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BMJ (Clinical Research Ed.) Dec 2020To evaluate evidence from randomised controlled trials and non-randomised controlled trials on the effectiveness of hospital clowns for a range of symptom clusters in...
OBJECTIVE
To evaluate evidence from randomised controlled trials and non-randomised controlled trials on the effectiveness of hospital clowns for a range of symptom clusters in children and adolescents admitted to hospital with acute and chronic conditions.
DESIGN
Systematic review of randomised and non-randomised controlled trials.
DATA SOURCES
Medline, ISI of Knowledge, Cochrane Central Register of Controlled Trials, Science Direct, Scopus, American Psychological Association PsycINFO, Cumulative Index to Nursing and Allied Health Literature, and Latin American and Caribbean Health Sciences Literature.
STUDY SELECTION
Randomised and non-randomised controlled trials were peer reviewed using the following eligibility criteria: children and adolescents who were admitted to hospital for acute conditions or chronic disorders, studies comparing use of hospital clowns with standard care, and studies evaluating the effect of hospital clowns on symptom management of inpatient children and adolescents as a primary outcome.
DATA EXTRACTION AND SYNTHESIS
Two investigators independently screened studies, extracted data, and appraised the risk of bias. Methodological appraisal was assessed by two investigators independently using the Jadad scale, the revised Cochrane risk-of-bias tool for randomised controlled trials (RoB 2), and the risk of bias in non-randomised studies (ROBINS-I) tool for non-randomised controlled trials.
RESULTS
24 studies (n=1612) met the inclusion criteria for data extraction and analysis. Most studies were randomised controlled trials (n=13). Anxiety was the most frequently analysed symptom (n=13), followed by pain (n=9), psychological and emotional responses and perceived wellbeing (n=4), stress (n=4), cancer related fatigue (n=3), and crying (n=2). Five studies used biomarkers, mainly cortisol, to assess stress or fatigue outcome following hospital clowns. Most of the randomised controlled trials (n=11; 85%) were rated as showing some concerns, and two trials were rated with a high risk of bias. Most non-randomised controlled trials (n=6; 55%) were rated with a moderate risk of bias according to ROBINS-I tool. Studies showed that children and adolescents who were in the presence of hospital clowns, either with or without a parent present, reported significantly less anxiety during a range of medical procedures, as well as improved psychological adjustment (P<0.05). Three studies that evaluated chronic conditions showed favourable results for the intervention of hospital clowns with significant reduction in stress, fatigue, pain, and distress (P<0.05).
CONCLUSIONS
These findings suggest that the presence of hospital clowns during medical procedures, induction of anaesthesia in the preoperative room, and as part of routine care for chronic conditions might be a beneficial strategy to manage some symptom clusters. Furthermore, hospital clowns might help improve psychological wellbeing in admitted children and adolescents with acute and chronic disorders, compared with those who received only standard care.
SYSTEMATIC REVIEW REGISTRATION
PROSPERO CRD42018107099.
Topics: Acute Disease; Anxiety; Child; Child, Hospitalized; Chronic Disease; Fatigue; Humans; Laughter Therapy; Non-Randomized Controlled Trials as Topic; Pain Management; Randomized Controlled Trials as Topic; Stress, Psychological
PubMed: 33328164
DOI: 10.1136/bmj.m4290 -
Critical Care (London, England) Dec 2019Memory gaps in intensive care unit (ICU) survivors are associated with psychiatric disorders. The ICU diaries improve the patient's factual memory of the ICU, but it is... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Memory gaps in intensive care unit (ICU) survivors are associated with psychiatric disorders. The ICU diaries improve the patient's factual memory of the ICU, but it is not clear if they reduce the incidence of psychiatric disorders in patients and relatives after hospital discharge. The aim of this study is to evaluate the literature on the effect of ICU diaries for patients admitted in ICU and their relatives.
METHODS
Two authors independently searched the online databases PubMed, OVID, Embase, EBSCO host, and PsycINFO from inception to July 2019. Studies were included if the intervention group (ICU diary) was compared with a group with no diaries and the sample was comprised patients ≥ 18 years old admitted in the ICU for more than 24 h and their relatives. Randomized clinical trials, observational studies, letter with original data, and abstracts were included, irrespective of the language. The search was not limited by any specific outcome. Review articles, commentaries, editorials, and studies without a control group were excluded. Structured tools were used to assess the methodological quality ("Risk Of Bias In Non-randomized Studies of Interventions (ROBINS-I)" for cohort studies and the "Cochrane Risk of Bias tool" for included RCTs and before/after studies). A random-effects model was employed considering the anticipated variability between the studies.
RESULTS
Seven hundred eighty-five titles were identified for screening. Two additional studies were selected after a reference search, and after a full-text review, a total of 12 studies were included. When pooling the results, ICU diary was associated with lower risk of depression (RR 0.41, 95% CI 0.23-0.75) and better quality of life (10.3 points higher in SF-36 general health score, 95% CI 0.79-19.8), without a decrease in anxiety or post-traumatic stress disorder (PTSD). For the relatives receiving an ICU diary, there was no difference in the incidence of PTSD, anxiety, or depression.
