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حَدَّثَنَا مُحَمَّدُ بْنُ عِيسَى، حَدَّثَنَا هُشَيْمٌ، أَخْبَرَنَا حُصَيْنٌ، عَنْ حَبِيبِ بْنِ أَبِي ثَابِتٍ، ح وَحَدَّثَنَا عُثْمَانُ بْنُ أَبِي شَيْبَةَ، حَدَّثَنَا مُحَمَّدُ بْنُ فُضَيْلٍ، عَنْ حُصَيْنٍ، عَنْ حَبِيبِ بْنِ أَبِي ثَابِتٍ، عَنْ مُحَمَّدِ بْنِ عَلِيِّ بْنِ عَبْدِ اللَّهِ بْنِ عَبَّاسٍ، عَنْ أَبِيهِ، عَنِ ابْنِ عَبَّاسٍ، ‏:‏ أَنَّهُ رَقَدَ عِنْدَ النَّبِيِّ صلى الله عليه وسلم فَرَآهُ اسْتَيْقَظَ فَتَسَوَّكَ وَتَوَضَّأَ وَهُوَ يَقُولُ ‏:‏ ‏{‏ إِنَّ فِي خَلْقِ السَّمَوَاتِ وَالأَرْضِ ‏}‏ حَتَّى خَتَمَ السُّورَةَ، ثُمَّ قَامَ فَصَلَّى رَكْعَتَيْنِ أَطَالَ فِيهِمَا الْقِيَامَ وَالرُّكُوعَ وَالسُّجُودَ، ثُمَّ إِنَّهُ انْصَرَفَ فَنَامَ حَتَّى نَفَخَ، ثُمَّ فَعَلَ ذَلِكَ ثَلاَثَ مَرَّاتٍ بِسِتِّ رَكَعَاتٍ، كُلُّ ذَلِكَ يَسْتَاكُ ثُمَّ يَتَوَضَّأُ وَيَقْرَأُ هَؤُلاَءِ الآيَاتِ، ثُمَّ أَوْتَرَ - قَالَ عُثْمَانُ ‏:‏ بِثَلاَثِ رَكَعَاتٍ، فَأَتَاهُ الْمُؤَذِّنُ فَخَرَجَ إِلَى الصَّلاَةِ - وَقَالَ ابْنُ عِيسَى ‏:‏ ثُمَّ أَوْتَرَ فَأَتَاهُ بِلاَلٌ فَآذَنَهُ بِالصَّلاَةِ حِينَ طَلَعَ الْفَجْرُ، فَصَلَّى رَكْعَتَىِ الْفَجْرِ ثُمَّ خَرَجَ إِلَى الصَّلاَةِ - ثُمَّ اتَّفَقَا - وَهُوَ يَقُولُ ‏:‏ ‏"‏ اللَّهُمَّ اجْعَلْ فِي قَلْبِي نُورًا، وَاجْعَلْ فِي لِسَانِي نُورًا، وَاجْعَلْ فِي سَمْعِي نُورًا، وَاجْعَلْ فِي بَصَرِي نُورًا، وَاجْعَلْ خَلْفِي نُورًا، وَأَمَامِي نُورًا، وَاجْعَلْ مِنْ فَوْقِي نُورًا، وَمِنْ تَحْتِي نُورًا، اللَّهُمَّ وَأَعْظِمْ لِي نُورًا ‏"‏ ‏.‏

Abd Allah b. 'Abbas said that he slept with the Prophet (ﷺ). He saw that he (the Prophet) awoke, used tooth-stick, performed ablution, and recited:"In the creation of the heavens and earth" [3:190] to the end of the surah. Then he stood up and prayed two rak'ahs in which he prolonged the standing, bowing, and prostrations. He then uttered turned away and slept till he bagan to snore. This he did three times. This made six rak'ahs in all. He would use tooth-stick, then perform ablution, and recite those verses. He then observed the witr prayer. The version of 'Uthman has: with three rak'ahs. The mu'adhdhin then came to him and he went out for prayer. The version of Ibn 'Isa adds: He then observed witr prayer ; then Bilal came to him and called him for prayer when the dawn broke. He then prayed the two rak'ahs of the dawn prayer. He then went out for prayer. Then both the narrators were agreed: He beagan to supplicate saying: O Allah, place light in my heart, light in my tongue, light in my hearing, light in my eyesight, light on my right hand, light on my left hand, light in front of me, light behing me, light below me, O Allah, give me abundant light

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The pharmacological and non-pharmacological treatment of attention deficit hyperactivity disorder in children and adolescents: A systematic review with network meta-analyses of randomised trials.

Background: Attention deficit hyperactivity disorder (ADHD) is one of the most commonly diagnosed psychiatric disorders in childhood. A wide variety of treatments have been used for the management of ADHD. We aimed to compare the efficacy and safety of pharmacological, psychological and complementary and alternative medicine interventions for the treatment of ADHD in children and adolescents. Methods and findings: We performed a systematic review with network meta-analyses. Randomised controlled trials (≥ 3 weeks follow-up) were identified from published and unpublished sources through searches in PubMed and the Cochrane Library (up to April 7, 2016). Interventions of interest were pharmacological (stimulants, non-stimulants, antidepressants, antipsychotics, and other unlicensed drugs), psychological (behavioural, cognitive training and neurofeedback) and complementary and alternative medicine (dietary therapy, fatty acids, amino acids, minerals, herbal therapy, homeopathy, and physical activity). The primary outcomes were efficacy (treatment response) and acceptability (all-cause discontinuation). Secondary outcomes included discontinuation due to adverse events (tolerability), as well as serious adverse events and specific adverse events. Random-effects Bayesian network meta-analyses were conducted to obtain estimates as odds ratios (ORs) with 95% credibility intervals. We analysed interventions by class and individually. 190 randomised trials (52 different interventions grouped in 32 therapeutic classes) that enrolled 26114 participants with ADHD were included in complex networks. At the class level, behavioural therapy (alone or in combination with stimulants), stimulants, and non-stimulant seemed significantly more efficacious than placebo. Behavioural therapy in combination with stimulants seemed superior to stimulants or non-stimulants. Stimulants seemed superior to behavioural therapy, cognitive training and non-stimulants. Behavioural therapy, stimulants and their combination showed the best profile of acceptability. Stimulants and non-stimulants seemed well tolerated. Among medications, methylphenidate, amphetamine, atomoxetine, guanfacine and clonidine seemed significantly more efficacious than placebo. Methylphenidate and amphetamine seemed more efficacious than atomoxetine and guanfacine. Methylphenidate and clonidine seemed better accepted than placebo and atomoxetine. Most of the efficacious pharmacological treatments were associated with harms (anorexia, weight loss and insomnia), but an increased risk of serious adverse events was not observed. There is lack of evidence for cognitive training, neurofeedback, antidepressants, antipsychotics, dietary therapy, fatty acids, and other complementary and alternative medicine. Overall findings were limited by the clinical and methodological heterogeneity, small sample sizes of trials, short-term follow-up, and the absence of high-quality evidence; consequently, results should be interpreted with caution. Conclusions: Clinical differences may exist between the pharmacological and non-pharmacological treatment used for the management of ADHD. Uncertainties about therapies and the balance between benefits, costs and potential harms should be considered before starting treatment. There is an urgent need for high-quality randomised trials of the multiple treatments for ADHD in children and adolescents. PROSPERO, number CRD42014015008.

PloS one · systematic review · 215 citationsread the source →

Collaborative Care for Opioid and Alcohol Use Disorders in Primary Care: The SUMMIT Randomized Clinical Trial.

