'trials.': [372, 1844], 'GUIDELINE': [373, 1172], 'Guideline': [375, 1174], '1:': [376, 1234, 1680], 'Research': [377], 'reports': [378, 1514], 'test': [380], 'hypotheses': [382], 'repeat': [384], 'analyses': [385, 423], 'but': [386, 537], 'make': [387, 2163, 2318], 'no': [388, 897, 2306], 'mention': [389], 'most': [397, 2346], 'reporting': [404], 'results.': [406, 1012, 1147, 1735], 'This': [407, 474, 1932, 2049, 2300, 2481, 2503], 'holds': [408], 'both': [410, 1728], 'single': [411, 417, 502, 758, 894, 1257, 1276, 1817, 1909, 2037, 2297], 'trials': [412, 660, 2257], 'meta-analyses.': [414, 1804], 'trial': [419, 585, 895, 921, 936, 1199, 1819, 1910, 1929, 1949, 1963, 2029], 'which': [421], 'interim': [422, 898], 'conducted': [425, 2025, 2040, 2485], 'after': [426, 1469, 2026, 2041], 'each': [427, 452, 563, 1927, 2027, 2077, 2112], 'new': [428, 553, 1928], 'patients': [431, 891, 924, 939, 1507, 1555, 1593, 1814], 'randomized': [433], '(hence': [434], 'name': [436], '“group': [437], 'sequential”': [438], 'design),': [439], 'mathematical': [440], 'functions': [441, 902], 'used': [443, 974], '“spend”': [445], 'prespecified': [449, 464], 'analysis,': [453], 'sure': [455], 'cumulatively': [457], 'spend': [459], 'than': [461, 739, 1815], '(usually': [466], '0.05)': [467], 'course': [470], 'trial.2–4': [473], 'increasing': [478, 566], 'value': [481, 789, 2339], '“bar”': [482], '(i.e.,': [483, 2269], 'requiring': [484], 'value)': [488], 'any': [492, 2331], 'particular': [493, 688, 855], 'beyond': [495], 'what': [496, 674, 1436], 'it': [497, 1874], 'analysis.': [503], 'As': [504, 575], 'well,': [505], 'often': [510], 'spent': [511], 'time': [513, 523, 530, 550, 1992, 2454], 'monitor': [515], 'futility.': [516], 'Combining': [517], 'into': [519], 'analogous': [525, 750, 1222], 'accumulating': [527], 'single-study': [533], 'design': [536, 604, 755], 'expected': [540, 635, 1194, 1799, 1865], 'heterogeneity': [541, 988, 1838, 1857, 1868, 1893, 1938, 1997, 2255], 'effects.': [543], 'add': [552], 'studies,': [554, 1099], 'practice': [556], 'uses': [557, 1854], 'customary': [559], '0.05': [560, 876, 1254, 1314], 'time,': [564], 'discussed': [576], 'al.,': [580, 1019, 1134], 'one': [581, 1262, 1471, 1886, 1948], 'promising': [582], 'solution': [583], '(TSA)5,6;': [588], 'other': [589], 'related': [590], 'approaches': [591], 'emerging': [593], 'well.7,8': [595], 'TSA': [596, 618, 679, 703, 971, 1130, 1220, 1847, 2139, 2263, 2329, 2438], 'applies': [597], 'α-spending': [599, 768], 'principle': [600], 'from': [601, 669, 885, 1763, 1947, 2186, 2400], '(say': [614, 1615], '5%).': [616], 'A': [617, 719, 1176, 1973], 'projects': [619], 'sample': [622, 811, 980, 996, 1186, 1273, 1303, 1394, 1456, 1918, 1989], 'size': [623, 812, 986, 1187, 1236, 1274, 1304, 1395, 1457, 1919, 1990, 2379], 'community': [630, 672, 683, 2442], 'target,': [632], 'based': [633, 647], 'variability': [636], 'interest': [642], '(the': [643], 'latter': [644], 'might': [645, 1472], 'average': [650], 'planned': [653, 716], 'sizes': [655], 'included': [658, 1087], 'consensus': [668], 'clinically': [676, 1497, 1661], 