Randomised trials conducted using cohorts: a scoping review.

INTRODUCTION: Cohort studies generate and collect longitudinal data for a variety of research purposes. Randomised controlled trials (RCTs) increasingly use cohort studies as data infrastructures to help identify and recruit trial participants and assess outcomes. OBJECTIVE: To examine the extent, range and nature of research using cohorts for RCTs and describe the varied definitions and conceptual boundaries for RCTs using cohorts. DESIGN: Scoping review. DATA SOURCES: Searches were undertaken in January 2021 in MEDLINE (Ovid) and EBM Reviews-Cochrane Methodology Registry (Final issue, third Quarter 2012). ELIGIBILITY CRITERIA: Reports published between January 2007 and December 2021 of (a) cohorts used or planned to be used, to conduct RCTs, or (b) RCTs which use cohorts to recruit participants and/or collect trial outcomes, or (c) methodological studies discussing the use of cohorts for RCTs. DATA EXTRACTION AND SYNTHESIS: Data were extracted on the condition being studied, age group, setting, country/continent, intervention(s) and comparators planned or received, unit of randomisation, timing of randomisation, approach to informed consent, study design and terminology. RESULTS: A total of 175 full-text articles were assessed for eligibility. We identified 61 protocols, 9 descriptions of stand-alone cohorts intended to be used for future RCTs, 39 RCTs using cohorts and 34 methodological papers.The use and scope of this approach is growing. The thematics of study are far-ranging, including population health, oncology, mental and behavioural disorders, and musculoskeletal conditions.Authors reported that this approach can lead to more efficient recruitment, more representative samples, and lessen disappointment bias and crossovers. CONCLUSION: This review outlines the development of cohorts to conduct RCTs including the range of use and innovative changes and adaptations. Inconsistencies in the use of terminology and concepts are highlighted. Guidance now needs to be developed to support the design and reporting of RCTs conducted using cohorts.

A cohort profile of the Graham Roberts study cohort.

Purpose: The Graham Roberts Study was initiated in 2018 and is the first Trials Within Cohorts (TwiCs) study for bladder cancer. Its purpose is to provide an infrastructure for answering a breadth of research questions, including clinical, mechanistic, and supportive care centred questions for bladder cancer patients. Participants: All consented patients are those aged 18 or older, able to provide signed informedconsent and have a diagnosis of new or recurrent bladder cancer. All patients are required to have completed a series of baseline questionnaires. The questionnaires are then sent out every 12 months and include information on demographics and medical history as well as questionnaires to collect information on quality of life, fatigue, depression, overall health, physical activity, and dietary habits. Clinical information such as tumor stage, grade and treatment has also been extracted for each patient. Findings to date: To date, a total of 125 bladder cancer patients have been consented onto the study with 106 filling in the baseline questionnaire. The cohort is made up of 75% newly diagnosed bladder cancer patients and 66% non-muscle invasive bladder cancer cases. At present, there is 1-year follow-up information for 70 patients, 2-year follow-up for 57 patients, 3-year follow-up for 47 patients and 4-year follow-up for 19 patients. Future plans: We plan to continue recruiting further patients into the cohort study. Using the data collected within the study, we hope to carry out independent research studies with a focus on quality of life. We are also committed to utilizing the Roberts Study Cohort to set up and commence an intervention. The future studies and trials carried out using the Roberts Cohort have the potential to identify and develop interventions that could improve the prevention, diagnosis, and treatment of bladder cancer.

Most patients reported positively or neutrally of having served as controls in the trials within cohorts design.

OBJECTIVES: To evaluate patients' experience of having served as controls without a notification at the time of randomization in the context of the trial within cohorts (TwiCs) design. METHODS: Patients were asked for their opinion on having served as controls in TwiCs, before and after having been provided the trial results. Patients had provided broad consent to randomization at cohort entry and had served as controls in one of two TwiCs (an exercise program after breast cancer treatment or radiotherapy dose-escalation for rectal cancer). RESULTS: Two to 6 years after cohort entry, 15% (n = 16) of all patients remembered having provided broad consent to randomization. Before disclosure of trial results, 47% (n = 52) of patients thought positively, 45% (n = 50) neutrally, and 2% (n = 2) negatively of having served as controls in one of the two trials. Seventeen percent (n = 18) of patients were positive, 65% (n = 71) neutral, and 11% (n = 12) negative about not having been notified when serving as controls. The survey results were comparable after disclosure of trial results. CONCLUSIONS: These results support the use of the TwiCs design with the staged-informed consent procedure. Keeping patients engaged and aware of the consents provided might further improve patients' experience of serving as controls in TwiCs.

