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International Journal of Chronic... 2017Randomized controlled trials (RCTs) indicate that long-acting bronchodilator combinations, such as β-agonist (LABA)/muscarinic antagonist (LAMA), have favorable... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Randomized controlled trials (RCTs) indicate that long-acting bronchodilator combinations, such as β-agonist (LABA)/muscarinic antagonist (LAMA), have favorable efficacy compared with commonly used COPD treatments. The objective of this analysis was to compare the efficacy and safety of LABA/LAMA with LAMA or LABA/inhaled corticosteroid (ICS) in adults with stable moderate-to-very-severe COPD.
METHODS
This systematic review and meta-analysis (PubMed/MEDLINE, Embase, Cochrane Library and clinical trial/manufacturer databases) included RCTs comparing ≥12 weeks' LABA/LAMA treatment with LAMA and/or LABA/ICS (approved doses only). Eligible studies were independently selected by two authors using predefined data fields; the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines were followed.
RESULTS
Eighteen studies (23 trials) were eligible (N=20,185). LABA/LAMA significantly improved trough forced expiratory volume in 1 second (FEV) from baseline to week 12 versus both LAMA and LABA/ICS (0.07 L and 0.08 L, <0.0001), with patients more likely to achieve clinically important improvements in FEV of >100 mL (risk ratio [RR]: 1.33, 95% confidence interval [CI]: [1.20, 1.46] and RR: 1.44, 95% CI: [1.33, 1.56], respectively, the number needed to treat being eight and six, respectively). LABA/LAMA improved transitional dyspnea index and St George's Respiratory Questionnaire scores at week 12 versus LAMA (both <0.0001), but not versus LABA/ICS, and reduced rescue medication use versus both (<0.0001 and =0.001, respectively). LABA/LAMA significantly reduced moderate/severe exacerbation rate compared with LABA/ICS (RR 0.82, 95% CI: [0.75, 0.91]). Adverse event (AE) incidence was no different for LABA/LAMA versus LAMA treatment, but it was lower versus LABA/ICS (RR 0.94, 95% CI: [0.89, 0.99]), including a lower pneumonia risk (RR 0.59, 95% CI: [0.43, 0.81]). LABA/LAMA presented a lower risk for withdrawals due to lack of efficacy versus LAMA (RR: 0.66, 95% CI: [0.51, 0.87]) and due to AEs versus LABA/ICS (RR: 0.83, 95% CI: [0.69, 0.99]).
CONCLUSION
The greater efficacy and comparable safety profiles observed with LABA/LAMA combinations versus LAMA or LABA/ICS support their potential role as first-line treatment options in COPD. These findings are of direct relevance to clinical practice because we included all currently available LABA/LAMAs and comparators, only at doses approved for clinical use.
Topics: Administration, Inhalation; Adrenal Cortex Hormones; Adrenergic beta-2 Receptor Agonists; Bronchodilator Agents; Chi-Square Distribution; Disease Progression; Drug Combinations; Forced Expiratory Volume; Humans; Lung; Muscarinic Antagonists; Odds Ratio; Pulmonary Disease, Chronic Obstructive; Randomized Controlled Trials as Topic; Recovery of Function; Risk Factors; Time Factors; Treatment Outcome
PubMed: 28360514
DOI: 10.2147/COPD.S130482 -
BMC Musculoskeletal Disorders Nov 2015Low back pain is a common and costly health complaint for which there are several moderately effective treatments. In some fields there is evidence that funder and... (Meta-Analysis)
Meta-Analysis Review
The effect of journal impact factor, reporting conflicts, and reporting funding sources, on standardized effect sizes in back pain trials: a systematic review and meta-regression.
BACKGROUND
Low back pain is a common and costly health complaint for which there are several moderately effective treatments. In some fields there is evidence that funder and financial conflicts are associated with trial outcomes. It is not clear whether effect sizes in back pain trials relate to journal impact factor, reporting conflicts of interest, or reporting funding.