'important).': [677], 'The': [678, 1540], 'gives': [680], 'information': [684, 744, 947], 'considered': [692, 969, 1180, 2244], 'conclusive': [695], 'needed.': [701], 'Clearly,': [702], 'proposes': [704], 'fairly': [706], 'drastic,': [707], 'arguably': [709], 'refreshing,': [710], 'change': [711, 721, 1713, 1721], 'how': [713, 1958, 2144], 'conducted.': [718], 'main': [720], 'initial': [724], 'question': [730, 2083, 2173, 2394, 2469], 'much': [734, 1749, 1760], 'higher': [735, 1530], 'bar': [736], 'later': [740], 'ones,': [741], 'available;': [747], 'trial.': [759, 2299], 'conservative': [764], 'Lan': [765], 'Demets': [767], 'function3': [769], '(which': [770], 'mimics': [771], 'less': [773, 1039, 1986], 'flexible': [774], 'O’Brien-Fleming': [775], 'method),': [776], 'recommended': [778, 978], 'al.': [782, 992, 1139, 2056], 'TSA,': [784, 1014], '<0.000014': [795], '25%,': [797], '<0.003': [799], '50%,': [801], '<0.018': [804], '75%': [806], 'required': [810, 843, 931, 1307, 1376, 1393, 1526, 1586, 1971], 'instead': [813], 'traditional': [816], '<0.05.': [818], 'Less': [819], 'stringent': [820, 2231], 'criteria': [821], 'early': [822, 1879], 'function': [826, 1241, 1286], 'mimicking': [827], 'aggressive': [830], 'Pocock': [831], 'spending': [832, 901], 'function),': [833], 'penalty': [836], 'increase': [839], 'maximum': [842, 910, 1916, 1970], 'n,': [844], 'could': [845, 972, 1623], 'used.9': [848], 'instance,': [850], 'anesthetic': [856], 'regimen': [857], 'can': [858, 1149, 1261, 1546, 1720, 1923, 1953, 2073], 'reduce': [859], '30-day': [860], 'mortality': [861, 887], 'another': [863], 'typically': [865, 1668, 1801], 'require': [866, 889], 'thousands': [867], 'patients.': [869, 1089], 'To': [870], '90%': [872, 1250, 1310, 1357], 'detect': [880, 1072, 1318, 1360, 1378, 1596, 1629], '20%': [882, 1048, 1074, 1380, 1488], 'relative': [883, 1045, 1243, 1293, 1320, 1363, 1401, 1437, 1484, 1598, 1631, 1644, 1653], 'reduction': [884, 1364, 1485], '5%': [886, 928, 1037], '18,150': [890], 'analyses.': [899], 'Conservative': [900], 'efficacy': [904, 1212, 2226], 'futility': [906], 'raise': [908], 'n': [911], 'approximately': [913, 943, 1349, 1371, 1474, 1487], '19,470.': [914], 'context,': [918], 'first': [920, 1415], '1000': [923, 1372, 1504], 'only': [926, 941, 1023, 1063, 1111, 1141, 1182, 1370, 1624, 1643, 2035], 'maximum.': [932], 'Adding': [933], 'second': [935], '5000': [938, 1350], 'reach': [942], '30%': [944, 1330, 1340], 'target.': [948], 'Early': [949, 2222], 'investigations': [950], 'encouraged': [954], 'fact': [958], 'needed': [963, 1354, 1594, 1670], 'before': [964], 'definitive.': [970, 2245], 'project': [976], 'target': [979], 'size,': [981], 'perhaps': [982], 'under': [983], 'various': [984, 1319, 1597], 'scenarios.': [989], 'studied': [993], 'random': [995], '50': [998, 1056], 'dichotomous': [1001], '(yes/no)': [1002], 'outcome': [1003, 1283, 1465, 1564], 'variables': [1004], 'reported': [1006], 'statistically': [1007, 1120, 2192], 'significant': [1008, 1057, 1079, 1121, 2193], 'striking': [1011], 'Applying': [1013], 'report': [1016, 1140, 