Cost-effectiveness of offering an area-level financial incentive on breast feeding: a within-cluster randomised controlled trial analysis.

OBJECTIVE: To provide the first estimate of the cost-effectiveness of financial incentive for breastfeeding intervention compared with usual care. DESIGN: Within-cluster ('ward'-level) randomised controlled trial cost-effectiveness analysis (trial registration number ISRCTN44898617). SETTING: Five local authority districts in the North of England. PARTICIPANTS: 5398 mother-infant dyads (intervention arm), 4612 mother-infant dyads (control arm). INTERVENTIONS: Offering a financial incentive (over a 6-month period) on breast feeding to women living in areas with low breastfeeding prevalence (<40% at 6-8 weeks). MAIN OUTCOME MEASURES: Babies breast fed (receiving breastmilk) at 6-8 weeks, and cost per additional baby breast fed. METHODS: Costs were compared with differences in area-level data on babies' breast fed in order to estimate a cost per additional baby breast fed and the quality-adjusted life year (QALY) gains required over the lifetime of babies to justify intervention cost. RESULTS: In the trial, the total cost of providing the intervention in 46 wards was £462 600, with an average cost per ward of £9989 and per baby of £91. At follow-up, area-level breastfeeding prevalence at 6-8 weeks was 31.7% (95% CI 29.4 to 34.0) in control areas and 37.9% (95% CI 35.0 to 40.8) in intervention areas. The adjusted difference between intervention and control was 5.7 percentage points (95% CI 2.7 to 8.6; p<0.001), resulting in 10 (95% CI 6 to 14) more additional babies breast fed in the intervention wards (39 vs 29). The cost per additional baby breast fed at 6-8 weeks was £974. At a cost per QALY threshold of £20 000 (recommended in England), an additional breastfed baby would need to show a QALY gain of 0.05 over their lifetime to justify the intervention cost. If decision makers are willing to pay £974 (or more) per additional baby breast fed at a QALY gain of 0.05, then this intervention could be cost-effective. Results were robust to sensitivity analyses. CONCLUSION: This study provides information to help inform public health guidance on breast feeding. To make the economic case unequivocal, evidence on the varied and long-term health benefits of breast feeding to both the baby and mother and the effectiveness of financial incentives for breastfeeding beyond 6-8 weeks is required.

Graham Roberts Study protocol: first 'trials within cohort study' for bladder cancer.

INTRODUCTION: Given the need for more bladder cancer research and the recently observed advantages of introducing the trials within cohort (TwiCs) design, the set-up of the Graham Roberts Study (Roberts Study) will provide valuable infrastructure to answer a wide variety of research questions of a clinical, mechanistic, as well as supportive care nature in the area of bladder cancer. METHODS: Using the TwiCs design, we will recruit patients aged 18 or older who are willing and able to provide signed informed consent and have a diagnosis of new or recurrent bladder cancer into this prospective cohort study. All patients must have a basic understanding of the English language. The following questionnaires will be collected at baseline and every 12 months subsequently: Functional Assessment of Chronic Illness Therapy for Bladder Cancer, the Functional Assessment of Chronic Illness Therapy-Fatigue, the Patient Heath Questionnaire-9, the standardised instrument for a generic health status (EQ-5D-5L), a Short Questionnaire to Assess Health-Enhancing Physical Activity and the Hertfordshire Short Questionnaire to Assess Diet Quality. ETHICS AND DISSEMINATION: Due to the nature of this study, we obtained full ethical clearance from the London-Fulham Research Ethics Committee (17/LO1975). All participants must provide full informed consent before recruitment onto the study. The results of this study will be published in peer-reviewed journals and data collected as part of the study will be made available to potential collaborators on an application basis.

