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The Cochrane Database of Systematic... Aug 2023Acute otitis media (AOM) is one of the most common childhood infectious diseases. Pain is the key symptom of AOM and central to children's and parents' experience of the... (Review)
Review
BACKGROUND
Acute otitis media (AOM) is one of the most common childhood infectious diseases. Pain is the key symptom of AOM and central to children's and parents' experience of the illness. Because antibiotics provide only marginal benefits, analgesic treatment including paracetamol (acetaminophen) and non-steroidal anti-inflammatory drugs (NSAIDs) is regarded as the cornerstone of AOM management. This is an update of a review first published in 2016.
OBJECTIVES
Our primary objective was to assess the effectiveness of paracetamol (acetaminophen) or NSAIDs, alone or combined, compared with placebo or no treatment in relieving pain in children with AOM. Our secondary objective was to assess the effectiveness of NSAIDs as compared with paracetamol in children with AOM.
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL), Issue 5, April 2023; MEDLINE (Ovid, from 1946 to May 2023), Embase (from 1947 to May 2023), CINAHL (from 1981 to May 2023), LILACS (from 1982 to May 2023), and Web of Science Core Collection (from 1955 to May 2023). We searched the WHO ICTRP and ClinicalTrials.gov for completed and ongoing trials (23 May 2023).
SELECTION CRITERIA
We included randomised controlled trials comparing the effectiveness of paracetamol or NSAIDs, alone or combined, for pain relief in non-hospitalised children aged six months to 16 years with AOM. We also included trials of paracetamol or NSAIDs, alone or combined, for children with fever or upper respiratory tract infections if we were able to extract subgroup data on pain relief in children with AOM either directly or after obtaining additional data from study authors. We extracted and summarised data for the following comparisons: paracetamol versus placebo, NSAIDs versus placebo, NSAIDs versus paracetamol, and NSAIDs plus paracetamol versus paracetamol alone.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures expected by Cochrane. We rated the overall certainty of evidence for each outcome of interest using the GRADE approach.
MAIN RESULTS
We included four trials (411 children) which were assessed at low to high risk of bias. Paracetamol versus placebo Data from one trial (148 children) informed this comparison. Paracetamol may be more effective than placebo in relieving pain at 48 hours (proportion of children with pain 10% versus 25%, risk ratio (RR) 0.38, 95% confidence interval (CI) 0.17 to 0.85; number needed to treat for an additional beneficial outcome (NNTB) 7; low-certainty evidence). The evidence is very uncertain about the effects of paracetamol on fever at 48 hours (RR 1.03, 95% CI 0.07 to 16.12; very low-certainty evidence) and adverse events (RR 1.03, 95% CI 0.21 to 4.93; very low-certainty evidence). No data were available for our other outcomes of interest. NSAIDs versus placebo Data from one trial (146 children) informed this comparison. Ibuprofen may be more effective than placebo in relieving pain at 48 hours (proportion of children with pain 7% versus 25%, RR 0.28, 95% CI 0.11 to 0.70; NNTB 6; low-certainty evidence). The evidence is very uncertain about the effect of ibuprofen on fever at 48 hours (RR 1.06, 95% CI 0.07 to 16.57; very low-certainty evidence) and adverse events (RR 1.76, 95% CI 0.44 to 7.10; very low-certainty evidence). No data were available for our other outcomes of interest. NSAIDs versus paracetamol Data from four trials (411 children) informed this comparison. The evidence is very uncertain about the effect of ibuprofen versus paracetamol in relieving ear pain at 24 hours (RR 0.83, 95% CI 0.59 to 1.18; 2 RCTs, 39 children; very low-certainty evidence); 48 to 72 hours (RR 0.91, 95% CI 0.54 to 1.54; 3 RCTs, 183 children; low-certainty evidence); and four to seven days (RR 0.74, 95% CI 0.17 to 3.23; 2 RCTs, 38 children; very low-certainty evidence). The evidence is very uncertain about the effect of ibuprofen versus paracetamol on mean pain score at 