"We should educate the public that cosmetic procedures are as safe as normal medicine": Understanding corporate social responsibility from the perspective of the cosmetic procedures industry.

The cosmetic procedures industry is profitable and expanding. Through its premise and promotion, the industry contributes to unrealistic societal appearance pressures considered harmful to body image. In the context of limited regulation, there is an uneasy reliance on businesses in the sector to act in a socially responsible way. Corporate social responsibility (CSR) refers to voluntary business practices designed to benefit society, and engagement in CSR is shaped by extrinsic and intrinsic drivers. This study aimed to explore how senior UK industry professionals view CSR as it applies to their sector and to body image. Findings from 14 semi-structured interviews show that participants' understanding of CSR was limited to a myopic focus on patients. Little reflexivity was demonstrated in relation to the industry's responsibilities concerning negative body image in society. More broadly, the drivers of socially responsible practice were overwhelmingly extrinsic - oftentimes explicitly linked to bolstering or protecting company and/ or industry reputation. Participants, acknowledging a lack of intrinsic motivation for CSR across the sector, were largely in support of greater regulation. This research contributes to understandings of how the adoption of a CSR agenda might combine with regulatory efforts to curb the industry's impact on negative body image.

'Your face freezes and so does your life': A qualitative exploration of adults' psychosocial experiences of living with acquired facial palsy.

OBJECTIVES: Facial palsy (FP) is a highly visible appearance-affecting condition and can have a significant impact on facial function. Qualitative research focussing on adults' experiences of living with acquired FP is limited. This study aimed to explore the psychosocial impact of acquired FP and to gain a greater understanding of patients' experiences of treatment and care in the United Kingdom. DESIGN: A qualitative interview study with individuals living with acquired FP. METHODS: Ten adults with acquired FP were recruited. Their experiences were explored using semi-structured telephone interviews. Data were analysed using thematic analysis. RESULTS: Five master themes were identified through the thematic analysis: 1) grappling with a new identity, 2) the psychosocial impact of living with facial palsy, 3) isolation: dealing with 'one hell of a problem on your own', 4) a life on hold, 5) coping strategies. Findings indicated high levels of distress and significant challenges in managing the functional and psychosocial changes associated with acquiring FP. Participants expressed grief for their former appearance and identity, with photographs and mirrors acting as agonizing reminders. Many reported a sense of abandonment due to uncoordinated care and, as a result, engaged in an endless and often fruitless pursuit to gain control over FP by experimenting with their own treatment. Many reported the negative impact of their altered facial expressions on social interactions and a fear of being negatively evaluated. CONCLUSIONS: This study highlights a pressing need to review how FP is managed in the UK. To improve patient well-being, health care professionals could benefit from FP education, and patients from timely access to psychological support and clearer standards of care following diagnosis.

Sex differences in perceived stigmatization, body image disturbance, and satisfaction with facial appearance and speech among adolescents with craniofacial conditions.

Youth with craniofacial conditions often have appearance and speech differences and are vulnerable to social stigmatization and body image disturbances. Given sociocultural pressures for female attractiveness, adolescent girls with craniofacial conditions may be especially vulnerable to body dissatisfaction and appearance-related social stigmatization, though such sex differences have been infrequently studied in this population. This study aimed to: (1) examine sex differences in body image disturbance, satisfaction with speech and facial appearance, and perceived stigmatization among adolescents with craniofacial conditions; and (2) evaluate whether stigmatization perceptions are predictive of body image disturbance and satisfaction with facial appearance and speech. Using a cross-sectional design, 110 adolescents from two craniofacial centers completed measures of body image disturbance, satisfaction with speech and facial appearance, and perceived stigmatization. Females reported significantly greater levels of body image disturbance and lower satisfaction with facial appearance compared to males. There were no significant sex differences for satisfaction with speech or perceived stigmatization. Perceived stigmatization was a significant predictor of body image disturbance, and satisfaction with facial appearance and speech while controlling for sex, body mass index, and age. Interventions to prevent and/or address body image and stigmatization concerns are clinically indicated for both sexes.

Achieving Consensus in the Measurement of Psychological Adjustment to Cleft Lip and/or Palate at Age 8+ Years.

