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With the widespread use of continuous glucose monitoring (CGM), glycaemic variability (GV) is a glucose metric that has been gaining increasing attention. However, unlike other glucose metrics that are easily defined and have clear targets, GV has a large number of different measures given the complexity involved in assessment. While variabilities in HbA1c, fasting and postprandial glucose have been incorporated under the GV banner, short‐term variability in glucose, within day and between days, is more in keeping with the correct definition of GV. This review is focused on short‐term GV, as assessed by CGM data, although studies calculating GV from capillary glucose testing are also mentioned as appropriate. The different measures of GV are addressed, and their potential role in microvascular and macrovascular complications, as well as patient‐related outcomes, discussed. It should be noted that the independent role of GV in vascular pathology is not always clear, given the inconsistent findings in different populations and the close association between GV and hypoglycaemia, itself an established risk factor for adverse outcomes. Therefore, this review attempts, where possible, to disentangle the contribution of GV to diabetes complications from other glycaemic parameters, particularly hypoglycaemia. Evidence to date strongly suggests an independent role for GV in vascular pathology but future large‐scale outcome studies are required to fully understand the exact contribution of this metric to vascular complications. This can be followed by setting appropriate GV measures and targets in different diabetes subgroups, in order to optimise glycaemic management and limit the risk of complications. Continuing Medical Education: Please visit https://health.learning.wiley.com/courses/dom-26s7 to complete an accredited learning activity for this article and receive 2.0 AMA PRA Category 1 Credit™. [ABSTRACT FROM AUTHOR]

Patients with sarcoidosis who develop severe clinical phenotypes of pulmonary fibrosis or multiorgan disease experience debilitating symptoms, with fatigue being a common chief complaint. Studies that have investigated this patient-related outcome measure (PROM) have used the Fatigue Assessment Scale (FAS), a self-reported questionnaire that reflects mental and physical domains. Despite extensive work, its cause is unknown and treatment options remain limited. Previously, we showed that the plasma of patients with sarcoidosis with extrapulmonary disease endorsing fatigue was enriched for mitochondrial DNA (mtDNA), a ligand for the innate immune receptor toll-like receptor 9 (TLR9). Through our cross-disciplinary platform, we investigated a relationship between sarcoidosis-induced fatigue and circulating mtDNA. Is there a psychobiologic mechanism that connects sarcoidosis-induced fatigue and mtDNA-mediated TLR9 activation? Using a local cohort of patients at Yale (discovery cohort) and the National Institutes of Health-sponsored Genomic Research in Alpha-1 Antitrypsin Deficiency and Sarcoidosis study (validation cohort), we scored the FAS and quantified in the plasma, mtDNA concentrations, TLR9 activation, and cytokine levels. Although FAS scores were independent of corticosteroid use and Scadding stage, we observed a robust association between FAS scores, which included mental and physical domains, and multiorgan sarcoidosis. Subsequently, we identified a significant correlation between plasma mtDNA concentrations and all domains of fatigue. Additionally, we found that TLR9 activation is associated with all aspects of the FAS and partially mediates this PROM through mtDNA. Last, we found that TLR9-associated soluble mediators in the plasma are independent of all facets of fatigue. Through our cross-disciplinary translational platform, we identified a previously unrecognized psychobiologic connection between sarcoidosis-induced fatigue and circulating mtDNA concentrations. Mechanistic work that investigates the contribution of mtDNA-mediated innate immune activation in this PROM and clinical studies with prospective cohorts has the potential to catalyze novel therapeutic strategies for this patient population and those with similar conditions. [Display omitted] [ABSTRACT FROM AUTHOR]

Background: Patients with lumbar spinal stenosis (LSS) sometimes have lower lumbar lordosis (LL), and the incidence of LSS correlates closely with the loss of LL. The few studies that have evaluated the association between LL and clinical outcomes after non-instrumented surgery for LSS show conflicting results. This study investigates the association between preoperative LL and changes in PROMs 2 years after decompressive surgery. Method: This prospective cohort study obtained preoperative and postoperative data for 401 patients from the multicenter randomized controlled spinal stenosis trial as part of the NORwegian degenerative spondylolisthesis and spinal STENosis (NORDSTEN) study. Before surgery, the radiological sagittal alignment parameter LL was measured using standing X-rays. The association between LL and 2-year postoperative changes was analyzed using the oswestry disability index (ODI), a numeric rating scale (NRS) for low back and leg pain, the Zurich claudication questionnaire (ZCQ), and the global perceived effect (GPE) score. The changes in PROMs 2 years after surgery for quintiles of lumbar lordosis were adjusted for the respective baseline PROMs: age, sex, smoking, and BMI. The Schizas index and the Pfirrmann index were used to analyze multiple regressions for changes in PROMs. Results: There were no associations in the adjusted and unadjusted analyses between preoperative LL and changes in ODI, ZCQ, GPE, and NRS for back and leg pain 2 years after surgery. Conclusion: LL before surgery was not associated with changes in PROMs 2 years after surgery. Lumbar lordosis should not be a factor when considering decompressive surgery for LSS. [ABSTRACT FROM AUTHOR]

Migraine is one of the most prevalent and disabling neurological conditions, presenting episodes of throbbing headache that limit activities of daily living. Several factors may influence migraine frequency, such as lifestyle or alcohol consumption. Among the most recognised ones, sleep plays a biunivocal role, since poor sleep quality may worsen migraine frequency, and a high migraine frequency may affect sleep quality. In this paper, the authors evaluate the relationship between migraine and insomnia by exploring a cohort of patients affected by episodic or chronic migraine. To do so, a phone interview was performed, asking patients about their migraine frequency and mean pain intensity, in addition to the questions of the Insomnia Severity Index. The last one explores several symptoms impairing sleep that focus on insomnia. Patients complaining of insomnia showed an increased migraine frequency, and a weak but significant correlation was found between headache days per month and insomnia scores. Such results were particularly evident in patients affected by chronic migraine. Such results suggest how insomnia, in the presented data, seems to be associated with migraine frequency but not with pain intensity.