24 hours (0.29 lower, 95% CI 0.79 lower to 0.20 higher; 3 RCTs, 111 children; very low-certainty evidence); 48 to 72 hours (0.25 lower, 95% CI 0.66 lower to 0.16 higher; 3 RCTs, 108 children; very low-certainty evidence); and four to seven days (0.30 higher, 95% CI 1.78 lower to 2.38 higher; 2 RCTs, 31 children; very low-certainty evidence). The evidence is very uncertain about the effect of ibuprofen versus paracetamol in resolving fever at 24 hours (RR 0.69, 95% CI 0.24 to 2.00; 2 RCTs, 39 children; very low-certainty evidence); 48 to 72 hours (RR 1.18, 95% CI 0.31 to 4.44; 3 RCTs, 182 children; low-certainty evidence); and four to seven days (RR 2.75, 95% CI 0.12 to 60.70; 2 RCTs, 39 children; very low-certainty evidence). The evidence is very uncertain about the effect of ibuprofen versus paracetamol on adverse events (RR 1.71, 95% CI 0.43 to 6.90; 3 RCTs, 281 children; very low-certainty evidence); reconsultations (RR 1.13, 95% CI 0.92 to 1.40; 1 RCT, 53 children; very low-certainty evidence); and delayed antibiotic prescriptions (RR 1.32, 95% CI 0.74 to 2.35; 1 RCT, 53 children; very low-certainty evidence). No data were available on time to resolution of pain. NSAIDs plus paracetamol versus paracetamol alone Data on the effectiveness of ibuprofen plus paracetamol versus paracetamol alone came from two trials that provided crude subgroup data for 71 children with AOM. The small sample provided imprecise effect estimates, therefore we were unable to draw any firm conclusions (very low-certainty evidence).
AUTHORS' CONCLUSIONS
Despite explicit guideline recommendations on the use of analgesics in children with AOM, the current evidence on the effectiveness of paracetamol or NSAIDs, alone or combined, in children with AOM is limited. Paracetamol and ibuprofen as monotherapies may be more effective than placebo in relieving short-term ear pain in children with AOM. The evidence is very uncertain for the effect of ibuprofen versus paracetamol on relieving short-term ear pain in children with AOM, as well as for the effectiveness of ibuprofen plus paracetamol versus paracetamol alone, thereby preventing any firm conclusions. Further research is needed to provide insights into the role of ibuprofen as adjunct to paracetamol, and other analgesics such as anaesthetic eardrops, for children with AOM.
Topics: Child; Humans; Acetaminophen; Ibuprofen; Anti-Inflammatory Agents, Non-Steroidal; Pain; Fever; Anti-Bacterial Agents; Otitis Media
PubMed: 37594020
DOI: 10.1002/14651858.CD011534.pub3 -
Journal of Medical Internet Research Aug 2023Video recordings of patients may offer advantages to supplement patient assessment and clinical decision-making. However, little is known about the practice of video... (Review)
Review
BACKGROUND
Video recordings of patients may offer advantages to supplement patient assessment and clinical decision-making. However, little is known about the practice of video recording patients for direct care purposes.
OBJECTIVE
We aimed to synthesize empirical studies published internationally to explore the extent to which video recording patients is acceptable and effective in supporting direct care and, for the United Kingdom, to summarize the relevant guidance of professional and regulatory bodies.
METHODS
Five electronic databases (MEDLINE, Embase, APA PsycINFO, CENTRAL, and HMIC) were searched from 2012 to 2022. Eligible studies evaluated an intervention involving video recording of adult patients (≥18 years) to support diagnosis, care, or treatment. All study designs and countries of publication were included. Websites of UK professional and regulatory bodies were searched to identify relevant guidance. The acceptability of video recording patients was evaluated using study recruitment and retention rates and a framework synthesis of patients' and clinical staff's perspectives based on the Theoretical Framework of Acceptability by Sekhon. Clinically relevant measures of impact were extracted and tabulated according to the study design. The framework approach was used to synthesize the reported ethico-legal considerations, and recommendations of professional and regulatory bodies were extracted and tabulated.