CONCLUSION AND RELEVANCE
This systematic review and meta-analysis supports the use of ICU diaries to reduce the risk of depression and preserve the quality of life of patients after ICU admission. ICU diaries do not seem to have any beneficial effect on the relatives of the patients.
TRIAL REGISTRATION
PROSPERO, CRD42019136639.
Topics: Critical Illness; Diaries as Topic; Family; Humans; Intensive Care Units; Memory Disorders; Outcome Assessment, Health Care; Patients; Stress Disorders, Post-Traumatic; Survivors
PubMed: 31842929
DOI: 10.1186/s13054-019-2678-0 -
BMJ (Clinical Research Ed.) Jan 2020To determine, in critically ill patients, the relative impact of proton pump inhibitors (PPIs), histamine-2 receptor antagonists (H2RAs), sucralfate, or no... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
To determine, in critically ill patients, the relative impact of proton pump inhibitors (PPIs), histamine-2 receptor antagonists (H2RAs), sucralfate, or no gastrointestinal bleeding prophylaxis (or stress ulcer prophylaxis) on outcomes important to patients.
DESIGN
Systematic review and network meta-analysis.
DATA SOURCES
Medline, PubMed, Embase, Cochrane Central Register of Controlled Trials, trial registers, and grey literature up to March 2019.
ELIGIBILITY CRITERIA FOR SELECTING STUDIES AND METHODS
We included randomised controlled trials that compared gastrointestinal bleeding prophylaxis with PPIs, H2RAs, or sucralfate versus one another or placebo or no prophylaxis in adult critically ill patients. Two reviewers independently screened studies for eligibility, extracted data, and assessed risk of bias. A parallel guideline committee ( Rapid Recommendation) provided critical oversight of the systematic review, including identifying outcomes important to patients. We performed random-effects pairwise and network meta-analyses and used GRADE to assess certainty of evidence for each outcome. When results differed between low risk and high risk of bias studies, we used the former as best estimates.
RESULTS
Seventy two trials including 12 660 patients proved eligible. For patients at highest risk (>8%) or high risk (4-8%) of bleeding, both PPIs and H2RAs probably reduce clinically important gastrointestinal bleeding compared with placebo or no prophylaxis (odds ratio for PPIs 0.61 (95% confidence interval 0.42 to 0.89), 3.3% fewer for highest risk and 2.3% fewer for high risk patients, moderate certainty; odds ratio for H2RAs 0.46 (0.27 to 0.79), 4.6% fewer for highest risk and 3.1% fewer for high risk patients, moderate certainty). Both may increase the risk of pneumonia compared with no prophylaxis (odds ratio for PPIs 1.39 (0.98 to 2.10), 5.0% more, low certainty; odds ratio for H2RAs 1.26 (0.89 to 1.85), 3.4% more, low certainty). It is likely that neither affect mortality (PPIs 1.06 (0.90 to 1.28), 1.3% more, moderate certainty; H2RAs 0.96 (0.79 to 1.19), 0.9% fewer, moderate certainty). Otherwise, results provided no support for any affect on mortality, infection, length of intensive care stay, length of hospital stay, or duration of mechanical ventilation (varying certainty of evidence).
CONCLUSIONS
For higher risk critically ill patients, PPIs and H2RAs likely result in important reductions in gastrointestinal bleeding compared with no prophylaxis; for patients at low risk, the reduction in bleeding may be unimportant. Both PPIs and H2RAs may result in important increases in pneumonia. Variable quality evidence suggested no important effects of interventions on mortality or other in-hospital morbidity outcomes.
SYSTEMATIC REVIEW REGISTRATION
PROSPERO CRD42019126656.
Topics: Critical Illness; Gastrointestinal Hemorrhage; Histamine H2 Antagonists; Humans; Patient Selection; Proton Pump Inhibitors; Risk Adjustment
PubMed: 31907166
DOI: 10.1136/bmj.l6744 -
BMC Health Services Research Oct 2021Accreditation is viewed as a reputable tool to evaluate and enhance the quality of health care. However, its effect on performance and outcomes remains unclear. This...
BACKGROUND
Accreditation is viewed as a reputable tool to evaluate and enhance the quality of health care. However, its effect on performance and outcomes remains unclear. This review aimed to identify and analyze the evidence on the impact of hospital accreditation.
METHODS
We systematically searched electronic databases (PubMed, CINAHL, PsycINFO, EMBASE, MEDLINE (OvidSP), CDSR, CENTRAL, ScienceDirect, SSCI, RSCI, SciELO, and KCI) and other sources using relevant subject headings. We included peer-reviewed quantitative studies published over the last two decades, irrespective of its design or language. Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, two reviewers independently screened initially identified articles, reviewed the full-text of potentially relevant studies, extracted necessary data, and assessed the methodological quality of the included studies using a validated tool. The accreditation effects were synthesized and categorized thematically into six impact themes.
