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  1. Article ; Online: Does weight management research for adults with severe obesity represent them? Analysis of systematic review data.

    Robertson, Clare / Aceves-Martins, Magaly / Cruickshank, Moira / Imamura, Mari / Avenell, Alison

    BMJ open

    2022  Volume 12, Issue 5, Page(s) e054459

    Abstract: Objective: Our objective was to determine the extent to which current evidence from long-term randomised controlled trials (RCTs) of weight management is generalisable and applicable to underserved adult groups with obesity (body mass index (BMI) ≥35 kg/ ...

    Abstract Objective: Our objective was to determine the extent to which current evidence from long-term randomised controlled trials (RCTs) of weight management is generalisable and applicable to underserved adult groups with obesity (body mass index (BMI) ≥35 kg/m
    Methods: Descriptive analysis of 131 RCTs, published after 1990-May 2017 with ≥1 year of follow-up, included in a systematic review of long-term weight management interventions for adults with BMI ≥35 kg/m
    Results: Few (6.1%) trials reported adapting recruitment to appeal to underserved groups. 10.0% reported culturally adapting their trial materials. Only 6.1% of trials gave any justification for their exclusion criteria, yet over half excluded participation for age or mental health reasons. Just over half (58%) of the trials reported participants' race or ethnicity, and one-fifth reported socioeconomic status. Where outcomes were reported for underserved groups, the most common analysis was by sex (47.3%), followed by race or ethnicity (16.8%). 3.1% of trials reported outcomes according to socioeconomic status.
    Discussion: Although we were limited by poor trial reporting, our results indicate inadequate representation of people most at risk of obesity. Guidance for considering underserved groups may improve the appropriateness of research and inform greater engagement with health and social care services.
    Funding: National Institute for Health Research Health Technology Assessment Programme (project number: 15/09/04).
    Prospero registration number: CRD42016040190.
    MeSH term(s) Adult ; Body Mass Index ; Educational Status ; Ethnicity ; Humans ; Obesity, Morbid ; Social Class
    Language English
    Publishing date 2022-05-31
    Publishing country England
    Document type Journal Article ; Systematic Review ; Research Support, Non-U.S. Gov't
    ZDB-ID 2599832-8
    ISSN 2044-6055 ; 2044-6055
    ISSN (online) 2044-6055
    ISSN 2044-6055
    DOI 10.1136/bmjopen-2021-054459
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  2. Article ; Online: Successful laparoscopic extirpation of a vasoactive intestinal polypeptide-secreting neuroblastoma originating from the right adrenal gland: A report of an infantile case.

    Sugita, Koshiro / Kaji, Tatsuru / Muto, Mitsuru / Nishikawa, Takuro / Okamoto, Yasuhiro / Imamura, Mari / Ieiri, Satoshi

    Asian journal of endoscopic surgery

    2021  Volume 14, Issue 3, Page(s) 611–614

    Abstract: We herein report a 10-month-old female infant with a 4-month history of diarrhea with electrolyte abnormalities and growth impairment. A 4-cm right adrenal tumor was detected by computed tomography. No metastasis or accumulation on ... ...

    Abstract We herein report a 10-month-old female infant with a 4-month history of diarrhea with electrolyte abnormalities and growth impairment. A 4-cm right adrenal tumor was detected by computed tomography. No metastasis or accumulation on I
    MeSH term(s) Adrenal Gland Neoplasms/metabolism ; Adrenal Gland Neoplasms/surgery ; Adrenal Glands/metabolism ; Adrenal Glands/surgery ; Female ; Humans ; Infant ; Laparoscopy ; Neuroblastoma/metabolism ; Neuroblastoma/surgery ; Vasoactive Intestinal Peptide/metabolism
    Chemical Substances Vasoactive Intestinal Peptide (37221-79-7)
    Language English
    Publishing date 2021-01-03
    Publishing country Japan
    Document type Case Reports
    ZDB-ID 2503256-2
    ISSN 1758-5910 ; 1758-5902
    ISSN (online) 1758-5910
    ISSN 1758-5902
    DOI 10.1111/ases.12916
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  3. Article ; Online: Management of the first stage of convulsive status epilepticus in adults: a systematic review of current randomised evidence.

    Cruickshank, Moira / Imamura, Mari / Counsell, Carl / Aucott, Lorna / Manson, Paul / Booth, Corinne / Scotland, Graham / Brazzelli, Miriam

    Journal of neurology

    2022  Volume 269, Issue 7, Page(s) 3420–3429

    Abstract: Background: Convulsive status epilepticus is the most severe form of epilepsy and requires urgent treatment. We synthesised the current evidence on first-line treatments for controlling seizures in adults with convulsive status epilepticus before, or at, ...