The association between long-term conditions and uptake of population-based screening for colorectal cancer: results from two English cohort studies.

INTRODUCTION: Uptake of screening for colorectal cancer (CRC) can reduce mortality, and population-based screening is offered in England. To date, there is little evidence on the association between having a long-term condition (LTC) and CRC screening uptake. The objective of this study was to examine the association between having an LTC and uptake of CRC screening in England with the guaiac fecal occult blood test, with a particular focus on common mental disorders. METHODS: The study was a preregistered secondary analysis of two cohorts: first, a linked data set between the regional Yorkshire Health Study (YHS) and the National Health Service National Bowel Cancer Screening Program (BCSP, years 2006-2014); second, the national English Longitudinal Study of Ageing (ELSA, years 2014-2015). Individuals eligible for BCSP screening who participated in either the YHS (7,142) or ELSA Wave 7 (4,099) were included. Study registration: ClinicalTrials.gov, number NCT02503969. RESULTS: In both the cohorts, diabetes was associated with lower uptake (YHS odds ratio [OR] for non-uptake 1.35, 95% CI 1.03-1.78; ELSA 1.33, 1.03-1.72) and osteoarthritis was associated with increased uptake (YHS 0.75, 0.57-0.99; ELSA 0.76, 0.62-0.93). After controlling for broader determinants of health, there was no evidence of significantly different uptake for individuals with common mental disorders. CONCLUSION: Two large independent cohorts provided evidence that uptake of CRC screening is lower among individuals with diabetes and higher among individuals with osteoarthritis. Further work should compare barriers and facilitators to screening among individuals with either of these conditions. This study also demonstrates the benefits of data linkage for improving clinical decision-making.

Ethical Acceptability of Postrandomization Consent in Pragmatic Clinical Trials.

Importance: Pragmatic clinical trials that seek informed consent after randomization (ie, postrandomization consent) are increasingly used, but debate on ethics persists because control arm patients are not specifically informed about the trials and randomization occurs before consent for the trials. The public's attitude toward postrandomization consent trials is unknown, but the way the trials are described could bias people's views. Objectives: To assess the attitudes of the US general public toward postrandomization informed consent for pragmatic trials and to measure potential framing and other factors associated with those attitudes. Design, Setting, and Participants: An online, 2 × 2 experimental survey (fielded between February 23 and April 3, 2018) portraying 4 scenarios of postrandomization informed consent (with prior broad consent for medical record use) was conducted. These scenarios included traditional randomized clinical trial language framing vs alternative framing in a high-stakes trial (ie, survival in leukemia) or low-stakes trial (ie, blood glucose level in diabetes). A total of 3793 individuals invited to participate were part of an existing panel representative of the US general public (GfK KnowledgePanel). Main Outcomes and Measures: The proportion of participants who would recommend that an ethics review board approve a postrandomization consent pragmatic trial. Results: A total of 2042 of 3739 invitees (54.6%) responded; after exclusion of 38 incomplete surveys, 2004 participants were included in the analysis. Of these, 997 (49.8%) were women, 1440 (71.9%) were white non-Hispanic, 199 (9.9%) were black non-Hispanic, and 233 (11.6%) were Hispanic. Mean (SD) age was 47.5 (17.4) years. Across scenarios, weighted data showed that 75.4% of the participants would recommend approval of the postrandomization consent pragmatic trial, 20.4% would probably not recommend approval, and 4.2% would definitely not recommend approval. Approval was not sensitive to framing language (traditional vs new framing in high-stakes scenario, 74.3% vs 76.8%, P = .40; in low-stakes scenario, 77.7% vs 72.9%, P = .10) or to the stakes (low vs high stakes in traditional framing, 77.7% vs 74.3%, P = .25; in new framing, 72.9% vs 76.8%, P = .18). Better understanding of the postrandomization consent design was associated with higher rate of approval (78.1% vs 65.0%, P = .002 for high-stakes scenario; 77.2% vs 64.9%, P = .004 for low-stakes scenario), especially among those with less education. However, opinions about personal involvement in the control arm were more cautious (range depending on scenario, 45.6%-59.7%) and sensitive to stakes but not to framing. Conclusions and Relevance: The public's generally high rate of approval of the ethics of postrandomization informed consent for pragmatic trial designs does not appear to be affected by whether postrandomization consent design is framed using traditional randomized clinical trial terminology, regardless of the stakes of the trial. Promoting better understanding of the design may increase its acceptance by the public.

