Methodological approaches to measuring mental health in a cost-of-living crisis: A rapid review.

BACKGROUND: Cost-of-living crises are damaging to population mental health and require a public health response. It is important to assess whether public health interventions are effective. We aimed to identify population-level methods and measures and the appropriateness of the measures for vulnerable populations. METHODS: A rapid evidence review was undertaken. Nineteen databases, including grey literature, were searched for evidence published between 1970 and April 2023. RESULTS: Seven reviews, nine primary studies and two reports from grey literature were identified. Methods consisted of analyses of existing data from national or regional cohort studies, household panel surveys, repeated cross-sectional surveys, routine medical data, or data on suicide death rates. Twelve brief validated mental health measurement tools, embedded in population-level surveys, were identified. Two quasi-experimental studies used data from a UK household panel survey to examine the impact of the introduction of specific welfare policies on mental health. Studies identified socio-economic vulnerabilities, but it was not possible to determine whether data were effectively captured from people from minority ethnic groups. CONCLUSION: Population-level surveys can be used in quasi-experimental studies to measure the effects of a public health initiative with specific roll out dates to tackle cost-of-living impacts. It is unclear as to whether the identified methods and tools are suitable for use with people from minority ethnic groups.

Low energy contact X-ray brachytherapy for treatment of rectal cancer: a health technology appraisal by Health Technology Wales.

AIM: Health Technology Wales sought to evaluate the clinical and cost-effectiveness of contact X-ray brachytherapy (CXB) for early-stage rectal cancer. METHODS: Relevant studies were identified through systematic searches of MEDLINE, Embase, Cochrane Library and Scopus. A cost-utility model was developed to estimate the cost-effectiveness of CXB in National Health Service Wales, using results of the Organ Preservation in Early Rectal Adenocarcinoma (OPERA) trial. Patient perspectives were obtained through the Papillon Patient Support group and All-Wales Cancer Network. RESULTS: The OPERA randomized controlled trial showed that CXB improved complete response and organ preservation rates compared with external-beam boost for people with T2-3b, N0-1, M0 rectal cancer who are fit for surgery. Managing more of this population non-operatively after CXB was estimated to provide 0.2 quality-adjusted life years at an additional cost of £887 per person. CXB was cost effective compared with external-beam boost at a cost of £4463 per quality-adjusted life year gained. This conclusion did not change in scenario analysis and CXB was cost effective in 91% of probabilistic sensitivity analyses. Patients valued receiving clear information on all available options to support their individual treatment choices. The detrimental impact of a stoma on quality of life led some patients to reject the idea that surgery was their only option. CONCLUSION: This evidence review and cost-utility analysis indicates that CXB is likely to be clinically and cost effective, as part of a watch and wait strategy for adults fit for surgery. Wider access to CXB is supported by patient testimonies.

Cervical priming before surgical abortion between 14 and 24 weeks: a systematic review and meta-analyses for the National Institute for Health and Care Excellence-new clinical guidelines for England.

OBJECTIVE: This study aimed to determine the optimal cervical priming regimen before surgical abortion between 14+0 and 24+0 weeks' gestation. DATA SOURCES: Embase, MEDLINE, and the Cochrane Library were searched for publications up to February 2020. Experts were consulted for any ongoing or missed trials. STUDY ELIGIBILITY CRITERIA: Randomized controlled trials, published in English after 1985, that compared (1) mifepristone, misoprostol, and osmotic dilators against each other, alone or in combination; (2) different doses of mifepristone and misoprostol; (3) different intervals between priming and abortion; or (4) different routes of administration of misoprostol were included. METHODS: Risk of bias was assessed using the Cochrane Collaboration checklist for randomized controlled trials, and data were meta-analyzed in Review Manager 5.3. Dichotomous outcomes were analyzed as risk ratios using the Mantel-Haenszel method, and continuous outcomes were analyzed as mean differences using the inverse variance method. Fixed effects models were used when there was no significant heterogeneity (I2<50%), random effects models were used for moderate heterogeneity (I2≤50% and <80%), and evidence was not pooled when there was high heterogeneity (I2≥80%). Subgroup analyses were undertaken based on parity where available. The overall quality of the evidence was assessed using Grades of Recommendation Assessment, Development, and Evaluation. RESULTS: A total of 15 randomized controlled trials (N=2454) were included and showed decreased difficulty of procedure and/or increased cervical dilation and decreased patient acceptability with regimens that included dilators compared with those that did not include dilators; increased preoperative expulsion of the pregnancy with sublingual misoprostol and mifepristone compared with sublingual misoprostol alone; increased difficulty of procedure with dilators and misoprostol compared with dilators and mifepristone; decreased difficulty of procedure with dilators and mifepristone compared with dilators alone; and increased cervical dilation when dilators were placed the day before abortion compared with the same day. CONCLUSION: Considered alongside clinical expertise, the published data support the use of osmotic dilators, misoprostol, or mifepristone before abortion for pregnancies at 14+0 to 16+0 weeks' gestation; osmotic dilators or misoprostol for pregnancies at 16+1 to 19+0 weeks' gestation; and osmotic dilators alone or with mifepristone for pregnancies at 19+1 to 24+0 weeks' gestation. The effectiveness of pharmacologic agents alone beyond 16+0 weeks' gestation and the optimal timing of dilator placement remain important questions for future research.

Expulsion at home for early medical abortion: A systematic review with meta-analyses.