Migraine is one of the most prevalent and disabling neurological conditions, presenting episodes of throbbing headache that limit activities of daily living. Several factors may influence migraine frequency, such as lifestyle or alcohol consumption. Among the most recognised ones, sleep plays a biunivocal role, since poor sleep quality may worsen migraine frequency, and a high migraine frequency may affect sleep quality. In this paper, the authors evaluate the relationship between migraine and insomnia by exploring a cohort of patients affected by episodic or chronic migraine. To do so, a phone interview was performed, asking patients about their migraine frequency and mean pain intensity, in addition to the questions of the Insomnia Severity Index. The last one explores several symptoms impairing sleep that focus on insomnia. Patients complaining of insomnia showed an increased migraine frequency, and a weak but significant correlation was found between headache days per month and insomnia scores. Such results were particularly evident in patients affected by chronic migraine. Such results suggest how insomnia, in the presented data, seems to be associated with migraine frequency but not with pain intensity. [ABSTRACT FROM AUTHOR]

Purpose: Coronal balance is a major factor impacting the surgical outcomes in adult spinal deformity (ASD). The Obeid coronal malalignment (O-CM) classification has been proposed to improve the coronal alignment in ASD surgery. Aim of this study was to investigate whether a postoperative CM < 20 mm and adherence to the O-CM classification could improve surgical outcomes and decrease the rate of mechanical failure in a cohort of ASD patients. Methods: Multicenter retrospective analysis of prospectively collected data on all ASD patients who underwent surgical management and had a preoperative CM > 20 mm and a 2-year follow-up. Patients were divided in two groups according to whether or not surgery had been performed in adherence to the guidelines of the O-CM classification and according to whether or not the residual CM was < 20 mm. The outcomes of interest were radiographic data, rate of mechanical complications and Patient-Reported Outcome Measures. Results: At 2 years, adherence to the O-CM classification led to a lower rate of mechanical complications (40 vs. 60%). A coronal correction of the CM < 20 mm allowed for a significant improvement in SRS-22 and SF-36 scores and was associated with a 3.5 times greater odd of achieving the minimal clinical important difference for the SRS-22. Conclusion: Adherence to the O-CM classification could reduce the risk of mechanic complications 2 years after ASD surgery. Patients with a residual CM < 20 mm showed better functional outcomes and a 3.5 times greater odd of achieving the MCID for the SRS-22 score. [ABSTRACT FROM AUTHOR]

Abstract Introduction Haemorrhoidal disease (HD) is a common condition with significant epidemiologic and economic implications. While it is possible to treat symptomatic grade 1–2 haemorrhoids with rubber band ligation (RBL) or sclerotherapy (SCL), the effectiveness of these treatments compatible with current standards has not yet been investigated with a randomised controlled trial. The hypothesis is that SCL is not inferior to RBL in terms of symptom reduction (patient-related outcome measures (PROMs)), patient experience, complications or recurrence rate. Methods and analysis This protocol describes the methodology of a non-inferiority, multicentre, randomised controlled trial comparing rubber band ligation and sclerotherapy for symptomatic grade 1–2 haemorrhoids in adults (> 18 years). Patients are preferably randomised between the two treatment arms. However, patients with a strong preference for one of the treatments and refuse randomisation are eligible for the registration arm. Patients either receive 4 cc Aethoxysklerol 3% SCL or 3 × RBL. The primary outcome measures are symptom reduction by means of PROMs, recurrence and complication rates. Secondary outcome measures are patient experience, number of treatments and days of sick leave from work. Data are collected at 4 different time points. Discussion The THROS trial is the first large multicentre randomised trial to study the difference in effectivity between RBL and SCL for the treatment of grade 1–2 HD. It will provide information as to which treatment method (RBL or SCL) is the most effective, gives fewer complications and is experienced by the patient as the best option. Ethics and dissemination The study protocol has been approved by the Medical Ethics Review Committee of the Amsterdam University Medical Centers, location AMC (nr. 2020_053). The gathered data and results will be submitted for publication in peer-reviewed journals and spread to coloproctological associations and guidelines. Trial registration Dutch Trial Register NL8377 . Registered on 12–02-2020.

Chronic migraine is a burdensome condition, and onabotulinumtoxinA is revealed to be an effective therapy. Migraine shows a bidirectional relationship with sleep, but the effects of preventive therapies on sleep quality are poorly studied. This study aims to evaluate the effects of a single session of onabotulinumtoxinA on patients' sleep quality and correlates the results with measures of comorbid anxiety/depression. Patients completed self-administrable questionnaires about sleep quality (Pittsburgh Sleep Quality Index—PSQI) and psychological symptoms (Beck Depression Inventory, 2nd edition—BDI-II—and Hospital Anxiety and Depression Scale—HADS—subscales "a" and "d" for anxiety and depression, respectively), and reported migraine frequency at baseline and after 12 weeks. The 42 included patients showed a significant reduction in migraine days (from 20.6 ± 6.0 to 13.6 ± 6.2, p < 0.001), while no changes were observed in sleep quality (PSQI score from 11.0 ± 5.0 to 9.8 ± 4.6, p = 0.277) or psychological measures (BDI-II from 16.7 ± 10.2 to 15.7 ± 10.3, p = 0.678; HADS-a from 10.3 ± 4.8 to 9.3 ± 5.5, p = 0.492; and HADS-d from 7.2 ± 3.9 to 7.1 ± 5.0, p = 0.901). On the other hand, a strong correlation among PSQI, BDI-II, HADS-a, and HADS-d scores (p < 0.001, rho > 0.7) was found. Despite its efficacy in migraine prevention, a single session of onabotulinumtoxinA was not able to affect patients' sleep quality or their psychological symptoms. [ABSTRACT FROM AUTHOR]

Abstract Introduction Several factors can influence the outcome after a distal radius fracture (DRF). The aim of this study was to assess whether postoperative pulp-to-palm (PTP) distance correlated with functional outcomes after plate fixation of DRF. Materials & methods This is a secondary analysis of a randomized controlled trial aimed to investigate the effects of plate fixation in patients with type-C fractures. Subjects (N = 135) were divided into 2 groups based on PTP distance (equal to or higher than 0 cm) at 4 weeks postoperatively. Outcome measures were collected prospectively at 3, 6 and 12 months and included Patient-Rated Wrist Evaluation (PRWE), Quick Disabilities of the Arm Shoulder and Hand (QuickDASH) scores, wrist range of motion (ROM), Visual Analog Scale (VAS) pain scores, and hand grip strength. Results Overall, at 3 and 6 months patients with PTP > 0 cm had significantly worse outcomes (PRWE, QuickDASH, wrist ROM) than those with PTP =0 cm. At 12 months, QuickDASH and wrist ROM were still significantly worse. In the volar-plating subgroup, patients with PTP > 0 cm had significantly worse wrist ROM and grip strength at 3 months, but no significant differences were found in subsequent follow-ups. In the combined-plating group, patients with PTP > 0 cm had significantly worse QuickDASH, wrist ROM and grip strength at 3 months. At 6 and 12 months, wrist ROM was still significantly worse. Conclusions Measurement of PTP distance appears to be useful to identify patients likely to have worse outcome after plating of a DRF. This could be a tool to improve the allocation of hand rehabilitation resources.

