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protocol supplement contains the original statistical analysis plan excerpted from the funded","text_display":"\n\nThis protocol supplement contains the original statistical analysis plan excerpted from the funded","confidence":1,"confidence_rate":1},{"cnt":[[245,636],[1212,636],[1212,685],[245,685]],"region":{"top_left_x":244,"top_left_y":635,"width":968,"height":51},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"92ef721997b44b39ad879fe64520def1","type":"text","conversion_output":true,"text":"research proposal (date of document: December 1, 2011).","text_display":" research proposal (date of document: December 1, 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Contamination effects related to primary care assignment are","text_display":" difference in the Roland disability score. 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The standard definition of","text_display":"\n\nWe will examine response rate as a secondary measure of effectiveness. 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Our power to detect a \\(20 \\%\\) difference in response rate ( 0.25 vs. 0.45 ) is 0.86 .","text_display":" the BPI Interference score. Our power to detect a \\(20 \\%\\) difference in response rate ( 0.25 vs. 0.45 ) is 0.86 .","confidence":0.9397596068126237,"confidence_rate":0.9995070170016426},{"cnt":[[183,1177],[1764,1177],[1764,1227],[183,1227]],"region":{"top_left_x":182,"top_left_y":1177,"width":1582,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3f06da1757134f0996fc9d93217da752","type":"text","conversion_output":true,"text":"This analysis will also allow us to calculate numbers-needed-to-treat (NNT) and harm (NNH).","text_display":" This analysis will also allow us to calculate numbers-needed-to-treat (NNT) and harm (NNH).","confidence":1,"confidence_rate":1},{"cnt":[[180,1242],[571,1242],[571,1300],[180,1300]],"region":{"top_left_x":180,"top_left_y":1241,"width":392,"height":59},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e478d5f9c1824463955f4d8e9f318e79","type":"section_header","conversion_output":false,"children_ids":["1745cad5155347e2a1b8bdc7552da393"],"text":"","text_display":""},{"cnt":[[185,1246],[569,1246],[569,1296],[185,1296]],"region":{"top_left_x":184,"top_left_y":1246,"width":386,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1745cad5155347e2a1b8bdc7552da393","type":"text","conversion_output":true,"parent_id":"e478d5f9c1824463955f4d8e9f318e79","text":"C7b. 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Preliminary analyses will compare baseline characteristics and potential","text_display":" originally assigned. Preliminary analyses will compare baseline characteristics and potential","confidence":1,"confidence_rate":1},{"cnt":[[183,1409],[1811,1409],[1811,1459],[183,1459]],"region":{"top_left_x":182,"top_left_y":1409,"width":1630,"height":50},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e353b144dc204706bf124bf141a069c3","type":"text","conversion_output":true,"text":"confounding variables between the two treatment arms. Any imbalance in a measure will lead to","text_display":" confounding variables between the two treatment arms. Any imbalance in a measure will lead to","confidence":0.998046875,"confidence_rate":0.9999800508639274},{"cnt":[[183,1457],[1824,1457],[1824,1506],[183,1506]],"region":{"top_left_x":182,"top_left_y":1456,"width":1643,"height":51},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c63db66357ee4fbc93f02d201ff36a51","type":"text","conversion_output":true,"text":"additional analyses, as described in C7c. Medication use at the end of the trial in each arm will be","text_display":" additional analyses, as described in C7c. Medication use at the end of the trial in each arm will be","confidence":0.998046875,"confidence_rate":0.9999813807939509},{"cnt":[[180,1506],[1886,1506],[1886,1555],[180,1555]],"region":{"top_left_x":180,"top_left_y":1506,"width":1707,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"213841da2e5a409aa35e3dcf807eb279","type":"text","conversion_output":true,"text":"presented in a descriptive table, including numbers using each drug and mean daily dose. For opioids,","text_display":" presented in a descriptive table, including numbers using each drug and mean daily dose. For opioids,","confidence":1,"confidence_rate":1},{"cnt":[[180,1555],[1869,1555],[1869,1605],[180,1605]],"region":{"top_left_x":180,"top_left_y":1555,"width":1690,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"13d560c5c47b4b2d94b38fa22a66c9f0","type":"text","conversion_output":true,"text":"doses will be described as morphine-equivalent mg per day; for non-opioids, doses will be described","text_display":" doses will be described as morphine-equivalent mg per day; for non-opioids, doses will be described","confidence":0.9990234375,"confidence_rate":0.9999911178608298},{"cnt":[[180,1603],[1867,1603],[1867,1652],[180,1652]],"region":{"top_left_x":180,"top_left_y":1602,"width":1687,"height":51},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"237d069801cc495ca4574df82d85ef11","type":"text","conversion_output":true,"text":"both as the actual daily dose and, as a standardized value to facilitate comparisons between drugs, as","text_display":" both as the actual daily dose and, as a standardized value to facilitate comparisons between drugs, as","confidence":1,"confidence_rate":1},{"cnt":[[180,1646],[831,1646],[831,1699],[180,1699]],"region":{"top_left_x":180,"top_left_y":1645,"width":652,"height":55},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d4845817880e4d5a9e319e630d0a2834","type":"text","conversion_output":true,"text":"percent of the maximum daily dose. \\({ }^{109}\\)","text_display":" percent of the maximum daily dose. \\({ }^{109}\\)","confidence":1,"confidence_rate":1},{"cnt":[[176,1714],[1910,1714],[1910,1820],[176,1820]],"region":{"top_left_x":176,"top_left_y":1714,"width":1734,"height":106},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0a9bf0d9abca4d90a0cee72b1c454596","type":"section_header","conversion_output":false,"children_ids":["170605dd66274786840db30bc0b1db7f","c1d5f4e82f7d4f9ca8e5fde773a447d3"],"text":"","text_display":""},{"cnt":[[185,1719],[1904,1719],[1904,1768],[185,1768]],"region":{"top_left_x":184,"top_left_y":1718,"width":1720,"height":51},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"170605dd66274786840db30bc0b1db7f","type":"text","conversion_output":true,"parent_id":"0a9bf0d9abca4d90a0cee72b1c454596","text":"Aim 1: To compare 12-month effects of opioid-intensive and opioid-avoidant prescribing strategies on","text_display":"\n\n\\section*{Aim 1: To compare 12-month effects of opioid-intensive and opioid-avoidant prescribing strategies on","confidence":1,"confidence_rate":1},{"cnt":[[183,1766],[857,1766],[857,1815],[183,1815]],"region":{"top_left_x":182,"top_left_y":1766,"width":676,"height":50},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c1d5f4e82f7d4f9ca8e5fde773a447d3","type":"text","conversion_output":true,"parent_id":"0a9bf0d9abca4d90a0cee72b1c454596","text":"pain-related function and pain intensity.","text_display":" pain-related function and pain intensity.