Significant Changes In Outcomes Research Articles

P-623 Post-market analysis of an AI-powered clinical decision support tool for ovarian stimulation

Abstract Study question How do treatment decisions and patient outcomes change with physician utilization of artificial intelligence (AI) to help determine FSH starting dose and trigger injection timing? Summary answer With physician use of an AI platform, patients were treated with significantly less starting and total FSH without statistically significant changes in outcomes. What is known already Stim Assist is an AI clinical decision support software providing physicians with adjunctive information for the prediction of the number of mature (MII) oocytes that may be retrieved from an ovarian stimulation cycle. The software is intended to assist with the selection of the starting dose of FSH as well as the decision of when to administer the trigger injection. Prior studies have retrospectively estimated the benefit of using AI for treatment decisions during ovarian stimulation, but there is a lack of post-market analyses evaluating the true efficacy of these tools when integrated in clinical practice. Study design, size, duration This study was conducted by multiple physicians at a single IVF clinic in the U.S. The treatment arm consisted of 292 patients seen by physicians using Stim Assist between December 2022 - December 2023. The control arm consisted of 292 matched historical control patients, treated between May 2019 - May 2022 at the same clinic without use of Stim Assist. Participants/materials, setting, methods Matching for each patient was performed for each physician individually, comparing each treatment-arm patient to a historical control-arm patient who was seen by the same physician. Patients were matched 1-to-1 based on age, baseline AMH, and baseline antral follicle count. The primary endpoints were the starting FSH and total FSH prescribed to the patient, as well as MIIs retrieved at the end of stimulation. Main results and the role of chance Comparing the treatment arm to the control arm, the average MIIs were 11.17 vs. 11.45 (p = 0.68), the average starting FSH was 397.09 vs. 443.58 (p < 0.01), and the average total FSH was 4181.77 vs 4601.8 (p < 0.01). The results were stratified by age groups of < 35, 35-40, and >40. For patients in the <35 group (N = 122), the average MIIs were 13.99 vs. 16.06 (p = 0.06), the average starting FSH was 346.72 vs. 380.53 (p < 0.01), and the average total FSH was 3525.84 vs. 3927.25 (p < 0.01). For patients in the 35-40 group (N = 129), the average MIIs were 9.46 vs. 8.71 (p = 0.34), the average starting FSH was 420.35 vs. 486.05 (p < 0.01), and the average total FSH was 4568.6 vs. 5063.37 (p < 0.01). For patients in the >40 group (N = 41), the average MIIs were 8.17 vs. 6.34 (p = 0.12), the average starting FSH was 473.78 vs. 497.56 (p = 0.16), and the average total FSH was 4916.46 vs. 5156.71 (p = 0.34). Limitations, reasons for caution This preliminary post-market analysis was performed at a single clinic in the U.S. We could not calculate live birth outcomes. Due to the limited sample size, differences in outcomes were not statistically significant. Wider implications of the findings These findings suggest that physician use of Stim Assist helped significantly reduce the starting and total FSH prescribed to patients. Additionally, MII outcome differences showed a trend towards an increase in MIIs for patients >35 years old, and a slight reduction in MIIs for younger, better prognosis patients. Trial registration number not applicable

Lifestyle modification interventions for adults with intellectual disabilities: systematic review and meta-analysis at intervention and component levels.