Importance: Primary care offers an important and underutilized setting to deliver treatment for opioid and/or alcohol use disorders (OAUD). Collaborative care (CC) is effective but has not been tested for OAUD. Objective: To determine whether CC for OAUD improves delivery of evidence-based treatments for OAUD and increases self-reported abstinence compared with usual primary care. Design, setting, and participants: A randomized clinical trial of 377 primary care patients with OAUD was conducted in 2 clinics in a federally qualified health center. Participants were recruited from June 3, 2014, to January 15, 2016, and followed for 6 months. Interventions: Of the 377 participants, 187 were randomized to CC and 190 were randomized to usual care; 77 (20.4%) of the participants were female, of whom 39 (20.9%) were randomized to CC and 38 (20.0%) were randomized to UC. The mean (SD) age of all respondents at baseline was 42 (12.0) years, 41(11.7) years for the CC group, and 43 (12.2) yearsfor the UC group. Collaborative care was a system-level intervention, designed to increase the delivery of either a 6-session brief psychotherapy treatment and/or medication-assisted treatment with either sublingual buprenorphine/naloxone for opioid use disorders or long-acting injectable naltrexone for alcohol use disorders. Usual care participants were told that the clinic provided OAUD treatment and given a number for appointment scheduling and list of community referrals. Main outcomes and measures: The primary outcomes were use of any evidence-based treatment for OAUD and self-reported abstinence from opioids or alcohol at 6 months. The secondary outcomes included the Healthcare Effectiveness Data and Information Set (HEDIS) initiation and engagement measures, abstinence from other substances, heavy drinking, health-related quality of life, and consequences from OAUD. Results: At 6 months, the proportion of participants who received any OAUD treatment was higher in the CC group compared with usual care (73 [39.0%] vs 32 [16.8%]; logistic model adjusted OR, 3.97; 95% CI, 2.32-6.79; P < .001). A higher proportion of CC participants reported abstinence from opioids or alcohol at 6 months (32.8% vs 22.3%); after linear probability model adjustment for covariates (β = 0.12; 95% CI, 0.01-0.23; P = .03). In secondary analyses, the proportion meeting the HEDIS initiation and engagement measures was also higher among CC participants (initiation, 31.6% vs 13.7%; adjusted OR, 3.54; 95% CI, 2.02-6.20; P < .001; engagement, 15.5% vs 4.2%; adjusted OR, 5.89; 95% CI, 2.43-14.32; P < .001) as was abstinence from opioids, cocaine, methamphetamines, marijuana, and any alcohol (26.3% vs 15.6%; effect estimate, β = 0.13; 95% CI, 0.03-0.23; P = .01). Conclusions and relevance: Among adults with OAUD in primary care, the SUMMIT collaborative care intervention resulted in significantly more access to treatment and abstinence from alcohol and drugs at 6 months, than usual care. Trial registration: clinicaltrials.gov Identifier: NCT01810159.

JAMA internal medicine · randomised controlled trial · 174 citationsread the source →

Effect of a condolence letter on grief symptoms among relatives of patients who died in the ICU: a randomized clinical trial.

Purpose: Family members of patients who die in the intensive care unit (ICU) may experience symptoms of stress, anxiety, depression, posttraumatic stress disorder (PTSD), and/or prolonged grief. We evaluated whether grief symptoms were alleviated if the physician and the nurse in charge at the time of death sent the closest relative a handwritten condolence letter. Methods: Multicenter randomized trial conducted among 242 relatives of patients who died at 22 ICUs in France between December 2014 and October 2015. Relatives were randomly assigned to receiving (n = 123) or not receiving (n = 119) a condolence letter. The primary endpoint was the Hospital Anxiety and Depression Score (HADS) at 1 month. Secondary endpoints included HADS, complicated grief (ICG), and PTSD-related symptoms (IES-R) at 6 months. Observers were blinded to group allocation. Results: At 1 month, 208 (85.9%) relatives completed the HADS; median score was 16 [IQR, 10-22] with and 14 [8-21.5] without the letter (P = 0.36). Although scores were higher in the intervention group, there were no significant differences regarding the HADS-depression subscale (8 [4-12] vs. 6 [2-12], mean difference 1.1 [-0.5 to 2.6]; P = 0.09) and prevalence of depression symptoms (56.0 vs. 42.4%, RR 0.76 [0.57-1.00]; P = 0.05). At 6 months, 190 (78.5%) relatives were interviewed. The intervention significantly increased the HADS (13 [7-19] vs. 10 [4-17.5], P = 0.04), HADS-depression subscale (6 [2-10] vs. 3 [1-9], P = 0.02), prevalence of depression symptoms (36.6 vs. 24.7%, P = 0.05) and PTSD-related symptoms (52.4 vs. 37.1%, P = 0.03). Conclusions: In relatives of patients who died in the ICU, a condolence letter failed to alleviate grief symptoms and may have worsened depression and PTSD-related symptoms. Trial registration Clinicaltrials.gov Identifier: NCT02325297.

Intensive care medicine · randomised controlled trial · 103 citationsread the source →

A recovery program to improve quality of life, sense of coherence and psychological health in ICU survivors: a multicenter randomized controlled trial, the RAPIT study.

Purpose: The aim of this randomized controlled trial (RCT) was to test the effectiveness of a post-ICU recovery program compared to standard care during the first year after ICU discharge. Methods: A pragmatic, non-blinded, multicenter, parallel-group RCT was conducted between December 2012 and December 2015, at ten intensive care units (ICUs) in Denmark. We randomly assigned 386 adult patients (≥18 years) after receiving mechanical ventilation (≥48 h) to standard care (SC) plus a nurse-led intensive care recovery program or standard care alone after ICU discharge (190 intervention, 196 SC). Primary outcome was health-related quality of life (HRQOL) at 12 months. Secondary outcomes were sense of coherence (SOC), anxiety, depression, and post-traumatic stress disorder (PTSD) assessed at 3 and 12 months after ICU discharge including utilization of healthcare services at 12 months. Results: At 12 months, we found no differences in HRQOL between groups (mean difference in the Physical Component Summary score, 1.41 [95 % CI, -1.53 to 4.35; p = 0.35] (n = 235); and in the Mental Component Summary score, 1.92 [95 % CI, -1.06 to 4.90; p = 0.11] (n = 235). No differences were found on self-reported SOC (p = 0.63), anxiety (p = 0.68), depression (p = 0.67), PTSD (p = 0.27), or the utilization of healthcare services including rehabilitation. We found a difference on anxiety, when a cut-off point ≥11 was applied, in per protocol analysis of complete cases at 3 months favoring the intervention (8.8 % vs. 16.2 %, p = 0.04). Conclusions: The tested recovery program was not superior to standard care during the first 12 months post-ICU. Trial registration: The trial is registered at Clinicaltrials.gov, identification no. NCT01721239.

Intensive care medicine · randomised controlled trial · 91 citationsread the source →

Mindfulness-based stress reduction increases stimulated IL-6 production among lonely older adults: A randomized controlled trial.

