Basics of qualitative research: Grounded theory procedures and techniques

Statistical methods in cancer research

Randomised controlled trials are widely accepted as the most reliable method of determining effectiveness, but most trials have evaluated the effects of a single intervention such as a drug. Recognition is increasing that other, non-pharmacological interventions should also be rigorously evaluated.1-3 This paper examines the design and execution of research required to address the additional problems resulting from evaluation of complex interventions—that is, those “made up of various interconnecting parts.”4 The issues dealt with are discussed in a longer Medical Research Council paper (www.mrc.ac.uk/complex_packages.html). We focus on randomised trials but believe that this approach could be adapted to other designs when they are more appropriate.

#### Summary points

Complex interventions are those that include several components

The evaluation of complex interventions is difficult because of problems of developing, identifying, documenting, and reproducing the intervention

A phased approach to the development and evaluation of complex interventions is proposed to help researchers define clearly where they are in the research process

Evaluation of complex interventions requires use of qualitative and quantitative evidence

There are specific difficulties in defining, developing, documenting, and reproducing complex interventions that are subject to more variation than a drug. A typical example would be the design of a trial to evaluate the benefits of specialist stroke units. Such a trial would have to consider the expertise of various health professionals as well as investigations, drugs, treatment guidelines, and arrangements for discharge and follow up. Stroke units may also vary in terms of organisation, management, and skill mix. The active components of the stroke unit may be difficult to specify, making it difficult to replicate the intervention. The box gives other examples of complex interventions.

#### Examples of complex interventions

Service delivery and organisation:

Stroke units

Hospital at home

Interventions directed at health professionals' behaviour:

Strategies for implementing guidelines

Computerised decision support

Community interventions:

Community …

https://www.bmj.com/content/bmj/321/7262/694.full.pdf

Framework for design and evaluation of complex interventions to improve health

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Systematic reviews: CRD's guidance for undertaking reviews in health care

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Evaluating patient-based outcome measures for use in clinical trials.

WHO ASSIST Working Group member: Robert Ali for Drug and Alcohol Addiction Services Council, Adelaide, Australia

/pdf/the-alcohol-smoking-and-substance-involvement-screening-test-2z9xyc2l5n.pdf

The alcohol, smoking and substance involvement screening test (ASSIST): development, reliability and feasibility

Quality of life is an increasingly important outcome measure in medicine and health care. Many measures of quality of life present patients with predetermined lists of questions that may or may not be relevant to the individual patient. This paper describes a brief measure, the SEIQoL-DW, which is derived from the schedule for evaluation of individual quality of life (SEIQoL). The measure allows respondents to nominate the areas of life which are most important, rate their level of functioning or satisfaction with each, and indicate the relative importance of each to their overall quality of life. Given its practicality and brevity, the measure should prove particularly useful in clinical situations where patient generated data on quality of life is important. This article describes the first clinical application of the measure, assessing the quality of life of a cohort of patients with HIV/AIDS managed in general practice.

A new short form individual quality of life measure (SEIQoL-DW) application in a cohort of individuals with HIV/AIDS.

The objectives of this study were to determine the prevalence of antibodies to hepatitis B core antigen, hepatitis C virus, and HIV in the prison population of the Republic of Ireland and to examine risk factors for infection. The study used a cross sectional, anonymous, unlinked survey, with self completed risk factor questionnaire and provision of oral fluid specimen for antibody testing. The study was carried out in nine of the 15 prisons in the Republic of Ireland, with 1366 prisoners, of whom 1205 (57 women) participated. In the smaller prisons all prisoners were surveyed, while in the three largest prisons one half of the population was randomly sampled. Three small prisons believed not to have a problem with injecting drug use were excluded. 