RESULTS
We screened a total of 17,830 studies, of which 76 empirical studies that examined the impact of accreditation met our inclusion criteria. These studies were methodologically heterogeneous. Apart from the effect of accreditation on healthcare workers and particularly on job stress, our results indicate a consistent positive effect of hospital accreditation on safety culture, process-related performance measures, efficiency, and the patient length of stay, whereas employee satisfaction, patient satisfaction and experience, and 30-day hospital readmission rate were found to be unrelated to accreditation. Paradoxical results regarding the impact of accreditation on mortality rate and healthcare-associated infections hampered drawing firm conclusions on these outcome measures.
CONCLUSION
There is reasonable evidence to support the notion that compliance with accreditation standards has multiple plausible benefits in improving the performance in the hospital setting. Despite inconclusive evidence on causality, introducing hospital accreditation schemes stimulates performance improvement and patient safety. Efforts to incentivize and modernize accreditation are recommended to move towards institutionalization and sustaining the performance gains. PROSPERO registration number CRD42020167863.
Topics: Accreditation; Health Personnel; Hospitals; Humans; Outcome Assessment, Health Care; Patient Satisfaction
PubMed: 34610823
DOI: 10.1186/s12913-021-07097-6 -
The Cochrane Database of Systematic... Oct 2022Collective leadership is strongly advocated by international stakeholders as a key approach for health service delivery, as a response to increasingly complex forms of... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Collective leadership is strongly advocated by international stakeholders as a key approach for health service delivery, as a response to increasingly complex forms of organisation defined by rapid changes in health technology, professionalisation and growing specialisation. Inadequate leadership weakens health systems and can contribute to adverse events, including refusal to prioritise and implement safety recommendations consistently, and resistance to addressing staff burnout. Globally, increases in life expectancy and the number of people living with multiple long-term conditions contribute to greater complexity of healthcare systems. Such a complex environment requires the contribution and leadership of multiple professionals sharing viewpoints and knowledge. OBJECTIVES: To assess the effects of collective leadership for healthcare providers on professional practice, healthcare outcomes and staff well-being, when compared with usual centralised leadership approaches.
SEARCH METHODS
We searched CENTRAL, MEDLINE, Embase, five other databases and two trials registers on 5 January 2021. We also searched grey literature, checked references for additional citations and contacted study authors to identify additional studies. We did not apply any limits on language.
SELECTION CRITERIA
Two groups of two authors independently reviewed, screened and selected studies for inclusion; the principal author was part of both groups to ensure consistency. We included randomised controlled trials (RCTs) that compared collective leadership interventions with usual centralised leadership or no intervention.
DATA COLLECTION AND ANALYSIS
Three groups of two authors independently extracted data from the included studies and evaluated study quality; the principal author took part in all groups. We followed standard methodological procedures expected by Cochrane and the Effective Practice and Organisation of Care (EPOC) Group. We used the GRADE approach to assess the certainty of the evidence.
MAIN RESULTS
We identified three randomised trials for inclusion in our synthesis. All studies were conducted in acute care inpatient settings; the country settings were Canada, Iran and the USA. A total of 955 participants were included across all the studies. There was considerable variation in participants, interventions and measures for quantifying outcomes. We were only able to complete a meta-analysis for one outcome (leadership) and completed a narrative synthesis for other outcomes. We judged all studies as having an unclear risk of bias overall. Collective leadership interventions probably improve leadership (3 RCTs, 955 participants). Collective leadership may improve team performance (1 RCT, 164 participants). We are uncertain about the effect of collective leadership on clinical performance (1 RCT, 60 participants). We are uncertain about the intervention effect on healthcare outcomes, including health status (inpatient mortality) (1 RCT, 60 participants). Collective leadership may slightly improve staff well-being by reducing work-related stress (1 RCT, 164 participants). We identified no direct evidence concerning burnout and psychological symptoms. We are uncertain of the intervention effects on unintended consequences, specifically on staff absence (1 RCT, 60 participants). AUTHORS' CONCLUSIONS: Collective leadership involves multiple professionals sharing viewpoints and knowledge with the potential to influence positively the quality of care and staff well-being. Our confidence in the effects of collective leadership interventions on professional practice, healthcare outcomes and staff well-being is moderate in leadership outcomes, low in team performance and work-related stress, and very low for clinical performance, inpatient mortality and staff absence outcomes. The evidence was of moderate, low and very low certainty due to risk of bias and imprecision, meaning future evidence may change our interpretation of the results. There is a need for more high-quality studies in this area, with consistent reporting of leadership, team performance, clinical performance, health status and staff well-being outcomes.
Topics: Delivery of Health Care; Health Personnel; Humans; Leadership; Occupational Stress; Professional Practice; Randomized Controlled Trials as Topic
PubMed: 36214207
DOI: 10.1002/14651858.CD013850.pub2 -
PloS One 2019Primary health professionals are well positioned to support the delivery of patient self-management in an evidence-based, structured capacity. A need exists to better...
