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JMIR Mental Health Nov 2022Informal caregivers commonly experience mental health difficulties related to their caregiving role. e-Mental health interventions provide mental health support in a... (Review)
Review
Implementation of e-Mental Health Interventions for Informal Caregivers of Adults With Chronic Diseases: Mixed Methods Systematic Review With a Qualitative Comparative Analysis and Thematic Synthesis.
BACKGROUND
Informal caregivers commonly experience mental health difficulties related to their caregiving role. e-Mental health interventions provide mental health support in a format that may be more accessible to informal caregivers. However, e-mental health interventions are seldom implemented in real-world practice.
OBJECTIVE
This mixed methods systematic review aimed to examine factors associated with the effectiveness and implementation of e-mental health interventions for informal caregivers of adults with chronic diseases. To achieve this aim, two approaches were adopted: combinations of implementation and intervention characteristics sufficient for intervention effectiveness were explored using qualitative comparative analysis, and barriers to and facilitators of implementation of e-mental health interventions for informal caregivers were explored using thematic synthesis.
METHODS
We identified relevant studies published from January 1, 2007, to July 6, 2022, by systematically searching 6 electronic databases and various secondary search strategies. Included studies reported on the effectiveness or implementation of e-mental health interventions for informal caregivers of adults with cancer, chronic obstructive pulmonary disease, dementia, diabetes, heart disease, or stroke. Randomized controlled trials reporting on caregivers' mental health outcomes were included in a crisp-set qualitative comparative analysis. We assessed randomized controlled trials for bias using the Risk of Bias 2.0 tool, and we assessed how pragmatic or explanatory their trial design was using the Pragmatic Explanatory Continuum Indicator Summary 2 tool. Studies of any design reporting on implementation were included in a thematic synthesis using the Consolidated Framework for Implementation Research to identify barriers to and facilitators of implementation.
RESULTS
Overall, 53 reports, representing 29 interventions, were included in the review. Most interventions (27/29, 93%) focused on informal cancer or dementia caregivers. In total, 14 reports were included in the qualitative comparative analysis, exploring conditions including the presence of peer or professional support and key persuasive design features. Low consistency and coverage prevented the determination of condition sets sufficient for intervention effectiveness. Overall, 44 reports were included in the thematic synthesis, and 152 barriers and facilitators were identified, with the majority related to the intervention and individual characteristic domains of the Consolidated Framework for Implementation Research. Implementation barriers and facilitators in the inner setting (eg, organizational culture) and outer setting (eg, external policies and resources) domains were largely unexplored.
CONCLUSIONS
e-Mental health interventions for informal caregivers tend to be well-designed, with several barriers to and facilitators of implementation identified related to the intervention and individual user characteristics. Future work should focus on exploring the views of stakeholders involved in implementation to determine barriers to and facilitators of implementing e-mental health interventions for informal caregivers, focusing on inner and outer setting barriers and facilitators.
TRIAL REGISTRATION
PROSPERO (International Prospective Register of Systematic Reviews) CRD42020155727; https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020155727.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
RR2-10.1136/bmjopen-2019-035406.
PubMed: 36314782
DOI: 10.2196/41891 -
Pain Physician Oct 2022Epidural injections are among the most commonly performed procedures for managing low back and lower extremity pain. Pinto et al and Chou et al previously performed... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Epidural injections are among the most commonly performed procedures for managing low back and lower extremity pain. Pinto et al and Chou et al previously performed systematic reviews and meta-analyses, which, along with a recent update from Oliveira et al showing the lack of effectiveness of epidural steroid injections in managing lumbar disc herniation, spinal stenosis, and radiculopathy. In contrast to these papers, multiple other systematic reviews and meta-analyses have supported the effectiveness and use of epidural injections utilizing fluoroscopically guided techniques. A major flaw in the review can be related to attributing active-controlled trials to placebo-controlled trials. The assumption that local anesthetics do not provide sustained benefit, despite extensive evidence that local anesthetics provide long-term relief, similar to a combination of local anesthetic with steroids is flawed.
