Participants' experiences of care during a randomized controlled trial comparing a lay-facilitated angina management programme with usual care: a qualitative study using focus groups.

AIM: This paper is a report of a qualitative study conducted as part of a randomized controlled trial comparing a lay-facilitated angina management programme with usual care. Its aim was to explore participants' beliefs, experiences, and attitudes to the care they had received during the trial, particularly those who had received the angina management intervention. BACKGROUND: Angina affects over 50 million people worldwide. Over half of these people have symptoms that restrict their daily life and would benefit from knowing how to manage their condition. DESIGN: A nested qualitative study within a randomized controlled trial of lay-facilitated angina management. METHOD: We conducted four participant focus groups during 2008; three were with people randomized to the intervention and one with those randomized to control. We recruited a total of 14 participants to the focus groups, 10 intervention, and 4 control. FINDINGS: Although recruitment to the focus groups was relatively low by comparison to conventional standards, each generated lively discussions and a rich data set. Data analysis demonstrated both similarities and differences between control and intervention groups. Similarities included low levels of prior knowledge about angina, whereas differences included a perception among intervention participants that lifestyle changes were more easily facilitated with the help and support of a lay-worker. CONCLUSION: Lay facilitation with the Angina Plan is perceived by the participants to be beneficial in supporting self-management. However, clinical expertise is still required to meet the more complex information and care needs of people with stable angina.

Randomized controlled trial of a lay-facilitated angina management programme.

AIMS: This article reports a randomized controlled trial of lay-facilitated angina management (registered trial acronym: LAMP). BACKGROUND: Previously, a nurse-facilitated angina programme was shown to reduce angina while increasing physical activity, however most people with angina do not receive a cardiac rehabilitation or self-management programme. Lay people are increasingly being trained to facilitate self-management programmes. DESIGN: A randomized controlled trial comparing a lay-facilitated angina management programme with routine care from an angina nurse specialist. METHODS: Participants with new stable angina were randomized to the angina management programme (intervention: 70 participants) or advice from an angina nurse specialist (control: 72 participants). Primary outcome was angina frequency at 6 months; secondary outcomes at 3 and 6 months included: risk factors, physical functioning, anxiety, depression, angina misconceptions and cost utility. Follow-up was complete in March 2009. Analysis was by intention-to-treat; blind to group allocation. RESULTS: There was no important difference in angina frequency at 6 months. Secondary outcomes, assessed by either linear or logistic regression models, demonstrated important differences favouring the intervention group, at 3 months for: Anxiety, angina misconceptions and for exercise report; and at 6 months for: anxiety; depression; and angina misconceptions. The intervention was considered cost-effective. CONCLUSION: The angina management programme produced some superior benefits when compared to advice from a specialist nurse.

Participants' preference for type of leaflet used to feed back the results of a randomised trial: a survey.

BACKGROUND: Hundreds of thousands of volunteers take part in medical research, but many will never hear from researchers about what the study revealed. There is a growing demand for the results of randomised trials to be fed back to research participants both for ethical research practice and for ensuring their co-operation in a trial. This study aims to determine participants' preferences for type of leaflet (short versus long) used to summarise the findings of a randomised trial; and to test whether certain characteristics explained participants' preferences. METHODS: 553 participants in a randomised trial about General Practitioners' access to Magnetic Resonance Imaging for patients presenting with suspected internal derangement of the knee were asked in the final follow-up questionnaire whether they would like to be fed back the results of the trial. Participants who agreed to this were included in a postal questionnaire survey asking about their preference, if any, between a short and a long leaflet and what it was about the leaflet that they preferred. Multinomial logistic regression was used to test whether certain demographics of responding participants along with treatment group explained whether a participant had a preference for type of leaflet or no preference. RESULTS: Of the participants who returned the final follow-up questionnaire, 416 (88%) agreed to receive the results of the trial. Subsequently 132 (32%) participants responded to the survey. Most participants preferred the longer leaflet (55%) and the main reasons for this were the use of technical information (94%) and diagrams (89%). There was weak evidence to suggest that gender might explain whether participants have a preference for type of leaflet or not (P = 0.084). CONCLUSIONS: Trial participants want to receive feed back about the results and appear to prefer a longer leaflet. Males and females might require information to be communicated to them differently and should be the focus of further research. TRIAL REGISTRATION: The trial is registered with http://www.isrctn.org/ and ID is ISRCTN76616358.

