Cleft@18–23 study research clinics: a protocol for a multicentre observational study across UK cleft centres to understand variation in outcomes at the end of routine cleft care

Cleft lip and palate are one of the most common congenital craniofacial malformations. As an initial treatment, presurgical orthopedics is considered standard treatment at many cleft centers. Digital impressions are becoming feasible in cleft care. Computer-aided design (CAD) and three-dimensional (3D) printing are manufacturing standards in dentistry. The assimilation of these technologies has the potential to alter the traditional workflow for the fabrication of customized presurgical orthopedic plates. We present a digital workflow comprising three steps: 3D digital image acquisition with an intraoral scanner, open-source CAD modeling, and point-of-care 3D printing for the fabrication of personalized passive presurgical plates for newborns with cleft lip and palate. The digital workflow resulted in patient-related benefits, such as no risk of airway obstruction with quicker data acquisition (range 1–2.5 min). Throughput time was higher in the digital workflow 260–350 min compared to 135 min in the conventional workflow. The manual and personal intervention time was reduced from 135 min to 60 min. We show a clinically useful digital workflow for presurgical plates in cleft treatment. Once care providers overcome procurement costs, digital impressions, and point-of-care 3D printing will simplify these workflows and have the potential to become standard for cleft care.

To review the progress of orofacial cleft care in Nigeria and propose a viewpoint for the future. Review of the available literature on cleft care in Nigeria and survey of the status of ongoing cleft care in Nigerian centers. We employed a pretested self-administered questionnaire sent and returned through electronic mail. Coordinators of cleft care centers in Nigeria. Findings of literature search and responses to mailed questionnaires. Available literature suggests that the fate of orofacial cleft patients during the precolonial era in Nigeria remains unclear. However, there is evidence of surgical care delivery just before the end of the colonial era. We identified and contacted 39 existing cleft care delivery centers, of which 30 (76.9%) responded. The majority (69.2%) of the responding centers began cleft care delivery between 2006 and 2010; 73.3% have designated cleft clinic locations and 66.7% offer interdisciplinary care. All responding centers offer cheiloplasty, while 86.7% offer palatoplasty. Other aspects of cleft care are provided sparingly in most centers due to paucity of manpower. Challenges with hospital administration, securing bed and theater spaces, drug availability, and performing laboratory investigations were the common limitations reported. We advocate for improved cleft care delivery through removing administrative bottlenecks, fortifying existing centers, and mentoring younger colleagues for entry into underserved specialties. Concerted effort and international collaborations aimed at transforming some of the existing cleft centers to standard pediatric craniofacial centers are desirable.

AimTo evaluate the attitudes of parents of 3 to 8 years old children with cleft lip and palate towards the provision of pediatric dental health care and assess the experience of dentistry in general dental practice.Materials and methodsA questionnaire was distributed to parents of 100 children in the age group of 3 to 8 years old with cleft lip and palate who visited the cleft lip and palate center in KS Hegde Medical Academy, Mangalore.ResultsOut of the hundred patients, 66% of the patients registered directly at the cleft center for their deformity. Only 20% of these children visited a local dental practitioner for their dental health care. 42% had neither undergone any dental treatment nor received any dietary or oral hygiene advices. Regarding the provision of the dental treatment, 74% wanted a pediatric dentist to provide dental check-up and treatment at the cleft center, whereas, 24% preferred a dental practitioner close to their home and 2% does not want treatment anywhere.ConclusionThe survey indicates that there is parental support for the pediatric dental assessment at the cleft center with subsequent arrangement of dental treatment with their local dental practitioners. The majority wanted a pediatric dentist to provide the dental check-up and treatment at the cleft center.

