The major conclusions related to the overall benefits and risks of MHT expressed as the number of women per 1000 taking MHT for 5 yr who would experience benefit or harm. Primary areas of benefit included relief of hot flashes and symptoms of urogenital atrophy and prevention of fractures and diabetes. Risks included venothrombotic episodes, stroke, and cholecystitis. In the subgroup of women starting MHT between ages 50 and 59 or less than 10 yr after onset of menopause, congruent trends suggested additional benefit including reduction of overall mortality and coronary artery disease. In this subgroup, estrogen plus some progestogens increased the risk of breast cancer, whereas estrogen alone did not. Beneficial effects on colorectal and endometrial cancer and harmful effects on ovarian cancer occurred but affected only a small number of women. Data from the various Women's Health Initiative studies, which involved women of average age 63, cannot be appropriately applied to calculate risks and benefits of MHT in women starting shortly after menopause. At the present time, assessments of benefit and risk in these younger women are based on lower levels of evidence.

Objective To show breast cancer patient involvement in the design of a national randomized trial of hormone replacement therapy (HRT) in symptomatic patients will increase accrual.Setting and participants Three stakeholder groups [(1) researchers from the Lynda Jackson Macmillan Centre, (2) the Consumers' Advisory Group for Clinical Trials (CAG-CT), (3) clinicians responsible for a pilot randomized HRT study in breast cancer patients] developed this collaborative study.Methods (1) Nine focus group discussions were conducted to identify issues relevant to breast cancer patients about HRT and a national trial: six involved women from breast cancer support groups nationwide and three patients who had previously participated in the pilot randomized HRT study. (2) Recommendations from the focus groups (analysed by Grounded Theory) were debated by the research stakeholders and focus group representatives at a 1-day meeting and consensus reached (using a voting system) on mutual priorities for incorporation into the design of a national HRT trial. (3) Representatives from the CAG-CT and focus groups participated in subsequent national HRT steering committee meetings to ensure that these priorities were accounted for and the resulting trial design summary was circulated to the CAG-CT and all focus group representatives for comment.Results Focus groups demonstrated that the complexity of factors relating to trial participation was not just restricted to the research topic in question. Patient-clinician interaction provided a platform for negotiating potential conflicts over trial design and outcomes. Patient feedback suggested that mutually agreed priorities were accounted for in the trial design.Interpretation Clinical research planning should involve all research stakeholders at the outset. Quantifying the impact of patient involvement in terms of trial accrual may be too simple given the complexity of their motivations for participating in trials.

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This study explores the unmet supportive needs of people with breast cancer attending a London NHS Foundation Trust Hospital. A mixed methods approach was used. One hundred and one patients completed a specially designed questionnaire focusing on their concerns in the previous week, and whether they felt they had been offered sufficient support from health professionals. Seven semi-structured interviews were then completed in order to gain insight into the need for future developments of services for patients with breast cancer. Pearson's chi-squared analysis was used to examine whether symptoms reported within 1 year of diagnosis differed from symptoms reported more than 1 year post diagnosis. Fatigue was the most common concern expressed (53%) with no significant difference between the two groups. Emotional concerns and pain were also highly reported (35% and 36%). Only 32% of the questionnaire participants reported that they had been offered support in dealing with their concerns. Most participants (65%) would have liked more support from the healthcare team. From the interviews it was clear that whilst there are gaps in services available, participants were not aware of the range of services already available for people with breast cancer. The results of this study have helped to inform service development, particularly around the management of fatigue.

In women at population risk of breast cancer (i.e. most), short-term exposure to hormone replacement therapy (i.e. up to five years' use) for symptom relief exceeds its potential harms, including the associated, increased risk of breast cancer diagnosis. Many women and health care professionals, however, consider this to be unacceptably high, although the degree of risk conferred appears equivalent to, or less than that of, other lifestyle risk factors for this condition. In contrast, it is recommended that symptomatic women at high baseline risk due to a family history or a biopsy-confirmed high-risk benign breast condition and those with previous breast cancer should be managed initially with lifestyle changes and non-hormonal alternatives. In a minority, whose symptoms are refractory, hormone replacement therapy and or topical estrogen can be considered but prescription should only take place after a discussion between the patient, her primary health care and breast specialist teams.

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