-
Depression and Anxiety Sep 2018Yoga has become a popular approach to improve emotional health. The aim of this review was to systematically assess and meta-analyze the effectiveness and safety of yoga... (Meta-Analysis)
Meta-Analysis Review
Yoga has become a popular approach to improve emotional health. The aim of this review was to systematically assess and meta-analyze the effectiveness and safety of yoga for anxiety. Medline/PubMed, Scopus, the Cochrane Library, PsycINFO, and IndMED were searched through October 2016 for randomized controlled trials (RCTs) of yoga for individuals with anxiety disorders or elevated levels of anxiety. The primary outcomes were anxiety and remission rates, and secondary outcomes were depression, quality of life, and safety. Risk of bias was assessed using the Cochrane tool. Eight RCTs with 319 participants (mean age: 30.0-38.5 years) were included. Risk of selection bias was unclear for most RCTs. Meta-analyses revealed evidence for small short-term effects of yoga on anxiety compared to no treatment (standardized mean difference [SMD] = -0.43; 95% confidence interval [CI] = -0.74, -0.11; P = .008), and large effects compared to active comparators (SMD = -0.86; 95% CI = -1.56, -0.15; P = .02). Small effects on depression were found compared to no treatment (SMD = -0.35; 95% CI = -0.66, -0.04; P = .03). Effects were robust against potential methodological bias. No effects were found for patients with anxiety disorders diagnosed by Diagnostic and Statistical Manual criteria, only for patients diagnosed by other methods, and for individuals with elevated levels of anxiety without a formal diagnosis. Only three RCTs reported safety-related data but these indicated that yoga was not associated with increased injuries. In conclusion, yoga might be an effective and safe intervention for individuals with elevated levels of anxiety. There was inconclusive evidence for effects of yoga in anxiety disorders. More high-quality studies are needed and are warranted given these preliminary findings and plausible mechanisms of action.
Topics: Adult; Anxiety; Anxiety Disorders; Humans; Randomized Controlled Trials as Topic; Yoga
PubMed: 29697885
DOI: 10.1002/da.22762 -
The Cochrane Database of Systematic... Dec 2017Pneumonia is a common and potentially serious illness. Corticosteroids have been suggested for the treatment of different types of infection, however their role in the... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Pneumonia is a common and potentially serious illness. Corticosteroids have been suggested for the treatment of different types of infection, however their role in the treatment of pneumonia remains unclear. This is an update of a review published in 2011.
OBJECTIVES
To assess the efficacy and safety of corticosteroids in the treatment of pneumonia.
SEARCH METHODS
We searched the Cochrane Acute Respiratory Infections Group's Specialised Register, CENTRAL, MEDLINE, Embase, and LILACS on 3 March 2017, together with relevant conference proceedings and references of identified trials. We also searched three trials registers for ongoing and unpublished trials.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) that assessed systemic corticosteroid therapy, given as adjunct to antibiotic treatment, versus placebo or no corticosteroids for adults and children with pneumonia.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures expected by Cochrane. Two review authors independently assessed risk of bias and extracted data. We contacted study authors for additional information. We estimated risk ratios (RR) with 95% confidence intervals (CI) and pooled data using the Mantel-Haenszel fixed-effect model when possible.
MAIN RESULTS
We included 17 RCTs comprising a total of 2264 participants; 13 RCTs included 1954 adult participants, and four RCTs included 310 children. This update included 12 new studies, excluded one previously included study, and excluded five new trials. One trial awaits classification.All trials limited inclusion to inpatients with community-acquired pneumonia (CAP), with or without healthcare-associated pneumonia (HCAP). We assessed the risk of selection bias and attrition bias as low or unclear overall. We assessed performance bias risk as low for nine trials, unclear for one trial, and high for seven trials. We assessed reporting bias risk as low for three trials and high for the remaining 14 trials.Corticosteroids significantly reduced mortality in adults with severe pneumonia (RR 0.58, 95% CI 0.40 to 0.84; moderate-quality evidence), but not in adults with non-severe pneumonia (RR 0.95, 95% CI 0.45 to 2.00). Early clinical failure rates (defined as death from any cause, radiographic progression, or clinical instability at day 5 to 8) were significantly reduced with corticosteroids in people with severe and non-severe pneumonia (RR 0.32, 95% CI 0.15 to 0.7; and RR 0.68, 95% CI 0.56 to 0.83, respectively; high-quality evidence). Corstocosteroids reduced time to clinical cure, length of hospital and intensive care unit stays, development of respiratory failure or shock not present at pneumonia onset, and rates of pneumonia complications.Among children with bacterial pneumonia, corticosteroids reduced early clinical failure rates (defined as for adults, RR 0.41, 95% CI 0.24 to 0.70; high-quality evidence) based on two small, clinically heterogeneous trials, and reduced time to clinical cure.Hyperglycaemia was significantly more common in adults treated with corticosteroids (RR 1.72, 95% CI 1.38 to 2.14). There were no significant differences between corticosteroid-treated people and controls for other adverse events or secondary infections (RR 1.19, 95% CI 0.73 to 1.93).