Adults with intellectual disabilities (IDs) are susceptible to multiple health risk behaviours such as alcohol consumption, smoking, low physical activity, sedentary behaviour and poor diet. Lifestyle modification interventions can prevent or reduce negative health consequences caused by these behaviours. We aim to determine the effectiveness of lifestyle modification interventions and their components in targeting health risk behaviours in adults with IDs. A systematic review and meta-analysis were conducted. Electronic databases, clinical trial registries, grey literature and citations of systematic reviews and included studies were searched in January 2021 (updated February 2022). Randomised controlled trials and non-randomised controlled trials targeting alcohol consumption, smoking, low physical activity, sedentary behaviours and poor diet in adults (aged≥18years) with ID were included. Meta-analysis was conducted at the intervention level (pairwise and network meta-analysis) and the component-level (component network meta-analysis). Studies were coded using Michie's 19-item theory coding scheme and 94-item behaviour change taxonomies. Risk of bias was assessed using the Cochrane Risk of Bias (ROB) Version 2 and Risk of Bias in Non-randomised Studies of Interventions (ROBINS-I). The study involved a patient and public involvement (PPI) group, including people with lived experience, who contributed extensively by shaping the methodology, providing valuable insights in interpreting results and organising of dissemination events. Our literature search identified 12180 articles, of which 80 studies with 4805 participants were included in the review. The complexity of lifestyle modification intervention was dismantled by identifying six core components that influenced outcomes. Interventions targeting single or multiple health risk behaviours could have a single or combination of multiple core-components. Interventions (2 RCTS; 4 non-RCTs; 228 participants) targeting alcohol consumption and smoking behaviour were effective but based on limited evidence. Similarly, interventions targeting low physical activity only (16 RCTs; 17 non-RCTs; 1413 participants) or multiple behaviours (low physical activity only, sedentary behaviours and poor diet) (17 RCTs; 24 non-RCTs; 3164 participants) yielded mixed effectiveness in outcomes. Most interventions targeting low physical activity only or multiple behaviours generated positive effects on various outcomeswhile some interventions led to no change or worsened outcomes, which could be attributed to the presence of a single core-component or a combination of similar core components in interventions. The intervention-level meta-analysis for weight management outcomes showed that none of the interventions were associated with a statistically significant change in outcomes when compared with treatment-as-usual and each other. Interventions with core-components combination of energy deficit diet, aerobic exercise and behaviour change techniques showed the highest weight loss [mean difference (MD)=-3.61, 95% credible interval (CrI) -9.68 to 1.95] and those with core-components combination dietary advice and aerobic exercise showed a weight gain (MD 0.94, 95% CrI -3.93 to 4.91). Similar findings were found with the component network meta-analysis for which additional components were identified. Most studies had a high and moderate risk of bias. Various theories and behaviour change techniques were used in intervention development and adaptation. Our systematic review is the first to comprehensively explore lifestyle modification interventions targeting a range of single and multiple health risk behaviours in adults with ID, co-produced with people with lived experience. It has practical implications for future research as it highlights the importance of mixed-methods research in understanding lifestyle modification interventions and the need for population-specific improvements in the field (e.g., tailored interventions, development of evaluation instruments or tools, use of rigorous research methodologies and comprehensive reporting frameworks). Wide dissemination of related knowledge and the involvement of PPI groups, including people with lived experience, will help future researchers design interventions that consider the unique needs, desires and abilities of people with ID.

Effectiveness of a multidisciplinary treatment with youth-initiated mentoring for youths with mental health needs from multi-problem families: a quasi-experimental study

BackgroundChildren from multi-problem families have an increased risk for experiencing mental health problems. These families face problems in several domains that are often found to be chronic and intergenerational. Yet, the effects of mental health care for youths from multi-problem families are small at best, urging research on new treatment programs. The InConnection approach is an integrated care program to improve resilience of youths with mental health needs from multi-problem families by connecting professional expertise from multiple disciplines with the informal social network of the youth. Youths are asked to nominate a youth-initiated mentor (YIM) from the supportive adults in their network.MethodsThis quasi-experimental study compared the effectiveness of the InConnection approach to treatment as usual in a sample of 107 families (n = 66 intervention group, n = 41 control group) with n = 115 youths receiving treatment (cases). Youths (n = 102 reports, Mage = 15.59 years), parents (n = 85 reports) and case managers (n = 107 reports) responded to questionnaires four times over 15 months. Using these data, we measured youth resilience as the primary outcome, seven secondary outcomes, and three intermediate outcomes.ResultsLatent growth models showed only one significant change in outcomes over time across conditions, namely a decrease in case manager-reported child unsafety, and only two condition effects, which were both parent-reported. Parents in the InConnection group reported improvements over time in youth’s emotional and behavioral problems and their own positive parenting, whereas control parents reported no changes (ps ≤ 0.013).DiscussionThe treatment conditions were not effective in improving most of the youth and parental outcomes over time, except for child safety reported by the case manager. The InConnection approach only outperformed care as usual on two parent-reported outcomes. Future research should examine for whom and under what circumstances the InConnection approach works more convincingly.Trial registrationNetherlands Trial Register NL7565. Retrospectively registered on 05/03/2019.

A preliminary study on the effect of renal function on the metabolism of 18F-FDG in the human cerebellum.

The cerebellum is less affected by normal aging or neurodegenerative diseases, the aim of this paper is to investigate the effect of renal function status on uptake of 2-deoxy-2-[18F]fluoro-D-glucose (18F-FDG) in human cerebellum based on independent creatinine (CRE) or blood urea nitrogen (BUN) levels. A total of 253 patients who underwent 18F-FDG PET/CT scans were included. The patients were divided into groups according to renal function status: 201 patients with normal renal function, 16 patients with increase CRE, 36 patients with decrease CRE, and 31 patients with abnormal BUN. The maximum standardized uptake values were obtained in regions of interest (ROIs) for multiple tissue types (right cerebellum, right lobe of liver, right lung, bone marrow and psoas muscle at the level of the fourth lumbar vertebra). Moreover, the selected normal CRE groups were pair-matched with CRE decrease group with respect to age, sex, body mass index and glucose, respectively. Among 253 patients who met the inclusion/exclusion criteria, the final analysis included 967 ROIs (244 cerebellum, 191 lungs, 230 muscles, 145 bone marrow, and 157 liver) from 18F-FDG PET/CT scans. Among patients grouped by CRE or BUN levels, the uptake of 18F-FDG by cerebellum was significantly decreased in patients with CRE decrease level (P=0.001). There were no statistically significant differences between the other groups. Matched-pair analysis indicated there were no significant changes in outcomes between the CRE decrease group and the age-, sex-, BMI-, and glucose-matched controls compared to pre-matching. In patients with normal renal function and reduced CRE concentration, decrease cerebellar glucose metabolism was observed; however, no abnormal uptake of 18F-FDG was found in the cerebellum and other normal tissues of patients with impaired renal function. Consequently, in the study of cerebellar 18F-FDG metabolism, it may be necessary to consider the influence of blood CRE level.