}","confidence":1,"confidence_rate":1},{"cnt":[[183,1835],[1654,1835],[1654,1884],[183,1884]],"region":{"top_left_x":182,"top_left_y":1834,"width":1473,"height":51},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a9fd31edeeab4b608f29fa60be8ec064","type":"text","conversion_output":true,"text":"The primary outcome is BPI Interference score measured at 12 months. Consistent with","text_display":"\n\nThe primary outcome is BPI Interference score measured at 12 months. Consistent with","confidence":1,"confidence_rate":1},{"cnt":[[180,1882],[1938,1882],[1938,1931],[180,1931]],"region":{"top_left_x":180,"top_left_y":1882,"width":1758,"height":50},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a261780e128243799abeb11f6be9a79c","type":"text","conversion_output":true,"text":"recommendations for pain clinical trials, we will assess group differences on additional core pain-related","text_display":" recommendations for pain clinical trials, we will assess group differences on additional core pain-related","confidence":1,"confidence_rate":1},{"cnt":[[183,1929],[1914,1929],[1914,1981],[183,1981]],"region":{"top_left_x":182,"top_left_y":1929,"width":1733,"height":52},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6a2acd7141814dcf8e226fca25f86e86","type":"text","conversion_output":true,"text":"domains as described in Section C6b. Preliminary analyses will use intent-to-treat analyses to compare","text_display":" domains as described in Section C6b. Preliminary analyses will use intent-to-treat analyses to compare","confidence":1,"confidence_rate":1},{"cnt":[[183,1979],[1755,1979],[1755,2030],[183,2030]],"region":{"top_left_x":182,"top_left_y":1978,"width":1574,"height":53},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1caaf7af3853449a9995c933dea04eda","type":"text","conversion_output":true,"text":"mean scores on primary and secondary pain measures between groups at 12 months (with last","text_display":" mean scores on primary and secondary pain measures between groups at 12 months (with last","confidence":1,"confidence_rate":1},{"cnt":[[183,2028],[1923,2028],[1923,2075],[183,2075]],"region":{"top_left_x":182,"top_left_y":2028,"width":1741,"height":48},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"400a3edee980455e8a5ea9e9fc046b6d","type":"text","conversion_output":true,"text":"observation carried forward for missing data) and at each time point. These will be based on analysis of","text_display":" observation carried forward for missing data) and at each time point. These will be based on analysis of","confidence":1,"confidence_rate":1},{"cnt":[[183,2075],[1901,2075],[1901,2125],[183,2125]],"region":{"top_left_x":182,"top_left_y":2075,"width":1720,"height":50},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7f95b9d5cea2428091bf5eb876893373","type":"text","conversion_output":true,"text":"variance (ANCOVA), which controls for the baseline score as a covariate. For analyses of the primary","text_display":" variance (ANCOVA), which controls for the baseline score as a covariate. For analyses of the primary","confidence":0.9990234375,"confidence_rate":0.9999906949037896},{"cnt":[[183,2123],[1813,2123],[1813,2172],[183,2172]],"region":{"top_left_x":182,"top_left_y":2122,"width":1632,"height":51},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"02e0732c4d24452faa91c35e9e85ef51","type":"text","conversion_output":true,"text":"outcome, all repeated measurements of BPI Interference score will be fitted in a mixed model for","text_display":" outcome, all repeated measurements of BPI Interference score will be fitted in a mixed model for","confidence":1,"confidence_rate":1},{"cnt":[[180,2168],[1914,2168],[1914,2219],[180,2219]],"region":{"top_left_x":180,"top_left_y":2167,"width":1735,"height":53},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d794c3c7fe294bf191f4f5326e9bb6d2","type":"text","conversion_output":true,"text":"repeated measures (MMRM) \\({ }^{111}\\) as a function of the group assignment, while controlling for time points","text_display":" repeated measures (MMRM) \\({ }^{111}\\) as a function of the group assignment, while controlling for time points","confidence":1,"confidence_rate":1},{"cnt":[[183,2219],[1858,2219],[1858,2271],[183,2271]],"region":{"top_left_x":182,"top_left_y":2219,"width":1677,"height":52},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e606b79c8bb64759a972f5dc28aac961","type":"text","conversion_output":true,"text":"and baseline values of the outcome as fixed effects, with patients as random effects. Between-group","text_display":" and baseline values of the outcome as fixed effects, with patients as random effects. Between-group","confidence":1,"confidence_rate":1},{"cnt":[[180,2264],[1919,2264],[1919,2318],[180,2318]],"region":{"top_left_x":180,"top_left_y":2264,"width":1739,"height":55},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cf384be19bd048ef81152d452d33b890","type":"text","conversion_output":true,"text":"differences at month 12 will be estimated and tested using an appropriate contrast as the primary test of","text_display":" differences at month 12 will be estimated and tested using an appropriate contrast as the primary test of","confidence":1,"confidence_rate":1},{"cnt":[[183,2316],[1944,2316],[1944,2365],[183,2365]],"region":{"top_left_x":182,"top_left_y":2316,"width":1763,"height":50},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"21814e46ee0c4315a7ad9f0fb61d5ef4","type":"text","conversion_output":true,"text":"intervention effect. BPI Severity score and other pain-related outcomes will be similarly analyzed, using","text_display":" intervention effect. BPI Severity score and other pain-related outcomes will be similarly analyzed, using","confidence":1,"confidence_rate":1},{"cnt":[[183,2363],[1884,2363],[1884,2413],[183,2413]],"region":{"top_left_x":182,"top_left_y":2363,"width":1703,"height":50},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"148a950ee8f04b67b996aa5081b2a5fd","type":"text","conversion_output":true,"text":"appropriate simple two-group comparisons at month 12 as preliminary analysis. Where the secondary","text_display":" appropriate simple two-group comparisons at month 12 as preliminary analysis. Where the secondary","confidence":1,"confidence_rate":1},{"cnt":[[183,2411],[1837,2411],[1837,2460],[183,2460]],"region":{"top_left_x":182,"top_left_y":2410,"width":1655,"height":50},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ba827d5cafa2472eb095b610f66674c1","type":"text","conversion_output":true,"text":"outcome variable has a non-normal distribution, an appropriate link function will be chosen for the","text_display":" outcome variable has a non-normal distribution, an appropriate link function will be chosen for the","confidence":1,"confidence_rate":1},{"cnt":[[185,2578],[1085,2578],[1085,2628],[185,2628]],"region":{"top_left_x":184,"top_left_y":2578,"width":901,"height":50},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dea5286ac9944dfcaa6e5890ba52b175","type":"page_info","conversion_output":false,"text":"SPACE Protocol Supplement: Original Analysis Plan","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1839,2625],[1880,2625],[1880,2655],[1839,2655]],"region":{"top_left_x":1839,"top_left_y":2625,"width":41,"height":31},"line":49,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"fe922907f2254daf8e9a5a9759cff8de","type":"page_info","conversion_output":false,"text":"27","text_display":"","confidence":0.99951171875,"confidence_rate":0.9997558295653994}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"fdd8d31a-0bec-4777-be42-0f52b433ba22-3","page":3,"lines":[{"cnt":[[180,251],[1899,251],[1899,303],[180,303]],"region":{"top_left_x":180,"top_left_y":251,"width":1720,"height":52},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"896d418f6ffc4932af255f6b0a2c6c25","type":"text","conversion_output":true,"text":"outcome