Satisfaction with social and residential environments of adults with mental retardation in supported independent living and group homes

The philosophy that has permeated Ontario’s policies and planning in the realm of adults with mental retardation has been that of integration into the community. Community based residences vary greatly in terms of size, type, and care given; however they generally fall in the category of the “least restrictive alternative”. The present study is focused on the similarities and distinctions between two of these alternatives, and in the satisfaction experienced by the consumers in these two programs themselves: community group homes and supported independent living programs. In the present study interviews with 40 adults with mental retardation were conducted. Twenty adults resided in community group homes, while 20 were clients of supported independent living programs. Clients were asked to answer questions based on the Halpern, Close and Nelson (1986) survey of independent living programs in the U.S., regarding five areas of their lives. They were also asked to provide information concerning their social support according to the Arizona Social Support Interview Schedule (Barrera, 1981). These interviews were used to provide a comparison between findings of satisfaction and levels of concern within the two residence types. Some authors had urged caution with respect to independent community living programs for these populations, due to concerns about social isolation, residential quality, increased vulnerability and so on. Results indicated that there were few differences between the two residence populations. Those differences that were found primarily favoured the independent living group, and included level of independent social skills, satisfaction with programs and residence, and supportiveness of one aspect of the client’s social network. However, residents in supported independent living programs continued to show considerable dependence on counselors for many aspects of their functioning. Overall, the participants in this program reported very similar attitudes and levels of satisfaction to those in the similar programs studied by Halpern et al. (1986). The relative lack of differences between programs has differing implications for each of them. While it shows that people in both programs are not isolated in the community, it also demonstrates that people in both programs rely on their counselors as the person turned to in the time of need. It is necessary to break this cycle if people are to be truly independent. The results of this study confirm the need to diversify clients’ social support networks beyond program staff

Perceived barriers to randomised controlled trials in breast reconstruction:obstacle to trial initiation or opportunity to resolve? A qualitative study

Background: Implant-based breast reconstruction (IBBR) is the most commonly performed breast reconstruction technique worldwide but the technique is evolving rapidly. High-quality evidence is needed to support practice. Randomised controlled trials (RCTs) provide the best evidence but can be challenging to conduct. iBRA is a four-phased study which aimed to inform the feasibility, design and conduct of an RCT in IBBR. In phase 3, the randomisation acceptability study, an electronic survey and qualitative interviews were conducted to explore professionals’ perceptions of future trials in IBBR. Findings from the interviews are presented here. Methods: Semi-structured qualitative interviews were undertaken with a purposive sample of 31 health professionals (HPs) who completed the survey to explore their attitudes to the feasibility of potential RCTs in more detail. All interviews were transcribed verbatim and data were analysed thematically using constant comparative techniques. Sampling, data collection and analysis were undertaken iteratively and concurrently until data saturation was achieved. Results: Almost all HPs acknowledged the need for better evidence to support the practice of IBBR and most identified RCTs as generating the highest-quality evidence. Despite highlighting potential challenges, most participants supported the need for an RCT in IBBR. A minority, however, were strongly opposed to a future trial. The opposition and challenges identified centred around three key themes; (i) limited understanding of pragmatic study design and the value of randomisation in minimising bias; (ii) clinician and patient equipoise and (iii) aspects of surgical culture and training that were not supportive of RCTs. Conclusion: There is a need for well-designed, large-scale RCTs to support the current practice of IBBR but barriers to their acceptability are evident. The perceived barriers to RCTs in breast reconstruction identified in this study are not insurmountable and have previously been overcome in other similar surgical trials. This may represent an opportunity, not only to establish the evidence base for IBBR, but also to improve engagement in RCTs in breast surgery in general to ultimately improve outcomes for patients. Trial Registration: International Standard Randomised Controlled Trial Number ISRCTN37664281.</p

Implant-Based Reconstruction following Mastectomy in Patients Who Have Had a Previous Breast Augmentation:Lessons from the National Multicenter Implant Breast Reconstruction Evaluation Study