RESULTS
Of the 14,221 abstracts screened, 27 studies met the inclusion criteria. Overall, 13 guidance documents were retrieved, of which 7 were retained for review. The views of patients and clinical staff (16 studies) were predominantly positive, although concerns were expressed about privacy, technical considerations, and integrating video recording into clinical workflows; some patients were anxious about their physical appearance. The mean recruitment rate was 68.2% (SD 22.5%; range 34.2%-100%; 12 studies), and the mean retention rate was 73.3% (SD 28.6%; range 16.7%-100%; 17 studies). Regarding effectiveness (10 studies), patients and clinical staff considered video recordings to be valuable in supporting assessment, care, and treatment; in promoting patient engagement; and in enhancing communication and recall of information. Observational studies (n=5) favored video recording, but randomized controlled trials (n=5) did not demonstrate that video recording was superior to the controls. UK guidelines are consistent in their recommendations around consent, privacy, and storage of recordings but lack detailed guidance on how to operationalize these recommendations in clinical practice.
CONCLUSIONS
Video recording patients for direct care purposes appears to be acceptable, despite concerns about privacy, technical considerations, and how to incorporate recording into clinical workflows. Methodological quality prevents firm conclusions from being drawn; therefore, pragmatic trials (particularly in older adult care and the movement disorders field) should evaluate the impact of video recording on diagnosis, treatment monitoring, patient-clinician communication, and patient safety. Professional and regulatory documents should signpost to practical guidance on the implementation of video recording in routine practice.
TRIAL REGISTRATION
PROSPERO CRD42022331825: https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=331825.
Topics: Humans; Aged; Patient Participation; Empirical Research; Communication; Narration; Clinical Decision-Making
PubMed: 37585249
DOI: 10.2196/46478 -
Journal of Plastic, Reconstructive &... Oct 2023Injuries to the extensor mechanism of the hand and forearm are common and cause significant functional disability. Complete tendon lacerations are managed with surgical...
Injuries to the extensor mechanism of the hand and forearm are common and cause significant functional disability. Complete tendon lacerations are managed with surgical repair, whereas selected partial tendon injuries may be managed without repair but with splinting and physiotherapy alone. There is limited evidence to support the management of partial lacerations, in particular the decision of whether to repair or not. We aimed to systematically review the literature to determine the optimal management of partial extensor tendon lacerations in the hand and forearm. A protocol for the systematic review was developed prospectively and registered with PROSPERO (CRD42021250431). PubMed, EMBASE, clinicaltrials.gov, and Cochrane Central Register of Controlled Trials (CENTRAL) were searched from 1990 to 27/05/2022. 4565 studies were screened, of which 88 underwent full text review. Five studies were included, one randomised control trial and four cohort studies. One study examined outcomes of partial lacerations treated without repair; the other four studies examined outcomes following repair. Pinch and grip strength and time to return to work were similar regardless of management. Adverse outcomes were reported for patients undergoing surgical repair; none were observed in those managed without repair. Meta-analysis was precluded by study heterogeneity and high risk of bias. There is limited evidence to support the management of partial extensor tendon lacerations, with some low-quality evidence that non-operative management of selected partial lacerations is safe. There is a pressing need for pragmatic, multicentre randomised trials to assess the cost-effectiveness of current treatments.
Topics: Humans; Forearm; Hand; Lacerations; Tendon Injuries; Tendons
PubMed: 37454548
DOI: 10.1016/j.bjps.2023.06.004 -
Clinical Psychology & Psychotherapy 2023Cognitive-behavioural therapy for insomnia (CBT-I) is the recommended first-line therapy for adults with chronic insomnia disorder (ID), which is characterized by... (Meta-Analysis)
Meta-Analysis Review
Can mindfulness-based interventions improve outcomes in cognitive-behavioural therapy for chronic insomnia disorder in the general population? Systematic review and meta-analysis.
