The clinical and cost effectiveness of splints for thumb base osteoarthritis: a randomized controlled clinical trial.

OBJECTIVES: To investigate the clinical effectiveness, efficacy and cost effectiveness of splints (orthoses) in people with symptomatic basal thumb joint OA (BTOA). METHODS: A pragmatic, multicentre parallel group randomized controlled trial at 17 National Health Service (NHS) hospital departments recruited adults with symptomatic BTOA and at least moderate hand pain and dysfunction. We randomized participants (1:1:1) using a computer-based minimization system to one of three treatment groups: a therapist supported self-management programme (SSM), a therapist supported self-management programme plus a verum thumb splint (SSM+S), or a therapist supported self-management programme plus a placebo thumb splint (SSM+PS). Participants were blinded to group allocation, received 90 min therapy over 8 weeks and were followed up for 12 weeks from baseline. Australian/Canadian (AUSCAN) hand pain at 8 weeks was the primary outcome, using intention to treat analysis. We calculated costs of treatment. RESULTS: We randomized 349 participants to SSM (n = 116), SSM+S (n = 116) or SSM+PS (n = 117) and 292 (84%) provided AUSCAN Osteoarthritis Hand Index hand pain scores at the primary end point (8 weeks). All groups improved, with no mean treatment difference between groups: SSM+S vs SSM -0.5 (95% CI: -1.4, 0.4), P = 0.255; SSM+PS vs SSM -0.1 (95% CI: -1.0, 0.8), P = 0.829; and SSM+S vs SSM+PS -0.4 (95% CI: -1.4, 0.5), P = 0.378. The average 12-week costs were: SSM £586; SSM+S £738; and SSM+PS £685. CONCLUSION: There was no additional benefit of adding a thumb splint to a high-quality evidence-based, supported self-management programme for thumb OA delivered by therapists. TRIAL REGISTRATION: ISRCTN 54744256 (http://www.isrctn.com/ISRCTN54744256).

Lifestage differences in young UK women's reasons for research participation.

Lifecourse epidemiology suggests that preconception is a valuable opportunity for health promotion with young women. Yet young women are less likely than older women to be research participants, limiting evidence about their needs and risks. Marketing data indicate that young adults are not engaged with one advertising strategy because they transition through three life stages: (i) limited independence and focus on own interests, (ii) increased independence and time with peers and (iii) establishing a home and family. The aim of this study was to explore whether these marketing lifestage categories could inform the tailoring of strategies to recruit young women. Three focus groups per lifestage category were conducted (49 women aged 16-34 years). Lifestage category (i) was represented by further education students, category (ii) by women in workplaces and (iii) by mothers. Questions explored participants' lifestyles, identity, reasons for participation in the current study and beliefs about researchers. Three major themes were identified through framework analysis: profiling how young women spend their time; facilitators of participating in research and barriers to participating. Students and women in work valued monetary remuneration whereas mothers preferred social opportunities. Participants' perceived identity influenced whether they felt useful to research. All groups expressed anxiety about participation. Altruism was limited to helping people known to participants. Therefore, the marketing categories did not map exactly to differences in young women's motivations to participate but have highlighted how one recruitment strategy may not engage all. Mass media communication could, instead, increase familiarity and reduce anxiety about participation.

Research recruitment: A marketing framework to improve sample representativeness in health research.

AIMS: This discussion paper proposes a five-part theoretical framework to inform recruitment strategies. The framework is based on a marketing model of consumer decision-making. BACKGROUND: Respondents in surveys are typically healthier than non-respondents, which has an impact on the availability of information about those most in need. Previous research has identified response patterns, provided theories about why people participate in research and evaluated different recruitment strategies. Social marketing has been applied successfully to recruitment and promotes focus on the needs of the participant, but little attention has been paid to the periods before and after participant-researcher contact (during advertising and following completion of studies). We propose a new model which conceptualises participation as a decision involving motivation, perception of information, attitude formation, integration of intention and action and finally evaluation and sharing of experience. DESIGN: Discussion paper. DATA SOURCES: This discussion paper presents a critical review. No literature was excluded on date and the included citations span the years 1981-2017. IMPLICATIONS FOR NURSING: The proposed framework suggests that researchers could engage a broader demographic if they shape research design and advertising to perform functions that participants are seeking to achieve. The framework provides a novel and useful conceptualisation of recruitment which could help to inform public engagement in research design, researcher training and research policy. CONCLUSION: This framework challenges researchers to investigate the goals of the potential participants when designing a study's advertising and procedures.

Patterns of response by sociodemographic characteristics and recruitment methods for women in UK population surveys and cohort studies.

