Blue-light filtering spectacle lenses for visual performance, sleep, and macular health in adults.

BACKGROUND: 'Blue-light filtering', or 'blue-light blocking', spectacle lenses filter ultraviolet radiation and varying portions of short-wavelength visible light from reaching the eye. Various blue-light filtering lenses are commercially available. Some claims exist that they can improve visual performance with digital device use, provide retinal protection, and promote sleep quality. We investigated clinical trial evidence for these suggested effects, and considered any potential adverse effects. OBJECTIVES: To assess the effects of blue-light filtering lenses compared with non-blue-light filtering lenses, for improving visual performance, providing macular protection, and improving sleep quality in adults. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL; containing the Cochrane Eyes and Vision Trials Register; 2022, Issue 3); Ovid MEDLINE; Ovid Embase; LILACS; the ISRCTN registry; ClinicalTrials.gov and WHO ICTRP, with no date or language restrictions. We last searched the electronic databases on 22 March 2022. SELECTION CRITERIA: We included randomised controlled trials (RCTs), involving adult participants, where blue-light filtering spectacle lenses were compared with non-blue-light filtering spectacle lenses. DATA COLLECTION AND ANALYSIS: Primary outcomes were the change in visual fatigue score and critical flicker-fusion frequency (CFF), as continuous outcomes, between baseline and one month of follow-up. Secondary outcomes included best-corrected visual acuity (BCVA), contrast sensitivity, discomfort glare, proportion of eyes with a pathological macular finding, colour discrimination, proportion of participants with reduced daytime alertness, serum melatonin levels, subjective sleep quality, and patient satisfaction with their visual performance. We evaluated findings related to ocular and systemic adverse effects. We followed standard Cochrane methods for data extraction and assessed risk of bias using the Cochrane Risk of Bias 1 (RoB 1) tool. We used GRADE to assess the certainty of the evidence for each outcome. MAIN RESULTS: We included 17 RCTs, with sample sizes ranging from five to 156 participants, and intervention follow-up periods from less than one day to five weeks. About half of included trials used a parallel-arm design; the rest adopted a cross-over design. A variety of participant characteristics was represented across the studies, ranging from healthy adults to individuals with mental health and sleep disorders. None of the studies had a low risk of bias in all seven Cochrane RoB 1 domains. We judged 65% of studies to have a high risk of bias due to outcome assessors not being masked (detection bias) and 59% to be at high risk of bias of performance bias as participants and personnel were not masked. Thirty-five per cent of studies were pre-registered on a trial registry. We did not perform meta-analyses for any of the outcome measures, due to lack of available quantitative data, heterogenous study populations, and differences in intervention follow-up periods. There may be no difference in subjective visual fatigue scores with blue-light filtering lenses compared to non-blue-light filtering lenses, at less than one week of follow-up (low-certainty evidence). One RCT reported no difference between intervention arms (mean difference (MD) 9.76 units (indicating worse symptoms), 95% confidence interval (CI) -33.95 to 53.47; 120 participants). Further, two studies (46 participants, combined) that measured visual fatigue scores reported no significant difference between intervention arms. There may be little to no difference in CFF with blue-light filtering lenses compared to non-blue-light filtering lenses, measured at less than one day of follow-up (low-certainty evidence). One study reported no significant difference between intervention arms (MD - 1.13 Hz lower (indicating poorer performance), 95% CI - 3.00 to 0.74; 120 participants). Another study reported a less negative change in CFF (indicating less visual fatigue) with high- compared to low-blue-light filtering and no blue-light filtering lenses. Compared to non-blue-light filtering lenses, there is probably little or no effect with blue-light filtering lenses on visual performance (BCVA) (MD 0.00 logMAR units, 95% CI -0.02 to 0.02; 1 study, 156 participants; moderate-certainty evidence), and unknown effects on daytime alertness (2 RCTs, 42 participants; very low-certainty evidence); uncertainty in these effects was due to lack of available data and the small number of studies reporting these outcomes. We do not know if blue-light filtering spectacle lenses are equivalent or superior to non-blue-light filtering spectacle lenses with respect to sleep quality (very low-certainty evidence). Inconsistent findings were evident across six RCTs (148 participants); three studies reported a significant improvement in sleep scores with blue-light filtering lenses compared to non-blue-light filtering lenses, and the other three studies reported no significant difference between intervention arms. We noted differences in the populations across studies and a lack of quantitative data. Device-related adverse effects were not consistently reported (9 RCTs, 333 participants; low-certainty evidence). Nine studies reported on adverse events related to study interventions; three studies described the occurrence of such events. Reported adverse events related to blue-light filtering lenses were infrequent, but included increased depressive symptoms, headache, discomfort wearing the glasses, and lower mood. Adverse events associated with non-blue-light filtering lenses were occasional hyperthymia, and discomfort wearing the spectacles. We were unable to determine whether blue-light filtering lenses affect contrast sensitivity, colour discrimination, discomfort glare, macular health, serum melatonin levels or overall patient visual satisfaction, compared to non-blue-light filtering lenses, as none of the studies evaluated these outcomes. AUTHORS' CONCLUSIONS: This systematic review found that blue-light filtering spectacle lenses may not attenuate symptoms of eye strain with computer use, over a short-term follow-up period, compared to non-blue-light filtering lenses. Further, this review found no clinically meaningful difference in changes to CFF with blue-light filtering lenses compared to non-blue-light filtering lenses. Based on the current best available evidence, there is probably little or no effect of blue-light filtering lenses on BCVA compared with non-blue-light filtering lenses. Potential effects on sleep quality were also indeterminate, with included trials reporting mixed outcomes among heterogeneous study populations. There was no evidence from RCT publications relating to the outcomes of contrast sensitivity, colour discrimination, discomfort glare, macular health, serum melatonin levels, or overall patient visual satisfaction. Future high-quality randomised trials are required to define more clearly the effects of blue-light filtering lenses on visual performance, macular health and sleep, in adult populations.

