<p> 1 Abstract</p><p>2</p><p>3 Objectives</p><p>4 To assess the impact of Public Health England’s recent ‘Be clear on cancer: Blood in</p><p>5 the pee’ mass media campaign on suspected cancer referral burden and new cancer</p><p>6 diagnosis.</p><p>7</p><p>8 Methods</p><p>9 A retrospective cohort study design was used; for two distinct time periods, August</p><p>10 2012 to May 2013 and August 2013 to May 2014, all referrals deemed to be at risk of</p><p>11 urological cancer by the referring primary health care physician to Imperial College</p><p>12 NHS Healthcare Trust were screened. Data points collected were: age and sex,</p><p>13 whether the referral was for visible haematuria, non-visible haematuria or other</p><p>14 suspected urological cancer. In addition to referral data, hospital episode data of all</p><p>15 new renal cell, and upper and lower tract transitional cell carcinoma for the same time</p><p>16 periods was obtained.</p><p>17</p><p>18 Results</p><p>19 Over campaign period and the subsequent three months the number of haematuria</p><p>20 referrals increased by 92% (p=0.013) when compared to the same period a year</p><p>21 earlier. This increase in referrals was not associated with a significant corresponding</p><p>22 rise in cancer diagnosis; instead changes of 26.8% (p=0.56) and -3.3% (p=0.84) were</p><p>23 seen in renal and transitional cell carcinomas respectively.</p><p>24</p><p>25 Conclusion 26 This study has demonstrated that the ‘Be clear on cancer: Blood in pee’ mass media</p><p>27 campaign significantly increased the number of new suspected cancer referrals with</p><p>28 no significant effect on the diagnosis of target cancers across a large catchment. In the</p><p>29 future similar mass media campaigns should have a step of pre-planned assessment, in</p><p>30 the form of a well-designed prospective study, to ensure that they confer a rise in</p><p>31 cancer diagnosis and public awareness. In addition they should be preceded by the</p><p>32 dissemination of information to primary physicians and secondary care providers to</p><p>33 educate them regarding the management of the pathology, and to allow appropriate</p><p>34 preparation for the increased referral burden.</p><p>35</p><p>36 Key words: haematuria; renal cell carcinoma; transitional cell carcinoma; public</p><p>37 health; cancer; campaign</p><p>38</p><p>39</p><p>40</p><p>41</p><p>42</p><p>43</p><p>44</p><p>45</p><p>46</p><p>47</p><p>48</p><p>49</p><p>50 51</p><p>52 Introduction</p><p>53</p><p>54 Public health campaigns are a corner stone of secondary prevention and have</p><p>55 repeatedly been shown to reduce cancer mortality [1]. Historically these campaigns</p><p>56 have focused on behaviour modification, aiming to mitigate for the ill effects of</p><p>57 specific behaviours deemed to be detrimental to health. Recently Public Health</p><p>58 England has embarked on a number of short duration, mass media public health</p><p>59 campaigns. In contrast to more traditional public heath drives these campaigns have</p><p>60 had the intention of increasing patient numbers seeking medical opinion when</p><p>61 exhibiting symptom specific ‘red flag’ symptoms. These mass media public health</p><p>62 campaigns offer significant potential benefits, namely that they are able to deliver</p><p>63 focused messages, to large audiences, repeatedly, at a relatively low cost per head [2].</p><p>64 Despite the potential benefits, the evidence underpinning the use of mass media</p><p>65 campaigns is both limited and mixed [2–4].</p><p>66</p><p>67 One of the most recent of Public Health England’s ‘Be clear on cancer’ mass media</p><p>68 campaigns targeted the attendance of patients to primary care with visible haematuria</p><p>69 (Figure 1). This national campaign was run across England between October and</p><p>70 November 2013 and was comprised of billboard, television and radio advertisements.