METHODS
We performed a systematic review of English-language papers reporting randomised controlled trials of treatments for non-specific low back pain, published between 2006-2012. We modelled the relationship using 5-year journal impact factor, and categories of reported of conflicts of interest, and categories of reported funding (reported none and reported some, compared to not reporting these) using meta-regression, adjusting for sample size, and publication year. We also considered whether impact factor could be predicted by the direction of outcome, or trial sample size.
RESULTS
We could abstract data to calculate effect size in 99 of 146 trials that met our inclusion criteria. Effect size is not associated with impact factor, reporting of funding source, or reporting of conflicts of interest. However, explicitly reporting 'no trial funding' is strongly associated with larger absolute values of effect size (adjusted β=1.02 (95 % CI 0.44 to 1.59), P=0.001). Impact factor increases by 0.008 (0.004 to 0.012) per unit increase in trial sample size (P<0.001), but does not differ by reported direction of the LBP trial outcome (P=0.270).
CONCLUSIONS
The absence of associations between effect size and impact factor, reporting sources of funding, and conflicts of interest reflects positively on research and publisher conduct in the field. Strong evidence of a large association between absolute magnitude of effect size and explicit reporting of 'no funding' suggests authors of unfunded trials are likely to report larger effect sizes, notwithstanding direction. This could relate in part to quality, resources, and/or how pragmatic a trial is.
Topics: Conflict of Interest; Evidence-Based Medicine; Humans; Journal Impact Factor; Low Back Pain; Peer Review, Research; Periodicals as Topic; Practice Guidelines as Topic; Publication Bias; Randomized Controlled Trials as Topic; Research Design; Research Support as Topic; Sample Size; Time Factors; Treatment Outcome
PubMed: 26620449
DOI: 10.1186/s12891-015-0825-6 -
The Journal of Allergy and Clinical... Jul 2022Inhaled medications are central to treating asthma and chronic obstructive pulmonary disease (COPD), yet critical inhaler technique errors are made by up to 90% of...
Is Inhaler Technique Adequately Assessed and Reported in Clinical Trials of Asthma and Chronic Obstructive Pulmonary Disease Therapy? A Systematic Review and Suggested Best Practice Checklist.
BACKGROUND
Inhaled medications are central to treating asthma and chronic obstructive pulmonary disease (COPD), yet critical inhaler technique errors are made by up to 90% of patients. In the clinical research setting, recruitment of subjects with poor inhaler technique may give a false impression of both the benefits and the necessity of add-on treatments such as biologic therapies.
OBJECTIVE
To assess the frequency with which inhaler technique is assessed and reliably optimized before and during patient enrollment into randomized controlled trials (RCTs) addressing the efficacy of topical therapy, and the escalation of therapy for asthma and COPD.
METHODS
Systematic searches were conducted of PubMed and Embase for RCTs published in the past 10 years involving patients with a diagnosis of asthma or COPD undergoing escalation of baseline inhaled therapy (stepping up, changing, adding, switching, increasing, etc) or the introduction of biologic agents.
RESULTS
Searches highlighted 1,014 studies, 118 of which were eligible after the removal of duplicates as well as screening and full text review. Of these, only 14 (11.9%) included accessible information in the methods section or referred to such information in online supplements or protocols concerning assessment of participants' inhaler technique. We therefore developed the proposed Best Practice Inhaler Technique Assessment and Reporting Checklist.
CONCLUSIONS
Our study identifies a concerning lack of checking and correcting inhaler technique, or at least reporting that this was undertaken, before enrollment in asthma and COPD RCTs, which may affect the conclusions drawn. Mandating the use of a standardized checklist in RCT protocols and ensuring all published RCTs report checking and correcting inhaler technique before enrollment are important next steps.
