Bias For Blinding Of Participants Research Articles

Topical clonidine for neuropathic pain in adults.

Topical clonidine for neuropathic pain in adults.

Specialised early intervention teams (extended time) for recent-onset psychosis.

Specialised early intervention teams (extended time) for recent-onset psychosis.

Specialised early intervention teams for recent-onset psychosis.

Specialised early intervention teams for recent-onset psychosis.

Orthotic treatment for stage I and II posterior tibial tendon dysfunction (flat foot): A systematic review

Objective: To investigate whether orthotic treatment is effective for the treatment of posterior tibial tendon dysfunction stages I and II (flat foot). Data Sources: Five databases (PubMed, Scopus, PEDro, SPORTDiscus and The Cochrane Library) were searched for potential RCTs from their inception until August 2020. Review Methods: Only randomised controlled trials (RCT) that included subjects diagnosed with posterior tibial dysfunction in the initial stage and treated with orthotic treatments were selected. The outcomes assessed were whatever symptom related to posterior tibial tendon dysfunction stage I and II. Included RCTs were appraised using the Cochrane collaboration risk of bias tool. Results: Four RCT articles and 186 subjects were included. 75% were at high risk of bias for blinding of participants and personnel. Three different types of conservative treatment were used in the studies: foot/ankle-foot orthoses, footwear and stretching /strengthening exercises. Foot orthoses, together with exercise programmes, seemed to improve the effect of orthotic treatment. Foot orthoses with personalised internal longitudinal arch support were more effective than flat insoles or standard treatments in reducing pain. Conclusions: The use of orthotic treatment may be effective in reducing pain in the early stages of posterior tibial tendon dysfunction. Further research is needed into individualised orthotic treatment and high-intensity monitored exercise programmes.

Acupuncture and related interventions for carpal tunnel syndrome: systematic review

Objective: To synthesize evidence on the effectiveness of acupuncture and related therapies for primary carpal tunnel syndrome (CTS) by conducting a systematic review of randomized controlled trials (RCTs). Data Sources: Nine databases were searched for potential RCTs from their inception till July 2019. Review Methods: RCTs which reported at least one of the three outcomes were included: symptom severity, functional status and pain. Included RCTs were appraised using the Cochrane Risk of Bias Tool. Results: A total of 10 RCTs (728 participants) were included. Majority were at high risk of bias for blinding of participants, personnel and outcome assessors. When compared to conventional medications, manual acupuncture showed significant superior effect in reducing symptom than ibuprofen (mean difference (MD) on Symptom Severity Scale (SSS)) = –5.80, 95% confidence interval (CI): −7.95 to −3.65) and prednisolone (MD = −6.50, 95% CI: −10.1, −2.86). Electroacupuncture plus splinting was more effective in reducing symptom severity than splinting alone (SSS score: MD = −0.20, 95% CI: −0.36 to −0.03). Manual acupuncture showed significantly superior effect than ibuprofen in improving functional status (Functional Status Scale (FSS): MD = −1.84, 95% CI: −2.66 to −1.02). The combination of electroacupuncture and splinting showed more improvement in functional status compared to splinting alone (FSS: MD = −6.22, 95%CI: −10.7 to −1.71). Triple treatment of acupuncture, magnetic spectrum heat lamp and splinting showed stronger pain relief than splinting alone. Conclusion: For both symptom relief and function improvement, manual acupuncture is superior to ibuprofen while electroacupuncture plus splinting outperforms splinting alone. Limited evidence showed electroacupuncture’s potential role in pain reduction.

Preventive lipid-based nutrient supplements given with complementary foods to infants and young children 6 to 23 months of age for health, nutrition, and developmental outcomes.

Preventive lipid-based nutrient supplements given with complementary foods to infants and young children 6 to 23 months of age for health, nutrition, and developmental outcomes.

Risk of bias assessment of randomised controlled trials referenced in the 2015 American Heart Association guidelines update for cardiopulmonary resuscitation and emergency cardiovascular care: a cross-sectional review

ObjectivesTo identify the risk of bias of randomised controlled trials (RCTs) referenced in the 2015 American Heart Association (AHA) guidelines update for cardiopulmonary resuscitation (CPR) and emergency cardiovascular care (ECC).DesignA...