INTRODUCTION: The safety and acceptability of medical abortion using mifepristone and misoprostol at home at ≤9+0  weeks' gestation is well established. However, the upper gestational limit at which the procedure remains safe and acceptable at home is not known. To inform a national guideline on abortion care we conducted a systematic review to determine what gestational limit for expulsion at home offers the best balance of benefits and harms for women who are having medical abortion. MATERIAL AND METHODS: We searched Embase, MEDLINE, Cochrane Library, Cinahl Plus and Web-of-Science on 2 January 2020 for prospective and retrospective cohort studies with ≥50 women per gestational age group, published in English from 1995 onwards, that included women undergoing medical abortion and compared home expulsion of pregnancies of ≤9+0  weeks' gestational age with pregnancies of 9+1 -10+0  weeks or >10+1  weeks' gestational age, or compared the latter two gestational age groups. We assessed risk-of-bias using the Newcastle-Ottowa scale. All outcomes were meta-analyzed as risk ratios (RR) using the Mantel-Haenszel method. The certainty of the evidence was assessed using GRADE. RESULTS: Six studies (n = 3381) were included. The "need for emergency care/admission to hospital" (RR = 0.79, 95% confidence interval [CI] 0.45-1.4), "hemorrhage requiring transfusion/≥500 mL blood loss" (RR = 0.62, 95% CI 0.11-3.55), patient satisfaction (RR = 0.99, 95% CI 0.95-1.03), pain (RR = 0.91, 95% CI 0.82-1.02), and "complete abortion without the need for surgical intervention" (RR = 1.03, 95% CI 1-1.05) did not differ statistically significantly between the ≤9+0 and >9+0  weeks' gestation groups. The rates of vomiting (RR = 0.8, 95% CI 0.69-0.93) and diarrhea (RR = 0.85, 95% CI 0.73-0.99) were statistically significantly lower in the ≤9+0  weeks group but these differences were not considered clinically important. We found no studies comparing pregnancies of 9+1 -10+0  weeks' gestation with pregnancies of >10+0  weeks' gestation. The certainty of this evidence was predominantly low and mainly compromised by low event rates and loss to follow up. CONCLUSIONS: Women who are having a medical abortion and will be taking mifepristone up to and including 10+0  weeks' gestation should be offered the option of expulsion at home after they have taken the misoprostol. Further research needs to determine whether the gestational limit for home expulsion can be extended beyond 10+0  weeks.

Cervical priming before surgical abortion up to 13+6 weeks' gestation: a systematic review and metaanalyses for the National Institute for Health and Care Excellence-new clinical guidelines for England.

OBJECTIVE: This study aimed to determine the optimal cervical priming regimen before surgical abortion up to and including 13+6 weeks' gestation. DATA SOURCES: Embase, MEDLINE, and the Cochrane Library were searched for publications up to February 2020. Experts were consulted for any ongoing or missed trials. STUDY ELIGIBILITY CRITERIA: This study included randomized controlled trials published in English after 2000 that compared the following: (1) mifepristone and misoprostol against each other, placebo, or no priming; (2) different doses of mifepristone or misoprostol; (3) different intervals between priming and abortion; or (4) different routes of misoprostol administration. STUDY APPRAISAL AND SYNTHESIS METHODS: Risk of bias was assessed using the Cochrane Collaboration checklist for randomized controlled trials, and data were metaanalyzed in Review Manager 5.3. Dichotomous outcomes were analyzed as risk ratios using the Mantel-Haenszel method, and continuous outcomes were analyzed as mean differences using the inverse variance method. Fixed effects models were used when there was no substantial heterogeneity (I2<50%), random effects models were used for moderate heterogeneity (I2≤50% and <80%), and evidence was not pooled when there was high heterogeneity (I2≥80%). Subgroup analyses were undertaken based on parity where available. The overall quality of the evidence was assessed using Grading of Recommendations Assessment, Development and Evaluation. RESULTS: A total of 18 randomized controlled trials (n=8538) were included and showed the following: decreased incomplete abortion rate (risk ratio=0.44; 95% confidence interval, 0.21-0.9) and force required to dilate the cervix (mean difference= -7.08 N; 95% confidence interval, -11.67 to -2.49) and increased preoperative bleeding (risk ratio=5.90; 95% confidence interval, 5.08-6.86) with misoprostol compared with no priming; decreased preoperative bleeding when sublingual misoprostol was given 1 hour before abortion compared with 3 hours before (risk ratio=0.14; 95% confidence interval, 0.03-0.56); and increased force required to dilate the cervix (mean difference=14.3 N; 95% confidence interval, 2.13-26.47) when mifepristone was given 24 hours before abortion compared with 48 hours before. The quality of the evidence base was limited by low event rates and risk of bias in included studies. CONCLUSION: Cervical priming with misoprostol decreases the force needed to dilate the cervix for first trimester surgical abortion and reduces the risk of incomplete abortion. Considered alongside clinical expertise, this evidence supports the use of routine cervical priming before first trimester surgical abortion with 400 µg misoprostol or, if misoprostol cannot be used, 200 mg oral mifepristone.

Access to and sustainability of abortion services: a systematic review and meta-analysis for the National Institute of Health and Care Excellence-new clinical guidelines for England.