    Abstract Background: Convulsive status epilepticus is the most severe form of epilepsy and requires urgent treatment. We synthesised the current evidence on first-line treatments for controlling seizures in adults with convulsive status epilepticus before, or at, arrival at hospital.
    Methods: We conducted a systematic review of randomised controlled trials (RCTs) assessing antiepileptic drugs offered to adults as first-line treatments. Major electronic databases were searched.
    Results: Four RCTs (1234 adults) were included. None were conducted in the UK and none assessed the use of buccal or intranasal midazolam. Both intravenous lorazepam and intravenous diazepam administered by paramedics were more effective than placebo and, notably, intramuscular midazolam was non-inferior to intravenous lorazepam. Overall, median time to seizure cessation from drug administration varied from 2 to 15 min. Rates of respiratory depression among participants receiving active treatments ranged from 6.4 to 10.6%. Mortality ranged from 2 to 7.6% in active treatment groups and 6.2 to 15.5% in control groups.
    Conclusions: Intravenous and intramuscular benzodiazepines are safe and effective in this clinical context. Further research is needed to establish the most clinically and cost-effective first-line treatment and preferable mode of administration. Head-to-head trials comparing buccal versus intranasal midazolam versus rectal diazepam would provide useful information to inform the management of the first stage of convulsive status epilepticus in adults, especially when intravenous or intramuscular access is not feasible. Approaches to improve adherence to clinical guidelines on the use of currently available benzodiazepines for the first-line treatment of convulsive status epilepticus should also be considered.
    MeSH term(s) Adult ; Anticonvulsants/therapeutic use ; Diazepam/therapeutic use ; Humans ; Lorazepam/therapeutic use ; Midazolam/therapeutic use ; Seizures/drug therapy ; Status Epilepticus/drug therapy
    Chemical Substances Anticonvulsants ; Lorazepam (O26FZP769L) ; Diazepam (Q3JTX2Q7TU) ; Midazolam (R60L0SM5BC)
    Language English
    Publishing date 2022-01-30
    Publishing country Germany
    Document type Journal Article ; Review ; Systematic Review
    ZDB-ID 187050-6
    ISSN 1432-1459 ; 0340-5354 ; 0012-1037 ; 0939-1517 ; 1619-800X
    ISSN (online) 1432-1459
    ISSN 0340-5354 ; 0012-1037 ; 0939-1517 ; 1619-800X
    DOI 10.1007/s00415-022-10979-2
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  4. Article ; Online: Open versus laparoscopic repair of inguinal hernia: an overview of systematic reviews of randomised controlled trials.

    Haladu, Nafi'u / Alabi, Adegoke / Brazzelli, Miriam / Imamura, Mari / Ahmed, Irfan / Ramsay, George / Scott, Neil W

    Surgical endoscopy

    2022  Volume 36, Issue 7, Page(s) 4685–4700

    Abstract: Background: Inguinal hernia has a lifetime incidence of 27% in men and 3% in women. Surgery is the recommended treatment, but there is no consensus on the best method. Open repair is most popular, but there are concerns about the risk of chronic groin ... ...

    Abstract Background: Inguinal hernia has a lifetime incidence of 27% in men and 3% in women. Surgery is the recommended treatment, but there is no consensus on the best method. Open repair is most popular, but there are concerns about the risk of chronic groin pain. Laparoscopic repair is increasingly accepted due to the lower risk of chronic pain, although its recurrence rate is still unclear. The aim of this overview is to compare the risk of recurrence and chronic groin pain in laparoscopic versus open repair for inguinal hernia.
    Methods: We searched Ovid MEDLINE, EMBASE and the Cochrane Database of Systematic Reviews for systematic reviews and meta-analyses. Only reviews of randomised controlled trials (RCTs) in adults published in English were included. Conference proceedings and editorials were excluded. The quality of the systematic reviews was assessed using the AMSTAR 2 checklist. Two outcomes were considered: hernia recurrence and chronic pain.
    Results: Twenty-one systematic reviews and meta-analyses were included. Laparoscopic repair was associated with a lower risk of chronic groin pain compared with open repair. In the four systematic reviews assessing any laparoscopic versus any open repairs, laparoscopic repair was associated with a statistically significant (range: 26-46%) reduction in the odds or risk of chronic pain. Most reviews showed no difference in recurrence rates between laparoscopic and open repairs, regardless of the types of repair considered or the types of hernia that were studied, but most reviews had wide confidence intervals and we cannot rule out clinically important effects favouring either type of repair.
    Conclusion: Meta-analyses suggest that laparoscopic repairs have a lower incidence of chronic groin pain than open repair, but there is no evidence of differences in recurrence rates between laparoscopic and open repairs.
    MeSH term(s) Adult ; Chronic Pain/etiology ; Chronic Pain/surgery ; Hernia, Inguinal/complications ; Hernia, Inguinal/surgery ; Herniorrhaphy/methods ; Humans ; Laparoscopy/methods ; Male ; Pain, Postoperative/etiology ; Pain, Postoperative/surgery ; Randomized Controlled Trials as Topic ; Recurrence ; Surgical Mesh/adverse effects ; Systematic Reviews as Topic
    Language English
    Publishing date 2022-03-14
    Publishing country Germany
    Document type Journal Article ; Review
    ZDB-ID 639039-0
    ISSN 1432-2218 ; 0930-2794
    ISSN (online) 1432-2218
    ISSN 0930-2794
    DOI 10.1007/s00464-022-09161-6
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  5. Article ; Online: Pre-hospital and emergency department treatment of convulsive status epilepticus in adults: an evidence synthesis.