BACKGROUND: Consensus regarding optimal outcome measurement has been identified as one of the most important, yet most challenging developments for the future of cleft lip and/or palate (CL/P) services. In 2011, a process began to adopt a shared conceptual framework and to identify a set of core outcome measures for the comprehensive assessment of psychological adjustment. OBJECTIVES: The aim of the current article is to outline the collaborative process used to achieve consensus in the academic and clinical measurement of psychological adjustment to CL/P from the age of 8 years onward. RESULTS: A conceptual framework and corresponding parent- and self-reported outcome measures for use at ages 8, 10, 12, 15, 18, 20, and 25 years have been agreed upon by clinicians, researchers, and patient and parent representatives. All measures have been evaluated according to their psychometric properties, clinical utility, ability to produce meaningful longitudinal data, and a range of pragmatic considerations. CONCLUSIONS: Although the collaborative process has been challenging and has required ongoing dedication from multiple stakeholders, consistency in data collection over time will allow for key research questions in CL/P to be addressed, both in the United Kingdom (UK) and internationally. The process has also demonstrated the clinical utility of the measures and the potential for the gradual integration of the measures into clinical practice. UK progress has sparked global interest, and the adaptation of the framework and its corresponding measures for worldwide use is now a prominent focus.

The Contribution of a Charitable Organization to Regional Cleft Lip and Palate Services in England and Scotland.

BACKGROUND: From diagnosis through to adulthood, a cleft lip and/or palate (CL/P) poses a number of challenges for those affected. Alongside the care provided by clinical teams, complementary information and support is offered by charitable organizations. In 2011, the Cleft Lip and Palate Association received funding to implement a new regional service across England and Scotland, with the aim of increasing support at a local level. The Centre for Appearance Research at the University of the West of England were commissioned to conduct an independent evaluation of the service over 7 years. METHODS: A pragmatic, mixed-methods approach was utilized to assess the impact of the service from the perspective of charity volunteers; children, young people, and adults with CL/P; caregivers; and clinicians. Feedback forms were distributed to stakeholders at a variety of events, and qualitative feedback was collected via focus groups and an online survey. RESULTS: The majority of participants indicated they had gained access to a local support network, felt more able to cope with CL/P-related challenges, and felt more confident in themselves. Qualitative investigation provided further support for these findings and highlighted additional benefits of the regional service for clinical teams. CONCLUSIONS: The evaluation provides encouraging evidence toward the contribution of a relatively small charitable organization in the context of cleft care. The importance of a pragmatic approach to community-based evaluation and the benefits of collaborative working between researchers and the charitable sector were also highlighted.

Risk and Protective Factors for Psychological Distress in Families Following a Diagnosis of Cleft Lip and/or Palate.

OBJECTIVES: Despite the potential psychological impact of a diagnosis of cleft lip and/or palate (CL/P) on parents, few large-scale studies currently exist. Utilizing data extracted from The Cleft Collective Birth Cohort Study, the current study aimed to examine the psychological impact of the diagnosis on parent and family functioning and to identify risk and/or protective factors contributing to parental adjustment in order to inform future psychological intervention. METHODS: Parent-reported questionnaire data were extracted for 1163 parents (644 mothers and 519 fathers). Outcome measures included the PedsQL-Family Impact Module, the Perceived Stress Scale, the Hospital Anxiety and Depression Scale, and a condition-specific tool designed by the Psychology Clinical Excellence Network. RESULTS: Overall, findings suggest that parents adjust well to the diagnosis. Factors found to be protective against psychological distress for both mothers and fathers included a positive life orientation, satisfaction with health care, and relationship satisfaction. Close friendships were also protective against depression in mothers. Risk factors for mothers included the presence of a prior mental health condition, and stressful life events during pregnancy. Risk factors for fathers included being older at the time of conception, and recently being absent from work. CONCLUSIONS: Findings suggest a need for appropriate psychological screening of both parents following a diagnosis of CL/P and emphasize the importance of coordinated multidisciplinary care for psychological health. Preventative models of intervention to strengthen familial relationships and build resilience require further investigation.

Looking to the future: Priorities for translating research to impact in the field of appearance and body image.

The field of body image and appearance research and practice is progressing; however, there is still work to be done to ensure broad societal impact. This article consolidates reflections from a range of established and early career experts in the field of appearance and body image, with a focus on stimulating and guiding future agenda setting and translation from research to impact. We conducted a thematic analysis of transcripts from nine recorded 5-minute presentations, delivered by researchers and clinicians as part of a special invited presentation session at a biennial international conference, 'Appearance Matters,' in the UK. Four themes were identified: Moving Beyond the Individual; Consolidation and Collaboration; Commitment to Implementation; and Positive and Protective Frameworks. These themes are discussed alongside recommendations for researchers and practitioners working in these fields to advance research, advocacy, and impact outside of academia.