Epidural analgesia for adults undergoing cardiac surgery with or without cardiopulmonary bypass.

General anaesthesia combined with epidural analgesia may have a beneficial effect on clinical outcomes. However, use of epidural analgesia for cardiac surgery is controversial due to a theoretical increased risk of epidural haematoma associated with systemic heparinization. This review was published in 2013, and it was updated in 2019. To determine the impact of perioperative epidural analgesia in adults undergoing cardiac surgery, with or without cardiopulmonary bypass, on perioperative mortality and cardiac, pulmonary, or neurological morbidity. We searched CENTRAL, MEDLINE, and Embase in November 2018, and two trial registers up to February 2019, together with references and relevant conference abstracts. We included all randomized controlled trials (RCTs) including adults undergoing any type of cardiac surgery under general anaesthesia and comparing epidural analgesia versus another modality of postoperative pain treatment. The primary outcome was mortality. We used standard methodological procedures as expected by Cochrane. We included 69 trials with 4860 participants: 2404 given epidural analgesia and 2456 receiving comparators (systemic analgesia, peripheral nerve block, intrapleural analgesia, or wound infiltration). The mean (or median) age of participants varied between 43.5 years and 74.6 years. Surgeries performed were coronary artery bypass grafting or valvular procedures and surgeries for congenital heart disease. We judged that no trials were at low risk of bias for all domains, and that all trials were at unclear/high risk of bias for blinding of participants and personnel taking care of study participants.Epidural analgesia versus systemic analgesiaTrials show there may be no difference in mortality at 0 to 30 days (risk difference (RD) 0.00, 95% confidence interval (CI) -0.01 to 0.01; 38 trials with 3418 participants; low-quality evidence), and there may be a reduction in myocardial infarction at 0 to 30 days (RD -0.01, 95% CI -0.02 to 0.00; 26 trials with 2713 participants; low-quality evidence). Epidural analgesia may reduce the risk of 0 to 30 days respiratory depression (RD -0.03, 95% CI -0.05 to -0.01; 21 trials with 1736 participants; low-quality evidence). There is probably little or no difference in risk of pneumonia at 0 to 30 days (RD -0.03, 95% CI -0.07 to 0.01; 10 trials with 1107 participants; moderate-quality evidence), and epidural analgesia probably reduces the risk of atrial fibrillation or atrial flutter at 0 to 2 weeks (RD -0.06, 95% CI -0.10 to -0.01; 18 trials with 2431 participants; moderate-quality evidence). There may be no difference in cerebrovascular accidents at 0 to 30 days (RD -0.00, 95% CI -0.01 to 0.01; 18 trials with 2232 participants; very low-quality evidence), and none of the included trials reported any epidural haematoma events at 0 to 30 days (53 trials with 3982 participants; low-quality evidence). Epidural analgesia probably reduces the duration of tracheal intubation by the equivalent of 2.4 hours (standardized mean difference (SMD) -0.78, 95% CI -1.01 to -0.55; 40 trials with 3353 participants; moderate-quality evidence). Epidural analgesia reduces pain at rest and on movement up to 72 hours after surgery. At six to eight hours, researchers noted a reduction in pain, equivalent to a reduction of 1 point on a 0 to 10 pain scale (SMD -1.35, 95% CI -1.98 to -0.72; 10 trials with 502 participants; moderate-quality evidence). Epidural analgesia may increase risk of hypotension (RD 0.21, 95% CI 0.09 to 0.33; 17 trials with 870 participants; low-quality evidence) but may make little or no difference in the need for infusion of inotropics or vasopressors (RD 0.00, 95% CI -0.06 to 0.07; 23 trials with 1821 participants; low-quality evidence).Epidural analgesia versus other comparatorsFewer studies compared epidural analgesia versus peripheral nerve blocks (four studies), intrapleural analgesia (one study), and wound infiltration (one study). Investigators provided no data for pulmonary complications, atrial fibrillation or flutter, or for any of the comparisons. When reported, other outcomes for these comparisons (mortality, myocardial infarction, neurological complications, duration of tracheal intubation, pain, and haemodynamic support) were uncertain due to the small numbers of trials and participants. Compared with systemic analgesia, epidural analgesia may reduce the risk of myocardial infarction, respiratory depression, and atrial fibrillation/atrial flutter, as well as the duration of tracheal intubation and pain, in adults undergoing cardiac surgery. There may be little or no difference in mortality, pneumonia, and epidural haematoma, and effects on cerebrovascular accident are uncertain. Evidence is insufficient to show the effects of epidural analgesia compared with peripheral nerve blocks, intrapleural analgesia, or wound infiltration.