Cognitive-behavioural therapy for insomnia (CBT-I) is the recommended first-line therapy for adults with chronic insomnia disorder (ID), which is characterized by hyperarousal. Mindfulness-based interventions (MBIs) are protocols aimed at stress reduction based on non-judgmental attention control in the present moment. However, MBIs have been increasingly used without a clear scientific basis. The objective of this analysis was to examine if MBIs could be useful as a component of the CBT-I therapeutic system through a systematic review and meta-analysis of randomized controlled trials (RCTs) and non-randomized studies (NRS) searched in PubMed, PsycINFO, Cochrane and WoS. The Insomnia Severity Index (ISI) was the primary outcome, while the Pittsburgh Sleep Quality Index (PSQI) and a composite sleep variable (CSV) were secondary outcomes. Thirteen articles corresponding to nine studies (three pragmatic RCTs, three explanatory RCTs and three NRS) were included. The omnibus test found that MBIs had a small to medium effect size on ISI nearing signification when comparing active control groups in the pretest-posttest period [Δ = 0.44, p = 0.07], a medium, non-significant, effect size on PSQI [Δ = 0.52, p = 0.18], and a significant though small effect size on CSV [Δ = 0.05, p < 0.01]. No heterogeneity was found. The analysis could not demonstrate that MBIs, combined with CBT-I components in some studies, positively affected ID in the general adult population. This was probably due to the lack of pragmatic designs and suitable measuring instruments. Recommendations are made for designing further studies to address these issues.
Topics: Adult; Humans; Mindfulness; Sleep Initiation and Maintenance Disorders; Cognitive Behavioral Therapy
PubMed: 37271575
DOI: 10.1002/cpp.2874 -
PEC Innovation Dec 2023Informal caregivers (ICs) are vital to supportive cancer care and assisting cancer patients, but this caregiving burden is associated with significant distress. While... (Review)
Review
OBJECTIVE
Informal caregivers (ICs) are vital to supportive cancer care and assisting cancer patients, but this caregiving burden is associated with significant distress. While addressing caregiving, it is important to explore if the caregivers are receiving care they need. Evaluating interventions that address burden and distress is integral to targeting ICs needs. This study evaluated interventions addressing IC burden and distress.
METHODS
Randomized control trials (RCT) assessing interventions for IC burden and distress and exploring supportive care as an adjunct to the intervention were included. Six electronic databases were searched in accordance with the Preferred Reporting Items for Systematic reviews and Meta-analyses guidelines through October 2021. Effect sizes were estimated, and risk of bias was assessed.
RESULTS
Of 678 studies, 11 were included. Most ICs were spouses, females, and white. Interventions included educational programs, cognitive behavioral treatment, and a telephone support program. Five studies utilized behavioral theories and seven included supportive care. Pooled results showed no significant effect on reducing caregiver distress (ES, -0.26, p<0.001).
CONCLUSIONS
Caring for the caregiver with interventions for reducing burden and distress are not efficacious. Innovative, well-designed, more pragmatic RCTs are needed.
INNOVATION
This study exclusively focused on interventions and supportive care needs for reducing distress and burden among cancer ICs.
PubMed: 37214528
DOI: 10.1016/j.pecinn.2023.100145 -
American Journal of Perinatology May 2024Palivizumab is a humanized monoclonal antibody approved for the prevention of serious lower respiratory tract infection (LRTI) caused by respiratory syncytial virus...
OBJECTIVE
Palivizumab is a humanized monoclonal antibody approved for the prevention of serious lower respiratory tract infection (LRTI) caused by respiratory syncytial virus (RSV) in infants and young children at high risk of RSV disease. This systematic review summarized evidence on the effectiveness and safety of palivizumab when used in approved populations.
STUDY DESIGN
A systematic review of Phase III trials and observational studies was conducted according to the population, intervention, comparator, outcome, timing, setting (PICOTS) approach (PROSPERO, CRD42021281380). Target populations consisted of infants with a history of premature birth (≤35-week gestational age) and children aged <2 years with bronchopulmonary dysplasia (BPD) or with hemodynamically significant congenital heart disease (hs-CHD). Outcomes of interest included RSV-related hospitalization, admission to intensive care unit (ICU), requirement for mechanical ventilation, treatment-related adverse events (AEs), and RSV-related deaths. Information sources were literature search (Ovid MEDLINE and Embase), pragmatic searches, and snowballing (covering the period up to 07 September 2021).