BACKGROUND: Induced abortion is a common procedure. However, there is marked variation in accessibility of services across England. Accessing abortion services may be difficult, particularly for women who live in remote areas, are in the second trimester of pregnancy, have complex pre-existing conditions or have difficult social circumstances. OBJECTIVE AND RATIONALE: This article presents a two-part review undertaken for a new National Institute of Health and Care Excellence guideline on abortion care, and aiming to determine: the factors that help or hinder accessibility and sustainability of abortion services in England (qualitative review), and strategies that improve these factors, and/or other factors identified by stakeholders (quantitative review). Economic modelling was undertaken to estimate cost savings associated with reducing waiting times. SEARCH METHODS: Ovid Embase Classic and Embase, Ovid MEDLINE(R) Epub Ahead of Print, In-Process & Other Non-Indexed Citations, Ovid MEDLINE(R) Daily and Ovid MEDLINE(R), PsycINFO, Cochrane Library via Wiley Online, Cinahl Plus and Web of Science Core Collection were searched for articles published up to November 2018. Studies were included if they were published in English after 2001, conducted in Organization for Economic Co-operation and Development (OECD) countries and were: qualitative studies reporting views of patients and/or staff on factors that help or hinder the accessibility and sustainability of a safe abortion service, or randomized or non-randomized studies that compared strategies to improve factors identified by the qualitative review and/or stakeholders. Studies were excluded if they were conducted in OECD countries where abortion is prohibited altogether or only performed to save the woman's life. One author assessed risk of bias of included studies using the following checklists: Critical Appraisal Skills Programme checklist for qualitative studies, Cochrane Collaboration quality checklist for randomized controlled trials, Newcastle-Ottawa scale for cohort studies, and Effective Practice and Organization of Care risk of bias tool for before-and-after studies.Qualitative evidence was combined using thematic analysis and overall quality of the evidence was assessed using Grading of Recommendations, Assessment, Development and Evaluations (GRADE) Confidence in the Evidence from Reviews of Qualitative Research (CERQual). Quantitative evidence was analysed in Review Manager 5.3 and overall quality of evidence was assessed using GRADE. OUTCOMES: Eight themes (service level barriers; financial barriers; logistical barriers; personal barriers; legal and policy barriers; privacy and confidentiality concerns; training and education; community prescribing and telemedicine introduce greater flexibility) and 18 subthemes were identified from 23 papers (n = 1016) included in the qualitative review. The quality of evidence ranged from very low to high, with evidence for one theme and seven subthemes rated as high quality. Nine studies (n = 7061) were included in the quantitative review which showed that satisfaction was better (low to high quality evidence) and women were seen sooner (very low quality evidence) when care was led by nurses or midwives compared with physician-led services, women were seen sooner when they could self-refer (very low quality evidence), and clinicians were more likely to provide abortions if training used an opt-out model (very low quality evidence). Economic modelling showed that even small reductions in waiting times could result in large cost savings for services. WIDER IMPLICATIONS: Self-referral, funding for travel and accommodation, reducing waiting times, remote assessment, community services, maximizing the role of nurses and midwives and including practical experience of performing abortion in core curriculums, unless the trainee opts out, should improve access to and sustainability of abortion services.

Surgical or medical abortion of pregnancies between 13+0 and 23+6 weeks' gestation? A systematic review and new NICE national guidelines.

BACKGROUND: Abortion in the second trimester may be performed surgically or medically. The objective of this systematic review was to examine the effectiveness, safety and acceptability/satisfaction of surgical compared with medical abortion of pregnancy between 13+0 and 23+6 weeks' gestation for a new national guideline. METHODS: We searched Embase, Medline and the Cochrane Library on 4 March 2019. We included randomised controlled trials (RCTs; any size) and non-randomised comparative studies with n≥100 in each arm, published in English from 1985. Risk-of-bias was assessed using the Cochrane Collaboration checklist for RCTs. Meta-analysis of risk ratios (RRs)used the Mantel-Haenszel method. The quality of the evidence was assessed using GRADE. RESULTS: Two RCTs (n=140) were included. 'Incomplete abortion requiring surgical intervention' was clinically significantly higher with medical than surgical methods (RR=4.58, 95% CI 1.07 to 19.64). 'Abortion completed by the intended method' was statistically, but not clinically, significantly lower after medical than surgical methods, but was marked by high between-study heterogeneity (RR=0.88, 95% CI 0.79 to 0.98). To the extent that 'haemorrhage requiring transfusion/≥500 mL blood loss', 'uterine injury', 'cervical injury requiring repair' and 'infection reported within 1 month of abortion' were reported, they did not differ significantly between methods. Depending on measurement method, 'patient satisfaction/acceptability' was either clinically significantly higher or comparable after surgical than medical methods. The quality of this evidence was limited by low event rates and attrition bias. CONCLUSION: Based on this evidence and consensus, women should be offered the choice of medical or surgical methods of abortion between 13+0 and 23+6 weeks' gestation, unless not clinically appropriate.

Simultaneous compared to interval administration of mifepristone and misoprostol for medical abortion up to 10+0 weeks' gestation: a systematic review with meta-analyses.