The Impact of the Addition of a Physical Therapy Assistant to the Treatment Team for Management of Neck Pain: A Retrospective Analysis of Outpatient Physical Therapy Clinics.

Introduction The impact of physical therapy assistants (PTAs) on patient outcomes, mostly in the acute and subacute setting, is well known in the literature. However, no study to date has examined the impact of using PTAs as part of a treatment team in the outpatient setting for common musculoskeletal conditions. The purpose of this study is to determine if physical therapy team composition, either physical therapists (PTs) only or a team consisting of PTs and PTAs, has a significant impact on patient outcomes in adult patients with musculoskeletal neck pain to help investigate an ideal practice pattern for outpatient physical therapy. Methods This is a retrospective cohort study analyzing the impact of physical therapy treatment team composition (PTs only, or team consisting of PTs and PTAs) on pain, active range-of-motion (AROM), and disability outcomes via the Neck Disability Index (NDI) in the conservative treatment of neck pain. All patients were treated with usual physical therapy care. Inclusion criteria involved patients with a diagnosis of neck pain (M48.2), older than 18 years old, a physical therapy evaluation procedure code (97161, 97162, 97163), and at least two visits per bout of physical therapy. Primary outcome measures were pain, bilateral rotation AROM, disability, and number of visits. Results Included patients (n=195) had an average age of 60.8 years ± 16.1 years with an average number of total physical therapy visits of 7.4 visits ± 4.3 visits (range, 2 visits - 22 visits) with 120 patients (61.5%) treated by a PT only (PT-only group) and 75 patients (38.5%) treated by a team consisting of a PT and a PTA (PTA group). The PT-only group had significantly fewer visits than the PTA group (p<0.001). The PT-only group had a pain improvement of 2.1 points ± 2.3 points whereas the PTA group had a pain improvement of 2.2 points ± 2.4 points with no significant difference between the two groups (p=0.573). The PT-only group (n=46 patients) had an average rotation AROM improvement of 20.0 ± 17.4 degrees whereas the PTA group (n=40 patients) had an average rotation AROM improvement of 16.8 degrees ± 23.0 degrees with no significant difference between the level of rotation AROM improvement between the two groups (p=0.408). Furthermore, there was also no significant difference in the amount of NDI improvement seen in both groups (p=0.594). Conclusion There was no significant difference in patient outcomes for pain, AROM, and disability when PTAs were added to the physical therapy treatment team in the conservative management of neck pain in the outpatient setting. However, patients treated with a treatment team consisting of PTAs had significantly more visits, despite no significant change in outcomes. Randomized controlled trials are needed as the reasons for these findings can be many and require further research.

The relevance of the meat value chain analysis to reducing malnutrition in developing countries: a systematic literature review

&lt;p class="MainHeading"&gt;&lt;em&gt;This study examines the evidence from the literature relevant to analysing the meat value chain and its relevance in reducing the prevalence of malnutrition in developing countries. A systematic literature review was performed to synthesise a qualitative evidence base, including information on the study country, time frame, methodology, research question, sample population, limitations, and recommendations for future research. The Cochrane methodology was employed to review 46 studies systematically. It was noted that studies are often conducted in multiple countries, mainly in Asia and Africa. The specific period over which the studies were conducted, or the period of data collection or observation, was often less than one year, highlighting significant changes in outcomes after the intervention, for example, increased Fe status. However, interventions are not known to reduce the prevalence of malnutrition directly. Research questions are asked using a variety of methods.&lt;/em&gt; &lt;em&gt;Quantitative, qualitative and mixed methods. Quantitative approaches focused on identifying potential risk hotspots, while qualitative research focused on assessing the impact of change. Economic systems and vulnerable groups are often investigated as concerns of developing countries. This study broadens the conceptual framework and demonstrates its potential to contribute to nutritional literacy and the meat industry. &lt;/em&gt;&lt;/p&gt;

Minimal Clinically Important Difference (MCID) in Patient-Reported Outcome Measures for Neurological Conditions: Review of Concept and Methods