Preliminary development of recommendations for the inclusion of patient-reported outcome measures in clinical quality registries.

BACKGROUND: Clinical quality registries (CQRs) monitor compliance against optimal practice and provide feedback to the clinical community and wider stakeholder groups. Despite a number of CQRs having incorporated the patient perspective to support the evaluation of healthcare delivery, no recommendations for inclusion of patient-reported outcome measures (PROMs) in CQRs exist. The aim of this study was to develop a core set of recommendations for PROMs inclusion of in CQRs. METHOD: An online two-round Delphi survey was performed among CQR data custodians, quality of life researchers, biostatisticians and clinicians largely recruited in Australia. A list of statements for the recommendations was identified from a literature and survey of the Australian registries conducted in 2019. The statements were grouped into the following domains: rationale, setting, ethics, instrument, administration, data management, statistical methods, and feedback and reporting. Eighteen experts were invited to participate, 11 agreed to undertake the first online survey (round 1). Of these, nine experts completed the online survey for round 2. RESULTS: From 117 statements presented to the Delphi panel in round 1, a total of 72 recommendations (55 from round 1 and 17 from round 2) with median importance (MI) ≥ 7 and disagreement index (DI) < 1 were proposed for inclusion into the final draft set and were reviewed by the project team. Recommendations were refined for clarity and to read as stand-alone statements. Ten overlapped conceptually and, therefore, were merged to reduce repetition. The final 62 recommendations were sent for review to the panel members for their feedback, which was incorporated into the final set. CONCLUSION: This is the first study to develop preliminary recommendations for PROMs inclusion in CQRs. Recommendations for PROMs implementation are critically important for registries to assure meaningful PROMs data capture, use, interpretation, and reporting to improve health outcomes and healthcare value.

An evaluation of a consumer directed care training program for nursing home staff.

OBJECTIVES: This study evaluated a training program to support the delivery of consumer directed care (CDC). It was hypothesized that both interventions, compared to the control condition, would demonstrate increased levels of CDC in nursing homes, increased staff practice of CDC, and improved resident QoL. The training plus support group was expected to show greater gains, compared to the training only group. MATERIALS AND METHODS: In a cluster RCT design, 33 nursing homes were randomly allocated to one of three conditions: training plus support, training only, and care as usual. Outcome measures included level of CDC within each home, staff practice of CDC, and resident QoL. RESULTS AND DISCUSSION: Hypotheses for this study were partially supported. Nursing homes became more CDC-oriented but with minimal changes in staff practice of CDC. Resident QoL also demonstrated limited change. The findings are discussed in terms of organizational barriers to change within nursing homes.

Program to Enhance Adjustment to Residential Living (PEARL): Effect on Adjustment, Anxiety, Quality of Life, and Stress.

OBJECTIVES: The Program to Enhance Adjustment to Residential Living (PEARL) is a five session intervention primarily designed to address high rates of depression in newly admitted residents. This study reports the efficacy of PEARL on secondary outcomes of resident adjustment, symptoms of anxiety, quality of life, and stress. METHODS: A cluster randomized controlled trial was conducted with 219 newly admitted nursing home residents (M age = 85.5 years) from 42 nursing homes. Outcomes were assessed at baseline, post-intervention, and at two and six month post-intervention follow-up, compared to a standard care condition. RESULTS: There was a significant overall condition by time interaction for adjustment (p = .027) and quality of life (p = .015), but not for stress (p = .309). While the overall condition by time interaction was not significant for anxiety (p = .221), there was a significant interaction contrast six-month post-intervention, indicating a greater decrease in anxiety scores in the intervention group relative to control (p = .039). CONCLUSIONS: This study demonstrates the broad effects of PEARL on the wellbeing of newly admitted residents. CLINICAL IMPLICATIONS: PEARL is a brief intervention that may be feasible for routine use in nursing homes to facilitate adjustment and improve residents' quality of life.

Trajectory and Predictors of Mental Health Symptoms and Wellbeing in Newly Admitted Nursing Home Residents.

OBJECTIVES: This study determined changes in multiple aspects of mental health and wellbeing in newly admitted nursing home residents, and identified risk and protective factors. METHODS: Participants were 204 residents recently admitted to one of 42 nursing homes in Melbourne, Australia. A subgroup of 82 participants were followed up eight months post-admission. Depression, anxiety, stress, adjustment, and quality of life were assessed at baseline and follow-up. Predictive factors (demographics, health, transition factors, nursing home characteristics) were examined in multiple regression analyses. RESULTS: Rates of depression and anxiety were high at both baseline and follow-up. Low self-rated health and medical comorbidity predicted poor wellbeing at baseline. Higher perceived control in the relocation to the nursing home and engagement in meaningful activities were associated with better post-admission outcomes. Baseline psychotropic medication use predicted lower anxiety at follow-up but did not impact depressive symptoms. CONCLUSIONS: There were no significant changes in mental health and wellbeing from one to eight months post-admission. The negative effect of residing in a for-profit nursing home requires further investigation. CLINICAL IMPLICATIONS: Individual activity scheduling and an opportunity to participate in relocation decision-making and planning may support resident wellbeing post-admission.

Surgical interventions for infantile nystagmus syndrome.

