-
Journal of Optometry 2020Phakic intraocular lenses (pIOL) are the main treatment for patients who have either high ametropia or contraindications for laser refractive surgery. The main feature...
Phakic intraocular lenses (pIOL) are the main treatment for patients who have either high ametropia or contraindications for laser refractive surgery. The main feature that makes this kind of lenses suitable for its implantation in young adults searching for independence of optical prescription is the conservation of accommodation, since lens extraction is not required. A systematic review has been performed to evaluate the scientific literature on the effect of pIOL implantation on accommodation. Critical assessment of the articles included in the review was achieved using the tool Critical Appraisal Skills Programme in its Spanish form (CASPe). After revising the complete text of 10 articles pre-selected, two quasi-experimental pre-post studies evaluating the outcomes of a specific model of posterior chamber pIOL were included in the systematic review. The CASPe scoring of both studies were 5/11. According to this outcome, the evidence describing the impact of the pIOL implantation on the accommodative function can be defined poor. Some trends are reported as the decrease in the amplitude of accommodation, a decrease positive relative accommodation and improvement of accommodation. However, these results should be confirmed in future controlled studies.
Topics: Accommodation, Ocular; Humans; Lens Implantation, Intraocular; Phakic Intraocular Lenses; Visual Acuity
PubMed: 31937486
DOI: 10.1016/j.optom.2019.08.001 -
Archives of Disease in Childhood. Fetal... Jul 2020Neonatal research evaluates many different outcomes using multiple measures. This can prevent synthesis of trial results in meta-analyses, and selected outcomes may not...
BACKGROUND
Neonatal research evaluates many different outcomes using multiple measures. This can prevent synthesis of trial results in meta-analyses, and selected outcomes may not be relevant to former patients, parents and health professionals.
OBJECTIVE
To define a core outcome set (COS) for research involving infants receiving neonatal care in a high-income setting.
DESIGN
Outcomes reported in neonatal trials and qualitative studies were systematically reviewed. Stakeholders were recruited for a three-round international Delphi survey. A consensus meeting was held to confirm the final COS, based on the survey results.
PARTICIPANTS
Four hundred and fourteen former patients, parents, healthcare professionals and researchers took part in the eDelphi survey; 173 completed all three rounds. Sixteen stakeholders participated in the consensus meeting.
RESULTS
The literature reviews identified 104 outcomes; these were included in round 1. Participants proposed 10 additional outcomes; 114 outcomes were scored in rounds 2 and 3. Round 1 scores showed different stakeholder groups prioritised contrasting outcomes. Twelve outcomes were included in the final COS: survival, sepsis, necrotising enterocolitis, brain injury on imaging, general gross motor ability, general cognitive ability, quality of life, adverse events, visual impairment/blindness, hearing impairment/deafness, retinopathy of prematurity and chronic lung disease/bronchopulmonary dysplasia.
CONCLUSIONS AND RELEVANCE
A COS for clinical trials and other research studies involving infants receiving neonatal care in a high-income setting has been identified. This COS for neonatology will help standardise outcome selection in clinical trials and ensure these are relevant to those most affected by neonatal care.
Topics: Biomedical Research; Humans; Infant; Neonatology; Outcome Assessment, Health Care
PubMed: 31732683
DOI: 10.1136/archdischild-2019-317501 -
The Cochrane Database of Systematic... Sep 2019Rheumatoid arthritis (RA) is a chronic, systemic, inflammatory, autoimmune disease that results in joint deformity and immobility of the musculoskeletal system. The...
BACKGROUND
Rheumatoid arthritis (RA) is a chronic, systemic, inflammatory, autoimmune disease that results in joint deformity and immobility of the musculoskeletal system. The major goals of treatment are to relieve pain, reduce inflammation, slow down or stop joint damage, prevent disability, and preserve or improve the person's sense of well-being and ability to function. Tai Chi, interchangeably known as Tai Chi Chuan, is an ancient Chinese health-promoting martial art form that has been recognized in China as an effective arthritis therapy for centuries. This is an update of a review published in 2004.
OBJECTIVES
To assess the benefits and harms of Tai Chi as a treatment for people with rheumatoid arthritis (RA).
SEARCH METHODS
We updated the search of CENTRAL, MEDLINE, Embase, and clinical trial registries from 2002 to September 2018.