in the mixed model, for a generalized MMRM. In particular, we will compare response rates","text_display":"\noutcome in the mixed model, for a generalized MMRM. In particular, we will compare response rates","confidence":1,"confidence_rate":1},{"cnt":[[180,299],[1790,299],[1790,350],[180,350]],"region":{"top_left_x":180,"top_left_y":298,"width":1610,"height":53},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2eb6f61cfea34c378ca33d3091f068ea","type":"text","conversion_output":true,"text":"for pain-related function and pain intensity between arms at 12 months using chi-square tests as","text_display":" for pain-related function and pain intensity between arms at 12 months using chi-square tests as","confidence":1,"confidence_rate":1},{"cnt":[[180,348],[1931,348],[1931,397],[180,397]],"region":{"top_left_x":180,"top_left_y":348,"width":1752,"height":50},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8ae91dfca54343d58227123552a2783a","type":"text","conversion_output":true,"text":"preliminary analyses, followed by a generalized MMRM with a logit link for the binomial outcomes. If","text_display":" preliminary analyses, followed by a generalized MMRM with a logit link for the binomial outcomes. If","confidence":1,"confidence_rate":1},{"cnt":[[180,395],[1912,395],[1912,445],[180,445]],"region":{"top_left_x":180,"top_left_y":395,"width":1733,"height":50},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e16a3397dd3647479b5e4781fa5656e4","type":"text","conversion_output":true,"text":"our findings are robust, we expect findings on the each of the secondary pain measures to be consistent","text_display":" our findings are robust, we expect findings on the each of the secondary pain measures to be consistent","confidence":1,"confidence_rate":1},{"cnt":[[180,443],[1901,443],[1901,494],[180,494]],"region":{"top_left_x":180,"top_left_y":442,"width":1722,"height":53},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"32da9e3dd4ce44bba1556f7fbae6edd8","type":"text","conversion_output":true,"text":"with findings on the primary outcomes and the preliminary comparisons to agree with results from the","text_display":" with findings on the primary outcomes and the preliminary comparisons to agree with results from the","confidence":1,"confidence_rate":1},{"cnt":[[180,490],[438,490],[438,537],[180,537]],"region":{"top_left_x":180,"top_left_y":489,"width":259,"height":49},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"37729ad74b744727a04ca92b69daa1e1","type":"text","conversion_output":true,"text":"mixed models.","text_display":" mixed models.","confidence":1,"confidence_rate":1},{"cnt":[[174,621],[1113,621],[1113,685],[174,685]],"region":{"top_left_x":174,"top_left_y":620,"width":939,"height":66},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"38c81cfa17df424896ae3148880d1500","type":"section_header","conversion_output":false,"children_ids":["482c05a542894edb88342dbcad083c07"],"text":"","text_display":""},{"cnt":[[180,627],[1106,627],[1106,679],[180,679]],"region":{"top_left_x":180,"top_left_y":627,"width":927,"height":52},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"482c05a542894edb88342dbcad083c07","type":"text","conversion_output":true,"parent_id":"38c81cfa17df424896ae3148880d1500","text":"C7c. Handling missing data and potential confounding","text_display":"\n\n\\section*{C7c. Handling missing data and potential confounding}","confidence":1,"confidence_rate":1},{"cnt":[[180,696],[1919,696],[1919,748],[180,748]],"region":{"top_left_x":180,"top_left_y":696,"width":1739,"height":52},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eb5988430a0f4c7f950fbe60967c2d98","type":"text","conversion_output":true,"text":"Although we expect a low rate of missing data, especially in the primary outcomes, reasons for missing","text_display":"\n\nAlthough we expect a low rate of missing data, especially in the primary outcomes, reasons for missing","confidence":1,"confidence_rate":1},{"cnt":[[180,746],[1914,746],[1914,795],[180,795]],"region":{"top_left_x":180,"top_left_y":745,"width":1735,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"62add01a12034d0487c6767ff1f02811","type":"text","conversion_output":true,"text":"data (dropouts and missing observations) will be documented and reported, and the observed outcomes","text_display":" data (dropouts and missing observations) will be documented and reported, and the observed outcomes","confidence":1,"confidence_rate":1},{"cnt":[[180,795],[1897,795],[1897,844],[180,844]],"region":{"top_left_x":180,"top_left_y":794,"width":1718,"height":51},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0299adcd86e74d6f88806260ef05113a","type":"text","conversion_output":true,"text":"at time points prior to dropout will be compared between groups. As long as the missingness depends","text_display":" at time points prior to dropout will be compared between groups. As long as the missingness depends","confidence":1,"confidence_rate":1},{"cnt":[[180,842],[1927,842],[1927,892],[180,892]],"region":{"top_left_x":180,"top_left_y":842,"width":1748,"height":50},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e74ed69728174b749b27672e4beafde1","type":"text","conversion_output":true,"text":"only on the observed data but not the unobserved missing data, the missing at random assumption in the","text_display":" only on the observed data but not the unobserved missing data, the missing at random assumption in the","confidence":1,"confidence_rate":1},{"cnt":[[180,889],[1897,889],[1897,939],[180,939]],"region":{"top_left_x":180,"top_left_y":889,"width":1718,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2a070a60e7e840a78f90a6a09168edca","type":"text","conversion_output":true,"text":"MMRM is met. Imputation of missing primary outcomes based on last-observation carried forward is","text_display":" MMRM is met. Imputation of missing primary outcomes based on last-observation carried forward is","confidence":1,"confidence_rate":1},{"cnt":[[180,937],[1914,937],[1914,986],[180,986]],"region":{"top_left_x":180,"top_left_y":936,"width":1735,"height":51},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"094bda25cf334b8eb05704dc5f2694cf","type":"text","conversion_output":true,"text":"only used for the preliminary analyses. To evaluate the robustness of our primary findings based on the","text_display":" only used for the preliminary analyses. To evaluate the robustness of our primary findings based on the","confidence":1,"confidence_rate":1},{"cnt":[[180,984],[1863,984],[1863,1033],[180,1033]],"region":{"top_left_x":180,"top_left_y":983,"width":1683,"height":51},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8136b3ee16244990a6700741cd9f2a2c","type":"text","conversion_output":true,"text":"mixed models, we will perform sensitivity analyses using different imputation strategies for missing","text_display":" mixed models, we will perform sensitivity analyses using different imputation strategies for missing","confidence":1,"confidence_rate":1},{"cnt":[[180,1031],[1880,1031],[1880,1085],[180,1085]],"region":{"top_left_x":180,"top_left_y":1031,"width":1700,"height":54},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3c6b3157ba0e4d7cad5a907e85b314c6","type":"text","conversion_output":true,"text":"data, including last observation carried forward for all outcomes and predicted values for the primary","text_display":" data, including