1409], '(Imberger': [1017, 1132], 'Table': [1020, 1135, 1571, 1582], '4)': [1021], '38%': [1024], '(19': [1025], '50)': [1027, 1067], 'preserved': [1031], 'powered': [1041, 1627], 'detecting': [1043], 'risk': [1046, 1244, 1366, 1438, 1492, 1654], 'between': [1049, 1503], 'groups,': [1050], 'suggesting': [1051], '31': [1053], 'may': [1059, 1966, 1978, 2007, 2174, 2233], 'false-positives.b': [1061], 'Furthermore,': [1062], '12%': [1064], '(6': [1065], 'had': [1068], '80%': [1069], 'reduction,': [1075], 'meaning': [1076, 1941], 'although': [1078, 1092], 'addition,': [1091], 'participants,': [1100], 'even': [1103, 1153, 1336, 2228, 2272, 2344], 'largest': [1105, 1117, 1770], 'were': [1107, 1118], 'generally': [1108, 1701], 'underpowered,': [1109], '60%': [1112], '70%': [1114], 'still': [1119, 1994], 'was': [1126, 2505], 'controlled': [1127], 'method': [1131], '5).': [1136], 'positive': [1145, 1734], '(significant)': [1146], 'One': [1148, 2072], 'safely': [1150], 'assume': [1151], 'larger': [1155, 1742], 'proportion': [1156], 'nonsignificant': [1158], 'underpowered;': [1161], 'those': 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1400, 1759, 2212], 'reference': [1323, 1341, 1385], 'incidences': [1325, 1387, 1677], '10%,': [1327], '20%,': [1328, 1391], 'outcome.': [1333], 'high': [1339], '(bottom': [1344], 'line': [1345], 'Fig.': [1347], '1),': [1348], '10%': [1362, 1389], '(relative': [1365, 1491], '0.90),': [1368], 'whereas': [1369], 'reduction.': [1381], 'With': [1382], 'substantially': [1397], 'risk.': [1402], 'Thus,': [1403, 1772], 'assessing': [1405, 1882], 'sufficiently': [1411, 1566, 1626], 'powered,': [1412, 1567], 'note': [1416], 'highest': [1418], 'observed': [1419, 1454, 1544, 1802, 1856, 1944], 'either': [1422, 1428], '(assuming': [1424], 'direction': [1429], 'being': [1431, 1727, 1828, 2376], 'tested': [1432], 'for).': [1433], 'Then': [1434], 'consider': [1435, 1888, 2143], 'makes': [1439, 2085, 2270], 'sense': [1440], 'refer': [1446], 'per-group': [1455], 'adequate.': [1459], 'major': [1467], 'infection': [1468], 'surgery,': [1470], 'observe': [1473], '15%': [1476], 'worst': [1480], 'group,': [1481], '0.80)': [1494], 'important.': [1498], 'indicates': [1501], '2000': [1506], 'give': [1511, 1903, 2234, 2356], 'adequate': [1512, 1672], 'power;': [1513], '<1000': [1516], 'meta-analysis,': [1524, 2113], 'numbers': [1527, 1785], 'between-trial': [1533], 'heterogeneity,': [1534], 'these': [1536], 'minimum': [1538], 'requirements.': [1539], 'events': [1545, 1590, 1612, 1666], 'nearly': [1548], 'indicative': [1550], 'determining': [1557, 2216], 'shown': [1569], '5': [1572], 'al.10': [1579], 'others.': [1581], 'provides': [1584], 'specific': [1601], 'incidences.': [1604], 'Notice': [1605], '<100': [1614], 'entire': [1618], 'meta-analysis),': [1619], 'then': [1620], 'huge': [1630], '0.5': [1634], 'greater,': [1636], '100': [1639], '200': [1641], 'events,': [1642], '0.60': [1647], 'greater.': [1649], 'Because': [1650, 1873], 'usually': [1651], '0.80': [1656], '(20%': [1657], 'reduction)': [1658], 'quite': [1660], 'important,': [1662], '500': [1665], '<50%.Table': [1679], 