Initial preference for drinking goal in the treatment of alcohol problems: II. Treatment outcomes.

AIMS: To compare treatment outcomes between clients preferring abstinence and those preferring non-abstinence at the screening stage of a randomized controlled trial of treatment for alcohol problems (the United Kingdom Alcohol Treatment Trial) and to interpret any differential outcome in light of baseline differences between goal preference groups outlined in an accompanying paper. METHODS: Outcomes at 3 and 12 months' follow-up were recorded both in categorical terms (abstinence/non-problem drinking/much improved/somewhat improved/same/worse) and on continuous measures (percent days abstinent, drinks per drinking day/dependence score). RESULTS: Clients initially stating a preference for abstinence showed a better outcome than those stating a preference for non-abstinence. This superior outcome was clearer at 3 months' follow-up but still evident at 12 months' follow-up. The better outcome consisted almost entirely in a greater frequency of abstinent days, with only a modest benefit in drinking intensity for goal abstainers that disappeared when baseline covariates of goal preference were controlled for. Type of successful outcome (abstinence/non-problem drinking) was related to initial goal preference, with clients preferring abstinence more likely to obtain an abstinent outcome and those preferring non-abstinence a non-problem drinking outcome. CONCLUSION: The client's personal drinking goals should be discussed in assessment at treatment entry and as a basis for negotiation. Clinicians should be prepared to identify and support goal change as an unexceptional part of the treatment process that need not jeopardize good outcome.

Shoulder acute pain in primary health care: is retraining GPs effective? The SAPPHIRE randomized trial: a cost-effectiveness analysis.

OBJECTIVES: To assess the cost-effectiveness of providing practical training to general practitioners (GPs) in shoulder problems, and administering a local anaesthetic (lignocaine) vs steroidal (cortisone) injection. METHODS: A cost-effectiveness analysis conducted alongside a cluster randomized trial with a factorial design, in general practices across five centres within the UK. A total of 155 participant GPs were randomized to receive training or no training with 200 participants randomized to either lignocaine or cortisone. Health care costs, quality-adjusted life years (QALYs) and incremental cost per QALY gained over 1 year estimated from a health system and a societal perspective were the main outcomes measured. RESULTS: Over 1 year, training GPs costs on average an additional pound sterling 211 (95% credibility interval - pound sterling 237, pound sterling 661) than no training and produces higher mean QALYs (0.075; -0.004, 0.154) per patient, yielding an incremental cost-effectiveness ratio of pound sterling 2813 per QALY gained for trained GPs. Over the same period of 1 year, lignocaine costs an average of pound sterling 122 more (- pound sterling 232, pound sterling 476) than cortisone and produces virtually no differential gain in mean QALYs (0.001; -0.068, 0.070), yielding an incremental cost per QALY gained of pound sterling 122,000 for lignocaine compared with cortisone. Across a range of cost-effectiveness thresholds, cortisone is as cost effective to inject as lignocaine. The probability that training is cost effective is above 0.95 at thresholds above pound sterling 20,000. CONCLUSIONS: Providing practical training to GPs about shoulder problems is cost effective and there is little uncertainty regarding this decision. The choice between lignocaine and cortisone is more uncertain and it is likely that there is significant value of further research to reduce this uncertainty. TRIAL REGISTRATION: The International Standard Randomised Controlled Trial Number is 58 537 244.