</p><p>71 Up to 20% of patients with visible haematuria will be found to have an underlying</p><p>72 malignancy [5,6] using protocol driven investigation including urinary tract</p><p>73 ultrasound, CT urogram and flexible cystoscopy [7]; the combination of which has</p><p>74 been shown to have high specificity and sensitivity for both renal and transitional cell</p><p>75 carcinoma detection [5,7]. Transitional and renal cell carcinomas represent a 76 significant cancer burden, with approximately 10,000 new cancer diagnoses of each in</p><p>77 the UK per year [8]. These factors combined make visible haematuria and the</p><p>78 malignancies that underlie it, an ideal target for a mass media public health campaign.</p><p>79 The primary objective of this paper was to assess the impact and longevity of the ‘Be</p><p>80 clear on cancer: blood in pee’ campaign on cancer diagnosis and referral burden.</p><p>81</p><p>82 Methods</p><p>83</p><p>84 A retrospective cohort study design was used; for two distinct time periods, August</p><p>85 2012 to May 2013 and August 2013 to May 2014, all referrals deemed to be at risk of</p><p>86 urological cancer by the referring primary health care physician to Imperial College</p><p>87 NHS Healthcare Trust (ICHT) were screened. Data points collected were: age and sex</p><p>88 of the patient, whether the referral was for visible haematuria, non-visible haematuria</p><p>89 or another non-haematuria related suspected urological cancer. In addition to referral</p><p>90 data, hospital episode data of all new renal cell, and upper and lower tract transitional</p><p>91 cell carcinoma for the same time periods was obtained, this second dataset set</p><p>92 comprised all diagnoses for the periods in question including those not identified</p><p>93 through the ‘suspected cancer’ pathway.</p><p>94</p><p>95 The 2012-13 time period was used as the comparator group to allow assessment of the</p><p>96 impact of the ‘Be clear on cancer: blood in pee’ public health campaign that ran from</p><p>97 October to November 2013. </p><p>98</p><p>99 A comparison of the August to May time periods (2012-13 versus 2013-14) was used</p><p>100 to gain an understanding of the longevity of effect. When undertaking comparisons to 101 establish its efficacy the data was limited to the periods of the campaign plus an</p><p>102 additional three months (October to February (2012-13 versus 2013-14), in order to</p><p>103 restrict the comparison to the months of maximal potential efficacy.</p><p>104</p><p>105 Study approval was obtained from the hospital’s ethical review body (Number 1671).</p><p>106</p><p>107 Statistical Analysis</p><p>108 All statistical analysis was performed in Graphpad Prism (GraphPad Software Inc., La</p><p>109 Jolla, California, USA). When comparing the time periods in question t-tests were</p><p>110 used for continuous data (paired and unpaired as appropriate) and the Chi-squared test</p><p>111 was used for for the categorical data, to establish the level of statistical significance.</p><p>112 Pearson’s correlation coefficients (r) were also calculated to establish the relationship</p><p>113 between cancer diagnosis and the number of referrals made over the time period</p><p>114 examined. </p><p>115</p><p>116 Results</p><p>117 Overall Referrals</p><p>118 Over the course of the campaign an increase in all urological cancer referrals was</p><p>119 observed (Figures 2 and 3) and was maintained for a period of approximately three</p><p>120 months at which point it appeared to return to its baseline (Figure 2).</p><p>121</p><p>122 In total 579 haematuria referrals were made between August 2013 and May 2014</p><p>123 representing a significant increase of 53.2% (p = 0.009) compared with the same time</p><p>124 period a year earlier (Figure 2). The majority of this increase was seen in the period</p><p>125 of, and immediately following (October ‘13 to Feburary ‘14), the ‘blood in pee’ 126 campaign with a 92% increase in haematuria referrals during this period (p = 0.013,</p><p>127 Table 1).</p><p>128</p><p>129 Visible, Non-Visible and suspected cancer referrals</p><p>130 The increase in number of referrals was made up largely of visible and non-visible</p><p>131 haematuria referrals with respective increases of 102.9% (p = 0.038) and 79.2% (p <</p><p>132 0.001) in the October to February time period (Table 1). A significant increase was</p><p>133 also seen in the number of other suspected urological cancer referrals made during the</p><p>134 same period (51% increase, p = 0.009, Table 1).