Trial Forge Guidance 4: a guideline for reporting the results of randomised Studies Within A Trial (SWATs).

BACKGROUND: Evidence to support decisions on trial processes is minimal. One way to generate this evidence is to use a Study Within A Trial (SWAT) to test trial processes or explore methodological uncertainties. SWAT evidence relies on replication to ensure sufficient power and broad applicability of findings. Prompt reporting is therefore essential; however, SWAT publications are often the first to be abandoned in the face of other time pressures. Reporting guidance for embedded methodology trials does exist but is not widely used. We sought therefore to build on these guidelines to develop a straightforward, concise reporting standard, which remains adherent to the CONSORT guideline. METHODS: An iterative process was used to develop the guideline. This included initial meetings with key stakeholders, development of an initial guideline, pilot testing of draft guidelines, further iteration and pilot testing, and finalisation of the guideline. RESULTS: We developed a reporting guideline applicable to randomised SWATs, including replications of previous evaluations. The guideline follows the Consolidated Standards for Reporting Trials (CONSORT) statement and provides example text to ensure ease and clarity of reporting across all domains. CONCLUSIONS: The SWAT reporting guideline will aid authors, reviewers, and journal editors to produce and review clear, structured reports of randomised SWATs, whilst also adhering to the CONSORT guideline. TRIAL REGISTRATION: EQUATOR Network - Guidelines Under Development ( https://www.equator-network.org/library/reporting-guidelines-under-development/reporting-guidelines-under-development-for-clinical-trials/#SWAT ). Registered on 25 March 2021.

The development and acceptability of an educational and training intervention for recruiters to neonatal trials: the TRAIN project.

BACKGROUND: Suboptimal or slow recruitment affects 30-50% of trials. Education and training of trial recruiters has been identified as one strategy for potentially boosting recruitment to randomised controlled trials (hereafter referred to as trials). The Training tRial recruiters, An educational INtervention (TRAIN) project was established to develop and assess the acceptability of an education and training intervention for recruiters to neonatal trials. In this paper, we report the development and acceptability of TRAIN. METHODS: TRAIN involved three sequential phases, with each phase contributing information to the subsequent phase(s). These phases were 1) evidence synthesis (systematic review of the effectiveness of training interventions and a content analysis of the format, content, and delivery of identified interventions), 2) intervention development using a Partnership (co-design/co-creation) approach, and 3) intervention acceptability assessments with recruiters to neonatal trials. RESULTS: TRAIN, accompanied by a comprehensive intervention manual, has been designed for online or in-person delivery. TRAIN can be offered to recruiters before trial recruitment begins or as refresher sessions during a trial. The intervention consists of five core learning outcomes which are addressed across three core training units. These units are the trial protocol (Unit 1, 50 min, trial-specific), understanding randomisation (Unit 2, 5 min, trial-generic) and approaching and engaging with parents (Unit 3, 70 min, trial-generic). Eleven recruiters to neonatal trials registered to attend the acceptability assessment training workshops, although only four took part. All four positively valued the training Units and resources for increasing recruiter preparedness, knowledge, and confidence. More flexibility in how the training is facilitated, however, was noted (e.g., training divided across two workshops of shorter duration). Units 2 and 3 were considered beneficial to incorporate into Good Clinical Practice Training or as part of induction training for new staff joining neonatal units. CONCLUSION: TRAIN offers a comprehensive co-produced training and education intervention for recruiters to neonatal trials. TRAIN was deemed acceptable, with minor modification, to neonatal trial recruiters. The small number of recruiters taking part in the acceptability assessment is a limitation. Scale-up of TRAIN with formal piloting and testing for effectiveness in a large cluster randomised trial is required.

Associations between patient factors and successful colon capsule endoscopy - A prospective cohort study.