STUDY DESIGN
The Cochrane Review of randomized controlled trials (RCTs) of epidural injections in managing chronic low back and lower extremity pain with sciatica or lumbar radiculopathy were reanalyzed using systematic methodology and meta-analysis.
OBJECTIVES
To re-evaluate Cochrane data on RCTs of epidural injections in managing chronic low back and lower extremity pain with sciatica or lumbar radiculopathy utilizing qualitative and quantitative techniques with dual-arm and single-arm analysis.
METHODS
In this systematic review, we have used the same RCTs from the Cochrane Review of a minimum of 20% change in pain scale or significant pain relief of >= 50%. The outcome measures were pain relief and functional status improvement. Significant improvement was defined as 50% or greater pain relief and functional status improvement. Our review was performed utilizing the Cochrane Review methodologic quality assessment and the Interventional Pain Management Techniques - Quality Appraisal of Reliability and Risk of Bias Assessment (IPM-QRB). Evidence was summarized utilizing the principles of best evidence synthesis and the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) system. Clinical relevance of the pragmatic nature of each study was assessed.
RESULTS
In evaluating the RCTs in the Cochrane Review, 10 trials were performed with fluoroscopic guidance. Utilizing conventional dual-arm and single-arm meta-analysis, the evidence is vastly different from the interpretation of the data within the Cochrane Review. The overall combined evidence is Level I, or strong evidence, at one and 3 months, and Level II, or moderate evidence, at 6 and 12 months.
LIMITATIONS
The limitation of this study is that only data contained in the Cochrane Review were analyzed.
CONCLUSION
A comparative systematic review and meta-analysis of the Cochrane Review of randomized controlled trials (RCTs) of epidural injections in managing chronic low back and lower extremity pain with sciatica or lumbar radiculopathy yielded different results. This review, based on the evidence derived from placebo-controlled trials and active-controlled trials showed Level I, or strong evidence, at one and 3 months and Level II at 6 and 12 months. This review once again emphasizes the importance of the allocation of studies to placebo-control and active-control groups, utilizing standards of practice with inclusion of only the studies performed under fluoroscopic guidance.
Topics: Humans; Radiculopathy; Anesthetics, Local; Sciatica; Low Back Pain; Injections, Epidural; Steroids
PubMed: 36288577
DOI: No ID Found -
BMJ Open Oct 2022To identify the evidence gaps that exist regarding the efficacy or effectiveness of hand surgery.
OBJECTIVES
To identify the evidence gaps that exist regarding the efficacy or effectiveness of hand surgery.
SETTING
A scoping review. We systematically searched MEDLINE, Embase and CENTRAL databases to identify all hand surgical randomised controlled trials from inception to 7 November 2020.
RESULTS
Of the 220 identified randomised controlled trials, none were fundamental efficacy trials, that is, compared surgery with placebo surgery. 172 (78%) trials compared the outcomes of different surgical techniques, and 143 (65%) trials were trauma related. We identified only 47 (21%) trials comparing surgery with non-operative care or injection.
CONCLUSION
The evidence supporting use of surgery especially for chronic hand conditions is scarce. To determine optimal care for people with hand conditions, more resources should be aimed at placebo-controlled trials and pragmatic effectiveness trials comparing hand surgery with non-operative care.
PROSPERO REGISTRATION NUMBER
CRD42019122710.
Topics: Hand; Humans; Randomized Controlled Trials as Topic
PubMed: 36216426
DOI: 10.1136/bmjopen-2022-062773 -
Journal of Clinical Epidemiology Dec 2022To explore qualitatively the relationship between selected trial design choices and proxies for a scientific and clinical uptake in a cohort of published randomized... (Review)
Review
The relationship between pragmatism, timing, and study size on impact of randomized trials: a qualitative, hypothesis generating study of trials of systemic corticosteroids for COVID-19.