AUTHORS' CONCLUSIONS
Corticosteroid therapy reduced mortality and morbidity in adults with severe CAP; the number needed to treat for an additional beneficial outcome was 18 patients (95% CI 12 to 49) to prevent one death. Corticosteroid therapy reduced morbidity, but not mortality, for adults and children with non-severe CAP. Corticosteroid therapy was associated with more adverse events, especially hyperglycaemia, but the harms did not seem to outweigh the benefits.
Topics: Adrenal Cortex Hormones; Ampicillin; Anti-Bacterial Agents; Budesonide; Dexamethasone; Humans; Hydrocortisone; Pneumonia; Prednisolone; Randomized Controlled Trials as Topic
PubMed: 29236286
DOI: 10.1002/14651858.CD007720.pub3 -
The Cochrane Database of Systematic... Jan 2015Patellofemoral pain syndrome (PFPS) is a common knee problem, which particularly affects adolescents and young adults. PFPS, which is characterised by retropatellar... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Patellofemoral pain syndrome (PFPS) is a common knee problem, which particularly affects adolescents and young adults. PFPS, which is characterised by retropatellar (behind the kneecap) or peripatellar (around the kneecap) pain, is often referred to as anterior knee pain. The pain mostly occurs when load is put on the knee extensor mechanism when climbing stairs, squatting, running, cycling or sitting with flexed knees. Exercise therapy is often prescribed for this condition.
OBJECTIVES
To assess the effects (benefits and harms) of exercise therapy aimed at reducing knee pain and improving knee function for people with patellofemoral pain syndrome.
SEARCH METHODS
We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (May 2014), the Cochrane Central Register of Controlled Trials (2014, Issue 4), MEDLINE (1946 to May 2014), EMBASE (1980 to 2014 Week 20), PEDro (to June 2014), CINAHL (1982 to May 2014) and AMED (1985 to May 2014), trial registers (to June 2014) and conference abstracts.
SELECTION CRITERIA
Randomised and quasi-randomised trials evaluating the effect of exercise therapy on pain, function and recovery in adolescents and adults with patellofemoral pain syndrome. We included comparisons of exercise therapy versus control (e.g. no treatment) or versus another non-surgical therapy; or of different exercises or exercise programmes.
DATA COLLECTION AND ANALYSIS
Two review authors independently selected trials based on pre-defined inclusion criteria, extracted data and assessed risk of bias. Where appropriate, we pooled data using either fixed-effect or random-effects methods. We selected the following seven outcomes for summarising the available evidence: pain during activity (short-term: ≤ 3 months); usual pain (short-term); pain during activity (long-term: > 3 months); usual pain (long-term); functional ability (short-term); functional ability (long-term); and recovery (long-term).
