A patient centred, solution-focused approach, DIALOG+ was assessed for effectiveness among patients with severe mental illness (SMI) and epilepsy in Uganda. Fourteen clinicians and 168 patients ...attending Butabika National Mental Referral Hospital and outreach clinics in Kampala, Uganda were randomised equally to receive DIALOG + once a month for six months or an active control (DIALOG scale only). The primary outcome was subjective quality of life measured by the Manchester Short Assessment of Quality of life (MANSA) at six months and secondary outcomes assessed at six and twelve months. A generalised linear model with a fixed effect for treatment and the baseline MANSA score and a random effect for clinicians to account for clustering was used to analyse effectiveness of the intervention. The primary outcome was assessed in 154 out of 168 patients (91.7%). Patients in the DIALOG + arm had significantly higher subjective quality of life with a medium Cohen's d effect size of 0.55 and higher adherence to medication after 6 months as compared to the control group. DIALOG + intervention could be a therapeutically effective option for improving quality of life for patients with severe mental illness and epilepsy with the potential to enhance routine review meetings in low-resource settings.
•Low cost psychosocial interventions are required in limited resource settings.•DIALOG+ was tested for effectiveness in patients with severe mental illness and epilepsy.•DIALOG + improved quality of life of patients with severe mental illness and epilepsy.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Background The integration of holistic and effective end-of-life (EOL) care into cancer management has increasingly become a recognized field. People living with terminal cancer and their caregivers ...face a unique set of emotional, spiritual, and social stressors, which may be managed by psychosocial interventions. Objectives This study aimed to explore the types and characteristics of psychosocial interventions at the EOL for adult cancer patients and their caregivers and to identify gaps in the current literature. Methods A systematic search was conducted through MEDLINE (Ovid) and CINAHL from January 1, 2011, to January 31, 2021, retrieving 2453 results. A final 15 articles fulfilled the inclusion criteria, reviewed by 2 independent reviewers. Ten percent of the original articles were cross-checked against study eligibility at every stage by 2 experienced researchers. Results Most interventions reported were psychotherapies, with a predominance of meaning or legacy-related psychotherapies. Most interventions were brief, with significant caregiver involvement. Most studies were conducted in high-income, English-speaking populations. Conclusion There is robust, although heterogeneous, literature on a range of psychosocial interventions at the EOL. However, inconsistencies in the terminology used surrounding EOL and means of outcome assessment made the comparison of interventions challenging. Implication for Practice Future studies will benefit from increased standardization of study design, EOL terminology, and outcome assessment to allow for a better comparison of intervention efficacy. There is a need for increased research in psychosocial interventions among middle- to low-income populations exploring social aspects, intimacy, and the impact of COVID-19.
Background
Excessive drinking is a significant cause of mortality, morbidity and social problems in many countries. Brief interventions aim to reduce alcohol consumption and related harm in hazardous ...and harmful drinkers who are not actively seeking help for alcohol problems. Interventions usually take the form of a conversation with a primary care provider and may include feedback on the person's alcohol use, information about potential harms and benefits of reducing intake, and advice on how to reduce consumption. Discussion informs the development of a personal plan to help reduce consumption. Brief interventions can also include behaviour change or motivationally‐focused counselling.
This is an update of a Cochrane Review published in 2007.
Objectives
To assess the effectiveness of screening and brief alcohol intervention to reduce excessive alcohol consumption in hazardous or harmful drinkers in general practice or emergency care settings.
Search methods
We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and 12 other bibliographic databases to September 2017. We searched Alcohol and Alcohol Problems Science Database (to December 2003, after which the database was discontinued), trials registries, and websites. We carried out handsearching and checked reference lists of included studies and relevant reviews.