OBJECTIVE
To explore qualitatively the relationship between selected trial design choices and proxies for a scientific and clinical uptake in a cohort of published randomized controlled trials (RCTs) of corticosteroids for COVID-19, to identify design characteristics that may result in trials with potential to eliminate equipoise, achieve uptake, and help reduce research waste.
STUDY DESIGN AND SETTING
A systematic literature search and qualitative, narrative review of published RCTs (up to April 13, 2021) evaluating the effectiveness of systemic corticosteroids in treatment of COVID-19. We extracted information on sample size, number of centers, single-country or multi-country conduct, dates of initiation and of publication, risk of bias and pragmatism scores, and also on an impact measured by citation in scientific literature and in clinical guidelines. We qualitatively compared design features of the highest impact vs. other trials.
RESULTS
Randomised Evaluation of COVID-19 Therapy (RECOVERY) was by the most impactful of the seven eligible RCTs as it was 10 times more frequently cited in peer-reviewed literature and influenced all the selected COVID-19 treatment guidelines. All trials started recruiting from similar dates. RECOVERY was a single-country, multicentre platform trial at low risk of bias, features which also fail to distinguish it from the other trials. RECOVERY was distinguished by more strongly pragmatic design features, more centers, and more rapid recruitment resulting in a larger sample size and early publication.
CONCLUSION
Higher pragmatism scores may contribute to recruiting more centers and more rapid recruitment of patients at each center, leading to larger size, earlier publication, and greater scientific and guideline uptake. By eliminating equipoise, RECOVERY rendered other simultaneous trials redundant. Further work is needed to confirm these findings in a larger quantitative study and to identify the individual contribution of each characteristic of pragmatism to conduct and impact of trials and their interaction in different national contexts. Until then, research waste might be reduced by designing trials with as many of the characteristics of RECOVERY as is feasible.
Topics: Humans; Adrenal Cortex Hormones; COVID-19; Randomized Controlled Trials as Topic
PubMed: 36209914
DOI: 10.1016/j.jclinepi.2022.09.018 -
The Cochrane Database of Systematic... Oct 2022Premature ovarian insufficiency (POI) is a clinical syndrome resulting from loss of ovarian function before the age of 40. It is a state of hypergonadotropic... (Review)
Review
BACKGROUND
Premature ovarian insufficiency (POI) is a clinical syndrome resulting from loss of ovarian function before the age of 40. It is a state of hypergonadotropic hypogonadism, characterised by amenorrhoea or oligomenorrhoea, with low ovarian sex hormones (oestrogen deficiency) and elevated pituitary gonadotrophins. POI with primary amenorrhoea may occur as a result of chromosomal and genetic abnormalities, such as Turner syndrome, Fragile X, or autosomal gene defects; secondary amenorrhoea may be iatrogenic after the surgical removal of the ovaries, radiotherapy, or chemotherapy. Other causes include autoimmune diseases, viral infections, and environmental factors; in most cases, POI is idiopathic. Appropriate replacement of sex hormones in women with POI may facilitate the achievement of near normal uterine development. However, the optimal effective hormone therapy (HT) regimen to maximise the reproductive potential for women with POI remains unclear.
OBJECTIVES
To investigate the effectiveness and safety of different hormonal regimens on uterine and endometrial development in women with POI.
SEARCH METHODS
We searched the Cochrane Gynaecology and Fertility (CGF) Group trials register, CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL, and two trials registers in September 2021. We also checked references of included studies, and contacted study authors to identify additional studies.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) investigating the effect of various hormonal preparations on the uterine development of women diagnosed with POI.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures recommended by Cochrane. The primary review outcome was uterine volume; secondary outcomes were endometrial thickness, endometrial histology, uterine perfusion, reproductive outcomes, and any reported adverse events.
