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Evidence based obstetrics and gynecology
International Journal of Gynecology and Obstetrics (2005) 89, 185 — 188
www.elsevier.com/locate/ijgo
EVIDENCE BASED OBSTETRICS AND GYNECOLOGY Abstracts of Cochrane Reviews
The editors of the International Journal of Gynecology & Obstetrics have selected the following abstracts of articles published in The Cochrane Library, Issue 1, 2005, because of their particular interest to practicing specialists in obstetrics and gynecology in all areas of the world. Surgical approach to hysterectomy for benign gynaecological disease (Cochrane Review) Johnson N, Barlow D, Lethaby A, Tavender E, Curr E, Garry R From The Cochrane Library, Issue 1, 2005. Chichester, UK: John Wiley and Sons, Ltd. All rights reserved. ABSTRACT: A substantive amendment to this systematic review was last made on 17 November 2004. Cochrane reviews are regularly checked and updated if necessary. Background: There are three approaches to hysterectomy for benign disease—abdominal hysterectomy (AH), vaginal hysterectomy (VH) and laparoscopic hysterectomy (LH). Laparoscopic hysterectomy has three further subdivisions—laparoscopic assisted vaginal hysterectomy (LAVH) where a vaginal hysterectomy is assisted by laparoscopic procedures that do not include uterine artery ligation, laparoscopic hysterectomy (which we will abbreviate to LH(a)) where the laparoscopic procedures include uterine artery ligation, and total laparoscopic hysterectomy (TLH) where there is no vaginal component and the vaginal vault is sutured laparoscopically. Objectives: To assess the most appropriate surgical approach to hysterectomy. doi:10.1016/j.ijgo.2005.03.001
Search strategy: We searched the Cochrane Menstrual Disorders and Subfertility Group’s Specialised Register of controlled trials (searched 23 March 2004), CENTRAL (The Cochrane Library Issue 1, 2004), MEDLINE (1966 to Mar 2004), EMBASE (1985 to Mar 2004), Biological Abstracts (1968 to Mar 2004), the National Research Register and relevant citation lists. Selection criteria: Only randomised trials comparing one surgical approach to hysterectomy with another were included. Data collection and analysis: Twenty-seven trials that included 3643 participants were included. Independent selection of trials and data extraction were employed following Cochrane guidelines. Main results: The benefits of VH versus AH were shorter duration of hospital stay (WMD 1.0 day, 95%CI 0.7 to 1.2 days), speedier return to normal activities (WMD 9.5 days, 95%CI 6.4 to 12.6 days), fewer unspecified infections or febrile episodes (OR 0.42, 95%CI 0.21 to 0.83). The benefits of LH versus AH were lower intraoperative bloodloss (WMD 45.3 ml, 95%CI 17.9 to 72.7 ml) and a smaller drop in haemoglobin level (WMD 0.55 g/L, 95%CI 0.28 to 0.82 g/L), shorter duration of hospital stay (WMD 2.0 days, 95%CI 1.9 to 2.2 days), speedier return to normal activities (WMD 13.6 days, 95%CI 11.8 to 15.4 days), fewer wound or abdominal wall infections (OR 0.32, 95%CI 0.12 to 0.85), fewer unspecified infections or febrile episodes (OR 0.65, 95%CI 0.49 to 0.87), at the cost of longer operating time (WMD 10.6 min, 95%CI 7.4 to 13.8 min) and more urinary tract (bladder or ureter) injuries (OR 2.61, 95%CI 1.22 to 5.60). There was no evidence of benefits of
186 LH versus VH and the operating time was increased (WMD 41.5 min, 95%CI 33.7 to 49.4 min). There was no evidence of benefits of LH(a) versus LAVH and the operating time was increased for LH(a) (WMD 25.3 min, 95%CI 10.0 to 40.6 min). There was statistical heterogeneity in many of the outcome measures when randomised trials were pooled for metaanalysis. No other statistically significant differences were found. However, for some important outcomes, the analyses were underpowered to detect important differences, or they were simply not reported in trials. Data were notably absent for many important long-term outcome measures. Authors’ conclusions: Significantly improved outcomes suggest VH should be performed in preference to AH where possible. Where VH is not possible, LH may avoid the need for AH, however the length of the surgery increases as the extent of the surgery performed laparoscopically increases, particularly when the uterine arteries are divided laparoscopically and laparoscopic approaches require greater surgical expertise. The surgical approach to hysterectomy should be decided by a woman in discussion with her surgeon in light of the relative benefits and hazards. Further research is required with full reporting of all relevant outcomes, particularly important long-term outcomes, in large RCTs, to minimise the possibility of reporting bias. Further research is also required to define the role of the newer approaches to hysterectomy such as TLH. Citation: Johnson N, Barlow D, Lethaby A, Tavender E, Curr E, Garry R. Surgical approach to hysterectomy for benign gynaecological disease. The Cochrane Database of Systematic Reviews 2005, Issue 1. Art. No.: CD003677.pub2. DOI: 10.1002/ 14651858.CD003677.pub2.