Topics: Administration, Inhalation; Asthma; Checklist; Humans; Nebulizers and Vaporizers; Pulmonary Disease, Chronic Obstructive
PubMed: 35364340
DOI: 10.1016/j.jaip.2022.03.013 -
Pain Physician 2009Post lumbar surgery syndrome or failed back surgery syndrome with persistent pain continues to increase over the years. The speculated causes of post lumbar laminectomy... (Review)
Review
BACKGROUND
Post lumbar surgery syndrome or failed back surgery syndrome with persistent pain continues to increase over the years. The speculated causes of post lumbar laminectomy syndrome include acquired stenosis, epidural fibrosis, arachnoiditis, radiculopathy, and recurrent disc herniation. Epidural fibrosis may account for as much as 20% to 36% of all cases of failed back surgery syndrome. Percutaneous epidural adhesiolysis has been employed in interventional pain management in the treatment of chronic, refractory low back and lower extremity pain after back surgery.
STUDY DESIGN
A systematic review of randomized trials and observational studies.
OBJECTIVE
To evaluate the effectiveness of percutaneous adhesiolysis in managing chronic low back and lower extremity pain due to post lumbar surgery syndrome.
METHODS
A comprehensive literature search was conducted utilizing electronic databases, as well as systematic reviews and cross references from 1966 through December 2008. The quality of individual articles used in this analysis was assessed by modified Cochrane review criteria for randomized trials and the Agency for Healthcare Research and Quality (AHRQ) criteria for assessment of observational studies. Clinical relevance was evaluated using 5 questions according to the criteria recommended by the Cochrane Review Back Group. Analysis was conducted using 5 levels of evidence, ranging from Level I to III, with 3 subcategories in Level II.
OUTCOME PARAMETERS
The primary outcome measure was pain relief (short-term relief of at least 6 months and long-term relief of more than 6 months). Secondary outcome measures were improvement in functional status, psychological status, return to work, and change in opioid intake.
RESULTS
Of the 13 studies considered for inclusion, 3 randomized trials and 4 observational studies met the inclusion criteria for methodologic quality assessment and evidence synthesis based on methodologic quality scores of 50 or more. Evidence of percutaneous adhesiolysis in the management of chronic low back pain in post-lumbar surgery syndrome is Level I to Level II-1, with evidence derived from 3 randomized trials.
LIMITATIONS
There is a paucity of efficacy and pragmatic trials. No trials have been published after 2006.
CONCLUSION
The indicated level of evidence for percutaneous adhesiolysis is Level I or II-1 based on the US Preventative Services Task Force (USPSTF) criteria.
Topics: Chronic Disease; Disability Evaluation; Epidural Space; Failed Back Surgery Syndrome; Humans; Low Back Pain; Lumbosacral Region; Postoperative Period; Tissue Adhesions; Treatment Outcome
PubMed: 19305485
DOI: No ID Found -
Journal of Neurology Dec 2016Migraine causes major health impairment and disability. Psychological interventions offer an addition to pharmacotherapy but they are not currently recommended by the... (Review)
Review
Migraine causes major health impairment and disability. Psychological interventions offer an addition to pharmacotherapy but they are not currently recommended by the National Institute of Clinical Excellence (NICE) or available in the National Health Service. We aimed to systematically review evidence on the efficacy of psychological interventions for migraine in adults. A search was done of MEDLINE, psychINFO, http://www.opengrey.eu , the meta-register of controlled trials and bibliographies. Twenty-four papers were included and rated independently by two people using the Yates scale, which has 35 points. Cochrane recommendations are that high quality reports score above the mid-point (18 points). Methods used in 17/24 papers were rated 'high quality'. However, frequently descriptions of key areas such as randomisation methods were omitted. Eighteen studies measured effects of psychological interventions on headache-related outcomes, fifteen reporting significant improvements, ranging 20-67 %. Interventions also produced improvements in psychological outcomes. Few trials measured or reported improvement in disability or quality of life. We conclude that evidence supports the efficacy of psychological interventions in migraine. Over half of the studies were from the USA, which did not provide universal health care at the time of the study, so it is difficult to generalise results to typical populations in receipt of publically funded health services. We agree with the NICE recommendation that high quality pragmatic randomised controlled trials are needed in the UK.
