Multimorbidity and co-occurring musculoskeletal pain do not modify the effect of the SELFBACK app on low back pain-related disability.

BACKGROUND: SELFBACK, an artificial intelligence (AI)-based app delivering evidence-based tailored self-management support to people with low back pain (LBP), has been shown to reduce LBP-related disability when added to usual care. LBP commonly co-occurs with multimorbidity (≥ 2 long-term conditions) or pain at other musculoskeletal sites, so this study explores if these factors modify the effect of the SELFBACK app or influence outcome trajectories over time. METHODS: Secondary analysis of a randomized controlled trial with 9-month follow-up. Primary outcome is as follows: LBP-related disability (Roland Morris Disability Questionnaire, RMDQ). Secondary outcomes are as follows: stress/depression/illness perception/self-efficacy/general health/quality of life/physical activity/global perceived effect. We used linear mixed models for continuous outcomes and logistic generalized estimating equation for binary outcomes. Analyses were stratified to assess effect modification, whereas control (n = 229) and intervention (n = 232) groups were pooled in analyses of outcome trajectories. RESULTS: Baseline multimorbidity and co-occurring musculoskeletal pain sites did not modify the effect of the SELFBACK app. The effect was somewhat stronger in people with multimorbidity than among those with LBP only (difference in RMDQ due to interaction, - 0.9[95 % CI - 2.5 to 0.6]). Participants with a greater number of long-term conditions and more co-occurring musculoskeletal pain had higher levels of baseline disability (RMDQ 11.3 for ≥ 2 long-term conditions vs 9.5 for LBP only; 11.3 for ≥ 4 musculoskeletal pain sites vs 10.2 for ≤ 1 additional musculoskeletal pain site); along with higher baseline scores for stress/depression/illness perception and poorer pain self-efficacy/general health ratings. In the pooled sample, LBP-related disability improved slightly less over time for people with ≥ 2 long-term conditions additional to LBP compared to no multimorbidity and for those with ≥4 co-occurring musculoskeletal pain sites compared to ≤ 1 additional musculoskeletal pain site (difference in mean change at 9 months = 1.5 and 2.2, respectively). All groups reported little improvement in secondary outcomes over time. CONCLUSIONS: Multimorbidity or co-occurring musculoskeletal pain does not modify the effect of the selfBACK app on LBP-related disability or other secondary outcomes. Although people with these health problems have worse scores both at baseline and 9 months, the AI-based selfBACK app appears to be helpful for those with multimorbidity or co-occurring musculoskeletal pain. TRIAL REGISTRATION: NCT03798288 . Date of registration: 9 January 2019.

Representativeness of antihypertensive trials: analysis of serious adverse events.

Context: Representativeness of 'standard' antihypertensive drug trials is uncertain, with limited recruitment of older people. Some trials specifically recruit older participants to address this. Trials are obliged to report hospitalizations and deaths, regardless of cause, as Serious Adverse Events (SAEs). If older-people's trials are representative, we would expect rates of SAEs in trials to be similar to the rate of hospitalisation and death in the community, and higher than standard trials. Objective: To compare the rate of SAEs in hypertension trials to rates of hospitalisation and death among people taking similar treatments in the community. Study Design: Observational study comparing trial populations to a community cohort. Dataset: We identified trials of Renin-Angiotensin-Aldosterone system (RAAS) drugs for hypertension from clinicatrials.gov. We identified a community comparison population of people with hypertension starting RAAS drugs using primary care data from the Wales, UK (SAIL databank). Population studied: Trial participants from 110 RAAS hypertension trials (11 older-people's trials, mean age 73, and 99 standard trials, mean age 56). Community cohort of people with hypertension (n=56,036, mean age 60) starting RAAS drugs. Outcomes: SAEs in trials (mostly accounted for by hospitalizations or deaths) and all-cause hospitalizations/deaths in the community comparison. SAE rates in older-people and standard trials were compared, adjusting for trial characteristics. The community rate was used to calculate the expected rate of hospitalizations/deaths given the age/sex distribution of each trial. We then compared the expected rate with the observed rate of SAEs in each trial. Results: Older-people's trials had higher SAEs rate than standard trials (0.18 versus 0.11 events/person/year, adjusted IRR 1.74, 95% CI 1.03-2.92). The hospitalisation and death rate in the community for those taking RAAS antihypertensives was much greater than the rate of SAEs reported in standard (ratio 3.70 (3.12-4.55)) and older-people's trials (4.35 (2.56-7.69)), adjusting for age and sex. Conclusion: Trials report substantially fewer SAEs than expected from rates of hospitalisations and deaths among similar-aged people receiving equivalent treatments in the community. SAE rates may be a useful metric to assess trial representativeness. Clinicians should be cautious when applying trial recommendations to older people, even when trials focus on older people.

The selfBACK artificial intelligence-based smartphone app can improve low back pain outcome even in patients with high levels of depression or stress.