Prevention and treatment of postpartum hypertension (Cochrane Review) Magee L, Sadeghi S From The Cochrane Library, Issue 1, 2005. Chichester, UK: John Wiley and Sons, Ltd. All rights reserved. ABSTRACT: A substantive amendment to this systematic review was last made on 04 November 2004. Cochrane reviews are regularly checked and updated if necessary. Background: Postpartum blood pressure (BP) is highest 3 to 6 days after birth when most women
Abstracts of Cochrane Reviews have been discharged home. A significant rise in BP may be dangerous (e.g., lead to stroke), but there is little information about how to prevent or treat postpartum hypertension. Objectives: To assess the relative benefits and risks of interventions to: (1) prevent postpartum hypertension, by assessing whether droutineT postpartum administration of oral antihypertensive therapy is better than placebo/no treatment; and (2) treat postpartum hypertension, by assessing whether (i) oral antihypertensive therapy is better than placebo/no therapy for mild-moderate postpartum hypertension; and (ii) one antihypertensive agent offers advantages over another for mild-moderate or severe postpartum hypertension. Search strategy: We searched the Cochrane Pregnancy and Childbirth Group trials register (March 2004), MEDLINE (1966 to May 2003), EMBASE (1980 to January 2003), bibliographies of retrieved papers and personal files. Selection criteria: For women with antenatal hypertension, trials comparing a medical intervention with placebo/no therapy. For women with postpartum hypertension, trials comparing one antihypertensive with either another or placebo/ no therapy. Data collection and analysis: We extracted the data independently and were not blinded to trial characteristics or outcomes. We contacted authors for missing data when possible. Main results: Six trials are included. Prevention in three trials (315 women; six comparisons) compared furosemide or nifedipine capsules with placebo/no therapy. There are insufficient data for conclusions about possible benefits and risks of these management strategies. Most outcomes included data from only one trial. No trial reported severe maternal hypertension or breastfeeding. Treatment in two trials (106 women; three comparisons), oral timolol or hydralazine were compared with oral methyldopa for treatment of mild to moderate postpartum hypertension. In one trial (38 women; one comparison), oral hydralazine plus sublingual nifedipine were compared with sublingual nifedipine for treatment of severe postpartum hypertension. The need for additional antihypertensive therapy did not differ between groups (relative risk 4.24, 95% confidence interval 0.96 to 18.84; three trials, N = 144 women), but three antihypertensive drugs were studied. All were well tolerated.
Abstracts of Cochrane Reviews Authors’ conclusions: There are no reliable data to guide management of women who are hypertensive postpartum or at increased risk of becoming so. If a clinician feels that hypertension is severe enough to treat, the agent used should be based on his/her familiarity with the drug. Future studies of prevention or treatment of postpartum hypertension should include information about use of postpartum analgesics and outcomes of severe maternal hypertension, breastfeeding, hospital length of stay, and maternal satisfaction with care. Citation: Magee L, Sadeghi S. Prevention and treatment of postpartum hypertension. The Cochrane Database of Systematic Reviews 2005, Issue 1. Art. No.: CD004351.pub2. DOI: 10.1002/ 14651858.CD004351.pub2.