The effectiveness and cost-effectiveness of opportunistic screening and stepped care interventions for older hazardous alcohol users in primary care (AESOPS) - a randomised control trial protocol.

BACKGROUND: There is a wealth of evidence regarding the detrimental impact of excessive alcohol consumption. In older populations excessive alcohol consumption is associated with increased risk of coronary heart disease, hypertension, stroke and a range of cancers. Alcohol consumption is also associated with an increased risk of falls, early onset of dementia and other cognitive deficits. Physiological changes that occur as part of the ageing process mean that older people experience alcohol related problems at lower consumption levels. There is a strong evidence base for the effectiveness of brief psychosocial interventions in reducing alcohol consumption in populations identified opportunistically in primary care settings. Stepped care interventions involve the delivery of more intensive interventions only to those in the population who fail to respond to less intensive interventions and provide a potentially resource efficient means of meeting the needs of this population. METHODS/DESIGN: The study design is a pragmatic prospective multi-centre two arm randomised controlled trial. The primary hypothesis is that stepped care interventions for older hazardous alcohol users reduce alcohol consumption compared with a minimal intervention at 12 months post randomisation. Potential participants are identified using the AUDIT questionnaire. Eligible and consenting participants are randomised with equal probability to either a minimal intervention or a three step treatment approach. The step treatment approach incorporates as step 1 behavioural change counselling, step 2 three sessions of motivational enhancement therapy and step 3 referral to specialist services. The primary outcome is measured using average standard drinks per day and secondary outcome measures include the Drinking Problems Index, health related quality of life and health utility. The study incorporates a comprehensive economic analysis to assess the relative cost-effectiveness of the interventions. DISCUSSION: The paper presents a protocol for the first pragmatic randomised controlled trial evaluating the effectiveness and cost-effectiveness of stepped care interventions for older hazardous alcohol users in primary care. TRIAL REGISTRATION: ISRCTN52557360.

A systematic evaluation of the impact of STRICTA and CONSORT recommendations on quality of reporting for acupuncture trials.

BACKGROUND: We investigated whether there had been an improvement in quality of reporting for randomised controlled trials of acupuncture since the publication of the STRICTA and CONSORT statements. We conducted a before-and-after study, comparing ratings for quality of reporting following the publication of both STRICTA and CONSORT recommendations. METHODOLOGY AND PRINCIPAL FINDINGS: Ninety peer reviewed journal articles reporting the results of acupuncture trials were selected at random from a wider sample frame of 266 papers. Papers published in three distinct time periods (1994-1995, 1999-2000 and 2004-2005) were compared. Assessment criteria were developed directly from CONSORT and STRICTA checklists. Papers were independently assessed for quality of reporting by two assessors, one of whom was blind to information which could have introduced systematic bias (e.g. date of publication). We detected a statistically significant increase in the reporting of CONSORT items for papers published in each time period measured. We did not, however, find a difference between the number of STRICTA items reported in journal articles published before and 3 to 4 years following the introduction of STRICTA recommendations. CONCLUSIONS AND SIGNIFICANCE: The results of this study suggest that general standards of reporting for acupuncture trials have significantly improved since the introduction of the CONSORT statement in 1996, but that quality in reporting details specific to acupuncture interventions has yet to change following the more recent introduction of STRICTA recommendations. Wider targeting and revision of the guidelines is recommended.

Educating nursing home staff on fracture prevention: a cluster randomised trial.