Effect of Financial Incentives on Breastfeeding: A Cluster Randomized Clinical Trial.

Importance: Although breastfeeding has a positive effect on an infant's health and development, the prevalence is low in many communities. The effect of financial incentives to improve breastfeeding prevalence is unknown. Objective: To assess the effect of an area-level financial incentive for breastfeeding on breastfeeding prevalence at 6 to 8 weeks post partum. Design, Setting, and Participants: The Nourishing Start for Health (NOSH) trial, a cluster randomized trial with 6 to 8 weeks follow-up, was conducted between April 1, 2015, and March 31, 2016, in 92 electoral ward areas in England with baseline breastfeeding prevalence at 6 to 8 weeks post partum less than 40%. A total of 10 010 mother-infant dyads resident in the 92 study electoral ward areas where the infant's estimated or actual birth date fell between February 18, 2015, and February 17, 2016, were included. Areas were randomized to the incentive plus usual care (n = 46) (5398 mother-infant dyads) or to usual care alone (n = 46) (4612 mother-infant dyads). Interventions: Usual care was delivered by clinicians (mainly midwives, health visitors) in a variety of maternity, neonatal, and infant feeding services, all of which were implementing the UNICEF UK Baby Friendly Initiative standards. Shopping vouchers worth £40 (US$50) were offered to mothers 5 times based on infant age (2 days, 10 days, 6-8 weeks, 3 months, 6 months), conditional on the infant receiving any breast milk. Main Outcomes and Measures: The primary outcome was electoral ward area-level 6- to 8-week breastfeeding period prevalence, as assessed by clinicians at the routine 6- to 8-week postnatal check visit. Secondary outcomes were area-level period prevalence for breastfeeding initiation and for exclusive breastfeeding at 6 to 8 weeks. Results: In the intervention (5398 mother-infant dyads) and control (4612 mother-infant dyads) group, the median (interquartile range) percentage of women aged 16 to 44 years was 36.2% (3.0%) and 37.4% (3.6%) years, respectively. After adjusting for baseline breastfeeding prevalence and local government area and weighting to reflect unequal cluster-level breastfeeding prevalence variances, a difference in mean 6- to 8-week breastfeeding prevalence of 5.7 percentage points (37.9% vs 31.7%; 95% CI for adjusted difference, 2.7% to 8.6%; P < .001) in favor of the intervention vs usual care was observed. No significant differences were observed for the mean prevalence of breastfeeding initiation (61.9% vs 57.5%; adjusted mean difference, 2.9 percentage points; 95%, CI, -0.4 to 6.2; P = .08) or the mean prevalence of exclusive breastfeeding at 6 to 8 weeks (27.0% vs 24.1%; adjusted mean difference, 2.3 percentage points; 95% CI, -0.2 to 4.8; P = .07). Conclusions and Relevance: Financial incentives may improve breastfeeding rates in areas with low baseline prevalence. Offering a financial incentive to women in areas of England with breastfeeding rates below 40% compared with usual care resulted in a modest but statistically significant increase in breastfeeding prevalence at 6 to 8 weeks. This was measured using routinely collected data. Trial Registration: International Standard Randomized Controlled Trial Registry: ISRCTN44898617.

Corrigendum: Can we deliver randomized trials of focal therapy in prostate cancer?

This corrects the article DOI: 10.1038/nrclinonc.2014.44.

Investigation of social, demographic and health variations in the usage of prescribed and over-the-counter medicines within a large cohort (South Yorkshire, UK).

