Quality of Life and Patient Satisfaction at 7-Year Follow-up of Antibiotic Therapy vs Appendectomy for Uncomplicated Acute Appendicitis: A Secondary Analysis of a Randomized Clinical Trial
IMPORTANCE: Long-term results support antibiotics for uncomplicated acute appendicitis as an alternative to appendectomy. To our knowledge, treatment-related long-term patient satisfaction and quality of life (QOL) are not known. OBJECTIVE: To determine patient satisfaction and QOL after antibiotic...
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| Veröffentlicht in: | Archives of surgery (Chicago. 1960) 2020-04, Vol.155 (4), p.283-289 |
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| creator | Sippola, Suvi Haijanen, Jussi Viinikainen, Lauri Grönroos, Juha Paajanen, Hannu Rautio, Tero Nordström, Pia Aarnio, Markku Rantanen, Tuomo Hurme, Saija Mecklin, Jukka-Pekka Sand, Juhani Jartti, Airi Salminen, Paulina |
| description | IMPORTANCE: Long-term results support antibiotics for uncomplicated acute appendicitis as an alternative to appendectomy. To our knowledge, treatment-related long-term patient satisfaction and quality of life (QOL) are not known. OBJECTIVE: To determine patient satisfaction and QOL after antibiotic therapy and appendectomy for treating uncomplicated acute appendicitis. INTERVENTIONS: Open appendectomy vs antibiotics with intravenous ertapenem, 1 g once daily, for 3 days followed by 7 days of oral levofloxacin, 500 mg once daily, and metronidazole, 500 mg 3 times per day. DESIGN, SETTING, AND PARTICIPANTS: This observational follow-up of the Appendicitis Acuta (APPAC) multicenter randomized clinical trial comparing appendectomy with antibiotics included 530 patients age 18 to 60 years with computed tomography–confirmed uncomplicated acute appendicitis who were randomized to undergo appendectomy (273 [52%]) or receive antibiotics (257 [49%]). The trial was conducted from November 2009 to June 2012; the last follow-up was May 9, 2018. The data were analyzed in February 2019. MAIN OUTCOMES AND MEASURES: In this analysis, post hoc secondary end points of postintervention QOL (EQ-5D-5L) and patient satisfaction and treatment preference were evaluated. RESULTS: Of the 530 patients enrolled in the trial (appendectomy group: 273 [174 men (64%)] with a median age of 35 years; (antibiotic group: 257 [155 men (60%)] with a median age of 33 years), 423 patients (80%) were available for phone interview at a median follow-up of 7 years; 206 patients (80%) took antibiotics and 217 (79%) underwent appendectomy. Of the 206 patients taking antibiotics, 81 (39%) had undergone appendectomy. The QOL between appendectomy and antibiotic group patients was similar (median health index value, 1.0 in both groups; 95% CI, 0.86-1.0; P = .96). Patients who underwent appendectomy were more satisfied in the treatment than patients taking antibiotics (68% very satisfied, 21% satisfied, 6% indifferent, 4% unsatisfied, and 1% very unsatisfied in the appendectomy group and 53% very satisfied, 21% satisfied, 13% indifferent, 7% unsatisfied, and 6% very unsatisfied in the antibiotic group; P |
| doi_str_mv | 10.1001/jamasurg.2019.6028 |
| format | Article |
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To our knowledge, treatment-related long-term patient satisfaction and quality of life (QOL) are not known. OBJECTIVE: To determine patient satisfaction and QOL after antibiotic therapy and appendectomy for treating uncomplicated acute appendicitis. INTERVENTIONS: Open appendectomy vs antibiotics with intravenous ertapenem, 1 g once daily, for 3 days followed by 7 days of oral levofloxacin, 500 mg once daily, and metronidazole, 500 mg 3 times per day. DESIGN, SETTING, AND PARTICIPANTS: This observational follow-up of the Appendicitis Acuta (APPAC) multicenter randomized clinical trial comparing appendectomy with antibiotics included 530 patients age 18 to 60 years with computed tomography–confirmed uncomplicated acute appendicitis who were randomized to undergo appendectomy (273 [52%]) or receive antibiotics (257 [49%]). The trial was conducted from November 2009 to June 2012; the last follow-up was May 9, 2018. The