Frameless versus classical intrauterine device for contraception (Cochrane Review) O’Brien PA, Marfleet C From The Cochrane Library, Issue 1, 2005. Chichester, UK: John Wiley and Sons, Ltd. All rights reserved. ABSTRACT: A substantive amendment to this systematic review was last made on 13 November 2004. Cochrane reviews are regularly checked and updated if necessary. Background: The frameless intrauterine device (IUD) dispenses with the frame in the classical IUD and holds the device in the uterus by anchoring one end of a nylon thread in the fundal myometrium, to which copper sleeves are attached. Objectives: This review examines the hypothesis that the frameless IUD Gynefix reduces risk of expulsion and pregnancy, and the problems of bleeding and pain necessitating early removal. Search strategy: We searched the Cochrane Controlled Trial Register (Cochrane Library Issue 2, 2004), MEDLINE, and Popline from 1980 to March 2004, and reference list of articles. Selection criteria: We selected for the review randomised trials that compared the frameless device to a classical framed device for contraception. Data collection and analysis: Both authors extracted data independently. We contacted study author for additional data. We calculated rate ratios
187 and rate differences for cumulative rates for each outcome at yearly intervals. We used the inverse variance-based method to combine trials, and tested the results for heterogeneity. Main results: Four trials were included in the review involving 5939 women randomised to either a frameless device or TCu380, with data up to 8 years for the largest, and with a total experience of 23,180 years. Apart from one small trial, nulliparous women were excluded from the trials. The two earlier trials used a prototype introducer and there was a higher expulsion rate at 1 year (relative risk 2.48, 95% confidence intervals 1.89 to 3.26). However, between 2 and 6 years in the large WHO trial, the risk of pregnancy was lower with the frameless device (relative risk 0.53, 95% confidence intervals 0.32 to 0.91). In a recent trial using GyneFix with a new introducer, early expulsions and pregnancies were not statistically different from the control device. Removals rates for excessive bleeding and/or pain were no different between the devices (relative risks 0.92, 95% confidence intervals 0.74 to 1.14, at 1 year and 1.13, 0.93 to 1.37, at 6 years). There was a tendency towards fewer removals for pain in early years but no difference at 6 years (relative risk 1.13, 95% confidence intervals 0.93 to 1.37). Authors’ conclusions: There is insufficient data to show that problems of early expulsions have been overcome with the modified introducer used in GyneFix. Apart from that, the frameless device performs similarly to TCu380, and appears to have a lower pregnancy rate in later years, although the absolute difference is small. Citation: O’Brien PA, Marfleet C. Frameless versus classical intrauterine device for contraception. The Cochrane Database of Systematic Reviews 2005, Issue 1. Art. No.: CD003282.pub2. DOI: 10.1002/ 14651858.CD003282.pub2.
Follow-up strategies for women treated for early breast cancer (Cochrane Review) Rojas MP, Telaro E, Russo A, Moschetti I, Coe L, Fossati R, Palli D, Roselli del Turco M, Liberati A From The Cochrane Library, Issue 1, 2005. Chichester, UK: John Wiley and Sons, Ltd. All rights reserved. ABSTRACT: A substantive amendment to this systematic review was last made on 17 November