</p><p>135</p><p>136 Cancer Diagnosis</p><p>137 This significant increase in referrals was not associated with a statistically significant</p><p>138 corresponding rise in cancer diagnosis; instead an insignificant increase of 26.8% (p =</p><p>139 0.56) was seen in the number of renal cell carcinomas diagnosed (Table 2), while an</p><p>140 insignificant decrease of 3.3% (p = 0.84) was seen in the diagnosis of transitional cell</p><p>141 carcinomas.</p><p>142</p><p>143 With regards to other urological cancers no significant increase was seen in the</p><p>144 number of testicular or prostate cancer in the periods examined (p = 0.35 and 0.71,</p><p>145 respectively, Table 2)</p><p>146</p><p>147 When assessing the relationship between the number of renal and transitional cell</p><p>148 carcinoma diagnoses and the number of haematuria referrals a strong positive</p><p>149 correlation between the two variables (r = 0.78) was seen for the 2012-13 time period</p><p>150 in comparison to a weak negative correlation in the 2013-14 time period (r = -0.36). 151 Population Demographics</p><p>152 As can be seen in Table 3, when comparing the demographic data collected on the</p><p>153 populations is question no statistically significant difference was seen in age or sex</p><p>154 for haematuria overall, and this remained true when substratifying by visible and non-</p><p>155 visible haematuria.</p><p>156</p><p>157 Discussion</p><p>158</p><p>159 Mass media public health campaigns are both expensive to run and have been shown</p><p>160 to increase cancer specific referrals [3,4], for these costs to be worthwhile they need</p><p>161 to be offset by a positive and sustained change in the target health benefit. This study</p><p>162 has demonstrated that the recent ‘Be clear on cancer: Blood in pee’ mass media</p><p>163 campaign significantly increased the number of new suspected cancer referrals with</p><p>164 no significant effect on the diagnosis of target cancers across a large catchment area</p><p>165 of more than two million for cancer specific services. In addition to an increase in the</p><p>166 number of patients referred the effect of the campaign seems to have been relatively</p><p>167 short lived with referral numbers appearing to return to a baseline level less than six</p><p>168 months after the cessation of the campaign, suggesting an fairly short lived increase in</p><p>169 public awareness.</p><p>170</p><p>171 To date there is only a small evidence base examining the efficacy of these short</p><p>172 duration mass media campaigns [2]. In previous studies examining the effects of</p><p>173 similar campaigns targeted at bowel cancer analogous findings to those observed here</p><p>174 were seen, with an increase in referrals lasting approximately three months, with no</p><p>175 concurrent increase in cancer diagnosis [3,4]. When looking at mass media campaigns 176 outside of the UK the majority relate to cervical cancer screening programmes</p><p>177 [2,9,10]. The findings of these studies again tally with those seen here demonstrating</p><p>178 only a short-term increase in the uptake of cancer screening investigations following</p><p>179 the campaign in question.</p><p>180</p><p>181 Although the findings here failed to show a statistically significant difference in the</p><p>182 numbers of cancers diagnosed, un-peer reviewed data published by Public Health</p><p>183 England from their pilot data demonstrated a 22% increase in cancer pick up [11].