Fetal Dysmorphology-Still an Essential Art. Analysis of the Limitations of Microarray in a Fetal Population and a Look Toward the Genome Sequencing Era.

Cytogenomic microarray allows assessment of the genome at higher resolutions than traditional karyotyping. The objective of this study is to evaluate the utility of microarray in a routine fetal autopsy setting before the advent of routine fetal exome/genome sequencing and the issues these technologies may generate. A systematic review of fetal postmortems at 12-24 weeks gestation between January 2011 and December 2014 was undertaken. Cases where there was no consent for audit, research, or genetic testing were excluded as were cases referred to the Procurator Fiscal, stillbirths, and neonatal deaths. Copy number variations were detected in 16 cases. In addition, there was 1 case of uniparental disomy; not all of these were related to the phenotype. There were a number of cases with phenotypic abnormalities and normal array results. Five of these underwent directed mutation analysis-3 were positive. Genetic laboratory investigations such as microarray and Quantitative Fluorescent-Polymerase Chain Reaction may increase the diagnostic yield in the assessment of fetal dysmorphology. However, this study shows that genetic results not only require careful review given the potential uncertain significance but also require phenotypic assessment of the fetus by a competent fetal dysmorphologist to determine the likely causative effect of any detected anomaly. This best practice will also extend to next generation sequencing and interpretation of variants of unknown significance. Fetal medicine teams should ideally include specialists well versed in assessment of fetal anomaly to provide families with the best possible information about the cause of their pregnancy loss and their options for future pregnancies.

Use of prenatal chromosomal microarray: prospective cohort study and systematic review and meta-analysis.

OBJECTIVES: Chromosomal microarray analysis (CMA) is utilized in prenatal diagnosis to detect chromosomal abnormalities not visible by conventional karyotyping. A prospective cohort of women undergoing fetal CMA and karyotyping following abnormal prenatal ultrasound findings is presented in the context of a systematic review and meta-analysis of the literature describing detection rates by CMA and karyotyping. METHODS: We performed a prospective cohort study of 243 women undergoing CMA alongside karyotyping when a structural abnormality was detected on prenatal ultrasound. A systematic review of the literature was also performed. MEDLINE (1970-Dec 2012), EMBASE (1980-Dec 2012) and CINAHL (1982-June 2012) databases were searched electronically. Selected studies included > 10 cases and prenatal CMA in addition to karyotyping. The search yielded 560 citations. Full papers were retrieved for 86, and 25 primary studies were included in the systematic review. RESULTS: Our cohort study found an excess detection rate of abnormalities by CMA of 4.1% over conventional karyotyping when the clinical indication for testing was an abnormal fetal ultrasound finding; this was lower than the detection rate of 10% (95% CI, 8-13%) by meta-analysis. The rate of detection for variants of unknown significance (VOUS) was 2.1% (95% CI, 1.3-3.3%) when the indication for CMA was an abnormal scan finding. The VOUS detection rate was lower (1.4%; 95% CI, 0.5-3.7%) when any indication for prenatal CMA was meta-analyzed. CONCLUSION: We present evidence for a higher detection rate by CMA than by karyotyping not just in the case of abnormal ultrasound findings but also in cases of other indications for invasive testing. It is likely that CMA will replace karyotyping in high-risk pregnancies.

Managing the consequences of cancer treatment and the English National Cancer Survivorship Initiative.

BACKGROUND: In 2007 the English National Cancer Survivorship initiative was launched as a partnership between a national charity, Macmillan Cancer Support, the English Department of Health (DH) and the quality improvement agency NHS Improvement. The initiative involved a number of work streams, one of which was to improve the detection and management of the Consequences of adult cancer Treatment (COT). MATERIAL AND METHODS: The adult COT group took evidence from a range of stakeholders and published a vision and work programme focused on awareness raising, linking self- administered questionnaires to routine activity data collection and testing new models of care with a particular focus on pelvic cancers. RESULTS: Key outputs include national media campaigns, publications demonstrating the value of linking cancer treatment episodes to routine recording of chronic illness, identification of sensitive Patient Reported Outcome Measures (PROMs) items for use in national surveys, evidence reviews and published national guidelines, together with the development of a three level risk stratified model of care. Pilot testing with survivors treated for pelvic cancers, and adult survivors with radiation-induced brachial plexopathy has been completed. CONCLUSION: Early results suggest that a systematic approach to the prevention, detection and management of some treatment-related consequences can significantly improve the ability of patients to manage their conditions. As a result of these findings, new services have now been commissioned by the NHS, initially for those with complex problems.