The objective of this investigation was to describe the characteristics of the current cleft treatment situation in a hospital-based cleft center in Shanghai and provide references to clinical diagnosis, treatment, and nursing. A total of 1584 patients from the Center for Cleft Lip and Palate, Department of Oral and Cranio-Maxillofacial Science, Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine during June 2006 to February 2008 were analyzed retrospectively. Data regarding sex, native place, type of cleft, cleft side, accompanied malformations, family history, and age at surgery were analyzed in detail. Length of stay after surgery, the primary operation fee, and some other hospitalized information were also investigated. From 1584 patients(1590 operations; 6 patients had 6 operations), there were 939 male and 645 female patients (M:F = 1.46:1). The number of Shanghai local patients is 249 (15.72%), whereas the other 1335 patients were from out of Shanghai. Approximately 15% of the patients had certain family history. The age at operating varied from 2 months to 36 years; the mean value was 6.95 years. The postoperation hospital stay varied from 1 day to 15 days; the mean value was 5.54 days. The primary operation fee was 235 to 673 USD depending on the different surgical procedures. The number of cleft types or other malformation, which had not been treated in the statistics varied from zero to 3; the mean value was 0.4375. The cleft morphology was classified as follows: cleft lip, 591 cases (37.31%); cleft palate, 651 cases (41.10%); alveolar cleft, 144 cases (9.10%); facial traverse cleft, 27 cases (1.70%); velopharyngeal insufficiency, 105 cases (6.63%); velocardiofacial syndrome, 57 cases (3.60%); and Pierre Robin sequence, 15 cases (0.95%). In all the classifications, left was more than right (L:R = 2.10:1). As a busy hospital-based cleft care center, most of the patients are from out of Shanghai. The current multidisciplinary protocol for cleft care in such specialist cleft center is cost-effective. There may be a tendency that the patients with cleft palate are more than the patients with cleft lips in recent years, which may due to the popularization of prenatal examination in China.

To compare the clinical efficacy, patient satisfaction, and cost of three specialist treatments for depressive illness with routine care by general practitioners in primary care. Prospective, randomised allocation to amitriptyline prescribed by a psychiatrist, cognitive behaviour therapy from a clinical psychologist, counselling and case work by a social worker, or routine care by a general practitioner. 121 patients aged between 18 and 65 years suffering depressive illness (without psychotic features) meeting the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Third Edition for major depressive episode in 14 primary care practices in southern Edinburgh. Standard observer rating of depression at outset and after four and 16 weeks. Numbers of patients recovered at four and 16 weeks. Total length and cost of therapist contact. Structured evaluation of treatment by patients at 16 weeks. Marked improvement in depressive symptoms occurred in all treatment groups over 16 weeks. Any clinical advantages of specialist treatments over routine general practitioner care were small, but specialist treatment involved at least four times as much therapist contact and cost at least twice as much as routine general practitioner care. Psychological treatments, especially social work counselling, were most positively evaluated by patients. The additional costs associated with specialist treatments of new episodes of mild to moderate depressive illness presenting in primary care were not commensurate with their clinical superiority over routine general practitioner care. A proper cost-benefit analysis requires information about the ability of specialist treatment to prevent future episodes of depression.

"OBJECTIVE--To compare the clinical efficacy, patient satisfaction, and cost of three specialist treatments for depressive illness with routine care by general practitioners in primary care. DESIGN--Prospective, randomised allocation to amitriptyline prescribed by a psychiatrist, cognitive behaviour therapy from a clinical psychologist, counselling and case work by a social worker, or routine care by a general practitioner. SUBJECTS AND SETTING--121 patients aged between 18 and 65 years suffering depressive illness (without psychotic features) meeting the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Third Edition for major depressive episode in 14 primary care practices in southern Edinburgh. MAIN OUTCOME MEASURES--Standard observer rating of depression at outset and after four and 16 weeks. Numbers of patients recovered at four and 16 weeks. Total length and cost of therapist contact. Structured evaluation of treatment by patients at 16 weeks. RESULTS--Marked improvement in depressive symptoms occurred in all treatment groups over 16 weeks. Any clinical advantage of specialist treatments over routine general practitioner care were small, but specialist treatment involved at least four times as much therapist contact and cost at least twice as much as routine general practitioner care. Psychological treatments, especially social work counselling, were most positively evaluated by patients. CONCLUSIONS--The additional costs associated with specialist treatments of new episodes of mild to moderate depressive illness presenting in primary care were not commensurate with their clinical superiority over routine general practitioner care. A proper cost-benefit analysis requires information about the ability of specialist treatment to prevent future episodes of depression.