</p><p>184 This same document also reports that the number of patients referred increased by</p><p>185 between 25-26% over the course of the study period [11], significantly less than the</p><p>186 92% increase in haematuria related referrals seen during, and in the three months after</p><p>187 the campaign in North West London. These data were collected after running pilot</p><p>188 campaigns, similar in both content and delivery to the campaign examined in this</p><p>189 study, in three areas in England. </p><p>190</p><p>191 Without the ability to examine these data in detail it is difficult to hypothesise the</p><p>192 reasons behind this difference, but there are a number of factors that could potentially</p><p>193 contribute. Firstly, the population examined in North West London may be different</p><p>194 from those populations examined in the pilot studies undertaken by Public Health</p><p>195 England prior to the wider roll out of the campaign. Although this may be the case,</p><p>196 previous studies comparing the effects of a mass media cancer related campaigns on</p><p>197 different socio-economic groups have found the effects of socio-economic factors to</p><p>198 be non-significant [10].</p><p>199 200 The referral criteria for visible haematuria are relatively straight forward with all</p><p>201 patients exhibiting this symptom requiring referral to secondary care [7]. This implies</p><p>202 that the increase in referrals relates to an increase in the number of patients presenting</p><p>203 to their GP reporting visible haematuria. Within the existing literature the conversion</p><p>204 rate of a patient presenting with visible haematuria to a urological cancer diagnosis</p><p>205 has been approximately 20% [5,6]. If those patients prompted into presentation by the</p><p>206 campaign had this risk profile for urological malignancy a corresponding increase in</p><p>207 new cancer diagnoses should have been seen. However, despite a significant increase</p><p>208 in referrals a corresponding surge in transitional cell carcinoma diagnosis was not</p><p>209 seen. </p><p>210</p><p>211 The fact that this rise in transitional cell carcinoma diagnosis was not observed</p><p>212 suggests that increased awareness amongst the population served only to increase the</p><p>213 number of patients without oncological pathology being referred to secondary care.</p><p>214 The reasons behind this dichotomy remain a question for debate but may relate to a</p><p>215 lowering of the populations barrier for presentation, due to the campaigns success in</p><p>216 increasing background awareness of ‘red flag’ symptoms. This increased concern,</p><p>217 driven by the campaign, may also be reflected in the referrals made by the primary</p><p>218 care physicians, who may be unnecessarily referring patients in order to mitigate their</p><p>219 concern. Whatever the reasons behind the increase in referrals of the ‘worried well’</p><p>220 there is a risk that patients are unnecessarily being subjected to the risks of screening</p><p>221 investigations with no mitigating increase in cancer detection rates.</p><p>222</p><p>223 Although the efficacy of the campaign, with regards its effect on cancer pickup, is</p><p>224 subject for debate the primary objective, namley prompting those people with visible 225 haematuria into presentation, seems to have been met with the number of people</p><p>226 presenting increasing by 102.9%. As well as increasing the awareness and</p><p>227 expectations of the general population the results of this study infer an additional</p><p>228 increased awareness for uro-oncology more generally amongst primary care</p><p>229 physicians. This manifested itself as increase in referrals for non-visible haematuria,</p><p>230 perhaps suggesting a lowering of the secondary care referral barrier or alternatively an</p><p>231 increase in primary care screening for non-visible haematuria. This increase in the</p><p>232 referrals for non-visible haematuria is perhaps unsurprising, however the concurrent</p><p>233 increase in referrals for other suspected uro-oncology is, and suggest a transient</p><p>234 increase in awareness for all uro-oncology associated with a public health campaign</p><p>235 targeting a system specific symptom rather than a single pathology. Interestingly,</p><p>236 once again, this increase in referrals did not lead to a significant increase in other</p><p>237 urological cancer (testicular and prostate) diagnoses. </p><p>238</p><p>239 When looking for differences in the demographic markers of age and sex between the</p><p>240 pre and peri campaign populations being referred to secondary care, none was seen.