Selection criteria
We included randomised controlled trials (RCTs) of brief interventions to reduce hazardous or harmful alcohol consumption in people attending general practice, emergency care or other primary care settings for reasons other than alcohol treatment. The comparison group was no or minimal intervention, where a measure of alcohol consumption was reported. 'Brief intervention' was defined as a conversation comprising five or fewer sessions of brief advice or brief lifestyle counselling and a total duration of less than 60 minutes. Any more was considered an extended intervention. Digital interventions were not included in this review.
Data collection and analysis
We used standard methodological procedures expected by Cochrane. We carried out subgroup analyses where possible to investigate the impact of factors such as gender, age, setting (general practice versus emergency care), treatment exposure and baseline consumption.
Main results
We included 69 studies that randomised a total of 33,642 participants. Of these, 42 studies were added for this update (24,057 participants). Most interventions were delivered in general practice (38 studies, 55%) or emergency care (27 studies, 39%) settings. Most studies (61 studies, 88%) compared brief intervention to minimal or no intervention. Extended interventions were compared with brief (4 studies, 6%), minimal or no intervention (7 studies, 10%). Few studies targeted particular age groups: adolescents or young adults (6 studies, 9%) and older adults (4 studies, 6%). Mean baseline alcohol consumption was 244 g/week (30.5 standard UK units) among the studies that reported these data. Main sources of bias were attrition and lack of provider or participant blinding. The primary meta‐analysis included 34 studies (15,197 participants) and provided moderate‐quality evidence that participants who received brief intervention consumed less alcohol than minimal or no intervention participants after one year (mean difference (MD) ‐20 g/week, 95% confidence interval (CI) ‐28 to ‐12). There was substantial heterogeneity among studies (I² = 73%). A subgroup analysis by gender demonstrated that both men and women reduced alcohol consumption after receiving a brief intervention.
We found moderate‐quality evidence that brief alcohol interventions have little impact on frequency of binges per week (MD ‐0.08, 95% CI ‐0.14 to ‐0.02; 15 studies, 6946 participants); drinking days per week (MD ‐0.13, 95% CI ‐0.23 to ‐0.04; 11 studies, 5469 participants); or drinking intensity (‐0.2 g/drinking day, 95% CI ‐3.1 to 2.7; 10 studies, 3128 participants).
We found moderate‐quality evidence of little difference in quantity of alcohol consumed when extended and no or minimal interventions were compared (‐20 g/week, 95% CI ‐40 to 1; 6 studies, 1296 participants). There was little difference in binges per week (‐0.08, 95% CI ‐0.28 to 0.12; 2 studies, 456 participants; moderate‐quality evidence) or difference in days drinking per week (‐0.45, 95% CI ‐0.81 to ‐0.09; 2 studies, 319 participants; moderate‐quality evidence). Extended versus no or minimal intervention provided little impact on drinking intensity (9 g/drinking day, 95% CI ‐26 to 9; 1 study, 158 participants; low‐quality evidence).
Extended intervention had no greater impact than brief intervention on alcohol consumption, although findings were imprecise (MD 2 g/week, 95% CI ‐42 to 45; 3 studies, 552 participants; low‐quality evidence). Numbers of binges were not reported for this comparison, but one trial suggested a possible drop in days drinking per week (‐0.5, 95% CI ‐1.2 to 0.2; 147 participants; low‐quality evidence). Results from this trial also suggested very little impact on drinking intensity (‐1.7 g/drinking day, 95% CI ‐18.9 to 15.5; 147 participants; very low‐quality evidence).
Only five studies reported adverse effects (very low‐quality evidence). No participants experienced any adverse effects in two studies; one study reported that the intervention increased binge drinking for women and two studies reported adverse events related to driving outcomes but concluded they were equivalent in both study arms.
Sources of funding were reported by 67 studies (87%). With two exceptions, studies were funded by government institutes, research bodies or charitable foundations. One study was partly funded by a pharmaceutical company and a brewers association, another by a company developing diagnostic testing equipment.