    Cruickshank, Moira / Imamura, Mari / Booth, Corinne / Aucott, Lorna / Counsell, Carl / Manson, Paul / Scotland, Graham / Brazzelli, Miriam

    Health technology assessment (Winchester, England)

    2022  Volume 26, Issue 20, Page(s) 1–76

    Abstract: Background: Convulsive status epilepticus is defined as ≥ 5 minutes of either continuous seizure activity or repetitive seizures without regaining consciousness. It is regarded as an emergency condition that requires prompt treatment to avoid ... ...

    Abstract Background: Convulsive status epilepticus is defined as ≥ 5 minutes of either continuous seizure activity or repetitive seizures without regaining consciousness. It is regarded as an emergency condition that requires prompt treatment to avoid hospitalisation and to reduce morbidity and mortality. Rapid pre-hospital first-line treatment of convulsive status epilepticus is currently benzodiazepines, administered either by trained caregivers in the community (e.g. buccal midazolam, rectal diazepam) or by trained health professionals via intramuscular or intravenous routes (e.g. midazolam, lorazepam). There is a lack of clarity about the optimal treatment for convulsive status epilepticus in the pre-hospital setting.
    Objectives: To assess the current evidence on the clinical effectiveness and cost-effectiveness of treatments for adults with convulsive status epilepticus in the pre-hospital setting.
    Data sources: We searched major electronic databases, including MEDLINE, EMBASE, PsycInfo
    Review methods: Systematic review of randomised controlled trials assessing adults with convulsive status epilepticus who received treatment before or on arrival at the emergency department. Eligible treatments were any antiepileptic drugs offered as first-line treatments, regardless of their route of administration. Primary outcomes were seizure cessation, seizure recurrence and adverse events. Two reviewers independently screened all citations identified by the search strategy, retrieved full-text articles, extracted data and assessed the risk of bias of the included trials. Results were described narratively.
    Results: Four trials (1345 randomised participants, of whom 1234 were adults) assessed the intravenous or intramuscular use of benzodiazepines or other antiepileptic drugs for the pre-hospital treatment of convulsive status epilepticus in adults. Three trials at a low risk of bias showed that benzodiazepines were effective in stopping seizures. In particular, intramuscular midazolam was non-inferior to intravenous lorazepam. The addition of levetiracetam to clonazepam did not show clear advantages over clonazepam alone. One trial at a high risk of bias showed that phenobarbital plus optional phenytoin was more effective in terminating seizures than diazepam plus phenytoin. The median time to seizure cessation from drug administration varied from 1.6 minutes to 15 minutes. The proportion of people with recurrence of seizures ranged from 10.4% to 19.1% in two trials reporting this outcome. Across trials, the rates of respiratory depression among participants receiving active treatments were generally low (from 6.4% to 10.6%). The mortality rate ranged from 2% to 7.6% in active treatment groups and from 6.2% to 15.5% in control groups. Only one study based on retrospective observational data met the criteria for economic evaluation; therefore, it was not possible to draw any robust conclusions on cost-effectiveness.
    Limitations: The limited number of identified trials and their differences in terms of treatment comparisons and outcomes hindered any meaningful pooling of data. None of the included trials was conducted in the UK and none assessed the use of buccal midazolam or rectal diazepam. The review of economic evaluations was hampered by lack of suitable data.
    Conclusions: Both intravenous lorazepam and intravenous diazepam administered by paramedics are more effective than a placebo in the treatments of adults with convulsive status epilepticus, and intramuscular midazolam is non-inferior to intravenous lorazepam. Large well-designed clinical trials are needed to establish which benzodiazepines are more effective and preferable in the pre-hospital setting.
    Study registration: This study is registered as PROSPERO CRD42020201953.
    Funding: This project was funded by the National Institute for Health Research (NIHR) Evidence Synthesis programme and will be published in full in
    MeSH term(s) Adult ; Anticonvulsants/therapeutic use ; Emergency Service, Hospital ; Hospitals ; Humans ; Retrospective Studies ; Status Epilepticus/drug therapy
    Chemical Substances Anticonvulsants
    Language English
    Publishing date 2022-03-23
    Publishing country England
    Document type Journal Article ; Systematic Review ; Research Support, Non-U.S. Gov't
    ZDB-ID 2006765-3
    ISSN 2046-4924 ; 1366-5278
    ISSN (online) 2046-4924
    ISSN 1366-5278
    DOI 10.3310/RSVK2062
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  6. Article ; Online: Celecoxib as a Potential Treatment for Intractable Lymphatic Malformation.