188 2004. Cochrane reviews are regularly checked and updated if necessary. Background: Follow-up examinations are commonly performed after primary treatment for women with breast cancer. They are used to detect recurrences at an early (asymptomatic) stage. Objectives: To assess the effectiveness of different policies of follow-up for distant metastases on mortality, morbidity and quality of life in women treated for stage I, II or III breast cancer. Search strategy: We searched, the Breast Cancer Group’s specialized register (May 14, 2004), the Cochrane Controlled Trial Register (Cochrane Library Issue 1, 2004), Medline (January 1966— May 2004) and EMBASE (1988—May 2004). References from retrieved articles were also checked. Selection criteria: All randomised controlled trials (RCTs) assessing the effectiveness of different policies of follow-up after primary treatment were reviewed for inclusion. Data collection and analysis: Two reviewers independently assessed trial quality and eligibility for inclusion in the review. Data were pooled in an individual patient data meta-analysis for the two RCTs testing the effectiveness of different follow-up schemes. Subgroup analyses were conducted by age, tumour size and lymph node status. Main results: Four RCTs involving 3055 women with breast cancer (clinical stage I, II or III) were included. Two of these involving 2563 women compared follow-up based on clinical visits and mammography with a more intensive scheme including radiological and laboratory tests. After pooling the data, no significant differences in overall survival (hazard ratio 0.96, 95% confidence
Abstracts of Cochrane Reviews interval 0.80 to 1.15) or disease-free survival (hazard ratio 0.84, 95% confidence interval 0.71 to 1.00) emerged. No differences in overall survival and disease-free survival emerged in subgroup analyses according to patient age, tumour size and lymph node status before primary treatment. In 1999, 10-year follow-up data became available for Rosselli Del Turco and no significant differences in overall survival were found. One RCT (296 women) compared follow-up performed by a hospital-based specialist to follow-up performed by general practitioners. No significant differences in time to detection of recurrence and quality of life emerged. Patient satisfaction was greater among patients treated by general practitioners. One RCT (196 women) compared regularly scheduled followup visits to less frequent visits restricted to the time of mammography. No significant differences emerged in interim use of telephone and frequency of GP’s consultations. Authors’ conclusions: This updated review of RCTs conducted almost 20 years ago suggests that follow-up programs based on regular physical examinations and yearly mammography alone are as effective as more intensive approaches based on regular performance of laboratory and instrumental tests in terms of timeliness of recurrence detection, overall survival and quality of life. In one RCT, follow-up care performed by trained general practitioners working in an organized practice setting had comparable effectiveness to that delivered by hospital-based specialists in terms of quality of life and time to detection of distant metastases. Citation: Rojas MP, Telaro E, Russo A, Moschetti I, Coe L, Fossati R, Palli D, Roselli del Turco M, Liberati A. Follow-up strategies for women treated for early breast cancer. The Cochrane Database of Systematic Reviews 2005, Issue 1. Art. No.: CD001768.pub2. DOI: 10.1002/14651858.CD001768.pub2.
www.elsevier.com/locate/ijgo
EVIDENCE BASED OBSTETRICS AND GYNECOLOGY Abstracts of Cochrane Reviews
The editors of the International Journal of Gynecology & Obstetrics have selected the following abstracts of articles published in The Cochrane Library, Issue 1, 2005, because of their particular interest to practicing specialists in obstetrics and gynecology in all areas of the world. Surgical approach to hysterectomy for benign gynaecological disease (Cochrane Review) Johnson N, Barlow D, Lethaby A, Tavender E, Curr E, Garry R From The Cochrane Library, Issue 1, 2005. Chichester, UK: John Wiley and Sons, Ltd. All rights reserved. ABSTRACT: A substantive amendment to this systematic review was last made on 17 November 2004. Cochrane reviews are regularly checked and updated if necessary. Background: There are three approaches to hysterectomy for benign disease—abdominal hysterectomy (AH), vaginal hysterectomy (VH) and