AIM: To establish patient factors associated with a successful colon capsule endoscopy (CCE) test. METHOD: This prospective cohort study used data collected from patients who underwent CCE as part of the ScotCap evaluation prior to April 2020. A CCE was defined as successful if the capsule visualized the whole colon and rectum (complete test) with sufficient bowel cleansing to permit assessment of the colonic mucosa (adequate bowel preparation). Factors from patients in symptomatic and surveillance groups were analysed for associations with a successful test, complete test, adequate bowel preparation and requirement for further procedure using univariate, multivariate logistic, least absolute shrinkage and selection operator regression. RESULTS: Data from 263 symptomatic and 137 surveillance patients were analysed. There was an association between a symptomatic patient's age and a successful test (OR = 0.97, 95% CI: 0.95-0.99), adequate bowel preparation (OR = 0.97, 95% CI: 0.94-1.00) and further procedure requirement (OR = 1.04, 95% CI: 1.02-1.06). An association was found, for symptomatic patients, between a faecal immunochemical test result in the range 10-399 µg/g and a further procedure (OR = 2.32, 95% CI: 1.23-4.48). In patients undergoing surveillance for previous colorectal cancer (OR = 0.42, 95% CI: 0.18-0.97), had previous bowel resection surgery (OR = 0.43, 95% CI: 0.19-0.98) or took a beta blocker medication (OR = 0.32, 95% CI: 0.11-0.88), an association was found with further procedure requirement. CONCLUSIONS: Among symptomatic patients, younger age was associated with obtaining a successful CCE test. Clinicians could consider patient selection based on these results to improve the rate of successful testing in clinical practice.

Value and engagement: what can clinical trials learn from techniques used in not-for-profit marketing?

Marketing is a core business function in commercial companies but is also frequently used by not-for-profit organisations. Marketing focuses on understanding what people value to make choices about engaging with a product or service: a concept also key to understanding why people may choose to engage with a clinical trial. Understanding the needs and values of stakeholders, whether they are participants, staff at recruiting sites or policy-makers, is critical for a clinical trial to be a success. As many trials fail to recruit and retain participants, perhaps it is time for us to consider approaches from other disciplines. Though clinical trial teams may consider evidence- and non-evidence-based recruitment and retention strategies, this is rarely done in a systematic, streamlined way and is often in response to challenges once the trial has started. In this short commentary, we argue the need for a formal marketing approach to be applied to clinical trials, from the outset, as a potential prevention to recruitment and retention problems.

Recruitment and retention of participants in UK surgical trials: survey of key issues reported by trial staff.

BACKGROUND: Recruitment and retention of participants in surgical trials is challenging. Knowledge of the most common and problematic issues will aid future trial design. This study aimed to identify trial staff perspectives on the main issues affecting participant recruitment and retention in UK surgical trials. METHODS: An online survey of UK surgical trial staff was performed. Respondents were asked whether or not they had experienced a range of recruitment and retention issues, and, if yes, how relatively problematic these were (no, mild, moderate or serious problem). RESULTS: The survey was completed by 155 respondents including 60 trial managers, 53 research nurses, 20 trial methodologists and 19 chief investigators. The three most common recruitment issues were: patients preferring one treatment over another (81·5 per cent of respondents); clinicians' time constraints (78·1 per cent); and clinicians preferring one treatment over another (76·8 per cent). Seven recruitment issues were rated moderate or serious problems by a majority of respondents, the most problematic being a lack of eligible patients (60·3 per cent). The three most common retention issues were: participants forgetting to return questionnaires (81·4 per cent); participants found to be ineligible for the trial (74·3 per cent); and long follow-up period (70·7 per cent). The most problematic retention issues, rated moderate or serious by the majority of respondents, were participants forgetting to return questionnaires (56·4 per cent) and insufficient research nurse time/funding (53·6 per cent). CONCLUSION: The survey identified a variety of common recruitment and retention issues, several of which were rated moderate or serious problems by the majority of participating UK surgical trial staff. Mitigation of these problems may help boost recruitment and retention in surgical trials.