Abstract The concept of the minimal clinically important difference (MCID) emerged from the recognition that statistical significance alone is not enough to determine the clinical relevance of treatment effects in clinical research. In many cases, statistically significant changes in outcomes may not be meaningful to patients or may not result in any tangible improvements in their health. This has led to a growing emphasis on the importance of measuring patient-reported outcome measures (PROMs) in clinical trials and other research studies, in order to capture the patient perspective on treatment effectiveness. MCID is defined as the smallest change in scores that is considered meaningful or important to patients. MCID is particularly important in fields such as neurology, where many of the outcomes of interest are subjective or based on patient-reported symptoms. This review discusses the challenges associated with interpreting outcomes of clinical trials based solely on statistical significance, highlighting the importance of considering clinical relevance and patient perception of change. There are two main approaches to estimating MCID: anchor-based and distribution-based. Anchor-based approaches compare change scores using an external anchor, while distribution-based approaches estimate MCID values based on statistical characteristics of scores within a sample. MCID is dynamic and context-specific, and there is no single ‘gold standard’ method for estimating it. A range of MCID thresholds should be defined using multiple methods for a disease under targeted intervention, rather than relying on a single absolute value. The use of MCID thresholds can be an important tool for researchers, neurophysicians and patients in evaluating the effectiveness of treatments and interventions, and in making informed decisions about care.

A 3-year analysis of the impact of COVID-19 pandemic on NSTEMI incidence, clinical characteristics, management, and outcomes.

The COVID-19 pandemic has been associated with decreased incidence of acute coronary syndrome with worsened outcomes. Few studies have addressed the effects beyond the initial phases of the pandemic. This study elucidated the incidence, clinical characteristics, management, and outcomes of NSTEMI at a tertiary referral center from sample time periods of 2019-2022. This study included consecutive NSTEMI patients from March 14-May9,2019-2022. Variables included baseline characteristics, clinical features on arrival, management strategy, time parameters, and adverse outcomes. The primary outcome was defined as death, heart failure requiring diuretics, and/or sustained ventricular arrhythmia. This study comprised 250 patients of whom 181 who were admitted during the COVID-19 outbreak. Baseline characteristics were similar among groups. There was a reduction in door-to-angiography time from 29 h in 2019 to 19 h in 2020 [p = 0.01]and 20 h in 2021 [p = 0.02]. PCI intervention increased from 31.8% in 2019% to 50.0% in 2020 [p = 0.05]and 54.7% in 2021 [p < 0.01]. Median length-of-stay (LOS) was reduced from 3 days in 2019 to 2 days in 2020 [p = 0.03]. There was no significant change in outcomes in COVID-19 cohorts compared to control year. NSTEMI patients during the first 2 years of the COVID-19 pandemic were associated with reduced door-to-angiography times and increased percutaneous coronary intervention (PCI), and patients in year one were associated with reduced LOS. This study suggests that NSTEMI may be managed more efficiently thus reducing hospital bed utilization and potential costs.

Data Analytics of Electronic Health Records to Enhance Care of Coronary Artery Disease in Younger Women with Avoiding Possible Delay in Treatment.

Early detection plays a key role to enhance the outcome for Coronary Artery Disease. We utilized a big data analytics platform on ∼32,000 patients to trace patients from the first encounter to CAD treatment. There are significant gender-based differences in patients younger than 60 from the time of the first encounter to Coronary Artery Bypass Grafting with a p-value=0.03. This recognition makes significant changes in outcome by avoiding delay in treatment.

A feasibility study of the Attention Training Technique in a group format for anxiety and depression in outpatients with coronary heart disease

Abstract Funding Acknowledgements Type of funding sources: None. Background Significant symptoms of anxiety and depression are prevalent (30-40%) in coronary heart disease (CHD) patients and these are associated with a greater risk of death, recurrent cardiovascular events, poorer quality of life, and more frequent use of healthcare services compared to those without this heart condition. To date, only a few psychological treatments have shown limited effectiveness on symptoms of anxiety and depression in CHD patients. Therefore, it is essential to develop and evaluate more effective treatments for depression and anxiety in CHD patients. Metacognitive therapy (MCT) is effective in reducing significant symptoms of anxiety and depression. A key component of MCT is the attention training technique (ATT), which is based on the self-regulatory executive function model. According to the MCT treatment manual, ATT is brief and does not require extensive training to be delivered by health care personnel in routine care. A review of the empirical evidence shows that ATT can be as effective as full MCT in alleviating anxiety and depressive symptoms. However, ATT has not yet been used as a stand-alone intervention in treating symptoms of anxiety and depression in CHD patients. Purpose To evaluate the feasibility of implementing group ATT in CHD patients with significant symptoms of anxiety and depression and describe changes in these symptoms. Methods Five consecutively referred CHD patients with significant anxiety and depressive symptoms, as assessed by the Hospital Anxiety and Depression Scale (HADS)-Anxiety or Depression subscale score &amp;gt; 8, were included in the study. They received six weekly group sessions of ATT in an open trial. Outcomes included symptoms measured by HADS at baseline, post-treatment and at six months follow-up. We also assessed psychiatric diagnoses and specific psychological factors (type D personality, insomnia, worry and rumination) as secondary measures. Results The sample comprised of five men between 52 and 65 years of age, with a mean age of 59.9 years. Four of the patients attended all six sessions, and one patient attended all but one session. The mean HADS-A scores at baseline, post-treatment, and follow up were 9.4 (SD 3.0), 4.2 (SD 3.0) and 4.0 (SD 2.5), and for HADS-D 8.6 (SD 3.3), 3.0 (3.7) and 1.6 (SD 1.5), respectively. The results showed clinically significant changes in anxiety, depression, psychiatric disorders, insomnia, worry, and rumination. Wilcoxon Signed Rank Tests revealed a significant change in outcome from pre- to post-treatment for HADS-A and worry, which was maintained at 6-months follow-up, and HADS-D significantly decreased from pre-treatment to 6-months follow up. Conclusions ATT in a group format appears to be a feasible stand-alone metacognitive treatment for CHD patients with significant symptoms of anxiety or depression. Based on these preliminary results, we believe that an adequately powered randomised controlled trial is now warranted.