laparoscopic hysterectomy (LH). Laparoscopic hysterectomy has three further subdivisions—laparoscopic assisted vaginal hysterectomy (LAVH) where a vaginal hysterectomy is assisted by laparoscopic procedures that do not include uterine artery ligation, laparoscopic hysterectomy (which we will abbreviate to LH(a)) where the laparoscopic procedures include uterine artery ligation, and total laparoscopic hysterectomy (TLH) where there is no vaginal component and the vaginal vault is sutured laparoscopically. Objectives: To assess the most appropriate surgical approach to hysterectomy. doi:10.1016/j.ijgo.2005.03.001
Search strategy: We searched the Cochrane Menstrual Disorders and Subfertility Group’s Specialised Register of controlled trials (searched 23 March 2004), CENTRAL (The Cochrane Library Issue 1, 2004), MEDLINE (1966 to Mar 2004), EMBASE (1985 to Mar 2004), Biological Abstracts (1968 to Mar 2004), the National Research Register and relevant citation lists. Selection criteria: Only randomised trials comparing one surgical approach to hysterectomy with another were included. Data collection and analysis: Twenty-seven trials that included 3643 participants were included. Independent selection of trials and data extraction were employed following Cochrane guidelines. Main results: The benefits of VH versus AH were shorter duration of hospital stay (WMD 1.0 day, 95%CI 0.7 to 1.2 days), speedier return to normal activities (WMD 9.5 days, 95%CI 6.4 to 12.6 days), fewer unspecified infections or febrile episodes (OR 0.42, 95%CI 0.21 to 0.83). The benefits of LH versus AH were lower intraoperative bloodloss (WMD 45.3 ml, 95%CI 17.9 to 72.7 ml) and a smaller drop in haemoglobin level (WMD 0.55 g/L, 95%CI 0.28 to 0.82 g/L), shorter duration of hospital stay (WMD 2.0 days, 95%CI 1.9 to 2.2 days), speedier return to normal activities (WMD 13.6 days, 95%CI 11.8 to 15.4 days), fewer wound or abdominal wall infections (OR 0.32, 95%CI 0.12 to 0.85), fewer unspecified infections or febrile episodes (OR 0.65, 95%CI 0.49 to 0.87), at the cost of longer operating time (WMD 10.6 min, 95%CI 7.4 to 13.8 min) and more urinary tract (bladder or ureter) injuries (OR 2.61, 95%CI 1.22 to 5.60). There was no evidence of benefits of
186 LH versus VH and the operating time was increased (WMD 41.5 min, 95%CI 33.7 to 49.4 min). There was no evidence of benefits of LH(a) versus LAVH and the operating time was increased for LH(a) (WMD 25.3 min, 95%CI 10.0 to 40.6 min). There was statistical heterogeneity in many of the outcome measures when randomised trials were pooled for metaanalysis. No other statistically significant differences were found. However, for some important outcomes, the analyses were underpowered to detect important differences, or they were simply not reported in trials. Data were notably absent for many important long-term outcome measures. Authors’ conclusions: Significantly improved outcomes suggest VH should be performed in preference to AH where possible. Where VH is not possible, LH may avoid the need for AH, however the length of the surgery increases as the extent of the surgery performed laparoscopically increases, particularly when the uterine arteries are divided laparoscopically and laparoscopic approaches require greater surgical expertise. The surgical approach to hysterectomy should be decided by a woman in discussion with her surgeon in light of the relative benefits and hazards. Further research is required with full reporting of all relevant outcomes, particularly important long-term outcomes, in large RCTs, to minimise the possibility of reporting bias. Further research is also required to define the role of the newer approaches to hysterectomy such as TLH. Citation: Johnson N, Barlow D, Lethaby A, Tavender E, Curr E, Garry R. Surgical approach to hysterectomy for benign gynaecological disease. The Cochrane Database of Systematic Reviews 2005, Issue 1. Art. No.: CD003677.pub2. DOI: 10.1002/ 14651858.CD003677.pub2.