MAIN RESULTS
In total, 31 heterogeneous trials including 1690 participants with patellofemoral pain are included in this review. There was considerable between-study variation in patient characteristics (e.g. activity level) and diagnostic criteria for study inclusion (e.g. minimum duration of symptoms) and exercise therapy. Eight trials, six of which were quasi-randomised, were at high risk of selection bias. We assessed most trials as being at high risk of performance bias and detection bias, which resulted from lack of blinding.The included studies, some of which contributed to more than one comparison, provided evidence for the following comparisons: exercise therapy versus control (10 trials); exercise therapy versus other conservative interventions (e.g. taping; eight trials evaluating different interventions); and different exercises or exercise programmes. The latter group comprised: supervised versus home exercises (two trials); closed kinetic chain (KC) versus open KC exercises (four trials); variants of closed KC exercises (two trials making different comparisons); other comparisons of other types of KC or miscellaneous exercises (five trials evaluating different interventions); hip and knee versus knee exercises (seven trials); hip versus knee exercises (two studies); and high- versus low-intensity exercises (one study). There were no trials testing exercise medium (land versus water) or duration of exercises. Where available, the evidence for each of seven main outcomes for all comparisons was of very low quality, generally due to serious flaws in design and small numbers of participants. This means that we are very unsure about the estimates. The evidence for the two largest comparisons is summarised here. Exercise versus control. Pooled data from five studies (375 participants) for pain during activity (short-term) favoured exercise therapy: mean difference (MD) -1.46, 95% confidence interval (CI) -2.39 to -0.54. The CI included the minimal clinically important difference (MCID) of 1.3 (scale 0 to 10), indicating the possibility of a clinically important reduction in pain. The same finding applied for usual pain (short-term; two studies, 41 participants), pain during activity (long-term; two studies, 180 participants) and usual pain (long-term; one study, 94 participants). Pooled data from seven studies (483 participants) for functional ability (short-term) also favoured exercise therapy; standardised mean difference (SMD) 1.10, 95% CI 0.58 to 1.63. Re-expressed in terms of the Anterior Knee Pain Score (AKPS; 0 to 100), this result (estimated MD 12.21 higher, 95% CI 6.44 to 18.09 higher) included the MCID of 10.0, indicating the possibility of a clinically important improvement in function. The same finding applied for functional ability (long-term; three studies, 274 participants). Pooled data (two studies, 166 participants) indicated that, based on the 'recovery' of 250 per 1000 in the control group, 88 more (95% CI 2 fewer to 210 more) participants per 1000 recovered in the long term (12 months) as a result of exercise therapy. Hip plus knee versus knee exercises. Pooled data from three studies (104 participants) for pain during activity (short-term) favoured hip and knee exercise: MD -2.20, 95% CI -3.80 to -0.60; the CI included a clinically important effect. The same applied for usual pain (short-term; two studies, 46 participants). One study (49 participants) found a clinically important reduction in pain during activity (long-term) for hip and knee exercise. Although tending to favour hip and knee exercises, the evidence for functional ability (short-term; four studies, 174 participants; and long-term; two studies, 78 participants) and recovery (one study, 29 participants) did not show that either approach was superior.
AUTHORS' CONCLUSIONS
This review has found very low quality but consistent evidence that exercise therapy for PFPS may result in clinically important reduction in pain and improvement in functional ability, as well as enhancing long-term recovery. However, there is insufficient evidence to determine the best form of exercise therapy and it is unknown whether this result would apply to all people with PFPS. There is some very low quality evidence that hip plus knee exercises may be more effective in reducing pain than knee exercise alone.Further randomised trials are warranted but in order to optimise research effort and engender the large multicentre randomised trials that are required to inform practice, these should be preceded by research that aims to identify priority questions and attain agreement and, where practical, standardisation regarding diagnostic criteria and measurement of outcome.
Topics: Adult; Exercise Therapy; Humans; Patellofemoral Pain Syndrome; Randomized Controlled Trials as Topic; Selection Bias
PubMed: 25603546
DOI: 10.1002/14651858.CD010387.pub2 -
The Journal of Investigative Dermatology Nov 2016Systematic reviews are increasingly utilized in the medical literature to summarize available evidence on a research question. Like other studies, systematic reviews are... (Review)
Review
Systematic reviews are increasingly utilized in the medical literature to summarize available evidence on a research question. Like other studies, systematic reviews are at risk for bias from a number of sources. A systematic review should be based on a formal protocol developed and made publicly available before the conduct of the review; deviations from a protocol with selective presentation of data can result in reporting bias. Evidence selection bias occurs when a systematic review does not identify all available data on a topic. This can arise from publication bias, where data from statistically significant studies are more likely to be published than those that are not statistically significant. Systematic reviews are also susceptible to bias that arises in any of the included primary studies, each of which needs to be critically appraised. Finally, competing interests can lead to bias in favor of a particular intervention. Awareness of these sources of bias is important for authors and consumers of the scientific literature as they conduct and read systematic reviews and incorporate their findings into clinical practice and policy making.
Topics: Dermatology; Disease Management; Humans; Research Design; Selection Bias; Skin Diseases
PubMed: 27772550
DOI: 10.1016/j.jid.2016.08.021 -
The Cochrane Database of Systematic... Mar 2017Empyema refers to pus in the pleural space, commonly due to adjacent pneumonia, chest wall injury, or a complication of thoracic surgery. A range of therapeutic options... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Empyema refers to pus in the pleural space, commonly due to adjacent pneumonia, chest wall injury, or a complication of thoracic surgery. A range of therapeutic options are available for its management, ranging from percutaneous aspiration and intercostal drainage to video-assisted thoracoscopic surgery (VATS) or thoracotomy drainage. Intrapleural fibrinolytics may also be administered following intercostal drain insertion to facilitate pleural drainage. There is currently a lack of consensus regarding optimal treatment.