Loneliness is a potent psychosocial stressor that predicts poor health and mortality among older adults, possibly in part by accelerating age-related declines in immunocompetence. Mindfulness interventions have shown promise for reducing loneliness and improving markers of physical health. In a sample of lonely older adults, this two-arm parallel trial tested whether mindfulness training enhances stimulated interleukin-6 (IL-6) production, a measure of innate immune responsivity. Lonely older adults (65-85 years; N = 190) were randomized to an 8-week Mindfulness-Based Stress Reduction (MBSR) or control Health Enhancement Program (HEP) intervention. Lipopolysaccharide (LPS)-stimulated production of IL-6 was measured in vitro by blinded outcome assessors at pre-intervention, post-intervention, and 3-month follow-up. Mixed-effects linear models tested time (pre, post, follow-up) by condition (MBSR vs. HEP) effects. As predicted, a significant time × condition effect on stimulated IL-6 production was observed across pre, post, and follow-up timepoints. Significant MBSR vs. HEP differences emerged from pre- to post-intervention (p =.009, d = 0.38) and from pre-intervention to 3-month follow-up (p =.017, d = 0.35), with larger increases in IL-6 production following MBSR compared to HEP. No study-related adverse events were reported. Results show that mindfulness training may be effective for boosting innate immunocompetence among lonely older adults. Given that immunocompetence tends to decline with age, mindfulness training may help to counteract the effects of aging and psychosocial stress on infection risk and recovery from injury.

Brain, behavior, and immunity · randomised controlled trial · 22 citationsread the source →

The effects of volunteering on loneliness among lonely older adults: the HEAL-HOA dual randomised controlled trial.

Background: Previous randomised controlled trials have largely relied on self-reported volunteer work to assess the effects of volunteering and have rarely provided structured volunteering activities during the intervention period. The present study aimed to investigate the effects of social volunteering work over 12 months on loneliness among older adults during the COVID-19 pandemic. Methods: A dual randomised controlled trial was done in Hong Kong to investigate the long-term effects of telephone-delivered psychosocial interventions by older Chinese volunteers who were screened as lonely, for older adult recipients who had low income, lived alone, felt lonely, and were digitally excluded. Participants were included if they were aged 50-70 years; had provided consent to be trained and serve as a volunteer for at least 2 h per week for 6 months; had at least 3 years of secondary school education; had no severe self-reported physical, mental, or cognitive health problems; were not working full or part-time; had engaged in formal volunteering fewer than four times within the past year; and were lonely (ie, had a score of at least 6 on the three-item UCLA Loneliness Scale). Participants were allocated into either the volunteering or control group (psychoeducation programme) using a random number method. The details of group allocation were concealed as the research assistant responsible for randomisation was different to the research assistants responsible for recruitment and assessments (who were masked to the condition). Following a 6-week training, the volunteers delivered a psychosocial intervention to older intervention recipients for 6 months. The primary outcome was loneliness measured with the 20-item UCLA Loneliness Scale and the De Jong Gierveld (DJG) Loneliness Scales at 6 months and 12 months. Assessments were performed before training (baseline; T1), at 6 months (T2), and at 12 months after training (T3). The intention-to-treat principle was used to compare the effects of volunteering between the two groups. The trial was registered in the Clinical Trials Registry of the University of Hong Kong Clinical Trials Centre (HKUCTR-2929). This trial has completed. Findings: Between May 3, 2021, and Oct 6, 2022, a total of 375 individuals were recruited to the trial, including 84 males (22%) and 291 females (78%). 185 were randomly assigned to the volunteering group (56 to deliver a mindfulness intervention, 65 to deliver a behavioural activation intervention, and 64 to deliver a befriending intervention) and 190 were assigned to the control group. 311 (83%) of 375 participants were 60 years or older (median 64 years [SD 4·86]). Participants in the volunteering group reported a significantly lower level of loneliness at T2 (dppc2 ranged from -0·41 to -0·70) compared with T1 than participants in the control condition. There was a significant decrease in loneliness measured using the UCLA Loneliness Scale at T2 in the volunteering group but such a decline was not shown in the control group (condition × time interaction, estimate 0·19 [95% CI 0·08 to 0·29], p=0·00058, dppc2=-0·41). Similarly, when measured with the DJG Loneliness Scale, there was a significantly greater decrease in loneliness in the volunteering group compared with the control group at T2, including a medium to large effect size on total DJG scores (estimate 1·34 [95% CI 0·83 to 1·84], p<0·0001, dppc2=-0·70) and a medium effect size on emotional (estimate 0·63 [0·35 to 0·90], p<0·0001, dppc2=-0·59) and social subscales (estimate 0·71 [95% CI 0·37 to 1·05], p<0·0001, dppc2=-0·58). Although most of the positive effects of volunteering were not sustained at T3, the volunteers who continued to volunteer for more than 2 h per week at T3 reported lower levels of loneliness than those who did not maintain volunteering. Interpretation: This randomised controlled trial demonstrates the beneficial effect of volunteering on reducing loneliness in older adults who feel lonely, and that this benefit can be maintained through continued participation in voluntary work. Future intervention programmes should strengthen older adults' commitment to volunteer. Funding: Research Grants Committee of the Hong Kong Special Administrative Region, China.

The lancet. Healthy longevity · randomised controlled trial · 16 citationsread the source →

REFOCUS-PULSAR recovery-oriented practice training in specialist mental health care: a stepped-wedge cluster randomised controlled trial.

Background: Recovery-oriented practice promotes the strengths and recovery potential of individuals. We aimed to establish whether individuals who access mental health services where staff have received the REFOCUS-PULSAR intervention, an adaptation of the UK's REFOCUS recovery-oriented staff intervention for use in Australia, show increased recovery compared with people using non-intervention services. Methods: We did a pragmatic, two-step, stepped-wedge, randomised controlled trial at 18 sites grouped into 14 clusters across public mental health services and mental health community support services in Victoria, Australia. Eligible staff were working part-time or full-time in a direct service role at one of the 18 sites and had consumers being recruited for this study. Eligible consumers were receiving care from a participating cluster, with contact in the 3 months before data collection; aged 18-75 years; and not imprisoned. Clusters were randomly assigned with a web-based randomisation tool to receive the REFOCUS-PULSAR intervention in either the first year (step one) or second year (step two). Consumers, but not staff, were masked to treatment assignment. The primary outcome was the Questionnaire about the Process of Recovery (QPR), for which cross-sectional data were collected across three timepoints (baseline [T0], year 1 [T1], and year 2 [T2]). The primary analysis was done by intention to treat. This trial is registered with ANZCTR, number ACTRN12614000957695. Findings: 190 staff (111 from public mental health services and 79 from mental health community support services) received the REFOCUS-PULSAR recovery-oriented training intervention. Between Sept 18, 2014, and May 19, 2017, 942 consumers were recruited across the three timepoints (T0: n=301; T1: n=334; T2: n=307). The mean QPR score was 53·6 (SD 16·3) in the control group and 54·4 (16·2) in the intervention group (adjusted difference 3·7, 95% CI 0·5-6·8; p=0·023). The Cohen's d value for the intervention effect was small (d=0·23). Interpretation: The REFOCUS-PULSAR intervention had a small but significant effect on the QPRs of individuals using community mental health services and might be effective in promotion of recovery-oriented practice across sectors. Funding: Victorian Government Mental Illness Research Fund.

The lancet. Psychiatry · randomised controlled trial · 39 citationsread the source →

Inactivated poliovirus vaccine given alone or in a sequential schedule with bivalent oral poliovirus vaccine in Chilean infants: a randomised, controlled, open-label, phase 4, non-inferiority study.