The health and well-being of cancer survivors in the UK: findings from a population-based survey.

BACKGROUND: To compare self-reported health and well-being in a sample of cancer survivors with individuals who have not had cancer and with individuals who have a serious chronic condition other than cancer. PATIENTS AND METHODS: A cross-sectional survey drawn from an online panel of 400,000 UK citizens supplemented with other online recruitment and telephone recruitment. The participants were 4892 individuals 30 years of age or above, including 780 individuals with a previous cancer diagnosis, 1372 individuals with one or more of 10 chronic conditions but not cancer and 2740 individuals without a previous cancer diagnosis or chronic condition. Thirteen measures of health and well-being were constructed from answers to 25 survey items covering physical, psychological and social dimensions of health and well-being. RESULTS: Cancer survivors were significantly more likely to report poor health outcomes across all 13 measures than those with no history of cancer or a chronic condition. The adjusted odds ratios for cancer survivors with no chronic conditions compared with healthy participants ranged from 1.37 (95% confidence interval (CI): 1.31-1.96) for emotional well-being to 3.34 (95% CI: 2.74-4.08) for number of health professionals consulted in the last 12 months. The health profile of cancer survivors was similar to those with a history of a serious chronic health condition. CONCLUSIONS: A substantial number of individuals who have had a diagnosis of cancer experience ongoing poor health and well-being following cancer and cancer treatment. The results of this study provide an initial basis for the development of specific help and support for cancer survivors.

Results of a quantitative survey to explore both perceptions of the purposes of follow-up and preferences for methods of follow-up delivery among service users, primary care practitioners and specialist clinicians after cancer treatment.

AIMS: To ascertain perceptions of reasons for follow-up after cancer treatment among service users (patients and carers), primary care practitioners and specialist clinicians (doctors and specialist nurses) and to identify levels of preference for different models of follow-up and the effect of an individual's experience on preferred models. MATERIALS AND METHODS: A national survey designed to meet the needs of each key respondent group was carried out after a structured literature review, an extensive consultation process and a pilot scheme. Respondents were asked to assess their degree of preference for 10 pre-selected indications for follow-up. Eight models of follow-up were also identified and respondents were asked to state their experience and preference for each type. The questionnaire was distributed nationally via the 34 cancer networks in England and was available both online and in hard copy (postal). The uptake for the electronic format was in the main by primary care practitioners and specialist clinicians. Service users preferred the paper (postal) format. The survey was also publicised through the primary care and patient partnership forums at a Cancer Network Development event. RESULTS: In total, 2928 responses were received, comprising service users (21% of the sample), primary care practitioners (32%) and specialist clinicians (47%). Eighty-six per cent of responses were received from the 10 strategic health authorities in England, with the remaining 14% from Scotland, Wales and The Isle of Man. The responses from Scotland, Wales and the Isle of Man generally occurred where they interfaced with English cancer networks or had been engaged through word of mouth by colleagues. Among all respondents the main aims of cancer follow-up were considered to be: (1) to monitor for early complications after treatment; (2) to detect recurrences early; (3) to detect late effects of treatment. The most commonly experienced method of follow-up among all respondent groups was outpatient review with a doctor. This was considered to be the most preferred follow-up option among service users (86%). The least preferred option among service users was postal follow-up (32%). Primary care practitioners and specialist clinicians were more likely than service users to have experienced alternative methods of follow-up, such as telephone follow-up, self-triggered referral and non-specialist follow-up. These models were highly rated by those who had experience of them. CONCLUSIONS: There was a reasonable level of consensus between service users, primary care practitioners and specialist clinicians as to the reasons for follow-up. Service users seemed to have higher expectations of follow-up, particularly in relation to detecting recurrences early. As respondents were more likely to prefer a method of follow-up delivery that they had experienced than one they had not; there could be resistance to change from established methods to new methods without adequate explanation. This suggests that the communication of new methods could be critical to their successful introduction.

Patterns of complementary and alternative medicine use among patients undergoing cancer treatment.