SELECTION CRITERIA
We selected randomized controlled trials and controlled clinical trials examining the benefits (ACR improvement criteria or pain, disease progression, function, and radiographic progression), and harms (adverse events and withdrawals) of exercise programs with Tai Chi instruction or incorporating principles of Tai Chi philosophy. We included studies of any duration that included control groups who received either no therapy or alternate therapy.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures expected by Cochrane.
MAIN RESULTS
Adding three studies (156 additional participants) to the original review, this update contains a total of seven trials with 345 participants. Participants were mostly women with RA, ranging in age from 16 to 80 years, who were treated in outpatient settings in China, South Korea, and the USA. The majority of the trials were at high risk of bias for performance and detection bias, due to the lack of blinding of participants or assessors. Almost 75% of the studies did not report random sequence generation, and we judged the risk of bias as unclear for allocation concealment in the majority of studies. The duration of the Tai Chi programs ranged from 8 to 12 weeks.It is uncertain whether Tai Chi-based exercise programs provide a clinically important improvement in pain among Tai Chi participants compared to no therapy or alternate therapy. The change in mean pain in control groups, measured on visual analog scale (VAS 0 to 10 score, reduced score means less pain) ranged from a decrease of 0.51 to an increase of 1.6 at 12 weeks; in the Tai Chi groups, pain was reduced by a mean difference (MD) of -2.15 (95% confidence interval (CI) -3.19 to -1.11); 22% absolute improvement (95% CI, 11% to 32% improvement); 2 studies, 81 participants; very low-quality evidence, downgraded for imprecision, blinding and attrition bias.There was very low-quality evidence, downgraded for, blinding, and attrition, that was inconclusive for an important difference in disease activity, measured using Disease Activity Scale (DAS-28-ESR) scores (0 to 10 scale, lower score means less disease activity), with no change in the control group and 0.40 reduction (95% CI -1.10 to 0.30) with Tai Chi; 4% absolute improvement (95% CI 11% improvement to 3% worsening); 1 study, 43 participants.For the assessment of function, the change in mean Health Assessment Questionnaire (HAQ; 0 to 3 scale, lower score means better function) ranged from 0 to 0.1 in the control group, and reduced by MD 0.33 in the Tai Chi group (95% CI -0.79 to 0.12); 11% absolute improvement (95% CI 26% improvement to 4% worsening); 2 studies, 63 participants; very low-quality evidence, downgraded for imprecision, blinding, and attrition. We are unsure of an important improvement, as the results were inconclusive.Participants in Tai Chi programs were less likely than those in a control group to withdraw from studies at 8 to 12 weeks (19/180 in intervention groups versus 49/165 in control groups; risk ratio (RR) 0.40 (95% CI 0.19 to 0.86); absolute difference 17% fewer (95% CI 30% fewer to 3% fewer); 7 studies, 289 participants; low-quality evidence, downgraded for imprecision and blinding.There were no data available for radiographic progression. Short-term adverse events were not reported by group, but in two studies there was some narrative description of joint and muscle soreness and cramps; long-term adverse events were not reported.
AUTHORS' CONCLUSIONS
It is uncertain whether Tai Chi has any effect on clinical outcomes (joint pain, activity limitation, function) in RA, and important effects cannot be confirmed or excluded, since all outcomes had very low-quality evidence. Withdrawals from study were greater in the control groups than the Tai Chi groups, based on low-quality evidence. Although the incidence of adverse events is likely to be low with Tai Chi, we are uncertain, as studies failed to explicitly report such events. Few minor adverse events (joint and muscle soreness and cramps) were described qualitatively in the narrative of two of the studies. This updated review provides minimal change in the conclusions from the previous review, i.e. a pain outcome.
Topics: Arthralgia; Arthritis, Rheumatoid; Exercise Movement Techniques; Humans; Pain Management; Quality of Life; Randomized Controlled Trials as Topic; Tai Ji
PubMed: 31553478
DOI: 10.1002/14651858.CD004849.pub2 -
The Cochrane Database of Systematic... Jul 2019Cough both protects and clears the airway. Cough has three phases: breathing in (inspiration), closure of the glottis, and a forced expiratory effort. Chronic cough has...
BACKGROUND
Cough both protects and clears the airway. Cough has three phases: breathing in (inspiration), closure of the glottis, and a forced expiratory effort. Chronic cough has a negative, far-reaching impact on quality of life. Few effective medical treatments for individuals with unexplained (idiopathic/refractory) chronic cough (UCC) are known. For this group, current guidelines advocate the use of gabapentin. Speech and language therapy (SLT) has been considered as a non-pharmacological option for managing UCC without the risks and side effects associated with pharmacological agents, and this review considers the evidence from randomised controlled trials (RCTs) evaluating the effectiveness of SLT in this context.