Impact of prenatal substance use policies on commercially insured pregnant females with opioid use disorder

IntroductionStates' approaches to addressing prenatal substance use are widely heterogeneous, ranging from supportive policies that enhance access to substance use disorder (SUD) treatment to punitive policies that criminalize prenatal substance use. We studied the effect of these prenatal substance use policies (PSUPs) on medications for opioid use disorder (OUD) treatment, including buprenorphine, naltrexone, and methadone, psychosocial services for SUD treatment, opioid prescriptions, and opioid overdoses among commercially insured pregnant females with OUD. We evaluated: (1) punitive PSUPs criminalizing prenatal substance use or defining it as child maltreatment; (2) supportive PSUPs granting pregnant females priority access to SUD treatment; and (3) supportive PSUPs funding targeted SUD treatment programs for pregnant females. MethodsWe analyzed 2006–2019 MarketScan Commercial Claims and Encounters data. The longitudinal sample comprised females aged 15–45 with an OUD diagnosis at least once during the study period. We estimated fixed effects models that compared changes in outcomes between pregnant and nonpregnant females, in states with and without a PSUP, before and after PSUP implementation. ResultsOur analytical sample comprised 2,438,875 person-quarters from 164,538 unique females, of which 13% were pregnant at least once during the study period. We found that following the implementation of PSUPs funding targeted SUD treatment programs, the proportion of opioid overdoses decreased 45% and of any OUD medication increased 11%, with buprenorphine driving this increase (13%). The implementation of SUD treatment priority PSUPs was not associated with significant changes in outcomes. Following punitive PSUP implementation, the proportion receiving psychosocial services for SUD (12%) and methadone (30%) services decreased. In specifications that estimated the impact of criminalizing policies only, the strongest type of punitive PSUP, opioid overdoses increased 45%. ConclusionOur findings suggest that supportive approaches that enhance access to SUD treatment may effectively reduce adverse maternal outcomes associated with prenatal opioid use. In contrast, punitive approaches may have harmful effects. These findings support leading medical organizations' stance on PSUPs, which advocate for supportive policies that are centered on increased access to SUD treatment and safeguard against discrimination and stigmatization. Our findings also oppose punitive policies, as they may intensify marginalization of pregnant females with OUD seeking treatment.

Intracerebral bleeding in donors is associated with reduced short-term to midterm survival of heart transplant recipients.

AimThe quality of the donor heart is known to have a crucial effect on outcome after heart transplantation (HTx). Although leading to brain death in the end, the initial cause of death of the donor and its potential influences on organ quality are heterogeneous. However, it is still controversial to which extent the donor cause of death is associated with outcome or survival post‐HTx.Methods and resultsWe included all patients undergoing HTx in our centre between September 2010 and June 2021 (n = 218). Recipients were divided in five groups related to their donor cause of death: intracerebral bleeding (‘ICB’, n = 95, 44%), traumatic brain injury (‘trauma’, n = 54, 25%), hypoxic brain damage (‘hypoxic’, n = 34, 16%), cerebrovascular (‘vascular’, n = 15, 7%), or other cause (n = 20, 9%). Baseline characteristics, perioperative parameters, and survival after 30 and 90 days as well as 5 years after transplantation were collected.ResultsIntracerebral bleeding in donors compared with traumatic brain injury is associated with higher probability of need for ECLS post‐HTx (35% vs. 19%, P = 0.04) and significantly reduced survival up to 5 years post‐HTx (i.e. 1 year survival: 61% vs. 95%, P < 0.0001). Although other conditions also show significant changes in outcome and survival, the effect is strongest for ICB, where survival is also reduced compared with all other causes (1 year: 61% vs. 89%, P < 0.0001).ConclusionsIn this retrospective analysis, donor cause of death is associated with differing outcome and survival after HTx. Intracerebral bleeding hereby shows strongest decline in outcome and survival in comparison with all other causes.

Effects of State Opioid Prescribing Laws on Use of Opioid and Other Pain Treatments Among Commercially Insured U.S. Adults.