Topics: Databases as Topic; Humans; Migraine Disorders; Psychotherapy
PubMed: 27159991
DOI: 10.1007/s00415-016-8126-z -
PloS One 2019The NICE clinical guidelines on psychosocial interventions for the treatment of schizophrenia and psychosis in adults are based on the results of randomized controlled...
INTRODUCTION
The NICE clinical guidelines on psychosocial interventions for the treatment of schizophrenia and psychosis in adults are based on the results of randomized controlled trials (RCTs), which may not be studies with a pragmatic design, leading to uncertainty on applicability or recommendations to everyday clinical practice.
AIM
To assess the level of pragmatism of the evidence used to develop the NICE guideline for psychosocial interventions in psychoses.
MATERIAL AND METHODS
We conducted a systematic and critical appraisal of RCTs used to develop the 'psychological therapy and psychosocial interventions' section of the NICE guideline on the treatment and management of psychosis and schizophrenia in adults, published in 2014. For each study we assessed pragmatism using the pragmatic-explanatory continuum indicator summary-2 (PRECIS-2) and the Cochrane risk of bias tool. The mean score of PRECIS-2, averaging across nine domains, was calculated to describe the level of pragmatism of each individual study.
RESULTS
A total of 143 studies were included in the analysis. Based on the PRECIS-2 tool, 16.8% were explanatory, 33.6% pragmatic, and 49.7% were rated in an intermediate category. Compared to explanatory studies, pragmatic studies showed a lower risk of bias. Additionally, pragmatism did not significantly improve over time, and no associations were found between pragmatism and a number of trial characteristics. However, studies with a UK leading investigator had the highest mean score of pragmatism. Cognitive behavioural therapy (CBT), art therapy, family intervention, psychoeducation, and adherence therapy, showed the higher average pragmatism scores.
CONCLUSIONS
Two third of studies used to produce NICE recommendations on psychosocial interventions for the treatment of schizophrenia and psychosis in adults are based on studies that did not employ a pragmatic design.
Topics: Government Agencies; Humans; Practice Guidelines as Topic; Pragmatic Clinical Trials as Topic; Psychiatric Rehabilitation; Psychotic Disorders; Research Design; Schizophrenia; United Kingdom
PubMed: 31550279
DOI: 10.1371/journal.pone.0222891 -
The Cochrane Database of Systematic... Mar 2023Regularly transfused people with sickle cell disease (SCD) and people with thalassaemia are at risk of iron overload. Iron overload can lead to iron toxicity in... (Review)
Review
BACKGROUND
Regularly transfused people with sickle cell disease (SCD) and people with thalassaemia are at risk of iron overload. Iron overload can lead to iron toxicity in vulnerable organs such as the heart, liver and endocrine glands, which can be prevented and treated with iron-chelating agents. The intensive demands and uncomfortable side effects of therapy can have a negative impact on daily activities and wellbeing, which may affect adherence.
OBJECTIVES
To identify and assess the effectiveness of different types of interventions (psychological and psychosocial, educational, medication interventions, or multi-component interventions) and interventions specific to different age groups, to improve adherence to iron chelation therapy compared to another listed intervention, or standard care in people with SCD or thalassaemia.
SEARCH METHODS
We searched CENTRAL (Cochrane Library), MEDLINE, PubMed, Embase, CINAHL, PsycINFO, ProQuest Dissertations & Global Theses, Web of Science & Social Sciences Conference Proceedings Indexes and ongoing trial databases (13 December 2021). We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Haemoglobinopathies Trials Register (1 August 2022).
SELECTION CRITERIA
For trials comparing medications or medication changes, only randomised controlled trials (RCTs) were eligible for inclusion. For studies including psychological and psychosocial interventions, educational interventions, or multi-component interventions, non-randomised studies of interventions (NRSIs), controlled before-after studies, and interrupted time series studies with adherence as a primary outcome were also eligible for inclusion.