BACKGROUND
Primary health professionals are well positioned to support the delivery of patient self-management in an evidence-based, structured capacity. A need exists to better understand the active components required for effective self-management support, how these might be delivered within primary care, and the training and system changes that would subsequently be needed.
OBJECTIVES
(1) To examine self-management support interventions in primary care on health outcomes for a wide range of diseases compared to usual standard of care; and (2) To identify the effective strategies that facilitate positive clinical and humanistic outcomes in this setting.
METHOD
A systematic review of randomized controlled trials evaluating self-management support interventions was conducted following the Cochrane handbook & PRISMA guidelines. Published literature was systematically searched from inception to June 2019 in PubMed, Scopus and Web of Science. Eligible studies assessed the effectiveness of individualized interventions with follow-up, delivered face-to-face to adult patients with any condition in primary care, compared with usual standard of care. Matrices were developed that mapped the evidence and components for each intervention. The methodological quality of included studies were appraised.
RESULTS
6,510 records were retrieved. 58 studies were included in the final qualitative synthesis. Findings reveal a structured patient-provider exchange is required in primary care (including a one-on-one patient-provider consultation, ongoing follow up and provision of self-help materials). Interventions should be tailored to patient needs and may include combinations of strategies to improve a patient's disease or treatment knowledge; independent monitoring of symptoms, encouraging self-treatment through a personalized action plan in response worsening symptoms or exacerbations, psychological coping and stress management strategies, and enhancing responsibility in medication adherence and lifestyle choices. Follow-up may include tailored feedback, monitoring of progress with respect to patient set healthcare goals, or honing problem-solving and decision-making skills. Theoretical models provided a strong base for effective SMS interventions. Positive outcomes for effective SMS included improvements in clinical indicators, health-related quality of life, self-efficacy (confidence to self-manage), disease knowledge or control. An SMS model has been developed which sets the foundation for the design and evaluation of practical strategies for the construct of self-management support interventions in primary healthcare practice.
CONCLUSIONS
These findings provide primary care professionals with evidence-based strategies and structure to deliver SMS in practice. For this collaborative partnership approach to be more widely applied, future research should build on these findings for optimal SMS service design and upskilling healthcare providers to effectively support patients in this collaborative process.
Topics: Adaptation, Psychological; Depression; Diabetes Mellitus, Type 2; Health Behavior; Humans; Medication Adherence; Practice Guidelines as Topic; Primary Health Care; Pulmonary Disease, Chronic Obstructive; Quality of Life; Self-Management
PubMed: 31369582
DOI: 10.1371/journal.pone.0220116 -
The Cochrane Database of Systematic... Dec 2018Point-of-care sonography (POCS) has emerged as the screening modality of choice for suspected body trauma in many emergency departments worldwide. Its best known... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Point-of-care sonography (POCS) has emerged as the screening modality of choice for suspected body trauma in many emergency departments worldwide. Its best known application is FAST (focused abdominal sonography for trauma). The technology is almost ubiquitously available, can be performed during resuscitation, and does not expose patients or staff to radiation. While many authors have stressed the high specificity of POCS, its sensitivity varied markedly across studies. This review aimed to compile the current best evidence about the diagnostic accuracy of POCS imaging protocols in the setting of blunt thoracoabdominal trauma.
OBJECTIVES
To determine the diagnostic accuracy of POCS for detecting and excluding free fluid, organ injuries, vascular lesions, and other injuries (e.g. pneumothorax) compared to a diagnostic reference standard (i.e. computed tomography (CT), magnetic resonance imaging (MRI), thoracoscopy or thoracotomy, laparoscopy or laparotomy, autopsy, or any combination of these) in patients with blunt trauma.
SEARCH METHODS
We searched Ovid MEDLINE (1946 to July 2017) and Ovid Embase (1974 to July 2017), as well as PubMed (1947 to July 2017), employing a prospectively defined literature and data retrieval strategy. We also screened the Cochrane Library, Google Scholar, and BIOSIS for potentially relevant citations, and scanned the reference lists of full-text papers for articles missed by the electronic search. We performed a top-up search on 6 December 2018, and identified eight new studies which may be incorporated into the first update of this review.
SELECTION CRITERIA
We assessed studies for eligibility using predefined inclusion and exclusion criteria. We included either prospective or retrospective diagnostic cohort studies that enrolled patients of any age and gender who sustained any type of blunt injury in a civilian scenario. Eligible studies had to provide sufficient information to construct a 2 x 2 table of diagnostic accuracy to allow for calculating sensitivity, specificity, and other indices of diagnostic test accuracy.
DATA COLLECTION AND ANALYSIS
Two review authors independently screened titles, abstracts, and full texts of reports using a prespecified data extraction form. Methodological quality of individual studies was rated by the QUADAS-2 instrument (the revised and updated version of the original Quality Assessment of Diagnostic Accuracy Studies list of items). We calculated sensitivity and specificity with 95% confidence intervals (CI), tabulated the pairs of sensitivity and specificity with CI, and depicted these estimates by coupled forest plots using Review Manager 5 (RevMan 5). For pooling summary estimates of sensitivity and specificity, and investigating heterogeneity across studies, we fitted a bivariate model using Stata 14.0.