Background: Bivalent oral poliovirus vaccine (bOPV; types 1 and 3) is expected to replace trivalent OPV (tOPV) globally by April, 2016, preceded by the introduction of at least one dose of inactivated poliovirus vaccine (IPV) in routine immunisation programmes to eliminate vaccine-associated or vaccine-derived poliomyelitis from serotype 2 poliovirus. Because data are needed on sequential IPV-bOPV schedules, we assessed the immunogenicity of two different IPV-bOPV schedules compared with an all-IPV schedule in infants. Methods: We did a randomised, controlled, open-label, non-inferiority trial with healthy, full-term (>2·5 kg birthweight) infants aged 8 weeks (± 7 days) at six well-child clinics in Santiago, Chile. We used supplied lists to randomly assign infants (1:1:1) to receive three polio vaccinations (IPV by injection or bOPV as oral drops) at age 8, 16, and 24 weeks in one of three sequential schedules: IPV-bOPV-bOPV, IPV-IPV-bOPV, or IPV-IPV-IPV. We did the randomisation with blocks of 12 stratified by study site. All analyses were done in a masked manner. Co-primary outcomes were non-inferiority of the bOPV-containing schedules compared with the all-IPV schedule for seroconversion (within a 10% margin) and antibody titres (within two-thirds log2 titres) to poliovirus serotypes 1 and 3 at age 28 weeks, analysed in the per-protocol population. Secondary outcomes were seroconversion and titres to serotype 2 and faecal shedding for 4 weeks after a monovalent OPV type 2 challenge at age 28 weeks. Safety analyses were done in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT01841671, and is closed to new participants. Findings: Between April 25 and August 1, 2013, we assigned 570 infants to treatment: 190 to IPV-bOPV-bOPV, 192 to IPV-IPV-bOPV, and 188 to IPV-IPV-IPV. 564 (99%) were vaccinated and included in the intention-to-treat cohort, and 537 (94%) in the per-protocol analyses. In the IPV-bOPV-bOPV, IPV-IPV-bOPV, and IPV-IPV-IPV groups, respectively, the proportions of children with seroconversion to type 1 poliovirus were 166 (98·8%) of 168, 95% CI 95·8-99·7; 178 (100%), 97·9-100·0; and 175 (100%), 97·9-100·0. Proportions with seroconvsion to type 3 poliovirus were 163 (98·2%) of 166, 94·8-99·4; 177 (100%), 97·9-100·0, and 172 (98·9%) of 174, 95·9-99·7. Non-inferiority was thus shown for the bOPV-containing schedules compared with the all-IPV schedule, with no significant differences between groups. In the IPV-bOPV-bOPV, IPV-IPV-bOPV, and IPV-IPV-IPV groups, respectively, the proportions of children with seroprotective antibody titres to type 1 poliovirus were 168 (98·8%) of 170, 95% CI 95·8-99·7; 181 (100%), 97·9-100·0; and 177 (100%), 97·9-100·0. Proportions to type 3 poliovirus were 166 (98·2%) of 169, 94·9-99·4; 180 (100%), 97·9-100·0; and 174 (98·9%) of 176, 96·0-99·7. Non-inferiority comparisons could not be done for this outcome because median titres for the groups receiving OPV were greater than the assay's upper limit of detection (log2 titres >10·5). The proportions of children seroconverting to type 2 poliovirus in the IPV-bOPV-bOPV, IPV-IPV-bOPV, and IPV-IPV-IPV groups, respectively, were 130 (77·4%) of 168, 95% CI 70·5-83·0; 169 (96·0%) of 176, 92·0-98·0; and 175 (100%), 97·8-100. IPV-bOPV schedules resulted in almost a 0·3 log reduction of type 2 faecal shedding compared with the IPV-only schedule. No participants died during the trial; 81 serious adverse events were reported, of which one was thought to be possibly vaccine-related (intestinal intussusception). Interpretation: Seroconversion rates against polioviruses types 1 and 3 were non-inferior in sequential schedules containing IPV and bOPV, compared with an all-IPV schedule, and proportions of infants with protective antibodies were high after all three schedules. One or two doses of bOPV after IPV boosted intestinal immunity for poliovirus type 2, suggesting possible cross protection. Additionally, there was evidence of humoral priming for type 2 from one dose of IPV. Our findings could give policy makers flexibility when choosing a vaccination schedule, especially when trying to eliminate vaccine-associated and vaccine-derived poliomyelitis. Funding: Bill & Melinda Gates Foundation.

The Lancet. Infectious diseases · randomised controlled trial · 60 citationsread the source →

An RCT of the effect of motivational interviewing on medication adherence in hypertensive African Americans: rationale and design.

Background: Hypertension disproportionately affects African Americans compared to whites, and it is the single most common explanation for the disparity in mortality between African Americans and whites. Adherence with antihypertensive medications can help reduce risk of negative hypertension-related outcomes. Motivational interviewing is a promising patient-centered approach for improving adherence in patients with chronic diseases. In this paper we describe the rationale and design of an ongoing randomized controlled trial testing the effectiveness of motivational interviewing versus usual care in improving medication adherence among 190 African American uncontrolled hypertensive patients, who receive care in a primary care setting. Methods: The usual care group receives standard medical care, while those in the intervention group receive standard care plus four sessions of motivational interviewing at 3-month intervals for a period of 1 year. This technique consists of brief, patient-driven counseling sessions to facilitate initiation and maintenance of behavior change. The primary outcome is adherence to prescribed antihypertensive medication, assessed with the electronic medication events monitoring system (MEMS) and the Morisky self-report adherence questionnaire. Secondary outcomes are within-patient changes in blood pressure, self-efficacy, and intrinsic motivation between baseline and 12 months. We report the baseline sociodemographic and clinical characteristics of the participants. Conclusions: Despite the potential utility of motivational interviewing, little is known about its effectiveness in improving medication adherence among hypertensive patients, especially African Americans. In addition to the baseline data this study has generated, this trial should provide data with which we can assess the effectiveness of this approach as a behavioral intervention.

Contemporary clinical trials · randomised controlled trial · 53 citationsread the source →

Effects of lower-cost incentives on stimulant abstinence in methadone maintenance treatment: a National Drug Abuse Treatment Clinical Trials Network study.

Background: Contingency management interventions that provide tangible incentives based on objective indicators of drug abstinence have improved treatment outcomes of substance abusers, but have not been widely implemented in community drug abuse treatment settings. Objective: To compare outcomes achieved when a lower-cost prize-based contingency management treatment is added to usual care in community methadone hydrochloride maintenance treatment settings. Design: Random assignment to usual care with (n = 198) or without (n = 190) abstinence incentives during a 12-week trial. Setting: Six community-based methadone maintenance drug abuse treatment clinics in locations across the United States. Participants: Three hundred eighty-eight stimulant-abusing patients enrolled in methadone maintenance programs for at least 1 month and no more than 3 years. Intervention: Participants submitting stimulant- and alcohol-negative samples earned draws for a chance to win prizes; the number of draws earned increased with continuous abstinence time. Main outcome measures: Total number of stimulant- and alcohol-negative samples provided, percentage of stimulant- and alcohol-negative samples provided, longest duration of abstinence, retention, and counseling attendance. Results: Submission of stimulant- and alcohol-negative samples was twice as likely for incentive as for usual care group participants (odds ratio, 1.98; 95% confidence interval, 1.42-2.77). Achieving 4 or more, 8 or more, and 12 weeks of continuous abstinence was approximately 3, 9, and 11 times more likely, respectively, for incentive vs usual care participants. Groups did not differ on study retention or counseling attendance. The average cost of prizes was 120 dollars per participant. Conclusion: An abstinence incentive approach that paid 120 dollars in prizes per participant effectively increased stimulant abstinence in community-based methadone maintenance treatment clinics.