OBJECTIVES
To assess the effectiveness and safety of surgical versus non-surgical treatments for complicated parapneumonic effusion or pleural empyema.
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (2016, Issue 9), MEDLINE (Ebscohost) (1946 to July week 3 2013, July 2015 to October 2016) and MEDLINE (Ovid) (1 May 2013 to July week 1 2015), Embase (2010 to October 2016), CINAHL (1981 to October 2016) and LILACS (1982 to October 2016) on 20 October 2016. We searched ClinicalTrials.gov and WHO International Clinical Trials Registry Platform for ongoing studies (December 2016).
SELECTION CRITERIA
Randomised controlled trials that compared a surgical with a non-surgical method of management for all age groups with pleural empyema.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed trials for inclusion and risk of bias, extracted data, and checked the data for accuracy. We contacted trial authors for additional information. We assessed the quality of the evidence using the GRADE approach.
MAIN RESULTS
We included eight randomised controlled trials with a total of 391 participants. Six trials focused on children and two on adults. Trials compared tube thoracostomy drainage (non-surgical), with or without intrapleural fibrinolytics, to either VATS or thoracotomy (surgical) for the management of pleural empyema. Assessment of risk of bias for the included studies was generally unclear for selection and blinding but low for attrition and reporting bias. Data analyses compared thoracotomy versus tube thoracostomy and VATS versus tube thoracostomy. We pooled data for meta-analysis where appropriate. We performed a subgroup analysis for children along with a sensitivity analysis for studies that used fibrinolysis in non-surgical treatment arms.The comparison of open thoracotomy versus thoracostomy drainage included only one study in children, which reported no deaths in either treatment arm. However, the trial showed a statistically significant reduction in mean hospital stay of 5.90 days for those treated with primary thoracotomy. It also showed a statistically significant reduction in procedural complications for those treated with thoracotomy compared to thoracostomy drainage. We downgraded the quality of the evidence for length of hospital stay and procedural complications outcomes to moderate due to the small sample size.The comparison of VATS versus thoracostomy drainage included seven studies, which we pooled in a meta-analysis. There was no statistically significant difference in mortality or procedural complications between groups. This was true for both adults and children with or without fibrinolysis. However, mortality data were limited: one study reported one death in each treatment arm, and seven studies reported no deaths. There was a statistically significant reduction in mean length of hospital stay for those treated with VATS. The subgroup analysis showed the same result in adults, but there was insufficient evidence to estimate an effect for children. We could not perform a separate analysis for fibrinolysis for this outcome because all included studies used fibrinolysis in the non-surgical arms. We downgraded the quality of the evidence to low for mortality (due to wide confidence intervals and indirectness), and moderate for other outcomes in this comparison due to either high heterogeneity or wide confidence intervals.
AUTHORS' CONCLUSIONS
Our findings suggest there is no statistically significant difference in mortality between primary surgical and non-surgical management of pleural empyema for all age groups. Video-assisted thoracoscopic surgery may reduce length of hospital stay compared to thoracostomy drainage alone.There was insufficient evidence to assess the impact of fibrinolytic therapy.A number of common outcomes were reported in the included studies that were not directly examined in our primary and secondary outcomes. These included duration of chest tube drainage, duration of fever, analgesia requirement, and total cost of treatment. Future studies focusing on patient-centred outcomes, such as patient functional scores, and other clinically relevant outcomes, such as radiographic improvement, treatment failure rates, and amount of fluid drainage, are needed to inform clinical decisions.
Topics: Adult; Child; Drainage; Empyema, Pleural; Humans; Length of Stay; Randomized Controlled Trials as Topic; Selection Bias; Thoracic Surgery, Video-Assisted; Thoracostomy; Thrombolytic Therapy
PubMed: 28304084
DOI: 10.1002/14651858.CD010651.pub2 -
The Cochrane Database of Systematic... Jul 2017A stroke occurs when the blood supply to part of the brain is cut off. Activities of daily living (ADL) are daily home-based activities that people carry out to maintain... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
A stroke occurs when the blood supply to part of the brain is cut off. Activities of daily living (ADL) are daily home-based activities that people carry out to maintain health and well-being. ADLs include the ability to: eat and drink unassisted, move, go to the toilet, carry out personal hygiene tasks, dress unassisted, and groom. Stroke causes impairment-related functional limitations that may result in difficulties participating in ADLs independent of supervision, direction, or physical assistance.For adults with stroke, the goal of occupational therapy is to improve their ability to carry out activities of daily living. Strategies used by occupational therapists include assessment, treatment, adaptive techniques, assistive technology, and environmental adaptations. This is an update of the Cochrane review first published in 2006.