Introduction: Haemorrhoidal disease (HD) is a common condition with significant epidemiologic and economic implications. While it is possible to treat symptomatic grade 1–2 haemorrhoids with rubber band ligation (RBL) or sclerotherapy (SCL), the effectiveness of these treatments compatible with current standards has not yet been investigated with a randomised controlled trial. The hypothesis is that SCL is not inferior to RBL in terms of symptom reduction (patient-related outcome measures (PROMs)), patient experience, complications or recurrence rate. Methods and analysis: This protocol describes the methodology of a non-inferiority, multicentre, randomised controlled trial comparing rubber band ligation and sclerotherapy for symptomatic grade 1–2 haemorrhoids in adults (> 18 years). Patients are preferably randomised between the two treatment arms. However, patients with a strong preference for one of the treatments and refuse randomisation are eligible for the registration arm. Patients either receive 4 cc Aethoxysklerol 3% SCL or 3 × RBL. The primary outcome measures are symptom reduction by means of PROMs, recurrence and complication rates. Secondary outcome measures are patient experience, number of treatments and days of sick leave from work. Data are collected at 4 different time points. Discussion: The THROS trial is the first large multicentre randomised trial to study the difference in effectivity between RBL and SCL for the treatment of grade 1–2 HD. It will provide information as to which treatment method (RBL or SCL) is the most effective, gives fewer complications and is experienced by the patient as the best option. Ethics and dissemination: The study protocol has been approved by the Medical Ethics Review Committee of the Amsterdam University Medical Centers, location AMC (nr. 2020_053). The gathered data and results will be submitted for publication in peer-reviewed journals and spread to coloproctological associations and guidelines. Trial registration: Dutch Trial Register NL8377. Registered on 12–02-2020. [ABSTRACT FROM AUTHOR]

The treatment of chronic pain with cannabinoids is becoming more widespread and popular among patients. However, studies show that only a few patients experience any benefit from this treatment. It also remains unclear which domains are affected by cannabinoid treatment. Therefore, the present study is novel in that it explores the effects of cannabinoid treatment on four patient-related outcome measures (PROMs), and includes patients with chronic refractory pain conditions who have been given the option of cannabinoid treatment. A retrospective design was used to evaluate the impact of cannabinoid treatment on patients with refractory pain in two German outpatient pain clinics. The present study shows that pain intensity (mean relative reduction (−14.9 ± 22.6%), emotional distress (−9.2 ± 43.5%), pain-associated disability (−7.0 ± 46.5%) and tolerability of pain (−11 ± 23.4%)) improved with cannabinoid treatment. Interestingly, the trajectories of the PROMs seemed to differ between patients, with only 30% of patients responding with respect to pain intensity, but showing improvements in other PROMs. Although the mean treatment effects remained limited, the cumulative magnitude of change in all dimensions may affect patients' quality of life. In summary, a singular evaluation with pain intensity as the sole outcome does not cover the multidimensional effects of cannabinoids. Therefore, the treatment effects of cannabinoids should be evaluated with different PROMs. [ABSTRACT FROM AUTHOR]

Introduction: Several factors can influence the outcome after a distal radius fracture (DRF). The aim of this study was to assess whether postoperative pulp-to-palm (PTP) distance correlated with functional outcomes after plate fixation of DRF. Materials & methods: This is a secondary analysis of a randomized controlled trial aimed to investigate the effects of plate fixation in patients with type-C fractures. Subjects (N = 135) were divided into 2 groups based on PTP distance (equal to or higher than 0 cm) at 4 weeks postoperatively. Outcome measures were collected prospectively at 3, 6 and 12 months and included Patient-Rated Wrist Evaluation (PRWE), Quick Disabilities of the Arm Shoulder and Hand (QuickDASH) scores, wrist range of motion (ROM), Visual Analog Scale (VAS) pain scores, and hand grip strength. Results: Overall, at 3 and 6 months patients with PTP > 0 cm had significantly worse outcomes (PRWE, QuickDASH, wrist ROM) than those with PTP =0 cm. At 12 months, QuickDASH and wrist ROM were still significantly worse. In the volar-plating subgroup, patients with PTP > 0 cm had significantly worse wrist ROM and grip strength at 3 months, but no significant differences were found in subsequent follow-ups. In the combined-plating group, patients with PTP > 0 cm had significantly worse QuickDASH, wrist ROM and grip strength at 3 months. At 6 and 12 months, wrist ROM was still significantly worse. Conclusions: Measurement of PTP distance appears to be useful to identify patients likely to have worse outcome after plating of a DRF. This could be a tool to improve the allocation of hand rehabilitation resources. [ABSTRACT FROM AUTHOR]

Objective: Turner syndrome (TS) is associated with short stature, delayed puberty, primary ovarian insufficiency, and other features. Most girls with TS require oestrogen replacement for pubertal induction. There is paucity of data in adult TS on pubertal outcomes, including breast satisfaction. Here, we assess breast satisfaction in TS with the BREAST‐Q questionnaire, a well‐validated patient‐related outcome measure (PROM). Design: International survey distributed online through TS support groups. Patients: Adult women aged 18–45 years with TS (self‐reported). Measurements: The questionnaire contained demographics, health history and the four domains of the BREAST‐Q. BREAST‐Q scores were matched on a one‐to‐one basis for age, body mass index (BMI) and educational background to a normative data set derived from the 'Army of Women', an online community of healthy volunteers. Results: Of 97 total responses, 74 could be matched to the control cohort. Median age was 32 years (18–45 years) and 97% were White Caucasian. Median age at menarche was 15.5 years (12–34 years), 86% had received pubertal induction therapy as teenagers. We found significantly lower BREAST‐Q scores in TS in the domains 'Satisfaction with Breast' (p =.021), 'Psychosocial Wellbeing' (p <.0001) and 'Sexual Wellbeing' (p <.0001). TS who had received oestrogen replacement therapy reported lower scores compared to TS who had not received oestrogen therapy (p <.0001). Lower BMI and previous growth hormone therapy were associated with lower breast satisfaction. Conclusions: TS women who received oestrogen replacement for pubertal induction self‐report lower breast satisfaction scores and late menarche, suggesting that type, mode of delivery, dose and timing of hormone supplements merit prospective study. [ABSTRACT FROM AUTHOR]