This study aimed to assess the prevalence of complementary and alternative medicine (CAM) use in a representative cancer population prior to and within 6 months of diagnosis. A total of 304 newly diagnosed cancer patients from two UK cancer centres completed a postal survey. Of them, 100 patients (32.9%) used CAM before their cancer diagnosis, 59 of these CAM users continued post diagnosis. Twenty-nine individuals who had not used CAM before began to use it after their cancer diagnosis, creating a total of 88 (28.9%) CAM users in this sample. Reasons for not using CAM included lack of interest, lack of information or endorsement from professionals and satisfaction with conventional care. For those using CAM before diagnosis but not afterwards, the most common reason was a lack of expert guidance on what was safe to use. The use of CAM medicines bought from health food and other retail outlets was high. Complementary and alternative medicine use in cancer patients is common and demonstrates a complex pattern, but CAM use is not significantly greater than in the general population. Some patients purchase CAM medicines without seeking medical advice, thus risking drug interactions. Research to generate information on safety and efficacy of CAM is required.

An integrated support and information centre in a large U.K. Cancer Centre established in 1993 and replicated in more than 60 units across the United Kingdom and Australia.

Established in 1993 after a 2-year consultation between professionals and cancer patients, the Lynda Jackson Macmillan Centre (LJMC) has been a catalyst for change in the United Kingdom. The Centre began with a small core staff in a purpose-built building next to a cancer centre, networking with outreach workers in 12 surrounding hospitals, with a mission to improve information, communication, and support for cancer patients. Since 1996, the LJMC model has been adopted and developed by the charity Macmillan Cancer Support and has been spread to more than 60 units across the United Kingdom and Australia.Introducing complementary therapies (CAMS) to a cancer centre was a particular early challenge. Establishing a shared understanding of the role of complementary therapies and developing nationally accredited written information about them, credible recruitment and governance procedures for therapy practitioners, agreed outcome measures, and peer-reviewed evaluation and research have all been important in engaging cancer physicians and managers; however, charitable funding is still required to support free access to most complementary therapies.An integrated supportive care service for cancer patients begins with a shift in the culture of cancer treatment organizations, moving from a professional-centred to a patient-centred agenda. Real reach and impact requires "new" ideas and services to be integrated into the routine practice of the cancer care delivery organizations. A key lesson learned over the last 15 years is that an integrated support centre must continually adapt to be viable. Sustaining meaningful user guidance is a particular challenge. Support for self-management and the testing and development of CAM services are growing parts of the portfolio.

Survivorship, late effects and cancer of the cervix.

As the prevention and treatment of cervical cancer improves, there is increasing focus on the months and years after cancer treatment. Of those women living after a diagnosis of cancer, 10% will have a gynaecological malignancy and although the incidence of cervix cancer has dropped over the last 20 years, so has the age at diagnosis, with more than 60% surviving at least 5 years. In a recent report, 63% of 231 064 US survivors of cervix cancer were more than 10 years from diagnosis. More survivors are living long enough to develop chronic treatment-related conditions. The 2007 English Cancer Reform Strategy highlighted the importance of cancer survivorship and uses the US National Coalition for Cancer Survivorship definition-'living through and beyond cancer'. The emerging picture is of populations living after a diagnosis of cancer without active disease, still having similar health and disability profiles to populations with a diagnosis of a chronic illness. This offers new challenges in identifying and meeting their needs.

Learning the hard way! Setting up an RCT of aromatherapy massage for patients with advanced cancer.

Aromatherapy massage is used in cancer palliative care to improve quality of life but there is little evidence for its effectiveness. A large pragmatic multicentre randomized controlled trial was set up to examine the effectiveness of aromatherapy in improving psychological distress and quality of life in patients with cancer. This paper examines the challenges encountered in the design and execution of the study. The original design, i) focused on palliative care patients with advanced disease; ii) had both a no-intervention and a treatment control group (relaxation therapy); and iii) adopted 90% power for sample size calculations. A varied measurement strategy was employed. Recruitment proved difficult, referrers were 'gate-keeping', patients were often too ill to approach and others declined. The trial was modified to ensure viability. Eligibility was extended to all patients with cancer irrespective of stage, the relaxation group was removed and the power reduced to 80%. Although it is not generally good practice to change a study design once recruitment has started, the changes were consistent with the original basic study aims and design principles. The data collection phase was successfully completed in July 2002.