MAIN RESULTS
We included three studies (52 participants analysed in total) investigating the role of various hormonal preparations in three different contexts, which deemed meta-analysis unfeasible. We found very low-certainty evidence; the main limitation was very serious imprecision due to small sample size. Conjugated oral oestrogens versus transdermal 17ß-oestradiol We are uncertain of the effect of conjugated oral oestrogens compared to transdermal 17ß-oestradiol (mean difference (MD) -18.2 (mL), 95% confidence interval (CI) -23.18 to -13.22; 1 RCT, N = 12; very low-certainty evidence) on uterine volume, measured after 12 months of treatment. The study reported no other relevant outcomes (including adverse events). Low versus high 17ß-oestradiol dose We are uncertain of the effect of a lower dose of 17ß-oestradiol compared to a higher dose of 17ß-oestradiol on uterine volume after three or five years of treatment, or adverse events (1 RCT, N = 20; very low-certainty evidence). The study reported no other relevant outcomes. Oral versus vaginal administration of oestradiol and dydrogesterone We are uncertain of the effect of an oral or vaginal administration route on uterine volume and endometrial thickness after 14 or 21 days of administration (1 RCT, N = 20; very low-certainty evidence). The study reported no other relevant outcomes (including adverse events).
AUTHORS' CONCLUSIONS
No clear conclusions can be drawn in this systematic review, due to the very low-certainty of the evidence. There is a need for pragmatic, well designed, randomised controlled trials, with adequate power to detect differences between various HT regimens on uterine growth, endometrial development, and pregnancy outcomes following the transfer of donated gametes or embryos in women diagnosed with POI.
Topics: Amenorrhea; Dydrogesterone; Endometrium; Estradiol; Estrogens; Female; Humans; Menopause, Premature; Pregnancy
PubMed: 36200708
DOI: 10.1002/14651858.CD008209.pub2 -
The Cochrane Database of Systematic... Sep 2022People with asthma may experience exacerbations, or 'attacks', during which their symptoms worsen and additional treatment is required. Written action plans sometimes... (Review)
Review
BACKGROUND
People with asthma may experience exacerbations, or 'attacks', during which their symptoms worsen and additional treatment is required. Written action plans sometimes advocate a short-term increase in the dose of inhaled corticosteroids (ICS) at the first sign of an exacerbation to reduce the severity of the attack and to prevent the need for oral steroids or hospital admission.
OBJECTIVES
To compare the clinical effectiveness and safety of increased versus stable doses of ICS as part of a patient-initiated action plan for the home management of exacerbations in children and adults with persistent asthma.
SEARCH METHODS
We searched the Cochrane Airways Group Specialised Register, which is derived from searches of the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and CINAHL (Cumulative Index to Nursing and Allied Health Literature), and handsearched abstracts to 20 December 2021. We also searched major trial registries for ongoing trials.
SELECTION CRITERIA
We included parallel and cross-over randomised controlled trials (RCTs) that allocated people with persistent asthma to take a blinded inhaler in the event of an exacerbation which either increased their daily dose of ICS or kept it stable (placebo).
DATA COLLECTION AND ANALYSIS
Two review authors independently selected trials, assessed quality, and extracted data. We reassessed risk of bias for all studies at the result level using the revised risk of bias tool for RCTs (Risk of Bias 2), and employed the GRADE approach to assess our confidence in the synthesised effect estimates. The primary outcome was treatment failure, defined as the need for rescue oral steroids in the randomised population. Secondary outcomes were treatment failure in the subset who initiated the study inhaler (treated population), unscheduled physician visits, unscheduled acute care, emergency department or hospital visits, serious and non-serious adverse events, and duration of exacerbation.