OBJECTIVES: Prescribed and over-the-counter (non-prescribed) medicine usage has increased in recent years; however, there has been less investigation of the socioeconomic predictors of use. This has been due to a lack of data, especially for over-the-counter medicines. Our study aims to understand how prescribed and over-the-counter medicine patterns vary by demographic, social and health characteristics within a large population cohort. DESIGN: Cross-sectional data analysis. SETTING: South Yorkshire, UK. PARTICIPANTS: 27 806 individuals from wave 1 of the Yorkshire Health Study (2010-2012). MEASURES: Individuals self-reported each medicine they were taking and whether each was prescribed or not. The medicines were grouped into 14 categories (eg, cardiovascular system, infection, contraception). Negative binomial regression models were used to analyse the count of medicine usage. We included demographic (age, gender, ethnicity), social (education), health-related (body mass index, smoking, alcohol consumption, physical activity) factors and chronic health conditions (eg, stroke, anxiety and heart disease) in our analyses. RESULTS: 49% of men and 62% of women were taking medicine with the majority of this prescribed (88% and 83%, respectively). Health conditions were found to be positively associated with prescribed medicine usage, but mixed in their associated with over-the-counter medicines. Educational attainment was negatively associated with prescribed and positively associated with over-the-counter usage. CONCLUSIONS: Our study addresses a dearth of evidence to provide new insights into how behaviours in medicine usage vary by demographic, social and health-related factors. Differences in over-the-counter medicine usage by educational attainment may help our understanding of the determinants of health inequalities.

Future Directions for Surgical Trial Designs in Trigeminal Neuralgia.

Should patients undergo surgical intervention as soon as they receive a diagnosis of trigeminal neuralgia (TN), or should they wait until pharmacologic treatment fails? This article describes some of the challenges encountered in surgical trials for TN, and provides some guidance for future trials in this area. One future direction for TN research is to use the innovative "cohort multiple RCT design," This article describes some of the challenges encountered in surgical trials for TN, and provides some guidance for future trials in this area. One future direction for TN research is to use the innovative "cohort multiple RCT design," which enables multiple trials to be embedded within a single cohort of patients with TN diagnosis, providing an efficient and effective approach to the testing of multiple interventions for TN with each other and with usual care.

Encouraging breastfeeding: financial incentives.

The NOSH (Nourishing Start for Health) three-phase research study is testing whether offering financial incentives for breastfeeding improves six-eight-week breastfeeding rates in low-rate areas. This article describes phase one development work, which aimed to explore views about practical aspects of the design of the scheme. Interviews and focus groups were held with women (n = 38) and healthcare providers (n = 53). Overall both preferred shopping vouchers over cash payments, with a total amount of £200-250 being considered a reasonable amount. There was concern that seeking proof of breastfeeding might impact negatively on women and the relationship with their healthcare providers. The most acceptable method to all was that women sign a statement that their baby was receiving breast milk: this was co-signed by a healthcare professional to confirm that they had discussed breastfeeding. These findings have informed the design of the financial incentive scheme being tested in the feasibility phase of the NOSH study.

Deprivation, clubs and drugs: results of a UK regional population-based cross-sectional study of weight management strategies.

BACKGROUND: Despite rising levels of obesity in England, little is known about slimming club and weight loss drug (medication) use or users. In order to inform future commissioning, we report the prevalence of various weight management strategies and examine the associations between slimming club and medication use and age, gender, deprivation and body mass index. METHODS: A population based cross-sectional survey of 26,113 adults was conducted in South Yorkshire using a self-completed health questionnaire. Participants were asked whether they had ever used the following interventions to manage their weight: increasing exercise, healthy eating, controlling portion size, slimming club, over the counter weight loss medication, or meal replacements. Factors associated with slimming club and weight-loss medication use were explored using logistic regression. RESULTS: Over half of the sample was either overweight (36.6%) or obese (19.6%). Obesity was more common in the most deprived areas compared to the least deprived (26.3% vs. 12.0%). Healthy eating (49.0%), controlling portion size (43.4%), and increasing exercise (43.0%) were the most commonly reported weight management strategies. Less common strategies were attending a slimming club (17.2%), meal replacements (3.4%) and weight-loss medication (3.2%). Adjusting for BMI, age, deprivation and long standing health conditions, women were significantly more likely to report ever using a slimming club (adjusted OR = 18.63, 95% CI = 16.52-21.00) and more likely to report ever using over the counter weight-loss medications (AOR = 3.73, 95% CI = 3.10-4.48), while respondents from the most deprived areas were less likely to report using slimming clubs (AOR = 0.60, 95% CI = 0.53-0.68), and more likely to reporting using weight loss medications (AOR =1.38, 95% CI = 1.05-1.82). CONCLUSION: A large proportion of individuals report having used weight management strategies. Slimming clubs and over-the-counter weight loss medication account for a smaller proportion of the overall uptake. Those from less deprived areas were more likely to use slimming clubs while those from more deprived areas were more likely to use weight-loss medications. Future NHS and Local Authority commissioning of weight management services must be aware of this varying social gradient in weight management strategies.