Sir, The scenario of cleft care in India is rapidly changing and has taken rapid strides forward in the last decade or so. Thanks to the role of many NGOs who have come forward to fund free cleft care for the children suffering from this affliction in the developing world. However, controversies abound in this field as far as cleft protocols, timing, and effectiveness of various procedures are concerned. This is true not only in the developing world but in the western world too where societies and organizations are trying to find common ground to recommend or refute definite timelines or procedures to the surgeons performing cleft surgeries. It is in this context that the Indian Society of Cleft Lip Palate and Craniofacial Anomalies (ISCLPCA) sought to flesh out a “Consensus in Cleft Care” and recommend the same (timelines and procedures) to the surgeons performing cleft surgeries in India. The panels which discussed the various issues in cleft care sought to temper the “ideal” with a practical knowledge of the ground realities in India and thus, recommend a protocol which, while being targeted toward delivering world class results, were practical enough to be easily followed by various cleft centers across our country. The recommendations took hours of deliberations and personal communications and some work, thereafter, before they could see the light of the day and be accepted for print in the official organ of the ISCLPCA. It is unfortunate that some typographical errors inadvertently crept into the manuscript and also as commented upon by my colleague in the previous letter, escaped the careful eye of authors, reviewers, and the editorial board. The mistakes have hence been promptly rectified in the online version of the article. The authors sincerely regret this unfortunate slip-up and hope that this would not distract the attention of the reader from the important message that the article carries. Another issue that my colleague has touched upon is the recommendation for the timing of the cleft lip surgery. However, the authors wish to remind the readers that this is the considered recommendation of the panel regarding the preferred age of lip repair and does not stop any person from operating upon a patient if he or she turns up late for lip repair. Furthermore, it has been noted by various authors that cleft surgeons in various centers across India catering to cleft patients are already operating the lip at 3-6 months of age [1] and that the percentage of patients presenting before 1 year of age is nearly 15% [2] and almost 43.62% of children are operated before 2 years of age. [3] This is amazing statistics compared to a decade ago when the proportion of children to adults was much less than it is today. Most smile train centers today are seeing a perceptible fall in the mean age of children reporting for cleft surgery. Thanks to the aggressive outreach programs of these centers and the various information campaigns that these centers run (Khanna V. 2013. Personal communication). Keeping this very encouraging trend in mind, the panelists have no hesitation in recommending the preferred age of lip repair in India (permeated as it is by centers running various charity programs funding cleft care) as between 3 and 6 months of age. It was our sincere hope that the recommendations would bring uniformity in cleft care across India and stimulate better results and better research.

Highly specialized primary cleft surgery must ensure that normalized nasolabial esthetic appearance; intact primary and secondary palate; normalized speech, language, and hearing; nasal airway patency; class I occlusion with normal masticatory function; good dental and periodontal health; and normal psychosocial development are obtained (Ranganathan et al. 2015; Sitzman et al. 2014; Shaye 2014; Jones et al. 2014; Campbell et al. 2010). Interestingly, approaches to cleft care vary considerably between cleft centers (Table 6.1) and achieving optimal standards of cleft care across different countries and cleft centers remains an outstanding challenge (Persson et al. 2015; Dissaux et al. 2015, 2016; Long et al. 2011; Alonso et al. 2010; Semb et al. 2005a; Shaw et al. 2001; Sandy et al. 2001). Relevant examples of this diversity in cleft practices can be seen from the Eurocleft and Americleft intercenter outcome studies (Long et al. 2011; Shaw et al. 2001).

This is an overview of the present state of cleft lip and palate care in Nigeria. The aim is to stimulate further discussions on the need to improve standard of care and quality of life in patients with cleft lip and palate deformities. The number of cleft surgeries and surgeons involved in cleft repairs across Nigeria is increasing due to availability of free treatment grants provided by non-governmental organisation; therefore, it has become imperative to assess the quality of surgery and quality of cleft care. It is expected that as the number of repaired cleft lip/palate increases, more patients will require secondary repair, speech therapy, and orthodontics therapy and orthognathic surgery. The following recommendations are made to improve the standard of cleft care in Nigeria: establishment of multidisciplinary team approach, formulation of policy on quality control, establishment of fellowship training in cleft care and establishment of regional specialised cleft care centre.