BACKGROUND: Medical abortion with mifepristone and misoprostol usually involves an interval of 36-48 hours between administering these drugs; however, it is possible that the clinical efficacy at early gestations may be maintained when the drugs are taken simultaneously. The objective of this systematic review was to determine the safety and effectiveness of simultaneous compared with interval administration of mifepristone and misoprostol for abortion up to 10+0 weeks' gestation. METHODS: We searched Embase Classic, Embase; Ovid MEDLINE(R) including Daily, and Epub Ahead-of-Print, In-Process & Other Non-Indexed Citations; and Cochrane Library on 11 December 2019. We included randomised controlled trials (RCTs), published in English from 1985, comparing simultaneous to interval administration of mifepristone and misoprostol for early abortion. Risk of bias was assessed using the Cochrane Collaboration checklist for RCTs. Meta-analysis of risk ratios (RRs) using the Mantel-Haenszel method were performed. The quality of the evidence was assessed using GRADE. RESULTS: Meta-analyses of three RCTs (n=1280) showed no differences in 'ongoing pregnancy' (RR 1.78, 95% CI 0.38 to 8.36), 'haemorrhage requiring transfusion or ≥500 mL blood loss' (RR 0.11, 95% CI 0.01 to 2.03) and 'incomplete abortion with the need for surgical intervention' (RR 1.30, 95% CI 0.76 to 2.25) between the interventions. Individual study results showed no difference in patient satisfaction, or 'need for repeat misoprostol', although 'time to onset of bleeding or cramping' was longer after simultaneous than interval administration. The quality of evidence was very low to moderate. CONCLUSION: The published data support the use of simultaneous mifepristone and misoprostol for medical abortion up to 9+0 weeks in women who prefer this method of administration.

Long-acting reversible contraception immediately after medical abortion: systematic review with meta-analyses.

BACKGROUND: Long-acting reversible contraceptives (LARCs) are safe, effective and convenient post-abortal methods. However, there is concern that some LARCs may reduce the effectiveness of abortifacient drugs or result in other adverse outcomes. OBJECTIVE AND RATIONALE: We undertook two systematic reviews to examine the early administration of LARCs in women undergoing medical abortion with mifepristone and misoprostol. (i) For women who are having a medical abortion and who plan to use a progestogen-only contraceptive implant or injectable, does administration of the contraception at the same time as mifepristone influence the efficacy of the abortion? (Implant/injectable review). (ii) For women who have had a medical abortion, how soon after expulsion of the products of conception is it safe to insert an intrauterine contraceptive device/system? (LNG-IUS/Cu-IUD review). SEARCH METHODS: On 19 November 2018, we searched Embase Classic, Embase; Ovid MEDLINE(R) including Daily and Epub Ahead-of-Print, In-Process and Other Non-Indexed Citations; the Cochrane Library; Cinahl Plus; and Web of Science Core Collection. Eligible studies were randomised controlled trials (RCTs), in English from 1985 (Implant/injectable review) or 2007 (LNG-IUS/Cu-IUD review) onwards, conducted in women undergoing medical abortion with mifepristone and misoprostol and studying either (i) simultaneous administration of mifepristone and a progestogen-only contraceptive implant or injectable compared to administration >24 h after mifepristone, or (ii) immediate insertion of intrauterine contraception after expulsion of the products of conception compared to early insertion (≤7 days) or to delayed insertion (>7 days) or early compared to delayed insertion. One author assessed the risk of bias in the studies using the Cochrane Collaboration checklist for RCTs. All the outcomes were analysed as risk ratios and meta-analysed in Review Manager 5.3 using the Mantel-Haenszel statistical method and a fixed-effect model. The overall quality of the evidence was assessed using GRADE. OUTCOMES: Two RCTs (n = 1027) showed lower 'subsequent unintended pregnancy' rates and higher 'patient satisfaction' rates, and no other differences, after simultaneous administration of mifepristone and the implant compared to delayed administration. One RCT (n = 461) showed higher 'patient satisfaction' rates after simultaneous administration than after delayed administration of mifepristone and the injectable, but no other differences between these interventions. Three RCTs (n = 536) found no differences other than higher copper IUC uptake after early compared to delayed insertion at ≤9 weeks of gestation and higher rates of IUC expulsion, continuation and uptake after immediate compared to delayed insertion at 9+1-12+0 weeks of gestation and higher IUC continuation rates after immediate compared to delayed insertion at 12+1-20+0 weeks of gestation. The quality of this evidence ranged from very low to high and was mainly compromised by low event rates, high attrition and no blinding. WIDER IMPLICATIONS: The contraceptive implant or injectable should be offered on the day of taking mifepristone. Intrauterine methods of contraception should be offered as soon as possible after expulsion of the pregnancy.

Anti-D prophylaxis for rhesus D (RhD)-negative women having an abortion of a pregnancy up to 13+6 weeks' gestation: a systematic review and new NICE consensus guidelines.

BACKGROUND: In order to develop the 2019 National Institute for Health and Care Excellence (NICE) national guideline on abortion care for the National Health Service1 we undertook a systematic review comparing anti-D prophylaxis to no prophylaxis in rhesus D (RhD)-negative women undergoing medical or surgical abortion of pregnancy at ≤13+6 weeks' gestation METHODS: We searched Embase, Medline and the Cochrane Library on 19 October 2018. We also consulted experts and checked reference lists for any missed trials. Eligible studies were randomised controlled trials and non-randomised comparative studies, published in English from 1985 onwards, comparing anti-D prophylaxis to no anti-D prophylaxis in RhD-negative women undergoing medical or surgical abortion at ≤13+6 weeks' gestation, and reporting subsequent anti-D isoimmunisation/sensitisation or subsequent affected pregnancy. These outcomes were to be analysed as risk ratios in Review Manager 5.3 using the Mantel-Haenszel statistical method and a fixed or random effect model. The overall quality of the evidence was planned to be assessed using GRADE. RESULTS: The search identified 426 potentially relevant studies of which none met the inclusion criteria. Recommendations for practice were therefore based on the clinical expertise of the guideline committee. CONCLUSIONS: (1) Offer anti-D prophylaxis to women who are Rhesus D negative who are having an abortion after 10+0 weeks' gestation. (2) Do not offer anti-D prophylaxis to women who are having a medical abortion up to and including 10+0 weeks' gestation. (3) Consider anti-D prophylaxis for women who are rhesus D negative and are having a surgical abortion up to and including 10+0 weeks' gestation.