'Events': 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[1859], 'elicits': [1862], 'input': [1871], 'parameter.': [1872], 'unknown': [1876], 'stages': [1880], 'several': [1889, 2042], 'possible': [1890], 'levels': [1891], 'conducting': [1895, 2361, 2385, 2450], 'TSA;': [1897], 'unlikely': [1899], '“zero': [1900], 'heterogeneity”': [1901], 'very': [1905], 'similar': [1906], 'design.': [1913], 'Interestingly,': [1914], 'projected': [1917], 'vary': [1924, 1954], 'greatly': [1925], 'added.': [1931], 'typical': [1937], 'across': [1939, 2170, 2256], 'trials,': [1940], 'next': [1952], 'considerably;': [1955], 'depending': [1956], 'newly': [1961], 'added': [1962], 'strongly': [1967], 'affect': [1968], 'n.': [1972], 'future': [1974], 'area': [1975], 'obtain': [1984], 'variable': [1987], '“maximum”': [1988], 'adjust': [1995], 'Reviewers': [2002], 'conductors': [2004], 'wonder': [2009], 'completed': [2031], 'compared': [2032], 'published': [2045], 'topic.': [2048], 'relevant': [2051, 2126], 'point': [2057], 'out,': [2058], 'Cochrane': [2060], 'Collaboration': [2061], 'recommends': [2062], 'reviews': [2066], 'every': [2069], 'years.': [2071], 'argue': [2074], 'addresses': [2079], 'inference': [2087, 2108], 'about': [2088], 'simply': [2099, 2384], 'publishing': [2100], 'additional': [2106], '“summary”': [2107], 'thus,': [2115], 'topic': [2123], 'seems': [2125], 'It': [2133, 2321], 'my': [2135], 'understanding': [2136], 'does': [2141, 2388], 'previous': [2146, 2373], 'been': [2149, 2396, 2429, 2471], 'addressing': [2152], 'meta-analysis.': [2160], 'How': [2161], 'optimal': [2165], 'adjustment': [2169], 'debate.': [2183], 'Finally,': [2184], 'aside': [2185], 'result': [2190], 'not,': [2195], 'precision': [2196], 'estimated': [2199, 2350], 'measured': [2203], 'width': [2205], 'confidence': [2208, 2235, 2247, 2267, 2354], 'interval': [2209, 2355], 'considerable': [2213], 'weight': [2214], 'conclusive.': [2221], 'crossing': [2223], 'boundary,': [2227], 'criterion,': [2232], 'intervals': [2236, 2248, 2268], 'too': [2237], 'wide': [2238], 'Standard': [2246], 'effect.': [2261], 'Importantly,': [2262], 'adjusts': [2265], 'wider)': [2273], 'attempts': [2275], 'desired': [2283], 'testing,': [2287], 'good': [2303], 'thing,': [2304], 'doubt': [2307], 'best': [2315], 'ways': [2316], 'adjustment.': [2320], 'cannot': [2322], 'stressed': [2324], 'enough,': [2325], 'however,': [2326], 'effect,': [2335], 'sufficient': [2342], 'important': [2347, 2402], 'result;': [2348], 'information.': [2358], 'Indeed,': [2359], 'meta-analyses,': [2362], 'earnestly': [2364], 'strive': [2365], '“see': [2367], 'further”': [2368], 'compiling': [2370], 'investigations,': [2374], '“giants”': [2377], 'not.': [2382], 'mean': [2390], 'has': [2395, 2428, 2470], 'definitively': [2397, 2472], 'answered.': [2398, 2473], 'Aside': [2399], 'issues': [2403], 'combinability,': [2408], 'concerns': [2410], 'itself': [2415], 'and,': [2418], 'significant,': [2420], 'conclusion': [2427], 'controlled.': [2431], 'New': [2432], 'exciting': [2434], 'tools': [2435], 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