DATA COLLECTION AND ANALYSIS
For this update, two authors independently assessed trial eligibility and risk of bias, and extracted data. We assessed the certainty of the evidence using GRADE.
MAIN RESULTS
We included 19 RCTs and one NRSI published between 1997 and 2021. One trial assessed medication management, one assessed an education intervention (NRSI) and 18 RCTs were of medication interventions. Medications assessed were subcutaneous deferoxamine, and two oral chelating agents, deferiprone and deferasirox. We rated the certainty of evidence as very low to low across all outcomes identified in this review. Four trials measured quality of life (QoL) with validated instruments, but provided no analysable data and reported no difference in QoL. We identified nine comparisons of interest. 1. Deferiprone versus deferoxamine We are uncertain whether or not deferiprone affects adherence to iron chelation therapy (four RCTs, unpooled, very low-certainty evidence), all-cause mortality (risk ratio (RR) 0.47, 95% confidence interval (CI) 0.18 to 1.21; 3 RCTs, 376 participants; very low-certainty evidence), or serious adverse events (SAEs) (RR 1.43, 95% CI 0.83 to 2.46; 1 RCT, 228 participants; very low-certainty evidence). Adherence was reported as "good", "high" or "excellent" by all seven trials, though the data could not be analysed formally: adherence ranged from 69% to 95% (deferiprone, mean 86.6%), and 71% to 93% (deferoxamine, mean 78.8%), based on five trials (474 participants) only. 2. Deferasirox versus deferoxamine We are uncertain whether or not deferasirox affects adherence to iron chelation therapy (three RCTs, unpooled, very low-certainty evidence), although medication adherence was high in all trials. We are uncertain whether or not there is any difference between the drug therapies in serious adverse events (SAEs) (SCD or thalassaemia) or all-cause mortality (thalassaemia). 3. Deferiprone versus deferasirox We are uncertain if there is a difference between oral deferiprone and deferasirox based on a single trial in children (average age 9 to 10 years) with any hereditary haemoglobinopathy in adherence, SAEs and all-cause mortality. 4. Deferasirox film-coated tablet (FCT) versus deferasirox dispersible tablet (DT) One RCT compared deferasirox in different tablet forms. There may be a preference for FCTs, shown through a trend for greater adherence (RR 1.10, 95% CI 0.99 to 1.22; 1 RCT, 88 participants), although medication adherence was high in both groups (FCT 92.9%; DT 85.3%). We are uncertain if there is a benefit in chelation-related AEs with FCTs. We are uncertain if there is a difference in the incidence of SAEs, all-cause mortality or sustained adherence. 5. Deferiprone and deferoxamine combined versus deferiprone alone We are uncertain if there is a difference in adherence, though reporting was usually narrative as triallists report it was "excellent" in both groups (three RCTs, unpooled). We are uncertain if there is a difference in the incidence of SAEs and all-cause mortality. 6. Deferiprone and deferoxamine combined versus deferoxamine alone We are uncertain if there is a difference in adherence (four RCTs), SAEs (none reported in the trial period) and all-cause mortality (no deaths reported in the trial period). There was high adherence in all trials. 7. Deferiprone and deferoxamine combined versus deferiprone and deferasirox combined There may be a difference in favour of deferiprone and deferasirox (combined) in rates of adherence (RR 0.84, 95% CI 0.72 to 0.99) (one RCT), although it was high (> 80%) in both groups. We are uncertain if there is a difference in SAEs, and no deaths were reported in the trial, so we cannot draw conclusions based on these data (one RCT). 8. Medication management versus standard care We are uncertain if there is a difference in QoL (one RCT), and we could not assess adherence due to a lack of reporting in the control group. 9. Education versus standard care One quasi-experimental (NRSI) study could not be analysed due to the severe baseline confounding.