There is concern that state laws to curb opioid prescribing may adversely affect patients with chronic noncancer pain, but the laws' effects are unclear because of challenges in disentangling multiple laws implemented around the same time. To study the association between state opioid prescribing cap laws, pill mill laws, and mandatory prescription drug monitoring program query or enrollment laws and trends in opioid and guideline-concordant nonopioid pain treatment among commercially insured adults, including a subgroup with chronic noncancer pain conditions. Thirteen treatment states that implemented a single law of interest in a 4-year period and unique groups of control states for each treatment state were identified. Augmented synthetic control analyses were used to estimate the association between each state law and outcomes. United States, 2008 to 2019. 7694514 commercially insured adults aged 18 years or older, including 1976355 diagnosed with arthritis, low back pain, headache, fibromyalgia, and/or neuropathic pain. Proportion of patients receiving any opioid prescription or guideline-concordant nonopioid pain treatment per month, and mean days' supply and morphine milligram equivalents (MME) of prescribed opioids per day, per patient, per month. Laws were associated with small-in-magnitude and non-statistically significant changes in outcomes, although CIs around some estimates were wide. For adults overall and those with chronic noncancer pain, the 13 state laws were each associated with a change of less than 1 percentage point in the proportion of patients receiving any opioid prescription and a change of less than 2 percentage points in the proportion receiving any guideline-concordant nonopioid treatment, per month. The laws were associated with a change of less than 1 in days' supply of opioid prescriptions and a change of less than 4 in average monthly MME per day per patient prescribed opioids. Results may not be generalizable to non-commercially insured populations and were imprecise for some estimates. Use of claims data precluded assessment of the clinical appropriateness of pain treatments. This study did not identify changes in opioid prescribing or nonopioid pain treatment attributable to state laws. National Institute on Drug Abuse.

Long-Term and Transfer Effects of an Action Control Intervention in Overweight Couples: A Randomized Controlled Trial Using Text Messages.

Keeping a physically active lifestyle requires consistent self-regulatory effort such as action control (e.g., continuously monitoring and evaluating a behavior in terms of one’s goals). Involving the romantic partner in interventions might be particularly effective in the long run. The present study examined the long-term and transfer effects of an action control intervention in couples using text messaging for promoting target persons’ and partners’ physical activity, anthropometric measures and physical fitness 6 months post baseline. A total of 121 overweight and obese romantic couples, randomly allocated to an intervention (n = 60; information + action control text messages) or a control group (n = 61; information only) and to participating as target person or partner, completed baseline assessments (T1). 100 couples (82.6%) completed the 6-month follow-up (T3) assessment. Primary outcomes included self-reported moderate-to-vigorous physical activity (MVPA) and objective MVPA and MVPA adherence using triaxial accelerometers across a diary period of 14 days after T3. Secondary outcomes included BMI, waist-to-hip circumference and physical fitness (target persons only) using a submaximal aerobic cycle test. At T3, there were no significant between-group differences between target persons and partners with regard to their objective MVPA, self-reported MVPA, BMI, waist-hip ratio or physical fitness. No significant changes in outcomes were observed from T1 to T3; however, changes in BMI from T1 to T3 between target persons and partners in the intervention group were associated. Overall, the brief 14-days action control intervention was not effective in improving target person’s physical activity, body measures and physical fitness in the long-term. Moreover, no long-term benefits for partners emerged. While brief ecological momentary interventions might be a promising tool for short-term effects, future studies are needed to test features enhancing long-term effectiveness. Associations in romantic partners’ changes suggest that dyadic interventions can be a promising approach, as changes induced in one partner may then transfer over to the other (controlled-trials.com ISRCTN15705531).

Outcomes of permanent pacemaker insertion after TAVR: a systematic review and meta-analysis