BACKGROUND: Infantile nystagmus syndrome (INS) is a type of eye movement disorder that can negatively impact vision. Currently, INS cannot be cured, but its effects can potentially be treated pharmacologically, optically, or surgically. This review focuses on the surgical interventions for INS. Despite the range of surgical interventions available, and currently applied in practice for the management of INS, there is no clear consensus, and no accepted clinical guidelines regarding the relative efficacy and safety of the various treatment options. A better understanding of these surgical options, along with their associated side effects, will assist clinicians in evidence-based decision-making in relation to the management of INS. OBJECTIVES: To assess the efficacy and safety of surgical interventions for INS. SEARCH METHODS: We searched CENTRAL, MEDLINE Ovid, Embase Ovid, ISRCTN registry, ClinicalTrials.gov, and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) to 3 July 2020, with no language restrictions. SELECTION CRITERIA: We included randomised controlled trials (RCTs) studying the efficacy and safety of surgical options for treating INS. DATA COLLECTION AND ANALYSIS: Our prespecified outcome measures were the change from baseline in: binocular best-corrected distance visual acuity; head posture; amplitude, frequency, intensity, and foveation period durations of the nystagmus waveform; visual recognition times; quality of life and self-reported outcome measures; incidence of adverse effects with a probable causal link to treatment; and permanent adverse effects after surgery. Two review authors independently screened titles and abstracts and full-text articles, extracted data from eligible RCTs, and judged the risk of bias using the Cochrane tool. We reached consensus on any disagreements by discussion. We summarised the overall certainty of the evidence using the GRADE approach. MAIN RESULTS: We only identified one eligible RCT (N = 10 participants), undertaken in India. This trial randomised participants to receive either a large retro-equatorial recession of the horizontal rectus muscle of 9 mm on the medial rectus and 12 mm on the lateral rectus, or a simple tenotomy and resuturing of the four horizontal rectus muscles. We did not identify any RCTs comparing a surgical intervention for INS relative to no treatment. In the single eligible RCT, both eyes of each participant received the same intervention. The participants' age and gender were not reported, nor was information on whether participants were idiopathic or had sensory disorders. The study only included participants with null in primary position and did not explicitly exclude those with congenital periodic alternating nystagmus. The study did not report funding source(s) or author declaration of interests. The evaluation period was six months. We judged this study at low risk for sequence generation and other sources of bias, but at high risk of bias for performance and detection bias. The risk of bias was unclear for selection bias, attrition bias, and reporting bias. There is very uncertain evidence about the effect of the interventions on visual acuity and change in amplitude, frequency, and intensity of the nystagmus waveform. We were unable to calculate relative effects due to lack of data. None of the participants in either intervention group reported adverse effects at six-month follow-up (very low-certainty evidence). There was no quantitative data reported for quality of life, although the study reported an improvement in quality of life after surgery in both intervention groups (very low-certainty evidence). Change in head posture, foveation period durations of the nystagmus waveform, visual recognition times, and permanent adverse effects after surgery were not reported in the included study. We judged the certainty of the evidence, for both the primary and secondary efficacy outcomes, to be very low. Due to a lack of comprehensive reporting of adverse events, there was also very low-certainty of the safety profile of the evaluated surgical interventions in this population. As such, we are very uncertain about the relative efficacy and safety of these interventions for the surgical management of INS. AUTHORS' CONCLUSIONS: This systematic review identified minimal high-quality evidence relating to the efficacy and safety of surgical interventions for INS. The limited availability of evidence must be considered by clinicians when treating INS, particularly given these procedures are irreversible and often performed on children. More high-quality RCTs are needed to better understand the efficacy and safety profile of surgical interventions for INS. This will assist clinicians, people with INS, and their parents or caregivers to make evidence-based treatment decisions.

Evaluation of the Pain Impact Index for Community-Dwelling Older Adults Through the Application of Rasch Modelling.

OBJECTIVE: Evaluate the Pain Impact Index, a simple, brief, easy-to-use, and novel tool to assess the impact of chronic pain in community-dwelling older adults. METHODS: A Rasch modelling analysis was undertaken in Stata using a partial credit model suited to the Likert-type items that comprised the Index. The Index was evaluated for ordering of category thresholds, unidimensionality, overall fit to the Rasch model, measurement bias (Differential Item Functioning, DIF), targeting, and construct validity. RESULTS: The four-item Pain Impact Index was self-completed by 6454 community-dwelling Australians who were aged at least 70 years and experienced pain on most days. Two items showed evidence of threshold disordering, and this was resolved by collapsing response categories (from 5 to 3) for all items. The rescored Index conformed to the unidimensionality assumption and had satisfactory fit with the Rasch model (analyses conducted on a reduced sample size to mitigate the potential for overpowering: n = 377, P > 0.0125, power > 77%). When considering uniform DIF, the most frequent sources of measurement bias were age, knee pain, and upper back pain. When considering nonuniform DIF, the most frequent source of measurement bias was knee pain. The Index had good ability to differentiate between respondents with different levels of pain impact and had highest measurement precision for respondents located around the average level of pain impact in the study sample. Both convergent and discriminant validity of the Index were supported. CONCLUSION: The Pain Impact Index showed evidence of unidimensionality, was able to successfully differentiate between levels of pain impact, and had good evidence of construct validity.

Intense pulsed light (IPL) therapy for the treatment of meibomian gland dysfunction.