Prevention and treatment of postpartum hypertension (Cochrane Review) Magee L, Sadeghi S From The Cochrane Library, Issue 1, 2005. Chichester, UK: John Wiley and Sons, Ltd. All rights reserved. ABSTRACT: A substantive amendment to this systematic review was last made on 04 November 2004. Cochrane reviews are regularly checked and updated if necessary. Background: Postpartum blood pressure (BP) is highest 3 to 6 days after birth when most women
Abstracts of Cochrane Reviews have been discharged home. A significant rise in BP may be dangerous (e.g., lead to stroke), but there is little information about how to prevent or treat postpartum hypertension. Objectives: To assess the relative benefits and risks of interventions to: (1) prevent postpartum hypertension, by assessing whether droutineT postpartum administration of oral antihypertensive therapy is better than placebo/no treatment; and (2) treat postpartum hypertension, by assessing whether (i) oral antihypertensive therapy is better than placebo/no therapy for mild-moderate postpartum hypertension; and (ii) one antihypertensive agent offers advantages over another for mild-moderate or severe postpartum hypertension. Search strategy: We searched the Cochrane Pregnancy and Childbirth Group trials register (March 2004), MEDLINE (1966 to May 2003), EMBASE (1980 to January 2003), bibliographies of retrieved papers and personal files. Selection criteria: For women with antenatal hypertension, trials comparing a medical intervention with placebo/no therapy. For women with postpartum hypertension, trials comparing one antihypertensive with either another or placebo/ no therapy. Data collection and analysis: We extracted the data independently and were not blinded to trial characteristics or outcomes. We contacted authors for missing data when possible. Main results: Six trials are included. Prevention in three trials (315 women; six comparisons) compared furosemide or nifedipine capsules with placebo/no therapy. There are insufficient data for conclusions about possible benefits and risks of these management strategies. Most outcomes included data from only one trial. No trial reported severe maternal hypertension or breastfeeding. Treatment in two trials (106 women; three comparisons), oral timolol or hydralazine were compared with oral methyldopa for treatment of mild to moderate postpartum hypertension. In one trial (38 women; one comparison), oral hydralazine plus sublingual nifedipine were compared with sublingual nifedipine for treatment of severe postpartum hypertension. The need for additional antihypertensive therapy did not differ between groups (relative risk 4.24, 95% confidence interval 0.96 to 18.84; three trials, N = 144 women), but three antihypertensive drugs were studied. All were well tolerated.
Abstracts of Cochrane Reviews Authors’ conclusions: There are no reliable data to guide management of women who are hypertensive postpartum or at increased risk of becoming so. If a clinician feels that hypertension is severe enough to treat, the agent used should be based on his/her familiarity with the drug. Future studies of prevention or treatment of postpartum hypertension should include information about use of postpartum analgesics and outcomes of severe maternal hypertension, breastfeeding, hospital length of stay, and maternal satisfaction with care. Citation: Magee L, Sadeghi S. Prevention and treatment of postpartum hypertension. The Cochrane Database of Systematic Reviews 2005, Issue 1. Art. No.: CD004351.pub2. DOI: 10.1002/ 14651858.CD004351.pub2.
Frameless versus classical intrauterine device for contraception (Cochrane Review) O’Brien PA, Marfleet C From The Cochrane Library, Issue 1, 2005. Chichester, UK: John Wiley and Sons, Ltd. All rights reserved. ABSTRACT: A substantive amendment to this systematic review was last made on 13 November 2004. Cochrane reviews are regularly checked and updated if necessary. Background: The frameless intrauterine device (IUD) dispenses with the frame in the classical IUD and holds the device in the uterus by anchoring one end of a nylon thread in the fundal myometrium, to which copper sleeves are attached. Objectives: This review examines the hypothesis that the frameless IUD Gynefix reduces risk of expulsion and pregnancy, and the problems of bleeding and pain necessitating early removal. Search strategy: We searched the Cochrane Controlled Trial Register (Cochrane Library Issue 2, 2004), MEDLINE, and Popline from 1980 to March 2004, and reference list of articles. Selection criteria: We selected for the review randomised trials that compared the frameless device to a classical framed device for contraception. Data collection and analysis: Both authors extracted data independently. We contacted study author for additional data. We calculated rate ratios
187 and rate differences for cumulative rates for each outcome at yearly intervals. We used the inverse variance-based method to combine trials, and tested the results for heterogeneity. Main results: Four trials were included in the review involving 5939 women randomised to either a frameless device or TCu380, with data up to 8 years for the largest, and with a total experience of 23,180 years. Apart from one small trial, nulliparous women were excluded from the trials. The two earlier trials used a prototype introducer and there was a higher expulsion rate at 1 year (relative risk 2.48, 95% confidence intervals 1.89 to 3.26). However, between 2 and 6 years in the large WHO trial, the risk of pregnancy was lower with the frameless device (relative risk 0.53, 95% confidence intervals 0.32 to 0.91). In a recent trial using GyneFix with a new introducer, early expulsions and pregnancies were not statistically different from the control device. Removals rates for excessive bleeding and/or pain were no different between the devices (relative risks 0.92, 95% confidence intervals 0.74 to 1.14, at 1 year and 1.13, 0.93 to 1.37, at 6 years). There was a tendency towards fewer removals for pain in early years but no difference at 6 years (relative risk 1.13, 95% confidence intervals 0.93 to 1.37). Authors’ conclusions: There is insufficient data to show that problems of early expulsions have been overcome with the modified introducer used in GyneFix. Apart from that, the frameless device performs similarly to TCu380, and appears to have a lower pregnancy rate in later years, although the absolute difference is small. Citation: O’Brien PA, Marfleet C. Frameless versus classical intrauterine device for contraception. The Cochrane Database of Systematic Reviews 2005, Issue 1. Art. No.: CD003282.pub2. DOI: 10.1002/ 14651858.CD003282.pub2.