MAIN RESULTS
We included 34 studies with 8635 participants in this review. Summary estimates of sensitivity and specificity were 0.74 (95% CI 0.65 to 0.81) and 0.96 (95% CI 0.94 to 0.98). Pooled positive and negative likelihood ratios were estimated at 18.5 (95% CI 10.8 to 40.5) and 0.27 (95% CI 0.19 to 0.37), respectively. There was substantial heterogeneity across studies, and the reported accuracy of POCS strongly depended on the population and affected body area. In children, pooled sensitivity of POCS was 0.63 (95% CI 0.46 to 0.77), as compared to 0.78 (95% CI 0.69 to 0.84) in an adult or mixed population. Associated specificity in children was 0.91 (95% CI 0.81 to 0.96) and in an adult or mixed population 0.97 (95% CI 0.96 to 0.99). For abdominal trauma, POCS had a sensitivity of 0.68 (95% CI 0.59 to 0.75) and a specificity of 0.95 (95% CI 0.92 to 0.97). For chest injuries, sensitivity and specificity were calculated at 0.96 (95% CI 0.88 to 0.99) and 0.99 (95% CI 0.97 to 1.00). If we consider the results of all 34 included studies in a virtual population of 1000 patients, based on the observed median prevalence (pretest probability) of thoracoabdominal trauma of 28%, POCS would miss 73 patients with injuries and falsely suggest the presence of injuries in another 29 patients. Furthermore, in a virtual population of 1000 children, based on the observed median prevalence (pretest probability) of thoracoabdominal trauma of 31%, POCS would miss 118 children with injuries and falsely suggest the presence of injuries in another 62 children.
AUTHORS' CONCLUSIONS
In patients with suspected blunt thoracoabdominal trauma, positive POCS findings are helpful for guiding treatment decisions. However, with regard to abdominal trauma, a negative POCS exam does not rule out injuries and must be verified by a reference test such as CT. This is of particular importance in paediatric trauma, where the sensitivity of POCS is poor. Based on a small number of studies in a mixed population, POCS may have a higher sensitivity in chest injuries. This warrants larger, confirmatory trials to affirm the accuracy of POCS for diagnosing thoracic trauma.
Topics: Abdominal Injuries; Adult; Age Factors; Child; Female; Focused Assessment with Sonography for Trauma; Humans; Male; Point-of-Care Systems; Reference Standards; Sensitivity and Specificity; Thoracic Injuries; Wounds, Nonpenetrating
PubMed: 30548249
DOI: 10.1002/14651858.CD012669.pub2 -
The Cochrane Database of Systematic... Nov 2021Crohn's disease is a remitting and relapsing disorder that can affect the whole gastrointestinal tract. Active disease symptoms include abdominal pain, fatigue, weight... (Review)
Review
BACKGROUND
Crohn's disease is a remitting and relapsing disorder that can affect the whole gastrointestinal tract. Active disease symptoms include abdominal pain, fatigue, weight loss, and diarrhoea. There is no known cure; however, the disease can be managed, and therefore places a huge financial burden on healthcare systems. Abdominal pain is a common and debilitating symptom of Crohn's and other inflammatory bowel diseases (IBDs), and is multifaceted. Abdominal pain in Crohn's disease could be a symptom of disease relapse or related to medication adverse effects, surgical complications and strictures or adhesions secondary to IBD. In the absence of these factors, around 20 to 50% of people with Crohn's in remission still experience pain.
OBJECTIVES
To assess the efficacy and safety of interventions for managing abdominal pain in people with Crohn's disease and IBD (where data on ulcerative colitis and Crohn's disease could not be separated).
SEARCH METHODS
We searched CENTRAL, MEDLINE, three other databases, and clinical trials registries on 29 April 2021. We also searched the references of trials and systematic reviews for any additional trials.
SELECTION CRITERIA
All published, unpublished, and ongoing randomised trials that compared interventions for the management of abdominal pain in the setting of Crohn's disease and IBD, with other active interventions or standard therapy, placebo, or no therapy were included. We excluded studies that did not report on any abdominal pain outcomes.
DATA COLLECTION AND ANALYSIS
Five review authors independently conducted data extraction and 'Risk of bias' assessment of the included studies. We analysed data using Review Manager 5. We expressed dichotomous and continuous outcomes as risk ratios and mean differences with 95% confidence intervals. We assessed the certainty of the evidence using GRADE methodology.