last observation carried forward for all outcomes and predicted values for the primary","confidence":1,"confidence_rate":1},{"cnt":[[180,1079],[1820,1079],[1820,1130],[180,1130]],"region":{"top_left_x":180,"top_left_y":1078,"width":1640,"height":53},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5c0ca4cbc9e64670bb63d61c10c3049b","type":"text","conversion_output":true,"text":"outcomes from multiple regression on observed data. We will not have enough missing data to fit","text_display":" outcomes from multiple regression on observed data. We will not have enough missing data to fit","confidence":1,"confidence_rate":1},{"cnt":[[180,1128],[1884,1128],[1884,1179],[180,1179]],"region":{"top_left_x":180,"top_left_y":1127,"width":1705,"height":53},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b5392fe295314de8a4c58a6ea03308a4","type":"text","conversion_output":true,"text":"complex models that assume certain missing data models, especially when the assumptions cannot be","text_display":" complex models that assume certain missing data models, especially when the assumptions cannot be","confidence":1,"confidence_rate":1},{"cnt":[[180,1177],[337,1177],[337,1222],[180,1222]],"region":{"top_left_x":180,"top_left_y":1177,"width":158,"height":46},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"64540f0bd4934cf9baca7283b8e1aebc","type":"text","conversion_output":true,"text":"checked.","text_display":" checked.","confidence":1,"confidence_rate":1},{"cnt":[[180,1246],[1858,1246],[1858,1296],[180,1296]],"region":{"top_left_x":180,"top_left_y":1246,"width":1679,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"311cd1c5aacb4c53ae9c1c120e0ad301","type":"text","conversion_output":true,"text":"If potential confounding variables (e.g., prior failed analgesic trials, prior pain treatments, treatment","text_display":"\n\nIf potential confounding variables (e.g., prior failed analgesic trials, prior pain treatments, treatment","confidence":1,"confidence_rate":1},{"cnt":[[180,1293],[1921,1293],[1921,1343],[180,1343]],"region":{"top_left_x":180,"top_left_y":1293,"width":1741,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dcfdea27565f431086cf0b1d3f39261d","type":"text","conversion_output":true,"text":"expectations, co-interventions) are not balanced between groups, we will conduct additional analyses to","text_display":" expectations, co-interventions) are not balanced between groups, we will conduct additional analyses to","confidence":1,"confidence_rate":1},{"cnt":[[180,1341],[1888,1341],[1888,1390],[180,1390]],"region":{"top_left_x":180,"top_left_y":1340,"width":1709,"height":51},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"02070efc9dbf43cea8556bf233982bf3","type":"text","conversion_output":true,"text":"evaluate whether findings may be due at least in part to these imbalances. We will adjust for potential","text_display":" evaluate whether findings may be due at least in part to these imbalances. We will adjust for potential","confidence":1,"confidence_rate":1},{"cnt":[[180,1388],[1833,1388],[1833,1437],[180,1437]],"region":{"top_left_x":180,"top_left_y":1387,"width":1653,"height":51},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9ec1a0e8fce448eab601bb28bb0d9469","type":"text","conversion_output":true,"text":"confounders by adding them as covariates in models. Second, we will evaluate potential effects of","text_display":" confounders by adding them as covariates in models. Second, we will evaluate potential effects of","confidence":1,"confidence_rate":1},{"cnt":[[180,1435],[1815,1435],[1815,1485],[180,1485]],"region":{"top_left_x":180,"top_left_y":1435,"width":1636,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0172bf48c408437aaeecc123bc707e49","type":"text","conversion_output":true,"text":"interactions between confounders and treatment group by adding relevant interaction terms to the","text_display":" interactions between confounders and treatment group by adding relevant interaction terms to the","confidence":1,"confidence_rate":1},{"cnt":[[180,1485],[320,1485],[320,1532],[180,1532]],"region":{"top_left_x":180,"top_left_y":1484,"width":141,"height":48},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1d8c36917be842a48606e3bd16f9fa59","type":"text","conversion_output":true,"text":"models.","text_display":" models.","confidence":1,"confidence_rate":1},{"cnt":[[180,1553],[1934,1553],[1934,1605],[180,1605]],"region":{"top_left_x":180,"top_left_y":1553,"width":1754,"height":52},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"930b504147d14fd79ac2075f98d9e7c8","type":"text","conversion_output":true,"text":"Treatment groups may differ in the mean number of care manager contacts during the course of the trial,","text_display":"\n\nTreatment groups may differ in the mean number of care manager contacts during the course of the trial,","confidence":1,"confidence_rate":1},{"cnt":[[180,1603],[1818,1603],[1818,1652],[180,1652]],"region":{"top_left_x":180,"top_left_y":1602,"width":1638,"height":51},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7319c5f751264eef80ad2692a49af8ca","type":"text","conversion_output":true,"text":"but we expect the number of contacts will overlap substantially between groups. We will conduct","text_display":" but we expect the number of contacts will overlap substantially between groups. We will conduct","confidence":1,"confidence_rate":1},{"cnt":[[180,1650],[1876,1650],[1876,1699],[180,1699]],"region":{"top_left_x":180,"top_left_y":1650,"width":1696,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6a1445a48cdc40f3b8ba38e1961c994f","type":"text","conversion_output":true,"text":"sensitivity analyses to examine effects of care manager contacts; specifically, the number of contacts","text_display":" sensitivity analyses to examine effects of care manager contacts; specifically, the number of contacts","confidence":0.99951171875,"confidence_rate":0.9999954355197808},{"cnt":[[180,1697],[1841,1697],[1841,1747],[180,1747]],"region":{"top_left_x":180,"top_left_y":1697,"width":1662,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"128b7dd039754d32841af62b0878cbac","type":"text","conversion_output":true,"text":"will be added to models as a covariate. If between-group differences in outcomes are eliminated or","text_display":" will be added to models as a covariate. If between-group differences in outcomes are eliminated or","confidence":0.99951171875,"confidence_rate":0.9999952582588333},{"cnt":[[180,1745],[1916,1745],[1916,1796],[180,1796]],"region":{"top_left_x":180,"top_left_y":1744,"width":1737,"height":53},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0bb0e768607842dd8f52c822d9bc236c","type":"text","conversion_output":true,"text":"attenuated after this adjustment, it would suggest that intervention effects are, at least in part, explained","text_display":" attenuated after this adjustment, it would suggest that intervention effects are, at least in part, explained","confidence":1,"confidence_rate":1},{"cnt":[[180,1792],[814,1792],[814,1843],[180,1843]],"region":{"top_left_x":180,"top_left_y":1791,"width":635,"height":53},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"525b085685884ce78edf53f77d6f7977","type":"text","conversion_output":true,"text":"by non-specific care manager effects.","text_display":" by non-specific care manager