data were analyzed in February 2019. MAIN OUTCOMES AND MEASURES: In this analysis, post hoc secondary end points of postintervention QOL (EQ-5D-5L) and patient satisfaction and treatment preference were evaluated. RESULTS: Of the 530 patients enrolled in the trial (appendectomy group: 273 [174 men (64%)] with a median age of 35 years; (antibiotic group: 257 [155 men (60%)] with a median age of 33 years), 423 patients (80%) were available for phone interview at a median follow-up of 7 years; 206 patients (80%) took antibiotics and 217 (79%) underwent appendectomy. Of the 206 patients taking antibiotics, 81 (39%) had undergone appendectomy. The QOL between appendectomy and antibiotic group patients was similar (median health index value, 1.0 in both groups; 95% CI, 0.86-1.0; P = .96). Patients who underwent appendectomy were more satisfied in the treatment than patients taking antibiotics (68% very satisfied, 21% satisfied, 6% indifferent, 4% unsatisfied, and 1% very unsatisfied in the appendectomy group and 53% very satisfied, 21% satisfied, 13% indifferent, 7% unsatisfied, and 6% very unsatisfied in the antibiotic group; P < .001) and in a subgroup analysis this difference was based on the antibiotic group patients undergoing appendectomy. There was no difference in patient satisfaction after successful antibiotic treatment compared with appendectomy (cumulative odds ratio [COR], 7.8; 95% CI, 0.5-1.3; P < .36). Patients with appendectomy or with successful antibiotic therapy were more satisfied than antibiotic group patients who later underwent appendectomy (COR, 7.7; 95% CI, 4.6-12.9; P < .001; COR, 9.7; 95% CI, 5.4-15.3; P < .001, respectively). Of the 81 patients taking antibiotics who underwent appendectomy, 27 (33%) would again choose antibiotics as their primary treatment. CONCLUSIONS AND RELEVANCE: In this analysis, long-term QOL was similar after appendectomy and antibiotic therapy for the treatment of uncomplicated acute appendicitis. Patients taking antibiotics who later underwent appendectomy were less satisfied than patients with successful antibiotics or appendectomy. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT01022567</description><identifier>ISSN: 2168-6254</identifier><identifier>EISSN: 2168-6262</identifier><identifier>DOI: 10.1001/jamasurg.2019.6028</identifier><identifier>PMID: 32074268</identifier><language>eng</language><publisher>United States: American Medical Association</publisher><subject>Adolescent ; Adult ; Anti-Bacterial Agents - therapeutic use ; Antibiotics ; Appendectomy ; Appendicitis ; Appendicitis - therapy ; Clinical trials ; Drug resistance ; Female ; Finland ; Follow-Up Studies ; Humans ; Male ; Middle Aged ; Online First ; Original Investigation ; Patient Satisfaction ; Quality of Life ; Tomography</subject><ispartof>Archives of surgery (Chicago. 1960), 2020-04, Vol.155 (4), p.283-289</ispartof><rights>Copyright American Medical Association Apr 2020</rights><rights>Copyright 2020 American Medical Association. All Rights Reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-a356t-ee659fd30a2351525bbc3f5866f947ef461d7f49317cc6bed5e4df02dc1693223</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://jamanetwork.com/journals/jamasurgery/articlepdf/10.1001/jamasurg.2019.6028$$EPDF$$P50$$Gama$$H</linktopdf><linktohtml>$$Uhttps://jamanetwork.com/journals/jamasurgery/fullarticle/10.1001/jamasurg.2019.6028$$EHTML$$P50$$Gama$$H</linktohtml><link.rule.ids>64,230,314,780,784,885,3340,27924,27925,76489,76492</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32074268$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Sippola, Suvi</creatorcontrib><creatorcontrib>Haijanen, Jussi</creatorcontrib><creatorcontrib>Viinikainen, Lauri</creatorcontrib><creatorcontrib>Grönroos, Juha</creatorcontrib><creatorcontrib>Paajanen, Hannu</creatorcontrib><creatorcontrib>Rautio, Tero</creatorcontrib><creatorcontrib>Nordström, Pia</creatorcontrib><creatorcontrib>Aarnio, Markku</creatorcontrib><creatorcontrib>Rantanen, Tuomo</creatorcontrib><creatorcontrib>Hurme, Saija</creatorcontrib><creatorcontrib>Mecklin, Jukka-Pekka</creatorcontrib><creatorcontrib>Sand, Juhani</creatorcontrib><creatorcontrib>Jartti, Airi</creatorcontrib><creatorcontrib>Salminen, Paulina</creatorcontrib><title>Quality of Life and Patient Satisfaction at 7-Year Follow-up of Antibiotic Therapy vs Appendectomy for Uncomplicated Acute Appendicitis: A Secondary Analysis of a Randomized Clinical Trial</title><title>Archives of surgery (Chicago. 