A vision for chronic disease prevention intervention research: report from a workshop.

The Population Studies Research Network of Cancer Care Ontario hosted a strategic planning workshop to establish an agenda for a prevention intervention research program in Ontario, including priority topics for investigation and design considerations. The two-day workshop included: presentations on background papers developed to facilitate participants' preparation for and discussions in the workshop; keynote presentations on intervention research concerning primary prevention of chronic diseases, design and study implementation considerations; a dedicated session on critical and creative thinking to stimulate participation and discussion topics; break out groups to identify, discuss and present study ideas, designs, implementation considerations; and a consensus process to discuss and identify recommendations for research priorities and next steps. The retreat yielded the following recommendations: 1) develop an intervention research agenda that includes working with existing large-scale cohorts; 2) develop an intervention research agenda that includes novel research designs that could target individuals or groups; and 3) develop an intervention research agenda in which studies collect data on costs, define stakeholders, and ensure clear strategies for stakeholder engagement and knowledge transfer. The Population Studies Research Network will develop options from these recommendations and release a call for proposals in 2014 for intervention research pilot projects that reflect these recommendations. Pilot projects will be evaluated based on their fit with the retreat's recommendations, and their potential to scale up to full studies and application in practice.

Can we deliver randomized trials of focal therapy in prostate cancer?

Tissue-preserving focal therapies, such as brachytherapy, cryotherapy, high-intensity focused ultrasound and photodynamic therapy, aim to target individual cancer lesions rather than the whole prostate. These treatments have emerged as potential interventions for localized prostate cancer to reduce treatment-related adverse-effects associated with whole-gland treatments, such as radical prostatectomy and radiotherapy. In this article, the Prostate Cancer RCT Consensus Group propose that a novel cohort-embedded randomized controlled trial (RCT) would provide a means to study men with clinically significant localized disease, which we defined on the basis of PSA level (≤ 15 ng/ml or ≤ 20 ng/ml), Gleason grade (Gleason pattern ≤ 4 + 4 or ≤ 4 + 3) and stage (≤ cT2cN0M0). This RCT should recruit men who stand to benefit from treatment, with the control arm being whole-gland surgery or radiotherapy. Composite outcomes measuring rates of local and systemic salvage therapies at 3-5 years might best constitute the basis of the primary outcome on which to change practice.

Association between body mass index and health-related quality of life, and the impact of self-reported long-term conditions - cross-sectional study from the south Yorkshire cohort dataset.

BACKGROUND: We sought to quantify the relationship between body mass index (BMI) and health-related quality (HRQoL) of life, as measured by the EQ-5D, whilst controlling for potential confounders. In addition, we hypothesised that certain long-term conditions (LTCs), for which being overweight or obese is a known risk factor, may mediate the association between BMI and HRQoL. Hence the aim of our study was to explore the association between BMI and HRQoL, first controlling for confounders and then exploring the potential impact of LTCs. METHODS: We used baseline data from the South Yorkshire Cohort, a cross-sectional observational study which uses a cohort multiple randomised controlled trial design. For each EQ-5D health dimension we used logistic regression to model the probability of responding as having a problem for each of the five health dimensions. All continuous variables were modelled using fractional polynomials. We examined the impact on the coefficients for BMI of removing LTCs from our model. We considered the self-reported LTCs: diabetes, heart disease, stroke, cancer, osteoarthritis, breathing problems and high blood pressure. RESULTS: The dataset used in our analysis had data for 19,460 individuals, who had a mean EQ-5D score of 0.81 and a mean BMI of 26.3 kg/m². For each dimension, BMI and all of the LTCs were significant predictors. For overweight or obese individuals (BMI ≥ 25 kg/m²), each unit increase in BMI was associated with approximately a 3% increase in the odds of reporting a problem for the anxiety/depression dimension, a 8% increase for the mobility dimension, and approximately 6% for the remaining dimension s. Diabetes, heart disease, osteoarthritis and high blood pressure were identified as being potentially mediating variables for all of the dimensions. CONCLUSIONS: Compared to those of a normal weight (18.5 < BMI < 25 kg/m²), overweight and obese individuals had a reduced HRQoL, with each unit increase in BMI associated with approximately a 6% increase in the odds of reporting a problem on any of the EQ-5D health dimensions. There was evidence to suggest that diabetes, heart disease, osteoarthritis and high blood pressure may mediate the association between being overweight and HRQoL.