    Imamura, Mari / Okamoto, Yasuhiro / Nishikawa, Takuro / Yoneyama, Tomohide / Yamasaki, Yuichi / Kawamura, Junpei / Kawano, Yoshifumi

    Pediatrics

    2019  Volume 144, Issue 3

    Abstract: Lymphatic malformation (LM) is a congenital disorder resulting from an abnormal development of lymphatic vessels. LM may result in problems of cosmesis and functional impairment, including airway compression. An 11-year-old girl was referred to our ... ...

    Abstract Lymphatic malformation (LM) is a congenital disorder resulting from an abnormal development of lymphatic vessels. LM may result in problems of cosmesis and functional impairment, including airway compression. An 11-year-old girl was referred to our department with increasing dysphagia caused by a large left cervical LM with a long history of treatment. Because of the LM location, surgical resection was not an option, and various therapies, including use of picibanil, had proven ineffective. Celecoxib treatment (100 mg/day) was initiated for local pain management. Softening of the lesion was observed 2 weeks after treatment initiation, and the dose was increased to 200 mg/day with additional shrinking of the LM over the next 2 weeks. With parental consent, celecoxib was continued, with a 65% reduction in volume achieved at 6 months. The patient discontinued treatment at 12 months, and the LM volume increased. Control over the LM was achieved with resumption of celecoxib treatment. After 2 years of treatment, the LM persists, but the size of the malformation is significantly smaller. No adverse effects of celecoxib treatment were observed. The anti-cyclooxygenase-2 effect of celecoxib prevented lymphatic vessel growth through an inhibition of cyclooxygenase-2 activity in the conversion of prostaglandin to prostaglandin E2. In conclusion, celecoxib may be a promising therapeutic agent for LM management.
    MeSH term(s) Airway Obstruction/etiology ; Celecoxib/therapeutic use ; Child ; Cyclooxygenase 2 Inhibitors/therapeutic use ; Deglutition Disorders/etiology ; Female ; Humans ; Lymphatic Abnormalities/complications ; Lymphatic Abnormalities/diagnostic imaging ; Lymphatic Abnormalities/drug therapy ; Magnetic Resonance Imaging ; Medication Adherence ; Recurrence
    Chemical Substances Cyclooxygenase 2 Inhibitors ; Celecoxib (JCX84Q7J1L)
    Language English
    Publishing date 2019-08-28
    Publishing country United States
    Document type Case Reports ; Journal Article
    ZDB-ID 207677-9
    ISSN 1098-4275 ; 0031-4005
    ISSN (online) 1098-4275
    ISSN 0031-4005
    DOI 10.1542/peds.2019-0319
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    Zs.MO 357: Show issues

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  7. Article ; Online: Extended versus standard lymph node dissection for urothelial carcinoma of the bladder in patients undergoing radical cystectomy.

    Hwang, Eu Chang / Sathianathen, Niranjan J / Imamura, Mari / Kuntz, Gretchen M / Risk, Michael C / Dahm, Philipp

    The Cochrane database of systematic reviews

    2019  Volume 5, Page(s) CD013336

    Abstract: Background: In the treatment of urothelial carcinoma of the bladder, we are currently uncertain of the benefits and harms of standard pelvic lymph node dissection (PLND) compared to extended PLND.: Objectives: To assess the effects of extended versus ...