Interventions for the physical aspects of sexual dysfunction in women following pelvic radiotherapy.

BACKGROUND: Following pelvic radiotherapy (RT), a proportion of women experience problems related to sexual function, which are multifactorial in origin. The physical components relate to distortion of the perineum and vagina, which may occur as a result of surgery and/or radiotherapy and compromise sexual activity resulting in considerable distress. OBJECTIVES: The aim of this review was to evaluate the evidence for treatment options addressing the physical components of sexual dysfunction arising from pelvic radiotherapy as prevention or treatment of acute or late complications. SEARCH STRATEGY: The concepts used included synonyms for radiation therapy and brachytherapy and synonyms for the spectrum of physical aspects of sexual dysfunction in women. randomized. We searched the Cochrane Controlled Trials Register (CENTRAL), issue 1, 2002, MEDLINE 1966 to 2002, EMBASE 1980 to 2002, CANCERCD 1980 to 2002, Science Citation Index 1991 to 2002, CINAHL 1982 to 2002, as well as sources of grey literature. We also hand searched relevant textbooks and contacted experts in the field. SELECTION CRITERIA: Any study describing the therapeutic trial of a treatment to relieve the physical aspects of female sexual dysfunction which had developed following pelvic radiotherapy was considered. The quality of each study was then assessed by two reviewers independently to determine its suitability for inclusion in statistical analysis. DATA COLLECTION AND ANALYSIS: Thirty-two references met the inclusion criteria for the search but of these only four were suitable to be included for statistical analysis. MAIN RESULTS: The strongest evidence for benefit is the grade IC data in the topical oestrogens and benzydamine sections which describes the treatment of acute radiation vaginal changes. The use of vaginal dilators to prevent the development of vaginal stenosis is supported by grade IIC evidence. The value of hyperbaric oxygen therapy and surgical reconstruction is supported by the much weaker grade IIIC evidence in the form of case series. REVIEWER'S CONCLUSIONS: These findings reflect the quality of published data regarding interventions for this aspect of the management of radiation induced complications. Although there is grade IC evidence, these studies are not recent, the allocation concealment is unclear in the text, and overall there is a variable level of assessment of the response, emphasising the need for more studies to be conducted with improved designs to clarify the investigative process and support the final result.

How useful are observational reports in the evaluation of interventions for radiation morbidity?: an analysis of formalin therapy for late radiation proctitis.

BACKGROUND AND PURPOSE: Evidence-based medicine requires the systematic and critical evaluation of published and unpublished trials. Problems arise when a clinical condition is relatively rare and the only available data relate to experiential knowledge. The way forward would be to recommend the development of good quality randomized controlled studies. Until then, we are left with the situation where some information exists, albeit in the form of case reports and small series. Should this information be used and what features would determine its strength? METHODS: Using the example of formalin therapy in haemorrhagic radiation proctitis, a treatment for a rare condition, we were able to identify 16 published studies, 13 of which were retrospective and three of which were prospective. The quality of reporting detail was assessed by comparison to the features in a 'proposed minimum dataset' for an uncontrolled study addressing this topic. RESULTS: The mean score for quality of reporting detail for these studies was 50.6% (range 25-70%). Earlier studies reported a significantly higher response rate than subsequent studies and although there was a tendency for smaller studies to report higher response rates, this was not significant. The score for detail of reporting did not improve with year of publication and the correlation between the size of the study and the detail of reporting was not statistically significant. CONCLUSIONS: The information presented is of exceedingly variable quality. If these studies are to be used, where insufficient controlled trials are available, they should be scored for methodology, and these scores used to assist interpretation of results. This would be facilitated if an accepted reporting format including specific criteria was available.

Non-surgical interventions for late radiation cystitis in patients who have received radical radiotherapy to the pelvis.