The 'Pounds for Pounds' weight loss financial incentive scheme: an evaluation of a pilot in NHS Eastern and Coastal Kent.

BACKGROUND: Financial incentive programmes have the potential to modify health-related behaviours, including those associated with achieving weight loss. This study evaluated a pilot NHS commissioned financial incentive weight loss programme, based on the commercial Weight Wins 'Pounds for Pounds' programme. METHODS: Participants chose a weight loss plan based on their target weight. Plans ranged from 15 lb (6.8 kg) weight loss over 3 months to 50 lb (22.7 kg) weight loss over 7 months, with optional additional 'maintenance' periods. Rewards, which were received after successful plan completion, ranged from £70 to £425 per year. RESULTS: Mean baseline weight for the 402 participants was 101.8 kg (SD 46.1 kg), with 77.4% having a BMI ≥30 kg/m(2). Clinically significant weight loss (≥5%) occurred in 44.8% [95% confidence interval (CI): 40.0-49.7%] of participants. Estimated mean weight loss at 12 months was 4.0 kg (95% CI: 2.4-5.6 kg) under the assumption of return-to-baseline weight for those who had left the programme before reporting a 12 month weight. CONCLUSIONS: The estimated mean 12 month weight loss of 4.0 kg at 12 months is comparable to other evaluations of other non-medical weight loss interventions. A randomized controlled trial is required to evaluate the clinical and cost-effectiveness of this financial incentive scheme.

Healthcare provided by a homeopath as an adjunct to usual care for Fibromyalgia (FMS): results of a pilot Randomised Controlled Trial.

OBJECTIVES: To assess the feasibility of a Randomised Controlled Trial (RCT) design of usual care compared with usual care plus adjunctive care by a homeopath for patients with Fibromyalgia syndrome (FMS). METHODS: In a pragmatic parallel group RCT design, adults with a diagnosis of FMS (ACR criteria) were randomly allocated to usual care or usual care plus adjunctive care by a homeopath. Adjunctive care consisted of five in depth interviews and individualised homeopathic medicines. The primary outcome measure was the difference in Fibromyalgia Impact Questionnaire (FIQ) total score at 22 weeks. RESULTS: 47 patients were recruited. Drop out rate in the usual care group was higher than the homeopath care group (8/24 vs 3/23). Adjusted for baseline, there was a significantly greater mean reduction in the FIQ total score (function) in the homeopath care group than the usual care group (-7.62 vs 3.63). There were significantly greater reductions in the homeopath care group in the McGill pain score, FIQ fatigue and tiredness upon waking scores. We found a small effect on pain score (0.21, 95% CI -1.42 to 1.84); but a large effect on function (0.81, 95% CI -8.17 to 9.79). There were no reported adverse events. CONCLUSIONS: Given the acceptability of the treatment and the clinically relevant effect on function, there is a need for a definitive study to assess the clinical and cost effectiveness of adjunctive healthcare by a homeopath for patients with FMS.

Designing clinical trials of homeopathy for menopausal symptoms: a review of the literature.

Homeopathy is a system of therapeutics placed outside the boundaries of orthodox medicine and regarded as a complementary and alternative medicine. Homeopathy has been used to alleviate menopausal symptoms both in the climacteric and in breast cancer survivors. Individualized treatment by a homeopath, regarded as the gold standard of homeopathic care, is a complex intervention where the homeopathic medicine is matched to the individual using holistic principles. This review article describes and interprets the existing evidence from observational studies and clinical trials and makes recommendations for trial design in the future.