MAIN RESULTS
We included 14 studies (743 randomised participants). Five studies evaluated participants with Crohn's disease; seven studies evaluated participants with IBD where the data on ulcerative colitis and Crohn's disease could not be separated; and two studies provided separate results for Crohn's disease participants. Studies considered a range of disease activity states. Two studies provided intervention success definitions, whilst the remaining studies measured pain as a continuous outcome on a rating scale. All studies except one measured pain intensity, whilst three studies measured pain frequency. Withdrawals due to adverse events were directly or indirectly reported in 10 studies. No conclusions could be drawn about the efficacy of the majority of the interventions on pain intensity, pain frequency, and treatment success, except for the comparison of transcranial direct current stimulation to sham stimulation. The certainty of the evidence was very low in all but one comparison because of imprecision due to sparse data and risk of bias assessed as unclear or high risk. Two studies compared a low FODMAP diet (n=37) to a sham diet (n=45) in IBD patients. The evidence on pain intensity was of very low certainty (MD -12.00, 95% CI -114.55 to 90.55). One study reported pain intensity separately for CD participants in the low FODMAP group [n=14, mean(SD)=24 (82.3)] and the sham group [n=12, mean(SD)=32 (69.3)]. The same study also reported pain frequency for IBD participants in the low FODMAP group [n=27, mean(SD)=36 (26)] and sham group [n=25, mean(SD)=38(25)] and CD participants in the low FODMAP group [n=14, mean(SD)=36 (138.4)] and sham group [n=12, mean(SD)=48 (128.2)]. Treatment success was not reported. One study compared a low FODMAP diet (n=25) to high FODMAP/normal diet (n=25) in IBD patients. The data reported on pain intensity was unclear. Treatment success and pain frequency were not reported. One study compared medicine-separated moxibustion combined with acupuncture (n=51) versus wheat bran-separated moxibustion combined with shallow acupuncture (n=51) in CD patients. The data reported on pain intensity and frequency were unclear. Treatment success was not reported. One study compared mindfulness with CBT (n=33) versus no treatment (n=33) in IBD patients. The evidence is very uncertain about the effect of this treatment on pain intensity and frequency (MD -37.00, 95% CI -87.29 to 13.29). Treatment success was not reported. One study compared soft non-manipulative osteopathic treatment (n=16) with no treatment besides doctor advice (n=14) in CD patients. The evidence is very uncertain about the effect of this treatment on pain intensity (MD 0.01, 95% CI -1.81 to 1.83). Treatment success and pain frequency were not reported. One study compared stress management (n=15) to self-directed stress management(n=15) and to standard treatment (n=15) in CD patients. The evidence is very uncertain about the effect of these treatments on pain intensity (MD -30.50, 95% CI -58.45 to -2.55 and MD -34.30, 95% CI -61.99 to -6.61). Treatment success and pain frequency were not reported. One study compared enteric-release glyceryl trinitrate (n=34) with placebo (n=36) in CD patients. The data reported on pain intensity was unclear. Treatment success and pain frequency were not reported. One study compared 100 mg olorinab three times per day (n=8) with 25 mg olorinab three times per day (n=6) in CD patients. Pain intensity was measured as a 30% reduction in weekly average abdominal pain intensity score for the 100mg group (n=5) and the 25mg group (n=6). The evidence is very uncertain about the effect of this treatment on pain intensity (RR 0.66, 95% CI 0.38 to 1.15). Treatment success and pain frequency were not reported. One study compared relaxation training (n=28) to a waitlist (n=28) in IBD patients. The evidence is very uncertain about the effect of this treatment on pain intensity (MD -0.72, 95% CI -1.85 to 0.41). Treatment success and pain frequency were not reported. One study compared web-based education (n=30) with a book-based education (n=30) in IBD patients. The evidence is very uncertain about the effect of this treatment on pain intensity (MD -0.13, 95% CI -1.25 to 0.99). Treatment success and pain frequency were not reported. One study compared yoga (n=50) with no treatment (n=50) in IBD patients. The data reported on treatment success were unclear. Pain frequency and intensity were not reported. One study compared transcranial direct current stimulation (n = 10) to sham stimulation (n = 10) in IBD patients. There may be an improvement in pain intensity when transcranial direct current is compared to sham stimulation (MD -1.65, 95% CI -3.29 to -0.01, low-certainty evidence). Treatment success and pain frequency were not reported. One study compared a kefir diet (Lactobacillus bacteria) to no intervention in IBD patients and provided separate data for their CD participants. The evidence is very uncertain about the effect of this treatment on pain intensity in IBD (MD 0.62, 95% CI 0.17 to 1.07) and CD (MD -1.10, 95% CI -1.67 to -0.53). Treatment success and pain frequency were not reported. Reporting of our secondary outcomes was inconsistent. The most adverse events were reported in the enteric-release glyceryl trinitrate and olorinab studies. In the enteric-release glyceryl trinitrate study, the adverse events were higher in the intervention arm. In the olorinab study, more adverse events were observed in the higher dose arm of the intervention. In the studies on non-drug interventions, adverse events tended to be very low or zero. However, no clear judgements regarding adverse events can be drawn for any interventions due to the low number of events. Anxiety and depression were measured and reported at the end of intervention in only one study; therefore, no meaningful conclusions can be drawn for this outcome.