OBJECTIVES
To assess the effects of occupational therapy interventions on the functional ability of adults with stroke in the domain of activities of daily living, compared with no intervention or standard care/practice.
SEARCH METHODS
For this update, we searched the Cochrane Stroke Group Trials Register (last searched 30 January 2017), the Cochrane Controlled Trials Register (The Cochrane Library, January 2017), MEDLINE (1946 to 5 January 2017), Embase (1974 to 5 January 2017), CINAHL (1937 to January 2017), PsycINFO (1806 to 2 November 2016), AMED (1985 to 1 November 2016), and Web of Science (1900 to 6 January 2017). We also searched grey literature and clinical trials registers.
SELECTION CRITERIA
We identified randomised controlled trials of an occupational therapy intervention (compared with no intervention or standard care/practice) where people with stroke practiced activities of daily living, or where performance in activities of daily living was the focus of the occupational therapy intervention.
DATA COLLECTION AND ANALYSIS
Two review authors independently selected trials, assessed risk of bias, and extracted data for prespecified outcomes. The primary outcomes were the proportion of participants who had deteriorated or were dependent in personal activities of daily living and performance in activities of daily living at the end of follow-up.
MAIN RESULTS
We included nine studies with 994 participants in this update. Occupational therapy targeted towards activities of daily living after stroke increased performance scores (standardised mean difference (SMD) 0.17, 95% confidence interval (CI) 0.03 to 0.31, P = 0.02; 7 studies; 749 participants; low-quality evidence) and reduced the risk of poor outcome (death, deterioration or dependency in personal activities of daily living) (odds ratio (OR) 0.71, 95% CI 0.52 to 0.96; P = 0.03; 5 studies; 771 participants; low-quality evidence). We also found that those who received occupational therapy were more independent in extended activities of daily living (OR 0.22 (95% CI 0.07 to 0.37); P = 0.005; 5 studies; 665 participants; low-quality evidence). Occupational therapy did not influence mortality (OR: 1.02 (95% CI 0.65 to 1.61); P = 0.93; 8 studies; 950 participants), or reduce the combined odds of death and institutionalisation (OR 0.89 (95% CI 0.60 to 1.32); P = 0.55; 4 studies; 671 participants), or death and dependency (OR 0.89 (95% CI 0.64 to 1.23); P = 0.47; 4 trials; 659 participants). Occupational therapy did not improve mood or distress scores (OR 0.08 (95% CI -0.09 to 0.26); P = 0.35; 4 studies; 519 participants; low-quality evidence). There were insufficient data to determine the effects of occupational therapy on health-related quality of life. We found no studies of consenting carers prior to study participation and therefore there were no carer-related outcomes in our review. There were insufficient data to determine participants' and carers' satisfaction with services.Using GRADE, the quality of evidence was low. The major limitation was the number of studies at unclear risk of selection bias and an inevitable high risk of performance and detection bias, as both participants and occupational therapists could not be blinded to the intervention. In addition, there was a sparseness of data for our outcomes of interest and we downgraded the quality of our evidence for these reasons.
AUTHORS' CONCLUSIONS
We found low-quality evidence that occupational therapy targeted towards activities of daily living after stroke can improve performance in activities of daily living and reduce the risk of deterioration in these abilities. Because the included studies had methodological flaws, this research does not provide a reliable indication of the likely effect of occupational therapy for adults with stroke.
Topics: Activities of Daily Living; Adult; Depression; Humans; Occupational Therapy; Randomized Controlled Trials as Topic; Stroke; Stroke Rehabilitation
PubMed: 28721691
DOI: 10.1002/14651858.CD003585.pub3 -
International Urogynecology Journal Mar 2021To evaluate the evidence for pathologies underlying stress urinary incontinence (SUI) in women. (Meta-Analysis)
Meta-Analysis Review
INTRODUCTION AND HYPOTHESIS
To evaluate the evidence for pathologies underlying stress urinary incontinence (SUI) in women.
METHODS
For the data sources, a structured search of the peer-reviewed literature (English language; 1960-April 2020) was conducted using predefined key terms in PubMed and Embase. Google Scholar was also searched. Peer-reviewed manuscripts that reported on anatomical, physiological or functional differences between females with signs and/or symptoms consistent with SUI and a concurrently recruited control group of continent females without any substantive urogynecological symptoms. Of 4629 publications screened, 84 met the inclusion criteria and were retained, among which 24 were included in meta-analyses.