Abstract Background/Introduction Conduction abnormalities are frequently encountered after transcatheter aortic valve replacement (TAVR) performed for severe aortic stenosis, leading to post-procedure permanent pacemaker (PPM) insertion. Although the predictors of- and factors leading to post-TAVR PPM have been studied extensively, its short-term and long-term outcomes have not been established. Purpose PPM placement can lead to significant changes in outcomes in post-TAVR patients, which remain unclear. With this analysis, we aim to evaluate the differences between outcomes of patients requiring PPM and those not requiring PPM post-TAVR. Methods A comprehensive literature search was performed in PubMed, EMBASE, and Cochrane to identify relevant trials. Outcomes were compared between the two groups of patients- those requiring post-TAVR PPM and those not requiring post-TAVR PPM. Summary effects were calculated using a DerSimonian and Laird random-effects model as odds ratio (OD) with 95% confidence intervals (CI) for all the clinical endpoints. Results 34 studies, including observational and prospective studies, met our inclusion criteria, with a total of 76,402 patients undergoing TAVR and 10,381 requiring post-TAVR PPM. There were no significant differences between 30-days (OR 1.04; 95% CI 0.96–1.13) and 1-year (OR 1.09; 95% CI 0.72–1.03) all-cause mortality rates, and 30-days (OR 0.86; 95% CI 0.72–1.03) and 1-year (OR 0.85; 95% CI 0.70–1.04) cardiovascular deaths among the two groups. Incidence of heart failure was higher in the post-TAVR PPM group at 30 days (OR 1.26; 95% CI 1.05–1.51) but not at 1 year (OR 1.21; 95% CI 0.93–1.57). No significant difference was noted between the two groups in 30-days or 1-year stroke, 30-days or 1-year myocardial infarction, 30-days or 1-year atrial fibrillation, 30-days or 1-year major bleeding, or 30-days and 1-year readmission rate. Other outcomes, including post-procedure aortic regurgitation, major vascular complications, minor bleeding, valve migration, and device success, also did not have any statistically significant difference in the two patient groups (Figure 1). Of all the patients who received post-TAVR PPM, an average of 46.4% and 58.5% patients had &amp;gt;40% ventricular pacing, and 48.9% and 41.4% had &amp;lt;40% ventricular pacing at 1-month, and 1-year follow up respectively. Conclusions Although there were no differences in the outcomes between the two groups at 30-days and 1-year follow-ups (except the higher incidence of heart failure at 30 days in the post-TAVR PPM group), long-term follow-up studies would be needed to identify any possible adverse events after one year. Also, a significant number of patients requiring post-TAVR PPM had &amp;lt;40% ventricular pacing at 1-month and even at 1-year intervals, which might suggest adopting an alternate approach of closely monitoring any conduction disturbances and avoiding early PPM implantation in post-TAVR patients, if possible. Funding Acknowledgement Type of funding sources: None. Forest plot of differences in outcomes

945 Elective Autologous Free Tissue Transfer for Breast Reconstruction During the Covid-19 Pandemic: A Comparative Analysis of Outcomes

Abstract Introduction The demand placed on the National Health Service by Covid-19 has led to increased delays on elective surgery. Despite these challenges, our unit was the first centre in the UK to recommence elective breast reconstruction following the development of an evidence-based pathway to select low-risk patients. An enhanced recovery protocol was introduced to reduce length of stay. The aim of this study was to compare post-operative outcomes between our Pre-Covid group and our Covid-group of free tissue transfer breast reconstruction. Method We retrospectively reviewed autologous free tissue transfer breast reconstruction within our department between January 15th and September 27th 2020. Comparative data was split into two groups. A ‘pre-Covid group’ from 15th January to 12th March 2020 and a ‘Covid group’ from 3rd June to 27th September 2020. Both groups contained 15 patients. Operative notes and case notes were reviewed. Length of stay, haematoma-rate, flap failure, infection, fat necrosis, ischaemic time, re-do anastomosis and return-to-theatre were compared. Results Average length of stay was reduced from 4 to 3 days amongst our Covid group, haematoma rate was 7% pre-Covid and 13% during Covid. There was no evidence of flap failure, fat necrosis and donor site dehiscence in either group. Infection and flap dehiscence were 7% pre-Covid and 0% during Covid. Re-do anastomosis was 20% pre-Covid and 7% during Covid. Conclusions No statistically significant changes in outcomes were identified. This early review suggests that elective breast reconstructive surgery can still be achieved with comparable outcomes, despite the added challenges of Covid-19.

FOCUS Program: Treating Patients With Cancer and Family Caregivers as a Unit of Care

Studies indicate that patients' and caregivers' responses to illness are interdependent; each person affects the other. Existing evidence reinforces the need to recognize family caregivers as equal recipients of care and support. This evidence-based pilot study evaluated the feasibility and preliminary efficacy of the nurse-guided, psychoeducational, family-based FOCUS program intervention at a local oncology outpatient clinic. 30 patient-caregiver dyads were recruited from a local oncology clinic. Intervention delivery occurred using home visits and telephone calls. Self-administered questionnaires were used to assess participants' self-efficacy, quality of life (QOL), and coping pre- and postintervention, and intervention satisfaction postintervention. Three tailored psychosocial education sessions were held during a 6- to 9-week period. Significant changes in outcomes were found, including increased self-efficacy in both patients and caregivers, higher QOL in caregivers, and decreased use of substances for coping in patients. There was a trend for patients' emotional well-being to improve over time; other aspects of QOL showed little change. There were no significant changes in caregivers' coping.

Decompressive Craniectomy in Patients with Malignant Middle Cerebral Artery Infarction: Prognostic Factors and Timing Dilemma