OBJECTIVE: to assess whether specialist osteoporosis nurses delivering training to care home staff can reduce fractures and improve the prescription of treatments to reduce fractures versus usual care. DESIGN: pragmatic cluster randomised controlled trial (RCT) with randomisation at the Primary Care Organisation (PCO) level. SETTING: care homes (residential, nursing and EMI) across England and Wales within PCOs. PARTICIPANTS: all 300 PCOs in England and Wales were invited to take part. Of these, 58 agreed to participate and gained ethical approval in time to start the study: 29 clusters were randomised to the intervention group and 29 to the control. INTERVENTION: specialist osteoporosis nurses undertaking short training sessions with care home staff emphase the importance of fracture and fall prevention and train staff on how to identify those residents at high risk of fracture. Residents' risk of fracture and falls was reported to general practitioners (GPs) of patients along with treatment recommendations. OUTCOME MEASURES: primary outcome measures were total fractures over the past 12 months and total hip fractures over past the 12 months. Secondary outcome measures were total home falls, number of residents sustaining a fall, number of residents prescribed bisphosphonates, number of residents prescribed calcium and vitamin D and number of residents wearing hip protectors. All outcomes were measured at the care home level. RESULTS: of the 230 care homes randomised data were collected from 209 of these containing 5,637 residents. There were no differences between the groups in the incidence rate ratios (IRRs) for total fractures (IRR = 0.94 [0.71, 1.26] P = 0.70) or total hip fractures (IRR = 0.86 [0.63, 1.18] P = 0.36). No differences were found between groups for home falls or hip protector use. A significant increase in bisphosphonate prescription was seen in the intervention group over the control group (IRR = 1.50 [1.00, 2.24] P = 0.05). Calcium and vitamin D prescription was significantly increased in the intervention group over the control group (IRR = 1.64 [1.23, 2.18] P<0.01). CONCLUSION: the intervention significantly increased the prescription of bisphosphonates and calcium/vitamin D, but was not associated with a significant effect on the rate of falls or fractures.

Using postal randomization to replace telephone randomization had no significant effect on recruitment of patients.

OBJECTIVE: To test the effect of postal randomization on recruitment of patients into a randomized trial in primary care. STUDY DESIGN AND SETTING: General practices used a telephone service to randomize patients in our trial. Delays in the start of recruitment at some sites led us to modify the randomization procedure. When new practices took part patients completed and posted baseline materials to the Trial Secretary in York who performed the randomization and informed those concerned of the allocation. RESULTS: Of the 647 practices who were invited to take part, 130 (45%) of 288 agreed to participate using telephone randomization and 155 (43%) of 359 using the postal method. These practices recruited 553 patients from November 2002 to October 2004 across 11 sites in the United Kingdom. The postal method reduced the number of patients recruited by a factor of 0.86 (95% confidence interval=0.62-1.20), or 14%. The number of general practitioners working in a practice significantly increased patient recruitment by a factor of 1.12 (1.05-1.20), whereas practice distance from hospital significantly decreased recruitment by a factor of 0.98 (0.97-0.99). CONCLUSION: Postal randomization had no significant effect on recruitment of patients into our trial.

Improving response rates using a monetary incentive for patient completion of questionnaires: an observational study.

BACKGROUND: Poor response rates to postal questionnaires can introduce bias and reduce the statistical power of a study. To improve response rates in our trial in primary care we tested the effect of introducing an unconditional direct payment of 5 pounds for the completion of postal questionnaires. METHODS: We recruited patients in general practice with knee problems from sites across the United Kingdom. An evidence-based strategy was used to follow-up patients at twelve months with postal questionnaires. This included an unconditional direct payment of 5 pounds to patients for the completion and return of questionnaires. The first 105 patients did not receive the 5 pounds incentive, but the subsequent 442 patients did. We used logistic regression to analyse the effect of introducing a monetary incentive to increase the response to postal questionnaires. RESULTS: The response rate following reminders for the historical controls was 78.1% (82 of 105) compared with 88.0% (389 of 442) for those patients who received the 5 pounds payment (diff = 9.9%, 95% CI 2.3% to 19.1%). Direct payments significantly increased the odds of response (adjusted odds ratio = 2.2, 95% CI 1.2 to 4.0, P = 0.009) with only 12 of 442 patients declining the payment. The incentive did not save costs to the trial--the extra cost per additional respondent was almost 50 pounds. CONCLUSION: The direct payment of 5 pounds significantly increased the completion of postal questionnaires at negligible increase in cost for an adequately powered study.