1960)</title><addtitle>JAMA Surg</addtitle><description>IMPORTANCE: Long-term results support antibiotics for uncomplicated acute appendicitis as an alternative to appendectomy. To our knowledge, treatment-related long-term patient satisfaction and quality of life (QOL) are not known. OBJECTIVE: To determine patient satisfaction and QOL after antibiotic therapy and appendectomy for treating uncomplicated acute appendicitis. INTERVENTIONS: Open appendectomy vs antibiotics with intravenous ertapenem, 1 g once daily, for 3 days followed by 7 days of oral levofloxacin, 500 mg once daily, and metronidazole, 500 mg 3 times per day. DESIGN, SETTING, AND PARTICIPANTS: This observational follow-up of the Appendicitis Acuta (APPAC) multicenter randomized clinical trial comparing appendectomy with antibiotics included 530 patients age 18 to 60 years with computed tomography–confirmed uncomplicated acute appendicitis who were randomized to undergo appendectomy (273 [52%]) or receive antibiotics (257 [49%]). The trial was conducted from November 2009 to June 2012; the last follow-up was May 9, 2018. The data were analyzed in February 2019. MAIN OUTCOMES AND MEASURES: In this analysis, post hoc secondary end points of postintervention QOL (EQ-5D-5L) and patient satisfaction and treatment preference were evaluated. RESULTS: Of the 530 patients enrolled in the trial (appendectomy group: 273 [174 men (64%)] with a median age of 35 years; (antibiotic group: 257 [155 men (60%)] with a median age of 33 years), 423 patients (80%) were available for phone interview at a median follow-up of 7 years; 206 patients (80%) took antibiotics and 217 (79%) underwent appendectomy. Of the 206 patients taking antibiotics, 81 (39%) had undergone appendectomy. The QOL between appendectomy and antibiotic group patients was similar (median health index value, 1.0 in both groups; 95% CI, 0.86-1.0; P = .96). Patients who underwent appendectomy were more satisfied in the treatment than patients taking antibiotics (68% very satisfied, 21% satisfied, 6% indifferent, 4% unsatisfied, and 1% very unsatisfied in the appendectomy group and 53% very satisfied, 21% satisfied, 13% indifferent, 7% unsatisfied, and 6% very unsatisfied in the antibiotic group; P < .001) and in a subgroup analysis this difference was based on the antibiotic group patients undergoing appendectomy. There was no difference in patient satisfaction after successful antibiotic treatment compared with appendectomy (cumulative odds ratio [COR], 7.8; 95% CI, 0.5-1.3; P < .36). Patients with appendectomy or with successful antibiotic therapy were more satisfied than antibiotic group patients who later underwent appendectomy (COR, 7.7; 95% CI, 4.6-12.9; P < .001; COR, 9.7; 95% CI, 5.4-15.3; P < .001, respectively). Of the 81 patients taking antibiotics who underwent appendectomy, 27 (33%) would again choose antibiotics as their primary treatment. CONCLUSIONS AND RELEVANCE: In this analysis, long-term QOL was similar after appendectomy and antibiotic therapy for the treatment of uncomplicated acute appendicitis. Patients taking antibiotics who later underwent appendectomy were less satisfied than patients with successful antibiotics or appendectomy. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT01022567</description><subject>Adolescent</subject><subject>Adult</subject><subject>Anti-Bacterial Agents - therapeutic use</subject><subject>Antibiotics</subject><subject>Appendectomy</subject><subject>Appendicitis</subject><subject>Appendicitis - therapy</subject><subject>Clinical trials</subject><subject>Drug resistance</subject><subject>Female</subject><subject>Finland</subject><subject>Follow-Up Studies</subject><subject>Humans</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Online First</subject><subject>Original Investigation</subject><subject>Patient Satisfaction</subject><subject>Quality of Life</subject><subject>Tomography</subject><issn>2168-6254</issn><issn>2168-6262</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpdks1u1DAUhSMEolXpC3SBLLFhk8E_iR2zQBqNKCCNxE-nC1aW49itR04cbKcoPBsPh6OZjgBvbOl-59zrq1MUVwiuEITozV72Mk7hboUh4isKcfOkOMeINiXFFD89vevqrLiMcQ_zaSCsCH9enBEMWYVpc178_jpJZ9MMvAFbazSQQwe-yGT1kMBNvqORKlk_AJkAK79rGcC1d87_LKdxEa2HZFvrk1Vgd6-DHGfwEMF6HPXQaZV8PwPjA7gdlO9HZ5VMugNrNSV9hKyyuctbsAY3Wvmhk2HOptLN0calgQTf8ky-t7-ycOPskD0c2AUr3YvimZEu6svjfVHcXr_fbT6W288fPm3W21KSmqZSa1pz0xEoMalRjeu2VcTUDaWGV0ybiqKOmYoTxJSire5qXXUG4k4hygnG5KJ4d_Adp7bXncq7CdKJMdg-Tyu8tOLfymDvxZ1_EAxWmCOWDV4fDYL_MemYRG-j0s7JQfspijwXrzKHq4y--g_d-ynkfSwUZ5TXjNWZwgdKBR9j0OY0DIJiyYd4zIdY8iGWfGTRy7-_cZI8piEDVwcga09VzCgiCJM_NP7EJQ</recordid><startdate>20200401</startdate><enddate>20200401</enddate><creator>Sippola, Suvi</creator><creator>Haijanen, Jussi</creator><creator>Viinikainen, Lauri</creator><creator>Grönroos, Juha</creator><creator>Paajanen, Hannu</creator><creator>Rautio, Tero</creator><creator>Nordström, Pia</creator><creator>Aarnio, Markku</creator><creator>Rantanen, Tuomo</creator><creator>Hurme, Saija</creator><creator>Mecklin, Jukka-Pekka</creator><creator>Sand, Juhani</creator><creator>Jartti, Airi</creator><creator>Salminen, Paulina</creator><general>American Medical Association</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>K9.</scope><scope>NAPCQ</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20200401</creationdate><title>Quality of Life and Patient Satisfaction at 7-Year Follow-up of Antibiotic Therapy vs Appendectomy for Uncomplicated Acute Appendicitis: A Secondary Analysis of a Randomized Clinical Trial</title><author>Sippola, Suvi ; Haijanen, Jussi ; Viinikainen, Lauri ; Grönroos, Juha ; Paajanen, Hannu ; Rautio, Tero ; Nordström, Pia ; Aarnio, Markku ; Rantanen, Tuomo ; Hurme, Saija ; Mecklin, Jukka-Pekka ; Sand, Juhani ; Jartti, Airi ; Salminen, Paulina</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-a356t-ee659fd30a2351525bbc3f5866f947ef461d7f49317cc6bed5e4df02dc1693223</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Anti-Bacterial Agents - therapeutic use</topic><topic>Antibiotics</topic><topic>Appendectomy</topic><topic>Appendicitis</topic><topic>Appendicitis - therapy</topic><topic>Clinical trials</topic><topic>Drug resistance</topic><topic>Female</topic><topic>Finland</topic><topic>Follow-Up Studies</topic><topic>Humans</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Online First</topic><topic>Original Investigation</topic><topic>Patient Satisfaction</topic><topic>Quality of Life</topic><topic>Tomography</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Sippola, Suvi</creatorcontrib><creatorcontrib>Haijanen, Jussi</creatorcontrib><creatorcontrib>Viinikainen, Lauri</creatorcontrib><creatorcontrib>Grönroos, Juha</creatorcontrib><creatorcontrib>Paajanen, Hannu</creatorcontrib><creatorcontrib>Rautio, Tero</creatorcontrib><creatorcontrib>Nordström, Pia</creatorcontrib><creatorcontrib>Aarnio, Markku</creatorcontrib><creatorcontrib>Rantanen, Tuomo</creatorcontrib><creatorcontrib>Hurme, Saija</creatorcontrib><creatorcontrib>Mecklin, Jukka-Pekka</creatorcontrib><creatorcontrib>Sand, Juhani</creatorcontrib><creatorcontrib>Jartti, Airi</creatorcontrib><creatorcontrib>Salminen, Paulina</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Premium</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Archives of surgery (Chicago. 1960)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Sippola, Suvi</au><au>Haijanen, Jussi</au><au>Viinikainen, Lauri</au><au>Grönroos, Juha</au><au>Paajanen, Hannu</au><au>Rautio, Tero</au><au>Nordström, Pia</au><au>Aarnio, Markku</au><au>Rantanen, Tuomo</au><au>Hurme, Saija</au><au>Mecklin, Jukka-Pekka</au><au>Sand, Juhani</au><au>Jartti, Airi</au><au>Salminen, Paulina</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Quality of Life and Patient Satisfaction at 7-Year Follow-up of Antibiotic Therapy vs Appendectomy for Uncomplicated Acute Appendicitis: A Secondary Analysis of a Randomized Clinical Trial</atitle><jtitle>Archives of surgery (Chicago. 