The main outcome measures were prevalence of antibodies to hepatitis B core antigen, antibodies to hepatitis C virus, and antibodies to HIV. Self reported risk factor status. Prevalence of antibodies to hepatitis B core antigen was 104/1193 (8.7%; 95% confidence interval 7.2% to 10.5%), to hepatitis C virus, 442/1193 (37%; 34.3% to 39.9%), and to HIV, 24/1193 (2%; 1.3% to 3%). The most important predictor of being positive for hepatitis B and hepatitis C was a history of injecting drug use. Thirty four women (60%) and 474 men (42%) reported ever injecting drugs. A fifth (104) of 501 injecting drug users reported first injecting in prison, and 347 (71%) users reported sharing needles in prison. The authors concluded that infection with hepatitis C secondary to use of injected drugs is endemic in Irish prisons. Better access to harm reduction strategies is needed in this environment

https://www.bmj.com/content/bmj/321/7253/78.full.pdf

Prevalence of antibodies to hepatitis B, hepatitis C, and HIV and risk factors in Irish prisoners: results of a national cross sectional survey

Objectives: To determine exposure to violence by a partner or spouse among women attending general practice and its association with respondents' demographic and personal characteristics; frequency of inquiry about violence by general practitioners; and women's views on routine questioning about domestic violence by general practitioners. Design: Cross sectional, self administered, anonymous survey. Setting: 22 volunteer Irish general practices. Participants: 1871 women attending general practice. Main outcome measures: Proportion who had experienced domestic violence, severity of such violence, and context in which violence occurred. Results: Of the 1692 women who had ever had a sexual relationship, 651 (39%, 95% confidence interval 36% to 41%) had experienced violent behaviour by a partner. 78/651 (12%) women reported that their doctor had asked about domestic violence. 298/651 (46%, 42% to 50%) women had been injured, 60 (20%) of whom reported that their doctor had asked about domestic violence. 1304/1692 (77%, 77% to 80%) were in favour of routine inquiry about domestic violence by their usual general practitioner. 1170 women (69%) reported controlling behaviour by their partner and 475 (28%) reported feeling afraid of their previous or current partner. Women who reported domestic violence were 32 times more likely to be afraid of their partner than women who did not report such violence. Conclusions: Almost two fifths of women had experienced domestic violence but few recalled being asked about it. Most women favoured routine questioning by their practitioner about such violence. Asking women about fear of their partner and controlling behaviour may be a useful way of identifying those who have experienced domestic violence.

Primary care Reported frequency of domestic violence: cross sectional survey of women attending general practice

Objective: To assess the effectiveness of a programme to coordinate and support follow up care in general practice after a hospital diagnosis of myocardial infarction or angina. Design: Randomised controlled trial; stratified random allocation of practices to intervention and control groups. Setting: All 67 practices in Southampton and south west Hampshire, England. Subjects: 597 adult patients (422 with myocardial infarction and 175 with a new diagnosis of angina) who were recruited during hospital admission or attendance at a chest pain clinic between April 1995 and September 1996. Intervention: Programme to coordinate preventive care led by specialist liaison nurses which sought to improve communication between hospital and general practice nurses to provide structures follow up. Main outcome measures: Serum total cholesterol concentration, blood pressure, distance walked in 6 minutes, confirmed smoking cessation, and body mass index measured at 1 year follow up. Results: Of 559 surviving patients at 1 year, 502 (90%) were followed up. There was no significant difference between the intervention and control groups in smoking (cotinine validated quit rate 19% v 20%), lipid concentrations (serum total cholesterol 5.80 v 5.93 mmol/l), blood pressure (diastolic pressure 84 v 85 mmHg), or fitness (distance walked in 6 minutes 443 v 433 m). Body mass index was slightly lower in the intervention group (27.4 v 28.2; P = 0.08). Conclusions: Although the programme was effective in promoting follow up in general practice, it did not improve health outcome. Simply coordinating and supporting existing NHS care is insufficient. Ischaemic heart disease is a chronic condition which requires the same systematic approach to secondary prevention applied in other chronic conditions such as diabetes mellitus.

https://www.bmj.com/content/bmj/318/7185/706.full.pdf

Randomised controlled trial of follow up care in general practice of patients with myocardial infarction and angina: final results of the Southampton heart integrated care project (SHIP)

Fiona Bradley

Papers

The alcohol, smoking and substance involvement screening test (ASSIST): development, reliability and feasibility

A new short form individual quality of life measure (SEIQoL-DW) application in a cohort of individuals with HIV/AIDS.

Prevalence of antibodies to hepatitis B, hepatitis C, and HIV and risk factors in Irish prisoners: results of a national cross sectional survey

Primary care Reported frequency of domestic violence: cross sectional survey of women attending general practice

Randomised controlled trial of follow up care in general practice of patients with myocardial infarction and angina: final results of the Southampton heart integrated care project (SHIP)