RESULTS
Selection bias was moderate to high; < 25% of studies controlled for major confounding variables for SUI (e.g., age, BMI and parity). There was a lack of standardization of methods among studies, and several measurement issues were identified. Results were synthesized qualitatively, and, where possible, random-effects meta-analyses were conducted. Deficits in urethral and bladder neck structure and support, neuromuscular and mechanical function of the striated urethral sphincter (SUS) and levator ani muscles all appear to be associated with SUI. Meta-analyses showed that observed bladder neck dilation and lower functional urethral length, bladder neck support and maximum urethral closure pressures are strong characteristic signs of SUI.
CONCLUSION
The pathology of SUI is multifactorial, with strong evidence pointing to bladder neck and urethral incompetence. While there is also evidence of impaired urethral support and levator ani function, standardized approaches to measurement are needed to generate higher levels of evidence.
Topics: Female; Humans; Parity; Pelvic Floor; Pregnancy; Urethra; Urinary Bladder; Urinary Incontinence, Stress
PubMed: 33416968
DOI: 10.1007/s00192-020-04622-9 -
The Cochrane Database of Systematic... Jun 2017Incurable cancer, which often constitutes an enormous challenge for patients, their families, and medical professionals, profoundly affects the patient's physical and... (Review)
Review
BACKGROUND
Incurable cancer, which often constitutes an enormous challenge for patients, their families, and medical professionals, profoundly affects the patient's physical and psychosocial well-being. In standard cancer care, palliative measures generally are initiated when it is evident that disease-modifying treatments have been unsuccessful, no treatments can be offered, or death is anticipated. In contrast, early palliative care is initiated much earlier in the disease trajectory and closer to the diagnosis of incurable cancer.
OBJECTIVES
To compare effects of early palliative care interventions versus treatment as usual/standard cancer care on health-related quality of life, depression, symptom intensity, and survival among adults with a diagnosis of advanced cancer.
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycINFO, OpenGrey (a database for grey literature), and three clinical trial registers to October 2016. We checked reference lists, searched citations, and contacted study authors to identify additional studies.
SELECTION CRITERIA
Randomised controlled trials (RCTs) and cluster-randomised controlled trials (cRCTs) on professional palliative care services that provided or co-ordinated comprehensive care for adults at early advanced stages of cancer.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures as expected by Cochrane. We assessed risk of bias, extracted data, and collected information on adverse events. For quantitative synthesis, we combined respective results on our primary outcomes of health-related quality of life, survival (death hazard ratio), depression, and symptom intensity across studies in meta-analyses using an inverse variance random-effects model. We expressed pooled effects as standardised mean differences (SMDs, or Hedges' adjusted g). We assessed certainty of evidence at the outcome level using GRADE (Grading of Recommendations Assessment, Development, and Evaluation) and created a 'Summary of findings' table.
MAIN RESULTS
We included seven randomised and cluster-randomised controlled trials that together recruited 1614 participants. Four studies evaluated interventions delivered by specialised palliative care teams, and the remaining studies assessed models of co-ordinated care. Overall, risk of bias at the study level was mostly low, apart from possible selection bias in three studies and attrition bias in one study, along with insufficient information on blinding of participants and outcome assessment in six studies.Compared with usual/standard cancer care alone, early palliative care significantly improved health-related quality of life at a small effect size (SMD 0.27, 95% confidence interval (CI) 0.15 to 0.38; participants analysed at post treatment = 1028; evidence of low certainty). As re-expressed in natural units (absolute change in Functional Assessment of Cancer Therapy-General (FACT-G) score), health-related quality of life scores increased on average by 4.59 (95% CI 2.55 to 6.46) points more among participants given early palliative care than among control participants. Data on survival, available from four studies enrolling a total of 800 participants, did not indicate differences in efficacy (death hazard ratio 0.85, 95% CI 0.56 to 1.28; evidence of very low certainty). Levels of depressive symptoms among those receiving early palliative care did not differ significantly from levels among those receiving usual/standard cancer care (five studies; SMD -0.11, 95% CI -0.26 to 0.03; participants analysed at post treatment = 762; evidence of very low certainty). Results from seven studies that analysed 1054 participants post treatment suggest a small effect for significantly lower symptom intensity in early palliative care compared with the control condition (SMD -0.23, 95% CI -0.35 to -0.10; evidence of low certainty). The type of model used to provide early palliative care did not affect study results. One RCT reported potential adverse events of early palliative care, such as a higher percentage of participants with severe scores for pain and poor appetite; the remaining six studies did not report adverse events in study publications. For these six studies, principal investigators stated upon request that they had not observed any adverse events.