    Abstract Background: In the treatment of urothelial carcinoma of the bladder, we are currently uncertain of the benefits and harms of standard pelvic lymph node dissection (PLND) compared to extended PLND.
    Objectives: To assess the effects of extended versus standard PLND in patients undergoing cystectomy to treat muscle-invasive (cT2 and cT3) and treatment-refractory, non-muscle-invasive (cT1 with or without carcinoma in situ) urothelial carcinoma of the bladder.
    Search methods: We performed a comprehensive literature search using multiple databases (PubMed, Embase, Cochrane Controlled Trials, Web of Science, and LILACS), trial registries, and conference proceedings published up to April 29, 2019, with no restrictions on the language or status of publication.
    Selection criteria: We included randomized controlled trials in which participants underwent radical cystectomy (RC) for muscle-invasive or therapy-refractory non-muscle-invasive urothelial carcinoma of the bladder with either an extended PLND with a superior extent reaching as far cranially as the inferior mesenteric vein, or a standard PLND with a superior extent of the bifurcation of the internal and external iliac artery, with otherwise the same anatomical boundaries.
    Data collection and analysis: Two review authors independently assessed the included studies and extracted data from them for the primary outcomes: time to death from any cause, time to death from bladder cancer and Clavien-Dindo classification of surgical complications grade III-V, and the secondary outcomes: time to recurrence, Clavien-Dindo I-II complications and disease-specific quality of life.We performed statistical analyses using a random-effects model and rated the certainty of evidence according to the GRADE approach.
    Main results: The search identified one multicenter trial based in Germany that enrolled 401 participants with histologically confirmed T1 grade 3 or muscle-invasive urothelial carcinoma. The median age was 67 years (range: 59 to 74) and the majority of participants were male (78.3%). No participant received neoadjuvant chemotherapy; a small subset received adjuvant chemotherapy (14.5%).Primary outcomesOur results indicate that extended PLND may reduce the risk of death from any cause over time as compared to standard PLND, but the confidence interval includes the possibility of no effect (hazard ratio [HR]: 0.78, 95% confidence interval [CI]: 0.57 to 1.07, 401 participants, low-certainty evidence). After five years of follow-up, this may result in 83 fewer deaths (95% CI: 174 fewer to 24 more overall deaths) per 1000 participants: 420 deaths for extended PLND compared to 503 deaths per 1000 for standard PLND. We downgraded the certainty of evidence by two levels due to study limitations and imprecision.Our results indicate that extended PLND may reduce the risk of death from bladder cancer over time as compared to standard PLND but, again, the confidence interval includes the possibility of no effect (HR: 0.70, 95% CI: 0.45 to 1.07, participants = 401, low-certainty evidence). After five years of follow-up, this corresponds to 91 fewer deaths per 1000 participants (95% CI: 176 fewer to 19 more bladder cancer deaths): 264 deaths for extended PLND compared to 355 deaths per 1000 for standard PLND. We downgraded the certainty of evidence by two levels due to study limitations and imprecision.Based on follow-up of up to 30 days, we are uncertain whether extended PLND leads to more grade III-V complications as compared to standard PLND, because of study limitations and imprecision (risk ratio [RR]: 1.13, 95% CI: 0.84 to 1.52, participants = 401, very low-certainty evidence).Secondary outcomesWe are uncertain whether extended PLND reduces the risk of recurrence over time as compared to standard PLND, because of study limitations and imprecision (HR: 0.84, 95% CI: 0.58 to 1.22, participants = 401, very low-certainty evidence).Based on follow-up of up to 30 days, we are uncertain whether extended PLND leads to similar grade I-II complications as compared to standard PLND because of study limitations and imprecision (RR: 0.94, 95% CI: 0.74 to 1.19, participants = 401, very low-certainty evidence).We found no trials that reported on disease-specific quality of life.
    Authors' conclusions: Results from a single trial indicate that extended PLND in patients undergoing radical cystectomy for invasive urothelial carcinoma of the bladder may reduce death from any cause and death from bladder cancer over time; however, the results include the possibility of no effect. We are uncertain whether the risk of serious complications up to 30 days may be increased. We are also uncertain as to whether the risk of recurrence over time or the risk of minor complications up to 30 days changes. We were unable to conduct any of the preplanned subgroup analyses, in particular, analyses based on extended lymph node dissection templates, clinical tumor stage, and use of neoadjuvant chemotherapy that may be important effect modifiers. Important additional data is expected from a larger, ongoing trial that will also consider the role of neoadjuvant chemotherapy. Inclusion of this trial in the meta-analysis may help address the issue of imprecision which was a common reason for downgrading the certainty of the evidence.
    MeSH term(s) Aged ; Carcinoma, Transitional Cell/surgery ; Cystectomy/methods ; Female ; Humans ; Lymph Node Excision ; Male ; Middle Aged ; Postoperative Complications ; Randomized Controlled Trials as Topic ; Treatment Outcome ; Urinary Bladder Neoplasms/surgery
    Language English
    Publishing date 2019-05-14
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't ; Systematic Review
    ISSN 1469-493X
    ISSN (online) 1469-493X
    DOI 10.1002/14651858.CD013336
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  8. Article ; Online: Systematic review of obstetric care from a women-centered perspective in Nigeria since 2000.