AUTHORS' CONCLUSIONS
The medication comparisons included in this review had higher than average adherence rates not accounted for by differences in medication administration or side effects, though often follow-up was not good (high dropout over longer trials), with adherence based on a per protocol analysis. Participants may have been selected based on higher adherence to trial medications at baseline. Also, within the clinical trial context, there is increased attention and involvement of clinicians, thus high adherence rates may be an artefact of trial participation. Real-world, pragmatic trials in community and clinic settings are needed that examine both confirmed or unconfirmed adherence strategies that may increase adherence to iron chelation therapy. Due to lack of evidence this review cannot comment on intervention strategies for different age groups.
Topics: Child; Humans; Anemia, Sickle Cell; Chelating Agents; Chelation Therapy; Deferoxamine; Drug-Related Side Effects and Adverse Reactions; Iron; Thalassemia
PubMed: 36877640
DOI: 10.1002/14651858.CD012349.pub3 -
The Journal of Pain Dec 2015Chronic neuropathic pain, the most frequent condition affecting the peripheral nervous system, remains underdiagnosed and difficult to treat. Inhaled cannabis may... (Meta-Analysis)
Meta-Analysis Review
UNLABELLED
Chronic neuropathic pain, the most frequent condition affecting the peripheral nervous system, remains underdiagnosed and difficult to treat. Inhaled cannabis may alleviate chronic neuropathic pain. Our objective was to synthesize the evidence on the use of inhaled cannabis for chronic neuropathic pain. We performed a systematic review and a meta-analysis of individual patient data. We registered our protocol with PROSPERO CRD42011001182. We searched in Cochrane Central, PubMed, EMBASE, and AMED. We considered all randomized controlled trials investigating chronic painful neuropathy and comparing inhaled cannabis with placebo. We pooled treatment effects following a hierarchical random-effects Bayesian responder model for the population-averaged subject-specific effect. Our evidence synthesis of individual patient data from 178 participants with 405 observed responses in 5 randomized controlled trials following patients for days to weeks provides evidence that inhaled cannabis results in short-term reductions in chronic neuropathic pain for 1 in every 5 to 6 patients treated (number needed to treat = 5.6 with a Bayesian 95% credible interval ranging between 3.4 and 14). Our inferences were insensitive to model assumptions, priors, and parameter choices. We caution that the small number of studies and participants, the short follow-up, shortcomings in allocation concealment, and considerable attrition limit the conclusions that can be drawn from the review. The Bayes factor is 332, corresponding to a posterior probability of effect of 99.7%.
PERSPECTIVE
This novel Bayesian meta-analysis of individual patient data from 5 randomized trials suggests that inhaled cannabis may provide short-term relief for 1 in 5 to 6 patients with neuropathic pain. Pragmatic trials are needed to evaluate the long-term benefits and risks of this treatment.
Topics: Administration, Inhalation; Adult; Aged; Bayes Theorem; Cannabis; Chronic Pain; Female; Humans; Male; Medical Marijuana; Middle Aged; Pain; Peripheral Nervous System; Peripheral Nervous System Diseases; Randomized Controlled Trials as Topic; Young Adult
PubMed: 26362106
DOI: 10.1016/j.jpain.2015.07.009 -
BMJ Open Jul 2020To synthesise findings from randomised controlled trials (RCTs) of interventions aimed at increasing medication adherence in individuals with type 2 diabetes (T2DM)... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
To synthesise findings from randomised controlled trials (RCTs) of interventions aimed at increasing medication adherence in individuals with type 2 diabetes (T2DM) and/or cardiovascular disease (CVD). And, in a novel approach, to compare the intervention effect of studies which were categorised as being more pragmatic or more explanatory using the Pragmatic-Explanatory Continuum Indicator Summary-2 (PRECIS-2) tool, to identify whether study design affects outcomes. As explanatory trials are typically held under controlled conditions, findings from such trials may not be relatable to real-world clinical practice. In comparison, pragmatic trials are designed to replicate real-world conditions and therefore findings are more likely to represent those found if the intervention were to be implemented in routine care.