Cannabis for the treatment of ulcerative colitis.

Cannabis for the treatment of ulcerative colitis.

Exercise for reducing falls in people living with and beyond cancer.

Current treatment modalities for cancer have been successful in achieving improved survivorship; however, they come with a number of long-term adverse effects. Accidental falls are a common and clinically significant adverse event in people living with and beyond cancer and rates are higher than in the rest of the population. To assess the effects of prescribed or provided exercise for reducing accidental falls, and falls risk factors of strength, flexibility and balance, in people living with and beyond cancer. We searched the following electronic databases from inception to 10 July 2018, with no restrictions: CENTRAL, MEDLINE, Embase, and seven other databases. We searched clinicaltrials.gov and the World Health Organization International Clinical Trials Registry Platform (ICTRP) for ongoing trials, and reference lists of reviews and retrieved articles for additional studies. We included all randomised controlled trials investigating exercise interventions versus no treatment, usual care or non-exercise interventions on falls incidence or falls risk factors in adults living with and beyond cancer (18 years of age or older at diagnosis). We excluded cross-over studies and studies in acute or inpatient hospice care. At least two review authors independently completed data extraction for included papers. We used Covidence software to manage screening, data collection and extraction. We assessed evidence using GRADE and presented results in a 'Summary of findings' table. Eleven studies (835 participants) compared exercise to usual care. No studies compared exercise with no treatment or non-exercise interventions. The quality of the evidence was very low for the primary outcome rates of falls, and very low to low for the secondary outcomes. We downgraded the evidence due to study limitations (risk of bias), and issues of imprecision due to small sample sizes, inconsistency and indirectness. All studies were at high risk of bias for blinding of participants and personnel due to inability to blind participants to an exercise intervention. Risk of bias was generally low or unclear for other categories.There was generally little information on the important outcomes comparing exercise to usual care.Rates of falls and number of fallers: one study (223 participants) measured accidental falls, but reported neither the rate of falls or the number of fallers; there was no difference in the number of falls between exercise and usual care (very low-quality evidence).Strength: 10 studies (813 participants) reported on strength outcomes. Two analyses favoured exercise over usual care: quadriceps strength (2 studies, 72 participants; mean difference (MD) 8.99 kg, 95% confidence interval (CI) 1.29 to 16.70; low-quality evidence), and leg press (4 studies, 388 participants; MD 21.1 kg, 95% CI 8.47 to 33.74; low-quality evidence). In one analysis of the Sit-to-Stand Test, there was no difference between exercise and usual care (4 studies, 214 participants; standardised mean difference (SMD) -0.45, 95% CI -1.05 to 0.14; very low-quality evidence).Flexibility: one study (21 participants) reported on flexibility for Sit-and-Reach Distance (MD 2.05 cm, 95% CI 0.59 to 3.51; very low-quality evidence).Balance: five studies (350 participants) measured three different balance outcomes. Two analyses favoured exercise over usual care: postural balance (4 studies, 127 participants; standardised mean difference (SMD) 0.44, 95% CI 0.08 to 0.79; very low-quality evidence), and Backward Walk Test (2 studies, 280 participants; SMD -0.24, 95% CI -0.48 to -0.01; low-quality evidence). There was no difference between exercise and usual care for the Timed Up-and-Go Test (1 study, 15 participants; MD -0.35 seconds, 95% CI -1.47 to 0.77; low-quality evidence).Number of people sustaining a fall-related fracture: the quality of the evidence for exercise reducing fall-related fractures was very low.Adverse events: a single study (223 participants) noted some temporary muscle soreness on initiation of exercise or when there was an increase in the weight lifted. As no occurrence data were reported, we could not assess this variable further. No studies reported musculoskeletal injury. Analysis indicated that there was very low-quality evidence that exercise did not increase fatigue. There is a paucity of evidence for exercise training to reduce fall rates in people living with and beyond cancer. Exercise training may improve strength, flexibility and balance for people in this population, but the evidence is very low quality.