BACKGROUND: selfBACK provides individually tailored self-management support for low back pain (LBP) via an artificial intelligence-based smartphone app. We explore whether those with depressive/stress symptoms can benefit from this technology. METHODS: Secondary analysis of the selfBACK randomized controlled trial (n = 461). Participants with LBP were randomized to usual care (n = 229), or usual care plus selfBACK (n = 232). PRIMARY OUTCOME: LBP-related disability (Roland-Morris Disability Questionnaire, RMDQ) over 9 months. SECONDARY OUTCOMES: global perceived effect (GPE)/pain self-efficacy (PSEQ)/satisfaction/app engagement. Baseline depressive symptoms were measured using the patient health questionnaire (PHQ-8) and stress with the perceived stress scale (PSS). Outcomes stratified by baseline PHQ-8/PSS scores to assess associations across the whole cohort, and intervention versus control groups. RESULTS: Participants with higher levels of depressive/stress symptoms reported more baseline LBP-related disability (RMDQ 3.1; 1.6 points higher in most vs least depressed/stressed groups respectively); lower self-efficacy (PSEQ 8.1; 4.6 points lower in most vs least depressive/stressed groups respectively). LBP-related disability improved over time; relative risk of improvement in those with greatest depressive/stress symptoms versus nil symptom comparators at 9 months: 0.8 (95% CI: 0.6 to 1.0) and 0.8 (95% CI: 0.7 to 1.0) respectively. No evidence that different baseline levels of depressive/perceived stress symptoms are associated with different RMDQ/GPE/PSEQ outcomes. Whilst participants with higher PHQ-8/PSS were less likely to be satisfied or engage with the app, there was no consistent association among PHQ-8/PSS level, the intervention and outcomes. CONCLUSIONS: The selfBACK app can improve outcomes even in those with high levels of depressive/stress symptoms and could be recommended for patients with LBP. SIGNIFICANCE: We have demonstrated that an app supporting the self-management of LBP is helpful, even in those with higher levels of baseline depression and stress symptoms. selfBACK offers an opportunity to support people with LBP and provides clinicians with an additional tool for their patients, even those with depression or high levels of stress. This highlights the potential for digital health interventions for chronic pain.

Medical treatment for small abdominal aortic aneurysms.

BACKGROUND: Screening for abdominal aortic aneurysm (AAA) in selected groups is now performed in England, the USA and Sweden. Patients with aneurysms over 55 mm in diameter are generally considered for elective surgical repair. Patients with aneurysm diameters below or equal to 55 mm (termed 'small AAAs') are managed with aneurysm surveillance as there is currently insufficient evidence to recommend surgery in these cases. As more patients are screened, there will be an increasing number of small AAAs identified. There is interest in pharmaceutical interventions (for example angiotensin converting enzyme (ACE) inhibitors, antibiotics, beta-blockers, statins) which could be given to such patients to delay or reverse aneurysm expansion and reduce the need for elective surgical repair. OBJECTIVES: To assess the effects of medical treatment on the expansion rate of small abdominal aortic aneurysms. SEARCH METHODS: The Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator searched the Specialised Register (May 2012) and CENTRAL (2012, Issue 5). Clinical trials databases were searched for details of ongoing or unpublished studies. The reference lists of articles retrieved by electronic searches were searched for additional citations. SELECTION CRITERIA: We selected randomised trials in which patients with small AAAs allocated to medical treatment with the intention of retarding aneurysm expansion were compared to patients allocated to a placebo treatment, alternative medical treatment, a different regimen of the same drug or imaging surveillance alone. DATA COLLECTION AND ANALYSIS: Two authors independently extracted the data and assessed the risk of bias in the trials. Meta-analyses were used when heterogeneity was considered low. The two primary outcomes were the mean difference (MD) in aneurysm diameter and the odds ratio (OR) calculated to compare the number of individuals referred to AAA surgery in each group over the trial period. MAIN RESULTS: Seven trials involving 1558 participants were included in this review; 457 were involved in four trials of antibiotic medication, and 1101 were involved in three trials of beta-blocker medication. Five of the studies were rated at a high risk of bias.Individually, all of the included trials reported non-significant differences in AAA expansion rates between their intervention and control groups.The two major drug groups were then analysed separately. For AAA expansion it was only possible to combine two of the antibiotic trials in a meta-analysis. This demonstrated that roxithromycin had a small but significant protective effect (MD -0.86 mm; 95% confidence interval (CI) -1.57 to -0.14). When referral to AAA surgery was compared (including all four antibiotic trials in the meta-analysis), non-significantly fewer patients were referred in the intervention groups (OR 0.96; 95% CI 0.59 to 1.57) than the control groups. When only the trials reporting actual elective surgery were included in a subgroup analysis, the result remained statistically non-significant (OR 1.17; 95% CI 0.57 to 2.42).For the beta-blocker trials, when all were combined in a meta-analysis, there was a very small, non-significant protective effect for propranolol on AAA expansion (MD -0.08 mm; 95% CI -0.25 to 0.10), and non-significantly fewer patients were referred to AAA surgery in the propranolol group (OR 0.74; 95% CI 0.52 to 1.05). Bronchospasm and shortness of breath were the main adverse effects from the beta-blockers. In one trial the adverse effects were reportedly so severe that the trial was stopped early after two years. AUTHORS' CONCLUSIONS: There is some limited evidence that antibiotic medication may have a slight protective effect in retarding the expansion rates of small AAAs. The quality of the evidence makes it unclear whether this translates into fewer referrals to AAA surgery, owing mainly to the small sample sizes of the studies.Antibiotics were generally well tolerated with minimal adverse effects. Propranolol was poorly tolerated by patients in all of the beta-blocker trials and demonstrated only minimal and non-significant protective effects. Further research on beta-blockers for AAA needs to consider the use of drugs other than propranolol.In general, there is surprisingly little high quality evidence on medical treatment for small AAAs, especially in relation to the use of newer beta-blockers, ACE inhibitors and statins.