Authors' conclusions
We found moderate‐quality evidence that brief interventions can reduce alcohol consumption in hazardous and harmful drinkers compared to minimal or no intervention. Longer counselling duration probably has little additional effect. Future studies should focus on identifying the components of interventions which are most closely associated with effectiveness.
This article articulates how common difficulties encountered when attempting to implement or scale-up evidence-based treatments are exacerbated by fundamental design problems, which may be addressed ...by a set of principles and methods drawn from the contemporary field of user-centered design. User-centered design is an approach to product development that grounds the process in information collected about the individuals and settings where products will ultimately be used. To demonstrate the utility of this perspective, we present four design concepts and methods: (a) clear identification of end users and their needs, (b) prototyping/rapid iteration, (c) simplifying existing intervention parameters/procedures, and (d) exploiting natural constraints. We conclude with a brief design-focused research agenda for the developers and implementers of evidence-based treatments.
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BFBNIB, CEKLJ, FFLJ, FZAB, GIS, IJS, KILJ, NLZOH, NUK, ODKLJ, OILJ, PEFLJ, SBCE, SBMB, UL, UM, UPUK
Objective: Effective psychosocial interventions exist for numerous mental health conditions. However, despite decades of research, limited progress has been made in clarifying the mechanisms that ...account for their beneficial effects. We know that many treatments work, but we know relatively little about why they work. Mechanisms of change may be obscured due to prior research collapsing across heterogeneous subgroups of patients with differing underlying mechanisms of response. Studies identifying baseline individual characteristics that predict differential response (i.e., moderation) may inform research on why (i.e., mediation) a particular subgroup has better outcomes to an intervention via tests of moderated mediation. Method: In a recent randomized controlled trial comparing a 4-week meditation app with a control condition in school system employees (N = 662), we previously developed a "Personalized Advantage Index" (PAI) using baseline characteristics, which identified a subgroup of individuals who derived relatively greater benefit from meditation training. Here, we tested whether the effect of mindfulness acquisition in mediating group differences in outcome was moderated by PAI scores. Results: A significant index of moderated mediation (IMM = 1.22, 95% CI 0.30, 2.33) revealed that the effect of mindfulness acquisition in mediating group differences in outcome was only significant among those individuals with PAI scores predicting relatively greater benefit from the meditation app. Conclusions: Subgroups of individuals may differ meaningfully in the mechanisms that mediate their response to an intervention. Considering subgroup-specific mediators may accelerate progress on clarifying mechanisms of change underlying psychosocial interventions and may help inform which specific interventions are most beneficial for whom.
What is the public health significance of this article?
Individuals receiving psychosocial interventions likely differ substantially in which intervention elements they respond to and in their causal pathways of change. This study demonstrates the utility of considering subgroup-specific mediators, which may accelerate progress on clarifying mechanisms of change underlying psychosocial interventions and may help inform which specific interventions are most beneficial for whom.
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CEKLJ, FFLJ, NUK, ODKLJ, PEFLJ, UPUK
Background
Given the significant impact epilepsy can have on the health‐related quality of life (HRQoL) of individuals with epilepsy and their families, there is great clinical interest in ...evidence‐based psychological treatments, aimed at enhancing psychological well‐being in people with epilepsy. A review of the current evidence was needed to assess the effects of psychological treatments for people with epilepsy on HRQoL outcomes, in order to inform future therapeutic recommendations and research designs.
Objectives
To assess the effects of psychological treatments for people with epilepsy on HRQoL outcomes.
Search methods
We searched the following databases on 20 September 2016, without language restrictions: Cochrane Epilepsy Group Specialized Register, CENTRAL, MEDLINE PsycINFO, ClinicalTrials.gov, WHO International Clinical Trials Registry Platform (ICTRP). We screened the references from included studies and relevant reviews, and contacted researchers in the field for unpublished studies.