Follow-up strategies for women treated for early breast cancer (Cochrane Review) Rojas MP, Telaro E, Russo A, Moschetti I, Coe L, Fossati R, Palli D, Roselli del Turco M, Liberati A From The Cochrane Library, Issue 1, 2005. Chichester, UK: John Wiley and Sons, Ltd. All rights reserved. ABSTRACT: A substantive amendment to this systematic review was last made on 17 November
188 2004. Cochrane reviews are regularly checked and updated if necessary. Background: Follow-up examinations are commonly performed after primary treatment for women with breast cancer. They are used to detect recurrences at an early (asymptomatic) stage. Objectives: To assess the effectiveness of different policies of follow-up for distant metastases on mortality, morbidity and quality of life in women treated for stage I, II or III breast cancer. Search strategy: We searched, the Breast Cancer Group’s specialized register (May 14, 2004), the Cochrane Controlled Trial Register (Cochrane Library Issue 1, 2004), Medline (January 1966— May 2004) and EMBASE (1988—May 2004). References from retrieved articles were also checked. Selection criteria: All randomised controlled trials (RCTs) assessing the effectiveness of different policies of follow-up after primary treatment were reviewed for inclusion. Data collection and analysis: Two reviewers independently assessed trial quality and eligibility for inclusion in the review. Data were pooled in an individual patient data meta-analysis for the two RCTs testing the effectiveness of different follow-up schemes. Subgroup analyses were conducted by age, tumour size and lymph node status. Main results: Four RCTs involving 3055 women with breast cancer (clinical stage I, II or III) were included. Two of these involving 2563 women compared follow-up based on clinical visits and mammography with a more intensive scheme including radiological and laboratory tests. After pooling the data, no significant differences in overall survival (hazard ratio 0.96, 95% confidence
Abstracts of Cochrane Reviews interval 0.80 to 1.15) or disease-free survival (hazard ratio 0.84, 95% confidence interval 0.71 to 1.00) emerged. No differences in overall survival and disease-free survival emerged in subgroup analyses according to patient age, tumour size and lymph node status before primary treatment. In 1999, 10-year follow-up data became available for Rosselli Del Turco and no significant differences in overall survival were found. One RCT (296 women) compared follow-up performed by a hospital-based specialist to follow-up performed by general practitioners. No significant differences in time to detection of recurrence and quality of life emerged. Patient satisfaction was greater among patients treated by general practitioners. One RCT (196 women) compared regularly scheduled followup visits to less frequent visits restricted to the time of mammography. No significant differences emerged in interim use of telephone and frequency of GP’s consultations. Authors’ conclusions: This updated review of RCTs conducted almost 20 years ago suggests that follow-up programs based on regular physical examinations and yearly mammography alone are as effective as more intensive approaches based on regular performance of laboratory and instrumental tests in terms of timeliness of recurrence detection, overall survival and quality of life. In one RCT, follow-up care performed by trained general practitioners working in an organized practice setting had comparable effectiveness to that delivered by hospital-based specialists in terms of quality of life and time to detection of distant metastases. Citation: Rojas MP, Telaro E, Russo A, Moschetti I, Coe L, Fossati R, Palli D, Roselli del Turco M, Liberati A. Follow-up strategies for women treated for early breast cancer. The Cochrane Database of Systematic Reviews 2005, Issue 1. Art. No.: CD001768.pub2. DOI: 10.1002/14651858.CD001768.pub2.