ANTECEDENTES: El reclutamiento y la retención de participantes en los ensayos quirúrgicos es un desafío. Conocer los problemas más habituales y conflictivos ayudará al diseño de futuros ensayos. Este estudio tuvo como objetivo identificar la percepción de los participantes sobre cuáles son los principales problemas que afectan el reclutamiento y la retención de participantes en los ensayos quirúrgicos del Reino Unido. MÉTODOS: Encuesta electrónica a profesionales de la salud que habían participado en ensayos quirúrgicos del Reino Unido. Se preguntó a los encuestados si habían experimentado o no algún problema en temas de reclutamiento o retención y, en caso afirmativo, qué tan conflictivos fueron (ningún problema/problema leve/moderado/grave). RESULTADOS: Completaron la encuesta 155 participantes, de los que 60 eran directores del ensayo, 53 enfermeras de investigación, 20 metodólogos de ensayos y 19 investigadores principales. Los tres problemas más comunes en el reclutamiento fueron: pacientes que prefieren un tratamiento sobre otro (81,5% de los encuestados), escaso tiempo de dedicación de los médicos (78,1%) y médicos que prefieren un tratamiento sobre otro (76,8%). La mayoría de los encuestados calificaron siete problemas de reclutamiento como "moderados" o "graves", siendo el más conflictivo la falta de pacientes elegibles (60,3%). Los tres problemas de retención más habituales fueron: participantes que olvidaron devolver los cuestionarios (81,4%), participantes que no fueron elegibles para el ensayo (74,3%) y el largo período de seguimiento (70,7%). Los problemas de retención más conflictivos, calificados como "moderados" o "graves" por la mayoría de los encuestados, fueron el olvido de los participantes para devolver los cuestionarios (56,4%) y el escaso tiempo/financiación para la enfermera investigadora (53,6%). CONCLUSIÓN: La encuesta identificó una serie de problemas habituales en el reclutamiento y la retención de los pacientes, muchos ellos calificados como "moderados" o "graves" por la mayoría del personal involucrado en los ensayos quirúrgicos del Reino Unido. Mitigar estos problemas puede ayudar a impulsar el reclutamiento y la retención en los ensayos quirúrgicos.

ELECtric Tibial nerve stimulation to Reduce Incontinence in Care homes: protocol for the ELECTRIC randomised trial.

BACKGROUND: Urinary incontinence (UI) is highly prevalent in nursing and residential care homes (CHs) and profoundly impacts on residents' dignity and quality of life. CHs predominantly use absorbent pads to contain UI rather than actively treat the condition. Transcutaneous posterior tibial nerve stimulation (TPTNS) is a non-invasive, safe and low-cost intervention with demonstrated effectiveness for reducing UI in adults. However, the effectiveness of TPTNS to treat UI in older adults living in CHs is not known. The ELECTRIC trial aims to establish if a programme of TPTNS is a clinically effective treatment for UI in CH residents and investigate the associated costs and consequences. METHODS: This is a pragmatic, multicentre, placebo-controlled, randomised parallel-group trial comparing the effectiveness of TPTNS (target n = 250) with sham stimulation (target n = 250) in reducing volume of UI in CH residents. CH residents (men and women) with self- or staff-reported UI of more than once per week are eligible to take part, including those with cognitive impairment. Outcomes will be measured at 6, 12 and 18 weeks post randomisation using the following measures: 24-h Pad Weight Tests, post void residual urine (bladder scans), Patient Perception of Bladder Condition, Minnesota Toileting Skills Questionnaire and Dementia Quality of Life. Economic evaluation based on a bespoke Resource Use Questionnaire will assess the costs of providing a programme of TPTNS. A concurrent process evaluation will investigate fidelity to the intervention and influencing factors, and qualitative interviews will explore the experiences of TPTNS from the perspective of CH residents, family members, CH staff and managers. DISCUSSION: TPTNS is a non-invasive intervention that has demonstrated effectiveness in reducing UI in adults. The ELECTRIC trial will involve CH staff delivering TPTNS to residents and establish whether TPTNS is more effective than sham stimulation for reducing the volume of UI in CH residents. Should TPTNS be shown to be an effective and acceptable treatment for UI in older adults in CHs, it will provide a safe, low-cost and dignified alternative to the current standard approach of containment and medication. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03248362. Registered on 14 August 2017. ISRCTN, ISRCTN98415244. Registered on 25 April 2018. https://www.isrctn.com/.

Achieving Self-Directed Integrated Cancer Aftercare (ASICA) in melanoma: protocol for a randomised patient-focused pilot trial of delivering the ASICA intervention as a means to earlier detection of recurrent and second primary melanoma.