To report speech outcomes following Orticochea pharyngoplasty in 43 patients with cleft palate and noncleft velopharyngeal dysfunction. A retrospective surgical audit of patients undergoing Orticochea pharyngoplasty between 2004 and 2012, with speech as a primary outcome measure. Patients known to a regional UK cleft center. Forty-three patients underwent Orticochea pharyngoplasty by a single surgeon in a UK regional cleft center. Twenty-one patients had undergone a prior procedure for velopharyngeal dysfunction. Pre- and postoperative speech samples were assessed blindly using the Cleft Audit Protocol for Speech-Augmented by a specialist cleft speech and language therapist, external to the team. Speech samples were rated on the following parameters: hypernasality, hyponasality, audible nasal emission, nasal, turbulence, and passive cleft speech characteristics. Statistical differences in pre- and postoperative speech scores were tested using the Wilcoxon matched-pairs signed-ranks test. Inter- and intrareliability scores were calculated using weighted Cohen κ. Whole group: A statistically significant difference in pre- and postoperative scores for hypernasality (P < .001), hyponasality (P < .05), nasal emission (P < .01), and passive cleft speech characteristics (P < .01) were reported. Patients with cleft diagnoses: A statistically significant difference in scores for hypernasality (P < .001), nasal emission (P < .01), and passive cleft speech characteristics (P < .01) were reported for this group of patients. Patients with noncleft diagnoses: The only parameter to demonstrate a statistically significant difference was hypernasality (P < .01) in this group. Orticochea pharyngoplasty is a successful surgical procedure in treating velopharyngeal dysfunction in both the cleft and noncleft populations.

Summary: The traditional method of capturing cleft lip and palate morphology using dental impressions and plaster casts has long been considered the gold standard. However, especially for infants, digital impressions have proven to be accurate and safe. We present a protocol successfully adopted by 2 cleft centers that utilize intraoral scanners for cleft care in an outpatient setting, as well as in the operating theater. We demonstrate the positioning of the patient, scanner, monitor, and clinician, along with technical steps to capture a digital impression of the lip, nose, and cleft palate within approximately 1 minute. We also show how digital impressions can improve documentation, allow digital pretreatment, and be used for outcome comparison. The illustrated description is accompanied by a step-by-step video. Digital impressions provide enhanced 3-dimensional reconstructions of the complete cleft anatomy, which are beneficial for presurgical orthopedic planning, anatomical studies, and long-term treatment documentation. This approach minimizes risks such as airway obstruction and storage challenges encountered with physical models. Its adoption in cleft centers represents a significant advancement in cleft care, facilitating more accurate records and improving patient safety. Digital impressions can set a new standard in cleft care, improving record-taking for clinical needs and outcome analysis, and replacing traditional methods.

The contributions of all physician specialties and ancillary services involved in cleft and craniofacial center care must be evaluated to fairly assess the financial impact of a cleft and craniofacial center. The authors hypothesized that the cleft and craniofacial center generates profitable downstream productivity for the academic health system. This was a retrospective cohort study of all patients who presented to a cleft and craniofacial center in the first quarter of 2011. Analysis included all health system encounters for each patient over a 2-year period using the electronic medical record and health system financial database. Sixty-two patients were seen (mean age, 11.4 years; 38 boys and 24 girls; 18 new and 44 established patients). Over 2 years, there were 618 health system encounters (599 outpatient and 19 inpatient encounters), 68 hospital days, and 110 procedures. The most common physician specialty was plastic surgery [312 encounters (50.5 percent)] and the most common ancillary service was speech therapy [256 encounters (41.4 percent)]. The overall reimbursement rate was 39.9 percent, with a majority payor-mix of government payors (62.1 percent). The total profit margin percentage from all encounters was 13.7 percent, which was greater for managed care compared with government payor (38.9 percent versus -10.8 percent; p = 0.022), inpatient compared to outpatient (24.5 percent versus -2.8 percent; p < 0.001), and plastic surgery compared to other specialty encounters (19.7 percent versus 8.7 percent; p = 0.003). The cleft and craniofacial center generated profitable downstream productivity for the academic health system with referrals to 39 different physician and nonphysician specialties. Health system providers and the business team should align to analyze the center, enhance patient outcomes, and improve specialty care access for patients.