effects.","confidence":1,"confidence_rate":1},{"cnt":[[180,1861],[625,1861],[625,1914],[180,1914]],"region":{"top_left_x":180,"top_left_y":1860,"width":446,"height":55},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2edd2f811f164c96b7c0d981310c1375","type":"text","conversion_output":true,"text":"C7d. Secondary Analyses","text_display":"\nC7d. Secondary Analyses","confidence":1,"confidence_rate":1},{"cnt":[[180,1929],[1807,1929],[1807,1983],[180,1983]],"region":{"top_left_x":180,"top_left_y":1929,"width":1627,"height":55},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b82a0b9ee0a241d3bbc8a234641b61c4","type":"text","conversion_output":true,"text":"Aim 2: To compare harms of opioid-intensive and opioid-avoidant prescribing strategies over 12","text_display":"\nAim 2: To compare harms of opioid-intensive and opioid-avoidant prescribing strategies over 12","confidence":1,"confidence_rate":1},{"cnt":[[180,1981],[329,1981],[329,2026],[180,2026]],"region":{"top_left_x":180,"top_left_y":1980,"width":149,"height":46},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4aa98cd364254655b1afdc1298771e2f","type":"text","conversion_output":true,"text":"months.","text_display":" months.","confidence":1,"confidence_rate":1},{"cnt":[[180,2047],[1884,2047],[1884,2099],[180,2099]],"region":{"top_left_x":180,"top_left_y":2047,"width":1705,"height":53},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ac17a33366364d1cbb57b645573d567a","type":"text","conversion_output":true,"text":"Analyses of harms will be conducted to better understand the risk of harms between treatment groups","text_display":"\n\nAnalyses of harms will be conducted to better understand the risk of harms between treatment groups","confidence":1,"confidence_rate":1},{"cnt":[[180,2097],[1899,2097],[1899,2146],[180,2146]],"region":{"top_left_x":180,"top_left_y":2096,"width":1720,"height":51},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4009537d98854ac193ce53354d579129","type":"text","conversion_output":true,"text":"and, secondarily, as associated with the specific drug or opioid dose received. We will assess potential","text_display":" and, secondarily, as associated with the specific drug or opioid dose received. We will assess potential","confidence":1,"confidence_rate":1},{"cnt":[[180,2144],[1882,2144],[1882,2194],[180,2194]],"region":{"top_left_x":180,"top_left_y":2144,"width":1703,"height":50},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"56f56783d7dd4e05935b3a6ca83701c9","type":"text","conversion_output":true,"text":"medication-related harms in three domains: 1) patient-reported adverse symptoms; 2) adverse events;","text_display":" medication-related harms in three domains: 1) patient-reported adverse symptoms; 2) adverse events;","confidence":0.9990236759185791,"confidence_rate":0.9999906077268363},{"cnt":[[180,2191],[1910,2191],[1910,2241],[180,2241]],"region":{"top_left_x":180,"top_left_y":2191,"width":1730,"height":50},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ffd0ea12933a497da1a1f970cfebce9b","type":"text","conversion_output":true,"text":"and 3) adverse effects on physical and cognitive performance. Given the limited available evidence for","text_display":" and 3) adverse effects on physical and cognitive performance. Given the limited available evidence for","confidence":1,"confidence_rate":1},{"cnt":[[180,2239],[1906,2239],[1906,2288],[180,2288]],"region":{"top_left_x":180,"top_left_y":2238,"width":1726,"height":51},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fcf092457c9442348b311af2e3c6e045","type":"text","conversion_output":true,"text":"long-term opioid safety, we aim to assess the harms domain as comprehensively as possible; therefore,","text_display":" long-term opioid safety, we aim to assess the harms domain as comprehensively as possible; therefore,","confidence":1,"confidence_rate":1},{"cnt":[[180,2288],[1824,2288],[1824,2335],[180,2335]],"region":{"top_left_x":180,"top_left_y":2288,"width":1645,"height":48},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6d9a8ddbdf984ea5afc9e2e8e62b232e","type":"text","conversion_output":true,"text":"our assessment of potential adverse effects is broad and exploratory at the risk of finding spurious","text_display":" our assessment of potential adverse effects is broad and exploratory at the risk of finding spurious","confidence":1,"confidence_rate":1},{"cnt":[[180,2333],[1931,2333],[1931,2385],[180,2385]],"region":{"top_left_x":180,"top_left_y":2333,"width":1752,"height":52},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2297fabcbc9d4159b895d74f5294898e","type":"text","conversion_output":true,"text":"associations. No adjustment is made for multiple testing because we want our analyses to be sensitive to","text_display":" associations. No adjustment is made for multiple testing because we want our analyses to be sensitive to","confidence":1,"confidence_rate":1},{"cnt":[[180,2383],[1783,2383],[1783,2434],[180,2434]],"region":{"top_left_x":180,"top_left_y":2382,"width":1604,"height":53},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"60a06d95a879485b89a0928810bcc133","type":"text","conversion_output":true,"text":"any potential harm signals. Findings from these analyses will be reported cautiously as needing","text_display":" any potential harm signals. Findings from these analyses will be reported cautiously as needing","confidence":1,"confidence_rate":1},{"cnt":[[180,2432],[879,2432],[879,2481],[180,2481]],"region":{"top_left_x":180,"top_left_y":2432,"width":699,"height":50},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"00c5b7c07c7649f5873c0bf0e7639e7a","type":"text","conversion_output":true,"text":"prospective evaluation in future research.","text_display":" prospective evaluation in future research.","confidence":1,"confidence_rate":1},{"cnt":[[183,2578],[1085,2578],[1085,2632],[183,2632]],"region":{"top_left_x":182,"top_left_y":2578,"width":903,"height":54},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"29c2db24d3ba45b999debf7955b5dd04","type":"page_info","conversion_output":false,"text":"SPACE Protocol Supplement: Original Analysis Plan","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1839,2625],[1882,2625],[1882,2655],[1839,2655]],"region":{"top_left_x":1839,"top_left_y":2625,"width":44,"height":31},"line":45,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"3b37346fd55f4aa9b02986e5ad3aebbb","type":"page_info","conversion_output":false,"text":"28","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"fdd8d31a-0bec-4777-be42-0f52b433ba22-4","page":4,"lines":[{"cnt":[[180,251],[1901,251],[1901,303],[180,303]],"region":{"top_left_x":180,"top_left_y":251,"width":1722,"height":52},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ee8a9dc24f3d4bee8055e4158cf46f7d","type":"text","conversion_output":true,"text":"Patient-reported adverse symptoms: The primary patient-reported symptom outcome is the number of","text_display":"\n\nPatient-reported adverse symptoms: The primary patient-reported symptom outcome is the number of","confidence":0.95068359375,"confidence_rate":0.9994993928625459},{"cnt":[[180,301],[1919,301],[1919,350],[180,350]],"region":{"top_left_x":180,"top_left_y":300,"width":1739,"height":51},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0819a5d5c7ba42b6935a2e1a9bb36528","type":"text","conversion_output":true,"text":"symptoms (range 0-15) reported on the Symptom Checklist. Using repeated measures with four follow-","text_display":" symptoms (range 0-15) reported on the Symptom Checklist. Using repeated measures with four