BACKGROUND: Melanoma is common; 15,906 people in the UK were diagnosed with melanoma in 2015 and incidence has increased fivefold in 30 years. Melanoma affects old and young people, with poor prognosis once metastatic. UK guidelines recommend people treated for cutaneous melanoma receive extended outpatient, hospital follow up to detect recurrence or new primaries. Such follow up of the growing population of melanoma survivors is burdensome for both individuals and health services. Follow up is important since approximately 20% of patients with early-stage melanoma experience a recurrence and 4-8% develop a new primary; the risk of either is highest in the first 5 years. Achieving Self-directed Integrated Cancer Aftercare (ASICA) is a digital intervention to increase total-skin-self-examination (TSSE) by people treated for melanoma, with usual follow up. METHODS: We aim to recruit 240 adults with a previous first-stage 0-2C primary cutaneous melanoma, from secondary care in North-East Scotland and the East of England. Participants will be randomised to receive the ASICA intervention (a tablet-based digital intervention to prompt and support TSSE) or control group (treatment as usual). Patient-reported and clinical data will be collected at baseline, including the modified Melanoma Worry Scale (MWS), the Hospital Anxiety and Depression Scale (HADs), the EuroQoL 5-dimension 5-level questionnaire (EQ-5D-5 L), and questions about TSSE practice, intentions, self-efficacy and planning. Participants will be followed up by postal questionnaire at 3, 6 and 12 months following randomization, along with a 12-month review of clinical data. The primary timepoint for outcome analyses will be12 months after randomisation. DISCUSSION: If the ASICA intervention improves the practice of TSSE in those affected by melanoma, this may lead to improved psychological well-being and earlier detection of recurrent and new primary melanoma. This could impact both patients and National Health Service (NHS) resources. This study will determine if a full-scale randomised controlled trial can be undertaken in the UK NHS to provide the high-quality evidence needed to determine the effectiveness of the intervention. ASICA is a pilot study evaluating the effectiveness of the practice of digitally supported TSSE in those affected by melanoma. TRIAL REGISTRATION: Clinical Trials.gov, NCT03328247 . Registered on 1 November 2017.

The intervention process in the European Fans in Training (EuroFIT) trial: a mixed method protocol for evaluation.

BACKGROUND: EuroFIT is a gender-sensitised, health and lifestyle program targeting physical activity, sedentary time and dietary behaviours in men. The delivery of the program in football clubs, led by the clubs' community coaches, is designed to both attract and engage men in lifestyle change through an interest in football or loyalty to the club they support. The EuroFIT program will be evaluated in a multicentre pragmatic randomised controlled trial (RCT), for which ~1000 overweight men, aged 30-65 years, will be recruited in 15 top professional football clubs in the Netherlands, Norway, Portugal and the UK. The process evaluation is designed to investigate how implementation within the RCT is achieved in the various football clubs and countries and the processes through which EuroFIT affects outcomes. METHODS: This mixed methods evaluation is guided by the Medical Research Council (MRC) guidance for conducting process evaluations of complex interventions. Data will be collected in the intervention arm of the EuroFIT trial through: participant questionnaires (n = 500); attendance sheets and coach logs (n = 360); observations of sessions (n = 30); coach questionnaires (n = 30); usage logs from a novel device for self-monitoring physical activity and non-sedentary behaviour (SitFIT); an app-based game to promote social support for physical activity outside program sessions (MatchFIT); interviews with coaches (n = 15); football club representatives (n = 15); and focus groups with participants (n = 30). Written standard operating procedures are used to ensure quality and consistency in data collection and analysis across the participating countries. Data will be analysed thematically within datasets and overall synthesis of findings will address the processes through which the program is implemented in various countries and clubs and through which it affects outcomes, with careful attention to the context of the football club. DISCUSSION: The process evaluation will provide a comprehensive account of what was necessary to implement the EuroFIT program in professional football clubs within a trial setting and how outcomes were affected by the program. This will allow us to re-appraise the program's conceptual base, optimise the program for post-trial implementation and roll out, and offer suggestions for the development and implementation of future initiatives to promote health and wellbeing through professional sports clubs. TRIAL REGISTRATION: ISRCTN81935608 . Registered on 16 June 2015.

Colorectal adenomas and diabetes: implications for disease prevention.

AIM: This study assessed the baseline type II diabetes mellitus (T2DM) risk status among overweight patients with screen-detected colorectal adenomas and explored the implications of the findings for preventative practice. METHOD: Participants aged between 50 and 74 years (73% of whom were men) were recruited from four Scottish health boards and assessed for diabetes risk. Participants were categorized as at 'high' diabetes risk if glycated haemoglobin (HbA1c) was between 6.0 and 6.4% or fasting plasma glucose (FPG) was between 5.5 and 6.9 mmol/l and as potentially undiagnosed T2DM when HbA1c ≥ 6.5% or FPG ≥ 7 mmol/l. Secondary outcome measures included anthropometric measurements, blood pressure and the plasma lipid profile. The tests were repeated at 12 months and diabetes risk categories were reassessed following intervention procedures. RESULTS: Forty-seven (14.3%) of the 329 participants had a preexisting diagnosis of T2DM. Of the remainder with complete biochemistry results (n = 250), 19 (7.6%) were classified as having potentially undiagnosed T2DM and 125 (50.0%) as being at high risk of developing diabetes. More than a quarter of participants in all categories had raised waist circumference, hypertension and plasma lipids, indicative of raised cardiovascular risk. At 12 months' follow-up, the diabetes risk category diminished in 20% of the intervention group vs 11% in the controls [OR 2.26 (95% CI 1.03-4.96)]. CONCLUSION: Our results suggest that a diagnosis of adenoma in overweight patients provides a health service opportunity for diabetes assessment, prevention and management in a high-risk population at a potentially teachable moment.