MAIN RESULTS
This review update added a new study that increased the number of people in the primary analysis from 1520 to 1774, and incorporates the most up-to-date methods to assess the likely impact of bias within the meta-analyses. The updated review now includes nine RCTs (1923 participants; seven parallel and two cross-over) conducted in Europe, North America, and Australasia and published between 1998 and 2018. Five studies evaluated adult populations (n = 1247; ≥ 15 years), and four studies evaluated child or adolescent populations (n = 676; < 15 years). All study participants had mild to moderate asthma. Studies varied in the dose of maintenance ICS, age, fold increase of ICS in the event of an exacerbation, criteria for initiating the study inhaler, and allowed medications. Approximately 50% of randomised participants initiated the study inhaler (range 23% to 100%), and the included studies reported treatment failure in a variety of ways, meaning assumptions were required to permit the combining of data. Participants randomised to increase their ICS dose at the first signs of an exacerbation had similar odds of needing rescue oral corticosteroids to those randomised to a placebo inhaler (odds ratio (OR) 0.97, 95% confidence interval (CI) 0.76 to 1.25; 8 studies; 1774 participants; I = 0%; moderate quality evidence). We could draw no firm conclusions from subgroup analyses conducted to investigate the impact of age, time to treatment initiation, baseline dose, smoking history, and fold increase of ICS on the primary outcome. Results for the same outcome in the subset of participants who initiated the study inhaler were unchanged from the previous version, which provides a different point estimate with very low confidence due to heterogeneity, imprecision, and risk of bias (OR 0.84, 95% CI 0.54 to 1.30; 7 studies; 766 participants; I = 42%; random-effects model). Confidence was reduced due to risk of bias and assumptions that had to be made to include study data in the intention-to-treat and treated-population analyses. Sensitivity analyses that tested the impact of assumptions made for synthesis and to exclude cross-over studies, studies at overall high risk of bias, and those with commercial funding did not change our conclusions. Pooled effects for unscheduled physician visits, unscheduled acute care, emergency department or hospital visits, and duration of exacerbation made it very difficult to determine where the true effect may lie, and confidence was reduced by risk of bias. Point estimates for both serious and non-serious adverse events favoured keeping ICS stable, but imprecision and risk of bias due to missing data and outcome measurement and reporting reduced our confidence in the effects (serious adverse events: OR 1.69, 95% CI 0.77 to 3.71; 2 studies; 394 participants; I² = 0%; non-serious adverse events: OR 2.15, 95% CI 0.68 to 6.73; 2 studies; 142 participants; I² = 0%).
AUTHORS' CONCLUSIONS
Evidence from double-blind trials of adults and children with mild to moderate asthma suggests there is unlikely to be an important reduction in the need for oral steroids from increasing a patient's ICS dose at the first sign of an exacerbation. Other clinically important benefits and potential harms of increased doses of ICS compared with keeping the dose stable cannot be ruled out due to wide confidence intervals, risk of bias in the trials, and assumptions that had to be made for synthesis. Included studies conducted between 1998 and 2018 reflect evolving clinical practice and study methods, and the data do not support thorough investigation of effect modifiers such as baseline dose, fold increase, asthma severity and timing. The review does not include recent evidence from pragmatic, unblinded studies showing benefits of larger dose increases in those with poorly controlled asthma. A systematic review is warranted to examine the differences between the blinded and unblinded trials using robust methods for assessing risk of bias to present the most complete view of the evidence for decision makers.
Topics: Adolescent; Adrenal Cortex Hormones; Adult; Anti-Asthmatic Agents; Asthma; Child; Hospitalization; Humans; Nebulizers and Vaporizers; Randomized Controlled Trials as Topic
PubMed: 36161875
DOI: 10.1002/14651858.CD007524.pub5 -
The Cochrane Database of Systematic... Sep 2022People diagnosed with borderline personality disorder (BPD) frequently present to healthcare services in crisis, often with suicidal thoughts or actions. Despite this,... (Review)
Review
BACKGROUND
People diagnosed with borderline personality disorder (BPD) frequently present to healthcare services in crisis, often with suicidal thoughts or actions. Despite this, little is known about what constitutes effective management of acute crises in this population and what type of interventions are helpful at times of crisis. In this review, we will examine the efficacy of crisis interventions, defined as an immediate response by one or more individuals to the acute distress experienced by another individual, designed to ensure safety and recovery and lasting no longer than one month. This review is an update of a previous Cochrane Review examining the evidence for the effects of crisis interventions in adults diagnosed with BPD.