Selection criteria
We considered randomized controlled trials (RCTs) and quasi‐RCTs for this review. HRQoL was the main outcome measure. For the operational definition of 'psychological treatments', we included a broad range of treatments that used psychological or behavioral techniques designed to improve HRQoL, seizure frequency and severity, and psychiatric comorbidities for adults and children with epilepsy, compared to treatment as usual (TAU) or an active control group.
Data collection and analysis
We used standard methodological procedures expected by the Cochrane Collaboration.
Main results
We included 24 completed RCTs, with a total of 2439 participants. Eleven studies investigated psychological interventions, such as cognitive, behavioral, and mindfulness‐based interventions. The remaining studies were classified as educational interventions (N = 7), self‐management interventions (N = 3), adherence interventions (N = 1), and mixed interventions (N = 2). Two studies investigated interventions for children and adolescents, and five studies investigated interventions for adolescents and adults. Based on satisfactory clinical and methodological homogeneity, we pooled data from six adult studies, two studies on adolescents and adults, and one on adolescents and young adults (468 participants) for HRQoL, measured with the Quality of Life in Epilepsy‐31 (QOLIE‐31). We found significant mean changes for the QOLIE‐31 total score and six subscales (emotional well‐being, energy and fatigue, overall QoL, seizure worry, medication effects, and cognitive functioning). The mean changes of the QOLIE‐31 total score (mean improvement of 5.68 points (95% CI 3.11 to 8.24; P < 0.0001), and three subscales, emotional well‐being (mean improvement of 7.03 points (95% CI 2.51 to 11.54; P = 0.002); energy and Fatigue (mean improvement of 6.90 points (95% CI 3.49 to 10.31; P < 0.0001); and overall QoL (mean improvement of 6.47 points (95% CI 2.68 to 10.25; P = 0.0008) exceeded the threshold of minimally important change (MIC), indicating a clinically meaningful post‐intervention improvement of QoL. We downgraded the quality of the evidence provided by the meta‐analysis because of serious risk of bias in some of the included studies. Consequentially, these results provided evidence of moderate quality that psychological treatments for adults with epilepsy may enhance overall QoL in people with epilepsy.
Authors' conclusions
Implications for practice: Psychological interventions and self‐management interventions improved QoL, and emotional well‐being, and reduced fatigue in adults and adolescents with epilepsy. Adjunctive use of psychological treatments for adults and adolescents with epilepsy may provide additional benefits to QoL in those who incorporate patient‐centered management.
Implications for research: Authors should strictly adhere to the CONSORT guidelines to improve the quality of reporting on their interventions. A thorough description of the intervention protocol is necessary to ensure reproducibility.
When researching psychological treatments for people with epilepsy, the use of Quality of Life in Epilepsy Inventories (QOLIE‐31, QOLIE‐31‐P, and QOLIE‐89) would increase comparability. There is a critical gap in pediatric RCTs for psychological treatments, particularly those that use an epilepsy‐specific measure of HRQoL.
Finally, in order to increase the overall quality of study designs, adequate randomization with allocation concealment and blinded outcome assessment should be pursued when conducting RCTs. As attrition is often high in research that requires active participant participation, an intention‐to‐treat analysis should be carried out.
Background
Alcohol use disorder (AUD) confers a prodigious burden of disease, disability, premature mortality, and high economic costs from lost productivity, accidents, violence, incarceration, and ...increased healthcare utilization. For over 80 years, Alcoholics Anonymous (AA) has been a widespread AUD recovery organization, with millions of members and treatment free at the point of access, but it is only recently that rigorous research on its effectiveness has been conducted.
Objectives
To evaluate whether peer‐led AA and professionally‐delivered treatments that facilitate AA involvement (Twelve‐Step Facilitation (TSF) interventions) achieve important outcomes, specifically: abstinence, reduced drinking intensity, reduced alcohol‐related consequences, alcohol addiction severity, and healthcare cost offsets.
Search methods
We searched the Cochrane Drugs and Alcohol Group Specialized Register, Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, Embase, CINAHL and PsycINFO from inception to 2 August 2019. We searched for ongoing and unpublished studies via ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) on 15 November 2018. All searches included non‐English language literature. We handsearched references of topic‐related systematic reviews and bibliographies of included studies.