Supporting postpartum weight loss in women living in deprived communities: design implications for a randomised control trial.

BACKGROUND/OBJECTIVES: Pregnancy is a life stage where excess weight gain may occur and the postpartum period is often characterised by weight retention. The aim of the current study was to evaluate the feasibility of undertaking a randomised controlled trial of a weight loss intervention (WeighWell) in postpartum women living in areas of social disadvantage. SUBJECTS/METHODS: The study aimed to recruit 60 women who were not pregnant, 6-18 months postpartum with a body mass index >25 kg/m(2) living in areas of deprivation within Tayside, UK. Recruitment strategies focused on visits to community groups; writing directly to postpartum women living in areas of deprivation and primary care teams who covered the most deprived 15% of the population and advertising in community settings. The 12-week intervention used motivational interviewing techniques to promote an energy deficit diet and increased physical activity, delivered by three face-to-face consultations plus three structured telephone calls. RESULTS: Of 142 women screened, 63 were eligible and 52 (83%) were recruited and randomised to an intervention (n=29) or comparison group (n=23). Over the 12-week intervention, body weight changed significantly by -1.6 ± 2.0 kg in the intervention group compared with +0.2 ± 2.2 kg in the comparison group, indicating the potential efficacy of the intervention. Loss to follow-up was 24% in the intervention group and 39% for the comparison group. CONCLUSIONS: The findings support the development of a definitive trial that embraces personalised recruitment strategies and the development of approaches to improve retention over a clinically relevant intervention period.

A cost analysis of monoplace hyperbaric oxygen therapy with and without recirculation.

OBJECTIVE: Hyperbaric oxygen therapy is covered by the NHS under Specialist Services Definition Set 28. The indications and availability of the therapy have been influenced by educational failures, perceived costs and, compared with drug studies, the small number of controlled trials. This study aimed to inform this debate by calculating the direct costs to the health service of hyperbaric oxygen therapy for inpatients using a single, one-person chamber. METHOD: The costs included in this cost analysis were: hyperbaric chambers, staff, oxygen, property and cleaning, miscellaneous and general overheads. All costs are for 2004. RESULTS: Lower and upper costs were calculated. Start-up costs range from pounds 64,800 to pounds 110,000 depending on the hardware selected. Annual costs, including 10-year amortisation of capital costs, range from pounds 40,069 to pounds 57,618 and per-treatment costs range from pounds 30 to pounds 41. Oxygen recirculation becomes cost effective after four to six years. CONCLUSION: Hyperbaric oxygen therapy is an inexpensive treatment that should be routinely available for conditions where evidence indicates that tissue hypoxia is a significant component of the injury or disease.

A post-discharge functional outcome measure for lower limb amputees: test-retest reliability with trans-tibial amputees.

There are approximately 700 lower limb amputations performed throughout Scotland each year. A national system of survey and analysis conducted by the Scottish Physiotherapy Amputee Research Group (SPARG) provides information on these patients up until discharge from hospital. However, there has been no method of collecting long-term functional and prosthetic use information following discharge. The Functional Measure for Amputees (FMA) has, therefore, been developed from the Prosthetic Profile of the Amputee (PPA) questionnaire, designed by Gauthier-Gagnon and colleagues in Canada (Grisé et al, 1993). Modifications to the PPA were carried out to make it more appropriate for the Scottish amputee population; these changes were approved by the original authors. The test-retest reliability of the 14-question FMA was assessed using a repeat postal questionnaire study. One hundred and thirty-three (133) from a possible 390 trans-tibial amputees were returned. Comparing sociodemographic and clinical variables between consenters and non-consenters showed no evidence to support sample bias. Continuous data items on the FMA analysed using an intraclass correlation coefficient showed ICC values of 0.74, 0.85, 0.96 and 0.64. Categorical data items analysed using percentage agreements showed reliability of over 70% for seven items, between 40% and 70% for three items and between 20% and 40% for the remaining three items. The FMA questionnaire was found to be reliable on the majority of its questions and moderately reliable on the remaining questions during successive follow-up postal administrations.