</p><p>241 This suggests that the campaign had little effect on the demographics of the</p><p>242 population presenting, succeeding in avoiding increased presentation of the lower risk</p><p>243 populations (i.e women and those under 50) but also failing to promote the</p><p>244 presentation of those more at risk, older men [12].</p><p>245</p><p>246 Although this paper has demonstrated an apparent increase in cancer specific</p><p>247 urological referrals, probably attributable to the ‘Be clear on cancer: Blood in the pee’</p><p>248 campaign, with no tangible increase in cancer diagnosis, it is not without its</p><p>249 limitations. First and foremost is the potential under-powering of the dataset with 250 regards to cancer pick up. In addition the study only examined the population of</p><p>251 North West London and as such any extrapolation of the specific findings of this</p><p>252 study to the wider population both within and outside of the UK must be exercised</p><p>253 with caution. This point is particularly pertinent considering the starkly different</p><p>254 results found by Public Health England when assessing its pilot campaigns. </p><p>255</p><p>256 Aside from the limitations specific to the dataset, limitations also exist resulting from</p><p>257 the retrospective nature of the data collection, specifically the granularity</p><p>258 demographic data. Ideally the demographic parameters would have been extended to</p><p>259 examine in more detail the characteristics of the population prompted into</p><p>260 presentation, specifically the socio-economic and smoking status, in addition to race</p><p>261 distribution, would have been of interest.</p><p>262</p><p>263 Conclusions</p><p>264</p><p>265 A successful public health campaign must meet similar criteria to those laid out by</p><p>266 Wilson in 1968 for screening campaigns [13]. In addition it must also provide an</p><p>267 increase in the diagnosis and public awareness of the target pathology. All of these</p><p>268 criteria need to be balanced against the direct and indirect costs of the campaign. In</p><p>269 the case of the mass media campaign in question the data presented would suggest</p><p>270 that the campaign was only a partial success, managing to achieve an increase in</p><p>271 awareness amongst health care professionals and the public, but crucially failing to</p><p>272 convert this increased awareness into a concurrent increase in the diagnosis of the</p><p>273 target pathologies.</p><p>274 275 In the future similar mass media campaigns should have a step of pre-planned</p><p>276 assessment, in the form of a well-designed prospective study, to ensure that they</p><p>277 confer a sustained rise in cancer diagnosis and public awareness. The information</p><p>278 gleaned from this data collection exercise can then be published in the peer-reviewed</p><p>279 literature allowing the respective successes and failures of a given campaign to be</p><p>280 learnt from by the wider public health community. In addition they should be</p><p>281 preceded by the dissemination of information to primary physicians and secondary</p><p>282 care providers to educate them regarding the management of the pathology, and to</p><p>283 allow appropriate preparation for the increased referral burden.</p><p>284</p><p>285 References</p><p>286 1 Marseille E, Jiwani A, Raut A, et al. Scaling up integrated prevention 287 campaigns for global health: costs and cost-effectiveness in 70 countries. BMJ 288 Open 2014;4:e003987. doi:10.1136/bmjopen-2013-003987 289 2 Wakefield M, Loken B, Hornik RC. Use of mass media campaigns to change 290 health behaviour. Lancet 2010;376:1261–71. doi:10.1016/S0140- 291 6736(10)60809-4 292 3 Bethune R, Marshall MJ, Mitchell SJ, et al. Did the “Be Clear on Bowel 293 Cancer” public awareness campaign pilot result in a higher rate of cancer 294 detection? Postgrad Med J 2013;89:390–3. doi:10.1136/postgradmedj-2012- 295 131014 296 4 Peacock O, Clayton S, Atkinson F, et al. “Be Clear on Cancer”: the impact of 297 the UK National Bowel Cancer Awareness Campaign. Colorectal Dis 298 2013;15:963–7. doi:10.1111/codi.12220 299 5 Edwards TJ, Dickinson AJ, Natale S, et al. A prospective analysis of the 300 diagnostic yield resulting from the attendance of 4020 patients at a protocol- 301 driven haematuria clinic. BJU Int 2006;97:301–5; discussion 305. 