Women are an important public health focus, because they are more likely to experience some social determinants of disease, and they influence family health. Little research has explored the sociodemographic representativeness of women in research studies. We examined the representativeness of female respondents across four sociodemographic factors in UK population surveys and cohort studies. Six UK population-based health surveys (from 2009-2013) and eight Medical Research Council cohort studies (from 1991 to 2014) were included. Percentages of women respondents by age, income/occupation, education status, and ethnicity were compared against contemporary population estimates. Women aged <35 years were under-represented. The oldest women were under-represented in four of nine studies. Within income/occupation, at the highest deprivation level, the range was 4 percent under-representation to 43 percent over-representation; at the lowest level, it was 6 percent under-representation to 21 percent over representation. Of nine studies reporting educational level, four under-represented women without school qualifications, and three under-represented women with degrees. One of five studies over-represented non-white groups and under-represented white women (by 9 percent). Response patterns varied by topic and recruitment and data collection methods. Future research should focus upon the methods used to identify, reach, and engage women to improve representativeness in studies addressing health behaviors.

The effects of flavanone-rich citrus juice on cognitive function and cerebral blood flow: an acute, randomised, placebo-controlled cross-over trial in healthy, young adults.

A plausible mechanism underlying flavonoid-associated cognitive effects is increased cerebral blood flow (CBF). However, behavioural and CBF effects following flavanone-rich juice consumption have not been explored. The aim of this study was to investigate whether consumption of flavanone-rich juice is associated with acute cognitive benefits and increased regional CBF in healthy, young adults. An acute, single-blind, randomised, cross-over design was applied with two 500-ml drink conditions - high-flavanone (HF; 70·5 mg) drink and an energy-, and vitamin C- matched, zero-flavanone control. A total of twenty-four healthy young adults aged 18-30 years underwent cognitive testing at baseline and 2-h after drink consumption. A further sixteen, healthy, young adults were recruited for functional MRI assessment, whereby CBF was measured with arterial spin labelling during conscious resting state at baseline as well as 2 and 5 h after drink consumption. The HF drink was associated with significantly increased regional perfusion in the inferior and middle right frontal gyrus at 2 h relative to baseline and the control drink. In addition, the HF drink was associated with significantly improved performance on the Digit Symbol Substitution Test at 2 h relative to baseline and the control drink, but no effects were observed on any other behavioural cognitive tests. These results demonstrate that consumption of flavanone-rich citrus juice in quantities commonly consumed can acutely enhance blood flow to the brain in healthy, young adults. However, further studies are required to establish a direct causal link between increased CBF and enhanced behavioural outcomes following citrus juice ingestion.

The Osteoarthritis Thumb Therapy (OTTER) II Trial: a study protocol for a three-arm multi-centre randomised placebo controlled trial of the clinical effectiveness and efficacy and cost-effectiveness of splints for symptomatic thumb base osteoarthritis.

INTRODUCTION: The economic cost of osteoarthritis (OA) is high. At least 4.4 million people have hand OA in the UK. Symptomatic thumb base OA affects 20% of people over 55 years, causing more pain, work and functional disability than OA elsewhere in the hand. Most evidence-based guidelines recommend splinting for hand OA. Splints that support or immobilise the thumb base are routinely used despite there being limited evidence on their effectiveness. The potential effects of placebo interventions in OA are acknowledged, but few studies investigate the clinical efficacy of rehabilitation interventions nor the impact of any placebo effects associated with splints. METHODS AND ANALYSIS: Participants aged 30 years and over with symptomatic thumb base OA will be recruited into the trial from secondary care occupational therapy and physiotherapy centres. Following informed consent, participants will complete a baseline questionnaire and then be randomised into one of three treatment arms: a self-management programme, a self-management programme plus a verum thumb splint or a self-management programme plus a placebo thumb splint. The primary outcome is the Australian Canadian Osteoarthritis Hand Index (AUSCAN) hand pain scale. The study endpoint is 8 weeks after baseline. Baseline assessments will be carried out prior to randomisation and outcomes collected at 4, 8 and 12 weeks. Cost-effectiveness analysis will be conducted and individual qualitative interviews conducted with up to 40 participants after 8 weeks to explore perceptions and outcome expectations of verum and placebo splints and exercise. ETHICS AND DISSEMINATION: South Central-Oxford C Research Ethics Committee approved this study (16/SC/0188). The findings will be disseminated to health professional conferences, journals and lay publications for patient organisations. The research will contribute to improving the management of thumb base OA and help clinicians and patients make informed decisions about the value of different interventions. TRIAL REGISTRATION NUMBER: ISRCTN54744256.

The specificity of age-related decline in interpretation of emotion cues from prosody.

Older adults are not as good as younger adults at decoding prosodic emotions. We sought to determine the specificity of this finding. Performance of older and younger adults was compared on a prosodic emotion task, a "pure" prosodic emotion task, a linguistic prosody task, and a "pure" linguistic prosody task. Older adults were less accurate at interpreting prosodic emotion cues and nonemotional contours, concurrent semantic processing worsened interpretation, and performance was further degraded when identifying negative emotions and questions. Older adults display a pervasive problem interpreting prosodic cues, but further study is required to clarify the stage at which performance declines.