BACKGROUND: Meibomian gland dysfunction (MGD) is the major cause of evaporative dry eye disease, which is the more prevalent form of dry eye disease. Intense pulsed light (IPL) therapy, involving treatment of the skin near the eyelids, has emerged as a potential treatment for MGD. OBJECTIVES: To evaluate the effectiveness and safety of intense pulsed light (IPL) for the management dry eye disease resulting from meibomian gland dysfunction (MGD). SEARCH METHODS: We searched CENTRAL, MEDLINE (Ovid), Embase Ovid and three trial registers for eligible clinical trials on 1 August 2019. There were no restrictions on publication status, date or language. SELECTION CRITERIA: We included randomised controlled trials (RCTs) studying the effectiveness or safety of IPL for treating MGD. DATA COLLECTION AND ANALYSIS: Our outcomes of interest were the change from baseline in subjective dry eye symptoms, adverse events, changes to lipid layer thickness, tear break-up time (TBUT), tear osmolarity, eyelid irregularity, eyelid telangiectasia, meibomian gland orifice plugging, meibomian gland dropout, corneal sodium fluorescein staining and conjunctival lissamine green staining. Two review authors independently screened abstracts and full-text articles, extracted data from eligible RCTs and judged the risk of bias using the Cochrane tool. We reached consensus on any disagreements by discussion. We summarised the overall certainty of the evidence using the GRADE Working Group approach. MAIN RESULTS: We included three RCTs, one from New Zealand, one from Japan and one from China, published between 2015 and 2019. Together, these trials enrolled 114 adults (228 eyes). Two studies used a paired-eye (inter-eye comparison) design to evaluate the effects of a sham (control) IPL treatment relative to an actual IPL treatment. One study randomised individuals to either an IPL intervention combined with meibomian gland expression (MGX), or MGX alone (standard therapy). The study follow-up periods ranged from 45 days to nine months. None of the trials were at low risk of bias in all seven domains. The first authors of two included studies were in receipt of funding from patents or the manufacturers of IPL devices. The funding sources and declaration of interests were not given in the report of the third included trial. All three trials evaluated the effect of IPL on dry eye symptoms, quantified using the Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire. Pooling data from two trials that used a paired-eye design, the summary estimate for these studies indicated little to no reduction in dry eye symptoms with IPL relative to a sham intervention (mean difference (MD) -0.33 units, 95% confidence interval (CI) -2.56 to 1.89; I² = 0%; 2 studies, 144 eyes). The other study was not pooled as it had a unit-of-analysis error, but reported a reduction in symptoms in favour of IPL (MD -4.60, 95% CI -6.72 to -2.48; 84 eyes). The body of evidence for this outcome was of very low certainty, so we are uncertain about the effect of IPL on dry eye symptoms. There were no relevant combinable data for any of the other secondary outcomes, thus the effect of IPL on clinical parameters relevant to dry eye disease are currently unclear. For sodium fluorescein TBUT, two studies indicated that there may be an improvement in favour of IPL (MD 2.02 seconds, 95% CI 0.87 to 3.17; MD 2.40 seconds, 95% CI 2.27 to 2.53; 172 eyes total; low-certainty evidence). We are uncertain of the effect of IPL on non-invasive tear break-up time (MD 5.51 seconds, 95% CI 0.79 to 10.23; MD 3.20, 95% CI 3.09 to 3.31 seconds; two studies; 140 eyes total; very low-certainty evidence). For tear osmolarity, one study indicated that there may be an improvement in favour of IPL (MD -7.00 mOsmol/L, 95% -12.97 to -1.03; 56 eyes; low-certainty evidence). We are uncertain of the effect of IPL on meibomian gland orifice plugging (MD -1.20 clinical units, 95% CI -1.24 to -1.16; 84 eyes; very low-certainty evidence). We are uncertain of the effect of IPL on corneal sodium fluorescein staining. One study reported no evidence of a difference between the IPL and sham intervention arms at three months of follow-up (P = 0.409), and a second study reported data favouring IPL (MD -1.00 units, 95% CI -1.07 to -0.93 units; 172 eyes in total; very low-certainty evidence). We considered the incidence of adverse events at the study endpoint, as a measure of safety. As most trials did not specifically report adverse events, the safety of IPL as a treatment for MGD could also not be determined with any certainty. Very low-certainty results from individual studies suggest some adverse effects that may be experienced by participants, include mild pain and burning, and the potential for partially losing eyelashes (due to clinician error). AUTHORS' CONCLUSIONS: This systematic review finds a scarcity of RCT evidence relating to the effectiveness and safety of IPL as a treatment for MGD. Whether IPL is of value for modifying the symptoms or signs of evaporative dry eye disease is currently uncertain. Due to a lack of comprehensive reporting of adverse events, the safety profile of IPL in this patient population is also unclear. The current limitations in the evidence base should be considered by clinicians using this intervention to treat MGD, and outlined to individuals potentially undergoing this procedure with the intent of treating dry eye disease. The results of the 14 RCTs currently in progress will be of major importance for establishing a more definitive answer regarding the effectiveness and safety of IPL for treating MGD. We intend to update this review when results from these trials become available.

Do replicable profiles of multimorbidity exist? Systematic review and synthesis.

This systematic review aimed to synthesise multimorbidity profiling literature to identify replicable and clinically meaningful groupings of multimorbidity. We searched six electronic databases (Medline, EMBASE, PsycINFO, CINAHL, Scopus, and Web of Science) for articles reporting multimorbidity profiles. The identified profiles were synthesised with multidimensional scaling, stratified by type of statistical analysis used in the derivation of profiles. The 51 studies that met inclusion criteria reported results of 98 separate analyses of multimorbidity profiling, with a total of 407 multimorbidity profiles identified. The statistical techniques used to identify multimorbidity profiles were exploratory factor analysis, cluster analysis of diseases, cluster analysis of people, and latent class analysis. Reporting of methodological details of statistical methods was often incomplete. The discernible groupings of multimorbidity took the form of both discrete categories and continuous dimensions. Mental health conditions and cardio-metabolic conditions grouped along identifiable continua in the synthesised results of all four methods. Discrete groupings of chronic obstructive pulmonary disease with asthma, falls and fractures with sensory deficits and of Parkinson's disease and cognitive decline where partially replicable (identifiable in the results of more than one method), while clustering of musculoskeletal conditions and clustering of reproductive systems were each observed only in one statistical approach. The two most replicable multimorbidity profiles were mental health conditions and cardio-metabolic conditions. Further studies are needed to understand aetiology and evolution of these multimorbidity groupings. Guidelines for strengthening the reporting of multimorbidity profiling studies are proposed.

Blue-light filtering intraocular lenses (IOLs) for protecting macular health.