Background: Breast augmentation is the most commonly performed cosmetic procedure, and increasingly women in this group present with breast cancer or request risk-reducing surgery, but their optimal management is unclear. The authors explored the clinical and patient-reported outcomes of patients undergoing immediate implant-based breast reconstruction following previous augmentation and compared these with outcomes of patients who had not had cosmetic implants in the Implant Breast Reconstruction Evaluation (iBRA) Study.   Methods: Patients undergoing immediate implant-based breast reconstruction were prospectively recruited from breast and plastic surgical units across the United Kingdom. Demographic, operative, and oncologic data, and information regarding complications within 3 postoperative months were collected. Patient-reported outcomes at 18 months were assessed using the BREAST-Q. The clinical and patient-reported outcomes of patients undergoing immediate implant-based breast reconstruction with and without previous breast augmentation were compared.   Results: A total of 2108 women were included in the iBRA Study, of whom 49 had undergone a previous augmentation. Women in the augmentation group were younger (median age, 45 years versus 50 years; p = 0.01), had a lower body mass index (22.8 kg/m2 versus 24.9 kg/m2; p < 0.01), and had smaller tumors (15 mm versus 25 mm; p = 0.01) than patients without augmentation. No differences were seen in operative technique between the groups. Complications at 3 months were similar in both groups and there were no significant differences in patient-reported outcomes at 18 months.   Conclusions: The clinical and patient-reported outcomes of patients undergoing immediate implant-based breast reconstruction following previous augmentation are consistent with those observed in the wider iBRA Study cohort, supporting the safety of this approach

Recommendations for optimising pilot and feasibility work in surgery

BackgroundSurgical trials are recognised as inherently challenging. Pilot and feasibility studies (PAFS) are increasingly acknowledged as a key method to optimise the design and conduct of randomised trials but remain limited in surgery. We used a mixed methods approach to develop recommendations for how surgical PAFS could be optimised. MethodsThe findings from a quantitative analysis of funded surgical PAFS over a 10-year period and in-depth qualitative interviews with surgeons, methodologists and funders were triangulated and synthesised with available methodological guidance on PAFS.ResultsThe synthesis informed development of an explanatory model describing root causes and compounding challenges that contribute to how and why surgical PAFS are not currently optimised. The four root causes identified include issues relating to i) understanding the full scope of PAFS; ii) design and conduct of PAFS; iii) reporting of PAFS; and iv) lack of appreciation of the value of PAFS by all stakeholder groups. Compounding challenges relate to both cultural issues and access to and interpretation of available methodological PAFS guidance. The study findings and explanatory model were used to inform development of a practical guidance tool for surgeons and study teams to improve research practice.ConclusionsOptimisation of PAFS in surgery requires a cultural shift in research practice amongst funders, academic institutions, regulatory bodies and journal editors, as well as amongst surgeons. Our ‘Top Tips’ guidance tool offers an accessible framework for surgeons designing PAFS. Adoption and utilisation of these recommendations will optimise surgical PAFS, facilitating successful and efficient future surgical trials.<br/

Exploring methods for selection and integration of stakeholder views in the development of core outcome sets:a case study in reconstructive breast surgery

BACKGROUND: The development and use of core outcome sets (COSs) in trials may improve data synthesis and reduce outcome reporting bias. The selection of outcomes in COSs is informed by views of key stakeholders, yet little is known about the role and influence of different stakeholders’ views during COS development. We report an exploratory case study examining how stakeholder selection and incorporation of stakeholders’ views may influence the selection of outcomes for a COS in reconstructive breast surgery (RBS). We also make recommendations for future considerations. METHODS: Key stakeholder groups and subgroups were identified from the literature and expert opinion by the COS management group. They included health care professionals, subdivided by profession (breast and plastic surgeons, specialist nurses and psychologists) and patients, subdivided according to type of surgery received, timing of reconstruction, time since surgery and patient age. All participated in a survey in which they were asked to prioritise outcomes. Outcomes were prioritised using a 9-point scale from 1 (not important) to 9 (extremely important). The proportion of (1) all participants, ignoring stakeholder group (single heterogeneous panel analysis), (2) ‘professional’ and ‘patient’ groups separately (two heterogeneous panels), ignoring prespecified subgroups and (3) each participant subgroup separately (multiple homogeneous panel analysis) rating each item ‘extremely important’ was summarised and compared to explore how selection and integration of stakeholder views may influence outcome prioritisation. RESULTS: There were many overlaps between items rated as most important by all groups. Specific stakeholders, however, prioritised specific concerns and a broader range of outcomes were prioritised when the subgroups were considered separately. For example, two additional outcomes were prioritised when patient and professional groups were considered separately and eight additional outcomes were identified when the views of the individual subgroups were explored. In general, patient subgroups preferentially valued additional clinical outcomes, including unplanned surgery, whereas professional subgroups prioritised additional psychosocial issues including body image. CONCLUSION: Stakeholder groups value different outcomes. Selection of groups, therefore, is important. Our recommendations for robust and transparent stakeholder selection and integration of stakeholder views may aid future COS developers in the design and conduct of their studies and improve the validity and value of future COS