RESULTS
A total of 60 sources were included (5 Phase III trials and 55 observational studies). RSV-related hospitalization rates following palivizumab prophylaxis in Phase III trials were 1.8% in premature infants and 7.9% in children with BPD, which were significantly lower than rates in placebo arms. In the real-world setting, similar hospitalization rates were found (0.7-4.0% in premature infants [16 studies] and 0-5.5% in patients with BPD [10 studies]) with ICU admission reported in 0 to 33.3% of patients hospitalized for RSV. In Phase III trials, RSV-related mortality rates were 0.2 and 0.3%, while AEs occurred in 11% of premature and/or BPD patients and 7.2% of hs-CHD patients, consisting mainly of injection site reaction, fever, and diarrhea. Similar results were found in observational studies.
CONCLUSION
This systematic review supports the effectiveness and safety of palivizumab in the indicated populations.
KEY POINTS
· Systematic review supports the positive benefit-risk profile of palivizumab in the indicated populations.. · Real-world safety and effectiveness of palivizumab are consistent with Phase III trials results.. · Palivizumab reduces RSV-related hospitalizations, ICU admissions, and need for mechanical ventilation..
Topics: Humans; Palivizumab; Respiratory Syncytial Virus Infections; Antiviral Agents; Infant; Infant, Newborn; Infant, Premature; Hospitalization; Bronchopulmonary Dysplasia; Heart Defects, Congenital; Respiration, Artificial; Respiratory Tract Infections; Observational Studies as Topic; Clinical Trials, Phase III as Topic
PubMed: 36452969
DOI: 10.1055/a-1990-2633 -
Child and Adolescent Mental Health Sep 2023School-based mental health literacy interventions aim to prevent mental disorders and promote mental wellbeing through improving the knowledge and understanding of... (Review)
Review
BACKGROUND
School-based mental health literacy interventions aim to prevent mental disorders and promote mental wellbeing through improving the knowledge and understanding of mental health, mental disorders, and reducing stigma. Evidence suggests that good mental health literacy helps young people recognise mental health difficulties in themselves and in others, and seek help for mental health problems. Improved help-seeking can allow for early intervention, which prevents the progression of mental disorders and ultimately reduces the burden of mental disorders. The aim of this review is to identify and synthesise evidence on the effectiveness of school-based mental health literacy interventions in improving help-seeking outcomes.
METHODS
We searched MEDLINE, Embase, PsycINFO, ERIC, Child Development and Adolescent Studies, British Education Index and ASSIA (June 2020). Additional searches were conducted a year later to identify any new publications (June 2021). We included randomised controlled trials (RCTs) assessing the effectiveness or cost-effectiveness of school-based interventions to improve help-seeking outcomes for children and young people aged 4-18 years. Included studies were critically appraised.
RESULTS
We identified 11 studies investigating help-seeking outcomes of school-based mental health literacy interventions including a total of 7066 participants from 66 secondary schools. Overall, there is no strong evidence for the effectiveness of school-based mental health literacy interventions in improving help-seeking outcomes, including general attitudes towards help-seeking, personal intentions to seek help, knowledge of when and how to seek help for mental disorders, confidence to seek help, and actual help-seeking behaviours. None of the studies investigated the cost-effectiveness of the interventions.
CONCLUSION
The lack of standardised measures with established reliability and validity for help-seeking outcomes, and the incomprehensive consideration of the multi-faceted concepts of MH literacy and MH stigma have contributed to the scarcity of evidence for the effectiveness. Future research should focus on developing standardised measurement tools and including economic evaluations to understand pragmatic and financial aspects of school-based mental health literacy interventions.
Topics: Child; Adolescent; Humans; Mental Health; Health Literacy; Mental Disorders; School Nursing; Schools
PubMed: 36377083
DOI: 10.1111/camh.12609