AUTHORS' CONCLUSIONS
We found low certainty evidence that transcranial direct current stimulation may improve pain intensity compared to sham stimulation. We could not reach any conclusions on the efficacy of any other interventions on pain intensity, pain frequency, and treatment success. The certainty of the evidence was very low due to the low numbers of studies and participants in each comparison and clinical heterogeneity amongst the studies. While no serious or total adverse events were elicited explicitly with any of the treatments studied, the reported events were very low. The certainty of the evidence for all comparisons was very low, so no conclusions can be drawn.
Topics: Abdominal Pain; Colitis, Ulcerative; Crohn Disease; Humans; Inflammatory Bowel Diseases; Transcranial Direct Current Stimulation
PubMed: 34844288
DOI: 10.1002/14651858.CD013531.pub2 -
Psychiatric Services (Washington, D.C.) Apr 2021Two primary compounds of the cannabis plant (), delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD), differentially and dose-dependently affect mood and anxiety. In...
OBJECTIVE
Two primary compounds of the cannabis plant (), delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD), differentially and dose-dependently affect mood and anxiety. In this systematic review, the authors summarize the design and results of controlled trials assessing the effects of THC and CBD on affective disorders, anxiety disorders, and posttraumatic stress disorder (PTSD).
METHODS
A keyword search of eight online literature databases identified eight randomized controlled trials of defined CBD or THC doses for the target populations.
RESULTS
A 1-month trial of daily THC (up to 3 mg per day) for anxiety disorder reduced anxiety symptoms, but symptoms were very low throughout the study. Another trial of sequential, single-day, low-dose THC in social anxiety disorder found no symptom changes. Two studies reported that single-dose CBD pretreatment reduced anxiety in laboratory paradigms among individuals with social anxiety disorder. A study of daily CBD for 4 weeks among adolescents with social anxiety disorder indicated modest symptom improvements. One crossover trial involving 10 patients with PTSD showed that THC added to standard pharmacotherapy reduced self-reported nightmares. Two small studies of THC for hospitalized patients with unipolar or bipolar depression found no improvement of depression; instead, anxiety and psychotic symptoms emerged in >50% of patients.
CONCLUSIONS
With only eight very small studies, insufficient evidence was found for efficacy of CBD and THC to manage affective disorders, anxiety disorders, or PTSD. Therefore, medical cannabis should not be recommended for treating patients with these disorders. Further research should investigate the safety and efficacy of managing psychiatric disorders with cannabinoids.
Topics: Adolescent; Anxiety Disorders; Cannabidiol; Cannabinoids; Humans; Mood Disorders; Stress Disorders, Post-Traumatic
PubMed: 33530732
DOI: 10.1176/appi.ps.202000189 -
The Cochrane Database of Systematic... Jun 2020People with cancer experience a variety of symptoms as a result of their disease and the therapies involved in its management. Inadequate symptom management has...
BACKGROUND
People with cancer experience a variety of symptoms as a result of their disease and the therapies involved in its management. Inadequate symptom management has implications for patient outcomes including functioning, psychological well-being, and quality of life (QoL). Attempts to reduce the incidence and severity of cancer symptoms have involved the development and testing of psycho-educational interventions to enhance patients' symptom self-management. With the trend for care to be provided nearer patients' homes, telephone-delivered psycho-educational interventions have evolved to provide support for the management of a range of cancer symptoms. Early indications suggest that these can reduce symptom severity and distress through enhanced symptom self-management.
OBJECTIVES
To assess the effectiveness of telephone-delivered interventions for reducing symptoms associated with cancer and its treatment. To determine which symptoms are most responsive to telephone interventions. To determine whether certain configurations (e.g. with/without additional support such as face-to-face, printed or electronic resources) and duration/frequency of intervention calls mediate observed cancer symptom outcome effects.
SEARCH METHODS
We searched the following databases: the Cochrane Central Register of Controlled Trials (CENTRAL; 2019, Issue 1); MEDLINE via OVID (1946 to January 2019); Embase via OVID (1980 to January 2019); (CINAHL) via Athens (1982 to January 2019); British Nursing Index (1984 to January 2019); and PsycINFO (1989 to January 2019). We searched conference proceedings to identify published abstracts, as well as SIGLE and trial registers for unpublished studies. We searched the reference lists of all included articles for additional relevant studies. Finally, we handsearched the following journals: Cancer, Journal of Clinical Oncology, Psycho-oncology, Cancer Practice, Cancer Nursing, Oncology Nursing Forum, Journal of Pain and Symptom Management, and Palliative Medicine. We restricted our search to publications published in English.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) and quasi-RCTs that compared one or more telephone interventions with one other, or with other types of interventions (e.g. a face-to-face intervention) and/or usual care, with the stated aim of addressing any physical or psychological symptoms of cancer and its treatment, which recruited adults (over 18 years) with a clinical diagnosis of cancer, regardless of tumour type, stage of cancer, type of treatment, and time of recruitment (e.g. before, during, or after treatment).