BACKGROUND: Chronic radiation cystitis occurs a minimum of three months after completion of pelvic radiotherapy and represents a range of clinical symptoms for which there is as yet no recommended standard management. OBJECTIVES: The aim of this review was to identify the various non-surgical treatment options for the management of late chronic radiation cystitis and evaluate the evidence. SEARCH STRATEGY: Synonyms for radiation therapy and for the spectrum of radiation toxicity to the bladder in both text and MeSH terms were combined and applied to a range of databases without restriction of year of publication, methodology or language. SELECTION CRITERIA: The inclusion criteria included studies of interventions for the non-surgical management of all grades of late radiation cystitis. DATA COLLECTION AND ANALYSIS: Out of 80 relevant studies, there were no RCTs that met the inclusion criteria, but there were three prospective case series and two non-randomised studies which assessed different interventions and were not comparable. MAIN RESULTS: Sixty-three reports met the stated inclusion criteria. The majority were predominantly retrospective case series with the exception of two trials which were unrandomised and unblinded studies with a control group for comparison of effect. Although these two trials, Micic 1988, (intravesical placental extract) and Milani 1988, (flavoxate) provided the strongest evidence they were not randomised and were essentially isolated controlled studies. REVIEWER'S CONCLUSIONS: In such a relatively rare condition there are obvious difficulties in identifying sufficient patients to participate in a randomised controlled trial. The number of published reports is a reflection of the degree of medical interest that exists in providing therapeutic solutions for late radiation cystitis. However, in spite of the two studies of level IIA evidence, the absence of randomised controlled trials makes it impossible to draw any firm conclusions.

Systematic review for non-surgical interventions for the management of late radiation proctitis.

Chronic radiation proctitis produces a range of clinical symptoms for which there is currently no recommended standard management. The aim of this review was to identify the various non-surgical treatment options for the management of late chronic radiation proctitis and evaluate the evidence for their efficacy. Synonyms for radiation therapy and for the spectrum of lower gastrointestinal radiation toxicity were combined in an extensive search strategy and applied to a range of databases. The included studies were those that involved interventions for the non-surgical management of late radiation proctitis. Sixty-three studies were identified that met the inclusion criteria, including six randomised controlled trials that described the effects of anti-inflammatory agents in combination, rectal steroids alone, rectal sucralfate, short chain fatty acid enemas and different types of thermal therapy. However, these studies could not be compared. If the management of late radiation proctitis is to become evidence based, then, in view of its episodic and variable nature, placebo controlled studies need to be conducted to clarify which therapeutic options should be recommended. From the current data, although certain interventions look promising and may be effective, one small or modest sized study, even if well-conducted, is insufficient to implement changes in practice. In order to increase recruitment to trials, a national register of cases with established late radiation toxicity would facilitate multi-centre trials with specific entry criteria, formal baseline and therapeutic assessments providing standardised outcome data.

Treatment-related morbidity and hospital league tables: experience from a national audit of radiotherapy-induced morbidity in cervical carcinoma.

Data are now available from a U.K. audit of survival and late morbidity following curative radiotherapy for cancer of the cervix treated in 1993. The complication rate per centre ranges from 0 to 67%. Although the frequency of complications following curative radiotherapy for cancer of the cervix might be considered to be an indicator of clinical performance, variation in treatment outcomes can be explained by sampling variability rather than real differences in quality of care. In the present study we have asked the question: could the disparity in complication rates between centres be no more or less than would be expected by chance? Our analysis suggests that this is the case, and for this reason it would be premature to use such outcome data to produce league tables or to assess institutional differences. Thus, ranking centres according to complication rate would not be valid, as the differences in rates observed are probably not significantly different from the national average. It is important that audit data are not used inappropriately and this analysis further highlights the need for reliable prospective collection of clinical information and the importance of considering sampling variability in interpreting the results of such studies.

Non surgical interventions for late radiation proctitis in patients who have received radical radiotherapy to the pelvis.