A Web-Based Self-Help Psychosocial Intervention for Adolescents Distressed by Appearance-Affecting Conditions and Injuries (Young Persons' Face IT): Feasibility Study for a Parallel Randomized Controlled Trial.

BACKGROUND: Disfigurement (visible difference) from wide-ranging congenital or acquired conditions, injuries, or treatments can negatively impact adolescents' psychological well-being, education and health behaviours. Alongside medical interventions, appearance-specific cognitive behavioural and social skills training to manage stigma and appearance anxiety may improve psychosocial outcomes. YP Face IT (YPF), is a Web-based seven session self-help program plus booster quiz, utilising cognitive behavioural and social skills training for young people (YP) struggling with a visible difference. Co-designed by adolescents and psychologists, it includes interactive multimedia and automated reminders to complete sessions/homework. Adolescents access YPF via a health professional who determines its suitability and remotely monitors clients' usage. OBJECTIVE: To establish the feasibility of evaluating YPF for 12-17 year olds self-reporting appearance-related distress and/or bullying associated with a visible difference. METHODS: Randomized controlled trial with nested qualitative and economic study evaluating YPF compared with usual care (UC). Feasibility outcomes included: viability of recruiting via general practitioner (GP) practices (face to face and via patient databases) and charity advertisements; intervention acceptability and adherence; feasibility of study and data collection methods; and health professionals' ability to monitor users' online data for safeguarding issues. Primary psychosocial self-reported outcomes collected online at baseline, 13, 26, and 52 weeks were as follows: appearance satisfaction (Appearance Subscale from Mendleson et al's (2001) Body Esteem Scale); social anxiety (La Greca's (1999) Social Anxiety Scale for Adolescents). Secondary outcomes were; self-esteem; romantic concerns; perceived stigmatization; social skills and healthcare usage. Participants were randomised using remote Web-based allocation. RESULTS: Thirteen charities advertised the study yielding 11 recruits, 13 primary care practices sent 687 invitations to patients on their databases with a known visible difference yielding 17 recruits (2.5% response rate), 4 recruits came from GP consultations. Recruitment was challenging, therefore four additional practices mass-mailed 3,306 generic invitations to all 12-17 year old patients yielding a further 15 participants (0.5% response rate). Forty-seven YP with a range of socioeconomic backgrounds and conditions were randomised (26% male, 91% white, mean age 14 years (SD 1.7)); 23 to YPF, 24 to UC). At 52 weeks, 16 (70%) in the intervention and 20 (83%) in UC groups completed assessments. There were no intervention-related adverse events; most found YPF acceptable with three withdrawing because they judged it was for higher-level concerns; 12 (52%) completed seven sessions. The study design was acceptable and feasible, with multiple recruitment strategies. Preliminary findings indicate no changes from baseline in outcome measures among the UC group and positive changes in appearance satisfaction and fear of negative evaluation among the YPF group when factoring in baseline scores and intervention adherence. CONCLUSIONS: YPF is novel, safe and potentially helpful. Its full psychosocial benefits should be evaluated in a large-scale RCT, which would be feasible with wide-ranging recruitment strategies. TRIAL REGISTRATION: ISRCTN registry ISRCTN40650639; http://www.isrctn.com/ISRCTN40650639.

Systematic review of body image measures.

This systematic review synthesizes and critically appraises measurement properties of influential body image measures. Eight measures that met the definition of an assessment of body image (i.e., an individual's cognitive or affective evaluation of their body or appearance with a positive or negative valence), and scored high on systematic expert priority ranking, were included. These measures were: the Body Appreciation Scale (original BAS and BAS-2), the Body Esteem Scale for Adolescents and Adults, the Body Shape Questionnaire, the Centre for Appearance Research Valence Scale, the Drive for Muscularity Scale, two subscales of the Eating Disorders Examination Questionnaire, one subscale of the Eating Disorder Inventory 3, and two subscales of the Multidimensional Body Relations Questionnaire. Articles assessing these scales' psychometric properties (N = 136) were evaluated for their methodological quality using the Consensus-based Standards for the selection of health Measurement Instruments (COSMIN) checklist, and a best evidence synthesis was performed. The results supported the majority of measures in terms of reliability and validity; however, suitability varied across populations, and some measurement properties were insufficiently evaluated. The measures are discussed in detail, including recommendations for their future use in research and clinical practice.