Selection criteria
We included randomized controlled trials (RCTs), quasi‐RCTs and non‐randomized studies that compared AA or TSF (AA/TSF) with other interventions, such as motivational enhancement therapy (MET) or cognitive behavioral therapy (CBT), TSF treatment variants, or no treatment. We also included healthcare cost offset studies. Participants were non‐coerced adults with AUD.
Data collection and analysis
We categorized studies by: study design (RCT/quasi‐RCT; non‐randomized; economic); degree of standardized manualization (all interventions manualized versus some/none); and comparison intervention type (i.e. whether AA/TSF was compared to an intervention with a different theoretical orientation or an AA/TSF intervention that varied in style or intensity). For analyses, we followed Cochrane methodology calculating the standard mean difference (SMD) for continuous variables (e.g. percent days abstinent (PDA)) or the relative risk (risk ratios (RRs)) for dichotomous variables. We conducted random‐effects meta‐analyses to pool effects wherever possible.
Main results
We included 27 studies containing 10,565 participants (21 RCTs/quasi‐RCTs, 5 non‐randomized, and 1 purely economic study). The average age of participants within studies ranged from 34.2 to 51.0 years. AA/TSF was compared with psychological clinical interventions, such as MET and CBT, and other 12‐step program variants.
We rated selection bias as being at high risk in 11 of the 27 included studies, unclear in three, and as low risk in 13. We rated risk of attrition bias as high risk in nine studies, unclear in 14, and low in four, due to moderate (> 20%) attrition rates in the study overall (8 studies), or in study treatment group (1 study). Risk of bias due to inadequate researcher blinding was high in one study, unclear in 22, and low in four. Risks of bias arising from the remaining domains were predominantly low or unclear.
AA/TSF (manualized) compared to treatments with a different theoretical orientation (e.g. CBT) (randomized/quasi‐randomized evidence)
RCTs comparing manualized AA/TSF to other clinical interventions (e.g. CBT), showed AA/TSF improves rates of continuous abstinence at 12 months (risk ratio (RR) 1.21, 95% confidence interval (CI) 1.03 to 1.42; 2 studies, 1936 participants; high‐certainty evidence). This effect remained consistent at both 24 and 36 months.
For percentage days abstinent (PDA), AA/TSF appears to perform as well as other clinical interventions at 12 months (mean difference (MD) 3.03, 95% CI ‐4.36 to 10.43; 4 studies, 1999 participants; very low‐certainty evidence), and better at 24 months (MD 12.91, 95% CI 7.55 to 18.29; 2 studies, 302 participants; very low‐certainty evidence) and 36 months (MD 6.64, 95% CI 1.54 to 11.75; 1 study, 806 participants; very low‐certainty evidence).
For longest period of abstinence (LPA), AA/TSF may perform as well as comparison interventions at six months (MD 0.60, 95% CI ‐0.30 to 1.50; 2 studies, 136 participants; low‐certainty evidence).
For drinking intensity, AA/TSF may perform as well as other clinical interventions at 12 months, as measured by drinks per drinking day (DDD) (MD ‐0.17, 95% CI ‐1.11 to 0.77; 1 study, 1516 participants; moderate‐certainty evidence) and percentage days heavy drinking (PDHD) (MD ‐5.51, 95% CI ‐14.15 to 3.13; 1 study, 91 participants; low‐certainty evidence).
For alcohol‐related consequences, AA/TSF probably performs as well as other clinical interventions at 12 months (MD ‐2.88, 95% CI ‐6.81 to 1.04; 3 studies, 1762 participants; moderate‐certainty evidence).
For alcohol addiction severity, one study found evidence of a difference in favor of AA/TSF at 12 months (P < 0.05; low‐certainty evidence).