BACKGROUND: An intraocular lens (IOL) is a synthetic lens that is surgically implanted within the eye following removal of the crystalline lens, during cataract surgery. While all modern IOLs attenuate the transmission of ultra-violet (UV) light, some IOLs, called blue-blocking or blue-light filtering IOLs, also reduce short-wavelength visible light transmission. The rationale for blue-light filtering IOLs derives primarily from cell culture and animal studies, which suggest that short-wavelength visible light can induce retinal photoxicity. Blue-light filtering IOLs have been suggested to impart retinal protection and potentially prevent the development and progression of age-related macular degeneration (AMD). We sought to investigate the evidence relating to these suggested benefits of blue-light filtering IOLs, and to consider any potential adverse effects. OBJECTIVES: To assess the effects of blue-light filtering IOLs compared with non-blue-light filtering IOLs, with respect to providing protection to macular health and function. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register) (2017, Issue 9); Ovid MEDLINE; Ovid Embase; LILACS; the ISRCTN registry; ClinicalTrials.gov and the ICTRP. The date of the search was 25 October 2017. SELECTION CRITERIA: We included randomised controlled trials (RCTs), involving adult participants undergoing cataract extraction, where a blue-light filtering IOL was compared with an equivalent non-blue-light filtering IOL. DATA COLLECTION AND ANALYSIS: The prespecified primary outcome was the change in distance best-corrected visual acuity (BCVA), as a continuous outcome, between baseline and 12 months of follow-up. Prespecified secondary outcomes included postoperative contrast sensitivity, colour discrimination, macular pigment optical density (MPOD), proportion of eyes with a pathological finding at the macula (including, but not limited to the development or progression of AMD, or both), daytime alertness, reaction time and patient satisfaction. We evaluated findings related to ocular and systemic adverse effects.Two review authors independently screened abstracts and full-text articles, extracted data from eligible RCTs and judged the risk of bias using the Cochrane tool. We reached a consensus on any disagreements by discussion. Where appropriate, we pooled data relating to outcomes and used random-effects or fixed-effect models for the meta-analyses. We summarised the overall certainty of the evidence using GRADE. MAIN RESULTS: We included 51 RCTs from 17 different countries, although most studies either did not report relevant outcomes, or provided data in a format that could not be extracted. Together, the included studies considered the outcomes of IOL implantation in over 5000 eyes. The number of participants ranged from 13 to 300, and the follow-up period ranged from one month to five years. Only two of the studies had a trial registry record and no studies referred to a published protocol. We did not judge any of the studies to have a low risk of bias in all seven domains. We judged approximately two-thirds of the studies to have a high risk of bias in domains relating to 'blinding of participants and personnel' (performance bias) and 'blinding of outcome assessment' (detection bias).We found with moderate certainty, that distance BCVA with a blue-light filtering IOL, at six to 18 months postoperatively, and measured in logMAR, was not clearly different to distance BCVA with a non-blue-light filtering IOL (mean difference (MD) -0.01 logMAR, 95% confidence interval (CI) -0.03 to 0.02, P = 0.48; 2 studies, 131 eyes).There was very low-certainty evidence relating to any potential inter-intervention difference for the proportion of eyes that developed late-stage AMD at three years of follow-up, or any stage of AMD at one year of follow-up, as data derived from one trial and two trials respectively, and there were no events in either IOL intervention group, for either outcome. There was very low-certainty evidence for the outcome for the proportion of participants who lost 15 or more letters of distance BCVA at six months of follow-up; two trials that considered a total of 63 eyes reported no events, in either IOL intervention group.There were no relevant, combinable data available for outcomes relating to the effect on contrast sensitivity at six months, the proportion of eyes with a measurable loss of colour discrimination from baseline at six months, or the proportion of participants with adverse events with a probable causal link with the study interventions after six months.We were unable to draw reliable conclusions on the relative equivalence or superiority of blue-light filtering IOLs versus non-blue-light filtering IOLs in relation to longer-term effects on macular health. We were also not able to determine with any certainty whether blue-light filtering IOLs have any significant effects on MPOD, contrast sensitivity, colour discrimination, daytime alertness, reaction time or patient satisfaction, relative to non-blue-light filtering IOLs. AUTHORS' CONCLUSIONS: This systematic review shows with moderate certainty that there is no clinically meaningful difference in short-term BCVA with the two types of IOLs. Further, based upon available data, these findings suggest that there is no clinically meaningful difference in short-term contrast sensitivity with the two interventions, although there was a low level of certainty for this outcome due to a small number of included studies and their inherent risk of bias. Based upon current, best-available research evidence, it is unclear whether blue-light filtering IOLs preserve macular health or alter risks associated with the development and progression of AMD, or both. Further research is required to fully understand the effects of blue-light filtering IOLs for providing protection to macular health and function.

Prevalence and characteristics of musculoskeletal complaints in primary care: an analysis from the population level and analysis reporting (POLAR) database.

BACKGROUND: Electronic health record datasets have been used to determine the prevalence of musculoskeletal complaints in general practice but not to examine the associated characteristics and healthcare utilisation at the primary care level. AIM: To describe the prevalence and characteristics of patients presenting to general practitioners with musculoskeletal complaints. DESIGN AND SETTING: A five-year analysis within three Primary Health Networks (PHNs) in Victoria, Australia. METHOD: We included patients with at least one face-to-face consultation 2014 to 2018 inclusive and a low back (≥ 18 years), and/or neck, shoulder or knee (≥ 45 years) complaint determined by SNOMED codes derived from diagnostic text within the medical record. We determined prevalence, socio-demographic characteristics and diagnostic codes for patients with an eligible diagnosis; and number of consultations within one year of diagnosis. RESULTS: 324,793/1,294,021 (25%) presented with at least one musculoskeletal diagnosis, of whom 41% (n = 133,279) fulfilled our inclusion criteria. There were slightly more females (n = 73,428, 55%), two-thirds (n = 88,043) were of working age (18-64 years) and 83,816 (63%) had at least one comorbidity. Over half had a low back diagnosis (n = 76,504, 57%) followed by knee (n = 33,438, 25%), shoulder (n = 26,335, 20%) and neck (n = 14,492, 11%). Most codes included 'pain' and/or 'ache' (low back: 58%, neck: 41%, shoulder: 32%, knee 26%). Median (IQR) all-cause consultations per patient within one year of diagnosis was 7 (4-12). CONCLUSION: The burden of MSK complaints at the primary care level is high as evidenced by the prevalence of people with musculoskeletal complaints presenting to a general practitioner, the preponderance of comorbidities and the numerous consultations per year. Identification and evaluation of strategies to reduce this burden are needed.