Using Photo-Elicitation to Explore Families' Experiences of Burn Camp.

A qualitative study using photo-elicitation was conducted to investigate the experiences of family members attending a residential burn camp. Six families were provided with cameras and asked to take photographs of their time at camp. They were subsequently interviewed about their experiences of camp, using their photographs as prompts. Thematic analysis of interview transcripts identified three main themes: benefits for the family as a whole (new activities and experiences and lasting impacts), benefits for the child (having fun without feeling different), and benefits for the parent/carer (support from those who understand). This is the first study to specifically investigate the experience of the whole family at a burn camp and suggests that attendance may offer a number of benefits for parents/carers and children. Photo-elicitation was an effective method for encouraging participants to recall and discuss their time at camp, and should be considered in future burns research.

An evaluation of the impact of a burn camp on children and young people's concerns about social situations, satisfaction with appearance and behaviour.

INTRODUCTION: This evaluation aimed to assess the impact of a burn camp on children and young people's concerns about social situations, satisfaction with appearance and behaviour. METHODS: Young people completed the Perceived Stigmatisation Questionnaire (PSQ), Social Comfort Questionnaire (SCQ) and Satisfaction with Appearance Scale (SWAP) one month before camp (n=23), on the last day of camp (n=21) and at a three-month follow-up (n=13). Parents completed the Strengths and Difficulties Questionnaire (SDQ) one month before camp (n = 22) and at follow-up (n=12). Parents and young people also completed open-ended questions before camp and at the follow-up. RESULTS: Results in this evaluation were mixed. While parents' reported scores on the SDQ were poorer after camp, young people's reported outcomes on all three measures improved at the end of camp. PSQ and SWAP scores were maintained and improved, respectively, at the follow-up. Qualitative responses were generally consistent with these scores. Significant improvements were found between the scores before camp and at the three-month follow-up for both the SWAP and PSQ. These results indicate that the burn camp may help to improve young people's satisfaction with their appearance and concerns about social situations. However, there was no comparison group and there was a significant loss of participants at follow-up. CONCLUSION: Burn camps may therefore offer a range of psychosocial benefits to young people with burn injuries. This was the first evaluation to demonstrate a positive impact of a burn camp on satisfaction with appearance and concerns about social situations using outcome measures validated with the burns population.

Efficacy of psychosocial and physical activity-based interventions to improve body image among women treated for breast cancer: A systematic review.

OBJECTIVE: Body image concerns warrant attention among women who have undergone treatment for breast cancer, due to their significant consequences for psychological and physical health, and interpersonal relationships. This paper systematically reviews the effectiveness of interventions on body image outcomes among this group, in order to inform health care provision and strategic directions for research. METHODS: Fourteen electronic databases were searched for articles published between 1992 and 2017 that evaluated interventions with women who had undergone treatment for breast cancer in controlled trials with at least one body image measure. Data were extracted and studies were assessed for their methodological quality using the Cochrane Collaboration tool for assessing risk of bias. RESULTS: Twenty-one articles evaluating 26 interventions met inclusion criteria. Nine interventions significantly improved body image at either post-test or follow-up (ds = 0.15-1.43), with none reporting sustained effects across all time points. Effective interventions comprised psychotherapy, psychoeducation, or physical activity, were delivered at different treatment stages and mostly adopted a multisession, face-to-face, group format. However, only 4 interventions were evaluated within methodologically rigorous studies and are therefore recommended for use by health professionals aiming to improve the body image of women at different stages of treatment for breast cancer. CONCLUSIONS: To advance the field, we recommend a less biomedical disease- and treatment-focused approach to interventions, and instead a more biopsychosocial theoretical approach targeting broader modifiable psychosocial influences upon body image. Replication and randomised controlled trials of greater rigour are also required to improve the methodological quality of studies.

Understandings and experiences of visible difference and romantic relationships: A qualitative exploration.