    Hirose, Atsumi / Owolabi, Oluwatoyin / Imamura, Mari / Okonofua, Friday / Hussein, Julia

    International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics

    2017  Volume 136, Issue 1, Page(s) 13–18

    Abstract: Background: A women-centered approach can improve the quality of patient care.: Objective: To review issues in the provision of obstetric care from a patient-centered care perspective in Nigeria.: Search strategy: Using terms related to maternal ... ...

    Abstract Background: A women-centered approach can improve the quality of patient care.
    Objective: To review issues in the provision of obstetric care from a patient-centered care perspective in Nigeria.
    Search strategy: Using terms related to maternal and perinatal mortality, in combination with "Nigeria", MEDLINE, Embase, CINAHL, Web of Knowledge, and African Journal Online were searched, between December 1, 2013 and January 31, 2014, for articles in any language.
    Selection criteria: Articles published in a Nigerian setting after 2000 that investigated causes of and circumstance surrounding maternal deaths and complications, or clinical practice related to maternal care were included.
    Data collection and analysis: Data were extracted by two reviewers using a standardized abstraction form and were analyzed from a patient-centered perspective.
    Main results: The analysis included 57 studies. Clandestine induced abortions, lack of prenatal care, delays in seeking care, and the use of spiritual churches for delivery were found to contribute to adverse pregnancy outcomes.
    Conclusions: Healthcare systems respond inadequately to patients' needs in terms of abortion care, information sharing, transitioning between prenatal and obstetric care, and patients' non-medical needs. Data from clinician-led maternal death audits provided insights into how women-centered care can be provided; nonetheless, more-focused studies from a primarily patient-centered perspective are warranted.
    MeSH term(s) Abortion, Induced/statistics & numerical data ; Cause of Death ; Delivery of Health Care/standards ; Developing Countries ; Female ; Humans ; Maternal Death/statistics & numerical data ; Maternal Death/trends ; Nigeria ; Patient Acceptance of Health Care ; Pregnancy ; Pregnancy Outcome ; Prenatal Care/standards ; Religion
    Language English
    Publishing date 2017-01
    Publishing country United States
    Document type Journal Article ; Review
    ZDB-ID 80149-5
    ISSN 1879-3479 ; 0020-7292
    ISSN (online) 1879-3479
    ISSN 0020-7292
    DOI 10.1002/ijgo.12007
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  9. Article ; Online: Biomarkers for assessing acute kidney injury for people who are being considered for admission to critical care: a systematic review and cost-effectiveness analysis.

    Brazzelli, Miriam / Aucott, Lorna / Aceves-Martins, Magaly / Robertson, Clare / Jacobsen, Elisabet / Imamura, Mari / Poobalan, Amudha / Manson, Paul / Scotland, Graham / Kaye, Callum / Sawhney, Simon / Boyers, Dwayne

    Health technology assessment (Winchester, England)

    2022  Volume 26, Issue 7, Page(s) 1–286

    Abstract: Background: Acute kidney injury is a serious complication that occurs in the context of an acute critical illness or during a postoperative period. Earlier detection of acute kidney injury may facilitate strategies to preserve renal function, prevent ... ...