The incidence of nosocomial bloodstream infection and urinary tract infection in Australian hospitals before and during the COVID-19 pandemic: an interrupted time series study.

BACKGROUND: The COVID-19 pandemic has had a significant impact on healthcare including increased awareness of infection prevention and control (IPC). The aim of this study was to explore if the heightened awareness of IPC measures implemented in response to the pandemic influenced the rates of healthcare associated infections (HAI) using positive bloodstream and urine cultures as a proxy measure. METHODS: A 3 year retrospective review of laboratory data from 5 hospitals (4 acute public, 1 private) from two states in Australia was undertaken. Monthly positive bloodstream culture data and urinary culture data were collected from January 2017 to March 2021. Occupied bed days (OBDs) were used to generate monthly HAI incidence per 10,000 OBDs. An interrupted time series analysis was undertaken to compare incidence pre and post February 2020 (the pre COVID-19 cohort and the COVID-19 cohort respectively). A HAI was assumed if positive cultures were obtained 48 h after admission and met other criteria. RESULTS: A total of 1,988 bloodstream and 7,697 urine positive cultures were identified. The unadjusted incident rate was 25.5 /10,000 OBDs in the pre-COVID-19 cohort, and 25.1/10,000 OBDs in the COVID-19 cohort. The overall rate of HAI aggregated for all sites did not differ significantly between the two periods. The two hospitals in one state which experienced an earlier and larger outbreak demonstrated a significant downward trend in the COVID-19 cohort (p = 0.011). CONCLUSION: These mixed findings reflect the uncertainty of the effect the pandemic has had on HAI's. Factors to consider in this analysis include local epidemiology, differences between public and private sector facilities, changes in patient populations and profiles between hospitals, and timing of enhanced IPC interventions. Future studies which factor in these differences may provide further insight on the effect of COVID-19 on HAIs.

Monitoring the lifetime risk of revision knee arthroplasty over a decade : a population-level analysis of Australian national registry data.

AIMS: This study aimed to describe the use of revision knee arthroplasty in Australia and examine changes in lifetime risk over a decade. METHODS: De-identified individual-level data on all revision knee arthroplasties performed in Australia from 2007 to 2017 were obtained from the Australian Orthopaedic Association National Joint Replacement Registry. Population data and life tables were obtained from the Australian Bureau of Statistics. The lifetime risk of revision surgery was calculated for each year using a standardized formula. Separate calculations were undertaken for males and females. RESULTS: In total, 43,188 revision knee arthroplasty procedures were performed in Australia during the study period, with a median age at surgery of 69 years (interquartile range (IQR) 62 to 76). In 2017, revision knee arthroplasty rates were highest for males aged 70 to 79 years (102.9 procedures per 100,000 population). Lifetime risk of revision knee arthroplasty for females increased slightly from 1.61% (95% confidence interval (CI) 1.53% to 1.69%) in 2007 to 2.22% (95% CI 2.13% to 2.31%) in 2017. A similar pattern was evident for males, with a lifetime risk of 1.43% (95% CI 1.36% to 1.51%) in 2007 and 2.02% (95% CI 1.93% to 2.11%) in 2017. A decline in procedures performed for loosening/lysis (from 41% in 2007 to 24% in 2017) and pain (from 14% to 9%) was evident, while infection became an increasingly common indication (from 19% in 2007 to 29% in 2017). CONCLUSION: Well-validated national registry data can help us understand the epidemiology of revision knee arthroplasty, including changing clinical indications. Despite a small increase over a decade, the lifetime risk of revision knee arthroplasty in Australia is low at one in 45 females and one in 50 males. These methods offer a population-level approach to quantifying revision burden that can be used for ongoing national surveillance and between-country comparisons. Cite this article: Bone Joint J 2022;104-B(5):613-619.

Use of Placebo and Nonoperative Control Groups in Surgical Trials: A Systematic Review and Meta-analysis.

Importance: Nonspecific effects, particularly placebo effects, are thought to contribute significantly to the observed effect in surgical trials. Objective: To estimate the proportion of the observed effect of surgical treatment that is due to nonspecific effects (including the placebo effect). Data Sources: Published Cochrane reviews and updated, extended search of MEDLINE, Embase, and CENTRAL until March 2019. Study Selection: Published randomized placebo-controlled surgical trials and trials comparing the effect of the same surgical interventions with nonoperative controls (ie, no treatment, usual care, or exercise program). Data Extraction and Synthesis: Pairs of authors independently screened the search results, assessed full texts to identify eligible studies and the risk of bias of included studies, and extracted data. The proportion of all nonspecific effects was calculated as the change in the placebo control divided by the change in the active surgery and pooled in a random-effect meta-analysis. To estimate the magnitude of the placebo effect, we pooled the difference in outcome between placebo and nonoperative controls and used metaregression to estimate the association between the type of control group and the treatment effect (difference between the groups), adjusting for risk of bias, sample size, and type of outcome. Main Outcomes and Measures: Between- and within-group effect sizes expressed as Hedges g. Results: In this review, 100 trials were included comprising data from 62 trials with placebo controls (3 also included nonoperative controls), and 38 trials with nonoperative controls (32 interventions; 10 699 participants). Risk of bias across trials was comparable except for performance and detection bias, which was high in trials with nonoperative controls. The mean nonspecific effects accounted for 67% (95% CI, 61% to 73%) of the observed change after surgery; however, this varied widely between different procedures. The estimated surgical placebo effect had a standardized mean difference (SMD) of 0.13 (95% CI, -0.26 to 0.51). Trials with placebo and nonoperative controls found comparable treatment effects (SMD, -0.09 [95% CI, -0.35 to 0.18]; 15 interventions; 73 between-group effects; adjusted analysis: SMD, -0.11 [95% CI, -0.37 to 0.15]). Conclusions and Relevance: In this review, the change in health state after surgery was composed largely of nonspecific effects, but no evidence supported a large placebo effect. Placebo-controlled surgical trials may be redundant when trials with nonoperative controls consistently report no substantial association from surgery compared with nonoperative treatment.