Abstract Background The Mayo Elbow Performance Score (MEPS) is a rating system consisting of four dimensions to evaluate elbow performance. It is a common tool for assessment of elbow impairments worldwide. We determined the validity and reliability of its German version (MEPS-G) after cross-cultural adaptation. Methods Six investigators examined 57 patients with elbow pathologies. The MEPS-G was compared to validated elbow scores such as the German versions of DASH, the Oxford Elbow Score, pain level and subjective elbow performance on a VAS. Inter-rater reliability (IRR) and validity of the score and its dimensions were also reviewed. Verification was performed using the intraclass correlation coefficient (ICC), the prevalence and bias with adjusted Kappa (PABAK) and the Spearman correlation. Results The IRR of the MEPS-G score was moderate (ICC (2.1) = 0.65). The IRR of the four individual dimensions was moderate to high (K PABAK = 0.55 -0.81). Validity for the sum score (r = 0.52–0.65) and the dimensions pain (r = 0.53–0.62), range of motion (r = 0.7) and stability (r = − 0.61) was verified. The function subscale reached insufficient validity (r = 0.15–0.39). Conclusion The MEPS-G is not sufficiently valid, which is consistent with its English version. The patient-based dimensions were a weakness, demonstrating high risk of bias. There is no general recommendation for the utilization of the MEPS-G as outcome measurement for patients with elbow pathologies.

Abstract Background The distal radius fracture (DRF) is the most common fracture in adults. With an ageing population, the number of wrist fractures in the superelderly (≥ 80 years) is expected to rise. Optimal treatment for displaced DRFs remains controversial, especially in the superelderly group. In addition, basic knowledge of the outcome after a DRF in this heterogenic group is lacking. The aim of this study was to study injury characteristics, treatment and outcome of DRFs in superelderly patients using data from a large national register. Methods We used prospectively collected data from the Swedish Fracture Register. All distal radius fractures registered between April 2012 and December 2018 in patients ≥ 80 years of age were included. Data on epidemiology, fracture type, trauma mechanism and treatment are registered by the physician treating the patient. Patients are also sent a subjective outcome questionnaire including EQ-5D, EQ-VAS and Short Musculoskeletal Function Assessment questionnaire (SMFA-score) at the time of injury and after 12 months. The 12-month questionnaire was sent to those who had completed the questionnaire at the time of injury. A Mann–Whitney U-test was used to assess differences between treatment methods. Results Mean age for this population was 86 years (80–105 years), a majority of the patients were female (86.7%). The dominating injury mechanism was a simple fall (74.6%) in the patient’s residence. The majority of fractures were AO type A (70%) followed by AO type C (20.9%) and type B (8.6%). The incidence of open fractures was significantly higher in females (2.6%) compared to males (1.5%). A majority of the fractures were treated with a cast (87.5%) with volar locking plate as the second most common treatment method (6.6%). Patient-reported outcome measures (PROMs) EQ-5D, EQ-VAS and the Arm Hand Function Index of the SMFA-score deteriorated somewhat one year after injury compared to pre-injury. PROMs did not correlate to treatment with cast or a volar plate. Conclusions This nationwide register study provides detailed data on DRFs in the superelderly regarding epidemiology, treatment and self-reported outcome. A good self-reported outcome is possible, but many patients do not recover completely. PROMs did not correlate to type of treatment. The frequency of open fractures was significantly higher in females. The reason for this is unclear but different skin thickness in older males versus females may be one explanation.

In cases of severely compromised teeth, dental practitioners are confronted with the therapeutic decision of whether to restore a tooth or replace it with an implant. Comparative scientific evidence on patient perception of both treatment approaches is scarce. The subject of this prospective clinical study was to compare oral health-related quality of life (OHRQoL) between two treatment groups: restoration of severely destroyed teeth after orthodontic extrusion (FOE) versus tooth extraction and implant-supported single crown restoration (ISC). A self-selected trial was performed with 21 patients per group. OHRQoL was assessed with the aid of the Oral Health Impact Profile (OHIP-G49) at different time intervals: before treatment (T1), after treatment (T2), after restoration (T3) and at recall (T4). Overall, OHIP scores improved from baseline to follow-up for both concepts with no significant differences between groups. There were no significant differences in subscales between FOE and ISC at T1, T3 and T4. In terms of functional limitations (p = 0.003) and physical disability (p = 0.021), patients in the FOE group temporarily exhibited lower OHRQoL at T2 in comparison to the ISC group. However, at baseline, after final restoration and at recall, the study demonstrates the same level of OHRQoL for both treatment concepts. [ABSTRACT FROM AUTHOR]

Chronic migraine is a burdensome condition, and onabotulinumtoxinA is revealed to be an effective therapy. Migraine shows a bidirectional relationship with sleep, but the effects of preventive therapies on sleep quality are poorly studied. This study aims to evaluate the effects of a single session of onabotulinumtoxinA on patients’ sleep quality and correlates the results with measures of comorbid anxiety/depression. Patients completed self-administrable questionnaires about sleep quality (Pittsburgh Sleep Quality Index—PSQI) and psychological symptoms (Beck Depression Inventory, 2nd edition—BDI-II—and Hospital Anxiety and Depression Scale—HADS—subscales “a” and “d” for anxiety and depression, respectively), and reported migraine frequency at baseline and after 12 weeks. The 42 included patients showed a significant reduction in migraine days (from 20.6 ± 6.0 to 13.6 ± 6.2, p < 0.001), while no changes were observed in sleep quality (PSQI score from 11.0 ± 5.0 to 9.8 ± 4.6, p = 0.277) or psychological measures (BDI-II from 16.7 ± 10.2 to 15.7 ± 10.3, p = 0.678; HADS-a from 10.3 ± 4.8 to 9.3 ± 5.5, p = 0.492; and HADS-d from 7.2 ± 3.9 to 7.1 ± 5.0, p = 0.901). On the other hand, a strong correlation among PSQI, BDI-II, HADS-a, and HADS-d scores (p < 0.001, rho > 0.7) was found. Despite its efficacy in migraine prevention, a single session of onabotulinumtoxinA was not able to affect patients’ sleep quality or their psychological symptoms.