380 Risk of Bias Assessment among Randomized Controlled Trials Referenced in the 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care: A Cross-Sectional Review

Randomized controlled trials (RCTs) provide the most reliable evidence of the impact of medical intervention, however bias can invalidate the results of RCTs. This study aimed to identify the risk of bias of randomized controlled trials (RCTs) referenced in the 2015 American Heart Association (AHA) guidelines update for cardiopulmonary resuscitation (CPR) and emergency cardiovascular care (ECC). All RCTs cited as references in the 2015 AHA guidelines update for CPR and ECC were extracted. After excluding non-human trials, crossover studies, cluster trials, etc, 2 reviewers assessed the risk of bias among RCTs included in this study. The Cochrane Collaboration’s tool for assessing the risk of bias in 6 domains (random sequence generation, allocation concealment, blinding of participants and personnel, blinding of outcome assessment, incomplete outcome data, and selective reporting) was used. A total of 166 RCTs were selected for analyses. Of these, 72.9% (121/166) had a high risk of bias for blinding of participants and personnel. Although a small proportion of the trials was at high risk of bias in the remaining 5 domains, 33.7% (56/166) had an unclear risk of bias for random sequence generation, and 45.2% (75/166) had an unclear risk of bias for blinding of outcome assessment. Additionally, among 5 domains of risk of bias excluding random sequence generation, the proportion of trials at unclear or high risk of bias in journals with a relatively high IF (≥5 and <10) and high IF (≥10) was lower than that in journals with a low IF (<5) The proportion of trials at unclear or high risk of bias was high in the 2015 AHA guidelines for CPR and ECC, especially for random sequence generation and blinding of participants/outcome assessment. This tendency was more prominent in journals with a low IF (<5). Risk of bias should be considered when interpreting and applying the CPR guidelines in the clinical setting.

Interventions for preventing high altitude illness: Part 2. Less commonly-used drugs.