Abstract Background: About 10 percent of ischemic strokes are defined as a malignant one due to associated massive brain edema which is severe enough to produce elevated intracranial pressure and brain herniation. Decompressive Craniectomy (DC) with duraplasty is a surgical technique that involves the creation of extra roomy space and incision of the tight dural covering the brain allowing swollen brain tissue to herniate outwards to reduce the Intracranial Pressure (ICP). Aim of Study: This study aims to share the experience of performing decompressive craniectomy in the treatment of malignant Middle Cerebral Artery Infarction (MMCAI) >48 hours after stroke with an analysis of the results and prognostic factors. Patients and Methods: From January 2016 to June 2018, we performed a decompressive craniectomy in eleven patients with massive middle cerebral artery infarction. Retrospectively we reviewed the clinical and radiological data, Glasgow coma scale at admission, pre and post-operatively. Serial Computed Tomography (CT) with measurement of midline shift pre and post-operatively. Patients were evaluated according to the following factors: Age, sex, the time between admission and surgery, the time between deterioration and surgery, the pre and post-operative Glasgow coma scale, pre and post-operative midline shift on CT scan, dominancy, and Glasgow outcome scale. Results: Eleven patients (11) have been operated on by decompressive hemicraniectomy and duroplasty, there were no significant changes in outcome in relation to the admission GCS, GCS (p=0.2599) or in GCS (p=0.3713), but there was a significant correlation between the pre-operative GCS and outcome and decompressive craniectomy leads to highly significant relieve of the midline shift (p < 0.000). No significant correlation was detected between the time interval elapsed between admission and the time surgery and patient outcome (p=0.3032), but there was also a significant correlation between the time interval between patient deterioration and time of decompressive craniectomy and patient outcome (p=0.92161). Conclusion: Very strict close observation of patients with Malignant Middle Cerebral Artery (MMCA) infarction in the Neuro ICU is highly recommended and surgery should be done as early as possible before the clinical deterioration of the brain herniation for better benefit. Decompressive craniec-tomy could be a life-saving procedure for large hemispheric infarction but postoperative morbidity and quality of life are the main challenges. Although early surgery is recommended by many studies but still DC even after 48 hours may be a life-saving procedure for some patients especially those operated on within a small time window once the clinical deterioration has happened but the post-operative morbidity and quality of life are the main challenges.

Hidden consequences of patient satisfaction: A survey of pediatric surgeons

BackgroundPatient satisfaction surveys are increasingly utilized to assess patients’ perceptions of their health care. Recently, these scores have been linked to payment, potentially incentivizing practices to meet certain metrics. We hypothesize that increasing pressures to receive positive reviews have led physicians to alter the delivery of their care to accommodate patient expectations over standards of care. MethodsAn 11-question REDCap™ survey was developed and emailed anonymously to all sixty-two surgeons across all surgical subspecialties at our children's hospital. Multiple-choice and open-ended questions were included. A modified Delphi method was used to acquire general consensus. ResultsSurvey response rate for analysis was 41/62 (66%). 23 (56%) stated that they have changed their clinical practice patterns due to concerns regarding patient dissatisfaction. Examples of such changes included: requesting imaging tests or laboratory studies, performing invasive procedures, referring for second opinions, and prescribing medications. Only 2% felt that these interventions led to any significant change in outcome of a patient's condition. Several respondents expressed concerns that factors outside their control (scheduling, parking, wait times) contributed to patient dissatisfaction and affected providers’ ratings, while others expressed concerns about inherent biases driving survey participants. ConclusionsAs a result of patient satisfaction surveys, a significant number of surgeons reported altering their clinical practice beyond standard care to meet patient expectations. Some of these modifications included performing unnecessary interventions. Reliance on these surveys may be at odds with reducing health care costs and avoiding physician burnout. These and other unintended consequences of patient satisfaction surveys warrant further study before they are widely accepted as appropriate quality metrics. Level of evidence: Level IV, questionnaire

A Randomized Controlled Trial Comparing Two Self-Administered Educational Strategies for Patients With Knee Osteoarthritis.

ObjectiveThe objective of this study was to assess the efficacy of self‐administered patient educational tools in improving knowledge and behaviors for the management of knee osteoarthritis.MethodsWe conducted a randomized clinical trial in patients with knee osteoarthritis to assess the efficacy of providing a video for entertainment education, in combination with two booklets, compared with providing the booklets alone. We evaluated changes in scores on a patient knowledge questionnaire, the Decisional Conflict Scale, the Arthritis Self‐Efficacy Scale, and the Effective Consumer Scale between baseline and same day, 3 months, and 6 months post intervention. We used linear regression models to explore associations between demographic characteristics and outcomes, testing for interactions.ResultsTwo hundred nineteen participants were randomly assigned to receive the video + booklets (n = 109) or the booklets alone (n = 110). The mean age of participants was 64.6 (±8.3) years. At 6 months, statistically significant improvements were observed in knowledge and decisional conflict scores for both groups, and statistically significant improvements in the behavior to participate in their health care were observed in the video + booklets group. The video + booklets group was more knowledgeable immediately post intervention than the booklet group (mean difference 0.39 [95% confidence interval 0.02‐0.76]). No other significant changes in outcomes were observed at 6 months between the two groups. The video + booklets combination was associated with decreased decisional conflict in Spanish speakers and increased self‐efficacy in those with less than a high school education.ConclusionAlthough both education strategies were associated with improved knowledge and reduced decisional conflict at 6 months, receiving the video + booklets in combination, compared with receiving the booklets alone, proved to be more effective in changing behaviors and appeared to have some advantages for Spanish speakers and those who were less educated.