    Abstract Background: Acute kidney injury is a serious complication that occurs in the context of an acute critical illness or during a postoperative period. Earlier detection of acute kidney injury may facilitate strategies to preserve renal function, prevent further disease progression and reduce mortality. Acute kidney injury diagnosis relies on a rise in serum creatinine levels and/or fall in urine output; however, creatinine is an imperfect marker of kidney function. There is interest in the performance of novel biomarkers used in conjunction with existing clinical assessment, such as NephroCheck
    Objective: The objective was to evaluate the role of biomarkers for assessing acute kidney injury in critically ill patients who are considered for admission to critical care.
    Data sources: Major electronic databases, conference abstracts and ongoing studies were searched up to June 2019, with no date restrictions. MEDLINE, EMBASE, Health Technology Assessment Database, Cumulative Index to Nursing and Allied Health Literature, Cochrane Central Register of Controlled Trials, Web of Science, World Health Organization Global Index Medicus, EU Clinical Trials Register, International Clinical Trials Registry Platform and ClinicalTrials.gov were searched.
    Review methods: A systematic review and meta-analysis were conducted to evaluate the performance of novel biomarkers for the detection of acute kidney injury and prediction of other relevant clinical outcomes. Random-effects models were adopted to combine evidence. A decision tree was developed to evaluate costs and quality-adjusted life-years accrued as a result of changes in short-term outcomes (up to 90 days), and a Markov model was used to extrapolate results over a lifetime time horizon.
    Results: A total of 56 studies (17,967 participants), mainly prospective cohort studies, were selected for inclusion. No studies addressing the clinical impact of the use of biomarkers on patient outcomes, compared with standard care, were identified. The main sources of bias across studies were a lack of information on blinding and the optimal threshold for NGAL. For prediction studies, the reporting of statistical details was limited. Although the meta-analyses results showed the potential ability of these biomarkers to detect and predict acute kidney injury, there were limited data to establish any causal link with longer-term health outcomes and there were considerable clinical differences across studies. Cost-effectiveness results were highly uncertain, largely speculative and should be interpreted with caution in the light of the limited evidence base. To illustrate the current uncertainty, 15 scenario analyses were undertaken. Incremental quality-adjusted life-years were very low across all scenarios, ranging from positive to negative increments. Incremental costs were also small, in general, with some scenarios generating cost savings with tests dominant over standard care (cost savings with quality-adjusted life-year gains). However, other scenarios generated results whereby the candidate tests were more costly with fewer quality-adjusted life-years, and were thus dominated by standard care. Therefore, it was not possible to determine a plausible base-case incremental cost-effectiveness ratio for the tests, compared with standard care.
    Limitations: Clinical effectiveness and cost-effectiveness results were hampered by the considerable heterogeneity across identified studies. Economic model predictions should also be interpreted cautiously because of the unknown impact of NGAL-guided treatment, and uncertain causal links between changes in acute kidney injury status and changes in health outcomes.
    Conclusions: Current evidence is insufficient to make a full appraisal of the role and economic value of these biomarkers and to determine whether or not they provide cost-effective improvements in the clinical outcomes of acute kidney injury patients.
    Future work: Future studies should evaluate the targeted use of biomarkers among specific patient populations and the clinical impact of their routine use on patient outcomes and management.
    Study registration: This study is registered as PROSPERO CRD42019147039.
    Funding: This project was funded by the National Institute for Health Research (NIHR) Evidence Synthesis programme and will be published in full in
    MeSH term(s) Acute Kidney Injury/diagnosis ; Biomarkers ; Cost-Benefit Analysis ; Critical Care ; Humans ; Prospective Studies ; Quality-Adjusted Life Years
    Chemical Substances Biomarkers
    Language English
    Publishing date 2022-02-03
    Publishing country England
    Document type Meta-Analysis ; Systematic Review
    ZDB-ID 2006765-3
    ISSN 2046-4924 ; 1366-5278
    ISSN (online) 2046-4924
    ISSN 1366-5278
    DOI 10.3310/UGEZ4120
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  10. Article ; Online: Interventions for treating people with symptoms of bladder pain syndrome: a network meta-analysis.

    Imamura, Mari / Scott, Neil W / Wallace, Sheila A / Ogah, Joseph A / Ford, Abigail A / Dubos, Yann A / Brazzelli, Miriam

    The Cochrane database of systematic reviews

    2020  Volume 7, Page(s) CD013325

    Abstract: Background: Bladder pain syndrome (BPS), which includes the condition of interstitial cystitis, is a poorly understood clinical condition for which patients present with varying symptoms. Management of BPS is challenging for both patients and ... ...