Archives of general psychiatry · randomised controlled trial · 252 citationsread the source →

Daily left prefrontal transcranial magnetic stimulation therapy for major depressive disorder: a sham-controlled randomized trial.

Context: Daily left prefrontal repetitive transcranial magnetic stimulation (rTMS) has been studied as a potential treatment for depression, but previous work had mixed outcomes and did not adequately mask sham conditions. Objective: To test whether daily left prefrontal rTMS safely and effectively treats major depressive disorder. Design: Prospective, multisite, randomized, active sham-controlled (1:1 randomization), duration-adaptive design with 3 weeks of daily weekday treatment (fixed-dose phase) followed by continued blinded treatment for up to another 3 weeks in improvers. Setting: Four US university hospital clinics. Patients: Approximately 860 outpatients were screened, yielding 199 antidepressant drug-free patients with unipolar nonpsychotic major depressive disorder. Intervention: We delivered rTMS to the left prefrontal cortex at 120% motor threshold (10 Hz, 4-second train duration, and 26-second intertrain interval) for 37.5 minutes (3000 pulses per session) using a figure-eight solid-core coil. Sham rTMS used a similar coil with a metal insert blocking the magnetic field and scalp electrodes that delivered matched somatosensory sensations. Main outcome measure: In the intention-to-treat sample (n = 190), remission rates were compared for the 2 treatment arms using logistic regression and controlling for site, treatment resistance, age, and duration of the current depressive episode. Results: Patients, treaters, and raters were effectively masked. Minimal adverse effects did not differ by treatment arm, with an 88% retention rate (90% sham and 86% active). Primary efficacy analysis revealed a significant effect of treatment on the proportion of remitters (14.1% active rTMS and 5.1% sham) (P = .02). The odds of attaining remission were 4.2 times greater with active rTMS than with sham (95% confidence interval, 1.32-13.24). The number needed to treat was 12. Most remitters had low antidepressant treatment resistance. Almost 30% of patients remitted in the open-label follow-up (30.2% originally active and 29.6% sham). Conclusion: Daily left prefrontal rTMS as monotherapy produced statistically significant and clinically meaningful antidepressant therapeutic effects greater than sham. Trial registration: clinicaltrials.gov Identifier: NCT00149838.

Archives of general psychiatry · randomised controlled trial · 753 citationsread the source →

A randomized, controlled trial of furosemide with or without albumin in hypoproteinemic patients with acute lung injury.

Objective: Hypoproteinemia is a common condition in critically ill patients, associated with the development of acute lung injury and acute respiratory distress syndrome and subsequent worse clinical outcomes. Albumin with furosemide benefits lung physiology in hypoproteinemic patients with acute lung injury/acute respiratory distress syndrome, but the independent pharmacologic effects of these drugs are unknown. Design: Randomized, double-blinded, placebo-controlled multicentered trial. Setting: Eleven medical, surgical, and trauma intensive care units including 190 beds within two university hospital systems. Patients: Forty mechanically ventilated patients with acute lung injury/acute respiratory distress syndrome, whose serum total protein concentrations were <6.0 g/dL were included. Patients were excluded for hemodynamic instability or significant renal or hepatic failure. Interventions: Subjects were equally randomly allocated to receive furosemide with albumin or furosemide with placebo for 72 hrs, titrated to fluid loss and normalization of serum total protein concentration. Measurements and main results: The primary outcome was change in oxygenation from baseline to day 1, with secondary physiologic and clinical outcomes. There were no differences in baseline characteristics of the subjects in relation to group assignment. Albumin-treated patients had greater increases in oxygenation (mean change in Pao2/Fio2: +43 vs. -24 mm Hg at 24 hrs and +49 vs. -13 mm Hg at day 3), serum total protein (1.5 vs. 0.5 g/dL at day 3), and net fluid loss (-5480 vs. -1490 mL at day 3) throughout the study period (all p < .05). Fluid bolus administration to control patients reduced net negative fluid balance; control patients more frequently developed hypotension and had fewer shock-free days, which translated to differences in organ failure at study end. Conclusions: The addition of albumin to furosemide therapy in hypoproteinemic patients with acute lung injury/acute respiratory distress syndrome significantly improves oxygenation, with greater net negative fluid balance and better maintenance of hemodynamic stability. Additional randomized clinical trials are necessary to examine mechanisms and determine the effect on important clinical outcomes, such as the duration of mechanical ventilation.

Critical care medicine · randomised controlled trial · 192 citationsread the source →

Medicinal plants used in Jeddah, Saudi Arabia: A gender perspective.

Ethnopharmacological relevance: Very few studies examining quantitatively gender differences in the knowledge and use of medicinal plants exist for the Arab world. Differences in ethnobotanical knowledge of medicinal plants between men and women in Jeddah are explored here for the first time. Aim of the study: Our study aims to document urban medicinal plant knowledge in Jeddah, and to answer the following questions: (1) What medicinal plants are used by Saudis in Jeddah? (2) To what extent do men and women use medicinal plants? (3) Are plants used by men significantly different to those used by women? And, (4) do men and women learn about medicinal plants in different ways? Given the gendered nature of space and relations in the Arab world, we hypothesise that men and women learn about plants in different ways and that this will contribute to explain any possible differences. Materials and methods: Ethnobotanical fieldwork took place in Jeddah from August 2018 to September 2019. Individual free-listing, semi-structured interviews and an online survey questionnaire were carried out to document local medicinal plant. In total, 50 men and 50 women were interviewed face-to-face and 344 people responded to the questionnaire, of which 154 were men and 190 were women. Results: A total of 94 medicinal plant vernacular names were documented representing 85 different plant species belonging to 37 families. Men cited 63 plants (33 plant families) and women 83 (36 plant families). Sixty-one plants were cited by both men and women, two only by men and 22 only by women. Men and women learn in similar ways, but generally use medicinal plants to treat different ailments. Women rely on medicinal plant use to a larger extent. Conclusion: Medicinal plant use is dependent on gendered social roles and experience, as well as preference for biomedicine or medicinal plant use. Men and women use similar plants, but women have greater knowledge that increases with age. Given the food-medicine continuum, women's double role of family food and care providers may explain their expertise in medicinal plant use.

Journal of ethnopharmacology · cohort or longitudinal · 21 citationsread the source →

Barriers to and facilitators of smoking cessation in pregnancy and following childbirth: literature review and qualitative study.