Abstract Background As a consequence of tooth loss due to trauma or extraction, a reduced alveolar crest volume limits the deployment of standard implants in certain patient cases. For this reason, minimal-invasive treatment with mini-dental implants (MDI) might be an option to allow implant treatment even in cases with severe horizontal bone loss without augmentation measures. The aim of this retrospective cohort study was to investigate clinical and radiological implant, as well as patient-related parameters after treatment with MDI. Results Clinical and radiological records of 19 female (82.6%) and 4 male patients (17.4%) (N = 23), who received 52 mini-dental implants with a two-piece design in a single surgical center between November 2011 and October 2018, were retrospectively analyzed. Implants were submitted to conventional loading on different types of screwed superstructures. Crestal bone loss was measured on standardized periapical radiographs. Patient-related outcome parameters (PROMs) were recorded during follow-up period. Mean clinical and radiological follow-up was 69.6 months (5.8 years) and 51.6 months (4.3 years), respectively. Three implants were lost in two patients, leading to an implant survival rate of 94.2%. Mean radiological crestal bone loss was 1.6 mm. Both amount of peri-implant recession and crestal bone loss were significantly correlated (r = 0.65; p < 0.001). Likewise, a significant correlation was observed between deeper probing depths and increased peri-implant bone loss (r = 0.41; p = 0.012). Alveolar ridges with a reduced alveolar crest width were significantly correlated with higher peri-implant bone loss as well (r = − 0.33; p = 0.011). No prosthetic complications were reported during follow-up. Extent of midfacial recession and papilla height loss had a significant negative impact on most of the PROMs. Conclusions Treatment with MDI seems to be a successful alternative treatment option, especially for elderly patients with reduced crest width at implant sites. Due to the good clinical results and high survival and success rates, this treatment option was associated with high patient satisfaction. Despite the promising results, particular consideration should be given to appropriate treatment planning in these patients due to the strong correlation between peri-implant soft-tissue parameters, crestal bone loss, and reduced alveolar crest width.

Abstract Background The Catquest-9SF questionnaire is a patient reported outcome measure that quantifies the visual benefits from cataract surgery. The purpose of this study was to translate and adapt the Catquest-9SF questionnaire for France, to assess its psychometric properties via Rasch analysis, and to assess its validity when completed using an electronic notepad. Methods The Catquest-9SF questionnaire was translated following the guidelines of the International Society for Pharmacoeconomics and Outcomes Research. Catquest-9SF and clinical data were collected from patients before and after routine cataract surgery. All questionnaire data were collected via an electronic notepad. Rasch analysis was performed to assess psychometric properties, and sensitivity to change was analysed for patients with complete paired pre- and post-operative questionnaires. Results A complete filled-in preoperative questionnaire was obtained for 848 patients. Rasch analysis showed good precision (person separation: 2.32, person reliability: 0.84), ordered category probability curves, no item misfit, and unidimensionality. The respondents were slightly more able than the level of item difficulty (targeting: −1.12 logits). Sensitivity was analysed on 211 paired questionnaires, and the postoperative questionnaires showed a clear ceiling effect. The effect size was 2.6. The use of an electronic notepad for completing the questionnaire worked out very well after some adjustments. Conclusions The French version of Catquest-9SF has good psychometric properties and is suitable for use in French-speaking patients. The use of the Catquest-9SF questionnaire in an electronic format showed good validity.

The treatment of chronic pain with cannabinoids is becoming more widespread and popular among patients. However, studies show that only a few patients experience any benefit from this treatment. It also remains unclear which domains are affected by cannabinoid treatment. Therefore, the present study is novel in that it explores the effects of cannabinoid treatment on four patient-related outcome measures (PROMs), and includes patients with chronic refractory pain conditions who have been given the option of cannabinoid treatment. A retrospective design was used to evaluate the impact of cannabinoid treatment on patients with refractory pain in two German outpatient pain clinics. The present study shows that pain intensity (mean relative reduction (−14.9 ± 22.6%), emotional distress (−9.2 ± 43.5%), pain-associated disability (−7.0 ± 46.5%) and tolerability of pain (−11 ± 23.4%)) improved with cannabinoid treatment. Interestingly, the trajectories of the PROMs seemed to differ between patients, with only 30% of patients responding with respect to pain intensity, but showing improvements in other PROMs. Although the mean treatment effects remained limited, the cumulative magnitude of change in all dimensions may affect patients’ quality of life. In summary, a singular evaluation with pain intensity as the sole outcome does not cover the multidimensional effects of cannabinoids. Therefore, the treatment effects of cannabinoids should be evaluated with different PROMs.

Background: The Mayo Elbow Performance Score (MEPS) is a rating system consisting of four dimensions to evaluate elbow performance. It is a common tool for assessment of elbow impairments worldwide. We determined the validity and reliability of its German version (MEPS-G) after cross-cultural adaptation. Methods: Six investigators examined 57 patients with elbow pathologies. The MEPS-G was compared to validated elbow scores such as the German versions of DASH, the Oxford Elbow Score, pain level and subjective elbow performance on a VAS. Inter-rater reliability (IRR) and validity of the score and its dimensions were also reviewed. Verification was performed using the intraclass correlation coefficient (ICC), the prevalence and bias with adjusted Kappa (PABAK) and the Spearman correlation. Results: The IRR of the MEPS-G score was moderate (ICC (2.1) = 0.65). The IRR of the four individual dimensions was moderate to high (KPABAK = 0.55 -0.81). Validity for the sum score (r = 0.52–0.65) and the dimensions pain (r = 0.53–0.62), range of motion (r = 0.7) and stability (r = − 0.61) was verified. The function subscale reached insufficient validity (r = 0.15–0.39). Conclusion: The MEPS-G is not sufficiently valid, which is consistent with its English version. The patient-based dimensions were a weakness, demonstrating high risk of bias. There is no general recommendation for the utilization of the MEPS-G as outcome measurement for patients with elbow pathologies. [ABSTRACT FROM AUTHOR]