Follow-up strategies to confirm the success of medical abortion of pregnancies up to 10 weeks' gestation: a systematic review with meta-analyses.

OBJECTIVE: To compare the effectiveness, safety, and acceptability of in-clinic and remote/self-assessment, as well as different remote/self-assessments, for confirming the success of medical abortion at ≤10+0 weeks' gestation. DATA SOURCES: Ovid Embase Classic and Embase; Ovid MEDLINE(R) and Epub Ahead-of-Print, In-Process & Other Non-Indexed Citations and Daily; and the Cochrane Library. We also consulted experts in this field for any ongoing or missed trials. STUDY ELIGIBILITY CRITERIA: Randomized controlled trials published in English from 2000 onward, comparing in-clinic assessment with ultrasound to remote or self-assessment or comparing different remote or self-assessment strategies to confirm the success of medical abortion of pregnancies up to and including 10+0 weeks gestation, reporting any of the following outcomes: "missed ongoing pregnancy," "correct implementation of the follow-up strategy," patient satisfaction/preference, "adherence to follow-up strategy," "unscheduled visits/telephone calls to the abortion service," and surgical intervention. STUDY APPRAISAL AND SYNTHESIS METHODS: One author assessed the risk of bias in the studies using the Cochrane Collaboration checklist for randomized controlled trials. All outcomes were analyzed as risk ratios and meta-analysed in Review Manager 5.3 using the Mantel-Haenszel statistical method and a fixed effect model. The overall quality of the evidence was assessed using GRADE. RESULTS: Four randomized controlled trials (n = 5761) compared in-clinic to remote self-assessment and found no clinically significant differences apart from higher preference rates for remote follow-up, especially in the remote follow-up groups. The quality of this evidence was compromised by attrition, no blinding, inconsistency, indirectness, and low event rates. Two randomized controlled trials (n = 1125) compared different remote assessment strategies (using urine pregnancy tests) and also found no clinically significant differences apart from a clinically significantly lower rate of unscheduled visits to the abortion service in the remote follow-up group using a multilevel urine pregnancy test compared to remote follow-up using a high-sensitivity urine pregnancy test. The quality of this evidence was compromised by small event rates, lack of blinding, indirectness and high attrition rates. CONCLUSION: The published data support offering women who have had a medical abortion up to and including 10+0 weeks' gestation the choice of self-assessment, remote assessment, or clinic follow-up.

Initiation of abortion before there is definitive ultrasound evidence of intrauterine pregnancy: A systematic review with meta-analyses.

INTRODUCTION: Women are increasingly presenting for abortion at very early gestation. However, providers may be reluctant to conduct abortion at this stage as they may be concerned that they cannot exclude an ectopic pregnancy or that they may terminate a non-viable pregnancy, or may be concerned that both medical and surgical methods may be less effective at this stage of gestation. This provider concern may result in delays in the abortion as additional investigations may be required until an intrauterine pregnancy can be confirmed. Additional unnecessary visits may be distressing for women and waste health service resources. The objective of this systematic review was to determine whether it is safe and effective to initiate abortion before there is ultrasound evidence of an intrauterine pregnancy. MATERIAL AND METHODS: We searched Embase Classic, Embase; Ovid MEDLINE® Epub Ahead-of-Print, In-Process & Other Non-Indexed Citations, Ovid MEDLINE® Daily, Ovid MEDLINE®; and Cochrane Library on 25 October 2019. Eligible studies were randomized and non-randomized comparative studies, published in English from 1985, comparing initiation of abortion before there is definitive evidence of an intrauterine pregnancy with initiation afterwards. We assessed risk-of-bias using the Newcastle-Ottowa scale. All outcomes were analyzed as risk ratios (RR) and meta-analyzed using the Mantel-Haenszel method. The quality of the evidence was assessed using GRADE. RESULTS: Two non-randomized studies (n = 3785) showed no differences in "missed ectopic pregnancy" (RR = 0.26, 95% CI 0.03-2.12), "ongoing pregnancy" (RR = 1.06, 95% CI 0.34-3.34), or "complete abortion without surgical intervention" (RR = 1, 95% CI 0.98-1.02) between initiation of medical abortion before or after ultrasound evidence of an intrauterine pregnancy. A third non-randomized study (n = 1530) showed no differences between initiation of surgical abortion before or after ultrasound evidence of an intrauterine pregnancy in "missed ectopic pregnancy" (no events), "ongoing pregnancy" (RR = 0.56, 95% CI 0.03-11.59) or "complete abortion without repeat surgical intervention" (RR = 1, 95% CI 0.99-1.01). The quality of evidence was very low. CONCLUSIONS: Initiation of abortion before there is definitive ultrasound evidence of an intrauterine pregnancy in women without signs or symptoms of an ectopic pregnancy should be considered.

Diagnosis and management of pancreatic cancer in adults: A summary of guidelines from the UK National Institute for Health and Care Excellence.

To enable standardisation of care of pancreatic cancer patients and facilitate improvement in outcome, the United Kingdom's National Institute for Health and Care Excellence (NICE) developed a clinical guideline for the diagnosis and management of pancreatic cancer in adults. Systematic literature searches, systematic review and meta-analyses were undertaken. Recommendations were drafted on the basis of the group's interpretation of the best available evidence of clinical and cost effectiveness. There was patient involvement and public consultation. Recommendations were made on: diagnosis; staging; monitoring of inherited high risk; psychological support; pain; nutrition management; and the specific management of people with resectable-, borderline-resectable- and unresectable-pancreatic cancer. The guideline committee also made recommendations for future research into neoadjuvant therapy, cachexia interventions, minimally invasive pancreatectomy, pain management and psychological support needs. These NICE guidelines aim to promote best current practice and support and stimulate research and innovation in pancreatic cancer.