Background: Although many women stop smoking in pregnancy, others continue, causing harm to maternal and child health. Smoking behaviour is influenced by many factors, including the role of women's significant others (SOs) and support from health-care professionals (HPs). Objectives: To enhance understanding of the barriers to, and facilitators of, smoking cessation and the feasibility and acceptability of interventions to reach and support pregnant women to stop smoking. Design: Four parts: (1) a description of interventions in the UK for smoking cessation in pregnancy; (2) three systematic reviews (syntheses) of qualitative research of women's, SOs' and HPs' views of smoking in pregnancy using meta-ethnography (interpretative approach for combining findings); (3) semistructured interviews with pregnant women, SOs and HPs, guided by the social-ecological framework (conceptualises behaviour as an outcome of individuals' interactions with environment); and (4) identification of new/improved interventions for future testing. Setting: Studies in reviews conducted in high-income countries. Qualitative research was conducted from October 2013 to December 2014 in two mixed urban/rural study sites: area A (Scotland) and area B (England). Participants: Thirty-eight studies (1100 pregnant women) in 42 papers, nine studies (150 partners) in 14 papers and eight studies described in nine papers (190 HPs) included in reviews. Forty-one interviews with pregnant women, 32 interviews with pregnant women's SOs and 28 individual/group interviews with 48 HPs were conducted. Main outcome measures: The perceived barriers to, and facilitators of, smoking cessation in pregnancy and the identification of potential new/modified interventions. Results: Syntheses identified smoking-related perceptions and experiences for pregnant women and SOs that were fluid and context dependent with the capacity to help or hinder smoking cessation. Themes were analysed in accordance with the social-ecological framework levels. From the analysis of the interviews, the themes that were central to cessation in pregnancy at an individual level, and that reflected the findings from the reviews, were perception of risk to baby, self-efficacy, influence of close relationships and smoking as a way of coping with stress. Overall, pregnant smokers were faced with more barriers than facilitators. At an interpersonal level, partners' emotional and practical support, willingness to change smoking behaviour and role of smoking within relationships were important. Across the review and interviews of HPs, education to enhance knowledge and confidence in delivering information about smoking in pregnancy and the centrality of the client relationship, protection of which could be a factor in downplaying risks, were important. HPs acknowledged that they could best assist by providing support and understanding, and access to effective interventions, including an opt-out referral pathway to Stop Smoking Services, routine carbon monoxide screening, behavioural support and access to pharmacotherapy. Additional themes at community, organisational and societal levels were also identified. Limitations: Limitations include a design grounded in qualitative studies, difficulties recruiting SOs, and local service configurations and recruitment processes that potentially skewed the sample. Conclusions: Perceptions and experiences of barriers to and facilitators of smoking cessation in pregnancy are fluid and context dependent. Effective interventions for smoking cessation in pregnancy should take account of the interplay between the individual, interpersonal and environmental aspects of women's lives. Future work: Research focus: removing barriers to support, improving HPs' capacity to offer accurate advice, and exploration of weight concerns and relapse prevention. Interventions focus: financial incentives, self-help and social network interventions. Study registration: This study is registered as PROSPERO CRD42013004170. Funding: The National Institute for Health Research Health Technology Assessment programme.

Health technology assessment (Winchester, England) · review · 51 citationsread the source →

Exploring the costs, consequences and efficiency of three types of palliative care day services in the UK: a pragmatic before-and-after descriptive cohort study.

Background: Palliative Care Day Services (PCDS) offer supportive care to people with advanced, progressive illness who may be approaching the end of life. Despite the growth of PCDS in recent years, evidence of their costs and effects is scarce. It is important to establish the value of such services so that health and care decision-makers can make evidence-based resource allocation decisions. This study examines and estimates the costs and effects of PCDS with different service configurations in three centres across the UK in England, Scotland and Northern Ireland. Methods: People who had been referred to PCDS were recruited between June 2017 and September 2018. A pragmatic before-and-after descriptive cohort study design analysed data on costs and outcomes. Data on costs were collected on health and care use in the 4 weeks preceding PCDS attendance using adapted versions of the Client Service Receipt Inventory (CSRI). Outcomes, cost per attendee/day and volunteer contribution to PCDS were also estimated. Outcomes included quality of life (MQOL-E), health status (EQ-5D-5L) and capability wellbeing (ICECAP-SCM). Results: Thirty-eight attendees were recruited and provided data at baseline and 4 weeks (centre 1: n = 8; centre 2: n = 8, centre 3: n = 22). The cost per attendee/day ranged from £121-£190 (excluding volunteer contribution) to £172-£264 (including volunteer contribution) across the three sites. Volunteering constituted between 28 and 38% of the total cost of PCDS provision. There was no significant mean change at 4 week follow-up from baseline for health and care costs (centre 1: £570, centre 2: -£1127, centre 3: £65), or outcomes: MQOL-E (centre 1: - 0.48, centre 2: 0.01, centre 3: 0.24); EQ-5D-5L (centre 1: 0.05, centre 2: 0.03, centre 3: - 0.03) and ICECAP-SCM (centre 1:0.00, centre 2: - 0.01, centre 3: 0.03). Centre costs variation is almost double per attendee when attendance rates are held constant in scenario analysis. Conclusions: This study highlights the contribution made by volunteers to PCDS provision. There is insufficient evidence on whether outcomes improved, or costs were reduced, in the three different service configurations for PCDS. We suggest how future research may overcome some of the challenges we encountered, to better address questions of cost-effectiveness in PCDS.

BMC palliative care · 10 citationsread the source →

Brief teacher training improves student behavior and student-teacher relationships in middle school.

Despite research demonstrating the importance of student-teacher relationships for student functioning, little is known about strategies to enhance such relationships, particularly in secondary school. The current study examined effects of a professional development for middle school teachers on the Establish-Maintain-Restore (EMR) approach. EMR aims to enhance teachers' skills in cultivating relationships with students and involves brief training (3 hr) and ongoing implementation supports. In a randomized controlled trial, 20 teachers and 190 students were assigned to EMR or control. Observers rated academically engaged time and disruptive behavior, and teachers reported on relationship quality. Multilevel models showed that EMR resulted in significant improvements in student-teacher relationships (Hedge's g = .61, 95% CI [0.21, 1.02]), academically engaged time (g = .81, 95% CI [0.01, 1.63]), and disruptive behavior (g = 1.07, 95% CI [0.01, 2.16]). Results indicate potential promise for EMR. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

School psychology (Washington, D.C.) · 22 citationsread the source →

Alcohol Craving Predicts Relapse After Residential Addiction Treatment.

Aims: Replicate the previously reported association of elevated alcohol craving, measured by Penn Alcohol Craving Scale (PACS) during residential treatment, with post-treatment relapse and explore whether elevated craving scores 3 months post-treatment are also associated with subsequent relapse. Methods: Alcohol craving was assessed with the PACS on admission and at several time points post-treatment in 190 subjects with DSM-IV diagnosis of alcohol dependence admitted to residential treatment. Data about relapse to any drinking (primary outcome measure) was collected at 3, 6, 9 and 12 months after treatment. Cox regression models were used to determine whether PACS scores were associated with relapse. Statistical models were adjusted for meaningful demographic and clinical covariates. Results: Follow-up data was available for 149/190 (78%) of subjects. Elevated PACS scores at discharge were associated with increased relapse risk within the first 3 and 12 months after discharge (P = 0.032 and P = 0.045, respectively). Elevated PACS scores at 3 months were associated with increased risk of subsequent relapse within 12 months after treatment in contacted subjects (P = 0.034) and in the intent-to-treat analysis (P = 0.0001). Conclusions: Our findings indicate strong association of post-treatment relapse with elevated alcohol craving measured at treatment completion and at 3 months after treatment and justify the use of this measure to guide relapse-prevention efforts.

Alcohol and alcoholism (Oxford, Oxfordshire) · 67 citationsread the source →

Disparities in Video and Telephone Visits Among Older Adults During the COVID-19 Pandemic: Cross-Sectional Analysis.