AA/TSF (non‐manualized) compared to treatments with a different theoretical orientation (e.g. CBT) (randomized/quasi‐randomized evidence)
For the proportion of participants completely abstinent, non‐manualized AA/TSF may perform as well as other clinical interventions at three to nine months follow‐up (RR 1.71, 95% CI 0.70 to 4.18; 1 study, 93 participants; low‐certainty evidence).
Non‐manualized AA/TSF may also perform slightly better than other clinical interventions for PDA (MD 3.00, 95% CI 0.31 to 5.69; 1 study, 93 participants; low‐certainty evidence).
For drinking intensity, AA/TSF may perform as well as other clinical interventions at nine months, as measured by DDD (MD ‐1.76, 95% CI ‐2.23 to ‐1.29; 1 study, 93 participants; very low‐certainty evidence) and PDHD (MD 2.09, 95% CI ‐1.24 to 5.42; 1 study, 286 participants; low‐certainty evidence).
None of the RCTs comparing non‐manualized AA/TSF to other clinical interventions assessed LPA, alcohol‐related consequences, or alcohol addiction severity.
Cost‐effectiveness studies
In three studies, AA/TSF had higher healthcare cost savings than outpatient treatment, CBT, and no AA/TSF treatment. The fourth study found that total medical care costs decreased for participants attending CBT, MET, and AA/TSF treatment, but that among participants with worse prognostic characteristics AA/TSF had higher potential cost savings than MET (moderate‐certainty evidence).
Authors' conclusions
There is high quality evidence that manualized AA/TSF interventions are more effective than other established treatments, such as CBT, for increasing abstinence. Non‐manualized AA/TSF may perform as well as these other established treatments. AA/TSF interventions, both manualized and non‐manualized, may be at least as effective as other treatments for other alcohol‐related outcomes. AA/TSF probably produces substantial healthcare cost savings among people with alcohol use disorder.
Objectives: We undertook a cluster-randomised controlled trial exploring the effect of a therapeutic companion robot (PARO) compared to a look-alike plush toy and usual care on dementia symptoms of ...long-term care residents. Complementing the reported quantitative outcomes , this paper provides critical reflection and commentary on individual participant responses to PARO, observed through video recordings , with a view to informing clinical practice and research.
Method: A descriptive, qualitative design with five participants selected from the PARO intervention arm of the trial. The trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12614000508673).
Results: The five participants and their responses to PARO are presented in terms of three issues: i.) Different pre-intervention clinical presentations and different responses; ii.) Same individual, different response - the need for continual assessment and review; and iii.) The ethics of giving and retrieving PARO. Implications for clinical practice and future research are discussed in relation to each issue.
Conclusion: The findings suggest that one approach does not fit all, and that there is considerable variation in responses to PARO. A number of recommendations are discussed to aid the delivery of psychosocial interventions with PARO in practice, as well as to guide future research.
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BFBNIB, DOBA, IZUM, KILJ, NUK, OILJ, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK, VSZLJ
Objective
Breast cancer is the most commonly diagnosed cancer in women across the world. The majority of women diagnosed with the disease undergo surgery, which is often associated with significant ...psychosocial morbidity. The aim of this meta‐analysis was to identify the efficacy of psychosocial interventions for women following breast cancer surgery.
Method
A comprehensive literature search was undertaken using keyword and subject headings within 7 databases. Included studies employed a quantitative methodology presenting empirical findings focusing on interventions for female breast cancer patients following surgery.
Results
Thirty‐two studies were included and based on conventional values of effect sizes. Small effects emerged for the efficacy of psychosocial interventions in relation to anxiety (Hedges g = 0.31), depression (0.38), quality of life (0.40), mood disturbance (0.31), distress (0.27), body image (0.40), self‐esteem (0.35), and sexual functioning (0.22). A moderate to large effect emerged for the efficacy of interventions in promoting improvements in sleep disturbance (0.67). Clear evidence emerged for the efficacy of cognitive behavioral therapy in promoting improvements in anxiety, depression, and quality of life.