The objective of this prospective randomized controlled single-center clinical trial was to prove the efficacy of adjunctive photobiomodulation in improving selected outcomes following the use of laterally closed tunnel technique for the management of isolated gingival recession. Nineteen participants (with isolated gingival recession) each treated by laterally closed tunnel technique were randomized to either add on treatment with control (sham laser application) or test group (photobiomodulation with 660 nm diode, 3.5 J/cm2 per point of application). The primary outcome variable was change in recession depth and secondary variables included recession width, width of keratinized gingiva, periodontal biotype, and VAS score for pain assessment and EHS index for early wound healing assessment. Analysis was performed using a linear mixed effects model. There were no significant differences in the gingival recession depth (p = 0.8324) and recession width (p-0.969) at 3-month follow-up. The VAS scores were significantly lower for the test (laterally closed tunnel technique + photobiomodulation) group as compared to control (laterally closed tunnel technique + sham laser) over time (p = < 0.0001) as well as per site (p = 0.0006) The Early Wound Healing Index scores were significantly higher in the test (laterally closed tunnel technique + photobiomodulation) group as compared to control (laterally closed tunnel technique + sham laser) group (p < 0.0001). The adjunctive use of photobiomodulation did not show a better outcome concerning recession depth but appears to provide faster healing of the surgical wounds and better patient comfort. The result needs further evaluation in particular with respect to long-term effect and due to limitation in sample size. Clinical Trial Registry of India: CTRI/2019/11/022012. [ABSTRACT FROM AUTHOR]

Oral immunotherapy (OIT) is effective at inducing desensitization in food-allergic individuals, and is a valid therapeutic option for those allergic to peanut, cow's milk and egg. However, there is a high rate of dose-related adverse events, and at least one fatality to OIT has been reported. We provide an update on the broader framework of issues which will impact on the availability and uptake of OIT. The need for standardized products remains controversial. A licensed product exists for peanut-OIT, but OIT can also be safely achieved using peanut-containing foods at much lower cost. For other allergens, OIT can only be done with non-pharma products – something which has been done safely for over 2 decades. There is a need to develop personalized protocols for OIT, particularly for the 20% of patients unable to tolerate standard OIT. Cost-effectiveness is dependent on improved quality of life, but evidence for this is currently lacking, and is a key evidence gap. OIT is likely to be cost-effective, particularly if noncommercial products are used. There may be a trade-off: in patients with lower reaction thresholds, a commercial product may be needed for initial updosing, until a level of desensitization is achieved when they can be switched to natural food products. [ABSTRACT FROM AUTHOR]

Background: The distal radius fracture (DRF) is the most common fracture in adults. With an ageing population, the number of wrist fractures in the superelderly (≥ 80 years) is expected to rise. Optimal treatment for displaced DRFs remains controversial, especially in the superelderly group. In addition, basic knowledge of the outcome after a DRF in this heterogenic group is lacking. The aim of this study was to study injury characteristics, treatment and outcome of DRFs in superelderly patients using data from a large national register.Methods: We used prospectively collected data from the Swedish Fracture Register. All distal radius fractures registered between April 2012 and December 2018 in patients ≥ 80 years of age were included. Data on epidemiology, fracture type, trauma mechanism and treatment are registered by the physician treating the patient. Patients are also sent a subjective outcome questionnaire including EQ-5D, EQ-VAS and Short Musculoskeletal Function Assessment questionnaire (SMFA-score) at the time of injury and after 12 months. The 12-month questionnaire was sent to those who had completed the questionnaire at the time of injury. A Mann-Whitney U-test was used to assess differences between treatment methods.Results: Mean age for this population was 86 years (80-105 years), a majority of the patients were female (86.7%). The dominating injury mechanism was a simple fall (74.6%) in the patient's residence. The majority of fractures were AO type A (70%) followed by AO type C (20.9%) and type B (8.6%). The incidence of open fractures was significantly higher in females (2.6%) compared to males (1.5%). A majority of the fractures were treated with a cast (87.5%) with volar locking plate as the second most common treatment method (6.6%). Patient-reported outcome measures (PROMs) EQ-5D, EQ-VAS and the Arm Hand Function Index of the SMFA-score deteriorated somewhat one year after injury compared to pre-injury. PROMs did not correlate to treatment with cast or a volar plate.Conclusions: This nationwide register study provides detailed data on DRFs in the superelderly regarding epidemiology, treatment and self-reported outcome. A good self-reported outcome is possible, but many patients do not recover completely. PROMs did not correlate to type of treatment. The frequency of open fractures was significantly higher in females. The reason for this is unclear but different skin thickness in older males versus females may be one explanation. [ABSTRACT FROM AUTHOR]

Aim: The aim of this study was to evaluate the efficacy of a xenogeneic collagen matrix to augment the width of keratinized mucosa (KM), concomitantly to the surgical treatment of peri‐implantitis, when compared to the use of an autologous soft tissue graft. Material and methods: In this 12‐month parallel‐arm randomized controlled clinical trial, patients with peri‐implantitis were randomly assigned, one month after non‐surgical therapy, to surgical resective treatment of peri‐implantitis consisting on an apically positioned flap (APF) in combination with a KM augmentation procedure, either with an autologous free gingival graft (FGG) or a collagen matrix (CM). Primary outcomes were the increase in the width of KM and probing pocket depth (PPD) reduction at 12 months. As secondary outcomes, peri‐implant radiographic and patient‐reported outcomes were assessed. Results: The intention‐to‐treat population consisted of 49 subjects, assigned to either the APF + FGG (n = 23) or APF + CM (n = 26) group. PPDs were reduced by 1.6 mm (SD 1.0) and 1.7 mm (SD 1.2), respectively, being these differences non statistically significant (p =.782). However, the increase in KM was significantly higher in the APF + FGG compared with APF + CM (2.5 mm [SD 1.6] vs. 1.6 mm [SD 1.2], respectively (p =.033). Conclusion: The tested surgical modalities resulted in similar improvements of the clinical parameters. Both free gingival graft and collagen matrix significantly increased the peri‐implant keratinized mucosa, but this KM gain was significantly higher with the free gingival graft. Use of CM, however, was better appreciated by the patients, in terms of pain perception and analgesic consumption, although the surgical time was similar. [ABSTRACT FROM AUTHOR]