OBJECTIVES
To assess the effects of crisis interventions in adults diagnosed with BPD in any setting.
SEARCH METHODS
We searched CENTRAL, MEDLINE, Embase, nine other databases and three trials registers up to January 2022. We also checked reference lists, handsearched relevant journal archives and contacted experts in the field to identify any unpublished or ongoing studies.
SELECTION CRITERIA
Randomised controlled trials (RCTs) comparing crisis interventions with usual care, no intervention or waiting list, in adults of any age diagnosed with BPD.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures expected by Cochrane.
MAIN RESULTS
We included two studies with 213 participants. One study (88 participants) was a feasibility RCT conducted in the UK that examined the effects of joint crisis plans (JCPs) plus treatment as usual (TAU) compared to TAU alone in people diagnosed with BPD. The primary outcome was self-harm. Participants had an average age of 36 years, and 81% were women. Government research councils funded the study. Risk of bias was unclear for blinding, but low in the other domains assessed. Evidence from this study suggested that there may be no difference between JCPs and TAU on deaths (risk ratio (RR) 0.91, 95% confidence interval (CI) 0.06 to 14.14; 88 participants; low-certainty evidence); mean number of self-harm episodes (mean difference (MD) 0.30, 95% CI -36.27 to 36.87; 72 participants; low-certainty evidence), number of inpatient mental health nights (MD 1.80, 95% CI -5.06 to 8.66; 73 participants; low-certainty evidence), or quality of life measured using the EuroQol five-dimension questionnaire (EQ-5D; MD -6.10, 95% CI -15.52 to 3.32; 72 participants; very low-certainty evidence). The study authors calculated an Incremental Cost Effectiveness Ratio of GBP -32,358 per quality-adjusted life year (QALY), favouring JCPs, but they described this result as "hypothesis-generating only" and we rated this as very low-certainty evidence. The other study (125 participants) was an RCT conducted in Sweden of brief admission to psychiatric hospital by self-referral (BA) compared to TAU, in people with self-harm or suicidal behaviour and three or more diagnostic criteria for BPD. The primary outcome was use of inpatient mental health services. Participants had an average age of 32 years, and 85% were women. Government research councils and non-profit foundations funded the study. Risk of bias was unclear for blinding and baseline imbalances, but low in the other domains assessed. The evidence suggested that there is no clear difference between BA and TAU on deaths (RR 0.49, 95% CI 0.05 to 5.29; 125 participants; low-certainty evidence), mean number of self-harm episodes (MD -0.03, 95% CI -2.26 to 2.20; 125 participants; low-certainty evidence), violence perpetration (RR 2.95, 95% CI 0.12 to 71.13; 125 participants; low-certainty evidence), or days of inpatient mental health care (MD 0.70, 95% CI -14.32 to 15.72; 125 participants; low-certainty evidence). The study suggested that BA may have little or no effect on the mean number of suicide attempts (MD 0.00, 95% CI -0.06 to 0.06; 125 participants; very low-certainty evidence). We also identified three ongoing RCTs that met our inclusion criteria. The results will be incorporated into future updates of this review.
AUTHORS' CONCLUSIONS
A comprehensive search of the literature revealed very little RCT-based evidence to inform the management of acute crises in people diagnosed with BPD. We included two studies of two very different types of intervention (JCP and BA). We found no clear evidence of a benefit over TAU in any of our main outcomes. We are very uncertain about the true effects of either intervention, as the evidence was judged low- and very low-certainty, and there was only a single study of each intervention. There is an urgent need for high-quality, large-scale, adequately powered RCTs on crisis interventions for people diagnosed with BPD, in addition to development of new crisis interventions.
Topics: Adult; Borderline Personality Disorder; Crisis Intervention; Female; Hospitalization; Humans; Male; Quality of Life; Self-Injurious Behavior
PubMed: 36161394
DOI: 10.1002/14651858.CD009353.pub3 -
Annals of Medicine Dec 2022Psychotropic medications are commonly prescribed among adults with intellectual disability, often in the absence of a psychiatric diagnosis. The aim of this scoping...