BACKGROUND: Chronic radiation proctitis (inflammation of the rectum) may develop after the completion of pelvic radiotherapy. Presently there is no recommended standard management. OBJECTIVES: To assess the effects of various non-surgical treatment options for the management of late chronic radiation proctitis. SEARCH STRATEGY: We searched the Cochrane Controlled Trials Register, issue 1, 2001, MEDLINE 1966 to 2001, EMBASE 1980 to 2001, CANCERCD 1980 to 2001, Science Citation Index 1991 to 2001, CINAHL 1982 to 2001, as well as sources of grey literature. We also hand searched relevant textbooks and contacted experts in the field. SELECTION CRITERIA: Studies (preferentially randomised controlled trials) of interventions for the non-surgical management of late radiation proctitis in patients who have undergone pelvic radiotherapy as part of their cancer treatment. DATA COLLECTION AND ANALYSIS: The inclusion criteria were independently applied by two of the reviewers (AD and EJM) and where there was disagreement this was resolved by involving a third reviewer to form a consensus. MAIN RESULTS: Six randomised controlled trials were included. None of the trials compared anti-inflammatories with placebo. However rectal sucralfate showed greater clinical improvement for proctitis than anti-inflammatories (odds ratio 14.00, 95% confidence interval 1.46 to 134.26; n=1 study), though no difference was seen for endoscopic improvement (odds ratio 2.74, 95% confidence interval 0.64 to 11.76, n=1 study). The addition of metronidazole to the anti-inflammatory regime also appeared to improve the response rate, as measured by the reduction in rectal bleeding, diarrhoea, erythema and ulceration (n=1 study). Similarly rectal hydrocortisone appeared to be more effective than rectal betamethasone for clinical improvement although no difference was seen in endoscopic improvement (n=1 study). Short chain fatty acid enemas did not appear to be effective compared to placebo (n=2 studies). In the comparison of the heater probe and bipolar electrocautery (n=1 study), there was no discernible difference for severe bleeding after one year, but the heater probe demonstrated a greater increase in the haematocrit and reduced transfusion requirements. REVIEWER'S CONCLUSIONS: Late radiation complications are a relatively rare manifestation, with many potential carers and poor diagnostic criteria. Although certain interventions look promising and may be effective (such as rectal sucralfate, adding metronidazole to the anti-inflammatory regime and heater probes), single small studies (even if well conducted) provide insufficient evidence. The episodic and variable nature of late radiation proctitis also requires placebo controlled studies to establish whether particular treatments are effective. Regional or centralised registers of radiation toxicity should be established so that interventions can be administered in the setting of multi-centre trials with specific entry criteria, formal baseline and therapeutic assessments providing standardised outcome data including quality of life evaluations.

Chemotherapy for advanced breast cancer: what influences oncologists' decision-making?

Chemotherapy is widely used in the management of patients with advanced breast cancer. However, a considerable proportion of patients experience toxic side effects without gaining benefit. This study aimed to elicit oncologists' views of the goals of chemotherapy for patients with advanced breast cancer and to elicit which factors are important in decisions to recommend chemotherapy to such patients. 30 oncologists underwent a semi-structured interview to examine their views of 5 goals of chemotherapy and of various disease, treatment and patient-related factors that might influence decisions to offer treatment. The clinicians also made decisions regarding treatment in relation to a hypothetical patient scenario under varying clinical conditions. Relief of symptoms and improvement of activity were rated as the most valuable and achievable goals of treatment. The patient's performance status, frailty and their wishes regarding treatment were the most important patient-related factors in determining decision-making. The most important disease/treatment-related factors were pace of the disease, previous poor response to chemotherapy, co-existing symptoms and concurrent medical conditions. The hypothetical scenario revealed that co-existing medical conditions, adverse previous response, increased age and depression would decrease the likelihood of recommending chemotherapy, whereas key symptoms (e.g. breathlessness) and the patient's goals would increase the likelihood. The findings suggest that British oncologists primarily aim to improve patients' physical function, although subjective factors, such as a patient's desire for anti-cancer treatment and their future goals, also influence decisions to offer treatment.

A 12 country field study of the EORTC QLQ-C30 (version 3.0) and the head and neck cancer specific module (EORTC QLQ-H&N35) in head and neck patients. EORTC Quality of Life Group.

This study tests the reliability and validity of the European Organization for Research and Treatment of Cancer (EORTC) head and neck cancer module (QLQ-H&N35) and version 3.0 of the EORTC Core Questionnaire (QLQ-C30) in 622 head and neck cancer patients from 12 countries. The patients completed the QLQ-C30, the QLQ-H&N35 and a debriefing questionnaire before antineoplastic treatment or at a follow-up. 232 patients receiving treatment completed a second questionnaire after treatment. Compliance was high and the questionnaire was well accepted by the patients. Multitrait scaling analysis confirmed the proposed scale structure of the QLQ-H&N35. The QLQ-H&N35 was responsive to differences between disease status, site and patients with different Karnofsky performance status, and to changes over time. The new physical functioning scale (with a four-point response format) of version 3.0 of the QLQ-C30 was shown to be more reliable than previous versions. Thus, the QLQ-H&N35, in conjunction with the QLQ-C30, appears to be reliable, valid and applicable to broad multicultural samples of head and neck cancer patients.