Lumbar spinal fusion surgery outcomes in a cohort of injured workers in the Victorian workers' compensation system.

BACKGROUND: Lumbar spinal fusion (LSF) outcomes for workers' compensation patients are worse than for the general population. The objectives were to examine the long-term work capacity, opioid prescription and mental health outcomes of injured workers who have undergone LSF surgery in Victoria, Australia, and to identify demographic and pre- and post-operative characteristics associated with these outcomes. METHODS: Retrospective study of 874 injured workers receiving elective LSF from 2008 to 2016 in the Victorian workers' compensation system. WorkSafe Victoria's claims data were used to infer outcomes for recovery. Association of demographics, pre-surgery and surgery variables with outcomes were modelled using multivariate multinomial logistic regression analyses. RESULTS: Twenty-four months after LSF surgery, 282 (32.3%) of the 874 injured workers had substantial work capacity, 388 (44.4%) were prescribed opioids, and 330 (37.8%) were receiving mental health treatment. Opioid prescription and limited work capacity before surgery were independent strong predictors of opioid prescription, reduced work capacity and mental health treatment 24 months after LSF. Pre-operative mental health treatment was associated with the use of mental health treatment at 24 months. Other predictors for poor outcomes included a greater than 12-month duration from injury to surgery, LSF re-operation and common law or impairment benefit lodgement before surgery. CONCLUSION: An association between pre-operative factors and post-operative outcomes after LSF in a Victorian workers' compensation population was identified, suggesting that pre-operative status may influence outcomes and should be considered in LSF decisions. The high opioid use indicates that opioid management before and after surgery needs urgent review.

Hemoglobin is a key determinant of quality of life before and during azacitidine-based therapy for myelodysplasia and low blast count acute myeloid leukemia.

Myelodysplastic syndromes (MDS) have a major impact on quality of life (QoL). We performed a post hoc analysis of two multicenter trials of azacitidine-based disease-modifying therapy for patients with MDS and low blast count acute myeloid leukemia (AML), to identify factors associated with QoL. 231 patients were included (median age 70 years). At baseline, higher initial hemoglobin, but not neutrophil or platelet count, was associated with better global QoL and physical function (p < 0.001 and p = 0.001, respectively). During therapy, increase in hemoglobin was associated with improvement in QoL and physical function (p = 0.005 and p < 0.001, respectively). Lower initial hemoglobin was associated with higher dyspnea and fatigue scores (p < 0.001 and p = 0.001, respectively), and hemoglobin response was associated with improvement in dyspnea and fatigue (p < 0.001 for each). In patients with MDS and low blast count AML, hemoglobin level was strongly correlated with global QoL, physical functioning, dyspnea and fatigue, both before and during azacitidine-based therapy.

Lifetime Risk of Primary Shoulder Arthroplasty From 2008 to 2017: A Population-Level Analysis Using National Registry Data.

OBJECTIVE: To estimate the lifetime risk of primary shoulder arthroplasty in Australia and to examine changes over time. METHODS: For this retrospective population-level analysis, de-identified individual-level data on all primary partial shoulder arthroplasty (PSA) and total shoulder arthroplasty (TSA) procedures performed in Australia from 2008 to 2017 (n = 38,868) were obtained from the Australian Orthopaedic Association National Joint Replacement Registry. Population data and life tables were obtained from the Australian Bureau of Statistics. Lifetime risk of primary shoulder arthroplasty was calculated for each year using a standardized formula. Separate calculations were undertaken by sex and for PSA and TSA. RESULTS: The lifetime risk of shoulder arthroplasty increased significantly over time. For men, this risk more than doubled from 0.78% (95% confidence interval [95% CI] 0.73-0.84) in 2008 to 1.78% (95% CI 1.70-1.86) in 2017. Lifetime risk for women rose from 1.54% (95% CI 1.46-1.62) to 2.88% (95% CI 2.78-2.99) over the study period. This increase was predominantly driven by growth in lifetime risk of TSA. In contrast, lifetime risk of PSA decreased over time, from 0.25% (95% CI 0.22-0.28) in 2008 to 0.11% (95% CI 0.09-0.13) in 2017 for men, and from 0.55% (95% CI 0.51-0.60) to 0.11% (95% CI 0.09-0.13) for women. CONCLUSION: By the end of 2017, the lifetime risk of primary shoulder arthroplasty in Australia increased to 1 in 57 for men and 1 in 35 for women. Compared to declining PSA trends, there was substantial growth in TSA use over a decade. These data improve our understanding of the rising national burden of primary shoulder arthroplasty and can assist in planning to meet future surgical demand.

Lifetime Risk of Revision Hip Replacement Surgery in Australia Remains Low: A Population-Level Analysis Using National Registry Data.