BACKGROUND/OBJECTIVE(S)
Psychotropic medications are commonly prescribed among adults with intellectual disability, often in the absence of a psychiatric diagnosis. The aim of this scoping review is to provide an overview of the extent, range, and nature of the available research on medication use and practices and medication management in people with intellectual disability taking psychotropic medications for behaviours that challenge.
MATERIALS AND METHODS
A scoping review of research studies (qualitative, quantitative, and mixed design) and Grey Literature (English) was carried out. Databases included: Ovid MEDLINE, Embase, CINAHL, JBI Evidence Synthesis, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, PsycINFO, and Scopus. A three-step search strategy was followed, with results screened by two independent reviewers. Data was extracted independently by two reviewers using a data extraction tool with results mapped and presented using a narrative form supported by tables and diagrams to the research questions.
RESULTS
Following the removal of duplicates, records were screened, full texts assessed, and 49 studies were included. Medication outcomes included reduced repetitive, stereotypic, and/or aggressive behaviours. High dosing/prescribing in the setting of an absent/unclear clinical indication was associated with worsening of symptoms for which psychotropics were prescribed. While psychotropics had a role in managing behaviours that challenge, reducing or discontinuing psychotropics is sometimes warranted. Study designs were frequently pragmatic resulting in small sample sizes and heterogeneous cohorts receiving different doses and combinations of medications. Access to multidisciplinary teams, guidelines, medication reviews, staff training, and enhanced roles for carers in decision-making were warranted to optimize psychotropic use.
CONCLUSIONS
These findings can inform prescribing interventions and highlight the need for timely and comprehensive patient outcome data, especially on long-term use of high doses of psychotropics and what happens when reduce or stop prescribing these doses.KEY MESSAGESPsychotropic medications are frequently prescribed for people with intellectual disabilities, often at high doses and these medications are associated with both positive and negative patient outcomes.Work to rationalize psychotropic use has been reported with interventions aiming to reduce polypharmacy or deprescribe a single psychotropic medicine. These interventions had mixed success and risk of relapse was documented in some studies.Limitations in sample size and heterogenous patient cohorts make it challenging to understand the risks and benefits associated with reducing or stopping psychotropic medicines.Patient, carer, and clinician partnerships are critical to advance medication management.
Topics: Adult; Databases, Factual; Humans; Intellectual Disability; Polypharmacy; Psychotropic Drugs; Systematic Reviews as Topic
PubMed: 36120887
DOI: 10.1080/07853890.2022.2121853 -
Dermatology (Basel, Switzerland) 2023Hidradenitis suppurativa (HS) is a chronic inflammatory disease that disproportionally affects women, as well as Black and biracial individuals. While adalimumab remains...
BACKGROUND
Hidradenitis suppurativa (HS) is a chronic inflammatory disease that disproportionally affects women, as well as Black and biracial individuals. While adalimumab remains the only therapy approved by the Food and Drug Administration for HS, many HS clinical trials for novel and re-tasked therapies are ongoing or upcoming. To optimize treatment equity, reflect the patient population, and facilitate trial participation, it is important to elucidate aspects of clinical trial protocols that may systematically exclude specific patient groups or impose hardships.
OBJECTIVE
The study aimed to systematically review inclusion and exclusion criteria as well as participant demographics in HS clinical trials.
METHODS
A literature search of PubMed, Embase, Cochrane Central, and Web of Science databases was conducted. Peer-reviewed publications of randomized controlled trials that were written in English and had at least 10 participants were included. Title and abstract screening and data extraction were completed by two independent reviewers, with disagreements resolved by a third.