Background: As a consequence of tooth loss due to trauma or extraction, a reduced alveolar crest volume limits the deployment of standard implants in certain patient cases. For this reason, minimal-invasive treatment with mini-dental implants (MDI) might be an option to allow implant treatment even in cases with severe horizontal bone loss without augmentation measures. The aim of this retrospective cohort study was to investigate clinical and radiological implant, as well as patient-related parameters after treatment with MDI. Results: Clinical and radiological records of 19 female (82.6%) and 4 male patients (17.4%) (N = 23), who received 52 mini-dental implants with a two-piece design in a single surgical center between November 2011 and October 2018, were retrospectively analyzed. Implants were submitted to conventional loading on different types of screwed superstructures. Crestal bone loss was measured on standardized periapical radiographs. Patient-related outcome parameters (PROMs) were recorded during follow-up period. Mean clinical and radiological follow-up was 69.6 months (5.8 years) and 51.6 months (4.3 years), respectively. Three implants were lost in two patients, leading to an implant survival rate of 94.2%. Mean radiological crestal bone loss was 1.6 mm. Both amount of peri-implant recession and crestal bone loss were significantly correlated (r = 0.65; p < 0.001). Likewise, a significant correlation was observed between deeper probing depths and increased peri-implant bone loss (r = 0.41; p = 0.012). Alveolar ridges with a reduced alveolar crest width were significantly correlated with higher peri-implant bone loss as well (r = − 0.33; p = 0.011). No prosthetic complications were reported during follow-up. Extent of midfacial recession and papilla height loss had a significant negative impact on most of the PROMs. Conclusions: Treatment with MDI seems to be a successful alternative treatment option, especially for elderly patients with reduced crest width at implant sites. Due to the good clinical results and high survival and success rates, this treatment option was associated with high patient satisfaction. Despite the promising results, particular consideration should be given to appropriate treatment planning in these patients due to the strong correlation between peri-implant soft-tissue parameters, crestal bone loss, and reduced alveolar crest width. [ABSTRACT FROM AUTHOR]

Purpose: Urinary tract infections (UTI) occur in nearly half of all women at least once, with around 35% experiencing recurrences. Bladder mucosal glycosaminoglycan (GAG) layer damage is postulated to contribute. Sodium hyaluronate (SH) replenishes the GAG layer and is believed to be protective. However, there is limited literature on patient-reported outcomes and quality of life (QoL) after treatment. Our objective was to observe changes in UTI severity and QoL after treatment with intravesical SH. Methods: In this retrospective, observational patient-reported outcome study, we examined outcomes in UTI patients treated with intravesical SH. SH was instilled weekly for 6 weeks. If symptoms persisted, patients received further instillations on demand. Patients were sent postal questionnaires to score symptoms before and after treatment. Patient-reported UTI occurrences before treatment were compared with recurrences after treatment collected from their primary care providers. Results: There were 18 (58.1%) valid replies. The median age was 75. The median duration of illness before treatment was 4.5 (IQR 2.8–7) years. The median number of infections fell from ten per year (IQR 7–10) before treatment to two per year (IQR 0–5) after treatment. Pain improved by 34%, urgency 30%, nocturia 30%, frequency 32%, 'inability to carry out daily activities due to UTI related ill-health' 37% and 'loss of sleep' by 38%. Patients reported a 76% improvement in 'UTI-related QoL.' No adverse events were reported. Conclusion: SH is safe and useful for managing patients with recurrent UTI, with improvements in symptoms, QoL, a decrease in the number of UTI episodes and in the best interests of antimicrobial stewardship. [ABSTRACT FROM AUTHOR]

Introduction and hypothesis: Urethral injection therapy (UIT) has been performed since the early 20th century and a variety of agents have been launched. In 2006, polyacrylamide hydrogel (PAGH) was introduced and is now widely used as an agent. The objective was to evaluate the efficacy of PAGH based on a national population over a 5-year period (2007-2011) and the influence of patient-related factors, surgeon experience, and department volume. Methods: A retrospective cohort study was carried out based on data from the Danish Urogynaecological Database (DugaBase). Results: A total of 731 women were registered in the DugaBase. Cure was achieved in 75 out of 252 women (29.8%) and no leakage at all in 23 out of 252 (9.1%) at the 3-month follow-up. The mean total International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) score decreased from 16 (SD 3.8) to 10.6 (SD 6.2; p < 0.001). UIT was performed at 16 departments, of which four high-volume departments performed 547 out of 814 UITs (67.2%). Women with severe UI had a decreased chance of cure (all ICIQ-SF scores), as did women on antimuscarinic drugs (adjusted OR 0.14; 95%, CI 0.04-0.41 'frequency') and (adjusted OR 0.33; 95%, CI 0.13-0.82, 'amount'). Women treated by a high-volume surgeon had a higher chance of cure (OR 4.51; 95% CI, 1.21-16.82, 'frequency') and a lower risk of 30-day hospital contacts (OR 0.27; 95% CI 0.09-0.76). Conclusion: The study represented a cure for UIT among women in an everyday life setting. A surgeon learning curve for UIT was indicated, as was assigning interventions to fewer hands to improve the surgical training value and consequently the cure rate for women with UIT. [ABSTRACT FROM AUTHOR]

Chronic rhinosinusitis is an important disease entity that affects patients worldwide, yet there is limited public awareness regarding the disease. The Canadian Rhinosinusitis Working Group, a group of diverse medical professionals, has made a multitude of efforts to help improve the health literacy of patients and important stakeholders, as well as the quality of life of patients with chronic rhinosinusitis. This review will aim to outline these initiatives. [ABSTRACT FROM AUTHOR]

Purpose To establish patient satisfaction after collagenase clostridium histolyticum (CCH) injection. Methods In a cross-sectional study, 213 patients who had been treated for Dupuytren disease with CCH were reviewed between 37 and 1421 days after injection. Results A total of 73% of the patients were very satisfied or satisfied, and 21% were dissatisfied; 75% would probably or definitely have CCH again, whereas 17% probably or definitely would not. We found that satisfaction and willingness to undergo a second treatment decreased over time and had a negative relationship with recurrence. Dissatisfaction was greater in those with a poor initial outcome but not in those with an initial complication. Of 212 patients, 78 had previously experienced surgery for Dupuytren disease of whom 71% would prefer CCH to surgery and 15% the converse. Satisfaction shows a relationship with function as measured by both Quick DASH and the Southampton Dupuytren Scoring Scheme. Conclusions Patient satisfaction with CCH is generally high but deteriorates over time as the disease recurs. To manage patient expectation, this issue should be made explicit to patients in the consent process. Clinical relevance Overall satisfaction with CCH is high, with initial satisfaction rates especially good. Forewarning of complications and recurrence can help maintain satisfaction levels. [ABSTRACT FROM AUTHOR]