Axillary treatment for operable primary breast cancer.

BACKGROUND: Axillary surgery is an established part of the management of primary breast cancer. It provides staging information to guide adjuvant therapy and potentially local control of axillary disease. Several alternative approaches to axillary surgery are available, most of which aim to spare a proportion of women the morbidity of complete axillary dissection. OBJECTIVES: To assess the benefits and harms of alternative approaches to axillary surgery (including omitting such surgery altogether) in terms of overall survival; local, regional and distant recurrences; and adverse events. SEARCH METHODS: We searched the Cochrane Breast Cancer Group Specialised Register, MEDLINE, Pre-MEDLINE, Embase, CENTRAL, the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov on 12 March 2015 without language restrictions. We also contacted study authors and checked reference lists. SELECTION CRITERIA: Randomised controlled trials (RCTs) including women with clinically defined operable primary breast cancer conducted to compare axillary lymph node dissection (ALND) with no axillary surgery, axillary sampling or sentinel lymph node biopsy (SLNB); RCTs comparing axillary sampling with SLNB or no axillary surgery; RCTs comparing SLNB with no axillary surgery; and RCTs comparing ALND with or without radiotherapy (RT) versus RT alone. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed each potentially relevant trial for inclusion. We independently extracted outcome data, risk of bias information and study characteristics from all included trials. We pooled data according to trial interventions, and we used hazard ratios (HRs) for time-to-event outcomes and odds ratios (OR) for binary outcomes. MAIN RESULTS: We included 26 RCTs in this review. Studies were at low or unclear risk of selection bias. Blinding was not done, but this was only considered a source of bias for outcomes with potential for subjectivity in measurements. We found no RCTs of axillary sampling versus SLNB, axillary sampling versus no axillary surgery or SLNB versus no axillary surgery. No axillary surgery versus ALND Ten trials involving 3849 participants compared no axillary surgery versus ALND. Moderate quality evidence showed no important differences between overall survival of women in the two groups (HR 1.06, 95% confidence interval (CI) 0.96 to 1.17; 3849 participants; 10 studies) although no axillary surgery increased the risk of locoregional recurrence (HR ranging from 1.10 to 3.06; 20,863 person-years of follow-up; four studies). It was uncertain whether no surgery increased the risk of distant metastasis compared with ALND (HR 1.06, 95% CI 0.87 to 1.30; 946 participants; two studies). Low-quality evidence indicated no axillary surgery decreased the risk of lymphoedema compared with ALND (OR 0.31, 95% CI 0.23 to 0.43; 1714 participants; four studies). Axillary sampling versus ALND Six trials involving 1559 participants compared axillary sampling versus ALND. Low-quality evidence indicated similar effectiveness of axillary sampling compared with ALND in terms of overall survival (HR 0.94, 95% CI 0.73 to 1.21; 967 participants; three studies) but it was unclear whether axillary sampling led to increased risk of local recurrence compared with ALND (HR 1.41, 95% CI 0.94 to 2.12; 1404 participants; three studies). The relative effectiveness of axillary sampling and ALND for locoregional recurrence (HR 0.74, 95% CI 0.46 to 1.20; 406 participants; one study) and distant metastasis was uncertain (HR 1.05, 95% CI 0.74 to 1.49; 406 participants; one study). Lymphoedema was less likely after axillary sampling than after ALND (OR 0.32, 95% CI 0.13 to 0.81; 80 participants; one study). SLNB versus ALND Seven trials involving 9426 participants compared SLNB with ALND. Moderate-quality evidence showed similar overall survival following SLNB compared with ALND (HR 1.05, 95% CI 0.89 to 1.25; 6352 participants; three studies; moderate-quality evidence). Differences in local recurrence (HR 0.94, 95% CI 0.24 to 3.77; 516 participants; one study), locoregional recurrence (HR 0.96, 95% CI 0.74 to 1.24; 5611 participants; one study) and distant metastasis (HR 0.80, 95% CI 0.42 to 1.53; 516 participants; one study) were uncertain. However, studies showed little absolute difference in the aforementioned outcomes. Lymphoedema was less likely after SLNB than ALND (OR ranged from 0.04 to 0.60; three studies; 1965 participants; low-quality evidence). Three studies including 1755 participants reported quality of life: Investigators in two studies found quality of life better after SLNB than ALND, and in the other study observed no difference. RT versus ALND Four trials involving 2585 participants compared RT alone with ALND (with or without RT). High-quality evidence indicated that overall survival was reduced among women treated with radiotherapy alone compared with those treated with ALND (HR 1.10, 95% CI 1.00 to 1.21; 2469 participants; four studies), and local recurrence was less likely in women treated with radiotherapy than in those treated with ALND (HR 0.80, 95% CI 0.64 to 0.99; 22,256 person-years of follow-up; four studies). Risk of distant metastasis was similar for radiotherapy alone as for ALND (HR 1.07, 95% CI 0.93 to 1.25; 1313 participants; one study), and whether lymphoedema was less likely after RT alone than ALND remained uncertain (OR 0.47, 95% CI 0.16 to 1.44; 200 participants; one study). Less surgery versus ALND When combining results from all trials, treatment involving less surgery was associated with reduced overall survival compared with ALND (HR 1.08, 95% CI 1.01 to 1.17; 6478 participants; 18 studies). Whether local recurrence was reduced with less axillary surgery when compared with ALND was uncertain (HR 0.90, 95% CI 0.75 to 1.09; 24,176 participant-years of follow up; eight studies). Locoregional recurrence was more likely with less surgery than with ALND (HR 1.53, 95% CI 1.31 to 1.78; 26,880 participant-years of follow-up; seven studies). Whether risk of distant metastasis was increased after less axillary surgery compared with ALND was uncertain (HR 1.07, 95% CI 0.95 to 1.20; 2665 participants; five studies). Lymphoedema was less likely after less axillary surgery than with ALND (OR 0.37, 95% CI 0.29 to 0.46; 3964 participants; nine studies).No studies reported on disease control in the axilla. AUTHORS' CONCLUSIONS: This review confirms the benefit of SLNB and axillary sampling as alternatives to ALND for axillary staging, supporting the view that ALND of the clinically and radiologically uninvolved axilla is no longer acceptable practice in people with breast cancer.