follow","confidence":0.99755859375,"confidence_rate":0.9999762683268261},{"cnt":[[180,348],[1936,348],[1936,397],[180,397]],"region":{"top_left_x":180,"top_left_y":348,"width":1756,"height":50},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"32fd2c132cf243fc81590181801b9210","type":"text","conversion_output":true,"text":"up time points and assuming \\(SD =4\\) and \\(r =0.5\\), our power is \\(87 \\%\\) to detect a between-group difference of","text_display":"up time points and assuming \\(SD =4\\) and \\(r =0.5\\), our power is \\(87 \\%\\) to detect a between-group difference of","confidence":0.994639625194963,"confidence_rate":0.9999555812083425},{"cnt":[[185,391],[1878,391],[1878,445],[185,445]],"region":{"top_left_x":184,"top_left_y":391,"width":1694,"height":54},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"978045384d6b466886cc1c21e2551141","type":"text","conversion_output":true,"text":"1.0 symptom (from 2.5 to 3.5 ). \\({ }^{87}\\) As a secondary outcome, we will examine the number of symptoms","text_display":" 1.0 symptom (from 2.5 to 3.5 ). \\({ }^{87}\\) As a secondary outcome, we will examine the number of symptoms","confidence":0.98681640625,"confidence_rate":0.9998865767854139},{"cnt":[[183,443],[1886,443],[1886,492],[183,492]],"region":{"top_left_x":182,"top_left_y":442,"width":1705,"height":50},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5f466667187945b0b64bb1db50f50c76","type":"text","conversion_output":true,"text":"causing \"a lot\" of bother (range 0-15). Between-group differences will be tested using MMRM. If the","text_display":" causing \"a lot\" of bother (range 0-15). Between-group differences will be tested using MMRM. If the","confidence":0.9980475902557373,"confidence_rate":0.9999812086555921},{"cnt":[[180,490],[1880,490],[1880,544],[180,544]],"region":{"top_left_x":180,"top_left_y":489,"width":1700,"height":55},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a4119531e43b4fe0b0a88797a7a8c695","type":"text","conversion_output":true,"text":"distribution is non-normal, an appropriate link function will be used. We will secondarily explore the","text_display":" distribution is non-normal, an appropriate link function will be used. We will secondarily explore the","confidence":0.9990234375,"confidence_rate":0.9999908688300274},{"cnt":[[180,539],[1867,539],[1867,591],[180,591]],"region":{"top_left_x":180,"top_left_y":539,"width":1687,"height":52},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4aaed287e21b4b7989159ce0fb10f7cc","type":"text","conversion_output":true,"text":"risk of events as functions of drug class and, in the subset of those receiving opioids, opioid dose (in","text_display":" risk of events as functions of drug class and, in the subset of those receiving opioids, opioid dose (in","confidence":1,"confidence_rate":1},{"cnt":[[180,587],[1927,587],[1927,638],[180,638]],"region":{"top_left_x":180,"top_left_y":586,"width":1748,"height":53},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"333862f0f50942e889cebae6a053f454","type":"text","conversion_output":true,"text":"daily morphine equivalents); these factors will be added to the models as time varying covariates within","text_display":" daily morphine equivalents); these factors will be added to the models as time varying covariates within","confidence":1,"confidence_rate":1},{"cnt":[[183,636],[1916,636],[1916,685],[183,685]],"region":{"top_left_x":182,"top_left_y":635,"width":1735,"height":51},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"659b6d58e46e4147a5cfdee77504145a","type":"text","conversion_output":true,"text":"60-day exposure windows preceding each follow-up time point. For this analysis, medications received","text_display":" 60-day exposure windows preceding each follow-up time point. For this analysis, medications received","confidence":1,"confidence_rate":1},{"cnt":[[180,683],[1760,683],[1760,733],[180,733]],"region":{"top_left_x":180,"top_left_y":683,"width":1580,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5f7a4ec82b22476f81b7e3815f285465","type":"text","conversion_output":true,"text":"by the participant will be included as exposures regardless of their source. The same approach","text_display":" by the participant will be included as exposures regardless of their source. The same approach","confidence":1,"confidence_rate":1},{"cnt":[[180,730],[1888,730],[1888,780],[180,780]],"region":{"top_left_x":180,"top_left_y":730,"width":1709,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a76eed5b027749e3888f86bd373d019a","type":"text","conversion_output":true,"text":"(generalized MMRM to test between-group differences followed by the addition of time varying drug","text_display":" (generalized MMRM to test between-group differences followed by the addition of time varying drug","confidence":1,"confidence_rate":1},{"cnt":[[180,778],[1794,778],[1794,827],[180,827]],"region":{"top_left_x":180,"top_left_y":777,"width":1614,"height":51},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"10252274c8b6428fb1e3d4fa37645c3c","type":"text","conversion_output":true,"text":"class and opioid dose to test their effects on the outcome) will be used to analyze the other harm","text_display":" class and opioid dose to test their effects on the outcome) will be used to analyze the other harm","confidence":0.99951171875,"confidence_rate":0.9999952582588333},{"cnt":[[180,827],[1446,827],[1446,879],[180,879]],"region":{"top_left_x":180,"top_left_y":827,"width":1266,"height":52},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2144106a88584e8abbc7ff36d73d400d","type":"text","conversion_output":true,"text":"outcomes using appropriate link functions for their respective distributions.","text_display":" outcomes using appropriate link functions for their respective distributions.","confidence":1,"confidence_rate":1},{"cnt":[[180,896],[1914,896],[1914,947],[180,947]],"region":{"top_left_x":180,"top_left_y":895,"width":1735,"height":53},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c61ee2e2badf42b394450671ffe86af6","type":"text","conversion_output":true,"text":"Power estimates for secondary patient-reported adverse symptom measures are presented in Table 4. In","text_display":"\nPower estimates for secondary patient-reported adverse symptom measures are presented in Table 4. In","confidence":1,"confidence_rate":1},{"cnt":[[180,941],[1893,941],[1893,995],[180,995]],"region":{"top_left_x":180,"top_left_y":941,"width":1713,"height":54},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7d266a85d263458ca9aaa30216d021df","type":"text","conversion_output":true,"text":"general, 115 subjects per group will yield \\(80 \\%\\) power to detect between-group differences \\(>0.375 SD\\).","text_display":" general, 115 subjects per group will yield \\(80 \\%\\) power to detect between-group differences \\(>0.375 SD\\).","confidence":0.9546117782592773,"confidence_rate":0.9995996445079434},{"cnt":[[180,990],[1869,990],[1869,1040],[180,1040]],"region":{"top_left_x":180,"top_left_y":990,"width":1690,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"934d343f27e04251a34b1a4b76bfeb79","type":"text","conversion_output":true,"text":"If the 12 -month outcome is correlated with its baseline measure with \\(r =0.5\\), the detectable difference","text_display":" If the 12 -month outcome is correlated with its baseline measure with \\(r =0.5\\), the detectable