Background: Telephone and video telemedicine appointments have been a crucial service delivery method during the COVID-19 pandemic for maintaining access to health care without increasing the risk of exposure. Although studies conducted prior to the pandemic have suggested that telemedicine is an acceptable format for older adults, there is a paucity of data on the practical implementation of telemedicine visits. Due to prior lack of reimbursement for telemedicine visits involving nonrural patients, no studies have compared telephone visits to video visits in geriatric primary care. Objective: This study aimed to determine (1) whether video visits had longer durations, more visit diagnoses, and more advance care planning discussions than telephone visits during the rapid implementation of telemedicine in the COVID-19 pandemic, and (2) whether disparities in visit type existed based on patient characteristics. Methods: We conducted a retrospective, cross-sectional analysis of patients seen at two geriatric clinics from April 23 to May 22, 2020. Approximately 25% of patients who had telephone and video appointments during this time underwent chart review. We analyzed patient characteristics, visit characteristics, duration of visits, number of visit diagnoses, and the presence of advance care planning discussion in clinical documentation. Results: Of the 190 appointments reviewed, 47.4% (n=90) were video visits. Compared to telephone appointments, videoconferencing was, on average, 7 minutes longer (mean 37.3 minutes, SD 10 minutes; P<.001) and had, on average, 1.2 more visit diagnoses (mean 5.7, SD 3; P=.001). Video and telephone visits had similar rates of advance care planning. Furthermore, hearing, vision, and cognitive impairment did not result in different rates of video or telephone appointments. Non-White patients, patients who needed interpreter services, and patients who received Medicaid were less likely to have video visits than White patients, patients who did not need an interpreter, and patients who did not receive Medicaid, respectively (P=.003, P=.01, P<.001, respectively). Conclusions: Although clinicians spent more time on video visits than telephone visits, more than half of this study's older patients did not use video visits, especially if they were from racial or ethnic minority backgrounds or Medicaid beneficiaries. This potential health care disparity merits greater attention.

JMIR aging · 102 citationsread the source →

Fairness, prosociality, hypocrisy, and happiness: Children's and adolescents' motives for showing unselfish behaviour and positive emotions.

The present study examined what motives account for age-related decreases in selfish behaviour and whether these motives equally predict positive emotions when making a moral decision. The study was based on a sample of 190 children and adolescents (101 females) from three different age groups (childhood, early adolescence, and middle adolescence, M = 12.9 years, SD = 2.58). A decision-making task was used where participants chose between (1) maximizing their own self-interest versus (2) being prosocial, (3) being fair, or (4) appearing fair while avoiding the costs of actually being fair. Overall, prosociality and fairness were equally important motives for unselfish behaviour. At the same time, the importance of fairness motivation increased with age. Hypocrisy motivation was less frequent than expected by chance. Prosociality was most strongly and positively associated with self-rated happiness about the decision, whereas the opposite was found for individuals who were motivated by fairness. Overall, the study indicates that children's or adolescents' unselfish behaviour in decision-making tasks are driven by a variety of motives with diverse emotional implications. The relative importance of these motives changes over the course of development. STATEMENT OF CONTRIBUTION: What is already known on this subject? Older children behave less selfishly in resource allocation tasks. Prosocial behaviour is associated with positive emotions. What the present study adds? Unselfish behaviour is equally motivated by fairness and prosociality. Fairness motivation increases from childhood throughout adolescence. Decisions motivated by prosociality are experienced as more positive than decisions motivated by fairness.

The British journal of developmental psychology · 7 citationsread the source →

Monofocal bone transport technique for bone defects greater than 5 cm in tibia: our experience in a case series of 24 patients.

Background: As the tibial bone defect increases in size, the problems in treatment also increase. The treatment may be problematic but different treatment approaches can be used. Among these approaches, distraction osteogenesis is a method an orthopedic surgeon with limited conditions can use although it has a longer treatment period. In our case series, we evaluated current treatment approaches. Method: Retrospective study based on patient records and radiographs. We evaluated our cases with tibial bone defects Type B and greater than 5 cm. Twenty four cases were operated between 1995 and 2013. Clinical follow-up consisted of physical examination, review of radiographs, and Association for the Study of the Method of Ilizarov (ASAMI) scoring system of bone and functional results. Results: The defects had an average lenght of 7.01 cm (SD:2.88) (range, 5-18). The mean follow-up time from removal of the apparatus to the time of the last clinic visit averaged 74.08 ±24.17 months (range: 39-122). The Ilizarov frame was placed for transport and until bone was solid, average of 275.5 ± 70.6 days (range: 190-437 days). The mean external fixator time (EFT) was 350.91 ± 89.22 days (range: 261-627 days). The mean external fixator index (EFI) was 52 days/cm (range: 34.8-62.8 days/cm). Bone union was obtained in 23/24 (95.8%) patients. Seven patients suffered from stiffness (2 knee, 5 ankle) from which 3 patients developed equinus deformity and required tenoplasty (Achilles tendon lengthening at the time of frame removal. After reaching docking site, 5 patients needed intramedullary nailing to speed up union. Twelve (50%) cases had excellent radiological results, 8 (33%) cases had good, 2 (8%) cases fair and 2 (8%) cases had poor results. Regarding the functional ASAMI scoring system 14 (58%) cases had excellent, 9 (38%) cases had good and one case (4%) had fair result. Conclusion: According to our experience, the Ilizarov bone transport technique remains a reliable method to repair bone defects. However, the treatment time is lengthy with a considerable risk of complications. We found closed intramedullary nailing as an effective and easy solution for cases without pin tract infections to manage the nonunion problem of the docking site and this option should be considered where the surgeon envisages difficulties of healing or the patient has lost patience with the frame. Careful selection of case and patient profile can optimize the outcomes.

Injury · 42 citationsread the source →

Behaviour change techniques: the development and evaluation of a taxonomic method for reporting and describing behaviour change interventions (a suite of five studies involving consensus methods, randomised controlled trials and analysis of qualitative data).

Background: Meeting global health challenges requires effective behaviour change interventions (BCIs). This depends on advancing the science of behaviour change which, in turn, depends on accurate intervention reporting. Current reporting often lacks detail, preventing accurate replication and implementation. Recent developments have specified intervention content into behaviour change techniques (BCTs) - the 'active ingredients', for example goal-setting, self-monitoring of behaviour. BCTs are 'the smallest components compatible with retaining the postulated active ingredients, i.e. the proposed mechanisms of change. They can be used alone or in combination with other BCTs' (Michie S, Johnston M. Theories and techniques of behaviour change: developing a cumulative science of behaviour change. Health Psychol Rev 2012;6:1-6). Domain-specific taxonomies of BCTs have been developed, for example healthy eating and physical activity, smoking cessation and alcohol consumption. We need to build on these to develop an internationally shared language for specifying and developing interventions. This technology can be used for synthesising evidence, implementing effective interventions and testing theory. It has enormous potential added value for science and global health. Objective: (1) To develop a method of specifying content of BCIs in terms of component BCTs; (2) to lay a foundation for a comprehensive methodology applicable to different types of complex interventions; (3) to develop resources to support application of the taxonomy; and (4) to achieve multidisciplinary and international acceptance for future development. Design and participants: Four hundred participants (systematic reviewers, researchers, practitioners, policy-makers) from 12 countries engaged in investigating, designing and/or delivering BCIs. Development of the taxonomy involved a Delphi procedure, an iterative process of revisions and consultation with 41 international experts; hierarchical structure of the list was developed using inductive 'bottom-up' and theory-driven 'top-down' open-sort procedures (n = 36); training in use of the taxonomy (1-day workshops and distance group tutorials) (n = 161) was evaluated by changes in intercoder reliability and validity (agreement with expert consensus); evaluating the taxonomy for coding interventions was assessed by reliability (intercoder; test-retest) and validity (n = 40 trained coders); and evaluating the taxonomy for writing descriptions was assessed by reliability (intercoder; test-retest) and by experimentally testing its value (n = 190). Results: Ninety-three distinct, non-overlapping BCTs with clear labels and definitions formed Behaviour Change Technique Taxonomy version 1 (BCTTv1). BCTs clustered into 16 groupings using a 'bottom-up' open-sort procedure; there was overlap between these and groupings produced by a theory-driven, 'top-down' procedure. Both training methods improved validity (both p < 0.05), doubled the proportion of coders achieving competence and improved confidence in identifying BCTs in workshops (both p < 0.001) but did not improve intercoder reliability. Good intercoder reliability was observed for 80 of the 93 BCTs. Good within-coder agreement was observed after 1 month (p < 0.001). Validity was good for 14 of 15 BCTs in the descriptions. The usefulness of BCTTv1 to report descriptions of observed interventions had mixed results. Conclusions: The developed taxonomy (BCTTv1) provides a methodology for identifying content of complex BCIs and a foundation for international cross-disciplinary collaboration for developing more effective interventions to improve health. Further work is needed to examine its usefulness for reporting interventions. Funding: This project was funded by the Medical Research Council Ref: G0901474/1. Funding also came from the Peninsula Collaboration for Leadership in Applied Health Research and Care.