302 doi:10.1111/j.1464-410X.2006.05976.x 303 6 Khadra MH, Pickard RS, Charlton M, et al. A prospective analysis of 1,930 304 patients with hematuria to evaluate current diagnostic practice. J Urol 305 2000;163:524–7. 306 7 Rodgers M, Nixon J, Hempel S, et al. Diagnostic tests and algorithms used in 307 the investigation of haematuria. Health Technol Assess (Rockv) 2006;10. 308 8 Cancer Statistics. Cancer Res. UK. 309 2014.http://www.cancerresearchuk.org/cancer-info/cancerstats/ (accessed 27 310 Oct2014). 311 9 Mullins R, Wakefield M, Broun K. Encouraging the right women to attend for 312 cervical cancer screening: results from a targeted television campaign in 313 Victoria, Australia. Health Educ Res 2008;23:477–86. doi:10.1093/her/cym021 314 10 Anderson JO, Mullins RM, Siahpush M, et al. Mass media campaign improves 315 cervical screening across all socio-economic groups. Health Educ Res 316 2009;24:867–75. doi:10.1093/her/cyp023 317 11 Duffy S. Be Clear on Cancer evaluation update. London: 2014. 318 12 Danaei G, Hoorn S Vander, Lopez AD, et al. Causes of cancer in the world : 319 comparative risk assessment of nine behavioural and environmental risk 320 factors. Lancet 2005;366:1784–93. 321 13 Wilson JM, Jungner YG. Principles and practice of mass screening for disease. 322 WHO Chron World Heal Organ 1968;22:473. 323 Conflicts of Interest</p><p>324 Archie Hughes-Hallett: No conflicts of interest to declare 325 Daisy Browne: No conflicts of interest to declare 326 Elsie Mensah: No conflicts of interest to declare 327 Justin Vale: No conflicts of interest to declare 328 Erik Mayer: No conflicts of interest to declare 329</p><p>330</p><p>331</p><p>332</p><p>333</p><p>334</p><p>335</p><p>336</p><p>Oct ’12 – Feb ‘13 Oct ’13 – Feb ‘14 % Increase p-value Haematuria 181 349 92 0.013 VH 104 211 102.9 0.038 NVH 77 138 79.2 0.001 Other 233 352 51 0.009 337 Table 1 – Number of suspected cancer referrals made by presenting complaint in the 338 period during and immediately following the ‘Be clear on cancer: Blood in the pee’ 339 campaign. 340 VH = Visible haematuria, NVH= Non-visible haematuria, Other = Non-haematuria 341 related suspected urological cancer referrals 342 Oct ‘12 – Feb ‘13 Oct ‘13 – Feb ‘14 % Increase p-value Total 133 141 6.0 0.71 TCC 92 89 -3.3 0.84 RCC 41 52 26.8 0.56 Prostate 192 226 17.8 0.35 Testicular 16 13 -18.8 0.71 343 Table 2 – Number of new cancer diagnoses in the period during and immediately 344 following the ‘Be clear on cancer: Blood in the pee’ campaign 345 TCC – Transitional cell carcinoma, RCC = Renal cell carcinoma 346</p><p>Oct ’12 – Feb ‘13 Oct ’13 – Feb ‘14 p-value Mean Age Haematuria 65.53 ± 14.28 63.83 ± 15.93 0.86 VH 64.84 ± 16.70 61.97 ± 17.17 0.20 NVH 66.88 ± 11.34 67.10 ± 11.69 0.88 % Male Haematuria 62.15 65.15 0.66 VH 70.32 77.66 0.18 NVH 55.70 42.60 0.08 347 Table 3 – Demographic differences between the periods during and immediately 348 following the ‘Be clear on cancer blood in the pee’ campaign 349 VH = Visible haematuria, NVH= Non-visible haematuria 350</p><p>351 Dr Anant Sachdev</p><p>If you notice blood in your pee, even if it’s ‘just the once’, tell your doctor.</p><p>352</p><p>353 Figure 1. Campaign Poster</p><p>354 355 356 Figure 2. Number of transitional and renal cell carcinoma diagnoses and referrals</p><p>357 month-by-month. Area highlighted represents the duration of the ‘blood in pee’</p><p>358 campaign.</p><p>359 360 361</p><p>362</p><p>363</p><p>364</p><p>365 366 367 Figure 3. Month-by-month suspected cancer referrals by type for the two time periods</p><p>368 examined. The highlighted period represents duration of the campaign</p><p>369</p>
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