An evaluation of the Amputee Mobility Aid (AMA) early walking aid.

The most popular early walking aid (EWA) in the United Kingdom (UK) is the Pneumatic Post-Amputation Mobility aid or PPAM aid. A disadvantage of this device is that it does not allow a trans-tibial amputee to flex or extend the knee during walking. The Amputee Mobility Aid (AMA) was developed to allow knee movement, enabling trans-tibial amputees to practise a more natural gait. The benefits of using EWAs include early walking, reduction in post-operative oedema and improvement in patient morale. This pilot study investigated the pneumatic bag/stump interface pressures of the PPAM aid and the AMA. In addition, the range of motion of the knee on the amputated side and the mechanical knee of the AMA were compared. The AMA was found to have higher interface pressures than the PPAM aid during standing and similar pressures during supported walking. Subjects using the AMA did flex and extend their knee during walking but through a reduced range of motion. There were no significant differences between the angular movements of the AMA's mechanical knee and the patient's knee within it.

Screening for diabetes in lower limb amputees: a pilot study.

The Saint Vincent Declaration includes 5-year targets to improve the outcome of diabetic patients as a central tenet. Meeting these targets requires a comprehensive screening and monitoring programme to establish the current incidence of diabetic complications and show that the major goals of the declaration are being achieved. The Scottish Physiotherapy Amputee Research Group and the Scottish Vascular Audit Group jointly organized a three month prospective screening programme of 146 patients presenting for a lower limb amputation. The results suggest that a significant proportion of patients have undiagnosed diabetes. Further, only around half of the patients eligible for testing actually had a test done, highlighting the difficulties associated with establishing a national screening programme. This programme is now ongoing and particular importance is being given to improving the proportion of patients actually being tested.

Three measures of functional outcome for lower limb amputees: a retrospective review.

Outcome measures are becoming increasingly important in health care. Functional outcome measures are of particular importance for lower limb amputees since much of the rehabilitation process is concerned with increasing mobility and personal independence. The Scottish Physiotherapy Amputee Research Group (SPARG) has used three measures of functional outcome: the Barthel Index, Russek's classification and the Locomotor Index. The review reported here involves 938 patients having a primary amputation at the transtibial or transfemoral level between October 1992 and July 1997. Differences in function due to age and level of amputation are well known clinically and the measures were compared by looking at their ability to detect these differences. The Barthel Index lacked sensitivity because of ceiling effects and should not be considered as a suitable functional outcome measure for amputee patients. Russek's classification does detect significant differences but requires a large number of patients making it unsuitable for single hospital investigations. The Locomotor Index demonstrates significant differences due to age and amputation level despite fewer patients being assessed by this measure during the period covered by this paper. The range of the Locomotor Index can be extended to cover more active amputees by considering its 'advanced activities' subscale separately. The Locomotor Index is a promising measure and should be considered by rehabilitation teams looking for a valid, reliable and sensitive functional outcome measure for use with lower limb amputees.

Direct measurement of the optical properties of human breast skin.

The optical properties of thin tissue samples are obtained using goniometric apparatus. Direct measurements of the scattering of 633 nm light by 20-120 microns thick samples of in vitro human breast epidermis and dermis are numerically integrated to obtain values for the scattering and absorption coefficients mu s and mu a, respectively, and the anisotropy parameter g. The total attenuation coefficient mu t is obtained from transmission measurements. The Beer-Lambert law is found to be sufficiently valid for congruent to 100 microns thick samples to be used as the basis of the numerical integration. However, normalisation errors involved with the integration mean that only approximate values of mu a could be obtained. Values of congruent to 40 mm-1 are obtained for mu t and mu s, with the value of mu a estimated as 1 mm-1. The optical properties of human breast epidermis and dermis are found to be similar at 633 nm, and the two could be considered as a single layer for modelling light propagation at this wavelength. Further, the intersubject variability seen in this study suggests that a model that uses a range of values for each optical property may be more useful in a clinical situation.