The association between disfigurement ('visible difference') and romantic relationships has received relatively little consideration in the research literature. This qualitative research, conducted in the United Kingdom, explored participants' accounts of their visible difference and romantic life. Semi-structured interviews were conducted with 22 participants who had a variety of visible differences. Inductive thematic analysis demonstrated that participants understood their difference as having a pervasive and enduring impact. These encompassed challenges that must be negotiated in the formation of romantic relationships, including feeling unattractive to others and feeling personally devalued. Relevant physical and sexual sequelae were comprised of anxieties regarding informing partners of a difference, impacted sexual activity, and concerns about heritability. Finally, the potential for partner support and acceptance to positively impact romantic relationships was recognised. This research highlighted the need to extend our understanding of visible difference and intimate relationships and to develop effective interventions to ameliorate appearance-related concern.

More than my RA: A randomized trial investigating body image improvement among women with rheumatoid arthritis using a functionality-focused intervention program.

OBJECTIVE: Negative body image is prevalent in women with rheumatoid arthritis and can affect other areas of well-being. Patients have expressed desire for body image to be addressed in treatment. Yet, it is not routinely addressed and no experimental intervention research has been conducted, until now. This randomized trial evaluated a brief online body image intervention for women with rheumatoid arthritis, with a focus on body functionality (everything the body is capable of doing) as the primary technique. METHOD: Women with rheumatoid arthritis and who wanted to feel better about their body (N = 84; Mage = 44.82) were randomized to the Expand Your Horizon intervention (comprising 3 writing exercises focusing on body functionality) or a waitlist control group. Primary outcomes concerned body image and secondary outcomes related to rheumatoid arthritis; these outcomes were assessed at pretest, posttest, and at 1-week and 1-month follow-up. RESULTS: Multilevel modeling analyses showed that, relative to control, participants in the intervention experienced improvements in various aspects of body image (functionality appreciation, body appreciation, body satisfaction, body-self alienation) and decreases in depression, with effects persisting at 1-week and 1-month follow-up. No intervention effects were found for body-self harmony, rheumatoid arthritis-specific disability, pain-related disability, and anxiety. CONCLUSIONS: Focusing on body functionality can improve body image and reduce depression in women with rheumatoid arthritis. The intervention technique is easy and affordable to deliver and could be a fruitful addition to extant treatments for rheumatoid arthritis. (PsycINFO Database Record

A randomised-controlled trial investigating potential underlying mechanisms of a functionality-based approach to improving women's body image.

Focusing on body functionality is a promising technique for improving women's body image. This study replicates prior research in a large novel sample, tests longer-term follow-up effects, and investigates underlying mechanisms of these effects (body complexity and body-self integration). British women (N = 261) aged 18-30 who wanted to improve their body image were randomised to Expand Your Horizon (three online body functionality writing exercises) or an active control. Trait body image was assessed at Pretest, Posttest, 1-week, and 1-month Follow-Up. To explore whether changes in body complexity and body-self integration 'buffer' the impact of negative body-related experiences, participants also completed beauty-ideal media exposure. Relative to the control, intervention participants experienced improved appearance satisfaction, functionality satisfaction, body appreciation, and body complexity at Posttest, and at both Follow-Ups. Neither body complexity nor body-self integration mediated intervention effects. Media exposure decreased state body satisfaction among intervention and control participants, but neither body complexity nor body-self integration moderated these effects. The findings underscore the value of focusing on body functionality for improving body image and show that effects persist one month post-intervention.

Combined immunosuppression and radiotherapy in thyroid eye disease (CIRTED): a multicentre, 2 × 2 factorial, double-blind, randomised controlled trial.