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To investigate whether a tailored intersectoral discharge program (TIDP) impacts on multidimensional frailty, rehospitalization days, and patient-related outcome measures in older in-patients undergoing acute care and usual rehabilitative care. Randomized controlled trial of TIDP vs usual rehabilitative care with a 6-month follow-up, 2019–2020, and historical control with a 6-month follow-up, 2016–2019. Geriatric co-managed internal medicine ward of a metropolitan university hospital. One hundred-twelve multimorbid patients older than age 60 years were consecutively assessed for eligibility and inclusion (age ≥60 years, multimorbidity, admitted for treatment of acute disease, at least 2 geriatric syndromes requiring usual rehabilitative care, and able to consent) and signed informed consent, with 110 recruited and randomized to either TIDP or usual rehabilitative care. At discharge, 104 patients were alive in the intention-to-treat group, the 6-month follow-up was completed for 91 patients. A historical control group of 468 patients was included for comparison. TIDP as intervention included contact with treating general practitioner to discuss the further treatment plan, a structured medical and lifestyle counseling to patients and caregivers at admission as well as a discharge program with internist, geriatrician, and general practitioner in shared decision making with patients. Fifty-four patients underwent TIDP, 53 patients underwent usual rehabilitative care only. Rehospitalization days at follow-up as primary endpoint; multidimensional frailty and prognosis (Multidimensional Prognostic Index, Geriatric Depression Scale, Rosenberg Self-Esteem Scale, quality of life, falls, mortality, home care service need, and need of long-term care at 1-, 3- and 6-month follow-up as secondary endpoints. TIDP (median age 76.0 years, 56% female) showed significantly improved Multidimensional Prognostic Index scores at discharge compared with usual rehabilitative care (median age 78.5 years, 58% female) (0.43 vs 0.49, P =.011). Compared with usual rehabilitative care, TIDP improved self-confidence (Rosenberg Self-Esteem Scale 13.9 vs 12.4, P =.009) and mood (Geriatric Depression Scale 4 vs 5, P =.027) at follow-up. Compared with historical control (median age 77.0 years, 39 % female), usual rehabilitative care patients showed significantly lower rehospitalization rates (53% vs 70%, P =.002) and lower mortality rates (13% vs 32%, P <.001). A feasible TIDP improves frailty and mood in advanced age. In older patients undergoing potentially disabling acute treatments, usual rehabilitative care significantly reduces rehospitalization rates. Therefore, implementing geriatric treatment in general is useful to improve outcomes in older in-patients and a tailored discharge program can further increase the benefit for this frail population. [ABSTRACT FROM AUTHOR]

Purpose: To describe current evidence on single- and double-bundle anterior cruciate ligament (ACL) reconstruction, in terms of differences in knee kinematics, functional outcomes, patient-reported outcomes and graft failures. Methods: An electronic search was made using PubMed (MEDLINE), EMBASE and Cochrane Library. Studies published from January 1995 to August 2011 were included, and an updated search was made in PubMed in July 2012. Therapeutic studies, level of evidence I-III, for isolated primary ACL tears written in English comparing single- and double-bundle reconstruction reporting clinical outcome were included. Quality appraisal based on Cochrane Collaboration's tool for assessing risk of bias was performed. Results: Of 7,154 potentially eligible studies, 60 papers were included (25 randomised controlled trials, 21 prospective comparative studies, 14 retrospective comparative studies), comprising 4,146 patients (2,072 single-bundle, 2,074 double-bundle). Minor differences were found between study types. An analysis of graft failures revealed fewer re-ruptures in double-bundle reconstruction than single-bundle, 19 and 44, respectively. Up to 45 % of the studies reported a superior outcome in double-bundle reconstruction in terms of antero-posterior laxity, measured with the Lachman, anterior drawer, KT-1000/2000 and navigation. Measurements of rotatory laxity revealed superior results in double-bundle reconstruction measured with pivot shift and navigation in 18/42 (8/15 anatomically reconstructed) and 9/20 studies, respectively. Patient-reported outcome measures and functional outcomes did not differ to a large extent; however, differences when identified were almost exclusively in favour of double-bundle reconstruction. Conclusion: Based on current evidence, double-bundle reconstruction appears to have fewer re-ruptures and less antero-posterior and rotatory laxity. Furthermore, no differences were found in short-term patient-reported outcome measures or objective findings. However, detailed statistical analyses of the included studies divided into homogeneous groups are needed to avoid reporting bias and to confirm any statistical difference. Level of evidence: III. [ABSTRACT FROM AUTHOR]

Abstract: We reviewed the revision rate and functional outcome of all patients who had a total knee arthroplasty (TKA) after an osteotomy or unicompartmental knee arthroplasty (UKA) on the New Zealand Joint Registry. We used these data to compare the results with primary TKA scores, including comparison of age-matched subgroups. There were 711 patients who had undergone TKA as salvage for a failed osteotomy with a revision rate of 1.33 per 100 component years and a mean 6-month Oxford Knee Score (OKS) of 36.9. There were 205 patients who had a failed UKA converted to TKA with a revision rate of 1.97 per 100 component years and a mean OKS of 29.1. The revision rates of TKA for both failed osteotomy and failed UKA were significantly poorer than after primary TKA (0.48 per 100 component years). The mean OKS after revision of a UKA was significantly poorer than both primary TKA and TKA for a failed osteotomy. There was no significant difference in mean OKS between primary TKA and TKA for a failed osteotomy, even among patients younger than 65 years. Revision of a failed osteotomy to a TKA has improved functional results compared with revision of a failed UKA. However, both yield poorer survivorship rates compared with primary TKA. [Copyright &y& Elsevier]

The article presents a study which examines the relationship of obstructive sleep apnea (OSA) to sleepiness and fatigue in patients with multiple sclerosis (MS). The study measures fatigue among MS patients using the Fatigue Severity Scale (FSS) and the Multidimensional Fatigue Inventory (MFI), and sleepiness by Epworth Sleepiness Scale. Results show the association of MFI-mental fatigue and severe fatigue to OSA and respiratory-related arousals.

In the UK there has been a shift over the last decade towards the setting of targets by commissioning or regulatory bodies so that health services provide improved levels of care. For mental health services this has occurred in three phases: phase one related to simple key performance indicators (for example collection of patients' diagnostic codes); phase two placed greater emphasis on more meaningful clinical outcome data; the third and most recent phase placed prominence on patient-focused data collection. We report the development and preliminary findings of a piloting of a patient-related outcome measure (PROM) and patient-related experience measure (PREM) created specifically for older adult mental health services in Central and North West London NHS Foundation Trust. PROMs/PREMs are in keeping with an increased focus on patients' experience of health care, the provision of quality services and various key policies such as the recent government white paper Equity and Excellence: Liberating the NHS. [ABSTRACT FROM AUTHOR]