difference","confidence":0.9990234375,"confidence_rate":0.9999916492686468},{"cnt":[[180,1040],[483,1040],[483,1089],[180,1089]],"region":{"top_left_x":180,"top_left_y":1039,"width":304,"height":51},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0a10a9d41a724b199ea2fb0302f94248","type":"text","conversion_output":true,"text":"drops to 0.28 SD .","text_display":" drops to 0.28 SD .","confidence":0.9839081764221191,"confidence_rate":0.9994207855620434},{"cnt":[[176,1102],[1532,1102],[1532,1164],[176,1164]],"region":{"top_left_x":176,"top_left_y":1102,"width":1356,"height":63},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"77f18203b1004423815648fd37b0f51d","type":"figure_label","conversion_output":false,"text":"Table 4: Power Estimates for Secondary Patient-Reported Harm 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Measure & Estimated power* & Clinical context \\\\\n\\hline Multidimensional Fatigue Inventory & 81\\% to detect 6 points (60 vs. 66, \\(SD =16\\) ) & MCID in rheumatoid arthritis = 16.6 points. \\({ }^{112}\\) \\\\\n\\hline Athens Insomnia Scale & 87\\% to detect 2 points (5 vs. 7, \\(SD =4.9\\) ) & Difference between persons with and without insomnia \\(=8.8\\) points \\({ }^{113}\\) \\\\\n\\hline Headache Impact Test & \\(88 \\%\\) to detect 2.5 points (50 vs. 50.5, \\(SD =6\\) ) & Difference between mild and moderate headache severity = 7 points \\({ }^{90}\\) \\\\\n\\hline Arizona Sexual Experience & \\(88 \\%\\) to detect 2 points ( 11 vs. 13, \\(SD =4.8\\) ) & Difference between male patients and controls \\(=6.3^{91}\\) \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 4: Power Estimates for Secondary Patient-Reported Harm Measures}\n\\begin{tabular}{|l|l|l|}\n\\hline Measure & Estimated power* & Clinical context \\\\\n\\hline Multidimensional Fatigue Inventory & 81\\% to detect 6 points (60 vs. 66, \\(SD =16\\) ) & MCID in rheumatoid arthritis = 16.6 points. \\({ }^{112}\\) \\\\\n\\hline Athens Insomnia Scale & 87\\% to detect 2 points (5 vs. 7, \\(SD =4.9\\) ) & Difference between persons with and without insomnia \\(=8.8\\) points \\({ }^{113}\\) \\\\\n\\hline Headache Impact Test & \\(88 \\%\\) to detect 2.5 points (50 vs. 50.5, \\(SD =6\\) ) & Difference between mild and moderate headache severity = 7 points \\({ }^{90}\\) \\\\\n\\hline Arizona Sexual Experience & \\(88 \\%\\) to detect 2 points ( 11 vs. 13, \\(SD =4.8\\) ) & Difference between male patients and controls \\(=6.3^{91}\\) 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Using two","confidence":0.8696888168385379,"confidence_rate":0.998797104980368},{"cnt":[[180,700],[1876,700],[1876,754],[180,754]],"region":{"top_left_x":180,"top_left_y":700,"width":1696,"height":55},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"40848e6838d545cebf8ede0a31c2612b","type":"text","conversion_output":true,"text":"follow-up time points and assuming SD \\(=7\\) and \\(r =0.5\\), we have \\(86 \\%\\) power to detect a between-group","text_display":" follow-up time points and assuming SD \\(=7\\) and \\(r =0.5\\), we have \\(86 \\%\\) power to detect a between-group","confidence":0.7998116403379986,"confidence_rate":0.998025147030314},{"cnt":[[180,748],[776,748],[776,801],[180,801]],"region":{"top_left_x":180,"top_left_y":747,"width":596,"height":55},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b6ac82487c7d49d6826d56f5560a79ae","type":"text","conversion_output":true,"text":"difference of 2.0 (from 30 to 32). \\({ }^{98}\\)","text_display":" difference of 2.0 (from 30 to 32). \\({ }^{98}\\)","confidence":0.99951171875,"confidence_rate":0.9999909555872323},{"cnt":[[180,816],[1914,816],[1914,872],[180,872]],"region":{"top_left_x":180,"top_left_y":816,"width":1735,"height":57},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7e8bc0ae8e09442d949d622bf820f1e4","type":"text","conversion_output":true,"text":"Aim 3: To compare effects of opioid-intensive and opioid-avoidant prescribing strategies on secondary","text_display":"\nAim 3: To compare effects of opioid-intensive and opioid-avoidant prescribing strategies on secondary","confidence":1,"confidence_rate":1},{"cnt":[[180,868],[1910,868],[1910,922],[180,922]],"region":{"top_left_x":180,"top_left_y":867,"width":1730,"height":55},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"415b84d6560d48b8bae5fc2fc39b8ae2","type":"text","conversion_output":true,"text":"outcomes, including health-related quality of life, pain sensitivity, and aberrant drug-related behaviors.","text_display":" outcomes, including health-related quality of life, pain sensitivity, and aberrant drug-related behaviors.","confidence":1,"confidence_rate":1},{"cnt":[[180,937],[1936,937],[1936,988],[180,988]],"region":{"top_left_x":180,"top_left_y":936,"width":1756,"height":53},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"beca9b9fb5ee4a378defc17ffda1da06","type":"text","conversion_output":true,"text":"Health related quality of life: The approach described above (generalized MMRM to test between-group","text_display":"\nHealth related quality of life: The approach described above (generalized MMRM to test between-group","confidence":1,"confidence_rate":1},{"cnt":[[180,984],[1893,984],[1893,1036],[180,1036]],"region":{"top_left_x":180,"top_left_y":983,"width":1713,"height":53},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"570d0a91df674efc8d14aed8ce15e02d","type":"text","conversion_output":true,"text":"differences followed by the addition of time varying drug class and opioid dose to test their effects on","text_display":" differences followed by the addition of time varying drug class and opioid dose to test their effects on","confidence":1,"confidence_rate":1},{"cnt":[[180,1031],[1919,1031],[1919,1085],[180,1085]],"region":{"top_left_x":180,"top_left_y":1031,"width":1739,"height":54},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b8ce1b8e8ea24b84a7383d4617162283","type":"text","conversion_output":true,"text":"the outcome) will be used to analyze SF-12 data. We estimate \\(81 \\%\\) power to detect a 3-point difference","text_display":" the outcome) will be used to analyze SF-12 data. We estimate \\(81 \\%\\) power to detect a 3-point difference","confidence":0.51171875,"confidence_rate":0.993872245124697},{"cnt":[[180,1079],[969,1076],[969,1132],[181,1134]],"region":{"top_left_x":180,"top_left_y":1076,"width":790,"height":59},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"78f223ea59314c93acd28c4e1276822a","type":"text","conversion_output":true,"text":"in the Physical Component Score (PCS-12). \\({ }^{118}\\)","text_display":" in the Physical Component Score (PCS-12). \\({ }^{118}\\)","confidence":0.998046875,"confidence_rate":0.99996508927304},{"cnt":[[180,1147],[1916,1147],[1916,1201],[180,1201]],"region":{"top_left_x":180,"top_left_y":1147,"width":1737,"height":54},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"efcde148bb674cbfb852b5783c354a2b","type":"text","conversion_output":true,"text":"Pain sensitivity: Pain threshold and tolerance at 12 months will be compared between study arms using","text_display":"\nPain sensitivity: Pain threshold and tolerance at 12 months will be compared between study arms using","confidence":1,"confidence_rate":1},{"cnt":[[180,1197],[1880,1197],[1880,1248],[180,1248]],"region":{"top_left_x":180,"top_left_y":1196,"width":1700,"height":53},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8bcc48d6df1042789d8b86e99cc8b7cb","type":"text","conversion_output":true,"text":"linear models, with outcomes transformed to normality if necessary. Covariates will then be added to","text_display":" linear models, with outcomes