BACKGROUND: Standard treatment for thyroid eye disease is with systemic corticosteroids. We aimed to establish whether orbital radiotherapy or antiproliferative immunosuppression would confer any additional benefit. METHODS: CIRTED was a multicentre, double-blind, randomised controlled trial with a 2 × 2 factorial design done at six centres in the UK. Adults with active moderate-to-severe thyroid eye disease associated with proptosis or ocular motility restriction were recruited to the trial. Patients all received a 24 week course of oral prednisolone (80 mg per day, reduced to 20 mg per day by 6 weeks, 10 mg per day by 15 weeks, and 5 mg per day by 21 weeks) and were randomly assigned via remote computerised randomisation to receive either radiotherapy or sham radiotherapy and azathioprine or placebo in a 2 × 2 factorial design. Randomisation included minimisation to reduce baseline disparities in potential confounding variables between trial interventions. Patients and data analysts were masked to assignment, whereas trial coordinators (who monitored blood results), pharmacists, and radiographers were not. The radiotherapy dose was 20 Gy administered to the retrobulbar orbit in ten to 12 fractions over 2 to 3 weeks. Azathioprine treatment was provided for 48 weeks at 100-200 mg per day (dispensed as 50 mg tablets), depending on bodyweight (100 mg for <50 kg, 150 mg 50-79 kg, 200 mg for ≥80 kg). The primary outcomes were a binary composite clinical outcome score and an ophthalmopathy index at 48 weeks, and a clinical activity score at 12 weeks. The primary analysis was based on the intention-to-treat allocation and safety was assessed in all participants. This study is registered with ISRCTN, number 22471573. FINDINGS: Between Feb 15, 2006, and Oct 3, 2013, 126 patients were recruited and randomly assigned to groups: 31 patients to radiotherapy plus azathioprine, 31 to sham radiotherapy and azathioprine, 32 to radiotherapy and placebo, and 32 to sham radiotherapy and placebo. Outcome data were available for 103 patients (54 for sham radiotherapy vs 49 for radiotherapy and 53 for placebo vs 50 for azathioprine), of whom 84 completed their allocated treatment of radiotherapy or sham radiotherapy and 57 continued to take azathioprine or placebo up to 48 weeks. There was no interaction betweeen azathioprine and radiotherapy (pinteraction=0·86). The adjusted odds ratio (ORadj) for improvement in the binary clinical composite outcome measure was 2·56 (95% CI 0·98-6·66, p=0·054) for azathioprine and 0·89 (0·36-2·23, p=0·80) for radiotherapy. In a post-hoc analysis of patients who completed their allocated therapy the ORadj for improvement was 6·83 (1·66-28·1, p=0·008) for azathioprine and 1·32 (0·30-4·84, p=0·67) for radiotherapy. The ophthalmopathy index, clinical activity score, and numbers of adverse events (161 with azathioprine and 156 with radiotherapy) did not differ between treatment groups. In both groups, the most common adverse events were mild infections. No patients died during the study. INTERPRETATION: In patients receiving oral prednisolone for 24 weeks, radiotherapy did not have added benefit. We also did not find added benefit for addition of azathioprine in the primary analysis; however, our conclusions are limited by the high number of patients who withdrew from treatment. Results of post-hoc analysis of those who completed the assigned treatment suggest improved clinical outcome at 48 weeks with azathioprine treatment. FUNDING: National Eye Research Centre, Above and Beyond, and Moorfields Eye Charity.

Centralization of Cleft Lip and Palate Services in the United Kingdom: The Views of Adult "Returners".

BACKGROUND: Since the implementation of centralized services in the United Kingdom for those affected by cleft lip and/or palate (CL/P), several studies have investigated the impact of service rationalization on the delivery of care. While large-scale quantitative studies have demonstrated improvements in a range of patient outcomes, and smaller studies have reported on the benefits and challenges of centralization from the views of health professionals, little research has attempted to capture the patient perspective. Furthermore, few studies have investigated the views of adult "returners" who have undergone treatment both pre- and postcentralization. METHODS: Qualitative data relevant to the subject of this article were extracted from 2 previous larger studies carried out between January 2013 and March 2014. A total of 16 adults born with CL/P contributed data to the current study. These data were subjected to inductive thematic analysis. RESULTS: The findings suggest that centralization of CL/P services has considerably enhanced the patient experience. Specifically, the overall standard and coordination of care has improved, service delivery has become more patient centered, and access to professional psychological support and peer support has greatly improved patients' capacity to cope with the associated emotional challenges. CONCLUSIONS: The data collected provide additional insight into the impact of centralization from the perspective of a largely unexplored patient population. In combination with other literature, these findings are also relevant to future efforts to centralize other specialist services around the world.

Toward a Conceptual and Methodological Shift in Craniofacial Research.