OBJECTIVES
To evaluate the effectiveness of speech and language therapy for treatment of people with unexplained (idiopathic/refractory) chronic cough.
SEARCH METHODS
We searched the Cochrane Airways Trials Register, CENTRAL, MEDLINE, Embase, CINAHL, trials registries, and reference lists of included studies. Our most recent search was 8 February 2019.
SELECTION CRITERIA
We included RCTs in which participants had a diagnosis of UCC having undergone a full diagnostic workup to exclude an underlying cause, as per published guidelines or local protocols, and where the intervention included speech and language therapy techniques for UCC.
DATA COLLECTION AND ANALYSIS
Two review authors independently screened the titles and abstracts of 94 records. Two clinical trials, represented in 10 study reports, met our predefined inclusion criteria. Two review authors independently assessed risk of bias for each study and extracted outcome data. We analysed dichotomous data as odds ratios (ORs), and continuous data as mean differences (MDs) or geometric mean differences. We used standard methods recommended by Cochrane. Our primary outcomes were health-related quality of life (HRQoL) and serious adverse events (SAEs).
MAIN RESULTS
We found two studies involving 162 adults that met our inclusion criteria. Neither of the two studies included children. The duration of treatment and length of sessions varied between studies from four sessions delivered weekly, to four sessions over two months. Similarly, length of sessions varied slightly from one 60-minute session and three 45-minute sessions to four 30-minute sessions. The control interventions were healthy lifestyle advice in both studies.One study contributed HRQoL data, using the Leicester Cough Questionnaire (LCQ), and we judged the quality of the evidence to be low using the GRADE approach. Data were reported as between-group difference from baseline to four weeks (MD 1.53, 95% confidence interval (CI) 0.21 to 2.85; participants = 71), revealing a statistically significant benefit for people receiving a physiotherapy and speech and language therapy intervention (PSALTI) versus control. However, the difference between PSALTI and control was not observed between week four and three months. The same study provided information on SAEs, and there were no SAEs in either the PSALTI or control arms. Using the GRADE approach we judged the quality of evidence for this outcome to be low.Data were also available for our prespecified secondary outcomes. In each case data were provided by only one study, therefore there were no opportunities for aggregation; we judged the quality of this evidence to be low for each outcome. A significant difference favouring therapy was demonstrated for: objective cough counts (ratio for mean coughs per hour on treatment was 59% (95% CI 37% to 95%) relative to control; participants = 71); symptom score (MD 9.80, 95% CI 4.50 to 15.10; participants = 87); and clinical improvement as defined by trialists (OR 48.13, 95% CI 13.53 to 171.25; participants = 87). There was no significant difference between therapy and control regarding subjective measures of cough (MD on visual analogue scale of cough severity: -9.72, 95% CI -20.80 to 1.36; participants = 71) and cough reflex sensitivity (capsaicin concentration to induce five coughs: 1.11 (95% CI 0.80 to 1.54; participants = 49) times higher on treatment than on control). One study reported data on adverse events, and there were no adverse events reported in either the therapy or control arms of the study.
AUTHORS' CONCLUSIONS
The paucity of data in this review highlights the need for more controlled trial data examining the efficacy of SLT interventions in the management of UCC. Although a large number of studies were found in the initial search as per protocol, we could include only two studies in the review. In addition, this review highlights that endpoints vary between published studies.The improvements in HRQoL (LCQ) and reduction in 24-hour cough frequency seen with the PSALTI intervention were statistically significant but short-lived, with the between-group difference lasting up to four weeks only. Further studies are required to replicate these findings and to investigate the effects of SLT interventions over time. It is clear that SLT interventions vary between studies. Further research is needed to understand which aspects of SLT interventions are most effective in reducing cough (both objective cough frequency and subjective measures of cough) and improving HRQoL. We consider these endpoints to be clinically important. It is also important for future studies to report information on adverse events.Because of the paucity of data, we can draw no robust conclusions regarding the efficacy of SLT interventions for improving outcomes in unexplained chronic cough. Our review identifies the need for further high-quality research, with comparable endpoints to inform robust conclusions.
Topics: Chronic Disease; Cough; Humans; Language Therapy; Physical Therapy Modalities; Randomized Controlled Trials as Topic; Speech Therapy
PubMed: 31335963
DOI: 10.1002/14651858.CD013067.pub2