The readability of general practice websites: a cross-sectional analysis of all general practice websites in Scotland.

BACKGROUND: General practice websites are an increasingly important point of interaction, but their readability is largely unexplored. One in four adults struggle with basic literacy, and there is a socioeconomic gradient. Readable content is a prerequisite to promoting health literacy. AIM: To assess general practice website readability by analysing text and design factors, and to assess whether practices adapted their website text to the likely literacy levels of their populations. DESIGN AND SETTING: Websites for all general practices across Scotland were analysed from March to December 2019, using a cross-sectional design. METHOD: Text was extracted from five webpages per website and eight text readability factors were measured, including the Flesch Reading Ease and the Flesch-Kincaid Grade Level. The relationship between readability and a practice population's level of deprivation, measured using the Scottish Index of Multiple Deprivation (SIMD), was assessed. Overall, 10 design factors contributing to readability and accessibility were scored. RESULTS: In total, 86.4% (n = 813/941) of Scottish practices had a website; 22.9% (n = 874/3823) of webpages were written at, or below, the government-recommended reading level for online content (9-14 years old), and the content of the remaining websites, 77.1% (n = 2949/3823), was suitable for a higher reading age. Of all webpages, 80.5% (n = 3077/3823) were above the recommended level for easy-to-understand 'plain English'. There was no statistically significant association between webpage reading age and SIMD. Only 6.7% (n = 51/764) of websites achieved all design and accessibility recommendations. CONCLUSION: Changes to practice websites could improve readability and promote health literacy, but practices will need financial resources and ongoing technical support if this is to be achieved and maintained. Failure to provide readable and accessible websites may widen health inequalities; the topic will become increasingly important as online service use accelerates.

Observed and expected serious adverse event rates in randomised clinical trials for hypertension: an observational study comparing trials that do and do not focus on older people.

BACKGROUND: Representativeness of antihypertensive drug trials is uncertain, as many trials recruit few or no older people. Some trials specifically recruit older participants to address this. Here, we assess the representativeness of trials focusing on older people by comparing the rates of serious adverse events in these trials with the rates in trials of a general adult population (ie, standard trials), and comparing these findings to the rate of hospitalisations and deaths in people with hypertension starting a similar treatment in routine clinical practice. METHODS: For this observational study, we identified randomised controlled trials (phase 2/3, 3, or 4) of renin-angiotensin-aldosterone system (RAAS) drugs for hypertension registered from 1999 onwards with ClinicalTrials.gov. Serious adverse events are routinely included in trial reports and are predominantly accounted for by all-cause hospitalisations and deaths. We compared serious adverse event rates in older-people trials (minimum inclusion age ≥60 years) and standard trials (minimum inclusion age <60 years) using Poisson regression models adjusted for trial characteristics (drug type, comparison type, phase, and outcome type). We identified a community cohort of 56 036 adults with hypertension commencing similar drugs to obtain an expected rate of emergency or urgent hospitalisations or deaths, and compared this rate to observed serious adverse event rates in each trial, adjusted for age and sex. For standard trials and for older-people trials, we calculated the standardised ratio of the expected to the observed rate of serious adverse events using Poisson regression models. FINDINGS: We included 110 trials, of which 11 (10%) were older-people trials and 99 (90%) were standard trials. Older-people trials had a higher rate of serious adverse events than did standard trials (median events per person per year 0·18 [IQR 0·12-0·29] vs 0·11 [0·08-0·18]; adjusted incidence rate ratio 1·76 [95% CI 1·01-3·03]). The hospitalisation and death rate in the community for those taking RAAS antihypertensives was much greater than the rate of serious adverse events reported in standard trials (standardised ratio [SR] 4·23, 95% CI 3·51-5·09) and older-people trials (4·76, 2·89-7·86), adjusting for age and sex. The magnitude of risk increase for serious adverse events in community patients taking RAAS did not differ when comparing older-people and standard trials (ratio of SRs 1·13, 95% CI 0·66-1·92). INTERPRETATION: Trials report substantially fewer serious adverse events than expected from rates of hospitalisations and deaths among similar-aged people receiving equivalent treatments in the community. Serious adverse event rates might be a useful metric to assess trial representativeness. Clinicians should be cautious when applying trial recommendations to older people, even when trials focus on older participants. FUNDING: Wellcome Trust, Medical Research Council.