DESIGN
Systematic review and meta-analysis.
DATA SOURCES
Ovid Medline, Ovid Embase, Web of Science and CINAHL from 1 January 2013 to 31 December 2018.
ELIGIBILITY CRITERIA FOR SELECTING STUDIES
RCTs lasting ≥3 months (90 days), involving ≥200 patients in the analysis, with either established CVD and/or T2DM and which measured medication adherence. From 4403 citations, 103 proceeded to full text review. Studies published in any language other than English and conference abstracts were excluded.
MAIN OUTCOME MEASURE
Change in medication adherence.
RESULTS
Of 4403 records identified, 34 studies were considered eligible, of which 28, including 30 861 participants, contained comparable outcome data for inclusion in the meta-analysis. Overall interventions were associated with an increase in medication adherence (OR 1.57 (95% CI: 1.33 to 1.84), p<0.001; standardised mean difference 0.24 (95% CI: -0.10 to 0.59) p=0.101). The effectiveness of interventions did not differ significantly between studies considered pragmatic versus explanatory (p=0.598), but did differ by intervention type, with studies that included a multifaceted rather than a single-faceted intervention having a more significant effect (p=0.010). The analysis used random effect models and used the revised Cochrane Risk of Bias Tool to assess study quality.
CONCLUSIONS
In this meta-analysis, interventions were associated with a significant increase in medication adherence. Overall multifaceted interventions which included an element of education alongside regular patient contact or follow-up showed the most promise. Effectiveness of interventions between pragmatic and explanatory trials was comparable, suggesting that findings can be transferred from idealised to real-word conditions.
PROSPERO REGISTRATION NUMBER
CRD42017059460.
Topics: Cardiovascular Diseases; Humans; Medication Adherence
PubMed: 32709649
DOI: 10.1136/bmjopen-2019-036575 -
Global Mental Health (Cambridge,... 2020We systematically reviewed implementation research targeting depression interventions in low- and middle-income countries (LMICs) to assess gaps in methodological... (Review)
Review
BACKGROUND
We systematically reviewed implementation research targeting depression interventions in low- and middle-income countries (LMICs) to assess gaps in methodological coverage.
METHODS
PubMed, CINAHL, PsycINFO, and EMBASE were searched for evaluations of depression interventions in LMICs reporting at least one implementation outcome published through March 2019.
RESULTS
A total of 8714 studies were screened, 759 were assessed for eligibility, and 79 studies met inclusion criteria. Common implementation outcomes reported were acceptability ( = 50; 63.3%), feasibility ( = 28; 35.4%), and fidelity ( = 18; 22.8%). Only four studies (5.1%) reported adoption or penetration, and three (3.8%) reported sustainability. The Sub-Saharan Africa region ( = 29; 36.7%) had the most studies. The majority of studies ( = 59; 74.7%) reported outcomes for a depression intervention implemented in pilot researcher-controlled settings. Studies commonly focused on Hybrid Type-1 effectiveness-implementation designs ( = 53; 67.1), followed by Hybrid Type-3 ( = 16; 20.3%). Only 21 studies (26.6%) tested an implementation strategy, with the most common being revising professional roles ( = 10; 47.6%). The most common intervention modality was individual psychotherapy ( = 30; 38.0%). Common study designs were mixed methods ( = 27; 34.2%), quasi-experimental uncontrolled pre-post ( = 17; 21.5%), and individual randomized trials ( = 16; 20.3).
CONCLUSIONS
Existing research has focused on early-stage implementation outcomes. Most studies have utilized Hybrid Type-1 designs, with the primary aim to test intervention effectiveness delivered in researcher-controlled settings. Future research should focus on testing and optimizing implementation strategies to promote scale-up of evidence-based depression interventions in routine care. These studies should use high-quality pragmatic designs and focus on later-stage implementation outcomes such as cost, penetration, and sustainability.
PubMed: 32346482
DOI: 10.1017/gmh.2020.1