The DAMASK trial protocol: a pragmatic randomised trial to evaluate whether GPs should have direct access to MRI for patients with suspected internal derangement of the knee.

BACKGROUND: Though new technologies like Magnetic Resonance Imaging (MRI) may be accurate, they often diffuse into practice before thorough assessment of their value in diagnosis and management, and of their effects on patient outcome and costs. MRI of the knee is a common investigation despite concern that it is not always appropriate. There is wide variation in general practitioners (GPs) access to, and use of MRI, and in the associated costs. The objective of this study was to resolve uncertainty whether GPs should refer patients with suspected internal derangement of the knee for MRI or to an orthopaedic specialist in secondary care. METHODS/DESIGN: The design consisted of a pragmatic multi-centre randomised trial with two parallel groups and concomitant economic evaluation. Patients presenting in general practice with suspected internal derangement of the knee and for whom their GP was considering referral to an orthopaedic specialist in secondary care were eligible for inclusion. Within practices, GPs or practice nurses randomised eligible and consenting participants to the local radiology department for an MRI examination, or for consultation with an orthopaedic specialist. To ensure that the waiting time from GP consultation to orthopaedic appointment was similar for both trial arms, GPs made a provisional referral to orthopaedics when requesting the MRI examination. Thus we evaluated the more appropriate sequence of events independent of variations in waiting times. Follow up of participants was by postal questionnaires at six, twelve and 24 months after randomisation. This was to ensure that the evaluation covered all events up to and including arthroscopy. DISCUSSION: The DAMASK trial should make a major contribution to the development of evidence-based partnerships between primary and secondary care professionals and inform the debate when MRI should enter the diagnostic pathway.

Regression to the mean: treatment effect without the intervention.

Regression to the mean (RTM) is a widespread statistical phenomenon. It is a group phenomenon that occurs whenever an extreme group is selected from a population based on the measurement of a particular variable. If a second measurement is then taken for the same group, the second mean will be closer to the population mean than the first measurement. This decrease (or increase) can be mistakenly attributed to a treatment effect; the conclusion can be drawn that an effect results from treatment when it in fact results from chance. Any intervention that is aimed at a group or characteristic that is very different from the average will appear to be successful because of RTM. It is therefore important that any genuine reductions because of the treatment are separated out from the effect of RTM. If the problem is ignored then this will lead to errors in the interpretation of results and, potentially, decisions made on the evidence of those results. This paper highlights the importance of the issue and its effects on many common clinical, public health and managerial decisions.

Increasing response rates to postal questionnaires: a randomised trial of variations in design.

OBJECTIVES: Low response rates to postal questionnaires can threaten the validity of studies by reducing the effective sample size and introducing bias. The identification of methods with which to optimise response rates could, therefore, improve the quality of studies. In an attempt to identify such methods, we undertook a randomised trial of two simple variations in questionnaire design. METHODS: Using a 2 x 2 factorial design, we conducted a randomised trial to test two variations in questionnaire design; the questionnaires were printed on either single-sided or double-sided paper and had either a single- or multiple-booklet layout. Using equal random allocation, 3836 women were randomised to receive one of these questionnaires as part of a study investigating risk factors for osteoporotic fractures. RESULTS: One thousand eight hundred and seventy questionnaires were returned, giving an overall response rate of 48.7%. There were no significant differences in the overall response to each of the four questionnaire designs. When the number of responders who completed at least 50% of each of the three sections was identified, it was found that single-booklet questionnaires had a better response than the multiple-booklet questionnaires and that single-sided questionnaires had a better response than double-sided questionnaires. However, these results were not significant at the 5% level. There were no significant differences in the response to questions on the odd (left-hand side) pages for the single- compared with the double-sided questionnaires. CONCLUSION: As the most cost-effective use of resources, we would advocate the use of double- rather than single-sided questionnaires, and use of a single- rather than multiple-booklet design.