Axillary surgery in women with sentinel node-positive operable breast cancer: a systematic review with meta-analyses.

Traditionally, women with node-positive operable breast cancer have received complete axillary lymph node dissection (ALND), which is associated with significant morbidity, but recently less invasive alternatives have been explored. We conducted a systematic review of randomised controlled trials assessing alternative approaches to axillary surgery in patients with pathologically-confirmed sentinel node-positive operable breast cancer. We searched on 16/3/15 the Specialized Register of the Cochrane Breast Cancer group; CENTRAL; MEDLINE; PreMEDLINE; EMBASE; WHO International Clinical Trials Registry Portal; ClinicalTrials.gov; conference proceedings from ASCO and the San Antonio Breast Cancer meetings; checked reference lists and contacted authors to identify relevant studies. Double, independent study sifting, extraction, appraisal and summarising were undertaken using standard Cochrane Collaboration methodology. We included three studies (2020 patients) comparing ALND with sentinel lymph node dissection (SLND) to SLND alone, and two studies (1899 patients) comparing ALND to axillary radiotherapy (aRT). No differences in survival or recurrence were observed between ALND and SLND or aRT, but morbidity may have been increased in ALND, and all the results were subject to different biases, such as recruitment bias, performance bias, and outcome-reporting bias. Whilst it is encouraging that there appears to be no adverse effect on recurrence or survival, it will be appropriate to confirm these findings and provide additional data confirming quality of life effects and long term outcomes.

PET-CT for assessing mediastinal lymph node involvement in patients with suspected resectable non-small cell lung cancer.

BACKGROUND: A major determinant of treatment offered to patients with non-small cell lung cancer (NSCLC) is their intrathoracic (mediastinal) nodal status. If the disease has not spread to the ipsilateral mediastinal nodes, subcarinal (N2) nodes, or both, and the patient is otherwise considered fit for surgery, resection is often the treatment of choice. Planning the optimal treatment is therefore critically dependent on accurate staging of the disease. PET-CT (positron emission tomography-computed tomography) is a non-invasive staging method of the mediastinum, which is increasingly available and used by lung cancer multidisciplinary teams. Although the non-invasive nature of PET-CT constitutes one of its major advantages, PET-CT may be suboptimal in detecting malignancy in normal-sized lymph nodes and in ruling out malignancy in patients with coexisting inflammatory or infectious diseases. OBJECTIVES: To determine the diagnostic accuracy of integrated PET-CT for mediastinal staging of patients with suspected or confirmed NSCLC that is potentially suitable for treatment with curative intent. SEARCH METHODS: We searched the following databases up to 30 April 2013: The Cochrane Library, MEDLINE via OvidSP (from 1946), Embase via OvidSP (from 1974), PreMEDLINE via OvidSP, OpenGrey, ProQuest Dissertations & Theses, and the trials register www.clinicaltrials.gov. There were no language or publication status restrictions on the search. We also contacted researchers in the field, checked reference lists, and conducted citation searches (with an end-date of 9 July 2013) of relevant studies. SELECTION CRITERIA: Prospective or retrospective cross-sectional studies that assessed the diagnostic accuracy of integrated PET-CT for diagnosing N2 disease in patients with suspected resectable NSCLC. The studies must have used pathology as the reference standard and reported participants as the unit of analysis. DATA COLLECTION AND ANALYSIS: Two authors independently extracted data pertaining to the study characteristics and the number of true and false positives and true and false negatives for the index test, and they independently assessed the quality of the included studies using QUADAS-2. We calculated sensitivity and specificity with 95% confidence intervals (CI) for each study and performed two main analyses based on the criteria for test positivity employed: Activity > background or SUVmax ≥ 2.5 (SUVmax = maximum standardised uptake value), where we fitted a summary receiver operating characteristic (ROC) curve using a hierarchical summary ROC (HSROC) model for each subset of studies. We identified the average operating point on the SROC curve and computed the average sensitivities and specificities. We checked for heterogeneity and examined the robustness of the meta-analyses through sensitivity analyses. MAIN RESULTS: We included 45 studies, and based on the criteria for PET-CT positivity, we categorised the included studies into three groups: Activity > background (18 studies, N = 2823, prevalence of N2 and N3 nodes = 679/2328), SUVmax ≥ 2.5 (12 studies, N = 1656, prevalence of N2 and N3 nodes = 465/1656), and Other/mixed (15 studies, N = 1616, prevalence of N2 to N3 nodes = 400/1616). None of the studies reported (any) adverse events. Under-reporting generally hampered the quality assessment of the studies, and in 30/45 studies, the applicability of the study populations was of high or unclear concern.The summary sensitivity and specificity estimates for the 'Activity > background PET-CT positivity criterion were 77.4% (95% CI 65.3 to 86.1) and 90.1% (95% CI 85.3 to 93.5), respectively, but the accuracy estimates of these studies in ROC space showed a wide prediction region. This indicated high between-study heterogeneity and a relatively large 95% confidence region around the summary value of sensitivity and specificity, denoting a lack of precision. Sensitivity analyses suggested that the overall estimate of sensitivity was especially susceptible to selection bias; reference standard bias; clear definition of test positivity; and to a lesser extent, index test bias and commercial funding bias, with lower combined estimates of sensitivity observed for all the low 'Risk of bias' studies compared with the full analysis.The summary sensitivity and specificity estimates for the SUVmax ≥ 2.5 PET-CT positivity criterion were 81.3% (95% CI 70.2 to 88.9) and 79.4% (95% CI 70 to 86.5), respectively.In this group, the accuracy estimates of these studies in ROC space also showed a very wide prediction region. This indicated very high between-study heterogeneity, and there was a relatively large 95% confidence region around the summary value of sensitivity and specificity, denoting a clear lack of precision. Sensitivity analyses suggested that both overall accuracy estimates were marginally sensitive to flow and timing bias and commercial funding bias, which both lead to slightly lower estimates of sensitivity and specificity.Heterogeneity analyses showed that the accuracy estimates were significantly influenced by country of study origin, percentage of participants with adenocarcinoma, (¹8F)-2-fluoro-deoxy-D-glucose (FDG) dose, type of PET-CT scanner, and study size, but not by study design, consecutive recruitment, attenuation correction, year of publication, or tuberculosis incidence rate per 100,000 population. AUTHORS' CONCLUSIONS: This review has shown that accuracy of PET-CT is insufficient to allow management based on PET-CT alone. The findings therefore support National Institute for Health and Care (formally 'clinical') Excellence (NICE) guidance on this topic, where PET-CT is used to guide clinicians in the next step: either a biopsy or where negative and nodes are small, directly to surgery. The apparent difference between the two main makes of PET-CT scanner is important and may influence the treatment decision in some circumstances. The differences in PET-CT accuracy estimates between scanner makes, NSCLC subtypes, FDG dose, and country of study origin, along with the general variability of results, suggest that all large centres should actively monitor their accuracy. This is so that they can make reliable decisions based on their own results and identify the populations in which PET-CT is of most use or potentially little value.