DATA COLLECTION AND ANALYSIS
We used Cochrane methods for trial selection, data extraction and analysis. When possible, anxiety, depressive symptoms, fatigue, emotional distress, pain, uncertainty, sexually-related and lung cancer symptoms as well as secondary outcomes are reported as standardised mean differences (SMDs) with 95% confidence intervals (CIs), and we presented a descriptive synthesis of study findings. We reported on findings according to symptoms addressed and intervention types (e.g. telephone only, telephone combined with other elements). As many studies included small samples, and because baseline scores for study outcomes often varied for intervention and control groups, we used change scores and associated standard deviations. The certainty of the evidence for each outcome was interpreted using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.
MAIN RESULTS
Thirty-two studies were eligible for inclusion; most had moderate risk of bias,often related to blinding. Collectively, researchers recruited 6250 people and studied interventions in people with a variety of cancer types and across the disease trajectory, although many participants had breast cancer or early-stage cancer and/or were starting treatment. Studies measured symptoms of anxiety, depression, emotional distress, uncertainty, fatigue, and pain, as well as sexually-related symptoms and general symptom intensity and/or distress. Interventions were primarily delivered by nurses (n = 24), most of whom (n = 16) had a background in oncology, research, or psychiatry. Ten interventions were delivered solely by telephone; the rest combined telephone with additional elements (i.e. face-to-face consultations and digital/online/printed resources). The number of calls delivered ranged from 1 to 18; most interventions provided three or four calls. Twenty-one studies provided evidence on effectiveness of telephone-delivered interventions and the majority appeared to reduce symptoms of depression compared to control. Nine studies contributed quantitative change scores (CSs) and associated standard deviation results (or these could be calculated). Likewise, many telephone interventions appeared effective when compared to control in reducing anxiety (16 studies; 5 contributed quantitative CS results); fatigue (9 studies; 6 contributed to quantitative CS results); and emotional distress (7 studies; 5 contributed quantitative CS results). Due to significant clinical heterogeneity with regards to interventions introduced, study participants recruited, and outcomes measured, meta-analysis was not conducted. For other symptoms (uncertainty, pain, sexually-related symptoms, dyspnoea, and general symptom experience), evidence was limited; similarly meta-analysis was not possible, and results from individual studies were largely conflicting, making conclusions about their management through telephone-delivered interventions difficult to draw. Heterogeneity was considerable across all trials for all outcomes. Overall, the certainty of evidence was very low for all outcomes in the review. Outcomes were all downgraded due to concerns about overall risk of bias profiles being frequently unclear, uncertainty in effect estimates and due to some inconsistencies in results and general heterogeneity. Unsubstantiated evidence suggests that telephone interventions in some capacity may have a place in symptom management for adults with cancer. However, in the absence of reliable and homogeneous evidence, caution is needed in interpreting the narrative synthesis. Further, there were no clear patterns across studies regarding which forms of interventions (telephone alone versus augmented with other elements) are most effective. It is impossible to conclude with any certainty which forms of telephone intervention are most effective in managing the range of cancer-related symptoms that people with cancer experience.
AUTHORS' CONCLUSIONS
Telephone interventions provide a convenient way of supporting self-management of cancer-related symptoms for adults with cancer. These interventions are becoming more important with the shift of care closer to patients' homes, the need for resource/cost containment, and the potential for voluntary sector providers to deliver healthcare interventions. Some evidence supports the use of telephone-delivered interventions for symptom management for adults with cancer; most evidence relates to four commonly experienced symptoms - depression, anxiety, emotional distress, and fatigue. Some telephone-delivered interventions were augmented by combining them with face-to-face meetings and provision of printed or digital materials. Review authors were unable to determine whether telephone alone or in combination with other elements provides optimal reduction in symptoms; it appears most likely that this will vary by symptom. It is noteworthy that, despite the potential for telephone interventions to deliver cost savings, none of the studies reviewed included any form of health economic evaluation. Further robust and adequately reported trials are needed across all cancer-related symptoms, as the certainty of evidence generated in studies within this review was very low, and reporting was of variable quality. Researchers must strive to reduce variability between studies in the future. Studies in this review are characterised by clinical and methodological diversity; the level of this diversity hindered comparison across studies. At the very least, efforts should be made to standardise outcome measures. Finally, studies were compromised by inclusion of small samples, inadequate concealment of group allocation, lack of observer blinding, and short length of follow-up. Consequently, conclusions related to symptoms most amenable to management by telephone-delivered interventions are tentative.
Topics: Adult; Anxiety; Cancer Pain; Depression; Dyspnea; Fatigue; Female; Humans; Male; Neoplasms; Randomized Controlled Trials as Topic; Self Care; Sexual Dysfunction, Physiological; Stress, Psychological; Symptom Assessment; Telemedicine; Telephone; Time Factors; Uncertainty
PubMed: 32483832
DOI: 10.1002/14651858.CD007568.pub2