OBJECTIVE: To date, research investigating the psychological impact of craniofacial conditions has produced variability across outcomes. The aims of this article were to summarize the challenges that may contribute to this variability, and to offer alternative perspectives and approaches to guide future research and practice. DESIGN: A comprehensive evaluation of papers exploring adjustment to congenital craniofacial conditions was conducted. Methodological approaches and underlying conceptual issues were identified and summarized. RESULTS: The conceptual limitations identified include inherent challenges pertaining to the multifactorial and fluctuating nature of adjustment, a lack of consensus regarding the primary constituents of a positive outcome, scant use of appropriate models and theories, and a predominant focus on "deficits" over "strengths." The methodological shortcomings identified include a lack of representative samples, biomedical inclusion/exclusion criteria, inconsistency in measurement, a relative absence of the patient perspective, variability in approaches to data analysis and interpretation, and the failure to draw on knowledge from other disciplines and related fields of health research. Findings are believed to be relevant to all disciplines involved in craniofacial research and practice. CONCLUSIONS: Existing literature remains markedly affected by a range of conceptual and methodological challenges, despite these challenges being identified 25 years ago. The present article proposes that a shift in the way we conceptualize and study craniofacial conditions is needed, in order to construct a comprehensive understanding of adjustment to craniofacial conditions, and to address the key unanswered questions important to all stakeholders.

Recruiting to cohort studies in specialist healthcare services: Lessons learned from clinical research nurses in UK cleft services.

AIMS AND OBJECTIVES: To explore the experiences of clinical research nurses recruiting patients in a large specialist care-based cohort study. BACKGROUND: Longitudinal studies are vital to better understand the aetiology and moderators of health conditions. This need is especially salient for congenital conditions, such as cleft lip and/or palate, where establishing large, comprehensive data sets from birth is vital to improve understanding and to inform interventions. Various barriers exist in recruiting patients to large cohort studies. The role of clinical research nurses embedded within health settings has grown over past decades to facilitate data collection, yet challenges remain. DESIGN: Qualitative descriptive study. METHODS: Individual semi-structured interviews with 12 clinical research nurses based in 10 National Health Service cleft services across the UK, recruiting to the Cleft Collective Birth Cohort Study. RESULTS: Of seven emergent themes, three highlighted challenges to recruiting patients, another three described facilitative factors, and one theme overlapped challenges and facilitators. Challenges included the life circumstances of potential participants; language barriers; and limited clinical research nurse time for study. Facilitative factors included integrating research into clinical practice; patient information shared with clinical research nurses; and support from the university-based research study team. The theme "Method of data collection" related to both challenges and facilitators. CONCLUSIONS: The qualitative data from clinical research nurses recruiting to a large birth cohort study provide helpful practical detail for specialist healthcare teams, specialist nurses, clinical research nurses and researchers looking to optimise recruitment and data collection in longitudinal studies. RELEVANCE TO CLINICAL PRACTICE: The findings suggest the importance of specialist clinical services and research study teams cooperating to embed research into everyday clinical practice, without compromising care. This should facilitate patients' willingness to participate in important research like the Cleft Collective study and provide them with a positive experience of research.

Setting up a cohort study in speech and language therapy: lessons from The UK Cleft Collective Speech and Language (CC-SL) study.

BACKGROUND: Efforts to increase the evidence base in speech and language therapy are often limited by methodological factors that have restricted the strength of the evidence to the lower levels of the evidence hierarchy. Where higher graded studies, such as randomized controlled trials, have been carried out, it has sometimes been difficult to obtain sufficient power to detect a potential effect of intervention owing to small sample sizes or heterogeneity in the participants. With certain clinical groups such as cleft lip and palate, systematic reviews of intervention studies have shown that there is no robust evidence to support the efficacy of any one intervention protocol over another. AIMS: To describe the setting up of an observational clinical cohort study and to present this as an alternative design for answering research questions relating to prevalence, risk factors and outcomes from intervention. METHODS: The Cleft Collective Speech and Language (CC-SL) study is a national cohort study of children born with cleft palate. Working in partnership with regional clinical cleft centres, a sample size of over 600 children and 600 parents is being recruited and followed up from birth to age 5 years. Variables being collected include demographic, psychological, surgical, hearing, and speech and language data. MAIN CONTRIBUTION: The process of setting up the study has led to the creation of a unique, large-scale data set which is available for researchers to access now and in future. As well as exploring predictive factors, the data can be used to explore the impact of interventions in relation to individual differences. Findings from these investigations can be used to provide information on sample criteria and definitions of intervention and dosage which can be used in future trials. CONCLUSIONS: The observational cohort study is a useful alternative design to explore questions around prevalence, risk factors and intervention for clinical groups where robust research data are not yet available. Findings from such a study can be used to guide service-delivery decisions and to determine power for future clinical trials.