AUTHORS' CONCLUSIONS
This systematic review of a small number of trials indicates that early palliative care interventions may have more beneficial effects on quality of life and symptom intensity among patients with advanced cancer than among those given usual/standard cancer care alone. Although we found only small effect sizes, these may be clinically relevant at an advanced disease stage with limited prognosis, at which time further decline in quality of life is very common. At this point, effects on mortality and depression are uncertain. We have to interpret current results with caution owing to very low to low certainty of current evidence and between-study differences regarding participant populations, interventions, and methods. Additional research now under way will present a clearer picture of the effect and specific indication of early palliative care. Upcoming results from several ongoing studies (N = 20) and studies awaiting assessment (N = 10) may increase the certainty of study results and may lead to improved decision making. In perspective, early palliative care is a newly emerging field, and well-conducted studies are needed to explicitly describe the components of early palliative care and control treatments, after blinding of participants and outcome assessors, and to report on possible adverse events.
Topics: Communication; Humans; Neoplasms; Palliative Care; Physician-Patient Relations; Quality of Life
PubMed: 28603881
DOI: 10.1002/14651858.CD011129.pub2 -
The Cochrane Database of Systematic... May 2022Comprehensive Geriatric Assessment (CGA) is a multidimensional interdisciplinary diagnostic process focused on determining an older person's medical, psychological and... (Review)
Review
BACKGROUND
Comprehensive Geriatric Assessment (CGA) is a multidimensional interdisciplinary diagnostic process focused on determining an older person's medical, psychological and functional capability in order to develop a co-ordinated and integrated care plan. CGA is not limited simply to assessment, but also directs a holistic management plan for older people, which leads to tangible interventions. While there is established evidence that CGA reduces the likelihood of death and disability in acutely unwell older people, the effectiveness of CGA for community-dwelling, frail, older people at risk of poor health outcomes is less clear.
OBJECTIVES
To determine the effectiveness of CGA for community-dwelling, frail, older adults at risk of poor health outcomes in terms of mortality, nursing home admission, hospital admission, emergency department visits, serious adverse events, functional status, quality of life and resource use, when compared to usual care.
SEARCH METHODS
We searched CENTRAL, MEDLINE, Embase, CINAHL, three trials registers (WHO ICTRP, ClinicalTrials.gov and McMaster Aging Portal) and grey literature up to April 2020; we also checked reference lists and contacted study authors.
SELECTION CRITERIA
We included randomised trials that compared CGA for community-dwelling, frail, older people at risk of poor healthcare outcomes to usual care in the community. Older people were defined as 'at risk' either by being frail or having another risk factor associated with poor health outcomes. Frailty was defined as a vulnerability to sudden health state changes triggered by relatively minor stressor events, placing the individual at risk of poor health outcomes, and was measured using objective screening tools. Primary outcomes of interest were death, nursing home admission, unplanned hospital admission, emergency department visits and serious adverse events. CGA was delivered by a team with specific gerontological training/expertise in the participant's home (domiciliary Comprehensive Geriatric Assessment (dCGA)) or other sites such as a general practice or community clinic (community Comprehensive Geriatric Assessment (cCGA)).
DATA COLLECTION AND ANALYSIS
Two review authors independently extracted study characteristics (methods, participants, intervention, outcomes, notes) using standardised data collection forms adapted from the Cochrane Effective Practice and Organisation of Care (EPOC) data collection form. Two review authors independently assessed the risk of bias for each included study and used the GRADE approach to assess the certainty of evidence for outcomes of interest.
MAIN RESULTS
We included 21 studies involving 7893 participants across 10 countries and four continents. Regarding selection bias, 12/21 studies used random sequence generation, while 9/21 used allocation concealment. In terms of performance bias, none of the studies were able to blind participants and personnel due to the nature of the intervention, while 14/21 had a blinded outcome assessment. Eighteen studies were at low risk of attrition bias, and risk of reporting bias was low in 7/21 studies. Fourteen studies were at low risk of bias in terms of differences of baseline characteristics. Three studies were at low risk of bias across all domains (accepting that it was not possible to blind participants and personnel to the intervention). CGA probably leads to little or no difference in mortality during a median follow-up of 12 months (risk ratio (RR) 0.88, 95% confidence interval (CI) 0.76 to 1.02; 18 studies, 7151 participants (adjusted for clustering); moderate-certainty evidence). CGA results in little or no difference in nursing home admissions during a median follow-up of 12 months (RR 0.93, 95% CI 0.76 to 1.14; 13 studies, 4206 participants (adjusted for clustering); high-certainty evidence). CGA may decrease the risk of unplanned hospital admissions during a median follow-up of 14 months (RR 0.83, 95% CI 0.70 to 0.99; 6 studies, 1716 participants (adjusted for clustering); low-certainty evidence). The effect of CGA on emergency department visits is uncertain and evidence was very low certainty (RR 0.65, 95% CI 0.26 to 1.59; 3 studies, 873 participants (adjusted for clustering)). Only two studies (1380 participants; adjusted for clustering) reported serious adverse events (falls) with no impact on the risk; however, evidence was very low certainty (RR 0.82, 95% CI 0.58 to 1.17).