High altitude illness (HAI) is a term used to describe a group of mainly cerebral and pulmonary syndromes that can occur during travel to elevations above 2500 metres (˜ 8200 feet). Acute mountain sickness (AMS), high altitude cerebral oedema (HACE) and high altitude pulmonary oedema (HAPE) are reported as potential medical problems associated with high altitude ascent. In this second review, in a series of three about preventive strategies for HAI, we assessed the effectiveness of five of the less commonly used classes of pharmacological interventions. To assess the clinical effectiveness and adverse events of five of the less commonly used pharmacological interventions for preventing acute HAI in participants who are at risk of developing high altitude illness in any setting. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, LILACS and the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) in May 2017. We adapted the MEDLINE strategy for searching the other databases. We used a combination of thesaurus-based and free-text search terms. We scanned the reference lists and citations of included trials and any relevant systematic reviews that we identified for further references to additional trials. We included randomized controlled trials conducted in any setting where one of five classes of drugs was employed to prevent acute HAI: selective 5-hydroxytryptamine(1) receptor agonists; N-methyl-D-aspartate (NMDA) antagonist; endothelin-1 antagonist; anticonvulsant drugs; and spironolactone. We included trials involving participants who are at risk of developing high altitude illness (AMS or HACE, or HAPE, or both). We included participants with and without a history of high altitude illness. We applied no age or gender restrictions. We included trials where the relevant medication was administered before the beginning of ascent. We excluded trials using these drugs during ascent or after ascent. We used the standard methodological procedures employed by Cochrane. We included eight studies (334 participants, 9 references) in this review. Twelve studies are ongoing and will be considered in future versions of this review as appropriate. We have been unable to obtain full-text versions of a further 12 studies and have designated them as 'awaiting classification'. Four studies were at a low risk of bias for randomization; two at a low risk of bias for allocation concealment. Four studies were at a low risk of bias for blinding of participants and personnel. We considered three studies at a low risk of bias for blinding of outcome assessors. We considered most studies at a high risk of selective reporting bias.We report results for the following four main comparisons.Sumatriptan versus placebo (1 parallel study; 102 participants)Data on sumatriptan showed a reduction of the risk of AMS when compared with a placebo (risk ratio (RR) = 0.43, CI 95% 0.21 to 0.84; 1 study, 102 participants; low quality of evidence). The one included study did not report events of HAPE, HACE or adverse events related to administrations of sumatriptan.Magnesium citrate versus placebo (1 parallel study; 70 participants)The estimated RR for AMS, comparing magnesium citrate tablets versus placebo, was 1.09 (95% CI 0.55 to 2.13; 1 study; 70 participants; low quality of evidence). In addition, the estimated RR for loose stools was 3.25 (95% CI 1.17 to 8.99; 1 study; 70 participants; low quality of evidence). The one included study did not report events of HAPE or HACE.Spironolactone versus placebo (2 parallel studies; 205 participants)Pooled estimation of RR for AMS was not performed due to considerable heterogeneity between the included studies (I² = 72%). RR from individual studies was 0.40 (95% CI 0.12 to 1.31) and 1.44 (95% CI 0.79 to 2.01; very low quality of evidence). No events of HAPE or HACE were reported. Adverse events were not evaluated.Acetazolamide versus spironolactone (1 parallel study; 232 participants)Data on acetazolamide compared with spironolactone showed a reduction of the risk of AMS with the administration of acetazolamide (RR = 0.36, 95% CI 0.18 to 0.70; 232 participants; low quality of evidence). No events of HAPE or HACE were reported. Adverse events were not evaluated. This Cochrane Review is the second in a series of three providing relevant information to clinicians and other interested parties on how to prevent high altitude illness. The assessment of five of the less commonly used classes of drugs suggests that there is a scarcity of evidence related to these interventions. Clinical benefits and harms related to potential interventions such as sumatriptan are still unclear. Overall, the evidence is limited due to the low number of studies identified (for most of the comparison only one study was identified); limitations in the quality of the evidence (moderate to low); and the number of studies pending classification (24 studies awaiting classification or ongoing). We lack the large and methodologically sound studies required to establish or refute the efficacy and safety of most of the pharmacological agents evaluated in this review.

Acupuncture for neuropathic pain in adults.

Acupuncture for neuropathic pain in adults.

Methylphenidate for children and adolescents with autism spectrum disorder.