Conclusion
This is the first meta‐analysis to demonstrate the efficacy of interventions on a range of psychosocial outcomes following breast cancer surgery. The meta‐analysis highlighted that cognitive behavioral therapy was consistently the most effective psychosocial intervention promoting improvements in anxiety, depression, and quality of life. However, there are shortcomings in existing studies; the length of the follow‐up period is typically short and the generalizability of findings was limited by small samples, both of which should be addressed in future studies.
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BFBNIB, DOBA, FZAB, GIS, IJS, IZUM, KILJ, NLZOH, NUK, OILJ, PILJ, PNG, SAZU, SBCE, SBMB, UILJ, UKNU, UL, UM, UPUK
Background
Epilepsy is a neurological disorder affecting both children and adults. Epileptic seizures are the result of excessive and abnormal cortical cell electrical activity in the brain. In ...response to criticism that epilepsy care for children has little impact on long‐term outcomes, healthcare professionals and administrators have developed various service models and strategies to address perceived inadequacies.
This is an updated version of a Cochrane Review previously published in 2018.
Objectives
To assess the effects of any specialised or dedicated intervention for epilepsy versus usual care in children and adolescents with epilepsy and their families.
Search methods
We searched the following databases on 14 January 2020: the Cochrane Register of Studies (CRS Web), MEDLINE (Ovid, 1946 to 13 January 2020), PsycINFO (1887 to 14 January 2020), CINAHL Plus (1937 to 14 January 2020), ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry Platform. The Cochrane Register of Studies (CRS Web) includes the Cochrane Epilepsy Group Specialised Register and the Cochrane Central Register of Controlled Trials (CENTRAL). We also contacted experts in the field seeking information on unpublished and ongoing studies and checked the websites of epilepsy organisations and the reference lists of included studies.
Selection criteria
We included randomised controlled trials recruiting children and adolescents with epilepsy.
Data collection and analysis
Two review authors independently selected trials for inclusion and extracted the relevant data. We assessed the following outcomes: 1. Seizure frequency and severity; 2. Appropriateness and volume of medication prescribed (including evidence of drug toxicity); 3. Participants' reported knowledge of information and advice received from professionals; 4. Participants' reports of health and quality of life; 5. Objective measures of general health status; 6. Objective measures of social or psychological functioning (including the number of days spent on sick leave/absence from school or work, and employment status); and 7. Costs of care or treatment. The results of the data extraction and quality assessment for each study were presented in structured tables and as a narrative summary. All summary statistics were extracted for each outcome.
Main results
We included nine studies of eight interventions in the review, reporting on seven distinct self‐management programmes for educating or counselling children with epilepsy and their parents, and one new model of care. Based largely on self‐reported outcomes, each programme showed some benefits for the well‐being of children with epilepsy; however, all of the included studies had methodological flaws. No single programme was evaluated with different study samples, and in no instance was the same outcome measured and reported in the same way across studies, precluding any possible meta‐analysis, even if the interventions were considered sufficiently similar to include in meta‐analysis.
We chose the outcomes for which data might be important for decisions about the interventions as per guidance in the Cochrane Handbook for Systematic Reviews of Interventions. We found moderate certainty evidence that one of the educational interventions reduced seizure frequency. There was low certainty evidence that two other educational interventions reduced seizure severity, seizure control, and seizure cure rates. The evidence for all other outcomes (drug adherence, knowledge, self‐efficacy and self‐perception of epilepsy on quality of life) was mixed.
Authors' conclusions
Whilst each of the programmes evaluated in this review showed some benefit to children with epilepsy, their impact was extremely variable. No programme showed benefits across the full range of outcomes, and all studies had methodological problems. There is currently insufficient evidence in favour of any single programme. Further evidence from randomised controlled trials using validated measures and considering clinical meaningfulness as well as statistical significance of results is required.
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