AUTHORS' CONCLUSIONS
CGA had no impact on death or nursing home admission. There is low-certainty evidence that community-dwelling, frail, older people who undergo CGA may have a reduced risk of unplanned hospital admission. Further studies examining the effect of CGA on emergency department visits and change in function and quality of life using standardised assessments are required.
Topics: Aged; Frail Elderly; Geriatric Assessment; Hospitalization; Humans; Independent Living; Quality of Life
PubMed: 35521829
DOI: 10.1002/14651858.CD012705.pub2 -
The Cochrane Database of Systematic... Sep 2015Nausea, retching and vomiting are very commonly experienced by women in early pregnancy. There are considerable physical, social and psychological effects on women who... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Nausea, retching and vomiting are very commonly experienced by women in early pregnancy. There are considerable physical, social and psychological effects on women who experience these symptoms. This is an update of a review of interventions for nausea and vomiting in early pregnancy last published in 2014.
OBJECTIVES
To assess the effectiveness and safety of all interventions for nausea, vomiting and retching in early pregnancy, up to 20 weeks' gestation.
SEARCH METHODS
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register, the Cochrane Complementary Medicine Field's Trials Register (19 January 2015) and reference lists of retrieved studies.
SELECTION CRITERIA
All randomised controlled trials of any intervention for nausea, vomiting and retching in early pregnancy. We excluded trials of interventions for hyperemesis gravidarum, which are covered by another Cochrane review. We also excluded quasi-randomised trials and trials using a cross-over design.
DATA COLLECTION AND ANALYSIS
Four review authors, in pairs, reviewed the eligibility of trials and independently evaluated the risk of bias and extracted the data for included trials.
MAIN RESULTS
Forty-one trials involving 5449 women, met the inclusion criteria. These trials covered many interventions, including acupressure, acustimulation, acupuncture, ginger, chamomile, lemon oil, mint oil, vitamin B6 and several antiemetic drugs. There were no included studies of dietary and other lifestyle interventions. Evidence regarding the effectiveness of P6 acupressure, auricular (ear) acupressure and acustimulation of the P6 point was limited. Acupuncture (P6 or traditional) showed no significant benefit to women in pregnancy. The use of ginger products may be helpful to women, but the evidence of effectiveness was limited and not consistent, though three recent studies support ginger over placebo. There was only limited evidence from trials to support the use of pharmacological agents including vitamin B6, Doxylamine-pyridoxoine and other anti-emetic drugs to relieve mild or moderate nausea and vomiting. There was little information on maternal and fetal adverse outcomes and on psychological, social or economic outcomes.We were unable to pool findings from studies for most outcomes due to heterogeneity in study participants, interventions, comparison groups, and outcomes measured or reported. The methodological quality of the included studies was mixed. Risk of bias was low related to performance bias, detection bias and attrition bias for most studies. Selection bias risk was unclear for many studies and almost half of the studies did not fully or clearly report all pre-specified outcomes.
AUTHORS' CONCLUSIONS
Given the high prevalence of nausea and vomiting in early pregnancy, women and health professionals need clear guidance about effective and safe interventions, based on systematically reviewed evidence. There is a lack of high-quality evidence to support any particular intervention. This is not the same as saying that the interventions studied are ineffective, but that there is insufficient strong evidence for any one intervention. The difficulties in interpreting and pooling the results of the studies included in this review highlight the need for specific, consistent and clearly justified outcomes and approaches to measurement in research studies.
Topics: Acupuncture Therapy; Antiemetics; Female; Zingiber officinale; Humans; Morning Sickness; Nausea; Phytotherapy; Pregnancy; Pregnancy Complications; Randomized Controlled Trials as Topic; Treatment Outcome; Vitamin B 6; Vitamin B Complex; Vomiting
PubMed: 26348534
DOI: 10.1002/14651858.CD007575.pub4