Children with autistic spectrum disorder (ASD) frequently present with inattention, impulsivity and hyperactivity, which are the cardinal symptoms of attention deficit hyperactivity disorder (ADHD). The effectiveness of methylphenidate, a commonly used ADHD treatment, is therefore of interest in these children. To assess the effects of methylphenidate for symptoms of ADHD (inattention, impulsivity and hyperactivity) and ASD (impairments in social interaction and communication, and repetitive, restricted or stereotypical behaviours) in children and adolescents aged 6 to 18 years with ASD. In November 2016, we searched CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL, 11 other databases and two trials registers. We also checked reference lists and contacted study authors and pharmaceutical companies. Randomised controlled trials (RCTs) that investigated the effect of methylphenidate versus placebo on the core symptoms of ASD or ADHD-like symptoms, or both, in children aged 6 to 18 years who were diagnosed with ASD or pervasive developmental disorder. The primary outcome was clinical efficacy, defined as an improvement in ADHD-like symptoms (inattention, impulsivity and hyperactivity) and in the core symptoms of ASD (impaired social interaction, impaired communication, and stereotypical behaviours), and overall ASD. Secondary outcomes examined were: rate of adverse events; caregiver well-being; need for institutionalisation, special schooling or therapy to achieve learning outcomes; and overall quality of life. We used standard Cochrane methodological procedures. We combined outcome measures that used different psychometric scales, where clinically appropriate. We used a coefficient of 0.6 to calculate standard deviations and adjust for the studies' cross-over design. We considered a standardised mean difference (SMD) of 0.52 as the minimum clinically relevant inter-treatment difference. We applied the GRADE rating for strength of evidence for each outcome. The studies: we included four cross-over studies, with a total of 113 children aged 5 to 13 years, most of whom (83%) were boys. We included two studies with five-year-old children since we were unable to obtain the disaggregated data for those aged six years and above, and all other participants were in our target age range. All participants resided in the USA. The duration of treatment in the cross-over phase was one week for each dose of methylphenidate. Studies used a range of outcome scales, rated by parents, teachers or both; clinicians; or programme staff. We report parent-rated outcomes separately. Risk of bias: we considered three trials to be at high risk of bias due to selective reporting and all trials to be at unclear risk of bias for blinding of participants and assessors, due to the potential for recognising the side effects of methylphenidate. We judged all trials to be at low or unclear risk of bias for other items. Primary outcomes: the meta-analysis suggested that high-dose methylphenidate (0.43 mg/kg/dose to 0.60 mg/kg/dose) had a significant and clinically relevant benefit on hyperactivity, as rated by teachers (SMD -0.78, 95% confidence interval (CI) -1.13 to -0.43; 4 studies, 73 participants; P no data were available for the secondary outcomes of caregiver well-being; need for institutionalisation, special schooling options or therapy to achieve learning outcomes; or overall quality of life. No trials reported serious adverse events. The only adverse effect that was significantly more likely with treatment was reduced appetite as rated by parents (risk ratio 8.28, 95% CI 2.57 to 26.73; 2 studies, 74 participants; P We found that short-term use of methylphenidate might improve symptoms of hyperactivity and possibly inattention in children with ASD who are tolerant of the medication, although the low quality of evidence means that we cannot be certain of the true magnitude of any effect. There was no evidence that methylphenidate has a negative impact on the core symptoms of ASD, or that it improves social interaction, stereotypical behaviours, or overall ASD. The evidence for adverse events is of very low quality because trials were short and excluded children intolerant of methylphenidate in the test-dose phase. Future RCTs should consider extending the duration of treatment and follow-up. The minimum clinically important difference also needs to be confirmed in children with ASD using outcome scales validated for this population.

Provision of preventive lipid-based nutrient supplements given with complementary foods to infants and young children 6 to 23 months of age for health, nutrition, and developmental outcomes

Provision of preventive lipid-based nutrient supplements given with complementary foods to infants and young children 6 to 23 months of age for health, nutrition, and developmental outcomes

Breastfeeding for procedural pain in infants beyond the neonatal period.

Breastfeeding for procedural pain in infants beyond the neonatal period.

L-acetylcarnitine for treating fragile X syndrome.

People with fragile X syndrome (FXS) have an intellectual dysfunction that can range from very mild to severe. Symptoms can include speech and language delays and behavioural difficulties such as aggression or self injurious behaviours, emotional lability, and anxiety-related problems (for example obsessive-compulsive symptoms and perseverative behaviours). In some cases, affected people may have an additional diagnosis of attention deficit hyperactivity disorder or an autism spectrum disorder. To review the efficacy and safety of L-acetylcarnitine in improving the psychological, intellectual, and social performance of people with FXS. In May 2015 we searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, PsycINFO, Web of Science, and two other databases. We also searched three trials registers, four theses databases, and the reference lists of relevant studies and reviews. Randomised controlled trials (RCTs) that assessed the efficacy of L-acetylcarnitine, at any dose, in people of any age diagnosed with FXS compared with placebo. For each trial, two review authors independently extracted data on the children included and interventions compared, and assessed the risk of bias of the studies across the following domains: randomisation sequence generation, allocation concealment, blinding (of participants, personnel, and outcome assessors), incomplete outcome data, selective outcome reporting, and other potential sources of bias. We found only two RCTs that compared oral L-acetylcarnitine (LAC) with oral placebo in children with FXS. The studies included a total of 83 participants, all of them male, who were treated and followed for one year. The age of participants at the start of treatment ranged from 6 to 13 years, with a mean age of 9 years. Neither study provided information on randomisation, allocation concealment procedures, or blinding of outcome assessment, and we received no responses from the authors we emailed for clarification. We therefore rated studies as being at unclear risk of bias on these domains. We judged both studies to be at low risk of bias for blinding of participants and personnel, incomplete outcome data, and selective reporting, but to be at high risk of other bias, as at least one study was funded by a drug company, and in both studies people working for the company were part of the research team.We used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to rate the quality of the available evidence. Overall, the quality of the evidence was low due to the imprecision of results and high risk of other bias.Regarding the primary outcome of psychological and learning capabilities, both studies assessed the effect of interventions on children's verbal and non-verbal intellectual functioning using the Wechsler Intelligence Scale for Children - Revised. The authors did not provide detailed data on those results but said that they found no important differences between treatment and placebo.Both studies evaluated the impact of the treatment on hyperactive behaviour using the Conners' Abbreviated Parent-Teacher Questionnaire. In one study, teachers' assessments of the children found no clear evidence of a difference (mean difference (MD) 0.50, 95% confidence interval (CI) -5.08 to 6.08, n = 51; low-quality evidence). The other study stated that there were no differences between treated and untreated participants, but did not provide detailed data for inclusion in the meta-analysis.Parents' assessments favoured LAC in one study (MD -0.57, 95% CI -0.94 to -0.19, n = 17; low-quality evidence), but not in the other (MD -2.80, 95% CI -7.61 to 2.01, n = 51; low-quality evidence), though changes were not large enough to be considered clinically relevant.Regarding social skills, one study reported no clear evidence of a difference in Vineland Adaptive Behavior composite scores (MD 8.20, 95% CI -0.02 to 16.42, n = 51; low-quality evidence), yet results in the socialisation domain favoured LAC (MD 11.30, 95% CI 2.52 to 20.08, n = 51; low-quality evidence).Both studies assessed the safety of the active treatment and recorded no side effects. Neither of the included studies assessed the secondary outcome of caregiver burden. Low-quality evidence from two small trials showed that when compared to placebo, LAC may not improve intellectual functioning or hyperactive behaviour in children with FXS.