1960)</jtitle><addtitle>JAMA Surg</addtitle><date>2020-04-01</date><risdate>2020</risdate><volume>155</volume><issue>4</issue><spage>283</spage><epage>289</epage><pages>283-289</pages><issn>2168-6254</issn><eissn>2168-6262</eissn><abstract>IMPORTANCE: Long-term results support antibiotics for uncomplicated acute appendicitis as an alternative to appendectomy. To our knowledge, treatment-related long-term patient satisfaction and quality of life (QOL) are not known. OBJECTIVE: To determine patient satisfaction and QOL after antibiotic therapy and appendectomy for treating uncomplicated acute appendicitis. INTERVENTIONS: Open appendectomy vs antibiotics with intravenous ertapenem, 1 g once daily, for 3 days followed by 7 days of oral levofloxacin, 500 mg once daily, and metronidazole, 500 mg 3 times per day. DESIGN, SETTING, AND PARTICIPANTS: This observational follow-up of the Appendicitis Acuta (APPAC) multicenter randomized clinical trial comparing appendectomy with antibiotics included 530 patients age 18 to 60 years with computed tomography–confirmed uncomplicated acute appendicitis who were randomized to undergo appendectomy (273 [52%]) or receive antibiotics (257 [49%]). The trial was conducted from November 2009 to June 2012; the last follow-up was May 9, 2018. The data were analyzed in February 2019. MAIN OUTCOMES AND MEASURES: In this analysis, post hoc secondary end points of postintervention QOL (EQ-5D-5L) and patient satisfaction and treatment preference were evaluated. RESULTS: Of the 530 patients enrolled in the trial (appendectomy group: 273 [174 men (64%)] with a median age of 35 years; (antibiotic group: 257 [155 men (60%)] with a median age of 33 years), 423 patients (80%) were available for phone interview at a median follow-up of 7 years; 206 patients (80%) took antibiotics and 217 (79%) underwent appendectomy. Of the 206 patients taking antibiotics, 81 (39%) had undergone appendectomy. The QOL between appendectomy and antibiotic group patients was similar (median health index value, 1.0 in both groups; 95% CI, 0.86-1.0; P = .96). Patients who underwent appendectomy were more satisfied in the treatment than patients taking antibiotics (68% very satisfied, 21% satisfied, 6% indifferent, 4% unsatisfied, and 1% very unsatisfied in the appendectomy group and 53% very satisfied, 21% satisfied, 13% indifferent, 7% unsatisfied, and 6% very unsatisfied in the antibiotic group; P < .001) and in a subgroup analysis this difference was based on the antibiotic group patients undergoing appendectomy. There was no difference in patient satisfaction after successful antibiotic treatment compared with appendectomy (cumulative odds ratio [COR], 7.8; 95% CI, 0.5-1.3; P < .36). Patients with appendectomy or with successful antibiotic therapy were more satisfied than antibiotic group patients who later underwent appendectomy (COR, 7.7; 95% CI, 4.6-12.9; P < .001; COR, 9.7; 95% CI, 5.4-15.3; P < .001, respectively). Of the 81 patients taking antibiotics who underwent appendectomy, 27 (33%) would again choose antibiotics as their primary treatment. CONCLUSIONS AND RELEVANCE: In this analysis, long-term QOL was similar after appendectomy and antibiotic therapy for the treatment of uncomplicated acute appendicitis. Patients taking antibiotics who later underwent appendectomy were less satisfied than patients with successful antibiotics or appendectomy. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT01022567</abstract><cop>United States</cop><pub>American Medical Association</pub><pmid>32074268</pmid><doi>10.1001/jamasurg.2019.6028</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Adolescent Adult Anti-Bacterial Agents - therapeutic use Antibiotics Appendectomy Appendicitis Appendicitis - therapy Clinical trials Drug resistance Female Finland Follow-Up Studies Humans Male Middle Aged Online First Original Investigation Patient Satisfaction Quality of Life Tomography |
| title | Quality of Life and Patient Satisfaction at 7-Year Follow-up of Antibiotic Therapy vs Appendectomy for Uncomplicated Acute Appendicitis: A Secondary Analysis of a Randomized Clinical Trial |
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