RESULTS
Twenty-three studies totaling 1,496 adult participants met the inclusion criteria. Race and ethnicity were not reported in 473/1,496 (31.6%) and 1,420/1,496 (94.9%) trial participants, respectively. Trial participants were predominantly white (811/1,023, 79.3%) and female (1,057/1,457, 72.5%). The median of each study's average age was 35.7 years (IQR 33.5-38.0), and 17/23 (73.9%) trials excluded pediatric patients. Nearly all participants had Hurley Stage II (499/958, 52.0%) or Hurley Stage III (385/958, 40.2%) disease. Many trials excluded patients who were pregnant (19/23, 82.6%) and breastfeeding (13/23, 56.5%), or who had HS that was "too severe" (8/23, 34.8%) or "too mild" (16/23, 70.0%). Frequently, trial protocols required prolonged washout periods from HS therapies, relatively long duration in the study's placebo arm, and prohibited concurrent analgesic use.
CONCLUSIONS
This systematic review of 23 HS clinical trials totaling 1,496 participants identified substantial hardships imposed by trial participation, high rates of missing race and ethnicity data, and low representation of key patient groups, including those who identify as Black. Future trials with pragmatic study designs, broader inclusion criteria, and study sites in diverse communities may alleviate burdens of trial participation and improve enrollment of diverse patient groups.
Topics: Adult; Humans; Female; Hidradenitis Suppurativa; Clinical Trials as Topic; Adalimumab; Demography; Randomized Controlled Trials as Topic
PubMed: 36108592
DOI: 10.1159/000526069 -
JAMA Pediatrics Nov 2022Adequate sleep duration is necessary for many aspects of child health, development, and well-being, yet sleep durations for children are declining, and effective... (Meta-Analysis)
Meta-Analysis
IMPORTANCE
Adequate sleep duration is necessary for many aspects of child health, development, and well-being, yet sleep durations for children are declining, and effective strategies to increase sleep in healthy children remain to be elucidated.
OBJECTIVE
To determine whether nonpharmaceutical interventions to improve sleep duration in healthy children are effective and to identify the key components of these interventions.
DATA SOURCES
CENTRAL, MEDLINE, Embase, PsycINFO, Web of Science Core collection, ClinicalTrials.gov, and WHO trials databases were searched from inception to November 15, 2021.
STUDY SELECTION
Randomized clinical trials of interventions to improve sleep duration in healthy children were independently screened by 2 researchers. A total of 28 478 studies were identified.
DATA EXTRACTION AND SYNTHESIS
Data were processed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) reporting guideline. Random-effects meta-analytic models were used to estimate pooled effect sizes.
MAIN OUTCOMES AND MEASURES
Difference in sleep duration, measured in minutes.
RESULTS
A total of 13 539 child participants from 45 randomized clinical trials were included. Of these, 6897 (50.9%) were in the intervention group and 6642 (49.1%) in the control group, and the mean age ranged from 18 months to 19 years. Pooled results indicate that sleep interventions were associated with 10.5 minutes (95% CI, 5.6-15.4) longer nocturnal sleep duration. There was substantial variation between trials. Sources of variation that were not associated with the study effect size included age group, whether the population was identified as having a sleep problem or being at a socioeconomic disadvantage (eg, coming from a low-income family or area), method of assessment of sleep duration (objective vs subjective), location of intervention delivery (home vs school), whether interventions were delivered in person or used parental involvement, whether behavioral theory was used, environmental change, or had greater or lower intensity. Interventions that included earlier bedtimes were associated with a 47-minute sleep extension (95% CI, 18.9-75.0; 3 trials) compared with remaining studies (7.4 minutes; 95% CI, 2.9-11.8; 42 trials) (P = .006 for group difference). Trials of shorter duration (6 months or less) had larger effects.
CONCLUSIONS AND RELEVANCE
Interventions focused on earlier bedtimes may offer a simple, pragmatic, effective way to meaningfully increase sleep duration that could have important benefits for child health.
Topics: Child; Humans; Infant; Sleep; Parents; Schools; Time Factors
PubMed: 36094530
DOI: 10.1001/jamapediatrics.2022.3172