Electronic Symptom Reporting Between Patient and Provider for Improved Health Care Service Quality: A Systematic Review of Randomized Controlled Trials. Part 2: Methodological Quality and Effects

BackgroundWe conducted in two parts a systematic review of randomized controlled trials (RCTs) on electronic symptom reporting between patients and providers to improve health care service quality. Part 1 reviewed the typology of patient groups, health service innovations, and research targets. Four innovation categories were identified: consultation support, monitoring with clinician support, self-management with clinician support, and therapy.ObjectiveTo assess the methodological quality of the RCTs, and summarize effects and benefits from the methodologically best studies.MethodsWe searched Medline, EMBASE, PsycINFO, Cochrane Central Register of Controlled Trials, and IEEE Xplore for original studies presented in English-language articles between 1990 and November 2011. Risk of bias and feasibility were judged according to the Cochrane recommendation, and theoretical evidence and preclinical testing were evaluated according to the Framework for Design and Evaluation of Complex Interventions to Improve Health. Three authors assessed the risk of bias and two authors extracted the effect data independently. Disagreement regarding bias assessment, extraction, and interpretation of results were resolved by consensus discussions.ResultsOf 642 records identified, we included 32 articles representing 29 studies. No articles fulfilled all quality requirements. All interventions were feasible to implement in a real-life setting, and theoretical evidence was provided for almost all studies. However, preclinical testing was reported in only a third of the articles. We judged three-quarters of the articles to have low risk for random sequence allocation and approximately half of the articles to have low risk for the following biases: allocation concealment, incomplete outcome data, and selective reporting. Slightly more than one fifth of the articles were judged as low risk for blinding of outcome assessment. Only 1 article had low risk of bias for blinding of participants and personnel. We excluded 12 articles showing high risk or unclear risk for both selective reporting and blinding of outcome assessment from the effect assessment. The authors’ hypothesis was confirmed for 13 (65%) of the 20 remaining articles. Articles on self-management support were of higher quality, allowing us to assess effects in a larger proportion of studies. All except one self-management interventions were equally effective to or better than the control option. The self-management articles document substantial benefits for patients, and partly also for health professionals and the health care system.ConclusionElectronic symptom reporting between patients and providers is an exciting area of development for health services. However, the research generally is of low quality. The field would benefit from increased focus on methods for conducting and reporting RCTs. It appears particularly important to improve blinding of outcome assessment and to precisely define primary outcomes to avoid selective reporting. Supporting self-management seems to be especially promising, but consultation support also shows encouraging results.