BACKGROUND: Well-validated data from arthroplasty registries provide an opportunity to understand contemporary use of revision hip replacement at a national level. Such information can underpin health-care resource allocation and surgical workforce planning. The purposes of the present study were to describe the demographic characteristics of patients managed with revision hip replacement surgery in Australia and to examine changes in the lifetime risk of revision hip replacement over a decade. METHODS: Deidentified individual-level data on all revision hip replacement procedures performed in Australia from 2007 to 2017 were obtained from the Australian Orthopaedic Association National Joint Replacement Registry. Life tables and population data were sourced from the Australian Bureau of Statistics. The lifetime risk of revision surgery each year was estimated with use of a standardized approach, with separate calculations for males and females. RESULTS: A total of 46,086 revision hip replacement procedures were performed from 2007 to 2017. The median age at the time of surgery was 72 years (interquartile range, 63 to 80 years). While loosening or lysis became less frequent reasons for revision over time (from 51% in 2007 to 28% in 2017), revision hip replacement for infection became increasingly common (from 14% in 2007 to 25% in 2017). Revisions for metal-related pathology peaked in 2011. Utilization rates were highest for males ≥80 years of age (127.9 procedures per 100,000 population in 2017). Although a small rise was evident in 2011 and 2012 (to 2.39% and 2.22%, respectively), the lifetime risk of revision hip replacement in females decreased from 1.90% (95% confidence interval [CI], 1.82% to 1.99%) in 2007 to 1.74% (95% CI, 1.66% to 1.82%) in 2017. A similar pattern was evident for males; the lifetime risk was 1.78% (95% CI, 1.69% to 1.86%) in 2007 and 1.57% (95% CI, 1.49% to 1.65%) in 2017. CONCLUSIONS: These data enable us to understand the epidemiology of revision hip replacement in Australia, including the shifting clinical indications for this procedure. At a population level, the lifetime risk of revision hip replacement remains low at <1 in 50 people in 2017. These methods can be utilized for population-level surveillance of revision burden and to enable between-country benchmarking. LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Do sociodemographic variables moderate effects of an internet intervention for mild to moderate depressive symptoms? An exploratory analysis of a randomised controlled trial (EVIDENT) including 1013 participants.

OBJECTIVE: To explore the moderating effects of sociodemographic variables on treatment benefits received from participating in an internet intervention for depression. DESIGN: Randomised, assessor-blind, controlled trial. SETTING: Online intervention, with participant recruitment using multiple settings, including inpatient and outpatient medical and psychological clinics, depression online forums, health insurance companies and the media (eg, newspaper, radio). PARTICIPANTS: The EVIDENT trial included 1013 participants with mild to moderate depressive symptoms. INTERVENTIONS: The intervention group subjects (n=509) received an online intervention (Deprexis) in addition to care as usual (CAU), while 504 participants received CAU alone. METHODS: To explore subgroup differences, moderating effects were investigated using linear regression models based on intention-to-treat analyses. Moderating effects included sex, age, educational attainment, employment status, relationship status and lifetime frequency of episodes. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary endpoint was change in self-rated depression severity measured by the Patient Health Questionnaire-9 (PHQ-9), comparing baseline versus 12-week post-test assessment. Secondary outcome measures were the Hamilton Rating Scale for Depression and the Quick Inventory of Depressive Symptoms each at 12 weeks and at 6 and 12 months, and PHQ-9 at 6 and 12 months, respectively. In this article, we focus on the primary outcome measure only. RESULTS: Between-group differences were observed in post-test scores, indicating the effectiveness of Deprexis. While the effects of the intervention could be demonstrated across all subgroups, some showed larger between-group differences than others. However, after exploring the moderating effects based on linear regression models, none of the selected variables was found to be moderating treatment outcomes. CONCLUSIONS: Our findings suggest that Deprexis is equally beneficial to a wide range of people; that is, participant characteristics were not associated with treatment benefits. Therefore, participant recruitment into web-based psychotherapeutic interventions should be broad, while special attention may be paid to those currently under-represented in these interventions. TRIAL REGISTRATION NUMBER: NCT01636752.

Patterns of care for people presenting to Australian general practice with musculoskeletal complaints based on routinely collected data: protocol for an observational cohort study using the Population Level Analysis and Reporting (POLAR) database.

INTRODUCTION: General practice is integral to the Australian healthcare system. Outcome Health's POpulation Level Analysis and Reporting (POLAR) database uses de-identified electronic health records to analyse general practice data in Australia. Previous studies using routinely collected health data for research have not consistently reported the codes and algorithms used to describe the population, exposures, interventions and outcomes in sufficient detail to allow replication. This paper reports a study protocol investigating patterns of care for people presenting with musculoskeletal conditions to general practice in Victoria, Australia. Its focus is on the systematic approach used to classify and select eligible records from the POLAR database to facilitate replication. This will be useful for other researchers using routinely collected health data for research. METHODS AND ANALYSIS: This is a retrospective cohort study. Patient-related data will be obtained through electronic health records from a subset of general practices across three primary health networks (PHN) in southeastern Victoria. Data for patients with a low back, neck, shoulder and/or knee condition and who received at least one general practitioner (GP) face-to-face consultation between 1 January 2014 and 31 December 2018 will be included. Data quality checks will be conducted to exclude patients with poor data recording and/or non-continuous follow-up. Relational data files with eligible and valid records will be merged to select the study cohort and the GP care received (consultations, imaging requests, prescriptions and referrals) between diagnosis and 31 December 2018. Number and characteristics of patients and GPs, and number, type and timing of imaging requests, prescriptions for pain relief and referrals to other health providers will be investigated. ETHICS AND DISSEMINATION: Ethics approval was obtained from the Cabrini and Monash University Human Research Ethics Committees (Reference Numbers 02-21-01-19 and 16975, respectively). Study findings will be reported to Outcome Health, participating PHNs, disseminated in academic journals and presented in conferences.