Intimate partner violence (IPV) is a common concern among military Veterans that negatively impacts health. The United States’ Veterans Health Administration (VHA) has launched a national IPV Assistance Program (IPVAP) to provide comprehensive services to Veterans, their families and caregivers, and VHA employees who use or experience IPV. Grounded in a holistic, Veteran-centered psychosocial rehabilitation framework that guides all facets of the program, the IPVAP initiated the pilot implementation of a novel intervention called Recovering from IPV through Strengths and Empowerment (RISE). This evidence-based, person-centered, trauma-informed, and empowerment-oriented brief counseling intervention is designed to support those who experience IPV and to improve their psychosocial wellbeing. This program evaluation study describes clinical outcomes from patients who participated in a pilot implementation of RISE in routine care. We examined changes in general self-efficacy, depression, and valued living, as well as treatment satisfaction among patients who received RISE and completed program evaluation measures at VHA facilities during the pilot. Results from 45 patients (84% women) indicate that RISE was associated with significant pretreatment to posttreatment improvements in self-efficacy, depression, and valued living (Cohen’s d s of 0.97, 1.09, and 0.51, respectively). Patients reported high satisfaction with treatment. Though preliminary results were similar across gender and IPV types, findings from the evaluation of the pilot implementation of RISE demonstrate the intervention’s feasibility, acceptability, and clinical utility in routine VHA care and inform the scalability of RISE. Additionally, findings provide preliminary support for the effectiveness and acceptability of RISE with men. Modification to RISE and its implementation are discussed, which may be useful to other settings implementing IPV interventions.

BackgroundThe transitional period from hospital to home is vital for stroke patients, but it poses serious challenges. Good self-management ability can optimize disease outcomes. However, stroke patients in China have a low level of self-management ability during the transitional period, and a lack of effective support may be the reason. With the rapid development of technology, using wearable monitors to achieve real-time and individualized support may be the key to solving this problem. This study uses a randomized controlled trial design to assess the efficacy of using wearable technology to realize real-time and individualized self-management support in stroke patients’ self-management behavior during the transitional period following discharge from hospital.MethodsThis parallel-group randomized controlled trial will be conducted in two hospitals and patients’ homes. A total of 183 adult stroke patients will be enrolled in the study and randomly assigned to three groups in a 1:1:1 ratio. The smartwatch intervention group (n = 61) will receive Real-time and Individualized Self-management Support (RISS) program + routine care, the wristband group (n = 61) will wear a fitness tracker (self-monitoring) + routine care, and the control group (n = 61) will receive routine stroke care. The intervention will last for 6 months. The primary outcomes are neurological function status, self-management behavior, quality of life, biochemical indicators, recurrence rate, and unplanned readmission rate. Secondary outcomes are resilience, patient activation, psychological status, and caregiver assessments. The analysis is intention-to-treat. The intervention effect will be evaluated at baseline (T0), 2 months after discharge (T1), 3 months after discharge (T2), and 6 months after discharge (T3).DiscussionThe cloud platform designed in this study not only has the function of real-time recording but also can push timely solutions when patients have abnormal conditions, as well as early warnings or alarms. This study could also potentially help patients develop good self-management habits through resilience theory, wearable devices, and individualized problem–solution library of self-management which can lay the foundation for long-term maintenance and continuous improvement of good self-management behavior in the future.Trial registrationThe ethics approval has been granted by the Ethics Committee of West China Hospital, Sichuan University (2022–941). All patients will be informed of the study details and sign a written informed consent form before enrollment. The research results will be reported in conferences and peer-reviewed publications. The trial registration number is ChiCTR2300070384. Registered on 11 April 2023.

Documenting cleft lip and palate morphology prior to surgery is standard care. Presurgical orthopedic treatment also requires a 3D cleft model. Endangering the airway, conventional impressions require additional safety measures and resources. We investigate the implementation and risks of digital impressions for the youngest patients with orofacial clefts. We report a retrospective cohort study of patients with cleft lip and palate, aged up to 6 years, treated at two cleft centers in Europe (Basel (A), Warsaw (B)). We scanned with the Medit i500 (Medit Corp, Seoul, South Korea). Center A for presurgical orthopedics and prior surgery from June 2020 to March 2022. Center B prior surgery from December 2020 to May 2021. Scanning data were analyzed for adverse events and adverse device effects, scanning duration, and number of images according to cleft type and age. We analyzed 342 digital impressions in 190 patients (center A: 71, B: 119). The median age was 8.7 months with a range from the first day of birth (presurgical orthopedics) to six years of life (early alveolar bone grafting). No adverse events or adverse device effects were observed. The median scan duration was 85.5s for cleft palate and 50s for cleft lip and nose (IQR 56s and 39s, respectively). Digital impressions with intraoral scanners are safe in patients with cleft lip and palate from newborn to preschool age. Given the funding to purchase an intraoral scanner, interfaces to electronic patient records, and point-of-care 3D printing, cleft centers can successfully implement this technology.