transformed to normality if necessary. Covariates will then be added to","confidence":0.99951171875,"confidence_rate":0.9999953485775026},{"cnt":[[180,1246],[1919,1246],[1919,1296],[180,1296]],"region":{"top_left_x":180,"top_left_y":1246,"width":1739,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4c58836386cc4b4f8b548030ad8b6033","type":"text","conversion_output":true,"text":"determine whether pain sensitivity after 12 months of treatment is affected by the drug class and opioid","text_display":" determine whether pain sensitivity after 12 months of treatment is affected by the drug class and opioid","confidence":1,"confidence_rate":1},{"cnt":[[180,1293],[1936,1293],[1936,1343],[180,1343]],"region":{"top_left_x":180,"top_left_y":1293,"width":1756,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"184018121d8d4d7dbf2345163877cb25","type":"text","conversion_output":true,"text":"dose, controlling for baseline pain sensitivity. We will also use generalized linear models to test whether","text_display":" dose, controlling for baseline pain sensitivity. We will also use generalized linear models to test whether","confidence":1,"confidence_rate":1},{"cnt":[[180,1341],[1880,1341],[1880,1394],[180,1394]],"region":{"top_left_x":180,"top_left_y":1340,"width":1700,"height":55},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"525f7f6213854317b6899a2207d7adb9","type":"text","conversion_output":true,"text":"pain sensitivity at baseline predicts the number and distribution of patient-reported pain symptoms or","text_display":" pain sensitivity at baseline predicts the number and distribution of patient-reported pain symptoms or","confidence":1,"confidence_rate":1},{"cnt":[[180,1388],[501,1388],[501,1442],[180,1442]],"region":{"top_left_x":180,"top_left_y":1387,"width":321,"height":55},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"735aba25143e4c4d976a6329461945eb","type":"text","conversion_output":true,"text":"headache severity.","text_display":" headache severity.","confidence":1,"confidence_rate":1},{"cnt":[[180,1457],[1768,1457],[1768,1508],[180,1508]],"region":{"top_left_x":180,"top_left_y":1456,"width":1589,"height":53},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"26f908272ce541b5b45fa24b5a2d9267","type":"text","conversion_output":true,"text":"Aberrant drug-related behavior: Data from patient, clinician, and chart-review sources will be","text_display":"\nAberrant drug-related behavior: Data from patient, clinician, and chart-review sources will be","confidence":0.9980475902557373,"confidence_rate":0.9999802596071612},{"cnt":[[180,1504],[1871,1504],[1871,1558],[180,1558]],"region":{"top_left_x":180,"top_left_y":1503,"width":1692,"height":55},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"db17c63857904d088acdc23ce4a2e658","type":"text","conversion_output":true,"text":"categorized according to nature and severity into the following 3 groups: 1) serious ADRB, meaning","text_display":" categorized according to nature and severity into the following 3 groups: 1) serious ADRB, meaning","confidence":0.96923828125,"confidence_rate":0.999705281239636},{"cnt":[[180,1555],[1764,1555],[1764,1605],[180,1605]],"region":{"top_left_x":180,"top_left_y":1555,"width":1584,"height":50},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5132839fc63545adbb37dd50708f66f6","type":"text","conversion_output":true,"text":"documentation of prescription drug diversion, buying prescription drug from illicit sources, or","text_display":" documentation of prescription drug diversion, buying prescription drug from illicit sources, or","confidence":1,"confidence_rate":1},{"cnt":[[180,1601],[1858,1601],[1858,1652],[180,1652]],"region":{"top_left_x":180,"top_left_y":1600,"width":1679,"height":53},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4ad58e8c9a054566876ee6078ef65f3e","type":"text","conversion_output":true,"text":"simultaneously obtaining controlled substances for the same condition from multiple prescribers; 2)","text_display":" simultaneously obtaining controlled substances for the same condition from multiple prescribers; 2)","confidence":0.951171875,"confidence_rate":0.9995187648504423},{"cnt":[[180,1650],[1876,1650],[1876,1699],[180,1699]],"region":{"top_left_x":180,"top_left_y":1650,"width":1696,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3566b4a504ba43f48f874fad4fc76a05","type":"text","conversion_output":true,"text":"minor ADRB, including behaviors other than those included under serious ADRB; and 3 ) substance-","text_display":" minor ADRB, including behaviors other than those included under serious ADRB; and 3 ) substance","confidence":0.5226707458496094,"confidence_rate":0.9937809232215791},{"cnt":[[180,1697],[1916,1697],[1916,1747],[180,1747]],"region":{"top_left_x":180,"top_left_y":1697,"width":1737,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d83a631cc3504f0ba6b64497898ad337","type":"text","conversion_output":true,"text":"related ADRB, including documented alcohol disorders or illicit drug use, health or legal consequences","text_display":"related ADRB, including documented alcohol disorders or illicit drug use, health or legal consequences","confidence":1,"confidence_rate":1},{"cnt":[[180,1745],[1824,1745],[1824,1796],[180,1796]],"region":{"top_left_x":180,"top_left_y":1744,"width":1645,"height":53},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"afb8f7b1559d4d15859d558219df8487","type":"text","conversion_output":true,"text":"of alcohol or illicit drug use, or any urine drug screen positive for an illicit drug or non-prescribed","text_display":" of alcohol or illicit drug use, or any urine drug screen positive for an illicit drug or non-prescribed","confidence":1,"confidence_rate":1},{"cnt":[[180,1792],[1807,1792],[1807,1846],[180,1846]],"region":{"top_left_x":180,"top_left_y":1791,"width":1627,"height":55},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6ff6c16a308c4cd0a324a7b91dc881f2","type":"text","conversion_output":true,"text":"controlled medication (e.g., opioid or benzodiazepine). Using ordinal logistic regression, we will","text_display":" controlled medication (e.g., opioid or benzodiazepine). Using ordinal logistic regression, we will","confidence":1,"confidence_rate":1},{"cnt":[[180,1841],[1706,1841],[1706,1893],[180,1893]],"region":{"top_left_x":180,"top_left_y":1841,"width":1526,"height":52},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a4b70166d12c4829bd76247024b07cb0","type":"text","conversion_output":true,"text":"compare rates of misuse between arms; secondarily, we will examine predictors of misuse.","text_display":" compare rates of misuse between arms; secondarily, we will examine predictors of misuse.","confidence":1,"confidence_rate":1},{"cnt":[[180,2578],[1085,2578],[1085,2632],[180,2632]],"region":{"top_left_x":180,"top_left_y":2578,"width":905,"height":54},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7f57e06c734444c986acfcde17997284","type":"page_info","conversion_output":false,"text":"SPACE Protocol Supplement: Original Analysis Plan","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1839,2625],[1882,2625],[1882,2660],[1839,2660]],"region":{"top_left_x":1839,"top_left_y":2625,"width":44,"height":35},"line":34,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"832cada2c9db4a43b1a6aed5d825c4ae","type":"page_info","conversion_output":false,"text":"30","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]}]}
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