    Abstract Background: Bladder pain syndrome (BPS), which includes the condition of interstitial cystitis, is a poorly understood clinical condition for which patients present with varying symptoms. Management of BPS is challenging for both patients and practitioners. At present, there is no universally accepted diagnosis and diverse causes have been proposed. This is reflected in wide-ranging treatment options, used alone or in combination, with limited evidence. A network meta-analysis (NMA) simultaneously comparing multiple treatments may help to determine the best treatment options for patients with BPS.
    Objectives: To conduct a network meta-analysis to assess the effects of interventions for treating people with symptoms of bladder pain syndrome (BPS).
    Search methods: We searched the Cochrane Incontinence Specialised Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL, in the Cochrane Library), MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, ClinicalTrials.gov, the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) and handsearched journals and conference proceedings (searched 11 May 2018) and the reference lists of relevant articles. We conducted a further search on 5 June 2019, which yielded four small studies that were screened for eligibility but were not incorporated into the review.
    Selection criteria: We included randomised controlled trials (RCTs) and quasi-RCTs of interventions for treating adults with BPS. All types of interventions (including conservative, pharmacological and surgical) were eligible.
    Data collection and analysis: We assessed the risk of bias of included studies using Cochrane's 'Risk of bias' tool. Primary outcomes were the number of people cured or improved, pain, frequency and nocturia. For each outcome, random-effects NMA models were fitted using WinBUGS 1.4. We monitored median odds ratios (ORs) for binary outcomes and mean differences (MDs) for continuous outcomes with 95% credible intervals (Crls). We compared results of the NMA with direct evidence from pairwise meta-analysis of head-to-head trials. We used the CINeMA tool to assess the certainty of evidence for selected treatment categories.
    Main results: We included 81 RCTs involving 4674 people with a median of 38 participants (range 10 to 369) per RCT. Most trials compared treatment against control; few trials compared two active treatments. There were 65 different active treatments, and some comparisons were informed by direct evidence from only one trial. To simplify, treatments were grouped into 31 treatment categories by mode of action. Most studies were judged to have unclear or high risk of bias for most domains, particularly for selection and detection bias. Overall, the NMA suggested that six (proportion cured/improved), one (pain), one (frequency) and zero (nocturia) treatment categories were effective compared with control, but there was great uncertainty around estimates of effect. Due to the large number of intervention comparisons in this review, we focus on three interventions: antidepressants, pentosan polysulfate (PPS) and neuromuscular blockade. We selected these interventions on the basis that they are given 'strong recommendations' in the EAU Guidelines for management of BPS (EAU Guidelines 2019). We found very low-certainty evidence suggesting that antidepressants were associated with greater likelihood of cure or improvement compared with control (OR 5.91, 95% CrI 1.12 to 37.56), but it was uncertain whether they reduced pain (MD -1.27, 95% CrI -3.25 to 0.71; low-certainty evidence), daytime frequency (MD -2.41, 95% CrI -6.85 to 2.05; very low-certainty evidence) or nocturia (MD 0.01, 95% CrI -2.53 to 2.50; very low-certainty evidence). There was no evidence that PPS had improved cure/improvement rates (OR 0.14, 95% CrI 0.40 to 3.35; very low-certainty evidence) or reduced pain (MD 0.42, 95% CrI -1.04 to 1.91; low-certainty evidence), frequency (MD -0.37, 95% CrI -5.00 to 3.44; very low-certainty evidence) or nocturia (MD -1.20, 95% CrI -3.62 to 1.28; very low-certainty evidence). There was evidence that neuromuscular blockade resulted in greater cure or improvement (OR 5.80, 95% CrI 2.08 to 18.30) but no evidence that it improved pain (MD -0.33, 95% CrI -1.71 to 1.03), frequency (MD -0.91, 95% CrI -3.24, 1.29) or nocturia (MD -0.04, 95% CrI -1.35 to 1.27). The certainty of this evidence was always very low.
    Authors' conclusions: We are uncertain whether some treatments may be effective in treating patients with BPS because the certainty of evidence was generally low or very low. Data were available for a relatively large number of trials, but most had small sample sizes and effects of treatments often could not be estimated with precision. An NMA was successfully conducted, but limited numbers of small trials for each treatment category hampered our ability to fully exploit the advantages of this analysis. Larger, more focused trials are needed to improve the current evidence base.
    MeSH term(s) Antidepressive Agents/therapeutic use ; Bias ; Cystitis, Interstitial/therapy ; Female ; Humans ; Male ; Network Meta-Analysis ; Neuromuscular Blocking Agents/therapeutic use ; Nocturia/therapy ; Pentosan Sulfuric Polyester/therapeutic use ; Randomized Controlled Trials as Topic
    Chemical Substances Antidepressive Agents ; Neuromuscular Blocking Agents ; Pentosan Sulfuric Polyester (37300-21-3)
    Language English
    Publishing date 2020-07-30
    Publishing country England
    Document type Journal Article ; Meta-Analysis ; Research Support, Non-U.S. Gov't ; Systematic Review
    ISSN 1469-493X
    ISSN (online) 1469-493X
    DOI 10.1002/14651858.CD013325.pub2
    Database MEDical Literature Analysis and Retrieval System OnLINE

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