The effect of preoperative smoking cessation or preoperative pulmonary rehabilitation on outcomes after lung cancer surgery: a systematic review.

The preferred treatment for lung cancer is surgery if the disease is considered resectable and the patient is considered surgically fit. Preoperative smoking cessation and/or preoperative pulmonary rehabilitation might improve postoperative outcomes after lung cancer surgery. The objectives of this systematic review were to determine the effectiveness of (1) preoperative smoking cessation and (2) preoperative pulmonary rehabilitation on peri- and postoperative outcomes in patients who undergo resection for lung cancer. We searched MEDLINE, PreMedline, Embase, Cochrane Library, Cinahl, BNI, Psychinfo, Amed, Web of Science (SCI and SSCI), and Biomed Central. Original studies published in English investigating the effect of preoperative smoking cessation or preoperative pulmonary rehabilitation on operative and longer-term outcomes in ≥ 50 patients who received surgery with curative intent for lung cancer were included. Of the 7 included studies that examined the effect of preoperative smoking cessation (n = 6) and preoperative pulmonary rehabilitation (n = 1) on outcomes after lung cancer surgery, none were randomized controlled trials and only 1 was prospective. The studies used different smoking classifications, the baseline characteristics differed between the study groups in some of the studies, and most had small sample sizes. No formal data synthesis was therefore possible. The included studies were marked by methodological limitations. On the basis of the reported bodies of evidence, it is not possible to make any firm conclusions about the effect of preoperative smoking cessation or of preoperative pulmonary rehabilitation on operative outcomes in patients undergoing surgery for lung cancer.

What is the most effective follow-up model for lung cancer patients? A systematic review.

INTRODUCTION: In the U.K. more than 40,000 people are diagnosed with lung cancer every year and an estimated 65,000 people are living with lung cancer. The most effective follow-up strategy for these patients is undetermined. This article reports a systematic review of studies comparing different follow-up strategies for patients with lung cancer. METHODS: We searched Medline, Premedline, Embase, Cochrane Library, Cinahl, BNI, Psychinfo, Amed, Web of Science (SCI & SSCI), and Biomed Central and included any original study published in English comparing one type of follow-up strategy to another in patients with lung cancer who had received treatment with curative or palliative intent and/or best supportive care. Studies were included if there were 50 patients or more per follow-up group. RESULTS: Of the four included studies that compared different follow-up strategies in patients with lung cancer, one was a randomized controlled trial and three were retrospective. The studies all examined different follow-up strategies and tended to be marked by various limitations. No formal data synthesis was therefore possible. However, in one article there was some evidence that regular review was associated with less emergency-department crisis attendances than symptom-generated review. CONCLUSIONS: The included studies were marked by a number of methodological compromises. On the basis of the reported body of evidence it is therefore not possible to make any firm conclusions about the most effective follow-up strategy but the review has identified a need for urgent research into all aspects of follow-up.