Health technology assessment (Winchester, England) · 428 citationsread the source →

Temporal trends and patterns in heart failure incidence: a population-based study of 4 million individuals.

Background: Large-scale and contemporary population-based studies of heart failure incidence are needed to inform resource planning and research prioritisation but current evidence is scarce. We aimed to assess temporal trends in incidence and prevalence of heart failure in a large general population cohort from the UK, between 2002 and 2014. Methods: For this population-based study, we used linked primary and secondary electronic health records of 4 million individuals from the Clinical Practice Research Datalink (CPRD), a cohort that is representative of the UK population in terms of age and sex. Eligible patients were aged 16 years and older, had contributed data between Jan 1, 2002, and Dec 31, 2014, had an acceptable record according to CPRD quality control, were approved for CPRD and Hospital Episodes Statistics linkage, and were registered with their general practice for at least 12 months. For patients with incident heart failure, we extracted the most recent measurement of baseline characteristics (within 2 years of diagnosis) from electronic health records, as well as information about comorbidities, socioeconomic status, ethnicity, and region. We calculated standardised rates by applying direct age and sex standardisation to the 2013 European Standard Population, and we inferred crude rates by applying year-specific, age-specific, and sex-specific incidence to UK census mid-year population estimates. We assumed no heart failure for patients aged 15 years or younger and report total incidence and prevalence for all ages (>0 years). Findings: From 2002 to 2014, heart failure incidence (standardised by age and sex) decreased, similarly for men and women, by 7% (from 358 to 332 per 100 000 person-years; adjusted incidence ratio 0·93, 95% CI 0·91-0·94). However, the estimated absolute number of individuals with newly diagnosed heart failure in the UK increased by 12% (from 170 727 in 2002 to 190 798 in 2014), largely due to an increase in population size and age. The estimated absolute number of prevalent heart failure cases in the UK increased even more, by 23% (from 750 127 to 920 616). Over the study period, patient age and multi-morbidity at first presentation of heart failure increased (mean age 76·5 years [SD 12·0] to 77·0 years [12·9], adjusted difference 0·79 years, 95% CI 0·37-1·20; mean number of comorbidities 3·4 [SD 1·9] vs 5·4 [2·5]; adjusted difference 2·0, 95% CI 1·9-2·1). Socioeconomically deprived individuals were more likely to develop heart failure than were affluent individuals (incidence rate ratio 1·61, 95% CI 1·58-1·64), and did so earlier in life than those from the most affluent group (adjusted difference -3·51 years, 95% CI -3·77 to -3·25). From 2002 to 2014, the socioeconomic gradient in age at first presentation with heart failure widened. Socioeconomically deprived individuals also had more comorbidities, despite their younger age. Interpretation: Despite a moderate decline in standardised incidence of heart failure, the burden of heart failure in the UK is increasing, and is now similar to the four most common causes of cancer combined. The observed socioeconomic disparities in disease incidence and age at onset within the same nation point to a potentially preventable nature of heart failure that still needs to be tackled. Funding: British Heart Foundation and National Institute for Health Research.

Lancet (London, England) · 925 citationsread the source →

Leukocyte telomere length is associated with HDL cholesterol levels: The Bogalusa heart study.

Objective: This study examined the relationships of high-density lipoprotein cholesterol (HDL-C) with LTL and the rate of its shortening. Background: Diminished levels of HDL-C are associated with an increased risk for atherosclerosis. Shortened leukocyte telomere length (LTL) also entails an increased atherosclerotic risk. Methods: We studied 472 Whites and 190 African Americans (AfAs) enrolled in the Bogalusa Heart Study. Subjects were examined serially 3-13 times for HDL-C over an average period of 27.8 years from childhood through young adulthood. LTL was measured twice during adulthood at a mean age of 31.5 years (baseline exam) and 37.8 years (follow-up exam). HDL-C trajectories with age were constructed and the area under the curve (AUC) was used as a measure of cumulative HDL-C levels. Results: Multivariate regression analyses showed that LTL was positively associated with HDL-C in childhood (regression coefficient (bp per mg/dL) beta=3.1, p=0.024), adulthood (beta=4.4, p=0.058) and AUC from childhood to adulthood (beta=12.2, p=0.0004) in the combined sample of AfAs and Whites. The association between LTL and HDL-C AUC was stronger in females (beta=18.5, p<0.001) than in males (beta=2.9, p=0.590) (difference in slopes p=0.037). A slower rate of LTL shortening per year was associated with higher HDL-C AUC in the total sample (p=0.033), adjusting for baseline LTL. Conclusions: As HDL-C exerts anti-oxidant and anti-inflammatory effects and LTL registers the accruing burden of oxidative stress and inflammation, the association between HDL-C and LTL might be explained by the lifelong status of oxidative stress and inflammation.

Atherosclerosis · 59 citationsread the source →

Evaluation of marital and sexual interactions of Polish infertile couples.

Introduction: The World Health Organization defines infertility as inability to conceive despite regular sexual intercourse sustained for a period exceeding 12 months with no contraceptive methods. Aim: The aim of this study was to evaluate the effect of infertility on marital and sexual interactions among infertile couples. Methods: Two hundred six infertile couples were qualified to the study as the research group. The control group consisted of 190 fertile couples. Main outcome measures: A specific questionnaire was used as a research tool in this study. It included the sociodemographic part, infertility status, and validated scales: Polish version of Index of Marital Satisfaction and Index of Sexual Satisfaction. Statistica 6.0 (Medical University of Silesia; Katowice, Poland) was used in the statistical analysis. The statistical analysis made use of: Mann-Whitney U-test, chi-square with Yates' continuity correction, ancova log-linear analysis of covariance, and logistic regression analysis. Results: The study showed a significantly better partner relationship in female infertile as compared with female fertile. Clinically significant disorders of partnership stability were observed in 11.65% of studied women and in 20% of controls. Marital adjustment and sexual satisfaction were comparable among male groups. The probability of marital disorders increased with: age above 30 (odds ratio [OR] = 1.6), female sex (OR = 1.5), and lower education (OR = 1.7) among the study population. Diagnosed male factor and infertility duration of 3-6 years were connected with the highest relationship instability and the lowest sexual satisfaction both in female and male infertile. Conclusions: The risk factors of marital dissatisfaction in infertility include: female sex, age over 30, lower education level, diagnosis of male infertility, and infertility duration of 3-6 years.

The journal of sexual medicine · 65 citationsread the source →